Acino ? Delivering Health
Acino ? Delivering Health
Acino ? Delivering Health
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<strong>Acino</strong> – <strong>Delivering</strong> <strong>Health</strong><br />
Annual Results 2011<br />
Peter Burema, CEO<br />
Robert Schmid, CFO (until end of February 2012)<br />
Dr. Jean-Daniel Bonny, Head Group R&D<br />
<strong>Acino</strong> Holding Ltd.<br />
Erlenstrasse 1 | CH-4058 Basle | www.acino-pharma.com<br />
Phone +41 61 338 60 00 | Fax +41 61 338 60 80
Performance 2011<br />
Zurich, March 9, 2012<br />
Robert Schmid, CFO<br />
<strong>Acino</strong> Holding Ltd.<br />
Erlenstrasse 1 | CH-4058 Basle | www.acino-pharma.com<br />
Phone +41 61 338 60 00 | Fax +41 61 338 60 80
2011 operating performance<br />
EUR<br />
million<br />
130<br />
110<br />
90<br />
70<br />
50<br />
30<br />
10<br />
‐10<br />
Revenue<br />
134.9<br />
Parenteral<br />
33.5<br />
Peroral<br />
101.4<br />
Goods / change in<br />
inventory<br />
(48.3)<br />
Employee benefits<br />
(41.4)<br />
Other<br />
OPEX<br />
(26.7)<br />
Capitalized<br />
work performed<br />
5.2<br />
Key Financials<br />
(EUR million)<br />
2011 2010 Change<br />
Revenue 134.9 127.5 6%<br />
EBITDA<br />
% of revenue<br />
currency adjusted<br />
EBIT<br />
% of revenue<br />
Net profit<br />
EPS (diluted)<br />
Other<br />
income<br />
1.8<br />
EBITDA<br />
25.7<br />
19%<br />
23%<br />
6.7<br />
5%<br />
5.7<br />
1.80<br />
18.0<br />
14%<br />
(9.0)<br />
(7%)<br />
4.5<br />
1.42<br />
(0.9)<br />
43%<br />
175%<br />
27%<br />
Depreciation<br />
& Amortization 0.8 Financial result<br />
(1.2) Tax<br />
(0.4) Associates<br />
(19.0)<br />
EBIT<br />
25.7 6.7<br />
Net profit<br />
5.7<br />
3
2011 cash flow<br />
EUR<br />
million<br />
12<br />
7<br />
2<br />
‐3<br />
‐8<br />
‐13<br />
‐18<br />
‐23<br />
Change in<br />
working capital<br />
Cash<br />
flow<br />
(11.5)<br />
20.4<br />
CF from<br />
operating<br />
activities<br />
8.9<br />
Payment<br />
PPE<br />
(20.5)<br />
(11.2)<br />
(EUR million) 2011 2010 Change<br />
Cash flow (11.5) 46.0 (125%)<br />
Changes in working capital 20.4 (25.6)<br />
Cash flow from operations 8.9 20.4 (56%)<br />
Cash flow from investing (31.7) (25.7) 23%<br />
Cash flow from financing 6.6 (7.1)<br />
Net change in cash (16.1) (12.1)<br />
Free cash flow (22.8) (5.2)<br />
Payment<br />
intangibles &<br />
Financial assets<br />
Proposal to the AGM: Distribution of CHF 1.00 / share<br />
(out of legal reserve exempt from withholding tax)<br />
Financing<br />
activities<br />
6.6<br />
(0.0)<br />
Forex<br />
effects<br />
(16.1)<br />
Net change<br />
in cash<br />
(22.8)<br />
Free cash<br />
flow<br />
4
Balance sheet<br />
EUR<br />
million<br />
31.12.2011<br />
EUR 330.4 million<br />
4.4<br />
53.8<br />
18.8<br />
79.9<br />
2011<br />
71.0<br />
257.4<br />
EQUITY RATIO<br />
• Maintained at high 78%<br />
Deferred revenues<br />
Deferred tax liabilities<br />
Other liabilities<br />
Current financial liabilities<br />
71.0<br />
102.5<br />
Assets Liabilities &<br />
Shareholders‘<br />
equity<br />
Shareholders’ equity<br />
Cash and cash equivalents<br />
Working capital<br />
Other non-current assets<br />
Other intangible assets<br />
Goodwill<br />
Property, plant & equipment<br />
89.9<br />
Assets<br />
31.12.2010<br />
EUR 344.8 million<br />
20.5<br />
13.3<br />
26.2<br />
13.0<br />
ASSETS<br />
• Higher PPE: high investments<br />
Miesbach<br />
• Lower working capital: agreement<br />
concerning claim clopidogrel<br />
LIABILITIES AND SHAREHOLDERS’<br />
EQUITY<br />
•Lower provisions: agreement<br />
20.5<br />
68.4<br />
15.9<br />
27.5<br />
12.9<br />
51.5<br />
0.0<br />
concerning claim clopidogrel<br />
•New current financial liabilities<br />
79.1<br />
252.9<br />
Liabilities &<br />
Shareholders‘<br />
equity<br />
5
Break-down of <strong>Acino</strong>’s revenue<br />
150<br />
135<br />
120<br />
105<br />
90<br />
75<br />
60<br />
45<br />
30<br />
15<br />
Proprietary products &<br />
contract manufacturing<br />
Total product sales in EUR million<br />
