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Valuing Oncology Assets: Strategies in an evolving clinical and commercial landscape May 23, 2012
Many Thanks to the Event Organizers and Sponsors!
Adam Bristol (Aquilo Partners)
Zeenat Petrawala (Medivo)
Mike Iacoviello (Capgemini Consulting)
Thomas Celerier (Capgemini Consulting)
Carol Koch (Capgemini Consulting)
Brittany Howe (Capgemini Consulting)
German American Chamber of Commerce Team
Copyright © 2012 Capgemini Consulting. All rights reserved.
2
Copyright © 2012 Capgemini Consulting. All rights reserved.
3
Agenda
Introduction
Keynote speakers:
– Peter Radovich: Sr. Director, Onyx Pharmaceuticals
– Dave Raksin: Director, Inverness Advisors
– Kevin Sin: Director, Oncology Business Development, Genentech
– Mark Charest: Vice President, New Leaf Ventures Partners
Panel Discussion / Q&A
Wrap-up
Copyright © 2012 Capgemini Consulting. All rights reserved.
4
% of Total Biopharma Sales and Anticipated Growth % from 2011 – 2106 by Therapeutic Area
0%
5%
10%
15%
20%
25%
-27%
+18%
+6%
+36% +27%
-1%
-47%
+9%
+2%
Analysts predict that oncology will be the largest therapeutic area, in terms of worldwide revenue, by 2016
Copyright © 2012 Capgemini Consulting. All rights reserved.
5
2011
2016
Source: “Therapeutic Categories Outlook”, Cowen and Company, February 2012
Oncology drugs are estimated to represent close to 20% of the total $678bn worldwide pharmaceutical market in 2016
Breast, Lung and Colorectal cancers dominate in terms of prevalence and global market potential…
-
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000
$-
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
$40,000
# o
f N
ew
Pat
ien
ts p
er Y
ear
Glo
bal
Mar
ket
Po
ten
tial
($
M)
Global Market Potential New Patients
NHL: Non-Hodgkin's Lymphoma; CTCL: Cutaneous T-Cell Lymphoma; GBM: Glioblastoma Multiforme; CLL: Chronic Lymphocytic Leukemia
Source: “Oncology Market” JP Morgan, June 2008; “Pharm Exec 50” Pharmexec.com, May 2010
Global Market Potential and New Patients by Tumor Type
…However niche indications are becoming increasingly crowded and drive more competition per patient than is seen in tumors that affect larger patient populations
Copyright © 2012 Capgemini Consulting. All rights reserved.
6
Cancer mAb partnering deals by dvpt stage
Number of Cancer mAb partnering deals 2007-2012* (Q1)
Global Oncology Market by Therapy Type
MAbs / Targeted Therapies dominate the oncology market, as they offer validated MOAs in a TA where probability of success is lower than average…
7
Source: Total revenue, “Therapeutic Categories Outlook”, Cowen and Company, Feb 2012
44%
31%
23%
1% 1%
Mabs/Targeted Therapies
Chemotherapeutics
Blood Cell Factors
Chemopreventatives
Other Therapies
57% 27%
16%
0% 0%
2011
2016E
…driving steady number of partnering deals over the past few years (over 330 deals since 2007)
0
20
40
60
80
2007 2008 2009 2010 2011 2012*
0 50 100 150 200
Formulation Marketed
Regulatory Phase III Phase II Phase I
Preclinical Discovery
80%
Source: Current Partnering, Cancer mAb Partnering Terms and Agreements, April 2012
Source: Current Partnering, Cancer mAb Partnering Terms and Agreements, April 2012
Copyright © 2012 Capgemini Consulting. All rights reserved.
Major trends will re-shape the oncology market and potentially impact asset valuation and Partnering decisions
Decreasing R&D productivity
Healthcare Reform
– Biosimilars
– Comparative Effectiveness Research
Increased pressure on reimbursement and utilization management for oncolytics
Providers
– Pressure on oncology community business and margins, leading to consolidation
– Shift of Site of Care
– Decreased Providers access
Access to capital
– Broken VC model
– Better IRR and lower capital intensity in other sectors
Copyright © 2012 Capgemini Consulting. All rights reserved.
