Our Mission: To Serve PatientsAbout Amgen Amgen Values ProductsAmgen discovers, develops, manufactures, and delivers innovative Be science-based Aranesp® (darbepoetin alfa) ®human therapeutics. A biotechnology pioneer since 1980, Amgen was Compete intensely and win Enbrel (etanercept) ®one of the first companies to realize the new science’s promise by Create value for patients, EPOGEN (epoetin alfa) ®bringing safe, effective medicines from lab to manufacturing plant to staff, and stockholders Neulasta (pegﬁlgrastim) ®patient. Amgen therapeutics have changed the practice of medicine, Be ethical NEUPOGEN (Filgrastim) ®helping millions of people around the world in the fight against Trust and respect each other Nplate (romiplostim) ®cancer, kidney disease, rheumatoid arthritis, bone disease, and other Ensure quality Prolia (denosumab) ® ®serious illnesses. With a deep and broad pipeline of potential new Work in teams Sensipar /Mimpara (cinacalcet) ®medicines, Amgen remains committed to advancing science to Collaborate, communicate, Vectibix (panitumumab) ®dramatically improve people’s lives. and be accountable XGEVA (denosumab) 2011 $15,582 2011 $3,116 2011 $5,119 2011 $5.33 2010 15,053 2010 2,773 2010 5,787 2010 5.21 2009 14,642 2009 2,739 2009 6,336 2009 4.91 2008 15,003 2008 2,910 2008 5,988 2008 4.55 2007 14,771 2007 3,064 2007 5,401 2007 4.29 07 08 09 10 11 07 08 09 10 11 07 08 09 10 11 07 08 09 10 11Total revenues ($ in millions) “Adjusted” research and development (R&D) Cash ﬂow from operations ($ in millions) “Adjusted” earnings per share (EPS)* expenses* ($ in mil ions)* “Adjusted” earnings per share and “adjusted” R&D expenses are non-GAAP ﬁnancial measures. See page 12 for reconciliations to U.S. generally accepted accounting principles (GAAP).
Amgen 2011 Annual Report 1 Letter to Stockholders Kevin W. Sharer, Chairman and Chief Executive Officer Robert A. Bradway, President and Chief Operating OfficerDear Stockholders,We’re proud of what Amgen accomplished in Neulasta®/NEUPOGEN®, the strength of new2011 — a solid year — and the outlook for 2012 is products Prolia® and XGEVA®, and the success Our Strategic Approacheven stronger. In the ﬁrst half of 2011, we outlined of Nplate®, Sensipar®/Mimpara®, and Vectibix®. • Bring medicines to market that advanceour strategy and long-term growth objectives That growth was partially offset by the decline treatment of serious illness ® ®at our business review meeting with investors. in sales of Aranesp and EPOGEN .We also discussed our plans designed to return • Make signiﬁcant and sustained investmentsigniﬁcant capital to you, our stockholders. Through We were very pleased to receive marketing approval in R&D and participate in a wide range ofstrong execution in 2011, Amgen delivered solid for XGEVA® in the European Union in 2011. We therapeutic areasoperating performance for the year and made entered the market with a novel therapy to treatgood progress toward our objectives. an important medical need —the prevention of • Reliably manufacture products with the skeletal-related events in adults with bone metastases highest quality and lowest costDespite another challenging year for our industry, from solid tumors — and we have seen growthwe grew revenues 4 percent and increased in the number of patients being treated in the • Expand our operating footprint into emergingadjusted earnings per share* 2 percent, and we European Union as well as in the United States. markets and Japanhad approximately $5.1 billion in operating cash We continue to seek new approvals and indicationsﬂow. We ended 2011 energized by our momentum for this important medicine. • Manage our cost structure to grow earningsand conﬁdent that 2012 will be a year to accelerate ahead of revenuesAmgen’s growth. This is also a time of planned Also in 2011, we recorded our first full year oftransition as a new generation of leaders prepares sales of Prolia®, which achieved signiﬁcant growth. • Use capital wisely, maintain a strong balanceto take Amgen forward. Combined sales of Prolia® and XGEVA® exceeded sheet, and return signiﬁcant capital to stockholders $500 million in 2011. Amgen will continue workingWe know it won’t be easy to deliver on our mission to ensure that these innovative medicines reach • Sustain a strong social architecture thatto serve patients: We still face global macroeconomic the right patients. attracts the best staff and enables them topressures and new regulatory and reimbursement perform at the highest levelschallenges. However, Amgen is uniquely well Our Pipeline Is Advancingequipped to meet those challenges and provide We are committed to making critical investmentsinnovative therapies for more patients. in Amgen’s pipeline— one of the best in our industry. We’re focused on advancing six later-stage (phase 2We Delivered in 2011 and 3) programs for the treatment of serious illnessesAmgen’s 4 percent revenue increase in 2011 was such as melanoma, ovarian cancer, pancreatic ®driven by the solid performance of Enbrel and cancer, psoriasis, asthma, cardiovascular disease,* “Adjusted” earnings per share is a non-GAAP ﬁnancial measure. See page 12 for reconciliations to U.S. generally accepted accounting principles (GAAP).