0<br />
2004 2005 2006 2007 2008 2009 2010 2011<br />
Peroral manufactured in Switzerland<br />
Peroral manufactured in India<br />
Contract manufacturing Peroral<br />
Parenteral<br />
Revenue of operating segments in 2011:<br />
– Renewed growth of Peroral +12%<br />
– Weaker period for Parenteral -9%<br />
Continued effort to optimize product mix<br />
Measures in manufacturing:<br />
– Focus on newer, higher margin<br />
products (example MUPS)<br />
– Discontinuation of betalactame<br />
production by the end of 2013<br />
– Aim to qualify Miesbach and<br />
Liesberg sites for FDA regulated<br />
markets<br />
Future: major part of revenue and profit<br />
growth to derive from Operating<br />
Segment Parenteral<br />
6
R&D and development pipeline<br />
Zurich, March 9, 2012<br />
Dr. Jean-Daniel Bonny, Head Group R&D<br />
<strong>Acino</strong> Holding Ltd.<br />
Erlenstrasse 1 | CH-4058 Basle | www.acino-pharma.com<br />
Phone +41 61 338 60 00 | Fax +41 61 338 60 80
R&D organization<br />
Very positive impact of acquisition in the area of oral<br />
dosage forms:<br />
By early 2013: Move from rented labs in Basle<br />
(WRO/Rosental) to own R&D building in Aesch<br />
Savings in rental costs (about EUR 500k from 2013<br />
onwards) and in capital expenditure for equipment<br />
Additional R&D projects enrich <strong>Acino</strong>‘s pipeline<br />
Expansion of expertise and know-how in development<br />
Broadening of our technology platforms:<br />
Microtablets as a complementary addition to pellets.<br />
Own FDA-approved production facility in Aesch lowers<br />
entry barrier to develop projects for US<br />
<strong>Acino</strong><br />
Basel<br />
13,3 km<br />
Mepha<br />
Aesch<br />
8
In-house technologies<br />
Complex, solid oral forms<br />
Locations Liesberg and Aesch,<br />
Switzerland<br />
Focus on MUPS (Multiple Unit Pellet<br />
System)<br />
Both in-house development projects<br />
as well as customer projects<br />
Oxycodone matrix to be submitted in<br />
2012<br />
New: Microtablets<br />
9
In-house technologies<br />
Transdermal systems<br />
Location Miesbach, Germany<br />
Fentanyl & buprenorphine on the market, new formulations with USPs in<br />
development<br />
Rivastigmine EU submitted 2011, US submission targeted 2012<br />
Development and production of a contraceptive patch for Bayer <strong>Health</strong>care<br />
Pharmaceuticals<br />
Additional customer projects under negotiation<br />
10
In-house technologies<br />
Bio-degradable drug implants<br />
Location Miesbach, Germany<br />
Goserelin approved in several B2C<br />
markets, launch in Europe targeted 2013<br />
Leuprorelin launch targeted for 2013<br />
Customer projects are being evaluated<br />
Oral dispersibles<br />
Location Liesberg , Switzerland (and<br />
Miesbach, Germany)<br />
Technology for tablets (ODTs), films<br />
(ODFs) and pellets in stickpacks<br />
Project candidates under evaluation<br />
11
<strong>Acino</strong>’s development pipeline<br />
Preclinical<br />
development<br />
Oral<br />
Depression<br />
Oral<br />
Iron overload, Thalassemia<br />
TDS<br />
Parkinson’s disease<br />
TDS, Fentanyl 3-day (low load)<br />
EU & US, Pain<br />
Implant, Goserelin Japan<br />
Prostate / Mamma carcinoma<br />
(updated March 2012)<br />
5<br />
Clinical<br />
Phase I / Pilot<br />
Oral<br />
Schizophrenia<br />
Oral<br />
Pain<br />
TDS<br />
Pain<br />
TDS<br />
Alzheimer’s disease<br />
Oral*<br />
CNS/Pain<br />
Oral*<br />
Cancer<br />
Oral dispersible*<br />
Urology<br />
* Projects taken over from Mepha. Several additional projects<br />
in evaluation.<br />
Undisclosed:<br />
Additional customer projects in different stages of development.<br />
Clinical<br />
Phase III / Pivotal<br />
Oral<br />
Schizophrenia<br />
Oxycodone Matrix<br />
Pain<br />
TDS, Rivastigmine USA<br />
Alzheimer’s disease<br />
I.V. injection, Iclaprim<br />
Infection<br />
TDS, Contraceptive; customer<br />
project Bayer <strong>Health</strong>care<br />
Legend:<br />
Oral<br />
Oral<br />
dispersible<br />
TDS Implant<br />
