Alexion Pharmaceuticals
Annual Report 2011

Plain-text annual report

2011 Annual Report Transforming lives through innovation in ultra-rare diseases “My daughter was three years old when I was diagnosed with aHUS. I was so scared that I would not see her start kindergarten, much less graduate from college, get married and have her own children. After years of hospitalizations and constant dialysis, I was put on Soliris in 2011. I feel extremely blessed to be living a normal life now.” Jill Z., Patient with aHUS receiving Soliris® 2011 Accomplishments Soliris® (eculizumab) becomes available to patients with Alexion receives FDA approval for Soliris as the first and only paroxysmal nocturnal hemoglobinuria (PNH) in Australia treatment for adult and pediatric patients with aHUS in the following a pivotal government reimbursement decision United States; the same day, the European Committee for that Soliris is life-saving Alexion acquires Taligen Therapeutics and creates the Alexion Translational Medicine Group Alexion acquires an investigational cPMP replacement therapy from Orphatec Pharmaceuticals for infants suffering from molybdenum cofactor deficiency (MoCD) Type A, a Medicinal Products for Human Use (CHMP) recommends that Soliris be approved for the treatment of pediatric and adult patients with aHUS in Europe An exploratory, 14-patient Phase 2 study of eculizumab in patients with severe and refractory myasthenia gravis shows a strong disease-improvement signal catastrophic, ultra-rare genetic metabolic disorder The European Commission grants marketing authorization for Alexion is added to the NASDAQ-100 Index, a list of the largest domestic and international non-financial companies on the NASDAQ Stock Market Alexion responds to the earthquake and tsunami in Japan by supporting relief efforts and working to maintain continuity of Soliris therapy for PNH patients in Japan Soliris as the first and only treatment for adult and pediatric patients with aHUS in Europe At the American Society of Nephrology (ASN) annual meeting, clinical investigators present longer-term data showing significant and sustained benefits of Soliris in patients with aHUS enrolled in Phase 2 extension studies In a separate presentation at the ASN annual meeting, investigators report strong interim data from an open-label clinical trial to investigate eculizumab as a treatment for Alexion submits marketing applications to the US Food and patients with STEC-HUS Drug Administration (FDA) and the European Medicines Agency (EMA) for Soliris as a treatment for patients with atypical hemolytic uremic syndrome (aHUS) Researchers present nine studies related to Soliris in patients with PNH and aHUS at the 16th Congress of the European Hematology Association (EHA); data include the consequences of PNH and the positive impact of Soliris on long-term outcomes, and final results from the pivotal Phase 2 studies of Soliris in patients with aHUS Alexion responds to the Enterohemorrhagic Escherichia coli (EHEC) crisis in Germany by providing free compassionate access to Soliris for several hundred patients and initiating an open-label clinical trial to investigate eculizumab as a treatment for Shiga toxin-producing E. coli hemolytic uremic syndrome (STEC-HUS) resulting from the EHEC outbreak Data presented at the American Society of Hematology (ASH) annual meeting underscore the severity of PNH and confirm the importance of consistently testing high-risk patients for PNH Alexion agrees to acquire Enobia Pharma Corp. and asfotase alfa, the first potential treatment for patients with hypophosphatasia (HPP), an ultra-rare, inherited, life-threatening, metabolic disease for which there are no approved or effective treatments The New England Journal of Medicine publishes data from a Phase 2 study of asfotase alfa in life-threatening hypophosphatasia; the study met its primary endpoint with 90% of patients showing substantial skeletal healing at 24 weeks, and achieved key secondary endpoints including improvement in cognitive development and motor and Provincial reimbursement decisions in Canada significantly pulmonary function broaden access to Soliris for Canadian patients with PNH Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases 1 J a n u a r y F e b r u a r y M a r c h A p r i l J u n e J u l y S e p t e m b e r N o v e m b e r D e c e m b e r E a r l y 2 0 1 2 “My life changed dramatically in 2002 when I went from an active and energetic event security manager who was busy planning a