8
Drivers
Population Demographics
Healthcare Reform
– Affordable Care Act / Individual mandate
Oncolytics Business Model
– Price premium associated to high cost of burden
– Typical DOT between 4 to 12 months
Innovation:
– Targeted therapies
– Companion Dx
– Antibody-Drug Conjugates
– Administration (e.g. nanotechnologies)
– Therapeutic Vaccines
Emerging Market Growth
Drivers Barriers
Valuing Oncology Assets: Strategies in an evolving clinical and commercial landscape
Copyright © 2012 Capgemini Consulting. All rights reserved.
9
What Partnering Strategy? How to Execute?
What areas of oncology have the greatest unmet needs today?
Which players (big or small) currently possess the most potential in fulfilling those needs?
What novel technologies present significant opportunities?
What trends are shaping the market and partnering in oncology?
Their Perspective
Where is the “smart money” in the current oncology environment?
What are some the “best-in-breed” techniques used to value an early stage product / company?
What factors are considered when determining whether to in-license, JV, or acquire?
What are the innovative partnering approaches?
Copyright © 2012 Capgemini Consulting. All rights reserved.
10
Benoit Berthoux
Head of LS West Coast Practice
San Francisco, CA
Mob.: +1 415 200 9859
Oncology Commercialization Peter Radovich Senior Director, Global Product Strategy Carfilzomib Product Development Team Lead
May 23, 2012
DISCLAIMER
Slides, comments and opinions expressed in this presentation are my own and do not represent
the views of my employer, Onyx Pharmaceuticals.
12
What has made the Oncology market interesting for drug development and commercialization?
• Nearly all metastatic solid tumors are uniformly fatal and many opportunities to improve outcomes in earlier stages
• Significant unmet needs remain in many hematologic malignancies, despite progress
High unmet needs
Receptive to Innovation
Favorable Dynamics
• Key actors in market generally have been receptive to innovation (providers, patients, payers, regulators)
• Limited & concentrated provider universe
• Historically favorable pricing, reimbursement & access environment
Global Oncology Market Continues to Grow $35B Today and ~$100+B by 2020
0
5
10
15
20
25
30
35
40
45
0
10
20
30
40
50
60
70
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
% G
RO
WTH
SALE
S U
S$B
N
Global oncology Global oncology growth Europe oncology growth
Global pharma growth Japan oncology growth US oncology growth
Global Oncology Annual Sales & Sales Growth
Source: IMS Health, MIDAS, MAT Mar 2010. *Oncology includes both solid & heme tumors and is defined by IMS as L1 (cytotoxics & targeted cytotoxics) and L2 (hormonals). 1
4
15
Developed Countries Have Generally Accepted “US Price” Levels for Innovative Products
Oncology Blockbusters: Top 10
1.5
1.7
1.8
2.2
2.5
2.8
4.3
5.2
6.1
6.2
Arimidex
Velcade
Erbitux
Alimta
Revlimid
Taxotere
Gleevec
Herceptin
Rituxan
Avastin
Global Sales 2010 (in billions)
Roche
Roche
Roche
Novartis
Celgene
Sanofi
Lilly
BMS
Takeda
AZ
Company Brand
*
16 Source: IMS Health
In 2010, approximately 40% of Global Sales for the Top 10 came from US
17
Successful Oncology Launches in 2011
Source: Kantar Health “The Most Promising Technologies for Unmet Needs in Oncology”
Success Factors
Uniform: •Strong value proposition • High unmet need • First in class
Others: •Small patient population • “Personalized” medicine • Companion diagnostic
What Lies in the Road Ahead??
• Challenging global market access environment leading to increased pressure from payers – Healthcare spend trajectory unsustainable – Oncology becoming chronic; escalating cost burden – Increasing complexity in price negotiations, risk sharing, HTA’s, cost effectiveness, etc. (EU, AP, ROW) – Regional heterogeneity – Increasing financial burden on patients (US)
• Provider, patient & payer desire for stronger value proposition & differentiation
– E.g., increase in H2H trials in oncology
• Impact of generics and biosimilars
• Increasing role of the patient; aided by PR, digital & social media, advocacy
• Emergence of emerging markets
Partnerships: Medivaiton / Astellas (Ph3)
19
Partnerships: Incyte / Novartis (Ph3)
20
Partnerships: Seattle Genetics / Takeda (Ph2)
21
Partnerships: Pharmacyclics / J&J
22
• Development and commercialization of PCI-32765 globally in hematologic malignancies • $150M upfront; up to $825M in additional development and regulatory milestones • Each company leads on specific indications outlined in development plan • Development cost sharing: 40% PCYC / 60% J&J • Both Pharmacyclics and J&J book revenue and co-commercialize PCI-32765.
