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26 August 2009<br />

Listing Prospectus


�<br />

�<br />

�<br />

�<br />

�<br />

�<br />

LISTING�PROSPECTUS�<br />

mondoBIOTECH�holding�AG�<br />

(a�stock�corporation�under�Swiss�law)�<br />

Listing�of�1’248’671�registered�shares�with�a�nominal�value�of�CHF�0.10�each�<br />

�<br />

�<br />

This� listing� prospectus� (the� “Listing� Prospectus”)� relates� to� the� listing� (the� “Listing”)� of� all� of� the� 1’248’671�<br />

registered�shares�with�a�nominal�value�of�CHF�0.10�each�(the�“Common�Shares”)�of�mondoBIOTECH�holding�AG,�<br />

Stans,�Switzerland�(the�“Company”,�and�together�with�its�subsidiaries,�“mondoBIOTECH”�or�the�“Group”)�according�<br />

to� the� Main� Standard� of� the� SIX� Swiss� Exchange.� Prior� to� the� Listing,� there� has� been� no� public� market� for� the�<br />

Common�Shares.��<br />

�<br />

The�Common�Shares�will�be�listed�and�trading�in�the�Common�Shares�will�commence�on�26�August�2009�under�the�<br />

symbol�RARE.�<br />

�<br />

In� addition,� application� has� been� made� and� approval� has� been� given� by� the� SIX� Swiss� Exchange� to� formally� list�<br />

according�to�the�Main�Standard�of�the�SIX�Swiss�Exchange�1’800’000�additional�registered�shares�with�a�nominal�<br />

value�of�CHF�0.10�each�that�may�be�issued�under�the�conditional�share�capital�of�the�Company.�<br />

�<br />

The� Common� Shares� have� been� accepted� for� clearance� through� SIX� SIS� AG,� Olten� (“SIS”).� No� shares� and� share�<br />

certificates� will� be� issued� and� be� available� for� individual� physical� delivery with� respect� to� the� Common� Shares�<br />

(aufgehobener�Titeldruck).�<br />

�<br />

The�1’248’671�Common�Shares�constitute�2.31%�of�all�the�shares�and�voting�rights�in�the�Company�and�19.10%�of�<br />

the�nominal�value�of�all�the�shares�in�the�Company.�For�the�time�being,�only�the�Common�Shares�(and�any�further�<br />

registered�shares�of�the�Company�with�a�nominal�value�of�CHF�0.10�each)�shall�be�listed�and�traded�on�the�SIX�Swiss�<br />

Exchange.�Accordingly,�the�other�category�of�issued�shares�of�the�Company,�i.e.,�the�52’901’560�registered�shares�<br />

with� a� nominal� value� of� CHF� 0.01� each� (the� “Voting� Right� Shares”,� and� together� with� the� Common� Shares,� the�<br />

“Shares”)�shall�not�be�listed�and�traded�on�the�SIX�Swiss�Exchange�pursuant�to�this�Listing�Prospectus.�<br />

�<br />

See�“3��Risk�Factors”�beginning�on�page�8�for�a�discussion�of�factors�that�investors�in�the�Common�Shares�should�<br />

consider.�<br />

�<br />

This� document� is� not� an� issue� prospectus� pursuant� to� art.� 652a� of� the� Swiss� Code� of� Obligations� (the� “CO”).� It�<br />

constitutes�a�listing�prospectus�pursuant�to�art.�27�et�seq.�of�the�listing�rules�of�the�SIX�Swiss�Exchange�(the�“Listing�<br />

Rules”).��<br />

�<br />

This�Listing�Prospectus�does�not�constitute�an�offer�to�sell,�or�a�solicitation�of�an�offer�to�buy,�any�Common�Shares.�<br />

This�Listing�Prospectus�may�not�be�sent�to�any�person�in�the�United�States�(the�“US”)�or�any�other�jurisdiction�in�<br />

which�it�would�not�be�permissible�to�distribute�this�Listing�Prospectus�or�to�sell�or�offer�the�Common�Shares,�nor�<br />

should�this�document�be�forwarded�to�any�such�person.�This�Listing�Prospectus�has�been�prepared�solely�for�use�in�<br />

connection�with�the�Listing.�There�has�been�no�offering�of�the�Common�Shares�in�connection�with�the�Listing.��<br />

�<br />

�<br />

�<br />

�<br />

The�date�of�this�Listing�Prospectus�is�26�August�2009�<br />

�<br />

�<br />

�<br />


The� Company� assumes� responsibility� for� the� completeness� and� accuracy� of� this� Listing� Prospectus� pursuant� to�<br />

Scheme�A�and�Section�4�of�the�Listing�Rules�as�of�the�date�of�this�Listing�Prospectus.�To�the�best�of�the�Company’s�<br />

knowledge� and� belief,� the� information� given� in� this� Listing� Prospectus� is� correct� and� no� material� facts� or�<br />

circumstances�have�been�omitted.�<br />

�<br />

This�Listing�Prospectus�is�being�furnished�by�the�Company�in�connection�with�the�admission�of�all�of�the�Common�<br />

Shares�for�listing�according�to�the�Main�Standard�of�and�trading�on�the�SIX�Swiss�Exchange.�<br />

�<br />

Lenz�&�Staehelin,�Zurich,�listing�agent�to�the�Company�(the�“Listing�Agent”),�is�acting�as�recognised�representative�<br />

of�the�Company�for�the�Listing�within�the�meaning�of�art.�43�of�the�Listing�Rules.�<br />

�<br />

Prospective�investors�should�rely�only�on�the�information�contained�in�this�Listing�Prospectus�and�any�notices�that�<br />

are� published� by� the� Company� and� that� expressly� amend� or� supplement� this� Listing� Prospectus.� No� person� is�<br />

authorised� or� has� been� authorised� to� give� any� information� or� make� any� representation� in� connection� with� the�<br />

Listing� other� than� as� contained� in� this� Listing� Prospectus,� and,� if� given� or� made,� any� other� information� or�<br />

representation� must� not� be� relied� upon� as� having� been� authorised� by� the� Company� or� the� Listing� Agent.� The�<br />

delivery� of� this� Listing� Prospectus� shall,� under� no� circumstances,� create� any� implication� that� there� has� been� no�<br />

change�in�the�affairs�of�the�Company�or�its�subsidiaries�since� the�date�hereof�or�that�the�information�contained�<br />

herein�is�correct�as�of�any�time�subsequent�to�its�date.��<br />

�<br />

No�representation�or�warranty,�express�or�implied,�is�made�by�the�Listing�Agent�as�to�the�accuracy�or�completeness�<br />

of�the�information�set�forth�herein,�and�nothing�contained�in�this�Listing�Prospectus�is,�or�shall�be�relied�upon,�as�<br />

representation,�warranty�or�promise,�whether�as�to�the�past,�the�present�or�the�future.�<br />

�<br />

Information�on�the�Company’s�website,�any�website�directly�or�indirectly�linked�to�the�Company’s�website�or�any�<br />

website�mentioned�in�this�Listing�Prospectus�does�not�constitute�in�any�way�part�of�this�Listing�Prospectus�and�is�not�<br />

incorporated�by�reference�into�this�Listing�Prospectus,�and�investors�should�not�rely�on�it�in�making�their�decision�to�<br />

invest�in�the�Common�Shares.�<br />

�<br />

The�distribution�of�this�Listing�Prospectus�is�restricted�by�law�in�certain�jurisdictions.�Persons�into�whose�possession�<br />

this�Listing�Prospectus�may�come�are�required�by�the�Company�and�the�Listing�Agent�to�inform�themselves�about�<br />

and�to�observe�any�such�restrictions.�Neither�the�Company�nor�the�Listing�Agent�accept�any�legal�responsibility�for�<br />

any�violation�by�any�person,�whether�or�not�a�prospective�purchaser�of�Common�Shares,�of�any�such�restrictions.�<br />

This�Listing�Prospectus�does�not�constitute�an�offer�to�sell,�or�a�solicitation�by�or�on�behalf�of�the�Company�or�the�<br />

Listing�Agent�of�an�offer�to�purchase�Common�Shares.�<br />

�<br />

In�making�an�investment�decision,�prospective�investors�must�rely�(and�will�be�deemed�to�have�relied)�solely�on�<br />

their� own� independent� examination� of� the� Company� and� the� contents� of� this� Listing� Prospectus,� including� the�<br />

merits�and�risks�involved.�<br />

�<br />

Neither�the�Company�nor�the�Listing�Agent�or�any�of�their�respective�representatives�is�making�any�representation�<br />

to�any�prospective�purchaser�of�Common�Shares�hereby�regarding�the�legality�of�an�investment�by�such�prospective�<br />

purchaser� or� purchase� under� appropriate� legal� investment� or� similar� laws.� Each� investor� should� consult� with� his�<br />

own�advisors�as�to�the�legal,�tax,�business,�financial�and�related�aspects�of�the�purchase�of�the�Common�Shares.�<br />

�<br />

In�connection�with�the�Listing,�the�Listing�Agent�is�not�acting�for�anyone�other�than�the�Company�and�will�not�be�<br />

responsible�to�anyone�other�than�the�Company�for�providing�advice�in�relation�to�the�Listing.�<br />

�<br />

Certain�terms�in�this�Listing�Prospectus�are�defined�in�the�section�“17��Glossary”.�<br />

�<br />

� II<br />


Table�of�contents�<br />

�<br />

Letter�from�the�Founders.............................................................................................................................................. IV�<br />

1 US�Related�Matters,�Forward�Looking�Statements,�Financial�and�Other�Information ...................................... 1<br />

2 Summary............................................................................................................................................................ 3<br />

3 Risk�Factors........................................................................................................................................................ 8<br />

4 Dividends�and�Dividend�Policy......................................................................................................................... 17<br />

5 Capitalisation................................................................................................................................................... 18<br />

6 Selected�Consolidated�Financial�Information .................................................................................................. 19<br />

7 General�Information�on�mondoBIOTECH ........................................................................................................ 20<br />

8 Management’s�Discussion�and�Analysis�of�Financial�Condition�and�Result�of�Operations.............................. 23<br />

9 Business........................................................................................................................................................... 31<br />

10 Directors,�Managers�and�Employees............................................................................................................... 43<br />

11 Related�Party�Transactions.............................................................................................................................. 47<br />

12 Major�Shareholders ......................................................................................................................................... 48<br />

13 Share�Capital�and�Shares ................................................................................................................................. 50<br />

14 Certain�Swiss�Taxation�Considerations ............................................................................................................ 57<br />

15 Market�Information......................................................................................................................................... 60<br />

16 Additional�Information .................................................................................................................................... 62<br />

17 Glossary ........................................................................................................................................................... 64<br />

Index�to�the�Financial�Statements….……………………………………………………………………………………..………………………………..F�1�<br />

�<br />

�<br />

�<br />

� III<br />


Letter�from�the�Founders 1 �<br />

�<br />

Founded�by�Vera,�Michael,�Fabio,�and�Patrick�with�Dorian�–�an�expert�in�the�fields�of�immunology,�retrovirology�and�<br />

molecular� genetics� –� the� aim� of� mondoBIOTECH� is� to� assist� a� community� of� patients� that� mainstream� medical�<br />

practice� has� overlooked� and� underserved:� patients� suffering� from� rare� and� neglected� diseases.� Helping� this�<br />

community�is�mondoBIOTECH’s�sole�mission�and�priority.�<br />

�<br />

mondoBIOTECH� analyses� peptides� that� are� naturally� occurring� in� the� human� body� in� order� to� identify� promising�<br />

candidates�for�the�development�of�medicinal�products�for�use�in�the�treatment�of�rare�and�neglected�diseases.�The�<br />

candidates�in�question�are�then�licensed�or�sold�to�third�parties.�Thus�far�more�than�300�such�candidates�have�been�<br />

discovered;�seven�have�already�been�licensed�to�pharmaceutical�and�biotechnology�companies.�<br />

�<br />

More�than�just�a�company,�mondoBIOTECH�is�a�community�of�people�dedicated�to�the�search�for�treatments�of�rare�<br />

and�neglected�diseases�and�to�the�support�of�sufferers�from�these�diseases.�The�community�in�question�is�made�up�<br />

of� biologists,� biochemists,� physicians,� patients� and� patient� advocacy� organisations� as� well� as� other� persons� and�<br />

organisations�who�share�their�experiences,�know�how,�expertise�and�skills.�<br />

�<br />

mondoBIOTECH�traces�its�origins�back�to�2000.�Throughout�the�course�of�its�subsequent�growth�we�have�sought�to�<br />

infuse�it�with�an�ethos�of�humanitarianism�and�service�to�society.�In�line�with�these�ideals,�mondoBIOTECH�is�now�<br />

being�listed�on�the�SIX�Swiss�Exchange�under�the�ticker�symbol�RARE.�<br />

�<br />

The�ticker�symbol�RARE�stands�for�mondoBIOTECH’s�core�ambition:�to�improve�the�lives�of�patients�afflicted�by�rare�<br />

and�neglected�diseases.�We�believe�that�people�affected�by�or�involved�in�rare�diseases�will�benefit�thanks�to�the�<br />

public�listing�of�mondoBIOTECH�and�have�designed�our�listing�to�achieve�this�end.�<br />

�<br />

mondoBIOTECH’s� philosophy� is� summed� up� by� a� single� phrase:� to� change� the� world� by� changing� the� world� of�<br />

medicine.��<br />

�<br />

Corporate�Structure�<br />

A�dual�class�share�structure�providing�for�common�shares�(Stammaktien)�and�shares�with�privileged�voting�rights�<br />

(Stimmrechtsaktien)�has�been�put�in�place�by�our�existing�shareholders.�Only�the�common�shares�will�be�listed�for�<br />

the� time� being.� This� dual� structure� will� make� it� harder� for� outside� parties� to� take� over� or� gain� influence� over�<br />

mondoBIOTECH.�It�will�also�insure�that�the�company’s�leadership�has�the�ability�to�continue�the�innovative,�long�<br />

term�approach�that�has�characterised�mondoBIOTECH�from�the�outset.�<br />

�<br />

mondoBIOTECH's�board�of�directors�consists�in�individuals�who�are�recognized�leaders�in�their�fields.�It�includes:�<br />

Prinz�Michael�von�und�zu�Liechtenstein,�who�acts�as�chairman�of�the�board�and�is�an�experienced�entrepreneur�with�<br />

a�long�term�commitment�to�mondoBIOTECH;�Prof.�Dr.�Robert�Huber,�who�in�1988�was�awarded�the�Nobel�Prize�in�<br />

Chemistry�for�the�first�structure�determination�of�a�membrane�bound�protein;�Prof.�Dr.�Thomas�Cerny,�Head�of�the�<br />

Medical� Oncology�Hematology� Department� of� the� Kantonsspital� of� St.� Gallen,� and� president� of� the� Swiss� Cancer�<br />

League;� and� Prof.� Michael� A.� Keller,� Stanford� University’s� Chief� Librarian,� a� world� leader� in� the� creation� of�<br />

innovative�WWW�based�publishing,�research�environments�and�digital�libraries.�<br />

�<br />

We� believe� that� our� expert� management� team’s� passionate� commitment� to� the� care� and� support� of� patients�<br />

affected�by�rare�and�neglected�diseases�will�insure�mondoBIOTECH’s�continuing�success.�<br />

�<br />

Business�<br />

At�the�present�time,�mondoBIOTECH�has�licensed�seven�medicinal�product�candidates�with�NASDAQ�listed�biotech�<br />

companies�(InterMune�(ITMN);�Biogen�Idec�MA�(BIIB);�United�Therapeutics/LungRX�(UTHR)).�<br />

�<br />

More� than� 300� medicinal� product� candidates� discovered� by� mondoBIOTECH� researchers� are� currently� in�<br />

development.� Six� orphan� medicinal� product� designations� (OMPD)� have� already� been� received� from� regulatory�<br />

agencies�such�as�the�U.S.�Food�and�Drug�Administration�(FDA)�and�the�European�Medicines�Agency�(EMEA).�<br />

�<br />

Future�Funding�<br />

To�continue�its�growth�strategy�and�to�fund�further�development�of�its�medicinal�product�candidates,�the�company�<br />

plans�to�increase�its�share�capital�through�the�issuance�of�new�shares�out�of�its�existing�authorized�share�capital�on�<br />

a�continuous�basis�following�the�listing.�The�company�intends�to�issue�such�new�shares�to�existing�shareholders,�<br />

new� investors� and/or� individuals� and� entities� that� are� directly� or� indirectly� affected� by� and/or� involved� in� the�<br />

treatment� of� rare� and� neglected� diseases,� such� as� patients,� their� relatives� and� friends,� patient� advocacy�<br />

organisations,� physicians,� scientists,� academic� organisations,� research� institutions,� hospitals,� employees,�<br />

consultants�and�other�service�providers�to�mondoBIOTECH.�<br />

�<br />

� IV<br />


What�is�a�Rare�Disease?�<br />

It� is� estimated� that� there� are� more� than� 7’000� rare� diseases� in� the� world.� Rare� diseases� are� often� chronic,�<br />

progressive,�debilitating,�disabling,�severe�and�life�threatening.�They�disproportionally�affect�infants�and�children.�<br />

Information�about�them�is�scarce�and�the�research�pipeline�inadequate.�<br />

�<br />

People� afflicted� by� rare� diseases� face� multiple� challenges:� diagnosis� delays,� misdiagnoses,� psychological� burdens�<br />

and�a�lack�of�practical�support.�Many�rare�disease�patients�are�denied�their�right�to�receive�the�highest�attainable�<br />

standard�of�health�care.�About�60�million�people�in�USA�and�Europe�are�directly�affected�by�one�or�several�rare�<br />

diseases.�<br />

�<br />

Rare� diseases� frequently� affect� the� entire� families� of� individual� patients.� More� than� is� the� case� with� common�<br />

diseases,�rare�diseases�require�advocacy�on�the�part�of�family�members�in�order�to�obtain�information�about�the�<br />

disease,�appropriate�referrals,�and�access�to�needed�services�and�treatments.�<br />

�<br />

Conclusion�<br />

Our� objective� is� to� develop� the� greatest� possible� number� of� medicinal� product� candidates� that� promise� to�<br />

significantly�improve�the�lives�of�the�greatest�possible�number�of�patients�affected�by�rare�and�neglected�diseases.�<br />

In�pursuing�this�goal,�we�seek�to�have�a�transformative�impact�upon�the�lives�of�millions.�<br />

�<br />

�<br />

Michael�von�und�zu�Liechtenstein� Fabio�Cavalli� Vera�Cavalli� Patrick�Pozzorini� Dorian�Bevec�<br />

�<br />

�<br />

�<br />

1 �Much�of�this�was�inspired�by�the�letter�of�the�founders�of�Google�Inc.�contained�in�the�prospectus�of�Google�Inc.�for�its�initial�public�offering�in�2004.��<br />

� V<br />


[This page has intentionally been left blank]


1 US�Related�Matters,�Forward�Looking�Statements,�Financial�and�Other�Information�<br />

1.1 US�Related�Matters�<br />

Neither�the�Common�Shares�nor�the�Voting�Right�Shares�have�been�and�will�be�registered�under�the�US�Securities�<br />

Act�with�any�securities�regulatory�authority�of�any�state�or�other�jurisdiction�of�the�US.�Neither�the�Common�Shares�<br />

nor�the�Voting�Right�Shares�have�been�approved�or�disapproved�by�the�US�Securities�and�Exchange�Commission,�any�<br />

state�securities�commission�in�the�US�or�any�other�US�regulatory�authority,�nor�have�any�of�the�foregoing�authorities�<br />

passed�upon�the�accuracy�or�adequacy�of�this�Listing�Prospectus.�<br />

1.2 No�Stabilisation�Measures�<br />

In�connection�with�the�Listing,�no�stabilisation�measures�will�be�effected�by�the�Company�on�the�SIX�Swiss�Exchange,�<br />

the�over�the�counter�market�or�otherwise.�<br />

1.3 Availability�of�Documents�<br />

For� as� long� as� this� Listing� Prospectus� is� valid,� copies� of� this� Listing� Prospectus� are� available� free� of� charge� in�<br />

Switzerland�at�the�offices�of�mondoBIOTECH�holding�AG,�Mürgstrasse�18,�CH���6370�Stans,�(tel.:�+41�(0)�840�200�010,�<br />

fax:�+41�(0)�840�200�011,�e�mail:�investor@mondobiotech.com).�<br />

1.4 Forward�Looking�Statements�<br />

This�Listing�Prospectus�includes�forward�looking�statements�that�involve�substantial�risks�and�uncertainties.�These�<br />

forward�looking�statements�are�based�on�the�Company’s�current�expectations�and�projections�about�future�events.�<br />

All�statements,�other�than�statements�of�historical�facts,�included�in�this�Listing�Prospectus�regarding�the�Company’s�<br />

strategy,� future� operations,� future� financial� position,� future� revenues,� projected� costs,� prospects,� plans� and�<br />

objectives� of� management� are� forward�looking� statements.� The� words� “anticipates”,� “believes”,� “estimates”,�<br />

“expects”,� “intends”,� “may”,� “plans”,� “projects”,� “will”,� “would”� and� similar� expressions� are� intended� to� identify�<br />

forward�looking� statements,� although� not� all� forward�looking� statements� contain� these� identifying� words.� The�<br />

Company� may� not� achieve� the� plans,� intentions� or� expectations� disclosed� in� its� forward�looking� statements� and�<br />

prospective� investors� should� not� place� reliance� on� the� Company’s� forward�looking� statements.� There� can� be� no�<br />

assurance� that� results� of� the� Company’s� activities� and� its� results� of� operations� will� not� differ� materially� from� its�<br />

expectations.�Factors�that�could�cause�actual�results�to�differ�from�expectations�include,�among�others:�<br />

�<br />

� The�Company’s�ability�to�develop�safe�and�efficacious�medicinal�product�candidates;�<br />

� The�Company’s�ability�to�obtain�market�acceptance�for�its�medicinal�product�candidates;�<br />

� The�Company’s�ability�to�enter�into�future�collaboration�agreements�and/or�licensing�out�agreements;�<br />

� The�impact�of�competition�and�technology�change;�<br />

� Existing�and�future�regulations�affecting�the�Company’s�business;�<br />

� Adverse�changes�in�governmental�oversight�of�pharmaceutical�product�development;�<br />

� The�future�scope�of�the�Company’s�patent�coverage�or�that�of�third�parties;�<br />

� The�effects�of�any�future�litigation;�<br />

� General�economic�and�business�environment,�including�exchange�rate�variations;�<br />

� Future�capital�needs�and�the�uncertainty�of�additional�funding;�<br />

� The�availability�and�terms�of�third�party�reimbursement�for�the�Company’s�potential�medicinal�products;�<br />

� The�attraction�and�retention�of�people�forming�the�mondoBIOTECH�Community�(as�defined�below);�<br />

� The� uncertainty� of� the� grant� and� maintenance� of� patents,� proprietary� technology� and� other� intellectual�<br />

property�rights,�and�OMPD�(as�defined�below);�and�<br />

� The�risk�of�product�liability.�<br />

�<br />

Forward�looking�statements�are�subject�to�inherent�risks�and�uncertainties,�some�of�which�cannot�be�predicted�or�<br />

quantified.� Future� events� and� actual� results� could� differ� materially� from� those� set� forth� in,� contemplated� by� or�<br />

underlying� the� forward�looking� statements.� Statements� in� this� Listing� Prospectus,� including,� but� not� limited� to,�<br />

those�set�forth�in�the�section�“3��Risk�Factors”�of�this�Listing�Prospectus,�describe�some�of�the�risk�factors�that�could�<br />

contribute�to�or�cause�such�differences.�Given�these�uncertainties,�prospective�investors�are�cautioned�not�to�place�<br />

undue�reliance�on�such�forward�looking�statements�which�speak�only�as�of�the�date�of�this�Listing�Prospectus.�Other�<br />

than�in�accordance�with�the�ad�hoc�publicity�rules�of�the�SIX�Swiss�Exchange,�the�Company�does�not�undertake�any�<br />

obligation�to�publicly�update�or�revise�any�forward�looking�statements�contained�in�this�Listing�Prospectus�to�reflect�<br />

any�change�in�the�Group’s�expectations�with�regard�thereto�or�any�change�in�events,�conditions�or�circumstances�on�<br />

which�any�such�statement�is�based.�<br />

� 1<br />


1.5 Financial�and�Certain�Other�Information�<br />

The�Company�prepares�its�financial�statements�in�accordance�with�the�CO�and�its�consolidated�financial�statements�<br />

in�accordance�with�the�International�Financial�Reporting�Standards�(“IFRS”).�<br />

�<br />

Certain�numbers�set�out�in�this�Listing�Prospectus�have�been�subject�to�rounding�adjustments.�Accordingly,�amounts�<br />

shown�as�totals�in�tables�or�elsewhere�in�this�Listing�Prospectus�may�not�be�an�arithmetic�aggregation�of�the�figures�<br />

which�precede�them.�In�addition,�certain�percentages�presented�in�the�tables�or�elsewhere�in�this�Listing�Prospectus�<br />

reflect� calculations� based� upon� the� underlying� information� prior� to� rounding� and,� accordingly,� may� not� conform�<br />

exactly� to� the� percentages� that� would� be� derived� if� the� relevant� calculations� were� based� upon� the� rounded�<br />

numbers.��<br />

�<br />

All�references�in�this�Listing�Prospectus�to�“CHF”�are�to�Swiss�francs,�to�“EUR”�are�to�Euros�and�to�“USD”�are�to�US�<br />

dollars.�The�numbers�set�out�in�this�Listing�Prospectus�are�presented�in�Swiss�francs�if�not�otherwise�stated.��<br />

�<br />

Except�as�otherwise�specified,�the�terms�“we”,�“us”�and�“our”�in�this�Listing�Prospectus�refer�to�the�Group.�<br />

1.6 Market�and�Industry�Information�<br />

Industry� data� used� in� this� Listing� Prospectus� were� obtained� from� various� scientific� and� pharmaceutical� industry�<br />

publications�and�sources.�While�the�Company�believes�that�such�publications�and�sources�are�reliable,�the�Company�<br />

has�not�independently�verified�such�data�and�makes�no�representation�as�to�the�accuracy�of�such�information.�<br />

�<br />

� 2<br />


2 Summary�<br />

The�following�summary�highlights�information�contained�elsewhere�in�this�Listing�Prospectus.�It�does�not�contain�all�<br />

of� the� information� that� you� should� consider� before� investing� in� the� Common� Shares.� You� should� read� this� entire�<br />

Listing� Prospectus� carefully� including� the� information� set� forth� under� “3��Risk� Factors”� beginning� on� page� 8.� This�<br />

summary�is�qualified�in�its�entirety�by,�and�should�be�read�in�conjunction�with,�the�detailed�information�set�out�in�<br />

this�Listing�Prospectus�including�the�financial�statements�included�in�the�F�Pages�of�this�Listing�Prospectus.�<br />

2.1 mondoBIOTECH�<br />

mondoBIOTECH�analyses�peptides�and�other�biological�immuno�modulating�substances�that�are�naturally�occurring�<br />

in�the�human�body�in�order�to�identify�promising�candidates�for�the�development�of�medicinal�products�for�use�in�<br />

the�treatment�of�rare�and�neglected�diseases.�We�then�seek�to�license�or�sell�such�medicinal�product�candidates�to�<br />

third� parties� (such� as� pharmaceutical� or� biotechnology� companies)� and/or� a� collaborating� with� third� parties� for�<br />

obtaining�market�authorisation�and�commercialising�such�candidates.�<br />

�<br />

mondoBIOTECH�traces�its�origins�back�to�2000�when�Vera�Cavalli�and�Dorian�Bevec�started�to�work�on�the�concept�<br />

that�the�most�effective�and�safe�medicinal�products�will�be�derived�from�the�use�of�peptides�and�other�biological�<br />

immuno�modulating�substances�naturally�existing�in�the�human�body�that�are�already�known,�or,�even�better,�that�<br />

are�already�approved�in�clinical�development�for�other�indications.�In�the�beginning�of�2001,�Fabio�Cavalli�decided�<br />

to�contribute�his�long�standing�experience�and�know�how�in�developing�and�managing�start�up�companies�to�this�<br />

concept�and�started�to�promote�it�among�private�investors.�Patrick�Pozzorini�joined�the�project�during�the�first�half�<br />

of�2001,�bringing�a�strong�financial�management�oriented�culture�to�the�project.�<br />

�<br />

The�first�licensing�out�of�a�medicinal�product�candidate�of�mondoBIOTECH�related�to�the�use�of�a�substance�called�<br />

Interferon���(“INF��”)�for�the�treatment�of�idiopathic�pulmonary�fibrosis�(“IPF”),�on�which�in�2002�mondoBIOTECH�<br />

signed� a� licensing�out� agreement� with� NASDAQ�listed� InterMune,� Inc.� (“InterMune”).� Until� 2006,� the� Company�<br />

invested�the�revenues�generated�and�funds�raised�through�different�capital�increases�with�private�investors�to�build�<br />

up� an� engine� capable� of� generating� a� large� number� of� medicinal� product� candidates.� In� 2006,� mondoBIOTECH�<br />

licensed�its�second�medicinal�product�candidate�to�Biogen�Idec�MA,�Inc.�(“Biogen”),�a�NASDAQ�listed�company.�In�<br />

2007,� mondoBIOTECH� entered� into� an� agreement� with� LungRX,� Inc.� (“LungRX”),� a� wholly� owned� subsidiary� of�<br />

NASDAQ�listed� United� Therapeutics,� Inc.,� regarding� the� licensing�out� of� five� medicinal� product� candidates� at� the�<br />

option�of�LungRX.�This�agreement�was�at�that�time�insofar�important�for�mondoBIOTECH�as�it�related�to�medicinal�<br />

product�candidates�in�the�early� stage�(i.e.,�immediately�after�we�<strong>file</strong>d�the�relevant�patent�applications)�and�thus�<br />

demonstrated� the� scientific� fundament� of� mondoBIOTECH’s� business� model.� The� first� choice� was� made� in�<br />

December�2008,�when�LungRX�decided�to�license�from�mondoBIOTECH�the�medicinal�product�candidate�related�to�<br />

the�use�of�the�substance�called�“Secretin”�for�the�treatment�of�Methicillin�resistant�Staphylococcus�aureus�(“MRSA”)�<br />

infections�in�patients�with�cystic�fibrosis.�To�date,�mondoBIOTECH�has�discovered�more�than�300�medicinal�product�<br />

candidates� covered� by� respective� patent� applications.� In� the� beginning� of� 2009,� mondoBIOTECH� entered� into� an�<br />

agreement�with�23andMe,�Inc.�(“23andMe”),�to�advance�research�on�genotyping�patients�affected�by�rare�diseases.�<br />

�<br />

For� its� vision,� business� model� and� potential� impact� on� our� society,� the� World� Economic� Forum� selected�<br />

mondoBIOTECH�as�“Technology�Pioneer�2008”.�<br />

2.2 Business�Strategy�<br />

Our�primary�goal�is�to�build�a�cash�generating,�profitable�and�sustainable�business�around�our�core�competences�of�<br />

the�continuous�discovery�of�medicinal�product�candidates�by�analysing�already�known�peptides�and�other�biological�<br />

immuno�modulating�substances�that�are�naturally�occurring�in�the�human�body�for�the�development�of�medicinal�<br />

products�for�use�in�the�treatment�of�rare�and�neglected�diseases.�We�then�seek�to�license�or�sell�such�medicinal�<br />

product�candidates�to�third�parties�(such�as�pharmaceutical�and�biotechnology�companies),�between�discovery�and�<br />

the� different� phases� of� development,� and/or� collaborate� with� third� parties� to� obtain� market� authorisation� and�<br />

commercialise�such�medicinal�product�candidates.�<br />

�<br />

The�fundamental�concept�underlying�mondoBIOTECH’s�business�is�the�belief�that:�<br />

�<br />

� The�most�effective�and�safe�medicinal�products�can�be�obtained�through�redirecting�known�peptides�and�other�<br />

biological� immuno�modulating� substances.� Such� substances� regulate� cell� interaction,� communication� and�<br />

behaviour�within�the�human�body,�and�their�mechanism�of�action�are�well�researched;�<br />

� There�is�no�correlation�between�the�high�amount�of�resources�invested�in�research�and�development�and�the�<br />

resulting�output�obtained,�at� least�not�measurable�in�the�numbers�of�new�chemical�entities�discovered�and�<br />

developed.�Therefore,�the�development�process�must�be�characterised�by�additional�value�drivers�such�as�in�<br />

depth�information�exchange,�interaction,�versatility�and�flexibility.�Based�on�this,�mondoBIOTECH�has�built�up�<br />

and� is� maintaining� a� continuously� growing� community� of� biologists,� biochemists,� physicians,� patients� and�<br />

patient�advocacy�organisations�and�other�persons�and�organisations�who�share�their�experience,�know�how,�<br />

� 3<br />


expertise,�and�skills�with�mondoBiOTECH�and,�like�mondoBIOTECH,�are�dedicated�to�the�search�for�treatments�<br />

of�rare�and�neglected�diseases�(the�“mondoBIOTECH�Community”);�<br />

� Today,�it�is�estimated�that�there�are�more�than�7’000�rare�and�neglected�diseases�without�appropriate�medical�<br />

treatment� in� the� world� affecting� about� 27� to� 36� million� people� in� the� European� Union� (“EU”)� and� 25� to� 30�<br />

million�people�in�the�US.�<br />

�<br />

The�business�model�of�mondoBIOTECH�is�therefore�focused�on:�<br />

�<br />

� Discovering�the�most�result�promising�medicinal�product�candidates�with�high�biological�pro<strong>file</strong>s,�by�analysing�<br />

already� known� peptides� and� other� biological� immuno�modulating� substances,� and� bringing� such� medicinal�<br />

product�candidates�to�the�awareness�of�the�mondoBIOTECH�Community;�<br />

� Interacting�and�networking�with�the�mondoBIOTECH�Community�to�(i)�continue�further�development�and�(ii)�<br />

explore�new�ways�to�develop,�finance,�promote�and�commercialise�the�medicinal�product�candidates;�<br />

� Advancing� the� development� up� to� late� development� stages� by� licensing� or� selling� such� medicinal� product�<br />

candidates�to�third�parties�(such�as�pharmaceutical�and�biotechnology�companies),�between�discovery�and�the�<br />

different�phases�of�development,�and/or�collaborating�with�third�parties�to�obtain�marketing�authorisation�and�<br />

commercialise�such�medicinal�product�candidates.�<br />

�<br />

On�the�date�of�this�Listing�Prospectus,�mondoBIOTECH�has:�<br />

�<br />

� Licensed�to�Biogen�a�medicinal�product�candidate�regarding�the�use�of�the�substance�called�“Aviptadil”�for�the�<br />

treatment�of�pulmonary�arterial�hypertension�(“PAH”)�with�certain�issued�patents�concerning�Aviptadil.�Under�<br />

this�licensing�out�agreement,�mondoBIOTECH�also�performs�certain�clinical�development�services�for�Biogen,�<br />

and�granted�to�Biogen�an�option�right�for�three�additional�indications;�<br />

� Licensed�to�InterMune�a�medicinal�product�candidate�regarding�the�use�of�INF���for�the�treatment�of�IPF.�The�<br />

clinical�development�of�this�medicinal�product�candidate�was�discontinued�in�the�beginning�of�2007�following�<br />

recommendation� of� the� study's� independent� data� monitoring� committee.� In� 2006,� mondoBIOTECH� sold� the�<br />

relevant�issued�patent�to�InterMune;�<br />

� Licensed�to�LungRX�five�medicinal�product�candidates�at�the�option�of�LungRX.�The�first�choice�was�made�in�<br />

December� 2008,� when� Lung� RX� decided� to� license� the� medicinal� product� candidate� related� to� the� use� of�<br />

Secretin�for�the�treatment�of�MRSA�infections�in�patients�with�cystic�fibrosis;�<br />

� Five�medicinal�product�candidates�on�which�pre�clininal�tests/Phase�I�tests�are�ongoing.�With�respect�to�one�of�<br />

such� medicinal� product� candidates,� mondoBIOTECH� has� entered� into� a� collaboration� agreement� with�<br />

Pharmarare� SA� (“Pharmarare”),� with� the� aim� to� develop� and� to� commercialise� such� medicinal� product�<br />

candidate;�<br />

� Twelve�medicinal�product�candidates�on�which�efficacy�and�safety�trials�(pre�clinical�tests)�are�in�preparation;�<br />

� Discovered� additional� 290� medicinal� product� candidates� for� use� in� the� treatment� of� rare� and� neglected�<br />

diseases�which�are�covered�by�287�<strong>file</strong>d�patent�applications�and�ready�for�further�development;�<br />

� Six�adopted�Orphan�Medicinal�Product�Designations�(“OMPD”);�and�<br />

� A� continuously� expanding� community� (i.e.,� the� mondoBIOTECH� Community)� dedicated� to� the� search� for�<br />

treatments�of�rare�and�neglected�diseases.�<br />

�<br />

To� continue� its� growth� strategy� and� to� fund� the� further� development� of� its� medicinal� product� candidates,� the�<br />

Company� plans�to� increase� its� share� capital� through� the� issue�of� new� shares� out� of� its� existing� authorized� share�<br />

capital� on� a� continuous� basis� following� the� Listing.� The� Company� intends� to� issue� such� new� shares� to� existing�<br />

shareholders,� new� investors� and/or� individuals� and� entities� which� are� directly� or� indirectly� affected� by� and/or�<br />

involved�in�the�treatment�of�rare�and�neglected�diseases,�such�as�patients�and�their�relatives�and�friends,�patient�<br />

advocacy�organisations,�physicians,�scientists,�academic�organisations,�research�institutions,�hospitals,�employees,�<br />

consultants�and�other�service�providers�of�mondoBIOTECH.�<br />

2.3 Key�Competitive�Strengths�<br />

mondoBIOTECH�believes�that�it�benefits�from�following�key�strengths:�<br />

�<br />

� “Search� and� match”� rather� than� classical� pharmaceutical� laboratory� research.� mondoBIOTECH� has� chosen� a�<br />

new� approach� by� screening� and� evaluating,� through� sophisticated� IT� tools/methods,� the� vast� amount� of�<br />

globally�available�data�on�biological�and�medical�activities�(including�clinical�experience)�with�known�peptides�<br />

and�other�biological�immuno�modulating�substances,�rather�than�by�engaging�in�the�traditional�approach�of�<br />

drug�discovery.�mondoBIOTECH�believes�that�in�doing�so,�it�can�engage�in�an�efficient�and�aimed�search�for�<br />

medicinal�product�candidates�thereby�reducing�time�and�costs�for�developing�new�therapeutics;�<br />

� Focus�on�bioactive�peptides�of�human�origin.�mondoBIOTECH�primarily�focuses�on�bioactive�peptides�of�human�<br />

origin.� mondoBIOTECH� believes� that� peptides� of� human� origin� offer� better� efficacy� and� safety� pro<strong>file</strong>s�<br />

compared�to�other�classes�of�molecular�entities.�As�a�consequence,�mondoBIOTECH�expects�the�risk�of�failure�<br />

of�development�associated�with�toxicity�and�other�adverse�effects�to�be�significantly�lower�than�with�respect�to�<br />

non�human�originated�peptides;�<br />

� 4<br />


� Focus�on�rare�and�neglected�diseases.�mondoBIOTECH�primarily�focuses�on�rare�and�neglected�diseases.�Today,�<br />

it�is�estimated�that�there�are�more�than�7’000�rare�and�neglected�diseases.�Focusing�on�rare�and�neglected�<br />

diseases�offers�competitive�advantages;�<br />

� Working�and�networking�in�a�worldwide�scientific�community.�mondoBIOTECH�has�build�up�and�is�maintaining�<br />

a� continuously� growing� community� of� biologists,� biochemists,� physicians,� patients� and� patient� advocacy�<br />

organisations�as�well�as�other�persons�and�organisations�who�share�their�experience,�know�how,�expertise,�and�<br />

skills�with�mondoBIOTECH�and,�like�mondoBIOTECH,�are�dedicated�to�the�search�for�treatments�of�rare�and�<br />

neglected�diseases�(the�mondoBIOTECH�Community);�<br />

� Market�protection�through�OMPD.�Parallel�to�its�seeking�of�patent�or�other�intellectual�property�protection,�<br />

mondoBIOTECH�seeks�to�apply���when�appropriate�and�legally�possible���for�OMPD�status�(in�the�EU�and�the�US)�<br />

in�order�to�help�to�build�up�and�defend�the�exclusive�market�position�of�the�relevant�therapeutics�granted�by�<br />

an�OMPD�once�marketing�approval�has�been�received;�<br />

� Strong�management�team.�mondoBIOTECH�has�an�internationally�experienced�management�team�of�industry�<br />

experts� recognised� in� their� fields,� with� diverse� backgrounds� and� complementary� management� skill�sets� in�<br />

innovation,�science,�development,�marketing�and�finance;�and�<br />

� Outsourcing� and� project� management.� As� integral� part� of� its� business� model,� mondoBIOTECH� works� with�<br />

leading� clinicians� and� regulatory� experts� on� the� set�up� of� clinical� protocols,� third� party� manufacturers� and�<br />

clinical�development�service�providers.�mondoBIOTECH�believes�that�outsourcing�or�collaborating�with�other�<br />

parties� is� the� optimal� way� to� achieve� its� business� goals.� mondoBIOTECH� remains� in� charge� of� the� project�<br />

management� and� has� a� highly� specialised� team� of� in�house� experts� able� to� competently� interact� with� its�<br />

partners,�thus�enabling�an�efficient�management�of�the�business�processes.�<br />

2.4 Risk�Factors�<br />

Any�investment�in�the�Common�Shares�involves�a�high�degree�of�risk.�Among�the�risks�and�other�factors�investors�<br />

should�consider�in�connection�with�an�investment�in�the�Common�Shares�are�the�following:�<br />

�<br />

Risks�Related�to�mondoBIOTECH’s�Medicinal�Product�Candidates�<br />

� Biogen� and� LungRX,� respectively,� may� be� unable� to� successfully� complete� further� development� and� obtain�<br />

marketing�approval�or�commercialise�the�medicinal�product�candidates�licensed�to�them;�<br />

� mondoBIOTECH�has�medicinal�product�candidates�in�pre�clinical�and�clinical�development�stages,�the�results�of�<br />

which�being�uncertain;�<br />

� The� concept� underlying� mondoBIOTECH’s� business� model� pursuant� to� which� the� most� effective� and� safe�<br />

medicinal�products�derive�from�substances�of�human�origin�may�be�wrong;�<br />

� mondoBIOTECH’s�medicinal�product�candidates�are�subject�to�regulatory�approval�requirements;�<br />

� The�ability�of�mondoBIOTECH�to�generate�revenue�from�its�medicinal�product�candidates�depends�on�market�<br />

acceptance;�<br />

� The�Off�label�use�(as�defined�below)�of�medicinal�products�may�adversely�affect�the�potential�revenue�from�<br />

mondoBIOTECH’s�medicinal�product�candidates;�and�<br />

� The�availability�of�third�party�reimbursement�for�mondoBIOTECH’s�medicinal�product�candidates�is�uncertain.�<br />

�<br />

Risks�Related�to�mondoBIOTECH’s�Business�<br />

� mondoBIOTECH�may�be�unable�to�achieve�profitability,�and�if�achieved,�may�not�be�sustained;�<br />

� mondoBIOTECH�may�not�be�able�to�raise�additional�funds�at�the�appropriate�time,�or�at�all;�<br />

� mondoBIOTECH� relies� on� the� expertise� and� contributions� of� the� mondoBIOTECH� Community� and� its�<br />

commercialisation�partners;�<br />

� mondoBIOTECH�may�not�be�able�to�retain�its�management�and�key�personnel�and�may�not�be�able�to�hire�or�<br />

retain�additional�qualified�personnel;�<br />

� mondoBIOTECH�relies/depends�on�third�party�manufacturers�and�service�providers;�<br />

� mondoBIOTECH�may�encounter�difficulties�managing�future�growth;�<br />

� mondoBIOTECH� faces� competition� from� other� companies� that� have� developed� or� are� developing� similar� or�<br />

different�medicinal�product�candidates�aiming�at�the�same�indications;�<br />

� mondoBIOTECH�may�become�exposed�to�costly�and�damaging�product�liability�claims;�<br />

� mondoBIOTECH�may�expend�its�limited�resources�to�pursue�an�unprofitable�medicinal�product�candidate;�<br />

� mondoBIOTECH’s�search�and�development�activities�could�be�delayed�or�become�more�expensive�as�a�result�of�<br />

restrictions�on�animal�testing;�and�<br />

� mondoBIOTECH�is�subject�to�environmental,�health�and�safety�regulations.�<br />

�<br />

Risks�Related�to�Intellectual�Property�<br />

� mondoBIOTECH�may�fail�to�secure�adequate�protection�of�its�own�intellectual�property�against�competitors;�<br />

� mondoBIOTECH�may�be�unable�to�protect�its�trading�secrets�and�know�how;�<br />

� mondoBIOTECH’s�medicinal�product�candidates�may�infringe�the�intellectual�property�rights�of�third�parties;�<br />

� An�OMPD�does�not�equal�a�patent�or�any�other�intellectual�property�right;�and�<br />

� mondoBIOTECH�may�fail�in�obtaining�or�maintaining�an�OMPD�for�its�medicinal�product�candidates.�<br />

�<br />

� 5<br />


Risks�Related�to�the�Common�Shares�and�the�Listing�<br />

� An�active�and�liquid�trading�market�for�the�Common�Shares�may�fail�to�develop�after�the�Listing;�<br />

� The�market�price�of�the�Common�Shares�may�be�highly�volatile;�<br />

� A�sale�of�a�substantial�number�of�Shares�following�the�Listing�could�adversely�affect�the�market�price�of�the�<br />

Common�Shares;�<br />

� Investors�will�not�be�able�to�affect�the�outcome�of�any�shareholders’�vote;�<br />

� The�Company’s�current�articles�of�association�(“Articles�of�Association”)�provide�for�an�“opting�out”�clause;�<br />

� The�Company�does�not�anticipate�paying�dividends�for�the�foreseeable�future;�<br />

� The�issuance�of�equity�or�debt�securities�that�are�convertible�into�equity�could�dilute�any�current�shareholdings;�<br />

� Investors�outside�of�Switzerland�face�additional�investment�risk�from�currency� exchange�rate�fluctuations�in�<br />

connection�with�their�holding�of�Common�Shares;�and�<br />

� Shareholders�may�not�be�able�to�participate�in�future�equity�offerings.�<br />

2.5 Listing�<br />

�<br />

Common�Shares� The� 1’248’671� Common� Shares� (Stammaktien)� have� a� nominal� value� of�<br />

CHF�0.10�each.�The�Common�Shares�are�in�registered�form�(Namenaktien),�<br />

are�fully�paid�in�and�rank�pari�passu�in�all�respect�with�each�other.�<br />

�<br />

The� 1’248’671� Common� Shares� constitute� 2.31%� of� the� Shares� and� voting�<br />

rights�in�the�Company,�and�19.10%�of�the�nominal�value�of�the�Shares.�<br />

�<br />

For� the� time� being,� only� the� Common� Shares� (and� any� further� registered�<br />

shares�of�the�Company�with�a�nominal�value�of�CHF�0.10�each)�shall�be�listed�<br />

and�traded�on�the�SIX�Swiss�Exchange.�<br />

�<br />

Listing� Application� has� been� made� and� approval� has� been� given� by� the� SIX� Swiss�<br />

Exchange� for� the� Common� Shares� and� 1’800’000� registered� shares� with� a�<br />

nominal� value� of� CHF� 0.10� each� that� may� be� issued� under� the� conditional�<br />

share�capital�of�the�Company�to�be�listed�according�to�the�Main�Standard�of�<br />

and�traded�on�the�SIX�Swiss�Exchange.�The�Common�Shares�will�be�listed�and�<br />

trading�of�the�Common�Shares�will�commence�on�26�August�2009.�<br />

�<br />

Clearance� The�Common�Shares�have�been�accepted�for�clearance�through�SIS.�<br />

�<br />

Publication� The�listing�notice�will�be�published�in�electronic�form�on�the�website�of�the�<br />

SIX� Exchange� Regulation� (www.six�exchange�regulation.com)� and� on� the�<br />

website�of�the�Company�(www.mondobiotech.com)�on�26�August�2009.�<br />

�<br />

Form�of�the�Common�Shares� The� Common� Shares� are� registered� in� book�entry� form� with� SIS.� No� share�<br />

certificates� will� be� issued� to� shareholders� (aufgehobener� Titeldruck),� and�<br />

shareholders�are�not�entitled�to�demand�printing�and�delivery�of�individual�<br />

share�certificates.�Shareholders�may�request�the�Company�to�issue�a�written�<br />

confirmation� of� their� shareholding.� However,� such� confirmation� is� not� a�<br />

negotiable�instrument.�<br />

�<br />

Voting�Rights� Each�Common�Share�carries�one�vote.�See�“13.7��Voting�Rights”.�<br />

Dividend�Entitlement�and�Dividend�<br />

Policy�<br />

� 6<br />

�<br />

The�Common�Shares�are�entitled�to�dividends�declared,�if�any.�The�Company�<br />

currently�does�not�intend�to�pay�any�dividends�in�the�foreseeable�future.�<br />

�<br />

Opting�out� The�Articles�of�Association�provide�for�an�opting�out�according�to�art.�22�of�<br />

the�Swiss�Federal�Act�on�Stock�Exchanges�and�Trading�dated�24�March�1995�<br />

(“SESTA”),�as�amended�,�i.e.,�a�purchaser�of�Shares�is�not�obliged�to�make�a�<br />

public� tender� offer� pursuant� to� art.� 32� SESTA.� See� “13.16��Public� Tender�<br />

Offers”.�<br />

�<br />

Swiss�Taxation� Any�dividends�paid�on�the�Common�Shares�will�be�subject�to�Swiss�Federal�<br />

withholding�tax�(“Withholding�Tax”).�See�“14.1��Withholding�Tax”.�<br />

�<br />

Listing�Agent� Lenz�&�Staehelin,�Zurich,�Switzerland.�<br />

�<br />

Paying�Agent� Graubündner�Kantonalbank,�Chur,�Switzerland.�<br />

�<br />

Applicable�Law�and�Jurisdiction� Swiss�law�/�Stans,�Switzerland.�<br />


Swiss�Security�Number�<br />

(Valorennummer)�<br />

International�Security�Identification�<br />

Number�(ISIN)�<br />

10191073�<br />

�<br />

SIX�Swiss�Exchange�Ticker�Symbol� RARE�<br />

�<br />

�<br />

� 7<br />

�<br />

CH0101910732�<br />

�<br />

�<br />


3 Risk�Factors�<br />

Any� investment� in� the� Company� and� its� Common� Shares� involves� a� high� degree� of� risk.� In� addition� to� the� other�<br />

information� contained� in� this� Listing� Prospectus,� prospective� investors� should� consider� carefully� the� specific� risk�<br />

factors�set�forth�below�before�making�a�decision�to�invest�in�the�Common�Shares.�<br />

�<br />

The� risks� described� below� are� not� the� only� ones� applicable� to� the� Company� and� the� Group.� Additional� risks� and�<br />

uncertainties�not�presently�known�to�the�Company�or�that�the�Company�currently�deems�immaterial�may�also�impair�<br />

its� business.� mondoBIOTECH’s� business,� financial� condition,� or� result� of� operations� could� be� materially� adversely�<br />

affected�by�any�of�these�risks.�In�addition,�if�a�combination�of�risks�occurs,�the�effect�on�mondoBIOTECH’s�business,�<br />

financial�condition�or�result�of�operations�may�be�greater�than�if�each�risk�had�occurred�independently�of�each�other.�<br />

The�trading�price�of�the�Common�Shares�could�decline�due�to�any�of�these�risks,�and�investors�may�lose�part�or�all�of�<br />

their�investment.�<br />

�<br />

The�order�of�presentation�of�the�risk�factors�below�does�not�indicate�the�likelihood�of�these�risks�actually�occurring�or�<br />

the�scope�of�any�potential�impairment�these�risks�might�cause�to�mondoBIOTECH’s�business,�financial�condition�or�<br />

result�of�operations.�<br />

�<br />

This� Listing� Prospectus� also� contains� forward�looking� statements� that� involve� risks� and� uncertainties.�<br />

mondoBIOTECH’s�actual�results�could�differ�materially�from�those�anticipated�in�these�forward�looking�statements�<br />

as�a�result�of�certain�factors,�including,�but�not�limited�to,�the�risks�it�faces�as�described�below�and�elsewhere�in�this�<br />

Listing�Prospectus.�<br />

3.1 Risks�Related�to�mondoBIOTECH’s�Medicinal�Product�Candidates�<br />

�<br />

Biogen� and� LungRX,� respectively,� may� not� be� able� to� successfully� complete� further� clinical� development� and�<br />

obtain� marketing� approval,� commercialise� and� gain� market� acceptance� for� the� respective� medicinal� product�<br />

candidates�within�the�time�frame�estimated�by�mondoBIOTECH’s�management,�or�at�all�<br />

mondoBIOTECH� has� entered� into� a� licensing�out� and� collaboration� agreement� with� Biogen� regarding� the� use� of�<br />

Aviptadil� for� the� treatment� of� PAH� and� with� LungRX� regarding� the� use� of� Secretin� for� the� treatment� of� MRSA�<br />

infections�in�cystic�fibrosis.�See�“9.3.2�Licensed�out�Medicinal�Product�Candidates���Material�Agreements”.�Biogen�is�<br />

completing�Phase�II�and�preparing�Phase�III�clinical�trials�for�the�Aviptadil.�LungRX�is�performing�pre�clinical�testing.�<br />

If�any�of�Biogen�and�LungRX,�is�unable�to�demonstrate�the�safety�and�efficacy�of�the�relevant�medicinal�product�<br />

candidates� in� the� relevant� testing,� or� if� they� are� unable� to� obtain� marketing� approval� or� to� successfully�<br />

commercialise�such�medicinal�product�candidates,�mondoBIOTECH�will�not�be�able�to�meet�the�revenue�forecasts�<br />

regarding�such�medicinal�product�candidates,�as�currently�provided�for�in�its�business�plan.��<br />

�<br />

Further,� if� any� of� Biogen� and� LungRX,� respectively,� terminates� its� licensing�out� and� collaboration� agreement�<br />

prematurely,�mondoBIOTECH�will�not�be�able�to�obtain�the�agreed�milestones�payments�and�royalties.�<br />

�<br />

Any�such�event�could�result�in�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�condition,�results�of�<br />

operations�and�prospects.��<br />

�<br />

mondoBIOTECH�has�medicinal�product�candidates�in�development�which�must�prove�their�efficacy�and�safety�in�<br />

rigorous�clinical�testing.�The�results�of�these�trials�are�uncertain��<br />

mondoBIOTECH’s� medicinal� product� candidates� need� to� fulfil� pre�clinical� and/or� clinical� stages� of� development.�<br />

Before� mondoBIOTECH� (and/or� its� commercialisation� partners)� may� seek� to� obtain� regulatory� approval� for� any�<br />

medicinal�product�candidate,�it�(and/or�its�commercialisation�partners)�must�undertake�extensive�clinical�testing�in�<br />

humans� to� demonstrate� the� safety� and� efficacy� of� the� medicinal� product� candidate.� To� date,� mondoBIOTECH�<br />

(and/or� its� commercialisation� partners)� has� not� completed� the� development� of� any� of� its� medicinal� product�<br />

candidates.��<br />

�<br />

The�development�of�medicinal�products�is�inherently�risky,�and�the�success�of�a�medicinal�product�candidate�will�<br />

among� other� things� depend� on� its� efficacy� and� side� effect� pro<strong>file</strong>� for� the� targeted� patients.� Pre�clinical� and/or�<br />

clinical�trials�are�long�and�expensive�processes�with�an�uncertain�outcome.�mondoBIOTECH�cannot�guarantee�that�<br />

any�of�its�medicinal�product�candidates�will�result�in�marketable�medicines.�It�may�take�mondoBIOTECH�(and/or�its�<br />

commercialisation�partners)�several�years�to�complete�clinical�development,�and�failure�can�occur�at�any�stage�of�<br />

the�process.�<br />

�<br />

Success�in�pre�clinical�and/or�early�clinical�testing�does�not�ensure�that�later�clinical�trials�will�be�successful.�It�may�<br />

turn�out�that�mondoBIOTECH’s�medicinal�product�candidates�have�unacceptable�toxicities,�trigger�undesirable�side�<br />

effects,�have�no�or�insufficient�effects�that�cannot�be�proven�or�exhibit�other�negative�characteristics�that�prevent�<br />

or�limit�their�successful�application�and�marketing�authorisation.�<br />

�<br />

� 8<br />


Before�a�clinical�trial�can�begin,�mondoBIOTECH�(and/or�its�commercialisation�partners)�must�obtain�approval�from�<br />

the�competent�national�authority�in�the�country�where�the�trial�is�planned�to�be�conducted.�A�favourable�opinion�<br />

from�a�competent�ethics�committee�or�an�independent�institutional�review�on�the�clinical�trial�application�is�needed.�<br />

No�assurance�can�be�given�that�mondoBIOTECH�(and/or�its�commercialisation�partners)�will�obtain�authorisation�for�<br />

further�testing�of�medicinal�product�candidates�already�in�clinical�trials�or�for�human�clinical�testing�of�any�or�all�of�<br />

its�medicinal�product�candidates�currently�in�development.�mondoBIOTECH�(and/or�its�commercialisation�partners)�<br />

or�regulatory�authorities�may�suspend�or�terminate�clinical�trials�at�any�time�if�it�is�thought�that�the�participants�are�<br />

exposed�to�unacceptable�health�risks.��<br />

�<br />

The� successful� and� timely� completion� of� clinical� trials� is� also� dependent� from� mondoBIOTECH’s� (and/or� its�<br />

commercialisation�partners’)�ability�to�enrol�a�statistically�significant�number�of�patients.�This�is�a�result�of�many�<br />

factors,� including� the� size� of� the� patient� population,� which� is� small� given� mondoBIOTECH’s� focus� on� rare� and�<br />

neglected�diseases,�the�nature�of�the�clinical�protocol,�the�proximity�of�patients�to�clinical�sites,�the�eligibility�criteria�<br />

for� the� trials� as� well� as� competition� for� patients� by� clinical� trial� programs� for� competing� and/or� concurring�<br />

treatment.�In�any�clinical�trial,�more�than�the�anticipated�number�of�patients�could�be�required,�and�enrolment�may�<br />

not�proceed�at�the�predicted�rate.�Any�increase�in�the�number�of�patients�or�any�decrease�in�recruitment�rates�may�<br />

result� in� increased� costs,� program� delays� or� both.� Patient� enrolment� taking� longer� than� anticipated� or� patient�<br />

withdrawal�could�result�in�material�delays�of�the�trials�which�in�turn�can�negatively�affect�mondoBIOTECH’s�(and/or�<br />

its�commercialisation�partners)�ability�to�eventually�commercialise�the�medicinal�product�candidate.�<br />

�<br />

If� pre�clinical� and/or� clinical� testing� cannot� be� satisfactorily� conducted� or� successfully� completed� or� if� medicinal�<br />

product�candidates�prove�to�have�insufficient�effect�or�have�undesirable�or�unintended�side�effects�or�toxicities�or�<br />

exhibit� other� negative� characteristics� that� prevent� or� limit� their� successful� application� and� commercial� use,� such�<br />

failures�could�have�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�condition,�results�of�operations�<br />

and�prospects.�<br />

�<br />

mondoBIOTECH’s�business�strategy�is�based�on�the�concept�that�the�most�effective�and�safe�medicinal�product�<br />

candidates�derive�from�substances�of�human�origin�acting�biologically�as�agonists.�This�concept�may�be�wrong�<br />

mondoBIOTECH’s� business� strategy� is� based� on� the� concept� that� the� most� effective� and� safe� medicinal� product�<br />

candidates�derive�from�substances�of�human�origin�that�naturally�exist�in�the�human�body�and�act�biologically�as�<br />

agonists.�It�may�turn�out�that�this�concept�is�wrong�and�that�mondoBIOTECH’s�medicinal�product�candidates�have�<br />

unacceptable� toxicities,� trigger� undesirable� side� effects,� have� no� or� insufficient� therapeutic� effects� that� would�<br />

prevent�or�limit�their�successful�application.�This�may�have�a�material�adverse�effect�on�mondoBIOTECH’s�business,�<br />

financial�condition,�results�of�operations�and�prospects.�<br />

�<br />

mondoBIOTECH’s� medicinal� product� candidates� are� subject� to� significant� regulatory� approval� requirements,�<br />

which�could�delay,�prevent�or�limit�the�commercialisation�of�the�medicinal�product�candidates�<br />

Prior� to� marketing,� mondoBIOTECH’s� medicinal� product� candidates� must� undergo� a� comprehensive� regulatory�<br />

approval�procedure�by�the�relevant�authorities,�including�the�European�Medicines�Agency�(“EMEA”)�for�Europe,�the�<br />

U.S.� Food� and� Drug� Administration� (“FDA”)� for� the� US� and� other� national� health� agencies,� including� the� Swiss�<br />

Agency�for�Therapeutic�Products�Swissmedic�(Schweizerisches�Heilmittelinstitut���Swissmedic),�the�Swiss�agency�for�<br />

therapeutic�products�(“Swissmedic”)�for�Switzerland.�See�“9.12��Governmental�Regulation”.�Such�procedures�may�<br />

last� several� years� and� require� considerable� financial� expenditure.� While� mondoBIOTECH� endeavours� to� design�<br />

development�programs�with�advice�from�regulatory�authorities,�such�plans�must�often�be�put�in�place�many�years�in�<br />

advance�of�the�planned�registration�dates.�At�the�time�of�registration,�the�clinical�and�regulatory�environment�may�<br />

have� changed� significantly� as� a� result� of� new� scientific� discoveries,� competitor� product� evaluations,� changes� in�<br />

medical�health�care�policies,�new�technical�standards�and�other�factors�outside�mondoBIOTECH’s�control.�<br />

�<br />

Health�authorities�evaluate�the�results�of�clinical�trials�in�the�context�of�existing�and�not�past�needs.�Approval�of�a�<br />

medicinal�product�for�the�original�indication�and�proposed�labelling�is�never�guaranteed,�a�dossier�may�be�rejected,�<br />

more�clinical�data�may�be�requested,�or�modifications�and�restrictions�to�product�labelling�may�be�implemented.�If�<br />

mondoBIOTECH� (and/or� its� commercialisation� partners)� does� not� succeed� in� obtaining� regulatory� approval,� or�<br />

succeeds�only�after�delays,�this�could�damage�mondoBIOTECH’s�reputation�and�adversely�affect�the�marketing�of�<br />

mondoBIOTECH’s� medicinal� product� candidates� and� its� ability� to� generate� revenue� and� could� have� a� material�<br />

adverse�effect�on�mondoBIOTECH’s�business,�financial�conditions,�results�of�operations�and�prospects.�<br />

�<br />

When� a� medicinal� product� candidate� receives� regulatory� approval,� the� approval� can� nonetheless� be� subject� to�<br />

limitations,� e.g.,� with� regard� to� the� indications� for� which� it� may� be� marketed.� The� approval� may� also� be� given�<br />

subject� to� conditions,� such� as� additional� proof� of� the� medicinal� product’s� effectiveness� and� safety.� Even� after�<br />

approval�is�granted,�a�marketed�product,�its�manufacturer�and�the�manufacturing�facilities�are�subject�to�on�going�<br />

scrutiny�and�regular�inspections�by�the�relevant�agencies.�As�a�consequence,�if�previously�unknown�problems�are�<br />

discovered�in�connection�with�an�approved�product,�its�manufacturer�or�the�manufacturing�facilities,�this�can�result�<br />

in�restrictions�on�the�product,�the�manufacturer�or�the�manufacturing�facilities�including�a�requirement�to�withdraw�<br />

the�product�from�the�market.�In�any�event,�changes�in�existing�regulations�or�adoption�of�new�regulations�could�<br />

prevent�mondoBIOTECH�(and/or�its�commercialisation�partners)�from�obtaining�or�maintaining,�or�affect�the�timing�<br />

� 9<br />


of,� future� regulatory� approvals.� Any� such� event� could� materially� adversely� affect� mondoBIOTECH’s� business,�<br />

financial�condition,�results�of�operations�and�prospects.�<br />

�<br />

mondoBIOTECH’s�medicinal�product�candidates�may�be�unable�to�achieve�the�expected�market�acceptance�and�<br />

consequently�the�estimate�revenue�<br />

Even�when�clinical�development�is�successful�and�regulatory�approval�has�been�obtained,�mondoBIOTECH’s�ability�<br />

to� generate� significant� revenue� depends� on� the� acceptance� of� its� medicinal� product� candidate� by� physicians,�<br />

patients�and�other�parties�able�to�have�any�sort�of�influence�on�market�side.�If�mondoBIOTECH’s�medicinal�product�<br />

candidates� fail� to� achieve� market� acceptance,� mondoBIOTECH� (and/or� its� commercialisation� partners)� may� be�<br />

unable� to� generate� revenue.� The� degree� of� market� acceptance� of� a� medicinal� product� depends� on� a� number� of�<br />

factors,� including� the� continued� demonstration� of� efficacy� and� safety� in� commercial� use,� cost�effectiveness,�<br />

convenience�and�ease�of�administration,�potential�advantage�over�alternative�treatment�methods,�competition�and�<br />

marketing�and�distribution�support.�Any�factors�preventing�or�limiting�the�market�acceptance�of�mondoBIOTECH’s�<br />

medicinal� product� candidates� could� result� in� a� material� adverse� effect� on� mondoBIOTECH’s� business,� financial�<br />

condition,�results�of�operations�and�prospects.�<br />

�<br />

The� off�label� use� of� medicinal� products� may� adversely� affect� the� potential� revenue� from� mondoBIOTECH’s�<br />

medicinal�product�candidates�<br />

Physicians�may�prescribe�legally�available�medicinal�products�for�uses�for�which�they�are�not�approved�but�which�<br />

they�consider�as�a�less�expensive�treatment�or�a�better�alternative�(the�“Off�label�use”),�in�particular�in�the�area�of�<br />

rare�and�neglected�diseases.�While�mondoBIOTECH�believes�that�the�Off�label�use�will�decrease�in�future�due�to�the�<br />

strengthening� of� regulatory� laws� and� standards,� the� Off�label� use� may� reduce� the� potential� revenue� from�<br />

mondoBIOTECH’s�medicinal�product�candidates.�Any�such�adverse�effect�could�result�in�a�material�adverse�effect�on�<br />

mondoBIOTECH’s�business,�financial�position,�results�of�operations�and�prospects.�<br />

