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Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines

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Amgen 2008 Annual Report and Financial Summary Pioneering Science Delivers Vital Medicines Amgen 2008 Annual Report and Financial Summary Pioneering science delivers vital medicines About Amgen Products Amgen discovers, develops, manufactures Aranesp® (darbepoetin alfa) and delivers innovative human therapeutics. ® A biotechnology pioneer since 1980, Amgen Enbrel (etanercept) was one of the fi rst companies to realize ® the new science’s promise by bringing EPOGEN (Epoetin alfa) safe and effective medicines from the lab Neulasta® (pegfi lgrastim) to the manufacturing plant to patients. NEUPOGEN® (Filgrastim) Amgen therapeutics have changed the practice of medicine, helping millions of Nplate® (romiplostim) people around the world in the fi ght against ® cancer, kidney disease, rheumatoid Sensipar (cinacalcet) arthritis and other serious illnesses, and so Vectibix® (panitumumab) far, more than 15 million patients worldwide have been treated with Amgen products. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. 0405 06 07 08 0405 06 07 08 0405 06 07 08 0405 06 07 08 Total revenues “Adjusted” earnings Cash fl ow from “Adjusted” research and ($ in millions) per share (EPS)* operations development (R&D) expenses* (Diluted) ($ in millions) ($ in millions) 2008 $15,003 2008 $4.55 2008 $5,988 2008 $2,910 2007 14,771 2007 4.29 2007 5,401 2007 3,064 2006 14,268 2006 3.90 2006 5,389 2006 3,191 2005 12,430 2005 3.20 2005 4,911 2005 2,302 2004 10,550 2004 2.40 2004 3,697 2004 1,996 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP fi nancial measures. See page 8 for reconciliations of these non-GAAP fi nancial measures to U.S. Generally Accepted Accounting Principles (GAAP). Letter to Stockholders Amgen’s most important news in 2008 was our progress in advancing our pipeline. Dear Stockholders, 2008 was a good year for Amgen, its stockholders and the We have now fi led for marketing approval in the United States, patients we serve. Amgen’s most important news in 2008 Europe and Canada in two indications for denosumab: was our progress in advancing our drug development prevention and treatment of postmenopausal osteoporosis pipeline. In July we received the clinical data from the pivotal and cancer treatment-induced bone loss. We look forward denosumab postmenopausal osteoporosis trial, which to working with the regulatory agencies in these markets. compared denosumab with placebo in assessing fracture Later in 2009 and in 2010, we expect to receive additional risk. Approximately 7,800 patients were tested over a data on denosumab’s ability to treat and prevent bone three-year period. The results were encouraging in both metastases in cancer patients. efficacy and safety: statistically significant reductions in fractures compared with placebo, with a rate of adverse Denosumab is the direct result of major discoveries in events similar to placebo. Doctors and experts who have bone biology made by Amgen scientists. It works in an reviewed the data are excited and optimistic that this entirely different way from any other available bone loss twice-a-year injection could bring new hope and benefi t therapies. In two phase 3 studies, denosumab provided to large numbers of patients. greater gains in bone density than those achieved with Amgen 2008 Annual Report 1 alendronate treatment. Osteoporosis affects an estimated Developing these medicines is a diffi cult, expensive and risky 200 million people worldwide. Many of these are women process, but delivering for patients makes it all worthwhile. over age 50, and hip and vertebral fractures are serious problems in this group. We think denosumab, once approved There were other accomplishments in 2008 that we feel and used in ways consistent with the approved label, has the good about. Through tight cost management and focused potential to help many people, and we are gathering the execution, we grew revenue and adjusted earnings per share* relevant data to demonstrate a clear and compelling value in the face of continued erosion in our anemia franchise. proposition. We have spent 15 years working on this important And we met our fi nancial objectives without compromising new medicine, from doing the fundamental research to investment in our pipeline. Our international business turned developing manufacturing processes that we expect will in a solid performance, as did our worldwide Neulasta® result in exceptionally effi cient and high-quality production and NEUPOGEN® franchise and Sensipar®/Mimpara®. capabilities. The denosumab story is Amgen at our best. We prevailed at trial in the patent case for erythropoietin against Roche. In Europe, we met the fi rst biosimilars challenge Another significant event in 2008 was the approval of in our history: as several biosimilar competitors, along with Nplate® (romiplostim). Nplate® has been approved in peg-EPO, entered European markets, Amgen’s innovative the United States, Europe and Australia for use in adult medicines continued to be chosen by patients