Global Pharmaceutical Industry Robert Agon Alex Luk Jacky Lui Ray Li – – – – Industry Analysis Bristol-Myers Squibb Pfizer Merck Overall Health Care Industry U.S. Government - Regulatory Body (FDA) For Profit Health Benefit Providers a) Service Organizations - Public Health Care Programs - Medicare - Medicaid - Hospital management Foreign Markets & Governments - Long term care (nursing homes) - Special services - Organizations providing health care plans (HMOs) U.S. Health Care Industry Biotechnology Companies b) Pharmaceutical Industry (product organizations) Not-for-Profit Health Benefit Providers - Diversified Companies - Products & Supplies - Drug Companies Research Institutions - Universities - National Institutes of Health Pharmaceutical vs. Biotech Two Distinctions: 1) Business model Biotech: Much smaller and limited resources to market drug Just a research engine Pharmaceutical Larger and market drug themselves 2) Field of Research Biotech: Use “genetic engineering” Pharmaceutical Use "empirical screening" to develop drugs Pharmaceutical Industry Background The U.S. is the leader in market share and has five of the ten largest companies Global pharmaceutical sales grew 9% in 2003 to $466.3 billion In 2003, 64 blockbuster drugs had sales over $1 billion Industry is less sensitive to swings in the business cycle COGS, R&D and Marketing are the largest expenditures Information from Phrma & Yahoo Finance November 2004 Industry Background (cont.) Patents are extremely important; they give a company exclusive rights to produce a drug for 20 years Many pharmaceutical companies attempt to extend their patents by significantly changing the nature of the drug Future success of a drug company depends heavily on the number and quality of drugs in the pipeline The industry has traditionally relied on the “blockbuster model”, where a few key drugs make up most of the company’s revenue Potential New Business Strategies The Diagnostic-Led Strategy The Single-Pill Strategy based on the observation that even when there are established treatments, significant numbers of patients are either not diagnosed in a timely manner or not diagnosed at all seeks to simplify the lives of those taking multiple medications The Treatment Platform Strategy based on the assumption that various medical conditions share common denominators and can be treated using the same therapeutic approach Key Issues Affecting the Industry In August 2004, New York officials filed a lawsuit against 44 drug makers, claiming they overcharged Medicaid for prescription drugs Merck’s Vioxx drug was pulled due to risk of heart attacks and strokes Possible legal action by various patient groups May affect sales of Pfizer's CeIebrex & Bextra COX-2 pain reliever U.S. citizens are increasingly angry over rising drug costs, which is fuelling political debate over Canadian imports Online sales to the U.S. from Canadian pharmacies are expected to be $1.2 billion US in 2004 By 2005, over $50 billion of branded pharmaceuticals will have their patents expire Ethical vs. Proprietary Drugs Ethical: branded and generic drugs sold only through prescription Proprietary: branded or generic drugs sold over the counter After patent expiration, many of the prescription drugs can apply to the FDA for over-the-counter status. Lower margins on over-the-counter products FDA requirements counter drugs are not as cumbersome for over-the- Product Focus Most ethical producers focus on 5 main therapeutic areas: - Central nervous system Cardiovascular Gastrointestinal / metabolism agents Anti-infective Respiratory drugs More concentrated on chronic rather than acute diseases with large patient populations (cancer, arthritis, CVD) Ulcer medications, cholesterol treatments, and antidepressants are the top three drug categories Two of the best-selling drugs are Pfizer's Lipitor and Merck’s Zocor for cholesterol Breakdown of Sales Figures by Area Central Nervous System 24% Cancers, endocrine system, & metabolic diseases 17% Digestive and genito-urinary system 13% Respiratory system 13% Parasitic and infectious diseases 11% Cardiovascular agents 10% Vitamins and related items 6% Dermatological items 3% Veterinary products 3% U.S. Department of Commerce 2002 2003 Top Selling Blockbuster Drugs Drug Maker Lipitor Zocor Zyprexa Norvasc Procrit/Eprex Prevacid Nexium Plavix Seretide/Advair Zoloft Pfizer Merck Eli Lilly Pfizer Johnson & Johnson Abbott & Takeda AstraZeneca Bristol Myers GlaxoKlineSmith Pfizer Total Purpose Cholesterol Cholesterol Antipsychotic Hypertension Anemia Stomach acid Stomach acid Cardiovascular Disease Asthma Antidepressant **Sales % Growth ($Billions) Rate 10.3 6.1 4.8 4.5 4 4 3.8 3.7 3.7 3.4 14 -4 13 7 13 0 62 40 40 11 $48.30 14% Source: IMS World Review 2004 **Figures have been adjusted by IMS to include drug sales from distribution