�<br />

The�availability�of�third�party�reimbursement�for�mondoBIOTECH’s�medicinal�product�candidates�will�be�uncertain,�<br />

and�it�may�be�difficult�to�obtain�and/or�maintain�targeted�price�levels�<br />

mondoBIOTECH’s� (and/or� its� commercialisation� partners’)� ability� to� successfully� commercialise� its� medicinal�<br />

product�candidates�will�depend�in�part�on�the�price�levels�and�on�the�extent�to�which�reimbursement�for�the�costs�<br />

of�treatment�with�these�medicinal�product�candidates�will�be�available�from�governmental�health�administration�<br />

authorities,�private�health�insurers�and�other�third�party�payers,�as�well�as�governmental�health�care�programmes.�<br />

�<br />

Governments�and�other�third�party�payers�are�increasingly�attempting�to�contain�health�care�costs�by�restricting�the�<br />

eligibility�for�reimbursement.�Reimbursement�by�third�party�payers�depends�on�a�number�of�factors,�including�the�<br />

payer’s� determination� that� the� use� of� the� medicinal� product� is� safe� and� effective,� not� experimental� or�<br />

investigational,� medically� necessary,� appropriate� for� the� specific� patient� and� cost�effective.� Seeking� such�<br />

reimbursement� is� a� time�consuming� and� costly� process� which� will� require� mondoBIOTECH� (and/or� its�<br />

commercialisation� partners)� to� provide� scientific� and� clinical� support� for� the� use� of� each� of� mondoBIOTECH’s�<br />

(and/or� its� commercialisation� partners’)� medicinal� product� candidates� to� each� third� party� payer� separately.�<br />

Significant�uncertainty�exists�as�to�the�payment�status�of�newly�approved�medical�products.�The�unavailability�or�<br />

inadequacy�of�third�party�reimbursement�would�have�a�material�adverse�effect�on�the�price�level,�and�consequently,�<br />

the�market�acceptance�of�mondoBIOTECH’s�(and/or�its�commercialisation�partners’)�medicinal�product�candidates.�<br />

In�addition,�mondoBIOTECH�is�unable�to�forecast�what�additional�legislation�or�regulation�relating�to�the�health�care�<br />

industry�or�third�party�coverage�and�reimbursement�may�be�enacted�in�the�future,�or�what�effect�such�legislation�or�<br />

regulation�would�have�on�its�business.�Any�such�event�could�have�a�material�adverse�effect�on�mondoBIOTECH’s�<br />

business,�financial�condition,�results�of�operations�and�prospects.�<br />

3.2 Risks�Related�to�mondoBIOTECH’s�Business�<br />

�<br />

mondoBIOTECH�is�currently�not�profitable�and�expects�that�it�will�continue�to�incur�further�losses.�mondoBIOTECH�<br />

may�never�achieve�profitability�<br />

mondoBIOTECH� has� generated� operating� losses� since� it� began� operations� in� 2001.� As� of� 31� December� 2008,�<br />

mondoBIOTECH�had�an�accumulated�loss�(total�consolidated�accumulated�loss)�of�CHF�23.2�million�(as�of�30�June�<br />

2009,�CHF�27.2�million).�This�loss�resulted�principally�from�costs�incurred�in�research�and�development�of�medicinal�<br />

product�candidates�as�well�as�general�and�administrative�expenses.��<br />

�<br />

As�of�the�date�of�this�Listing�Prospectus,�mondoBIOTECH�has�no�medicinal�products�on�the�market.�mondoBIOTECH�<br />

does�not�expect�that�it�(or�any�of�its�commercialisation�partners)�will�succeed�in�developing�and�commercialising�a�<br />

medicinal�product�for�at�least�more�three�to�four�years,�and,�even�if�a�marketable�medicinal�product�is�successfully�<br />

developed,�mondoBIOTECH�may�incur�losses�for�at�least�the�first�several�years�following�commercialisation.��<br />

�<br />

mondoBIOTECH�expects�its�operating�loss�to�increase�substantially�in�the�foreseeable�future,�primarily�due�to�the�<br />

costs�of�its�development�programmes,�including�pre�clinical�studies�and�clinical�trials.�mondoBIOTECH’s�ability�to�<br />

achieve�profitability�will�depend,�among�other�things,�on�successfully�completing�the�development�of�its�medicinal�<br />

product�candidates,�licensing�or�selling�its�medicinal�product�candidates�to�third�parties,�and/or�collaborating�with�<br />

� 10<br />


third� parties� to� obtain� market� authorisation� or� commercialise� its� medicinal� product� candidates,� and� on� raising�<br />

sufficient� funds� to� finance� its� activities.� No� assurance� can� be� given� that� mondoBIOTECH� will� be� able� to� achieve�<br />

profitability�or�that�profitability,�if�achieved,�can�be�sustained.��<br />

�<br />

mondoBIOTECH�intends�to�raise�additional�funds�in�the�future.�Any�difficulties�in�obtaining�additional�financing�at�<br />

the�appropriate�time�would�adversely�affect�mondoBIOTECH’s�development�<br />

To� continue� its� growth� strategy� and� to� fund� the� further� development� of� its� medicinal� product� candidates,�<br />

mondoBIOTECH�plans�to�increase�its�share�capital�through�the�issue�of�new�shares�out�of�its�existing�authorized�<br />

share�capital�on�a�continuous�basis�following�the�Listing.�mondoBIOTECH’s�future�funding�requirements�will�depend�<br />

on�financial,�economic�and�other�factors,�many�of�which�are�beyond�management’s�control.�In�particular,�delays�or�<br />

changes�in�the�development�of�the�medicinal�product�candidates�may�require�mondoBIOTECH�to�raise�additional�<br />

funds.��<br />

�<br />

Additional� funding� may� not� be� available� on� acceptable� terms,� or� at� all.� If� additional� funds� are� not� available,�<br />

mondoBIOTECH� may� be� forced� to� delay� or� terminate� development,� curtail� operations� or� obtain� funds� through�<br />

collaborative�and�licensing�out�arrangements�that�may�require�mondoBIOTECH�to�relinquish�commercial�rights�or�<br />

potential�markets�or�grant�licenses�on�terms�that�are�not�favourable�to�mondoBIOTECH,�and�mondoBIOTECH�may�<br />

not� be� able� to� achieve� its� business� goals.� Any� of� these� outcomes� may� have� a� material� adverse� effect� on�<br />

mondoBIOTECH’s�business,�operating�results,�financial�condition�and�prospects.��<br />

�<br />

Moreover,�if�mondoBIOTECH�raises�additional�funds�by�issuing�new�shares,�the�Company’s�shareholders�may�have�<br />

to� accept� equity� financing� terms� which� may� excessively� dilute� their� participation.� Debt� financing,� to� the� extent�<br />

available,�may�include�restrictive�covenants�that�limit�mondoBIOTECH’s�operating�flexibility.�<br />

�<br />

mondoBIOTECH� relies� on� the� expertise� and� contributions� of� the� mondoBIOTECH� Community� and� its�<br />

commercialisation�partners�<br />

In�mondoBIOTECH’s�business�model,�the�knowledge�of�the�relationship�between�medicinal�product�candidates�and�<br />

the� targeted� diseases� is� essential� for� conceiving� the� whole� development� and� gaining� the� necessary� competitive�<br />

advantages.�Because�of�the�large�number�of�its�medicinal�product�candidates,�mondoBIOTECH�depends�to�a�large�<br />

extent�on�the�continued�expertise,�know�how,�best�practice,�experience�and�research�skills�and�other�contributions�<br />

of�the�outside�biologists,�biochemists,�physicians,�patients�and�patient�advocacy�organisations,�and�other�persons�<br />

and�organisations��forming�the�mondoBIOTECH�Community,�and�its�commercialisation�partners.�<br />

�<br />

The�competition�for�such�relationships�is�intense,�and�there�can�be�no�assurance�that�mondoBIOTECH�will�be�able�to�<br />

retain� and� maintain� the� mondoBIOTECH� Community� and� its� commercialisation� partners� on� acceptable� terms.� If�<br />

mondoBIOTECH� fails� to� retain� and� maintain� such� parties,� this� may� have� a� material� adverse� effect� on�<br />

mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�prospects.�<br />

�<br />

mondoBIOTECH� may� not� be� able� to� retain� its�management� and� key� personnel� and� may� not� be� able� to� hire� or�<br />

retain�additional�qualified�personnel�<br />

mondoBIOTECH’s� success� is� largely� dependent� on� its� ability� to� retain� its� existing� management� and� other� key�<br />

personnel.�The�loss�of�the�services�of�one�or�more�managers�or�key�personnel�could�have�a�material�adverse�effect�<br />

on�mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�prospects.�<br />

�<br />

As�mondoBIOTECH’s�business�continues�to�grow,�its�success�is�also�dependent�on�its�ability�to�attract,�retain�and�<br />

motivate�additional�qualified�management�and�scientific�personnel.�Any�failure�to�attract,�retain�and�motivate�such�<br />

personnel� could� have� a� material� adverse� effect� on� mondoBIOTECH’s� business,� financial� condition,� results� of�<br />

operations�and�prospects.�<br />

�<br />

mondoBIOTECH� relies� on� third� party� manufacturers� and� service� providers� as� part� of� its� strategic� outsourcing�<br />

concept� and� is� dependent� on� such� third� parties� for� cost� effective� development� and� manufacture� and/or� for�<br />

adequate�performance�of�their�services�<br />

Developing� and� manufacturing� substances� for� clinical� trials� or� in� commercial� quantities� necessitates� specific�<br />

expertise�and�compliance�with�regulatory�requirements,�such�as�current�good�manufacturing�practices�(“cGMP”),�<br />

and� will� be� time�consuming� and� expensive.� As� part� of� its� business� strategy,� mondoBIOTECH� outsources� the�<br />

manufacturing�of�its�medicinal�product�candidates�to�third�parties�for�development�and/or�commercialisation.��<br />

�<br />

If�mondoBIOTECH’s�manufacturers�fail�to�perform�their�obligations,�if�the�availability�of�suitable�manufacturers�with�<br />

the�required�facilities�and�expertise�is�limited�or�interrupted,�if�contractual�disputes�occur�or�other�events�prevent�<br />

the� supply� of� contractual� manufacturing� services,� or� if� the� supply� of� components� or� other� materials� becomes�<br />

otherwise� limited� or� interrupted,� mondoBIOTECH� (and/or� its� commercialisation� partners)� may� not� be� able� to�<br />

develop�or�commercialise�its�medicinal�product�candidates�on�a�timely�or�cost�competitive�basis,�if�at�all.�Any�such�<br />

event�could�have�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�condition,�results�of�operations�<br />

and�prospects.�<br />

�<br />

� 11<br />


In� addition,� mondoBIOTECH’s� (and/or� its� commercialisation� partners’)� reliance� on� third� party� suppliers,�<br />

manufacturers�and�other�service�providers�poses�additional�risks�including:�<br />

�<br />

- Non�compliance�by�third�party�suppliers,�manufacturers�or�other�service�providers�with�regulatory�and�quality�<br />

control�standards;�<br />

- Breach�of�agreements�with�mondoBIOTECH�(and/or�its�commercialisation�partners)�by�third� party�suppliers,��<br />

manufacturers�or�other�third�party�providers;�and�<br />

- Termination� or� non�renewal� of� these� agreements� for� reasons� beyond� mondoBIOTECH’s� (and/or� its�<br />

commercialisation�partners’)�control.�<br />

�<br />

Further,�if�products�or�substances�supplied�or�manufactured�or�services�rendered�by�a�third�party�fail�to�comply�with�<br />

applicable� regulatory� standards,� mondoBIOTECH� could� be� sanctioned.� These� sanctions� could� include� fines,�<br />

injunctions,� civil� penalties,� failure� of� regulatory� authorities� to� grant� marketing� approval� of� mondoBIOTECH’s�<br />

medicinal�product�candidates,�delays,�suspension�or�withdrawal�of�approvals,�license�revocation,�seizures�or�recalls�<br />

of�products,�operating�restrictions�and�criminal�prosecutions,�any�of�which�could�significantly�and�adversely�affect�<br />

mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�prospects.�<br />

�<br />

mondoBIOTECH� will� carefully� select� manufacturers� that� it� believes� comply� with� cGMP� and� other� applicable�<br />

regulatory�standards.�However,�mondoBIOTECH�may�be�unable�to�reach�satisfactory�agreements�with�such�parties,�<br />

and�such�arrangements�may�be�unsuccessful�or�its�commercialisation�partners�may�not�be�able�to�develop�adequate�<br />

manufacturing� capabilities� for� cost�effective� products� and� services� in� commercial�scale� quantities.� It� is� also�<br />

uncertain� whether� mondoBIOTECH’s� medicinal� product� candidates� can� be� manufactured� in� large� scale� at�<br />

commercially�acceptable�cost�levels.�<br />

�<br />

mondoBIOTECH�does�not�conduct�clinical�trials�for�its�medicinal�product�candidates�itself�and�relies�therefore�on�<br />

third�parties�(such�as�medical�institutions,�academic�institutions,�clinical�investigators�and�contractual�laboratories)�<br />

for�conducting�clinical�trials.�Should�any�of�such�third�parties�not�perform�its�obligations�as�expected�or�agreed,�the�<br />

obtaining�of�regulatory�approval�or�the�commercialisation�of�mondoBIOTECH’s�medicinal�product�candidates�may�<br />

be�impaired.�This�may�result�in�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�condition,�results�<br />

of�operations�and�prospects.�<br />

�<br />

mondoBIOTECH�may�encounter�difficulties�managing�future�growth�<br />

mondoBIOTECH�will�need�to�significantly�expand�and�effectively�manage�its�organisation,�personnel�and�operations�<br />

in�order�to�successfully�develop�and�commercialise�its�product� candidates.�mondoBIOTECH�currently�employs�24�<br />

employees.� mondoBIOTECH� will� only� be� able� to� organise� operations� efficiently� and� to� avoid� the� misallocation� of�<br />

resources�if�it�continues�to�improve�its�operational�controls,�its�reporting�systems�and�procedures�as�well�as�attract�<br />

and� retain� sufficient� numbers� of� qualified� employees.� mondoBIOTECH� may� be� unable� to� successfully� implement�<br />

these� tasks� in� time� and� on� a� larger� scale� and,� accordingly,� may� not� achieve� its� research,� development� and�<br />

commercialisation�goals.�If�mondoBIOTECH�is�not�able�to�manage�growth�effectively,�its�operational�efficiency�could�<br />

be�materially�adversely�affected.�<br />

�<br />

mondoBIOTECH� faces� competition� from� other� companies� that� have� developed� or� are� developing� similar� or�<br />

different�product�candidates�aiming�at�the�same�indication�in�rare�and�neglected�diseases�<br />

mondoBIOTECH�is�engaged�in�the�development�of�medicinal�product�candidates�for�attractive�niche�markets�and�is�<br />

therefore� competing� with� pharmaceutical� and� biotechnology� companies.� mondoBIOTECH’s� competitors� have�<br />

developed,� or� are� developing,� or� will� develop� drug� candidates� and� processes� that� will� compete� with�<br />

mondoBIOTECH’s� medicinal� product� candidates.� Competitors� enjoy� a� significant� advantage� if� they� are� able� to�<br />

achieve� patent� protection,� obtain� regulatory� approvals� or� commence� commercial� sales� of� their� products� before�<br />

mondoBIOTECH.� Competing� existing� or� new� medicinal� products� could� also� prove� to� be� superior� treatment�<br />

alternatives,� have� fewer� side� effects,� be� less� expensive� or� have� achieved� better� market� acceptance� than�<br />

mondoBIOTECH’s�medicinal�product�candidates,�and�thus�may�adversely�affect�the�demand�for�mondoBIOTECH’s�<br />

medicinal� product� candidates� and� the� availability� of� marketing� exclusivity� on� the� basis� of� an� OMPD.� Since�<br />

competitors�of�mondoBIOTECH�may�have�significantly�larger�resources�than�mondoBIOTECH�or�are�or�may�be�more�<br />

advanced� in� the� development� of� their� products,� mondoBIOTECH� may� not� be� able� to� successfully� compete.� This�<br />

could�have�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�<br />

prospects.�<br />

�<br />

mondoBIOTECH� may� become� exposed� to� costly� and� damaging� product� liability� claims� and� may� not� be� able� to�<br />

maintain�sufficient�product�liability�insurance�to�cover�these�claims�<br />

mondoBIOTECH’s�business�entails�a�potential�risk�of�substantial�liability�for�damages�in�the�event�of�product�failure�<br />

or�adverse�side�effects.�It�is�always�possible�that�a�medicinal�product�candidate,�even�after�approval,�may�exhibit�<br />

unforeseen�failures�or�negative�side�effects.�It�cannot�be�assured�that�sufficient�insurance�coverage�will�be�available�<br />

to�mondoBIOTECH�at�acceptable�terms.�<br />

�<br />

If�any�of�mondoBIOTECH’s�medicinal�product�candidates�were�to�fail�or�produce�adverse�side�effects,�substantial�<br />

uninsured�losses�could�result�which�could�have�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�<br />

� 12<br />


condition,�results�of�operations�and�prospects.�Even�if�product�failures�or�negative�side�effects�are�not�so�serious�as�<br />

to� warrant� withdrawing� the� product� from� the� market,� they� may� reduce� the� medicinal� product� candidate’s�<br />

competitiveness� or� adversely� affect� mondoBIOTECH’s� reputation� which� could� have� a� material� adverse� effect� on�<br />

mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�prospects.�<br />

�<br />

mondoBIOTECH�may�expend�its�resources�to�pursue�a�particular�medicinal�product�candidate�and�fail�to�capitalise�<br />

on�a�medicinal�product�candidate�that�may�be�more�profitable�or�for�which�there�is�a�greater�likelihood�of�success�<br />

Because�mondoBIOTECH�has�limited�financial,�technical�and�managerial�resources,�mondoBIOTECH�should�focus�its�<br />

development�on�medicinal�product�candidates�that�it�believes�are�most�promising.�As�a�result,�mondoBIOTECH�may�<br />

forego�or�delay�pursuit�of�opportunities�with�other�medicinal�product�candidates�that�later�prove�to�have�greater�<br />

commercial�potential.�mondoBIOTECH’s�resource�allocation�may�cause�it�to�fail�to�capitalise�on�promising�medicinal�<br />

product�candidates.�In�addition,�mondoBIOTECH�may�spend�valuable�time�and�managerial,�technical�and�financial�<br />

resources�on�medicinal�product�candidates�that�ultimately�do�not�yield�any�commercially�viable�products.�<br />

�<br />

mondoBIOTECH’s�search�and�development�activities�could�be�delayed�or�become�more�expensive�as�a�result�of�<br />

restrictions�on�animal�testing�<br />

Certain� laws� and� regulations� relating� to� drug� development� require� mondoBIOTECH� to� test� its� medicinal� product�<br />

candidates� on� animals� before� initiating� clinical� trials� involving� humans.� Animal� testing� activities� have� been� the�<br />

subject� of� controversy� and� adverse� publicity.� Animal� rights� groups,� other� organisations� and� individuals� have�<br />

attempted�to�stop�animal�testing�activities�by�pressing�for�additional�legislation�and�regulation�and�by�disrupting�<br />

research�and�development�activities�through�protests�and�other�means.�The�activities�of�these�groups�may�result�in�<br />

regulations�or�restrictions�on�mondoBIOTECH’s�operations�or�may�cause�disruptions�which�could�delay�or�increase�<br />

the�costs�of�mondoBIOTECH’s�development�activities.�<br />

�<br />

mondoBIOTECH�is�subject�to�environmental,�health�and�safety�regulations�<br />

mondoBIOTECH�is�subject�to�a�variety�of�health,�safety�and�environmental�regulations�in�the�jurisdictions�in�which�it�<br />

operates,� particularly� in� its� research� and� development� activities,� as� well� in� its� pre�clinical� studies.� Currently,�<br />

mondoBIOTECH�does�not�anticipate�any�material�capital�expenditures�in�respect�of�such�regulations�outside�of�the�<br />

ordinary�course�of�its�business.�However,�the�risk�of�environmental�liability�is�inherent�in�mondoBIOTECH’s�business,�<br />

and� there� can� be� no� assurance� that� material� environmental� costs� inside� or� outside� of� the� ordinary� course� of�<br />

business�will�not�arise�in�the�future.�mondoBIOTECH�may�be�held�liable�for�any�resulting�damages,�which�in�turn�<br />

could� have� a� material� adverse� effect� on� mondoBIOTECH’s� business,� financial� condition,� results� of� operation� and�<br />

prospects.�<br />

3.3 Risks�Related�to�Intellectual�Property�<br />

�<br />

If� mondoBIOTECH� fails� to� secure� adequate� protection� of� its� own� intellectual� property,� it� may� not� be� able� to�<br />

protect�its�medicinal�product�candidates�and�technologies�against�competitors�<br />

mondoBIOTECH’s�success�depends�in�large�part�on�its�ability�to�obtain,�maintain�and�protect�its�intellectual�property�<br />

and� on� successfully� defending� it� against� third� party� challenges.� mondoBIOTECH’s� ability� to� commercialise� its�<br />

medicinal�product�candidates�will�also�depend�in�large�part�on�the�patent�positions�of�third�parties,�including�those�<br />

of�its�competitors.�The�patent�positions�of�pharmaceutical�and�biotechnology�companies�can�be�highly�uncertain�<br />

and�involve�complex�legal�and�factual�questions.�In�particular,�as�mondoBIOTECH�works�with�relatively�well�known�<br />

medicinal� product� candidates,� it� can� obtain� only� patent� protection� for� a� combination,� formula,� process� or� novel�<br />

indication�application�(second�medical�use�application).�As�in�all�industrial�fields,�patent�claims�may�be�interpreted�<br />

in�a�strict�or�broad�way.�It�is�not�possible�to�predict�with�any�certainty�how�the�patent�claims�will�be�interpreted.�<br />

�<br />

mondoBIOTECH� therefore� cannot� be� certain� that� it� will� be� able� to� successfully� achieve� and� enforce� desired�<br />

protection�of�proprietary�rights�for�its�medicinal�product�candidates�and�technologies,�and�failure�in�this�respect�<br />

could�have�a�material�adverse�effect�on�mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�<br />

prospects.�In�addition,�mondoBIOTECH�could�incur�substantial�costs�in�litigation�if�it�is�required�to�defend�against�<br />

patent�suits�brought�to�court�by�third�parties,�or�if�it�initiates�these�suits.�<br />

�<br />

The�degree�of�future�protection�for�mondoBIOTECH’s�proprietary�rights�is�uncertain,�and�mondoBIOTECH�cannot�<br />

ensure�that:�<br />

�<br />

� Its�pending�patent�applications�are�non�obvious;�<br />

� Others�will�not�independently�develop�similar�or�alternative�technologies�or�duplicate�any�of�mondoBIOTECH’s�<br />

technologies;�<br />

� Any�of�its�pending�patent�applications�will�result�in�issued�patents;�and�<br />

� Any�of�its�potentially�issued�patents�will�be�valid�and�enforceable.�<br />

�<br />

mondoBIOTECH�may�be�unable�to�protect�its�trade�secrets�and�know�how�<br />

mondoBIOTECH� also� relies� on� trade� secrets� and� non�patentable� know�how� it� seeks� to� protect,� in� part,� by�<br />

confidentiality�agreements�with�its�employees,�consultants,�suppliers,�licensees�and�other�contractual�parties.�Trade�<br />

� 13<br />


secrets�and�non�patentable�know�how�are�difficult�to�protect.�There�can�be�no�assurance�that�these�agreements�<br />

represent� effective� protection� or� that� they� will� not� be� breached,� that� mondoBIOTECH� would� have� adequate�<br />

remedies�for�any�breach,�or�that�its�trade�secrets�or�non�patentable�know�how�will�not�otherwise�become�known�or�<br />

be�independently�developed�by�competitors.�<br />

�<br />

mondoBIOTECH’s� medicinal� product� candidates� may� infringe� the� intellectual� property� rights� of� third� parties� of�<br />

which�mondoBIOTECH�is�not�aware,�and�mondoBIOTECH�could�be�subject�to�expensive�litigation�or�be�required�to�<br />

obtain�licenses�from�others�in�order�to�get�access�to,�develop�or�commercialise��its�medicinal�product�candidates�<br />

If� mondoBIOTECH’s� medicinal� product� candidates� and� technologies� or� other� subject� matters� are� claimed� under�<br />

other�existing�patents�or�are�otherwise�protected�by�third�party�proprietary�rights,�mondoBIOTECH�may�be�subject�<br />

to� infringement� actions.� If� mondoBIOTECH� is� required� to� defend� it� against� charges� of� patent� infringement� or� to�<br />

protect�its�own�proprietary�rights�against�third�parties,�including�by�challenging�the�validity�of�potentially�conflicting�<br />

patents�in�annulment�actions,�substantial�costs�could�be�incurred�and�significant�management�resources�could�be�<br />

consumed�regardless�of�whether�mondoBIOTECH�is�successful.�Such�proceedings�are�typically�protracted�with�no�<br />

certainty�of�success.�An�adverse�outcome�could�subject�mondoBIOTECH�to�significant�liabilities�to�third�parties,�and�<br />

force�it�to�curtail�or�to�cease�the�development�and�sale�of�its�products�and�processes,�or�require�it�to�obtain�licenses�<br />

at� unfavourable� terms� from� others� in� order� to� get� access� to,� develop� or� commercialise� its� medicinal� product�<br />

candidates.�<br />

�<br />

An�OMPD�does�not�equal�a�patent�or�any�other�intellectual�property�right�<br />

OMPD� status� is� adopted� by� regulatory� agencies.� It� represents� a� certification� of� the� scientific� backgrounds� of� a�<br />

project,� confers� certain� advantages� during� the� development� process� and� market� exclusivity� once� the� medicinal�<br />

product�candidate�is�market�authorised,�but�refers�exclusively�to�a�development�and�registration�process�exclusively�<br />

under�regulatory�settings.�OMPD�does�in�any�case�not�represent�a�proprietary�right�as�intended�under�intellectual�<br />

property�laws.�Therefore,�possessing�an�OMPD�will�not�prevent�mondoBIOTECH�from�any�third�party�intellectual�<br />

property� infringement,� which� could� have� a� material� adverse� effect� on� mondoBIOTECH’s� business,� financial�<br />

condition,�results�of�operations�and�prospects.�<br />

�<br />

In�order�to�obtain�certain�marketing�exclusivity,�mondoBIOTECH�could�have�to�exclusively�rely�on�an�OMPD�rather�<br />

than� on� patents.� mondoBIOTECH� may� fail� to� obtain� or� maintain� such� OMPD� or� a� third� party� should� obtain�<br />

marketing�approval�for�the�same�indication�using�the�same�medicinal�product�candidate�<br />

As�mondoBIOTECH�focuses�on�relatively�well�known�medicinal�product�candidates,�it�may�not�be�able�to�protect�its�<br />

medicinal� product� candidates� with� patents� and� will� have� to� rely� on� OMPD� in� order� to� obtain� limited� marketing�<br />

exclusivity.�OMPD�grants,�if�and�when�marketing�authorisation�should�be�obtained,�the�exclusivity�to�market�the�<br />

relevant�medicinal�product�for�the�specified�disease�during�seven�years�in�the�US�and�during�ten�years�in�the�EU.�<br />

�<br />

There� is,� however,� no� assurance� that� mondoBIOTECH� will� be� able� to� obtain� OMPD� for� its� medicinal� product�<br />

candidates�and,�once�obtained,�there�is�no�assurance�that�mondoBIOTECH�will�be�able�to�maintain�it.�Marketing�<br />

exclusivity�can�be�lifted�or�exceptions�to�the�granted�marketing�exclusivity�may�be�granted�to�other�applicants,�if�<br />

mondoBIOTECH�is�unable�to�timely�develop�its�medicinal�product�candidates,�to�supply�sufficient�quantities�of�the�<br />

medicinal� product� candidates� or,� if� a� potential� therapeutic� based� on� the� same�substance� of� another� applicant� is�<br />

clinically�superior.�Further,�the�protection�granted�by�OMPD�is�not�as�broad�and�long�lasting�as�patent�protection.�<br />

Also,�OMPD�does�not�exclude�that�the�same�status�is�granted�to�a�second�applicant�for�the�same�indication�using�a�<br />

different�substance.�<br />

�<br />

If,�for�any�of�these�reasons,�mondoBIOTECH�(and/or�its�commercialisation�partners)�cannot�obtain�or�maintain�such�<br />

marketing�exclusivity�or�may�not�market�its�potential�therapeutics�at�all,�this�could�have�a�material�adverse�effect�<br />

on�mondoBIOTECH’s�business,�financial�condition,�results�of�operations�and�prospects.�<br />

3.4 Risks�Related�to�the�Common�Shares�and�the�Listing�<br />

�<br />

An�active�or�liquid�trading�market�for�the�Common�Shares�may�fail�to�develop�after�the�Listing�<br />

Prior�to�the�Listing,�investors�could�not�buy�or�sell�the�Common�Shares�publicly,�and�the�Listing�does�not�increase�<br />

the�currently�limited�number�of�shareholders.�The�limited�number�of�shareholders�and�the�current�two�type�share�<br />

structure�of�the�Company�may�have�a�negative�impact�on�the�liquidity�of�the�trading�market�for�the�Common�Shares�<br />

and�result�in�a�lower�trading�volume�or�even�an�illiquid�market�for�the�Common�Shares,�which�could�adversely�affect�<br />

the�level�and�volatility�of�prevailing�market�prices�for�the�Common�Shares.�An�active�and�liquid�trading�market�for�<br />

the�Common�Shares�may�not�develop�or�be�sustained�after�the�Listing.�If�an�active�and�liquid�trading�market�for�the�<br />

Common�Shares�does�not�develop,�investors�may�have�difficulty�selling�their�Common�Shares�in�a�short�period�of�<br />

time,�or�at�all.�<br />

�<br />

The�market�price�of�the�Common�Shares�may�be�highly�volatile�<br />

The� market� price� of� the� Common� Shares� may� be� highly� volatile� and� may� be� negatively� affected� by� a� variety� of�<br />

events� involving� mondoBIOTECH,� its� partners,� its� competitors,� or� the� capital� markets� in� general,� and� the�<br />

� 14<br />


iotechnological�and�pharmaceutical�sectors�in�particular.�Factors�that�could�cause�this�volatility�in�the�price�of�the�<br />

Common�Shares�include,�but�are�not�limited�to:�<br />

�<br />

� Actual�or�anticipated�fluctuations�in�the�Company’s�results�of�operations�or�financial�conditions;�<br />

� Market�expectations�for�the�Group’s�financial�performance;�<br />

� Changes�in�the�estimate�of�the�Group’s�results�of�operations�by�securities�analysts;�<br />

� Investor�perception�of�the�impact�of�the�Listing�on�the�Group�and�the�shareholders;�<br />

� The�entrance�of�new�competitors�or�new�products�in�the�markets�of�the�Group;�<br />

� The�limited�liquidity�of�the�trading�market�for�the�Common�Shares;�<br />

� Price�and�volume�fluctuations�in�the�overall�capital�markets�from�time�to�time;�<br />

� Volatility�resulting�from�trading�in�derivative�securities�related�to�the�Common�Shares;�<br />

� General�economic�conditions�and�trends;�and�<br />

� The�factors�mentioned�in�this�section�of�this�Listing�Prospectus.�<br />

�<br />

A�sale�of�a�substantial�number�of�the�Shares�following�the�Listing�could�adversely�affect�the�market�price�of�the�<br />

Common�Shares�<br />

As�neither�the�principal�shareholders�nor�any�other�shareholder�are�subject�to�lock�up�agreements,�all�shareholders�<br />

may�sell�their�Shares�immediately�following�the�Listing.�Sales,�or�the�possibility�of�sales,�of�a�substantial�number�of�<br />

Shares�in�the�public�following�the�Listing�could�adversely�affect�the�prevailing�market�price�for�the�Common�Shares.�<br />

In�addition,�sales�of�Shares�by�the�principal�shareholders�may�be�interpreted�by�the�market�as�a�negative�signal�with�<br />

respect� to� such� shareholders’� belief� in� the� future� prospect� of� mondoBIOTECH’s� business.� That� interpretation,�<br />

whether�truthful�or�not,�may�also�adversely�affect�the�market�price�for�the�Common�Shares.�<br />

�<br />

Investors�will�not�be�able�to�affect�the�outcome�of�any�shareholder�vote�<br />

Immediately� following� the� Listing,� BIOPHARMAinvest� AKTIENGESELLSCHAFT,� CTB� HOLDING� AG� and� HEALTHCARE�<br />

FAMILY�OFFICES�AG,�Stiftung�PMSERV�and�Prinz�Michael�von�und�zu�Liechtenstein,�acting�as�a�group,�will�continue�<br />

to� own� 73.18%� of� the� Company’s� voting� rights� and� 60.60%� of� the� nominal� value� of� the� Shares.� See� “12��Major�<br />

Shareholders”.�As�a�result,�they�will�have�the�majority�necessary�to�direct�the�election�of�the�Company’s�board�of�<br />

directors�(the�“Board�of�Directors”)�and�to�determine�the�outcome�of�all�other�matters�submitted�to�the�vote�of�the�<br />

shareholders,�including�the�ability�to�control�dividend�payments,�mergers�and�other�extraordinary�transactions,�as�<br />

well�as�the�amendments�of�the�Articles�of�Association�or�alterations�of�the�Company’s�capital�structure,�including�<br />

authorising�the�issue�of�new�shares.�Further,�the�principal�shareholders�will�also�have�the�power�to�prevent�or�cause�<br />

a�change�in�control,�and�could�take�other�actions�that�might�not�be�favourable�to�all�shareholders,�including�the�<br />

holders�of�Common�Shares.�The�ownership�of�these�principal�shareholders�will�also�generally�enable�them�to�block�<br />

the�adoption�of�shareholders’�resolutions�they�do�not�favour.�Consequently,�holders�of�Common�Shares�will�not�be�<br />

able�to�affect�the�outcome�of�any�shareholder�vote.�In�addition,�to�the�extent�that�the�interests�of�the�shareholders’�<br />

group�may�differ�from�the�interests�of�the�other�shareholders�(including�the�holders�of�the�Common�Shares),�the�<br />

other�shareholders�may�be�disadvantaged�by�any�actions�that�the�shareholders’�group�may�seek�to�pursue.�<br />

�<br />

The�Articles�of�Association�provide�for�an�“opting�out”�clause�<br />

The�Articles�of�Association�exempt�shareholders�from�the�duty�to�make�a�public�tender�offer�pursuant�to�art.�32�of�<br />

the�SESTA.�As�a�result,�any�shareholder�or�a�group�of�shareholders�exceeding�the�thresholds�of�33 1 / 3%�of�the�voting�<br />

rights� of� the� Company� will� not� be� required� to�provide� other� shareholders� the� full� protection� afforded� by� SESTA,�<br />

which�among�other�things�requires�extending�the�offer�to�all�shareholders.�See�“13.16��Public�Tender�Offers”.�<br />

�<br />

The�Company�has�never�paid�dividends�on�its�Common�Shares,�and�does�not�anticipate�paying�dividends�for�the�<br />

foreseeable�future�<br />

The�Company�has�never�paid�any�dividends�on�its�Common�Shares,�and�it�currently�intends�to�retain�all�available�<br />

funds�and�future�earnings,�if�any,�to�fund�the�development�and�commercialisation�of�its�product�candidates�or�for�<br />

general�corporate�purposes.�As�a�result,�capital�appreciation,�if�any,�will�be�an�investor’s�only�source�of�financial�gain�<br />

from�an�investment�in�Common�Shares�for�the�foreseeable�future.�<br />

�<br />

The�issuance�of�equity�or�debt�securities�that�are�convertible�into�equity�could�dilute�any�current�shareholdings�<br />

The�Company�may�choose�to�raise�additional�capital�depending�on�market�conditions�or�strategic�considerations.�To�<br />

the�extent�that�additional�capital�is�raised�through�the�issuance�of�equity�or�other�securities�that�are�convertible�<br />

into�equity,�the�issuance�of�these�securities�could�further�dilute�the�investors’�proportional�holding�of�the�Common�<br />

Shares.�<br />

�<br />

Investors� in� countries� with� currencies� other� than� Swiss� francs� face� additional� investment� risk� from� currency�<br />

exchange�rate�fluctuations�in�connection�with�their�holding�of�Common�Shares�<br />

The�Common�Shares�will�be�quoted�and�traded�only�in�Swiss�francs�and�any�future�payments�of�dividends�on�the�<br />

Common�Shares�will�be�denominated�in�Swiss�francs.�The�foreign�currency�equivalent�to�any�dividends�paid�on�the�<br />

Common�Shares�or�received�in�connection�with�any�sale�of�the�Common�Shares�could�be�adversely�affected�by�a�<br />

depreciation�of�the�Swiss�franc�against�such�other�currency.�<br />

�<br />

� 15<br />


Shareholders�may�not�be�able�to�participate�in�future�equity�offerings�<br />

Under� Swiss� corporate� law,� holders� of� shares� are� generally� given� the� right� to� subscribe� for� and� to� pay� for� a�<br />

corresponding�number�of�shares�in�order�to�maintain�the�same�ownership�ratio�as�prior�to�the�issue�of�new�shares�<br />

or�convertible�bonds.�Certain�shareholders�in�certain�jurisdictions�may�not�be�entitled�to�exercise�their�rights�unless�<br />

the�rights�and�shares�are�registered�or�qualified�for�sale�under�the�relevant�legislation�or�regulatory�framework.�As�a�<br />

result,�there�is�the�risk�that�shareholders�may�suffer�dilution�of�their�shareholding,�should�they�not�be�permitted�to�<br />

participate�in�future�equity�offerings.�<br />

�<br />

� 16<br />


4 Dividends�and�Dividend�Policy�<br />

All�Shares,�including�the�Common�Shares,�are�entitled�to�dividends�in�proportion�to�the�nominal�value�of�the�Shares.�<br />

The� Company� has� not� paid� any� dividends� since� its� incorporation.� Future� dividend� payments� depend� on� the�<br />

performance�of�mondoBIOTECH,�its�financial�position,�its�cash�requirements,�the�general�economic�situation�of�the�<br />

markets�in�which�mondoBIOTECH�operates�as�well�as�on�the�general�legal,�fiscal�and�regulatory�environment�and�<br />

other�factors.�<br />

�<br />

The�Company�currently�intends�to�retain�all�earnings�for�use�in�the�operations�and�expansion�of�its�business�and�<br />

accordingly�does�not�anticipate�paying�dividends�on�its�Shares�in�the�foreseeable�future.�<br />

�<br />

Dividends,�if�any,�declared�by�the�Company�are�expected�to�be�paid�in�Swiss�francs.�<br />

�<br />

For�further�information,�see�“13.10��Dividends”.�<br />

�<br />

Any�dividends�paid�on�the�Shares�will�be�subject�to�Withholding�Tax.�See�“14.1��Withholding�Tax”.�<br />

�<br />

� 17<br />


5 Capitalisation�<br />

The�following�table�sets�forth�the�consolidated�capitalisation�of�the�Company�as�of�30�June�2009.�This�table�should�<br />

be�read�in�conjunction�with�the�historical�consolidated�financial�statements�and�the�related�notes�of�the�Group,�as�<br />

well�as�the�other�financial�statements�and�information�included�elsewhere�in�this�Listing�Prospectus.�<br />

�<br />

As�at<br />

30�June�2009<br />

(in�CHF)<br />

Cash�and�cash�equivalents 7'687'294<br />

Non�current�liabilities 297'299<br />

Unsecured,�contingent�liabilities 3'413'305<br />

Total�non�current�liabilities 3'710'604<br />

Share�capital 653'883<br />

Reserves 91'491'682<br />

Accumulated�loss (27'158'543)<br />

Total�shareholders'�equity 64'987'022<br />

Total�capitalisation 68'697'626<br />

�<br />

�<br />

As�at�30�June�2009,�mondoBIOTECH�did�not�have�any�outstanding�conversion�and�option�rights,�bonds�or�loans.�<br />

�<br />

There�has�been�no�material�adverse�change�to�shareholder’s�equity�as�disclosed�in�the�table�above�since�30�June�<br />

2009.�<br />

�<br />

Contingent�liabilities�of�the�Company�as�at�30�June�2009�amount�to�CHF�3‘413‘305.�<br />

�<br />

�<br />

� 18<br />


6 Selected�Consolidated�Financial�Information�<br />

The� following� selected� consolidated� financial� information� of� mondoBIOTECH� should� be� read� in� conjunction� with�<br />

mondoBIOTECH’s� consolidated� financial� statements� and� related� notes� and� “8� �Management’s� Discussion� and�<br />

Analysis�of�Financial�Condition�and�Result�of�Operations”,�each�appearing�elsewhere�in�this�Listing�Prospectus.�The�<br />

summary�consolidated�financial�data�for�the�years�2008,�2007�and�2006�and�for�the�first�six�months�ended�at�30�<br />

June� 2009� and� 2008� have� been� derived� from� the� Company’s� consolidated� financial� statements� 2008� and� 2007,�<br />

which� have� been� audited� by� PricewaterhouseCoopers� AG,� independent� accountants,� and� from� the� Company’s�<br />

unaudited�interim�financial�information�at�30�June�2009.�<br />

6.1 Consolidated�Income�Statement�Data�<br />

�<br />

� 19<br />

Six�months�ended�30�June<br />

Year�ended�31�December<br />

2009<br />

(unaudited)<br />

2008 2008<br />

(in�CHF)<br />

2007 2006<br />

Revenues 7'990'475 8'567'700 14'545'200 14'827'184 2'480'161<br />

Research�&�development�costs (9'293'482) (10'347'560) (20'172'940) (11'291'181) (4'823'805)<br />

Sales�&�marketing�costs (1'685'957) (1'327'722) (2'350'600) (3'761'635) (2'045'781)<br />

Management�&�administration�costs (916'986) (566'044) (1'190'778) (1'508'704) (1'754'063)<br />

Operating�result (3'905'950) (3'673'626) (9'169'118) (1'734'336) (6'143'488)<br />

Finance�income 163'191 227'828 548'196 623'418 176'784<br />

Finance�costs (208'000) (388'558) (779'913) (654'482) (1'045'427)<br />

Result�before�income�taxes (3'950'759) (3'834'356) (9'400'835) (1'765'400) (7'012'131)<br />

Income�taxes ���������������������������� ���������������������������� ��������������������������� � (234'888) (200'005)<br />

Result�of�the�period (3'950'759) (3'834'356) (9'400'835) (2'000'288) (7'212'136)<br />

Attributable�to:<br />

Equity�holders�of�the�Company (3'950'759) (3'834'356) (9'400'835) (1'605'210) (7'224'761)<br />

Minority�interest ���������������������������� ���������������������������� ��������������������������� � (395'078) 12'625<br />

(3'950'759) (3'834'356) (9'400'835) (2'000'288) (7'212'136)<br />

Basic�and�diluted�loss�per�share� 1 (0.078) (0.298) (0.729) (0.154) (2.021)<br />

�<br />

1�Basic�and�diluted�loss�per�share�refer�to�the�Voting�Right�Shares,�with�a�par�value�of�CHF�0.01.�The�Common�Shares�have�a�par�<br />

value�of�CHF�0.10.�There�are�no�differences�in�the�character�of�the�two�classes�of�shares�except�the�par�value.�Common�Shares�<br />

therefore�show�a�basic�and�diluted�loss�per�share�of�CHF�0.78�as�per�30�June�2009.�<br />

6.2 Consolidated�Balance�Sheet�Data�<br />

�<br />

As�at�30�June<br />

As�at�31�December<br />

2009<br />

(unaudited)<br />

2008 2007 2006<br />

(in�CHF)<br />

Total�non�current�and�other�current�assets<br />

(including�assets�classified�as�held�for�sale) 69'118'705 62'576'180 68'120'749 61'457'542<br />

Cash�and�cash�equivalents 7'687'294 14'085'329 11'009'299 15'306'187<br />

Total�assets 76'805'999 76'661'509 79'130'048 76'763'729<br />

Total�shareholders'�equity 64'987'022 68'936'483 64'496'168 66'133'939<br />

Non�current�liabilities 297'299 330'517 3'535'535 320'225<br />

Current�liabilities 11'521'678 7'394'509 11'098'345 10'309'565<br />

Total�equity�and�liabilities 76'805'999 76'661'509 79'130'048 76'763'729<br />

�<br />

�<br />

�<br />


7 General�Information�on�mondoBIOTECH�<br />

7.1 Incorporation,�Company�Name�and�Registered�Office�<br />

The� Company� is� a� stock� corporation� limited� by� shares� (Aktiengesellschaft)� incorporated� under� the� laws� of�<br />

Switzerland�in�accordance�with�art.�620�et�seq.�CO�for�an�unlimited�duration.�<br />

�<br />

The�Company�was�founded�on�5�March�2007�and�registered�on�20�March�2007�with�the�commercial�register�of�the�<br />

Canton�of�Zug�under�the�company�name�i�mondo�AG�(i�mondo�Ltd.;�i�mondo�SA).�The�founders�of�the�Company�<br />

were� BIOPHARMAinvest� AKTIENGESELLSCHAFT,� CTB� HOLDING� AG� and� HEALTHCARE� FAMILY� OFFICES� AG.�<br />

BIOPHARMAinvest�AKTIENGESELLSCHAFT�is�a�corporation�limited�by�shares�(Aktiengesellschaft)�organised�under�the�<br />

laws�of�Liechtenstein�with�a�share�capital�of�CHF�215’000�and�having�its�corporate�seat�in�Vaduz,�Liechtenstein.�Its�<br />

corporate� purpose� is� the� holding� and� financing� of� pharmaceutical� and� biochemical� enterprises� and� all� activities�<br />

related�thereto.�The�company’s�board�of�directors�consists�of�Prinz�Michael�von�und�zu�Liechtenstein,�Bernadette�<br />

Stadler,�and�Graf�Francis�von�Seilern�Aspang.�CTB�HOLDING�AG�is�a�corporation�limited�by�shares�(Aktiengesellschaft)�<br />

organised�under�the�laws�of�Liechtenstein�with�a�share�capital�of�USD�51’000�and�having�its�corporate�seat�in�Vaduz,�<br />

Liechtenstein.� Its� corporate� purpose� is� the� acquisition,� the� management,� and� the� sale� of� assets� of� all� kind,� the�<br />

participation� in� and� the�financing� of� other�enterprises� and� all� activities� related� thereto.� The�company’s� board� of�<br />

directors� consists� of� ZENITH� TRUST� REG.,� Graf� Francis� von� Seilern�Aspang� and� Ernst� Blöchlinger.� HEALTHCARE�<br />

FAMILY�OFFICES�AG�is�a�corporation�limited�by�shares�(Aktiengesellschaft)�organised�under�the�laws�of�Liechtenstein�<br />

with�a�share�capital�of�CHF�300’000�and�having�its�corporate�seat�in�Vaduz.�Its�corporate�purpose�is�the�holding�and�<br />

financing�of�pharmaceutical�and�biochemical�enterprises�and�all�activities�related�thereto.�The�company’s�board�of�<br />

directors� consists� of� Prinz� Michael� von� und� zu� Liechtenstein,� Bernadette� Stadler,� and� Graf� Francis� von� Seilern�<br />

Aspang.�See�also�“12��Major�Shareholders”.�<br />

�<br />

With� registration� in� the� commercial� register� on� 19� April� 2007,� the� Company� changed� its� company� name� into�<br />

mondoRPHAN�AG�(mondoRPHAN�Ltd;�mondoRPHAN�SA)�and�transferred�its�registered�seat�from�Zug�to�Basel.�With�<br />

registration�in�the�commercial�register�on�23�May�2008,�the�Company�changed�its�company�name�into�its�current�<br />

company� name� mondoBIOTECH� holding� AG� (mondoBIOTECH� holding� Ltd.;� mondoBIOTECH� holding� SA).� With�<br />

registration�in�the�commercial�register�on�27�February�2009,�the�Company�transferred�its�corporate�seat�to�Stans,�<br />

Switzerland.�<br />

�<br />

The� Company� is� registered� with� the� commercial� register� of� the� Canton� of� Nidwalden,� Switzerland,� under� the�<br />

registration�number�CH�170.3.030.530�0.�Its�corporate�seat�(Sitz)�is�Stans,�Switzerland,�and�its�registered�office�is�at�<br />

Mürgstrasse�18,�CH���6370�Stans,�Switzerland.�The�most�recent�version�of�the�Company’s�articles�of�association�(the�<br />

Articles�of�Association�was�adopted�at�the�extraordinary�shareholders’�meeting�of�10�June�2009.�<br />

7.2 Background�and�Development�of�the�Group�<br />

mondoBIOTECH�traces�its�origins�back�to�2000�when�Vera�Cavalli�and�Dorian�Bevec�started�to�work�on�the�concept�<br />

that�the�most�effective�and�safe�medicinal�products�will�be�derived�from�the�use�of�peptides�and�other�biological�<br />

immuno�modulating�substances�naturally�existing�in�the�human�body�that�are�already�known,�or,�even�better,�that�<br />

are�already�approved�in�clinical�development�for�other�indications.�In�the�beginning�of�2001,�Fabio�Cavalli�decided�<br />

to�contribute�his�long�standing�experience�and�know�how�in�developing�and�managing�start�up�companies�to�this�<br />

concept�and�started�to�promote�it�among�private�investors.�Patrick�Pozzorini�joined�the�project�during�the�first�half�<br />

of�2001,�bringing�a�strong�financial�management�oriented�culture�to�the�project.�<br />

�<br />

The� Group� started� its� activities� in� March� 2001� with� the� formation� of� Interferon� Medical� Use� SA� (formerly�<br />

<strong>Mondobiotech</strong>� SA,� then� mondoBIOTECH� Interferon� SA� and� finally� Interferon� Medical� Use� SA).� In� June� 2003,�<br />

Interferon� Medial� Use� SA� was� acquired� by� mondoBIOTECH� AG� (formerly,� mondoinvest� holding� SA,� then�<br />

mondoBIOTECH�Holding�SA�and�finally�mondoBIOTECH�AG).�mondoBIOTECH�holding�AG�was�established�in�March�<br />

2007�by�a�group�of�investors�led�by�BIOPHARMAinvest�AKTIENGESELLSCHAFT�and�CTB�HOLDING�AG�to�perform�a�<br />

business� combination� between� mondoBIOTECH� AG� and� mondoGEN� AG,� ultimately� controlled� by� the� same�<br />

shareholders.�The�business�combination�has�been�considered�for�accounting�purposes�as�a�reverse�acquisition�of�<br />

mondoBIOTECH� AG,� involving� mondoGEN� AG,� a� newly� formed� start�up� company� with� limited� history,� and�<br />

mondoBIOTECH�holding�AG,�an�entity�formed�for�the�issuance�of�shares�to�perform�the�business�combination.�The�<br />

consolidated� financial� statements� 2007� of� mondoBIOTECH� holding� AG� (formerly� mondoRPHAN� AG)� presented�<br />

elsewhere� in� this� Listing� Prospectus� were� therefore� the� continuation� of� the� consolidated� financial� statements� of�<br />

mondoBIOTECH�AG.�<br />

�<br />

For� its� vision,� business� model� and� potential� impact� on� our� society,� the� World� Economic� Forum� selected�<br />

mondoBIOTECH�as�“Technology�Pioneer�2008”.�<br />

� 20<br />


7.3 Corporate�Purpose�<br />

According�to�art.�2�of�the�Articles�of�Association,�the�purpose�of�the�Company�is�the�acquisition,�the�holding,�the�<br />

management,�the�sale�and�the�financing�of�direct�and�indirect�participations�in�enterprises�of�all�kind�in�Switzerland�<br />

and�abroad,�in�particular�in�the�field�of�the�economic�and�scientific�development�of�new�therapeutic�concepts�and�<br />

solutions� for� the� treatment� of� rare� diseases.� In� addition,� the� Company� may� engage� in� any� other� commercial,�<br />

financial�or�other�activities,�which�are�directly�or�indirectly�related�to�the�purpose�of�the�Company.�Particularly,�the�<br />

Company�may�grant�loans,�guarantees�and�other�kinds�of�financing�and�securing�for�companies�of�the�Group.�It�may�<br />

open�branch�offices�and�subsidiaries,�acquire,�manage,�exploit�and�sell�real�estate�and�intellectual�property�rights�in�<br />

Switzerland�and�abroad.�<br />

7.4 Financial�Year�<br />

Pursuant� to� the� Articles� of� Association,� the� financial� year� is� determined� by� the� Board� of� Directors.� Currently,� it�<br />

commences�on�1�January�and�ends�on�31�December�of�each�year.�<br />

7.5 Auditors�<br />

The� auditors� of� the� Company� and� of� the� Group� for� the� financial� year� 2009� are� PricewaterhouseCoopers� AG,�<br />

St.�Jakobs�Strasse�25,�CH���4002�Basel.�PricewaterhouseCoopers�AG�has�acted�as�auditor�for�the�Company�since�its�<br />

incorporation.�The�financial�statements�of�the�Company�as�of�and�for�the�years�ended�31�December�2008,�2007�and�<br />

2006� included� in� this� Listing� Prospectus� were� audited� by� PricewaterhouseCoopers� AG.� The� appointment� of� the�<br />

auditors�is�subject�to�confirmation�by�the�shareholders�at�the�ordinary�shareholders’�meeting�on�an�annual�basis.�<br />

See�also�“16.6��Financial�Reporting”.�<br />

7.6 Corporate�Structure�<br />

�<br />

Group�structure�<br />

The�Company�is�the�holding�company�of�the�Group.�The�below�table�shows�the�legal�structure�of�the�Group�as�of�<br />

the�date�of�this�Listing�Prospectus:�<br />

�<br />

Company Activities Share�capital Ownership�in�%<br />

mondoBIOTECH�AG,�Stans Sales�and�marketing�,�information�sharing�concepts<br />

and�networking<br />

CHF���338'364 100.00%<br />

mondoBIOTECH�Laboratories�AG,�Vaduz Economic�and�scientific�conceiving�of�new�therapeutic�<br />

approaches�and�their�intellectual�property�coverage<br />

CHF�����50'000 100.00%<br />

mondoGEN�AG,�Stans Management�on�all�phases�of�the�clinical<br />

development�cycle<br />

CHF���100'000 100.00%<br />

Interferon�Medical�Use�SA,�Collina�d'Oro Production�and�logistic�management CHF���138'750 100.00%<br />

www.mondoBIOTECH.com,�Inc.,�Palo�Alto Web�and�other�information�sharing�applications USD��������������1 100.00%<br />

Fast�Take�off�AG,�Stans� 1 Management�of�certain�Group�assets CHF���100'000 100.00%<br />

Alps�Air�AG,�Stans� 1 Management�of�certain�Group�assets CHF���100'000 100.00%<br />

TheraNostics�GmbH,�München� 2<br />

Actually,�no�operating�activities EUR�����50'000 100.00%<br />

mondoBIOTECH�US,�Inc.,�New�York� 2 Actually,�no�operating�activities USD����������200 100.00%<br />

�<br />

�<br />

1�<br />

The�airplane�currently�owned�by�Fast�Take�off�AG�is�for�sale,�either�directly,�by�selling�the�airplane,�or�by�selling�the�shares�of�Fast�<br />

Take�off�AG.�If�only�the�airplane�is�sold,�it�is�planned�to�merge�Fast�Take�off�AG�with�Alps�Air�AG.�<br />

2<br />

�The�interests�in�TheraNostics�GmbH�are�held�indirectly�through�Interferon�Medical�Use�SA.�Both�subsidiaries�were�formed�for�<br />

regulatory�authority�purposes�in�the�EU�and�US,�respectively.�With�the�formation�of�www.mondoBIOTECH.com,�Inc.,�Palo�Alto,�the�<br />

Group�started�the�liquidation�process�of�mondoBIOTECH�US,�Inc.,�New�York.�<br />

�<br />

Facilities�<br />

Details�relating�to�the�principal�facilities�of�the�Group�are�as�set�forth�below:�<br />

�<br />

Location Occupier Total�site�area Description Nature<br />

Stans mondoBIOTECH�AG 4'000�m 2 Group's�headquarters Building�right<br />

Stans mondoBIOTECH�AG 500�m 2 Temporary�office�space Lease<br />

Collina�d'Oro Interferon�Medical�Use�SA 900�m 2<br />

Campus�structure Lease<br />

Basel mondoBIOTECH�AG 1'200�m 2 Show�room Lease<br />

Vaduz mondoBIOTECH�AG�Laboratories�AG 100�m 2 Office�space Lease<br />

�<br />

�<br />

In�2007,�we�entered�into�an�agreement�with�the�Canton�of�Nidwalden�pursuant�to�which�the�Canton�of�Nidwalden�<br />

has�granted�mondoBIOTECH�a�60�year�building�right�(Baurecht)�relating�to�a�monastery�of�the�14 th �century�in�Stans�<br />

(the� “Monastery”)� which� is� used� as� the� new� Group’s� headquarter.� It� is� planned� to� start� renovating� the� building�<br />

during� 2009,� and� the� infrastructure� is� expected� to� be� fully� operative� by� 2012.� The� offices� in� Stans� are� currently�<br />

located�in�a�500�m 2 �temporary�office�space�on�the�premises�of�the�Monastery.�Further,�there�are�rented�facilities�in�<br />

Collina�d’Oro,�Switzerland,�consisting�of�approximately�900�m 2 �which�are�used�as�campus�space�by�the�Group�to�<br />

perform�community�and�network�activities,�in�Basel,�Switzerland,�consisting�of�approximately�1’200�m 2 �which�are�<br />

used�as�commercial�show�room�by�the�Group�to�perform�sales�activities,�and�in�Vaduz,�Liechtenstein,�consisting�of�<br />

� 21<br />


approximately�100�m 2 �which�are�used�as�office�space�by�mondoBIOTECH�Laboratories�AG.�See�also�“11��Related�<br />

Party�Transactions”.�<br />

�<br />

� 22<br />


8 Management’s�Discussion�and�Analysis�of�Financial�Condition�and�Result�of�Operations�<br />

The� following� discussion� of� the� financial� condition� and� results� of� operations� of� the� Group� should� be� read� in�<br />

conjunction� with� the� audited� consolidated� financial� statements� 2008� and� 2007� and� the� notes� thereto� and� the�<br />

unaudited�consolidated�interim�financial�information�at�30�June�2009,�each�prepared�in�accordance�with�IFRS�and�<br />

included�in�the�F�Pages�of�this�Listing�Prospectus.�This�discussion�contains�forward�looking�statements,�which�are�<br />

based�on�assumptions�about�the�Company’s�future�business�that�involve�risks�and�uncertainties.�The�Group’s�actual�<br />

results�may�differ�materially�from�those�anticipated�in�these�forward�looking�statements.�Factors�that�may�cause�<br />

such�a�difference�include,�but�are�not�limited�to,�those�outlined�in�the�section�“3��Risk�Factors”.�<br />

8.1 Overview�<br />

mondoBIOTECH�is�focused�on�the�continuous�discovery�of�medicinal�product�candidates�by�analysing�already�known�<br />

peptides�and�other�biological�immuno�modulating�substances�that�are�naturally�occurring�in�the�human�body�for�<br />

the�development�of�medicinal�products�for�use�in�the�treatment�of�rare�and�neglected�diseases.�mondoBIOTECH�<br />

then�seeks�to�license�or�sell�such�medicinal�product�candidates�to�third�parties,�between�discovery�and�the�different�<br />

phases� of� development,� and/or� collaborate� with� third� parties� to� obtain� market� authorisation� and� commercialise�<br />

such�medicinal�product�candidates.�<br />

�<br />

The�Group�generated�operating�revenues�of�CHF�31.8�million�in�the�three�years�ended�31�December�2008�mainly�<br />

from�licensing�out�activities�and�clinical�development�services.�<br />

�<br />

In�connection�with�its�search�and�development�program,�the�Group�incurred�accumulated�operating�expenses�of�<br />

CHF�48.9�million�in�the�three�years�ended�31�December�2008,�of�which�74%�related�to�research�and�development.�In�<br />

accordance�with�IFRS,�mondoBIOTECH�does�not�capitalise�any�research�and�development�expenses.�<br />

�<br />

The�Group�raised�net�proceeds�of�CHF�27.7�million�from�private�placements�of�new�shares�in�the�previous�three�<br />

years�ended�31�December�2008,�and�at�this�date,�the�Group�disposed�of�CHF�14�million�of�cash�and�cash�equivalents.�<br />

�<br />

The� Group� has� sufficient� cash� and� cash� equivalent� necessary� to� finance� its� actual� level� of� activities� for� at� least�<br />

twelve� months�from� the�date� of� this� Listing� Prospectus.� To� continue� its�growth� strategy� and� to� fund� the� further�<br />

development�of�its�medicinal�product�candidates,�mondoBIOTECH's�plans�to�increase�its�share�capital�through�the�<br />

issue� of� new� shares� out� of� its� existing� authorized� share� capital� on� a� continuous� basis� following� the� Listing.�<br />

mondoBIOTECH� intends� to� issue� such� new� shares� to� existing� shareholders,� new� investors� and/or� individuals� and�<br />

entities�which�are�directly�or�indirectly�affected�by�and/or�involved�in�the�treatment�of�rare�and�neglected�diseases,�<br />

such� as� patients� and� their� relatives� and� friends,� patient� advocacy� organisations,� physicians,� scientists,� academic�<br />

organisations,� research� institutions,� hospitals,� employees,� consultants� and� other� service� providers� of�<br />

mondoBIOTECH.�<br />

�<br />

The�Group�remains�subject�to�various�risks�and�uncertainties,�and�its�future�success�will�in�particular�depend�on�its�<br />

ability�to�achieve�profitability�and�raise�additional�capital�to�fund�its�activities.�mondoBIOTECH�cannot�estimate�the�<br />

precise�nature,�timing�and�expenses�of�all�efforts�necessary�to�complete�the�remainder�of�the�development�of�any�<br />

of�its�medicinal�product�candidates,�or�precisely�when,�if�at�all,�material�net�cash�inflow�will�commence�from�the�<br />

medicinal�product�candidates.�See�“3��Risk�Factors”.�<br />

8.2 Consolidated�Income�Statement��<br />

�<br />

� 23<br />

Six�months�ended�30�June<br />

Year�ended�31�December<br />

2009<br />

(unaudited)<br />

2008 2008<br />

(in�CHF)<br />

2007 2006<br />

Revenues 7'990'475 8'567'700 14'545'200 14'827'184 2'480'161<br />

Research�&�development�costs (9'293'482) (10'347'560) (20'172'940) (11'291'181) (4'823'805)<br />

Sales�&�marketing�costs (1'685'957) (1'327'722) (2'350'600) (3'761'635) (2'045'781)<br />

Management�&�administration�costs (916'986) (566'044) (1'190'778) (1'508'704) (1'754'063)<br />

Operating�result (3'905'950) (3'673'626) (9'169'118) (1'734'336) (6'143'488)<br />

Finance�income 163'191 227'828 548'196 623'418 176'784<br />

Finance�costs (208'000) (388'558) (779'913) (654'482) (1'045'427)<br />

Result�before�income�taxes (3'950'759) (3'834'356) (9'400'835) (1'765'400) (7'012'131)<br />

Income�taxes ���������������������������� ���������������������������� ��������������������������� � (234'888) (200'005)<br />

Result�of�the�period (3'950'759) (3'834'356) (9'400'835) (2'000'288) (7'212'136)<br />

Attributable�to:<br />

Equity�holders�of�the�Company (3'950'759) (3'834'356) (9'400'835) (1'605'210) (7'224'761)<br />

Minority�interest ���������������������������� ���������������������������� ��������������������������� � (395'078) 12'625<br />

(3'950'759) (3'834'356) (9'400'835) (2'000'288) (7'212'136)<br />

Basic�and�diluted�loss�per�share� 1 (0.078) (0.298) (0.729) (0.154) (2.021)<br />

�<br />


1 �Basic�and�diluted�loss�per�share�refer�to�Voting�Right�Shares,�with�a�par�value�of�CHF�0.01.�Common�Shares�have�a�par�value�of�<br />

CHF�0.10.�There�are�no�differences�in�the�character�of�the�two�classes�of�shares�except�the�par�value.�Common�Shares�therefore�<br />

show�a�basic�and�diluted�loss�per�share�of�CHF�0.78�as�per�30�June�2009.�<br />

8.3 Unaudited�Results�of�Operations�for�the�Six�Months�Ended�30�June�2009�and�2008�<br />

8.3.1 Revenues�<br />

mondoBIOTECH� is� performing� clinical� development� services� for� Biogen� in� particular� in� the� area� of� project�<br />

management�and�intellectual�property.�Such�revenues�were�CHF�7.54�million�in�the�first�six�months�of�2009�and�<br />