2 Amgen 2011 Annual Report and postmenopausal osteoporosis. At a time when stock by way of a modiﬁed Dutch auction tender fast-growing markets — and we are making plans others in the industry have chosen to reduce their offer. We intend to buy back the remaining to enter Japan and South Korea. In Brazil, we investment in research and development (R&D), $5 billion under our board authorization through acquired Bergamo, our largest international we have afﬁrmed that we will continue investing open-market purchases. In 2012, we plan to acquisition to date, and we now have commercial, at approximately 18 to 20 percent of sales and continue aggressively returning capital to manufacturing, and clinical development expect to be at the upper end of that range this stockholders while retaining signiﬁcant strategic operations there. year. The strength of our pipeline is recognized by ﬂexibility to grow our business. others: In 2011 we received the Prix Galien USA Amgen also took important steps to capitalize on Award for Best Biotechnology Product — for Strategic Plans for Higher Growth the developing biosimilars market. In December denosumab (Prolia®/XGEVA® )— and the Best Our growth strategy includes more emphasis on 2011, we announced an agreement with Watson Biotechnology Pipeline ranking from both adding innovative medicines through business Pharmaceuticals to work on several cancer R&D Directions and Med Ad News magazines. development initiatives. In 2011, Amgen acquired antibody biosimilar products, which we expect BioVex for its molecule in development for to sell under a joint label. The pairing of Amgen’s Delivering More Stockholder Value malignant melanoma, a condition for which there 30 years of experience in biologics together with In April 2011, during a comprehensive business is a large unmet medical need. In January 2012, Watson’s substantial generics and specialty review where we shared our strategy, growth we announced plans to acquire biotechnology pharmaceutical experience and complementary objectives, and capital allocation plans, we outlined company Micromet, including the worldwide commercial and distribution capabilities represents our speciﬁc approach for increasing stockholder rights to blinatumomab, a promising new therapy great potential for worldwide patient access to value. This included implementing our ﬁrst-ever in phase 2 clinical trials for patients with relapsed these medicines. dividend— with the intent to increase it meaningfully or treatment-refractory acute lymphoblastic over time—and continuing our stock repurchase leukemia (ALL), a group that has exhausted all We continue expanding our competitive advantage program. We paid our ﬁrst quarterly dividend of other therapeutic options. Through this acquisition, in manufacturing by embracing new technologies $0.28 per share in September and in December Amgen will also gain Micromet’s talented R&D that will help grow and sustain our brands as we announced an increase in the dividend by 29 percent staff and its R&D facility in Munich, Germany, as face new competition. to $0.36. In October, the Board of Directors well as the proprietary bispeciﬁc T-cell engager authorized an increase in the Company’s stock (BiTE® ) technology, which has been clinically Our Next Generation of Leadership repurchase program to $10 billion, and we validated through the blinatumomab program Late last year, we announced changes to certain announced our intent to accelerate repurchases of and provides an innovative platform for future executive roles — including our own —as part our stock. This reflected our confidence in the clinical research. of a broader transition to Amgen’s next generation long-term value of the Company and the attractive of leadership. Roger Perlmutter, executive vice interest rate environment. In December, we In addition, Amgen took steps to develop a presence president, R&D, retired in February 2012, and completed the repurchase of $5 billion of our in Brazil, China, Russia, and Turkey — all of them Sean Harper became the new head of R&D. Roger Perlmutter Retires “Roger Perlmutter has been a superb head of R&D. It’s hard to imagine Amgen without him, and we are profoundly grateful to have had him as a partner, colleague, and friend. His contributions have been enormous, and millions of patients have beneﬁted — and will continue beneﬁting — from the work he led with his colleagues in R&D. In our view, Roger is the best head of R&D in his generation. We were lucky he was ours. His legacy may be most obvious in the pipeline and team he leaves, but his mark of excellence will extend far beyond them.” — Kevin Sharer
Amgen 2011 Annual Report 3 Longer-term Prospects for AmgenSean is well qualiﬁed for his new responsibilities Awards and Recognitiongiven the depth of his R&D experience at Amgen While the challenges ahead are real, we’re excitedduring the past 10 years and his background in about the future. Aging populations and a growing • Denosumab (Prolia® and XGEVA® ) receives thethe industry and as a physician. Michael Severino, number of patients needing new medicines create 2011 Prix Galien USA Award for Best Biotechnologyour former vice president, Global Development, opportunity. Amgen is strong and widely admired Product. Prolia® (denosumab) also receives Prixand a seasoned R&D executive with experience as a leader in our ﬁeld, and we have the resources Galien awards in Belgium and Germany, whereacross a wide range of therapeutic areas, will step necessary to chart our course scientifically and Nplate® (romiplostim) is also honored.into Sean’s former role as senior vice president, operationally. The objectives we are tackling requireGlobal Development and Corporate Chief Medical the right investments, and we will make them. • In the cover story entitled “Two Brands in One,”Ofﬁcer. We are also pleased to have Tony Hooper Med Ad News honors denosumab — Prolia® andjoin us as head of Global Commercial Operations. The staff of Amgen — more than 17,000 XGEVA® —as Best New Medicine.Tony is an experienced global business leader, worldwide — represent our competitive advantage.having lived on four continents and led commercial Their commitment to serve patients is unmatched. • Amgen receives Best Biotechnologyoperations in both mature and emerging markets. With our solid underlying fundamentals, our Pipeline ranking from both R&D DirectionsWith Sean, Tony, Michael, and Jon Peacock, our ﬁnancial strength, the position of our franchises, and Med Ad News.chief ﬁnancial ofﬁcer who joined Amgen in 2010, our scientiﬁc assets, and the quality of our team,we have strengthened our senior leadership Amgen is well positioned to treat more patients • Fortune once again lists Amgen as one of theteam’s international experience and capability globally, deliver added stockholder value, and most-admired drug companies.to help us navigate our entry into new markets make a meaningful contribution to society.worldwide. In the coming months, we will all • Amgen ranks ﬁfth among large biotech andwork together to make sure the leadership pharmaceutical companies and 16th overall intransition is seamless. The Scientist ’s list of Best Places to Work in Industry.Growth Should Accelerate in 2012 Kevin W. Sharer • Science lists Amgen as one of the topWe are confident 2012 will be a strong year Chairman and Chief Executive Ofﬁcer employers in the biopharmaceutical industry.for Amgen. We expect continued strength insales of Enbrel® (etanercept) and Neulasta® • Great Place to Work Institute ranks Amgen(pegﬁlgrastim), strong growth trends for Nplate® as the number two employer in Europe. In other ® ®(romiplostim), Sensipar /Mimpara (cinacalcet), Robert A. Bradway surveys, Amgen ranks among the top employersand Vectibix® (panitumumab), and increased President and Chief Operating Ofﬁcer in the Czech Republic, Poland, and Spain and as ®momentum for Prolia (denosumab) and the number one employer in Belgium and Greece.XGEVA® (denosumab). February 23, 2012Kevin Sharer Announces Plans to RetireOn December 15, 2011, Kevin Sharer, chairman and CEO, announced his plan to retire fromAmgen at the end of 2012. To facilitate an orderly transition process, Kevin will step down asCEO effective May 23, 2012, and remain as chairman of the Company’s Board of Directorsuntil December 31, 2012, at which time he will retire from the board and from the Company.Robert Bradway, currently president and chief operating officer, will become CEO onMay 23, 2012. It is the intention of the Board of Directors to elect Robert chairman of theboard when Kevin retires from that position at the end of 2012.
