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State of the Art in Outsourcing

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CROs<br />

<strong>State</strong> <strong>of</strong> <strong>the</strong> <strong>Art</strong> <strong>in</strong> Outsourc<strong>in</strong>g<br />

• Despite M&A disruption, long-term outsourc<strong>in</strong>g trends should rema<strong>in</strong> healthy.<br />

Faced with significant patent cliffs (>$110bn worth <strong>of</strong> drugs <strong>of</strong>f patent by 2015),<br />

<strong>in</strong>effective R&D, ris<strong>in</strong>g cl<strong>in</strong>ical trial costs, and more str<strong>in</strong>gent FDA requirements,<br />

biopharmaceutical companies have <strong>in</strong>creas<strong>in</strong>gly turned to M&A (PFE/WYE,<br />

MRK/SGP, Roche/DNA, etc.), pipel<strong>in</strong>e rationalization, and outsourced research to<br />

control costs and improve operat<strong>in</strong>g performance. With new management at <strong>the</strong><br />

helm <strong>of</strong> all major pharmaceutical companies, cost cutt<strong>in</strong>g (<strong>in</strong>cl. R&D) is expected to<br />

accelerate with <strong>the</strong> close <strong>of</strong> M&A deals over <strong>the</strong> next several quarters, although we<br />

expect <strong>the</strong> focus on outsourc<strong>in</strong>g to also <strong>in</strong>crease as companies look to embrace a<br />

more variable cost structure and rebuild anemic pipel<strong>in</strong>es.<br />

• From niche providers to strategic partners. Orig<strong>in</strong>ally positioned as niche service<br />

providers <strong>in</strong> <strong>the</strong> 1970s, contract research organizations (CROs) have expanded<br />

greatly <strong>in</strong> number and scope, although today <strong>the</strong> $22bn market for outsourced<br />

research is still under-penetrated (~29% <strong>of</strong> drug development spend<strong>in</strong>g outsourced),<br />

highly fragmented, and <strong>in</strong> our view ripe for share ga<strong>in</strong>s for more nimble and<br />

strategic providers. With expectations for low double-digit <strong>in</strong>dustry growth longer<br />

term, we believe that larger and more strategic precl<strong>in</strong>ical and cl<strong>in</strong>ical companies,<br />

such as CVD, CRL, ICLR, and PPDI, will be positioned to capture grow<strong>in</strong>g share,<br />

driven by economies <strong>of</strong> scale, more diversified revenue streams, and <strong>the</strong> f<strong>in</strong>ancial<br />

flexibility for M&A and asset transfer (i.e. CVD/LLY) at <strong>the</strong> expense <strong>of</strong> smaller<br />

CROs.<br />

• M&A, overcapacity, and pric<strong>in</strong>g rema<strong>in</strong> near-term but manageable, challenges.<br />

While companies such as PFE have openly discussed plans for additional R&D cuts<br />

(PFE is cutt<strong>in</strong>g at least $1.2bn <strong>in</strong> R&D as part <strong>of</strong> <strong>the</strong> WYE <strong>in</strong>tegration, most likely<br />

more), <strong>the</strong> upshot is that many companies are also embrac<strong>in</strong>g a more variable cost<br />

structure, <strong>in</strong>cl. evaluat<strong>in</strong>g a broader range <strong>of</strong> strategic outsourc<strong>in</strong>g opportunities.<br />

Look<strong>in</strong>g at <strong>the</strong> announced transactions, WYE, MRK, and SGP do little outsourc<strong>in</strong>g<br />

(MRK contracts out ~5% <strong>of</strong> R&D and began contract<strong>in</strong>g out phase III work a year<br />

ago), and as a result consolidation is likely to prove a tipp<strong>in</strong>g po<strong>in</strong>t, with a<br />

disproportionate number <strong>of</strong> projects flow<strong>in</strong>g to preferred vendors (<strong>the</strong> preferred part<br />

be<strong>in</strong>g key, as smaller CROs are <strong>of</strong>ten deemed unqualified). MRK and LLY have also<br />

shifted <strong>the</strong> bus<strong>in</strong>ess model from FIPCO (fully <strong>in</strong>tegrated pharmaceutical company)<br />

to FIPNET (fully <strong>in</strong>tegrated pharmaceutical network), which places a greater<br />

emphasis on external collaborations.<br />

• We <strong>in</strong>itiate coverage <strong>of</strong> Covance (CVD, $48.65) and ICON (ICLR, $22.50), both<br />

with an Overweight rat<strong>in</strong>g. We believe that best-<strong>in</strong>-breed CROs will emerge <strong>in</strong> a<br />

position <strong>of</strong> strength follow<strong>in</strong>g <strong>the</strong> close <strong>of</strong> major M&A transactions and accord<strong>in</strong>gly<br />

that <strong>the</strong> best approach is to own both CVD and ICLR, while <strong>in</strong> <strong>the</strong> near term we<br />

rema<strong>in</strong> cautious on earlier stage CROs <strong>in</strong> our universe (CRL, WX) given limited<br />

visibility on a return to early stage fund<strong>in</strong>g.<br />

North America Equity Research<br />

16 July 2009<br />

Medical & Life Science<br />

Technology<br />

Tycho W. Peterson AC<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Sung Ji Nam<br />

(1-212) 622-4958<br />

sung.j.nam@jpmchase.com<br />

Abigail Darby<br />

(1-212) 622-6628<br />

abigail.w.darby@jpmorgan.com<br />

J.P. Morgan Securities Inc.<br />

See page 47 for analyst certification and important disclosures.<br />

J.P. Morgan does and seeks to do bus<strong>in</strong>ess with companies covered <strong>in</strong> its research reports. As a result, <strong>in</strong>vestors should be aware that <strong>the</strong> firm may<br />

have a conflict <strong>of</strong> <strong>in</strong>terest that could affect <strong>the</strong> objectivity <strong>of</strong> this report. Investors should consider this report as only a s<strong>in</strong>gle factor <strong>in</strong> mak<strong>in</strong>g <strong>the</strong>ir<br />

<strong>in</strong>vestment decision. Customers <strong>of</strong> J.P. Morgan <strong>in</strong> <strong>the</strong> United <strong>State</strong>s can receive <strong>in</strong>dependent, third-party research on <strong>the</strong> company or companies<br />

covered <strong>in</strong> this report, at no cost to <strong>the</strong>m, where such research is available. Customers can access this <strong>in</strong>dependent research at<br />

www.morganmarkets.com or can call 1-800-477-0406 toll free to request a copy <strong>of</strong> this research.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

2<br />

North America Equity Research<br />

16 July 2009<br />

Table <strong>of</strong> Contents<br />

Key Investment Po<strong>in</strong>ts .............................................................3<br />

CRO Industry Overview ...........................................................4<br />

Understand<strong>in</strong>g Drug Development .........................................9<br />

Precl<strong>in</strong>ical ....................................................................................................................9<br />

Cl<strong>in</strong>ical.......................................................................................................................10<br />

Near-term CRO <strong>in</strong>dustry challenges..........................................................................18<br />

O<strong>the</strong>r trends to watch.................................................................................................28<br />

Competitive Landscape .........................................................34<br />

Precl<strong>in</strong>ical ..................................................................................................................35<br />

Cl<strong>in</strong>ical.......................................................................................................................37<br />

The author acknowledges <strong>the</strong> contribution <strong>of</strong> Navneet Chahal <strong>of</strong> J.P. Morgan<br />

Services India Private Ltd., Mumbai, to this report.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Key Investment Po<strong>in</strong>ts<br />

Underly<strong>in</strong>g CRO trends should rema<strong>in</strong> healthy longer term<br />

Despite <strong>the</strong> challenges <strong>of</strong> pharmaceutical restructur<strong>in</strong>g, M&A (Pfizer/Wyeth,<br />

Merck/Scher<strong>in</strong>g, etc.), and a difficult f<strong>in</strong>anc<strong>in</strong>g environment for biotech companies,<br />

<strong>the</strong> $22 billion market for precl<strong>in</strong>ical and cl<strong>in</strong>ical research organizations, or CROs,<br />

rema<strong>in</strong>s under-penetrated, fragmented, and ripe for share ga<strong>in</strong>s for more nimble and<br />

strategically positioned providers. Reimbursement pressure and pend<strong>in</strong>g patent cliffs<br />

(over $110 billion worth <strong>of</strong> drugs go<strong>in</strong>g <strong>of</strong>f patent by 2015) have fur<strong>the</strong>r exacerbated<br />

<strong>the</strong> challenge for drug developers, as have <strong>the</strong> ris<strong>in</strong>g costs <strong>of</strong> cl<strong>in</strong>ical trials, although<br />

with new management at <strong>the</strong> helm <strong>of</strong> all major pharmaceutical companies, we expect<br />

<strong>the</strong> shift toward outsourc<strong>in</strong>g will cont<strong>in</strong>ue. As such, despite <strong>the</strong> near-term disruption<br />

<strong>of</strong> R&D cuts, we rema<strong>in</strong> favorably biased on <strong>the</strong> underly<strong>in</strong>g trends and, longer-term,<br />

toward early stage providers, which should ultimately benefit as capacity utilization<br />

beg<strong>in</strong>s to normalize and <strong>the</strong> pendulum sw<strong>in</strong>gs back to basic research, although this<br />

may take at least a year, if not more.<br />

Flight to quality expected to cont<strong>in</strong>ue<br />

Despite near-term headw<strong>in</strong>ds, we believe that <strong>the</strong> CRO <strong>in</strong>dustry rema<strong>in</strong>s positioned<br />

for at least 7-8% growth (and potentially low double0digit growth) over <strong>the</strong> next<br />

several years, with better positioned companies such as Covance, Charles River,<br />

ICON, and PPDI able to capture market share. Key to our <strong>the</strong>sis is <strong>the</strong> view that<br />

larger precl<strong>in</strong>ical and cl<strong>in</strong>ical CROs will cont<strong>in</strong>ue to benefit from economies <strong>of</strong> scale,<br />

diversified revenue streams, strong reputations, and <strong>the</strong> f<strong>in</strong>ancial flexibility for M&A<br />

and asset transfer (e.g., Covance/Eli Lilly). As customers move toward more variable<br />

cost structures, we also expect <strong>the</strong> natural wean<strong>in</strong>g process to accelerate, putt<strong>in</strong>g<br />

additional pressure on smaller service providers (MPI, WIL, Pharmanet, PRAI, etc.).<br />

M&A, overcapacity, and pric<strong>in</strong>g rema<strong>in</strong> near-term, but manageable, challenges<br />

While companies such as Pfizer have openly discussed plans for additional R&D cuts<br />

(Pfizer is cutt<strong>in</strong>g at least $1.2 billion <strong>in</strong> R&D as part <strong>of</strong> <strong>the</strong> Wyeth <strong>in</strong>tegration, most<br />

likely more), <strong>the</strong> upshot is that many companies are also embrac<strong>in</strong>g a more variable<br />

cost structure, <strong>in</strong>clud<strong>in</strong>g evaluat<strong>in</strong>g a broader range <strong>of</strong> strategic outsourc<strong>in</strong>g<br />

opportunities. Look<strong>in</strong>g at <strong>the</strong> announced transactions, Wyeth, Merck and Scher<strong>in</strong>g do<br />

little outsourc<strong>in</strong>g (Merck contracts out ~5% <strong>of</strong> R&D and only began contract<strong>in</strong>g out<br />

phase III work a year ago), and as a result consolidation is likely to prove a tipp<strong>in</strong>g<br />

po<strong>in</strong>t, with a disproportionate number <strong>of</strong> projects flow<strong>in</strong>g to preferred vendors (<strong>the</strong><br />

preferred part be<strong>in</strong>g key, as smaller CROs are <strong>of</strong>ten deemed unqualified). Merck and<br />

Eli Lilly have also shifted <strong>the</strong> bus<strong>in</strong>ess model from FIPCO (fully <strong>in</strong>tegrated<br />

pharmaceutical company) to FIPNET (fully <strong>in</strong>tegrated pharmaceutical network),<br />

which places a greater emphasis on external collaborations.<br />

We <strong>in</strong>itiate coverage <strong>of</strong> Covance (CVD, $48.65) and ICON (ICLR, $22.50), both<br />

with an Overweight rat<strong>in</strong>g<br />

We believe that best-<strong>in</strong>-breed CROs will emerge <strong>in</strong> a position <strong>of</strong> strength follow<strong>in</strong>g<br />

<strong>the</strong> close <strong>of</strong> major M&A transactions and accord<strong>in</strong>gly that <strong>the</strong> best approach is to<br />

own both Covance and ICON, while <strong>in</strong> <strong>the</strong> near term we rema<strong>in</strong> cautious on earlier<br />

stage CROs <strong>in</strong> our universe (Charles River, WuXi) given limited visibility on a<br />

return to early stage fund<strong>in</strong>g.<br />

3


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

4<br />

North America Equity Research<br />

16 July 2009<br />

CRO Industry Overview<br />

Contract research organizations (CROs) provide an <strong>in</strong>creas<strong>in</strong>gly broad range <strong>of</strong><br />

research and development services for pharmaceutical, biotech, medical, and<br />

academic customers, <strong>in</strong>clud<strong>in</strong>g product development and formulation, cl<strong>in</strong>ical trial<br />

management, central laboratory services, and data management for regulatory fil<strong>in</strong>gs<br />

(IND, NDA, etc.).<br />

Drug sponsors typically contract CROs to assist <strong>in</strong> tak<strong>in</strong>g products from early stage<br />

development through trials (precl<strong>in</strong>ical through phase IV), FDA approval, and <strong>in</strong><br />

some cases post market surveillance, with <strong>the</strong> primary value drivers be<strong>in</strong>g a shift<br />

from fixed to variable costs and added expertise across select <strong>the</strong>rapeutic areas.<br />

Figure 1: CRO Market Summary<br />

Total R&D<br />

Spend:<br />

~$110 Billion<br />

Research<br />

~$36B<br />

Development<br />

~$74B<br />

Source: Covance. 2008 data.<br />

Development<br />

Spend:<br />

~$74 Billion<br />

Internal<br />

~$53B<br />

Outsourced<br />

~$21.5B<br />

CRO<br />

Industry:<br />

~$21.5 Billion<br />

“O<strong>the</strong>r”<br />

Late-Stage<br />

Development<br />

~$12.4B<br />

Early<br />

Development<br />

~$6.1B<br />

CROs saw <strong>the</strong> first significant growth wave <strong>in</strong> <strong>the</strong> 1980s as pharmaceutical<br />

companies moved to outsource overflow projects, although demand and capacity<br />

utilization (and accord<strong>in</strong>gly, marg<strong>in</strong>s) rema<strong>in</strong>ed volatile.<br />

In 1994 Qu<strong>in</strong>tiles became <strong>the</strong> first public CRO, followed by Parexel and PPD (1996)<br />

and Covance (1997).<br />

Industry demand rema<strong>in</strong>ed strong for several years until pharmaceutical M&A led to<br />

a wave <strong>of</strong> cancelled and delayed projects beg<strong>in</strong>n<strong>in</strong>g <strong>in</strong> 2000. With excess capacity, a<br />

number <strong>of</strong> companies were forced to bid for projects at unpr<strong>of</strong>itable levels, and with<br />

multi-year contracts <strong>of</strong>ten <strong>in</strong> place, <strong>the</strong> fallout dampened earn<strong>in</strong>gs, lowered marg<strong>in</strong>s,<br />

and caused multiple contractions well <strong>in</strong>to 2003.<br />

However, <strong>the</strong> proliferation <strong>of</strong> specialty pharmaceutical and biotechnology companies<br />

<strong>in</strong> early 2000s led to a second growth wave for CROs as smaller companies, which<br />

<strong>of</strong>ten lacked <strong>the</strong> full capabilities needed for drug development, began outsourc<strong>in</strong>g an


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

<strong>in</strong>creas<strong>in</strong>gly broad range <strong>of</strong> precl<strong>in</strong>ical and cl<strong>in</strong>ical projects. At <strong>the</strong> same time,<br />

pharmaceutical companies began to embrace outsourc<strong>in</strong>g more strategically, as a<br />

means to conta<strong>in</strong> costs and address an <strong>in</strong>creas<strong>in</strong>gly global landscape.<br />

Figure 2: Number <strong>of</strong> Drugs <strong>in</strong> Development WW by Biopharmaceutical Companies<br />

No. <strong>of</strong> Drugs<br />

12000<br />

10000<br />

8000<br />

6000<br />

4000<br />

2000<br />

0<br />

Source: Pharmaprojects.<br />

5930 6046 5889<br />

No. <strong>of</strong> Drugs <strong>in</strong> Development<br />

6198 6416<br />

6994<br />

7360 7322 7406<br />

7737<br />

9217<br />

9605<br />

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009<br />

Year<br />

No. <strong>of</strong> Drugs<br />

Today, it is estimated that pharmaceutical and biotechnology companies spend over<br />

$110 billion on research and development ($36 billion on research, $74 billion on<br />

development), <strong>of</strong> which an estimated $22 billion is outsourced, <strong>in</strong>clud<strong>in</strong>g $6.1 billion<br />

<strong>in</strong>to early stage and $12.4 billion <strong>in</strong>to late stage development. Given <strong>the</strong> strong<br />

growth for outsourced services, we expect <strong>the</strong> market could grow to over $35 billion<br />

<strong>in</strong> <strong>the</strong> next 3-4 years.<br />

5


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

6<br />

North America Equity Research<br />

16 July 2009<br />

Figure 3: Total Number <strong>of</strong> Innovative Drugs Approved (1996-2008)<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

3<br />

53<br />

6<br />

39<br />

7<br />

30<br />

3<br />

35<br />

2<br />

27<br />

5<br />

24<br />

7<br />

17<br />

6<br />

21<br />

5<br />

31<br />

2<br />

4<br />

18 18<br />

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008<br />

Source: Nature Reviews Drug Discovery, February 2009.<br />

Figure 4: Late Stage Pipel<strong>in</strong>e Rema<strong>in</strong>s Light<br />

NMEs BLAs<br />

Source: Pharmaprojects. P = Precl<strong>in</strong>ical; C1 = Cl<strong>in</strong>ical Phase I, C2 = Cl<strong>in</strong>ical Phase II; C3 = Cl<strong>in</strong>ical Phase III; PR = Pre-Registration;<br />

R = Registered; L = Launched; S = Suspended.<br />

At <strong>the</strong> heart <strong>of</strong> <strong>the</strong> CRO <strong>in</strong>dustry is a cont<strong>in</strong>ued focus by biopharmaceutical<br />

companies to improve marg<strong>in</strong>s and pr<strong>of</strong>itability. While <strong>the</strong>re are some advantages <strong>in</strong><br />

time, given that an average drug development campaign lasts 6-8 years, <strong>the</strong> key<br />

advantage stems from shift<strong>in</strong>g personnel and facilities from fixed to variable costs<br />

and add<strong>in</strong>g services that may not be available <strong>in</strong> house. Cost sav<strong>in</strong>gs can be<br />

significant as revenues for an FTE (full time employee) on CRO payroll can average<br />

$183,200 (for Covance, <strong>in</strong> this case), while with<strong>in</strong> large pharmaceutical companies<br />

<strong>the</strong> cost/employee can be closer to $400,000. The <strong>in</strong>creas<strong>in</strong>g complexity <strong>of</strong> cl<strong>in</strong>ical<br />

trials, a grow<strong>in</strong>g focus on <strong>in</strong>ternational markets, and greater demand for services<br />

2<br />

16<br />

3<br />

21


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

around safety and post market surveillance have also heightened <strong>the</strong> appetite for<br />

outsourced research and development.<br />

In areas such as toxicology, surpris<strong>in</strong>gly little bus<strong>in</strong>ess is outsourced today, with<br />

approximately 70% <strong>of</strong> studies still done with<strong>in</strong> large pharmaceutical facilities.<br />

However, as pharmaceutical and biotech companies consolidate and <strong>in</strong>creas<strong>in</strong>gly<br />

focus on core skills (discovery, strategic development, market<strong>in</strong>g), <strong>the</strong> emphasis on<br />

outsourced research should <strong>in</strong>crease, and we expect that outsourc<strong>in</strong>g levels could<br />

ultimately reach 50-60%, driven by top-l<strong>in</strong>e pressures (i.e., patent expirations,<br />

emergence <strong>of</strong> biosimilars), M&A cost synergies, and a l<strong>in</strong>ger<strong>in</strong>g commitment to<br />

mature, albeit commoditized research methods, such as comb<strong>in</strong>atorial chemistry. As<br />

shown below, <strong>the</strong> cost <strong>of</strong> drug development has also cont<strong>in</strong>ued to escalate, driven by<br />

more complex trials and surveillance needs, and it is estimated that only two out <strong>of</strong><br />

every ten marketed drugs ultimately return revenues that match or exceed <strong>the</strong> R&D<br />

costs. Generics have also taken a grow<strong>in</strong>g share <strong>of</strong> <strong>the</strong> market, account<strong>in</strong>g for 72% <strong>of</strong><br />

sales today from 54% <strong>in</strong> 2003 (source: PhRMA).<br />

Table 1: Drug Development Costs Have Escalated<br />

Cost to develop a drug<br />

2006 $1.318 billion<br />

2001 $802 million<br />

1987 $318 million<br />

1975 $138 million<br />

Cost to develop a biologic<br />

2006 $1.2 billion<br />

Source: PhRMA<br />

The emergence <strong>of</strong> new technologies, such as computer-simulated model<strong>in</strong>g and<br />

targeted market<strong>in</strong>g, which may be easier to buy (i.e., outsource) than build, is also<br />

likely to drive cont<strong>in</strong>ued adoption <strong>of</strong> outsourced services, while <strong>in</strong>creas<strong>in</strong>g regulatory<br />

requirements, <strong>in</strong> particular around post market<strong>in</strong>g surveillance; <strong>the</strong> <strong>in</strong>creased<br />

globalization <strong>of</strong> cl<strong>in</strong>ical trials to regions where large pharma has not historically<br />

conducted research; and <strong>the</strong> emergence <strong>of</strong> “new” <strong>the</strong>rapeutic areas outside <strong>of</strong><br />

historical research are all likely to drive demand for more record keep<strong>in</strong>g and<br />

improved data management go<strong>in</strong>g forward.<br />

Table 2: Cost <strong>of</strong> R&D<br />

Year PhRMA Members Total Industry<br />

2008 $50.3 billion $65.2 billion<br />

2007 $47.9 billion $63.2 billion<br />

2006 $43.4 billion $56.1 billion<br />

2005 $39.9 billion $51.8 billion<br />

2004 $37.0 billion $47.6 billion<br />

2000 $26.0 billion not available<br />

1990 $8.4 billion not available<br />

1980<br />

Source: PhRMA<br />

$2.0 billion not available<br />

F<strong>in</strong>ally, with <strong>the</strong> dramatic reduction <strong>in</strong> genetic analysis costs and grow<strong>in</strong>g effort by<br />

payers to control costs, pharmacogenomics (i.e., personalized medic<strong>in</strong>e) is expected<br />

to play an <strong>in</strong>creas<strong>in</strong>g role, although it rema<strong>in</strong>s early and we do not expect DNA<br />

sequenc<strong>in</strong>g to be <strong>in</strong>corporated <strong>in</strong>to cl<strong>in</strong>ical trials for at least ano<strong>the</strong>r decade. In <strong>the</strong><br />

<strong>in</strong>terim, as shown below, an <strong>in</strong>creas<strong>in</strong>g number <strong>of</strong> approved drugs have genetic tests<br />

associated with use, three <strong>of</strong> which are now mandated.<br />

7


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

8<br />

North America Equity Research<br />

16 July 2009<br />

Table 3: Some <strong>of</strong> <strong>the</strong> Drugs with Companion Diagnostics on <strong>the</strong> Label<br />

Biomarker Drug O<strong>the</strong>r Drugs Associated with Biomarker<br />

C-KIT expression Imat<strong>in</strong>ibmesylate<br />

CYP2C19 Variants Voriconazole Omeprazole, Pantoprazole, Esomeprazole<br />

diazepam, Nelf<strong>in</strong>avir, Rabeprazole<br />

CYP2C9 Variants Warfar<strong>in</strong><br />

CYP2D6 Variants Atomoxet<strong>in</strong>e Venlafax<strong>in</strong>e, Risperidone, Tiotropium<br />