CHF�8.56�million�in�the�first�six�months�of�2008.�In�addition,�in�the�first�six�months�of�2009,�the�Company�recognized�<br />

CHF� 0.36� million� of� signing�up� fees,� of� which� CHF� 0.25� million� related� to� the� collaboration� agreement� with�<br />

Pharmarare�regarding�the�development�of�DasKloster0249�01�and�CHF�0.11�million�to�the�licensing�out�to�LungRX�of�<br />

the�use�of�Secretin�for�the�treatment�of�MRSA�infections�in�patients�with�cystic�fibrosis�plus�additional�CHF�0.09�<br />

million�for�services�related�to�such�licensing�out.�<br />

�<br />

8.3.2 Operating�Expenses�<br />

mondoBIOTECH’s� operating� expenses� consist� of� “Research� and� Development”,� “Sales� and� Marketing”� and�<br />

“Management�and�Administration”�expenses.�<br />

�<br />

Research�and�Development�<br />

Research�and�development�expenses�relate�to�the�variable�costs�of�the�activities�which�include�costs�inherent�to�<br />

intellectual�property�coverage,�costs�incurred�in�conjunction�with�pre�clinical�and�clinical�development,�chemistry�<br />

and�manufacturing�control�expenses�and�general�fixed�costs�mainly�represented�by�depreciation�and�amortisation,�<br />

employee� benefit� expenses,� rent� and� other� infrastructure� costs,� information� technology,� travel� and� business�<br />

entertainment� and� other� general� consulting� expenses� having� fixed� character.� Under� IFRS,� research� and�<br />

development�expenses�are�fully�charged�to�the�income�statement�as�incurred.�In�accordance�with�the�accounting�<br />

principles� of� IFRS,� research� and� development� costs� are� only� capitalised� when� respective� projects� have� achieved�<br />

technical�feasibility.�mondoBIOTECH�believes�that�regulatory�and�other�uncertainties�inherent�in�the�development�<br />

status�of�its�medicinal�product�candidates�preclude�mondoBIOTECH�from�capitalising�such�costs�because�technical�<br />

feasibility� is� considered� to� be� achieved� only� upon� EMEA� and� FDA� or� comparable� regulatory� body� approval� for�<br />

market�launch�of�a�medicinal�product.�<br />

�<br />

Research�and�development�expenses�decreased�from�CHF�10.3�million�in�the�first�six�months�of�2008�to�CHF�9.3�<br />

million� in� the� same� period� of� 2009.� The� decrease� is� mainly� driven� by� CHF� 0.5� million� in� the� research� and�<br />

development� services� outsourced� to� third� parties� in� connection� with� the� services� provided� for� Biogen� and� to�<br />

additional�CHF�0.4�million�deriving�from�the�effect�of�the�fluctuation�within�a�shorter�period�of�time�of�the�group�<br />

development� activities� on� its� medicinal� product� candidates.� The� additional� CHF� 0.1� million� decrease� is� mainly�<br />

related�to�a�decrease�in�traveling�and�business�entertainment�costs.�<br />

�<br />

Sales�and�Marketing�<br />

Sales�and�marketing�expenses�related�to�variable�costs�of�the�activity�like�communication�and�marketing�services,�<br />

other� general� expenses� related� to� former� activities� (printings,� layouts,� translations),� trademarks� and� branding�<br />

including� web� domain� registration,� merchandising,� sponsorships� and� general� fixed� costs� mainly� represented� by�<br />

depreciation,�employee�benefit�expenses,�rent�and�other�infrastructure�costs,�information�technology,�travel�and�<br />

business�entertainment�and�other�general�consulting�expenses�having�fixed�character.�<br />

�<br />

Sales�and�marketing�expenses�increased�from�CHF�1.32�million�in�the�first�six�months�of�2008�to�CHF�1.68�million�in�<br />

the�same�period�of�2009.�The�increase�is�mainly�due�to�an�increase�in�the�marketing�and�communication�services�<br />

acquired�in�the�first�six�months�of�2009�of�about�CHF�0.24�million.�Fixed�sales�and�marketing�costs�increased�from�<br />

the�first�six�months�2008�to�the�first�six�months�of�2009�about�CHF�0.12�million,�mainly�driven�by�the�increase�in�<br />

travel�and�business�entertainment�expenses�and�other�general�consulting�expenses.�<br />

�<br />

Management�and�Administration�<br />

Management� and� administration� expenses� relate� to� variable� costs� as� for� audit,� legal� consulting� and� accounting�<br />

services�and�general�fixed�costs�mainly�represented�by�depreciation,�employee�benefit�expenses,�rent�and�other�<br />

infrastructure� costs,� information� technology,� travel� and� business� entertainment� and� other� general� consulting�<br />

expenses�having�fixed�character.�<br />

�<br />

Management�and�administration�expenses�were�CHF�0.92�million�in�the�first�six�months�of�2009,�against�CHF�0.55�<br />

million� in� the� same� period� of� 2008.� The� increase� of� CHF� 0.37� million� is� mainly� due� to� the� variable� par� of� such�<br />

expenses,�in�particular�legal�services�related�to�the�listing�procedure�for�CHF�0.29�million.�The�remaining�increase�of�<br />

CHF�0.08�million�is�due�to�an�increase�in�travel�and�business�entertainment�expenses�and�other�general�consulting�<br />

expenses.�<br />

� 24<br />


8.3.3 Segment�Reporting�<br />

�<br />

Operating�segments�<br />

The� Group� reports� on� the� two� operating� segments� “Projects”� and� “Development� Services”,� determined� within� a�<br />

matrix� oriented� organisation� based� on� the� different� operating� and� strategic� approaches� characterising� each�<br />

operating�segment.�The�segment�Projects�derives�its�revenues�from�the�licensing�out�at�different�stages�of�projects�<br />

concerning�the�clinical�development�of�substances�for�the�treatment�of�certain�disease.�Revenues�in�this�operating�<br />

segment� are� mainly� signing�up� fees,� milestones� and� royalty� payments� received� from� licensing�out� partners.� The�<br />

segment� Development� Services� derives� its� revenues� from� providing� additional� clinical� development� services� to�<br />

partners� that� specifically� request� this� services� in� close� connection� with� a� licensing�out� agreement.� Results� of�<br />

activities�considered�incidental�to�mondoBIOTECH’s�main�operations�as�well�as�unallocated�revenues,�expenses�and�<br />

assets�are�reported�separately�under�the�caption�“Corporate”.�<br />

�<br />

Reporting�pursuant�to�operating�segments�includes�revenues�(from�external�customers),�inter�segment�revenues,�<br />

research�and�development,�sales�and�marketing�and�management�and�administration�costs�per�segment�(including�<br />

the�separate�disclosure�of�depreciation�and�amortisation),�until�evidencing�segment�operating�result.�The�reporting�<br />

also�evidences�the�total�assets�of�the�segments.�Liabilities�are�not�disclosed�because�they�make�no�object�of�the�<br />

reports�provided�to�the�operating�decision�maker.�<br />

�<br />

The�segment�reporting�for�the�six�months�ended�30�June�2009�and�2008�is�as�follows.�Pursuant�to�applied�standards,�<br />

the�interim�reporting�segment�does�not�evidence�the�separate�amount�for�depreciation�and�amortization�expenses�<br />

in�each�segment:�<br />

�<br />

� 25<br />

Six�months�ended�30�June�2009�(in�CHF)<br />

Development<br />

Projects Services Corporate Total<br />

Revenues�from�external�customers 360'000 7'630'475 ������������������������������� 7'990'475<br />

Inter�segment�revenues 360'000 ���������������������������� 400'186 760'186<br />

Segmental�revenues 720'000 7'630'475 400'186 8'750'661<br />

Research�&�development�costs (3'346'995) (6'367'478) (68'743) (9'783'215)<br />

Sales�&�marketing�costs (1'662'182) ��������������������������� � (31'728) (1'693'910)<br />

Management�&�administration�costs (171'190) (304'268) (704'029) (1'179'486)<br />

Segmental�operating�result (4'460'366) 958'730 (404'314) (3'905'950)<br />

�<br />

Total�segment�assets 66'785'444 12'581'141 26'885'281 106'251'866<br />

Six�months�ended�30�June�2008�(in�CHF)<br />

Development<br />

Projects Services Corporate Total<br />

Revenues�from�external�customers ���������������������������� 8'567'700 ������������������������������� 8'567'700<br />

Inter�segment�revenues ���������������������������� ���������������������������� 262'451 262'451<br />

Segmental�revenues ���������������������������� 8'567'700 262'451 8'830'151<br />

Research�&�development�costs (2'857'172) (7'496'589) ������������������������������ � (10'353'761)<br />

Sales�&�marketing�costs (1'327'722) ���������������������������� ������������������������������ � (1'327'722)<br />

Management�&�administration�costs (187'229) (269'859) (365'206) (822'294)<br />

Segmental�operating�result (4'372'123) 801'252 (102'755) (3'673'626)<br />

Total�segment�assets 67'935'065 5'889'459 5'829'725 79'654'249<br />

�<br />

�<br />

Geographical�segments�<br />

The� Group� recognises� the� two� geographical� segments� “Switzerland”� and� “Foreign� Countries”.� The� geographical�<br />

segment�information�for�the�six�months�ended�30�June�2009�und�2008�is�as�follows:�<br />

�<br />

Six�months�ended�30�June�2009�(in�CHF)<br />

Foreign<br />

Switzerland Countries Total<br />

Revenues�from�external�customers 7'740'475 250'000 7'990'475<br />

Research�&�development�costs (7'258'988) (2'034'494) (9'293'482)<br />

Sales�&�marketing�costs (1'503'374) (182'583) (1'685'957)<br />

Management�&�administration�costs (490'438) (426'548) (916'986)<br />

Operating�result (1'512'325) (2'393'625) (3'905'950)<br />

Non�current�assets<br />

Capital�expenditures:<br />

6'434'109 52'053'013 58'487'122<br />

� in�property,�plant�and�equipment 5'219'534 ������������������������������� 5'219'534<br />

� in�intangible�assets ���������������������������� ������������������������������� �����������������������������<br />

�<br />

�<br />


� 26<br />

Six�months�ended�30�June�2008�(in�CHF)<br />

Foreign<br />

Switzerland Countries Total<br />

Revenues�from�external�customers 8'567'700 ������������������������������� 8'567'700<br />

Research�&�development�costs (7'714'138) (2'633'422) (10'347'560)<br />

Sales�&�marketing�costs (1'243'520) (84'202) (1'327'722)<br />

Management�&�administration�costs (207'948) (358'096) (566'044)<br />

Operating�result (597'906) (3'075'720) (3'673'626)<br />

Non�current�assets<br />

Capital�expenditures:<br />

5'086'916 55'103'882 60'190'798<br />

� in�property,�plant�and�equipment 276'228 ������������������������������� 276'228<br />

� in�intangible�assets ���������������������������� ������������������������������� �����������������������������<br />

8.3.4 Net�Financial�Results�<br />

The�net�financial�result�for�the�six�months�ended�30�June�2009�was�a�loss�of�CHF�0.44�million,�in�respect�of�a�net�<br />

financial�loss�in�the�same�period�of�2008�of�CHF�0.160�million.�The�decrease�is�mainly�due�to�the�combined�effect�of�<br />

a�decrease�in�the�interest�costs�of�the�financial�leasing�positions�and�in�the�decrease�of�the�exchange�losses.�<br />

8.4 Results�of�Operations�for�the�Years�ended�31�December�2008,�2007�and�2006�<br />

8.4.1 Revenues�<br />

Revenues�recognised�in�2008�refer�to�services�deriving�from�a�licensing�out�agreement�with�Biogen�regarding�the�<br />

use�of�Aviptadil�in�the�treatment�of�PAH.�mondoBIOTECH�is�performing�clinical�development�services�for�Biogen�in�<br />

particular�in�the�area�of�project�management�and�intellectual�property.�Such�revenues�rose�from�CHF�7.0�million�in�<br />

2007� to� CHF� 14.5� million� in� 2008� due� to� the� fact� that� the� project� entered� its� core� development� phase� in� the�<br />

beginning�of�2008.�<br />

�<br />

In�2007,�the�Company�recognised�CHF�7.0�million�as�mentioned�for�clinical�development�services,�CHF�7.1�million�for�<br />

the�signing�up�fees�due�under�the�licensing�out�agreement�with�Biogen�and�CHF�0.7�million�for�royalties�deriving�<br />

from� certain� collaboration� agreements� with� a� manufacturer� related� to� the� peptides� object� of� mondoBIOTECH’s�<br />

medicinal�product�candidates.�<br />

�<br />

The�revenues�recognised�in�2006�for�about�CHF�2.5�million�refer�to�CHF�2.3�million�signing�up�fees�due�under�the�<br />

licensing�out�agreement�with�Biogen,�CHF�0.03�million�for�royalties�deriving�from�certain�collaboration�agreements�<br />

with�a�manufacturer�related�to�the�peptides�being�the�basis�of�mondoBIOTECH’s�medicinal�product�candidates�and�<br />

CHF�0.17�million�from�the�definitive�sale�to�InterMune�of�the�issued�patent�regarding�the�use�of�INF��.�<br />

8.4.2 Operating�Expenses�<br />

�<br />

Research�and�Development�<br />

Research�and�development�expenses�rose�from�CHF�11.3�million�in�2007�up�to�CHF�20.2�million�in�2008.�The�main�<br />

increase� is� due� to� additional� CHF� 6.2� million� costs� outsourced� to� third� parties� in� connection� with� the� services�<br />

provided�for�Biogen�and�to�additional�CHF�2.7�million�costs�due�to�the�general�increase�of�the�activities�on�other�<br />

Group�projects.�These�CHF�2.7�million�consist�of�37%�by�variable�costs�and�of�63%�by�a�general�increase�in�the�fixed�<br />

costs,�mainly�related�to�depreciation,�employee�benefit�expenses�and�travel�and�business�entertainment�expenses.�<br />

Research�and�development�expenses�in�2007�rose�about�CHF�6.5�million�from�CHF�4.8�million�in�2006�of�up�to�CHF�<br />

11.3�million.�The�increase�is�mainly�due�to�a�general�augmentation�of�the�costs�with�fixed�character�of��globally�CHF�<br />

4.2� million,� driven� by� increased� depreciation� and� amortisation� (in� 2007,� the� amortisation� of� goodwill� of� CHF� 3�<br />

million�is�accounted�for)�and�by�the�general�increase�of�the�employee�benefit�expenses.�The�CHF�4.8�million�in�2006�<br />

refer�to�CHF�3.2�million�of�variable�costs�related�to�the�Group�projects�and�to�CHF�1.6�million�of�fixed�costs,�mainly�<br />

related�to�employee�benefit�expenses,�rent�and�infrastructure�costs,�information�technology,�travel�and�business�<br />

entertainment�and�other�general�consulting�expenses.�<br />

�<br />

Sales�and�Marketing�<br />

Sale�and�marketing�expenses�where�reduced�from�CHF�3.8�million�in�2007�to�CHF�2.4�million�in�2008.�The�reduction�<br />

is�mainly�due�to�the�reduced�sponsoring�and�other�marketing�activities�in�2008�in�the�amount�of�CHF�1.5�million.�<br />

Fixed� sales� and� marketing� costs� increased� from� 2007� to� 2008� for� about� CHF� 0.1� million,� mainly� driven� by� the�<br />

increase�in�travel�and�business�entertainment�expenses.�<br />

�<br />

The�increase�in�sales�and�marketing�costs�from�2006�to�2007�refers�substantially�to�the�increase�of�CHF�1.7�million�<br />

due�to�sponsorships�and�other�marketing�activities.�From�2006�to�2007,�fixed�sales�and�marketing�costs�increased�<br />

from� CHF� 0.9� million� up� to� CHF� 1.0� million� due� to� a� general� increase� of� such� fixed� cost� but� in� particular� in�<br />

information�technology�expenses.�Sales�and�marketing�expenses�of�CHF�2.0�million�in�2006�refer�to�CHF�1.1�million�<br />

of�sponsoring�and�other�marketing�activities�and�CHF�0.9�million�of�fixed�costs,�mainly�related�to�employee�benefit�<br />

expenses,� rent� and� infrastructure� costs,� information� technology,� travel� and� business� entertainment� and� other�<br />

general�consulting�expenses.�<br />

�<br />


Management�and�Administration�<br />

Management�and�administration�expenses�amounted�to�CHF�1.2�million�in�2008,�CHF�1.5�million�in�2007�and�CHF�<br />

1.7�million�in�2006.�There�was�a�continuous�reduction�in�the�variable�part�of�such�expenses�related�to�the�incidence�<br />

of� certain� economies� of� scale� in� this� area,� in� particular� for� audit,� legal� and� accounting� services,� respectively� the�<br />

reduction�of�general�consulting�fees.�The�fixed�costs�are�of�approximately�CHF�0.5�million�over�all�three�years,�and�<br />

refer� mainly� to� depreciation,� employee� benefit� expenses,� rent� and� other� infrastructure� costs,� information�<br />

technology,�travel�and�business�entertainment�and�other�general�consulting�expenses�having�fixed�character.�<br />

8.4.3 Segment�Reporting�<br />

�<br />

Operating�segments�<br />

The�segment�reporting�for�the�years�ended�31�December�2008�and�2007�is�as�follows.�The�reporting�pursuant�to�<br />

operating�segments�has�been�early�adopted�by�the�Group�in�2008,�and�only�the�2007�figures�have�been�restated�<br />

consequently.�There�is�no�reporting�per�operating�segment�for�2006:�<br />

�<br />

� 27<br />

Year�ended�31�December�2008�(in�CHF)<br />

Development<br />

Projects Services Corporate Total<br />

Revenues�from�external�customers 316'200 14'229'000 ������������������������������� 14'545'200<br />

Inter�segment�revenues 261'970 ���������������������������� 631'624 893'594<br />

Segmental�revenues 578'170 14'229'000 631'624 15'438'794<br />

Research�&�development�costs (8'445'172) (11'816'538) (169'047) (20'430'757)<br />

Sales�&�marketing�costs (2'276'731) ��������������������������� � (78'022) (2'354'753)<br />

Management�&�administration�costs (899'813) (532'661) (389'928) (1'822'402)<br />

Segmental�operating�result (11'043'546) 1'879'801 (5'373) (9'169'118)<br />

Included�in�segmental�operating�result�are:<br />

� depreciation�and�amortisation (3'402'133) (206'341) (35'853) (3'644'327)<br />

�<br />

Total�segment�assets 57'737'230 3'628'421 25'566'201 86'931'852<br />

Year�ended�31�December�2007�(in�CHF)<br />

Development<br />

Projects Services Corporate Total<br />

Revenues�from�external�customers 7'826'225 6'616'672 384'287 14'827'184<br />

Inter�segment�revenues 134'240 ���������������������������� 622'402 756'642<br />

Segmental�revenues 7'960'465 6'616'672 1'006'689 15'583'826<br />

Research�&�development�costs (5'623'878) (5'667'302) ������������������������������ � (11'291'180)<br />

Sales�&�marketing�costs (3'736'958) ��������������������������� � (24'677) (3'761'635)<br />

Management�&�administration�costs (1'035'693) (400'757) (828'897) (2'265'347)<br />

Segmental�operating�result (2'436'064) 548'613 153'115 (1'734'336)<br />

Included�in�segmental�operating�result�are:<br />

� depreciation�and�amortisation (3'181'405) (173'932) (26'075) (3'381'412)<br />

Total�segment�assets 63'848'777 5'887'367 19'146'287 88'882'431<br />

�<br />

�<br />

Geographical�segments�<br />

The�Group�recognises�the�two�geographical�segments�Switzerland�and�Foreign�Countries.�The�geographical�segment�<br />

information�for�the�years�ended�31�December�2008,�2007�and�2006�is�as�follows:�<br />

�<br />

Year�ended�31�December�2008�(in�CHF)<br />

Foreign<br />

Switzerland Countries Total<br />

Revenues�from�external�customers 15'280'841 ������������������������������� 15'280'841<br />

Work�performed�by�the�Company�and�capitalized 97'085 ������������������������������� 97'085<br />

Research�&�development�costs (13'753'151) (7'218'535) (20'971'686)<br />

Sales�&�marketing�costs (2'254'929) (124'196) (2'379'125)<br />

Management�&�administration�costs (488'952) (707'281) (1'196'233)<br />

Operating�result (1'119'106) (8'050'012) (9'169'118)<br />

Non�current�assets<br />

Capital�expenditures:<br />

1'524'998 53'563'499 55'088'497<br />

� in�property,�plant�and�equipment 962'480 ������������������������������� 962'480<br />

� in�intangible�assets ���������������������������� ������������������������������� �����������������������������<br />

�<br />

�<br />

�<br />


� 28<br />

Year�ended�31�December�2007�(in�CHF)<br />

Foreign<br />

Switzerland Countries Total<br />

Revenues�from�external�customers 14'637'897 189'287 14'827'184<br />

Research�&�development�costs (6'137'634) (5'153'547) (11'291'181)<br />

Sales�&�marketing�costs (3'288'735) (472'900) (3'761'635)<br />

Management�&�administration�costs (673'961) (834'743) (1'508'704)<br />

Operating�result 4'537'567 (6'271'903) (1'734'336)<br />

Non�current�assets<br />

Capital�expenditures:<br />

5'086'939 56'628'067 61'715'006<br />

� in�property,�plant�and�equipment 4'621'614 ������������������������������� 4'621'614<br />

� in�intangible�assets ���������������������������� ������������������������������� �����������������������������<br />

�<br />

Year�ended�31�December�2006�(in�CHF)<br />

Foreign<br />

Switzerland Countries Total<br />

Other�operating�income 2'454'421 25'740 2'480'161<br />

Research�&�development�costs (1'989'010) (2'834'795) (4'823'805)<br />

Sales�&�marketing�costs (1'718'754) (327'027) (2'045'781)<br />

Management�&�administration�costs (1'426'462) (327'601) (1'754'063)<br />

Operating�result (2'679'805) (3'463'683) (6'143'488)<br />

Non�current�assets<br />

Capital�expenditures:<br />

900'579 59'571'657 60'472'236<br />

� in�property,�plant�and�equipment 725'356 118'886 844'242<br />

� in�intangible�assets ���������������������������� 59'777'766 59'777'766<br />

8.4.4 Net�Financial�Result�<br />

In�2008,�the�net�financial�result�was�a�loss�of�CHF�0.23�million,�in�respect�of�a�net�financial�loss�in�2007�of�CHF�0.03�<br />

million�and�a�net�financial�loss�in�2006�of�CHF�0.87�million.�The�net�loss�of�2008�is�mainly�due�to�the�combined�effect�<br />

of� increasing� interest� expenses�exclusively� due�to� an� increased� financial� lease� activity� and� a� decrease� in� interest�<br />

income�due�to�the�decreased�compensation�of�short�term�investments�performed�on�liquidity.�The�deviation�in�the�<br />

net�financial�result�of�2006�is�due�to�the�recognition�of�the�financial�costs�related�to�the�early�conversion�of�the�two�<br />

convertible�bonds�issued�in�2005�and�2006�respectively,�in�the�amount�of�CHF�0.98�million,�early�converted�in�the�<br />

beginning�of�second�quarter�2006.�<br />

8.5 Consolidated�Cash�Flow�Statement�<br />

�<br />

Six�months�ended�30�June<br />

Year�ended�31�December�<br />

2009<br />

(unaudited)<br />

2008 2008<br />

(in�CHF)<br />

2007 2006<br />

Result�of�the�period (3'950'759) (3'834'356) (9'400'835) (2'000'288) (7'212'136)<br />

Cumulative�adjustments�to�reconcile�net�result�to�net�cash 2'890'345 606'826 (153'804) (1'730'612) 9'463'826<br />

Cash�flow�from�operating�activities (1'060'414) (3'227'530) (9'554'639) (3'730'900) 2'251'690<br />

Cash�flow�from�investing�activities (5'141'903) (166'789) (734'048) 388'268 (424'656)<br />

Cash�flow�from�financing�activities (198'701) (223'500) 13'377'007 (965'419) 13'017'004<br />

Net�effect�of�currency�translation�on�cash�and�cash�equivalents 2'983 8'116 (12'290) 11'163 19'030<br />

Increase�(decrease)�in�cash�and�cash�equivalents (6'398'035) (3'609'703) 3'076'030 (4'296'888) 14'863'068<br />

�<br />

�<br />

In�the�year�ended�31�December�2008�and�in�the�first�six�months�of�2009,�mondoBIOTECH�has�mainly�financed�its�<br />

operations� and� met� working� capital� requirements� through� issuance� of� new� shares� and� the� proceeds� from�<br />

convertible�loans�which�have�been�early�converted�into�equity�in�the�beginning�of�second�quarter�2006.�<br />

�<br />

As�of�30�June�2009,�the�Company�disposed�of�CHF�7.7�million�of�cash�and�cash�equivalents.�The�Group�has�the�cash�<br />

and�cash�equivalents�necessary�to�finance�its�actual�level�of�activities�for�at�least�twelve�months�from�the�date�of�<br />

this�Listing�Prospectus.�Pursuant�to�such�level�of�activities,�mondoBIOTECH�will,�however,�not�be�in�a�position�to�<br />

finance�its�operating�cash�use�through�cash�generated�by�operations�until�at�least�end�of�2012�and�will�therefore�<br />

rely�on�cash�flow�from�financing�activities.�<br />

�<br />

Cash�used�in�investing�activities�primarily�consists�of�capital�expenditures.�In�2007,�the�cash�flow�generated�refers�to�<br />

a� business� combination.� Cash� provided� from� financing� activities� consisted� mainly� of� the� proceeds� from� capital�<br />

increases�and�third�party�financing,�net�of�issuance�costs,�reduced�by�the�cash�used�for�the�repayment�of�financial�<br />

payables�and�borrowings,�mainly�represented�by�financial�lease.�<br />

�<br />

�<br />


8.6 Consolidated�Balance�Sheet�<br />

�<br />

� 29<br />

As�at�30�June<br />

As�at�31�December<br />

2009<br />

(unaudited)<br />

2008 2007 2006<br />

(in�CHF)<br />

Total�non�current�and�other�current�assets<br />

(including�assets�classified�as�held�for�sale) 69'118'705 62'576'180 68'120'749 61'457'542<br />

Cash�and�cash�equivalents 7'687'294 14'085'329 11'009'299 15'306'187<br />

Total�assets 76'805'999 76'661'509 79'130'048 76'763'729<br />

Total�shareholders'�equity 64'987'022 68'936'483 64'496'168 66'133'939<br />

Non�current�liabilities 297'299 330'517 3'535'535 320'225<br />

Current�liabilities 11'521'678 7'394'509 11'098'345 10'309'565<br />

Total�equity�and�liabilities 76'805'999 76'661'509 79'130'048 76'763'729<br />

�<br />

General�<br />

At� 30� June� 2009,� cash� and� cash� equivalents� represented� 10%� of� the� total� assets.� Cash� and� cash� equivalents�<br />

amounted�to�CHF�15.3�million�in�2006,�decreased�to�CHF�11�million�in�2007�mainly�due�to�the�fact�that�the�increased�<br />

level�of�expenses�and�the�cash�drain�from�certain�financing�activities�were�not�fully�compensated�by�the�revenues�<br />

recognised� during� the� same� period,� and� no� share� capital� increases� were� performed� during� 2007.� In� 2008,� the�<br />

further� increase� in� the� activities� of� the� Group� generated� a� cash� drain� in� the� amount� of� CHF� 9.5� million,� but� the�<br />

issuance� of� shares� through� a� share� capital� increase� performed� during� October� 2008� in� the� amount� of� CHF� 13.8�<br />

million�net�of�transaction�costs�mainly�generated�the�increase�in�cash�and�cash�equivalents�up�to�CHF�14�million�as�<br />

of�31�December�2008.�Shareholders’�equity�decreased�from�CHF�66.1�million�in�2006�to�CHF�64.5�million�in�2007�<br />

due�to�the�losses�incurred�in�the�year.�The�increase�of�up�to�CHF�68.9�million�in�2008�is�due�to�the�issuance�of�shares�<br />

performed�in�October�2008.�The�reduction�to�CHF�64.9�million�in�the�six�months�ended�30�June�2009�refers�to�the�<br />

losses�incurred�in�this�period.�<br />

�<br />

Investments�<br />

Transacted�Investments:�In�the�period�2006�to�2008,�the�investments�in�fixed�assets�operated�by�the�Group�were�<br />

made� for� a� global� amount� of� CHF� 6.4� million� mainly� consisting� of� CHF� 0.3� million� for� starting� activities� of� the�<br />

renovation�of�the�Monastery�(which�is�owned�by�the�Group�pursuant�to�a�60�year�building�right�(Baurecht)�granted�<br />

by�the�Canton�of�Nidwalden�at�the�end�of�2007�and�which�serves�as�new�headquarter�of�the�Group)�and�of�CHF�0.2�<br />

million�for�leasehold�improvements�on�third�parties�facilities,�of�CHF�4.8�million�for�vehicles�and�an�aircraft�used�by�<br />

the�Group�for�business�travelling�of�which�CHF�4.3�million�is�financed�by�means�of�financial�leasing�agreements,�of�<br />

CHF�0.5�million�for�hardware�and�standard�software,�of�CHF�0.2�million�for�equipments,�and�of�CHF�0.3�million�to�<br />

furniture�of�which�CHF�0.2�million�financed�by�means�of�a�financial�leasing�agreement.�<br />

�<br />

Ongoing� Investments:� At� the� end� of� 2008,� the� Group’s� management� resolved� to� substitute� the� aircraft� acquired�<br />

during� the� year� 2007� and� financed� by� means� of� a� financial� leasing� agreement.� The� new� aircraft� was� acquired� in�<br />

February�2009�and�will�be�refinanced�through�a�sale�and�lease�back�transaction�as�soon�as�the�old�one�will�be�sold.�<br />

This�operation�is�ongoing.�The�Group�invested�additional�CHF�0.4�million�for�renovation�activities�of�the�Monastery.�<br />

There�are�no�other�material�ongoing�investments�in�Switzerland�or�abroad�as�of�the�date�of�this�Listing�Prospectus.�<br />

�<br />

Planned�Investments:�The�main�planned�investments,�starting�in�the�end�of�2010,�relate�to�the�renovation�of�the�<br />

Monastery� (expected� to� be� completed� within� 2012,� estimated� costs� between� CHF� 25� to� 30� million� and� to� be�<br />

financed�in�part�by�mortgages�over�the�buildings�of�the�Monastery�and�in�part�by�the�Company),�and�to�the�further�<br />

development�of�the�IT�infrastructure,�in�particular�web�instruments�and�other�community�tools�in�the�US�(through�<br />

the� US� subsidiary)� for� approximately� CHF� 0.5� million� within� the� next� two� years.� Currently,� there� are� no� other�<br />

material�investments�planned.�<br />

8.7 Critical�Accounting�Policies�and�Significant�Judgments�and�Estimates�<br />

The�preparation�of�the�Company’s�consolidated�financial�statements�requires�the�management�to�make�estimates�<br />

and�assumptions�that�affect�the�reported�amounts�of�revenues,�expenses,�assets�and�liabilities,�and�the�disclosure�<br />

of� contingent� liabilities� at� the� date� of� the� financial� statements.� If� in� the� future� such� estimates� and� assumptions,�<br />

which�are�based�on�management’s�best�judgment�at�the�date�of�the�financial�statements,�deviate�from�the�actual�<br />

circumstances,� the� original� estimates� and� assumptions� will� be� modified� as� appropriate� in� the� year� in� which� the�<br />

circumstances�change.�Where�necessary,�the�comparatives�have�been�reclassified�or�extended�from�the�previously�<br />

reported�results�to�take�into�account�presentational�changes.�Significant�accounting�policies,�if�any,�are�described�in�<br />

more� details� in� the� notes� to� the� consolidated� financial� statements.� The� management� bases� its� estimates� upon�<br />

historical� experience� and� on� various� other� factors� that� in� the� management’s� belief� are� reasonable� under� the�<br />

circumstances,� the� results� of� which� form� the� basis� for� making� judgments� about� the� carrying� value� of� assets� and�<br />

liabilities� that� are� not� apparent� from� other� sources.� The� actual� outcome� may� differ� from� the� assumptions� and�<br />

estimates�made.�<br />

�<br />

�<br />


Please�refer�to�the�financial�statements�of�the�Company�included�elsewhere�in�this�Listing�Prospectus�for�further�<br />

information�on�the�Company’s�critical�accounting�policies,�significant�judgments�and�estimates.�<br />

8.8 Financial�Risk�Management�<br />

The�Group�is�exposed�to�various�financial�risks�such�as�credit�risks,�liquidity�risks�and�market�risks�(including�interest�<br />

rate�and�currency�risks).�Please�refer�to�the�financial�statements�of�the�Company�included�elsewhere�in�this�Listing�<br />

Prospectus�for�further�information�on�the�Company’s�financial�risks.�<br />

8.9 Risk�Assessment�Disclosures�Required�by�Swiss�Law�<br />

The� Executive� Committee� (as� defined� below)� is� responsible� for� the� continuous� risk� assessment� and� risk�<br />

management.� The� risk� assessment� procedures� include� the� identification� of� internal� and� external� risks,� the�<br />

assessment�of�their�potential�impact�on�the�Group�as�well�as�the�definition�of�organisational�and�process�measures�<br />

to�identify�the�risk�and�where�appropriate�remediate.�The�Executive�Committee�(as�defined�below)�reports�to�the�<br />

Board� of� Directors� on� a� regular� basis� on� significant� risks� and� measures� taken� by� the� Group.� Please� refer� to� the�<br />

financial�statements�of�the�Company�included�elsewhere�in�this�Listing�Prospectus�for�further�information�on�the�<br />

Company’s�risk�assessment�disclosure.�<br />

8.10 Material�Changes�<br />

There�has�been�no�material�change�in�the�financial�condition�and�result�of�operation�since�30�June�2009.�<br />

� 30<br />


9 Business�<br />

9.1 mondoBIOTECH’s�Business�Strategy�<br />

�<br />

Our�primary�goal�is�to�build�up�a�cash�generating,�profitable�and�sustainable�business�around�our�core�competences�<br />

of� the� continuous� discovery� of� medicinal� product� candidates� by� analysing� already� known� peptides� and� other�<br />

biological�immuno�modulating�substances�that�are�naturally�occurring�in�the�human�body�for�the�development�of�<br />

medicinal�products�for�use�in�the�treatment�of�rare�and�neglected�diseases.�We�then�seek�to�license�or�sell�such�<br />

medicinal� product� candidates� to� third� parties� (such� as� pharmaceutical� and� biotechnology� companies),� between�<br />

discovery� and� the� different� phases� of� development,� and/or� collaborate� with� third� parties� to� obtain� market�<br />

authorisation�and�commercialise�such�medicinal�product�candidates.�<br />

�<br />

The�fundamental�concept�underlying�the�Company’s�business�is�the�belief�that:�<br />

�<br />

� The�most�effective�and�safe�medicinal�products�can�be�obtained�through�redirecting�known�peptides�and�other�<br />

biological� immuno�modulating� substances.� Such� substances� regulate� cell� interaction,� communication� and�<br />

behaviour�within�the�human�body,�and�their�mechanism�of�action�are�well�researched;�<br />

� There�is�no�correlation�between�the�high�amount�of�resources�invested�in�research�and�development�and�the�<br />

resulting� output� obtained,� at� least� not� measurable� in� numbers� of� new� chemical� entities� discovered� and�<br />

developed.�Therefore,�the�development�process�must�be�characterised�by�additional�value�drivers�such�as�in�<br />

depth�information�exchange,�interaction,�versatility�and�flexibility.�Based�on�this,�mondoBIOTECH�has�built�up�<br />

and� is� maintaining� a� continuously� growing� community� of� biologists,� biochemists,� physicians,� patients� and�<br />

patient�advocacy�organisations�and�other�persons�and�organisations�who�share�their�experience,�know�how,�<br />

expertise,�and�skills�with�mondoBIOTECH�and,�like�mondoBIOTECH,�are�dedicated�to�the�search�for�treatments�<br />

of�rare�and�neglected�diseases�(the�mondoBIOTECH�Community);�<br />

� Today,�it�is�estimated�that�there�are�more�than�7’000�rare�and�neglected�diseases�without�appropriate�medical�<br />

treatment�affecting�about�27�to�36�million�people�in�the�EU�and�25�to�30�million�people�in�the�US.�<br />

�<br />

The�business�model�of�mondoBIOTECH�is�therefore�focused�on:�<br />

�<br />

� Discovering�the�most�result�promising�medicinal�product�candidates�with�high�biological�pro<strong>file</strong>s,�by�analysing�<br />

already� known� peptides� and� other� biological� immuno�modulating� substances,� and� bringing� such� medicinal�<br />

product�candidates�to�the�awareness�of�the�mondoBIOTECH�Community;�<br />

� Interacting�and�networking�with�the�mondoBIOTECH�Community�to�(i)�continue�further�development�and�(ii)�<br />

explore�new�ways�to�develop,�finance,�promote�and�commercialise�the�medicinal�product�candidates;�<br />

� Advancing� the� development� up� to� late� development� stages� by� licensing� or� selling� such� medicinal� product�<br />

candidates�to�third�parties�(such�as�pharmaceutical�and�biotechnology�companies),�between�discovery�and�the��<br />

different�phases�of�development,�and/or�collaborating�with�third�parties�to�obtain�marketing�authorisation�and�<br />

commercialise�such�medicinal�product�candidates.�<br />

�<br />

Until�the�date�of�this�Listing�Prospectus,�mondoBIOTECH�has:�<br />

�<br />

� Licensed�to�Biogen�a�medicinal�product�candidate�regarding�the�use�of�Aviptadil�for�the�treatment�of�PAH�with�<br />

certain�issued�patents�concerning�Aviptadil.�Under�this�licensing�out�agreement,�mondoBIOTECH�also�performs�<br />

certain� clinical� development� services� for� Biogen,� and� granted� to� Biogen� an� option� right� for� three� additional�<br />

indications;�<br />

� Licensed�to�InterMune�a�medicinal�product�candidate�regarding�the�use�of�INF���for�the�treatment�of�IPF.�The�<br />

clinical�development�of�this�medicinal�product�candidate�was�discontinued�following�recommendation�of�the�<br />

study's�independent�data�monitoring�committee�in�the�beginning�of�2007.�In�2006,�mondoBIOTECH�sold�the�<br />

relevant�issued�patent�to�InterMune;�<br />

� Licensed�to�LungRX�five�medicinal�product�candidates�at�the�option�of�LungRX.�The�first�choice�was�made�in�<br />

December�2008,�when�Lung�RX�decided�to�license�out�the�medicinal�product�candidate�related�to�the�use�of�<br />

Secretin�for�the�treatment�of�MRSA�infections�in�patients�with�cystic�fibrosis;�<br />

� Five�medicinal�product�candidates�on�which�pre�clinical�tests/Phase�I�tests�are�ongoing.�With�respect�to�one�of�<br />

such� medicinal� product� candidate,� mondoBIOTECH� has� entered� into� a� collaboration� agreement� with�<br />

Pharmarare,�with�the�aim�to�develop�and�commercialise�such�medicinal�product�candidate;�<br />

� Twelve�medicinal�product�candidates�on�which�efficacy�and�safety�trials�(pre�clinical�tests)�are�in�preparation;�<br />

� Discovered� additional� 290� medicinal� product� candidates� for� use� in� the� treatment� of� rare� and� neglected�<br />

diseases�which�are�covered�by�287�<strong>file</strong>d�patent�applications�and�ready�for�further�development;�<br />

� Six�adopted�OMPD;�and�<br />

� A� continuously� expanding� mondoBIOTECH� Community� dedicated� to� the� search� for� treatments� of� rare� and�<br />

neglected�diseases.�<br />

� 31<br />


9.2 Key�Competitive�Strengths�<br />

Management�believes�that�mondoBIOTECH�can�successfully�compete�in�the�current�market�environment�based�on�<br />

its�following�key�strengths:�<br />

9.2.1 “Search�and�Match”�Rather�than�Research�<br />

The�entire�human�DNA�comprises�about�30’000�different�genes,�taking�into�consideration�of�the�complexity�of�the�<br />

human�body�an�astonishingly�small�number.�One�reason�for�such�relatively�small�number�of�different�genes�is�the�<br />

fact�that�a�single�gene�due�to�the�highly�regulated�process�of�transcription�and�translation�may�give�rise�to�more�<br />

than� one� different� protein� product� displaying� diverse� biological� functions.� There� are� many� more� proteins� and�<br />

peptides�in�a�human�body�than�genes.�Proteins�and�peptides�are�the�dominant�working�parts�of�living�organisms.�<br />

The�second�reason�for�the�small�number�of�different�genes�is�that�most�proteins�and�peptides�are�parts�of�biological�<br />

pathways�and�networks.�Therefore,�proteins�and�peptides�functionally�connect�to�each�others,�and�modulate�their�<br />

biological�functions�via�direct�or�indirect�feedback�mechanisms.��<br />

�<br />

Drugs�have�been�mainly�researched�and�developed�by�their�inhibitory�mode�of�action�on�a�single�target�molecule,�a�<br />

protein�for�instance�which�may�be�an�important�part�in�a�biological�network.�Other�parts�of�such�network�can�be�<br />

affected�by�a�drug�substance,�causing�either�unwanted�(negative)�side�effects�or�causing�beneficial�(positive)�side�<br />

effects�that�can�be�applied�for�other,�often�unrelated�diseases.�<br />

�<br />

mondoBIOTECH’s�is�to�discover�medicinal�product�candidates�with�highly�beneficial�features�for�the�treatment�of�<br />

rare�and�neglected�diseases.�Rather�than�engaging�in�the�traditional�approach�of�drug�targeting�by�identifying�new�<br />

chemical�molecules,�we�screen�and�evaluate�the�vast�amount�of�globally�available�data�on�biological�and�medicinal�<br />

activities�(including�clinical�experience)�with�known�substances�by�using�sophisticated�IT�tools/methods.�<br />

9.2.2 Focus�on�Bioactive�Peptides�of�Human�Origin�<br />

mondoBIOTECH�primarily�focuses�on�bioactive�peptides�of�human�origin.�Peptides�are�short�polymers�formed�from�<br />

the� linking,� in� a� defined� order,� of� ��amino� acids.� Twenty� standard� amino� acids� are� used� by� human� cells� to�<br />

biosynthesise�peptides,�and�these�are�specified�by�the�general�genetic�code.�Peptides�act�biologically�as�agonistsan�<br />

agonist�binds�to�a�receptor�of�a�cell�and�triggers�a�response�by�the�cell;�it�produces�an�action,�as�opposed�to�an�<br />

inhibitor,�that�blocks�an�action).�<br />

�<br />

mondoBIOTECH� believes� that� peptides� offer� better� safety� pro<strong>file</strong>s� compared� to� most� other� classes� of� molecular�<br />

entities.�As�a�consequence,�mondoBIOTECH�expects�the�risk�of�failure�of�development�associated�with�toxicity�and�<br />

other�adverse�effects�to�be�significantly�lower�than�in�respect�of�non�human�originated�products.�<br />

�<br />

Peptides�<br />

Amino�acids�are�the�building�blocks�of�peptides.�Amino�acids�combine�in�a�condensation�reaction,�that�is,�through�<br />

dehydration� synthesis,� that� releases� water� and� the� new� “amino� acid� residue”� held� together� by� a� peptide� bond.�<br />

Peptides�are�defined�by�their�unique�sequence�of�amino�acid�residues.�Just�as�the�letters�of�the�alphabet�can�be�<br />

combined�to�form�an�almost�endless�variety�of�words,�amino�acids�can�be�linked�in�varying�sequences�to�form�a�vast�<br />

variety�of�peptides.�<br />

�<br />

Peptides�used�by�mondoBIOTECH�are�the�synthetic�versions�(chemically�produced)�of�the�peptides�discovered�in�<br />

human�cells.�Irrespective�of�the�way�of�manufacturing,�all�peptides�have�the�same�primary�sequence�of�amino�acids�<br />

exhibit� the� same� biological� functions.� For� regulatory� reasons� (synthetic� peptides� fall� under� the� classification�<br />

“chemical�entity”�and�not�under�the�classification�“recombinant�products”),�mondoBIOTECH�works�with�synthetic�<br />

peptides�only.�However,�this�approach,�which�also�guarantees�to�the�patients�a�higher�safety�due�to�the�applied�<br />

manufacturing� process,� has� its� limitations.� Currently,� due� to� economic� constrains� in� the� production� process,�<br />

mondoBIOTECH� does� only� consider� peptides� between� two� and� 80� amino� acids� in� length� as� medicinal� product�<br />

candidates.�<br />

�<br />

Modes�of�Action�of�Peptides�<br />

Peptides�have�mainly�two�different�modes�of�action:�<br />

�<br />

� Peptide�acts�as�agonist�(an�agonist�binds�to�a�receptor�of�a�cell�and�triggers�a�response�by�the�cell;�it�produces�an�<br />

action,�as�opposed�to�an�inhibitor,�that�blocks�an�action);�<br />

� Peptide�acts�independently�from�a�receptor�and�produces�a�direct�action�(e.g.�antibacterial�activity).�<br />

�<br />

All� of� those� bioactive� peptides� (historically� published� in� peer�reviewed� scientific� literature)� are� commercially�<br />

available� products.� Their� production� process� is� known� and� established,� and� repeatable� at� the� same� quality�<br />

standards� to� allow� biological� testing.� However,� reports� on� bioactive� peptides� are� often� biased� by� the� reporting�<br />

authors;�they�often�describe�only�one�or�only�few�biological�functions�of�a�peptide�(due�to�interests,�funding,�and�<br />

focused�projects).��<br />

�<br />

mondoBIOTECH� applies� an� industrial� type� of� screening� approach:� we� have� screened� and� tested� and� continue� to�<br />

screen� and� test� at� the�same� time� in� parallel� and� randomly� bioactive� peptides� in� different� antibacterial,� antiviral,�<br />

� 32<br />


angiogenesis,�proliferation,�immunological,�second�messenger�and�cell�cycle�assay�systems�to�obtain�an�informative�<br />

picture�of�the�additional�bioactive�features�of�the�peptides,�many�of�them�not�being�known�to�the�public.�Based�on�<br />

such�data�generated,�we�have�<strong>file</strong>d�and�will�continue�to�<strong>file</strong>�patent�applications�for�all�peptides�tested�by�us.��<br />

�<br />

Safety�of�Human�Peptides�<br />

The�Company�believes�that�the�vast�majority�of�the�selected�peptides�will�have�a�highly�beneficial�safety�pro<strong>file</strong>�for�<br />

the�patients.��<br />

�<br />

The� Peptides’� cell� interactions,� communications� and� behaviours� within� the� organisms� have� been� selected� for�<br />

millions� of� years� for� efficacy� and� safety� and� represent� the� nature’s� compromise� for� said� features.� Almost� every�<br />

human�being�has�been�exposed�to�a�majority�of�those�peptides�and�the�human�immune�system�therefore�accepts�<br />

them�as�“its�own”.�Many�peptides�are�main�constituents�of�human�milk�–�a�nutriment�necessary�and�sufficient�to�<br />

provide�protection�and�all�elements�for�the�growth�of�babies.�Moreover,�a�significant�number�of�mondoBIOTECH’s�<br />

peptides�has�already�been�tested�in�clinical�trials�by�pharmaceutical�researchers�and�for�other�indications,�but�only�<br />

few� of� those� peptides� are� already� approved� and� on� the� market� for� other� indications.� This� means� that� for� those�<br />

peptides�already�reliable�and�favourable�safety�data�exist,�therefore�fast�exploitations�in�rare�disease�indications�are�<br />

more�likely.�<br />

9.2.3 Focus�on�Rare�Diseases�<br />

mondoBIOTECH� primarily� focuses� on� rare� diseases.� To� date,� it� is� estimated� that� there� are� more� than� 7’000� rare�<br />

diseases.�Often,�also�the�term�“orphan”�is�used�to�describe�these�diseases.�In�the�terminology�used�in�the�EU,�a�<br />

disease� is� considered� rare� if� it� affects� less� than� one� in� 2’000� habitants.� In� the� US,� a� disease� affecting� less� than�<br />

200’000�habitants�is�considered�rare.�Because�of�their�apparently�reduced�epidemiology,�rare�diseases�are�generally�<br />

emarginated�by�the�pharmaceutical�industry.�<br />

�<br />

Rare�diseases�are:�<br />

�<br />

� Often� chronic,� progressive,� degenerative,� and� life�threatening;� the� quality� of� life� of� patients� is� not� seldom�<br />

compromised�by�the�lack�or�loss�of�autonomy;�<br />

� Related�to�high�level�of�pain�and�suffering�for�the�patient�and�his/her�family;�<br />

� Mostly�without�effective�treatment;�<br />

� Affecting�children�in�75%�of�their�forms;�<br />

� Mortal�for�30%�of�the�patients�before�reaching�the�age�of�five;�<br />

� In�80%�of�their�forms�from�genetic�origin.�Other�rare�diseases�are�the�result�of�infections�(bacterial�or�viral),�<br />

allergies�and�environmental�causes,�or�are�degenerative�and�proliferative.�<br />

�<br />

Statistically,�the�probability�of�being�affected�by�a�rare�disease�is�significant.�About�27�to�36�million�people�in�the�EU�<br />

and�25�to�30�million�people�in�the�US�are�affected�by�one�or�more�rare�diseases.��<br />

�<br />

Moreover,�rare�diseases�are�characterised�by�a�broad�diversity�of�disorders�and�symptoms�that�vary�not�only�from�<br />

disease� to� disease� but� also� from� patient� to� patient� suffering� from� the� same� disease.� Rare� diseases� also� differ� in�<br />

terms�of�severity,�but�in�average�the�life�expectancy�of�rare�disease�patients�is�significantly�reduced.�The�impact�on�<br />

life� expectancy� varies� from� one� disease� to� the� other;� some� cause� death� at� birth,� many� are� degenerative� or� life�<br />

threatening,� whilst� others� are� compatible� with� a� normal� life� if� diagnosed� in� time� and� properly� managed� and/or�<br />

treated.�For�the�vast�majority�of�patients�with�rare�diseases,�no�adequate�therapeutics�exists.�<br />

�<br />

Some�rare�diseases,�such�as�tuberculosis�(“TB”),�haemophilia,�cystic�fibrosis,�Tay�Sachs�disease,�and�amyotrophic�<br />

lateral� sclerosis� (ALS)� have� names� that� are� familiar� to� the� public.� However,� there� are� thousands� of� other� rare�<br />

diseases�that�are�almost�unknown,�but�can�be�equally�devastating�to�those�affected.�People�who�have�rare�diseases�<br />

often�encounter�problems�(emotional,�medical,�and�financial)�that�are�related�to�the�fact�that�their�diseases�are�rare.�<br />

Rare� diseases� can� be� found� in� every� area� of� medicine:� in� particular� autoimmune,� cardiovascular,� chromosomal,�<br />

dermatologic,� infectious,� metabolic,� neurologic,� pulmonary,� renal,� and� so� forth.� Many� rare� diseases� are� “multi�<br />

system”�diseases,�affecting�several�different�parts�of�the�body.�<br />

�<br />

Most�rare�diseases�do�not�have�approved�treatments.�This�means�that�regulatory�agencies�have�not�approved�the�<br />

use�of�medicinal�products�for�the�treatment�of�rare�diseases.�This�is�mostly�due�to�the�lack�of�appropriate�clinical�<br />

data,�which�is�a�fundamental�prerequisite�for�obtaining�market�approval.�Many�rare�diseases�patients�are�treated�<br />

Off�label,�which�means�that�medicinal�products�approved�by�regulatory�agencies�for�other�diseases�or�conditions�<br />

are� prescribed�by� the� physicians� for� patients� with� rare� diseases,� without� the� clinical� proof� of� benefit.� Therefore,�<br />

health�insurers�and�other�third�party�payers�often/usually�refuse�to�cover�the�costs�for�Off�label�uses�of�approved�<br />

drugs� in� rare� diseases� without� data� from� clinical� trials,� since� such� uses� are� considered� as� investigational,� not�<br />

regulatory�approved�medicines�for�the�respective�rare�diseases.�<br />

�<br />

Commonly,� the� rarer� a� disease,� the� more� difficult� it� is� to� perform� systematic� research� and� development.� The�<br />

interlinking� of� basic� research� with� clinical� research� is� therefore� particularly� essential� for� developing� medicine�<br />

product�candidates�for�use�in�the�treatment�of�rare�diseases.�<br />

� 33<br />


Better�Diagnostics�for�Patients�with�Rare�Diseases�<br />

Beyond�the�diversity�of�the�diseases,�rare�disease�patients�and�their�families�are�confronted�with�a�wide�range�of�<br />

difficulties�arising�from�the�rarity�of�the�disease:�<br />

�<br />

� Lack�of�access�to�correct�diagnosis.�The�period�between�the�emergence�of�the�first�symptoms�and�the�accurate�<br />

diagnosis�may�involve�risky�delays;�further�an�inaccurate�diagnosis�may�lead�to�inaccurate�treatments;�<br />

� Lack� of� scientific� knowledge.� This� results� in� difficulties� in� developing� therapeutic� tools,� in� defining� the�<br />

therapeutic�strategy�and�in�missing�medicinalproducts�for�adequate�treatment.�<br />

�<br />

The� first� difficulty� patients� and� their� families� usually� face� is� to� obtain� an� accurate� diagnosis.� This� difficulty� is�<br />

repeated� at� every� new� stage� of� an� evolving� or� degenerative� rare� disease.� The� lack� of� knowledge� of� their� rare�<br />

pathology�often�puts�the�life�of�patients�at�risk�and�results�in�wastage,�delays,�multiple�medical�consultations�and�<br />

prescription�of�drugs�and�treatments�that�are�inappropriate�or�even�contra�productive.�Diagnosis�is�regularly�made�<br />

late,�when�the�patient�has�already�been�treated�–�during�many�months�or�even�years�–�for�another�more�common�<br />

disease.�Often,�only�some�of�the�symptoms�of�a�rare�disease�are�identified�and�treated.�<br />

�<br />

A�survey�of�the�delay�in�diagnosis�for�eight�rare�diseases�in�Europe�was�conducted�by�the�European�Organisation�for�<br />

Rare� Diseases� (“Eurordis”)� in� 2005.� In� collaboration� with� 67� European� rare� disease� organisations,� Eurordis�<br />

conducted� this� survey� to� study� the� delay� in� diagnosis� for� eight� rare� diseases� in� European� countries.� The� main�<br />

findings�of�this�survey�were�that�25%�of�the�patients�had�to�wait�between�five�and�30�years�from�early�symptoms�to�<br />

the� confirmatory� diagnosis� of� their� disease.� Before� receiving� a� confirmatory� diagnosis,� 40%� of� the� patients� first�<br />

received�an�erroneous�diagnosis,�others�received�none.�25%�of�the�patients�had�to�travel�to�a�different�region�to�<br />

obtain� the� confirmatory� diagnosis,� and� 2%� had�to� travel� to� a� different� country.� The� diagnosis�was� announced� in�<br />

unsatisfactory�terms�or�conditions�in�33%�of�the�cases,�and�in�unacceptable�ones�in�12.5%�of�the�cases.�The�genetic�<br />

nature�of�the�disease�was�not�communicated�to�the�patient�or�his/her�family�in�25%�of�the�cases.�<br />

�<br />

Similar�results�have�been�reported�by�the�US�National�Commission�on�Orphan�Diseases:�about�50%�of�the�patients�<br />

reported�receiving�a�diagnosis�within�a�year�of�their�first�visit�to�a�doctor.�Nearly�30%�of�the�patients�in�the�survey�<br />

reported�that�as�many�as�five�years�passed�before�their�disease�could�be�identified;�and�15%�reported�that�they�<br />

were�not�diagnosed�for�six�or�more�years.�The�consequences�of�diagnosis�delay�are�tragic:�<br />

�<br />

� Clinical�worsening�of�the�patient’s�health�in�terms�of�intellectual,�psychological�and�physical�conditions,�even�<br />

leading�to�the�death�of�the�patient;�and�<br />

� Loss�of�confidence�in�the�healthcare�system.�<br />

�<br />

Neglected�Diseases�<br />

Because�neglected�disease�patients�are�a�minority�in�industrialised�countries,�there�is�a�lack�of�public�awareness.�<br />

Diseases� like� TB� or� malaria� are� rare� diseases� in� industrial� countries� but� a� major� global� health� burden.� Neglected�<br />

diseases�are�common,�communicable�diseases�that�mainly�affect�patients�living�in�emerging�countries.�Because�they�<br />

are�not�a�public�health�priority�in�the�industrialised�countries,�little�research�and�drug�development�is�performed�in�<br />

respect�of�these�diseases.�They�are�“neglected”�by�the�pharmaceutical�industry�because�the�market�is�usually�seen�<br />

as�unprofitable.�<br />

�<br />

We� believe� that� focusing� on� rare� as� well� as� neglected� diseases� offers� competitive� advantages� in� respect� of� the�<br />

traditional�areas�of�activity�chosen�by�the�pharmaceutical�industry�that�usually�does�not�develop�drugs�for�neglected�<br />

diseases� in� emerging� countries.�We� expect� that� our� scientific� and� business� approach� enables�us� to� engage� in�an�<br />

efficient� and� aimed� search� for� medicinal� product� candidates� also� with� respect� to� the� treatment� of� neglected�<br />

diseases.�<br />

9.2.4 Genotyping�Patients�with�Rare�Diseases�to�Potentially�Improve�the�Diagnostics�<br />

For�more�than�a�century,�scientists�have�been�studying�how�genes�help�to�form�human�beings�the�way�they�are,�<br />

operating� in� conjunction� with� diet,� environment� and� other� factors� to� influence� aspects� of� their� appearance,�<br />

behaviour,�and�physiology.�Until�now�it�has�been�impossible�to�see�more�than�a�tiny�fragment�of�the�DNA�code�that�<br />

lies� inside� every� human� being.� Each� and� every� human� being� is� unique,� but� they� also� share� many� fundamental�<br />

similarities.�That�is�one�of�the�biggest�lessons�of�research�in�the�genomic�age�after�the�deciphering�of�the�human�<br />

genome.� mondoBIOTECH� intends� to� improve� the� understanding� of� how� genetics� influence� rare� and� neglected�<br />

diseases.�<br />

�<br />

By�simply�spitting�into�a�test�tube�it�is�nowadays�possible�to�genotype�persons.�At�its�most�basic�level,�the�human�<br />

genetic� sequence� is� a� three�billion� letter� string� of� A’s,� T’s,� G’s� and� C’s.� Most� of� that� sequence� is� the� same� in�<br />

everyone.� But� there� are� an� estimated� ten� million� places� in� the� genome� where� a� single� letter� of� the� sequence�<br />

sometimes�differs�from�one�person�to�another.�Those�one�letter�spelling�variations�are�known�as�single�nucleotide�<br />

polymorphisms�(“SNPs”),�and�they�form�the�basis�for�the�genotyping.�A�person,�who�has�a�“C”�at�a�particular�spot,�<br />

for�example,�might�be�more�sensitive�to�bitter�tastes�than�a�person�with�a�“G”�in�that�spot.�<br />

�<br />

� 34<br />


mondoBIOTECH� and� 23andMe� (investors� of� 23andMe� include� Google� Inc.,� Genentech,� Inc.,� and� New� Enterprises�<br />

Associates�(NEA))�entered�in�2009�into�an�agreement�to�advance�research�on�genotyping�patients�affected�by�rare�<br />

diseases.� The� genotyping� technology� process� relies� heavily� on� massive� computer� power,� and� the� chip� itself� is� a�<br />

miniaturised�genetics�laboratory.�This�technology�is�called�’BeadChip’,�which�is�a�small�glass�slide�with�millions�of�<br />

tiny�beads�on�its�surface.�Attached�to�each�bead�are�probes�–�bits�of�DNA�complementary�to�sites�in�human�genome�<br />

where� SNPs� of� interest� are� located.� The� patients’� DNA� will� stick� to� the� probe� that� matches� whichever� SNP� they�<br />

happen�to�have.�<br />

�<br />

In� the� genotyping� process,� a� patient’s� DNA� is� chopped� up� into� pieces� and� washed� over� the� chip,� where� each�<br />

fragment�sticks�to�any�probes�that�are�complementary�to�it.�Then�fragments�of�DNA�that�have�been�specially�tagged�<br />

are�introduced�to�the�chip�in�such�a�way�that�they�stick�to�any�probes�that�are�paired�perfectly�with�sample�DNA.�At�<br />

that�point,�the�tagged�DNA�fragments�are�triggered�to�glow�indicating�which�version�of�each�SNP�is�present�in�the�<br />

sample.�It’s�a�scientifically�complex�process,�but�a�simple�and�reliable�method�in�practice.�The�technology�used,�the�<br />

“Illumina�HumanHap�550�+�BeadChip”,�analyses�more�than�550’000�SNPs�that�cover�the�entire�genome.�Although�<br />

this�is�still�only�a�fraction�of�the�10�million�SNPs�that�are�estimated�to�be�in�the�human�genome,�these�550’000�are�<br />

specially� selected� because� they� provide� a� lot� of� information� about� other� nearby� SNPs.� This� maximises� the�<br />

information�mondoBIOTECH�can�obtain�from�every�SNP�it�analyses,�while�keeping�the�cost�low.�<br />

�<br />

As�the�majority�of�the�rare�diseases�have�genetic�origins,�mondoBIOTECH�believes�that�genotyping�patients�with�<br />

rare�or�neglected�diseases�in�the�long�run�will�contribute�to�identify�common�features�between�them�that�would�<br />

allow�to�predict�in�future�in�patients�not�yet�diagnosed�the�respective�disease�and�therefore�efficacy�improve�the�<br />

diagnostics.�<br />

9.2.5 Work�and�Networking�in�a�Global�Community�(the�mondoBIOTECH�Community)��<br />

mondoBIOTECH�believes�that�there�is�no�correlation�between�the�high�amount�of�resources�invested�in�research�<br />

and�development�and�the�resulting�output�obtained,�at�least�not�measurable�in�numbers�of�new�chemical�entities�<br />

discovered�and�developed.�Therefore,�the�development�process�must�be�characterised�by�additional�value�drivers�<br />

such�as�in�depth�information�exchange,�interaction,�versatility�and�flexibility.�<br />

�<br />

mondoBIOTECH�has�therefore�built�up�and�is�maintaining�a�continuously�growing�community�(the�mondoBIOTECH�<br />

Community)�of�biologists,�biochemists,�physicians,�patients�and�patient�advocacy�organisations�and�other�persons�<br />

and� organisations� who� share� their� experience,� know�how,� expertise,� and� skills� with� mondoBIOTECH� and,� like�<br />

mondoBIOTECH,�are�dedicated�to�the�search�for�treatments�of�rare�and�neglected�diseases.�<br />

9.2.6 Market�Protection�through�OMPD�<br />

A� product� intended� to� be� used� by� patients� with� rare� diseases� is� called� “Orphan� Drug”� or� “Orphan� Medicinal�<br />

Product”.� These� drugs� are� called� “orphan”�because� there� is� a�generally� known� understanding� that� it� is� not� cost�<br />

effective�for�the�pharmaceutical�industry�to�develop�and�market�medicinal�products�designed�for�a�small�number�of�<br />

patients�only.�For�this�reason,�health�authorities�recognised�the�necessity�to�introduce�incentives�to�encourage�the�<br />

pharmaceutical�industry�to�develop�and�commercialise�medicines�intended�for�patients�with�a�rare�diseases.�The�<br />

FDA�introduced�the�Orphan�Drug�Act�(“ODA”)�in�1982,�and�the�EMEA�the�European�Orphan�Legislation�in�2001.�<br />

�<br />

In�the�course�of�its�development�to�a�medicinal�product,�a�drug�can�therefore�assume�the�status�of�Orphan�Drug�or�<br />

the�designation�of�Orphan�Medicinal�Product,�provided�it�fulfils�certain�conditions.�As�an�incentive�to�develop�such�<br />

drugs,� health� authorities� give,� upon� the� granting� of� marketing� authorisation� in� the� designated� jurisdictions,� an�<br />

exclusivity�protection�right�for�the�medicinal�product�for�the�particular�disease.�Exclusivity�is�granted�for�up�to�seven�<br />

years�in�the�US�and�for�up�to�ten�years�in�the�EU,�starting�from�the�date�in�which�marketing�authorisation�is�granted�<br />

by� the� respective� authority.� Therefore,� during� the� exclusivity� period,� no� third� party� can� obtain� a� marketing�<br />

authorisation�for�the�same�drug�in�the�same�indication.�In�addition,�the�EMEA�offers�incentives�such�as:�(i)�protocol�<br />

assistance�(scientific�advice�during�the�product�development�phase);�(ii)�100%�reduction�for�protocol�assistance�and�<br />

follow�up;� (iii)� 100%� reduction� for� pre�authorisation� inspections;� (iv)� 50%� reduction� for� new� applications� for�<br />

marketing�authorisation;�and�(v)�50%�reduction�for�post�authorisation�activities,�including�annual�fees�(applies�only�<br />

to�small�and�medium�sized�enterprises)�within�the�first�year�after�granting�the�authorisation.�<br />

�<br />

Parallel� to� an� exhaustive� intellectual� property� program� including� patents� and� other� intellectual� properties,�<br />

mondoBIOTECH� seeks� to� apply� for� OMPD� (EU� and� US)� in� order� to� help� to� build� up� and� to� defend� the� exclusive�<br />

market�position�of�the�relevant�therapeutics�granted�by�such�a�designation�once�marketing�approval�is�received.�<br />