future to suddenly having debilitating pain, extreme fatigue, and long hospitalizations. It took two years until I was diagnosed with PNH, and then I was terrified that I would not be able to be part of a future with my wife. Today I am taking Soliris, sharing happy moments with my growing family, and living like other 35-year-old husbands and fathers.” Victor E., Patient with PNH receiving Soliris To Our Shareholders: In 2011, Alexion reached new levels in our mission to transform • Advance our eculizumab clinical programs in Shiga toxin- the lives of patients with severe and ultra-rare disorders. By producing E. coli hemolytic uremic syndrome (STEC-HUS), acting with urgency and strategic focus on behalf of the acute humoral transplant rejection (AHR), severe and patients and families we serve, we exceeded the ambitious refractory neuromyelitis optica (NMO), and severe and objectives we had set for the year. Our remarkable progress in refractory myasthenia gravis 2011 includes: • Drive development of asfotase alfa, a highly innovative • Bringing Soliris® (eculizumab) to more patients with enzyme replacement therapy that has the potential paroxysmal nocturnal hemoglobinuria (PNH) in our core to become the first treatment for patients with territories of the United States, Western Europe, and Japan, hypophosphatasia (HPP), an ultra-rare, inherited, and life- as well as to patients in new countries threatening metabolic disorder • Achieving regulatory approvals in the US and European • Accelerate the development of additional novel therapies, Union for Soliris as the first and only treatment for patients including cPMP replacement therapy for newborns with a with atypical hemolytic uremic syndrome (aHUS) fatal metabolic disorder; ALXN1007, our anti-inflammatory • Deepening our pipeline through three strategic acquisitions of highly innovative product candidates focused on what we know well and do well: developing and delivering innovative and transformative treatments for patients with severe and ultra-rare disorders • Advancing our lead development programs, which now include five highly innovative biotechnology drug candidates including Soliris, in eight severe and ultra-rare disorders beyond PNH and aHUS antibody; and TT30, a novel inhibitor of the alternative complement pathway Serving More Patients with PNH PNH is an ultra-rare blood disorder in which chronic, uncontrolled activation of the complement system causes destruction of red blood cells (hemolysis), leading to severe clinical manifestations, including recurring blood clots, progressive kidney disease, and significantly shortened lifespans. Historically, up to 35% of patients with PNH died • Sustaining high growth while maintaining strong within five years of diagnosis. financial discipline Today, we are building on this clinical and commercial expertise as we continue to expand our commitment to patients with severe and ultra-rare disorders. We entered 2012 with the widest global commercial operations and the deepest development pipeline in our Company’s history. As we look ahead, we are reaching even further with a growth strategy designed to deliver first-in-class, highly innovative therapies to more patients with ultra-rare and life-threatening disorders. In 2012, we will: • Expand our global presence in PNH to bring the transformative benefits of Soliris to more patients in more countries • Build on our strong medical, regulatory, and commercial capabilities worldwide to bring Soliris to a growing number of patients with aHUS in the US and EU Since receiving FDA approval for PNH in 2007, Soliris has been changing outcomes for patients and families suffering from the disease. In addition to dramatic clinical improvements in PNH manifestations, long-term retrospective data published by independent researchers in the journal Blood reported that the survival of studied patients with PNH who were treated with Soliris was no different than the survival of healthy, normal individuals. These data suggest that patients who once faced early mortality can now hope to live a normal life. In 2011, we continued the trajectory of growth we have achieved since launch, bringing Soliris to more patients with PNH, primarily in our core territories of the US, Japan, and Western Europe. We also widened our approach by assembling operational leadership that will enable us to serve patients in Turkey, Brazil, and Russia, as well as other countries in the Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases 3 Alexion is serving a growing number of patients around the world. Soliris is currently approved in more than 40 countries for the treatment of PNH, and in the United States and the European Union for the treatment of aHUS. Middle East, Latin America, Asia-Pacific, and Eastern Europe. after, on November 24, 2011, the European Commission granted In all territories, our work on behalf of patients is focused approval for Soliris as the first treatment for aHUS in the EU. on disease education and awareness, with an emphasis on In both the US and EU, the aHUS labels for Soliris are broad diagnostic testing of patients with a higher likelihood of and strong, including patients regardless of age, clinical profile, having PNH. Importantly, in our core territories, we continue identifiable genetic mutations, or history of supportive care. to observe that a majority of new patients who have started on Soliris are also newly diagnosed with PNH, reflecting the positive impact of these initiatives. The importance of Soliris to the aHUS community is clear. Historically, more than one-half of patients with aHUS have died, required kidney dialysis, or had permanent renal damage within Our disease education efforts are supported by the growing one year of diagnosis. For many patients, life with aHUS meant body of clinical data underscoring the severity of PNH and the frequent hospitalizations, reliance on dialysis, progressive damage significant impact of Soliris on survival. For example, data from to vital organs, and the threat of stroke, seizure, heart attack, and the South Korean National Registry, presented at the American other devastating events. Today, with ongoing Soliris treatment, Society of Hematology’s annual conference in December patients on dialysis have the chance to become and remain dialysis- 2011, showed that any PNH patient with elevated LDH, a free, and patients have the hope of improving and restoring kidney measure of hemolysis, is at risk for serious complications due function as well as returning to work, school, and their normal lives to uncontrolled complement activation, reinforcing the need for the first time since their devastating diagnosis. for early intervention. These and other independent studies are helping physicians make better-informed treatment decisions on behalf of their patients with PNH. However, despite our substantial progress over the five years since Soliris was approved for the treatment of PNH, we know that the majority of PNH patients still do not receive appropriate care. This is why our focus remains on expanding our presence in core territories, serving more patients in additional countries, and continuing to build a common, global understanding of PNH and its diagnosis and treatment. Bringing Life-Transforming Hope to Families Battling aHUS Leveraging Our Expertise for a Successful aHUS Launch The US and EU approvals of Soliris for the treatment of patients with aHUS exemplify our mission of transforming the lives of patients with severe and ultra-rare disorders. In both regions, we are leveraging the unique expertise we gained from the global rollout of Soliris for PNH to bring Soliris therapy to an increasing number of patients with aHUS. The US aHUS launch has been under way since late 2011, and we have begun to serve initial patients across the country. In the EU, reimbursement discussions are under way in Western Europe, and we plan to launch in major European countries throughout 2012 and 2013. As with PNH, our key objectives in aHUS are to build a common global understanding of the disease among In 2007, Soliris began transforming the lives of people living physicians and patients, facilitate broad and unrestricted access with PNH. In the fall of 2011, patients and families suffering to Soliris, and ensure appropriate utilization of Soliris. from aHUS gained hope for a similar transformation. Our educational efforts are bolstered by the growing body of aHUS is a chronic, ultra-rare, and life-threatening disease in compelling clinical evidence supporting the use of Soliris in both which a genetic deficiency in one or more complement regulatory adult and pediatric patients with aHUS. In November, data were genes causes lifelong uncontrolled complement activation, presented at the American Society of Nephrology (ASN) annual resulting in systemic thrombotic microangiopathy (TMA), the meeting from the extensions of two pivotal Phase 2 studies: formation of blood clots in small blood vessels throughout the one in patients with a long duration of disease and substantial body. On September 23, 2011, the FDA approved Soliris for the organ damage despite previously receiving long-term plasma treatment of patients with aHUS – the first-ever approval for an exchange/infusion (PE/PI), and one in patients with a shorter aHUS treatment and the second indication for Soliris. Shortly duration of disease with progressing clinical TMA complications. Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases 5 Research Pipeline: Lead Programs Paroxysmal Nocturnal Hemoglobinuria (PNH) Atypical Hemolytic Uremic Syndrome (aHUS) Shiga toxin E. coli-related Hemolytic Uremic Syndrome (STEC-HUS) Presensitized Kidney Transplant (Acute Humoral Rejection) Severe and Refractory Myasthenia Gravis Severe and Refractory Neuromyelitis Optica* Hypophosphatasia Molybdenum Cofactor Deficiency Type A Inflammatory Disorders Inflammatory Disorders Pipeline Key Hematology Inflammatory Disorders Metabolic Nephrology Neurology * Investigator-Initiated Trial P r e c l i n i c a l P h a s e I P h a s e I I P h a s e I I I M a r k e t S o l i r i s fi ( e c u l i z u m a b ) A s f o t a s e A l f a c P M P R e p l a c e m e n t T h e r a p y T T 3 0 A L X N 1 0 0 7 Both studies demonstrated that ongoing treatment with Soliris without treatment options. Our ongoing development program suppressed complement-mediated TMA, maintained or further for eculizumab is focused on diseases for which current improved longer-term renal function, and enhanced quality of supportive approaches are ineffective or nonexistent, where life. Additional long-term data from these studies, presented in the mechanism of action of the disease is well understood, December at the American Society of Hematology (ASH) annual and for which eculizumab has the potential to have a life- meeting, further illustrate the compelling clinical benefits of transforming impact. Our lead programs in nephrology and Soliris and support early and ongoing treatment. neurology all share these characteristics. Since the 2007 approval of Soliris for the treatment of PNH, In nephrology, scientists presented very encouraging interim we have had the objective that every patient with PNH who data at the ASN meeting in November from our STEC- can benefit from Soliris will have access to Soliris. Now, we HUS clinical trial, which was initiated in response to the have expanded that objective – and our long-standing access Enterohemorrhagic Escherichia coli (EHEC) crisis in Germany. initiatives – to include patients with aHUS. Our OneSource™ The interim findings showed that eight weeks of treatment Treatment Support program helps patients with both disorders with eculizumab substantially improved serious morbidities navigate the reimbursement processes in the US, the among studied patients with STEC-HUS. Soliris-treated patients Complement Foundation provides Soliris at no cost to patients experienced rapid, significant, and sustained reduction in TMA, who cannot obtain insurance, and patient assistance programs as well as reversal of organ damage, underscoring the critical are in place through third parties for patients whose insurance role of uncontrolled complement activation in the TMA process. leaves significant gaps with regard to treatment-related Final data are expected this year. expenses. Beyond the US, we are working with governments in major markets worldwide to ensure that patients with aHUS can have access to Soliris therapy. Alexion also supports the work of patient organizations in many countries that are involved in education and advocacy for rare diseases. A Robust Pipeline Focused on Severe and Ultra-Rare Disorders We finished 2011 with the most robust and promising pipeline in our Company’s history. Today, our R&D team is investigating five highly innovative compounds, including eculizumab, in eight severe and ultra-rare diseases beyond PNH and aHUS. Our aim is not just to provide incremental benefits but rather to dramatically alter the course of severe and ultra-rare diseases that have a devastating impact on patients’ lives. Exploring the Potential of Eculizumab and Other Innovative Complement Inhibitors Also in nephrology, we have recently begun enrolling patients in our Alexion-sponsored multinational living-donor trial for the prophylaxis of acute humoral rejection (AHR) for patients undergoing kidney transplant who are at elevated risk of rejection, as measured by the presence of high levels of donor-specific antibodies. Patients