• In the US, Pharmacyclics will book sales and take a lead role in US commercial strategy development and both Pharmacyclics and Janssen will share in commercialization activities. • Outside the United States, Janssen will book sales and lead and perform commercialization activities. • Profits and losses from the commercialization activities will be equally split on a worldwide basis.
Dave Raksin – Inverness Advisors
Capgemini Consulting Oncology Discussion
Inverness Advisors is a division of KEMA Partners LLC. Inverness Advisors conducts all securities business through KEMA Partners LLC, a FINRA member and SEC-registered broker-dealer.
May 23, 2012
Dx Transaction Landscape and Valuation Overview
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Oncology Largely Reflects Overall Dx Deal Trends
Agilent-Dako a sign oncology Dx M&A picking up again? ($2.2B, 6.6x/21.1x Rev./EBITDA) – Significant oncology Dx activity late ’10/early ’11, other areas picked up in ‘11 – Q1’12
Significant gap between strategic and public financial market valuations – Dx M&A avg. 35% premium last 18 months, even at moderate 3.6x rev./17.9x EBITDA
Revenue companies dominate: at least 24 of 30 >$15M value Dx deals we tracked – Median $103M revenue. At least 16 of 30 EBITDA positive as well
– Scarcity value on companies with meaningful revenue and earnings (not priced into publics?)
Expanding buyer universe could drive more activity and push Dx valuations upward – Led by Labs, Dx instrumentation, life sciences tools moving into clinical & private equity
• Larger acquirers good access to capital (e.g. LabCorp $560M, LifeTech $750M credit)
• Smaller consolidators some access (e.g. Transgenomic $22M PIPE, Sequenom $62M FO)
– Asian acquisitions in U.S. a notable recent trend: e.g. FUJIFILM-SonoSite, Samsung-Nexus
Pharma/biotech without Dx businesses still opting for partnership over M&A…for now – e.g. Takeda-Metabolon, BMS-Meso, GSK-Epistem, Amgen-Dako companion Dx deals
– GE Healthcare very active and Siemens entering companion Dx
– Strategics also taking advantage of weakened VC market; no IPO window for Dx
• Stepping in alongside stronger remaining financial VCs – e.g. Aviir ($30M, Merck GHI), Auxogyn ($20M Merck Serono), Pronota ($5M, JJDC),
Enterome ($7M Lundbeck), BioCartis ($98M J&J, Debio, Philips), Curetis ($16M Roche)
Data source: Capital IQ, Thomson Reuters and Company websites
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Oncology a Significant Component of Recent Dx M&A: Strong Premiums, Even at Moderate Multiples
Earn-out structure disclosed in 5 of 30 deals; pre-commercial/earlier-stage deal risk sharing mtm-Roche ($180M/$85M), Claros-Opko ($30M/$19M), QuantaLife-BioRad ($162M/undisc.),
Argene-BioMerieux ($53M/$7M), PVT-Roche ($91M/$28M) More common in Rx: 50%+ in comparable-sized deals