agreements Market Leaders Leaders by Market Capitalization ($ billion): Pfizer $205.1 Johnson & Johnson $179.7 GlaxoKlineSmith PLC $122.2 Novartis AG $118.8 Roche Holding AG $87.4 Aventis SA $70.9 AstraZeneca PLC $66.8 Abbot Laboratories $66.6 Eli Lilly & Co $62.5 Merck & Co Inc $60.1 Retrieved from Yahoo Finance November 22, 2004 2003 Pharmaceutical Sales by Region World Audited Market 2003 Sales ($ billion) % of Global sales ($) % Growth (constant $) North America 229.5 49% 11% European Union 115.4 25% 8% Rest of Europe 14.3 3% 14% Japan 52.4 11% 3% Asia, Africa and Australasia 37.3 8% 12% Latin America 17.4 4% 6% $466.3 100% 9% TOTAL Source: IMS World Review 2004 Customers Individual Patients Pharmacies Physicians Large Scale Purchasers Government Agencies (Medicare & Medicaid) (Hospitals & Managed Care Providers) Large Scale Purchasing Companies Health Maintenance Organizations (HMO) Offers consumers a comprehensive range of benefits at one annual fee Patients are assigned to a primary care doctor as a "gatekeeper" who decides what health services are needed and when. They receive a discount from health care providers based upon their volume of patients Pharmaceutical Benefits Management Companies (PBMs) Intermediary distributor between drug companies and large scale purchasers Process drug claims for managed care companies & large employers Immense buying power which allows saving to be passed to customers Medicare & Medicaid Medicare: Government health insurance program designed to subsidize health services for the elderly and disabled Medicaid: Government health insurance program designed to subsidize health services for those living in poverty These agencies buy in bulk to get a lower price, thus putting margin pressure on pharmaceutical companies Medicaid programs have preferred drug lists of reimbursable medicines that doctors can prescribe This decreases patients’ access to much needed medicines Lowers the overall quality of care Industry Politics & Government Pharmaceuticals spend millions of dollars on lobbying and campaign contributions to influence government Re-election of Bush is good for U.S. pharmaceuticals Note: The AMEX Pharmaceutical Index increased by 2.74% the day after the election Issue of importing cheaper drugs from Canada Industry is subject to extensive government regulation (ie. FDA, foreign governments, environmental, & price constraints) Food and Drug Administration Imposes requirements on product testing, safety, effectiveness, and marketing of pharmaceutical products Monitors for proper manufacturing and labeling standards Also responsible for food, medical devices, and cosmetics products Only one out of five medicines that enter clinical trials is approved for patient use by the FDA Source: www.fda.com (2004) Drug Approval Process Average of 10 - 15 years and $800 million to nurture a drug from initial discovery to market Process: Academic and Laboratory Research Testing done on animals Phase 1: Drug given to a small number of healthy people to test its safety Phase 2: Drug administered to 100 or more people with the disease that it was intended to treat Phase 3: Rigorous testing done on larger groups of ill patients FDA Review – Approval/Disapproval Source: www.fda.com (2004) Number of Drugs Approved by the FDA Each Year Industry Trends Globalization Aging worldwide population Longer life expectancy Increasing demand from developing nations Outsourcing more activities Increase in Direct-to-Consumer Advertising Industry Trends (cont.) Increasing drug prices Rising R&D costs Increase in mergers, acquisitions, and alliances Increasing size of the generics market Increased buying power of insurance companies Increase in licensing agreements with Biotech firms to improve drug pipelines R&D Spending Total R&D (billions) Total R&D as a % of Total Sales Year Domestic R&D (billions) R&D Abroad (billions) 2003 $27,407 $5,808 $33,215 15.6% 2002 $25,655 $5,357 $31,012 16.1% 2001 $23,502 $6,221 $29,773 16.7% 2000 $21,364 $4,667 $26,031 16.2% 1999 $18,471 $4,220 $22,691 16.5% 1998 $17,128 $3,839 $20,997 16.8% 1997 $15,466 $3,492 $18,958 17.1% 1996 $13,627 $3,279 $16,906 16.6% 1995 $11,874 $3,334 $15,207 16.7% 1994 $11,102 $2,348 $13,449 17.3% Growth in R&D U.S. Marketing Expenses Direct-to-consumer advertising Office, hospital, & journal promotions Retail value of samples Total $30 $25.3 $ Billions $25 $19.1 $20 $15 $13.9 $21.2 $15.7 $10 $5 $0 1999 Source: http//:www.phrma.org (2004) 2000 2001 2002 2003 Generics Market Generics now account for over 50% of all prescription drugs Americans spent over $182.7 billion dollars on prescription drugs in 2002 The average branded prescription cost four times as much as a generic drug Generics save consumers $8 - 10 billion per year Industry Financial Ratios Market Capitalization: 1253 B Price / Earnings: 