In registration<br />
7 4 4<br />
TDS, Rivastigmine EU<br />
Alzheimer’s disease<br />
Implant, Goserelin 3-month<br />
Prostate carcinoma<br />
Implant, Leuprorelin 1-month<br />
Prostate carcinoma<br />
Implant, Leuprorelin 3-month<br />
Prostate carcinoma<br />
20 Number of <strong>Acino</strong> own projects by stage<br />
NCE (new<br />
chemical entity)<br />
Customer<br />
project<br />
12
From 2013 onwards 2-3 projects per year<br />
are expected to get registration approval<br />
Expected launch date<br />
2012 2013 2014 2015 2016 2017<br />
Project<br />
TDS, rivastigmine EU<br />
Implant, leuprorelin 1-month<br />
Implant, leuprorelin 3-month<br />
Implant, goserelin 3-month<br />
Oxycodone matrix<br />
TDS, rivastigmine USA<br />
Project, x0040<br />
Project, x1140<br />
Project, x0410<br />
TDS, fentanyl 3D EU & USA<br />
Project, x1180<br />
Project, x1100<br />
Project, x1120<br />
Implant, goserelin Japan<br />
Project, x0230<br />
Project, x1450<br />
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4<br />
* Former Mepha projects are not included yet<br />
This slide only serves for information purposes and does not represent an offer from <strong>Acino</strong>. <strong>Acino</strong> respects the valid property rights of third parties, therefore developments and<br />
products are only offered under the condition that they are not in violation of third-party rights or only in countries where such rights do not apply.<br />
13
Business strategies & outlook<br />
Zurich, March 9, 2012<br />
Peter Burema, CEO <strong>Acino</strong> Group<br />
<strong>Acino</strong> Holding Ltd.<br />
Erlenstrasse 1 | CH-4058 Basle | www.acino-pharma.com<br />
Phone +41 61 338 60 00 | Fax +41 61 338 60 80
“Old” <strong>Acino</strong>: highly dependent on four<br />
customers and four markets<br />
Top 4 customers: 87%<br />
Product sales 2010<br />
Split by customer / country<br />
40%<br />
Top 4 markets: 60%<br />
3%<br />
5%<br />
10%<br />
Germany France Netherlands UK Rest<br />
(Product sales in end user markets, <strong>Acino</strong> estimate)<br />
42%<br />
15
Decision 2010:<br />
Growth along three dimensions<br />
Broadening of the customer base with generics companies and researchdriven<br />
pharmaceutical companies<br />
Marketing under the <strong>Acino</strong> Switzerland-Logo: in emerging markets (Middle<br />
East, North Africa, Subsaharan-Africa, Latin America, CIS and Asia)<br />
Development focused on promising niche products and complex drug<br />
delivery formulations<br />
Targeted M&A activities as complementary measure<br />
16
3-pillar business model of <strong>Acino</strong><br />
Accelerated growth<br />
Growth through acquisitions: targeted M&A activities<br />
Organic growth: high investments, exploit synergies & untapped potential<br />
B2B/Outlicensing<br />
<strong>Acino</strong><br />
Brand Marketing<br />
Drug Delivery<br />
Solutions<br />
17
What changes after the<br />
Mepha/Cephalon Acquisition?<br />
18
The acquisition includes:<br />
The marketing authorizations for a portfolio of 28 products from Mepha and<br />
the former Cephalon for Middle East, Africa, Latin America & Asia<br />
Direct presence in 60 countries<br />
The Mepha/Cephalon product and umbrellar brands for these regions<br />
All intellectual property for these products/brands<br />
All existing contracts with suppliers and distributors<br />
The inventory for these markets<br />
Part of the Mepha R&D pipeline<br />
The manufacturing, R&D and corporate office facilities in Aesch<br />
Manufacturing contracts with TEVA for former intercompany sales<br />
19
The manufacturing, R&D and<br />
corporate office facilities in Aesch<br />
20
Acquired business perfectly fits <strong>Acino</strong><br />
In line with <strong>Acino</strong>’s 3-pillar growth strategy<br />
Identical approach with regard to branded drugs/“branded generics”<br />
“Swissness” efficiently promoted in emerging markets:<br />
– Swiss/EU quality standards a differentiating feature<br />
– Preference for drugs manufactured in Switzerland/EU<br />