9.2.7 Strong�Management�Team�<br />

mondoBIOTECH�has�an�internationally�experienced�management�team�of�industry�experts�recognised�in�their�fields,�<br />

with� diverse� backgrounds� and� complementary� management� skill�sets� in� innovation,� science,� development,�<br />

marketing�and�finance.�<br />

9.2.8 Outsourcing�and�Project�Management�<br />

An� integral� part� of� mondoBIOTECH’s� business� model� is� the� cooperation� with� leading� clinicians� and� regulatory�<br />

experts�on�the�set�up�of�clinical�protocols,�third�party�manufacturers�and�clinical�development�service�providers.�<br />

� 35<br />


mondoBIOTECH�does�not�conduct�clinical�trials�for�its�medicine�product�candidates�itself.�mondoBIOTECH�believes�<br />

that�outsourcing�or�collaborating�with�other�parties�is�the�optimal�way�to�achieve�its�business�goals.�mondoBIOTECH�<br />

remains� in� charge� of� the� project� management� and� has� a� highly� specialised� team� of� in�house� experts� able� to�<br />

competently�interact�with�its�partners,�thus�enabling�an�efficient�management�of�the�business�processes.�<br />

9.3 mondoBIOTECH’s�Pipeline�<br />

9.3.1 Overview�<br />

�<br />

On�the�date�of�this�Listing�Prospectus,�mondoBIOTECH�has:�<br />

�<br />

� Licensed�to�Biogen�a�medicinal�product�candidate�regarding�the�use�of�Aviptadil�for�the�treatment�of�PAH�with�<br />

certain�issued�patents�concerning�Aviptadil.�Under�this�licensing�out�agreement,�mondoBIOTECH�also�performs�<br />

certain� clinical� development� services� for� Biogen,� and� granted� to� Biogen� an� option� right� for� three� additional�<br />

indications;�<br />

� Licensed�to�InterMune�a�medicinal�product�candidate�regarding�the�use�of�INF���for�the�treatment�of�IPF.�The�<br />

clinical�development�of�this�medicinal�product�candidate�was�discontinued�in�the�beginning�of�2007�following�<br />

recommendation� of� the� study's� independent� data� monitoring� committee.� In� 2006,� mondoBIOTECH� sold� the�<br />

relevant�issued�patent�to�InterMune;�<br />

� Licensed�to�LungRX�five�medicinal�product�candidates�at�the�option�of�LungRX.�The�first�choice�was�made�in�<br />

December� 2008,� when� Lung� RX� decided� to� license� from� mondoBIOTECH� the� medicinal� product� candidate�<br />

related�to�the�use�of�Secretin�for�the�treatment�of�MRSA�infections�in�patients�with�cystic�fibrosis;�<br />

� Five�medicinal�product�candidates�on�which�pre�clinical�tests/Phase�I�tests�are�ongoing.�With�respect�to�one�of�<br />

such� medicinal� product� candidates,� mondoBIOTECH� has� entered� into� a� collaboration� agreement� with�<br />

Pharmarare,�with�the�aim�to�develop�and�commercialise�such�medicinal�product�candidate;�<br />

� Twelve�medicinal�product�candidates�on�which�efficacy�and�safety�trials�(pre�clinical�tests)�are�in�preparation;�<br />

� Discovered� additional� 290� medicinal� product� candidates� for� use� in� the� treatment� of� rare� and� neglected�<br />

diseases�which�are�covered�by�287�<strong>file</strong>d�patent�applications�and�ready�for�further�development;�<br />

9.3.2 Licensed�out�Medicinal�Product�Candidates���Material�Agreements�<br />

�<br />

Aviptadil�for�the�Treatment�of�PAH,�Licensed�out�to�Biogen�<br />

PAH�is�a�debilitating�and�often�fatal�disease�affecting�the�small�pulmonary�arteries�and�regularly�leads�to�death�of�<br />

the�sufferer.�The�disease�is�characterised�by�deregulated�biology�of�certain�cells�in�the�lung�leading�to�a�narrowing�of�<br />

the� blood� vessels� (vasoconstriction).� As� a� consequence,� abnormally� high� blood� pressure� is� built� up� in� the� lungs�<br />

placing� a� strain� on� the� right� part� of� the� heart,� which� consequently� has� to� work� harder� than� usual� against� the�<br />

resistance� to� move� adequate� amounts� of� blood� through� the� lungs.� PAH� tends� to� cause� progressive� right� heart�<br />

failure�with�an�ultimately�fatal�outcome�after�a�period�of�severe�debilitation.�<br />

�<br />

Aviptadil� is� a� synthetically� produced� version� of� the� natural,� endogenous� human� vasoactive� intestinal� peptide.�<br />

Since�the�1970s,�the�biological�role�of�Aviptadil,�its�role�in�a�variety�of�diseases�and�its�role�as�a�therapeutic�agent�<br />

have�been�widely�researched.�To�date,�more�than�11’900�scientific�publications�and�more�than�1’000�review�articles�<br />

describe�Aviptadil’s�characteristics.�Aviptadil�is�an�abundant�biologically�active�peptide,�naturally�present�in�humans�<br />

as�well�as�in�other�mammalian�species�in�the�identical�composition.�It�is�produced�by�neurons�in�the�peripheral�and�<br />

central�nervous�system,�by�endocrine�cells,�as�well�as�by�cells�of�the�immune�system.�Aviptadil�is�mainly�distributed�<br />

within�the�intestines,�the�genital�tract,�and�in�respiratory�cell�linings.�<br />

�<br />

Aviptadil�is�known�to�exert�the�following�biological�activities:�<br />

�<br />

� Regulator�of�immunological�reactions�–�anti�inflammatory�and�in�part�immuno�suppressive�activities;�<br />

� Regulator�of�neurological�reactions;�<br />

� Regulator�of�blood�pressure�in�the�vessels�of�the�lung;�<br />

� Regulator�of�proliferation�in�certain�lung�cell�types;�<br />

� Regulator�of�intestine�activity;�<br />

� Regulator�of�cells�involved�in�thrombosis;�and�<br />

� Regulator�of�cellular�apoptosis�(programmed�cell�death).�<br />

�<br />

As�the�primary�chemical�structure�of�Aviptadil�is�identical�in�humans�and�in�various�mammals,�in�the�last�20�years,�<br />

the�acute�effects�of�Aviptadil�administration�were�investigated�in�a�number�of�animal�models�with�results�published�<br />

in�scientific�journals.�In�general,�the�studies�observed�a�heart�rate�increase�of�about�10%�and�a�systemic�vascular�<br />

resistance� decrease� (vasodilatation).� Also,� since� the� 1970s,� a� number� of� clinical� Phase� I/II� trials� using� systemic�<br />

administration�of�Aviptadil�have�been�performed�on�humans.�Furthermore,�Aviptadil�is�regulatorily�approved�as�a�<br />

combination� therapy� with� phentolamine� as� injectable� treatment� for� erectile� dysfunction� in� UK,� Denmark� and�<br />

New�Zealand.�<br />

�<br />

� 36<br />


In�September�2006,�mondoBIOTECH�entered�into�a�license�and�collaboration�agreement�with�Biogen�regarding�an�<br />

exclusive�and�worldwide�license�to�develop,�manufacture�and�commercialise�Aviptadil�in�the�field�of�PAH�and�to�use�<br />

mondoBIOTECH’s�relevant�know�how�to�this�effect,�in�consideration�for�an�up�front�payment,�milestones�payments�<br />

related�to�the�development�process�of�Aviptadil�in�PAH�and�royalties�on�the�net�sales�of�Aviptadil.�For�indications�<br />

different�from�PAH�(as�the�case�for�sarcoidosis,�acute�respiratory�distress�syndrome�(ARDS)�and�IPF),�Biogen�granted�<br />

back�to�mondoBIOTECH�a�license�to�develop�Aviptadil�until�the�end�of�Phase�II�trials.�Biogen�will�have�an�option�to�<br />

take�over�the�development�and�commercialisation�rights�regarding�Aviptadil�in�such�other�indications�(designation�<br />

of� other� licensed� indications).� In� case� Biogen� designates� additional� indications� with� respect� to� PAH,� additional�<br />

milestones�payments�have�to�be�made�under�the�agreement.�The�agreement�has�a�minimum�term�of�20�years,�but�<br />

may� be� terminated� without� cause� by� Biogen� with� six� months� prior� notice� starting� from� June� 2007.� The� license�<br />

covers� all� rights� under� patent� applications� regarding� Aviptadil.� Biogen� is� granted� the� exclusive� control� over� and�<br />

responsibility� for� the� development� and� commercialisation� of� the� derived� medicinal� product� (including� clinical�<br />

studies,�regulatory�matters�and�approval,�product�pricing�etc.).�OMPD�for�Aviptadil�in�the�field�of�PAH�in�the�US�and�<br />

in� Europe� has� been� transferred� to� Biogen.� Under� this� agreement,� mondoBIOTECH� is� also� providing� clinical�<br />

development�services�for�Biogen�in�particular�in�the�area�of�project�management�and�intellectual�property.�<br />

�<br />

Secretin�for�the�Treatment�of�MRSA�Infections�in�Patients�with�Cystic�Fibrosis,�Licensed�out�to�LungRX��<br />

Cystic�fibrosis�is�the�most�common�potentially�fatal�genetic�disorder�among�Caucasian�children.�It�is�characterised�by�<br />

alterations�in�the�cystic�fibrosis�transmembrane�conductance�regulator�protein�(“CFTR”),�the�most�well�documented�<br />

function� of� which� is� the� regulation� of� transmembrane� hydroelectrolytic� flux.� Alterations� in� the� protein� lead� to�<br />

changes�in�the�characteristics�of�exocrine�excretions.�An�absence�of�functional�CFTR�in�the�epithelial�cell�membrane�<br />

leads�to�the�production�of�sweat�with�a�high�salt�content�and� mucus�secretions�with�an�abnormal�viscosity.�The�<br />

disease�is�chronic�and�generally�progressive,�with�onset�usually�occurring�during�early�childhood�or,�occasionally,�at�<br />

birth.�Virtually�any�internal�organ�may�be�involved�but�the�primary�manifestations�affect�the�breathing�apparatus,�<br />

pancreas� and,� more� rarely,� the� intestine� or� liver.� The� most� common� form� of� cystic� fibrosis� is� associated� with�<br />

respiratory�symptoms,�and�digestive�problems.�<br />

�<br />

Staphylococci� are� bacteria� with� multiple� lifestyles� in� animals� and� humans.� The� broad� flexibility� of� the� major�<br />

opportunistic�pathogen�of�this�genus,�Staphylococcus�aureus,�which�produces�a�large�variety�of�toxins,�to�adapt�to�a�<br />

variety� of� environmental� conditions� is� mediated� by� signal� transduction� systems� sensing� cell� density,� energy�<br />

availability�and�environmental�signals.�The�ability�of�Staphylococcus�aureus�to�thrive�under�anaerobic�conditions�is�<br />

particularly� important� in� the� context� of� several� human� diseases,� including� chronic� lung� disease� in� patients� with�<br />

cystic�fibrosis.�Biofilm�production�of�the�pathogen�is�triggered�by�the�anaerobic�conditions�in�cystic�fibrosis�airway�<br />

mucus.� Staphylococcus� aureus� is� one� of� the� most� commonly� isolated� pathogens� from� the� respiratory� tract� of�<br />

patients� with� cystic� fibrosis� and� one� of� the� first� microbes� to� infect� the� lungs� of� patients� with� cystic� fibrosis.�<br />

Staphylococcus� aureus� continues� to� be� one� of� the� most� commonly� isolated� pathogens� from� patients� with� cystic�<br />

fibrosis.�In�2005,�Staphylococcus�aureus�was�isolated�from�respiratory�tract�secretions�in�51.8%�of�all�cystic�fibrosis�<br />

patients�reported�to�the�US�CF�Foundation�Patient�Registry;�the�prevalence�of�Staphylococcus�aureus�colonisation�<br />

was� highest� among� children� and� adolescent� persons� aged� 17� years� or� younger.� Moreover,� the� prevalence� of�<br />

Staphylococcus�aureus�has�increased�during�the�past�decade�as�has�the�prevalence�of�MRSA.�Among�the�patients�<br />

with�cystic�fibrosis�reported�to�the�US�CF�Foundation�Patient�Registry,�MRSA�was�found�to�grow�from�respiratory�<br />

tract�secretions�of�only�7%�of�the�patients�in�2001,�compared�with�17.2%�of�the�patients�in�2005.��<br />

�<br />

Secretin�is�an�endogenous�human�peptide�known�in�the�literature�since�1906.�To�date,�more�than�8’000�scientific�<br />

publications� describe� Secretin’s� characteristics.� The� primary� action� of� Secretin� is� to� increase� the� volume� and�<br />

bicarbonate�content�of�secreted�pancreatic�juices.�Secretin�administered�intravenously�stimulates�gastrin�release�in�<br />

patients� with� gastrinoma� (Zollinger�Ellison� Syndrome),� whereas� no� or� only� small� changes� in� serum� gastrin�<br />

concentrations�occur�in�normal�subjects.�Secretin�is�regulatory�approved�and�indicated�for:�<br />

�<br />

� Diagnosis�of�pancreatic�exocrine�disease;�<br />

� As�an�adjunct�in�obtaining�desquamated�pancreatic�cells�for�cytopathologic�examination;�<br />

� Diagnosis�of�gastrinoma�(Zollinger�Ellison�syndrome).�<br />

�<br />

mondoBIOTECH�discovered�that�Secretin�inhibits�the�proliferation�of�MRSA�bacteria.�<br />

�<br />

In� December� 2007,� the� Group� entered� into� a� license� agreement� with� LungRX� regarding� five� medicinal� product�<br />

candidates�within�the�mondoBIOTECH’s�pipeline.�According�to�the�agreement,�LungRX�has�the�right�to�choose�at�its�<br />

discretion�five�medicinal�product�candidates�among�mondoBIOTECH’s�pipeline�and�to�develop,�to�manufacture�and�<br />

to� commercialise� the� derived� medicinal� products� worldwide� in� exchange� for� an� up�front� payment,� milestones�<br />

payments�related�to�the�development�processes�and�royalties�on�the�net�sales.�LungRX�made�its�first�choice�at�the�<br />

end�of�2008,�in�applying�for�Secretin�for�the�treatment�of�MRSA�infections�in�patients�with�cystic�fibrosis.�LungRX�<br />

will�make�its�second�choice�in�the�course�of�2009.�<br />

�<br />

INF���for�the�Treatment�of�IPF,�Licensed�out�to�InterMune�<br />

INF���is�a�natural�human�cytokine�that�exerts�a�wide�range�of�biological�effects,�especially�within�the�immune�system.�<br />

The� anti�fibrotic� (anti�scarring)� properties� of� INF��� are� well�documented.� INF���1b� is� a� recombinant� form� of� the�<br />

� 37<br />


natural� human� INF��� containing� 140� amino� acids� and� is� approved� by� the� FDA� for� the� treatment� of� chronic�<br />

granulomatous�disease�(CGD)�and�for�severe,�malignant�osteopetrosis.�<br />

�<br />

IPF�is�a�devastating,�progressive�illness�of�the�lung,�with�a�median�survival�time�of�only�a�few�years�after�the�onset�of�<br />

symptoms.� IPF� is� a� form� of� interstitial� lung� diseases� (“ILD”).� In� ILD,� healthy� tissue� is� progressively� replaced� by�<br />

components�of�the�connective�and�supporting�tissue.�This�process�is�based�on�tissue�repair,�which�would�normally�<br />

accomplish� regular� wound� healing,� but� in� an� exaggerated� way,� thus,� scar� formation� replaces� organ� tissue� until�<br />

complete� loss� of� organ� function� may� occur.� Currently,� besides� lung� transplantation,� there� is� no� regulatorily�<br />

approved�drug�therapy.�The�only�proven�therapeutic�option�for�IPF�is�lung�transplantation.��<br />

�<br />

The�use�of�INF���in�the�indication�IPF�was�originally�licensed�to�InterMune�in�December�2001.�mondoBIOTECH�has�<br />

not�been�involved�in�the�clinical�development�of�INF���in�IPF.�InterMune�conducted�multiple�clinical�phase�studies�<br />

using� INF���1b� in� IPF,� the� last� one� (Clinical� Phase� III� study)� discontinued� in� the� beginning� of� 2007� following�<br />

recommendation�of�the�study’s�independent�data�monitoring�committee.�In�2006,�mondoBIOTECH�definitively�sold�<br />

European� Patent� EP� 0� 795� 332� (validated� for� Germany,� Italy,� Austria,� Switzerland� and� Liechtenstein),� the� EMEA�<br />

Orphan�Drug�Designation�on�INF���for�the�treatment�of�IPF�(granted�on�1�June�2005)�and�the�related�know�how�to�<br />

InterMune.�Under�the�relevant�sale�agreement�which�terminated�the�original�license�agreement�mondoBIOTECH�is�<br />

entitled�to�receive�an�additional�lump�sum�payment�and�royalties�on�net�sales�of�the�product�should�the�relevant�<br />

medicinal�product�candidate�(ever)�be�developed�and�approved�at�a�later�time�.�<br />

9.3.3 Additional�Medicinal�Product�Candidates�<br />

�<br />

DasKloster0247�01�for�the�Treatment�of�Chronic�Thromboembolic�Pulmonary�Hypertension�(“CTEPH”)�<br />

CTEPH�is�a�unique�form�of�pulmonary�hypertension.�Unlike�PAH,�the�principal�therapy�is�surgery.�Without�surgery,�<br />

patients�with�CTEPH�have�a�poor�prognosis�and�succumb�to�right�heart�failure.�Current�data�do�not�support�medical�<br />

treatment�with�PAH�approved�therapies.�<br />

�<br />

DasKloster0247�is�an�endogenous�human�peptide�which�is�produced�by�the�heart�in�response�to�stress�to�the�heart�<br />

tissue.� To� this� date,� more� than� 7’000� scientific� publications� describe� the� characteristics� of� DasKloster0247.�<br />

mondoBIOTECH�discovered�that�DasKloster0247�is�a�potent�vasodilator�in�an�acute�animal�lung�model,�administered�<br />

either�via�inhalation�or�via�injection.�mondoBIOTECH�believes�that�DasKloster0247�will�have�beneficial�effects�for�<br />

patients�affected�by�CTEPH.�DasKloster0247�in�its�recombinant�version�is�approved�in�the�US�for�the�intravenous�<br />

treatment� of� patients� with� acutely� decompensated� congestive� heart� failure� who� have� dyspnea� at� rest� or� with�<br />

minimal�activity.�DasKloster0247�01�is�currently�in�pre�clinical�testing.�<br />

�<br />

DasKloster0182�01�for�the�Treatment�of�Sarcoidosis�<br />

Sarcoidosis�is�a�multisystemic�disorder�of�unknown�cause�characterised�by�the�formation�of�immune�granulomas�in�<br />

involved�organs.�It�is�a�ubiquitous�disease�with�incidence�(varying�according�to�age,�sex,�race�and�geographic�origin)�<br />

estimated� at� around� one� out� of� 6’300� in� men� and� one� out� of� 5’300� in� women� respectively.� The� lung� and� the�<br />

lymphatic� system� are� predominantly� affected,� but� virtually� every� organ� may� be� involved.� Other� severe�<br />

manifestations�result�from�cardiac,�neurological,�ocular,�kidney�or�laryngeal�localisations.�In�most�cases,�Sarcoidosis�<br />

is�revealed�by�persistent�dry�cough,�eye�or�skin�manifestations,�peripheral�lymph�nodes,�fatigue,�weight�loss,�fever�<br />

or� night� sweats,� and� erythema� nodosum.� Chest� radiography� is� abnormal� in� about� 90%� of� the� cases� and� shows�<br />

lymphadenopathy�and/or�pulmonary�infiltrates�(without�or�with�fibrosis),�defining�Sarcoidosis�stages�from�I�to�IV.�<br />

The�etiology�remains�unknown,�but�the�prevailing�hypothesis�is�that�various�unidentified,�likely�poorly�degradable�<br />

antigens�of�either�infectious�or�environmental�origin�could�trigger�an�exaggerated�immune�reaction�in�genetically�<br />

susceptible� hosts.� Diagnosis� relies� on� compatible� clinical� and� radiographic� manifestations,� evidence� of� non�<br />

caseating�granulomas�obtained�by�biopsy�through�tracheobronchial�endoscopy�or�at�other�sites,�and�exclusion�of�all�<br />

other�granulomatous�diseases.�<br />

�<br />

DasKloster0182� is� an� endogenous� human� peptide� mainly� produced� by� the� stomach.� It� was� initially� described� to�<br />

induce� sensations� of� hunger.� Meanwhile,� more� than� 3’500� scientific� literature� articles� describe� the� anti�<br />

inflammatory,� immuno�modulatory,� vasodilatory� or� cardiovascular� effects� of� DasKloster0182.� mondoBIOTECH�<br />

discovered� that� DasKloster0182� has� also� significant� anti�angiogenic� biological� properties,� and� believes� that�<br />

DasKloster0182� will� have� highly� beneficial� effects� for� patients� affected� by� Sarcoidosis.� DasKloster0182�01� is�<br />

currently�in�pre�clinical�testing.�<br />

�<br />

DasKloster0210�01�for�the�Treatment�of�Chronic�Beryllium�Disease�(“CBD”)�<br />

CBD,�also�known�as�berylliosis,�is�an�occupational�hypersensitivity�disorder�caused�by�continued�beryllium�exposure.�<br />

It�is�characterised�by�non�caseating,�non�necrotising�granulomata�within�affected�organs,�most�frequently�lung�and�<br />

skin.�The�main�symptoms�include�dry�coughing,�fatigue,�weight�loss,�chest�pain,�and�increasing�shortness�of�breath.�<br />

Inhalation�of�beryllium�dust�or�fumes�and�dermal�contact�with�beryllium�and�its�compounds�represent�the�primary�<br />

ways�of�human�beryllium�uptake.�Genetic�predisposition�seems�to�play�an�important�role�in�CBD�development.�The�<br />

diagnosis�is�based�on�the�association�of�beryllium�exposure�and�sensitisation�with�symptomatic�disease�including�<br />

abnormal�lung�function�and�chest�radiographs.�<br />

�<br />

� 38<br />


DasKloster0210� is� an� endogenous� human� peptide� initially� described� in� the� year� 1957.� To� date,� more� than� 4’000�<br />

scientific� literature� articles� describe� the� immuno�modulatory,� anti�inflammatory,� and� antipyretic� effects� of�<br />

DasKloster0210.�In�combination�with�Met�Enkephalin,�DasKloster0210�is�regulatory�approved�in�Bosnia�Herzegovina�<br />

for� the� treatment� of� Asthma� and� Multiple� Sclerosis.� mondoBIOTECH� believes� that� DasKloster0210� will� have�<br />

beneficial�effects�for�patients�affected�by�CBD.�DasKloster0210�01�is�currently�in�pre�clinical�testing.�<br />

�<br />

DasKloster0274�01�for�the�Treatment�of�Pseudomonas�Aeruginosa�Infections�in�Patients�with�Cystic�Fibrosis�<br />

Pseudomonas� aeruginosa� bacteria� cause� a� wide� range� of� diseases� in� humans� at� various� body� sites.� In� general,�<br />

patients�immuno�suppressed�due�to�underlying�disease�or�immuno�suppressive�therapy�are�highly�susceptible�to�<br />

Pseudomonas�aeruginosa.�This�relates�also�to�patients�with�the�hereditary�disease�cystic�fibrosis.�<br />

�<br />

Pseudomonas�aeruginosa�virulence�is�both�multifactorial�and�combinatorial,�the�result�of�a�pool�of�pathogenicity�<br />

related�genes�that�interact�in�various�combinations�in�different�genetic�backgrounds�under�different�host�conditions.�<br />

The�result�is�a�variety�of�serious�acute�infections�mediated�by�several�extracellular�and�cell�bound�toxins�which�lead�<br />

to� sepsis� with� high� mortality� rates� and� chronic� localised� infections� in� which� bacteria� grow� in� a� biofilm� structure�<br />

leading�to�persistence.�Pseudomonas�aeruginosa�is�the�leading�killer�in�patients�with�cystic�fibrosis.�Since�the�early�<br />

description�of�cystic�fibrosis,�pulmonary�infections�with�Pseudomonas�aeruginosa�have�been�recognised�as�having�<br />

the�greatest�role�in�morbidity�and�mortality�leading�to�premature�death�in�90%�of�the�patients.�Multidrug�resistant�<br />

Pseudomonas�aeruginosa�is�increasingly�common,�creating�expanding�unmet�need�in�an�area�of�critical�importance�<br />

to� human� health.� There� is� no� doubt� that� the� present� treatment� of� Pseudomonas� aeruginosa� infections� using�<br />

antimicrobial� chemotherapy� is� unsatisfactory,� leading� to� increased� morbidity� and� mortality� in� a� wide� range� of�<br />

patients.� Many� Pseudomonas� aeruginosa� strains� do� not� respond� to� the� use� of� anti�pseudomonal� drugs� and�<br />

infections�become�chronic.��<br />

�<br />

DasKloster0274� is� an� endogenous� human� peptide� consisting� of� only� three� amino� acids.� More� than� 500� scientific�<br />

articles� describe� its� biological� features.� DasKloster0274� can� be� taken� in� orally.� mondoBIOTECH� discovered� that�<br />

DasKloster0274� inhibits� the� proliferation� of� Pseudomonas� aeruginosa� bacteria� and� exerts� immuno�modulatory�<br />

properties,�and�believes�that�DasKloster0274�may�have�beneficial�effects�for�patients�affected�by�cystic�fibrosis�and�<br />

pseudomonas�aeruginosa�infections.�DasKloster0274�01�is�currently�in�pre�clinical�testing.�<br />

�<br />

DasKloster0249�01:�Treatment�of�Drug�Resistant�TB�<br />

TB� is� an� often� severe� and� contagious� airborne� disease� caused� by� infection� with� mycobacteria� tuberculosis� (“TB�<br />

bacteria”).�TB�typically�affects�the�lungs�but�it�may�also�affect�any�other�organ�of�the�body.�It�is�usually�treated�with�<br />

a�regimen�of�drugs�taken�for�six�months�to�two�years�depending�on�the�type�of�infection.�TB�infection�begins�when�<br />

the�TB�bacteria�reach�the�pulmonary�alveoli,�where�they�invade�and�replicate�within�alveolar�macrophages.�Further,�<br />

they� spread� through� the� bloodstream� to� the� more� distant� tissues� and� organs� where� secondary� TB� lesions� can�<br />

develop� in� lung� apices,� peripheral� lymph� nodes,� kidneys,� the� brain,� and� bones.� TB� is� classified� as� one� of� the�<br />

granulomatous� inflammatory� conditions.� If� TB� bacteria� gain� entry� to� the� bloodstream� from� an� area� of� damaged�<br />

tissue�they�spread�through�the�body�and�set�up�many�sources�of�infection,�all�appearing�as�tiny�white�tubercles�in�<br />

the� tissues.� This� severe� form� of� TB� disease� is� most� common� by� infants� and� elderly� people.� Patients� with� this�<br />

disseminated� TB� have� a�fatality� rate� of� approximately� 20%,� even� with� intensive� treatment.� In�many� patients� the�<br />

infection�waxes�and�wanes.�Tissue�destruction�and�necrosis�are�balanced�by�healing�and�fibrosis.�Affected�tissue�is�<br />

replaced� by� scarring� and� cavities� filled� with� cheese�like� white� necrotic� material.� Drug�resistant� TB� is� TB� that� is�<br />

resistant�to�single�anti�TB�treatments�like�Isoniazid,�Rifampicin,�Streptomycin,�or�para�aminosalicylic�acid.�<br />

�<br />

DasKloster0249�is�an�endogenous�human�peptide.�To�date,�more�than�27’000�scientific�literature�articles�describe�<br />

the� features� of�this� peptide.� The� peptide� is� approved� for� evaluating� the� functional� capacity� and� response� of� the�<br />

gonadotropes�of�the�anterior�pituitary.�mondoBIOTECH�discovered�that�DasKloster0249�inhibits�the�replication�of�<br />

the� drug�resistant� TB� bacteria� to� the� treatments� with� para�aminosalicylic� acid,� Streptomycin� and� Isoniazid,� and�<br />

believes�that�DasKloster0249�will�have�beneficial�effects�for�patients�affected�by�drug�resistant�TB.�<br />

�<br />

For� the� development� of� dasKloster0249�01,� mondoBIOTECH� entered� into� a� collaboration� agreement� with�<br />

Pharmarare.� The� parties� will� share� costs� of� the� clinical� development� and� the� revenues� deriving� from� the�<br />

commercialisation�of�this�medicinal�product�candidate,�in�whatever�form�it�will�be�realised.�DasKloster0249�01�is�<br />

currently�in�pre�clinical�testing.�<br />

9.4 Other�Medicinal�Product�Candidates�<br />

mondoBIOTECH� is� actually� working� on� additional� twelve� development� project� dossiers,� most� of� them� in� the�<br />

oncology�area.�<br />

9.5 Further�Funding�<br />

To� continue� its� growth� strategy� and� to� fund� the� further� development� of� its� medicinal� product� candidates,� the�<br />

Company�intends�to�increase�its�share�capital�through�the�issue�of�new�shares�out�of�its�existing�authorized�share�<br />

capital� on� a� continuous� basis� following� the� Listing.� The� Company� intends� to� issue� such� new� shares� to� existing�<br />

� 39<br />


shareholders,� new� investors� and/or� individuals� and� entities� which� are� directly� or� indirectly� affected� by� and/or�<br />

involved� in� the� treatment� of� rare� and� neglected� diseases,� such� as� patients,� their� relatives� and� friends,� patient�<br />

advocacy�organisations,�physicians,�scientists,�academic�organisations,�research�institutions,�hospitals,�employees,�<br />

consultants�and�other�service�providers�of�mondoBIOTECH.�See�“13.1��Share�Capital�Structure�and�Changes�to�Share�<br />

Capital”.�<br />

9.6 Intellectual�Property�and�Orphan�Medical�Product�Designation�<br />

�<br />

Strategy�<br />

mondoBIOTECH�seeks�to�apply�for�patent�protection�for�its�inventions.�Further,�mondoBIOTECH�develops�medicinal�<br />

product� candidates� which� meet� the� criteria� of� OMPD.� mondoBIOTECH’s� strategy� is� to� protect� its� activities� and�<br />

potential�marketing�exclusivity�if�legally�possible�and�adequate,�by�a�combination�of�patents�(for�substance�product,�<br />

use,�other�formulations�and�processes)�and�OMPD.�<br />

�<br />

mondoBIOTECH�does�not�rely�on�the�in�licensing�of�intellectual�property�rights�from�third�parties.�<br />

�<br />

mondoBIOTECH’s�commercial�success�will�depend�in�part�on�its�ability�to�obtain�and�maintain�patent�protection�for�<br />

its�medicinal�product�candidates,�preserve�trade�secrets,�prevent�third�parties�from�infringing�upon�its�proprietary�<br />

rights�and�operate�without�infringing�upon�the�proprietary�rights�of�others.�See�“3.3��Risks�Related�to�Intellectual�<br />

Property”.�<br />

�<br />

Patents�<br />

A� patent� confers� an� exclusive� right� to� use,� develop,� manufacture� and� commercialise� an� invention.� Exclusivity� is�<br />

granted� for� up� to� 20� years.� This� term� is� computed� from� the� date� of� filing� (or� from� another� date� claimed� and�<br />

recognised�as�relevant�priority�date)�but�may,�in�the�case�of�pharmaceuticals,�be�prolonged�for�up�to�five�years�by�<br />

means�of�a�supplementary�protection�certificate�required�before�the�expiring�date�of�the�patent.�In�most�countries�<br />

(but,�e.g.,�not�in�Italy)�it�is�also�possible�to�secure�the�necessary�priority�by�filing�of�a�provisional�patent�application�if�<br />

an�invention�is�to�be�completed�within�the�following�twelve�months.�The�fastest�way�to�protect�inventions�is�to�<strong>file</strong>�a�<br />

European�Patent�Application�or�an�International�Patent�Application�(according�to�the�Patent�Cooperation�Treaty),�<br />

definitive� or� provisional,� with� the� European� Patent� Office� (“EPO”)� and� to� further� extend� it� to� other� countries.� A�<br />

European�Patent,�once�granted,�is�usually�seen�as�highly�confident�due�to�the�in�depth�examination�of�applicants’�<br />

merits�by�the�EPO�and�due�to�the�opposition�procedure�which�gives�third�parties�the�opportunity�to�raise�objections.�<br />

�<br />

Wherever�appropriate�and�legally�possible,�we�aim�at�obtaining�patent�protection�for�drug�substances,�composition�<br />

of�matter�and�uses�for�therapeutics�and�inventions�originating�from�our�research�and�development�efforts,�as�well�<br />

as�manufacturing�and�other�processes�and�formulations.�See�“3.3��Risks�Related�to�Intellectual�Property”.�<br />

�<br />

At�the�date�of�this�Listing�Prospectus,�we�have�313�patent�applications,�of�which�four�have�resulted�in�issued�patents.�<br />

�<br />

Orphan�Medical�Product�Designation�(OMPD)�Status�<br />

Parallel� to� its� seeking� of� patent� or� other� intellectual� property� protection,� mondoBIOTECH,� wherever� appropriate�<br />

and�legally�possible,�seeks�to�apply�for�OMPD�status�(both�in�the�EU�and�the�US)�in�order�to�help�to�build�up�and�<br />

defend�the�exclusive�market�position�of�the�relevant�medicinal�product�candidates�granted�by�such�a�designation�<br />

once�marketing�approval�is�received.��<br />

�<br />

As�the�OMPD�can�be�transferred,�it�is�a�business�asset�for�licensing�out.�Currently,�mondoBIOTECH�is�granted�six�<br />

OMPD.�See�also�“9.2.6��Market�Protection�through�OMPD”.�<br />

9.7 Technical�Development�and�Drug�Supply�Management�<br />

For� the� time� being,� mondoBIOTECH� does� not� intend� to� manufacture� the� medicinal� product� candidates� itself.�<br />

mondoBIOTECH�is�developing�production�processes�for�its�medicinal�product�candidates�in�collaboration�with�third�<br />

parties�benefiting�from�their�expertise,�reliability,�development�and�production�capabilities.�<br />

9.8 Competition�<br />

The�pharmaceutical�and�biotechnology�industry�is�highly�competitive.�mondoBIOTECH�seeks�to�evade�competition�<br />

with�companies�having�significantly�larger�financial,�manufacturing,�marketing�and�product�development�resources�<br />

than�itself�by�focusing�primarily�on�human�peptides�and�their�use�as�medicinal�product�candidates�for�the�treatment�<br />

of�rare�and�neglected�diseases.�<br />

9.9 Insurance�<br />

mondoBIOTECH� has� obtained� insurance� coverage� for� its� operations� at� levels� which� it� considers� prudent� and� in�<br />

conformity�with�its�business�risk�pro<strong>file</strong>s.�mondoBIOTECH�has�taken�out�global�coverage�for�a�variety�of�risks�and�<br />

activities,� including� business� interruption� insurance.� These� insurance� policies� generally� exclude� acts� of� wilful�<br />

� 40<br />


misconduct� and� gross� negligence.� mondoBIOTECH� intends� to� continue� its� practice� of� obtaining� global� insurance�<br />

coverage� where� practicable,� increasing� coverage� where� necessary,� and� reducing� costs.� mondoBIOTECH� does� not�<br />

anticipate�difficulties�in�obtaining�adequate�levels�of�insurance�in�the�future.�<br />

9.10 Legal�Proceedings�<br />

As�of�the�date�of�this�Listing�Prospectus,�neither�the�Company�nor�any�of�its�subsidiaries�is�involved�in�any�pending�<br />

legal�proceedings,�and�they�are�not�aware�of�any�threatened�claims�against�them.�<br />

9.11 Recent�Developments/Post�Balance�Sheet�Events�<br />

There�has�been�no�material�change�in�the�assets�and�liabilities,�financial�condition�and�result�of�operation�since�30�<br />

June�2009,�the�date�of�which�the�last�interim�consolidated�financial�statements�of�the�Company�were�prepared.�<br />

9.12 Governmental�Regulation�<br />

�<br />

Marketing�Approval�<br />

The�process�of�developing�a�therapeutic�from�discovery�through�testing,�registration�and�initial�product�launch�may�<br />

take�ten�years�or�more.�Medicinal�products�must�in�most�countries�receive�regulatory�approval�before�they�can�be�<br />

marketed,� and� the� regulatory� requirements� follow� stringent� standards� that� vary� from� country� to� country.� The�<br />

development�process�usually�involves�the�following�steps:�<br />

�<br />

� After�identifying�a�drug�candidate�and�conducting�pre�clinical�tests�which�include�pharmacological�efficacy�as�<br />

well�as�safety�testing,�clinical�trials�are�conducted�in�three�sequential�phases�prior�to�approval,�but�the�phases�<br />

may�overlap:�In�Phase�I�the�drug�candidate�is�initially�introduced�into�humans,�usually�a�small�group�of�healthy�<br />

volunteers� and� tested� for� safety� and� dosage� tolerance.� Absorption,� metabolism,� distribution� and� excretion�<br />

(ADME)� studies� are� generally� performed� at� this� stage.� In� Phase� II,� a� drug� candidate� is� tested� on� a� limited�<br />

number� of� patients� with� the� disease� to� evaluate� the� efficacy� of� the� drug� for� specific,� targeted� indications,�<br />

determine� dosage� tolerance� and� optimal� dosage,� and� identify� possible� adverse� effects� and� safety� risks.� In�<br />

Phase�III,�the�clinical�trial�programme�will�be�expanded�to�further�demonstrate�clinical�efficacy,�optimal�dosage�<br />

and�safety�within�an�expanded�patient�population�at�geographically�dispersed�clinical�trial�sites;�Phase�III�trials�<br />

usually�include�several�hundred�to�several�thousand�patients�depending�on�the�indication�being�studied�and�<br />

the�expected�effect�size;�<br />

� The� results� of� these� clinical� trials� are� then� submitted� to� the� appropriate� regulatory� authorities� to� obtain�<br />

approval� for� marketing� the� drug.� The� submission� is� done� through� the� filing� of� a� registration� dossier.� The�<br />

registration�dossier�principally�contains�detailed�information�about�the�safety,�efficacy�and�quality�of�the�drug�<br />

gathered�from�the�pre�clinical�tests�and�the�Phase�I�through�Phase�III�clinical�studies.�It�also�provides�details�<br />

about� the� manufacturing� process,� the� production� facilities� and� information� to� be� provided� to� patients.� The�<br />

registration�process�can�last�from�a�few�months�to�a�few�years�and�depends�on�the�nature�of�the�drug�under�<br />

review,�the�quality�of�the�submitted�data�and�the�efficiency�of�the�relevant�agency;�<br />

� If�a�drug�candidate�meets�the�approval�requirements,�the�regulatory�authority�will�grant�a�product�license�for�<br />

marketing.� In� some� countries,� negotiations� on� pricing� and� reimbursement� follow� the� grant� of� the� product�<br />

license;�<br />

� After�commercial�launch,�the�manufacturer�remains�subject�to�regulatory�oversight�and�is�typically�required�to�<br />

report�adverse�reactions,�if�any,�to�the�appropriate�authorities.�<br />

�<br />

In�the�US,�the�FDA�administers�requirements�covering�the�testing,�approval,�safety,�effectiveness,�manufacturing,�<br />

labelling� and� marketing� of� prescription� pharmaceuticals.� In� the� EU,� there� are� two� different� approval� procedures�<br />

available:�a�centralised�procedure�and�one�based�on�mutual�recognition�(so�called�“decentralised�procedure”).�The�<br />

EMEA�governs�the�centralised�drug�registration�and�approval�process.�Following�the�EMEA’s�recommendation,�the�<br />

European� Commission� issues� its� formal� decision,� which� is� valid� throughout� the� EU� without� further� action.� If�<br />

successfully�approved,�the�drug�may�be�marketed�in�all�EU�member�states.�Under�the�mutual�recognition�procedure�<br />

(decentralised� procedure),� one� country,� known� as� the� reference� member� state,� makes� the� principal� evaluation.�<br />

Member� states� then� have� 90� days� to� decide� whether� they� accept� or� reject� the� decision� made� by� the� reference�<br />

member�state.�If�a�country�does�not�follow�the�decision�of�the�reference�member�state,�the�applicant�may�refer�the�<br />

process� to� the� EMEA� for� review� as� in� the� centralised� procedure,� or� may� withdraw� that� member� state� from� the�<br />

procedure.�<br />

�<br />

In� Switzerland,� mondoBIOTECH� is� subject� to� various� regulations� concerning� the� development� of� pharmaceutical�<br />

products,�such�as,�but�not�limited�to,�the�regulations�requiring�approval�of�clinical�studies�in�the�laboratory�by�the�<br />

Ethical� Commission� for� Clinical� Tests� (Ethikkommission� für� klinische� Versuche)� and� the� regulations� requiring� the�<br />

approval�by�Swissmedic.�<br />

�<br />

After� obtaining� marketing� approval,� pharmaceutical� products� remain� subject� to� significant� regulatory� oversight.�<br />

Failure�to�comply�with�post�marketing�regulatory�requirements�can�result�in�the�suspension�of�regulatory�approval,�<br />

� 41<br />


as�well�as�in�possible�civil�and�criminal�sanctions.�In�the�EU,�regulators�may�require�additional�data�in�connection�<br />

with� renewals� of� approval� if� they� believe� this� is� warranted� by� the� additional� data.� In� both� the� US� and� the� EU,�<br />

regulators� have� the� authority� to� require� changes� in� the� labelling� of� approved� products,� revoke� or� suspend� the�<br />

approval�of�previously�approved�products,�request�product�recalls,�seize�or�stop�shipment�of�violative�products�and�<br />

prevent�companies�and�individuals�from�participating�in�the�therapeutic�approval�process.�<br />

�<br />

In�addition�to�the�regulations�governing�marketing�approval�of�drugs,�mondoBIOTECH�is�also�subject�to�regulations�<br />

with�respect�to�its�operating�activities,�including�regulations�on�workplace�safety,�health�and�the�preservation�of�the�<br />

environment.�<br />

�<br />

mondoBIOTECH’s� management� believes� that� mondoBIOTECH� has� obtained� all� permits� required� to� conduct� its�<br />

business� as� presently� conducted� and� that� mondoBIOTECH� is� in� material� compliance� with� all� applicable�<br />

governmental�regulations.�<br />

�<br />

Orphan�Medical�Product�Designation�(OMPD)�<br />

As�an�incentive�to�develop�new�medicinal�products�for�rare�diseases�and�conditions,�OMPD�confers,�upon�granting�<br />

of�marketing�authorisation,�among�other�benefits,�an�exclusive�distribution�right�for�the�relevant�medicinal�product�<br />

with� regard� to� a� particular� indication� (see� “9.2.6��Market� Protection� through� OMPD”).� OMPD� can� offer� market�<br />

protection�even�where�patent�protection�is�not�yet�available,�as�OMPD�and�patents�operate�on�different�levels.�<br />

�<br />

OMPD� status� can� be� obtained� in� the� US� pursuant� to� the� ODA� and� in� the� EU� pursuant� to� the� EC� Regulation�<br />

no.141/2000.�The�criteria�for�designation�in�Europe�are:�<br />

�<br />

� The�medicinal�product�is�intended�for�the�diagnosis,�prevention�or�treatment�of�a�life�threatening�condition�<br />

affecting�not�more�than�five�people�in�10’000;�<br />

� It�is�unlikely�that�without�incentives,�the�marketing�of�the�above�medicinal�product�would�generate�sufficient�<br />

return�to�justify�investments;�<br />

� No�satisfactory�method,�diagnosis,�prevention�or�treatment�of�the�above�conditions�has�been�authorised�in�the�<br />

EU�or,�if�such�methods�exist,�the�medicinal�product�will�be�of�significant�benefit�to�those�affected�by�the�above�<br />

conditions.�<br />

�<br />

A�specific�committee�and�an�agency�examine�the�application.�The�opinion�of�the�Committee�for�Orphan�Medicinal�<br />

Products�(“COMP”)�at�the�EMEA�will�be�given�within�90�days�and�an�appeal�against�the�negative�opinion�is�possible�<br />

within�the�following�90�days.�Following�the�COMP’s�recommendation,�the�European�Commission�issues�its�formal�<br />

decision,� which� is� valid� throughout� the� EU� without� further� action.� Assignments� of� the� OMPD� status� are� allowed�<br />

through�the�filing�of�a�specific�application.�<br />

�<br />

The�criteria�for�designation�in�the�US�are:�<br />

�<br />

� The�disease�or�condition�for�which�the�drug�is�intended�affects�fewer�than�200’000�people�in�the�US�or,�if�the�<br />

drug�is�a�vaccine,�diagnostic�drug,�or�preventive�drug,�the�persons�to�whom�the�drug�will�be�administered�in�<br />

the�US�are�fewer�than�200’000�per�year;�<br />

� For�a�drug�intended�for�diseases�or�conditions�affecting�200’000�or�more�people,�or�for�a�vaccine,�diagnostic�<br />

drug,� or� preventive� drug� to� be� administered� to� 200’000� or� more� persons� per� year� in� the� US,� there� is� no�<br />

reasonable�expectation�that�costs�of�research�and�development�of�the�drug�for�the�indication�can�be�recovered�<br />

by�sales�of�the�drug�in�the�US.�<br />

�<br />

� 42<br />


10 Directors,�Managers�and�Employees�<br />

10.1 Board�of�Directors�<br />

The�Articles�of�Association�provide�for�a�Board�of�Directors�consisting�of�at�least�three�members.�Members�of�the�<br />

Board� of� Directors� are� appointed� and� removed� by�shareholders’� resolution.� Their� term� of� office� is� one� year.�Re�<br />

election�is�allowed.�The�chairman�of�the�Board�of�Directors�(the�“Chairman”)�and�the�vice�chairman�of�the�Board�of�<br />

Directors�(the�“Vice�Chairman”)�are�appointed�by�the�Board�of�Directors.�<br />

�<br />

The� Board� of� Directors� is� entrusted� with� the� ultimate� direction� of� the� Company� and� the� supervision� of� the�<br />

Management.� The� Boards� of� Directors’� non�transferable� and� irrevocable� duties� include� to� ultimately� direct� the�<br />

Company�and�to�issue�the�necessary�directives,�to�determine�the�organisation,�to�organise�the�accounting�system,�<br />

the� financial� controls� as� well� as� the� financial� planning� and� to� appoint,� to� recall� and� to� ultimately� supervise� the�<br />

persons�entrusted�with�the�management�and�representation�of�the�Company.�Furthermore,�these�duties�comprise�<br />

the� responsibility� for� the� preparation� of� the� annual� report� and� the� shareholders’� meeting,� the� carrying� out� of�<br />

shareholders’�resolutions�and�the�notification�of�the�judge�in�case�of�over�indebtedness�of�the�Company.�<br />

�<br />

According�to�the�current�organisational�regulations�(Organisationsreglement)�of�the�Company�enacted�by�the�Board�<br />

of�Directors,�resolutions�of�the�Board�of�Directors�are�passed�by�way�of�simple�majority.�The�members�of�the�Board�<br />

of�Directors�may�only�vote�in�person,�but�not�in�proxy.�In�the�event�of�a�tied�vote,�the�vote�of�the�Chairman�shall�<br />

count�double.�To�validly�pass�a�resolution,�the�majority�of�the�members�of�the�Board�of�Directors�have�to�attend�the�<br />

meeting.� No� quorum� is� required� for� confirmation� resolutions� (Feststellungsbeschlüsse)� and� adaptations� of� the�<br />

articles�of�association�in�connection�with�capital�increases.�<br />

�<br />

In�accordance�with�the�Articles�of�Association�and�the�Company’s�organisational�regulations,�the�Board�of�Directors�<br />

has�delegated�the�operational�management�of�the�Group�to�an�executive�management�committee�(the�“Executive�<br />

Committee”)�under�the�direction�of�the�Chief�Executive�Officer�(the�“CEO”).�<br />

�<br />

The� following� table� sets� forth� the� name,� year� of� taking� office� on� the�Board� of�Directors,� position,� as� well� as� the�<br />

committee� memberships,� of� each� of� the� Board� of� Directors,� followed� by� a� short� description� of� each� member’s�<br />

business�experience,�education�and�activities:�<br />

Joined�Board<br />

Board�Committees<br />

Name of�Directors�in Position AFC NCC SC<br />

Prinz�Michael�von�und�zu�Liechtenstein 2007 Chairman X X<br />

Giovanni�Cusmano 2008 Vice�Chairman X<br />

Prof.�Dr.�Robert�Huber 2008<br />

X<br />

Prof.�Dr.�med.�Thomas�Cerny 2009<br />

X<br />

Prof.�Michael�A.�Keller 2009<br />

X<br />

Christoph�Rentsch<br />

2007<br />

Hans�Rudolf�Schnieper<br />

2007<br />

Vera�Cavalli<br />

2008<br />

Fabio�Cavalli 2007<br />

X<br />

�<br />

Giovanni�Cusmano�also�serves�as�representative�within�the�meaning�of�art.�709�CO�for�the�holders�of�the�Common�<br />

Shares�on�the�Board�of�Directors.�<br />

�<br />

All�the�members�of�the�Board�of�Directors�can�be�reached�at�their�business�address�at�mondoBIOTECH�holding�AG,�<br />

Mürgstrasse�18,�CH���6370�Stans.�<br />

�<br />

Prinz�Michael�von�und�zu�Liechtenstein�is�the�Chairman�and�one�of�the�founders�of�mondoBIOTECH.�Prinz�Michael�von�<br />

und�zu�Liechtenstein�holds�a�degree�in�social�sciences�and�business�economics�from�the�University�of�Vienna.�He�<br />

studied�further�in�Canada�and�Europe�and�worked�with�Nestlé�in�the�fields�of�controlling,�general�management�and�<br />

marketing,�both�in�Europe�and�Africa.�Since�1987,�he�has�been�the�chairman�of�INDUSTRIE��UND�FINANZKONTOR�<br />

ETABLISSEMENT,� a� leading� financial� services� and� trust� company� in� Liechtenstein.� Prinz� Michael� von� und� zu�<br />

Liechtenstein� is� also� chairman� of� BIOPHARMAinvest� AKTIENGESELLSCHAFT� which� is� one� of� the� three� majority�<br />

shareholders�of�the�Company.�See�“12��Major�Shareholders”.�He�was�member�of�the�board�of�Constantia�Privatbank�<br />

AG� and� Constantia� Packaging� AG� until� October� 2008� and� May� 2009� respectively.� Prinz� Michael� von� und� zu�<br />

Liechtenstein�is�a�citizen�of�Liechtenstein.�He�was�born�in�1951.�<br />

�<br />

Giovanni� Cusmano�is�the�Vice�Chairman.�He�holds�an�MBA�from�Bocconi�University�in�Milan.�He�is�CEO�of�ABM�<br />

S.p.A.� Cusmano� was� the� founder� and� previously� CEO� of� Enthusia� S.p.A.,� a� corporate� finance� and� investment�<br />

boutique,�lately�sold�to�the�Swiss�banking�group�Crédit�du�Lac�SA.�Prior�to�that,�he�served�for�five�years�as�head�of�<br />

Corporate� Finance� and� Equity� Capital� Markets� at� Banca� Leonardo.� His� experience� includes� several� roles� in� the�<br />

Corporate� Finance� Department� of� Credito� Italiano,� Euromobliere� and� Nuovo� Banco� Ambrosiano.� While� covering�<br />

such�roles,�he�acted�as�advisor�to�a�number�of�transactions�including�initial�public�offerings,�public�tender�offers�and�<br />

financing�arrangements.�Giovanni�Cusmano�is�an�Italian�citizen.�He�was�born�in�1962.�<br />

� 43<br />

�<br />


Prof.� Dr.� Robert� Huber� is� a� biochemist� with� a� doctorate� from� the� Technical� University� of� Munich,� and� is� Nobel�<br />

Laureate�in�1988�in�chemistry�along�with�Dr.�Johann�Deisenhofer�and�Dr.�Hartmut�Michael�for�the�determination�of�<br />

the�three�dimensional�structure�of�a�photosynthetic�reaction�centre.�In�1972,�he�joined�the�Max�Planck�Institut�für�<br />

Biochemie� in� Martinsried,� Germany,� where� he� served� as� director� until� his� retirement� in� 2005.� He� is� a� guest�<br />

professor�at�the�University�Duisburg�Essen,�at�Cardiff�University,�at�the�Universidad�Autonoma�de�Barcelona�and�the�<br />

Universidad� de�Sevilla,� and� at� the� Korean� German� Institute� of� Technology,� Seoul.� He� is� member� of� the� Scientific�<br />

Advisory�Board�of�Bayer�CropScience�Company,�Monheim,�and�of�the�Hochschulrat�der�Universität�Bayreuth.�He�co�<br />

founded�two�biotech�companies,�Proteros�Biostructures�GmbH�and�SuppreMol�GmbH,�both�located�in�Martinsried.�<br />

Robert�Huber�is�a�German�citizen.�He�was�born�in�1937.�<br />

�<br />

Prof.�Michael�Alan�Keller�earned�a�bachelor�of�arts�in�biology�and�music�from�Hamilton�College�and�master�degrees�<br />

from�the�New�York�State�University�in�musicology�and�library�science.�He�is�Stanford�University’s�librarian,�director�<br />

of� Academic� Information� Resources,� founder� and� publisher� of� High� Wire� Press,� publisher� of� Stanford� University�<br />

Press�and�has�led�libraries�at�Cornell,�Berkeley�and�Yale.�Michael�Keller�was�a�leader�in�exploiting�the�Internet�and�<br />

the�World�Wide�Web�as�a�free�communication�place�for�exchange�of�information�using�mass�digitisation,�generating�<br />

new� services,� creating� innovative� publishing� environments,� and� identifying� new� potential� for� research.� Michael�<br />

Keller’s� board� service� includes� Research� Data� and� Information� of� the� National� Research� Council� of� the� National�<br />

Academy�of�Sciences�USA,�Hamilton�College,�Long�Now�Foundation,�Bibliotheca�Alexandrina�and�National�Institute�<br />

for�Informatics�of�Japan.�Michael�Keller�is�an�a.b.d.�in�musicology�from�New�York�State�University.�He�was�senior�<br />

lecturer�in�musicology�at�Cornell�and�at�Stanford.�He�is�a�guest�professor�at�the�Chinese�Academy�of�Sciences,�Senior�<br />

Presidential� Fellow� of� the� Council� on� Library� and� Information� Resources,� advisor� and� consultant� to� numerous�<br />

colleges,� universities,� foundations,� scientific� and� scholarly� societies,� for� the� city� of� Ferrara,� Italy,� Newsweek�<br />

magazine,� the�National� Library� of� China,� the� National� Library� of� Israel,� the� British� Library,� and� the� King� Abdullah�<br />

University� of� Science� and� Technology.� He� was� a� founder� and� then� president� of� the� Digital� Library� Federation.�<br />

Michael�Keller�is�a�Siemens�Stiftung�2008�Lecturer,�Distinguished�Senior�Presidential�Fellow�of�the�Council�on�Library�<br />

and�Information�Resources�and�fellow�of�the�American�Association�for�the�Advancement�of�Science.�Michael�Keller�<br />

is�a�US�citizen.�He�was�born�in�1945.�<br />

�<br />

Prof.�Dr.�med.�Thomas�Cerny�graduated�from�the�Medical�School�of�the�University�in�Berne,�Switzerland,�where�he�<br />

also�became�a�professor�for�medical�oncology.�Since�1998,�Thomas�Cerny�is�Head�of�Medical�Oncology�Hematology�<br />

Department�at�the�Kantonsspital�of�St.�Gallen,�St.�Gallen,�Switzerland.�Currently,�he�is�the�President�of�the�Swiss�<br />

Cancer�League�and�member�of�numerous�international�cancer�associations,�aiming�to�develop�new�diagnostics�and�<br />

medications�for�cancer�patients.�Thomas�Cerny�is�a�Swiss�citizen.�He�was�born�in�1952.�<br />

�<br />

Christoph�Rentsch�is�a�certified�business�economist�HWV.�He�has�over�20�years�experience�in�the�corporate�finance�<br />

field� and� a� profound� knowledge� in� the� public� and� private� funding� industry.� He� worked� in� various� functions� for�<br />

(former)�Alusuisse�Lonza�Group�both�in�Zurich�and�the�US.�In�1994,�he�joined�F.�Hoffmann�La�Roche�in�Basel�where�<br />

he�became�Head�of�Group�Funding�and�Capital�Markets.�Since�2002,�he�is�a�managing�partner�of�Caperis�Ltd.,�an�<br />

investment�advisory� and� management�firm� focused� on� investment� structuring� in� the� area� of� growth� and� project�<br />

finance�and�infrastructure�fund�management.�He�is�a�member�of�the�investment�committee�of�two�Luxembourg�<br />

based�infrastructure�direct�investment�funds.�Christoph�Rentsch�is�a�Swiss�citizen.�He�was�born�in�1959.�<br />

�<br />

Hans� Rudolf� Schnieper� is� a� certified� business� economist� HWV.� He� is� a� partner� of� Intex� Wirtschaftsprüfung� +�<br />

Management�AG.�Since�1980,�he�has�been�providing�comprehensive�support�to�small�and�medium�sized�enterprises�<br />

in� the� fields� of� internal� and� external� auditing,� bookkeeping/accounting� and� reporting,� the� assumption� of�<br />

management� and� fiduciary� mandates,� advisory� services� and� involvement� in� new� company� formations,� mergers,�<br />

recapitalisation� and� liquidations.� Further� focal� points� of� his� activity� are� the� preparation� of� expert� opinions,� tax�<br />

consultancy�and�planning�as�well�as�the�time�limited�assumption�of�management�functions.�Hans�Rudolf�Schnieper�<br />

is�a�Swiss�citizen.�He�was�born�in�1954.�<br />

�<br />

Vera�Cavalli�graduated�in�pharmacy�at�the�University�of�Basel,�serves�as�mondoBIOTECH’s�Chief�Pharmacy�Officer�<br />

and�is�one�of�the�founder�of�mondoBIOTECH.�She�gained�five�years�of�pharmacy�business�experience�working�in�<br />

various� pharmacies.� From� 1999� to� 2000,� she� worked� in� the� sales� department� for� the� Swiss� market� of� the�<br />

pharmaceutical�company�Searle�SA�(Monsanto�group).�Vera�Cavalli�is�a�Swiss�citizen.�She�was�born�in�1968.�<br />

�<br />

Fabio� Cavalli� serves� as� mondoBIOTECH’s� CEO� and� Chief� Business� Architect� and� is� one� of� the� founders� of�<br />

mondoBIOTECH.� He� has� founded� several� successful� start�ups� in� IT,� consumer� services� and� sports� goods� fields,�<br />

gaining�thereby�considerable�marketing�and�sales�experience.�Fabio�Cavalli�is�a�Swiss�citizen.�He�was�born�in�1955.�<br />

�<br />

Except�for�Vera�Cavalli�and�Fabio�Cavalli,�none�of�the�current�members�of�the�Board�of�Directors�have�ever�been�a�<br />

member�of�the�management�of�the�Company�or�any�of�its�subsidiaries.�<br />

10.2 Board�Committees�<br />

The�Board�of�Directors�has�established�the�following�committees�to�further�strengthen�the�corporate�governance�<br />

structure�of�the�Company:�<br />

� 44<br />


Audit�and�Finance�Committee�(“AFC”)�<br />

The� AFC� currently� consists� of� the� Chairman,� Prinz� Michael� von� und� zu� Liechtenstein,� and� the� Vice�Chairman,�<br />

Giovanni�Cusmano.�The�AFC�advises�the�Board�of�Directors�in�the�performance�of�its�supervisory�duties.�In�particular,�<br />

the�AFC�reviews�the�financial�reporting�to�shareholders�and�the�general�public�as�well�as�the�relationship�with�the�<br />

external�auditors,�satisfies�itself�that�the�Company’s�financial�risk�management�and�the�Company’s�internal�controls�<br />

are� of� an� appropriate� standard,� ensures� that� its� activities� are� consistent� and� compliant� with� the� organisational�<br />

regulations,�assesses�the�adherence�to�the�relevant�“best�practice”�corporate�governance�provisions,�to�the�extent�<br />

such�practice�has�effect�on�the�activities�and�the�functions�of�the�AFC,�satisfies�itself�that�the�Company’s�overall�<br />

fraud� prevention� procedures� are� of� an� appropriate� standard� and� ensures� that� appropriate� procedures� to� enable�<br />

employees� to� confidentially� and� anonymously� submit� their� concerns� regarding� accounting,� internal� controls� or�<br />

auditing�matters�are�in�place.�<br />

�<br />

Nomination�and�Compensation�Committee�(“NCC”)�<br />

The�NCC�currently�consists�of�the�Chairman,�Prinz�Michael�von�und�zu�Liechtenstein�and�the�CEO,�Fabio�Cavalli.�The�<br />

NCC� advises� the� Board� of� Directors� in� the� performance� of� its� supervisory� duties� related� to� nomination� and�<br />

remuneration� matters.� It� is� responsible� for� ensuring� best� possible� leadership� and� management� talent� for� the�<br />

Company� and� for� identifying� board� candidates� with� the� necessary� skills� and� expertise� for� submission� to� the�<br />

shareholders’�meeting,�for�determining�the�compensation�policies,�including�share�based�incentive�programs�and�<br />

specific�compensation�packages�for�the�management,�if�any,�and�for�determining�the�emoluments�of�the�directors.�<br />

�<br />

Scientific�Committee�(“SC”)�<br />

The� SC� currently� consists� of� Prof.� Dr.� Robert� Huber,� Prof.� Dr.� Thomas� Cerny� and� Prof.� Michael� A.� Keller.� The� SC�<br />

advises�the�Board�of�Directors�in�the�performance�of�its�supervisory�duties�with�particular�regard�to�the�scientific�<br />

issues�deriving�from�the�search�and�development�fields�in�which�the�Group�is�performing�its�business.�In�particular,�<br />

the� SC� evaluates� the� scientific� perspectives� of� the� Group’s� search� and� development� strategy� and� reviews� the�<br />

Group’s�search�and�development�portfolio.�<br />

10.3 Executive�Committee�<br />

The�Executive�Committee�currently�comprises�four�officers.�The�Executive�Committee,�under�the�direction�of�the�<br />

CEO�and�the�control�of�the�Board�of�Directors,�conducts�the�operational�management�of�the�Group�pursuant�to�the�<br />

Company’s�organisational�regulations.�The�CEO�reports�to�the�Board�of�Directors�on�a�regular�basis.�<br />

�<br />

Fabio� Cavalli� is� mondoBIOTECH’s� CEO,� Chief� Business� Architect� and� one� of� the� founders� of� mondoBIOTECH.�<br />

Fabio�Cavalli� has� founded� several� successful� start�ups� in� IT,� consumer� services� and� sports� goods� fields,� gaining�<br />

thereby�considerable�marketing�and�sales�experience.�Fabio�Cavalli�was�born�in�1955.�<br />

�<br />

Patrick� Pozzorini� is� mondoBIOTECH’s� Chief� Financial� Officer� and� one� of� the� founders� of� mondoBIOTECH.� Patrick�<br />

Pozzorini�holds�a�degree�in�business�economics�from�the�University�of�Zurich.�Prior�to�that,�Patrick�Pozzorini�was�<br />

Chief�Financial�Officer�for�a�start�up�company�active�in�the�field�of�the�web�based�enterprise�management.�From�<br />

1995� to� 2000,� he� worked� for� PricewaterhouseCoopers� AG� and� from� 1992� to� 1995� for� Fidinam� Group.� Patrick�<br />

Pozzorini�was�born�in�1967.�<br />

�<br />

Dr.�habil.�Dorian�Bevec�is�mondoBIOTECH’s�Chief�Science�Officer�and�Scientific�Auditor�in�Chief�and�a�co�founder�<br />

of�mondoBIOTECH.�Dorian�Bevec�holds�a�Ph.D.�(Dr.�rer.�nat.)�from�the�Ludwig�Maximilians�University�of�Munich�and�<br />

a�habilitation�(Venia�Docendi)�from�the�University�of�Vienna.�Prior�to�that,�Dorian�Bevec�had�been�working�as�Head�<br />

of�Molecular�Biology�and�project�team�leader�at�the�Sandoz�Research�Institute�in�Vienna�for�ten�years�and�at�Axxima�<br />

AG�in�Martinsried�for�two�years.�Dorian�Bevec�was�born�in�1957.�<br />

�<br />

Vera�Cavalli�is�mondoBIOTECH’s�Chief�Pharmacy�Officer�and�one�of�the�founders�of�mondoBIOTECH.�Vera�Cavalli�<br />

graduated� in� pharmacy� at� the� University� of� Basel.� Prior� to� that,� she� gained� five� years� of� pharmacy� business�<br />

experience�working�in�various�pharmacies.�From�1999�to�2000�she�worked�in�the�sales�department�for�the�Swiss�<br />

market�of�the�pharmaceutical�company�Searle�SA�(Monsanto�group).�Vera�Cavalli�was�born�in�1968.�<br />

�<br />

All�members�of�the�Executive�Committee�have�their�business�address�at�mondoBIOTECH�holding�AG,�Mürgstrasse�<br />

18,�CH���6370�Stans.�<br />

10.4 Compensation�of�the�Members�of�the�Board�of�Directors�and�the�Executive�Committee�<br />

In� 2008,� The� aggregate� compensation� (including� refunding� of� expenses� and� social� security� costs)� paid� to� the�<br />

members�of�the�Board�of�Directors�(excluding�Fabio�Cavalli�and�Vera�Cavalli)�was�CHF�134’238.�The�highest�amount�<br />

paid�in�2008�to�a�member�of�the�Board�of�Directors�(excluding�Fabio�Cavalli�and�Vera�Cavalli)�was�CHF�35’135�and�<br />

was�paid�to�Prinz�Michael�von�und�zu�Liechtenstein,�our�Chairman�of�the�Board�of�Directors.�<br />