and physicians. patients with chronic immune thrombocytopenic purpura. We introduced six new molecules into human trials in 2008 ITP patients suffer from low platelet counts, live with the and shared promising new data for several of our investigational possibility of dangerous excessive bleeding from even a cancer therapies. Amgen’s manufacturing network improved minor injury, and have few long-term treatment options. efficiency and productivity while maintaining the highest At our Annual Meeting of Stockholders last May, I met a quality standards. man enrolled in a clinical trial of Nplate® who told me how this medicine made a profound difference in his life. His We also remain committed to serving the broader community story, and the shared experience of the patients who have and environment. As our business expands to new customers benefi ted from Amgen’s medicines, serve as a constant and regions, the Amgen Foundation, our philanthropic arm, motivation for all of us at Amgen as we work to better expands to respond to needs in our communities. In 2008, understand biology and deliver innovative new medicines. the Amgen Foundation announced the expansion to Europe of *Non-GAAP fi nancial measure. See reconciliation on page 8. 2 Amgen Scholars, our groundbreaking $27.5 million program is in crisis, and there are many factors beyond our control. that gives undergraduate students opportunities to do Despite these uncertainties, we enter 2009 focused on what we hands-on scientifi c research with eminent faculty at leading need to do, prepared for whatever the year brings and confi dent universities. Through our philanthropy and our business, we have the team, resources and strategy to succeed. we are intensifying our actions to help solve complex issues of access to medicines and to connect patients to the information, assistance and support they need. Last year our stock was one of the best performers on the S&P 500, rising 24 percent as the S&P 500 fell 38 percent KEVIN W. SHARER in the midst of the worst fi nancial crisis since the Great Chairman and Chief Executive Offi cer Depression. This performance was welcome news to our February 6, 2009 stockholders following a very diffi cult 2007. We feel fortunate to have a strong and vital business that is performing well, with a meaningful mission and good prospects for the future. To all of our staff members worldwide, thank you for your conviction, your efforts, your leadership, and your results. Over the years we have had a consistent strategy, and I am convinced our strategy will serve us well in 2009 and beyond. Amgen’s strategy includes putting patients fi rst, focusing solely on human therapeutics, investing heavily in our pipeline, fostering a high-performing and diverse workforce grounded in our values, remaining independent by delivering superior value to our stockholders, and striving to be a leader in every therapeutic area we serve. We know that the environment for our industry is diffi cult, the economy Amgen 2008 Annual Report 3 2008 Highlights Products • Nplate® (romiplostim) received regulatory approval in the • Amgen submitted a Biologics License Application (BLA) United States and Australia for treatment of adult chronic to the FDA for denosumab for approval in two indications: immune thrombocytopenic purpura (ITP) in patients who have the treatment and prevention of postmenopausal osteoporosis had an insuffi cient response to corticosteroids, immunoglobulins, in women and the treatment and prevention of bone loss in or splenectomy. Nplate®, the first U.S. Food and Drug patients undergoing hormone ablation for either prostate or Administration (FDA)-approved platelet producer, is a peptibody breast cancer. The BLA submission contained data from six protein. In February 2009, Nplate® was approved in Europe for phase 3 trials involving more than 11,000 patients. the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments. • Amgen published a biomarker analysis from a pivotal phase 3 randomized, controlled clinical trial that affirms • Sensipar® (cinacalcet), Amgen’s treatment for secondary the link between wild-type KRAS in tumors and the effi cacy hyperparathyroidism in chronic kidney disease patients on of treatment with Vectibix® in patients with metastatic hemodialysis, reached $1 billion in U.S. cumulative net sales colorectal cancer. after four years on the market. • The EVOLVE (EValuation Of Cinacalcet Therapy to Lower • European regulators approved the extension of the marketing CardioVascular Events)™ trial reached its enrollment goal of authorization for Mimpara® (cinacalcet) in the European Union 3,800 patients. The EVOLVE trial is a phase 3 randomized, for the reduction of hypercalcemia in patients with primary double-blind, placebo-controlled study, the largest of its kind hyperparathyroidism for whom parathyroidectomy would be in the dialysis population. indicated on the basis of serum calcium levels (as defi ned by relevant treatment guidelines), but in whom parathyroidectomy Philanthropy, Community and Environment is not clinically appropriate or is contraindicated.
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