4 Amgen 2011 Annual Report Amgen Aims to Grow by Serving the Needs of More Patients Globally At Amgen, we aspire to be the world’s best human therapeutics company. To earn that distinction, we not only strive to deliver important new therapies to treat serious illnesses, but also to make our treatments available to more and more patients worldwide. Over the past four years, we’ve expanded our Brazilian distributor Mantecorp, reacquiring the • In a transaction that will help secure and commercial footprint from 35 to more than local rights to Mimpara® (cinacalcet), Vectibix® expand our global supply of medicines, Amgen 50 countries. By 2015, we plan to be in 75 (panitumumab), and Nplate® (romiplostim). Together, acquired a state-of-the-art manufacturing plant countries through Amgen afﬁliates, partnerships, these deals provide Amgen with a diverse and local in Dun Laoghaire, Ireland. The facility has space and distribution agreements. product portfolio and a strong country organization for future expansion to meet a growing worldwide to guide our growth in this thriving market. demand for our therapeutics. Global expansion plays an increasingly central role in our business strategy. Emerging markets are • To build on our existing business in Russia, Globalization of Clinical Research poised to provide a large share of the growth in we signed our ﬁrst partnership, contracting with Clinical research is important to Amgen. Nearly global demand for new therapies, and we aim to PharmEco LLC for the packaging of Aranesp® 70 percent of patients enrolled in our clinical trials ensure that more patients in those countries have (darbepoetin alfa), Mimpara®, and Nplate®. We are now in countries outside the United States. access to our medicines. Strong performance in are considering further partnerships to expand Investigators in Central and Eastern Europe and the those countries will help Amgen diversify its revenue our footprint in Russia in the coming years. Nordic countries played a lead role in developing base and fund our pipeline and future innovation. Prolia® (denosumab) and XGEVA® (denosumab). • In Turkey, we reacquired all our product rights Emerging markets such as Mexico, Turkey, and Amgen’s Brand and Core Assets Open Doors from our distributor partner and formed a local India also contribute a steadily growing share of our A unique alignment of strengths has helped Amgen afﬁliate in this important growing market. clinical trial sites and patients. The globalization of accelerate Amgen’s entry into new markets. Our our clinical research has also helped us understand reputation as a biotechnology leader precedes • In the Middle East and Africa, an area that we the needs in countries important to Amgen’s future. us, and countries seeking to build a stronger entered in 2006, we continue to enter new countries biotech sector are attracted by Amgen’s R&D and have significant sales growth of our core With our growing international presence, we and manufacturing capabilities. These assets products that have established share leadership. continue to strive not only to deliver important have accelerated the progress of Amgen’s global new therapies for the treatment of serious expansion effort, which achieved several major • In Asia, we launched our ﬁrst clinical trial for illnesses, but also to make those treatments milestones in 2011, including the following: registration in China. In Japan, the world’s available to more patients around the world. second largest market for biopharmaceuticals, • In Latin America, we acquired Bergamo to establish we continue our several important partnerships a signiﬁcant commercial presence in Brazil. In addition, across our product portfolio. we purchased the specialty business of our former Amgen completed the acquisition of Bergamo in April 2011. Amgen’s business operations in Brazil now include R&D, manufacturing, and commercial operations. From left, the transportation leader and the plant manager, shown outside Bergamo facilities in Brazil. Amgen’s facility in Dun Laoghaire, Ireland, which specializes in aseptic freeze-dry products and liquid-vial filling, was purchased in May 2011.