20.1 Price / Book: 4.51 Quarterly Revenue Growth (YOY): 5.65% Return on Equity: 24.10% Total Debt / Equity: 0.4 Long-Term Debt to Equity 0.37 Dividend Yield: Source: Yahoo Finance 2004 2.64% Industry Performance (cont.) AMEX pharmaceutical index is a market-capitalization weighted index Comparison of Pharmaceutical Index and Economy Amex (DRG) Dow Jones Industrial (DJI) S&P 500 (GSPC) Nasdaq (IXIC) Future Industry Growth Growth rates for 2005 are estimated by IMS to be: Country Growth Rate U.S. United Kingdom Germany France 12% 7% 5% 4% Japan 1.5% IMS and Standard & Poors 2003 History - Squibb Founded by Dr. Edward Squibb in 1858 Bought by Mathieson Chemical in 1952 Bought by Olin Industries in 1953 1858 History – Bristol-Myers William Bristol and John Myers founded Clinton Pharmaceutical in 1887 Renamed to Bristol-Myers in 1900 Went public in 1929 Bought Squibb in 1989 and formed Bristol-Myers Squibb 1887 Mission To extend and enhance human life by providing the highest-quality pharmaceuticals and health care products. Company Statistics Employee: 44,000 in over 100 countries (2003) Global Sales: $20.9 billion (2003) Market Capitalization: $46.05 billion (Sep 30, 04) Stock Price: $23.50 (Nov 19, 2004) Number of Outstanding Shares: 2,201 million Annual R&D expense as a percentage of sales: 10% -12% Largest Market: U.S., Europe, Japan Company Overview Bristol-Myers Squibb (BMS) is a diversified worldwide health and personal care company that researches and manufactures medicines and other products. The Company's products include therapies for various diseases and disorders, consumer medicines, wound management, nutritional supplements, infant formulas, and skin care products. Management Team Peter R. Dolan (49) ($5.92 million ex. option) Andrew R. J. Bonfield (42) ($3.80 million ex. option) Chief Scientific Officer and President of The Pharmaceutical Research Institute Joined in 1997 Donald J. Hayden Jr. (48) ($2.66 million ex. option) Senior Vice President and Chief Financial Officer Joined in 2002 Elliot Sigal, M.D., Ph.D. (52) ($2.59 million ex. option: figures for previous CSO) CEO, Chairman of the Board Joined in 1988, became Chairman in 2000 and CEO in May 2001 Executive Vice President and President, Americas Joined in 1993 John L. McGoldrick (63) ($1.92 million ex. option) Executive Vice President and General Counsel Joined in 1995 Recent Events March 2004 - BMS was found liable for damage for “channel stuffing” between 1999 and 2001 – BMS was fined $150 million May – BMS & Sanofi sued Apotex on patent infringement on Plavix August – Investors sued BMS for $300 million claiming that BMS lied about its accounting and investment in ImClone Key Elements of 5yr Strategy Focus on 10 Disease Areas Increase Sales and Marketing emphasis on specialists and high value Primary Care prescribers Invest in R&D and R&D growth Increase A&P spending behind growth drivers Enter the biologics business Target all other spending flat or slightly down over the next several years Successful Past Partnerships Sanofi-Synthelabo Co-developed Otsuka Pharmaceutical Co-developed Avapro and Plavix Abilify ImClone Systems Co-developed Erbitux Current Strategic Partnerships Merck & Co. Corgentech co-developing Basulin Solvay Pharmaceuticals co-developing E2F Decoy Flamel Technologies S.A. co-developing and co-promoting Muraglitazar co-developing SLV319 Pierre Fabre Médicament S.A. co-developing Javlor Major Acquisition/Divestiture Action Date Subsidiaries/Product Line Value Sold Dec 13, 2003 Mead Johnson Adult Nutrition $385 million cash Sold Nov 15, 2001 Clairol $4.95 billion cash Invested Nov 2001 ImClone 14.4 million share at $70 (19.9% of outstanding share) Acquired Oct 1, 2001 DuPont Pharmaceuticals $7.8 billion cash partly financed by $1.5 billion commercial paper and $5 billion medium term note Spin-off Aug 6, 2001 Zimmer (in tax free distribution) Paid $203 million in common share dividend Patent Expiration 2003 Sales ($million) 2002 Sales ($million) 2001 Sales ($million) Expiration Year in U.S. Pravachol 2,827 2,266 2,101 2006 Plavix 2,467 1,890 1,171 2011 Taxol 934 857 1,112 1997 Paraplatin 905 727 592 2004 Avapro/Avalide 757 586 487 2011 Sustiva 544 455 68 2013 Monopril 470 426 413 2003 Glucovance 424 246 269 2004 Glucophage XR 395 297 230 2003 Zerit/Zerit ER 354 443 515 2008 Coumadin 303 300 63 1997 Abilify 283 25 --- 2009 Videx/Videx EC 267 262 240 2001 Tequin 208 262 240 2007 Glucophage IR 118 184 250 2000 Serzone 98 221 234 2003 Reyataz 88 --- --- 2017 Buspar 35 53 297 2001 Erbitux --- --- --- 2017 Pharmaceutical Product Selected Product Sales % Change Change ($ million) 2004 3rdQ Sales ($ million) Pravachol -24% -189 598 787 Plavix 30% 208 908 694 Taxol 2% 5 243 238 Paraplatin -28% -68 177 245 Avapro/Avalide 32% 59 241 182 Sustiva 65% 62 157 95 Glucophage -82% -193 43 236 Zerit 