in the study will be treated with eculizumab for nine weeks post-transplant and then observed for a year. In neurology, we have two clinical development programs under way – one in severe and refractory myasthenia gravis, and another in patients with severe neuromyelitis optica (NMO). Data from our company-sponsored Phase 2 study in myasthenia gravis, presented in the fall of 2011 at the Myasthenia Gravis Foundation of America meeting, showed a strong disease-improvement signal in a group of 14 patients. In NMO, enrollment has been completed in an investigator-initiated Phase 2 clinical trial, with data expected in the second half of this year. We are also expanding our pipeline in complement inhibitors As the world’s first and only approved terminal complement beyond eculizumab with a Phase 1 development program inhibitor, Soliris represents a long-awaited medical for TT30, a unique inhibitor of the alternative complement breakthrough – not only for patients with PNH and aHUS, but pathway. Once we have data from the current Phase 1 study, also for patients with numerous other complement-mediated we can better evaluate the therapeutic potential of TT30 for disorders that are also severe, ultra-rare, life-threatening, and various disease targets. Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases 7 “Alexion enters 2012 with the most robust and innovative pipeline in our history, with five highly innovative compounds, including Soliris, currently being investigated at various stages of development across eight severe and ultra-rare indications beyond PNH and aHUS.” Stephen P. Squinto, PhD Executive Vice President and Head of R&D Innovation in Severe and Ultra-Rare Disorders Beyond our objectives for this innovative therapy are to advance the Eculizumab and Complement pediatric development program, expand the adult development As we expand our development activities, we have sharpened program, and optimize commercial-scale manufacturing. We our focus on what we know well and do well – using our look forward to moving with urgency to bring an approved, life- proven skills in severe and ultra-rare disorders to develop first- transforming treatment to patients with HPP and their families. in-class, highly innovative therapies. We put this strategy into action most recently with the acquisition of Enobia Pharma, a company well aligned with our values and areas of focus. The acquisition, which closed in February 2012, brings us asfotase alfa, a highly innovative, late-stage compound with the potential to transform the lives of patients with HPP, a severe, ultra-rare, and life-threatening metabolic disorder for which there are no approved or effective therapies. Additionally, we are accelerating the development of a highly innovative cPMP replacement therapy as a potential treatment for molybdenum cofactor deficiency (MoCD) Type A, a devastating, ultra-rare disorder in newborns. MoCD Type A is among the rarest and most deadly disorders that can affect a newborn, with survival typically measured only in weeks or months. There are currently no treatment options for this disease, which means children will either die or survive with devastating Due to a genetic defect, patients with HPP are deficient in an brain damage. Early experience with the cPMP replacement enzyme known as tissue non-specific alkaline phosphatase. therapy has shown encouraging results, and in 2011 we made Without this enzyme, patients can face severe outcomes substantial progress in our manufacturing process for the including progressive damage to multiple vital organs, destruction treatment, allowing us to begin conducting IND-enabling studies. and deformity of bones, profound muscle weakness, impaired renal function, and respiratory failure. Tragically, about one-half of newborns with severe HPP do not survive past their first birthday, due to a profound bone mineralization defect and compromised respiratory function. Older children with HPP may not be able to climb a single stair or take a single step. By targeting replacement of the missing enzyme directly to the necessary tissue, asfotase alfa is designed to normalize the defective metabolic process and prevent or reverse the severe and life-threatening complications of life-long uncontrolled mineral metabolism in patients with HPP. In Phase 2 studies, asfotase alfa demonstrated the potential to bring the first real hope to patients and families facing this devastating disorder. In a study recently published in the New