�<br />

� 45<br />


The�aggregate�compensation�paid�to�the�members�of�the�Executive�Committee�for�the�year�ended�31�December�<br />

2008�was�CHF�1.27�million.�The�highest�amount�paid�to�a�member�of�the�Executive�Committee�was�CHF�659’366�and�<br />

was�paid�to�Fabio�Cavalli,�our�CEO.�<br />

�<br />

Except� for� Fabio� Cavalli,� all� members� of� the� Executive� Committee� have� employment� agreements� with� us.� Fabio�<br />

Cavalli�has�entered�into�a�consulting�agreement�with�us�pursuant�to�which�he�renders�his�services�as�member�of�the�<br />

Board�of�Directors�and�CEO.�In�case�of�termination�of�such�consulting�agreement�as�a�consequence�of�a�change�of�<br />

the�Company’s�control,�Fabio�Cavalli�is�entitled�to�receive�a�termination�payment�equal�to�his�current�annual�fees.�<br />

10.5 Transactions�with�Members�of�the�Board�of�Directors�and�the�Executive�Committee�<br />

Transactions�with�members�of�the�Board�of�Directors�or�members�of�the�Executive�Committee,�if�any,�are�made�at�<br />

arm’s� length.� No� options,� loans,� advances� or� credits� were� granted� to� any� member� of� the� Board� of� Directors� or�<br />

Executive�Committee�in�2008�and�until�the�date�of�this�Listing�Prospectus.�See�“11��Related�Party�Transactions”.�<br />

10.6 Shares�and�Options�held�by�Members�of�the�Board�of�Directors�and�the�Executive�Committee�<br />

As�of�the�date�of�this�Listing�Prospectus,�no�member�of�the�Board�of�Directors�or�the�Executive�Committee�directly�<br />

or�indirectly�owns�any�Shares�or�option�rights�in�Shares.�<br />

�<br />

However,�Prinz�Michael�von�und�zu�Liechtenstein�through�BIOPHARMAinvest�AKTIENGESELLSCHAFT,�HEALTHCARE�<br />

FAMILY�OFFICES�AG,�CTB�HOLDING�AG�and�Stiftung�PMSERV�controls�in�aggregate�39’626’675�Voting�Right�Shares�<br />

(representing� 73.18%� of� the� Shares� and� voting� rights� of� the� Company).� The� ultimate� principal� beneficiaries�<br />

(Begünstigte)� of� Stiftung� PMSERV,� the� controlling� shareholder� of� BIOPHARMAinvest� AKTIENGESELLSCHAFT,�<br />

HEALTHCARE�FAMILY�OFFICES�AG�and�CTB�HOLDING�AG,�are�currently�his�spouse�and�his�existing�and�future�direct�<br />

and�indirect�descendants.�See�“12��Major�Shareholders”.�<br />

�<br />

Fabio� Cavalli,� Vera� Cavalli� and� Patrick� Pozzorini� jointly� hold� 10.42%� of� the� shares� of� BIOPHARMAinvest�<br />

AKTIENGESELLSCHAFT,� Vaduz,� Liechtenstein,� one� of� the� three� principal� shareholders� of� the� Company.�<br />

BIOPHARMAinvest�AKTIENGESELLSCHAFT�individually�holds�16’953’620�Voting�Right�Shares�(representing�31.31%�of�<br />

the�Shares�and�voting�rights�in�the�Company)�and,�together�with�the�other�two�principal�shareholders,�in�aggregate�<br />

39’626’675�Voting�Right�Shares�(representing�73.18%�of�the�Shares�and�voting�rights�in�the�Company),�while�the�<br />

remaining�89.58%�of�the�shares�of�BIOPHARMAinvest�AKTIENGESELLSCHAFT�are�held�by�Stiftung�PMSERV.�See�“12��<br />

Major�Shareholders”.�As�Fabio�Cavalli,�Vera�Cavalli�and�Patrick�Pozzorini�have�only�a�minority�stake�of�10.42%�in�<br />

BIOPHARMAinvest� AKTIENGESELLSCHAFT,� no� Shares� held� by� BIOPHARMAinvest� AKTIENGESELLSCHAFT� are� for�<br />

purposes�of�this�section�attributed�to�them.�<br />

10.7 Legal� Proceedings� and� Convictions� against� Members� of� Board� of� Directors� and� the� Executive�<br />

Committee�<br />

There� have� been� no� convictions� against� any� member� of� the� Board� of� Directors� or� the� Executive� Committee� for�<br />

major�or�minor�finance�or�business�related�crimes�in�the�last�five�years,�and�there�have�been�no�legal�proceedings�<br />

against�any�member�of�the�Board�of�Directors�or�the�Executive�Committee�by�statutory�or�regulatory�authorities�<br />

(including�designated�professional�bodies)�that�are�ongoing�or�have�resulted�in�a�sanction.�<br />

10.8 Employees�<br />

As�of�31�December�2008,�2007�and�2006,�the�Group�had�19,�18�and�11�full�time�equivalent�employees,�respectively.�<br />

As�of�the�date�of�this�Listing�Prospectus,�mondoBIOTECH�has�24�employees.�<br />

10.9 Employee�Participation�Program�<br />

As�of�the�date�of�this�Listing�Prospectus,�the�Board�of�Directors�has�not�yet�adopted�any�participation�program�for�<br />

employees� and�the� management.� However,� the� Company� is� considering� adopting� a� participation� program� for� its�<br />

employees�and�the�management�in�the�near�future.�<br />

�<br />

The� Articles� of� Association� provide� for� a� conditional� share� capital� in� the� amount� of� CHF� 180’000� consisting� of�<br />

1’800’000� registered� shares� with� a� nominal� value� of� CHF� 0.10� each� which� may� be� used� for� future� participation�<br />

programs�for�employees,�the�members�of�the�Board�of�Directors�and�consultants.�See�“13.1��Share�Capital�Structure�<br />

and�Changes�to�Share�Capital”.�<br />

�<br />

�<br />

� 46<br />


11 Related�Party�Transactions�<br />

11.1 Lease� and� Financial� Leasing� Agreement� with� Stadtpalais� Hardhof� Anstalt� for� Facilities� and�<br />

Furniture�in�Basel�<br />

Under� a� lease� agreement,� Stadtpalais� Hardhof�Anstalt,� Vaduz,� Liechtenstein,� has� leased� 1’000�m 2 � office� space�at�<br />

Hardstrasse�52�in�Basel,�Switzerland,�to�mondoBIOTECH�AG.�Stadtpalais�Hardhof�Anstalt�is�owned�by�Fabio�Cavalli,�<br />

our�CEO.�The�relevant�lease�agreement�may�be�terminated�with�effect�from�1�January�2016,�at�the�earliest.�The�rent�<br />

for� the� year� ended� 31� December� 2008� was� CHF� 360’000.� Further,� under� a� second� lease� agreement,� Stadtpalais�<br />

Hardhof�Anstalt�has�leased�furniture�to�Interferon�Medical�Use�SA.�The�relevant�agreement�may�be�terminated�by�<br />

the�end�of�2010�with�full�acquisition�of�the�ownership�of�the�furniture�by�the�Company�at�that�point�of�time.�The�<br />

Company�believes�that�these�agreements�have�been�made�in�the�ordinary�course�of�business�and�on�arm’s�length�<br />

terms.�<br />

11.2 Lease�Agreements�with�Vera�Cavalli�for�spaces�in�Collina�d’Oro�<br />

Under�two�lease�agreements,�Vera�Cavalli,�member�of�the�Board�of�Directors�and�of�the�Executive�Committee,�has�<br />

leased� approximately� 900� m 2 � multi�character� spaces� at� Via� Pasquée� 21/23� in� Collina� d’Oro,� Switzerland,� to�<br />

Interferon� Medical� Use� SA.� These� lease� agreements� may� be� terminated� with� effect� as� of� 1� January� 2014,� at� the�<br />

earliest.�The�rent�for�the�year�ended�31�December�2008�was�CHF�272’400.�The�Company�believes�that�these�lease�<br />

agreements�have�been�made�in�the�ordinary�course�of�business�and�on�arm’s�length�terms.�<br />

11.3 Agreements�with�Vierjahreszeiten�Immobilien�AG�<br />

Under�a�lease�agreement,�VIERJAHRESZEITEN�IMMOBILIEN�AG,�Beckenried,�Switzerland,�which�is�owned�by�Fabio�<br />

Cavalli,� our� CEO,� has� leased� an� apartment� of� approximately� 110� m 2 � in� Sils,� Switzerland,� to� mondoBIOTECH.� The�<br />

lease� agreement� started� on� 1� January� 2009� and� may� be� terminated� with� effect� as� of� 31� December� 2010,� at�the�<br />

earliest.�The�rent�for�the�year�ending�31�December�2009�will�be�of�CHF�45’000.�In�the�year�ended�31�December�2008,�<br />

the� Group� received� non� recurring� real� estate� consulting� services� from� such� company� in� connection� with� the�<br />

acquisition�of�the�Monastery�for�an�amount�of�CHF�28’520.�The�Company�believes�that�these�agreements�have�been�<br />

made�in�the�ordinary�course�of�business�and�on�arm’s�length�terms.�<br />

11.4 Commission�Agreement�with�Imperial�Asset�Management�Corp.�<br />

Imperial�Asset�Management�Corp.,�Panama,�of�which�Mr.�Giovanni�Cusmano,�our�Vice�Chairman,�is�a�director,�is�the�<br />

investment� manager� of� Imperial� Fund� Ltd.,� a� Cayman� Islands� investment� company.� In� 2008,� the� Company�<br />

conducted�a�share�capital�increase�whereby�the�newly�issued�shares�of�the�Company�were�mainly�subscribed�for�by�<br />

Imperial�Fund�Ltd.�The�commission�paid�by�the�Company�to�Imperial�Asset�Management�Corp.�as�consideration�for�<br />

its�successful�raising�of�new�funds�amounted�to�CHF�975’136.�The�Company�believes�that�this�agreement�has�been�<br />

made�in�the�ordinary�course�of�business�and�on�arm’s�length�terms.�<br />

11.5 Agreements�with�INDUSTRIE��UND�FINANZKONTOR�ETABLISSEMENT�<br />

The� Company� has� retained� INDUSTRIE�� UND� FINANZKONTOR� ETABLISSEMENT,� Vaduz,� Liechtenstein,� in� which�<br />

Stiftung� PMSERV,� Vaduz,� Liechtenstein,� owns� a� majority� stake,� for� rendering� general� consulting� services� to� the�<br />

Group.�The�principal�beneficiary�of�Stiftung�PMSERV�is�Stiftung�Prinz�Michael,�Vaduz,�Liechtenstein,�whose�current�<br />

beneficiaries�are�the�spouse�and�existing�and�future�direct�and�indirect�descendants�of�Prinz�Michael�von�und�zu�<br />

Liechtenstein.� See� “12��Major� Shareholders”.� The� fees� for� such� services� for� the� year� ended� 31� December� 2008�<br />

amounted�to�CHF�119’246.�The�Company�has�also�retained�such�entity�for�rendering�accounting�and�administration�<br />

services�to�the�Group�which�also�include�the�making�available�of�office�space�to�mondoBIOTECH�Laboratories�AG�at�<br />

its�registered�office�at�Herrengasse�21,�FL���9490�Vaduz,�Liechtenstein.�The�fees�for�such�services�(including�the�fee�<br />

for�using�the�office�space�at�Herrengasse�21)�for�the�year�ended�31�December�2008�amounted�to�CHF�280’654.�The�<br />

Company�believes�that�these�agreements�have�been�made�in�the�ordinary�course�of�business�and�on�arm’s�length�<br />

terms.�<br />

� 47<br />


12 Major�Shareholders�<br />

The�table�below�shows�those�shareholders�or�groups�of�shareholders�who,�according�to�information�available�to�the�<br />

Company,�hold�more�than�3%�of�the�shares�capital�and�voting�rights�(whether�exercisable�or�not)�as�of�the�date�of�<br />

this�Listing�Prospectus:�<br />

�<br />

� � Purchase�Positions:�<br />

� �<br />

Shareholders� Type�of�<br />

shares�<br />

Shareholders�group 3� �consisting�<br />

of�(1)�BIOPHARMAinvest�<br />

AKTIENGESELLSCHAFT 4 ,��<br />

(2)�HEALTHCARE�FAMILY�<br />

OFFICES�AG 5 ,�(3)�CTB�HOLDING�<br />

AG 6� ,�as�the�direct�holders�of�<br />

Shares�in�the�Company,�and�(4)�<br />

Stiftung�PMSERV 7 �as�common�<br />

controlling�shareholder�of�the�<br />

companies�listed�under�(1)�to�<br />

(3),�and�(5)�Prinz�Michael�von�<br />

und�zu�Liechtenstein 8 �<br />

controlling�the�entities�listed�<br />

under�(1)�to�(4)�<br />

Other�shareholders 9 �<br />

Voting�<br />

Right�<br />

Shares�<br />

Voting�<br />

Right�<br />

Shares�<br />

and�<br />

Common�<br />

Shares�<br />

Voting�rights�conferred�by�<br />

shares/equity�securities 1 �<br />

Number�of�<br />

shares�<br />

� 48<br />

Percentage 2 � Number�<br />

of�shares�<br />

Financial�Instruments��<br />

(Voting�rights�conferred�<br />

by�conversion�rights,�<br />

share�purchase�rights�and�<br />

granted�share�sale�rights�<br />

and�others)�<br />

Percentage 2 � Number�of�<br />

shares�<br />

Resulting�total�percentage�<br />

holding�of�voting�rights�at�<br />

time�of�notification�<br />

Percentage 2 �<br />

39’626’675� 73.18%� �� �� 39’626’675� 73.18%�<br />

14’523’556 10 � 26.82%� �� �� 14’523’556� 26.82%�<br />

Total�shares� � 54’150’231� 100.00%� �� �� 54’150’231� 100.00%�<br />

�<br />

1 � As� of� the� date� of� this� Listing� Prospectus,� the� Company’s� issued� share� capital� consists� of� 52’901’560� registered� shares� with� a� nominal� value� of�<br />

CHF�0.01�each�being�shares�with�privileged�voting�right�(Stimmrechtsaktien)�(the�Voting�Right�Shares)�and�1’248’671�registered�shares�with�a�nominal�<br />

value�of�CHF�0.10�each�being�common�shares�(Stammaktien)�(the�Common�Shares).�<br />

� 2�Calculated�on�the�basis�of�the�total�number�of�Shares/voting�rights�of�the�Company�as�registered�in�the�relevant�commercial�register.�<br />

�<br />

3�<br />

BIOPHARMAinvest� AKTIENGESELLSCHAFT,� HEALTHCARE� FAMILY� OFFICES� AG� and� CTB� HOLDING� AG� are� acting� in� concert� in� relation� to� their�<br />

shareholdings� in� the� Company� as� a� consequence� of� their� direct� common� controlling� shareholder,� Stiftung� PMSERV.� Prinz� Michael� von� und� zu�<br />

Liechtenstein�through�his�board�memberships�in�BIOPHARMAinvest�AKTIENGESELLSCHAFT,�HEALTHCARE�FAMILY�OFFICES�AG�and�Stiftung�PMSERV�<br />

indirectly�controls�the�other�group�members.�Representative�of�the�shareholders’�group�(Gruppenvertreter)�is�Prinz�Michael�von�und�zu�Liechtenstein,�<br />

Vaduz,�Liechtenstein.��<br />

�<br />

4<br />

� c/o� INDUSTRIE�� UND� FINANZKONTOR� ETABLISSEMENT,� Herrengasse� 21,� FL���9490� Vaduz,� Liechtenstein.� All� of� the� shares� of� BIOPHARMAinvest�<br />

AKTIENGESELLSCHAFT� are� held� by� Stiftung� PMSERV,� except� for� 10.42%� of� the� shares� which� are� held� by� Fabio� Cavalli,� Beckenried,� Vera� Cavalli,�<br />

Muzzano,� and� Patrick� Pozzorini,� Beckenried.� As� Fabio� Cavalli,� Vera� Cavalli� and� Patrick� Pozzorini� only� hold� a� minority� stake� of� 10.42%� in�<br />

BIOPHARMAinvest�AKTIENGESELLSCHAFT,�all�the�Shares�held�by�BIOPHARMAinvest�AKTIENGESELLSCHAFT�are�for�disclosure�purposes�attributed�to�<br />

the� shareholder’s� group� consisting� of� BIOPHARMAinvest� AKTIENGESELLSCHAFT,� HEALTHCARE� FAMILY� OFFICES� AG,� CTB� HOLDING� AG,� Stiftung�<br />

PMSERV�and�Prinz�Michael�von�und�zu�Liechtenstein.�See�footnote�3.�<br />

�<br />

5<br />

�c/o�INDUSTRIE��UND�FINANZKONTOR�ETABLISSEMENT,�Herrengasse�21,�FL���9490�Vaduz,�Liechtenstein.�All�of�the�shares�of�CTB�HOLDING�AG�are�<br />

held�by�Stiftung�PMSERV.�See�footnote�3.�<br />

�<br />

6�c/o�INDUSTRIE��UND�FINANZKONTOR�ETABLISSEMENT,�Herrengasse�21,�FL���9490�Vaduz,�Liechtenstein.�All�of�the�shares�of�HEALTHCARE�FAMILY�<br />

OFFICES�AG�are�held�by�Stiftung�PMSERV.�See�footnote�3.�<br />

�<br />

7�c/o�INDUSTRIE��UND�FINANZKONTOR�ETABLISSEMENT,�Herrengasse�21,�FL���9490�Vaduz,�Liechtenstein.�Stiftung�PMSERV,�a�foundation�(Stiftung)�<br />

organised�under�the�laws�of�Liechtenstein,�is�the�direct�controlling�shareholder�of�BIOPHARMAinvest�AKTIENGESELLSCHAFT,�HEALTHCARE�FAMILY�<br />

OFFICES�AG�and�CTB�HOLDING�AG.�See�footnotes�3�to�6.��<br />

�<br />

The� principal� beneficiary� (Begünstigter)� of� Stiftung� PMSERV� is� Stiftung� Prinz� Michael,� Vaduz,� Liechtenstein,� whose� current� beneficiaries� are� the�<br />

spouse�and�existing�and�future�direct�and�indirect�descendants�of�Prinz�Michael�von�und�zu�Liechtenstein.�Currently,�none�of�the�beneficiaries�of�<br />

Stiftung�PMSERV�and�Stiftung�Prinz�Michael,�respectively,�is�a�member�of�the�board�(Stiftungsrat)�of�Stiftung�PMSERV�and�Stiftung�Prinz�Michael,�<br />

respectively,�and�none�of�them�has�a�right�to�issue�instructions�to,�or�to�compel�a�distribution�from�Stiftung�PMSERV�and�Stiftung�Prinz�Michael,�<br />

respectively.�Currently,�Prinz�Michael�von�und�zu�Liechtenstein�is�a�beneficiary�neither�of�Stiftung�PMSERV�nor�of�Prinz�Michael�Stiftung.�<br />

�<br />

8<br />

�Vaduz,�Liechtenstein.�See�footnote�3�and�7.�<br />

�<br />

9�According�to�the�information�available�to�the�Company,�none�of�the�other�shareholders�holds�more�than�3%�of�the�Shares�and�the�voting�rights�in�<br />

the�Company�as�of�the�date�of�this�Listing�Prospectus.�<br />

�<br />


10<br />

�13’274’885�Voting�Right�Shares�and�1’248’671�Common�Shares.�<br />

�<br />

As�of�the�date�of�this�Listing�Prospectus,�the�Company�is�not�aware�of�any�other�person�or�group�of�persons�directly�<br />

or�indirectly�holding,�alone,�together�or�in�concert�with�third�parties,�3%�or�more�of�the�Shares�and�voting�rights�in�<br />

the�Company�or�has�or�have�a�sale�position�of�more�than�3%�of�the�Shares�and�voting�rights�in�the�Company.�<br />

�<br />

� 49<br />


13 Share�Capital�and�Shares�<br />

Set�forth�below�is�certain�information�concerning�the�share�capital�of�the�Company�and�brief�summaries�of�certain�<br />

provisions� of� the� Articles� of� Association� (Statuten),� the� CO� and� other� Swiss� statutes� relating� to� the� Shares.� This�<br />

description�does�not�purport�to�be�complete�and�is�qualified�in�its�entirety�by�reference�to�the�Articles�of�Association,�<br />

the�CO�and�such�other�statutes�as�in�effect�on�the�date�of�this�Listing�Prospectus.�<br />

13.1 Share�Capital�Structure�and�Changes�to�Share�Capital�<br />

�<br />

Past�Corporate�Events�and�Changes�to�Share�Capital�<br />

mondoBIOTECH�holding�AG�(former�e�mondo�AG�and�mondoRPHAN�AG)�was�founded�on�5�March�2007.�The�initial�<br />

share�capital�of�CHF�600’000,�composed�of�12’000’000�bearer�shares�with�a�nominal�value�of�CHF�0.05�each,�was�<br />

fully�subscribed�for�and�paid�in�through�contribution�in�kind�of�27’097’276�registered�shares�of�mondoBIOTECH�AG�<br />

(corresponding� to� an� equity� interest� of� 80.08%� in� mondoBIOTECH� AG),� a� contribution� in� kind� of� 9’999’995�<br />

registered� shares� of� mondoGEN� AG� (corresponding� to� an� equity� interest� of� 100%� in� mondoGEN� AG)� and� a�<br />

contribution�in�cash�of�CHF�239’957.�<br />

�<br />

The�extraordinary�shareholders’�meetings�of�18�September�2007�and�10�December�2007�decided�to�increase�the�<br />

share� capital� for� an� amount� of� CHF� 42’666� allowing� the� minority� shareholders� of� mondoBIOTECH� AG� to� convert�<br />

their�shareholdings�into�shares�of�mondoBIOTECH�holding�AG.�The�capital�increase�was�conducted�on�28�December�<br />

2007.�The�shares�were�fully�subscribed�for�and�paid�in�through�contribution�in�kind�of�6’739’133�bearer�shares�of�<br />

mondoBIOTECH�AG�(corresponding�to�an�equity�interest�of�19.92%�in�mondoBIOTECH�AG).�<br />

�<br />

On�24�October�2008,�the�Company’s�share�capital�was�increased�from�CHF�642’666.25�to�CHF�653’882.70�through�<br />

the�issuance�of�224’429�new�bearer�shares�with�a�nominal�value�of�CHF�0.05�each�at�an�issue�price�of�CHF�66.91�<br />

each�out�of�the�Company’s�authorised�share�capital.�The�new�shares�were�exclusively�offered�to�and�subscribed�for�<br />

by�the�existing�shareholders�of�the�Company.�The�new�bearer�shares�were�fully�paid�in�in�cash.�Out�of�236’300�new�<br />

shares�offered,�224’329�new�shares�were�subscribed�for�and�paid�in�by�existing�shareholders�participating�in�the�<br />

offering.�The�preemptive�rights�could�be�assigned�among�the�existing�shareholders,�but�there�was�no�trading�on�any�<br />

regulated� or� over�the�counter� securities� market.� The� capital� increase� was� implemented� and� registered� with� the�<br />

commercial�register�on�28�October�2008.�<br />

�<br />

On�20�February�2009,�an�extraordinary�shareholders’�meeting�resolved�to�convert�the�then�existing�bearer�shares�<br />

into�registered�shares�and�at�the�same�time�to�split�each�such�bearer�share�with�a�nominal�value�of�CHF�0.05�into�<br />

five�registered�shares�with�a�nominal�value�of�CHF�0.01�each.�<br />

�<br />

In�May�2009,�the�shareholders�of�the�Company�were�offered�to�exchange�their�existing�registered�shares�with�a�par�<br />

value�of�CHF�0.01�into�registered�shares�with�a�par�value�of�CHF�0.10�by�way�of�consolidation�(Zusammenlegung)�or�<br />

a� “reverse� split”.� Following� this� offer,� the� extraordinary� shareholders’� meeting� of� 10� June� 2009� resolved� on� the�<br />

reverse�split�of�12’486’710�registered�shares�with�a�nominal�value�of�CHF�0.01�each�into�1’248’671�registered�shares�<br />

with�a�nominal�value�of�CHF�0.10�each.�Thereby�the�registered�shares�with�a�nominal�value�of�CHF�0.10�issued�at�<br />

that� point� of� time� became� common� shares� (Stammaktien)� and� the� registered� with� a� nominal� value� of� CHF� 0.01�<br />

shares�became�shares�with�privileged�voting�right�(Stimmrechtsaktien).�<br />

�<br />

Issued�Share�Capital�at�30�June�2009�and�at�the�time�of�Listing�<br />

At�30�June�2009�and�at�the�time�of�the�Listing,�the�Company’s�issued�share�capital�amounts�to�CHF�653’882.70,�<br />

divided� into� 1’248’671� registered� shares� with� a� nominal� value� of� CHF� 0.10� each� (the� Common� Shares)� and�<br />

52’901’560�registered�shares�with�a�nominal�value�of�CHF�0.01�each�(the�Voting�Right�Shares).�<br />

�<br />

The�1’248’671�Common�Shares�and�the�52’901’560�Voting�Right�Shares�constitute�2.31%�and�97,69%,�respectively,�<br />

of�the�issued�Shares�and�voting�rights�in�the�Company,�and�19.10%�und�80.90%,�respectively,�of�the�nominal�value�<br />

of�the�issued�Shares.�<br />

�<br />

Authorised�Share�Capital�<br />

The�extraordinary�shareholders’�meeting�of�20�February�2009�(inter�alia)�resolved�to�cancel�the�Company’s�then�<br />

existing�authorised�share�capital�and�to�create�new�authorised�share�capital�in�the�amount�of�CHF�326’941.30�to�be�<br />

used�until�20�February�2011.�The�relevant�art.�3a�of�the�Articles�of�Association�in�its�informal�English�translation�now�<br />

reads�as�follows:�<br />

�<br />

“Art.�3a�–�Authorised�Share�Capital�<br />

1 �The�Board�of�Directors�shall�be�authorised,�at�any�time�until�20�February�2011,�to�increase�the�share�capital�in�an�<br />

amount�not�to�exceed�CHF�326’941.30�through�the�issuance�of�up�to�3’269’413�fully�paid�in�registered�shares�with�a�<br />

nominal� value� of� CHF� 0.10� each.� An� increase� in� partial� amounts� shall� be� permitted.� Besides,� also� an� increase�<br />

through�original�subscription�of�the�new�shares�by�the�Company�shall�in�accordance�with�art.�659�et�seq.�CO�be�<br />

allowed�for�the�purpose�of�offering�them�to�or�placing�them�among�shareholders�or�third�parties.�The�new�shares�<br />

� 50<br />


shall� be� subject� to� the� restrictions� of� art.� 5� of� the� Articles� of� Association.� The� respective� exercise� price,� the�<br />

beginning�of�the�entitlement�to�dividends�and�the�kind�of�contribution�will�be�defined�by�the�Board�of�Directors.�The�<br />

Board� of� Directors� may� issue� new� shares� also� by� means� of� a� firm� underwriting� or� otherwise� through� a� banking�<br />

institution�or�a�syndicate�of�banks�with�a�subsequent�offer�of�these�shares�to�the�shareholders�or�third�parties.�The�<br />

Board�of�Directors�may�permit�preferential�subscription�rights�that�have�not�been�exercised�to�expire�or�it�may�place�<br />

these�rights�and�shares�respectively�as�to�which�preferential�subscription�rights�have�been�granted�but�not�exercised,�<br />

at�market�conditions�or�use�them�for�other�purposes�in�the�interest�of�the�Company.�<br />

�<br />

2 �The�Board�of�Directors�is�authorised�to�restrict�or�exclude�the�pre�emptive�rights�of�shareholders�and�allocate�such�<br />

rights�to�third�parties�or�to�the�Company�if�the�shares�are�to�be�used:�(1)�for�the�acquisition�of�an�enterprise,�parts�<br />

of�an�enterprise�or�participations,�or�for�new�investments,�or,�in�case�of�a�share�placement,�for�the�financing�or�<br />

refinancing� of� such� transactions;� (2)� for� the� purpose� of� enlarging� the� shareholders’� basis� with� natural� or� legal�<br />

persons�bearing�direct�or�indirect�reference�to�(in�particular�as�patients�or�relatives�and�acquaintances�of�patients)�<br />

or�dealing�directly�or�indirectly�with�(in�particular�as�a�drug�producer,�scientist,�research�institutions,�universities,�<br />

patient� advocacy� or� charity�organisation� or� hospitals)� the� diseases� in� terms� of� which� the� Company� and� its�<br />

subsidiaries� are� conceiving,� researching,� developing,� offering� or� commercialising� new� approaches� and� treatment�<br />

solutions;�(3)�for�the�purpose�of�the�participation�of�strategic�partners�or�for�the�purpose�of�an�expansion�of�the�<br />

shareholders’�basis�in�certain�investor�markets�or�in�connection�with�the�listing,�the�admission�for�trading�or�the�<br />

registration�of�shares�on�domestic�or�foreign�stock�exchanges;�(4)�for�the�purpose�of�the�participation�of�employees,�<br />

members�of�the�Board�of�Directors�and�consultants�to�the�Company�and�its�subsidiaries�pursuant�to�one�or�more�<br />

regulations�released�by�the�Board�of�Directors;�or�(5)�in�connection�with�an�offer�of�shares�in�order�to�cover�a�over�<br />

allotment�option�granted�to�one�or�more�banks.”�<br />

�<br />

Conditional�Share�Capital�<br />

The�extraordinary�shareholders’�meeting�of�20�February�2009�resolved�(inter�alia)�to�cancel�the�Company’s�then�<br />

existing�conditional�share�capital�and�to�create�new�conditional�share�capital�in�the�total�amount�of�CHF�326’941.30.�<br />

The�relevant�art.�3b�of�the�Articles�of�Association�in�its�informal�English�translation�now�reads�as�follows:�<br />

�<br />

“Art.�3b�–�Conditional�Share�Capital�<br />

1 �The�share�capital�of�the�Company�shall�be�increased�by�a�maximum�aggregate�amount�of�CHF�180’000�through�the�<br />

issuance�of�a�maximum�of�1’800’000�registered�shares,�which�shall�be�fully�paid�in,�with�a�par�value�of�CHF�0.10�per�<br />

share�by�the�exercise�of�option�rights�which�are�granted�to�employees,�to�members�of�the�Board�of�Directors�or�to�<br />

consultants�of�the�Company�or�its�subsidiaries.�The�shareholders’�advance�subscription�right�and�the�pre�emptive�<br />

right�shall�be�excluded.�The�Company�issues�the�option�rights�for�employees,�members�of�the�Board�of�Directors�<br />

and� consultants.� The� terms� of� the� options� rights,� e.g.� the� exercise� price� of� the� shares,� the� beginning� of� the�<br />

entitlement� to� dividends� and� the� kind� of� contribution,� are� defined� by� the� Board� of� Directors� in� the� context� of�<br />

regulations.�The�acquisition�of�shares�through�exercise�of�option�rights�as�well�as�every�subsequent�transfer�of�those�<br />

shares�is�subject�to�the�restrictions�of�art.�5�of�the�Articles�of�Association.�<br />

�<br />

2 �The�share�capital�of�the�Company�shall�be�increased�by�a�maximum�aggregate�amount�of�CHF�146’941.30�through�<br />

the�issuance�of�a�maximum�of�1’469’413�registered�shares,�which�shall�be�fully�paid�in,�with�a�par�value�of�CHF�0.10�<br />

per� share�by� exercise� of� warrants� or� conversion� rights� which� have� been� granted� in� connection� with� the� issue�of�<br />

bonds� or� similar� financial� instruments� of� the� Company� or� its� subsidiaries.� The� shareholders’� pre�emptive� right� is�<br />

excluded.�The�terms�of�the�warrants�and�the�option�rights,�the�exercise�price�and�the�beginning�of�the�entitlement�<br />

to�dividends�are�defined�by�the�Board�of�Directors.�The�Board�of�Directors�shall�be�authorised�to�restrict�or�exclude�<br />

the� advance� subscription� rights� of� shareholders:� (1)� for� the� financing� or� refinancing� of� the� acquisition� of� an�<br />

enterprise,� parts� of� an� enterprise� or� participations� or� new� investments� of� the� Company;� (2)� for� the� financing� or�<br />

refinancing� of� the� Company� or� its� subsidiaries;� (3)� for� the� placement� of� conversion� and/or� warrant� bonds� on�<br />

national�or�international�capital�markets�for�the�purpose�of�strategically�enlarging�the�investors’�basis�including�the�<br />

placement�by�one�or�several�strategic�partners;�or�(4)�for�the�purpose�of�a�firm�underwriting�of�such�bonds�and�<br />

other�financial�instruments�by�a�banking�institution�or�a�syndicate�of�banks�with�subsequent�offering�to�the�public.�<br />

As�far�as�the�subscription�rights�are�excluded�and�neither�indirectly�granted,�(i)�the�conversion�and�warrant�bonds�<br />

must�be�placed�at�market�conditions�and�(ii)�the�exercise�of�the�conversion�rights�and�warrant�must�be�made�during�<br />

a�maximum�10�year�period�after�the�relevant�issue.�The�acquisition�of�shares�through�exercise�of�option�rights�as�<br />

well� as� every� subsequent� transfer� of� those� shares� is� subject� to� the� restrictions� of� art.� 5� of� the� Articles� of�<br />

Association.”�<br />

�<br />

As�of�the�date�of�this�Listing�Prospectus,�no�shares�out�of�the�Company’s�conditional�share�capital�have�been�issued.�<br />

The�Company�has�neither�convertible�bonds�nor�secured�or�unsecured�bonds�outstanding.�<br />

�<br />

Future�Capital�Increases�<br />

To� continue� its� growth� strategy� and� to� fund� the� further� development� of� its� medicinal� product� candidates,�<br />

mondoBIOTECH�intends�to�increase�its�share�capital�through�the�issue�of�new�shares�out�of�its�existing�authorized�<br />

share� capital� on� a� continuous� basis� following� the� Listing.� mondoBIOTECH� intends� to� issue� such� new� shares� to�<br />

existing� shareholders,� new� investors� and/or� individuals� and� entities� which� are� directly� or� indirectly� affected� by�<br />

and/or� involved� in� the� treatment� of� rare� and� neglected� diseases,� such� as� patients,� their� relatives� and� friends,�<br />

� 51<br />


patient� advocacy� organisations,� physicians,� scientists,� academic� organisations,� research� institutions,� hospitals,�<br />

employees,�consultants�and�other�service�providers�of�mondoBIOTECH.�<br />

�<br />

Participation�Certificates�and�Profit�Sharing�Certificate�<br />

The�Company�has�not�issued�any�non�voting�equity�security,�such�as�participation�certificates�(Partizipationsscheine)�<br />

or�profit�sharing�certificates�(Genussscheine).�<br />

13.2 Alternation�of�Share�Capital�<br />

Under� Swiss� law,� there� are� three� ways� to� increase� share� capital� and� issue� new� shares:� (i)� the� ordinary� capital�<br />

increase,�(ii)�the�authorised�capital�increase�and�(iii)�the�conditional�capital�increase.�<br />

�<br />

Ordinary�Capital�Increase�<br />

The� shareholders’� meeting� of� the� Company� may� decide,� with� an� absolute� majority� of� the� votes� cast� (subject� to�<br />

certain�exceptions),�to�increase�the�share�capital�of�the�Company�and�issue�new�shares.�Such�an�increase�has�to�be�<br />

executed�and�registered�in�the�relevant�commercial�register�by�the�Board�of�Directors�within�three�months�of�the�<br />

resolution�of�the�shareholders’�meeting�to�increase�the�share�capital.�Such�a�resolution�must�be�made�in�the�form�of�<br />

a�notarised�deed�(öffentliche�Beurkundung).�In�addition,�such�resolution�must�set�out�the�amount�of�capital�increase,�<br />

number,�nature,�nominal�value�and�price�of�the�shares�to�be�issued�and�specific�terms,�if�any.�Current�shareholders�<br />

have� a� preemptive� right� to� subscribe� for� newly� issued� shares� (Bezugsrecht)� which� must� be� proportionate� to� the�<br />

nominal� value� of� the� shares� they� hold.� The� shareholders’� meeting� may� restrict� or� exclude� the� shareholders’�<br />

preemptive� rights� based� on�a� valid� reason� (wichtiger� Grund)� with� a� qualified� majority� of� two�thirds� of� the� votes�<br />

represented�and�the�absolute�majority�of�the�nominal�share�capital�represented.�According�to�the�CO,�a�valid�reason�<br />

constitutes,�in�particular,�the�acquisition�of�a�company�or�parts�thereof,�and�the�participation�of�employees.�<br />

�<br />

Authorised�Capital�Increase�<br />

The� shareholders’� meeting� may� create,� with� a� qualified� majority� of� two�thirds� of� the� votes� represented� and� the�<br />

absolute�majority�of�the�nominal�share�capital�represented,�an�authorised�share�capital�of�up�to�a�maximum�of�50%�<br />

of�the�existing�share�capital.�The�shareholders’�resolution�entails�an�amendment�of�the�Articles�of�Association�and�<br />

has�to�be�made�in�the�form�of�a�notarised�deed�(öffentliche�Beurkundung)�and�registered�in�the�relevant�commercial�<br />

register.�The�shareholders’�resolution�has�to�state�the�amendments�made�to�the�Articles�of�Association�by�outlining�<br />

the�relevant�terms�of�the�capital�increase,�such�as�the�number,�nature�and�nominal�value�of�the�shares�to�be�issued.�<br />

In�addition,�the�shareholders’�resolution�has�to�state�whether�the�preemptive�rights�of�the�existing�shareholders�<br />

have�been�excluded�or�restricted�for�a�valid�reason�or�whether�the�Board�of�Directors�is�granted�the�right�to�exclude�<br />

or�restrict�the�preemptive�rights�of�shareholders�for�a�valid�reason.�Any�valid�reason�for�which�preemptive�rights�<br />

may� be� excluded� or� restricted� must� be� stated� in� the� shareholders’� resolution� and,� accordingly,� must� also� be�<br />

reflected� in� the� Articles� of� Association.� The� Board� of� Directors� must� execute� the� capital� increase� and� issue� new�<br />

shares� within� two� years� of� the� registration� of� the� shareholders’� resolution� to� create� authorised� share� capital,�<br />

otherwise�such�resolution�becomes�void.�Upon�the�Board�of�Directors’�decision�to�increase�the�share�capital,�the�<br />

Board� of� Directors� has� to� prepare� a� share� capital� increase� report� which� in� certain� circumstances� is� subject� to�<br />

examination�by�auditors.�The�Articles�of�Association�must�be�amended�accordingly.�The�resolution�of�the�Board�of�<br />

Directors�including�the�amendment�of�the�Articles�of�Association�must�be�made�in�the�form�of�a�notarised�deed�<br />

(öffentliche�Beurkundung).�<br />

�<br />

Conditional�Capital�Increase�<br />

The� shareholders’� meeting� may� create,� with� a� qualified� majority� of� two�thirds� of� the� votes� represented� and� the�<br />

absolute�majority�of�the�nominal�share�capital�represented,�a�conditional�share�capital�of�up�to�a�maximum�of�50%�<br />

of�the�existing�share�capital.�Under�Swiss�law,�the�conditional�share�capital�may�only�be�used�for�a�limited�number�<br />

of� purposes,� i.e.� for� option� or� conversion� rights� issued� to� the� employees� or� to� creditors� of� warrants� or� similar�<br />

obligations.� The� shareholders’� resolution� entails� an� amendment� of� the� Articles� of� Association.� Accordingly,� the�<br />

shareholders’� resolution� and� the� Articles� of� Association� must� outline� the� basic� terms� of� the� conditional� capital�<br />

increase,� such� as� number,� nature� and� nominal� value� of� the� shares,� a� general� description� of� the� persons� holding�<br />

option� or� conversion� rights,� the� exclusion� of� the� preemptive� rights� of� existing�shareholders� and� the� exclusion� or�<br />

restriction�of�their�advanced�subscription�rights�for�a�valid�reason�or�whether�the�Board�of�Directors�is�granted�the�<br />

right�to�exclude�or�restrict�such�rights�for�a�valid�reason.�Any�valid�reason�for�which�advanced�subscription�rights�<br />

may� be� excluded� or� restricted� must� be� stated� in� the� shareholders’� resolution� and,� accordingly,� must� also� be�<br />

reflected�in�the�Articles�of�Association.�<br />

13.3 Pre�emptive�Rights�and�Advanced�Subscription�Rights�<br />

Under�Swiss�law,�any�share�issue,�whether�for�cash�or�non�cash�consideration,�is�subject�to�the�prior�approval�or�<br />

authorisation� by� the� shareholders’� meeting.� Shareholders� of� the� Company� have� certain� preemptive� rights�<br />

(Bezugsrechte)� or� advanced� subscription� rights� (Vorwegzeichnungsrechte)� to� subscribe� to� new� issues� of� shares,�<br />

bonds� with� stock� options� or� convertible� bonds� in� proportion� to� the� nominal� amount� of� shares� held.� Thus,� if�the�<br />

share�capital�is�increased,�each�shareholder�is�entitled�to�newly�issued�shares�in�proportion�to�his�shareholding,�or�<br />

to�bonds�and�similar�debt�instruments�with�conversion�privileges�or�options,�i.e.,�such�debt�instruments�must�first�<br />

� 52<br />


e� offered� for� subscription� to� the� shareholders� corresponding� to� their� prior� participation,� since� the� instruments�<br />

incorporate� a� right� to� receive� shares� at� a� later� stage.� A� resolution� adopted� at� a� shareholders’� meeting� with� a�<br />

qualified�majority�may,�however,�limit�or�suspend�preemptive�rights�and�advanced�subscription�rights�based�on�a�<br />

valid�reason.�A�valid�reason�includes,�in�particular,�the�acquisition�of�a�company�or�a�part�thereof,�the�purchase�of�a�<br />

participation�in�a�company�or�the�grant�of�participation�to�employees�(stock�option�plans).�<br />

13.4 Form�of�the�Shares�<br />

The�Shares�will�not�be�certificated�(aufgehobener�Titeldruck).�The�Shares�are�included�in�the�SIS�clearing�system�for�<br />

transferred�shares�(SIS�registered�share�system)�for�booking�purposes.�Shareholders�may�call�upon�the�Company�to�<br />

issue� a� written� confirmation� of� their� shareholdings.� However,� shareholders� are� not� entitled� to� receive� share�<br />

certificates�for�their�Shares.��<br />

13.5 Transferability�of�Shares�<br />

Pursuant�to�art.�5�para.�1�and�2�of�the�Articles�of�Association,�the�purchaser�of�Shares�is�entered�in�the�register�of�<br />

shares,�if�there�is�an�express�declaration�that�the�purchaser�is�holding�the�shares�for�himself.�The�Board�of�Directors�<br />

regulates�the�principles�for�the�inscription�of�persons�who�hold�the�shares�in�the�name�and�for�the�account�of�a�third�<br />

person,�so�called�nominees.�<br />

�<br />

The�restrictions�of�art.�5�of�the�Articles�of�Association�also�apply�in�case�of�an�acquisition�of�shares�on�the�occasion�<br />

of�the�exercise�of�purchase,�option�or�conversion�rights.�<br />

13.6 Own�Shares�<br />

As�of�the�date�of�this�Listing�Prospectus,�neither�the�Company�nor�any�of�its�subsidiaries�hold�any�Shares�in�treasury.�<br />

13.7 Voting�Rights�<br />

Each�Share�carries�one�vote�at�shareholders’�meetings.�<br />

�<br />

As� a� consequence� of� the� reverse� split� of� the� then� issued� shares� of� the� Company� conducted� in� June� 2009,� the�<br />

Common� Shares� have� a� nominal� value� which� is� ten� times� larger� than� that� of� the� Voting� Right� Shares.� See� “13.1��<br />

Share� Capital� Structure� and� Changes� to� Share� Capital”.� As� each� Share� carries� one� vote� regardless� of� its� nominal�<br />

value,�the�voting�power�of�the�Voting�Right�Shares�is�ten�times�larger�than�that�of�the�Common�Shares.�See�also�<br />

“13.8��Shareholders’�Meeting”.�<br />

�<br />

Voting�rights�may�be�exercised�only�after�a�shareholder�has�been�registered�in�the�Company’s�share�register�as�a�<br />

shareholder�with�voting�rights.�<br />

13.8 Shareholders’�Meeting�<br />

Under�Swiss�law,�an�annual�ordinary�shareholders’�meeting�must�be�held�within�six�months�after�the�end�of�the�<br />

Company’s�business�year.�Shareholders’�meetings�may�be�convened�by�the�Board�of�Directors,�or,�if�necessary,�by�<br />

the� statutory� auditors.� The� Board� of� Directors� is� further� required� to� convene� an� extraordinary� shareholders’�<br />

meeting�if�so�resolved�by�a�shareholders’�meeting�or�if�so�requested�by�shareholders�holding�in�aggregate�at�least�<br />

10%� of� the� nominal� share� capital� of� the� Company.� Shareholders� holding� Shares� with� a� nominal� value� of� at� least�<br />

CHF�1�million�have�the�right�to�request�that�a�specific�proposal�be�put�on�the�agenda�and�voted�upon�at�the�next�<br />

shareholders’� meeting.� This� request� must� be� submitted� at� least� six� weeks� before� the� date� of� the� shareholders’�<br />

meeting.�<br />

�<br />

Extraordinary�shareholders’�meeting�can�be�called�as�often�as�necessary,�in�particular�if�required�by�law.�<br />

�<br />

Shareholders’� resolutions� of� the� Company� generally� require� the� approval� of� an� absolute� majority� of� the� votes�<br />

represented�at�a�shareholders’�meeting.�A�resolution�passed�at�a�shareholders’�meeting�with�a�qualified�majority�of�<br />

at�least�two�thirds�of�the�votes�represented�and�the�absolute�majority�of�the�nominal�value�represented�at�such�<br />

meeting�is�required�for:�(i)�changes�in�the�Company’s�business�purpose;�(ii)�the�creation�or�elimination�of�shares�<br />

with� privileged� voting� rights;� (iii)� the� creation� of� authorised� or� conditional� share� capital;� (iv)� an� increase� in� the�<br />

Company’s� share� capital� by� way� of� capitalisation� of� reserves� (Kapitalerhöhung� aus� Eigenkapital),� against�<br />

contribution� in� kind� (Kapitalerhöhung� gegen� Sacheinlage),� for� the� acquisition� of� assets� (Kapitalerhöhung� zwecks�<br />

Sachübernahme),� or� involving� the� granting� of� special� privileges;� (v)� the� restriction� or� elimination� of� subscription�<br />

rights� of� the� shareholders;� (vi)� a� relocation� of� domicile;� or� (vii)� the� dissolution� of� the� Company.� In� addition,� any�<br />

provision�in�the�Articles�of�Association�for�a�greater�voting�requirement�than�is�prescribed�by�law�or�the�existing�<br />

Articles�of�Association�must�be�adopted�in�accordance�with�such�greater�voting�requirements.�<br />

�<br />

The� shareholders’� meeting� also� has� the� power� to� vote� by� an� absolute� majority� of� the� votes� cast� (excluding� the�<br />

abstentions�of�voting�as�well�as�the�blank�and�invalid�votes)�on�amendments�to�the�Articles�of�Association�in�general,�<br />

� 53<br />


to�elect�the�members�of�the�Board�of�Directors�and�the�statutory�auditors,�to�approve�the�annual�report�and�the�<br />

annual� consolidated� financial� statements,� to� set� the� annual� dividend,� to� grant� the� members� of� the� Board� of�<br />

Directors�and�the�Management�any�discharge�from�liability�for�matters�disclosed�to�the�shareholders’�meeting�and�<br />

to�order�an�independent�investigation�into�specific�matters�(Sonderprüfung).�<br />

�<br />

At� a� shareholders’� meeting,� shareholders� can� be� represented� by� proxy� issued� by� another� shareholder,� a� proxy�<br />

holder� appointed� by� the� Company� (Organvertreter),� an� independent� representative� nominated� by� the� Company�<br />

(unabhängiger�Stimmrechtsvertreter)�or�a�custodial�institution�(Depotvertreter).�<br />

�<br />

A� shareholders’� meeting� is� convened� by� publishing� a� notice� in� the� Swiss� Official� Gazette� of� Commerce� and� by�<br />

sending�a�letter�to�the�shareholders’�address�entered�in�the�Company’s�share�register�as�of�20�days�prior�to�the�date�<br />

of�such�shareholders’�meeting.�<br />

13.9 Shareholders’�Claims�<br />

Under�Swiss�law,�any�claims�by�shareholders�against�the�Company�must,�as�a�general�rule,�be�brought�exclusively�at�<br />

its�place�of�incorporation.�<br />

13.10 Dividends�<br />

Under�the�CO,�a�minimum�of�5%�of�the�financial�year’s�profits�must�be�allocated�to�the�general�legal�reserves�for�as�<br />

long�as�these�reserves�amount�to�less�than�20%�of�the�paid�in�share�capital.�The�law�provides�for�additional�legal�<br />

reserves.�The�general�legal�reserves�of�the�Company�currently�exceed�this�threshold.�Any�net�profits�remaining�are�<br />

at�the�disposal�of�the�shareholders’�meeting,�except�that,�if�an�annual�dividend�payment�exceeds�5%�of�the�nominal�<br />

share�capital,�an�amount�equal�to�10%�of�such�excess�must�be�retained�as�general�reserves.�<br />

�<br />

Payment� of� dividends� is� possible,� according� to� Swiss� law,� only� after� the� legal� and� statutory� allocations� to� the�<br />

reserves�have�been�made,�and�only�insofar�as�sufficient�balance�sheet�profit�is�available.�Under�Swiss�law,�dividends�<br />

are� paid�out� only� after� approval� by� the� shareholders’� meeting.� The� board� of� directors� may� propose� to� the�<br />

shareholders’�meeting�that�a�dividend�be�paid�out,�but�cannot�itself�set�the�dividend.�The�company’s�auditors�must�<br />

confirm�that�any�proposal�by�the�board�of�directors�to�declare�a�dividend�is�in�accordance�with�Swiss�law�and�the�<br />

company’s�articles�of�association.�Dividends�are�usually�due�and�payable�not�earlier�than�three�trading�days�after�<br />

the� shareholders’� resolution� relating� to� the� allocation� of� profits� has� been� passed.� The� statute� of� limitations� in�<br />

respect�of�dividend�payments�is�five�years.�<br />

�<br />

The�Shares�are�entitled�to�dividends�declared,�if�any.�The�Company�currently�does�not�intend�to�pay�any�dividends�in�<br />

the�foreseeable�future.��<br />

�<br />

The�dividends�are�distributed�to�shareholders�according�to�the�respective�paid�in�share�capital.�For�information�on�<br />

the�deduction�of�withholding�taxes,�see�“14.1��Withholding�Tax”.�See�also�“4��Dividends�and�Dividend�Policy”.�<br />

13.11 Borrowing�Power�<br />

Neither� Swiss� law� nor� the� Articles� of� Association� generally� restrict� the� Company’s� power� to� borrow� and� to� raise�<br />

funds.�The�Board�of�Directors�decides�upon�or�authorises�the�borrowing�of�funds�and�no�shareholders’�resolution�is�<br />

required�in�relation�to�such�action.�<br />

13.12 Conflicts�of�Interest�<br />

Swiss� law� does� not� contain� any� specific� provision� in� relation� to� the� handling� of� conflicts� of� interest� within� a�<br />

company’s�organisation.�However,�the�CO�requires�directors�and�members�of�senior�management�to�apply�due�care�<br />

and�generally�to�safeguard�the�interests�of�the�company�in�the�performance�of�their�respective�duties�(duty�of�care�<br />

and�duty�of�loyalty).�This�rule�is�generally�understood�as�disqualifying�directors�and�members�of�senior�management�<br />

from�participating�in�decisions�that�directly�affect�them.�Further,�holders�of�signatory�powers�for�the�company�may�<br />

be�unable�to�validly�exercise�such�powers�by�reason�of�a�conflict�of�interest.�Under�Swiss�law,�payments�made�and�<br />

other� benefits� granted� to� a� shareholder� or� a� director� or� any� persons� associated� with� them,� other� than� at� arm’s�<br />

length,�must�be�repaid�to�the�company�if�the�shareholder�or�director�was�acting�in�bad�faith.�In�addition,�pursuant�<br />

to�a�new�provision�in�the�CO�that�came�into�force�in�January�2008,�if,�in�connection�with�the�conclusion�of�a�contract,�<br />

the� Company� is� represented� by� the� person� with� whom� it� is� concluding� the� contract,� such� contract� has� to� be� in�<br />

writing.�This�requirement�does�not�apply�to�contracts�relating�to�daily�business�matters�if�the�performance�of�the�<br />

Company�does�not�exceed�CHF�1’000.�<br />

�<br />

According� to� the� CO,� listed� companies� are� obliged� to� disclose� the� total� amount� of� all� remuneration� and� loans�<br />

granted�to�the�present�or�past�members�of�the�board�of�directors�and�the�management.�In�addition,�remuneration�<br />

of�and�loans�to�persons�closely�related�to�the�members�of�the�board�of�directors�or�the�management�have�to�be�<br />

disclosed.�The�disclosure�is�to�be�made�individually�for�every�member�of�the�board�of�directors,�including�name�and�<br />

function.�With�respect�to�the�management,�only�the�highest�contribution�awarded,�indicating�the�recipient�and�his�<br />

� 54<br />


function� has� to� be� disclosed� individually.� Finally,� the� shares� held� by� members� of� the� board� of� directors,� the�<br />

management�and�such�persons�closely�related�to�them�shall�also�be�disclosed.�The�respective�disclosures�need�to�be�<br />

made�in�the�notes�to�the�accounts.�See�“8.4.1��Revenues”.�<br />

�<br />

The�corporate�governance�directive�of�the�SIX�Swiss�Exchange�also�addresses�conflict�of�interest�issues.�See�“15.4��<br />

Corporate�Governance�Directive”.�<br />

13.13 Repurchase�of�Shares�<br />

Swiss�law�limits�the�right�of�a�company�to�purchase�and�hold�its�own�shares.�A�company�and�its�subsidiaries�may�<br />

only�purchase�their�shares�if�and�to�the�extent�that:�(i)�the�company�has�freely�distributable�reserves�in�the�amount�<br />

of�the�purchase�price;�and�(ii)�the�aggregate�nominal�value�of�all�shares�held�by�the�company�does�not�exceed�10%�<br />

of�the�company’s�share�capital�(20%�in�specific�circumstances).�<br />

�<br />

Shares�held�by�a�company�or�its�subsidiaries�are�not�entitled�to�vote�at�shareholders’�meetings,�but�are�entitled�to�<br />

the� economic� benefits,� including� dividends,� generally� applicable� to� the� shares.� See� “4��Dividends� and� Dividend�<br />

Policy”.�Furthermore,�under�Swiss�law,�upon�the�purchase�of�shares,�a�company�must�create�a�special�reserve�on�its�<br />

balance�sheet�in�the�amount�of�the�purchase�price�of�the�acquired�shares.�In�addition,�selective�share�repurchases�<br />

are� only� permitted� under� certain� circumstances;� in� particular,� repurchases� of� listed� shares�are�subject� to� certain�<br />

restrictions� promulgated� by� the� Swiss� Takeover� Board� (the� regulatory� board� for� takeover� bids� in� Switzerland).�<br />

Within�these�limitations,�a�company�may�purchase�and�sell�its�own�shares�from�time�to�time�in�order�to�meet�the�<br />

variations�of�supply�and�demand,�to�provide�liquidity�and�to�modulate�swings�in�the�market�price�for�shares.�<br />

13.14 Duration�and�Liquidation�<br />

The�Articles�of�Association�do�not�limit�the�Company’s�duration.�The�Company�may�be�dissolved�at�any�time�by�a�<br />

shareholders’�resolution,�which�must�be�approved�by�shareholders�holding�at�least�two�thirds�of�the�voting�rights�<br />

represented�and�the�absolute�majority�of�the�nominal�value�of�all�shares�represented�at�a�shareholders’�meeting.�<br />

Dissolution� and� liquidation� by� court� order� is� possible� if� the� Company� becomes� bankrupt� or� for� valid� reasons� if�<br />

shareholders�holding�at�least�10%�of�the�Company’s�share�capital�so�request.�<br />

�<br />

Under� Swiss� law,� any� surplus� arising� out� of� liquidation� (after� the� settlement� of� all� claims� of� all� creditors)� is�<br />

distributed�to�the�shareholders�in�proportion�to�the�paid�up�nominal�value�of�shares�held,�but�this�surplus�is�subject�<br />

to�Withholding�Tax�of�35%.�See�“14.1��Withholding�Tax”).�<br />

13.15 Disclosure�of�Major�Shareholders�<br />

The�Company�and�persons�who�acquire�or�dispose�of�the�Shares�or�rights�based�thereon�or�derived�therefrom�are�<br />

subject�to�the�notification�and�disclosure�requirements�of�the�SESTA,�that�require�persons�who�directly,�indirectly�or�<br />

in�concert�with�third�parties�acquire�or�dispose�of�shares�or�derivative�rights�with�respect�to�shares�in�a�company�<br />

incorporated�in�Switzerland�whose�equity�securities�are�listed�in�whole�or�in�part�in�Switzerland�and�thereby�reach,�<br />

exceed�or�fall�below�the�thresholds�of�3%,�5%,�10%,�15%,�20%,�25%,�33 1 / 3%,�50%,�or�66 2 / 3%�of�the�voting�rights�in�<br />

such�company,�notify�the�company�and�the�SIX�Swiss�Exchange�of�such�acquisition�or�disposal�in�writing�within�four�<br />

trading� days,� whether� or� not� the� voting� rights� can� be� exercised.� The� detailed� disclosure� requirements� and� the�<br />

methodology�for�calculating�the�thresholds�are�defined�in�the�Ordinance�of�the�Swiss�Financial�Market�Supervisory�<br />

Authority� FINMA� on� the� Stock� Exchanges� and� Securities� Trading� (the� “SESTO�FINMA”).� In� particular,� the� SESTO�<br />

FINMA� prohibits� the� netting� of� so�called� acquisition� positions� (e.g.,� conversion� rights� and� acquisition� rights� or�<br />

obligations)�with�disposal�positions�(i.e.,�rights�or�obligations�to�sell).�It�further�requires�that�each�such�position�be�<br />

calculated� separately� and� reported� simultaneously� as� soon� as� it� reaches� a� threshold.� Transactions� with� financial�<br />

instruments�that�make�it�economically�possible�to�acquire�equity�securities�in�a�company�in�view�of�a�public�tender�<br />

offer�are�deemed�an�indirect�acquisition�of�shares.�The�exercise�of�conversion�or�acquisition�rights�and�the�exercise�<br />

of�sale�rights�are�deemed�to�be�acquisitions�and�sales,�respectively,�of�shares.�<br />

�<br />

A�group�of�shareholders�organised�pursuant�to�an�agreement�or�otherwise�acting�in�concert�has�to�comply�with�the�<br />

obligation� to� notify� as� a� group� and� has� to� disclose� (a)� its� total� holdings,� (b)� the� identity� of� its� members,� (c)� the�<br />

nature�of�the�agreement,�and�(d)�the�identity�of�its�representatives.�The�acquisition�and�sale�between�associates�<br />

who�have�notified�their�total�holdings�are�exempt�from�the�obligation�to�notify.�<br />

�<br />

The�respective�company�must�inform�the�public�within�two�trading�days�of�receiving�such�notification.�<br />

�<br />

Further,� under� the� CO,� the� Company� as� a� company� whose� shares� are� listed� on� a� stock� exchange� will� have� to�<br />

annually�disclose�the�identity�of�all�of�its�shareholders�(or�related�groups�of�shareholders)�holding�more�than�5%�of�<br />

the� Company’s� voting� rights.� Disclosure� must� be� made� once� a� year� in� the� notes� to� the� financial� statements� as�<br />

published�in�the�annual�report.�<br />

�<br />

� 55<br />


For� information� on� major� shareholders� in� the� Company,� see� “11��Related� Party� Transactions”� and� “12��Major�<br />

Shareholders”.�<br />

13.16 Public�Tender�Offers�<br />

Pursuant�to�art.�32�SESTA,�anyone�who�directly,�indirectly�or�acting�in�concert�with�third�parties�acquires�shares�in�a�<br />

company�incorporated�in�Switzerland,�whose�shares�are�listed�in�whole�or�in�part�in�Switzerland,�and�together�with�<br />

shares�already�owned,�exceeds�the�threshold�of�33 1 / 3%�of�the�voting�rights�of�the�company�will�be�required�to�make�<br />

a�public�offer�to�acquire�all�the�listed�securities�of�the�company.�<br />

�<br />

Swiss�law�provides�for�the�possibility�that�the�articles�of�association�contain�a�provision�which�would�eliminate�the�<br />

obligation�of�an�acquirer�of�shares�exceeding�the�threshold�of�33 1 / 3%�of�the�voting�rights�to�proceed�with�a�public�<br />

tender�offer�(opting�out�provision�pursuant�to�art.�22�para.�2�SESTA)�or�which�would�increase�such�threshold�up�to�<br />

49%�of�the�voting�rights�(opting�up�provision�pursuant�to�art.�32�para.�1�SESTA).�<br />

�<br />

The�Articles�of�Association�waive�the�requirement�to�make�a�public�tender�offer.�<br />

13.17 Cancellation�of�Remaining�Equity�Securities,�Squeeze�out�Merger�<br />

Under�the�SESTA,�any�offeror�who�has�made�a�tender�offer�for�the�shares�of�a�listed�Swiss�target�company,�and�who,�<br />

as�a�result�of�such�offer,�holds�more�than�98%�of�the�voting�rights�of�the�target�company,�may�petition�the�court�to�<br />

cancel�the�remaining�equity�securities.�The�petition�must�be�<strong>file</strong>d�against�the�target�company�within�three�months�<br />

after�the�expiration�of�the�offer�period.�The�remaining�shareholders�may�join�in�the�proceedings.�If�the�court�orders�<br />

cancellation� of� the� remaining� equity� securities,� the� company� will� reissue� the� equity� securities� and� deliver� such�<br />

securities� to� the� offeror� against� performance� of� this� offer� for� the� benefit� of� the� holders� of� the� cancelled� equity�<br />

securities.�<br />

�<br />

Under�the�Swiss�Federal�Merger�Act,�shareholders�of�the�transferring�company�may�be�offered�a�settlement�(in�cash�<br />

or� by� other� consideration)� instead� of� shares� in�the� surviving� company� if� at� least� 90%� of� the� shareholders� of� the�<br />

transferring�company�who�are�entitled�to�vote�give�their�consent�(squeeze�out�merger).�It�is�unclear�and�disputed�<br />

whether�the�90%�approval�relates�to�the�total�number�of�votes�represented�by�all�shares�outstanding�of�the�total�<br />

number�of�shareholders�entitled�to�vote.�<br />

13.18 Exchange�Controls�and�Other�Limitations�<br />

Other� than� in� connection� with� government� sanctions� imposed� on� certain� persons� and� organisations,� there� are�<br />

currently�no�governmental�laws,�decrees,�or�regulations�in�Switzerland�that�restrict�the�export�or�import�of�capital,�<br />

including,�but�not�limited�to,�Swiss�foreign�exchange�controls�on�the�payment�of�dividends,�interest�or�liquidation�<br />

proceeds,�if�any,�to�non�resident�holders�of�shares�in�Swiss�entities.�<br />

�<br />

� 56<br />


14 Certain�Swiss�Taxation�Considerations�<br />

The�following�is�a�general�summary�of�certain�tax�consequences�of�the�acquisition,�ownership�and�disposition�of�the�<br />

Shares.� These� discussions� are� based,� as� applicable,� on� the� tax� laws,� regulations,� decrees,� rulings,� income� tax�<br />

conventions�(treaties),�administrative�practice�and�judicial�decisions�of�Switzerland�as�in�effect�on�the�date�of�this�<br />

Listing�Prospectus�which�are�subject�to�change�(or�subject�to�changes�in�interpretations),�possibly�with�retroactive�<br />

effect.�This�is�not�a�complete�analysis�of�the�potential�tax�effects�relevant�to�a�decision�to�invest�in�Shares.�Nor�does�<br />

the�following�summary�take�into�account�or�discuss�the�tax�laws�of�any�jurisdiction�other�than�Switzerland.�It�also�<br />

does�not�take�into�account�investors’�individual�circumstances.�This�summary�does�not�purport�to�be�a�legal�opinion�<br />

or�to�address�all�tax�aspects�that�may�be�relevant�to�a�holder�of�Shares.�Investors�are�advised�to�consult�their�own�<br />

tax�advisors�as�to�Swiss�or�other�tax�consequences�of�the�acquisition,�ownership�and�disposition�of�the�Shares.�Tax�<br />

consequences� may� differ� according� to� the� provisions� of� different� double� taxation� treaties� and� the� investor’s�<br />

particular�circumstances.�The�statements�and�discussion�of�certain�Swiss�taxes�set�out�below�are�of�a�general�nature�<br />

and�do�not�relate�to�persons�in�the�business�of�buying�and�selling�shares�or�other�securities.�<br />

14.1 Withholding�Tax�<br />

Any�dividends�and�similar�cash�or�in�kind�distributions�of�profit�and�reserves�made�by�the�Company�in�respect�of�the�<br />

Shares,�including�stock�dividends�and�the�distribution�of�any�liquidation�proceeds�in�excess�of�the�nominal�value�of�<br />

the�Shares�are�subject�to�Withholding�Tax�(Verrechnungssteuer),�imposed�on�the�gross�amount�at�the�current�rate�<br />

of� 35%.� Thus,� the� Company� may� only� pay� out� 65%� of� the� gross� amount� of� any� dividend� to� the� shareholder.� A�<br />

portion�equal�to�35%�of�the�gross�amount�of�such�dividends�and�similar�contributions�must�be�paid�to�the�Swiss�<br />