6% 4 69 65 Abilify 63% 64 165 101 Videx/Videx EC 18% 10 67 57 Reyataz 172% 67 106 39 Erbitux N/A 84 84 0 4.13% 113 2,852 2,739 Pharmaceutical Product Total 2003 3rdQ Sales ($ million) Selected Key Products Pravachol Cholesterol lowering $2,827 million sales in 2003 (13.01% of total company sales) Licensed patent to Sankyo Company for exclusive distribution in four Asia countries Patent expires in U.S. in 2006 Selected Key Products Plavix Cardiovascular product $2,467 million sales in 2003 (11.35% of total company sales) Co-developed with Sanofi Patent expires in US in 2011 Selected Key Products Taxol Anti-cancer agent $934 million sales in 2003 (4.30% of total company sales) Co-developed with U.S. Government Patent expired in U.S. in 1997 – no generic competition until January 2002 Patent expired in EU and Japan in 2003 Recently Released Drugs Abilify (schizophrenia) Erbitux (cancer) Reyataz (HIV/AIDS) Compounds in Development Number of Compound 10 8 6 4 2 0 Phase I Phase II Number of Compound Phase III Compounds Under Development Abatacept (phase III) hepatitis B Muraglitazar (phase III) rheumatoid arthritis Entecavir (phase III) LEA29Y (phase II) E2F Decoy (phase III) vein graft failure prevention Ixabepilone (phase III) cancer MDX-010 (phase III) metastatic melanoma deep vein thrombosis prevention Javlor (phase II,III) solid organ transplant Razaxaban (phase II) type 2 diabetes and other metabolic disorder phase III for bladder and nonsmall cell lung cancer phase II for breast and ovarian cancer Other Business Segment Oncology Therapeutic Network (OTN) Nutrition Mead Johnson Other Healthcare ConvaTec Medical Imaging Consumer Medicine Sales Breakdown by Business Segment 100% 80% 8% 10% 11% 9% 10% 10% 7% 10% 8% Other 60% 40% Nutrition 71% 71% OTN 75% Pharmaceuticals 20% 0% 2003 2002 2001 Source: 2003 Annual Report Sales by Geographic Areas 100% 80% 8% 6% 8% 7% 7% 7% 24% 22% 20% Pacific 60% Other Western Hemisphere 40% Europe, Middle East and Africa 62% 63% 65% United States 20% 0% 2003 2002 2001 Source: 2003 Annual Report Cost Breakdown (2003) R&D 14% A&P 9% Marketing, S&A 29% Others 2% COGS 46% R&D as a Percentage of Sales $ million $25,000 50% $20,000 40% $15,000 30% $10,000 20% $5,000 10% 0% $0 2004 (ttm) 2003 2002 Sales 2001 2000 % R&D of Sales 1999 Stock Price Summary Ticker Symbol: BMY (NYSE) Price as of Nov. 19, 2004: $23.50 52 weeks low: $22.22 52 weeks high: $31.30 Average Daily Volume 5,149,227 Number of Shares Outstanding: 2,201 million Dividend Record Year Ended Div per Quarter Total Div Dividend Yield 2004 (ttm) $ 0.28 $ 1.12 4.73% 2003 $ 0.28 $ 1.12 3.92% 2002 $ 0.28 $ 1.12 4.84% 2001 $ 0.275 $ 1.11 2.18% 2000 $ 0.245 $ 0.98 1.33% One Year Stock History Fined for Overstated Revenue BMS sued Apotex for Patent Infringement BMS sued by Investors for ImClone Scandal Five Years Stock History Five Years Stock Comparison Financial Statements Summary 2004 (ttm) 2003 2002 2001 2000 Share Price (End of period): 23.67 28.60 23.15 51.00 73.94 Revenue ($ million): 21,703 20,894 18,106 18,044 17,695 Net Earnings ($ million): 2,249 3,106 2,067 1,871 3,686 EBIT ($ million) 3,614 4,971 3,125 2,445 5,355 Total Assets ($ million) 30,176 27,391 25,022 27,864 17,921 Total Liabilities ($ million): 19,513 17,605 16,266 18,737 8,398 Total Debt ($ million): 10,190 8,649 7,640 6,411 1,498 219 277 364 182 108 Stockholder’s Equity ($ million): 10,663 9,786 8,756 8,762 9,180 Shares Outstanding (million): 2,201 2,201 2,201 2,200 2,198 Operating Cash Flow ($ million): 2,493 3,512 945 5,372 4,652 Dividend per share: 1.12 1.12 1.11 1.01 0.89 Interest Expense ($ million): Financial Ratios 2004 (ttm) 2003 2002 2001 2000 Price to Book Ratio (P/B) 4.31 6.43 5.82 12.36 20.60 Debt/Equity Ratio 0.80 0.87 0.72 0.69 0.19 Return on Asset (ROA) 9.13% 11.31% 8.54% 16.76% 25.18% Return on Equity (ROE) 25.84% 31.74% 24.41% 51.37% 56.68% Earning per Share (EPS basic) 1.63 1.60 1.07 0.96 1.95 Price Earning (P/E) 16.67 17.88 21.64 53.13 37.92 Operating Margin 33.12% 34.58% 34.83% 40.29% 41.99% Liquid Asset per share $ 5.50 $ 4.69 $ 3.84 $ 5.25 $ 3.78 Free Cash Flow ($ million) $ 2,938 $ 2,575 $ (130) $ 4,192 $ 4,063 Recommendation Pros Extremely strong pipeline High dividend yield Cons Patent expiration for key products Uncertain litigation outcome Dividend payout sustainability in question Financial statement accuracy in question Strong cash flow HOLD Mission Statement Mission We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live Purpose We dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in pharmaceutical, consumer, and animal health products Company Overview A research-based, global pharmaceutical company that discovers, develops, manufactures and markets prescription medicines for humans and animals, and consumer healthcare products Company Statistics Market capitalization: US$205.07 billion