Oncology deals: large acquirors & strategic rationale cited at least as important as revenue/earnings
($M, except per share data)Date Implied Value Stock Premium LTM Enterprise Value
Announced Target/Issuer Buyers/Investors Equity Enterprise 1 Month 1 Week 1 Day Revenue EBITDA Revenue EBITDA Target Main Focus
05/17/12 Dako A/S Agilent Technologies $2,200.0 $2,200.0 - - - $330.9 $104.5 6.6x 21.1x Cancer
04/30/12 Gen-Probe Hologic 3,757.9 3,868.8 24.6% 22.1% 20.4% 586.6 183.5 6.6x 21.1x Blood diseases/transplant
04/23/12 CareFusion NeuroDx Natus Medical 58.0 58.0 - - - 96.7 - 0.6x N.A. Critical care
02/13/12 SeraCare Life Sciences Linden LLC 80.8 62.6 30.7% 23.8% 11.7% 44.4 4.7 1.4x 13.4x Research Dx
12/15/11 SonoSite FUJIFILM Holdings 755.8 855.9 27.8% 26.9% 29.2% 308.8 37.1 2.8x 23.0x POC ultrasound10/18/11 Reichert Tech. (from BPO Ametek 150.0 150.0 - - - 55.6 - 2.7x N.A. Eye care devices10/13/11 Claros Dx Opko Health 25.0 49.1 - - - 0.0 (4.1) N.M. N.M. POC urology immunoassay
10/05/11 Quanta-Life Bio-Rad 162.0 162.0 - - - - - N.A. N.A. Digital PCR
07/26/11 Orasure DNA Genotek 53.0 53.0 - - - 14.0 - 3.8x N.A. DNA and RNA collection07/19/11 mtm laboratories AG Roche Holding 184.3 269.4 - - - - - N.A. N.A. Cervical cancer
07/19/11 Argene SA BioMérieux 53.2 60.3 - - - 14.2 - 4.2x N.A. Autoimmune
07/06/11 Axis-Shield plc Alere 354.0 369.0 40.8% 47.3% 40.3% 162.4 20.8 2.3x 17.7x Diabetes, vitamin, RA
07/02/11 Immucor Inc. TPG Capital 1,902.2 1,653.2 34.7% 34.6% 30.2% 331.5 149.1 5.0x 11.1x Blood transfusion
06/21/11 EraGen Biosciences Luminex 34.0 34.0 - - - 8.0 - 4.3x N.A. PCR in infectious disease
06/15/11 Ipsogen SA Qiagen NV 92.6 86.0 69.7% 72.5% 70.9% 11.9 (4.3) 7.2x N.M. Cancer
05/23/11 Stanbio Laboratory EKF Dx 19.3 25.3 - - - 16.4 3.1 1.5x 8.3x Clinical chemistry devices
05/19/11 Phadia (Cinven PE) Thermo Fisher 3,512.0 3,512.0 - - - 520.0 212.8 6.8x 16.5x Allergy and autoimmune
04/27/11 Rules-Based Medicine Myriad Genetics 80.0 80.0 - - - - - N.A. N.A. Protein chip, CNS
04/06/11 Orchid-Cellmark LabCorp. 85.4 66.7 39.3% 40.7% 36.6% 66.0 1.5 1.0x 44.0x Forensic and family DNA
04/03/11 Cellestis Ltd. Qiagen NV 354.4 331.3 40.9% 37.4% 29.1% 45.8 12.4 7.2x 26.8x Infectious diseases
03/17/11 Celera Corporation Quest Dx 657.2 330.4 23.5% 27.0% 27.6% 128.2 (21.1) 2.6x N.M. Cancer, cardio, infectious
03/15/11 PVT Lab Systems Roche 119.0 90.8 - - - - - N.A. N.A. IVD automation
02/24/11 Athena Dx(Thermo Unit) Quest Dx 740.0 740.0 - - - 110.0 - 6.7x N.A. CNS
02/01/11 Accuri Cytometers Becton Dickinson 205.0 205.0 - - - - - N.A. N.A. Flow cytometry
01/24/11 Genoptix Novartis 442.3 310.9 28.0% 23.0% 26.5% 196.9 47.0 1.6x 6.6x Blood cancers
11/18/10 Genzyme Dx Sekisui Medical 265.0 265.0 - - - 167.0 - 1.6x N.A. Diagnostic intermediaries
11/04/10 ITC Nexus Dx 55.0 55.0 - - - - - N.A. N.A. POC Hemostasis
10/30/10 Standard Dx Alere 276.4 241.4 - - - 76.2 42.9 3.2x 5.6x Korea and India dist.