Federal� Tax� Administration.� The� redemption� of� Shares� by� the� Company� may� under� certain� circumstances� (in�<br />

particular,�if�the�Shares�are�redeemed�for�subsequent�cancellation)�be�taxed�as�a�partial�liquidation�for�Withholding�<br />

Tax�purposes�with�the�effect�that�Withholding�Tax�at�the�current�rate�of�35%�is�due�on�the�difference�between�the�<br />

redemption�price�and�nominal�value�of�the�redeemed�Shares.�Any�repayment�of�nominal�value�and,�after�1�January�<br />

2011,� when� the� capital� contribution� regime� will� have� entered� into� force,� any� repayment� of� the� share� premium�<br />

received�by�the�Company�for�the�issuance�of�Shares�will�not�be�subject�to�Withholding�Tax.�<br />

�<br />

The�Withholding�Tax�must�be�withheld�by�the�Company�from�the�gross�distribution�and�must�be�paid�to�the�Swiss�<br />

Federal�Tax�Administration.�Swiss�resident�beneficiaries�of�taxable�dividends�and�similar�contributions�in�respect�of�<br />

the�Shares�are�entitled�to�full�subsequent�relief�of�the�Withholding�Tax,�either�through�a�tax�refund�or�tax�credit�<br />

against� their� income� tax� liability,� if� they� duly� report� the� underlying� income� in� their� tax� returns� or� financial�<br />

statements�used�for�tax�purposes,�as�the�case�may�be,�and�if�there�is�no�tax�avoidance.�The�same�holds�true�for�<br />

foreign�resident�investors�who�hold�Shares�through�a�permanent�establishment�or�a�fixed�place�of�business�situated�<br />

in�Switzerland,�as�defined�for�Swiss�tax�purposes.�Other�non�Swiss�resident�beneficiaries�of�dividends�and�similar�<br />

distributions�in�respect�of�Shares�may�be�entitled�to�a�partial�or�full�refund�of�the�Withholding�Tax�in�accordance�<br />

with�any�applicable�double�taxation�convention�between�Switzerland�and�the�beneficiary’s�country�of�tax�residence�<br />

(the� “Tax� Treaty”).� Besides� these� Tax� Treaties� Switzerland� has� entered� into� an� agreement� with� the� European�<br />

Community�providing�for�measures�equivalent�to�those�laid�down�in�Council�Directive�2003/48/EC�on�taxation�of�<br />

savings�income�in�the�form�of�interest�payments.�This�agreement�contains�in�its�art.�15�provisions�on�taxation�of�<br />

dividends�which�apply�with�respect�to�EU�member�states.�<br />

�<br />

A�non�Swiss�resident�recipient�of�a�taxable�distribution�may�be�entitled�to�a�full�or�partial�refund�of�the�Withholding�<br />

Tax,� if� the� country� in� which� the� non�Swiss� resident� resides� for� tax� purposes� has� entered� into� a� Tax� Treaty� with�<br />

Switzerland�and�the�further�conditions�of�such�treaty�are�met.�Non�Swiss�resident�holders�should�be�aware�that�the�<br />

procedures�for�claiming�Tax�Treaty�refunds�(and�the�time�required�for�obtaining�a�refund)�might�differ�from�country�<br />

to�country.�Non�Swiss�resident�holders�should�consult�their�own�tax�advisor�regarding�the�tax�consequences�of�the�<br />

receipt,�ownership,�purchase,�sale�or�other�dispositions�of�the�Shares�and�the�procedure�for�claiming�a�refund�of�the�<br />

Withholding� Tax.� If� the� non�Swiss� resident� holder� holds� the� Shares� through� a� permanent� establishment� or� fixed�<br />

place�of�business�situated�in�Switzerland,�the�entitlement�to�refunds�of�the�Withholding�Tax�is�governed�by�Swiss�<br />

domestic�law.�<br />

14.2 Income�and�Profit�Tax�<br />

�<br />

Income�Tax�for�Individuals�<br />

An� individual� who� is� a� Swiss� resident� for� tax� purposes,� or� a� non�Swiss� resident� holding� Shares� as� part� of� a�<br />

permanent�establishment�or�a�fixed�place�of�business�situated�in�Switzerland�(as�defined�for�Swiss�tax�purposes),�<br />

receiving�dividends�and�similar�distributions�(including�liquidation�proceeds�in�excess�of�nominal�value�and�stock�<br />

dividends)�from�the�Company,�has�to�include�these�distributions�in�his�or�her�personal�tax�return�and�will�be�subject�<br />

to� federal,� cantonal� and� communal� income� tax� on� any� net� taxable� income� for� the� respective� tax� period.� Any�<br />

repayment�of�nominal�value�and,�after�1�January�2011�when�the�capital�contributions�regime�will�have�entered�into�<br />

force,�any�repayment�of�the�share�premium�received�by�the�Company�for�the�issuance�of�the�Shares�will�not�be�<br />

subject�to�federal,�cantonal�and�communal�income�tax.�<br />

�<br />

� 57<br />


Profit�Tax�for�Legal�Entities�<br />

Legal� entities� resident� in� Switzerland� or� non�Swiss� resident� entities� holding� Shares� as� part� of� a� Swiss� permanent�<br />

establishment� are� required� to� include� all� taxable� distributions� received� on� the� Shares� in� their� profit� and� loss�<br />

statement�relevant�for�profit�tax�purposes�and�will�be�subject�to�federal,�cantonal�and�communal�corporate�income�<br />

tax�on�any�net�taxable�earnings�for�such�period.�A�Swiss�corporation�or�cooperative,�or�a�non�Swiss�corporation�or�<br />

cooperative�holding�Shares�as�part�of�a�Swiss�permanent�establishment�may,�under�certain�circumstances,�benefit�<br />

from�taxation�relief�with�respect�to�distributions�(Beteiligungsabzug),�provided�such�Shares�represent�at�the�time�of�<br />

the�distribution�at�least�20%�of�the�share�capital�or�a�fair�market�value�of�at�least�CHF�2�million.�As�of�1�January�2011,�<br />

these�thresholds�will�be�lowered�to�10%�of�the�share�capital�or�10%�of�the�profit�and�reserves�respectively�CHF�1�<br />

million.�<br />

�<br />

Non�Swiss�Residents�<br />

A�holder�of�Shares�who�is�not�a�resident�of�Switzerland�for�tax�purposes�will�not�be�liable�for�any�Swiss�income�or�<br />

profit�taxes�on�dividends�and�similar�distributions�with�respect�to�the�Shares,�unless�the�Shares�are�attributable�to�a�<br />

permanent�establishment�or�a�fixed�place�of�business�maintained�in�Switzerland�by�such�non�Swiss�resident.�<br />

14.3 Net�Worth�and�Capital�Taxes�<br />

An� individual,� who� is� a� Swiss� resident� for� tax� purposes,� or� a� non�Swiss� resident� holding� Shares� as� part� of� a�<br />

permanent�establishment�or�fixed�place�of�business�situated�in�Switzerland,�is�required�to�include�his�or�her�Shares�<br />

in�an�accounting�of�his�or�her�assets�which�are�subject�to�cantonal�and�communal�net�worth�taxes.�No�net�worth�tax�<br />

is�levied�at�the�federal�level.�<br />

�<br />

Legal�entities�resident�in�Switzerland�or�non�Swiss�resident�legal�entities�with�a�Swiss�permanent�establishment�are�<br />

subject�to�cantonal�and�communal�capital�tax.�The�cantonal�and�communal�capital�tax�is�levied�on�the�basis�of�the�<br />

net�equity�of�the�legal�entities.�Usually,�the�acquisition�of�Shares�should�not�influence�the�equity�of�a�legal�entity�<br />

and�should�therefore�have�no�or�only�limited�influence�on�its�capital�tax�charge.�However,�the�acquisition�of�Shares�<br />

may� change� the� basis� for� international� or� inter�cantonal� allocation� of� the� taxable� equity� of� the� legal� entity.� No�<br />

capital�tax�is�levied�at�the�federal�level.�<br />

14.4 Taxes�on�Capital�Gains�upon�Disposal�of�Shares�<br />

�<br />

Individuals�<br />

Individuals�who�are�resident�in�Switzerland�for� tax�purposes�and�hold�Shares�as�part�of�his�or� her�private�assets�<br />

(Privatvermögen)�generally�are�exempt�from�Swiss�federal,�cantonal�and�communal�taxes�with�respect�to�capital�<br />

gains� realised� upon� the� sale� or� other� disposal� of� Shares,� unless� such� individuals� are� qualified� as� professional�<br />

securities� dealers� (Wertschriftenhändler)� for� income� tax� purposes.� Under� certain� circumstances,� Share� sale�<br />

proceeds�of�a�private�individual�may�be�recharacterised�into�taxable�dividend�income.�Upon�repurchase�of�Shares�by�<br />

the�Company,�the�portion�of�the�repurchase�price�in�excess�of�the�nominal�amount�may�be�classified�as�taxable�<br />

income�if�the�shares�repurchased�are�not�sold�within�a�six�year�period�or�if�the�Shares�are�repurchased�for�a�capital�<br />

reduction.�Capital�gains�realised�by�an�individual�on�Shares�that�are�held�as�part�of�its�business�assets�are�subject�to�<br />

income�taxation�and�social�security�contributions.�The�same�tax�treatment�applies�to�individuals�who,�for�income�<br />

tax�purposes,�are�classified�as�professional�securities�dealers.�<br />

�<br />

Legal�Entities�<br />

Capital� gains� upon� the� sale� or� other� disposal� of� Shares� realised� by� legal� entities� resident� in� Switzerland� for� tax�<br />

purposes�or�foreign�legal�entities�holding�Shares�as�part�of�a�Swiss�permanent�establishment�are�generally�subject�to�<br />

ordinary� income� or� profit� taxation.� A� Swiss� corporation� or� cooperative,� or� non�Swiss� corporation� or� cooperative�<br />

holding�Shares�as�part�of�a�Swiss�permanent�establishment�may,�under�certain�circumstances,�benefit�from�taxation�<br />

relief�on�capital�gains�realised�upon�the�disposal�of�Shares�(Beteiligungsabzug),�provided�such�Shares�represent�at�<br />

the�time�of�disposal�at�least�20%�of�the�share�capital�and�were�held�for�at�least�one�year.�As�of�1�January�2011,�these�<br />

thresholds�will�be�lowered�to�10%�of�the�share�capital�or�10%�of�the�profit�and�reserves�respectively�a�fair�market�<br />

value�of�CHF�1�million�if�the�participation�in�Shares�falls�below�the�threshold�of�10%�of�the�Shares.�<br />

�<br />

Non�resident�Individuals�and�Legal�Entities�<br />

Individuals�and�legal�entities�which�are�not�Swiss�residents�for�tax�purposes�and�do�not�hold�Shares�as�part�of�a�<br />

Swiss�business�operation�or�a�Swiss�permanent�establishment�or�fixed�place�of�business�situated�in�Switzerland�are�<br />

generally�not�subject�to�Swiss�income�or�profit�taxes�on�gains�realised�upon�the�disposal�of�the�Shares.�<br />

14.5 Gift�and�Inheritance�Taxes�<br />

The�transfer�of�Shares�may�be�subject�to�cantonal�and/or�communal�gift,�estate�or�inheritance�taxes�if�the�donor�is�<br />

or�the�deceased�was�resident�for�tax�purposes�in�a�canton�levying�such�taxes.�<br />

� 58<br />


14.6 Federal�Stamp�Tax�and�Stock�Exchange�Levy�upon�Transfer�of�Shares�<br />

The�transfer�of�any�Shares�may�be�subject�to�a�federal�transfer�stamp�tax�(Umsatzabgabe)�at�a�current�rate�of�up�to�<br />

0.15%,� as� well� as� the� SIX� Swiss� Exchange� turnover� fee� for� Common� Shares� and� the� Swiss� Financial� Market�<br />

Supervisory�Authority�(FINMA)�surcharge,�if�such�transfer�occurs�through�or�with�a�Swiss�or�Liechtenstein�bank�or�<br />

securities�dealer�as�defined�in�the�Swiss�Federal�Stamp�Tax�Act.�<br />

�<br />

� 59<br />


15 Market�Information�<br />

15.1 SIX�Swiss�Exchange�<br />

The�SIX�Swiss�Exchange�AG�(SIX�Swiss�Exchange)�(formerly�SWX�Swiss�Exchange�AG)�was�founded�in�1993�as�the�<br />

successor�to�the�local�stock�exchanges�of�Zurich,�Basel�and�Geneva.�In�1996,�the�SIX�Swiss�Exchange�introduced�full�<br />

electronic�trading�in�Swiss�equities,�derivatives�and�bonds.�The�SWX�Swiss�Exchange�AG�was�renamed�to�SIX�Swiss�<br />

Exchange�in�2008.�The�aggregate�turnover�of�the�SIX�Swiss�Exchange,�for�both�equity�and�debt�instruments�as�well�<br />

as�options,�was�in�2008�in�excess�of�CHF�1’934�billion.�<br />

�<br />

Pursuant�to�the�new�Listing�Rules�which�entered�into�force�per�1�July�2009,�a�listing�according�to�the�Main�Standard�<br />

of�the�SIX�Swiss�Exchange�requires,�inter�alia,�that�(i)�the�operating�and�financial�track�record�of�the�issuer�extends�<br />

over�a�period�of�at�least�three�years,�(ii)�the�issuer’s�reported�equity�capital�amounts�to�at�least�CHF�25�million,�(iii)�<br />

the�total�market�value�of�the�issuer’s�shares�to�be�listed�amounts�to�a�minimum�of�CHF�25�million,�and�(iv)�25%�of�<br />

the�issuer’s�share�capital�to�be�listed�must�be�placed�in�public�hands.�<br />

15.2 Trading�System�<br />

In� September� 2007,� x�clear� AG� (today:� SIX� x�clear� AG)� became� operational� as� a� central� counterparty� for� the� SIX�<br />

Swiss�Exchange�trades�in�eligible�securities.�<br />

�<br />

Trading�on�the�SIX�Swiss�Exchange�occurs�through�a�fully�integrated�trading�system�covering�the�entire�process�from�<br />

trade� order� through� settlement.� Trading� for� equities,� exchange� traded� funds� (ETF)� and� investment� funds� begins�<br />

each�business�day�at�9:00�a.m.�and�continues�until�5:30�p.m.�After�the�close�of�exchange�trading,�new�orders�can�be�<br />

entered�or�deleted�until�10:00�p.m.�From�6:00�a.m.�(the�system�is�not�available�between�10:00�p.m.�and�6:00�a.m.)�<br />

new�entries�and�inquiries�can�be�made�until�9:00�a.m.�For�the�opening�phase�(starting�at�9:00�a.m.),�the�system�<br />

closes�the�order�book�and�starts�opening�procedures;�it�establishes�the�opening�prices�and�determines�orders�to�be�<br />

executed�according�to�the�SIX�Swiss�Exchange’s�matching�rules.�Closing�auctions�will�be�held�to�determine�the�daily�<br />

closing�price�for�all�equity�securities�traded�on�the�SIX�Swiss�Exchange.�At�the�start�of�the�closing�auction�(shortly�<br />

before�the�close�of�trading),�the�status�of�all�equity�order�books�will�change�from�permanent�trading�to�auction.�The�<br />

auction�itself�consists�of�a�pre�opening�period�and�the�actual�auction�according�to�rules�which�are�similar�to�the�<br />

opening�procedure.�<br />

�<br />

Transactions�take�place�through�the�automatic�matching�of�orders.�Each�valid�order�of�at�least�a�round�lot�is�entered�<br />

and�listed�according�to�the�price�limit.�A�round�lot�of�shares�is�currently�only�one�share.�In�general,�market�orders�<br />

(orders�placed�at�best�price)�are�executed�first,�followed�by�limit�orders�(orders�placed�at�a�price�limit).�If�several�<br />

orders�are�listed�at�the�same�price,�they�are�executed�according�to�the�time�of�entry.�During�the�trading�period,�<br />

members�of�the�SIX�Swiss�Exchange�are�in�principle�required�to�enter�all�orders�in�the�order�books�of�the�exchange,�<br />

i.e.� to� execute� them� by� means� of� the� matcher.� Off�exchange� transactions� are� permitted� as� an� exception,� if� the�<br />

market�value�of�an�individual�order�for�equity�securities�exceeds�CHF�200’000.�Members�of�the�SIX�Swiss�Exchange�<br />

must� observe� the� principle� of� best� execution� for� any� off�exchange� transaction� during� the� trading� period.�<br />

Transactions�in�shares�effected�by�or�through�members�of�the�SIX�Swiss�Exchange�are�subject�to�a�stock�exchange�<br />

levy�(including�a�supplementary�surcharge�by�the�Swiss�Financial�Market�Supervisory�Authority�(FINMA))�of�up�to�<br />

0.02%,�calculated�on�the�settlement�price).�<br />

�<br />

Banks�and�broker�dealers�doing�business�in�Switzerland�are�required�to�report�all�transactions�in�listed�securities�<br />

traded�on�the�SIX�Swiss�Exchange.�For�transactions�effected�via�the�exchange�system,�reporting�occurs�automatically.�<br />

Off�exchange�transactions�must�be�reported�to�the�SIX�Swiss�Exchange�within�30�minutes.�Transaction�information�<br />

is�collected,�processed�and�immediately�distributed�by�the�SIX�Swiss�Exchange.�Transactions�outside�trading�hours�<br />

must� be� reported� no� later� than� the� next� opening.� The� SIX� Swiss� Exchange� distributes� a� comprehensive� range� of�<br />

information� through� various� publications,� including� in� particular� the� Swiss� Market� Feed� (SMF)� and� the� Pan�<br />

European� Market� Feed� (PEX� MF),� which� are� both� coached� by� a� firm� called� SIX� Exfeed.� The� Swiss� Market� Feed�<br />

supplies�the�SIX�Swiss�Exchange�data�in�real�time�to�all�subscribers�as�well�as�to�other�information�providers�such�as�<br />

the�Investdata�System�of�the�SIX�Swiss�Exchange,�Telekurs�und�Reuters.�<br />

�<br />

A� quotation� may� be� suspended� by� the� SIX� Swiss� Exchange� if� large� price� fluctuations� are� observed,� if� important,�<br />

price�sensitive� information� is� about� to� be� disclosed,� or� in� other� situations� that� might� endanger� fair� and� orderly�<br />

trading.�Surveillance�and�monitoring�is�the�responsibility�of�the�SIX�Swiss�Exchange�as�the�organiser�of�the�market.�<br />

The�aim�of�such�self�regulation�is�to�ensure�fair�trading�and�an�orderly�market.�<br />

15.3 Clearing,�Payment�and�Settlement�<br />

Exchange� transactions� are� usually� settled� on� a� T+3� basis,� meaning� that� delivery� against� payment� of� exchange�<br />

transactions�occurs�three�working�days�after�the�trade�date.�Clearing�and�settlement�for�securities�listed�on�the�SIX�<br />

Swiss�Exchange�are�made�through�SIS.�<br />

� 60<br />


15.4 Corporate�Governance�Directive�<br />

The� Directive� on� Information� relating� to� Corporate� Governance� of� 17� April� 2002� of� the� SIX� Swiss� Exchange� (the�<br />

“DCG”)�entered�into�force�on�1�July�2002.�It�applies�to�all�annual�reports�of�issuers�listed�on�the�SIX�Swiss�Exchange�<br />

covering� the� financial� year� which� began� on� 1� January� 2002,� or� thereafter.� The� DCG� requires� issuers� to� disclose�<br />

important� information� on� the� management� and� control� mechanisms� at� the� highest� corporate� level� or� to� give�<br />

specific�reasons�why�this�information�is�not�disclosed.�On�1�January�2007,�the�amended�DCG�entered�into�force.�The�<br />

amendments�mainly�reflect�the�changes�to�the�CO�regarding�provisions�on�the�transparency�of�compensations�of�<br />

members�of�board�of�directors�and�management�boards�which�entered�into�force�on�1�January�2007.�In�the�course�<br />

of�the�general�renewal�of�the�SIX�Swiss�Exchange�regulations,�the�DCG�was�retained�based�on�the�resolution�of�29�<br />

October�2008.�<br />

15.5 Management�Transactions�Directive�<br />

The� Directive� on� the� Disclosure� of� Management� Transactions� of� 7� January� 2005� of� the� SIX� Swiss� Exchange��(the�<br />

“DMT”)�entered�into�force�on�1�July�2005.�By�resolution�of�29�October�2008,�it�was�decided�that�the�DMT�will�be�<br />

retained� in� the� course� of� the� renewal� of� the� SIX� Swiss� Exchange� regulations.� It� applies� to� issuers� whose� equity�<br />

securities� are� listed� on� the� SIX� Swiss� Exchange� and� whose� registered� office� is� in� Switzerland.� The� DMT� requires�<br />

issuers�to�ensure�that�members�of�their�board�of�directors�and�senior�management�disclose�transactions�they�have�<br />

made�in�the�securities�of�their�own�company.�<br />

�<br />

According�to�the�DMT,�the�respective�individual�must�disclose�any�such�transaction�to�the�issuer.�The�issuer�must�<br />

forward� that� information� to� the� SIX� Swiss� Exchange.� Transactions� by� an� individual� that� exceed� alone� or� in� the�<br />

aggregate�a�threshold�value�of�CHF�100’000�within�one�calendar�month�are�subsequently�published�on�a�no�name�<br />

basis�on�the�SIX�Swiss�Exchange�website.�Transactions�that�do�not�exceed�the�threshold�value�must�also�be�reported�<br />

to�the�SIX�Swiss�Exchange,�but�are�not�published.�<br />

�<br />

� 61<br />


16 Additional�Information�<br />

16.1 Listing�and�Trading�<br />

Prior� to� the� Listing,� there� has� been� no� public� market� for� the� Common� Shares.� Application� has� been� made� and�<br />

approval� has� been� given� by� the� SIX� Swiss� Exchange� for� all� 1’248’671� Common� Shares� of� the� Company� with� a�<br />

nominal�value�of�CHF�0.10�each�to�be�listed�according�to�the�Main�Standard�and�traded�on�the�SIX�Swiss�Exchange.�<br />

The�first�trading�day�is�26�August�2009.�<br />

�<br />

In� addition,� application� has� been� made� and� approval� has� been� given� by� the� SIX� Swiss� Exchange� to� formally� list�<br />

according� to� the� Main� Standard� of� the� SIX� Swiss� Exchange� 1’800’000� Common� Shares� with� a� nominal� value� of�<br />

CHF�0.10�each�that�are�part�of�the�conditional�share�capital�of�the�Company.�<br />

�<br />

The�Common�Shares�have�been�accepted�for�clearance�through�SIS.�No�share�certificates�will�be�issued�with�respect�<br />

to�the�Common�Shares�and�the�Voting�Right�Shares�(aufgehobener�Titeldruck).�<br />

�<br />

No�application�has�been�made�to�list�the�Voting�Right�Shares�on�the�SIX�Swiss�Exchange.�Accordingly,�following�the�<br />

Listing,�only�the�Common�Shares�will�be�listed�and�admitted�to�trading�on�the�SIX�Swiss�Exchange.�<br />

16.2 Clearing�Codes�<br />

The� Swiss� Security� number� (Valorennummer)� of� the� Common� Shares� is� 10191073.� The� international� security�<br />

identification�number�(ISIN)�is�CH0101910732.�The�SIX�Swiss�Exchange�ticker�symbol�is�RARE.�<br />

16.3 Listing�Agent�<br />

In�accordance�with�art.�43�of�the�Listing�Rules,�Lenz�&�Staehelin,�Zurich,�Switzerland,�being�recognised�as�an�expert�<br />

by�the�SIX�Swiss�Exchange,�has�been�appointed�as�listing�agent�for�the�Company.�<br />

16.4 Paying�Agent�<br />

The�principal�paying�agent�(Hauptzahlstelle)�for�the�Shares�is�Graubündner�Kantonalbank,�Chur,�Switzerland.�<br />

16.5 Applicable�law�and�jurisdiction�<br />

Swiss�law�/�Stans,�Switzerland.�<br />

16.6 Financial�Reporting�<br />

According�to�legal�regulations�such�as�the�CO�and�the�regulations�of�the�SIX�Swiss�Exchange,�the�Company�publishes:�<br />

�<br />

� Annual�audited�consolidated�and�statutory�financial�statements�within�four�months�as�from�the�end�of�each�<br />

financial� year.� The� consolidated� financial� statements� include� an� income� statement,� a� balance� sheet,� a�<br />

statement�of�changes�in�shareholders’�equity,�a�cash�flow�statement,�related�notes,�and�an�audit�report.�The�<br />

statutory�financial�statements�include�an�income�statement,�a�balance�sheet,�related�notes�and�an�audit�report;�<br />

� Unaudited� consolidated� interim� financial� statements� within� three� months� as� from� the� end� of� June� of� each�<br />

financial�year.�Semi�annual�financial�statements�contain�an�income�statement,�a�balance�sheet,�a�statement�of�<br />

changes�in�shareholders’�equity,�a�cash�flow�statement,�and�related�notes.�<br />

�<br />

Year�end�consolidated�financial�statements�are�prepared�as�of�31�December�of�each�year�and�are�presented�in�CHF.�<br />

The�consolidated�financial�statements�are�prepared�in�accordance�with�IFRS,�the�statutory�accounts�in�accordance�<br />

with� Swiss� law� and� the� Articles� of� Association.� Copies� of� the� annual� report� and� interim� report� will� normally� be�<br />

available�to�shareholders�within�four�months�and�three�months,�respectively,�of�the�end�of�the�period�to�which�they�<br />

relate.�Shareholders�may�<strong>download</strong>�the�reports�from�the�Company’s�website�(www.mondobiotech.com)�or�address�<br />

their�request�to�mondoBIOTECH�holding�AG,�Mürgstrasse�18,�CH���6370�Stans�(investor@mondobiotech.com).�<br />

16.7 Notices�<br />

Pursuant� to� the� Articles� of� Association,� official� notices� from� the� Company� are� made� by� publication� in� the� Swiss�<br />

Official� Gazette� of� Commerce� (Schweizerisches� Handelsamtsblatt,� SHAB).� Notices� to� shareholders� are� made� by�<br />

regular�mail�to�the�addresses�registered�in�the�share�register�or�through�publication�in�the�Swiss�Official�Gazette�of�<br />

Commerce.�According�to�the�Articles�of�Association,�the�Board�of�Directors�may�designate�additional�publications�in�<br />

which�notices�are�published.�<br />

�<br />

To�the�extent�required�under�the�Listing�Rules,�notices�will�also�be�published�in�Swiss�newspapers�or�in�electronic�<br />

form�on�the�website�of�the�SIX�Swiss�Exchange�(www.six�exchange�regulation.com).�<br />

� 62<br />


16.8 Information�Policy�<br />

The�Company�informs�its�shareholders�and�the�public�each�year�by�publishing�an�annual�and�half�year�report.�They�<br />

provide�both�a�summary�account�of�the�business�performance�and�the�financial�statements�(complete�or�condensed)�<br />

for� the� full� calendar� year� and� for� the� period� from� the� beginning� of� the� year� to� the� end� of� the� first� semester�<br />

respectively.�The�Company�also�provides�press�releases,�presentations�and�brochures�as�needed.�The�documents�<br />

are�generally�available�to�the�public�in�electronic�form�at�www.mondobiotech.com.�<br />

�<br />

Important�dates��<br />

February�2010:� Annual�report�<br />

March�2010:�� Ordinary�Annual�General�Meeting�<br />

16.9 Contact�Address�<br />

mondoBIOTECH�holding�AG�<br />

Mürgstrasse�18�<br />

CH���6370�Stans�<br />

Telephone:�+41�(0)�840�200�010�<br />

Facsimile:�+41�(0)�840�200�011�<br />

www.mondobiotech.com�<br />

16.10 Investor�Relations�<br />

Patrick�Pozzorini�(Chief�Financial�Officer)�<br />

Telephone:�+41�(0)�840�200�010�<br />

Facsimile:�+41�(0)�840�200�011�<br />

investor@mondobiotech.com�<br />

�<br />

� 63<br />


17 Glossary�<br />

The�following�terms�and�expressions�have�the�meanings�set�forth�below,�unless�otherwise�defined�in�this�Listing�<br />

Prospectus:�<br />

�<br />

Agonist� A�drug�that�binds�to�a�receptor�of�a�cell�and�triggers�a�response�by�<br />

the�cell.�An�agonist�produces�an�action.�<br />

�<br />

CBG� Chronic�Beryllium�disease.�<br />

�<br />

Clinical�trial� A� test� in� healthy� volunteers� or� patients� that� examines� a� drug�<br />

candidate’s�properties�(e.g.�safety�and�efficacy).�<br />

�<br />

COMP� Committee�for�Orphan�Medicinal�Products.�<br />

�<br />

CTEPH� Chronic�thromboembolic�pulmonary�hypertension.�<br />

�<br />

Development� Is�a�blanket�term�used�to�define�the�entire�process�of�bringing�a�new�<br />

drug�to�the�market.�It�includes�discovery,�product�development,�pre�<br />

clinical�research�and�clinical�trials.�<br />

�<br />

Drug� Any�substance�that,�when�absorbed�in�the�body�of�living�organism�<br />

alters� bodily� functions.� A� drug�is� defined� is�used� in� the� treatment,�<br />

cure,� prevention,� or� diagnosis� of� disease� or� used� to� otherwise�<br />

enhance�physical�or�mental�well�being.�<br />

�<br />

Efficacy� Strength,� effectiveness;� the� ability� of� a� drug� to� control� or� cure� an�<br />

illness.�<br />

�<br />

EMEA� European�Medicines�Agency.�<br />

�<br />

EPO� European�Patent�Office.�<br />

�<br />

Eurordis�<br />

European�Organisation�for�Rare�Diseases.�<br />

�<br />

FDA� The�U.S.�Food�and�Drug�Administration.�<br />

�<br />

Genome� All�of�the�genetic�information�of�an�organism.�<br />

�<br />

ILD� Interstitial�lung�diseases.�<br />

�<br />

INF��� Interferon��.�<br />

�<br />

IPF� Idiopathic�pulmonary�fibrosis.�<br />

�<br />

Medicinal�product� As� defined� in� the� EU� Directive� 2001/83/EC� of� the� European�<br />

Parliament� and� of� the� Council� of� 6� November� 2001� on� the�<br />

Community�code�relating�to�medicinal�products�for�human�use�(as�<br />

amended),� any� substance� or� combination� of� substances� presented�<br />

for�treating�or�preventing�diseases�in�human�beings.�<br />

�<br />

Medicinal�product�candidate� Any� substance� or� combination� of� substances� which� qualifies� to�<br />

become�a�medicinal�product.�<br />

��<br />

MRSA� Methicillin�resistant�Staphylococcus�aureus.�<br />

�<br />

ODA� Orphan�Drug�Act.�<br />

�<br />

Off�label�use� The�use�of�a�drug�in�a�way�neither�approved�nor�permitted�to�be�put�<br />

on�its�label�and�advertised�as�its�intended�purpose.�<br />

�<br />

OMPD� Orphan�medicinal�product�designation.�A�designation�of�the�FDA�and�<br />

EMEA� to� grant� orphan� drug� status� once� the� drug� has� received�<br />

marketing�approval.�<br />

�<br />

Peptides� Short� polymers� formed� from� the� linking,� in� a� defined� order,� of���<br />

� 64<br />


amino�acids.�<br />

�<br />

PAH� Pulmonary�arterial�hypertension.�<br />

�<br />

Phase�I� Phase� of� drug� development� conducting� clinical� studies� in� healthy�<br />

volunteers�primarily�to�determine�the�behaviour�of�the�drug�in�the�<br />

human� body� and� possible� side� effects,� and� to� assess� safety� and�<br />

tolerance�pro<strong>file</strong>.�<br />

�<br />

Phase�II� Phase�of�drug�development�conducting�clinical�studies�in�patients�to�<br />

test� therapeutic� activity� and� observe� safety� and� tolerance� usually�<br />

comparing�a�few�dosing�regimens.�<br />

�<br />

Phase�III� Phase�of�drug�development�conducting�clinical�studies�in�patients�to�<br />

confirm�therapeutic�activity�and�acceptable�safety�and�tolerance�of�<br />

the�selected�dosing�regimen.�<br />

�<br />

Pre�clinical� Phase�of�non�clinical�activities�where�a�new�drug�candidate�is�tested�<br />

in�vitro�and�in�animals.�<br />

�<br />

Receptor� A�specialised�protein�structure�on�the�cell�surface�or�inside�the�cell�<br />

which� relays� information� of� one� cell� to� another,� delivered� by�<br />

chemical�messengers�called�transmitters.�<br />

�<br />

SNP� Single�nucleotide�polymorphism.�<br />

�<br />

Swissmedic� Swiss�Agency�for�Therapeutic�Products.�<br />

�<br />

TB� Tuberculosis.�<br />

�<br />

�<br />

� 65<br />


[This page has intentionally been left blank]


Financial Information<br />

mondoBIOTECH holding AG - Interim financial information 30 June 2009 (unaudited)<br />

Condensed consolidated balance sheet ………………………………………….................................................................... F-3<br />

Condensed consolidated income statement ……………………………………….………………...……………………………………….. F-4<br />

Condensed consolidated statement of comprehensive income……………….…………….………………………………………… F-5<br />

Condensed consolidated statement of changes in equity ….…….………………..………….………………………………………… F-6<br />

Condensed consolidated cash flow statement ..…………………….………………………………………..……………………………... F-7<br />

Notes to the interim financial information ……...……………...……….…………..……………………………………..………………… F-8<br />

mondoBIOTECH holding AG - Consolidated financial statements 2008<br />

Report of the group auditors …………………………….…………………………………………………………………………………….......... F-12<br />

Consolidated balance sheet …………………………………………...................................................................................... F-14<br />

Consolidated income statement …………………………………………………………………………...……………………………………….. F-15<br />

Consolidated cash flow statement ..…………………….…………………………………………………………..……………………………... F-16<br />

Consolidated statements of changes in equity ….…………………………….…….………………………………………………………… F-17<br />

Notes to the consolidated financial statements ………….………………..………………………………………………………………… F-18<br />

mondoBIOTECH holding AG (former mondoRPHAN AG) - Consolidated financial statements 2007<br />

Report of the group auditors …………………………….…………………………………………………………………………………….......... F-37<br />

Consolidated balance sheet ...………………………………………...................................................................................... F-38<br />

Consolidated income statement …………………………………………………………………………...……………………………………….. F-39<br />

Consolidated cash flow statement ..…………………….…………………………………………………………..……………………………... F-40<br />

Consolidated statements of changes in equity ….…………………………….…….………………………………………………………… F-41<br />

Notes to the consolidated financial statements ………….………………..………………………………………………………………… F-42<br />

mondoBIOTECH holding AG - Statutory financial statements 2008<br />

Report of the statutory auditors ……………………….…………………………………………………………………………………….......... F-64<br />

Balance sheet ..…………………….………………………………………...................................................................................... F-65<br />

Income statement ………………………………………………………………………………………………...……………………………………….. F-66<br />

Cash flow statement ……………………….………………….…………………………………………………………..……………………………... F-67<br />

Notes to the statutory financial statements ………………..………………..………………………………………………………………… F-68<br />

F - 1


mondoBIOTECH holding AG – Interim financial information 30 June 2009 (unaudited)<br />

(in CHF)<br />

F - 2


Condensed, consolidated balance sheet<br />

(in CHF)<br />

ASSETS<br />

As at<br />

30.06.2009 31.12.2008<br />

Property, plant and equipment 6'446'676 1'553'437<br />

Intangible assets 52'040'446 53'535'060<br />

Non current assets 58'487'122 55'088'497<br />

Trade and other receivables 6'019'184 1'189'429<br />

Other assets 293'922 517'986<br />

Accrued income and prepaid expenses 465'099 1'845'582<br />

Cash and cash equivalents 7'687'294 14'085'329<br />

14'465'499 17'638'326<br />

Assets of disposal group classified as held-for-sale 3'853'378 3'934'686<br />

Current assets 18'318'877 21'573'012<br />

Total assets 76'805'999 76'661'509<br />

EQUITY AND LIABILITIES<br />

Share capital 653'883 653'883<br />

Reserves 91'491'682 91'490'384<br />

Accumulated loss (27'158'543) (23'207'784)<br />

Equity attributable to mondoBIOTECH's shareholders 64'987'022 68'936'483<br />

Minority interest -<br />

-<br />

Total shareholders' equity 64'987'022 68'936'483<br />

Long-term financial debts 286'210 329'252<br />

Pension obligations 11'089 1'265<br />

Non current liabilities 297'299 330'517<br />

Trade and other payables 5'204'151 780'619<br />

Short-term financial debts 174'109 186'695<br />

Income tax liabilies 21'451 437'912<br />

Accrued liabilities and deferred income 3'035'883 2'888'519<br />

8'435'594 4'293'745<br />

Liabilities of disposal group classified as held-for-sale 3'086'084 3'100'764<br />

Current liabilities 11'521'678 7'394'509<br />

Total equity and liabilities 76'805'999 76'661'509<br />

The notes on pages F-8 to F-10 are an integral part of this condensed, consolidated interim financial information.<br />

F - 3


Condensed, consolidated income statement<br />

(in CHF)<br />

Six months ended 30 June<br />

2009 2008<br />

Revenues 7'990'475 8'567'700<br />

Research & development (9'293'482) (10'347'560)<br />

Sales & marketing (1'685'957) (1'327'722)<br />

Management & administration (916'986) (566'044)<br />

Operating result (3'905'950) (3'673'626)<br />

Finance income 163'191 227'828<br />

Finance costs (208'000) (388'558)<br />

Result before income taxes (3'950'759) (3'834'356)<br />

Income taxes -<br />

-<br />

Result of the period (3'950'759) (3'834'356)<br />

Attributable to:<br />

Equity holders of the Company (3'950'759) (3'834'356)<br />

Minority interest -<br />

-<br />

(3'950'759) (3'834'356)<br />

Basic and diluted loss per voting right share 1<br />

(0.078) (0.298)<br />

1 Basic and diluted loss per share refer to the Voting Right Shares, with a par value of CHF 0.01. The Common Shares have a par<br />

value of CHF 0.10. There are no differences in the character of the two classes of shares except the par value. Common Shares<br />

therefore show a basic and diluted loss per share of CHF 0.78 as per 30 June 2009<br />

The notes on pages F-8 to F-10 are an integral part of this condensed, consolidated interim financial information.<br />

F - 4


Condensed, consolidated statement of comprehensive income<br />

(in CHF)<br />

Six months ended 30 June<br />

2009 2008<br />

Result of the period (3'950'759) (3'834'356)<br />

Other comprehensive income:<br />

Currency translation differences 1'298 1'103<br />

Other comprehensive income for the period, net of tax 1'298 1'103<br />

Total comprehensive income for the period (3'949'461) (3'833'253)<br />

Attributable to:<br />

Equity holders of the Company (3'949'461) (3'833'253)<br />

Minority interest -<br />

-<br />

(3'949'461) (3'833'253)<br />

The notes on pages F-8 to F-10 are an integral part of this condensed, consolidated interim financial information.<br />

F - 5


Condensed, consolidated statement of changes in equity<br />

(in CHF)<br />

Share<br />

Attributable to equity<br />

holders on the Company<br />

Retained<br />

capital Reserves earnings<br />

Balance at 1 January 2008 642'666 77'660'451 (13'806'949) -<br />

Minority Total<br />

interest equity<br />

Total comprehensive income for the period - 1'103 (3'834'356) -<br />

Balance at 30 June 2008 642'666 77'661'554 (17'641'305) -<br />

Balance at 1 January 2009 653'883 91'490'384 (23'207'784) -<br />

Total comprehensive income for the period - 1'298 (3'950'759) -<br />

Balance at 30 June 2009 653'883 91'491'682 (27'158'543) -<br />

64'496'168<br />

(3'833'253)<br />

60'662'915<br />

68'936'483<br />

(3'949'461)<br />

64'987'022<br />

The notes on pages F-8 to F-10 are an integral part of this condensed, consolidated interim financial information.<br />

F - 6


Condensed, consolidated cash flow statement<br />

(in CHF)<br />

Six months ended 30 June<br />

2009 2008<br />

Cash generated from operations (643'409) (3'227'530)<br />

Income taxes paid (417'005) -<br />

Cash flow from operating activities (1'060'414) (3'227'530)<br />

Purchase of property, plant and equipment (5'147'044) (226'323)<br />

Interest received 5'141 59'534<br />

Cash flow from investing activities (5'141'903) (166'789)<br />

Repayment of borrowings (142'799) (134'702)<br />

Interest paid (55'902) (88'798)<br />

Cash flow from financing activities (198'701) (223'500)<br />

Net effect of currency translation on cash and cash equivalents 2'983 8'116<br />

Increase (decrease) in cash and cash equivalents (6'398'035) (3'609'703)<br />

Cash and cash equivalents at beginning of period 14'085'329 11'009'299<br />

Cash and cash equivalents at end of period 7'687'294 7'399'596<br />

The notes on pages F-8 to F-10 are an integral part of this condensed, consolidated interim financial information.<br />

F - 7


Notes to the interim financial information<br />

1 General information<br />

mondoBIOTECH holding AG (the “Company”) is a corporation limited by shares incorporated under Swiss law. The<br />

domicile and registered office is at Mürgstrasse 18, CH-6370 Stans, Switzerland. The principal activities of the<br />

Company and its subsidiaries (together the “Group”) are focused on the search and development of biological<br />

therapeutics for the treatment of rare and neglected diseases. The Group operates under the trade name<br />

‘mondoBIOTECH’.<br />

This condensed consolidated interim financial information was authorized for issue by the Board of Directors on 19<br />

August 2009, and is unaudited.<br />

2 Basis of presentation<br />

The condensed consolidated interim financial information for the six months ended 30 June 2009 of the Company<br />

has been prepared in accordance with IAS 34 ‘Interim financial reporting’. This condensed consolidated interim<br />

financial information should be read in conjunction with the consolidated financial statements 2008 which have<br />

been prepared in accordance with IFRS.<br />

The preparation of the interim financial statements requires management to make estimates and assumptions that<br />

affect the reported amounts of revenues, expenses, assets, liabilities and disclosure of contingent liabilities at the<br />

date of the interim financial statements. If in the future such estimates and assumptions, which are based on<br />

management’s best judgment at the date of the interim financial statements, deviate from the actual<br />

circumstances, the original estimates and assumptions will be modified as appropriate in the year in which the<br />

circumstances change<br />

3 Accounting policies<br />

Except as described below, the accounting policies applied are consistent with those of the consolidated financial<br />

statements 2008, as described in those financial statements.<br />

Changes in accounting policies – New standards and interpretations<br />

a) Standards, amendments and interpretations effective in 2009:<br />

IAS 1 (revised), ‘Presentation of financial statements’. The revised standard prohibits the presentation of items<br />

of income and expenses (that is ‘non-owner changes in equity’) in the statement of changes in equity, requiring<br />

‘non-owner changes in equity’ to be presented separately from owner changes in equity. All ‘non-owner<br />

changes in equity’ are required to be shown in a performance statement. Entities can choose whether to<br />

present one performance statement (the statement of comprehensive income) or two statements (the income<br />

statement and statement of comprehensive income). The Group has elected to present two statements: an<br />

income statement and a statement of comprehensive income. The interim financial statements have been<br />

prepared under the revised disclosure requirements;<br />

IFRS 8 ‘Operating segments’: IFRS 8 replaces IAS 14 ‘Segment Reporting’. The new standard requires a<br />

‘management approach’, under which segment information is presented on the same basis as that used for<br />

internal reporting purposes. This has resulted in an increase in the number of reportable segments presented<br />

and in additional disclosure for operating segments. The Group still adopted IFRS 8 in the consolidated financial<br />

statements 2008.<br />

b) Standards, amendments and interpretations to existing standards that are mandatory for the first time for the<br />

financial year beginning 1 January 2009, but are not currently relevant for the Group:<br />

IAS 23 (amendment), ‘Borrowing costs’; IFRS 2 (amendment), ‘Share-based payment’; IAS 32 (amendment),<br />

‘Financial instruments: Presentation’; IFRIC 13, ‘Customer loyalty programs’; IFRIC 15, ‘Agreements for the<br />

construction of real estate’; IFRIC 16, ‘Hedges of a net investment in a foreign operation’; IAS 39 (amendment),<br />

‘Financial instruments: Recognition and measurement’.<br />

c) Following new standards, amendments and interpretations have been issued, but are not effective for the<br />

financial year beginning 1 January 2009 and have not been early adopted. The Group is currently assessing the<br />

potential impacts of these new standards and interpretations:<br />

IFRS 3 (revised), ‘Business combinations’ and consequential amendments to IAS 27, ‘Consolidated and separate<br />

financial statements’, IAS 28, ‘Investments in associates’ and IAS 31, ‘Interests in joint ventures’, effective<br />

prospectively to business combinations for which the acquisition date is on or after the beginning of the first<br />

annual reporting period beginning on or after 1 July 2009;<br />

F - 8


IFRIC 17, ‘Distributions of non-cash assets to owners’, effective for annual periods beginning on or after 1 July<br />

2009;<br />

IFRIC 18, ‘Transfers of assets from customers’, effective for transfers of assets received on or after 1 July 2009.<br />

4 Operating segments<br />

The Group has two operating segments: ‘Projects’ and ‘Development Services’. The operating segments were<br />

determined within a matrix-oriented organization based on the different operating and strategic approaches<br />

characterising each operating segment. The segment ‘Projects’ derives its revenues from the licensing-out at<br />

different stages of development projects on biological therapeutics for the treatment of rare and neglected diseases.<br />

Revenues in this operating segment are mainly signing-up fees, milestones and royalty payments received from<br />

licensing-out partners. The segment ‘Development Services’ derives its revenues from providing additional clinical<br />

development services to partners that specifically request this services in close connection with a licensing-out<br />

agreement.<br />

Results of activities considered incidental to mondoBIOTECH’s main operations as well as unallocated revenues,<br />

expenses and assets are reported separately under the caption ‘Corporate’. Liabilities are not disclosed because<br />

they make no object of the reports provided to the operating decision maker.<br />

The segment information including reconciliation of total segmental operating results to consolidated result before<br />

income tax for the six months ended 30 June 2009 and 2008 is as follows:<br />

Six months ended 30 June 2009<br />

Development<br />

Projects Services Corporate Total<br />

Revenues from external customers 360'000 7'630'475 - 7'990'475<br />

Inter-segment revenues 360'000 - 400'186 760'186<br />

Segmental revenues 720'000 7'630'475 400'186 8'750'661<br />

Research & development costs (3'346'995) (6'367'478) (68'743) (9'783'215)<br />

Sales & marketing costs (1'662'182) - (31'728) (1'693'910)<br />

Management & administration costs (171'190) (304'268) (704'029) (1'179'486)<br />

Segmental operating result (4'460'366) 958'730 (404'314) (3'905'950)<br />

Finance income 163'191<br />

Finance costs (208'000)<br />

Result before income taxes (3'950'759)<br />

Total segment assets 66'785'444 12'581'141 26'885'281 106'251'865<br />

Revenues from external customers -<br />

Inter-segment revenues -<br />

Segmental revenues -<br />

Six months ended 30 June 2008<br />

Development<br />

Projects Services Corporate Total<br />

8'567'700 - 8'567'700<br />

- 262'451 262'451<br />

8'567'700 262'451 8'830'151<br />

Research & development costs (2'857'172) (7'496'589) - (10'353'761)<br />

Sales & marketing costs (1'327'722) -<br />

- (1'327'722)<br />

Management & administration costs (187'229) (269'859) (365'206) (822'294)<br />

Segmental operating result (4'372'123) 801'252 (102'755) (3'673'626)<br />

Finance income 227'828<br />

Finance costs (388'558)<br />

Result before income taxes (3'834'356)<br />

Total segment assets 67'935'065 5'889'459 5'829'725 79'654'249<br />

F - 9


Reportable segments’ assets are reconciled to total assets as follow:<br />

As at 30 June<br />

2009 2008<br />

Segment assets for reportable segments 106'251'865 79'654'249<br />

Investment in subsidiaries (878'888) (728'888)<br />

Loans to subsidiaries (21'663'744) (4'930'735)<br />

Trade and other receivables against subsidiaries (10'756'612) (1'282'838)<br />

Unallocated:<br />

Assets of disposal group classified as held-for-sale 3'853'378 -<br />

Total assets per the balance sheet 76'805'999 72'711'788<br />

5 Share capital<br />

Share capital<br />

With the extraordinary general meeting held on 20 February 2009, the shareholders of the Company approved the<br />

split of the company’s shares from previously 13’077’654 bearer shares with a par value of CHF 0.05 each into new<br />

65’388’270 registered shares with a par value of CHF 0.01 each. Further, with the extraordinary general meeting<br />

held on 10 June 2009, the shareholders of the Company approved the reverse split of 12’486’710 registered shares<br />

with a par value of CHF 0.01 into new 1’248’671 registered shares with a par value of CHF 0.10.<br />

At 30 June 2009, the issued share capital of the Company amounts to CHF 653’883, consisting of 1’248’671 fully<br />

paid-in registered shares with a par value of CHF 0.10 (being therefore ‘Common Shares’) and 52’901’560 fully paidin<br />

registered shares with a par value of CHF 0.01 (being therefore ‘Voting Right Shares’).<br />

Authorized, unissued nominal capital<br />

At 30 June 2009, as a consequence of the decisions taken at the extraordinary general meeting held on 20 February<br />

2009, the Company has an authorized share capital of CHF 326’941, consisting of 3’269’413 registered shares with a<br />

par value of CHF 0.10 each<br />

Conditional share capital<br />

At 30 June 2009, as a consequence of the decisions taken at the extraordinary general meeting held on 20 February<br />

2009, the Company has a conditional share capital of CHF 326’941, consisting of 3’269’413 registered shares with a<br />

par value of CHF 0.10 each, of which CHF 180’000 to be used for a Share Option Plans for employees, members of<br />

the board of directors and consultants and CHF 146’941 to be used for the exercise of conversion option rights<br />

granted in connection with bonds, notes or similar debt instruments issued by the Group. To date, there is no share<br />

option plan in place for employees, members of the board of directors and consultants.<br />

6 Legal proceedings<br />

At balance sheet date, the Group is not involved in any legal proceeding.<br />

7 Events after the balance sheet date<br />

The Company plans a listing of the 1’248’671 registered common shares with a par value of CHF 0.10 according to<br />

the main standard of the SIX Swiss Exchange. The trading of the Common Shares will presumably commence on 26<br />

August 2009 under the ticker symbol RARE.<br />

There have been no further material post-balance sheet events which would require disclosure or adjustment to<br />

the condensed, consolidated interim financial information.<br />

***<br />

F - 10


mondoBIOTECH holding AG – Consolidated financial statements 2008<br />

F - 11


Report of the group auditors<br />

F - 12


F - 13


Consolidated balance sheet<br />

(in CHF)<br />

ASSETS<br />

Note<br />

As at 31 December<br />

2008 2007<br />

Property, plant and equipment 7 1'553'437 5'157'571<br />

Intangible assets 8 53'535'060 56'557'435<br />

Non current assets 55'088'497 61'715'006<br />

Trade and other receivables 10 1'189'429 6'385'707<br />

Other assets 11 517'986 4'950<br />

Accrued income and prepaid expenses 1'845'582 15'086<br />

Cash and cash equivalents 12 14'085'329 11'009'299<br />

17'638'326 17'415'042<br />

Assets of disposal group classified as held-for-sale 13 3'934'686 -<br />

Current assets 21'573'012 17'415'042<br />

Total assets 76'661'509 79'130'048<br />

EQUITY AND LIABILITIES<br />

Share capital 14 653'883 642'666<br />

Reserves 15 91'490'384 77'660'451<br />

Accumulated loss (23'207'784) (13'806'949)<br />

Equity attributable to mondoBIOTECH's shareholders 68'936'483 64'496'168<br />

Minority interest -<br />

-<br />

Total shareholders' equity 68'936'483 64'496'168<br />

Long-term financial debts 16 329'252 3'530'382<br />

Pension obligations 17 1'265 5'153<br />

Non current liabilities 330'517 3'535'535<br />

Trade and other payables 18 780'619 7'713'999<br />

Short - term financial debts 16 186'695 242'649<br />

Income tax liabilies 25 437'912 440'222<br />

Accrued liabilities and deferred income 19 2'888'519 2'701'475<br />

4'293'745 11'098'345<br />

Liabilities of disposal group classified as held-for-sale 13;16 3'100'764 -<br />

Current liabilities 7'394'509 11'098'345<br />

Total equity and liabilities 76'661'509 79'130'048<br />

The notes to the financial statements are an integral part of these financial statements.<br />

F - 14


Consolidated income statement<br />

(in CHF)<br />

Year ended 31 December<br />

Note 2008 2007<br />

Revenues 20 14'545'200 14'827'184<br />

Research & development 21 (20'172'940) (11'291'181)<br />

Sales & marketing 21 (2'350'600) (3'761'635)<br />

Management & administration 21 (1'190'778) (1'508'704)<br />

Operating result (9'169'118) (1'734'336)<br />

Finance income 23 548'196 623'418<br />

Finance costs 24 (779'913) (654'482)<br />

Result before income taxes (9'400'835) (1'765'400)<br />

Income taxes 25 - (234'888)<br />

Result of the period (9'400'835) (2'000'288)<br />

Attributable to:<br />

Equity holders of the Company (9'400'835) (1'605'210)<br />

Minority interest - (395'078)<br />

(9'400'835) (2'000'288)<br />

Basic and diluted loss per share 26 (0.729) (0.154)<br />

The notes to the financial statements are an integral part of these financial statements.<br />

F - 15


Consolidated cash flow statement<br />

(in CHF)<br />

Year ended 31 December<br />

Note 2008 2007<br />

Cash generated from operations 27 (9'554'639) (3'730'900)<br />

Income taxes paid -<br />

-<br />

Cash flow from operating activities (9'554'639) (3'730'900)<br />

Purchase of property, plant and equipment 7 (824'861) (300'825)<br />

Business combination by reverse acquisition - 308'528<br />

Interest received 23 90'813 380'565<br />

Cash flow from investing activities (734'048) 388'268<br />

Proceeds from issuance of ordinary shares, net of transaction costs 14;15 13'850'822 -<br />

Repayment of borrowings (293'939) (940'376)<br />

Interest paid 24 (179'876) (25'043)<br />

Cash flow from financing activities 13'377'007 (965'419)<br />

Net effect of currency translation on cash and cash equivalents (12'290) 11'163<br />

Increase (decrease) in cash and cash equivalents 3'076'030 (4'296'888)<br />

Cash and cash equivalents at beginning of period 11'009'299 15'306'187<br />

Cash and cash equivalents at end of period 14'085'329 11'009'299<br />

The notes to the financial statements are an integral part of these financial statements.<br />

F - 16


Consolidated statement of changes in equity<br />

(in CHF)<br />

Attributable to equity<br />

holders on the Company<br />

Share Retained<br />

Note capital Reserves earnings<br />

Minority Total<br />

interest equity<br />

Balance at 1 January 2007 338'364 81'031'908 (15'236'333) - 66'133'939<br />

Currency translation differences -<br />

1'981 -<br />

493 2'474<br />

Net income recognized directly in equity -<br />

1'981 -<br />

493 2'474<br />

Result of the period - - (1'605'210) (395'078) (2'000'288)<br />

Total recognized result for the period -<br />

1'981 (1'605'210) (394'585) (1'997'814)<br />

Business combination by reverse acquisition 261'636 (16'141'434) 3'034'594 13'205'247 360'043<br />

Acquisition of minority interests 42'666 12'767'996 - (12'810'662) -<br />

304'302 (3'373'438) 3'034'594 394'585 360'043<br />

Balance at 31 December 2007 642'666 77'660'451 (13'806'949) -<br />

Balance at 1 January 2008 642'666 77'660'451 (13'806'949) -<br />

Currency translation differences - (9'672) -<br />

-<br />

Net income recognized directly in equity - (9'672) -<br />

-<br />

Result of the period - - (9'400'835) -<br />

Total recognized result for the period - (9'672) (9'400'835) -<br />

Capital increase, net of transaction costs 14;15 11'217 13'839'605 -<br />

11'217 13'839'605 -<br />

Balance at 31 December 2008 653'883 91'490'384 (23'207'784) -<br />

The notes to the financial statements are an integral part of these financial statements.<br />

-<br />

-<br />

64'496'168<br />

64'496'168<br />

(9'672)<br />

(9'672)<br />

(9'400'835)<br />

(9'410'507)<br />

13'850'822<br />

13'850'822<br />

68'936'483<br />

F - 17


Notes to the consolidated financial statements<br />

1 General information<br />

mondoBIOTECH holding AG (the “Company”), formerly mondoRPHAN AG, is a limited company incorporated under<br />

the Swiss law. The domicile and registered office is at Mürgstrasse 18, CH-6370 Stans, Switzerland.<br />

The principal activities of the Company and its subsidiaries (together the “Group”) are focused on the search and<br />

development of biological therapeutics for the treatment of rare and neglected diseases that may qualify for<br />

Orphan Drug Designation status (the “Business”). The Group operates under the trade name ‘mondoBIOTECH’.<br />

These Group consolidated financial statements were authorized for issue by the Board of Directors on 27 February<br />

2009 and are subject to approval by the Annual General Meeting of shareholders.<br />

2 Summary of significant accounting policies<br />

Basis of preparation<br />

The consolidated financial statements of mondoBIOTECH holding AG have been prepared in accordance with<br />

International Financial Reporting Standards (IFRS) and comply with Swiss law. They have been prepared under the<br />

historical cost convention, as modified by the revaluation of financial assets at fair value through profit or loss and<br />

available-for-sale financial assets, and are presented in Swiss francs (CHF).<br />

The preparation of the consolidated financial statements in conformity with IFRS requires management to make<br />

estimates and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities, and the<br />

disclosure of contingent liabilities at the date of the financial statements. The actual outcome may differ from the<br />

assumptions and estimates made. If in the future such estimates and assumptions, which are based on<br />

management’s best judgment at the date of the financial statements, deviate from the actual circumstances, the<br />

original estimates and assumptions will be modified as appropriate in the year in which the circumstances change.<br />

Uncertainties and ability to continue operations<br />

The Group is in its start up phase and subject to various risks and uncertainties, including but not limited to timing<br />

of achieving profitability and the substantial uncertainty of the drug development process, including uncertainty of<br />

the outcome of clinical trials and significant regulatory approval requirements.<br />

At 31 December 2008, the Group disposes of CHF 14 million of cash and cash equivalents. The Group has the<br />

liquidity necessary to finance its actual level of activities at least in the next twelve months. Management is also<br />

confident that it will be able to raise additional funds through ordinary capital increases or through other channels,<br />

if necessary to further develop the activities and plans of the Group. For these reasons, management believes that it<br />

is appropriate to prepare these financial statements on a going concern basis.<br />

Consolidation policy<br />

Subsidiaries are all entities over which the Company has the power to govern the financial and operating policies of<br />

an enterprise so as to obtain benefits from its activities. This control is normally evidenced when the Company owns,<br />

either directly or indirectly, more than 50% of the voting rights or potential voting rights. Companies acquired<br />

during the year are consolidated from the date on which control is transferred to the Group, and subsidiaries to be<br />

divested are included up to the date on which control passes from the Group. Inter-company transactions, balances<br />

and unrealized gains on transactions between Group companies are eliminated. Unrealized inter-company losses<br />

are also eliminated unless the transaction provides evidence of an impairment of the asset transferred. The<br />

accounting policies of subsidiaries are consistent with the policies adopted by the Group.<br />

The purchase method of accounting is used to account for the acquisition of subsidiaries by the Group. The cost of<br />

an acquisition is measured as the fair value of the assets given, equity instruments issued and liabilities incurred or<br />

assumed at the date of exchange, plus costs directly attributable to the acquisition. Identifiable assets acquired and<br />

contingent liabilities assumed in a business combination are measured initially at their fair values at the acquisition<br />

date, irrespective of the extent of any minority interest. The excess of the cost of acquisition over the fair value of<br />

the Group’s share of the identifiable net assets is recorded as goodwill. If the cost of acquisition is less than the fair<br />

value of the net assets of the subsidiary acquired, the difference is recognized directly in the income statement.<br />

Business combinations involving entities under common control are accounted for using the values of the acquired<br />

assets and liabilities according to the financial statements of the acquired entity, prepared in conformity with IFRS.<br />

Comparatives are not restated.<br />

F - 18


Foreign currency translation<br />

Items included in the financial statements of each of the Group’s entities are measured using the currency of the<br />

primary economic environment in which the entity operates (“the functional currency”). The consolidated financial<br />

statements are presented in Swiss francs, which is the functional and presentation currency of the Company.<br />

Foreign currency transactions are translated into the functional currency using the exchange rate prevailing at the<br />

dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and<br />

from the translation of monetary assets and liabilities denominated in other currencies are recognized in the<br />

income statement, except when deferred in equity as qualifying cash flow hedges and qualifying net investment<br />

hedges.<br />

Upon consolidation, assets and liabilities of Group companies using measurement currencies other than Swiss<br />

francs (foreign entities) are translated into Swiss francs using year-end rates of exchange. Sales, costs, expenses, net<br />

income and cash flows are translated at the average rates of exchange for the year (unless the average is not a<br />

reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case<br />

they are translated at the dates of the transactions). Translation differences due to the changes in exchange rates<br />

between the beginning and the end of the year and the difference between net income translated at the average<br />

and year-end exchange rate are taken directly to equity. On the divestment of a foreign entity, the identified<br />

cumulative currency translation difference relating to that foreign entity is recognized in income as part of the gain<br />

or loss on divestment.<br />

Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities<br />

of the foreign entity and translated at the closing rate.<br />

Property, plant and equipment<br />

Property, plant and equipment is stated at historical cost less depreciation. Historical costs include expenditures<br />

that are directly attributable to the acquisition of the items. Costs may also include transfers from equity of any<br />

gains/losses on qualifying cash flow hedges of foreign currency purchases of property, plant and equipment.<br />

Subsequent costs are included in the assets’ carrying amount or recognized as a separate asset, as appropriate, only<br />

when it is probable that future economic benefits associated with the item will flow to the Group and the cost of<br />

the item can be measured reliably. All other repairs and maintenance are charged to the income statement during<br />

the financial period in which they are incurred. Gains and losses on disposals are determined by comparing<br />

proceeds with carrying amount and are included in the income statement.<br />

Depreciation of property, plant and equipment is calculated using the straight-line method to allocate costs to<br />

residual values over each asset’s estimated useful lives as follows:<br />

Leasehold improvements 5 years<br />

Plant and equipment 5 years<br />

Motor vehicles 4 years<br />

Aircraft 25 years<br />

Hardware and standard software 3 years<br />

Other (office equipment) 3 - 5 years<br />

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.<br />

Where the carrying amount of an asset is greater than its estimated recoverable amount, it is written down<br />

immediately to its recoverable amount.<br />

Leases<br />

Leases of property, plant and equipment where the Group has substantially all of the risks and rewards of<br />

ownership are classified as finance leases. Finance leases are capitalized at the lower of the fair value of the leased<br />

property or the present value of minimum lease payments at the inception of the lease. The rental obligation, net of<br />

finance charges, is included in long-term financial payables. Assets acquired under finance leases are depreciated in<br />

accordance with the Group’s above policy on property, plant and equipment over the shorter of the lease term or<br />

their useful life. The interest element of the lease payment is charged against income over the lease term based on<br />

the interest rate implicit in the lease.<br />

Leases under which substantially all of the risks and rewards of ownership are not transferred to the Group are<br />

classified as operating leases. Payments made under operating leases are charged against income on a straight-line<br />

basis over the period of the lease.<br />

Intangible assets<br />

Intangible assets are initially recorded at cost. Where these assets have been acquired through a business<br />

combination, this will be the fair value allocated in the acquisition accounting. Costs related to intangible assets are<br />

F - 19


capitalized only when it is probable that future economic benefits will flow to the Group. Otherwise, the costs are<br />

fully expensed in the period in which they occur.<br />

Intangible assets with a finite useful live are amortized over their useful lives on a straight-line basis as follows:<br />

Patents the lower of legal duration or economic useful lives (at present 17.5 years)<br />

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.<br />

Intangible assets with an indefinite useful life are not amortized, but are tested for impairment annually or more<br />

frequently if an impairment indicator is triggered.<br />

In the case of business combinations, the excess of the purchase price over the fair value of net identifiable assets<br />

acquired is recorded as goodwill in the balance sheet. Goodwill on acquisitions of subsidiaries is included in<br />

intangible assets. Goodwill on acquisitions of associates is included in investments in associates. Goodwill is tested<br />

annually for impairment and carried at cost less accumulated impairment losses. Gains and losses on the disposal of<br />

an entity include the carrying amount of goodwill relating to the entity sold.<br />

Impairment of non-financial assets<br />

Assets that have an indefinite useful life are not subject to amortisation and are tested annually for impairment.<br />

