1 Deborah Dunsire, M.D. President & CEO Millennium Pharmaceuticals, Inc. Maximizing Long-term Value: Capitalizing on Innovation Through M&A and Strategic Partnering A Biopharmaceutical Perspective 2 Imagine Starting a Company Knowing That…….. Drug Discovery and Development Genomics HTS Pharmacology Regulatory Biology DMPK Clinical Manufacturing Commercial Approval Toxicology Chemistry Target IND PhI PhIIa PhIIb PhIII Filing ~2% probability 10 - 15 years* $1B** *PhRMA Pharmaceutical Industry Profile: 2007 **Parexel’s Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008 3 It’s A Fierce Battle To Become A Leading Biopharmaceutical Company Amgen ;Genentech Gilead; Genzyme OSI Imclone Onyx Synta *Pro forma profitability 4 Big Pharma Industry Consolidation Has Been The Trend… Rank 1988* 2007** 1 Mereck Sharp & Dohme Johnson & Johnson 2 Wyeth-Ayerst Pfizer 3 Eli Lilly GlaxoSmithKline 4 Smith Kline & French Labs Bayer 5 Schering Novartis 6 The Upjohn Company Sanofi-Aventis 7 Pfizer Laboratories Roche 8 Lederle Laboratories AstraZeneca 9 Ross Laboratories Merck & Co 10 Merrell Dow Pharm Abbott Laboratories … But economies of scale due to consolidation is not always advantageous in R&D innovation * Med Ad News 1988 **Med Ad News 2007 5 Big Pharma is Turning Towards Biotech Innovation for Sustainable Growth Multiple pathways to access innovation – Wholesale acquisition – Serial acquisitions – Key alliances and licensing deals High cost of entry - competitive environment No “one size fits all” approach – Dependent on pre-existing expertise 6 An Increasingly High Stakes, Complex Market Has Raised The Ante… Capital markets are tightening Regulatory environment is becoming global Consolidation has created a smaller playing field of possible big pharma partners Few possible biotech partners have fully integrated end-to-end capabilities …An Accurate Assessment Of The Current And Future Environment Shapes And Guides The Correct Approach 7 Innovation Occurs Via Two Possible Pathways Using A Variety Of Tools… Internal External Scale M&A Re-org In-Licensing Partnerships …But Success Depends Upon Defining Which Tool To Use And When It Applies 8 M&A and Partnering for Strategic Value Creation Increase value of acquired asset Create new product combinations Leverage commercialization infrastructure Create critical mass and diversification Choose between buy vs. build capabilities Access to global markets 9 Global Access to Innovation is Growing In All Directions… INDIA Partner of choice for CMOs and CROs by Western manufacturers Acquisitions of Indian companies are increasing while many Indian-based firms are buying European assets to access larger markets Increasing novel R&D CHINA Provides drug discovery, R&D, clinical trials for multi-national companies – Talent pool of scientists, low cost, advancements in genomics and gene therapy – Increase in international wholly owned R&D facilities 10 Successful Companies Blend Internal and External Sources of Innovation Company % in-licensed or acquired Genentech 56% Johnson & Johnson 55% Millennium 50% Hoffman-La Roche 49% Bayer 44% Takeda 41% Novartis 39% Source: PAREXEL Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008 11 However, Consolidation and M&A Activity Are Not The Only Long-Term Solutions To Building Shareholder Value New Innovation is the Therapeutic only opportunity that Areas creates a near limitless capacity to build value Strategic synergies via M&A can maximize value of Innovation the innovation Economies of scale Precision as cost conserving Improved With measures have Patient Targeted diminishing Outcomes Therapies marginal returns over time 12 Development Control Early-stage development (Ph I thru IIa) routinely in hands of biotech partner For late-stage deals, biotech participation increasingly required Partners Product/Phase US Dvpt Control in Ph 3 Pozen/AZ Naproxen-PPI combo/Ph 2 Pozen Atherogenics/AZ AGIX 1067/Ph 3 Atherogenics Nuvelo/Bayer Alfimeprase/Ph 3 Nuvelo Vertex/J&J VX-950/Ph 2 Vertex GSK/Myogen Ambrisentan/Ph 3 Myogen FibroGen/Astellas FG-2216 & 4592/Ph 2 Shared Affymax/Takeda Hematide/Ph 2 Shared SOURCE: Windhover’s Strategic Intelligence Systems 13 Millennium: From Genomics to Leading Biopharmaceutical Company Year 1 Year 14 30 People 1000 People >$800M Cash Value = $4.2B $8M Cash M&A – 3 acquisitions Market-leading, novel cancer Value = $13M therapy Alliances – >$2 billion partnering revenue 10 Molecules Genomics in the clinic Vision funding 14 Successful Partnerships are Complex… Collaborative planning Clear decision making Culture Balancing the commonalities and differences of priorities and the partnership …Yet, Partnerships can drive significant growth…. 