10/22/10 Clarient GE Healthcare 455.0 585.1 45.8% 39.3% 33.7% 110.1 6.6 5.3x N.M. Cancer
09/13/10 Genzyme Genetic LabCorp. 925.0 925.0 - - - 371.0 - 2.5x N.A. Fetal and oncology
Average 36.9% 35.9% 32.4% $157.2 $50.6 3.6x 17.9xMedian 34.7% 34.6% 29.2% $103.3 $12.4 3.0x 17.1x
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Public Dx Specialty Comparables
($M, except per share data)
Enterprise Value
Price % of 52 Equity Enterprise Revenue EBITDA P/E PEG LT Growth % Price Gain % EV Gain Covering
Company 05/22/12 Wk High Value Value 2012E 2013E 2012E 2013E 2012E 2013E 2012E 2013E Rate Since IPO Since IPO Analysts
Quest Diagnostics (DGX) $57.45 92% $9,114.4 $12,888.6 1.7x 1.6x 7.8x 7.4x 12.5x 11.4x 1.2x 1.1x 10.7% 14
LabCorp (LH) 85.11 84% 8,238.6 10,230.1 1.8x 1.7x 7.6x 7.2x 12.3x 11.3x 1.0x 1.0x 11.8% 19
Myriad Genetics (MYGN) 25.78 95% 2,187.8 1,850.5 3.5x 3.2x 9.4x 8.1x 18.6x 16.2x 1.8x 1.6x 10.1% 15
VCA Antech (WOOF) 21.07 81% 1,843.6 2,427.7 1.4x 1.3x 8.1x 7.3x 14.5x 12.9x 1.2x 1.1x 12.2% 10
Genomic Health (GHDX) 32.98 94% 991.1 889.3 3.7x 3.3x N.M. N.M. N.M. N.M. N.A. N.A. 37.0% 174.8% 283.3% 13
Exact Sciences (EXAS) 10.27 91% 586.8 504.3 N.M. N.M. N.M. N.M. N.M. N.M. N.A. N.A. 23.3% -26.6% 145.3% 13
Bio-Reference (BRLI) 20.29 78% 563.6 575.4 0.8x 0.7x 6.1x 5.0x 13.6x 11.2x 0.8x 0.7x 17.3% 5
Sequenom (SQNM) 4.38 50% 501.7 399.2 4.6x 2.5x N.M. N.M. N.M. N.M. N.A. N.A. 27.5% -83.2% -12.8% 10
MEDTOX Scientific (MTOX) 19.89 88% 178.4 171.4 1.4x 1.3x 9.8x 8.2x 25.4x 20.4x 1.3x 1.0x 20.0% 2
Neogenomics(NGNM.OB) 1.65 90% 74.0 74.3 1.2x 1.0x 17.8x 16.2x 55.0x 15.7x 0.6x 0.2x 86.0% 2
Response Genetics (RGDX) 1.50 49% 37.2 31.5 1.6x N.A. N.A. N.A. N.M. N.M. N.A. N.A. N.A. -78.6% -36.9% 1
Vermillion (VRML) 1.82 32% 27.2 14.3 5.0x 2.2x N.M. N.M. N.M. N.M. N.A. N.A. N.A. 3
Mean 77% 2.4x 1.9x 9.5x 8.5x 21.7x 14.2x 1.1x 0.9x 25.6% 9
Median 86% 1.7x 1.7x 8.1x 7.4x 14.5x 12.9x 1.2x 1.0x 18.6% 10
MID-CAP BIOTECH
Mean 76% 8.9x 6.6x 12.2x 10.5x 27.8x 33.2x 0.8x 0.7x 38.0% 14
Median 91% 8.5x 6.9x 12.2x 10.5x 22.0x 36.8x 0.3x 0.9x 36.3% 15
Comments: Financial valuations on average lag strategic (M&A) valuations On PEG basis, Dx actually slightly richer than comparable Rx (Mid-Cap biotech)
Growth numbers may be more reliable than Rx which still have many binary events priced in Premium multiples to peers for “critical mass” revenue companies, e.g. Genomic Health & Myriad
Sequenom in hot area, relatively rich valuation despite travails Big labs need higher margin products and growth, trade at low multiples
Very large gap in research coverage between ~$500M market cap. companies and smaller Wider gap than in Rx; Smaller names tend to “pop” on good news. Strategics interested earlier.