Assets that are subject to amortisation are reviewed for impairment whenever events or changes in circumstances<br />

indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by<br />

which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an<br />

asset’s fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at<br />

the lowest levels for which there are separately identifiable cash flows (cash-generating units). Non-financial assets<br />

other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at each<br />

reporting date.<br />

Non-current assets (or disposal groups) held for sale<br />

Non-current assets (or disposal groups) are classified as assets held for sale when their carrying amount is to be<br />

recovered principally through a sale transaction and sale is considered highly probable. They are stated at the lower<br />

of its carrying amount and fair value less costs to sell.<br />

Financial assets<br />

The Group classifies its financial assets in the following categories: ‘at fair value through profit or loss’, ‘loans and<br />

receivables’ and ‘available-for-sale’. The classification depends on the purpose for which the financial assets were<br />

acquired. Management determines the classification of its financial assets at initial recognition and re-evaluates this<br />

designation at every reporting date. A financial asset is classified as at fair value through profit or loss if acquired<br />

principally for the purpose of selling in the short-term or if so designated by management. Assets in this category<br />

are classified as current assets if they are either held for trading or are expected to be realized within 12 months of<br />

the balance sheet date. Loans and receivables are non-derivative financial assets with fixed or determinable<br />

payments that are not quoted in an active market. They are included in current assets, except for maturities greater<br />

than 12 months after the balance sheet date. These are classified as non-current assets. Available-for-sale financial<br />

assets are non-derivatives that are either designated in this category or not classified in any of the other categories.<br />

They are included in non-current assets unless management intends to dispose of the investment within 12 months<br />

of the balance sheet date.<br />

Financial assets at fair value through profit or loss and available-for-sale financial assets are carried at fair value.<br />

Regular purchases and sales are recognized on settlement date, the date that an asset is delivered to or by an entity.<br />

Investments are initially recognized at fair value plus transaction costs for all financial assets not carried at fair value<br />

through profit or loss. Financial assets carried at fair value through profit or loss are initially recognized at fair value<br />

and transaction costs are expensed in the income statement. Gains or losses arising from changes in the fair value<br />

of the financial assets at fair value through profit and loss are recognized in the income statement in the period in<br />

which they arise. Changes in the fair value of available-for-sale financial assets are recognized in equity, except for<br />

translation differences on monetary securities denominated in a foreign currency, which are recognized in profit or<br />

loss. When they are sold or impaired, the accumulated fair value adjustments recognized in equity are included in<br />

the income statement. The Group assesses at each balance sheet date whether there is objective evidence that a<br />

financial asset is impaired. In the case of equity securities classified as available for sale, a significant or prolonged<br />

decline in the fair value of the security below its cost is considered as an indicator that the securities are impaired. If<br />

any such evidence exists for available-for-sale financial assets, the cumulative loss, measured as the difference<br />

between the acquisition cost and the current fair value, less any impairment loss on that financial asset previously<br />

recognised in profit or loss, is removed from equity and recognised in the income statement. Impairment losses<br />

recognised in the income statement are not reversed through the income statement. Impairment testing of trade<br />

receivables is described in the corresponding note.<br />

F - 20


Financial assets are derecognised when the contractual rights to the cash flows of the assets expire or when the<br />

Group sells or otherwise disposes of the contractual rights to the cash flows, including situations where the Group<br />

retains the contractual rights but assumes a contractual obligation to pay the cash flows to a third party.<br />

Trade receivables<br />

Trade receivables are recognized initially at fair value and subsequently measured at amortised costs using the<br />

effective interest method, less provision for impairment. A provision for impairment is established when there is<br />

objective evidence that the Group will not be able to collect all amounts due according to the original terms.<br />

Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial<br />

reorganisation, and default or delinquency in payments (more than 30 days overdue) are considered indicators that<br />

the trade receivable is impaired. The amount of the provision is the difference between the asset’s carrying amount<br />

and the present value of estimated future cash flows, discounted at the original interest rate. The carrying amount<br />

of the asset is reduced through the use of an allowance account, and the amount of the loss is recognised in the<br />

income statement within “sales and marketing”. When a trade receivable is uncollectible, it is written off against<br />

the allowance account.<br />

Supplies used in the development process<br />

Supplies used in the development process are stated at cost and classified as ‘other assets’. Cost is determined<br />

using the first-in, first-out method (FIFO). When supplies are used, the associated cost forms part of the research &<br />

development expense.<br />

Cash and cash equivalents<br />

Cash and cash equivalents include cash in hand, deposits held at call with banks and other short-term highly liquid<br />

investments with original maturities of three months or less. Bank overdrafts are shown within financial debts in<br />

current liabilities on the balance sheet. This definition is also used for the purposes of the cash flow statement.<br />

Financial debts<br />

Financial debts are initially recorded at fair value, net of transaction costs. Financial debts are subsequently stated<br />

at amortized cost using the effective interest rate method. When convertible bonds are issued, the fair value of the<br />

liability portion is determined using a market interest rate for an equivalent non-convertible bond. This amount is<br />

recorded as a liability on an amortized cost basis. The remainder of the proceeds is allocated to the conversion<br />

option. This is recognized and included in shareholders’ equity, net of income tax effects. Financial debts are<br />

normally classified as current liabilities unless the Group has an unconditional right to defer settlement of the<br />

liability for at least 12 months after the balance sheet date.<br />

Provisions<br />

The Group recognizes provisions when it has a present legal or constructive obligation to transfer economic benefits<br />

as a result of past events and a reasonable estimate of the obligation can be made. Provisions are measured at the<br />

present value of the expenditures expected to be required to settle the obligation using a pre-tax rate that reflects<br />

current market assessments of the time value of money and the risks specific to the obligation. The increase in the<br />

provision due to passage of time is recognized as interest expense.<br />

Fair values<br />

Fair value is the amount for which a financial asset, liability or instrument could be exchanged between<br />

knowledgeable and willing parties in an arm’s length transaction. It is determined by reference to quoted market<br />

prices or by the use of established estimation techniques such as estimated discounted values of cash flows. The fair<br />

values of financial assets and liabilities at the balance sheet date are not materially different from their reported<br />

carrying values unless specifically mentioned in the Notes to the Consolidated Financial Statements.<br />

Royalty income<br />

Revenue arising from royalties is recognized on an accrual basis according to the relevant agreements when it is<br />

probable that the economic benefits will flow to the Group and the amount of the revenue can be measured<br />

reliably.<br />

Revenues arising from upfront and milestone payments<br />

Recognition of revenues from upfront payments depends on whether a service has to be provided in relation of the<br />

upfront payment. When the Group has to provide services in relation to the upfront payment, revenues are<br />

deferred and recognized by reference to the stage of completion of the activities to be performed. Receipts for<br />

achievement of milestones are generally recognized as revenue when the milestone is achieved.<br />

Revenues arising from clinical development services<br />

Revenues arising from clinical development services are recognized in the accounting period in which the services<br />

are performed.<br />

F - 21


Research and development<br />

Research and development costs consist primarily of remuneration and other expenses related to research and<br />

development personnel, costs associated with preclinical testing and clinical trials of product candidates (including<br />

the costs of manufacturing the product candidates), expenses for research and development services under<br />

collaboration agreements and outsourced research and development expenses. Furthermore the Group may<br />

acquire in-process research and development assets, either through business combinations or through purchases of<br />

specific assets.<br />

Internal development costs are capitalised as intangible assets only when there is an identifiable asset that can be<br />

completed and that will generate probable future economic benefits and when the cost of such an asset can be<br />

measured reliably. The Group does not currently have any such internal development costs that qualify for<br />

capitalisation as intangible assets. Internal development costs are therefore charged against income as incurred<br />

since the criteria for their capitalisation are not met. In-process research and development assets acquired either<br />

through business combinations or separate purchases are capitalized as intangible assets and reviewed for<br />

impairment at each reporting date. Once available for use, such intangible assets are amortized on a straight-line<br />

basis over the period of the expected benefit.<br />

Deferred income tax<br />

Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax<br />

bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, the<br />

deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction<br />

other than a business combination that at the time of the transaction affects neither accounting nor taxable profit<br />

or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantively<br />

enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realised<br />

or the deferred income tax liability is settled.<br />

Deferred income tax assets are recognised to the extent that it is probable that future taxable profit will be<br />

available against which the temporary differences can be utilised.<br />

Deferred income tax is provided on temporary differences arising on investments in subsidiaries and associates,<br />

except where the timing of the reversal of the temporary difference is controlled by the Group and it is probable<br />

that the temporary difference will not reverse in the foreseeable future.<br />

Employee benefits<br />

(a) General<br />

Wages, salaries, social security contributions, paid annual leave and sick leave, bonuses, and non-monetary benefits<br />

are accrued in the year in which the associated services are rendered by employees of the Group.<br />

(b) Pension obligations<br />

The Group maintains retirement plans where expressly required by the applicable pension legislation. This refers<br />

exclusively to the Swiss subsidiaries. In general, the plans cover retirement benefits and risks of death and disability<br />

and are based on fixed contributions. As they guarantee a minimum return, they are considered as defined benefit<br />

plans. The plans are financed by contributions of the employer and the employee, the first paying 50% and the<br />

second 50% of the related premiums.<br />

The liability recognized in the balance sheet in respect of defined benefit pension plans is the present value of the<br />

defined benefit obligation at the balance sheet date less the fair value of plan assets, together with adjustments for<br />

unrecognized actuarial gains or losses and past service costs. The defined benefit obligation is calculated<br />

periodically by independent actuaries using the projected unit credit method. The present value of the defined<br />

benefit obligation is determined by discounting the estimated future cash outflows using interest rates of highquality<br />

corporate bonds that are denominated in the currency in which the benefits will be paid, and that have<br />

terms to maturity approximating to the terms of the related pension liability.<br />

Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions in excess of<br />

the greater of 10% of the value of plan assets or 10% of the defined benefit obligation are charged or credited to<br />

income over the employee’s expected average remaining working lives.<br />

(c) Termination benefits<br />

Termination benefits are payable when a member of the management accepts voluntary redundancy in exchange<br />

for these benefits. The Group recognizes termination benefits when it is demonstrably committed to provide<br />

termination benefits as a result of an offer made to encourage voluntary redundancy. No other post-employment<br />

obligations and termination benefits exist within the Group.<br />

Transactions with minority shareholders<br />

The Group applies a policy of treating transactions with minority interests as transactions with equity owners of the<br />

group. For purchases from minority interests, the difference between any consideration paid and the relevant share<br />

F - 22


acquired of the carrying value of net assets of the subsidiary is deducted from equity. Gains or losses on disposals to<br />

minority interests are also recorded in equity. For disposals to minority interests, differences between any proceeds<br />

received and the relevant share of minority interests are also recorded in equity.<br />

Segment reporting<br />

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating<br />

decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing<br />

performance of the operating segments, has been identified as the Executive Committee.<br />

The accounting policies used for segment reporting are the same as those used for the preparation of these<br />

financial statements. Sales between segments are carried out at arm’s length.<br />

For the purposes of segment reporting, intercompany invoices are eliminated and replaced by the effective costs<br />

sustained by the company delivering the specific service.<br />

Changes in accounting policies – New standards and interpretations<br />

a) Standards, amendments and interpretations effective in 2008:<br />

IFRIC 14, 'IAS 19 – The limit on a defined benefit asset, minimum funding requirements and their interaction',<br />

provides guidance on assessing the limit in IAS 19 on the amount of the surplus that can be recognised as an<br />

asset. It also explains how the pension asset or liability may be affected by a statutory or contractual minimum<br />

funding requirement. This interpretation does not have any impact on the current financial statements;<br />

IFRIC 11, 'IFRS 2 – Group and treasury share transactions'; IFRIC 12, 'Service concession arrangements'; IFRIC 13,<br />

‘Customer loyalty programmes’ and IFRIC 16, ‘Hedges of a net investment in a foreign operation’. These<br />

interpretations are not relevant for the Group’s financial statements.<br />

b) Standards and amendments early adopted:<br />

IFRS 8 ‘Operating segments’: IFRS 8 replaces IAS 14 ‘Segment Reporting’. The new standard requires a<br />

‘management approach’, under which segment information is presented on the same basis as that used for<br />

internal reporting purposes. This has resulted in an increase in the number of reportable segments presented<br />

and in additional disclosure for operating segments. Comparatives 2007 have been restated.<br />

c) Standards, amendments and interpretations to existing standards that are not yet effective for 2008 and have not<br />

been early adopted. The Group is currently assessing the potential impacts of these new standards and<br />

interpretations:<br />

IAS 1 (amended); IAS 19 (amended), IAS 23 (amended); IAS 27 (amended); IAS 28 (amended); IAS 32 (amended);<br />

IAS 36 (amended), IAS 38 (amended), IAS 39 (amended); IFRS 1 (amended); IFRS 2 (amended); IFRS 3<br />

(amended); IFRS 5 (amended) and a number of minor amendments to other standards, which are part of the<br />

IASB’s annual improvements project published in May 2008; IFRIC 15, ‘Agreements for the construction of real<br />

estate’, IFRIC 17, ‘Distributions of non-cash assets to owners’ and IFRIC 18, ‘Transfers of assets from customers’.<br />

3 Summary of critical accounting estimates and assumptions<br />

The preparation of the consolidated financial statements in conformity with IFRS requires management to make<br />

estimates and assumptions that affect the application of policies and reported amounts of assets, liabilities, income,<br />

expenses and related disclosures. The estimates and underlying assumptions are based on historical experience and<br />

various other factors that are believed to be reasonable under the circumstances, the results of which form the<br />

basis for making the judgments about carrying values of assets and liabilities that are not readily apparent from<br />

other sources. Actual results may differ from these estimates. The estimates and assumptions that have a significant<br />

risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year<br />

are described below.<br />

Going concern assumption<br />

The Group is subject to various risks and uncertainties and its future success will in particular depend on its ability to<br />

achieve profitability and raise additional capital to fund operations. Management assesses the going concern<br />

assumption at each reporting date. See note 2, paragraph ‘Ability to continue operations’, for further details and<br />

explanations.<br />

Impairment of intangible assets<br />

In 2006, the Group acquired certain intellectual properties which are in the process of being registered and that<br />

claim, among others, the formulation and administration of medicaments (in particular peptides) through inhalation,<br />

as to expand the intellectual property coverage on its out licensed products in development stage. The recoverable<br />

amount of these intellectual properties depends on the continuing operation of the Group, the successful<br />

development of the related products, anticipated sales and future synergic effects. Factors such as changes in the<br />

planned use, presence or absence of competition, technical obsolescence can also result in shortened useful lives or<br />

F - 23


impairment. These intellectual property rights are reviewed for impairment whenever events or changes in<br />

circumstances indicate that the carrying amount may not be recoverable.<br />

The carrying value of such intellectual property at 31 December 2008 is CHF 53’535’060 (31 December 2007: CHF<br />

56’557’323). If the estimated cash flows and synergistic effects decrease by 10%, the Group would not have to<br />

recognize impairment (previous year: no recognition of impairment). If pre-tax discount rate applied to discount<br />

estimated future synergistic effects would increase by 10%, the Group would not have to recognize an impairment<br />

(31 December 2007: CHF 2.5 million).<br />

Revenue recognition<br />

The Group is party to out-licensing agreements which can involve upfront and milestone payments that may occur<br />

over several years. These agreements may also involve certain future obligations. Revenue is only recognized when,<br />

in management’s judgment, the obligation has been fulfilled. For some transactions this can result in cash receipts<br />

being initially recognized as deferred income and then released to income over subsequent periods on the basis of<br />

the performance of the conditions specified in the agreement.<br />

Deferred tax assets<br />

The assessment as to whether deferred tax assets relating to tax loss carry-forwards and temporary differences<br />

have to be recognised requires significant judgment, in particular on the future availability of taxable profits. At 31<br />

December 2008 the Group did not capitalize any deferred tax assets because the capitalisation criteria are not met.<br />

Deferred tax assets relating to tax loss carry-forwards and temporary differences that have not been recognized are<br />

reported in note 25.<br />

4 Financial risk management<br />

The Group is exposed to various financial risks such as credit risk, liquidity risk and market risk (including interestrate<br />

and currency risk). The following sections provide an overview of the extent of the individual risks and the goals,<br />

principles and processes employed to handle these risks.<br />

Credit risk<br />

Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument fails to<br />

meet contractual obligations. The maximum credit risk exposure as per balance sheet date amounts to CHF<br />

14’202’278 (CHF 13’691’594 in 2007), as disclosed in note 9, corresponding to the global carrying amounts of the<br />

financial assets. The Group does not hold any collateral as security and has not entered into any guarantees or<br />

similar obligations that would increase the risk over and above the carrying amounts.<br />

Trade receivables. The Group is subject to a cluster risk on trade receivables, deriving from the fact that the number<br />

of counterparties within trade receivables is strictly related with the number of projects out-licensed. At 31<br />

December 2008, trade receivables with Biogen Idec, Inc. (a NASDAQ listed company) was equivalent to CHF 65’000,<br />

representing 100% of the Group trade receivable (31 December 2007: CHF 2’304’600, representing 88%). The<br />

objective of the management is to sustain the growth of the Group by increasing the number of licensing out<br />

agreements whilst maintaining credit risks at acceptable levels. For this purpose, only technically qualified and<br />

financially strong counterparties are selected in the licensing out process. The progressive increase of the outlicensed<br />

projects and number of counterparties will reduce the cluster risk on trade receivables.<br />

Cash and cash equivalents. Cash and cash equivalents are held only with important, credit-worthy financial<br />

institutions, mainly with rating AA+ (Standard & Poor’s).<br />

Liquidity risk<br />

Liquidity risk is the risk that the Group will not be able to meet its financial obligations as they fall due. A shortage in<br />

liquidity may occur at any particular point in time due to adverse developments in the operational environment and<br />

in the financial markets. The Group’s approach to liquidity risk is to maintain sufficient readily available reserves in<br />

order to meet its liquidity requirements at any point in time. Group liquidity is reported on a monthly basis whilst<br />

12 to 24 months forecasts are reported on a quarterly basis. The major liquidity source are represented by the<br />

license and collaboration agreements signed by the Group and by the network of private investors who<br />

systematically come up for major liquidity requirements.<br />

The table below analyses the group’s financial liabilities into relevant maturity groupings based on the remaining<br />

period at the balance sheet to the contractual maturity date. The financial debts presented in the tables below,<br />

referring exclusively to finance lease, are at undiscounted cash flows, whereas the carrying value in the<br />

consolidated balance sheet reflects discounted cash flows.<br />

F - 24


Maturity analysis of financial liabilities at 31 December 2008<br />

between between between between 1 more than<br />

1-3 months 4-6 months 7-12 months and 5 years 5 years<br />

Financial debts 108'734 85'600 75'565 349'451 -<br />

Trade and other payables 715'113 -<br />

-<br />

-<br />

-<br />

Accrued liabilities 369'979 2'416'340 -<br />

-<br />

-<br />

Liabilities of disposal group classified as held-for-sale - 23'134 138'804 1'110'432 2'532'029<br />

Total financial liabilities 1'193'826 2'525'074 214'369 1'459'883 2'532'029<br />

Maturity analysis of financial liabilities at 31 December 2007<br />

between between between between 1 more than<br />

1-3 months 4-6 months 7-12 months and 5 years 5 years<br />

Financial debts 106'441 106'441 212'882 1'493'275 2'804'117<br />

Trade and other payables 1'248'607 -<br />

-<br />

-<br />

-<br />

Accrued liabilities 400'204 2'208'571 -<br />

-<br />

-<br />

Total financial liabilities 1'755'252 2'315'012 212'882 1'493'275 2'804'117<br />

Interest rate risk<br />

Interest rate risk arises from movements in interest rates which could affect the Group’s financial result or the value<br />

of Group equity. Changes in interest rates may cause variations in interest income and expense. In addition, they<br />

may affect the market value of certain financial assets, liabilities and hedging instruments. With the exception of<br />

short term cash deposits and finance leases, the Group has no other interest-bearing assets or liabilities.<br />

Currency risk<br />

The Group operates in foreign countries and is exposed to movements in foreign currencies affecting the Group<br />

financial result and the value of Group’s equity. Foreign exchange risk arises because the amount of local currency<br />

paid or received for transactions denominated in foreign currencies may vary due to changes in exchange rates<br />

(‘transaction exposures’) and because the foreign currency denominated financial statements of the Group’s foreign<br />

subsidiaries may vary upon consolidation into the Swiss franc denominated Group Financial Statements (‘translation<br />

exposures’). The Group monitors its currency exposure with the objective to better preserve the economic value of<br />

its current and future assets and to minimize the volatility of the Group’s financial result. The focus of the Group’s<br />

foreign exchange risk management activities is on hedging receivables exposures and monetary positions held in<br />

foreign currencies.<br />

A 10% change in exchange rates CHF/EUR and a 10% in CHF/USD at 31 December 2008 would have increased or<br />

decreased net income by the amounts of respectively CHF 120’090 and CHF 61’174. A 10% change in exchange rates<br />

CHF/EUR and a 10% in CHF/USD at 31 December 2007 would have increased or decreased net income by the<br />

amounts of respectively CHF 15’040 and CHF 114’772. Assumption underlying this analysis is that all other variables,<br />

in particular interest rates, remain unchanged. Substantially larger effects on the income statement can be caused<br />

by exchange rate changes related to business transactions during the year, which do not lie in the scope of<br />

application of IFRS 7.<br />

A 10% change in the exchange rate CHF/EUR related to equity invested as per 31 December 2008 would have<br />

increased or decreased the Group's equity by CHF 7’456. A 10% change in the exchange rate CHF/EUR related to<br />

equity invested as per 31 December 2007 would have increased or decreased the Group's equity by CHF 8’280.<br />

5 Capital risk management<br />

The Group’s objectives when managing capital (defined as “equity attributable to mondoBIOTECH’s shareholders”)<br />

are to safeguard the group’s ability to continue as a going concern in order to provide returns for shareholders and<br />

benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital. In order to<br />

maintain or adjust the capital structure, the group may issue new shares or sell assets to reduce debts.<br />

mondoBIOTECH does not have to comply with loan covenants or regulatory capital adequacy requirements as<br />

known in other industries.<br />

6 Operating and geographic segment information<br />

The Group has two operating segments: ‘Projects’ and ‘Development Services’. The operating segments were<br />

determined within a matrix oriented organization based on the different operating and strategic approaches<br />

characterizing each operating segment.<br />

The segment ‘Projects’ derives its revenues from the licensing-out at different stages of development projects on<br />

biological therapeutics for the treatment of rare and neglected diseases. Revenues in this operating segment are<br />

F - 25


mainly signing-up fees, milestones and royalty payments received from licensing-out partners. The segment<br />

‘Development Services’ derives its revenues from providing additional clinical development services to partners that<br />

specifically request this services in close connection with a licensing-out agreement.<br />

Results of activities considered incidental to mondoBIOTECH’s main operations as well as unallocated revenues,<br />

expenses and assets are reported separately under the caption ‘Corporate’. Liabilities are not disclosed because<br />

they make no object of the reports provided to the operating decision maker.<br />

The segment information for the year ended 31 December 2008 is as follows:<br />

Year ended 31 December 2008<br />

Development<br />

Projects Services Corporate Total<br />

Revenues from external customers (note 20) 316'200 14'229'000 - 14'545'200<br />

Inter-segment reveneus 261'970 - 631'624 893'594<br />

Segmental revenues 578'170 14'229'000 631'624 15'438'794<br />

Research & development costs (8'445'172) (11'816'538) (169'047) (20'430'757)<br />

Sales & marketing costs (2'276'731) - (78'022) (2'354'753)<br />

Management & administration costs (899'813) (532'661) (389'928) (1'822'402)<br />

Segmental operating result (11'043'546) 1'879'801 (5'373) (9'169'118)<br />

Included in segmental operating result are:<br />

- depreciation and amortization (3'402'133) (206'341) (35'853) (3'644'327)<br />

Total segment assets 57'737'230 3'628'421 25'566'201 86'931'852<br />

The segment information for the year ended 31 December 2007 is as follow:<br />

Year ended 31 December 2007<br />

Development<br />

Projects Services Corporate Total<br />

Revenues from external customers (note 20) 7'826'225 6'616'672 384'287 14'827'184<br />

Inter-segment reveneus 134'240 - 622'402 756'642<br />

Segmental revenues 7'960'465 6'616'672 1'006'689 15'583'826<br />

Research & development costs (5'623'878) (5'667'302) - (11'291'180)<br />

Sales & marketing costs (3'736'958) - (24'677) (3'761'635)<br />

Management & administration costs (1'035'693) (400'757) (828'897) (2'265'347)<br />

Segmental operating result (2'436'064) 548'613 153'115 (1'734'336)<br />

Included in segmental operating result are:<br />

- depreciation and amortization (3'181'405) (173'932) (26'075) (3'381'412)<br />

Total segment assets 63'848'777 5'887'367 19'146'287 88'882'431<br />

Reportable segments’ assets are reconciled to total assets as follow:<br />

2008 2007<br />

Segment assets for reportable segments 86'931'852 88'882'431<br />

Investment in subsidiaries (878'888) (808'888)<br />

Loans to subsidiaries (11'307'894) (7'150'933)<br />

Trade and other receivables against subsidiaries (2'018'247) (1'792'562)<br />

Unallocated:<br />

Assets of disposal group classified as held-for-sale 3'934'686 -<br />

Total assets per the balance sheet 76'661'509 79'130'048<br />

Revenues from external customers located in Switzerland are CHF 14’545’200 (2007: 14’637’897) and in foreign<br />

countries CHF 0 (2007: CHF 189’287). Revenues from external customers were allocated to geographical areas<br />

according to the location in which the revenue was originated. The total non-current assets other than financial<br />

instruments (there are no deferred tax assets, post-employment benefit assets and rights arising under insurance<br />

contracts) located in Switzerland is CHF 1’524’998 (2007: CHF 5’086’939), and the total non-current assets located<br />

in foreign countries is CHF 53’563’499 (2007: 56’628’067). All revenues arise from a licensing and collaboration<br />

agreement with Biogen Idec, Inc. Non-current assets in foreign countries in 2008 and 2007 refers principally to<br />

certain intellectual properties acquired by the Group in 2006 which are in the process of being registered and that<br />

claim, among others, the administration of peptides based medicaments by inhalation devices. The details about<br />

such intellectual properties are disclosed in note 8.<br />

F - 26


7 Property, plant and equipment<br />

Year ended 31 December 2007:<br />

Opening net book amount -<br />

Additions -<br />

Depreciation charges -<br />

Currency translation effects -<br />

Closing net book amount -<br />

Buildings under Leasehold Vehicles &<br />

construction improvements aircraft Hardware Other Total<br />

148'685 210'233 166'497 375'164 900'579<br />

23'298 4'320'789 208'502 69'025 4'621'614<br />

(37'945) (88'658) (115'904) (124'683) (367'190)<br />

-<br />

-<br />

-<br />

2'567 2'567<br />

134'038 4'442'364 259'095 322'073 5'157'570<br />

Cost value - 228'415 4'606'193 423'945 692'285 5'950'838<br />

Accumulated depreciation - (94'377) (163'829) (164'850) (370'212) (793'268)<br />

Net book amount 134'038 4'442'364 259'095 322'073 5'157'570<br />

Year ended 31 December 2008:<br />

Opening net book amount - 134'038 4'442'364 259'095 322'073 5'157'570<br />

Additions 343'343 101'193 355'520 95'031 67'393 962'480<br />

Disposals -<br />

- (4'884) -<br />

- (4'884)<br />

Depreciation charges - (65'362) (301'571) (139'223) (115'796) (621'952)<br />

Currency translation effects -<br />

-<br />

-<br />

- (5'092) (5'092)<br />

To disposal group classified as held-for-sale (note 13) -<br />

- (3'934'686) -<br />

- (3'934'686)<br />

Closing net book amount 343'343 169'869 556'743 214'903 268'578 1'553'436<br />

Cost value 343'343 314'225 819'879 518'977 747'989 2'744'413<br />

Accumulated depreciation - (144'356) (263'135) (304'074) (479'411) (1'190'976)<br />

Net book amount 343'343 169'869 556'744 214'903 268'578 1'553'437<br />

Property, plant and equipment transferred to disposal group classified as held-for-sale (CHF 3’934’696) relates to an<br />

aircraft expected to be sold in 2009. See note 13 for further details regarding the disposal group held-for-sale.<br />

The position “Buildings under construction” relates to the renovation of an antique monastery in Stans, where the<br />

Group locates its headquarter. The renovation is expected to be terminated within 2011.<br />

Depreciation expense of CHF 401’751 (2007: CHF 243’772) is included in “Research & Development”, CHF 175’619<br />

(2007: CHF 88’563) is included in “Sales & Marketing” and CHF 44’582 (2007: CHF 34’855) is included in<br />

“Management & Administration”. The classes of assets “Vehicles and aircraft” and “Other” includes items under<br />

financial lease for a net carrying value of CHF 421’896 (2007: CHF 4’599’830).<br />

The minimum lease payments within the next years are as follows:<br />

2008 2007<br />

Within one year 269'898 425'764<br />

Between one and five years 349'451 1'493'275<br />

More than five years - 2'804'117<br />

619'349 4'723'156<br />

Future finance charges on financial leases (103'402) (950'125)<br />

Present value of finance lease liabilities 515'947 3'773'031<br />

The present value of the future lease payments within the next years is as follow:<br />

2008 2007<br />

Within one year 186'695 414'264<br />

Between one and five years 329'252 1'301'506<br />

More than five years - 2'057'261<br />

Total 515'947 3'773'031<br />

Lease liabilities are effectively secured as the rights to the leased asset revert to the lessor in the event of default.<br />

F - 27


8 Intangible assets<br />

Patents Total<br />

Year ended 31 December 2007:<br />

Opening net book amount 59'571'657 59'571'657<br />

Amortisation charges (3'014'222) (3'014'222)<br />

Closing net book amount 56'557'435 56'557'435<br />

Cost value 59'778'853 59'778'853<br />

Accumulated amortisation (3'221'418) (3'221'418)<br />

Net book amount 56'557'435 56'557'435<br />

Year ended 31 December 2008:<br />

Opening net book amount 56'557'435 56'557'435<br />

Amortisation charges (3'022'375) (3'022'375)<br />

Closing net book amount 53'535'060 53'535'060<br />

Cost value 59'778'853 59'778'853<br />

Accumulated amortisation (6'243'793) (6'243'793)<br />

Net book amount 53'535'060 53'535'060<br />

All amortisation charges are included in “Research & Development”. In 2006, the Group acquired certain intellectual<br />

properties which are in the process of being registered and that claim, among others, the administration of peptides<br />

based medicaments by inhalation devices. The carrying value of such intellectual property at 31 December 2008 is<br />

CHF 53’535’060 (31 December 2007: CHF 56’557’323) and the remaining amortisation period is 17.5 years.<br />

9 Financial instruments by category<br />

Note 2008 2007<br />

Trade and other receivables 10 116'949 2'682'295<br />

Cash and cash equivalents 12 14'085'329 11'009'299<br />

Loans and receivables 14'202'278 13'691'594<br />

Total financial assets 14'202'278 13'691'594<br />

Financial debts (finance lease) 16 515'947 3'773'031<br />

Trade and other payables 18 715'113 1'248'607<br />

Accrued liabilities 19 2'786'319 2'608'775<br />

Liabilities of disposal group classified as held-for-sale 16 3'100'764 -<br />

Total financial liabilities measured at amortized costs 7'118'143 7'630'413<br />

Total financial liabilities 7'118'143 7'630'413<br />

10 Trade and other receivables<br />

2008 2007<br />

Trade receivables 65'000 2'630'090<br />

Less: provision for impairment -<br />

-<br />

Trade receivables - net 65'000 2'630'090<br />

Receivables from related parties (note 29) 51'949 52'205<br />

Total financial instruments (note 9) 116'949 2'682'295<br />

Tax authorities (for value added tax and withholding tax) 403'763 845'331<br />

Prepayments 492'035 2'721'399<br />

Other 176'682 136'682<br />

Total non-financial instruments 1'072'480 3'703'412<br />

Trade and other receivables 1'189'429 6'385'707<br />

Significant concentration of credit risks within trade receivables is described in note 4. All trade receivables arise<br />

from a licensing and collaboration agreement with a selected primary partner and are still not yet due. The Group<br />

does not anticipate any defaults and the provision for impairment of trade receivable didn’t change in 2008 and<br />

2007.<br />

11 Other asset<br />

2008 2007<br />

Supplies used in the development process 517'986 4'950<br />

Other assets 517'986 4'950<br />

The above asset refers to GMP quality vials and other medical instruments to be to be used in clinical development<br />

processes.<br />

F - 28


12 Cash and cash equivalents<br />

2008 2007<br />

Cash at bank and on hand 13'450'278 2'009'990<br />

Short-term deposits 635'051 8'999'309<br />

Cash and cash equivalents (note 9) 14'085'329 11'009'299<br />

13 Assets and liabilities of disposal group classified as held-for-sale<br />

The disposal group is composed by an aircraft and by the associated financial lease. Both are expected to be<br />

disposed in the first half of 2009. The Group has already signed an agreement for the purchase of a new aircraft.<br />

The purchase will also be financed through a financial lease. In relation to the operating segment information (note<br />

6), the disposal group is reported in the operating segment ‘Projects’.<br />

14 Share capital<br />

Number Nominal<br />

of shares value<br />

At 1 January 2007 4'801'279 338'364<br />

Business combination by reverse acquisition 7'198'721 261'636<br />

Acquisition of minority interests 853'325 42'666<br />

Year ended 31 December 2007 12'853'325 642'666<br />

Share capital increase 224'329 11'217<br />

Year ended 31 December 2008 13'077'654 653'883<br />

Share capital<br />

mondoBIOTECH holding AG (formerly: mondoRPHAN AG) was founded on 20 March 2007 to perform a business<br />

combination between the companies’ mondoBIOTECH AG and mondoGEN AG. The initial share capital of CHF<br />

600’000, composed of 12’000’000 bearer shares with a par value of CHF 0.05 each, was fully subscribed and paid in<br />

through contributions in kind of an equity interest of 80.08% in mondoBIOTECH AG, of an equity interest of 100% in<br />

mondoGEN AG and a contribution in cash of CHF 239’957. This business combination has been accounted for as a<br />

reverse acquisition performed by mondoBIOTECH AG. These consolidated IFRS financial statements are therefore a<br />

continuation of the consolidated financial statements of mondoBIOTECH AG. However, the equity structure<br />

appearing in those consolidated financial statements reflects the equity structure of mondoBIOTECH holding AG.<br />

The extraordinary shareholders’ meetings of 18 September and 10 December 2007 decided to perform a share<br />

capital increase for an amount of CHF 42’666 exclusively reserved to residual holders of shares of mondoBIOTECH<br />

AG. The capital increase was performed on 28 December 2007 and the shares were fully subscribed and paid in<br />

through contribution in kind of an equity interest of 19.92% in mondoBIOTECH AG.<br />

On 29 October 2008, the share capital was increased by CHF 11’217 by issuing 224’329 bearer shares with a par<br />

value of CHF 0.05 each. The capital increase was performed using the authorized capital at a price of CHF 66.91 per<br />

share. The amount collected, net of transactions costs amounting to CHF 1’159’029, was CHF 13’850’825.<br />

As 31 December 2008, the issued share capital amounts to CHF 653’883, consisting of 13’077’654 fully paid-in<br />

bearer shares with a par value of CHF 0.05 each.<br />

Authorized, unissued nominal capital<br />

At 31 December 2008, the Company has an authorized but not yet issued nominal capital of CHF 288’783, consisting<br />

of 5’775’671 bearer shares with a par value of CHF 0.05 each, that the Board of Directors is authorized to issue at<br />

any time by 5 March 2009.<br />

Conditional share capital<br />

The conditional share capital of mondoBIOTECH holding AG as at 31 December 2008, was CHF 300’000, consisting of<br />

6’000’000 bearer shares with a par value of CHF 0.05 each, of which CHF 82’079 to be used for a Share Option Plan<br />

for employees and consultants and CHF 217’921 to be used for the exercise of conversion option rights granted in<br />

connection with bonds, notes or similar debt instruments issued by the Group. To date, there is no share option<br />

plan in place for employees and consultants.<br />

F - 29


15 Reserves<br />

Share Currency<br />

premium translation Total<br />

At 1 January 2007 81'030'363 1'545 81'031'908<br />

Business combination by reverse acquisition (16'141'126) (308) (16'141'434)<br />

Acquisition of minority interests 12'767'996 - 12'767'996<br />

Currency translation differences -<br />

1'981 1'981<br />

Year ended 31 December 2007 77'657'233 3'218 77'660'451<br />

Share capital increase 13'839'605 - 13'839'605<br />

Currency translation differences - (9'672) (9'672)<br />

Year ended 31 December 2008 91'496'838 (6'454) 91'490'384<br />

16 Financial debts<br />

2008 2007<br />

Finance lease:<br />

- third parties 416'377 3'634'450<br />

- related parties (note 29) 99'570 138'581<br />

Liabilities of disposal group classified as held-for-sale (note 13) 3'100'764 -<br />

Total financial instruments (note 9) 3'616'711 3'773'031<br />

Reported as:<br />

- long-term financial debts 329'252 3'530'382<br />

- short-term financial debts 186'695 242'649<br />

- liabilities of disposal group classified as held-for-sale 3'100'764 -<br />

Total financial debts 3'616'711 3'773'031<br />

Financial debts refer exclusively to finance leasing agreements in place for financing property, plant and equipments<br />

(see note 7). The duration of the agreements is between 2 and 4 years, at the end of which the Group has a<br />

purchase option. Early termination is possible. The interest rates implicit in the lease agreements are between<br />

4.65% and 8.00%. Liabilities of disposal group held-for-sale refer to the finance lease associated to the aircraft as<br />

disclosed in note 13.<br />

17 Pension obligations<br />

The Group maintains retirement plans where expressly required by the applicable pension legislation. This refers<br />

exclusively to the Swiss subsidiaries. Such plans are considered as defined benefit plans in accordance with IAS 19.<br />

The Company and its employees pay retirement contributions, which are defined as a percentage of the employees’<br />

covered salaries, to a collective pension fund operated by an insurance company. Interest is credited to the<br />

employees’ accounts at the minimum rate provided in the plan, payment of which is guaranteed by the insurance<br />

contract. Additionally, the plans provide benefits on the death or long-term disability of the insured. For accounting<br />

purposes this insurance contract represents the sole asset of the plan. Fair value of plan asset is the estimated cash<br />

surrender at the respective balance sheet date.<br />

The amounts recognized in the balance sheet are determined as follows:<br />

Change in the benefit obligation<br />

2008 2007<br />

Present value of obligations, beginning of period 465'457 341'123<br />

Current service cost 63'675 48'098<br />

Interest cost 33'106 14'137<br />

Employee contributions 85'806 60'577<br />

Benefits paid 878'567 (5'689)<br />

Actuarial (gain) loss on obligations (34'126) 7'211<br />

At end of the period 1'492'485 465'457<br />

Change in the plan assets<br />

2008 2007<br />

Fair value of assets, beginning of period 385'596 291'570<br />

Expected returns on plan assets 17'282 11'098<br />

Employee contributions 85'806 60'577<br />

Employer contributions 85'806 60'582<br />

Benefits paid 878'567 (5'689)<br />

Actuarial gain (loss) on assets 4'521 (32'542)<br />

At end of the period 1'457'578 385'596<br />

The pension asset of the Group is a claim from the insurance company.<br />

F - 30


Funding status<br />

2008 2007<br />

Present value of obligations 1'492'485 465'457<br />

Fair value of assets (1'457'578) (385'596)<br />

34'907 79'861<br />

Unrecognized actuarial losses (33'642) (74'708)<br />

Pension obligation recognized in the balance sheet 1'265 5'153<br />

Movement in the liability recognized in the balance sheet<br />

2008 2007<br />

Pension obligation at beginning of period 5'153 14'519<br />

Company's net periodic pension cost 81'918 51'216<br />

Employers contributions (85'806) (60'582)<br />

At end of the period 1'265 5'153<br />

Net periodic costs recognized in the income statement<br />

2008 2007<br />

Current service cost 63'675 48'098<br />

Interest cost 33'106 14'137<br />

Expected return on plan assets (17'282) (11'098)<br />

Recognition of actuarial losses 2'419 79<br />

Total, included in staff costs (note 19) 81'918 51'216<br />

The actual return on plan assets was CHF 20’669 (2007: CHF -80’663).<br />

Overview and experience adjustments<br />

2008 2007 2006 2005 2004<br />

Defined benefit obligations 1'492'485 465'457 341'123 262'896 211'605<br />

Plan assets (1'457'578) (385'596) (291'570) (206'868) (162'334)<br />

Deficit (Surplus) 34'907 79'861 49'553 56'028 49'271<br />

Actuarial adjustments on plan obligations 34'126 (7'211) (10'942) 2'297 (13'979)<br />

Difference between actual and expected return on plan assts (17'282) (91'761) 9'937 (10'942) (7'374)<br />

Principal actuarial assumptions used<br />

2008 2007<br />

Discount rate 3.00% 3.50%<br />

Expected return on plan assets 2.50% 3.00%<br />

Future salary increases 1.00% 1.00%<br />

Future pension increases 0.00% 0.00%<br />

Assumptions regarding mortality take into account historic patterns and expected changes, such as further<br />

increases in longevity. The Group operates defined benefit plans only in Switzerland, for which the adjusted<br />

mortality tables EVK2000 were used, for which the average life-expectance for a 65-year-old male and female is<br />

17.6 years and 20.4 years respectively.<br />

Expected contributions for 2008<br />

Expected contributions to post-employment benefit plans for the year ending 31 December 2009 are CHF 90’000.<br />

18 Trade and other payables<br />

2008 2007<br />

Trade payables 217'083 940'421<br />

Social security and other employment related payables 58'753 145'075<br />

Tax authorities (for value added tax and deduction at source) 63'771 154'062<br />

Advance payments received - 6'289'000<br />

Other 1'735 22'330<br />

Trade and other payables to related parties (note 29) 439'277 163'111<br />

Trade and other payables 780'619 7'713'999<br />

F - 31


19 Accrued liabilities and deferred income<br />

2008 2007<br />

Accrued liabilities for services 2'306'928 2'183'318<br />

Accrued liabilities for legal and audit services 84'167 78'458<br />

Interests on convertible loans before early conversion 167'191 167'191<br />

Accruals for other taxes 102'200 92'700<br />

Accrued liabilities for services from related parties (note 29) 228'033 179'808<br />

Accrued liabilities and deferred income 2'888'519 2'701'475<br />

20 Revenues<br />

2008 2007<br />

Royalty income - 674'850<br />

Revenues from upfront and milestones payments - 7'151'375<br />

Revenues from clinical development services 14'545'200 7'000'959<br />

Revenues 14'545'200 14'827'184<br />

21 Expenses by nature<br />

2008 2007<br />

Depreciation and amortisation (note 6, 7 and 8) (3'644'325) (3'381'412)<br />

Employee benefit expenses (note 22) (2'423'739) (1'993'598)<br />

Clinical development services (12'671'047) (5'543'372)<br />

Marketing services, sponsoring (1'280'220) (2'788'334)<br />

Consulting, financial and other management services (652'682) (869'962)<br />

Rent and other occupancy costs (1'005'495) (897'616)<br />

Travel and business entertainment (1'656'493) (487'795)<br />

Information tecnology (380'317) (479'415)<br />

Other - (120'016)<br />

Total research & development, sales & marketing, general & administration (23'714'318) (16'561'520)<br />

22 Employee benefit expenses<br />

2008 2007<br />

Wages and salaries (2'166'773) (1'770'780)<br />

Social security costs (175'048) (171'602)<br />

Pension costs - defined benefit plans (note 17) (81'918) (51'216)<br />

Total employee benefit expenses (Note 21) (2'423'739) (1'993'598)<br />

23 Finance income<br />

2008 2007<br />

Interest income 90'813 380'565<br />

Foreign exchange gains 457'383 242'853<br />

Finance income 548'196 623'418<br />

24 Finance costs<br />

2008 2007<br />

Interest expense:<br />

- finance lease (175'579) (24'121)<br />

- other interests (4'297) (922)<br />

(179'876) (25'043)<br />

Foreign exchange losses (600'037) (629'439)<br />

Finance costs (779'913) (654'482)<br />

Effectively paid:<br />

- finance lease (175'579) (24'121)<br />

- other interests (4'297) (922)<br />

(179'876) (25'043)<br />

F - 32


25 Taxes<br />

Income taxes<br />

Income tax expenses -<br />

Total taxes on income -<br />

2008 2007<br />

234'888<br />

234'888<br />

The weighted average applicable tax rate of the Group is 7.1% (2007: 18.8%) and was determined using the<br />

domestic tax rates applicable to results in the countries concerned. The reduction is due to the provenance of<br />

higher quotes of result from countries with lower tax rates.<br />

2008 2007<br />

Loss of the period (9'400'835) (1'765'400)<br />

Tax at the domestic rates applicable in the country concerned 493'801 328'595<br />

Income not subject to tax - 240'515<br />

Utilization of previously unrecognized tax losses 137'558 77'658<br />

Tax losses for which no deferred income tax asset was recognized (631'359) (881'656)<br />

Total tax expenses charged to income statement - (234'888)<br />

Income tax liability<br />

2008 2007<br />

At 1 January 440'222 200'005<br />

Income statement charge - 234'888<br />

Echange differences (2'310) 5'329<br />

Year ended 31 December 437'912 440'222<br />

Deferred taxes<br />

In accordance with IAS 12, the Company did not capitalize any deferred tax asset relating to tax loss carry-forwards<br />

and temporary differences since the criteria for recognition (i.e. the probability of future taxable profits) are not<br />

met. The gross value of unused tax losses which have not been capitalized as deferred tax asset will expire as<br />

follows:<br />

2008 2007<br />

Within one year (8'969) -<br />

Later than one year and not later than five years (16'952'058) (10'862'133)<br />

More than five years (5'630'855) (11'930'815)<br />

Total (22'591'882) (22'792'948)<br />

Deferred tax assets and liabilities on temporary differences that have not been recognized are as follows:<br />

2008 2007<br />

Deferred tax assets by types of temporary difference:<br />

Intangible assets 66'417 41'906<br />

Pension obligations 1'661 3'587<br />

Total deferred tax assets 68'078 45'493<br />

Deferred tax liabilities by types of temporary difference:<br />

Property, plant and equipment 43 130<br />

Total deferred tax liability 43 130<br />

No deferred tax liability was recognized due to the ability of the Group to offset by recognizing deferred tax assets<br />

for an equivalent amount in the period when temporary differences would reverse.<br />

26 Earnings per share<br />

Basic and diluted losses per share are calculated by dividing the net loss attributable to the shareholders by the<br />

weighted average shares outstanding during the period.<br />

2008 2007<br />

Net loss attributable to equity holders of the Company (9'400'835) (1'605'210)<br />

Weighted average number of shares outstanding 12'892'045 10'429'212<br />

Basic and diluted loss per share (0.729) (0.154)<br />

F - 33


27 Cash generated from operations<br />

Year ended 31 December<br />

Note 2008 2007<br />

Result of the period (9'400'835) (2'000'288)<br />

Adjustments for:<br />

- Depreciation 7 621'952 367'190<br />

- Amortisation 8 3'022'375 3'014'222<br />

- Changes in pension obligations (3'888) (9'366)<br />

- loss from disposal of property, plant and equipment 4'884 -<br />

- Income tax expenses 24 - 234'888<br />

- Finance income 22 (90'813) (380'565)<br />

- Finance costs 23 179'876 25'043<br />

Changes in working capital:<br />

- Trade and other receivables 5'192'552 (5'455'047)<br />

- Other assets (513'036) 27'210<br />

- Accrued income and prepaid expenses (1'830'496) 566'282<br />

- Trade and other payables (6'924'898) 5'455'029<br />

- Accrued liabilities and deferred income 187'688 (5'575'498)<br />

Cash generated from operations (9'554'639) (3'730'900)<br />

28 Commitments and contingencies<br />

The Group contracted for future planned capital expenditures of CHF 4’107’197. The future aggregate minimum<br />

rent payments for office space under non-cancellable rent agreements is as follows:<br />

2008 2007<br />

Within one year 632'400 682'800<br />

Later than one and not later than five years 2'529'600 2'674'800<br />

Lather than five years 720'000 1'352'400<br />

Total 3'882'000 4'710'000<br />

At balance sheet date the Group is involved in a legal proceeding regarding the termination of a former employee<br />

contract for which, based on the inconsistency of the counterparty’s arguments, no accruals where considered.<br />

29 Related parties<br />

Senior executive and Board compensation<br />

2008 2007<br />

Compensation of senior executives:<br />

- fees, salaries and other short-term employee benefits 1'249'842 1'416'061<br />

- post-employment benefits 24'825 22'845<br />

Board of directors:<br />

- compensation for serving as board members 134'238 70'440<br />

Total 1'408'905 1'509'346<br />

Purchase of services<br />

2008 2007<br />

From board members:<br />

- financial advisory services - 196'897<br />

- scientific consulting services<br />

From entities related to board members:<br />

28'113 31'481<br />

- financial advisory and consulting services 119'246 21'417<br />

- accounting and administration 280'654 236'578<br />

- commissions on fund rising 975'136 -<br />

- rent and occupancy services 655'200 663'600<br />

- real estate consultancy services 28'520 -<br />

Total 2'086'869 1'149'973<br />

F - 34


Year-end balances arising from purchase of services<br />

2008 2007<br />

Trade and other receivables (note 10) 51'949 52'205<br />

Accrued income and prepaid expenses 13'768 9'002<br />

Total 65'717 61'207<br />

Long-term financial debt (note 16) 57'437 99'569<br />

Trade and other payables (note 18) 439'277 163'111<br />

Short - term financial payables (note 16) 42'133 39'012<br />

Accrued liabilities and deferred income (note 19) 228'033 179'808<br />

Total 766'880 481'500<br />

Year-end balances regarding trade receivables are due within 30 days. None of them are overdue. Long-term and<br />

short-term financial debts refer to a financial leasing agreement with an implicit interest rate of 8% (see notes 7 and<br />

16). Trade and other payables are due within 30 days.<br />

30 Events after the balance sheet date<br />

At the extraordinary general meeting held on 20 February 2009, the shareholders of mondoBIOTECH holding AG<br />

approved the transfer of the Company’s legal domicile from Basel to Stans, Switzerland, and the split of the<br />

company’s shares from previously 13’077’654 bearer shares with a par value of CHF 0.05 each into new 65’388’270<br />

registered shares with a par value of CHF 0.01 each. The shareholders also approved the amendment of the<br />

authorized share capital form previously CHF 288’783, consisting of 5’775’671 bearer shares with a par value of CHF<br />

0.05 each into new CHF 326’941, consisting of 3’269’413 registered shares with a par value of CHF 0.10 each and<br />

the amendment of the conditional share capital from previously CHF 300’000, consisting of 6’000’000 bearer shares<br />

with a par value of CHF 0.05 each, of which CHF 82’079 to be used for a Share Option Plan for employees and<br />

consultants and CHF 217’921 to be used for the exercise of conversion option rights granted in connection with<br />

bonds, notes or similar debt instruments issued by the Group into new CHF 326’941, consisting of 3’269’413<br />

registered shares with a par value of CHF 0.10 each, of which CHF 180’000 to be used for a Share Option Plans for<br />

employees and consultants and CHF 146’941 to be used for the exercise of conversion option rights granted in<br />

connection with bonds, notes or similar debt instruments issued by the Group.<br />

There have been no further material post-balance sheet events which would require disclosure or adjustment to<br />

the 2008 financial statements.<br />

31 Risk assessment disclosures required by Swiss law<br />

The Executive Committee is responsible for continuous risk assessment and risk management. The risk assessment<br />

procedures include the identification of internal and external risks, the assessment of their potential impact on the<br />

Group as well as the definition of organizational and process measures to identify the risk and where appropriate<br />

remediate. The Executive Committee reports to the Board on a regular basis on significant risks and measure taken<br />

by the Group.<br />

Financial risk management is described in more detail in note 4 of this Group’s consolidated financial statements.<br />

***<br />

F - 35


mondoBIOTECH holding AG (former mondoRPHAN AG) – Consolidated financial statements 2007<br />

F - 36


Report of the group auditors<br />

F - 37


Consolidated balance sheet<br />

(in CHF)<br />

ASSETS<br />

Note<br />

As at 31 December<br />

2007 2006<br />

Property, plant and equipment 7 5'157'571 900'579<br />

Intangible assets 8 56'557'435 59'571'657<br />

Non current assets 61'715'006 60'472'236<br />

Trade and other receivables 10 6'385'707 916'373<br />

Other assets 11 4'950 32'160<br />

Accrued income and prepaid expenses 15'086 36'773<br />

Cash and cash equivalents 12 11'009'299 15'306'187<br />

Current assets 17'415'042 16'291'493<br />

Total assets 79'130'048 76'763'729<br />

EQUITY AND LIABILITIES<br />

Share capital 13 642'666 338'364<br />

Reserves 14 77'660'450 81'031'908<br />

Accumulated loss (13'806'948) (15'236'333)<br />

Equity attributable to mondoRPHAN's shareholders 64'496'168 66'133'939<br />

Minority interest -<br />

-<br />

Total shareholders' equity 64'496'168 66'133'939<br />

Long-term financial debt 15 3'530'382 305'706<br />

Pension obligations 16 5'153 14'519<br />

Non current liabilities 3'535'535 320'225<br />

Trade and other payable 17 7'713'999 2'201'820<br />

Short - term financial payables 15 242'649 86'912<br />

Income tax liabilies 24 440'222 200'005<br />

Accrued liabilities and deferred income 18 2'701'475 7'820'828<br />

Current liabilities 11'098'345 10'309'565<br />

Total equity and liabilities 79'130'048 76'763'729<br />

The notes to the financial statements are an integral part of these financial statements.<br />

F - 38


Consolidated income statement<br />

(in CHF)<br />

Year ended 31 December<br />

Note 2007 2006<br />

Revenues 19 14'827'184 2'480'161<br />

Research & development 20 (11'291'181) (4'823'805)<br />

Sales & marketing 20 (3'761'635) (2'045'781)<br />

Management & administration 20 (1'508'704) (1'754'063)<br />

Operating result (1'734'336) (6'143'488)<br />

Finance income 22 623'418 176'784<br />

Finance costs 23 (654'482) (1'045'427)<br />

Result before income taxes (1'765'400) (7'012'131)<br />

Income taxes 24 (234'888) (200'005)<br />

Result of the period (2'000'288) (7'212'136)<br />

Attributable to:<br />

Equity holders of the Company (1'605'210) (7'224'761)<br />

Minority interest (395'078) 12'625<br />

(2'000'288) (7'212'136)<br />

Basic and diluted loss per share 25 (0.154) (2.021)<br />

The notes to the financial statements are an integral part of these financial statements.<br />

F - 39


Consolidated cash flow statement<br />

(in CHF)<br />

Year ended 31 December<br />

Note 2007 2006<br />

Cash generated from operations 27 (3'730'900) 2'251'690<br />

Income taxes paid -<br />

-<br />

Cash flow from operating activities (3'730'900) 2'251'690<br />

Purchase of property, plant and equipment 7 (300'825) (474'602)<br />

Acquisition of subsidiaries - (7'061)<br />

Business combination by reverse acquisition 26 308'528 -<br />

Interest received 22 380'565 57'007<br />

Cash flow from investing activities 388'268 (424'656)<br />

Proceeds from issuance of convertible bonds, net of issuance costs - 13'858'836<br />

Increase in short-term borrowings - 250'000<br />

Repayment of financial payables and borrowings (940'376) (1'067'566)<br />

Interest paid 23 (25'043) (24'266)<br />

Cash flow from financing activities (965'419) 13'017'004<br />

Net effect of currency translation on cash and cash equivalents 11'163 19'030<br />

Increase (decrease) in cash and cash equivalents (4'296'888) 14'863'068<br />

Cash and cash equivalents at beginning of period 15'306'187 443'119<br />

Cash and cash equivalents at end of period 11'009'299 15'306'187<br />

The notes to the financial statements are an integral part of these financial statements.<br />

F - 40


Consolidated statement of changes in equity<br />

(in CHF)<br />

Share<br />

Attributable to equity<br />

holders on the Company<br />

Retained<br />

Note capital Reserves earnings<br />

Minority Total<br />

interest equity<br />

Balance at 1 January 2006 239'919 6'681'755 (8'011'572) 26'671 (1'063'227)<br />

Currency translation differences - 1'331 -<br />

- 1'331<br />

Net income recognized directly in equity - 1'331 -<br />

- 1'331<br />

Result of the period - - (7'224'761) 12'625 (7'212'136)<br />

Total recognized result for the period - 1'331 (7'224'761) 12'625 (7'210'805)<br />

Capital increase, net of issuance costs 19'591 14'656'056 -<br />

Acquisition of minority interests -<br />

-<br />

-<br />

Acquisition, net of transaction costs 78'854 59'692'766 -<br />

98'445 74'348'822 -<br />

Balance at 31 December 2006 338'364 81'031'908 (15'236'333) -<br />

- 14'675'647<br />

(39'296) (39'296)<br />

- 59'771'620<br />

(39'296) 74'407'971<br />

66'133'939<br />

Balance at 1 January 2007 338'364 81'031'908 (15'236'333) - 66'133'939<br />

Currency translation differences 14 - 1'981 -<br />

493 2'474<br />

Net income recognized directly in equity - 1'981 -<br />

493 2'474<br />

Result of the period - - (1'605'210) (395'078) (2'000'288)<br />

Total recognized result for the period - 1'981 (1'605'210) (394'585) (1'997'814)<br />

Business combination by reverse acquisition 13;14;26 261'636 (16'141'434) 3'034'594 13'205'247 360'043<br />

Acquisition of minority interests 13;14;26 42'666 12'767'996 - (12'810'662) -<br />

304'302 (3'373'438) 3'034'594 394'585 360'043<br />

Balance at 31 December 2007 642'666 77'660'451 (13'806'949) -<br />

The notes to the financial statements are an integral part of these financial statements.<br />

64'496'168<br />

F - 41


Notes to the consolidated financial statements<br />

1 General information<br />

Introduction<br />

mondoRPHAN AG (the “Company”) is a limited company incorporated under the Swiss law. The domicile and<br />

registered office is at Hardstrasse 52, CH-4052 Basel, Switzerland.<br />

The principal activities of the Company and its subsidiaries (together the “Group”) are focused on the search and<br />

development of biological therapeutics for the treatment of life-threatening and rare diseases that may qualify for<br />

Orphan Drug Designation status (the “Business”). The subsidiaries of mondoRPHAN AG are listed in Note 30. The<br />

Group operates under the trade name ‘mondoBIOTECH’.<br />

These Group consolidated financial statements were authorized for issue by the Board of Directors on 4 April 2008<br />

and are subject to approval by the Annual General Meeting of shareholders.<br />

Development of the Group<br />

mondoRPHAN AG was established on 20 March 2007 to perform the business combination between<br />

mondoBIOTECH AG and mondoGEN AG, ultimately controlled by the same group of shareholders.<br />

The business combination between mondoRPHAN AG, mondoBIOTECH AG and mondoGEN AG has been accounted<br />

for as a reverse acquisition performed by mondoBIOTECH AG (being mondoGEN AG a newly formed start-up<br />

company with limited history and mondoRPHAN AG an entity formed to issue equity instruments to perform the<br />

business combination). The consolidated IFRS financial statements of the Company are therefore a continuation of<br />

the consolidated financial statements of mondoBIOTECH AG. For details about the business combination, see Note<br />

26.<br />

2 Summary of significant accounting policies<br />

Basis of preparation<br />

The consolidated financial statements of mondoRPHAN AG have been prepared in accordance with International<br />

Financial Reporting Standards (IFRS) and comply with Swiss law. They have been prepared under the historical cost<br />

convention, as modified by the revaluation of financial assets at fair value through profit or loss and available-forsale<br />

financial assets, and are presented in Swiss francs (CHF).<br />

The preparation of the consolidated financial statements in conformity with IFRS requires management to make<br />

estimates and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities, and the<br />

disclosure of contingent liabilities at the date of the financial statements. The actual outcome may differ from the<br />

assumptions and estimates made. If in the future such estimates and assumptions, which are based on<br />

management’s best judgment at the date of the financial statements, deviate from the actual circumstances, the<br />

original estimates and assumptions will be modified as appropriate in the year in which the circumstances change.<br />

Uncertainties and ability to continue operations<br />

The Group is in its start up phase and subject to various risks and uncertainties, including but not limited to its<br />

reliance on some lead products in order to achieve future revenues, timing of achieving profitability, its marketing<br />

capacity and the substantial uncertainty of the drug development process, including uncertainty of the outcome of<br />

clinical trials and significant regulatory approval requirements for marketing authorizations.<br />

At 31 December 2007, the Group disposes of CHF 11 million of cash and cash equivalents. The Group has also the<br />

liquidity necessary to finance its actual level of activities at least in the next twelve months. Management is also<br />

confident that it will be able to increase the revenues and raise additional funds through an ordinary capital<br />

increase or through other channels, if necessary to further develop the activities and plans of the Group. For these<br />

reasons, management believes that it is appropriate to prepare these financial statements on a going concern basis.<br />

Consolidation policy<br />

Subsidiaries are all entities over which the Company has the power to govern the financial and operating policies of<br />

an enterprise so as to obtain benefits from its activities. This control is normally evidenced when the Company owns,<br />

either directly or indirectly, more than 50% of the voting rights or potential voting rights. Companies acquired<br />

during the year are consolidated from the date on which control is transferred to the Group, and subsidiaries to be<br />

divested are included up to the date on which control passes from the Group. Inter-company transactions, balances<br />

and unrealized gains on transactions between Group companies are eliminated. Unrealized inter-company losses<br />

F - 42


are also eliminated unless the transaction provides evidence of an impairment of the asset transferred. The<br />

accounting policies of subsidiaries are consistent with the policies adopted by the Group.<br />

The purchase method of accounting is used to account for the acquisition of subsidiaries by the Group. The cost of<br />

an acquisition is measured as the fair value of the assets given, equity instruments issued and liabilities incurred or<br />

assumed at the date of exchange, plus costs directly attributable to the acquisition. Identifiable assets acquired and<br />

contingent liabilities assumed in a business combination are measured initially at their fair values at the acquisition<br />

date, irrespective of the extent of any minority interest. The excess of the cost of acquisition over the fair value of<br />

the Group’s share of the identifiable net assets is recorded as goodwill. If the cost of acquisition is less than the fair<br />

value of the net assets of the subsidiary acquired, the difference is recognized directly in the income statement.<br />

Business combinations involving entities under common control are accounted for using the values of the acquired<br />

assets and liabilities according to the financial statements of the acquired entity, prepared in conformity with IFRS.<br />

Comparatives are not restated.<br />

Foreign currency translation<br />

Items included in the financial statements of each of the Group’s entities are measured using the currency of the<br />

primary economic environment in which the entity operates (“the functional currency”). The consolidated financial<br />

statements are presented in Swiss francs, which is the functional and presentation currency of the Company.<br />

Foreign currency transactions are translated into the functional currency using the exchange rate prevailing at the<br />

dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and<br />

from the translation of monetary assets and liabilities denominated in other currencies are recognized in the<br />

income statement, except when deferred in equity as qualifying cash flow hedges and qualifying net investment<br />

hedges.<br />

Upon consolidation, assets and liabilities of Group companies using measurement currencies other than Swiss<br />

francs (foreign entities) are translated into Swiss francs using year-end rates of exchange. Sales, costs, expenses, net<br />

income and cash flows are translated at the average rates of exchange for the year (unless the average is not a<br />

reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case<br />

they are translated at the dates of the transactions). Translation differences due to the changes in exchange rates<br />

between the beginning and the end of the year and the difference between net income translated at the average<br />

and year-end exchange rate are taken directly to equity. On the divestment of a foreign entity, the identified<br />

cumulative currency translation difference relating to that foreign entity is recognized in income as part of the gain<br />

or loss on divestment.<br />

Goodwill and fair value adjustments arising on the acquisition of a foreign entity are treated as assets and liabilities<br />

of the foreign entity and translated at the closing rate.<br />

Property, plant and equipment<br />

Property, plant and equipment is stated at historical cost less depreciation. Historical costs include expenditures<br />

that are directly attributable to the acquisition of the items. Costs may also include transfers from equity of any<br />

gains/losses on qualifying cash flow hedges of foreign currency purchases of property, plant and equipment.<br />

Subsequent costs are included in the assets’ carrying amount or recognized as a separate asset, as appropriate, only<br />

when it is probable that future economic benefits associated with the item will flow to the Group and the cost of<br />

the item can be measured reliably. All other repairs and maintenance are charged to the income statement during<br />

the financial period in which they are incurred. Gains and losses on disposals are determined by comparing<br />

proceeds with carrying amount and are included in the income statement.<br />

Depreciation of property, plant and equipment is calculated using the straight-line method to allocate costs to<br />

residual values over each asset’s estimated useful lives as follows:<br />

Leasehold improvements 5 years<br />

Plant and equipment 5 years<br />

Motor vehicles 4 years<br />

Aircraft 25 years<br />

Hardware and standard software 3 years<br />

Other (office equipment) 3 - 5 years<br />

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.<br />

Where the carrying amount of an asset is greater than its estimated recoverable amount, it is written down<br />

immediately to its recoverable amount.<br />

F - 43


Leases<br />

Leases of property, plant and equipment where the Group has substantially all of the risks and rewards of<br />

ownership are classified as finance leases. Finance leases are capitalized at the lower of the fair value of the leased<br />

property or the present value of minimum lease payments at the inception of the lease. The rental obligation, net of<br />

finance charges, is included in long-term financial payables. Assets acquired under finance leases are depreciated in<br />

accordance with the Group’s above policy on property, plant and equipment over the shorter of the lease term or<br />

their useful life. The interest element of the lease payment is charged against income over the lease term based on<br />

the interest rate implicit in the lease.<br />

Leases under which substantially all of the risks and rewards of ownership are not transferred to the Group are<br />

classified as operating leases. Payments made under operating leases are charged against income on a straight-line<br />

basis over the period of the lease.<br />

Intangible assets<br />

Intangible assets are initially recorded at cost. Where these assets have been acquired through a business<br />

combination, this will be the fair value allocated in the acquisition accounting. Costs related to intangible assets are<br />

capitalized only when it is probable that future economic benefits will flow to the Group. Otherwise, the costs are<br />

fully expensed in the period in which they occur.<br />

Intangible assets with a finite useful live are amortized over their useful lives on a straight-line basis as follows:<br />