England Journal of Medicine, treatment with asfotase alfa led to a striking improvement in skeletal abnormalities, pulmonary and physical function, and cognitive development in infants and young children with HPP. These and other findings in patients of all ages provide strong support for the potential of asfotase alfa to transform the lives of patients with HPP by correcting the enzyme deficiency that underlies the mortality and morbidities of the disease. Asfotase alfa was awarded orphan drug designation in the US and EU in 2008 and Fast Track status in the US in 2009. In 2012, Another key drug candidate in our pipeline is ALXN1007, a novel antibody designed to target rare and severe inflammatory disorders. ALXN1007 is a product of our proprietary antibody discovery technologies. We have commenced Phase 1 clinical trials in healthy volunteers. Continued Strong Financial Performance In 2011, our world-class research, clinical, regulatory, and commercial capabilities delivered sustained high growth and positioned us for continued success in 2012. Soliris sales for 2011 totaled $783 million, representing a 45% increase from the previous year and the 19th consecutive quarter of growth for our Company. By serving an increasing number of patients while maintaining rigorous financial discipline, we achieved non-GAAP net income of $266 million, or $1.38 per diluted share, a 59% increase from 2010. We also finished 2011 with cash, cash equivalents, and marketable securities totaling $541 million, up from $362 million in 2010. Importantly, the Enobia acquisition was executed in early 2012 with strong financial discipline, using cash on hand and bank debt, thus adding a significant late- stage asset to our pipeline with an investment well within our strict financial parameters. Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases 9 “2011 was a year of strong performance in all of our major global initiatives. In 2012 we will reach further, driving forward with the same passion and commitment we have demonstrated over the years to transform the lives of more patients and families suffering with more disorders that are severe, devastating, and ultra-rare.” Leonard Bell, MD Chief Executive Officer Strengthening Our Human Capital Throughout 2011, we continued to strengthen and expand our world-class capabilities in translational medicine, drug development, regulatory affairs, and commercial operations. To help guide this growth and success, we added exceptional talent to our management team. Clare Carmichael joined as Senior Vice President and Chief Human Resources Officer, with extensive experience in building cohesive organizations with integrated, high-performance teams. Claus Weisemann, PhD also joined as Senior Vice President, Corporate Quality and Compliance, with responsibility for global quality initiatives and regulatory compliance worldwide. Alexion has more than 1,100 employees in Company facilities in more than 20 countries. Our employees are among the best and brightest in our industry. We are grateful for their sense of urgency and steadfast commitment to serving patients with severe, ultra-rare disorders. Global Citizenship During 2011, we demonstrated our deep commitment to patients following an unusually widespread EHEC outbreak in Germany. Physicians faced the daunting challenge of caring for a subset of patients who developed STEC-HUS, a severe complication caused by uncontrolled complement activation. Alexion responded immediately, providing eculizumab at no cost to hundreds of patients who had no other treatment option. Our medical team worked closely and urgently with German health authorities to initiate one of the largest In addition, thanks to the dedication of our employees, we are involved in a broad range of charitable programs in our local communities, including the renovation and restoration of homes for people in need, scholarship grants, and fundraising for organizations involved in public health initiatives. And in 2011, we again expanded our commitment to environmental sustainability and energy conservation with the installation of a micro-turbine cogeneration system at our global headquarters in Connecticut – a state-of-the-art technology that reduces greenhouse gas emissions by 50% while generating both electricity and heat for our labs and offices. Looking Ahead in 2012 Our progress and performance during 2011 position us for even greater achievements on behalf of more patients in 2012. We are strengthening our capabilities, expanding