Amgen 2011 Annual Report 5 Our Pipeline Modalities: Antibody Cancer Immunotherapy Oral/Small Molecule Protein/Peptibody Phase 1 Phase 2 Phase 3 Approved AMG 139 AMG 145 AMG 386 Aranesp® (darbepoetin alfa) Inﬂammatory diseases Hypercholesterolemia Ovarian cancer Anemia caused by concomitant chemotherapy in nonmyeloid malignancies AMG 157 AMG 151 Aranesp® (darbepoetin alfa) Asthma Type 2 diabetes Anemia in heart failure Aranesp® ® Anemia of chronic kidney disease AMG 167* AMG 386 Aranesp Bone-related conditions Various cancer types Myelodysplastic syndromes Enbrel® (etanercept) Ankylosing spondylitis AMG 181 AMG 785* Ganitumab (arthritis of the spine) Inﬂammatory diseases Bone-related conditions, including Pancreatic cancer postmenopausal osteoporosis and ENBREL fracture healing Motesanib § Chronic moderate-to-severe AMG 208 plaque psoriasis Various cancer types First-line non-small cell AMG 827 lung cancer Inﬂammatory diseases ENBREL AMG 319 Moderate-to-severe polyarticular Prolia® (denosumab) juvenile idiopathic arthritis Hematologic malignancies AMG 888 † Male osteoporosis Various cancer types ENBREL AMG 337 Sensipar®/Mimpara® Moderate-to-severe rheumatoid Various cancer types (cinacalcet) arthritis Ganitumab Various cancer types Cardiovascular disease in AMG 557 patients with secondary ENBREL Systemic lupus erythematosus Nplate® (romiplostim) hyperparathyroidism and chronic Psoriatic arthritis Chemotherapy-induced kidney disease undergoing AMG 579 thrombocytopenia maintenance dialysis EPOGEN® (epoetin alfa) Neuroscience Anemia of end-stage renal disease Omecamtiv mecarbil ‡ Sensipar®/Mimpara® Heart failure Post renal transplant Mimpara® (cinacalcet) (EU) AMG 729 Autoimmune diseases Hypercalcemia of primary Talimogene laherparepvec hyperparathyroidism (intractable) Prolia® (denosumab) Malignant melanoma AMG 745 Rheumatoid arthritis Neulasta® (pegﬁlgrastim) Muscle-wasting disorders Vectibix® (panitumumab) Chemotherapy-induced febrile Rilotumumab First- and second-line colorectal neutropenia AMG 747 Various cancer types cancer (U.S.) Neuroscience NEUPOGEN® (Filgrastim) Vectibix® (panitumumab) XGEVA® (denosumab) Delay or prevention of bone Neutropenia (multiple indications) Locally advanced head and AMG 761 neck cancer metastases in breast cancer Asthma Nplate® (romiplostim) ® XGEVA® Adult chronic immune XGEVA (denosumab) thrombocytopenic purpura AMG 780 Giant cell tumor of the bone Delay or prevention of bone Various cancer types metastases in prostate cancer Prolia® (denosumab) Bone loss induced by hormone AMG 811 ablation therapy in breast cancer Systemic lupus erythematosus or prostate cancer AMG 820 Prolia® Various cancer types Postmenopausal osteoporosis AMG 876 Sensipar®/Mimpara® Type 2 diabetes (cinacalcet) Hypercalcemia of parathyroid carcinoma AMG 900 Various cancer types Sensipar®/Mimpara® Secondary hyperparathyroidism in end-stage renal disease Sensipar® (U.S.) Severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy Vectibix® (panitumumab) (EU) First- and second-line* These product candidates are being developed in collaboration with UCB. colorectal cancer† This product candidate is being developed in collaboration with Daiichi Sankyo. Vectibix®‡ This product candidate is being developed in collaboration with Cytokinetics, Inc. Metastatic colorectal cancer with§ This product candidate is being developed in collaboration with Takeda and Millennium: The Takeda Oncology Company. disease progression on or following standard chemotherapyThis chart shows selected clinical programs and molecules in Amgen’s development pipeline as of February 10, 2012, and is qualiﬁed by the information presented in Amgen’s most XGEVA® (denosumab)recent Form 10-K, which is included as part of this publication. Amgen’s product pipeline will change over time as programs and molecules move through the drug development process, Prevention of skeletal-relatedincluding progressing to market or failing in clinical trials, due to the nature of the development process, and Amgen disclaims any duty to update this information. For more information on events in patients with advancedour pipeline, visit www.amgen.com or refer to Amgen’s most recent Form 10-K. For important safety information about Amgen’s approved, marketed, or commercially available medicines, malignancies involving bonevisit www.amgen.com for links to the product websites.
6 Amgen 2011 Annual Report The Next Wave: A Look Inside Amgen’s New Drug Pipeline Amgen’s pursuit of pioneering science has always been driven by the goal of providing truly novel therapies for patients with serious illnesses. We believe that a deep understanding of human biology is the key to helping patients with needs that lie beyond the reach of current therapies. This science-based approach has given Amgen by blocking PCSK9. In a phase 1 study, a single density (BMD), AMG 785 significantly increased highly innovative products, and it also accounts for dose of AMG 145 lowered LDL levels by 64 percent BMD at the lumbar spine. It is also being studied the breadth of potential ﬁrst-in-class therapeutics for approximately one month. Amgen has started in fracture healing. in our pipeline. a large phase 2 program to evaluate AMG 145 as both a stand-alone agent and a combination Turning a Virus from an Enemy into an Ally Notable examples include AMG 145, a novel therapy with statins. One major goal is to investigate Talimogene laherparepvec is a cancer cholesterol-lowering agent that could redefine whether PCSK9 inhibition can work synergistically immunotherapy, a new modality for targeting treatment targets in high-risk patients; AMG 785 with statins to achieve reductions in LDL that are solid tumors and their metastases. Pioneered (also known as CDP7851), a sclerostin antibody well below those attainable with current therapies. by Amgen’s BioVex subsidiary, this experimental with the potential to build new bone; and talimogene therapy is a genetically engineered herpes simplex GM-CSF laherparepvec, formerly known as OncoVEX , Insights from genetics also led to the discovery of type 1 virus that is inactive in normal cells but able which has shown promise in metastatic melanoma. sclerostin, a key regulator of bone growth. Scientists when injected to selectively replicate in and rupture at Celltech (now part of UCB) discovered this protein local tumor cells and distant uninjected tumors. Translating Genetic Insights by studying patients with sclerosteosis, a rare genetic The modiﬁed virus also expresses the human gene into New Medicines disorder marked by abnormally thick bones. Amgen’s for GM-CSF, which heightens the body’s immune AMG 145 aims to benefit patients with high own expertise in bone helped form the basis for response to tumors and primes T cells to hunt cholesterol who can’t take statins to lower their risk a co-development partnership, which resulted in down and attack distant tumor metastases. of disease or can’t reach their treatment targets on AMG 785, a humanized monoclonal antibody that statins alone. The science behind this novel agent is designed to inhibit sclerostin. In a phase 2 study of patients with metastatic includes genetic studies, which revealed that people melanoma, talimogene laherparepvec produced lacking a protein called PCSK9 have low levels of If successful, this novel investigational product encouraging results. There were both evidence LDL cholesterol and a very low risk of heart disease. could complement antiresorptive therapies like of activity in tumors directly injected with this ® Amgen scientists helped elucidate PCSK9’s structure Prolia (denosumab). Antiresorptives reduce fracture agent and a secondary immune response and function and helped show how that protein risk by preventing further bone loss and increasing against uninjected skin and visceral metastases. boosts LDL levels by degrading the receptors that the density of existing bone. By contrast, anabolic A larger, phase 3 study is now under way to remove LDL from the bloodstream. agents like AMG 785 could actually build new conﬁrm those ﬁndings. bone in patients who have already experienced AMG 145 is a fully human monoclonal antibody substantial loss of bone mass. In a phase 2 study that aims to increase the number of LDL receptors of postmenopausal women with low bone mineral Amgen launched New Insights in Bone Biology, a multimedia website featuring scientific animation that brings to life the dynamic environment concealed within the human skeleton. For a virtual tour, visit www.bonebiology.amgen.com.