CYP2D6 with alternate<br />

Context<br />

Source: www.FDA.gov<br />

bromide, Tamoxifen, Timolol, Maleate<br />

Fluoxet<strong>in</strong>e HCL Fluoxet<strong>in</strong>e HCL, Olanzap<strong>in</strong>e, Cevimel<strong>in</strong>e<br />

hydrochloride, Tolterod<strong>in</strong>e, Tolterod<strong>in</strong>e,<br />

Terb<strong>in</strong>af<strong>in</strong>e, Tramadol + Acetamophen,<br />

Clozap<strong>in</strong>e, Aripiprazole, Metoprolol,<br />

Propranolol, Carvedilol, Propafenone,<br />

Thioridaz<strong>in</strong>e, Protriptyl<strong>in</strong>e HCl


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Understand<strong>in</strong>g Drug Development<br />

Drug development rema<strong>in</strong>s a highly risky, time consum<strong>in</strong>g, and expensive affair for<br />

biopharmaceutical companies. Average costs <strong>in</strong>curred <strong>in</strong> <strong>the</strong> development <strong>of</strong> a drug<br />

run close to $1.3 billion (or $1.2 billion for biologics), and it is estimated that only 1<br />

<strong>in</strong> 5,000 candidate compounds ultimately make it to market.<br />

Figure 5: The Pharma R&D Process<br />

Pre-discovery<br />

Drug<br />

Discovery<br />

5,000-10,000<br />

Compounds<br />

Cl<strong>in</strong>ical Trials<br />

Precl<strong>in</strong>ical Phase 1 Phase 2 Phase 3<br />

250 5<br />

Number <strong>of</strong> Volunteers:<br />

20-100 100-500 1,000-5,000<br />

FDA<br />

Review<br />

3-6 years 6-7 years ½-2 years<br />

IND<br />

submitted<br />

Source: PhRMA's Pharmaceutical Industry Pr<strong>of</strong>ile 2009<br />

Figure 6: Understand<strong>in</strong>g <strong>the</strong> New Drug Development Paradigm<br />

Source: Ba<strong>in</strong> & Company<br />

NDA<br />

submitted<br />

Large-<br />

Scale Mfg<br />

One FDA-<br />

Approved Drug<br />

Precl<strong>in</strong>ical<br />

Precl<strong>in</strong>ical studies <strong>in</strong>volve <strong>in</strong> vitro (test tube) and <strong>in</strong> vivo (animal) test<strong>in</strong>g to decide<br />

whe<strong>the</strong>r a study drug is reasonably safe to be adm<strong>in</strong>istered to research subjects (i.e.,<br />

“first <strong>in</strong> human” studies) and can be advanced as an <strong>in</strong>vestigational new drug (IND).<br />

Only after an IND application is approved can a drug enter phase I cl<strong>in</strong>ical trials,<br />

although notably 80% <strong>of</strong> candidate drugs fail dur<strong>in</strong>g <strong>the</strong> precl<strong>in</strong>ical development<br />

stage. Toge<strong>the</strong>r with Phase I studies, early activities account for approximately 25%<br />

9<br />

Phase 4: Post-market<strong>in</strong>g surveillance<br />

surveillance<br />

surveillance


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

10<br />

North America Equity Research<br />

16 July 2009<br />

<strong>of</strong> CRO revenues and generally require high fixed costs and, depend<strong>in</strong>g on <strong>the</strong> area,<br />

can be highly pr<strong>of</strong>itable. Major services <strong>in</strong>clude:<br />

• Toxicology: Services <strong>in</strong>clude <strong>the</strong> determ<strong>in</strong>ation <strong>of</strong> safe start<strong>in</strong>g doses, effects on<br />

target organs, reversibility and exposure levels. Studies, 70% <strong>of</strong> which are still<br />

done <strong>in</strong> house with<strong>in</strong> large pharmaceutical companies (much greater levels <strong>of</strong><br />

outsourc<strong>in</strong>g at biotech), are typically done on animals and cells to determ<strong>in</strong>e <strong>the</strong><br />

toxicity <strong>of</strong> a drug and metabolites, with results <strong>the</strong>n extrapolated to human<br />

research subjects (FDA requires that new drug candidates be tested on two<br />

species <strong>of</strong> animals for safety assessment before a drug can move to human<br />

models). Studies can <strong>in</strong>volve <strong>the</strong> determ<strong>in</strong>ation <strong>of</strong> acute, subacute, and chronic<br />

toxicity, carc<strong>in</strong>ogenicity, mutagenicity, and teratogenicity as well as <strong>the</strong> effects <strong>of</strong><br />

a drug on <strong>the</strong> reproductive system. Early toxicology work is <strong>of</strong>ten done <strong>in</strong> vitro<br />

on cultured bacteria or cells, while subsequent <strong>in</strong> vivo studies, which test a drug<br />

on animals (rodents, dogs, primates), are more commonly outsourced to CROs.<br />

Toxicology typically requires an <strong>in</strong>vestment <strong>in</strong> dedicated laboratory space, and a<br />

number <strong>of</strong> CROs have built facilities that match or exceed <strong>in</strong>-house capabilities<br />

<strong>of</strong> major pharmaceutical companies.<br />

• Chemistry: In chemistry studies, factors such as stability, solubility, metabolic<br />

stability, absorption, bioavailability, and compound half life are evaluated. Ease<br />

<strong>of</strong> manufactur<strong>in</strong>g and formulation are also determ<strong>in</strong>ed and evaluated before <strong>the</strong><br />

cl<strong>in</strong>ical trial stage. O<strong>the</strong>r services may <strong>in</strong>clude develop<strong>in</strong>g a pharmacological<br />

pr<strong>of</strong>ile and evaluat<strong>in</strong>g drug absorption, distribution, metabolism and excretion<br />

(ADME), which are essential to <strong>the</strong> successful launch <strong>of</strong> <strong>the</strong> drug. Chemistry labs<br />

can also serve o<strong>the</strong>r <strong>in</strong>dustries (agricultural, nutritional) by study<strong>in</strong>g <strong>the</strong> potential<br />

risk <strong>of</strong> a compound to humans, analyz<strong>in</strong>g nutritional content, etc.<br />

• O<strong>the</strong>r (research products, laboratory services, etc.): CRO laboratories also<br />

leverage <strong>in</strong>frastructure and know-how to provide clients with a number <strong>of</strong><br />

specialized products and services. Examples <strong>in</strong>clude polyclonal and monoclonal<br />

antibody services, validated assays, or purpose bred animals. The creation <strong>of</strong> such<br />

products, which are used <strong>in</strong> early stage test<strong>in</strong>g, are typically standardized enough<br />

to be outsourced.<br />

Cl<strong>in</strong>ical<br />

• Phase I: Phase I studies <strong>in</strong>volve test<strong>in</strong>g an experimental drug or treatment for <strong>the</strong><br />

first time on a small group (20-80 people) <strong>of</strong> generally healthy <strong>in</strong>dividuals, over<br />

<strong>the</strong> course <strong>of</strong> six to twelve months to evaluate safety (pharmacovigilance), dosage<br />

and side effects. Because Phase I studies are <strong>in</strong>patient trials, <strong>the</strong>y require<br />

significant fixed costs, <strong>in</strong>clud<strong>in</strong>g overnight facilities for patients and full-time<br />

medical staff (Phase I and IIa trials are <strong>of</strong>ten referred to by <strong>the</strong> broader term <strong>of</strong><br />

“cl<strong>in</strong>ical pharmacology”). A study <strong>of</strong> drug pharmacok<strong>in</strong>etics (what does <strong>the</strong> body<br />

do to <strong>the</strong> drug) and pharmacodynamics (what does <strong>the</strong> drug do to <strong>the</strong> body) is<br />

also done at this stage, as are label<strong>in</strong>g studies (drug/drug <strong>in</strong>teraction; food/drug<br />

<strong>in</strong>teraction; etc.)<br />

Phase II and III<br />

Phase II and III studies are <strong>the</strong> bread and butter <strong>of</strong> <strong>the</strong> CRO <strong>in</strong>dustry, represent<strong>in</strong>g<br />

over 25% <strong>of</strong> overall <strong>in</strong>dustry revenues. Less capital <strong>in</strong>tensive than Phase I, Phase II<br />

studies <strong>of</strong>fer large and lucrative contracts that typically run 2-4 years <strong>in</strong> length.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

• Phase II: In Phase II studies, a drug/treatment is tested on a group <strong>of</strong> 100-300<br />

people to study effectiveness and fur<strong>the</strong>r evaluate safety. Phase II studies can be<br />

divided <strong>in</strong>to Phase IIA (dosage requirements) and Phase IIB (efficacy), and<br />

protocol design is critical as each new study requires unique endpo<strong>in</strong>ts,<br />

<strong>in</strong>clusion/exclusion criteria, and drug adm<strong>in</strong>istration processes. Designers must<br />

also decide what data to collect, layout <strong>of</strong> <strong>the</strong> case report form (CRF), and what<br />

statistical analysis will be used to draw conclusions.<br />

• Phase III: Phase III trials <strong>in</strong>volve test<strong>in</strong>g on larger groups (1,000-3,000 people)<br />

to confirm effectiveness and side effects, weigh aga<strong>in</strong>st commonly used<br />

treatments, and compile safety <strong>in</strong>formation. Follow<strong>in</strong>g successful completion <strong>of</strong><br />

Phase III trials, an NDA/BLA is filed with FDA.<br />

• Phase IV/Post Approval: Phase IV trials <strong>in</strong>volve post market<strong>in</strong>g studies,<br />

<strong>in</strong>clud<strong>in</strong>g safety surveillance (pharmacovigilance) to detect rare or long-term<br />

adverse effects. In <strong>the</strong> event that harmful effects are discovered, drug sales may<br />

be halted or restricted to certa<strong>in</strong> uses.<br />

Figure 7: Biopharma R&D Spend by Stage<br />

30.0%<br />

25.0%<br />

20.0%<br />

15.0%<br />

10.0%<br />

5.0%<br />

0.0%<br />

27.3%<br />

Discovery/<br />

Precli ni cal<br />

7.4%<br />

Source: PhRMA, 2009 Annual Membership Survey<br />

13.0%<br />

28.5%<br />

5.0%<br />

13.4%<br />

5.2%<br />

Phase I Phase II Phase III Approval Phase IV Uncategorized<br />

Industry R&D spend<strong>in</strong>g has rema<strong>in</strong>ed stable, despite macroeconomic backdrop<br />

In 2008 U.S.-based pharmaceutical and biotech companies <strong>in</strong>vested approximately<br />

$65 billion <strong>in</strong> research and development as compared to $63 billion <strong>in</strong> 2007<br />

accord<strong>in</strong>g to PhRMA (Pharma Pr<strong>of</strong>ile 2009 Report).<br />

Today, <strong>the</strong>re are 2,900 compounds <strong>in</strong> <strong>the</strong> U.S. biopharmaceutical pipel<strong>in</strong>e await<strong>in</strong>g<br />

FDA review.<br />

11


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

12<br />

North America Equity Research<br />

16 July 2009<br />

Figure 8: Recent BioPharma R&D Spend<strong>in</strong>g Trend Has Been Steady<br />

$70.0<br />

$63.2<br />

$60.0<br />

$50.0<br />

$40.0<br />

$30.0<br />

$20.0<br />

$10.0<br />

$0.0<br />

$47.6<br />

$51.8<br />

$56.1<br />

$65.2<br />

2004 2005 2006 2007 2008<br />

Source: PhRMA, Pharmaceutical Industry Pr<strong>of</strong>ile 2009<br />

Table 4: Top R&D Spenders <strong>in</strong> 2008<br />

Company 2008 budget ($ <strong>in</strong> billions)<br />

Roche $8.18<br />

Pfizer $7.95<br />

Johnson & Johnson $7.58<br />

Novartis $7.21<br />

GlaxoSmithKl<strong>in</strong>e $6.83<br />

San<strong>of</strong>i-Aventis $6.74<br />

AstraZeneca $5.18<br />

Merck & Co. $4.81<br />

Takeda $4.58<br />

Eli Lilly $3.84<br />

Bristol-Myers Squibb $3.59<br />

Scher<strong>in</strong>g-Plough $3.53<br />

Wyeth $3.37<br />

Boehr<strong>in</strong>ger Ingelheim $3.11<br />

Amgen $3.03<br />

Genentech $2.80<br />

Abbott $2.69<br />

Bayer $2.57<br />

Daiichi Sankyo $1.89<br />

Astellas Pharma $1.62<br />

Source: PharmaLive.com


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Table 5: Top 20 Biopharma (by R&D Spend <strong>in</strong> 2008) Drugs Await<strong>in</strong>g Approval<br />

Company (2008<br />

R&D <strong>in</strong> US$bn)<br />

Product Disease/Medical Use Region Type <strong>of</strong> Drug<br />

Pegasys Hepatitis B Europe Biotechnology Drug Delivery<br />

Xeloda Colorectal cancer Europe Chemical<br />

Roche<br />

MabThera Chronic lymphocytic leukemia Europe Biotechnology<br />

($8.18bn)<br />

Avast<strong>in</strong><br />

Renal cell carc<strong>in</strong>oma, Colorectal cancer,<br />

Breast Cancer<br />

Europe Biotechnology<br />

Tarceva Non-small cell lung cancer Europe Chemical<br />

Lyrica Fibromyalgia Europe Chemical<br />

Pfizer ($7.95bn)<br />

Fablyn<br />

Oporia<br />

Osteoporosis<br />

Vag<strong>in</strong>al atrophy<br />

United <strong>State</strong>s<br />

United <strong>State</strong>s<br />

Chemical<br />

Chemical<br />

Eraxis Candidemia Europe Biotechnology<br />

J&J ($7.58bn)<br />

Paliperidone Palmitate IM Long Act<strong>in</strong>g Injectable<br />

Comfyde Partial onset seizure<br />

United <strong>State</strong>s<br />

United <strong>State</strong>s<br />

Chemical<br />

Chemical<br />

Certican Organ transplant rejection United <strong>State</strong>s, Japan Biotechnology<br />

Reclast Corticosteroid-<strong>in</strong>duced osteoporosis United <strong>State</strong>s Chemical<br />

QAB149 Chronic obstructive pulmonary disease United <strong>State</strong>s Chemical Drug Delivery<br />

Xolair Allergic Asthma United <strong>State</strong>s Biotechnology<br />

Comtan Park<strong>in</strong>son disease Japan Chemical<br />

Galvus Type 2 diabetes United <strong>State</strong>s Chemical<br />

Stalevo Park<strong>in</strong>son disease United <strong>State</strong>s Chemical<br />

Novartis<br />

($7.21bn)<br />

Extavia<br />

Tekturna fixed dose comb<strong>in</strong>ation with Valsartan<br />

Exforge HCT<br />

Multiple Sclerosis<br />

Hypertension<br />

Hypertension<br />

United <strong>State</strong>s<br />

United <strong>State</strong>s<br />

Europe<br />

Biotechnology<br />

Chemical<br />

Chemical<br />

Xolair Allergic Asthma Europe Biotechnology<br />

Aclasta Cl<strong>in</strong>ical fracture prevention Europe Chemical<br />

Exelon Patch<br />

Dementia associated with park<strong>in</strong>son<br />

disease<br />

Europe Chemical Drug Delivery<br />

Eucreas Diabetes Mellitus Europe Chemical<br />

QAB149 Chronic obstructive pulmonary disease Europe Chemical Drug Delivery<br />

Ilaris Cryopyr<strong>in</strong>-associated periodic syndromes Europe Biotechnology<br />

Arixtra Acute coronary syndrome United <strong>State</strong>s Chemical<br />

Cervarix Human papillomavirus <strong>in</strong>fection United <strong>State</strong>s Biotechnology Biological<br />

Tykerb Metastatic breast cancer United <strong>State</strong>s Chemical<br />

Requib extended release Restless legs syndrome United <strong>State</strong>s Chemical Drug Delivery<br />

GlaxoSmithKl<strong>in</strong>e<br />

($6.83bn)<br />

Votrient<br />

Rezonic<br />

Solzira<br />

Renal cell cancer<br />

Postoperative nausea and vomit<strong>in</strong>g<br />

Restless legs syndrome<br />

United <strong>State</strong>s<br />

United <strong>State</strong>s<br />

United <strong>State</strong>s<br />

Chemical<br />

Chemical<br />

Chemical Drug Delivery<br />

Tyverb Metastatic breast cancer Europe Chemical<br />

Synflorix Streptococcus pneumonia Europe Biological<br />

Avandia<br />

Acute coronary syndrome, Type 2<br />

diabetes progression prevention<br />

Europe Chemical<br />

Multaq Atrial fibrillation Europe, United <strong>State</strong>s Chemical<br />

Ketek Sk<strong>in</strong> and s<strong>of</strong>t tissue <strong>in</strong>fections Japan Chemical<br />

Taxotere Prostate cancer Japan Chemical<br />

San<strong>of</strong>i-Aventis<br />

($6.74bn)<br />

Allegra<br />

Apidra<br />

Allegra ODT<br />

Allergies<br />

Diabetes Mellitus<br />

Allergic rh<strong>in</strong>itis<br />

Europe<br />

Japan, Europe<br />

Japan<br />

Chemical<br />

Biological Biotechnology<br />

Chemical Drug Delivery<br />

Ciltyri Chronic Insomnia Europe, United <strong>State</strong>s Chemical<br />

Lantus Ret<strong>in</strong>opathy United <strong>State</strong>s Biotechnology<br />

Sculptra Nasolabial fold wr<strong>in</strong>kles United <strong>State</strong>s Chemical<br />

Symbicort pMDI<br />

Asthma, Chronic obstructive pulmonary<br />

disease<br />

Europe, United <strong>State</strong>s Chemical<br />

Seroquel<br />

Bipolar disorder ma<strong>in</strong>ta<strong>in</strong>ance, bipolar<br />

depression<br />

Europe Chemical<br />

Seroquel Schizophrenia, acute manic episodes United <strong>State</strong>s Chemical<br />

AstraZeneca Nexium Peptic ulcer bleed<strong>in</strong>g Europe Chemical<br />

($5.18bn)<br />

Nexium<br />

Peptic ulcer bleed<strong>in</strong>g, Duodenal ulcers,<br />

Gastric ulcers<br />

United <strong>State</strong>s Chemical<br />

Iressa Non-small cell lung cancer Europe Biotechnology<br />

Seroquel XR<br />

Generalized anxiety disorder, major<br />

depressive disorder, bipolar depression<br />

Europe, United <strong>State</strong>s Chemical Drug Delivery<br />

Onglyza/Metform<strong>in</strong> Comb<strong>in</strong>ation Type 2 diabetes Europe Chemical<br />

Merck & Co.<br />

Arcoxia Rheumatoid arthiritis, Pa<strong>in</strong> United <strong>State</strong>s Chemical<br />

13


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

($4.81bn)<br />

Takeda ($4.58)<br />

Eli Lilly &<br />

Co.($3.84bn)<br />

Bristol-Myers<br />

Squibb<br />

($3.59bn)<br />

Scher<strong>in</strong>g-Plough<br />

($3.53bn)<br />

Wyeth ($3.37bn)<br />

Boehr<strong>in</strong>ger<br />

Ingelheim<br />

($3.11bn)<br />

14<br />

Gardasil<br />

North America Equity Research<br />

16 July 2009<br />

Cervical Cancer, Cervical <strong>in</strong>traepi<strong>the</strong>lial<br />

neoplasia, Vulvar <strong>in</strong>traepi<strong>the</strong>lial<br />

neoplasia, Vag<strong>in</strong>al <strong>in</strong>traepi<strong>the</strong>lial<br />

neoplasia, Genital warts, Vag<strong>in</strong>al Cancer,<br />

Vulvar Cancer<br />

United <strong>State</strong>s Biotechnology<br />

Gardasil Vag<strong>in</strong>al cancer Europe Biotechnology<br />

Isentress HIV Infection United <strong>State</strong>s Chemical<br />

Basen Impaired glucose tolerance Japan Chemical<br />

Actos Diabetes Japan Chemical<br />

Takepron Gastric Ulcers Japan Chemical<br />

Aloglipt<strong>in</strong> Type 2 diabetes Europe, United <strong>State</strong>s Chemical<br />

Aloglipt<strong>in</strong> Diabetes Mellitus Japan Chemical<br />

Ramelteon Insomnia Japan, Europe Chemical<br />

Enantone 6-Months Depot Prostate cancer Europe Chemical<br />

Vectibix Colorectal cancer Japan Biotechnology<br />

Blopress fixed-dose comb<strong>in</strong>ation with Amlodip<strong>in</strong>e<br />

Hypertension Japan Chemical<br />

besylate<br />

Alimta Non-small cell lung cancer Europe, United <strong>State</strong>s Chemical<br />

Cialis Pulmonary arterial hypertension Europe, Canada Chemical<br />

Cymbalta Chronic pa<strong>in</strong> United <strong>State</strong>s Chemical<br />

Forteo Osteoporosis United <strong>State</strong>s Biotechnology<br />

Arxxant Diabetic ret<strong>in</strong>opathy United <strong>State</strong>s Chemical<br />

Zyprexa Schizophrenia United <strong>State</strong>s Chemical<br />

Prasugrel A<strong>the</strong>rosclerosis United <strong>State</strong>s Chemical<br />

Humalog ILPS Diabetes United <strong>State</strong>s Biotechnology<br />

Exenatide Type 2 diabetes United <strong>State</strong>s Chemical<br />

Onglyza Type 2 diabetes United <strong>State</strong>s, Europe Chemical<br />

Iscover A<strong>the</strong>rothrombotic events Europe Chemical<br />

Ixempra Kit Breast cancer Europe Biotechnology<br />

Ixabepilone Breast cancer Europe, Japan Biotechnology<br />

Peglntron Malignant melanoma United <strong>State</strong>s<br />

Biotechnology Drug Delivery<br />

Biological<br />

Asmanex Asthma Japan Chemical Drug Delivery<br />

Noxafil Fungan Infections United <strong>State</strong>s Chemical<br />

Golimumab<br />

Psoriatic <strong>Art</strong>hiritis, Ankylos<strong>in</strong>g spondylitis,<br />

Europe Biotechnology<br />

Rheumatoid arthiritis<br />

Saphris Acute mania, Schizophrenia United <strong>State</strong>s Chemical<br />

Sugammadex Neuromuscular blocker United <strong>State</strong>s Chemical<br />

Remeron Depression Japan Chemical<br />

Fertavid Infertility Europe Biotechnology Biological<br />

Sycrest Schizophrenia, Bipolar I disorder Europe Chemical<br />

Viviant Postmenopausal osteoporosis United <strong>State</strong>s Chemical<br />

Prevnar 13 Pneumococcal disease United <strong>State</strong>s, Europe Biological<br />

Pristiq Vasomotor symptoms United <strong>State</strong>s Chemical<br />

Enbrel Psoriasis Europe Biotechnology<br />

Mylotarg Acute myeloid leukemia Europe Biotechnology<br />

Torisel Mantle cell lymphoma Europe Chemical<br />

Conbriza Osteoporosis Europe Chemical<br />

Xeristar Fibromyalgia Europe Chemical<br />

Aptivus Oral Solution HIV supression Europe Chemical<br />

Mimpara Hyperparathyroidism Europe Chemical<br />

Amgen<br />

($3.03bn)<br />

Denosumab<br />

Nplate<br />

Bone loss, Postmenopausal osteoporosis<br />

Blood disorder treatment<br />

United <strong>State</strong>s, Europe,<br />

Canada<br />

Canada<br />

Biotechnology<br />

Biotechnology Biological<br />

Enbrel Psoriasis United <strong>State</strong>s Biotechnology<br />

Genentech Avast<strong>in</strong> Breast cancer, Renal cell carc<strong>in</strong>oma United <strong>State</strong>s Biotechnology Biological<br />