Employees (worldwide): 122,000 Annual R&D expenses as a % of revenues: 15-16% Largest markets: North America, Europe and Japan Stock symbol: PFE (NYSE) Stock price: US$27.23 (as of November 19, 2004) Number of outstanding common shares: 7.53 billion Company Highlights in 2003 With the addition of Pharmacia in 2003, Pfizer became the #1 pharmaceutical company in every region of the world 14 of the company’s prescription medicines were category leaders In 2003: 65th consecutive year of cash dividends 37th consecutive year of dividend increases Strategic Alliance Has agreements to copromote pharmaceutical products discovered by other companies Alliance revenue is primarily based upon a percentage of our copromotion partners’ net sales Major Acquisitions Pharmacia Deal completed in April, 2003 US$55.97 billion Identifiable intangible assets: US$37.07 billion Goodwill: US$21.40 billion Financing Issuance of 1.8 billion shares of Pfizer common stock (≈29% dilution) 180 million options on Pfizer common stock 6,000 shares of Pfizer Series A convertible perpetual preferred stock (convertible into approximately 15.5 million shares of Pfizer common stock) Warner-Lambert Deal completed in June, 2000 Top Institutional Holders Institution Name Shares Held Position Value (000) % Shares Outstandi ng Portfolio Date BARCLAYS GLOBAL INVESTORS INTL 317,165,142 $10,872,421.07 4.20% 6/30/2004 FIDELITY MANAGEMENT & RESEARCH CO 313,574,154 $10,749,322.00 4.15% 6/30/2004 STATE STREET GLOBAL ADVISORS 238,527,803 $8,176,733.09 3.16% 6/30/2004 VANGUARD GROUP 163,360,414 $4,998,828.67 2.16% 9/30/2004 WELLINGTON MANAGEMENT 144,173,354 $4,942,262.58 1.91% 6/30/2004 ALLIANCE CAPITAL MANAGEMENT 133,272,306 $4,568,574.65 1.76% 6/30/2004 NORTHERN TRUST CO (CHICAGO) 115,212,146 $3,949,472.36 1.53% 6/30/2004 PUTNAM INVESTMENT MGMT 102,454,572 $3,512,142.73 1.36% 6/30/2004 SMITH BARNEY ASSET MANAGEMENT 86,040,999 $2,949,485.45 1.14% 6/30/2004 GOLDMAN SACHS ASSET MANAGEMENT 84,718,489 $2,904,149.80 1.12% 6/30/2004 STATE FARM INVESTMENT MGMT CORP 80,709,105 $2,766,708.12 1.07% 6/30/2004 DEUTSCHE BANK ALEX. BROWN 74,050,477 $2,538,450.35 0.98% 6/30/2004 CAPITAL RESEARCH & MANAGEMENT CO 69,650,780 $2,387,628.74 0.92% 6/30/2004 TIAA CREF INVESTMENT MANAGEMENT INC 73,608,756 $2,252,427.93 0.97% 9/30/2004 FAYEZ SAROFIM & CO 54,326,810 $1,862,323.05 0.72% 6/30/2004 Officers Henry A. McKinnell (1970), Chief Executive Officer (12th CEO in Pfizer’s history) David Shedlarz (1976), Chief Financial Officer, Executive Vice President Karen Katen (1974), Executive Vice President, President of Pfizer Pharmaceuticals Group Nat Ricciardi (1974), President of Pfizer Global Manufacturing John LaMattina (1977), Senior Vice President, President of Pfizer Global Research and Development Peter Corr (2000), Senior Vice President of Science and Technology (from Warner-Lambert) Yvonne Jackson (2002), Senior Vice President of Human Resources (from Compaq) Executive Compensation Annual Compensation Name Principal Position Long-Term Compensation Year Salary ($) Bonus ($) Restricted Stock Awards ($) Securities Underlying Options (#) LTIP Payouts ($) All Other Compensation ($) Dr. McKinnel Chairman and CEO 2,003 2,042,700 4,607,400 - 1,000,000 2,786,978 249,390 Ms. Katen Executive V.P.; President, Pfizer Global Pharmaceuticals 2,003 1,086,700 1,434,400 326,840 275,000 1,510,448 103,631 Mr. Schedlarz Executive V.P.; CFO 2,003 889,133 1,043,100 260,866 225,000 1,216,379 79,922 Mr. Kindler Senior V.P. of General Counsel 2,003 827,900 901,500 248,989 200,000 857,703 68,962 Dr. Corr Senior V.P. of Science and Technology 2,003 806,000 815,000 242,403 110,000 1,316,630 89,354 Major (Revenue) Markets – Geographic Breakdown (2003 figures) % of total revenues United States Japan All other 59% 6% 35% 100% Revenues Breakdown Millions of Dollars Revenues - Geographic Breakdown (2003 figures) 50,000 45,000 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 - All Other Countries Japan United States 2003 2002 Year 2001 Operating Segments (2003 figures) Pharmaceutical Consumer healthcare Animal healthcare Other % of total revenues 87.7% 6.7% 3.5% 2.1% 100% Major Product Areas Revenues % of total (billion $) revenues Cardiovascular & Metabolic Diseases $16.17 35.8% Central Nervous Systems Disorders 7.38 16.3% Arthritis & Pain 3.05 6.7% Infectious & Respiratory Diseases 4.68 10.4% Urology 2.46 5.4% $33.75 74.7% Major Revenue Drivers (2003 figures) Lipitor (Cardiovascular) Norvasc (Cardiovascular) Zoloft (Anti-depressant) Neurontin (Epilepsy) Zithromax (Infectious diseases) Celebrex (Arthritis) Viagra (Erectile dysfunction) $9.23 billion 4.34 billion 3.12 billion 2.70 billion 2.01 billion 1.88 billion 1.88 billion $25.14 billion (≈55.6% of total revenues) Major Products I Lipitor Treatment #1 for lowering cholesterol best-selling prescription drug in the