15 Millennium: From Genomics Startup To Fully Integrated Biopharmaceutical Company Targets/ Disease Genes Discovery Preclinical Clinical Commercial Bio 1994 Roche Getting Started 1996 Lilly (3), Wyeth, AZ Building critical mass Monsanto ($218M) Leveraging the platform in Agriculture 1997 ChemGenics Moving into discovery 1998 Bayer ($465M) Industrializing drug discovery 1999 Leukosite Moving into the clinic 2000 Abbott, Aventis Building franchises 2001 BZL, Xenova, TDT Adding to the pipeline Moving onto 2002 COR Therapeutics the market 2003 J&J Ex-U.S. 2004 GSK Ex-U.S. Onc. Commercial 2005 SP Focus 2006 Ortho Grow VELCADE 16 Millennium Today and Beyond M&A/ partnerships continue as critical focus Objectives have changed over time – From acquiring downstream capabilities to cost and risk sharing – Accessing external innovation to complement and accelerate growth Millennium as a Partner of Choice – Extensive successful experience with research, co-development & commercialization partnerships – Fully integrated capabilities to support broad partnerships 17 Profile of A Successful Biotech Company Of The Future Maintain innovation and risk-taking Focus and build on core competencies Strategic cost and risk-sharing Flexibility Access to global resources Visionary leadership 18 Partnership to Create Value will Continue to Accelerate Fostering innovation is the common goal to create sustainable future shareholder value As a result, accessing innovation in the form of M&A, partnerships and in-licensing will continue to increase… …Even as increasing marketplace complexity decreases the odds of success Choose Wisely 19 Breakthrough science. Breakthrough medicine. 20 Millennium – Roche (1994) The Deal: $70M Collaboration focused on obesity – at the time, the largest disease focused alliance in biotech Millennium Drivers − Validation of company and scientific platform − Equity at a step up in valuation, R&D funding Macro Drivers − Smith Kline Beecham and HGSI alliance Partner Drivers − Concerns about R&D productivity/impact of genomics − Strong interest in building obesity franchise 21 Millennium – Monsanto (1997) The Deal: $218M technology transfer, exclusive in agriculture field - at the time, the largest alliance in biotech Millennium Drivers – Agriculture not central to mission/strategy – Capture value of platform in non-pharma to fund pharma programs Macro Drivers − Genomics fever hits agriculture Partner Drivers − Transforming into a life sciences company (Solutia spinout) − Needed to establish IP position for trait determining genes − Looking for turn-key genomics solution 22 Millennium – Bayer (1999) The Deal: $465M focused on large scale genomics and industrialization of drug discovery - the largest technology focused alliance in biotech Millennium Drivers – Capture value of genomics lead to built critical mass in discovery, retain rights to built proprietary pipeline – Equity at a premium, value/performance based funding Macro Drivers – Genomics fever hits pharma Partner Drivers – Strategic review determined need for novel targets 23 Millennium – Aventis (2000) The Deal: $450M alliance – contract JV for joint development and commercialization of products in inflammation field - the broadest alliance ever between biotech and pharma Millennium Drivers – Equity to continue to strengthen balance sheet for investment – Capture value from technology while building inflammation pipeline Macro Drivers – Continuing industry consolidation – Pipeline concerns broadly throughout industry Partner Drivers – Transform culture and process to create leading capabilities post RP/HMR merger 24 Millennium – J&J/Ortho Biotech (2003) The Deal: $750M development and commercialization of Velcade (novel oncology product) outside the United States – the largest ex-US alliance in biotech Millennium Drivers – Cost and risk sharing vs. retention of US value – Access to capabilities in markets outside the US Macro Drivers – Late stage innovative products are scarce Partner Drivers – Building an oncology franchise ex-US 25 Global Perspective on Consolidation in the Biopharmaceutical Industry Ed Saltzman President Defined Health New York Pharma Forum General Assembly 7 December, 2007 New York Pharma Forum General Assembly © Defined Health 2007 December, 2007 - Pg. 26 The information in this presentation has been obtained from what are believed to be reliable sources and has been verified whenever possible. Nevertheless, we cannot guarantee the information contained herein as to accuracy or completeness. All expressions of opinion are the responsibility of Defined Health, and though current as of the date of this presentation, are subject to change. New York Pharma Forum General Assembly © Defined Health 2007 December, 2007 - Pg. 27 Introduction of Panelists Deborah Dunsire, MD President & CEO