($2.80bn) Tarceva Non-small cell lung cancer United <strong>State</strong>s Chemical<br />

Humira Juv<strong>in</strong>ile rheumatoid arthritis Europe Biotechnology<br />

Abbott<br />

Certriad Mixed dyslipidemia United <strong>State</strong>s Chemical<br />

($2.69bn)<br />

Flutiform Asthma United <strong>State</strong>s Chemical Drug Delivery<br />

Vicod<strong>in</strong> CR Pa<strong>in</strong> United <strong>State</strong>s Chemical Drug Delivery<br />

Bayer ($2.57bn) Visanne Endometriosis Europe Chemical<br />

Menostar Vasomotor symptoms Europe Chemical Drug Delivery<br />

Avelox Pelvic <strong>in</strong>flammatory disease Europe Chemical<br />

E2/LNG Menopausal symptoms Japan Chemical


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Daiichi Sankyo<br />

($1.89bn)<br />

Astellas Pharma<br />

($1.62bn)<br />

North America Equity Research<br />

16 July 2009<br />

Magnevist MRA Magnetic resonance angiography Japan Chemical<br />

EOB Primovist Liver magnetic resonance imag<strong>in</strong>g Japan Chemical<br />

DUB-OC Prevention <strong>of</strong> pregnancy United <strong>State</strong>s Chemical<br />

Rivaroxaban Venous thromboembolism Canada Biotechnology<br />

Sevikar Hypertension Europe Chemical<br />

Feron Hepatitis C Japan Biotechnology<br />

CS-866AZ Hypertension Japan Chemical<br />

Lev<strong>of</strong>loxac<strong>in</strong> High-Dose Bacterial Infection Japan Chemical<br />

Telavanc<strong>in</strong><br />

Complicated sk<strong>in</strong> & sk<strong>in</strong> structure<br />

United <strong>State</strong>s Chemical<br />

<strong>in</strong>fection, Hospital acquired pneumonia<br />

YM617 Lower ur<strong>in</strong>ary tract syndrome Japan Chemical<br />

YM086 Type 2 diabetic nephropathy Japan Chemical<br />

Prograf Ulcerative colitis Japan Chemical<br />

Protopic Atopic dermatitis Europe Chemical Drug Delivery<br />

YM177 Low back pa<strong>in</strong>, shoulder periarthritis Japan Chemical<br />

Advagraf Organ transplant rejection Europe Chemical Drug Delivery<br />

Nategl<strong>in</strong>ide Type 2 diabetes Japan Chemical<br />

Modigraf Organ transplant rejection Europe Chemical<br />

Qutenza Post-herpetic neuralgia Europe Chemical Drug Delivery<br />

Source: PharmaLive.com<br />

Figure 9: Most Active Therapeutic Categories Await<strong>in</strong>g Approval<br />

# Investigational Drugs<br />

80<br />

70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

Source: PharmaLive.com<br />

78<br />

43<br />

Cancer Drugs Anti-Infectiv e<br />

Agents<br />

32 32 32<br />

Diabetes drugs GastroIntest<strong>in</strong>alPsy<br />

cho<strong>the</strong>rapeutic<br />

Drugs<br />

Agents<br />

Therapeutic categories<br />

Although drug sales have held, patent expirations loom<br />

Despite a firm market for drug sales, pharmaceutical companies cont<strong>in</strong>ue to grapple<br />

with sizable headw<strong>in</strong>ds that threaten both pric<strong>in</strong>g and pr<strong>of</strong>itability. Specific<br />

challenges <strong>in</strong>clude:<br />

• Competition from generic products, which can account for half <strong>of</strong> drug sales <strong>in</strong><br />

major markets<br />

• Patent expiration <strong>of</strong> major branded products, which need to be replaced by new<br />

revenue streams (see follow<strong>in</strong>g table)<br />

• Increas<strong>in</strong>gly complex cl<strong>in</strong>ical trials and regulatory approval processes, coupled<br />

with shorter exclusivity w<strong>in</strong>dows, that challenge pr<strong>of</strong>itability <strong>of</strong> new drugs<br />

15


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

16<br />

North America Equity Research<br />

16 July 2009<br />

• Hostility over end-user costs from government and managed care plans, a threat<br />

to pric<strong>in</strong>g power and pr<strong>of</strong>itability<br />

As shown below, patent expirations with<strong>in</strong> <strong>the</strong> biopharmaceutical <strong>in</strong>dustry are one <strong>of</strong><br />

<strong>the</strong> most significant challenges, with over $110 billion <strong>in</strong> drugs go<strong>in</strong>g <strong>of</strong>f patent by<br />

2015.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Table 6: Major Drugs Com<strong>in</strong>g Off Patent (2009-2015)<br />

Key Drugs<br />

Amgen<br />

2008 Revs<br />

($ <strong>in</strong> millions)<br />

Patent expiration<br />

Enbrel $3,598 2009<br />

Neulasta $3,318 2015<br />

Anaresp $3,137 EU: 2010<br />

Epogen $2,456 US: 2012, EU: Expired<br />

Neupogen $1,341 US: 2013, EU Expired<br />

Total<br />

Astra-Zeneca<br />

$13,850<br />

Seroquel $4,452 2012<br />

Symbicort $2,004 2013<br />

Arimidex $1,857 2010<br />

Atacand $1,471 2011<br />

Total<br />

Bristol Myers<br />

$9,784<br />

Plavix $5,603 2012<br />

Avapro $1,290 2012<br />

Sustiva $1,149 2013<br />

Total<br />

Eli Lilly<br />

$8,042<br />

Zyprexa/Zyprexa LAI $4,696 2011<br />

Evista $1,076 2012<br />

Gemzar $1,720 2013<br />

Cymbalta $2,697 2014<br />

Yentreve (Duloxet<strong>in</strong>e SUI) $25 2014<br />

Total<br />

Genentech<br />

$10,213<br />

Rituxan $2,587 5,677,180 <strong>in</strong> 2014; 5,736,137 <strong>in</strong> 2015; 2013 <strong>in</strong> EU<br />

Total<br />

Genzyme<br />

$2,587<br />

Cerezyme $1,239 Manufactur<strong>in</strong>g Patent – 2010; Composition <strong>of</strong> Matter Patent -2011<br />

Total<br />

Gilead<br />

$1,239<br />

Hepsera $341 2014 <strong>in</strong> US; 2011 <strong>in</strong> EU<br />

Total<br />

GlaxoSmithKl<strong>in</strong>e<br />

$341<br />

Valtrex $645 2009<br />

Lamictal $500 2009<br />

Avandia $435 2012<br />

Imigran / Imitrex $371 2011<br />

Boniva $128 2012<br />

Total<br />

Merck<br />

$2,078<br />

S<strong>in</strong>gulair $4,336 2012<br />

Cozaar/Hyzaar $3,557 2010<br />

Primax<strong>in</strong> $744 2009<br />

Maxalt $530 2012<br />

Crixivan $275 2012<br />

EMEND $264 2013<br />

Total<br />

Novartis<br />

$9,706<br />

Diovan $5,740 2012<br />

Zometa $1,342 2012<br />

Femara $1,129 2011<br />

Sandostat<strong>in</strong> $1,123 2013<br />

Total<br />

Pfizer<br />

$9,334<br />

Lipitor $12,401 2011<br />

Celebrex $2,489 2014<br />

Viagra $1,934 2012<br />

Xalatan/Xalcom $1,745 2011<br />

Detrol/LA $1,214 2012<br />

Geodon $1,007 2012<br />

17


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

18<br />

North America Equity Research<br />

16 July 2009<br />

Caduet (Norvasc+Lipitor) $589 2011<br />

Relpax $350 2013<br />

Total $21,729<br />

Roche<br />

Cellcept $2,266 2009<br />

Xeloda $1,307 2013<br />

Total $3,573<br />

San<strong>of</strong>i Aventis<br />

Plavix $4,176 2011<br />

Taxotere $1,382 2010<br />

Eloxat<strong>in</strong> $916 2010<br />

Ambien $563 2009<br />

Actonel $224 2013<br />

Total $7,261<br />

Scher<strong>in</strong>g-Plough<br />

Temodar $1,002 2014<br />

Clar<strong>in</strong>ex $789 2007 US; EU 2011<br />

Puregon/Follistim $576 2015 US; EU 2H 2009<br />

Avelox $376 2011<br />

Integril<strong>in</strong> $314 2015<br />

Caelyx $296 2010<br />

Implanon $151 2009<br />

Total $3,504<br />

Wyeth<br />

Zosyn/Tazoc<strong>in</strong> $1,264 2009<br />

Effexor XR $3,928 2010<br />

Protonix $806 2011<br />

Rapamune $376 2012<br />

Tygacil $216 2013<br />

Torisel (Temsirolimus) $118 2014<br />

Total $6,709<br />

Source: Phrma; Company reports.<br />

Assum<strong>in</strong>g that pharma R&D growth drops to 3-5%, which we feel is a logical floor<br />

given <strong>the</strong> need to replenish anemic pipel<strong>in</strong>es, outsourc<strong>in</strong>g – which had been grow<strong>in</strong>g<br />

100 bps a year – could still <strong>in</strong>crease 200 bps, br<strong>in</strong>g<strong>in</strong>g <strong>the</strong> total level <strong>of</strong> outsourced<br />

work to 39% by 2013. As such, <strong>the</strong> CRO <strong>in</strong>dustry should be positioned to grow at<br />

least 7-8% on <strong>the</strong> top l<strong>in</strong>e for <strong>the</strong> next several years, while Covance and a few select<br />

o<strong>the</strong>rs can likely cont<strong>in</strong>ue to capture share from smaller, more fragmented<br />

competitors.<br />

As a rem<strong>in</strong>der, approximately 29% <strong>of</strong> dollars spent <strong>in</strong> development today are<br />

outsourced, and this is expected to cont<strong>in</strong>ue grow<strong>in</strong>g, although we do not expect<br />

penetration to reach significantly more than 60-65%, given that biopharmaceutical<br />

companies still need <strong>in</strong>-house management to oversee CRO contracts, create study<br />

protocols, make strategic go/no-go decisions, etc.<br />

A better way to look at <strong>the</strong> market potential, <strong>in</strong> our view, is to look at <strong>the</strong> number <strong>of</strong><br />

projects outsourced. Today, 40-50% <strong>of</strong> precl<strong>in</strong>ical GLP projects are outsourced, and<br />

we expect this could reach closer to 80-90% longer-term. While some companies,<br />

such as Eli Lilly, now outsource 100% <strong>of</strong> GLP work (small/mid-cap biotech<br />

companies <strong>of</strong>ten outsource close to 95% <strong>in</strong> some cases), o<strong>the</strong>rs such as Merck and<br />

Wyeth outsource less than 5% <strong>of</strong> projects, someth<strong>in</strong>g that could <strong>in</strong>crease dramatically<br />

given that pend<strong>in</strong>g <strong>in</strong>tegrations are likely to force a broader strategic overhaul.<br />

Near-term CRO <strong>in</strong>dustry challenges<br />

Despite favorable longer term trends for <strong>the</strong> CRO <strong>in</strong>dustry, <strong>the</strong> group has faced<br />

challenges <strong>in</strong> recent years, someth<strong>in</strong>g reflected by stock performance over <strong>the</strong> past


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

year. As shown below, performance for a basket <strong>of</strong> CROs (CVD, ICON, PPDI,<br />

PRXL, KNDL, CRL) has tightened somewhat relative to <strong>the</strong> S&P, while for<br />

pharmaceutical companies (SGP, PFE, MRK, LLY, BMY, WYE) <strong>the</strong> correlation has<br />

historically been fairly tight.<br />

Figure 10: Relative Stock Performance: Average CRO vs. Pharma vs. S&P 500 (06/00-06/09)<br />

800<br />

700<br />

600<br />

500<br />

400<br />

300<br />

200<br />

100<br />

0<br />

Jun-00<br />

Oct-00<br />

Feb-01<br />

Jun-01<br />

Oct-01<br />

Feb-02<br />

Jun-02<br />

Oct-02<br />

Feb-03<br />

CRO<br />

Jun-03<br />

Oct-03<br />

Feb-04<br />

Jun-04<br />

Oct-04<br />

Feb-05<br />

Jun-05<br />

Oct-05<br />

Feb-06<br />

Jun-06<br />

Oct-06<br />

CRO Pharma S&P 500<br />

Pharma<br />

S&P 500<br />

Feb-07<br />

Jun-07<br />

Oct-07<br />

Feb-08<br />

Jun-08<br />

Oct-08<br />

Feb-09<br />

Jun-09<br />

Source: FactSet. CRO Index <strong>in</strong>cludes CRL, CVD, ICLR, KNDL, PRXL, and PPDI. Pharma <strong>in</strong>dex <strong>in</strong>cludes BMY, LLY, MRK, PFE, SGP<br />

and WYE.<br />

Figure 11: Forward P/E: Average CRO vs. Pharma vs. S&P 500 (10/00-06/09)<br />

60.0x<br />

50.0x<br />

40.0x<br />

30.0x<br />

20.0x<br />

10.0x<br />

0.0x<br />

Oct-00<br />

Feb-01<br />

Jun-01<br />

Oct-01<br />

Feb-02<br />

Jun-02<br />

Oct-02<br />

Feb-03<br />

Jun-03<br />

Oct-03<br />

Feb-04<br />

Jun-04<br />

Oct-04<br />

Feb-05<br />

Jun-05<br />

Oct-05<br />

Feb-06<br />

Jun-06<br />

CRO Pharma S&P 500<br />

Oct-06<br />

Feb-07<br />

CRO<br />

Pharma S&P 500<br />

Source: FactSet. CRO Index <strong>in</strong>cludes CRL, CVD, ICLR, KNDL, PRXL, and PPDI. Pharma <strong>in</strong>dex <strong>in</strong>cludes BMY, LLY, MRK, PFE, SGP<br />

and WYE.<br />

Jun-07<br />

Oct-07<br />

Feb-08<br />

Jun-08<br />

Oct-08<br />

Feb-09<br />

Jun-09<br />

19


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

20<br />

North America Equity Research<br />

16 July 2009<br />

Pharma restructur<strong>in</strong>g/consolidation<br />

As mentioned previously, low visibility around pharmaceutical R&D plans rema<strong>in</strong>s a<br />

significant headw<strong>in</strong>d <strong>in</strong> <strong>the</strong> near term, with pend<strong>in</strong>g M&A transactions expected to<br />

<strong>in</strong>volve significant cost sav<strong>in</strong>gs, likely exceed<strong>in</strong>g <strong>in</strong>itial targets.<br />

Table 7: Biopharmaceutical M&A Transactions Announced <strong>in</strong> 2009<br />

Month Deal Size<br />

January Pfizer/Wyeth $66.7 billion<br />

January GSK/UCB $670 million<br />

February Lundbeck/Ovation $900 million<br />

March Merck/Scher<strong>in</strong> gPlough $42 billion<br />

March Gilead/CV Therapeutics $1.3 billion<br />

Source: In Vivo (May 2009)<br />

The follow<strong>in</strong>g table highlights some <strong>of</strong> <strong>the</strong> <strong>in</strong>itial anticipated cost synergies from<br />

announced M&A transactions, while Table 9 highlights restructur<strong>in</strong>g <strong>in</strong>itiatives<br />

disclosed over <strong>the</strong> past year.<br />

Table 8: Expected Synergies from Pend<strong>in</strong>g M&A Deals<br />

Expected Total Synergies Expected SG&A Sav<strong>in</strong>gs Expected R&D and Manufactur<strong>in</strong>g<br />

Sav<strong>in</strong>gs<br />

PFE/WYE ~$4bn - 50% <strong>in</strong> first 12 months, 75% <strong>in</strong> first ~50% from SG&A Comb<strong>in</strong>ed R&D and Manufactur<strong>in</strong>g<br />

24 months, 100% <strong>in</strong> first 36 months<br />

sav<strong>in</strong>gs ~50%<br />

SGP/MRK ~$3.5bn cost sav<strong>in</strong>gs expected beyond ~60% from Market<strong>in</strong>g & ~40% from R&D and Manufactur<strong>in</strong>g<br />

2011: 50% <strong>in</strong> first yr, 75% <strong>in</strong> first 2 yrs. Adm<strong>in</strong>istration<br />

comb<strong>in</strong>ed<br />

RHHBY/DNA Pretax sav<strong>in</strong>gs <strong>of</strong> ~$750-850mm/yr NA NA<br />

Source: Company reports


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Table 9: Top pharma R&D and outsourc<strong>in</strong>g strategies<br />

2008 Revenue /R&D<br />

Company expense Latest corporate / R&D strategy Latest on Outsourc<strong>in</strong>g<br />

Abbott $29.5bn (57%<br />

Annual Shareholders Meet<strong>in</strong>g (April 24, 2009)<br />

pharma)/$2.7bn<br />

“We cont<strong>in</strong>ue to <strong>in</strong>vest at a high rate to build our diverse R&D pipel<strong>in</strong>e.<br />

With our n<strong>in</strong>e new product launches last year alone, we’re now focused<br />

on our early- to mid-stage opportunities, where we’ve seen productivity<br />

improvements, and have nearly doubled our Phase I and Phase II<br />

starts. Many <strong>of</strong> <strong>the</strong> compounds <strong>in</strong> pharmaceutical pipel<strong>in</strong>e represent truly<br />

novel science and, if successful, would result <strong>in</strong> significant advances <strong>in</strong><br />

treatment for patients.”<br />

Baxter $12.3bn (44%<br />

Annual Meet<strong>in</strong>g <strong>of</strong> Shareholders Presentation (May 5, 2009)<br />

BioScience)/$868mm -- Accelerated R&D spend<strong>in</strong>g to historic level <strong>in</strong> 2008: 1) Received<br />

approval and launched an array <strong>of</strong> new products, 2) Initiated 8 Phase III<br />

cl<strong>in</strong>ical trials, and 3) Advanced numerous early-stage <strong>in</strong>ternal programs<br />

-- R&D Spend<strong>in</strong>g 2005 – 2008 = CAGR 18%<br />

2008 Annual Report<br />

-- (Baxter) cont<strong>in</strong>ues to <strong>in</strong>vest to support <strong>the</strong> company’s ongo<strong>in</strong>g strategic<br />

focus on R&D with <strong>the</strong> expansion <strong>of</strong> research facilities, pilot<br />

manufactur<strong>in</strong>g sites and laboratories.<br />

-- (Baxter) also plans to cont<strong>in</strong>ue to pursue bus<strong>in</strong>ess development<br />

<strong>in</strong>itiatives, collaborations and alliances as part <strong>of</strong> <strong>the</strong> execution <strong>of</strong> its<br />

long-term growth strategy.<br />

AstraZeneca $31.6bn/$5.2bn June 2009 presentation<br />

June 2009 presentation<br />

-- Restructur<strong>in</strong>g benefits <strong>of</strong> $2.5bn by 2013; reduction <strong>of</strong> ~15,000 positions -- Cl<strong>in</strong>ical data outsourc<strong>in</strong>g <strong>of</strong> 82 studies<br />

when completed, <strong>in</strong>cl. R&D headcount reduction <strong>of</strong> 1,400 when completed Activities <strong>in</strong> drug discovery/development<br />

-- Investment <strong>in</strong> externalization (40% <strong>of</strong> product portfolio <strong>in</strong> 2009 is -- Forms JV (<strong>in</strong>itially for 5 years) with Jubilant Biosys (Indian<br />

<strong>in</strong>-licensed, from 15% <strong>in</strong> 2005) and biologics (25% <strong>of</strong> product portfolio <strong>in</strong> subsidiary <strong>of</strong> Jubilant Organosys), which will develop<br />

2009 vs. 2% <strong>in</strong> 2005) deliver<strong>in</strong>g results<br />

precl<strong>in</strong>ical candidates <strong>in</strong> return for research fund<strong>in</strong>g, milestone<br />

-- Enhanced capabilities <strong>in</strong> Biologicals (<strong>in</strong>cl. expand<strong>in</strong>g external strategic payments and royalties (May 2009)<br />

opportunities), balanced with reduction <strong>in</strong> selected small molecule areas -- Extends previous agreement with WX ($14mm, 2-yrs) for<br />

-- “Faster, Leaner, Better”<br />

high throughput screen<strong>in</strong>g services for ano<strong>the</strong>r three years<br />

*Precl<strong>in</strong>ical and Phase I on target for 2010 speed with <strong>in</strong>creased<br />

(June 2008)<br />

volumes and decreased cost<br />

Activities <strong>in</strong> data management<br />

*Focus on Phase II <strong>in</strong> 2009<br />

-- Spent ~$12mm <strong>in</strong> 2008 for electronic cl<strong>in</strong>ical data<br />

F<strong>in</strong>ancial Times Interview with CEO David Brennan (April 17, 2009)<br />

management system from Medidata<br />

-- “Our view is more oriented toward collaboration than<br />

-- 5-yr deal with Cognizant for ma<strong>in</strong>tenance services <strong>of</strong><br />

consolidation. If <strong>the</strong>re were acquisition opportunities for AstraZeneca, research, cl<strong>in</strong>ical development, sales and market<strong>in</strong>g (Oct<br />

<strong>the</strong>y would be <strong>in</strong> <strong>the</strong> small company, product, technology side <strong>of</strong> th<strong>in</strong>gs, 2008)<br />

not a large-scale transaction to take out capacity. That's not what we're -- $95mm, 5-yr deal with Cognizant for a range <strong>of</strong> data<br />

look<strong>in</strong>g for.”<br />

management services for global cl<strong>in</strong>ical development<br />

programs (March 2008)<br />

Bristol- $20.6bn/$3.6bn May 27, 2009 presentation to <strong>in</strong>vestors<br />

May 27, 2009 presentation to <strong>in</strong>vestors<br />

Myers<br />

-- BMY is more focused – Biopharma is 86% <strong>of</strong> revenues<br />

-- Various outsourc<strong>in</strong>g <strong>in</strong>itiatives underway (HR, IM, R&D,<br />

Squibb<br />

-- Biopharma headcount is down 14% to about 30,000<br />

F<strong>in</strong>ance)<br />

-- Focus on productivity: $2.5bn <strong>in</strong> sav<strong>in</strong>gs <strong>in</strong>itiatives underway (<strong>in</strong>troduced IT outsourc<strong>in</strong>g<br />

<strong>in</strong> Dec 2007)<br />

-- $715mm, 7-yr agreement with EDS for streaml<strong>in</strong><strong>in</strong>g global<br />

-- Plans to reduce 27 manufactur<strong>in</strong>g plants by ~50%<br />

IT (Dec 2007)<br />

-- Procurement – vendor consolidation and terms<br />

-- $324mm, 10-yr agreement with IBM for HR functions across<br />

-- Rationaliz<strong>in</strong>g:<br />

<strong>the</strong> globe (Jun 2008)<br />

*155 focused markets <strong>in</strong> 2007 to 63 <strong>in</strong> 2011<br />

-- $550mm, 10-yr contract with Accenture for IT and f<strong>in</strong>ancial<br />

*212 products <strong>in</strong> 2007 to 92 products <strong>in</strong> 2011<br />

*6,550 mature brand SKUs to 2,450 SKUs <strong>in</strong> 2011<br />

support services (Sept 2008)<br />

21


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

22<br />

North America Equity Research<br />

16 July 2009<br />

Eli Lilly $20.4bn/$3.8bn Investor presentation (December 11, 2008)<br />

-- Transition<strong>in</strong>g from FIPCO (functional outsourc<strong>in</strong>g, Indiana-centric,<br />

centralized decision mak<strong>in</strong>g, LLY funds, absorbs all risk, control) to:<br />

-- FIPNet:<br />

*Integrated global capacity (cont<strong>in</strong>ued outsourc<strong>in</strong>g with greater<br />

coord<strong>in</strong>ation)<br />

*Global portfolio network<br />

*Common R&D goals, local execution<br />

*Shared risk/reward<br />

*Variety <strong>of</strong> deal structures, coord<strong>in</strong>ation mechanisms<br />