world Worldwide 20.43% of total company sales 10% sales of $9.23 billion in 2003 growth in Sept. 2004 in U.S. Maintained a 43% total prescription share Major Products II Norvasc World’s most-prescribed branded antihypertensive therapy 4th best-selling drug in the world Worldwide sales of $4.34 billion in 2003 9.60% of total company sales declined in the 3rd quarter of 2004 compared to the same period in 2003 Sales Patent expirations in some EU countries Major Products III Zoloft World’s #10 leading antidepressant best selling drug in the world Worldwide sales of $3.12 billion in 2003 6.90% of total company sales declined in 3rd quarter of 2004 compared to same period in 2003 Sales Overall market decline due to media coverage of the use of antidepressants in children and teenagers Revenues Growth – Major Products Revenues (millions of dollars) 2003 2002 % change 2001 03/02 02/01 Cardiovascular: Lipitor 9,231 7,972 6,448 15.79% 23.64% Norvasc 4,336 3,846 3,581 12.74% 7.40% Zoloft 3,118 2,742 2,365 13.71% 15.94% Neurontin 2,702 2,269 1,751 19.08% 29.58% 1,883 100 76 1783.00% 31.58% - - N/A N/A Central Nervous System: Arthritis and Pain: Celebrex Bextra 687 Infectious and Respiratory Diseases: Zithromax 2,010 1,516 1,506 32.59% 0.66% Diflucan 1,176 1,112 1,066 5.76% 4.32% 1,879 1,735 1,518 8.30% 14.30% 1,338 1,115 990 20.00% 12.63% Urology: Viagra Others: Zyrtec Research & Development R&D Expenses Billions of Dollars 9.0 7.8 8.0 7.0 6.0 5.0 7.1 4.8 5.2 R&D Expenses 4.0 3.0 2.0 1.0 2001 2002 2003 Year 2004 Patent Expirations Drug Expiration Year Annual Sales (2003) % of Total Sales Zithromax 2005 2,010 4.4% Zoloft 2006 3,118 6.9% Norvasc 2007 4,336 9.6% Zyrtec 2007 1,338 3.0% Aricept 2010 254 0.6% Lipitor 2010 9,231 20.4% Xalatan 2011 623 1.4% Viagra 2012 1,879 4.2% Detrol 2012 544 1.2% Celebrex 2013 1,883 4.2% Bextra 2015 687 1.5% Genotropin 2015 481 1.1% 2,702 6.0% Total 29,086 64.4% Total sales 45,188 Neurontin 20-in-5 Goal Pfizer’s goal is to submit an unprecedented 20 new medicines for regulatory approval during the fiveyear period ending in 2006 Major Drugs in the Pipeline MIDDLE STAGE (PHASE 2): HIV/AIDS UK-427,857 a mechanistically unprecedented CCR-5 inhibitor Organ Transplant Rejection CP-690,500 a Janus kinase-3 inhibitor for immunosuppression Sleep Disorders PD-200,390 a novel alpha-2 delta compound LATE STAGE (PHASE 3): Atherosclerosis Lipitor/torcetrapib a combination to elevate HDL cholesterol and lower LDL Cancer edotecarin a next-generation topoisomerse inhibitor for cancer Cancer* SU-11,248 a novel angiogenesis inhibitor COPD/ASTHMA roflumilast a novel anti-inflammatory agent distinct from existing treatments Diabetes Exubera an inhaled insulin system HIV/AIDS capravirine a novel antiviral compound active against resistant strains of HIV Insomnia indiplon a unique non-benzodiazepine GABA modulator Macular Degeneration* Macugen a novel anti-VEGF therapy Neuropathic Pain/Epilepsy/Generalized Anxiety Disorder pregabalin a neurologic agent develoepd by Pfizer Osteoporosis lasofoxifene a selective estrogen receptor modulator to maintain bone density Parkinson's Disease sumanirole a novel leva-dopa-enhancing compound Schizophrenia & Bipolar Disorder asenapine a 5HT2/D2 antagonist Smoking cessation* varenicline a selective nicotine partial agonist Recently Launched Products Geodon Schizophrenia Competitor Spiriva Novel to Abilify (Bristol-Myers Squibb) treatment for obstructive pulmomnary disease Relpax Migraine headaches Caduet Single-pill dual therapy of Lipitor and Norvasc Inspra Post-myocardial-infarction (MI) heart failure Recent News Sept. 30, 2004 Merck withdrew arthritis drug Vioxx from the market Oct. 15, 2004 Pfizer warns that Bextra “may raise heart attack risk in high-risk bypass surgery patients” Nov. 10, 2004 Study by American Heart Association shows that Bextra has shown a high incidence of heart attacks and strokes among patients 1-year Stock Chart _1year price chart 5-year Stock Chart 5year price chart Stock chart with industry benchmark Financial Highlights (millions of dollars, except share price and dividend) Share price (e.o.p.) 2004 (ttm) 2003 2002 2001 27.23 35.33 30.57 39.85 52,027 45,188 32,373 29,024 9,138 3,910 9,126 7,788 122,229 116,775 46,356 39,153 53,846 51,398 26,406 20,860 7,956 5,755 3,140 2,609 68,383 65,377 19,950 18,293 7,554 8,702 6,829 6,792 Operating cash flow 14,746 11,725 9,864 8,861 Capital expenditures 2,305 2,641 1,758 2,105 Free cash flow (FCF) 12,441 9,084 8,106 6,756 Dividends per share 0.66 0.60 0.52 0.44 Price-to-book ratio 3.01 4.70 10.46 14.80 Earnings per share (EPS) 1.21 0.45 1.34 1.15 Price-to-earnings (P/E) 22.51 78.63 22.88 34.75 ROA 7.48% 3.35% 19.69% 19.89% ROE 13.36% 5.98% 45.74% 42.57% Debt-to-equity ratio 11.63% 8.80% 15.74% 14.26% Dividend yield (based on purchase @ b.o.p.) 2.17% 1.96% 1.30% 