Dx IPO companies from the last two windows have not fared well from group, with exception of Genomic Health (much higher than expected dilution in tough markets and product setbacks)
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Investors Will Take a Wait and See Approach Post-IPO For Dx Companies Until Revenue Trajectory Clearer
($M, except
per share
data) Year 1 Year 5
Current/
at Sale Year 1 Year 5
Current/
at Sale Year 1 Year 5
Current/
at Sale Year 1 Year 5
Current/
at Sale
Market Cap. 113.8$ 267.8$ 1,489.5$ 222.6$ 426.4$ 2,430.0$ 234.4$ 592.0$ 991.1$ 180.3$ 151.1$ 155.0$
Growth 135.3% 456.2% 91.6% 469.9% 152.6% 67.4% -16.2% 2.6%
Share Price 8.88$ 18.37$ 97.27$ 8.44$ 10.15$ 37.05$ 9.58$ 20.69$ 32.98$ 54.75$ 16.80$ 4.55$
Growth 106.9% 429.5% 20.3% 265.0% 116.0% 59.4% -69.3% -72.9%
Revenue 2.9$ 28.2$ 309.0$ 7.1$ 53.0$ 294.7$ 5.2$ 146.6$ 240.3$ 7.5$ 36.8$ 61.7$
Growth 872.4% 995.7% 646.5% 455.9% 2719.2% 63.9% 390.7% 67.7%
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Inverness Active as Advisor in Capital Raising and Strategic Advisory in Dx/MedTech, as Well as Rx
28 Note: Technology banking group, additionally, has two completed financings & one M&A in past 12 months.
Completed Transactions On-going Transactions
Up to $30MM capital raise
Led by Merck Global Health Innovation Fund
$10MM capital raise
Fund comprehensive POC diagnostic launch in China and U.S.
Strategic investment by Smith & Nephew
Includes co-marketing rights for lead product
Sell-side M&A
System for real-time , ultra sensitive rapid pathogen detection
Public company asset sale
Fairness opinion
~$30MM transaction value
Expedited timetable – engagement in October 2010 and signed definitive agreement in January 2011
$20MM capital / strategic process
Preclinical Parkinson’s therapeutic
Therapeutic asset sale
Cross-border
$15MM capital raise
Phase IIb onychomycosis therapeutic
Merger with ITC
Private equity buyout funded by Warburg Pincus
~$55MM transaction value
$20MM capital / strategic process
Phase II pain therapeutic
Sale of Therapeutic Royalty
Leading health care venture capital firm sale to a hedge fund
Partnering antibody platform and Huntington’s Disease drug candidate
Valuing Oncology Assets
A view from Sand Hill Road
Mark G. Charest, PhD Vice President
New Leaf Venture Partners
CONFIDENTIAL Slide 30
What Influences a Venture Investor’s Return on Investment? It’s Just Math….
Investment Valuation Exit Valuation
Money Required (Dilution)
Probability of Success
Required Return
Valuation primarily function of: 1. Potential exit valuation
2. A “required return” which is related to the “probability of success”
3. Expected cash needed to reach an “exit”
4. Type of exit (IPO or M&A)
Fundamental valuation also plays an important role
This is the valuation that a company gets once it’s “through the gate” and can be acquired
– Strategic Reasons for a Deal (Most Important)
– Precedent Transactions
– Discounted Cash Flows / Fundamental Value
– Comparable Company Analysis
– Viewpoints of Wall Street
Return To Investors (Expressed as IRR or Cash-on-Cash Return)
CONFIDENTIAL Slide 31
Compared to Some Therapeutic Areas, Cash to Reach an Exit Is Low for Cancer Companies
Acquirers willing to buy cancer drugs at earlier stages in development, and as a result often require less capital to reach an exit
Companies focused on cancer can obtain much more data from early development work than companies focused on other therapeutic areas
‒ Phase I in patients – especially useful if Phase I is in a selected/sensitive population
‒ Clinical endpoints such as tumor shrinkage make it relatively easier to prove efficacy at an earlier stage than longer term survival-type of endpoints
‒ Biomarkers are more relevant, which can provide useful data on whether a drug is or is not working or which patient population is the most relevant
‒ Targeted therapies have a greater chance of success in development because they are going after validated mechanisms of action
Generally, less patients needed to show drug effect (so less cash is required to generate the data)
Acquirer interest due to high unmet need generally within oncology
CONFIDENTIAL Slide 32
Probability of Success: In The Drug Development Casino, Some Games Have Better Odds…
Source: Overall Success Rates – BioMedTracker.