Outsourc<strong>in</strong>g-pharma.com (March 2008)<br />

-- Works with over 80 contractors to perform various functions across its<br />

bus<strong>in</strong>ess<br />

-- 20% <strong>of</strong> manufactur<strong>in</strong>g and sales, and 40% <strong>of</strong> IT work outsourced<br />

-- Expectation to outsource up to half <strong>of</strong> its precl<strong>in</strong>ical and cl<strong>in</strong>ical R&D by<br />

2010<br />

GlaxoSmith<br />

Kl<strong>in</strong>e<br />

Johnson &<br />

Johnson<br />

$45.1bn/$6.8bn (1) Releas<strong>in</strong>g resources to <strong>in</strong>vest <strong>in</strong> growth (February 5, 2009 <strong>in</strong>vestor<br />

presentation)<br />

-- Simplify<strong>in</strong>g manufactur<strong>in</strong>g network; announced closure <strong>of</strong> 12 sites s<strong>in</strong>ce<br />

2006<br />

-- US sales force restructure results <strong>in</strong> 1,450 headcount reduction <strong>in</strong> 2008<br />

-- Reduc<strong>in</strong>g <strong>in</strong>frastructure <strong>in</strong> R&D; announced planned closure <strong>of</strong> 3<br />

UK R&D sites <strong>in</strong> <strong>the</strong> past 2 years<br />

-- R&D strategy<br />

*Diversify and de-risk through externalization (acquisition <strong>of</strong> platform<br />

technologies, assets, academic collaborations)<br />

*Focused and cost-effective development (~30 assets <strong>in</strong> Phase III /<br />

registration)<br />

*Overall reduction <strong>of</strong> 36% <strong>in</strong>ternal discovery projects (exited urology,<br />

GI, hypertension)<br />

*Rebuild<strong>in</strong>g portfolios <strong>in</strong>ternally and externally (ophthalmology,<br />

sirtu<strong>in</strong>s)<br />

March 2008 announcement<br />

-- Opens first pilot plant <strong>in</strong> S<strong>in</strong>gapore ($82mm facility) for design <strong>of</strong><br />

$63.7bn (39% pharma)<br />

/$7.6bn<br />

manufactur<strong>in</strong>g processes<br />

Pharmaceutical Bus<strong>in</strong>ess Review, June 4, 2009<br />

-- Portfolio expansion through licens<strong>in</strong>g and acquisitions, establish<strong>in</strong>g<br />

collaborations, creat<strong>in</strong>g new partnerships <strong>in</strong> emerg<strong>in</strong>g regions<br />

-- Strategy for Pharmaceutical R&D: (1) focus on end-to-end, research<br />

to market approach <strong>in</strong> five <strong>the</strong>rapeutic areas, (2) comb<strong>in</strong>e <strong>in</strong>ternal<br />

<strong>in</strong>novation with external <strong>in</strong>novation (academic, biotech, govt, consortia),<br />

(3) embed customer, physician, and payor <strong>in</strong>sights, and (4) leverage<br />

broad-based expertise and global capabilities<br />

-- Build<strong>in</strong>g capabilities <strong>in</strong> Asia: (1) chemical pharmaceutical facility<br />

launched <strong>in</strong> Mumbai, (2) expand<strong>in</strong>g network <strong>in</strong> Ch<strong>in</strong>a, and (3) expand<strong>in</strong>g<br />

cl<strong>in</strong>ical development <strong>in</strong> Japan<br />

Contract research<br />

-- Cardiovascular R&D collaboration with Zydus, an Indian<br />

company, for up to six years and $300mm <strong>in</strong> milestone<br />

payments as well as royalties on future commercial products.<br />

Zydus to carry out up to Phase II. (March 2009)<br />

-- ICON to manage all <strong>of</strong> Lilly’s cl<strong>in</strong>ical data outside <strong>the</strong> US<br />

and Japan (<strong>in</strong> more than three dozen countries) (Nov 2008)<br />

and cl<strong>in</strong>ical trial site set up and monitor<strong>in</strong>g <strong>in</strong> Europe (>$50mm<br />

value, June 2009)<br />

-- Expands drug discovery collaboration with India’s Jubilant<br />

target<strong>in</strong>g oncology, metabolic diseases, cardiovascular and<br />

diabetes (up to Phase II) (Oct 2008)<br />

-- Covance buys Lilly’s 600K sq ft Greenfield lab facility <strong>in</strong><br />

Indiana (precl<strong>in</strong>ical toxicology and o<strong>the</strong>r early-stage drug<br />

discovery work) for $50mm, and receives $1.6bn <strong>in</strong> drug<br />

development contracts over 10-yrs. (Aug 2008)<br />

-- Qu<strong>in</strong>tiles to conduct all <strong>of</strong> Lilly’s cl<strong>in</strong>ical trial monitor<strong>in</strong>g work<br />

<strong>in</strong> <strong>the</strong> U.S. and Puerto Rico, as well as Phase III development<br />

for two lead molecules <strong>in</strong> Alzheimer’s disease program (Aug<br />

2008)<br />

-- i3 to conduct <strong>the</strong> majority <strong>of</strong> Lilly’s data management work <strong>in</strong><br />

<strong>the</strong> U.S. (Aug 2008)<br />

-- BioConvergence to provide global materials management<br />

services over 10-yrs (March 2008)<br />

-- India’s Suven to conduct precl<strong>in</strong>ical research <strong>of</strong> CNS<br />

<strong>the</strong>rapeutic category for up to $23mm per small molecule<br />

candidate, and potentially additional research fund<strong>in</strong>g and<br />

royalties (March 2008)<br />

-- India’s NPIL to carry out early cl<strong>in</strong>ical development, <strong>in</strong> a deal<br />

worth up to $110mm (Feb 2008)<br />

July 1, 2009 announcement<br />

-- Multi-million dollar cl<strong>in</strong>ical trial services contract with Phase<br />

Forward for licens<strong>in</strong>g and study support services, and data<br />

host<strong>in</strong>g over a multi-year period<br />

Precl<strong>in</strong>ical services<br />

-- Expands R&D services with WX, which now <strong>in</strong>cl discovery<br />

biology, chemical and analytical development services,<br />

formulation, and precl<strong>in</strong>ical and bio-analytical services, <strong>in</strong><br />

addition to discovery chemistry (Oct 2008)<br />

-- €1bn deal with Galapagos to discover and develop five or<br />

six first-<strong>in</strong>-class jo<strong>in</strong>t arthritis drugs (Jan 2008)<br />

Activities <strong>in</strong> data management<br />

-- Spent ~$11mm <strong>in</strong> 2008 for electronic cl<strong>in</strong>ical data<br />

management system from Medidata<br />

Contract manufactur<strong>in</strong>g<br />

-- Canada-based Draxis to produce >60 <strong>of</strong> J&J’s non-sterile<br />

specialty semi-solid products for <strong>the</strong> US market. Deal worth up<br />

to $120mm over 5 yrs.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Merck /<br />

Scher<strong>in</strong>g-<br />

Plough<br />

MRK: $23.9bn / $4.8bn<br />

SGP: $18.5bn / $3.5bn<br />

North America Equity Research<br />

16 July 2009<br />

May 28, 2009 <strong>in</strong>vestor presentation<br />

-- Enhance R&D efforts and pipel<strong>in</strong>e: Add high potential early-, mid-and<br />

late-stage pipel<strong>in</strong>e candidates to provide platform for susta<strong>in</strong>able<br />

growth (Double <strong>the</strong> number <strong>of</strong> Merck Phase III candidates to 18)<br />

-- Expanded global presence: Dramatically accelerated Merck's<br />

<strong>in</strong>ternational growth efforts, especially <strong>in</strong> key emerg<strong>in</strong>g markets<br />

-- Substantial synergies beyond 2011: $950mm MRK standalone, $1.5bn<br />

SGP standalone, $3.5bn merger synergies<br />

March 9, 2009 MRK/SGP transaction presentation<br />

-- Enhance f<strong>in</strong>ancial flexibility to <strong>in</strong>vest <strong>in</strong> promis<strong>in</strong>g drug candidates as<br />

well as external R&D<br />

Novartis $41.5bn / $7.2bn March 18, 2009 Investor presentation<br />

-- Portfolio streng<strong>the</strong>ned with targeted acquisitions and strategic<br />

<strong>in</strong>vestments: 25% stake <strong>in</strong> Alcon, Speedel, Protez, Nektar’s pulmonary<br />

bus<strong>in</strong>ess<br />

January 28, 2009, 2008 Annual Results presentation<br />

-- Achieved $648mm <strong>in</strong> cost sav<strong>in</strong>gs and reduced headcount by 2,372 <strong>in</strong><br />

<strong>the</strong> Pharma division <strong>in</strong> 2008<br />

Pfizer /<br />

Wyeth<br />

PFE: $48.3bn / $7.9bn<br />

WYE: $22.8bn / $3.4bn<br />

JPM Pharma team meet<strong>in</strong>g with management (June 18, 2009)<br />

-- Pfizer’s new bus<strong>in</strong>ess structure <strong>in</strong>cludes changes to <strong>the</strong> view <strong>of</strong> R&D<br />

with <strong>in</strong>ternal and external R&D dollars now be<strong>in</strong>g evaluated as<br />

<strong>in</strong>terchangeable. Effectively, <strong>the</strong> company’s new bus<strong>in</strong>ess unit structure<br />

<strong>in</strong>centivizes unit heads to seek out new revenues regardless <strong>of</strong> whe<strong>the</strong>r<br />

<strong>the</strong>y are <strong>in</strong>ternally or externally sourced.<br />

May 19, 2009 presentation to <strong>in</strong>vestors<br />

Biopharmaceutical Research follow<strong>in</strong>g Wyeth clos<strong>in</strong>g<br />

-- Two Research Groups (PharmaTherapeutics and BioTherapeutics)<br />

deliver<strong>in</strong>g positive Pro<strong>of</strong>s <strong>of</strong> Concept for <strong>the</strong> Bus<strong>in</strong>ess Units across key<br />

<strong>the</strong>rapeutic areas<br />

-- Operational design ensures collaboration with Bus<strong>in</strong>ess Units and<br />

between PharmaTherapeutics and BioTherapeutics<br />

January 2008 announcement<br />

-- $25mm, Five-year, ‘<strong>in</strong>novative” research collaboration with Wash<strong>in</strong>gton<br />

University (St. Louis) for immuno-<strong>in</strong>flammatory diseases. Pfizer and<br />

Wash<strong>in</strong>gton Univ will jo<strong>in</strong>tly carry out research projects<br />

Facility divestitures<br />

-- UPS acquires 200K sq ft <strong>of</strong> pharmaceuticals and vacc<strong>in</strong>es<br />

distribution and logistics space and will provide significant<br />

portion <strong>of</strong> distribution and package transportation needs (Jan<br />

2009)<br />

-- PPDI buys 130K sq ft vacc<strong>in</strong>e test<strong>in</strong>g and assay<br />

development lab, <strong>in</strong>cl >80 staff members, and will provide<br />

assay development and immunogenicity test<strong>in</strong>g services as<br />

well as central lab and sample storage services to MRK for<br />

five years (Jan 2009)<br />

-- Divests API plant to PRWT Services <strong>in</strong>cl 400 employees.<br />

API supply contract with PRWT is roughly $100-$200m<br />

annually for five years (Jan 2008)<br />

Precl<strong>in</strong>ical <strong>of</strong>fshor<strong>in</strong>g<br />

-- Ranbaxy is responsible for new anti-<strong>in</strong>fective drugs (up to<br />

Phase IIa), and could receive over $100mm for each target<br />

from <strong>the</strong> collaboration, <strong>in</strong> addition to royalties and up-front<br />

payment (May 2008)<br />

-- NPIL is responsible for entire process <strong>of</strong> oncology (2<br />

targets) drug discovery to cl<strong>in</strong>ical studies for up to $175mm<br />

per target <strong>in</strong> milestones and royalties, and MRK will have <strong>the</strong><br />

option to advance most promis<strong>in</strong>g candidates <strong>in</strong>to late stage<br />

trials and commercialization (Nov 2007)<br />

Research collaboration<br />

-- Morphosys to create antibodies aga<strong>in</strong>st Novartis targets.<br />

Deal could be worth >$1bn, with guaranteed payment <strong>of</strong><br />

$600mm <strong>in</strong> technology access fees and research fund<strong>in</strong>g (Dec<br />

2007)<br />

Contract development and manufactur<strong>in</strong>g<br />

-- Lonza to co-develop and manufacture Novartis’ biological<br />

pipel<strong>in</strong>e (July 2008)<br />

Contract sales<br />

-- PDI, contract sales organization, will supply 100 sales reps<br />

for an unidentified Novartis product over four years (April<br />

2008)<br />

Contract research (PFE)<br />

-- Signs 3-yr contract with WX, which will conduct ADME<br />

assay for <strong>in</strong> vitro screen<strong>in</strong>g compounds WX syn<strong>the</strong>sizes for<br />

PFE (Nov 2008)<br />

Contract manufactur<strong>in</strong>g (PFE)<br />

-- Sells production facility <strong>in</strong> Lat<strong>in</strong>a, Italy (450 employees) to<br />

Haupt Pharma. Haupt will manufacture for PFE on a contract<br />

basis. (Feb 2009)<br />

-- Hovione (Portuguese CMO) buys PFE’s Cork, Ireland<br />

production plant, and will carry out manufactur<strong>in</strong>g for PFE. 70-<br />

80 <strong>of</strong> <strong>the</strong> 230 employees to be kept. (Dec 2008)<br />

Contract sales<br />

-- NovaMed to serve as distribution and promotional partner<br />

for six <strong>of</strong> PFE’s oncology products throughout Ch<strong>in</strong>a (July<br />

2008)<br />

23


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Roche /<br />

Genenetch<br />

San<strong>of</strong>i<br />

Aventis<br />

24<br />

Roche:<br />

$42.3bn / $8.2bn (2)<br />

DNA:<br />

$13.4bn / $2.8bn<br />

North America Equity Research<br />

16 July 2009<br />

Roche 2008 Bus<strong>in</strong>ess Report<br />

-- “Over <strong>the</strong> last 18 months Roche Pharmaceuticals has decentralized <strong>the</strong><br />

management <strong>of</strong> its R&D projects by creat<strong>in</strong>g five Disease Biology Areas).<br />

The Oncology, Viral Diseases, Inflammation, Metabolic Diseases and<br />

Central Nervous System DBAs set priorities and make portfolio decisions<br />

for <strong>the</strong>ir specific diseases. This is already help<strong>in</strong>g to streaml<strong>in</strong>e <strong>the</strong><br />

research portfolio and is expected to <strong>in</strong>crease <strong>the</strong> number and quality <strong>of</strong><br />

programmes be<strong>in</strong>g advanced <strong>in</strong>to cl<strong>in</strong>ical development.”<br />

-- “The (Diagnostic) division is also us<strong>in</strong>g know-how to support<br />

pharmaceuticals R&D at Roche – for example, by help<strong>in</strong>g <strong>in</strong> <strong>the</strong> search for<br />

relevant biomarkers. These could accelerate <strong>the</strong> development <strong>of</strong> important<br />

drugs and <strong>in</strong> some cases might yield companion diagnostics enabl<strong>in</strong>g<br />

more targeted <strong>the</strong>rapy.”<br />

-- “Licens<strong>in</strong>g and targeted acquisitions play an important role <strong>in</strong><br />

streng<strong>the</strong>n<strong>in</strong>g Roche’s R&D portfolio and expand<strong>in</strong>g <strong>the</strong> company’s<br />

technology capabilities. In 2008 Roche Pharmaceuticals signed a total<br />

<strong>of</strong> 57 new agreements, <strong>in</strong>clud<strong>in</strong>g seven product transactions and 43<br />

research and technology collaborations.”<br />

$40.6bn / $6.7bn (3) Investor presentation (May 19, 2009)<br />

"R&D transformation process is ongo<strong>in</strong>g”<br />

-- Conduct a detailed objective review <strong>of</strong> our R&D pipel<strong>in</strong>e<br />

-- Redef<strong>in</strong>e <strong>in</strong>vestment decision mak<strong>in</strong>g process<br />

-- Reallocate resources to external R&D partnerships (e.g. BiPar<br />

acquisition)<br />

-- Focus R&D strategy on key technologies and disease areas<br />

-- Implement new R&D organization to encourage <strong>in</strong>novation<br />

-- 4 Phase II and 4 Phase III projects discont<strong>in</strong>ued s<strong>in</strong>ce Feb 11, 2009<br />

-- 6 Phase I projects also discont<strong>in</strong>ued <strong>in</strong> <strong>the</strong> recent portfolio review<br />

-- Go<strong>in</strong>g forward, a complete R&D pipel<strong>in</strong>e review will be conducted<br />

regularly by newly-created “Portfolio Management Group”<br />

-- Expect<strong>in</strong>g a low s<strong>in</strong>gle digit decl<strong>in</strong>e <strong>of</strong> <strong>the</strong> R&D spend at constant<br />

exchange rates <strong>in</strong> 2009<br />

-- Accelerat<strong>in</strong>g R&D partnerships & alliances to expand access to<br />

new technologies and enrich our portfolio with <strong>in</strong>novative<br />

compounds <strong>in</strong> all stages <strong>of</strong> development<br />

Source: Company reports; Outsourc<strong>in</strong>g-Pharma.com (1) Used GBP/USD 2008 average exchange rate <strong>of</strong> 1.8524. (2) Used CHF/USD 2008 average exchange rate <strong>of</strong> 0.9265. (3) Used EUR/USD<br />

2008 average exchange rate <strong>of</strong> 1.4712.<br />

Biotech f<strong>in</strong>anc<strong>in</strong>g environment<br />

Ano<strong>the</strong>r challenge for <strong>the</strong> CRO <strong>in</strong>dustry has been <strong>the</strong> dramatic decl<strong>in</strong>e <strong>in</strong> biotech<br />

f<strong>in</strong>anc<strong>in</strong>gs throughout 2008 and 1H09, someth<strong>in</strong>g that has been noted <strong>in</strong> recent calls<br />

by both Charles River and Covance.<br />

In 2008 Covance derived 10% <strong>of</strong> revenues from emerg<strong>in</strong>g, VC-backed biotech<br />

customers. While such clients were hit particularly hard dur<strong>in</strong>g <strong>the</strong> credit crisis and<br />

are just now show<strong>in</strong>g early signs <strong>of</strong> resurgence, larger biotech clients (Amgen, etc.)<br />

and smaller self-funded biotech companies have rema<strong>in</strong>ed more stable customers.<br />

Table 10: U.S. Biotech F<strong>in</strong>anc<strong>in</strong>gs 2006-08<br />

2006 2007 2008<br />

($mm) Total Total Q1'08 Q2'08 Q3'08 Q4'08 Total<br />

IPOs 920 2,041 6 0 0 0 6<br />

Follow-ons 5,766 6,311 701 312 693 20 1,726<br />

PIPEs 2,027 1,818 370 203 308 197 1,078<br />

Debt 13,978 6,749 1,622 360 408 434 2,824<br />

VC 4,236 4,445 837 1,007 1,085 1,246 4,175<br />

O<strong>the</strong>r 425 611 20 226 20 28 294<br />

Partener<strong>in</strong>g 19,796 23,365 3,091 4,141 2,962 9,829 20,023<br />

Total (ex-Partener<strong>in</strong>g) 27,352 21,975 3,556 2,108 2,514 1,925 10,103<br />

Total 47,148 45,340 6,647 6,249 5,476 11,754 30,126<br />

Source: Burrill & Company


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Overcapacity and pric<strong>in</strong>g pressure<br />

Follow<strong>in</strong>g a period <strong>of</strong> high capital <strong>in</strong>vestment <strong>in</strong> 2007-2008, overcapacity has<br />

emerged as ano<strong>the</strong>r significant challenge for many CROs, <strong>in</strong> particular, for smaller<br />

companies (such as MPI) that do not have <strong>the</strong> f<strong>in</strong>ancial cushion to absorb lower<br />

utilization.<br />

Today, we estimate that <strong>the</strong>re could be as much as 20-25% excess physical capacity<br />

<strong>in</strong> certa<strong>in</strong> parts <strong>of</strong> <strong>the</strong> precl<strong>in</strong>ical market, such as toxicology, which has led to<br />

significant discount<strong>in</strong>g by some CROs, sometimes as much as 30-40%. For Covance,<br />

we estimate that roughly one-third <strong>of</strong> <strong>the</strong> toxicology bus<strong>in</strong>ess has faced pric<strong>in</strong>g<br />

pressure <strong>in</strong> one form or ano<strong>the</strong>r, while two-thirds <strong>of</strong> <strong>the</strong> bus<strong>in</strong>ess is dedicated space<br />

and <strong>the</strong>refore is not impacted. O<strong>the</strong>r areas, such as Program Management, are less<br />

impacted given that few companies have full capabilities <strong>in</strong> this area.<br />

At this po<strong>in</strong>t, capacity additions, which can <strong>in</strong>volve both “built” and “built and<br />

staffed” facilities, appear to be largely done, and a number <strong>of</strong> companies, <strong>in</strong>clud<strong>in</strong>g<br />

Charles River, are actively work<strong>in</strong>g to downsize and shutter redundant facilities (MPI<br />

recently term<strong>in</strong>ated 25% <strong>of</strong> <strong>the</strong> staff at <strong>the</strong> Ann Arbor, MI facility, for example).<br />

Go<strong>in</strong>g forward, we expect pric<strong>in</strong>g to stabilize as capacity is worked out <strong>of</strong> <strong>the</strong><br />

system, although this could take several quarters, if not longer. As discussed below,<br />

we also expect additional capacity transfers from large pharmaceutical companies<br />

(ak<strong>in</strong> to <strong>the</strong> Covance/Lilly deal) given <strong>the</strong> focus on pipel<strong>in</strong>e rationalization and<br />

expense control, although companies such as Covance rema<strong>in</strong> price sensitive and<br />

may only do such deals if <strong>the</strong>re is a clear pathway to accretion and significant tail <strong>of</strong><br />

bus<strong>in</strong>ess.<br />

25


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Table 11: Key Capacity Additions - Full Service CROs<br />

Full Service CROs<br />

26<br />

North America Equity Research<br />

16 July 2009<br />

Key ►Pre-Cl<strong>in</strong>ical Facility ■Cl<strong>in</strong>ical Facility ♦ Central Lab Facility ● O<strong>the</strong>r<br />

CVD<br />

Quntiles<br />

Region<br />

North America Europe Asia<br />

LatAm and O<strong>the</strong>r Emerg<strong>in</strong>g<br />

► May 24, 2007: Opens 21,000 sq. ft. ABSL-2<br />

facility <strong>in</strong> Denver, P.A. to enhance vacc<strong>in</strong>e<br />

service <strong>of</strong>fer<strong>in</strong>g<br />

►3Q07: Expands its precl<strong>in</strong>ical facility<br />

(toxicology centre <strong>of</strong> excellence) <strong>in</strong> Muenster,<br />

Germany.<br />

♦3Q07: Opens a new purpose-built 13,000 sq. ft. Central lab <strong>in</strong><br />

Shanghai to meet grow<strong>in</strong>g demand <strong>of</strong> Phase III cl<strong>in</strong>ical trials<br />

conducted <strong>in</strong> Ch<strong>in</strong>a.<br />

► Nov 20, 2007: Buys partially-built 410,000<br />

sq. ft. safety test<strong>in</strong>g and chemistry analysis<br />

facility from Eli Lilly (Virg<strong>in</strong>ia)<br />

►June, 2008: Completes 50,000 sq. ft cl<strong>in</strong>ical<br />

pharmacology research facility (Evansville,<br />

Indiana)<br />

► Aug 6, 2008: Buys toxicology facility from Eli<br />

Lilly (Greenfield, Indiana)<br />

►/■ Dec 16, 2008: Purchases equity stake <strong>in</strong><br />

Caprion Proteomics (Canada), with Covance<br />

serv<strong>in</strong>g as exclusive provider <strong>of</strong> Caprion's<br />

proteomic biomarker services<br />

► Mar 26, 2009: Opens 288,000 sq. ft. precl<strong>in</strong>ical<br />

and safety test<strong>in</strong>g facility (Chandler,<br />

Arizona)<br />

► May 15, 2007: Opens 236,000 sq ft.<br />

development services and cl<strong>in</strong>ical pharmacology<br />

facility (Kansas)<br />

■ Jan 17, 2008: Opens cl<strong>in</strong>ical development<br />

<strong>of</strong>fice <strong>in</strong> Wilm<strong>in</strong>gton, N.C.<br />