0.96% Revenue Net earnings Total assets Total liabilities Total debt Equity Number of shares outstanding (e.o.p.) Market capitalization (e.o.p.) 205,687 307,442 208,763 270,661 Financial Statement Analysis (I) Deferred taxes increased by $12.87 billion from 2003 to 2002 due to deferred taxes recorded in connection with the acquisition of Pharmacia 40% of revenue growth from 2002 to 2003 was mainly due to the acquisition of Pharmacia Financial Statement Analysis (II) ROE was very strong, above 40%, in 2001 & 2002 ROE in 2003 decreased dramatically to 5.98% Increase of $55.40 billion for additional paid-in capital due to the Pharmacia deal in 2003 Lower net income in 2003 due to merger-related in-process R&D charges => lower ROE Recommendation Excellent long-time management team Strong existing product lines Promising products in pipeline Market leader in 14 different prescription drugs Extensive financial resources BUY Ticker: MRK Ray Li Mission Statement “To provide society with superior products and services by developing innovations and solutions that improve the quality of life and satisfy customer needs, and to provide employees with meaningful work and advancement opportunities, and investors with a superior rate of return” Company Statistics $22.5 billion in sales worldwide (2003) 2.22 billion shares outstanding 59.54% held by institutions Stock price (Nov. 19): $27.12 Market cap: $60.206 billion 63,200 employees worldwide 33,200 employees in US Strategies Develop & launch novel medicines and vaccines at competitive prices Aggressively pursuing external alliances with smaller companies Lowering cost structure Maximizing in-line franchises 2003 Highlights Q4-03: Cut 4,400 positions, to be completed in 2004 Q4-03: Implemented new distribution program Lowered quantity limit of average purchases Withdrew 2 products from late-phase trials Diabetes and depression drug Management R. Gilmartin, Chairman, President & CEO (1994) Term ends 2006 D. Anstice, President, Human Health (1974) M. Avedon, Senior VP, Human Resources (2002) R. Clark, President, Manufacturing Division (1972) K. Frazier, Senior VP, General Counsel (1992) P. Kim, President, Research Laboratories (2001) J. Lewent, Executive VP, CFO (1980) P. Wold-Olsen, President Human Health, Europe, MidEast, Africa Executive Compensation Position R. V. Gilmartin Chairman, President, CEO J. C. Lewent P. Wold-Olsen D. W. Anstice P. S. Kim Executive VP, CFO, President, Human Health Asia President, Human Health Europe, Middle East, & Africa President, Human Health President, Merck Research Labs Annual Compensation Salary Bonus Other 1,583,340 1,375,000 Long-Term Compensation Options (#) 527,495 720,000 615,000 137,149 585,004 550,000 137,149 606,674 520,000 137,149 610,008 500,000 140,580 210,998 Joint Ventures AstraZeneca LP (Nexium, Prilosec) J&J (dev. & market non-prescription medicines in US) $669.0 million Merial (JV w/ Aventis; pharma/vaccines for animals) $445.8 million Aventis Pasteur (dev. & market vaccines in Eur) $1.9 billion plus $391.5 million in preferential return $1.84 billion Schering-Plough (cholesterol mgmt – Zetia/Ezetrol) $469.4 million Joint Ventures II Bristol Myers Squibb (Apr. 04) Jointly develop clinical and marketing strategy for a diabetes drug (muraglitazar ~Phase III) Development and commercialization costs to be shared equally H. Lundbeck A/S (Feb. 04) Exclusive development and commercialization of a sleep disorder drug (gaboxadol ~Phase III) Recent Acquisitions & Divestitures Increased ownership of Banyu from 51% to 99.4%, costing $1.5427 billion (2003) Banyu is one of Japan’s top 10 pharmaceutical companies Strengthens Merck’s position in Japan Took $101.8 million charge against useless products Spun-off Medco Health (2003) Medco: high volume, low margin mail-order pharmacy Merck shareholders got 0.1206 share of Medco per Merck share Recent Acquisitions & Divestitures II Sold its 50% stake in J&J/MSD Europe (Mar. 04) Non-prescription For joint venture $244 million Acquired Aton Pharma (Mar. 04) Privately-held biotech Anti-tumor agents Major Product Areas 2003 % $ millions Atherosclerosis (Zocor) 23% 5,077.9 Hypertension/hear failure (Cozaar, Hyzaar, Vasotec) 15% 3,421.6 Other (Maxalt, Propecia, Nexium, Prilosec) 13% 2,967.3 Anti-inflammatory/analgesics (Vioxx, Arcoxia) 12% 2,677.3 Osteoporosis (Fosamax) 12% 2,676.6 9% 2,009.4 84% 20,833.1 Repiratory (Singulair) Revenues by Region $ million US 13,321.1 Eur, Mid East, Afr 5,341.3 Japan 1,600.9 Other 2,222.6 Total 22,485.9 Pipeline I Phase I Diabetes c-3347 Pain c-1246 Alzheimer's disease c-7617 c-9138 Glaucoma c-3859 Osteoporosis c-3578 Multiple Sclerosis c-6448 AIDS c-1605 Vaccines HIV vaccine Pipeline II Phase II Obesity Phase III c-2735 Rotavirus vaccine RotaTeq c-2624 Shingles Zoster vaccine c-5093 Human papillomavirus HPV vaccine Diabetes MK-0431 (2Q04) Alzheimer's disease c-9136 Antherosclerosis c-8834 Respiratory disease c-3885 Muraglitazar* Sleep disorders Gaboxadol c-3193 Post-operative nausea and vomiting c-9280 2003 U.S. Submissions Vaccines Pediatric combination Pediatric combination vaccine Cancer SAHA Psychiatric Disease c-9054 2004 U.S. Submissions Arthritis c-5997 Arthritis/Pain c-4462 ProQuad Arcoxcia Patents Drug Cancidas Cosopt Cozaar/Hyzaar Crixivan Emend Fosamax Invanz Maxalt Propecia Proscar Singulair Vioxx Zocor Zetia Expiry 2013 Expired 2009 2012 2012 2008 2013 2012 2006 2006 2012 2013 2006 Revenue (billions) 0.27 0.49 2.5 0.29 0.03 2.7 0.03 0.33 0.24 0.61 2.0 2.6 5.0 2013 0.46 Zocor $5 billion in annual revenues (2003) -13% Q3-04 (Wholesaler buy-in in 2003) +12% Q2-04 +10% Q1-04 #2 selling cholesterol drug in the world Zocor reduces cholesterol by blocking an enzyme in the liver helps produce cholesterol Loses patent in US in 2006 Fosamax $2.7 billion in annual revenues (2003) +13% Q3-04 +45% Q2-04 -4% Q1-04 Most prescribed osteoporosis medicine in the world Inhibits bone removal by osteoclasts (cells that break down bone material) Vioxx $2.5 billion in annual revenues Sales grew by 2% in 2003 worldwide Recalled on Sep. 30, 2004 Announcement wiped out $27 billion in market cap Took Q3 charge of $0.25 per share due to the recall Regular use > 18 months increased cardiovascular risk On Sept. 29, MRK closed at $45.07, on Sept. 30 it was $33.00 #1 arthritis and pain medicine outside US #2 in US $491.6 million reduction in sales $93.2 million in inventory write-off $141.4 million in marketing and administrative expense Analysts expect a further charge of $0.25-$0.30 per share in Q4 COX-2 Inhibitors Enzyme: a protein that catalyzes a chemical reaction COX-2 is an enzyme that aids the production of chemical messengers (prostaglandins) that cause the pain and swelling of arthritis Vioxx works by blocking COX-2 Previous generation of arthritis drugs are called Nonsteroidal antiinflammatory drugs (NSAIDs) Aspirin, Motrin They inhibitor the COX enzyme but have gastrointestinal side effects Long-term NSAID usage could lead to stomach ulcers There was some evidence that COX-2 inhibitors interfered with enzymes that help prevent cardiovascular disease Arcoxia: launch possibly delayed until 2009 Litigation Over 20 million Americans have taken Vioxx Liability range is $4 billion-$18 billion This will be spread over the decade Mostly for CV Event liability, not incl. punitive damage Issues: Did Merck knowingly mislead consumers? 18 months usage? Proving causation Merck recall voluntary Cozaar, Hyzaar Hypertension drug $2.5 billion in annual revenues (2003) +14% and +15% Q3-04 +34% and +15% Q2-04 -1% Q1-04 Cozaar is a angiotensin II antagonists (AIIAs) Angiotensin is a hormone that causes blood vessels to narrow Cozaar is 2nd most prescribed AIIA in US and the topseller in Europe Hyzaar combines Cozaar and a diuretic, removing water from the blood and lessens blood pressure 1 Year Stock Performance 5 Years Stock Performance 5 Year Relative Performance Ratios ROA ROE TTM 14.63% 36.95% 2003 16.83% 43.85% 2002 15.02% 39.26% 2001 16.54% 45.37% 2000 16.99% 45.99% Debt/Equity 38.05% 43.63% 46.97% 55.24% 46.65% 9.91 3.50 15.25 6.69 18.03 7.08 18.73 8.50 32.28 14.85 7,510 16.64% 6,511 14.13% 6,583 12.48% 5,942 11.59% 4,960 11.71% Cash/sh. 0.82 0.54 1.00 0.94 1.10 Diluted EPS Dividends 2.74 1.49 3.03 1.46 3.14 1.42 3.14 1.38 2.90 1.26 2,217,584,609 2,221,763,509 2,244,983,250 P/E P/B FCF ($ billion) R&D % of Sales Shares outstanding Paid Pay dividends since 1935 out ratio of 40%-50% 2,272,729,321 2,307,599,179 2003 Cap Ex Breakdown Millions of $ Production facilities 788.3 R&D facilities 763.8 Environmental projects 41.8 Admin, safety, general 322 1915.9 Recommendation Pros Strong balance sheet Lots of cash May be cheap SELL Cons Weak pipeline Key management are outsiders Vioxx uncertainty Quarterly Income Statements Q3-04 Q2-04 Q1-04 Q4-03 5538.1 6021.7 5630.8 5627.1 Materials and production 1364.2 1131.3 1115.8 1228.3 Marketing and administrative 1752.9 1616.2 1611.4 1794.1 Research and development 919.3 986.0 996.3 906.3 Equity income from affiliates (307.1) (220.5) (194.7) (6.0) (4.2) 69.9 (240.9) (56.5) 3,725.1 3582.9 3287.9 3866.2 1,813.0 2438.8 2342.9 1,760.9 487.4 670.7 724.3 365.7 1325.6 1768.1 1618.6 1,395.2 - - - 1325.6 1768.4 1618.6 1,395.2 0.60 0.80 0.73 0.63 - - - - 0.60 0.80 0.73 0.63 Continuing Operations 0.60 0.79 0.73 0.62 Net Income 0.60 0.79 0.73 0.62 Sales Costs, Expenses and Other Other (income) expenses, net Income from Continuing Operations Before Taxes Taxes on Income Income from Continuing Operations Income from Discontinued Operations, Net of Taxes Net Income Basic Earnings per Common Share Continuing Operations Discontinued Operations Net Income Earnings per Common Share Assuming Dilution