Probability of Success
Across TAs
Probabilities of Success
within Oncology
41%36%
30%
24%
32%28% 29%
55%60%
63% 61%
55%
46%
34%
Infectious Diseases Endocrine Autoimmune Respiratory Neurology Cardiovascular Oncology
Phase II Phase III
Moving from Phase II to
Phase III may be less
meaningful
Overall Probability of Success at Phase II and Phase III
Overall Total Success Rates
2%
3%
3%
4%
6%
6%
7%
7%
8%
15%
19%
0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%
NSCLC
Colorectal Cancer
MDS
Prostate Cancer
HCC
CLL
Breast Cancer
Multiple Myeloma
Ovarian Cancer
RCC
Head & Neck
CONFIDENTIAL Slide 33
Targeted therapies have a greater chance of success in development
52%
44%
77%
85%
69%
80%
0% 25% 50% 75% 100%
Phase 3-
Registration
Phase 2-3
Phase 1-2Kinase inhibitors
All drugs
Sample size. All drugs, n=974; Kinase inhibitors, n=137; Source: Nature Reviews Drug Discovery
Phase transition probability of oncology drugs (1995-2007)
# of drugs that have to enter Phase 1 to get one
new drug approved
5.5 for oncology overall vs.
2.1 for kinase inhibitors
CONFIDENTIAL Slide 34
Consideration
Announce Target Acquiror Company Focus Stage Upfront Milestones Total
Preclinical, Phase 1, and Phase 2 Oncology M&A
1/26/2012 Avila Therapeutics Celgene Corporation AVL-292 - A Btk inhibitor for oncology Phase I $350 $575 $925
1/26/2012 Micromet Amgen Inc. Blinatumomab - drug for leukemia / NHL Phase I $1,116 $0 $1,116
12/20/2011 Intellikine, Inc. Takeda America INK128 - TORC1/2 inhibitor, PI3K selective inhibitor Phase I $190 $120 $310
3/20/2011 Gemin X Pharma Cephalon Inc. GX15-070 to reinitiate apoptosis; GMX1777 Phase II $225 $300 $525
12/19/2010 Arresto Biosciences, Inc. Gilead Sciences Inc. AB0024 - Solid Tumors and Idiopathic Fibrosis Phase I $225 Undisclosed $225
8/17/2010 Trubion Pharmaceuticals Emergent BioSolutions SCORPION technology, B-cell cancer, autoimmune Phase I $97 $39 $136
6/23/2010 CGI Pharmaceuticals, Inc. Gilead Sciences Small molecule kinase inhibitors Pre-clinical $120 $0 $120
6/30/2010 TargeGen, Inc. Sanofi-Aventis JAK2 Inhibitor for lymphona, leukemia, myelofibrosis Phase II $75 $485 $560
2/4/2010 LEAD Therapeutics, Inc. BioMarin Pharma LT-673 in oncology (also has MRSA product) Pre-clinical $29 $68 $97
Mean $270 -- $446
Median $190 -- $310
Phase 3 Oncology M&A
3/29/2011 Chemgenex Pharma Cephalon Inc. Chronic myelogenous leukemia Phase III $154 $0 $154
2/28/2011 Plexxikon, Inc. Daiichi Sankyo Oncogenic BRAF mutant melanoma / solid tumors Phase III $805 $130 $935
2/21/2011 Calistoga Pharma Gilead Sciences PI3K target - hematological cancers / autoimmune Phase III $375 $225 $600
1/24/2011 BioVex, Inc. Amgen Inc. Virus engineered to kill cancer - melanoma $ head & neck Phase III $425 $575 $1,000
Mean $440 -- $672
Median $400 -- $768
Rewards are High for Drug R&D Products That Can Finish the Marathon (Get Sold)
Appendix / Additional Slides Created
CONFIDENTIAL Slide 36
Current Reality in R&D and Venture Funding of Drug Development: Things Are Difficult
VC Dollars Invested Into Biopharma & Devices Declining ($ in billions)
$6.3
$4.8
$4.3
$3.4$3.9
$3.6
$3.0
$2.4
2007 2008 2009 2010
Biopharmaceuticals
Medical Devices
The current situation for funding drug discovery and development is challenging Venture dollars invested are declining and pharma is cutting earlier stage R&D programs, due to
several factors:
– Poor productivity of the pharma R&D
– Weak returns for many life science VCs
– Macro factors: less capital for PE/VC
Other sources of funding gaining prominence now – grants, foundations, etc
Source: Venturesource, PhRMA.
Total Industry R&D Spending in the U.S. ($B)
$37 $40$43
$48 $47 $46$49
$48
$52
$56
$63 $64$66 $67
$20
$30
$40
$50
$60
$70
2004 2005 2006 2007 2008 2009 2010E
PhRMA Members
Declining in 2011
and 2012