Amgen 2011 Annual Report 7 Clinical and Regulatory Milestones Upcoming Pipeline • Vectibix® (panitumumab) was approved in the European Union as a ﬁrst-line treatment in Milestones combination with FOLFOX in patients with wild-type KRAS metastatic colorectal cancer and as a In 2012, Amgen expects to deliver important second-line treatment with FOLFIRI in patients who have received ﬁrst-line ﬂuoropyrimidine-based results for several potential new therapies chemotherapy (excluding irinotecan). in our pipeline. • In a large extension study, postmenopausal women with osteoporosis taking Prolia® (denosumab) The anticipated milestones include: for up to six years continued to show improvements in bone mineral density, with a safety proﬁle similar to that observed in the original, three-year fracture study. • Announcement of data from phase 2 studies of AMG 145 in patients with high levels of • Prolia® received FDA approval for use in women at high risk for fracture due to adjuvant aromatase LDL cholesterol. inhibitor therapy for breast cancer and in men at high fracture risk due to androgen deprivation therapy for nonmetastatic prostate cancer. • Detailed phase 2 results for AMG 785 in women with postmenopausal osteoporosis • XGEVA® (denosumab) was approved in the European Union for the prevention of skeletal-related and low bone mineral density. Positive events in adults with bone metastases from solid tumors. top-line results were announced in 2011. • Results of a phase 3 study published in The Lancet showed that XGEVA® improved median bone • Interim data from the phase 3 study of cancer metastasis-free survival by 4.2 months in men with nonmetastatic castration-resistant prostate cancer. immunotherapy talimogene laherparepvec in This study was the ﬁrst to demonstrate that targeting the bone microenvironment prevents bone patients with metastatic melanoma. metastasis in men with prostate cancer. • Results of the E.V.O.L.V.E.™ study, which • Rilotumumab administered once every three weeks in combination with traditional chemotherapy aims to demonstrate that Sensipar® (cinacalcet) appeared to improve response rates, progression-free survival, and overall survival in patients with improves long-term cardiovascular outcomes in gastric cancer and may be especially effective in patients with tumors that highly expressed the patients with secondary hyperparathyroidism. receptor for hepatocyte growth factor, rilotumumab’s target.Prof. Ingo J. Diel, M.D.“Patients with bone metastases can now beneﬁt from innovative treatment with denosumab, which was grantedits European Union marketing authorization in July 2011. Publication of the outcome of the phase 3 studies hashighlighted the signiﬁcant beneﬁt of reducing skeletal events.” — Prof. Ingo J. Diel, M.D., of the Center for GynecologicalOncology (SPGO-Mannheim), is head of the German Osteooncological Society and has been an investigator in thephase 3 trial of denosumab versus zoledronic acid to prevent skeletal-related events in patients with breast cancerwho have metastatic bone disease.
