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Amgen 2007 Annual Report and Financial Summary

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Amgen 2007 Annual Report and Financial Summary Amgen 2007 Annual Report and Financial Summary Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 www.amgen.com © 2008 Amgen Inc. All rights reserved. MC39651 Amgen at a Glance Sector: Biotechnology Core business: Human therapeutics Products: Aranesp® (darbepoetin alfa) Enbrel® (etanercept) EPOGEN® (Epoetin alfa) Kepivance® (palifermin) Kineret® (anakinra) Amgen Mission Neulasta® (pegfilgrastim) Amgen is a biotechnology To serve patients NEUPOGEN® (Filgrastim) pioneer with a mission to Sensipar® (cinacalcet HCl) Vectibix™ (panitumumab) serve patients. Amgen Values Be science-based Compete intensely and win Create value for patients, staff and stockholders Be ethical Trust and respect each other Ensure quality Work in teams Collaborate, communicate 03 04 05 06 07 03 04 05 06 07 03 04 05 06 07 03 04 05 06 07 Total revenues “Adjusted” earnings Cash flow from “Adjusted” research and and be accountable ($ in millions) per share (EPS)* operations ($ in millions) development (R&D) expenses* ($ in millions) 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 2003 8,356 2003 1.90 2003 3,567 2003 1,621 * “ Adjusted” EPS and “adjusted” R&D expenses are non-GAAP financial measures. See page 6 for reconciliations of these non-GAAP financial measures to U.S. Generally Accepted Accounting Principles (GAAP). Amgen 2007 Annual Report 1 Letter to Stockholders Dear Stockholders, 2007 was not the year we expected. Amgen was challenged Then in the first quarter of 2007 a clinical trial, exploring the use as never before across a broad front. Shareholder value of our anemia medicine Aranesp® in cancer patients with anemia suffered, top and bottom line growth slowed, and we found related to their underlying disease, revealed a new safety it necessary to restructure and shrink the organization. concern in a population not indicated for this medicine. While this trial properly and appropriately explored an off-label use of There is another story about 2007 for Amgen that is equally Aranesp®, its results and those of several other off-label studies true, and one I want to expand upon here without at all led to more restrictive labeling and stricter reimbursement distancing ourselves from the difficult aspects of the year. limits in the U.S. Medicare program. At the beginning of 2007, we were still enjoying a long Amgen responded to new safety data as they became period of unprecedented growth. From 2001 to early 2007, known to us by making appropriately prompt and transparent we grew adjusted earnings per share (EPS)* and revenue disclosures of the relevant facts to regulatory authorities, at compound annual growth rates of 27 and 29 percent, physicians and patients. We put patients first, then dealt respectively;** our share price approached an all-time with the business consequences. That’s what shareholders high; the pipeline expanded dramatically; we successfully expect and what we demand of ourselves. completed and delivered on what was at the time the industry’s largest acquisition (Immunex) and two other major The safety challenges of 2007 drove a dramatic reduction acquisitions (Tularik and Abgenix); and the organization grew in planned revenue and profit and changed the financial to more than 20,000 staff operating in 35 countries. trajectory of the company. Amgen quickly adapted to this *See reconciliation on page 6. **From January 1, 2001, to December 31, 2006. 2 Amgen 2007 Annual Report new reality, kept focused on our mission to serve patients, Amgen has always been committed to meeting the very and demonstrated that we are resilient and can take a punch. highest standards with regard to patient safety, and we are We met the needs of patients and providers for our currently reinforcing those standards in every area of our organization. approved medicines, advanced the pipeline, successfully In practical terms that means continued full disclosure of defended our intellectual property, and positioned ourselves safety-related concerns; early, robust, and ongoing discussions to deliver strong financial results in the future. with regulators; aggressive and extensive clinical trial-based safety exploration and post-approval safety surveillance; and Before detailing our 2007 accomplishments, I want to share effective two-way dialogues with providers and patient groups. my thinking about the environment we face and how we are Our mission is to serve patients; our commitment to patient meeting the challenges and demands of this new world. safety is unwavering. Physicians, patients and regulators have always understood that no medicine is perfect and that benefit must always be I am very proud of our accomplishments in the face of our balanced against risk. There has also been a recognition recent challenges. It is in tough times that companies find out that while pre-approval clinical trials may be well designed what they are made of, and 2007 brought out exceptional and conducted, we often learn more about medicines as efforts by Amgen staff