State of the Art in Outsourcing
State of the Art in Outsourcing
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
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(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
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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 />
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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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