Portfolio for emerging markets:<br />
– <strong>Acino</strong> very active in the registration of products from own development<br />
– Product portfolios complement each other ideally<br />
Synergies in the commerical infrastructure; highly motivated Mepha /<br />
Cephalon sales team<br />
Expansion of R&D know-how: products with sophisticated galenical forms,<br />
complementary to <strong>Acino</strong>’s own expertise<br />
21
Share price development<br />
(last 6 months)<br />
120<br />
110<br />
100<br />
90<br />
80<br />
70<br />
60<br />
14 Oct 2011<br />
<strong>Acino</strong> to acquire<br />
Mepha / Cephalon's<br />
Middle East and<br />
African business<br />
19 Dec 2011<br />
<strong>Acino</strong> and Teva sign deal to<br />
complete acquisition of<br />
Mepha's production and R&D<br />
facilities and MENA / LATAM /<br />
Asian businesses<br />
ACIN<br />
SPI (adjusted)<br />
22
The “new” <strong>Acino</strong>: broad customer base<br />
and activities in >130 countries<br />
23
<strong>Acino</strong>’s revenue nearly doubling<br />
after acquisition<br />
EUR<br />
million<br />
Revenue development<br />
2004-2011A: actual sales<br />
2011E: with full-year sales of acquired<br />
Mepha/Cephalon business<br />
2012E: outlook 2012<br />
Mepha/Cephalon<br />
2011E EUR 105 million<br />
Outlook: total revenue<br />
2012E EUR 240-260 million<br />
24
Geographic break-down of revenue<br />
Main countries 2010<br />
Main countries/regions 2011<br />
plus acquired business<br />
(pro forma)<br />
(Product sales in end user markets, <strong>Acino</strong> estimate) (Product sales in end user markets, <strong>Acino</strong> estimate)<br />
25
Cephalon/Mepha portfolio<br />
Sales contribution by key products<br />
26
Our past and future strengths<br />
Expansion of our B2B/outlicensing business in existing and new markets<br />
Expansion of our technology platforms in Liesberg, Miesbach and Aesch<br />
New customer acquisition thanks to our expertise in the manufacturing of<br />
pellets/microtablets as well as patches and implants<br />
Excellent starting position with high Swiss/EU quality standards<br />
Effective and goal-oriented product development<br />
Contract manufacturing of novel higher margin products (NCE, new<br />
chemical entity)<br />
27
Mepha business integration<br />
progress<br />
2012 2013 2014<br />
Preparatory work for integration active since January 2012<br />
Closing February 17, 2012<br />
Combined global commercial structure operational since day 1<br />
New R&D structure (including regulatory) established<br />
Combined technical operations structures by June 2012<br />
Finance, HR and IT systems will run in parallel until H2 2012<br />
Financial reporting will be adapted to reflect the 3-pillar strategy<br />
Basel activities will be moved to Aesch by end 2012<br />
Mepha main warehouse activities transferred to <strong>Acino</strong><br />
premises by January 2013<br />
Mepha/Cephalon name in the<br />
markets to be changed to <strong>Acino</strong><br />
over a 2 year period<br />
28
Key Facts: <strong>Acino</strong> TODAY<br />
Fourth largest listed Swiss pharmaceutical company<br />
(<strong>Acino</strong> Holding Ltd., domiciled in Basle, listed at the SIX Swiss Exchange: ACIN)<br />
7 sites worldwide: 4x Switzerland (Basle, 2x Aesch, Liesberg), 1x Miesbach<br />
(DE), 1x Paris (FR), 1x Panama (LATAM)<br />
About 870 employees from over 40 nations<br />
46 products for own brand marketing in various international territories<br />
Marketing partnerships in over 130 countries<br />
– Own brand marketing in over 80 countries (~380 marketing & sales staff)<br />
– B2B/Outlicensing in more than 50 additional countries<br />
29
<strong>Acino</strong> – our shared vision<br />
We are successful on a worldwide basis and a benchmark for<br />
quality and innovative conception of pharmaceuticals – and<br />
proud of our commitment to enhance quality of life.<br />
30
<strong>Acino</strong> – <strong>Delivering</strong> <strong>Health</strong><br />
Thank you for<br />
your attention<br />
31