8 Amgen 2011 Annual Report Putting Patients First with Our Products, Programs, and Partnerships At Amgen, our work revolves around our mission to serve patients. Amgen therapeutics have reached more than 22 million people around the globe in their ﬁght against many diseases, including cancer, kidney disease, rheumatoid arthritis, and bone disease. From our innovative therapies to our growing advises patients and caregivers on how to assess started OsteoLink, the first social network for network of partnerships, we strive to expand and help lower infection risk. people in Europe and Australia with osteoporosis. support of and the options available to patients Amgen and GlaxoSmithKline are lead co-sponsors with serious illnesses. In 2011, we made good • Amgen became a founding sponsor of ON THE LINE, of the new network, which makes it easier for on that core commitment with new product a new prostate cancer awareness program in the patients, family members, and caregivers to share approvals (see page 7), important collaborations, United States that harnesses the influence of experiences and insights, ﬁnd credible information and signiﬁcant programs. sports celebrities to help men become more about osteoporosis, and learn from one another. aware of their risk factors and their options for Partnerships to Help and Educate Patients diagnosis and treatment. • Award-winning actress Blythe Danner teamed up • While battling cancer is hard enough, some with Amgen to launch Act 2 Reduce Fractures™, ® cancer treatments heighten the risk of serious • Amgen’s Breakaway from Cancer a campaign in the United States to promote infections by decreasing white blood cell counts. initiative launched an enhanced website, Prolia® (denosumab) as an option for treating Thousands of patients are hospitalized in the United www.breakawayfromcancer.com, that gives cancer osteoporosis in women after menopause who States for chemotherapy-related infections every patients, survivors, and caregivers essential resources are at high risk for fracture. year. Amgen hopes to help lower that toll through they need to help them maneuver through today’s a partnership with the CDC Foundation, a nonproﬁt complicated maze of online information. • To help patients, consumers, and healthcare organization that connects the Centers for Disease professionals in their discussions about the safe Control and Prevention with the private sector to • Inspired by a 2010 survey that found that use of medicines, Amgen has launched a new build public health programs. In 2011, Amgen patients with osteoporosis are more concerned section on Amgen.com titled Information about provided funding and oncology expertise to the than physicians realized when it comes to learning Medicine Safety. CDC Foundation in support of the CDC’s Preventing about risks and getting advice on managing their Infections in Cancer Patients program, which disease, the International Osteoporosis Foundation On Course with Phil — Helping Others Manage Psoriatic Arthritis While Phil Mickelson is accustomed to meeting challenges on the golf course, he wasn’t sure how to deal with the joint stiffness and severe pain that threatened his golf career two years ago. “It was so intense, I could hardly get out of bed,” Phil recalls. “It was really scary. I saw a rheumatologist and got diagnosed with psoriatic arthritis. I was lucky to ﬁnd out it was very treatable.” Phil’s treatment program includes Enbrel® (etanercept), which has helped improve his overall health so he can return to the things that matter most to him. But remembering the uncertainty he faced when his symptoms ﬁrst struck, he decided to tell about his experience. “I want to motivate and empower others with chronic inﬂammatory joint and skin conditions to take action,” Phil says. In partnership with Amgen and Pﬁzer, Phil launched On Course with Phil, a disease education website, which also features Be Joint Smart, a new educational effort sponsored by the Arthritis Foundation and the National Psoriasis Foundation.
Amgen 2011 Annual Report 9Judy —XGEVA® (denosumab)Judy remembers just how devastating it was to ﬁnd out that her lung cancer had returned and had spread to herbones— and to learn about debilitating skeletal consequences such as fractures. That was more than two yearsago. Today, Judy’s outlook on life is more upbeat. “Cancer doesn’t deﬁne me,” says Judy (shown here with hergrandchildren). “I have a lot of optimism, and I feel like I’m making great progress.” Judy now tries to look atcancer as a disease she can manage with her doctor’s help. “My doctor had been talking about XGEVA® for a longtime, and he said I could go on it as soon as it was approved” for the prevention of skeletal-related events frombone metastases. “I’m so grateful for all the support from my family and my medical team.” Bill — Neulasta® (pegﬁlgrastim) As general sales manager of a Los Angeles radio station, Bill set the ambitious goal of staying on the job while he battled lymphoma. “My doctors made a point of telling me I’d get Neulasta® the day after each chemotherapy session,” says Bill. “They said it was a vital part of my treatment because it could help increase the white blood cells killed off by the chemo.” Bill managed to avoid getting an infection during his chemotherapy treatment.Dora — Prolia® (denosumab)A retired laboratory assistant from West Sussex, United Kingdom, Dora, now 78, was ﬁrst diagnosed with postmenopausalosteoporosis in 1998, as the result of a routine scan for osteoporosis. Prior to her diagnosis, Dora had already been aware ofosteoporosis because both her mother and grandmother had suffered from it. “My mother’s was particularly bad,” Dora says. “Shebecame doubled over and suffered from a restricted airway as a result. She then fractured her hip and died in hospital shortly after.”Dora is currently receiving twice-yearly injections with Prolia®. She had previously taken bisphosphonates but could not tolerate them.“I have ﬁve grandchildren and two great-grandchildren to keep up with, so it’s important to me to help keep my bones strong.” Elena — Mimpara® (cinacalcet) Elena, a piano teacher from Elektrostal, a small town in Russia east of Moscow, has had type 1 diabetes since she was 11. She has lost a leg to the disease and has been on dialysis for many years due to declining kidney function. Her kidney disease led to osteodystrophy (defective formation of the bone), which left her with hand deformities and pain that prevented her from teaching. In 2010, Elena’s physician prescribed Mimpara® to help balance her levels of parathyroid hormone, calcium, and phosphorus. With the help of her mother—her closest friend—Elena strives to remain active and enthusiastic. She has also resumed giving piano lessons to children. Her optimism in the face of serious health problems is an inspiration to her doctors and other patients.Rodney — Enbrel® (etanercept)Before rheumatoid arthritis (RA) attacked his joints, Rodney had been an extremely ﬁt amateur athlete. As his RA progressed, hewent from running and exercising regularly to walking with a cane on his bad days. “I had never experienced pain like that before,”Rodney says. After trying several treatments that didn’t work for him, Rodney’s doctor prescribed ENBREL. “I noticed my energycoming back,” recalls Rodney. “That’s when I thought, ‘I can start running again!’” Slowly but steadily, he regained his stamina.“I’m not the fastest runner, but I’m enjoying the activity. I really feel good about where I’m at now.”