● May 7, 2008: Acquires Eidetics, a decisionanalytics<br />

and market research consult<strong>in</strong>g firm<br />

(Boston)<br />

♦ Dec 1, 2008: Acquires Targeted Molecular<br />

Diagnostics, a oncology-focused, speciality<br />

diagnostics laboratory (Ill<strong>in</strong>ois)<br />

Source: Company reports.<br />

► Feb 18, 2009: Adds an additional 8000 sq.<br />

ft. to its biotechnology services facility <strong>in</strong><br />

Harrogate, UK.<br />

■ Feb 3, 2009: Opens cl<strong>in</strong>ical development<br />

<strong>of</strong>fices <strong>in</strong> Ukra<strong>in</strong>e, Slovakia, and Israel.<br />

■ March 13, 2009: Buys Swiss Pharma<br />

Contract, a 50-bed early cl<strong>in</strong>ical development<br />

site <strong>in</strong> Basel, Switzerland.<br />

► Aug 28, 2007: Opens its first US$2 million 5,000 sq. ft.<br />

nutritional chemistry lab for Asia <strong>in</strong> S<strong>in</strong>gapore.<br />

► Sep 29, 2008: Ends strategy to pursue 50-50 jo<strong>in</strong>t venture<br />

with WX, decides to pursue orig<strong>in</strong>al strategy to build pre-cl<strong>in</strong>ical<br />

facility <strong>in</strong> Ch<strong>in</strong>a organically.<br />

■ April 7, 2009: Opens cl<strong>in</strong>ical development <strong>of</strong>fices <strong>in</strong> Chile,<br />

Peru, and expanded <strong>of</strong>fice <strong>in</strong> Argent<strong>in</strong>a.<br />

♦ Apr 6, 2007: Opens a new Central Lab <strong>in</strong> Mumbai, India.<br />

♦ Jan 9, 2008: Expands and consolidates Global Central<br />

Laboratories and CDS units <strong>in</strong> Beij<strong>in</strong>g, Ch<strong>in</strong>a. The new<br />

consolidated Qu<strong>in</strong>tiles Ch<strong>in</strong>a facility has approx. 17,000 sq ft <strong>of</strong><br />

space expand<strong>in</strong>g <strong>the</strong> lab space by 2,600 sq ft. CDS occupies<br />

10,000 sq ft <strong>of</strong> <strong>the</strong> comb<strong>in</strong>ed <strong>of</strong>fice area, a major expansion over<br />

its old facility <strong>of</strong> under 3,000 sq ft.<br />

♦ March 26, 2008: Announces an agreement with Medca Japan<br />

to provide central laboratory services <strong>in</strong> Saitama, Greater<br />

Tokyo, Japan.<br />

■ Jan 27, 2009: Partnership with Apollo Hospitals Group to<br />

open a Phase I cl<strong>in</strong>ical trial unit <strong>in</strong> Hyderabad, India.<br />

■ Oct 30, 2007: Acquires BioTrials, a Lat Am based CRO<br />

hav<strong>in</strong>g <strong>of</strong>fices <strong>in</strong> Panama, Costa Rica, Guatemala, Ecuador<br />

and Peru. BioTrials <strong>of</strong>fers cl<strong>in</strong>ical monitor<strong>in</strong>g, site co-ord<strong>in</strong>ation,<br />

study management and o<strong>the</strong>r services.<br />

■ June 16, 2009: Opens new cl<strong>in</strong>ical development <strong>of</strong>fice <strong>in</strong><br />

Ghana.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Aptuit<br />

CRL<br />

► Sep 15, 2009: Acquires MIR Precl<strong>in</strong>ical Services,<br />

provider <strong>of</strong> <strong>in</strong> vivo imag<strong>in</strong>g and o<strong>the</strong>r discovery<br />

services (Michigan)<br />

► April 3, 2009: Acquires Piedoment Research<br />

Center from PPD, provider <strong>of</strong> precl<strong>in</strong>ical services<br />

focuses on efficacy studies <strong>in</strong> oncology (N.C.)<br />

► 2Q09: An approx. 300,000 sq ft. Precl<strong>in</strong>ical<br />

facility scheduled to open <strong>in</strong> Sherbrooke, Quebec,<br />

Canada.<br />

■ Opens Phase I facility (300 beds) <strong>in</strong> Tempe,<br />

Arizona.<br />

North America Equity Research<br />

16 July 2009<br />

Table 12: Key Capacity Additions - Early Stage CROs<br />

North America<br />

Region<br />

Europe Asia<br />

LatAm and O<strong>the</strong>r Emerg<strong>in</strong>g<br />

► December 3, 2007: Acquires Chemical and ► June 18, 2007: Forms a new contract drug<br />

Pharmaceutical Development (CPD) bus<strong>in</strong>ess <strong>of</strong> development company with Laurus named Aptuit<br />

Evotec, which <strong>in</strong>tegrates an API facility <strong>in</strong> Oxford, Laurus. Adds Laurus's 160,000 sq ft R&D facility <strong>in</strong><br />

England and a parenteral (<strong>in</strong>jectable vials)<br />

Hyderabad, India & a manufactur<strong>in</strong>g plant built on over<br />

fill/f<strong>in</strong>ish facility <strong>in</strong> Glasgow, Scotland.<br />

34 acres <strong>in</strong> Pharma City, Vishakhapatnam, India.<br />

► March 6, 2007: Opens 450,000 sq ft. pre-cl<strong>in</strong>ical<br />

► 15 Oct, 2008: Opens 60,000 sq ft. precl<strong>in</strong>ical facility<br />

discovery facility (Shrewsbury, M.A.)<br />

► July 29, 2008: Opens 52,000 sq ft. RMS facility<br />

(Maryland)<br />

<strong>in</strong> Shanghai which will provide non-GLP and GLP<br />

services. GLP services to beg<strong>in</strong> <strong>in</strong> 2Q09.<br />

Early Stage CROs<br />

MDS<br />

MPI Research<br />

WX<br />

► April 22, 2008: Takes over two Pfizer facilities <strong>in</strong><br />

Kalamazoo, M.I.<br />

Source: Company reports.<br />

● Aug 1, 2007: Expands Development &<br />

Regulatory Services (DRS) bus<strong>in</strong>ess <strong>in</strong> Europe<br />

♦ Oct 30, 2007: Expands Central Lab Operations <strong>in</strong><br />

Ch<strong>in</strong>a with <strong>the</strong> open<strong>in</strong>g <strong>of</strong> an almost 25,000 sq. feet<br />

facility <strong>in</strong> Beij<strong>in</strong>g, Ch<strong>in</strong>a. (currently look<strong>in</strong>g for buyer)<br />

♦ 16 Oct, 2008: Expands S<strong>in</strong>gapore Global Central<br />

Laboratory Operation (currently look<strong>in</strong>g for buyer)<br />

► June 8, 2009: Announces expansion <strong>of</strong> early-stage<br />

development facility <strong>in</strong> Taiwan, to be completed <strong>in</strong> 2010<br />

♦ Jan 28, 2008: Opens cl<strong>in</strong>ical trial management <strong>of</strong>fice<br />

<strong>in</strong> Sao Paulo, Brazil<br />

► Dec 19, 2007: JV with Shanghai Medicilon to form<br />

Medicilon-MPI Precl<strong>in</strong>ical Research (Shanghai) LLC. To<br />

open a 50,000 sq. ft. precl<strong>in</strong>ical test<strong>in</strong>g facility <strong>in</strong><br />

Shanghai, Ch<strong>in</strong>a.<br />

► June 8, 2009: Opens <strong>of</strong>fice <strong>in</strong> Ahmedabad, India<br />

► Sep 29, 2008: Announces plan to construct, own<br />

and operate a 323,450 square foot GLP facility <strong>in</strong><br />

Suzhou, Ch<strong>in</strong>a to open <strong>in</strong> <strong>the</strong> second half <strong>of</strong> 2009.<br />

► 1Q09: Adds to 220,000 sq foot cGMP-quality<br />

process development and manufactur<strong>in</strong>g plant, a<br />

350,000 sq foot commercial manufactur<strong>in</strong>g plant <strong>in</strong><br />

J<strong>in</strong>shan, Ch<strong>in</strong>a.<br />

27


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

28<br />

ICLR<br />

► Nov 14, 2008: Acquires Prevaleres Life Sciences,<br />

a 49,000 sq. ft immunoassay and bioanalytical<br />

services lab (Whitesboro, N.Y.)<br />

►/■ Jan 8, 2009: Acquires rema<strong>in</strong><strong>in</strong>g 30% stake <strong>in</strong><br />

Beacon Biosciences, provider <strong>of</strong> digital imag<strong>in</strong>g data<br />

services (M.A.)<br />

■ April 28, 2009: Acquires assets <strong>of</strong> Qualia Cl<strong>in</strong>ical<br />

Services, Phase I facility <strong>in</strong> Omaha, N.E. (100 beds)<br />

►July 9, 2009: Acquires Veeda Laboratories,<br />

specialist provider <strong>of</strong> biomarker test<strong>in</strong>g services<br />

■ June 3, 2008: Acquires DecisionL<strong>in</strong>e Cl<strong>in</strong>ical<br />

Research Corp. - acq. adds a 36,000 sq-ft, 82-bed<br />

facility <strong>in</strong> Toronto, Canada.<br />

North America Equity Research<br />

16 July 2009<br />

Table 13: Key Capacity Additions - Late Stage CROs<br />

North America<br />

Region<br />

Europe Asia<br />

LatAm and O<strong>the</strong>r Emerg<strong>in</strong>g<br />

■ Feb 11, 2008: Acquires Healthcare Discoveries,<br />

Phase I facility <strong>in</strong> San Antonio, TX (85 beds)<br />

● July 12, 2007: Acquires DOCS International, European-based<br />

contract staff<strong>in</strong>g bus<strong>in</strong>ess<br />

♦ Late 2007: Opens central<br />

laboratory (limited services) <strong>in</strong><br />

S<strong>in</strong>gapore<br />

Late Stage CROs<br />

PRXL<br />

KNDL<br />

PPDI<br />

■ March 31, 2008: Expands cl<strong>in</strong>ical pharmacology<br />

facility <strong>in</strong> Baltimore, M.D. (90 beds)<br />

● Aug 14, 2008: Acquires Cl<strong>in</strong>Phone, cl<strong>in</strong>ical<br />

technolgoy organization (IVR, Medical Imag<strong>in</strong>g,<br />

EDC, and o<strong>the</strong>rs)<br />

► April 3, 2009: Divests Piedmont Research Center<br />

(to CRL), provider <strong>of</strong> precl<strong>in</strong>ical services focuses on<br />

efficacy studies <strong>in</strong> oncology (N.C.)<br />

Source: Company reports.<br />

▼ Jan 15, 2008: Opens cl<strong>in</strong>ical development <strong>of</strong>fices <strong>in</strong> Kiev,<br />

Prague, and Bucharest<br />

■ March 27, 2008: Divests bioanalytical laboratory <strong>in</strong> Poitiers,<br />

France<br />

■ March 31, 2008: Expands cl<strong>in</strong>ical pharmacology facilities <strong>in</strong><br />

London (64 beds) and Berl<strong>in</strong> (160 beds)<br />

■ Nov 20, 2008: Opens <strong>of</strong>fice <strong>in</strong> Lima, Peru<br />

■ Feb 22, 2007: Opens new 34,000 sq. ft. facility <strong>in</strong> Bellshill,<br />

Lanarkshire, Scotland.<br />

■ March 27, 2007: Opens <strong>of</strong>fice <strong>in</strong> A<strong>the</strong>ns, Greece.<br />

■ Feb 6, 2008: Acquires InnoPharm Ltd., an <strong>in</strong>dependent CRO,<br />

based <strong>in</strong> Smolensk, Russia.<br />

■ June, 2008: Opens cl<strong>in</strong>ical <strong>of</strong>fice <strong>in</strong> Istanbul, Turkey.<br />

► Dec 18, 2008: Expands <strong>in</strong>to Athlone, Ireland, by <strong>in</strong>itially<br />

establish<strong>in</strong>g a cGMP analytical test<strong>in</strong>g laboratory to meet grow<strong>in</strong>g<br />

client demand <strong>in</strong> EMEA for <strong>the</strong>se services.<br />

■ Apr 21, 2009: Acquires AbCRO and expands its operations <strong>in</strong><br />

Central & Eastern Europe.<br />

♦ Nov 12, 2008: Opens a full service<br />

15,000 sq-feet central laboratory <strong>in</strong><br />

Bangalore, India.<br />

■ Jan 14, 2009: Opens <strong>of</strong>fice <strong>in</strong><br />

Ahmedabad, India<br />

■ June 1, 2009: Opens <strong>of</strong>fices <strong>in</strong><br />

Kuala Lumpur, Bangkok and<br />

Manila.<br />

■ June 18, 2007: Opens a new<br />

location <strong>in</strong> Hyderabad, India that<br />

<strong>of</strong>fers a wide range <strong>of</strong> cl<strong>in</strong>ical<br />

research and data management<br />

services<br />

♦ Jan 23, 2008: Enters <strong>in</strong>to an<br />

agreement with PUL (Pek<strong>in</strong>g Union<br />

Lawke Biomedical Development<br />

Limited) expand<strong>in</strong>g its global central<br />

lab services <strong>in</strong>to Beij<strong>in</strong>g, Ch<strong>in</strong>a.<br />

■April 2009: Opens cl<strong>in</strong>ical <strong>of</strong>fice <strong>in</strong><br />

Tokyo, Japan.<br />

♦ Dec 16, 2008: Announces plan to<br />

build central laboratory <strong>in</strong> S<strong>in</strong>gapore<br />

(to be completed mid-2009)<br />

O<strong>the</strong>r trends to watch<br />

Capacity transfers (Covance/Lilly, MPI/Pfizer)<br />

As mentioned, <strong>the</strong> CRO <strong>in</strong>dustry has seen a number <strong>of</strong> significant capacity transfers,<br />

<strong>in</strong>clud<strong>in</strong>g Covance/Eli Lilly and MPI/Pfizer. For Covance, <strong>the</strong> Lilly deal allowed <strong>the</strong><br />

company to add more than 600,000 square feet <strong>of</strong> laboratory space, <strong>in</strong>clud<strong>in</strong>g over<br />

100 toxicology rooms and 130,000 square feet <strong>of</strong> new chemistry capacity, as well as<br />

access new specialty service l<strong>in</strong>es, such as non-GLP toxicology, <strong>in</strong> vivo<br />

pharmacology, and pre-cl<strong>in</strong>ical imag<strong>in</strong>g. The Covance/Eli Lilly deal represent <strong>the</strong><br />

most significant capacity transfer to date (privately held MPI acquired a smaller<br />

facility from Pfizer <strong>in</strong> Ann Arbor, although this was without staff and preexist<strong>in</strong>g


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Table 14: Selected Compound Partner<strong>in</strong>g Programs<br />

North America Equity Research<br />

16 July 2009<br />

contracts, while PPD announced <strong>the</strong> acquisition <strong>of</strong> a 130,000 square foot vacc<strong>in</strong>e<br />

development laboratory, along with 80 employees, from Merck).<br />

Go<strong>in</strong>g forward, we expect capacity transfers to cont<strong>in</strong>ue as pharmaceutical<br />

companies shift toward a more variable cost structure, with larger CROs better<br />

positioned to capitalize on opportunities. We expect that some partner<strong>in</strong>g cases may<br />

not <strong>in</strong>volve actual facility transfer but ra<strong>the</strong>r management <strong>of</strong> a given site (Charles<br />

River, for example, has discussed <strong>the</strong> potential to take over management duties at a<br />

number <strong>of</strong> customer locations).<br />

Compound partner<strong>in</strong>g (PPDI – J&J, Rambaxy, Takeda, etc.)<br />

Compound partner<strong>in</strong>g has been ano<strong>the</strong>r grow<strong>in</strong>g <strong>in</strong>dustry trend and a means for<br />

CROs to take on more potential upside, should a drug prove successful (this was a<br />

model that proved popular <strong>in</strong> <strong>the</strong> 1990s for companies such as Pharmacopeia,<br />

Discovery Partners, Albany Molecular, and o<strong>the</strong>rs). That said, a number <strong>of</strong> CROs,<br />

<strong>in</strong>clud<strong>in</strong>g Covance, Charles River, and ICON, are unlikely to embrace <strong>the</strong> shared<br />

ownership model, given <strong>the</strong> <strong>in</strong>herent risks <strong>of</strong> drug development.<br />

PPDI<br />

Compound Indication Phase Last Stage Partner Market Economics<br />

Priligy (dapoxet<strong>in</strong>e) Premature Ejaculation Market Johnson & Johnson 30% <strong>of</strong> males with PE Double-digit royalties<br />

grow with sales. Up to<br />

$50mm <strong>in</strong> sales<br />

milestones<br />

Aloglipt<strong>in</strong> Type 2 Diabetes NDA Takeda $10-12B and grow<strong>in</strong>g Up to $52.5mm rema<strong>in</strong><strong>in</strong>g<br />

<strong>in</strong> development<br />

milestones. Up to $33mm<br />

<strong>in</strong> sales milestones. US<br />

royalty rates: mid-s<strong>in</strong>gle<br />

to double-digit . RoW<br />

royalty rates: mid to upper<br />

s<strong>in</strong>gle-digit levels<br />

Aloglipt<strong>in</strong>/Actos Type 2 Diabetes NDA Takeda $10-12B and grow<strong>in</strong>g Formula based royalties<br />

SYR-472 Type 2 Diabetes Phase II Takeda<br />

PPD10558 (Stat<strong>in</strong>-outlicensed by Ranbaxy) Cholesterol Lower<strong>in</strong>g Phase I Seek<strong>in</strong>g Partner $32B<br />

MAG-131 Multiple Dermatology Indications Pre-IND $12B<br />

Ranbaxy<br />

Program Partner<br />

Drug Discovery and Cl<strong>in</strong>ical Development GSK<br />

Stat<strong>in</strong> Molecule Out Licensed PPD, USA<br />

Cipro OD Technology Out Licensed Bayer<br />

Albany Molecular<br />

Compound Indication Phase Partner<br />

Biogenic Am<strong>in</strong>es Central Nervous disorders Phase I Bristol-Myers Squibb<br />

Allegra/Telfast Seasonal allergic rh<strong>in</strong>itis Market San<strong>of</strong>i Aventis<br />

Source: Company reports.<br />

Growth <strong>in</strong> imag<strong>in</strong>g services<br />

A grow<strong>in</strong>g number <strong>of</strong> CROs, <strong>in</strong>clud<strong>in</strong>g Charles River Laboratories, Covance, and<br />

ICON have also recently expanded imag<strong>in</strong>g services encompass<strong>in</strong>g both early stage<br />

precl<strong>in</strong>ical and later stage development and <strong>in</strong>tegrat<strong>in</strong>g technologies such as MRI and<br />

PET/CT.<br />

ICON Imag<strong>in</strong>g (formerly Beacon Biosciences) provides specialized electronic<br />

solutions for digital imag<strong>in</strong>g data (X-Ray, MRI, CT, nuclear medic<strong>in</strong>e, PET,<br />

29


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

30<br />

North America Equity Research<br />

16 July 2009<br />

ultrasound, video, photography), <strong>in</strong>clud<strong>in</strong>g a browser <strong>in</strong>terface, real-time data access,<br />

and o<strong>the</strong>r collection and analysis services. ICON <strong>in</strong>itially took a 70% stake <strong>in</strong><br />

Massachusetts-based Beacon Biosciences <strong>in</strong> 2004 for $9.9 million and <strong>in</strong> December<br />

2008 acquired <strong>the</strong> rema<strong>in</strong><strong>in</strong>g 30% for $17.4 million.<br />

Charles River recently expanded <strong>the</strong> Discovery and Imag<strong>in</strong>g Services (DIS) bus<strong>in</strong>ess,<br />

which focuses on earlier-stage work, through <strong>the</strong> September 2009 acquisition <strong>of</strong><br />

Molecular Imag<strong>in</strong>g Research ($12.5 million). The MIR precl<strong>in</strong>ical bus<strong>in</strong>ess, which<br />

was founded <strong>in</strong> 2003 and operates <strong>in</strong> a 20,000 square foot facility (30 employees),<br />

focuses on apply<strong>in</strong>g <strong>in</strong> vivo imag<strong>in</strong>g technologies, <strong>in</strong>clud<strong>in</strong>g MRI, micro-CT,<br />

biolum<strong>in</strong>escence and PET/CT to oncology and <strong>in</strong>flammation studies, and ultimately,<br />

we expect, cardiovascular, metabolic and o<strong>the</strong>r disease areas.<br />

F<strong>in</strong>ally, when Covance acquired <strong>the</strong> Greenfield campus, it also acquired a range <strong>of</strong><br />

imag<strong>in</strong>g services, <strong>in</strong>clud<strong>in</strong>g non-cl<strong>in</strong>ical imag<strong>in</strong>g, which uses technologies such as<br />

MRI, PET, ultrasound, and optical imag<strong>in</strong>g.<br />

CRO consolidation<br />

With <strong>the</strong> number <strong>of</strong> CROs exceed<strong>in</strong>g 1,100 worldwide and a consolidat<strong>in</strong>g customer<br />

base (i.e., pharmaceutical M&A), we expect that M&A activity among service<br />

providers could pick up as large/merged entities, such as Pfizer/Wyeth and<br />

Merck/Scher<strong>in</strong>g Plough, become more reluctant to parse out smaller ($5-10 million)<br />

studies to niche vendors. That said, <strong>the</strong> top twenty public and private CROs cont<strong>in</strong>ue<br />

to dom<strong>in</strong>ate <strong>the</strong> landscape, and given <strong>the</strong> <strong>in</strong>creas<strong>in</strong>g scrut<strong>in</strong>y on process and speed,<br />

we expect that some <strong>of</strong> <strong>the</strong> smaller providers could face solvency issues.<br />

Table 15: Recent CRO M&A<br />

Announced Date Closed Date Buyer/Investors Role Target Size ($mm)<br />

Mar-13-2009 Mar-13-2009 Covance Inc. Buyer Swiss Pharma Contract AG -<br />

Dec-16-2008 Dec-16-2008 Covance Inc. Buys equity stake Caprion Proteomics, Inc. 3.1<br />

Aug-05-2008 Oct-03-2008 Covance Inc. Buyer Eli Lilly & Co., Greenfield Laboratories 50.0<br />

July 09 2009 July 09 2009 ICON plc Buyer Veeda Laboratories Ltd. -<br />

Apr-20-2009 Apr-20-2009 ICON plc Acquires Assets Qualia Cl<strong>in</strong>ical Services, Inc. -<br />

Jan-08-2009 Jan-08-2009 ICON plc Acquires Rema<strong>in</strong><strong>in</strong>g 30% Beacon BioScience Inc. -<br />

Stake<br />

Nov-14-2008 Nov-14-2008 ICON plc Buyer Prevalere Life Sciences, Inc. 42.6<br />

Feb-08-2008 Feb-08-2008 ICON plc Buyer Healthcare Discoveries LLC 20.9<br />

Apr-03-2009 Apr-03-2009 PPDI Buyer Magen BioSciences, Inc. 14.5<br />

Feb-09-2009 Apr-21-2009 PPDI Buyer AbCRO, Inc. -<br />

Dec-31-2008 Dec-31-2008 PPDI Buyer Merck & Co. Inc., Vacc<strong>in</strong>e Test<strong>in</strong>g Laboratory <strong>in</strong><br />

25.5<br />

Wayne, PA<br />

Feb-06-2008 Oct-01-2008 PPDI Buyer InnoPharm Ltd. 9.0<br />

Dec-01-2008 Dec-01-2008 Qu<strong>in</strong>tiles Transnational Buyer Targeted Molecular Diagnostics LLC -<br />