Patents the lower of legal duration or economic useful lives (at present 18.5 years)<br />

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date.<br />

Intangible assets with an indefinite useful life are not amortized, but are tested for impairment annually or more<br />

frequently if an impairment indicator is triggered.<br />

In the case of business combinations, the excess of the purchase price over the fair value of net identifiable assets<br />

acquired is recorded as goodwill in the balance sheet. Goodwill on acquisitions of subsidiaries is included in<br />

intangible assets. Goodwill on acquisitions of associates is included in investments in associates. Goodwill is tested<br />

annually for impairment and carried at cost less accumulated impairment losses. Gains and losses on the disposal of<br />

an entity include the carrying amount of goodwill relating to the entity sold.<br />

Impairment of non-financial assets<br />

Assets that have an indefinite useful life are not subject to amortisation and are tested annually for impairment.<br />

Assets that are subject to amortisation are reviewed for impairment whenever events or changes in circumstances<br />

indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by<br />

which the asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an<br />

asset’s fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at<br />

the lowest levels for which there are separately identifiable cash flows (cash-generating units). Non-financial assets<br />

other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at each<br />

reporting date.<br />

Financial assets<br />

The Group classifies its financial assets in the following categories: ‘at fair value through profit or loss’, ‘loans and<br />

receivables’ and ‘available-for-sale’. The classification depends on the purpose for which the investments were<br />

acquired. Management determines the classification of its investments at initial recognition and re-evaluates this<br />

designation at every reporting date. A financial asset is classified as at fair value through profit or loss if acquired<br />

principally for the purpose of selling in the short term or if so designated by management. Assets in this category<br />

are classified as current assets if they are either held for trading or are expected to be realized within 12 months of<br />

the balance sheet date. Loans and receivables are non-derivative financial assets with fixed or determinable<br />

payments that are not quoted in an active market. They are included in current assets, except for maturities greater<br />

than 12 months after the balance sheet date. These are classified as non-current assets. Available-for-sale financial<br />

assets are non-derivatives that are either designated in this category or not classified in any of the other categories.<br />

They are included in non-current assets unless management intends to dispose of the investment within 12 months<br />

of the balance sheet date.<br />

Financial assets at fair value through profit or loss and available-for-sale financial assets are carried at fair value.<br />

Regular purchases and sales are recognized on settlement date, the date that an asset is delivered to or by an entity.<br />

Investments are initially recognized at fair value plus transaction costs for all financial assets not carried at fair value<br />

through profit or loss. Financial assets carried at fair value through profit or loss are initially recognized at fair value<br />

and transaction costs are expensed in the income statement. Gains or losses arising from changes in the fair value<br />

of the financial assets at fair value through profit and loss are recognized in the income statement in the period in<br />

which they arise. Changes in the fair value of available-for-sale financial assets are recognized in equity, except for<br />

translation differences on monetary securities denominated in a foreign currency, which are recognized in profit or<br />

F - 44


loss. When they are sold or impaired, the accumulated fair value adjustments recognized in equity are included in<br />

the income statement.<br />

The Group assesses at each balance sheet date whether there is objective evidence that a financial asset is impaired.<br />

In the case of equity securities classified as available for sale, a significant or prolonged decline in the fair value of<br />

the security below its cost is considered as an indicator that the securities are impaired. If any such evidence exists<br />

for available-for-sale financial assets, the cumulative loss, measured as the difference between the acquisition cost<br />

and the current fair value, less any impairment loss on that financial asset previously recognised in profit or loss, is<br />

removed from equity and recognised in the income statement. Impairment losses recognised in the income<br />

statement are not reversed through the income statement. Impairment testing of trade receivables is described in<br />

the corresponding note.<br />

Financial assets are derecognised when the contractual rights to the cash flows of the assets expire or when the<br />

Group sells or otherwise disposes of the contractual rights to the cash flows, including situations where the Group<br />

retains the contractual rights but assumes a contractual obligation to pay the cash flows to a third party.<br />

Trade receivables<br />

Trade receivables are recognized initially at fair value and subsequently measured at amortized cost using the<br />

effective interest method, less provision for impairment. A provision for impairment is established when there is<br />

objective evidence that the Group will not be able to collect all amounts due according to the original terms.<br />

Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial<br />

reorganisation, and default or delinquency in payments (more than 30 days overdue) are considered indicators that<br />

the trade receivable is impaired. The amount of the provision is the difference between the asset’s carrying amount<br />

and the present value of estimated future cash flows, discounted at the original interest rate. The carrying amount<br />

of the asset is reduced through the use of an allowance account, and the amount of the loss is recognised in the<br />

income statement within “sales and marketing”. When a trade receivable is uncollectible, it is written off against<br />

the allowance account.<br />

Supplies used in the development process<br />

Supplies used in the development process are stated at cost and classified as ‘other assets’. Cost is determined<br />

using the first-in, first-out method (FIFO). When supplies are used, the associated cost forms part of the research &<br />

development expense.<br />

Cash and cash equivalents<br />

Cash and cash equivalents include cash in hand, deposits held at call with banks and other short-term highly liquid<br />

investments with original maturities of three months or less. Bank overdrafts are shown within financial debts in<br />

current liabilities on the balance sheet.<br />

Financial debts<br />

Financial debts are initially recorded at fair value, net of transaction costs. Financial debts are subsequently stated<br />

at amortized cost using the effective interest rate method. When convertible bonds are issued, the fair value of the<br />

liability portion is determined using a market interest rate for an equivalent non-convertible bond. This amount is<br />

recorded as a liability on an amortized cost basis. The remainder of the proceeds is allocated to the conversion<br />

option. This is recognized and included in shareholders’ equity, net of income tax effects. Financial debts are<br />

normally classified as current liabilities unless the Group has an unconditional right to defer settlement of the<br />

liability for at least 12 months after the balance sheet date.<br />

Provisions<br />

The Group recognizes provisions when it has a present legal or constructive obligation to transfer economic benefits<br />

as a result of past events and a reasonable estimate of the obligation can be made. Provisions are measured at the<br />

present value of the expenditures expected to be required to settle the obligation using a pre-tax rate that reflects<br />

current market assessments of the time value of money and the risks specific to the obligation. The increase in the<br />

provision due to passage of time is recognized as interest expense.<br />

Fair values<br />

Fair value is the amount for which a financial asset, liability or instrument could be exchanged between<br />

knowledgeable and willing parties in an arm’s length transaction. It is determined by reference to quoted market<br />

prices or by the use of established estimation techniques such as estimated discounted values of cash flows. The fair<br />

values of financial assets and liabilities at the balance sheet date are not materially different from their reported<br />

carrying values unless specifically mentioned in the Notes to the Consolidated Financial Statements.<br />

Royalty income<br />

Revenue arising from royalties is recognized on an accrual basis according to the relevant agreements when it is<br />

probable that the economic benefits will flow to the Group and the amount of the revenue can be measured<br />

reliably.<br />

F - 45


Revenues arising from upfront and milestone payments<br />

Recognition of revenues from upfront payments depends on whether a service has to be provided in relation of the<br />

upfront payment. When the Group has to provide services in relation to the upfront payment, revenues are<br />

deferred and recognized by reference to the stage of completion of the activities to be performed. Receipts for<br />

achievement of milestones are generally recognized as revenue when the milestone is achieved.<br />

Revenues arising from clinical development services<br />

Revenues arising from clinical development services are recognized in the accounting period in which the services<br />

are performed.<br />

Research and development<br />

Research and development costs consist primarily of remuneration and other expenses related to research and<br />

development personnel, costs associated with preclinical testing and clinical trials of product candidates (including<br />

the costs of manufacturing the product candidates), expenses for research and development services under<br />

collaboration agreements and outsourced research and development expenses. Furthermore the Group may<br />

acquire in-process research and development assets, either through business combinations or through purchases of<br />

specific assets.<br />

Internal development costs are capitalised as intangible assets only when there is an identifiable asset that can be<br />

completed and that will generate probable future economic benefits and when the cost of such an asset can be<br />

measured reliable. The Group does not currently have any such internal development costs that qualify for<br />

capitalisation as intangible assets. Internal development costs are therefore charged against income as incurred<br />

since the criteria for their capitalisation are not met. In-process research and development assets acquired either<br />

through business combinations or separate purchases are capitalized as intangible assets. Once available for use,<br />

such intangible assets are amortized on a straight-line basis over the period of the expected benefit and are<br />

reviewed for impairment at each balance sheet date.<br />

Deferred income tax<br />

Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax<br />

bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, the<br />

deferred income tax is not accounted for if it arises from initial recognition of an asset or liability in a transaction<br />

other than a business combination that at the time of the transaction affects neither accounting nor taxable profit<br />

or loss. Deferred income tax is determined using tax rates (and lows) that have been enacted or substantively<br />

enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realised<br />

or the deferred income tax liability is settled.<br />

Deferred income tax assets are recognised to the extent that it is probable that future taxable profit will be<br />

available against which the temporary differences can be utilised.<br />

Deferred income tax is provided on temporary differences arising on investments in subsidiaries and associates,<br />

except where the timing of the reversal of the temporary difference is controlled by the Group and it is probable<br />

that the temporary difference will not reverse in the foreseeable future.<br />

Employee benefits<br />

(a) General<br />

Wages, salaries, social security contributions, paid annual leave and sick leave, bonuses, and non-monetary benefits<br />

are accrued in the year in which the associated services are rendered by employees of the Group.<br />

(b) Pension obligations<br />

The Group maintains retirement plans where expressly required by the applicable pension legislation. This refers<br />

exclusively to the Swiss subsidiaries. In general, the plans cover retirement benefits and risks of death and disability<br />

and are based on fixed contributions. As they guarantee a minimum return, they are considered as defined benefit<br />

plans. The plans are financed by contributions of the employer and the employee, the first paying 50% and the<br />

second 50% of the related premiums.<br />

The liability recognized in the balance sheet in respect of defined benefit pension plans is the present value of the<br />

defined benefit obligation at the balance sheet date less the fair value of plan assets, together with adjustments for<br />

unrecognized actuarial gains or losses and past service costs. The defined benefit obligation is calculated<br />

periodically by independent actuaries using the projected unit credit method. The present value of the defined<br />

benefit obligation is determined by discounting the estimated future cash outflows using interest rates of highquality<br />

corporate bonds that are denominated in the currency in which the benefits will be paid, and that have<br />

terms to maturity approximating to the terms of the related pension liability.<br />

F - 46


Actuarial gains and losses arising from experience adjustments and changes in actuarial assumptions in excess of<br />

the greater of 10% of the value of plan assets or 10% of the defined benefit obligation are charged or credited to<br />

income over the employee’s expected average remaining working lives.<br />

(c) Termination benefits<br />

Termination benefits are payable when a member of the management accepts voluntary redundancy in exchange<br />

for these benefits. The Group recognizes termination benefits when it is demonstrably committed to provide<br />

termination benefits as a result of an offer made to encourage voluntary redundancy. No other post-employment<br />

obligations and termination benefits exist within the Group.<br />

(d) Equity compensation plans<br />

The board of directors of the Company will implement a stock option plan for selected employees and consultant of<br />

the group. The Company has not yet finalized the overall terms of the plan and the stock options have not yet been<br />

allocated. The transactions will be measured by reference to the fair value of the equity instruments granted.<br />

Transactions with minority shareholders<br />

The Group applies a policy of treating transactions with minority interests as transactions with equity owners of the<br />

group. For purchases from minority interests, the difference between any consideration paid and the relevant share<br />

acquired of the carrying value of net assets of the subsidiary is deducted from equity. Gains or losses on disposals to<br />

minority interests are also recorded in equity. For disposals to minority interests, differences between any proceeds<br />

received and the relevant share of minority interests are also recorded in equity.<br />

Segment reporting<br />

The Group’s primary format for reporting segment information is by business segment. A business segment is a<br />

group of assets and operations engaged in providing products or services that are subject to risks and returns that<br />

are different from those of other segments.<br />

The Group’s activities are focused on one primary business segment only, the search and development of biological<br />

therapeutics for the treatment of live-threatening and rare diseases that may qualify for Orphan Drug Designation<br />

status. For this reason, the Group only discloses geographic location of assets, capital expenditure and analysis of<br />

operating expenses.<br />

Changes in accounting policies – New standards and interpretations<br />

The following new standards, amendments to standards and interpretations are mandatory for financial year<br />

ending 31 December 2007:<br />

IFRS 7, 'Financial instruments: Disclosures', and the complementary amendment to IAS 1, 'Presentation of<br />

financial statements – Capital disclosures', introduces new and extended disclosures relating to financial<br />

instruments and financial risk management and does not have any impact on the classification and valuation of<br />

the group’s financial instruments.<br />

IFRIC 7, 'Applying the Restatement Approach under IAS 29, Financial Reporting in Hyperinflationary Economies';<br />

IFRIC 8, 'Scope of IFRS 2'; IFRIC 9, 'Re-assessment of embedded derivatives'; IFRIC 10, 'Interim financial<br />

reporting and impairment'. These interpretations are not relevant for the group.<br />

The following new standards, amendments and interpretations have been issued but are not effective for 2007 and<br />

have not been early adopted.<br />

IFRS 8 ‘Operating segments’ (from 1 January 2009): IFRS 8 replaces IAS 14 ‘Segment Reporting’. IFRS 8 requires<br />

entities to define operating segments and segment performance in the financial statements based on<br />

information used by the chief operating decision-maker. This new requirement could have an impact on the<br />

segments presented, the items reported and their respective measurement.<br />

IAS 1 (amended), ‘Presentation of financial statements’ (from 1 January 2009); IAS 23 (amended), 'Borrowing<br />

costs' (from 1 January 2009); IAS 27 (amended) (from 1 July 2009); IFRS 2 (amended) (from 1 January 2009);<br />

IFRS 3 (revised), ‘Business combinations’ (from 1 July 2009).<br />

IFRIC 11, 'IFRS 2 – Group and treasury share transactions' (from 1 March 2007); IFRIC 12, 'Service concession<br />

arrangements' (from 1 January 2008); IFRIC 13, 'Customer loyalty programmes' (from 1 July 2008); IFRIC 14,<br />

'IAS 19 – The limit on a defined benefit asset, minimum funding requirements and their interaction' (from 1<br />

January 2008).<br />

The Group is currently assessing the potential impacts of these new standards and interpretations.<br />

Changes in accounting policies – Voluntary changes<br />

The Group decided to change its accounting policy regarding ‘Transaction with minority shareholders’. The Group<br />

adopted the economic entity approach, which provides reliable and more relevant information about the effect of<br />

such transactions. The new accounting policy was applied retrospectively. No restatement was necessary for 2006.<br />

F - 47


3 Summary of critical accounting estimates and assumptions<br />

The preparation of the consolidated financial statements in conformity with IFRS requires management to make<br />

estimates and assumptions that affect the application of policies and reported amounts of assets, liabilities, income,<br />

expenses and related disclosures. The estimates and underlying assumptions are based on historical experience and<br />

various other factors that are believed to be reasonable under the circumstances, the results of which form the<br />

basis for making the judgments about carrying values of assets and liabilities that are not readily apparent from<br />

other sources. Actual results may differ from these estimates. The estimates and assumptions that have a significant<br />

risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year<br />

are described below.<br />

Going concern assumption<br />

The Group is in its start up phase and subject to various risks and uncertainties and its future success will in<br />

particular depend on its ability to realise revenues and raise additional capital to fund operations. Management<br />

assesses the going concern assumption at each balance sheet date. See note 2, paragraph ‘Ability to continue<br />

operations’, for further details and explanations.<br />

Impairment of intangible assets<br />

In 2006, the Group acquired certain intellectual properties which are in the process of being registered and that<br />

claim, among others, the administration of medicaments through a special inhalation device, as to expand the<br />

intellectual property coverage on its out licensed products in development stage. The recoverable amount of these<br />

intellectual properties depends on the continuing operation of the Group, the successful development of the<br />

related products, anticipated sales and future synergic effects. Factors such as changes in the planned use, presence<br />

or absence of competition, technical obsolescence can also result in shortened useful lives or impairment. These<br />

intellectual property rights are reviewed for impairment whenever events or changes in circumstances indicate that<br />

the carrying amount may not be recoverable.<br />

The carrying value of such intellectual property at 31 December 2007 is CHF 56’557’323 (31 December 2006: CHF<br />

59’571’327). If the estimated cash flows and synergistic effects decrease by 10%, the Group would not have to<br />

recognise any impairment loss (previous year: about CHF 5 million impairment loss). If pre-tax discount rate applied<br />

to discount estimated future synergistic effects would increase by 10%, the Group would have to recognise an<br />

impairment loss of CHF 2.5 million (31 December 2006: CHF 7 million).<br />

Revenue recognition<br />

The Group is party to out-licensing agreements which can involve upfront and milestone payments that may occur<br />

over several years. These agreements may also involve certain future obligations. Revenue is only recognized when,<br />

in management’s judgment, the obligation has been fulfilled. For some transactions this can result in cash receipts<br />

being initially recognized as deferred income and then released to income over subsequent periods on the basis of<br />

the performance of the conditions specified in the agreement.<br />

Deferred tax assets<br />

The assessment as to whether deferred tax assets relating to tax loss carry-forwards and temporary differences<br />

have to be recognised requires significant judgment, in particular on the future availability of taxable profits. At 31<br />

December 2007 the Group did not capitalize any deferred tax assets because the capitalisation criteria are not met.<br />

Deferred tax assets relating to tax loss carry-forwards and temporary differences that have not been recognized are<br />

reported in Note 25.<br />

4 Financial risk management<br />

The Group is exposed to various financial risks such as credit risk, liquidity risk and market risk (including interestrate<br />

and currency risk). The following sections provide an overview of the extent of the individual risks and the goals,<br />

principles and processes employed to handle these risks.<br />

Credit risk<br />

Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument fails to<br />

meet contractual obligations. The maximum credit risk exposure as per balance sheet date amounts to CHF<br />

13’691’594 (CHF 15’963’833 in 2006), as disclosed in Note 9, corresponding to the carrying amounts of the<br />

individual financial assets. The Group does not hold any collateral as security and has not entered into any<br />

guarantees or similar obligations that would increase the risk over and above the carrying amounts.<br />

Trade receivables. The Group is subject to a cluster risk on trade receivables, deriving from the fact that the number<br />

of counterparties within trade receivables is strictly related with the number of projects out-licensed. At 31<br />

December 2007, trade receivables with Biogen Idec, Inc. (a NASDAQ listed company) was equivalent to CHF<br />

2’304’600, representing 88% of the Group trade receivable (31 December 2006: CHF 532’185 representing 100%).<br />

The objective of the management is to sustain the growth of the Group by increasing the number of licensing out<br />

agreements whilst maintaining credit risks at acceptable levels. For this purpose, only technically qualified and<br />

F - 48


financially strong counterparties are selected in the licensing out process. The progressive increase of the outlicensed<br />

projects and number of counterparties will reduce the cluster risk on trade receivables.<br />

Cash and cash equivalents. Cash and cash equivalents are held only with important, credit-worthy financial<br />

institutions.<br />

Liquidity risk<br />

Liquidity risk is the risk that the Group will not be able to meet its financial obligations as they fall due. A shortage in<br />

liquidity may occur at any particular point in time due to adverse developments in the operational environment and<br />

in the financial markets. The Group’s approach to liquidity risk is to maintain sufficient readily available reserves in<br />

order to meet its liquidity requirements at any point in time. Group liquidity is reported on a monthly basis whilst<br />

12-months forecasts are reported on a quarterly basis. The major liquidity source is represented by the license and<br />

the collaboration agreements signed by the Group. Management is also confident that it will be able to access to a<br />

network of private investors in the event of major liquidity requirements.<br />

The table below analyses the group’s financial liabilities into relevant maturity groupings based on the remaining<br />

period at the balance sheet to the contractual maturity date. The financial debt presented in the tables below is at<br />

undiscounted cash flows, whereas the carrying value in the consolidated balance sheet reflects discounted cash<br />

flows.<br />

Maturity analysis of financial liabilities at 31 December 2007<br />

between between between 1 more than<br />

1-6 months 7-12 months and 5 years 5 years<br />

Financial debt 212'882 212'882 1'493'275 2'804'117<br />

Trade and other payable 1'248'607 -<br />

-<br />

-<br />

Accrued liabilities 2'608'775 -<br />

-<br />

-<br />

Total financial liabilities 4'070'264 212'882 1'493'275 2'804'117<br />

Maturity analysis of financial liabilities at 31 December 2006<br />

between between between 1 more than<br />

1-6 months 7-12 months and 5 years 5 years<br />

Financial debt 54'494 54'494 339'068 -<br />

Trade and other payable 2'171'827 -<br />

-<br />

-<br />

Accrued liabilities 987'663 -<br />

-<br />

-<br />

Total financial liabilities 3'213'984 54'494 339'068 -<br />

Interest rate risk<br />

Interest rate risk arises from movements in interest rates which could affect the Group financial result or the value<br />

of Group equity. Changes in interest rates may cause variations in interest income and expense. In addition, they<br />

may affect the market value of certain financial assets, liabilities and hedging instruments. With the exception of<br />

short term cash deposits and finance leases, the Group has no other interest-bearing assets or liabilities.<br />

Currency risk<br />

The Group operates in foreign countries and is exposed to movements in foreign currencies affecting the Group<br />

financial result and the value of Group’s equity. Foreign exchange risk arises because the amount of local currency<br />

paid or received for transactions denominated in foreign currencies may vary due to changes in exchange rates<br />

(‘transaction exposures’) and because the foreign currency denominated financial statements of the Group’s foreign<br />

subsidiaries may vary upon consolidation into the Swiss franc denominated Group Financial Statements (‘translation<br />

exposures’). The Group monitors its currency exposure with the objective to better preserve the economic value of<br />

its current and future assets and to minimize the volatility of the Group’s financial result. The focus of the Group’s<br />

foreign exchange risk management activities is on hedging receivables exposures and monetary positions held in<br />

foreign currencies.<br />

A 8% change in exchange rates CHF/EUR and a 20% in CHF/USD at 31 December 2007 would have increased or<br />

decreased net income by the amounts of respectively CHF 12’032 and CHF 229’544. A 8% change in exchange rates<br />

CHF/EUR and a 10% in CHF/USD at 31 December 2006 would have increased or decreased net income by the<br />

amounts of respectively CHF 70’529 and CHF 927’730. Assumption underlying this analysis is that all other variables,<br />

in particular interest rates, remain unchanged. Substantially larger effects on the income statement can be caused<br />

by exchange rate changes related to business transactions during the year, which do not lie in the scope of<br />

application of IFRS 7.<br />

F - 49


A 8% change in the exchange rate CHF/EUR related to equity invested as per 31 December 2007 would have<br />

increased or decreased the Group's equity by CHF 9’628. A 8% change in the exchange rate CHF/EUR related to<br />

equity invested as per 31 December 2006 would have increased or decreased the Group's equity by CHF 4’310.<br />

5 Capital risk management<br />

The Group’s objectives when managing capital (defined as “equity attributable to mondoRPHAN’s shareholders”)<br />

are to safeguard the group’s ability to continue as a going concern in order to provide returns for shareholders and<br />

benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital. In order to<br />

maintain or adjust the capital structure, the group may issue new shares or sell assets to reduce debts.<br />

6 Information by geographical area (segment reporting)<br />

Business segment is the primary reporting format of the Group. At 31 December 2007 the Group has only one<br />

business segment, namely the development of biological therapeutics for the treatment of live-threatening and rare<br />

lung diseases that may qualify for Orphan Drug Designation status.<br />

The geographical analysis of assets is as follows:<br />

2007 2006<br />

Switzerland 18'930'239 16'060'856<br />

Outside Switzerland 60'199'809 60'702'873<br />

Total assets 79'130'048 76'763'729<br />

The geographical analysis of capital expenditures is as follows:<br />

2007 2006<br />

Switzerland 4'621'614 725'356<br />

Outside Switzerland - 59'896'652<br />

Total capital expenditures 4'621'614 60'622'008<br />

The geographical analysis of revenues and operating expenses is as follows:<br />

Year ended 31 December 2007<br />

Outside<br />

Switzerland Switzerland Total<br />

Revenues 14'637'897 189'287 14'827'184<br />

Research and development (6'137'634) (5'153'547) (11'291'181)<br />

Sales and marketing (3'288'735) (472'900) (3'761'635)<br />

Management and administration (673'961) (834'743) (1'508'704)<br />

Operating result 4'537'567 (6'271'903) (1'734'336)<br />

Year ended 31 December 2006<br />

Outside<br />

Switzerland Switzerland Total<br />

Other operating income 2'454'421 25'740 2'480'161<br />

Research and development (1'989'010) (2'834'795) (4'823'805)<br />

Sales and marketing (1'718'754) (327'027) (2'045'781)<br />

Management and administration (1'426'462) (327'601) (1'754'063)<br />

Operating result (2'679'805) (3'463'683) (6'143'488)<br />

F - 50


7 Property, plant and equipment<br />

Leasehold Plant & Vehicles &<br />

improvements equip. aircraft Hardware Furniture Total<br />

Year ended 31 December 2006:<br />

Opening net book amount 56'781 46'259 117'004 41'065 48'197 309'306<br />

Additions 123'412 118'886 168'325 168'236 265'383 844'242<br />

Disposals -<br />

- (16'099) (8'816) - (24'915)<br />

Depreciation charges (31'508) (36'817) (58'997) (33'988) (61'891) (223'201)<br />

Currency translation effects - (4'853) -<br />

-<br />

- (4'853)<br />

Closing net book amount 148'685 123'475 210'233 166'497 251'689 900'579<br />

Cost value 205'117 230'850 285'404 215'443 389'075 1'325'889<br />

Accumulated depreciation (56'432) (107'375) (75'171) (48'946) (137'386) (425'310)<br />

Net book amount 148'685 123'475 210'233 166'497 251'689 900'579<br />

Year ended 31 December 2007:<br />

Opening net book amount 148'685 123'475 210'233 166'497 251'689 900'579<br />

Additions 23'298 53'702 4'320'789 208'502 15'323 4'621'614<br />

Depreciation charges (37'945) (56'089) (88'658) (115'904) (68'594) (367'190)<br />

Currency translation effects - 2'567 -<br />

-<br />

- 2'567<br />

Closing net book amount 134'038 123'655 4'442'364 259'095 198'418 5'157'570<br />

Cost value 228'415 287'887 4'606'193 423'945 404'398 5'950'838<br />

Accumulated depreciation (94'377) (164'232) (163'829) (164'850) (205'980) (793'268)<br />

Net book amount 134'038 123'655 4'442'364 259'095 198'418 5'157'570<br />

Depreciation expense of CHF 243’772 (2006: CHF 146’717) is included in “Research & Development”, CHF 88’563<br />

(2006: CHF 29’731) is included in “Sales & Marketing” and CHF 34’855 (2006: CHF 46’753) is included in<br />

“Management & Administration”. The classes of assets “Vehicles and aircraft” and “Furniture” includes items under<br />

financial lease for a net carrying value of CHF 4’559’830 and CHF 381’323 at 31 December 2007 and 2006<br />

respectively. The main addition in 2007 relates to the acquisition of an aircraft through a financial lease.<br />

The minimum lease payments within the next years are as follows:<br />

2007 2006<br />

Within one year 425'764 108'988<br />

Between one and five years 1'493'275 339'068<br />

More than five years 2'804'117 -<br />

4'723'156 448'056<br />

Future finance charges on financial leases (950'125) (55'438)<br />

Present value of finance lease liabilities 3'773'031 392'618<br />

The present value of the future lease payments within the next years is as follow:<br />

2007 2006<br />

Within one year 414'264 105'308<br />

Between one and five years 1'301'506 287'310<br />

More than five years 2'057'261 -<br />

Total 3'773'031 392'618<br />

Lease liabilities are effectively secured as the rights to the leased asset revert to the lessor in the event of default.<br />

F - 51


8 Intangible assets<br />

Patents Total<br />

Year ended 31 December 2006:<br />

Opening net book amount 550 550<br />

Acquisition of subsidiary 59'777'766 59'777'766<br />

Amortisation charges (206'659) (206'659)<br />

Closing net book amount 59'571'657 59'571'657<br />

Cost value 59'778'853 59'778'853<br />

Accumulated amortisation (207'196) (207'196)<br />

Net book amount 59'571'657 59'571'657<br />

Year ended 31 December 2007:<br />

Opening net book amount 59'571'657 59'571'657<br />

Amortisation charges (3'014'222) (3'014'222)<br />

Closing net book amount 56'557'435 56'557'435<br />

Cost value 59'778'853 59'778'853<br />

Accumulated amortisation (3'221'418) (3'221'418)<br />

Net book amount 56'557'435 56'557'435<br />

All amortisation charges are included in “Research & Development”. In 2006, the Group acquired certain intellectual<br />

properties which are in the process of being registered and that claim, among others, the administration of<br />

medicaments through a special inhalation device. The carrying value of such intellectual property at 31 December<br />

2007 is CHF 56’557’323 (31 December 2006: CHF 59’571’327) and the remaining amortisation period is 18.5 years.<br />

9 Financial instruments by category<br />

Note 2007 2006<br />

Trade and other receivables 10 2'682'295 657'646<br />

Cash and cash equivalents 12 11'009'299 15'306'187<br />

Loans and receivables 13'691'594 15'963'833<br />

Total financial assets 13'691'594 15'963'833<br />

Financial debt 15 3'773'031 392'618<br />

Trade and other payables 17 1'248'607 2'171'827<br />

Accrued liabilities 18 2'608'775 987'663<br />

Total financial liabilities measured ad amortized costs 7'630'413 3'552'108<br />

Total financial liabilities 7'630'413 3'552'108<br />

10 Trade and other receivables<br />

2007 2006<br />

Trade receivables 2'630'090 532'185<br />

Less: provision for impairment -<br />

-<br />

Trade receivables - net 2'630'090 532'185<br />

Receivables from related parties (Note 29) 52'205 125'461<br />

Total financial instruments (Note 9) 2'682'295 657'646<br />

Tax authorities for value added tax 845'331 177'145<br />

Prepayments 2'721'399 81'582<br />

Other 136'682 -<br />

Total non-financial instruments 3'703'412 258'727<br />

Trade and other receivables 6'385'707 916'373<br />

Significant concentration of credit risks within trade receivables is described in Note 4. The ageing structure of trade<br />

receivables is as follow:<br />

F - 52


2007 2006<br />

Not yet due 2'630'090 532'185<br />

Total trade receivables 2'630'090 532'185<br />

The receivables which are not yet due arise from collaboration and licensing agreements with selected primary<br />

partners. The Group does not anticipate any defaults.<br />

Movements on the provision for impairment of trade receivable are as follows:<br />

At 1 January -<br />

Receivables written off during the year as uncollectible -<br />

Year ended 31 December -<br />

11 Other asset<br />

2007 2006<br />

204'871<br />

(204'871)<br />

-<br />

2007 2006<br />

Supplies used in the development process 4'950 32'160<br />

Other assets 4'950 32'160<br />

The above asset refers to GMP quality production batches (good manufacturing praxis quality) of the active<br />

pharmaceutical ingredient ‘Aviptadil’ to be used in clinical development processes (phase II and III).<br />

12 Cash and cash equivalents<br />

2007 2006<br />

Cash at bank and on hand 2'009'990 1'156'187<br />

Short-term deposits 8'999'309 14'150'000<br />

Cash and cash equivalents (Note 9) 11'009'299 15'306'187<br />

13 Share capital<br />

Number Nominal<br />

of shares value<br />

At 1 January 2006 3'404'371 239'919<br />

Issuance of shares for conversion of bonds 277'990 19'591<br />

Issuance of shares for acquisition of subsidiary 1'118'918 78'854<br />

Year ended 31 December 2006 4'801'279 338'364<br />

Business combination by reverse acquisition (Note 26) 7'198'721 261'636<br />

Issuance of shares for acquisition of minority interests 853'325 42'666<br />

Year ended 31 December 2007 12'853'325 642'666<br />

Share capital<br />

mondoRPHAN AG was founded on 20 March 2007 to perform the business combination between mondoBIOTECH<br />

AG and mondoGEN AG. The initial share capital of CHF 600’000, composed of 12’000’000 bearer shares with a par<br />

value of CHF 0.05 each, was fully subscribed and paid in through contribution in kind of 27’097’276 registered<br />

shares of mondoBIOTECH AG (corresponding to an equity interest of 80.08% in mondoBIOTECH AG), a contribution<br />

in kind of 9’999’995 registered shares of mondoGEN AG (corresponding to an equity interest of 100% in mondoGEN<br />

AG) and a contribution in cash of CHF 239’957.<br />

As the business combination has been accounted for as a reverse acquisition performed by mondoBIOTECH AG,<br />

these consolidated IFRS financial statements are a continuation of the consolidated financial statements of<br />

mondoBIOTECH AG. However, the equity structure appearing in those consolidated financial statements reflects the<br />

equity structure of mondoRPHAN AG. The number of shares outstanding reported for the year ended 31 December<br />

2006 has been adjusted correspondingly.<br />

F - 53


The extraordinary shareholders’ meetings of 18 September and 10 December 2007 decided to increase the share<br />

capital for an amount of CHF 42’666 to allow minority shareholders to convert their shareholdings in<br />

mondoBIOTECH AG in shares of mondoRPHAN AG. The capital increase was performed on 28 December 2007. The<br />

shares were fully subscribed and paid in through contribution in kind of 6’739’133 bearer shares of mondoBIOTECH<br />

AG (corresponding to an equity interest of 19.92% in mondoBIOTECH AG).<br />

Authorized, unissued nominal capital<br />

At 31 December 2007, the Company has an authorized but not yet issued nominal capital of CHF 300’000, consisting<br />

of 6’000’000 bearer shares with a par value of CHF 0.05 each, that the Board of Directors is authorized to issue at<br />

any time by 5 March 2009.<br />

Conditional share capital<br />

The conditional share capital of mondoRPHAN AG as at 31 December 2007, was CHF 300’000, consisting of<br />

6’000’000 bearer shares with a par value of CHF 0.05 each, of which CHF 82’079 to be used for a Share Option Plan<br />

for employees and consultants and CHF 217’921 to be used for the exercise of conversion option rights granted in<br />

connection with bonds, notes or similar debt instruments issued by the Group. To date, there is no share option<br />

plan in place for employees and consultants.<br />

14 Reserves<br />

Share Currency<br />

premium translation Total<br />

Balance at 1 January 2006 6'681'541 214 6'681'755<br />

Conversion of bonds, net of issuance costs 14'656'056 -<br />

Acquisition of minority interests -<br />

-<br />

Acquisition of subsidiary, net of transaction costs 59'692'766 -<br />

14'656'056<br />

-<br />

59'692'766<br />

Currency translation differences - 1'331 1'331<br />

Year ended 31 December 2006 81'030'363 1'545 81'031'908<br />

Business combination by reverse acquisition (Note 26) (16'141'126) (308) (16'141'434)<br />

Acquisition of minority interests 12'767'996 - 12'767'996<br />

Currency translation differences - 1'981 1'981<br />

Year ended 31 December 2007 77'657'233 3'218 77'660'451<br />

15 Financial debts<br />

2007 2006<br />

Finance lease obligations 3'773'031 392'618<br />

Total financial debts (Note 9) 3'773'031 392'618<br />

Reported as:<br />

- long-term financial payables 3'530'382 305'706<br />

- short-term financial payables 242'649 86'912<br />

Total financial debts 3'773'031 392'618<br />

Financial debts refer to the finance leasing agreements in place for financing property, plant and equipments (see<br />

Note 7). The duration of the agreements is between 4 and 7 years, at the end of which the Group has a purchase<br />

option. Early termination is possible. The interest rates implicit in the lease agreements are between 4.65% and<br />

8.00%.<br />

16 Pension obligations<br />

The Group maintains retirement plans where expressly required by the applicable pension legislation. This refers<br />

exclusively to the Swiss subsidiaries. Such plans are considered as defined benefit plans in accordance with IAS 19.<br />

The Company and its employees pay retirement contributions, which are defined as a percentage of the employees’<br />

covered salaries, to a collective pension fund operated by an insurance company. Interest is credited to the<br />

employees’ accounts at the minimum rate provided in the plan, payment of which is guaranteed by the insurance<br />

contract. Additionally, the plans provide benefits on the death or long-term disability of the insured.<br />

For accounting purposes this insurance contract represents the sole asset of the plans. Fair value of plan asset is the<br />

estimated cash surrender at the respective balance sheet date.<br />

F - 54


The amounts recognized in the balance sheet are determined as follow:<br />

Change in the benefit obligation<br />

2007 2006<br />

Present value of obligations, beginning of period 341'123 262'896<br />

Current service cost 48'098 30'585<br />

Interest cost 14'137 8'939<br />

Employee contributions 60'577 43'593<br />

Benefits paid (5'689) (15'832)<br />

Actuarial (gain) loss on obligations 7'211 10'942<br />

At end of the period 465'457 341'123<br />

Change in the plan assets<br />

2007 2006<br />

Fair value of assets, beginning of period 291'570 206'868<br />

Expected returns on plan assets 11'098 6'924<br />

Employee contributions 60'577 43'593<br />

Employer contributions 60'582 40'080<br />

Benefits paid (5'689) (15'832)<br />

Actuarial gain (loss) on assets (32'542) 9'937<br />

At end of the period 385'596 291'570<br />

Funding status<br />

2007 2006<br />

Present value of obligations 465'457 341'123<br />

Fair value of assets (385'596) (291'570)<br />

79'861 49'553<br />

Unrecognized actuarial losses (74'708) (35'034)<br />

Pension obligation recognized in the balance sheet 5'153 14'519<br />

Movement in the liability recognized in the balance sheet<br />

2007 2006<br />

Pension obligation at beginning of period 14'519 21'276<br />

Company's net periodic pension cost 51'216 33'323<br />

Employers contributions (60'582) (40'080)<br />

At end of the period 5'153 14'519<br />

Net periodic costs recognized in the income statement<br />

2007 2006<br />

Current service cost 48'098 30'585<br />

Interest cost 14'137 8'939<br />

Expected return on plan assets (11'098) (6'924)<br />

Recognition of actuarial losses 79 723<br />

Total, included in staff costs (Note 19) 51'216 33'323<br />

The actual return on plan assets was CHF -80’663 (2006: CHF 16’861).<br />

Overview and experience adjustments<br />

2007 2006 2005 2004 2003<br />

Defined benefit obligations 465'457 341'123 262'896 211'605 75'009<br />

Plan assets (385'596) (291'570) (206'868) (162'334) (56'902)<br />

Deficit (Surplus) 79'861 49'553 56'028 49'271 18'107<br />

Actuarial adjustments on plan obligations (7'211) (10'942) 2'297 (13'979) (903)<br />

Difference between actual and expected return on plan assts (91'761) 9'937 (10'942) (7'374) (4'361)<br />

F - 55


Principal actuarial assumptions used<br />

2007 2006<br />

Discount rate 3.50% 3.00%<br />

Expected return on plan assets 3.00% 2.50%<br />

Future salary increases 1.00% 1.00%<br />

Future pension increases 0.00% 0.00%<br />

Assumptions regarding mortality take into account historic patterns and expected changes, such as further<br />

increases in longevity. The Group operates defined benefit plans only in Switzerland, for which the adjusted<br />

mortality tables EVK2000 were used.<br />

Expected contributions for 2008<br />

Expected contributions to post-employment benefit plans for the year ending 31 December 2008 are CHF 60’000.<br />

17 Trade and other payables<br />

2007 2006<br />

Trade payables 940'421 1'580'728<br />

Social security and other employment related payables 145'075 126'458<br />

Tax authorities for value added tax 154'062 -<br />

Advance payments received 6'289'000 -<br />

Other 22'330 29'993<br />

Trade and other payables to related parties (Note 29) 163'111 464'641<br />

Trade and other payables 7'713'999 2'201'820<br />

18 Accrued liabilities and deferred income<br />

2007 2006<br />

Accrued liabilities for services 2'183'318 260'513<br />

Accrued liabilities for legal and audit services 78'458 313'749<br />

Interests on convertible loans before early conversion 167'191 167'191<br />

Deferred income - 6'789'375<br />

Accruals for other taxes 92'700 43'790<br />

Accrued liabilities for services from related parties (Note 29) 179'808 246'210<br />

Accrued liabilities and deferred income 2'701'475 7'820'828<br />

Deferred income at 31 December 2006 refers to the portion of the upfront payment received from Biogen Idec, Inc.<br />

that was deferred according to the terms of the agreement.<br />

19 Revenues<br />

2007 2006<br />

Royalty income 674'850 30'000<br />

Revenues from upfront and milestones payments 7'151'375 2'263'125<br />

Revenues from clinical development services 7'000'959 -<br />

Other operating income - 187'036<br />

Revenues 14'827'184 2'480'161<br />

Revenues from upfront and milestones payments refers to the continuation of the collaboration and licensing-out<br />

agreement signed in 2006 with Biogen Idec, Inc. Revenues from clinical development services refers to clinical<br />

development services provided within this collaboration.<br />

F - 56


20 Expenses by nature<br />

2007 2006<br />

Depreciation and amortisation (3'381'412) (429'860)<br />

Employee remuneration (Note 21) (1'993'598) (1'392'325)<br />

Expenses for research & development services (5'543'372) (3'220'812)<br />

Expenses for sales & marketing services (2'788'334) (1'119'548)<br />

Expenses for management & administration services (869'962) (1'171'178)<br />

Rent and other occupancy costs (897'616) (709'268)<br />

Travel and business entertainment (487'795) (320'275)<br />

Information tecnology (479'415) (195'364)<br />

Other (120'016) (65'019)<br />

Total research & development, sales & marketing, general & administration (16'561'520) (8'623'649)<br />

21 Staff costs<br />

2007 2006<br />

Wages and salaries (1'770'780) (1'224'388)<br />

Social security costs (171'602) (134'614)<br />

Pension costs - defined benefit plans (Note 16) (51'216) (33'323)<br />

Total (Note 20) (1'993'598) (1'392'325)<br />

22 Finance income<br />

2007 2006<br />

Interest income 380'565 57'007<br />

Foreign exchange gains 242'853 119'777<br />

Finance income 623'418 176'784<br />

23 Finance costs<br />

2007 2006<br />

Interest expense:<br />

- convertible bond: interest expenses - (621'852)<br />

- convertible bond: loss at early conversion - (362'150)<br />

- finance lease (24'121) (18'501)<br />

- borrowings - (776)<br />

- other interests (922) (4'989)<br />

(25'043) (1'008'268)<br />

Foreign exchange losses (629'439) (37'159)<br />

Finance costs (654'482) (1'045'427)<br />

Effectively paid:<br />

- finance lease (24'121) (18'501)<br />

- borrowings - (776)<br />

- other interests (922) (4'989)<br />

(25'043) (24'266)<br />

24 Taxes<br />

Income taxes<br />

2007 2006<br />

Income tax expenses 234'888 200'005<br />

Total taxes on income 234'888 200'005<br />

The weighted average applicable tax rate of the Company is 18.8% (2006: 8.3%) and was determined using the<br />

domestic tax rates applicable to results in the countries concerned:<br />

F - 57


2007 2006<br />

Loss of the period (1'765'400) (7'012'131)<br />

Tax at the domestic rates applicable in the country concerned 328'595 581'388<br />

Income not subject to tax 240'515 226'270<br />

Utilization of previously unrecognized tax losses 77'658 13'814<br />

Tax losses for which no deferred income tax asset was recognized (881'656) (1'021'477)<br />

Total tax expenses charged to income statement (234'888) (200'005)<br />

Income tax liability<br />

2007 2006<br />

At 1 January 200'005 -<br />

Income statement charge 234'888 200'005<br />

Echange differences 5'329 -<br />

Year ended 31 December 440'222 200'005<br />

Deferred taxes<br />

In accordance with IAS 12, the Company did not capitalize any deferred tax asset relating to tax loss carry-forwards<br />

and temporary differences since the criteria for recognition (i.e. the probability of future taxable profits) are not<br />

met. The gross value of unused tax losses which have not been capitalized as deferred tax asset will expire as<br />

follows:<br />

2007 2006<br />

Within one year -<br />

-<br />

Later than one year and not later than five years (10'862'133) (6'660'199)<br />

More than five years (11'930'815) (13'071'504)<br />

Total (22'792'948) (19'731'703)<br />

Deferred tax assets and liabilities on temporary differences that have not been recognized are as follows:<br />

2007 2006<br />

Deferred tax assets by types of temporary difference:<br />

Intangible assets 41'906 55'992<br />

Pension obligations 3'587 2'958<br />

Total deferred tax assets 45'493 58'950<br />

Deferred tax liabilities by types of temporary difference:<br />

Property, plant and equipment 130 25<br />

Total deferred tax liability 130 25<br />

No deferred tax liability was recognized due to the ability of the Group to offset by recognizing deferred tax assets<br />

for an equivalent amount in the period when temporary differences would reverse.<br />

25 Earnings per share<br />

Basic and diluted losses per share are calculated by dividing the net loss attributable to the shareholders by the<br />

weighted average shares outstanding during the period.<br />

2007 2006<br />

Net loss attributable to equity holders of the Company (1'605'210) (7'224'761)<br />

Weighted average number of shares outstanding 10'429'212 3'574'688<br />

Basic and diluted loss per share (0.154) (2.021)<br />

26 Business combination involving entities under common control<br />

The business combination (the “Combination”) between mondoRPHAN AG, mondoBIOTECH AG and mondoGEN AG<br />

(see Note 1) has been performed and accounted for as follows:<br />

F - 58


Formation of mondoRPHAN AG on 20 March 2007 as new holding company and vehicle to perform the<br />

Combination. The share capital of mondoRPHAN AG has been paid-in through contribution in kind of a 80.08%<br />

equity interest in mondoBIOTECH AG, a 100% equity interest in mondoGEN AG and a contribution in cash of<br />

CHF 239’957;<br />

The Combination has been accounted for as a reverse acquisition of mondoBIOTECH AG, being mondoGEN AG<br />

a newly formed start-up company with limited history and mondoRPHAN AG the entity formed to issue equity<br />

instruments for the Combination. These consolidated financial statements are therefore a continuation of the<br />

consolidated financial statements of mondoBIOTECH AG. The equity structure appearing in these consolidated<br />

financial statements reflect the equity structure of mondoRPHAN AG, being the legal parent. The consolidated<br />

income statement for the year 2007 includes the results of mondoRPHAN AG and mondoGEN AG from 20<br />

March 2007;<br />

mondoGEN AG is a company specialized in the management of clinical development processes, and generated<br />

revenues of CHF 7’149’600 and a net loss of CHF 24’561 in the period from its formation on 16 January 2007 to<br />

31 December 2007;<br />

As the controlling shareholders before and after the Combination are the same, the business combination has<br />

been treated as a business combination involving entities under common control and accounted for using the<br />

values of the acquired assets and liabilities according to the financial statements of the acquired entities<br />

prepared in conformity with IFRS. No transaction costs and no goodwill arose on the Combination.<br />

The assets and liabilities contributed are as follows:<br />

mondoRPHAN mondoGEN<br />

AG AG Total<br />

Cash and cash equivalents 239'957 68'571 308'528<br />

Trade and other payables - 12'635 12'635<br />

Accrued income - 544'595 544'595<br />

Trade and other payables - (44'715) (44'715)<br />

Accrued liabilities - (461'000) (461'000)<br />

Net asset arising from the business combination 239'957 120'086 360'043<br />

The Combination generated an increase in cash and cash equivalents for an amount of CHF 308‘528, being the<br />

sum of the cash contributed at formation of mondoRPHAN AG and the cash and cash equivalents position of<br />

mondoGEN AG;<br />

Shareholders with an equity interest of 19.92% in mondoBIOTECH AG did not participate to the Combination.<br />

Their proportionate interest in the pre-combination carrying amounts of mondoBIOTECH AG’s net assets was<br />

measured in CHF 13’205’247 and treated as minority interests after 20 March 2007. Their proportionate<br />

interest in the result of the period from 20 March 2007 to 28 December 2007 was CHF (395'078). Having the<br />

minority shareholders converted their shareholdings in mondoBIOTECH AG into shares of mondoRPHAN AG on<br />

28 December 2007, no more minority interests are disclosed at 31 December 2007.<br />

F - 59


27 Cash flows<br />

Cash generated from operations<br />

Year ended 31 December<br />

Note 2007 2006<br />

Result of the period (2'000'288) (7'212'136)<br />

Adjustments for:<br />

- Depreciation 7 367'190 223'201<br />

- Amortisation 8 3'014'222 206'659<br />

- (Profit) / loss on sale and retirement of property, plant and equipment - (11'319)<br />

- Acquisition of minority interests - (39'296)<br />

- Changes in pension obligations (9'366) (6'757)<br />

- Income tax expenses 24 234'888 200'005<br />

- Finance income 22 (380'565) (57'007)<br />

- Finance costs 23 25'043 1'008'268<br />

Changes in working capital:<br />

- Trade and other receivable (5'455'047) (395'181)<br />

- Other assets 27'210 951'840<br />

- Accrued income and prepaid expenses 566'282 79'226<br />

- Trade and other payable 5'455'029 282'487<br />

- Accrued liabilities and deferred income (5'575'498) 7'021'700<br />

Cash generated from operations (3'730'900) 2'251'690<br />

Significant non-cash transactions<br />

An increase in property, plant and equipment of CHF 4’103’703 was recorded from financial leasing arrangements<br />

(see Notes 7 and 16) and there was a corresponding increase in long term debt.<br />

28 Commitments and Contingencies<br />

The future aggregate minimum rent payments for office space under non-cancellable rent agreements is as follows:<br />

2007 2006<br />

Within one year 682'800 632'400<br />

Later than one and not later than five years 2'674'800 2'529'600<br />

Lather than five years 1'352'400 1'984'800<br />

Total 4'710'000 5'146'800<br />

At balance sheet date the Group had no contingencies. The Group is involved in a legal proceeding regarding the<br />

termination of a former employee contract, the amount of which is defined and fully accrued.<br />

29 Related parties<br />

Senior executive and Board compensation<br />

2007 2006<br />

Compensation of senior executives:<br />

- fees, salaries and other short-term employee benefits 1'416'061 1'021'048<br />

- post-employment benefits 22'845 11'598<br />

Board of directors:<br />

- compensation for serving as board members 70'440 97'140<br />

Total 1'509'346 1'129'786<br />

F - 60


Purchase of services<br />

2007 2006<br />

From board members:<br />

- financial advisory services 196'897 285'585<br />

- scientific consulting services 31'481 -<br />

- commissions on fund rising<br />

From entities related to board members :<br />

- 746'871<br />

- financial advisory services 21'417 -<br />

- administration and business consulting services 236'578 150'295<br />

- commissions on fund rising - 69'940<br />

- rent and occupancy services 663'600 686'350<br />

Total 1'149'973 1'939'041<br />

Year-end balances arising from purchase of services<br />

2007 2006<br />

Trade and other receivables (Note 10) 52'205 125'461<br />

Accrued income and prepaid expenses 9'002 -<br />

Total 61'207 125'461<br />

Long-term financial debt (Note 15) 99'569 138'581<br />

Trade and other payables (Note 17) 163'111 464'641<br />

Short - term financial payables (Note 15) 39'012 50'790<br />

Accrued liabilities and deferred income (Note 18) 179'808 246'210<br />

Total 481'500 900'222<br />

Year-end balances regarding trade receivables are due within 30 days. None of them are overdue. Long-term and<br />

short-term financial debts refer to financial leasing agreements (see Notes 7 and 16). Trade and other payables are<br />

due within 30 days.<br />

Loans from related parties<br />

Beginning of the year -<br />

Borrowings received during the year -<br />

Repayment of borrowings -<br />

End of year -<br />

Interest charged (Note 23) -<br />

30 Subsidiaries undertaken<br />

The Company holds investments in the following subsidiaries:<br />

2007 2006<br />

750'000<br />

250'000<br />

(1'000'000)<br />

-<br />

Share<br />

Equity<br />

Country Company City capital<br />

interest<br />

Switzerland mondoBIOTECH AG Basel CHF 338'364 100.0%<br />

Interferon Medical Use SA Collina d'Oro CHF 138'750 100.0%<br />

mondoBIOTECH Licensing out AG Stans CHF 100'000 100.0%<br />

mondoGEN AG Zug CHF 100'000 100.0%<br />

Liechtenstein mondoBIOTECH Laboratories Anstalt Vaduz CHF 30'000 100.0%<br />

mondoBIOTECH Services AG Vaduz CHF 50'000 100.0%<br />

Germany TheraNostics GmbH München EUR 55'000 100.0%<br />

US mondoBIOTECH US, Inc. New York USD 200 100.0%<br />

31 Events after the balance sheet date<br />

There have been no events between 31 December 2007 and 4 April 2008 that would require an adjustment of these<br />

financial statements or would need to be disclosed under this heading.<br />

***<br />

776<br />

F - 61


mondoBIOTECH holding AG – Financial statements 2008<br />

F - 62


Statutory audit report<br />

F - 63


F - 64


Balance sheet<br />

(in CHF)<br />

ASSETS<br />

Note<br />

As at 31 December<br />

2008 2007<br />

Intangible assets 3 187'156 11'756<br />

Investments 4 719'184 569'184<br />

Loans to group companies 5 200'000 -<br />

Non current assets 1'106'340 580'940<br />

Other receivables 194'399 305'021<br />

third parties 134'399 305'021<br />

related parties 60'000 -<br />

Short-term loans to group companies 5 367'900 -<br />

Prepaid expenses 2'526 1'000<br />

Cash and cash equivalents 6 12'147'260 151'580<br />

Current assets 12'712'085 457'601<br />

Total assets 13'818'425 1'038'541<br />

EQUITY AND LIABILITIES<br />

Share capital 653'883 642'666<br />

General reserves 14'023'501 -<br />

Retained losses (3'421'940) (133'137)<br />

loss carried forward (133'137) -<br />

net result for the period (3'288'803) (133'137)<br />

Total shareholders' equity 7 11'255'444 509'529<br />

Trade payable 207'209 319'183<br />

third parties 1'011 8'537<br />

group companies 116'198 310'646<br />

related parties 90'000 -<br />

Short-term loans from group companies 8 2'200'824 166'475<br />

Accrued expenses and deferred income 154'948 43'354<br />

third parties 121'915 43'354<br />

related parties 33'033 -<br />

Current liabilities 2'562'981 529'012<br />

Total equity and liabilities 13'818'425 1'038'541<br />

F - 65


Income statement<br />

(in CHF)<br />

20.03.2007<br />

Note 2008 31.12.2007<br />

Revenues 75'000 -<br />

Research & development 9 (286'047) -<br />

Sales & marketing 9 (132'022) (24'677)<br />

Management & administration 9 (295'954) (108'635)<br />

Impairment on loans to group companies and investments (2'725'600) -<br />

Operating result (3'364'623) (133'312)<br />

Financial income 4'482 175<br />

Exchange differences 71'338 -<br />

Result before income taxes (3'288'803) (133'137)<br />

Income taxes -<br />

-<br />

Result of the period (3'288'803) (133'137)<br />

F - 66


Cash flow statement<br />

(in CHF)<br />

20.03.2007<br />

2008 31.12.2007<br />

Net result of the period<br />

Adjustments for<br />

(3'288'803) (133'137)<br />

- amortizations<br />

Changes in working capital:<br />

9'108 1'069<br />

- other receivable 110'622 (305'021)<br />

- prepaid expenses (1'526) (1'000)<br />

- trade payable (111'974) 319'183<br />

- accrued liabilities 111'594 43'354<br />

Cash used for operating activities before income taxes and interest paid (3'170'979) (75'552)<br />

Income tax paid -<br />

-<br />

Interest paid -<br />

-<br />

Cash flow (used) from operating activities (3'170'979) (75'552)<br />

Purchase of intangible assets (184'508) (12'825)<br />

Investment in subsidiaries (200'000) -<br />

Deinvestment in subsidiaries 50'000 -<br />

Intercompany loans (567'900) -<br />

Cash flow (used) from investing activities (902'408) (12'825)<br />

Proceeds from issuance of share capital 14'034'718 239'957<br />

Intercompany loans 2'034'349 -<br />

Cash flow from financing activities 16'069'067 239'957<br />

Increase (decrease) in cash and cash equivalents 11'995'680 151'580<br />

Cash and cash equivalents at beginning of period 151'580 -<br />

Cash and cash equivalents at end of period 12'147'260 151'580<br />

F - 67


Notes to the financial statements<br />

(all amounts in CHF)<br />

1 General information<br />

mondoBIOTECH holding AG (the “Company”), formerly mondoRPHAN AG, was incorporated on 20 March 2007 in<br />

Zug. Subsequently, the Company changed its legal domicile from Zug to Basel, and then form Basel to Stans. The<br />

main activity of the company is to buy, hold and manage investments in other Swiss and foreign companies in<br />

particular in the field of biotechnology.<br />

2 Significant accounting policies<br />

Basis of preparation of the financial statements<br />

The financial statements are closed at 31December 2008 and have been prepared in accordance with Swiss law and<br />

under the historical cost convention. The preparation of financial statements requires the use of estimates and<br />

assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and<br />

liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the<br />

reporting period. Although these estimates are based on management’s best knowledge, actual results ultimately<br />

may differ from those estimates.<br />

Uncertainties and ability to continue operations<br />

The Company is in its start up phase and subject to various risks and uncertainties, including but not limited to its<br />

reliance on some lead product candidates in order to achieve future revenues, timing of achieving profitability, its<br />

marketing capacity and the substantial uncertainty of the drug development process, including uncertainty of the<br />

outcome of clinical trials and significant regulatory approval requirements for market admission of product<br />

candidates.<br />

Intangible assets<br />

Intangibles are shown in the balance sheet as an asset if they have a measurable economic benefit for the company<br />

over several years. They are depreciated using the straight-line method over a useful life of 5 years.<br />

Formation expenses are capitalized under intangible fixed assets and amortized over 5 years.<br />

Investments<br />

Investments in subsidiaries and associates are recorded at their acquisition cost. The acquisition cost includes<br />

charges and expenses in connection with the acquisition. At the end of each fiscal quarter, a provision is made on<br />

the basis of an evaluation of each individual asset for any permanent impairment in value.<br />

Trade and other receivables<br />

Trade and other receivables are carried at original nominal amount less provision made for impairment of these<br />

receivables. A provision for impairment of receivables is established when there is objective evidence that the<br />

company will not be able to collect all amounts due according to the original terms of receivables.<br />

Cash and cash equivalents<br />

Cash and cash equivalents are carried in the balance sheet at cost. Cash and cash equivalents comprise cash on<br />

hand, deposits held at call with banks, other short-term highly liquid investments with original maturities up to<br />

three months. For the purpose of the cash flow statement, cash and cash equivalents comprise the balance sheet<br />

positions “cash and cash equivalents”.<br />

Unless otherwise stated, all other assets and liabilities are stated at their nominal values.<br />

F - 68


3 Intangible assets<br />

Formation<br />

& reorganiz.<br />

expenses Total<br />

Year ended 31 December 2007:<br />

Formation 12'825 12'825<br />

Amortisation charges (1'069) (1'069)<br />

Closing net book amount 11'756 11'756<br />

Cost value 12'825 12'825<br />

Accumulated amortisation (1'069) (1'069)<br />

Net book amount 11'756 11'756<br />

Year ended 31 December 2008:<br />

Opening net book amount 11'756 11'756<br />

Increase 184'508 184'508<br />

Amortisation charges (9'108) (9'108)<br />

Closing net book amount 187'156 187'156<br />

Cost value 197'333 197'333<br />

Accumulated amortisation (10'177) (10'177)<br />

Net book amount 187'156 187'156<br />

4 Investments<br />

The detail of all subsidiaries is as follow:<br />

Share Ownership in %<br />

Country Company City capital 2008<br />

Switzerland mondoBIOTECH AG Stans CHF 338'364 100.00%<br />

mondoGEN AG Stans CHF 100'000 100.00%<br />

Fast Take-off AG Stans CHF 100'000 100.00%<br />

Alps Air AG Stans CHF 100'000 100.00%<br />

Interferon Medical Use SA Collina d'Oro CHF 138'750 100.00%<br />

Liechtenstein mondoBIOTECH Laboratories AG Vaduz CHF 50'000 100.00%<br />

US mondoBIOTECH US, Inc. New York USD 200 100.00%<br />

5 Loans to group companies<br />

2008 2007<br />

Loans to group companies:<br />

- not subordinated 567'900 -<br />

- subordinated 2'705'600 -<br />

Provisions for impairment (2'705'600) -<br />

Loans to group companies 567'900 -<br />

Reported as<br />

- non-current assets 200'000 -<br />

- current assets 367'900 -<br />

Total 567'900 -<br />

The loans are subject to flexible payment-back opportunity. The management estimates that the loans are expected<br />

to be cashed-in, if the case, not before 12 moths after the balance sheet date.<br />

6 Cash and cash equivalents<br />

2008 2007<br />

Cash at bank and on hand 12'147'260 151'580<br />

Total 12'147'260 151'580<br />

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7 Shareholder’s equity<br />

Share Retained<br />

capital Reserves earnings Total<br />

Share capital at formation 600'000 - 600'000<br />

Capital increase by acquisition of a subsidiary 42'666 - 42'666<br />

Net result for the period -<br />

(133'137) (133'137)<br />

Balance at 31 December 2007 642'666 - (133'137) 509'529<br />

Balance at 1 January 2008 642'666 - (133'137) 509'529<br />

Capital increase, net of transaction costs 11'217 14'023'501 - 14'034'718<br />

Net result for the period -<br />

- (3'288'803) (3'288'803)<br />

Blance at 31 December 2008 653'883 14'023'501 (3'421'940) 11'255'444<br />

Share capital<br />

At 31 December 2008, the issued share capital amounts to CHF 653’882.70, consisting of 13’077’654 fully paid-in<br />

bearer shares with a nominal value of CHF 0.05 each.<br />

Authorized, unissued nominal capital<br />

At 31 December 2008, the Company has an authorized but not yet issued nominal capital of CHF 288’783.55,<br />

consisting of 5’775’671 bearer shares with a par value of CHF 0.05 each, that the Board of Directors is authorized to<br />

issue at any time by 5 March 2009.<br />

Conditional share capital<br />

The conditional share capital of mondoBIOTECH holding AG as at 31 December 2008 was CHF 300’000, consisting of<br />

6’000’000 bearer shares with a par value of CHF 0.05 each, of which CHF 82’079 to be used for share option for<br />

employees and consultants and CHF 217’921 to be used for the exercise of conversion option rights granted in<br />

connection with bonds, notes or similar debt instruments issued by the Company. To date, there is no share option<br />

plans in place for employees and consultants.<br />

8 Loans from group companies<br />

2008 2007<br />

Short-term loans from group companies: 2'200'824 -<br />

Total 2'200'824 -<br />

The short-term loans are not remunerated and are subject to flexible payment-back opportunity.<br />

9 Expenses by nature<br />

20.03.2007<br />

2008 31.12.2007<br />

Amortization (9'108) (1'069)<br />

Consulting services (459'903) (66'243)<br />

Rent and other occupancy costs (180'012) -<br />

Travel and business entertainment - (22'000)<br />

Audit (65'000) (44'000)<br />

Total research and development, sales and marketing, management and administration (714'023) (133'312)<br />

10 Events after the balance sheet date<br />

At the extraordinary general meeting held on 20 February 2009, the shareholders of mondoBIOTECH holding AG<br />

approved the transfer of the Company’s legal domicile from Basel to Stans, Switzerland, and the split of the<br />

company’s shares from previously 13’077’654 bearer shares with a par value of CHF 0.05 each into new 65’388’270<br />

registered shares with a par value of CHF 0.01 each. The shareholders also approved the amendment of the<br />

authorized share capital form previously CHF 288’783, consisting of 5’775’671 bearer shares with a par value of CHF<br />

0.05 each into new CHF 326’941, consisting of 3’269’413 registered shares with a par value of CHF 0.10 each and<br />

the amendment of the conditional share capital from previously CHF 300’000, consisting of 6’000’000 bearer shares<br />

with a par value of CHF 0.05 each, of which CHF 82’079 to be used for a Share Option Plan for employees and<br />

consultants and CHF 217’921 to be used for the exercise of conversion option rights granted in connection with<br />

bonds, notes or similar debt instruments issued by the Group into new CHF 326’941, consisting of 3’269’413<br />

registered shares with a par value of CHF 0.10 each, of which CHF 180’000 to be used for a Share Option Plans for<br />

employees and consultants and CHF 146’941.30 to be used for the exercise of conversion option rights granted in<br />

connection with bonds, notes or similar debt instruments issued by the Group.<br />

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There have been no further material post-balance sheet events which would require disclosure or adjustment to<br />

the 2008 financial statements.<br />

11 Risk assessment disclosures<br />

mondoBIOTECH holding AG, as the ultimate parent company of the mondoBIOTECH Group, is fully integrated into<br />

the Group-wide internal risk assessment process. The risk assessment process includes the identification of internal<br />

and external risks, the assessment of their potential impact on the Group as well as the definition of organizational<br />

and process measures to identify the risk and where appropriate remediate. The Executive Committee of the<br />

Company reports to the Board of Directors on a regular basis on significant risks and measure taken by the Group.<br />

This risk assessment also covers the specific risks related to mondoBIOTECH holding AG. Disclosure of the Groupwide<br />

risk assessment procedures are described in note 31 to the Group’s consolidated financial statements.<br />

12 Other disclosures in accordance with art. 663b of the Swiss Code of Obligations<br />

No other disclosure<br />

***<br />

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