10 Amgen 2011 Annual Report Making a Difference Where We Live and Work Amgen uses science and innovation to dramatically improve people’s lives, and our mission attracts a workforce committed to making a difference for others. Making that positive difference is ingrained in Amgen’s business and culture, and our philanthropic efforts form a vital part of what we do and stand for. Each year, thousands of Amgen staff generously University and the Science Learning Centre East of Amgen Scholars devote their personal time, talents, and funds to a England. The lab program brought the excitement variety of charitable organizations around the world. of biotechnology to more than 37,000 students in Europe Convene Amgen and the Amgen Foundation support staff this past school year. at Cambridge engagement in our communities in multiple ways, including helping staff ﬁnd local volunteer Other Ways Amgen, the Amgen Foundation, The Amgen Scholars Program provides the opportunities, earn monetary donations for their and Staff Made a Difference in 2011 opportunity for hundreds of talented undergraduates favorite charitable organizations, and receive • To support the Arthritis Foundation, Amgen to undertake research at top universities under recognition for their outstanding volunteer work. provided team and title sponsorship for two major the mentorship of leading academic scientists fund-raising events: the Amgen California Coast worldwide. Nearly 1,500 undergraduates from As the main vehicle for Amgen’s corporate Classic bicycle tour and the People’s Coast Classic more than 40 countries have now had the chance philanthropy, the Amgen Foundation also supports bicycle tour in Oregon. Amgen staff cycle in both to participate, and the latest data on program initiatives that enhance quality of care, advance events each year and consistently rank among the alumni show that 88 percent of those who’ve pioneering science education programs, and assist most productive fund-raisers. graduated from college are now pursuing advanced organizations providing vital community services. degrees or careers in scientiﬁc ﬁelds. • To help meet basic needs and bring vital health Inspiring the Next Generation of Scientists services to those impacted by natural disasters in In Europe, as in the United States, this unique • The Amgen Foundation provided a three-year, 2011, Amgen and the Amgen Foundation donated program features a symposium in which Amgen $1.5 million grant for the National Board for more than $1.2 million and worked with nonproﬁt Scholars share their research with others and in Professional Teaching Standards to help improve partners in Australia, Japan, Turkey, and the southern turn learn about drug discovery and development the effectiveness of science teaching and learning United States. from top industry and academic scientists. “Being in the United States. The grant supports science part of the Amgen Scholars Program has been teachers seeking National Board Certification, • Hundreds of Amgen staff members volunteer one of the most memorable and rewarding and it funds the formation of online professional in environmental education and cleanup activities experiences I’ve ever had,” says Gillian of Trinity development courses that will become available each year. In 2011, staff members from facilities College Dublin in Ireland. “I deﬁnitely feel that, to teachers across the nation. across North America removed more than two having taken part in the program, I have a clearer metric tons of debris through International idea of where I want to be.” • With support from the Amgen Foundation, the Coastal Cleanup events. Amgen–Bruce Wallace Biotechnology Lab Program expanded to communities in Boston and the United For more information, visit the Corporate Kingdom through new partnerships with Harvard Giving section at www.amgen.com. The 2011 European Symposium at the University of Cambridge brought together 74 undergraduates from 16 nations. To learn more about the Amgen Scholars Program, visit www.amgenscholars.com.
Amgen 2011 Annual Report 11 Sustaining Our Business, Reducing Our Environmental ImpactAmgen is committed to environmentally responsible operations, which includes using natural resourceswisely and considering our overall impact on the environment.Amgen has a twofold approach to conserving • Lowered the total manufacturing cost of one Our Culture ofresources and minimizing waste: First, we are of our molecules by 65 percent by using certainmaking progress against speciﬁc 2012 targets in waste-reducing and efficiency-enhancing Continuous Improvementthe areas of energy, carbon dioxide, waste, water, techniques of green chemistry. and Sustainabilityand U.S.-ﬂeet fuel efﬁciency, and second, we areworking to universally integrate environmental • Reduced the amount of printed materials Amgen’s success in environmental sustainabilitysustainability considerations throughout our business. we provide at trade shows by approximately is reliant on staff ingenuity and drive, combinedFrom the development of therapeutics to biologics 60 percent over the past few years by switching with a strong culture of continuous improvement,manufacturing to the construction of facilities, to digital materials. wherein teams assess ideas and respond by makingwe are designing processes to be cleaner, less improvements. One of many examples of staffresource-intensive, and more efﬁcient. We’ve been executing projects and initiatives that initiatives that are leading to a cumulative positive have resulted in signiﬁcant environmental beneﬁts impact involves our facility in Rhode Island:For example, among many gains, we have: and that have increased operational efﬁciencies. The site is conserving an extra 500,000 gallons Our focus on environmental sustainability is good of water a year after implementing a staff member’s• Achieved our energy, water, and waste recycling not only for the future of the planet, it’s good also idea to make a piping change. With both businesstargets; and we’re on track to accomplish the for our business. goals and environmental beneﬁts in mind, staffremaining targets by the end of 2012. members go beyond what’s asked of them to Amgen is committed to transparent communication improve the way Amgen does business. Each• Realized an annualized savings of more than about our progress in the area of environmental year, we name environmental champions —$11 million from our energy program projects sustainability, and in 2012 we plan to publish staff members who share their knowledge andand initiatives. our second annual environmental sustainability contribute ideas for living more lightly on Earth report in alignment with Global Reporting both at work and in their communities.• Reused approximately 72 percent of the treated Initiative (GRI) guidelines, the generally acceptedwastewater generated at our largest manufacturing industry-reporting standard.To learn more, visitfacility, located in Puerto Rico, thanks to an on-site http://environment.amgen.com.water treatment plant. A wastewater plant at Amgen Manufacturing Limited, Puerto Rico, allows nearly 72 percent of treated wastewater to be reused on-site. Scientists and engineers in drug development laboratories and at manufacturing sites are developing more environmentally friendly ways to produce Amgen medicines.