May-07-2008 May-31-2008 Qu<strong>in</strong>tiles Consult<strong>in</strong>g, Inc. Buyer Eidetics, Inc. -<br />

Jun-13-2008 Aug-14-2008 PRXL Buyer Cl<strong>in</strong>Phone PLC 198.2<br />

Mar-27-2008 Mar-27-2008 Synchron Research<br />

PRXL Sells Bioanalytical Lab PRXL's Bioanalytical Laboratory In Poitiers, France 6.7<br />

Services, Ahemdabad,<br />

India<br />

In Poitiers, France<br />

Apr-03-2009 May-01-2009 CRL Buyer Piedmont Research Center, LLC 46.0<br />

Sep-15-2008 Sep-15-2008 CRL Buyer MIR Precl<strong>in</strong>ical Services 12.5<br />

Aug-05-2008 Sep-10-2008 CRL Buyer NewLab BioQuality GmbH 53.0<br />

May-30-2008 May-30-2008 KNDL Buyer DecisionL<strong>in</strong>e Cl<strong>in</strong>ical Research Corporation 24.7<br />

Source: Company reports, Capital IQ<br />

International trials rema<strong>in</strong> a significant focus area<br />

Outside <strong>the</strong> U.S., <strong>the</strong> CRO market cont<strong>in</strong>ues to grow significantly, driven by<br />

favorable economics (a trial <strong>in</strong> India can cost as little as one tenth per patient versus


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

one <strong>in</strong> <strong>the</strong> U.S.), fast approval times, and reduced bureaucracy, although <strong>the</strong> logistics<br />

<strong>of</strong> patient enrollment and follow-up can be more complicated.<br />

Accord<strong>in</strong>g to a recent article <strong>in</strong> <strong>the</strong> New England Journal <strong>of</strong> Medic<strong>in</strong>e (February 19,<br />

2009), roughly one-third <strong>of</strong> phase III trials (n=509) by major U.S. pharmaceutical<br />

companies now take place entirely outside <strong>the</strong> U.S. with over half <strong>of</strong> study sites<br />

located overseas. The same study also found that <strong>the</strong> number <strong>of</strong> FDA-regulated<br />

<strong>in</strong>vestigators runn<strong>in</strong>g trials abroad has <strong>in</strong>creased by 15 percent per year, while <strong>the</strong><br />

number <strong>of</strong> U.S.-based <strong>in</strong>vestigators has decl<strong>in</strong>ed 5.5 percent.<br />

Not surpris<strong>in</strong>gly, <strong>the</strong> focus on trials outside <strong>the</strong> U.S. has skewed toward Ch<strong>in</strong>a and<br />

India, which account for approximately 28% and 37% <strong>of</strong> CRO revenues, with<strong>in</strong> <strong>the</strong><br />

$500 million Asian market. The transition has been driven largely by cost<br />

(<strong>in</strong>vestigator fees per patient, which can average over $5,000 <strong>in</strong> <strong>the</strong> U.S., can be as<br />

low as $2,000 <strong>in</strong> Ch<strong>in</strong>a and $1,300 <strong>in</strong> India), as well as an abundance <strong>of</strong> patients<br />

(1.17 billion people <strong>in</strong> India, 30% located <strong>in</strong> or around large urban areas) and more<br />

concentrated healthcare delivery (fewer trial sites needed) as well as faster start-up<br />

times (f<strong>in</strong>al protocol to first patient <strong>in</strong> India can take as little as 24 weeks versus 32-<br />

33 weeks <strong>in</strong> <strong>the</strong> U.S.). Of course, benefits are partially <strong>of</strong>fset by logistical challenges<br />

<strong>in</strong>clud<strong>in</strong>g language barriers, poor trial management, unreliable transportation, and<br />

hospital overcrowd<strong>in</strong>g.<br />

For India, <strong>the</strong> market has matured beyond fragmented work on generics and<br />

bioavailability, and it is estimated that <strong>the</strong> country could go from $100 million today<br />

to 15% <strong>of</strong> outsourced work with<strong>in</strong> three to five years, generat<strong>in</strong>g $2 billion <strong>in</strong><br />

revenues, accord<strong>in</strong>g to a recent report by Ernst & Young (<strong>the</strong>re are an estimated 150<br />

CROs <strong>in</strong> India today). As <strong>of</strong> June 2009 <strong>the</strong>re were 413 trials <strong>in</strong> India<br />

(Cl<strong>in</strong>icalTrials.gov), account<strong>in</strong>g for 1.5% <strong>of</strong> <strong>the</strong> 28,500 trials underway or <strong>in</strong><br />

enrollment, despite <strong>the</strong> fact that <strong>the</strong> market rema<strong>in</strong>s limited to Phase I-III, given strict<br />

regulations on animal test<strong>in</strong>g.<br />

Among CROs, Qu<strong>in</strong>tiles has had <strong>the</strong> longest presence <strong>in</strong> India (start<strong>in</strong>g <strong>in</strong> 1997) with<br />

1,260 employees at five sites, <strong>in</strong>clud<strong>in</strong>g a central laboratory <strong>in</strong> Mumbai and data<br />

management/cardiac safety <strong>in</strong> Bangalore. O<strong>the</strong>r CROs <strong>in</strong>clude PPD (approximately<br />

120 cl<strong>in</strong>ical staff <strong>in</strong> New Delhi and Mumbai); ICON (entered market <strong>in</strong> 2002, over<br />

400 employees, runn<strong>in</strong>g 10% <strong>of</strong> global trials across four locations); Kendle (entered<br />

<strong>in</strong> 2004, close to fifty employees); Parexel (entered 2004); and PRA (2006). Indian<br />

CROs also cont<strong>in</strong>ue to expand, led by companies such as Ranbaxy, Siro Cl<strong>in</strong>Pharm,<br />

and Sipra Labs.<br />

Ch<strong>in</strong>a also rema<strong>in</strong>s an attractive opportunity for CROs. Covance established <strong>the</strong> first<br />

central lab <strong>in</strong> 2007. More recently, <strong>in</strong> September 2008, <strong>the</strong> company term<strong>in</strong>ated a 50-<br />

50 jo<strong>in</strong>t venture LOI with WuXi AppTec, which had been aimed at provid<strong>in</strong>g<br />

toxicology services (Covance had planned to <strong>in</strong>vest $30 million <strong>in</strong>itially). That said,<br />

<strong>the</strong> company cont<strong>in</strong>ues to move forward <strong>in</strong> build<strong>in</strong>g out a small amount <strong>of</strong> precl<strong>in</strong>ical<br />

capacity <strong>in</strong> Ch<strong>in</strong>a, albeit at a slower pace. O<strong>the</strong>r CROs that have also built a presence<br />

<strong>in</strong> Ch<strong>in</strong>a <strong>in</strong>clude PPDI, which <strong>in</strong> 2008, expanded a central lab agreement with Pek<strong>in</strong>g<br />

Union Lawke Biomedical Development and Charles River Laboratories, which<br />

through a collaboration with Shanghai BioExplorer, opened a 60,000 sq. ft.<br />

precl<strong>in</strong>ical facility <strong>in</strong> 2008.<br />

31


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

32<br />

North America Equity Research<br />

16 July 2009<br />

Beyond India and Ch<strong>in</strong>a, a number <strong>of</strong> CROs have also expanded <strong>in</strong> Taiwan and<br />

Japan. Parexel entered Taiwan <strong>in</strong> 2007 via <strong>the</strong> acquisition <strong>of</strong> Apex International;<br />

MDS, which recently sold <strong>the</strong> late stage cl<strong>in</strong>ical bus<strong>in</strong>ess, also recently announced<br />

plans to expand pharmacology/DMPK studies. Parexel also has active programs<br />

underway <strong>in</strong> Japan, where it has completed over 500 studies.<br />

Figure 12: Open Phase III Cl<strong>in</strong>ical Trials Sponsored by <strong>the</strong> 20 Largest U.S.-Based Pharmaceutical<br />

Companies<br />

Source: N Engl J Med 360;8 (p. 316-323)<br />

Stimulus (i.e., NIH) potential should not be overblown, but also not ignored<br />

Given <strong>the</strong> focus on areas such as oncology and diabetes, <strong>the</strong> $10.4 billion NIH <strong>in</strong>flux<br />

(as part <strong>of</strong> <strong>the</strong> American Recovery and Re<strong>in</strong>vestment Act) is also likely to have a<br />

modest impact on CROs, albeit one less pronounced than for <strong>the</strong> tool suppliers, such<br />

as Bruker Biosciences, Illum<strong>in</strong>a, Life Technologies, Millipore, and Thermo Fisher<br />

Scientific.<br />

As a rem<strong>in</strong>der, <strong>the</strong> majority <strong>of</strong> ARRA fund<strong>in</strong>g for NIH is skewed toward basic and<br />

applied research grants, with a bias toward already-reviewed, highly meritorious R01<br />

applications that make scientific sense to fund for only two years.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Among CROs, Charles River has dedicated two-thirds <strong>of</strong> a 50,000 square foot<br />

facility <strong>in</strong> Frederick, Maryland, to a $112 million, 10-year contract with <strong>the</strong> National<br />

Cancer Institute for research model colonies (~700,000 models per year to<br />

laboratories receiv<strong>in</strong>g NCI fund<strong>in</strong>g), and we can envision o<strong>the</strong>r similar agreements as<br />

a result <strong>of</strong> ARRA and additional fund<strong>in</strong>g.<br />

Comparative effectiveness is ano<strong>the</strong>r area that could also prove <strong>in</strong>terest<strong>in</strong>g as <strong>the</strong><br />

$1.1 billion federal program to compare medical benefits and cost-effectiveness <strong>of</strong><br />

surgeries, medic<strong>in</strong>es, and devices is likely to drive additional outsourced research. To<br />

date, comparative-effectiveness research has been limited, but we expect efforts by<br />

<strong>the</strong> Federal Coord<strong>in</strong>at<strong>in</strong>g Council for Comparative Effectiveness Research to drive<br />

more work given <strong>the</strong> need to reduce unnecessary medical costs.<br />

Rise <strong>of</strong> eCROs<br />

F<strong>in</strong>ally, with<strong>in</strong> <strong>the</strong> CRO market, eCROs, which have developed a range <strong>of</strong> electronic<br />

tools to support drug, biologic, and device development processes (web-based<br />

document management, trial management systems, auto-encod<strong>in</strong>g <strong>of</strong> adverse events,<br />

electronic data capture), have become <strong>in</strong>creas<strong>in</strong>gly important. Among CROs, Parexel<br />

has taken a particularly pro active approach to <strong>the</strong> market with build-out <strong>of</strong> <strong>the</strong><br />

Perceptive Informatics bus<strong>in</strong>ess, which encapsulates cl<strong>in</strong>ical trial management<br />

systems, medical imag<strong>in</strong>g, electronic data capture, electronic patient reported<br />

outcomes, and <strong>in</strong>teractive voice/web response systems. O<strong>the</strong>r companies, such as<br />

Phase Forward, have also built a significant presence <strong>in</strong> <strong>the</strong> market.<br />

33


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

34<br />

North America Equity Research<br />

16 July 2009<br />

Table 16: 2009 Master Providers (from Cl<strong>in</strong>Page)<br />

Competitive Landscape<br />

The CRO landscape rema<strong>in</strong>s highly fragmented with well over 1,100 companies<br />

worldwide engaged <strong>in</strong> drug development work and competition split between <strong>the</strong><br />

CROs <strong>the</strong>mselves, <strong>in</strong>-house departments <strong>of</strong> pharmaceutical companies, and to a<br />

lesser extent academic facilities.<br />

Despite <strong>the</strong> highly dynamic and competitive landscape, CROs dist<strong>in</strong>guish <strong>the</strong>mselves<br />

through a range <strong>of</strong> areas, <strong>in</strong>clud<strong>in</strong>g quality and accuracy; speed and efficiency;<br />

cl<strong>in</strong>ical expertise; and size and scale.<br />

Company Location 2008 Revenue % Change 2008 Net % Change # Employees Revenue/<br />

(mm)<br />

Y/Y Income Y/Y<br />

employee<br />

Covance Pr<strong>in</strong>ceton, NJ $1,730 12% $194 12% 9,600 $180,208<br />

ERT Philadelphia, PA $133 34% $25 12% 400 $332,500<br />

Icon Dubl<strong>in</strong>, Ireland $865 37% $78 12% 6,570 $131,659<br />

Kendle C<strong>in</strong>c<strong>in</strong>atti, OH $475 19% $29 12% 3,325 $142,857<br />

Medidata (private) New York, NY $117 36% ($7) 12% 535 $218,692<br />

Medpace (private) C<strong>in</strong>c<strong>in</strong>atti, OH $143 50% NA 12% 859 $166,473<br />

Omnicare K<strong>in</strong>g <strong>of</strong> Prussia, PA $172 5% NA 12% 1,189 $144,659<br />

Parexel Waltham, MA $843 25% $58 12% 9,250 $91,135<br />

Phase Forward Waltham, MA $170 27% $14 12% 400 $425,000<br />

PPD Wilm<strong>in</strong>gton, NC $1,570 11% $188 12% 10,500 $149,524<br />

Qu<strong>in</strong>tiles (private) Raleigh, NC $3,000 25% NA 12% 22,000 $136,364<br />

RPS Fort Wash<strong>in</strong>gton, PA $157 31% $3,740 12% 1,200 $130,833<br />

Source: www.cl<strong>in</strong>page.com/images/photos/Cl<strong>in</strong>Page_Master_Providers-2009.pdf<br />

Table 17: Book-to-bill trends<br />

Book-to-bill, backlog, cancellation trends<br />

Book to bill, backlog, and cancellation trends are all metrics used by <strong>the</strong> Street to<br />

gauge performance. On <strong>the</strong> precl<strong>in</strong>ical side, book-to-bill ratios typically run close to<br />

1 (i.e., eat what you kill dur<strong>in</strong>g <strong>the</strong> quarter), although this can be higher for longer<br />

term studies, such as cancer projects, and dedicated space agreements (for example,<br />

<strong>in</strong> <strong>the</strong> quarter that <strong>the</strong> Lilly deal was signed, for example, Covance had book-to-bill<br />

<strong>of</strong> 4 – <strong>the</strong> highest ever).<br />

Net Book to Bill CY06 CY07 CY08<br />

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 C1Q09<br />

CVD (Net book to bill) 1.17 1.65 1.27 1.39 1.42 1.26 1.24 1.22 1.14 1.40 4.04 1.26 1.26<br />

CVD (Adj. Net book to bill) 1.31 1.26 1.28 1.24 1.17 1.30 1.20 1.29 1.34<br />

ICLR 1.70 1.60 1.30 1.30 1.60 1.60 1.40 1.90 1.80 1.50 1.60 1.20 1.20<br />

PPDI 1.37 1.44 1.51 1.23 1.39 1.09 1.36 1.45 1.51 1.09 1.36 1.73 1.07<br />

PRXL n/a 1.69 n/a 1.40 1.70 1.60 1.31 1.87 1.52 1.56 1.00 1.20 1.25<br />

KNDL 1.30 1.10 1.90 1.70 1.40 1.60 1.70 1.40 1.40 1.40 1.40 1.30 0.20<br />

Source: Company reports.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Table 18: CRO C2Q09 Earn<strong>in</strong>gs Schedule<br />

Earn<strong>in</strong>gs Release Conference Call 2Q09<br />

Consensus<br />

JPM<br />

Estimate<br />

Earn<strong>in</strong>gs Call<br />

Number<br />

Dial-<strong>in</strong><br />

Passcode<br />

CROs (Ticker) Date Time Date Time<br />

Charles River (CRL) 4-Aug AMC 5-Aug 8:30 AM $0.58 $0.56 800-230-1059 -<br />

Covance (CVD) 29-Jul AMC 30-Jul 9:00 AM $0.63 $0.65 877-795-3604 4995453<br />

Icon Plc (ICLR) 22-Jul BMO 22-Jul 10:00 AM $0.34 $0.34 866-966-5335 -<br />

Kendle (KNDL) N/A N/A N/A N/A $0.34 NR - -<br />

MDS Inc (MDZ) Sept-10 (F3Q) BMO N/A N/A $0.01 NR - -<br />

Parexel International (PRXL) 10-Aug AMC 11-Aug 10:00 AM $0.27 NR 706-758-4950 -<br />

Pharm. Prod. Development (PPDI) 21-Jul AMC 22-Jul 9:00 AM $0.32 NR 877-644-0692 89018262<br />

Wuxi Apptech (WX) N/A N/A N/A N/A $0.14 $0.12 - -<br />

Source: Thomson Street Events, Bloomberg Consensus estimates, J.P. Morgan estimates.<br />

Precl<strong>in</strong>ical<br />

Major contract research organizations provid<strong>in</strong>g precl<strong>in</strong>ical services <strong>in</strong>clude <strong>the</strong><br />

follow<strong>in</strong>g.<br />

Charles River<br />

Charles River Laboratories provides precl<strong>in</strong>ical services and animal research models<br />

to help with research and drug development by pharmaceutical and biotech<br />

companies, government agencies, and hospital and academic <strong>in</strong>stitutions.<br />

Charles River operates <strong>in</strong> two ma<strong>in</strong> bus<strong>in</strong>ess segments: PCS (Precl<strong>in</strong>ical services)<br />

and RMS (Research model services). Under <strong>the</strong> PCS division, <strong>the</strong> company <strong>of</strong>fers<br />

know-how <strong>in</strong> <strong>the</strong> design, execution, and report<strong>in</strong>g <strong>of</strong> general and specialty toxicology<br />

studies, especially concerned with new <strong>the</strong>rapies and biologicals. Under <strong>the</strong> RMS<br />

segment, <strong>the</strong> company (hav<strong>in</strong>g ~ 150 different stra<strong>in</strong>s) engages <strong>in</strong> production and<br />

sale <strong>of</strong> research models, pr<strong>in</strong>cipally genetically and virally def<strong>in</strong>ed purpose bred rats<br />

and mice.<br />

Be<strong>in</strong>g a precl<strong>in</strong>ical service provider, <strong>the</strong> company is currently exposed to end market<br />

weakness, driven by pharma restructur<strong>in</strong>g and R&D reprioritization, as well as<br />

cont<strong>in</strong>ued fund<strong>in</strong>g challenges for smaller biotech customers.<br />

Covance<br />

Covance <strong>of</strong>fers a range <strong>of</strong> non-cl<strong>in</strong>ical and cl<strong>in</strong>ical services, <strong>in</strong>clud<strong>in</strong>g toxicology,<br />

cl<strong>in</strong>ical pharmacology (Phase I/IIa cl<strong>in</strong>ical studies with a focus on high complexity<br />

studies such as first-<strong>in</strong>-human and drug-drug <strong>in</strong>teraction), and full management and<br />

monitor<strong>in</strong>g <strong>of</strong> Phase IIb/III trials. The company is <strong>the</strong> leader <strong>in</strong> provid<strong>in</strong>g central lab<br />

services and is larger than <strong>the</strong> next several competitors comb<strong>in</strong>ed, touch<strong>in</strong>g nearly<br />

one-quarter <strong>of</strong> all cl<strong>in</strong>ical trials performed. Covance also provides cl<strong>in</strong>ical trial<br />

support services, which is a relatively small bus<strong>in</strong>ess that helps clients track<strong>in</strong>g trials<br />

on a real-time basis us<strong>in</strong>g an <strong>in</strong>teractive trial management system. In addition, <strong>the</strong><br />

company also <strong>of</strong>fers clients peri-approval services, <strong>in</strong>clud<strong>in</strong>g studies conducted<br />

around <strong>the</strong> NDA approval period such as Phase IIIb cl<strong>in</strong>ical studies.<br />

Harlan (private)<br />

Harlan provides pre-cl<strong>in</strong>ical and non-cl<strong>in</strong>ical contract research, research models,<br />

animal diets, and services to clients that <strong>in</strong>clude pharmaceutical, biotech, medical<br />

device, agrochemical, chemical <strong>in</strong>dustries, as well as universities, government<br />

<strong>in</strong>stitutions, and o<strong>the</strong>r research organizations. The company has operations <strong>in</strong> over 12<br />

countries and more than 3,000 employees. Research services <strong>of</strong>fered by Harlan<br />

35


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

36<br />

North America Equity Research<br />

16 July 2009<br />

<strong>in</strong>clude discovery services (over 30,000 square feet <strong>of</strong> dedicated research space for<br />

rodent and non-rodent species), toxicology (<strong>in</strong>halation, reproductive, neurotoxicity,<br />

genotoxicity, and safety pharmacology), drug metabolism, and pharmacok<strong>in</strong>etics as<br />

well as consult<strong>in</strong>g and program management.<br />

Life Sciences Research (LSR)<br />

Founded <strong>in</strong> 1951, Life Sciences Research, which is <strong>the</strong> second largest contract<br />

research organization <strong>in</strong> <strong>the</strong> United K<strong>in</strong>gdom (80% <strong>of</strong> revenues denom<strong>in</strong>ated <strong>in</strong><br />

British pounds), has over 1,600 employees and annual revenues <strong>of</strong> approximately<br />

$240 million. The company provides precl<strong>in</strong>ical and non-cl<strong>in</strong>ical test<strong>in</strong>g services for<br />

biological safety evaluation research to pharmaceutical, biotechnology,<br />

agrochemical, and <strong>in</strong>dustrial chemical companies. The company also serves <strong>the</strong><br />

regulatory and commercial requirements <strong>of</strong> governments perform<strong>in</strong>g safety<br />

evaluations on pharmaceutical and chemical compounds.<br />

Around 85% <strong>of</strong> orders are from precl<strong>in</strong>ical test<strong>in</strong>g and non-cl<strong>in</strong>ical test<strong>in</strong>g services,<br />

while orders from safety and efficacy test<strong>in</strong>g for agrochemical, <strong>in</strong>dustrial chemical,<br />

veter<strong>in</strong>ary, and food <strong>in</strong>dustries account for <strong>the</strong> rema<strong>in</strong>der.<br />

On July 9 Life Sciences Research announced plans to enter <strong>in</strong>to a def<strong>in</strong>itive merger<br />

agreement to be acquired by Lion Hold<strong>in</strong>gs, an entity controlled by Chairman and<br />

CEO, Andrew Baker, who owns approximately 17.5% <strong>of</strong> <strong>the</strong> outstand<strong>in</strong>g shares, for<br />

$8.50 per share <strong>in</strong> cash. The transaction is expected to close <strong>in</strong> 4Q09.<br />

MDS<br />

MDS Pharma Services, one <strong>of</strong> <strong>the</strong> bus<strong>in</strong>ess units for MDS, provides drug discovery<br />

and development services to pharmaceutical and biotechnology customers. MDS<br />

Pharma Services is headquartered <strong>in</strong> K<strong>in</strong>g <strong>of</strong> Prussia, PA (MDS Inc. headquartered <strong>in</strong><br />

Toronto, Canada), with operations <strong>in</strong> n<strong>in</strong>e countries around <strong>the</strong> world.<br />

The company has historically <strong>of</strong>fered services across a range <strong>of</strong> drug discovery and<br />

development processes, <strong>in</strong>clud<strong>in</strong>g lead optimization, pre-IND research,<br />

pharmaceutical, and biopharmaceutical early cl<strong>in</strong>ical research (bioequivalence,<br />

phases I-IIa), bioanalysis, cl<strong>in</strong>ical development, central lab, and centralized cardiac<br />

services. On June 1, however, MDS announced plans to divest <strong>the</strong> late-stage bus<strong>in</strong>ess<br />

(phase II-IV) to INC Research for $50 million and focus solely on early-stage<br />

(discovery through Phase IIa) services. The late-stage operation had approximately<br />

800 employees conduct<strong>in</strong>g multi-site trials <strong>in</strong> over 25 countries. At <strong>the</strong> same time,<br />