our global reach, and advancing our deep pipeline of highly innovative, life-transforming therapies for patients with severe and ultra-rare disorders. We are grateful for those who support us in fulfilling this vital mission: our employees, our Board, our shareholders, and the patients, families, physicians and healthcare systems we serve around the world. Together we are reaching further. Together we are transforming lives. compassionate access programs for an already-approved drug Leonard Bell, MD in the developed world. Chief Executive Officer April 2012 From left: Stephen Squinto, PhD, Executive Vice President and Head of Research and Development; Leonard Bell, MD, Chief Executive Officer; Patrice Coissac, Senior Vice President and President, Alexion Pharma International Sàrl; Clare Carmichael, Senior Vice President and Chief Human Resources Officer; Thomas Dubin, JD, Senior Vice President and Chief Legal Officer; Vikas Sinha, MBA, CA, CPA, Senior Vice President and Chief Financial Officer; David Hallal, Senior Vice President, Global Commercial Operations Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases 11 Selected Financial Highlights (In thousands, except per share data) Net product sales Cost of sales $ 783,431 93,140 $ 540,957 64,437 $ 386,800 45,059 Research and development Selling, general and administrative Acquisition-related costs Amortization of purchased intangible assets Operating income Other expense Income before income taxes Income tax provision (benefit) 137,421 308,176 13,486 382 230,826 1,158 229,668 54,353 98,394 226,766 722 — 150,638 1,627 149,011 51,981 81,915 172,767 — — 87,059 3,745 83,314 (211,852) 2 Earnings per common share — diluted1 Shares used in computing earnings per share — diluted1 $ 0.91 191,806 $ 0.52 186,074 $ 1.63 181,164 Cash, cash equivalents, and marketable securities $ 540,865 $ 361,605 $ 176,220 Trade accounts receivable, net Inventories Property, plant and equipment, net Goodwill and intangible assets, net Deferred tax assets Other assets Accounts payable and accrued expenses Deferred revenue Contingent consideration Other liabilities 244,288 81,386 165,852 171,243 123,000 68,117 202,093 17,905 18,120 22,141 168,732 62,165 162,240 44,100 174,212 38,983 123,056 2,896 — 26,349 113,731 40,885 164,691 48,543 211,034 31,297 78,445 1,652 — 17,948 1 On May 20, 2011, we effected a two-for-one stock split, paid in the form of a 100% stock dividend. Stockholders of record at the close of trading on May 2, 2011 were issued one additional share of common stock for each share owned by such shareholder. All share and per share data presented in the accompanying table has been retroactively restated to reflect the stock split. 2 In 2009, we determined that it was more likely than not that a significant portion of our deferred tax assets in the United States, primarily net operating losses and research and development credits, would be realized. Accordingly, we recorded a tax benefit of $215,516 as a result of reversing the valuation allowance on these deferred tax assets. 12 Alexion Pharmaceuticals Transforming lives through innovation in ultra-rare diseases Y e a r E n d e d D e c e m b e r 3 1 , 2 0 1 1 2 0 1 0 2 0 0 9 O p e r a t i n g e x p e n s e s : T o t a l o p e r a t i n g e x p e n s e s 4 5 9 , 4 6 5 3 2 5 , 8 8 2 2 5 4 , 6 8 2 N e t i n c o m e $ 1 7 5 , 3 1 5 $ 9 7 , 0 3 0 $ 2 9 5 , 1 6 6 A s o f D e c e m b e r 3 1 , 2 0 1 1 2 0 1 0 2 0 0 9 C o n s o l i d a t e d B a l a n c e S h e e t D a t a : T o t a l a s s e t s 1 , 3 9 4 , 7 5 1 1 , 0 1 2 , 0 3 7 7 8 6 , 4 0 1 T o t a l l i a b i l i t i e s 2 6 0 , 2 5 9 1 5 2 , 3 0 1 9 8 , 0 4 5 T o t a l s t o c k h o l d e r s (cid:146) e q u i t y 1 , 1 3 4 , 4 9 2 8 5 9 , 7 3 6 6 8 8 , 3 5 6 T o t a l l i a b i l i t i e s a n d s t o c k h o l d e r s (cid:146) e q u i t y 1 , 3 9 4 , 7 5 1 1 , 0 1 2 , 0 3 7 7 8 6 , 4 0 1 Our Global Locations Cheshire, CT, USA North America Regional and Global Headquarters Barcelona, Spain Country Operations Bogotá, Colombia Country Operations Brussels, Belgium Country Operations Buenos Aires, Argentina Country Operations Cambridge, MA, USA Translational Medicine Group HPP Program Group Istanbul, Turkey Country Operations Lausanne, Switzerland EMEA Regional Headquarters International Operations Center Country Operations London, United Kingdom Country Operations Mexico City, Mexico LatAm Regional Headquarters Country Operations Milan, Italy Country Operations Montréal, Canada Translational Medicine Group