12 Amgen 2011 Annual Report Reconciliation of GAAP Earnings Per Share to “Adjusted” Earnings Per Share (Unaudited) Results for the years ended December 31, 2011 2010 2009 2008 2007 GAAP earnings per share (diluted) $4.04 $4.79 $4.51 $3.77 $2.74 Adjustments to GAAP earnings per share*: Legal settlements (a) 0.78 — 0.03 0.21 0.02 Amortization of acquired intangible assets, product technology rights (b) 0.20 0.19 0.18 0.17 0.16 Incremental non-cash interest expense (c) 0.10 0.17 0.15 0.13 0.11 Restructuring and cost-savings initiatives (d) 0.07 — 0.05 0.10 0.51 Stock option expense (e) 0.06 0.09 0.08 0.07 0.12 Charges associated with the Fremont manufacturing facility transaction (f) 0.05 0.08 — — — Other merger-related expenses (g) 0.03 — — — 0.02 Amortization of acquired intangible assets, research and development (R&D) technology rights (h) 0.01 0.05 0.04 0.04 0.04 Tax beneﬁt resulting from prior-period charges (i) (0.01) (0.01) (0.02) — — Tax settlement (j) — (0.15) (0.09) — (0.08) California tax law change (k) — — (0.02) — — Write-off of inventory (l) — — — 0.06 0.08 Write-off of acquired in-process R&D (m) — — — — 0.53 Other — — — — 0.04 “Adjusted” earnings per share (diluted) $5.33 $5.21 $4.91 $4.55 $4.29 Reconciliation of GAAP R&D Expense to “Adjusted” R&D (Unaudited) ($ in millions) Results for the years ended December 31, 2011 2010 2009 2008 2007 GAAP R&D expense $3,167 $2,894 $2,864 $3,030 $3,266 Adjustments to GAAP R&D expense: Stock option expense (e) (35) (51) (49) (46) (83) Amortization of acquired intangible assets, R&D technology rights (h) (21) (70) (70) (70) (71) Other merger-related expenses (g) (7) — — (1) (29) Restructuring and cost-savings initiatives (d) 12 — (6) (3) (19) “Adjusted” R&D expense $3,116 $2,773 $2,739 $2,910 $3,064 * The following adjustments are presented net of their related per-share tax impact of $0.38, $0.33, $0.29, (h) To exclude the non-cash amortization of the R&D technology intangible assets acquired in business $0.36, and $0.44 for 2011, 2010, 2009, 2008, and 2007, respectively. combinations in prior years. (a) To exclude loss accruals for legal settlements. (i) To exclude the tax beneﬁ t related to certain prior-period charges excluded from “Adjusted” earnings. (b) To exclude the non-cash amortization of product technology rights acquired in a prior-year business combination. (j) To exclude the net tax beneﬁ t recognized as the result of resolving certain non-routine transfer-pricing (c) To exclude the non-cash interest expense associated with our convertible notes. issues with tax authorities for prior periods. (d) To exclude restructuring and cost-savings initiatives charges and related expense reversals. (k) To exclude the net tax beneﬁ t resulting from adjustments to previously established deferred taxes, related primarily to prior acquisitions and stock option expense, due to changes in California tax law effective in 2011. (e) To exclude stock option expense. (l) To exclude the write-off of inventory resulting from, in 2008, a strategic decision to change manufacturing (f) To exclude charges as a result of our transaction with Boehringer Ingelheim involving our Fremont, processes and, in 2007, changing regulatory and reimbursement environments. California, manufacturing facility. (m) To exclude the non-cash expense associated with writing off the acquired in-process R&D related to (g) To exclude merger-related expenses. business combinations in prior years. Forward-looking statements: This Annual Report contains forward-looking statements that are based on Amgen management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including plans for the growth of our business and other ﬁ nancial metrics; expected clinical or regulatory results or practices; development of Amgen’s product candidates, including anticipated regulatory filings; and planned international expansion. Forward-looking statements involve significant risks and uncertainties, including those more fully described in the Risk Factors found in the Form 10-K contained within this Annual Report and in the most recent periodic reports on Form 10-Q and Form 8-K filed by Amgen with the U.S. Securities and Exchange Commission, and actual results may vary materially. Except where otherwise indicated, Amgen is providing this information as of February 29, 2012, and does not undertake any obligation to update any forward-looking statements contained in this Annual Report as a result of new information, future events, or otherwise.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K(Mark One) È ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2011 OR ‘ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 000-12477 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) One Amgen Center Drive, 91320-1799 Thousand Oaks, California (Zip Code) (Address of principal executive offices) (805) 447-1000 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on Which Registered Common stock, $0.0001 par value The NASDAQ Global Select Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the SecuritiesAct. Yes È No ‘ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of theAct. Yes ‘ No È Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filesuch reports), and (2) has been subject to such filing requirements for the past 90 days. Yes È No ‘ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, everyInteractive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) duringthe preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes È No ‘ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, andwill not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by referencein Part III of this Form 10-K or any amendment to this Form 10-K. ‘ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or asmaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” inRule 12b-2 of the Exchange Act. (Check one): Large accelerated filer È Accelerated filer ‘ Non-accelerated filer ‘ Smaller reporting company ‘ (Do not check if a smaller reporting company) Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act) Yes ‘ No È The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was$53,861,879,805 as of June 30, 2011(A)(A) Excludes 966,638 shares of common stock held by directors and executive officers at June 30, 2011. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, directly or indirectly, to direct or cause the direction of the management or policies of the registrant, or that such person is controlled by or under common control with the registrant. 791,432,134 (Number of shares of common stock outstanding as of February 10, 2012) DOCUMENTS INCORPORATED BY REFERENCE Specified portions of the registrant’s Proxy Statement with respect to the 2012 Annual Meeting of stockholders to be heldMay 23, 2012, are incorporated by reference into Part III of this annual report.