<strong>the</strong> company also announced plans to sell <strong>the</strong> Central Labs bus<strong>in</strong>ess (600 employees<br />

at six sites <strong>in</strong> Europe, North America, and Asia), which analyzes samples from<br />

cl<strong>in</strong>ical trials to monitor safety and test for physiological impact and provides realtime<br />

access to data us<strong>in</strong>g proprietary s<strong>of</strong>tware (Apollo).<br />

MPI Research (private)<br />

MPI, which is <strong>the</strong> third largest precl<strong>in</strong>ical provider <strong>in</strong> <strong>the</strong> U.S., focuses on precl<strong>in</strong>ical<br />

and early cl<strong>in</strong>ical services to pharmaceutical, biotech, medical device, animal health<br />

and agrichemical customers. Founded <strong>in</strong> 1995 and headquartered <strong>in</strong> Mattawan<br />

Michigan, <strong>the</strong> company employs over 1,800 employees, with 160 pr<strong>of</strong>essionals <strong>in</strong><br />

analytical services alone, and generates revenues <strong>of</strong> approximately $113 million.<br />

MPI provides services <strong>in</strong> general toxicology, <strong>in</strong>fusion toxicology, developmental and<br />

reproductive toxicology, bioanalytical and analytical sciences, safety pharmacology,


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

neurobehavioral sciences, drug metabolism, and pharmacok<strong>in</strong>etics as well as targeted<br />

discovery research, immunology, pathology services, and molecular imag<strong>in</strong>g.<br />

WIL Research (private)<br />

WIL Research provides toxicology, pharmacology, metabolism, and pharmacology<br />

services to biopharmaceutical, chemical, agricultural, veter<strong>in</strong>ary, and food and<br />

consumer products companies. Founded <strong>in</strong> 1976, <strong>the</strong> company is based <strong>in</strong> Ashland,<br />

Ohio, and has over 600 employees generat<strong>in</strong>g annual revenues <strong>of</strong> approximately $45<br />

million. Services provided by <strong>the</strong> company <strong>in</strong>clude developmental and reproductive<br />

toxicology, juvenile toxicology, general toxicology, neurotoxicology, <strong>in</strong>halation<br />

toxicology, <strong>in</strong>fusion toxicology, safety pharmacology, pathology, metabolism,<br />

analytical chemistry, bioanalytical chemistry, and support services, <strong>in</strong>clud<strong>in</strong>g quality<br />

assurance programs, <strong>in</strong>formation systems, study analysis, and validation services.<br />

Cl<strong>in</strong>ical<br />

In addition to data management companies (such as Phase Forward), CROs<br />

specialized <strong>in</strong> provid<strong>in</strong>g cl<strong>in</strong>ical services to biopharmaceutical companies <strong>in</strong>clude <strong>the</strong><br />

follow<strong>in</strong>g.<br />

Covance<br />

See prior description.<br />

ICON<br />

ICON, which was founded <strong>in</strong> 1990 and is headquartered <strong>in</strong> Dubl<strong>in</strong>, Ireland, is <strong>the</strong><br />

fourth largest CRO and provides outsourced development services from compound<br />

selection to Phase I-IV cl<strong>in</strong>ical studies to pharmaceutical, biotechnology, and<br />

medical device companies <strong>in</strong> <strong>the</strong> U.S., Ireland, and o<strong>the</strong>r parts <strong>of</strong> Europe. The<br />

company also provides various laboratory services, <strong>in</strong>clud<strong>in</strong>g sample analysis, safety<br />

test<strong>in</strong>g, custom flow cytometry, and electronic transmission <strong>of</strong> test results. More than<br />

half <strong>of</strong> ICON revenues are derived from sales outside <strong>the</strong> U.S.<br />

Kendle<br />

Kendle provides cl<strong>in</strong>ical development services on a contract basis to pharmaceutical<br />

and biotechnology companies worldwide. Services <strong>in</strong>clude cl<strong>in</strong>ical trial management,<br />

data management, statistical analysis, medical writ<strong>in</strong>g, regulatory consult<strong>in</strong>g, and<br />

publication. The majority <strong>of</strong> revenues come from late-stage trial services (Phase II-<br />

IV cl<strong>in</strong>ical trial services account for ~90% <strong>of</strong> revenues), while geographically, over<br />

50% <strong>of</strong> revenues are attributed to sales outside <strong>the</strong> U.S.<br />

While <strong>the</strong> geographic footpr<strong>in</strong>t provides some advantages, Kendle is currently fac<strong>in</strong>g<br />

significant pric<strong>in</strong>g pressure with<strong>in</strong> <strong>the</strong> core bus<strong>in</strong>ess l<strong>in</strong>es and has recently reported<br />

high cancellation rates (over 45% <strong>in</strong> 1Q versus <strong>in</strong>itial expectations <strong>of</strong> 18%). Strategic<br />

reposition<strong>in</strong>g <strong>of</strong> <strong>the</strong> Pfizer pipel<strong>in</strong>e, <strong>in</strong>clud<strong>in</strong>g a scale back <strong>of</strong> services provided by<br />

Kendle, coupled with biopharmaceutical consolidation trends and a challeng<strong>in</strong>g<br />

biotech fund<strong>in</strong>g environment have all put additional pressures on <strong>the</strong> bus<strong>in</strong>ess.<br />

Parexel<br />

Paraxel <strong>of</strong>fers a number <strong>of</strong> core services <strong>in</strong>clud<strong>in</strong>g cl<strong>in</strong>ical research services (Phase I-<br />

IV cl<strong>in</strong>ical trial services), consult<strong>in</strong>g and medical communication services, and IT<br />

solutions designed to improve product development (via <strong>the</strong> Perceptive portfolio <strong>of</strong><br />

products). Headquartered <strong>in</strong> Waltham, Massachusetts, <strong>the</strong> company manages 63<br />

37


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

38<br />

North America Equity Research<br />

16 July 2009<br />

locations <strong>in</strong> 51 countries, provid<strong>in</strong>g it with wide geographic reach as approximately<br />

56% <strong>of</strong> revenues are derived from outside <strong>the</strong> U.S. Revenues are split between three<br />

core segments: Cl<strong>in</strong>ical Research Services (73%), Perceptive Informatics (15%), and<br />

Consult<strong>in</strong>g & MedCom Services (12%). Approximately three-quarters <strong>of</strong> revenues<br />

come from large-cap biopharmaceutical companies, while <strong>the</strong> rema<strong>in</strong><strong>in</strong>g quarter<br />

come from small- and mid-cap clients.<br />

PPDI<br />

PPDI is <strong>the</strong> third largest CRO worldwide (annual revenues over $1.5 billion, 10,500<br />

employees and operations <strong>in</strong> 33 countries) and provides drug discovery and<br />

development services, post-approval expertise, and compound partner<strong>in</strong>g programs.<br />

The company is a market leader <strong>in</strong> late-stage development and provides end-to-end<br />

cl<strong>in</strong>ical trial management and central lab services. The company also <strong>of</strong>fers several<br />

support services, such as product launch services, medical <strong>in</strong>formation, patient<br />

compliance programs, patient and disease registry programs, product safety, and<br />

pharmacovigilance monitor<strong>in</strong>g.<br />

PRA (private)<br />

PRA International helps develop drug compounds, biologics, and drug delivery<br />

devices for pharmaceutical and biotechnology companies <strong>in</strong> <strong>the</strong> United <strong>State</strong>s,<br />

Europe, and Japan. Founded <strong>in</strong> 1976, <strong>the</strong> company has over 2,700 employees and<br />

annual revenues <strong>of</strong> approx $400 million. Core areas <strong>of</strong> service for PRA <strong>in</strong>clude<br />

Product Registration (design, management, and implementation <strong>of</strong> study protocols <strong>of</strong><br />

Phase II and Phase III), Scientific and Medical affairs (design<strong>in</strong>g and implement<strong>in</strong>g<br />

cl<strong>in</strong>ical development programs <strong>in</strong> a particular <strong>the</strong>rapeutic area, safety and risk<br />

management services, regulatory affairs advisory, and medical affairs post approval,<br />

Phase IV trials), and Early Development (first-<strong>in</strong>-man, etc.). The company also<br />

performs cl<strong>in</strong>ical trials management services <strong>in</strong> collaboration with <strong>in</strong>ternal staff and<br />

o<strong>the</strong>r CROs.<br />

Qu<strong>in</strong>tiles (private)<br />

Qu<strong>in</strong>tiles is <strong>the</strong> largest global CRO, with ~14% market share, operations <strong>in</strong> over 50<br />

countries, 22,000 employees, and annual revenues ~$3 billion. The company<br />

provides services through several channels, <strong>in</strong>clud<strong>in</strong>g Development Services (Phase I<br />

services, phase II-IV trial services <strong>in</strong>clud<strong>in</strong>g cl<strong>in</strong>ical trial management, medical and<br />

regulatory affairs and drug safety, central labs and data management); Commercial<br />

(services necessary to release a drug <strong>in</strong> <strong>the</strong> market and post market<strong>in</strong>g surveillance,<br />

as well as specifically services such as pric<strong>in</strong>g, due diligence, sales force tra<strong>in</strong><strong>in</strong>g,<br />

and advertis<strong>in</strong>g); and Partner<strong>in</strong>g Solutions, which provides fund<strong>in</strong>g, development,<br />

and commercialization services, and outsourc<strong>in</strong>g/<strong>in</strong>sourc<strong>in</strong>g decisions through <strong>the</strong><br />

NovaQuest strategic partner<strong>in</strong>g solutions group.<br />

Quest<br />

Quest provides central laboratory test<strong>in</strong>g <strong>in</strong> connection with cl<strong>in</strong>ical research trials to<br />

test <strong>the</strong> safety and efficacy <strong>of</strong> new drugs and vacc<strong>in</strong>es. The company has cl<strong>in</strong>ical<br />

trials test<strong>in</strong>g centers <strong>in</strong> <strong>the</strong> U.S. and UK and provides cl<strong>in</strong>ical trial test<strong>in</strong>g services <strong>in</strong><br />

Australia, Ch<strong>in</strong>a, and S<strong>in</strong>gapore through associated labs. The company also provides<br />

rout<strong>in</strong>e cl<strong>in</strong>ical test<strong>in</strong>g services, gene based and o<strong>the</strong>r esoteric test<strong>in</strong>g, and anatomy<br />

pathology services (o<strong>the</strong>r than risk assessment services for <strong>the</strong> life <strong>in</strong>surance<br />

<strong>in</strong>dustry), although it does not have phase III trial capabilities. Quest supports<br />

worldwide cl<strong>in</strong>ical trial test<strong>in</strong>g for GlaxoSmithKl<strong>in</strong>e and also provides services to<br />

government agencies and commercial laboratories.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

In <strong>the</strong> follow<strong>in</strong>g tables we highlight some <strong>of</strong> broader performance characteristics <strong>of</strong> CROs.<br />

Table 19: CRO Revenue Growth<br />

Rev Growth y/y<br />

Company 2000 2001 2002 2003 2004 2005 2006 2007 2008<br />

CRL Reported 33% 52% 19% 11% 18% 37% 7% 16% 9%<br />

Organic 12% 17% n/a 3% 11% 10% 6% 13% 8%<br />

PCS Segment (1) 18% 21% 14% 1% 42% 17% 12% 17% 6%<br />

CVD Reported 11% -2% 3% 5% 8% 18% 12% 16% 12%<br />

Organic 8% 10% 9% 3% 6% 17% 12% 13% 11%<br />

ICLR (2) Reported 35% 44% 35% 44% 32% 10% 32% 38% 37%<br />

Organic 35% 25% 35% 33% 21% 10% 31% 35% 32%<br />

KNDL Reported 33% 25% 10% -2% 3% 16% 49% 52% 19%<br />

Organic -4% 20% -3% -11% 4% 17% 22% 34% (3) 19%<br />

MDZ (2) Reported 21% 13% 1% -15% -18% 2% 8% 14% 9%<br />

Organic n/a n/a n/a 4% n/a 4% 6% 3% -1%<br />

Pharma Services 94% 30% 18% -1% 16% 7% 3% 4% -2%<br />

PRXL (2) Reported 30% 7% 17% 9% 6% 3% 13% 21% 27%<br />

Organic 9% 2.5% (3) 14.6% (3) 9% -3% -3% 13% 14% 19%<br />

PPDI (2) Reported 14% 25% 41% 19% 16% 23% 20% 13% 11%<br />

Source: Company reports; FactSet. (1) 2000-2002 represents Biomedical Products and Services bus<strong>in</strong>ess segment. 2001 <strong>in</strong>cl. PAI and Primedica<br />

acquisitions. For 2002, pro forma numbers <strong>in</strong>cl BioLabs and Spr<strong>in</strong>gborn. 2003 <strong>in</strong>cl. +9.8% from BioLabs and Spr<strong>in</strong>gborn. 2005 represents pro forma <strong>in</strong>cl<br />

Inveresk. After Phase II-IV divestiture <strong>in</strong> Aug 2006, segment <strong>in</strong>cl Phase I Cl<strong>in</strong>ical. 2008 <strong>in</strong>cl NewLab BioQuality. (2) For ICLR, revenue growth 2000-2005<br />

based on May fiscal year ends. MDS has October fiscal year end. PRXL has June fiscal year end. Only reported growth available for PPDI. (3) Organic<br />

figures unavailable.<br />

Table 20: Precl<strong>in</strong>ical / Early Stage CRO Operat<strong>in</strong>g Marg<strong>in</strong>s<br />

Operat<strong>in</strong>g Marg<strong>in</strong>s<br />

Company 1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CRL PCS Segment 15.8% 16.7% 17.8% 13.1% 13.8% 16.1% 17.2% 13.3% 7.5%<br />

CVD Early Development 24.4% 25.6% 26.0% 24.8% 25.0% 25.4% 25.4% 21.4% 14.1%<br />

Source: Company reports.<br />

Table 21: Precl<strong>in</strong>ical / Early Stage CRO EBITDA Marg<strong>in</strong>s<br />

EBITDA Marg<strong>in</strong>s<br />

Company 1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CRL PCS Segment 25.5% 26.3% 27.4% 22.9% 23.1% 25.0% 26.2% 23.0% 17.7%<br />

CVD Early Development 30.2% 31.0% 31.1% 29.7% 31.0% 31.1% 31.0% 27.0% 20.4%<br />

Source: Company reports.<br />

39


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

40<br />

North America Equity Research<br />

16 July 2009<br />

Figure 13: Historical OMs: CRL PCS vs. CVD Early Development<br />

30%<br />

25%<br />

20%<br />

15%<br />

10%<br />

5%<br />

0%<br />

CRL<br />

CVD<br />

1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CRL PCS Segment CVD Early Development<br />

Source: Company reports and J.P. Morgan estimates.<br />

Figure 14: Historical EBITDA: CRL PCS vs. CVD Early Development<br />

35%<br />

30%<br />

25%<br />

20%<br />

15%<br />

10%<br />

5%<br />

0%<br />

CRL<br />

CVD<br />

1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CRL PCS Segment CVD Early Development<br />

Source: Company reports and J.P. Morgan estimates.<br />

Table 22: Cl<strong>in</strong>ical / Late-Stage CRO Operat<strong>in</strong>g Marg<strong>in</strong>s<br />

Operat<strong>in</strong>g Marg<strong>in</strong>s<br />

1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CVD Late-Stage 16.3% 16.8% 17.5% 16.1% 18.5% 19.2% 19.7% 19.6% 22.6%<br />

ICLR 10.8% 10.9% 11.2% 11.0% 10.7% 11.2% 12.0% 12.0% 12.2%<br />

KNDL 13.1% 11.1% 15.9% 14.6% 12.2% 12.7% 12.7% 10.0% 7.5%<br />

PRXL 8.1% 8.2% 7.9% 8.6% 9.3% 9.9% 8.4% 8.2% 10.0%<br />

PPDI 19.7% 19.0% 16.1% 16.4% 18.5% 18.9% 19.5% 20.9% 19.1%<br />

Source: Company reports, FactSet.<br />

Table 23: Cl<strong>in</strong>ical / Late-Stage CRO EBITDA Marg<strong>in</strong>s<br />

EBITDA Marg<strong>in</strong>s<br />

1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CVD Late-Stage 19.2% 19.6% 20.2% 18.6% 20.5% 21.1% 21.6% 21.5% 24.3%<br />

ICLR 13.8% 13.9% 14.2% 13.9% 13.7% 14.2% 15.6% 15.2% 15.6%<br />

KNDL 16.9% 14.8% 19.8% 17.3% 15.2% 15.6% 16.1% 13.0% 11.2%<br />

PRXL 12.4% 12.4% 12.0% 12.7% 13.1% 13.6% 12.9% 13.2% 15.0%<br />

PPDI 23.9% 23.3% 20.4% 20.8% 22.5% 22.9% 23.6% 25.3% 23.6%<br />

Source: Company reports, FactSet.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Figure 15: Historical OMs Compar<strong>in</strong>g: CVD Late-Stage, ICLR, KNDL,<br />

PRXL, and PPDI<br />

25.0%<br />

20.0%<br />

15.0%<br />

10.0%<br />

5.0%<br />

0.0%<br />

KNDL<br />

PRXL<br />

PPDI<br />

CVD Late Stage<br />

ICLR<br />

1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CVD Late Stage ICLR KNDL PRXL PPDI<br />

Source: Company reports and J.P. Morgan estimates.<br />

Table 24: CRO Industry Comparable Company Analysis<br />

Figure 16: Historical EBITDA Compar<strong>in</strong>g: CVD Late-Stage, ICLR,<br />

KNDL, PRXL, and PPDI<br />

30.0%<br />

25.0%<br />

20.0%<br />

15.0%<br />

10.0%<br />

5.0%<br />

0.0%<br />

PRXL<br />

CVD Late Stage<br />

KNDL<br />

PPDI<br />

ICLR<br />

1Q07 2Q07 3Q07 4Q07 1Q08 2Q08 3Q08 4Q08 1Q09<br />

CVD Late Stage ICLR KNDL PRXL PPDI<br />

Source: Company reports and J.P. Morgan estimates.<br />

Price Mkt Cap. FC Calendar Year EPS FC Calendar Year P/E EPS Growth P/E-to-Growth EV / Sales EV / EBITDA<br />

Company<br />

Precl<strong>in</strong>ical (A)<br />

Ticker Rat<strong>in</strong>g 7/14/2009 ($ M) 2008 2009E 2010E 2008 2009E 2010E 08/07 09E/08 10E/09E 2008 2009E 2010E 2008 2009E 2010E 2008 2009E 2010E<br />

Charles River Laboratories CRL N $31.58 2,240 $2.89 $2.42 $2.78 10.9x 13.0x 11.3x 11% -16% 15% 1.0x nm 0.8x 1.9x 2.0x 1.9x 7.3x 8.3x 7.3x<br />

Covance, Inc. CVD OW $48.65 3,141 $3.03 $2.61 $3.10 16.1x 18.6x 15.7x 14% -14% 19% 1.1x nm 0.8x 1.8x 1.7x 1.5x 8.8x 9.6x 8.2x<br />

MDS, Inc. MDZ - $5.61 642 $0.18 $0.20 $0.30 30.9x 28.1x 18.9x -49% 10% 49% nm nm 0.4x 0.7x 0.8x 0.8x 4.9x 6.7x na<br />

Wuxi Apptech WX N $8.89 638 ($1.01) $0.49 $0.60 nm 18.1x 14.9x nm nm 21% nm nm 0.7x 2.4x 2.3x 1.9x 8.3x 9.0x 7.0x<br />

Cl<strong>in</strong>ical (B)<br />

Covance, Inc. CVD OW $48.65 3,141 $3.03 $2.61 $3.10 16.1x 18.6x 15.7x 14% -14% 19% 1.1x nm 0.8x 1.8x 1.7x 1.5x 8.8x 9.6x 8.2x<br />

Icon Plc ICLR OW $22.50 1,263 $1.30 $1.41 $1.63 17.3x 15.9x 13.8x 38% 9% 15% 0.5x 1.8x 0.9x 1.5x 1.4x 1.3x 9.8x 9.3x 8.2x<br />

Kendle International Inc. KNDL - $11.10 182 $1.96 $1.50 $1.55 5.7x 7.4x 7.2x 22% -23% 3% 0.3x nm 2.5x 0.6x 0.7x 0.7x 4.1x 5.9x 5.0x<br />

PAREXEL International Corporation PRXL - $13.21 828 $0.93 $1.02 $1.15 14.2x 13.0x 11.5x 21% 9% 13% 0.7x 1.5x 0.9x 1.0x 0.9x 0.9x 6.9x 6.7x 6.1x<br />

Pharmaceutical Product Development PPDI - $21.81 2,738 $1.70 $1.37 $1.53 12.8x 16.0x 14.2x 25% -20% 12% 0.5x nm 1.2x 1.5x 1.6x 1.5x 6.1x 7.1x 6.5x<br />

Source: FactSet, Company data, J.P. Morgan estimates. ICON and Covance estimates are J.P. Morgan estimates.<br />

Total Group Average 15.4x 16.3x 13.4x 12% -6% 18% 0.7x 1.6x 1.0x 1.4x 1.4x 1.3x 7.0x 7.8x 6.9x<br />

Total Group Average excl MDZ 12.8x 14.6x 12.7x 22% -9% 14% 0.7x 1.6x 1.1x 1.5x 1.5x 1.4x 7.3x 8.0x 6.9x<br />

Median 14.2x 16.0x 14.0x 21% -14% 15% 0.6x 1.6x 0.9x 1.5x 1.5x 1.4x 7.1x 7.7x 7.0x<br />

(A) Average Precl<strong>in</strong>ical 19.3x 19.5x 15.2x -8% -7% 17% 1.1x nm 0.7x 1.7x 1.7x 1.5x 7.3x 8.4x 7.5x<br />

(B) Average Cl<strong>in</strong>ical 13.2x 14.2x 12.5x 24% -8% 12% 0.6x 1.6x 1.3x 1.3x 1.3x 1.2x 7.2x 7.7x 6.8x<br />

As shown <strong>in</strong> <strong>the</strong> follow<strong>in</strong>g table, CRO customer mix by end market also vary.<br />

41


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

42<br />

North America Equity Research<br />

16 July 2009<br />

Table 25: CRO End Market Exposure<br />

End Markets<br />

CRL<br />

Net Revenue Mix FY2008 FY2007<br />

Commercial 84% 84%<br />

All Biotech 20%<br />

Non Rev Co's 5%<br />

Non-Commercial (Academic, Gov, etc) 16% 16%<br />

CVD<br />

Net Revenue Mix FY2008 FY2007<br />

Top 50 BioPharma 80%<br />

Top 10 BioPharma 33%<br />

Emerg<strong>in</strong>g Biopharma/Speciality Pharma 10%<br />

Govt./Food Manufacturers/Academia/O<strong>the</strong>rs 10%<br />

ICLR<br />

Net New Bus<strong>in</strong>ess W<strong>in</strong>s FY2008 FY2007<br />

Mid Sized Pharma 18% 18%<br />

Large Pharma 50% 59% (Top 20)<br />

Large Biotech 13%<br />

Mid Biotech 12% 23% (O<strong>the</strong>r Biotech)<br />

Non Rev Co's 7%<br />

PRXL<br />

Net Revenue Mix FY2008 FY2007<br />

Large BioPharma 74%<br />

Small & Midsize BioPharma 26%<br />

PPDI<br />

Net Revenue Mix FY2008 FY2007<br />

Pharma 56% 59%<br />

Biotech 31% 29%<br />

Govt./Academia/O<strong>the</strong>rs 13% 12%<br />

WX<br />

Net Revenue Mix 9M08 FY2007<br />

Top Ten Customers 54% 74%<br />

O<strong>the</strong>r Customers 46% 26%<br />

Source: Company reports and J.P. Morgan estimates.<br />

In precl<strong>in</strong>ical, typical metrics <strong>in</strong>clude capacity utilization, cash flow yield, marg<strong>in</strong>s,<br />

and cost structure. On <strong>the</strong> cl<strong>in</strong>ical side, key metrics <strong>in</strong>clude backlog/book to bill,<br />

orders/cancellations, and marg<strong>in</strong>s, and cost structure.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Table 26: CRO Capabilities Overview<br />