worldwide. they are more broadly used over the years in larger patient populations. Recently, a combination of factors has increased • We demonstrated that we take very seriously our the focus on the risk dimensions of medicines, and the FDA responsibility and obligation to disclose safety information and other regulators have responded. There is more focus quickly and transparently to regulatory authorities, on safety and greater urgency around ensuring that safety physicians and patients. concerns are quickly and fully disclosed, thoroughly explored and considered, and aggressively recognized in setting • We listened carefully to regulatory authorities, physicians payment and usage policy. and patient groups regarding our anemia medicines and worked with them to seek the best answers for patients. The implication for Amgen and our industry colleagues is that we must focus even more intently on safety risk management. • We restructured the company. We cut operating expenses, dramatically reduced planned capital expenditures, and took other swift and decisive actions to protect EPS and fund and advance the pipeline. Despite the unexpected reduction in operating income, we delivered 2007 adjusted EPS* of $4.29, very close to the low end of our original guidance. Dennis Fenton, Ph.D., • We successfully defended our intellectual property rights Retires After 25 Years against Roche. Following a jury trial in the U.S. Federal In 2007, Dennis Fenton announced his decision to retire—a District Court in Boston, Roche’s peg-EPO product was declaration that profoundly affected the thousands of Amgen found to infringe 10 of Amgen’s U.S. patent claims for staff who know firsthand Dennis’ energy and passion for our erythropoietin alfa. mission to serve patients. Over the years, Dennis worked in nearly every function at Amgen. After starting as a research • Product sales outside of our ESA franchise grew 14 percent. scientist, he helped to create Amgen’s Process Development Enbrel®, Neulasta® and NEUPOGEN® grew, Sensipar® thrived, and Manufacturing organizations. At various times he led and our international business delivered great results. Sales and Marketing, Research, Information Systems, Human Resources, and most recently Operations. Dennis helped build the world’s most reliable, efficient and skilled biotechnology • Even in the midst of a challenging restructuring, our manufacturing organization to ensure that Amgen delivers vital manufacturing operations group turned in a stellar performance, medicines to “every patient, every time.” Dennis, we’ll miss you, with an outstanding safety record and highly successful and we wish you and your family many happy times ahead. compliance-related inspections. Most importantly, we delivered reliable supply for patients. *See reconciliation on page 6. 3 2007 Highlights • We had an enormously productive year in research and • Submitted applications in the United States, European development, with unprecedented expansion of our early Union, Australia and Canada for NplateTM (romiplostim) for pipeline. We introduced 13 new molecules into development, the treatment of adult chronic immune thrombocytopenic including two phase 2 candidates from acquisitions of Ilypsa purpura (ITP), an autoimmune bleeding disorder. and Alantos. • Received conditional marketing authorization from the • We advanced our mid- to late-stage pipeline, including European Commission for VectibixTM (panitumumab) in the nine phase 2 programs that we hope to progress towards European Union for use as a monotherapy in patients with late-stage clinical trials. refractory metastatic colorectal cancer with non-mutated (wild-type) KRAS genes. • We also moved forward with denosumab, our novel monoclonal antibody we are developing for postmenopausal • Acquired Alantos and Ilypsa, two private companies osteoporosis, bone metastases, and other serious bone loss developing drugs for the treatment of diabetes and conditions. Early this year, we announced promising findings inflammatory diseases and for renal disorders, respectively. from our head-to-head study comparing denosumab to Both acquisitions added novel clinical programs to alendronate in postmenopausal women with low bone mineral Amgen’s pipeline. density. We look forward to communicating more study results as we have them, including important phase 3 fracture data we • Presented clinical data on investigational and marketed expect to review later this year. medicines, including first-time clinical data for five phase 1 oncology programs; phase 2 and phase 3 data for • We recently announced an exciting new partnership in denosumab, a late-stage investigational molecule for the Japan with Takeda, who will acquire rights in Japan to potential treatment of a variety of bone loss conditions; VectibixTM and Japanese development rights to as many as and new biomarker data for VectibixTM. 12 additional molecules from Amgen’s pipeline. In return, we receive a substantial upfront fee, success-based milestones • Entered a collaboration and license agreement for the and royalties, which we will use to advance our pipeline globally.
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