Moscow, Russia Country Operations Mumbai, India Global Business Services Munich, Germany Country Operations Paris, France European Service Center Country Operations São Paulo, Brazil Country Operations Shanghai, China Commercial Operations Smithfield, RI, USA Global Manufacturing Stockholm, Sweden Nordic Country Operations Sydney, Australia Asia-Pacific Regional Headquarters Country Operations Tokyo, Japan Country Operations Toronto, Canada Country Operations Shareholder Information Directors Senior Management Annual Shareholders Meeting To be held on May 7, 2012 5:00 p.m. Westin Providence Hotel One West Exchange Street Providence, RI 02903 tel 401.598.8000 fax 401 598.8200 Other Information Corporate Headquarters Alexion Pharmaceuticals, Inc. 352 Knotter Drive Cheshire, CT 06410 tel 203.272.2596 fax 203.271.8190 Transfer Agent and Registrar Computershare Trust Company, N.A. 250 Royall Street Canton, MA 02021 Investor Relations Rx Communications 445 Park Avenue, 10th Floor New York, NY 10022 tel 917.322.2569 fax 917.322.2570 Legal Counsel Ropes & Gray LLP Boston, MA Independent Auditors PricewaterhouseCoopers LLP Hartford, CT Trading Symbol Listing for Alexion Pharmaceuticals, Inc. is found on the NASDAQ stock market under the symbol ALXN. alexionpharma.com Max Link, PhD1,4 Chairman of the Board Former Chairman of the Board and CEO, Centerpulse AG Former CEO, Corange Former Chairman of the Board and CEO, Sandoz Pharma, Ltd. Leonard Bell, MD Chief Executive Officer Leonard Bell, MD Chief Executive Officer Stephen P. Squinto, PhD Executive Vice President, Head of Research and Development Clare Carmichael Senior Vice President, Chief Human Resources Officer William R. Keller2,3 Vice Chairman of Shanghai Association of Foreign Investment Enterprises Senior Consultant of Shanghai Foreign Investment Development Board Former General Manager, Roche China Ltd. Patrice Coissac Senior Vice President, President, Alexion Pharma International Sàrl Thomas I.H. Dubin, JD Senior Vice President and Chief Legal Officer Joseph A. Madri, PhD, MD2,4 Professor of Pathology, Yale University School of Medicine Larry L. Mathis1,3 Former President and CEO, The Methodist Hospital System R. Douglas Norby1,3 Former Senior Vice President, Chief Financial Officer, Tessera Technologies, Inc. Alvin S. Parven2,3 President, ASP Associates Former Vice President, Aetna Health Plans Andreas Rummelt, PhD1,4 CEO, InterPharmaLink AG Former Group Head, Quality Assurance and Technical Operations, Novartis Former Member of Executive Committee, Novartis Former CEO, Sandoz AG Ann M. Veneman2,3 Former Executive Director of UNICEF Former Secretary of US Department of Agriculture David L. Hallal Senior Vice President, Global Commercial Operations Vikas Sinha, MBA, CA, CPA Senior Vice President and Chief Financial Officer Camille L. Bedrosian, MD Senior Vice President and Chief Medical Officer Thomas Bock, MD, MBA Senior Vice President, Global Medical Affairs M. Stacy Hooks, PhD Senior Vice President, Technical Operations Claude Nicaise, MD Senior Vice President, Strategic Development and Global Regulatory Claus Weisemann, PhD Senior Vice President, Corporate Quality and Compliance James P. Bilotta, MBA Vice President and Chief Information Officer Daniel N. Caron, MS Vice President, Site Operations and Engineering Sven Ante (Bill) Lundberg, MD Vice President, Head of Translational Medicine Margaret M. Olinger, MBA Vice President, Global Hematology Franchise Jeremy P. Springhorn, PhD Vice President, Corporate Strategy and Business Development Jeroen van Beek, PhD Vice President, Global Nephrology Franchise Heidi L. Wagner, JD Vice President, Global Government Affairs 1 Member of the Audit Committee 2 Member of the Compensation Committee 3 Member of the Nominating and Corporate Governance Committee 4 Member of the Pharmaceutical Compliance and Quality Committee © 2012 Alexion Pharmaceuticals, Inc. Alexion®, Alexion Logo®, Soliris® and OneSource™ are trademarks of Alexion Pharmaceuticals, Inc. Alexion Pharmaceuticals, Inc. 352 Knotter Drive, Cheshire, CT 06410, USA Alexion Pharma International Sàrl Avenue du Tribunal Fédéral 34, 1005, Lausanne, Switzerland Alexion Pharma G.K. Ebisu Prime Square Tower, Tokyo 150-0012, Japan Alexion Pharmaceuticals Australasia Pty Limited Brooksvale NSW Australia, 2100 Alexion Pharma Mexico S de RL de CV Paseo de los Tamarindos 90 Torre 1 Piso 14, Col. Bosques de la Lomas, CP 05120 D.F. Mexico www.alexionpharma.com 

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