Annual Revenue Key: ▲ >$300 million, ► $100-300 million, ▼


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Table 27: CRO Capabilities Overview - Cont<strong>in</strong>ued<br />

Phase II- IV<br />

Central Laboratory<br />

44<br />

North America Equity Research<br />

16 July 2009<br />

CRL CVD ICLR KNDL MDZ (Pharma<br />

Services)<br />

Rat<strong>in</strong>g: ▲<br />

Rat<strong>in</strong>g: ▲<br />

Rat<strong>in</strong>g: ▲<br />

- Cl<strong>in</strong>ical development<br />

- Extensive Trial - Cl<strong>in</strong>ical Trial<br />

services, safety services management, Services<br />

- Cl<strong>in</strong>ical trial support services, monitor<strong>in</strong>g, and - Cl<strong>in</strong>cal<br />

data management services pharmacovigilance Development<br />

(EDC, IVR)<br />

capabilitites<br />

services<br />

- Highlights access to<br />

- Data<br />

- Biometrics unit<br />

specialized patient populations management and (connect <strong>in</strong>to<br />

for Phase II trials <strong>in</strong> specific statistical<br />

and utilize<br />

<strong>the</strong>rapeutic areas<br />

consult<strong>in</strong>g (EDC, company's own<br />

IVR, Imag<strong>in</strong>g data<br />

management management<br />

capabilities)<br />

systems)<br />

Rat<strong>in</strong>g: ▲<br />

- Central laboratory services<br />

(4 Labs <strong>in</strong> S<strong>in</strong>gapore, Ch<strong>in</strong>a,<br />

Switzerland, and U.S.)<br />

- World's largest provider,<br />

estimates process samples for<br />

~1/3 <strong>of</strong> all cl<strong>in</strong>ical trials<br />

conducted)<br />

Rat<strong>in</strong>g: ▼<br />

- Central<br />

laboratory services<br />

(4 Labs <strong>in</strong><br />

S<strong>in</strong>gapore, India,<br />

New York, and<br />

Ireland).<br />

Source: Company reports, J.P. Morgan estimates. Note * <strong>in</strong>dicates J.P. Morgan estimate.<br />

Rat<strong>in</strong>g:►<br />

- Central<br />

laboratory<br />

services (3 Labs<br />

<strong>in</strong> Kentucky,<br />

Belgium, and<br />

new facility <strong>in</strong><br />

S<strong>in</strong>gapore)<br />

Public Private<br />

Rat<strong>in</strong>g: ▼<br />

- Look<strong>in</strong>g for<br />

buyer<br />

PPDI PRXL WX Qunitles PRA<br />

International<br />

Rat<strong>in</strong>g: ▲<br />

Rat<strong>in</strong>g: ▲<br />

Rat<strong>in</strong>g: ▲<br />

Rat<strong>in</strong>g: ▲<br />

- Study protocol and - Cl<strong>in</strong>ical<br />

- Cl<strong>in</strong>ical monitor<strong>in</strong>g, - Project<br />

case report form design logistics<br />

data management management<br />

- Site and <strong>in</strong>vestigator - Investigator<br />

and biostatistical - Cl<strong>in</strong>ical<br />

recruitment, patient recruitment<br />

services<br />

monitor<strong>in</strong>g<br />

enrollment and study and patient<br />

- Patient and<br />

- Analysis and<br />

feasibility<br />

enrollment<br />

<strong>in</strong>vestigator<br />

report<strong>in</strong>g<br />

- Study monitor<strong>in</strong>g and - Program<br />

recruitment<br />

data collection<br />

design and<br />

- Last phase cl<strong>in</strong>ical<br />

- Informatics<br />

data<br />

studies<br />

management<br />

- Medical device<br />

- Perceptive<br />

Informatics<br />

studies<br />

Rat<strong>in</strong>g: ►<br />

- Central laboratory<br />

services<br />

Rat<strong>in</strong>g: ►*<br />

- Central<br />

laboratory<br />

services<br />

Rat<strong>in</strong>g:▲*<br />

- Wholly owned<br />

facilities <strong>in</strong> Ch<strong>in</strong>a,<br />

S<strong>in</strong>gapore, India,<br />

South America,<br />

Scotland, and <strong>the</strong><br />

United <strong>State</strong>s<br />

- Subcontractor labs<br />

<strong>in</strong> Argent<strong>in</strong>a, Brazil,<br />

and Japan<br />

Rat<strong>in</strong>g: ▼*<br />

- Relationship<br />

with Frontage<br />

Laboratories <strong>in</strong><br />

<strong>the</strong> U.S.


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Table 28: CRO Capabilities Overview - Cont<strong>in</strong>ued<br />

Specialty/O<strong>the</strong>r<br />

Recent Divestitures<br />

Emplo<br />

yees<br />

North America Equity Research<br />

16 July 2009<br />

CRL CVD ICLR KNDL MDZ (Pharma<br />

Services)<br />

-Research<br />

Model Services<br />

- "Navigators"<br />

consult<strong>in</strong>g<br />

- In Vitro<br />

Services group<br />

- Divests<br />

Ed<strong>in</strong>burgh (U.K)<br />

cl<strong>in</strong>ical research<br />

facility <strong>in</strong> May<br />

2009 (to<br />

Quotient<br />

Bioresearch)<br />

- Market access services<br />

- Regulatory affiars<br />

- Medical writ<strong>in</strong>g<br />

- Regulatory affairs<br />

- Medical writ<strong>in</strong>g<br />

- North American<br />

staff<strong>in</strong>g service<br />

and European<br />

staff<strong>in</strong>g service<br />

(DOCS<br />

International)<br />

- Regulatory<br />

affairs and<br />

quality<br />

- Medical<br />

education<br />

services<br />

- Medical writ<strong>in</strong>g<br />

Public Private<br />

- Divests<br />

Phase II-<br />

Phase IV<br />

services and<br />

Central Lab<br />

bus<strong>in</strong>ess (6<br />

labs) to INC<br />

Research <strong>in</strong><br />

June 2009<br />

PPDI PRXL WX Qu<strong>in</strong>tiles PRA<br />

International<br />

-Key differentiator: Has<br />

entered <strong>in</strong>to several<br />

compound collaboration<br />

partnerships, that allow<br />

PPDI to share <strong>in</strong> risks<br />

and rewards <strong>of</strong><br />

compound development<br />

- GMP manufactur<strong>in</strong>g<br />

laboratory<br />

- Technical writ<strong>in</strong>g and<br />

regulatory submissions<br />

-Divests Piedmont<br />

Research Center (to<br />

CRL) <strong>in</strong> March 2009, a<br />

provider <strong>of</strong> precl<strong>in</strong>ical<br />

services focus<strong>in</strong>g on<br />

efficacy studies <strong>in</strong><br />

oncology<br />

- Integrated<br />

producted<br />

development<br />

and compliance<br />

consult<strong>in</strong>g<br />

- Medical<br />

writ<strong>in</strong>g/communi<br />

cation services<br />

- GMP<br />

Manufactur<strong>in</strong>g<br />

(J<strong>in</strong>shan facility)<br />

- Closes<br />

Philadelphia<br />

Apptech<br />

biologics<br />

manufactur<strong>in</strong>g<br />

facility <strong>in</strong><br />

December 2008.<br />

No plans to reopen.<br />

- Contract sales and<br />

market<strong>in</strong>g services<br />

- O<strong>the</strong>r<br />

commercialization<br />

services<br />

- Medical<br />

writ<strong>in</strong>g/communicati<br />

on services<br />

- Regulatory<br />

affairs<br />

9,000 9,600 7,100 4,275 3,300 10,500 8,050 3,739 Estimated >20,000 Estimated<br />

>3,000<br />

Source: Company reports, J.P. Morgan estimates.Note: * <strong>in</strong>dicates J.P. Morgan estima<br />

45


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

46<br />

North America Equity Research<br />

16 July 2009


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Companies Recommended <strong>in</strong> This Report (all prices <strong>in</strong> this report as <strong>of</strong> market close on 15 July 2009)<br />

Charles River Laboratories (CRL/$31.71/Neutral), Covance (CVD/$47.63/Overweight), ICON Plc<br />

(ICLR/$23.31/Overweight), WuXi PharmaTech (WX/$9.00/Neutral)<br />

Analyst Certification:<br />

The research analyst(s) denoted by an “AC” on <strong>the</strong> cover <strong>of</strong> this report certifies (or, where multiple research analysts are primarily<br />

responsible for this report, <strong>the</strong> research analyst denoted by an “AC” on <strong>the</strong> cover or with<strong>in</strong> <strong>the</strong> document <strong>in</strong>dividually certifies, with<br />

respect to each security or issuer that <strong>the</strong> research analyst covers <strong>in</strong> this research) that: (1) all <strong>of</strong> <strong>the</strong> views expressed <strong>in</strong> this report<br />

accurately reflect his or her personal views about any and all <strong>of</strong> <strong>the</strong> subject securities or issuers; and (2) no part <strong>of</strong> any <strong>of</strong> <strong>the</strong> research<br />

analyst’s compensation was, is, or will be directly or <strong>in</strong>directly related to <strong>the</strong> specific recommendations or views expressed by <strong>the</strong><br />

research analyst(s) <strong>in</strong> this report.<br />

Important Disclosures<br />

• Market Maker: JPMSI makes a market <strong>in</strong> <strong>the</strong> stock <strong>of</strong> ICON Plc.<br />

• Lead or Co-manager: JPMSI or its affiliates acted as lead or co-manager <strong>in</strong> a public <strong>of</strong>fer<strong>in</strong>g <strong>of</strong> equity and/or debt securities for<br />

Covance, WuXi PharmaTech with<strong>in</strong> <strong>the</strong> past 12 months.<br />

• Client <strong>of</strong> <strong>the</strong> Firm: Charles River Laboratories is or was <strong>in</strong> <strong>the</strong> past 12 months a client <strong>of</strong> JPMSI; dur<strong>in</strong>g <strong>the</strong> past 12 months, JPMSI<br />

provided to <strong>the</strong> company <strong>in</strong>vestment bank<strong>in</strong>g services, non-<strong>in</strong>vestment bank<strong>in</strong>g securities-related service and non-securities-related<br />

services. Covance is or was <strong>in</strong> <strong>the</strong> past 12 months a client <strong>of</strong> JPMSI; dur<strong>in</strong>g <strong>the</strong> past 12 months, JPMSI provided to <strong>the</strong> company<br />

<strong>in</strong>vestment bank<strong>in</strong>g services and non-securities-related services. WuXi PharmaTech is or was <strong>in</strong> <strong>the</strong> past 12 months a client <strong>of</strong><br />

JPMSI; dur<strong>in</strong>g <strong>the</strong> past 12 months, JPMSI provided to <strong>the</strong> company <strong>in</strong>vestment bank<strong>in</strong>g services.<br />

• Investment Bank<strong>in</strong>g (past 12 months): JPMSI or its affiliates received <strong>in</strong> <strong>the</strong> past 12 months compensation for <strong>in</strong>vestment bank<strong>in</strong>g<br />

services from Charles River Laboratories, Covance, WuXi PharmaTech.<br />

• Investment Bank<strong>in</strong>g (next 3 months): JPMSI or its affiliates expect to receive, or <strong>in</strong>tend to seek, compensation for <strong>in</strong>vestment<br />

bank<strong>in</strong>g services <strong>in</strong> <strong>the</strong> next three months from Charles River Laboratories, Covance, WuXi PharmaTech.<br />

• Non-Investment Bank<strong>in</strong>g Compensation: JPMSI has received compensation <strong>in</strong> <strong>the</strong> past 12 months for products or services o<strong>the</strong>r<br />

than <strong>in</strong>vestment bank<strong>in</strong>g from Charles River Laboratories. An affiliate <strong>of</strong> JPMSI has received compensation <strong>in</strong> <strong>the</strong> past 12 months<br />

for products or services o<strong>the</strong>r than <strong>in</strong>vestment bank<strong>in</strong>g from Charles River Laboratories, Covance, WuXi PharmaTech.<br />

• J.P. Morgan Securities Inc and/or its affiliates is act<strong>in</strong>g as a f<strong>in</strong>ancial advisor to Wuxi Pharma Tech (NYSE: WX) on its announced<br />

acquisition <strong>of</strong> privately held Apptec Laboratory Services, Inc. announced on January 3, 2008. Under <strong>the</strong> agreement, Apptec will<br />

become a wholly-owned subsidiary <strong>of</strong> Wuxi Pharma Tech. The acquisition, which is subject to regulatory and o<strong>the</strong>r approvals is<br />

expected to be completed <strong>in</strong> <strong>the</strong> first quarter <strong>of</strong> 2008. This research report and <strong>the</strong> <strong>in</strong>formation here<strong>in</strong> is not <strong>in</strong>tended to provide<br />

vot<strong>in</strong>g advice, serve as an endorsement <strong>of</strong> <strong>the</strong> proposed transaction or result <strong>in</strong> procurement, withhold<strong>in</strong>g or revocation <strong>of</strong> a proxy or<br />

any o<strong>the</strong>r action by a security holder.<br />

Charles River Laboratories (CRL) Price Chart<br />

120<br />

100<br />

80<br />

Price($) 60<br />

40<br />

20<br />

0<br />

Jul<br />

06<br />

Oct<br />

06<br />

Jan<br />

07<br />

Apr<br />

07<br />

Jul<br />

07<br />

Oct<br />

07<br />

Jan<br />

08<br />

Apr<br />

08<br />

Jul<br />

08<br />

Oct<br />

08<br />

N $24<br />

Jan<br />

09<br />

N $28<br />

Source: Reuters and J.P. Morgan; price data adjusted for stock splits and dividends.<br />

This chart shows J.P. Morgan's cont<strong>in</strong>u<strong>in</strong>g coverage <strong>of</strong> this stock; <strong>the</strong> current analyst may or may not have covered it<br />

over <strong>the</strong> entire period.<br />

J.P. Morgan rat<strong>in</strong>gs: OW = Overweight, N = Neutral, UW = Underweight.<br />

Apr<br />

09<br />

Jul<br />

09<br />

Date Rat<strong>in</strong>g Share Price<br />

($)<br />

Price Target<br />

($)<br />

12-Jan-09 N 23.62 24.00<br />

11-Feb-09 N 27.56 28.00<br />

47


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

Covance (CVD) Price Chart<br />

48<br />

156<br />

130<br />

104<br />

Price($)<br />

78<br />

52<br />

26<br />

0<br />

Jul<br />

06<br />

Oct<br />

06<br />

Jan<br />

07<br />

Apr<br />

07<br />

Jul<br />

07<br />

North America Equity Research<br />

16 July 2009<br />

Source: Reuters and J.P. Morgan; price data adjusted for stock splits and dividends.<br />

This chart shows J.P. Morgan's cont<strong>in</strong>u<strong>in</strong>g coverage <strong>of</strong> this stock; <strong>the</strong> current analyst may or may not have covered it<br />

over <strong>the</strong> entire period.<br />

J.P. Morgan rat<strong>in</strong>gs: OW = Overweight, N = Neutral, UW = Underweight.<br />

ICON Plc (ICLR) Price Chart<br />

70<br />

56<br />

42<br />

Price($)<br />

28<br />

14<br />

0<br />

Jul<br />

06<br />

Oct<br />

06<br />

Jan<br />

07<br />

Apr<br />

07<br />

Jul<br />

07<br />

Oct<br />

07<br />

Oct<br />

07<br />

Source: Reuters and J.P. Morgan; price data adjusted for stock splits and dividends.<br />

This chart shows J.P. Morgan's cont<strong>in</strong>u<strong>in</strong>g coverage <strong>of</strong> this stock; <strong>the</strong> current analyst may or may not have covered it<br />

over <strong>the</strong> entire period.<br />

J.P. Morgan rat<strong>in</strong>gs: OW = Overweight, N = Neutral, UW = Underweight.<br />

Jan<br />

08<br />

Jan<br />

08<br />

Apr<br />

08<br />

Apr<br />

08<br />

Jul<br />

08<br />

Jul<br />

08<br />

Oct<br />

08<br />

Oct<br />

08<br />

Jan<br />

09<br />

Jan<br />

09<br />

Apr<br />

09<br />

Apr<br />

09<br />

Jul<br />

09<br />

Jul<br />

09


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

WuXi PharmaTech (WX) Price Chart<br />

Price($)<br />

75<br />

60<br />

45<br />

30<br />

15<br />

0<br />

Aug<br />

07<br />

Nov<br />

07<br />

Feb<br />

08<br />

May<br />

08<br />

North America Equity Research<br />

16 July 2009<br />

N N $9<br />

Source: Reuters and J.P. Morgan; price data adjusted for stock splits and dividends.<br />

Initiated coverage Sep 18, 2007. This chart shows J.P. Morgan's cont<strong>in</strong>u<strong>in</strong>g coverage <strong>of</strong> this stock; <strong>the</strong> current analyst<br />

may or may not have covered it over <strong>the</strong> entire period.<br />

J.P. Morgan rat<strong>in</strong>gs: OW = Overweight, N = Neutral, UW = Underweight.<br />

Aug<br />

08<br />

Nov<br />

08<br />

Feb<br />

09<br />

N $5<br />

N $7<br />

May<br />

09<br />

Aug<br />

09<br />

Date Rat<strong>in</strong>g Share Price<br />

($)<br />

18-Sep-07 N 27.11 -<br />

12-Jan-09 N 7.31 9.00<br />

27-Mar-09 N 5.20 5.00<br />

15-May-09 N 5.59 7.00<br />

Price Target<br />

($)<br />

Explanation <strong>of</strong> Equity Research Rat<strong>in</strong>gs and Analyst(s) Coverage Universe:<br />

J.P. Morgan uses <strong>the</strong> follow<strong>in</strong>g rat<strong>in</strong>g system: Overweight [Over <strong>the</strong> next six to twelve months, we expect this stock will outperform <strong>the</strong><br />

average total return <strong>of</strong> <strong>the</strong> stocks <strong>in</strong> <strong>the</strong> analyst’s (or <strong>the</strong> analyst’s team’s) coverage universe.] Neutral [Over <strong>the</strong> next six to twelve<br />

months, we expect this stock will perform <strong>in</strong> l<strong>in</strong>e with <strong>the</strong> average total return <strong>of</strong> <strong>the</strong> stocks <strong>in</strong> <strong>the</strong> analyst’s (or <strong>the</strong> analyst’s team’s)<br />

coverage universe.] Underweight [Over <strong>the</strong> next six to twelve months, we expect this stock will underperform <strong>the</strong> average total return <strong>of</strong><br />

<strong>the</strong> stocks <strong>in</strong> <strong>the</strong> analyst’s (or <strong>the</strong> analyst’s team’s) coverage universe.] The analyst or analyst’s team’s coverage universe is <strong>the</strong> sector<br />

and/or country shown on <strong>the</strong> cover <strong>of</strong> each publication. See below for <strong>the</strong> specific stocks <strong>in</strong> <strong>the</strong> certify<strong>in</strong>g analyst(s) coverage universe.<br />

Coverage Universe: Tycho W. Peterson: Accuray (ARAY), Affymetrix (AFFX), American Medical Systems (AMMD),<br />

Beckman Coulter (BEC), Charles River Laboratories (CRL), Covance (CVD), Gen-Probe (GPRO), Genomic Health<br />

(GHDX), Hologic (HOLX), Home Diagnostics, Inc. (HDIX), ICON Plc (ICLR), Illum<strong>in</strong>a, Inc. (ILMN), Intuitive Surgical,<br />

Inc. (ISRG), Life Technologies Corporation (LIFE), Lum<strong>in</strong>ex (LMNX), Mettler-Toledo (MTD), Millipore Corp (MIL),<br />

Sirona Dental Systems Inc (SIRO), SonoSite (SONO), Thermo Fisher Scientific (TMO), Varian Medical (VAR), Waters<br />

(WAT), WuXi PharmaTech (WX)<br />

J.P. Morgan Equity Research Rat<strong>in</strong>gs Distribution, as <strong>of</strong> June 30, 2009<br />

Overweight Neutral Underweight<br />

(buy) (hold) (sell)<br />

JPM Global Equity Research Coverage 36% 46% 18%<br />

IB clients* 55% 56% 42%<br />

JPMSI Equity Research Coverage 36% 52% 12%<br />

IB clients* 77% 72% 60%<br />

*Percentage <strong>of</strong> <strong>in</strong>vestment bank<strong>in</strong>g clients <strong>in</strong> each rat<strong>in</strong>g category.<br />

For purposes only <strong>of</strong> NASD/NYSE rat<strong>in</strong>gs distribution rules, our Overweight rat<strong>in</strong>g falls <strong>in</strong>to a buy rat<strong>in</strong>g category; our Neutral rat<strong>in</strong>g falls <strong>in</strong>to a hold<br />

rat<strong>in</strong>g category; and our Underweight rat<strong>in</strong>g falls <strong>in</strong>to a sell rat<strong>in</strong>g category.<br />

Valuation and Risks: Please see <strong>the</strong> most recent company-specific research report for an analysis <strong>of</strong> valuation methodology and risks on<br />

any securities recommended here<strong>in</strong>. Research is available at http://www.morganmarkets.com , or you can contact <strong>the</strong> analyst named on<br />

<strong>the</strong> front <strong>of</strong> this note or your J.P. Morgan representative.<br />

49


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

50<br />

North America Equity Research<br />

16 July 2009<br />

Analysts’ Compensation: The equity research analysts responsible for <strong>the</strong> preparation <strong>of</strong> this report receive compensation based upon<br />

various factors, <strong>in</strong>clud<strong>in</strong>g <strong>the</strong> quality and accuracy <strong>of</strong> research, client feedback, competitive factors, and overall firm revenues, which<br />

<strong>in</strong>clude revenues from, among o<strong>the</strong>r bus<strong>in</strong>ess units, Institutional Equities and Investment Bank<strong>in</strong>g.<br />

O<strong>the</strong>r Disclosures<br />

J.P. Morgan is <strong>the</strong> global brand name for J.P. Morgan Securities Inc. (JPMSI) and its non-US affiliates worldwide.<br />

Options related research: If <strong>the</strong> <strong>in</strong>formation conta<strong>in</strong>ed here<strong>in</strong> regards options related research, such <strong>in</strong>formation is available only to persons who<br />

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Standardized Options, please contact your J.P. Morgan Representative or visit <strong>the</strong> OCC’s website at<br />

http://www.optionsclear<strong>in</strong>g.com/publications/risks/riskstoc.pdf.<br />

Legal Entities Disclosures<br />

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http://www.hkex.com.hk/prod/dw/Lp.htm. Japan: There is a risk that a loss may occur due to a change <strong>in</strong> <strong>the</strong> price <strong>of</strong> <strong>the</strong> shares <strong>in</strong> <strong>the</strong> case <strong>of</strong><br />

share trad<strong>in</strong>g, and that a loss may occur due to <strong>the</strong> exchange rate <strong>in</strong> <strong>the</strong> case <strong>of</strong> foreign share trad<strong>in</strong>g. In <strong>the</strong> case <strong>of</strong> share trad<strong>in</strong>g, JPMorgan<br />

Securities Japan Co., Ltd., will be receiv<strong>in</strong>g a brokerage fee and consumption tax (shouhizei) calculated by multiply<strong>in</strong>g <strong>the</strong> executed price by <strong>the</strong><br />

commission rate which was <strong>in</strong>dividually agreed between JPMorgan Securities Japan Co., Ltd., and <strong>the</strong> customer <strong>in</strong> advance. F<strong>in</strong>ancial Instruments<br />

Firms: JPMorgan Securities Japan Co., Ltd., Kanto Local F<strong>in</strong>ance Bureau (k<strong>in</strong>sho) No. 82 Participat<strong>in</strong>g Association / Japan Securities Dealers


Tycho W. Peterson<br />

(1-212) 622-6568<br />

tycho.peterson@jpmorgan.com<br />

North America Equity Research<br />

16 July 2009<br />

Association, The F<strong>in</strong>ancial Futures Association <strong>of</strong> Japan. Korea: This report may have been edited or contributed to from time to time by<br />

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51

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