Transforming Discovery Into Care 2007 ANNUAL REPORT Highlights
Total Page:16
File Type:pdf, Size:1020Kb
George Harmon TYSABRI Patient Transforming Discovery Into Care 2007 ANNUAL REPORT Highlights MOVING INTO LATE-STAGE TRIALS Biogen Idec moves three programs into late-stage development, initiating Q1 registration trials for lumiliximab in chronic lymphocytic leukemia, galiximab in non-Hodgkin’s lymphoma and BG-12 for multiple sclerosis. INVESTING IN HEMOPHILIA Biogen Idec acquires Syntonix Pharmaceuticals, adding multiple preclinical programs in hemophilia to the pipeline and investing in the $3 billion market for recombinant factor products. DELIVERING SHAREHOLDER VALUE Q2 Biogen Idec returns $3 billion to investors through a share repurchase. POSITIVE RESULTS Biogen Idec and Genentech present detailed positive data from a Phase II clinical study of RITUXAN® (rituximab) in patients with relapsing-remitting multiple sclerosis. Mikael Nilsson Leadership Award Winner MEETING UNMET NEEDS An FDA Advisory Committee recommends approval of TYSABRI® Q3 (natalizumab) for the treatment of moderate-to-severe Crohn’s disease in patients who have failed or cannot tolerate available therapies. GROWING THE PIPELINE Biogen Idec partners with Cardiokine to jointly develop lixivaptan, an oral compound that entered a Phase III clinical trial in February 2008 for the potential treatment of hyponatremia in patients with acute decompensated congestive heart failure. GAINING MOMENTUM Less than 18 months after its reintroduction, TYSABRI exits the year at an Q4 annual run rate of $500 million in worldwide sales. FUELING INNOVATION Biogen Idec announces an alliance with Neurimmune Therapeutics to develop novel, fully human antibodies for the treatment of Alzheimer’s Maureen Shreve disease. It also announced the first occupant in the Biogen Idec Innovation Leadership Award Winner Incubator, a corporate initiative designed to contribute to the company’s pipeline by offering entrepreneurial scientists the opportunity to rapidly convert novel biological insights into life-saving and life-changing therapies. SAFE HARBOR This Annual Report contains forward-looking statements regarding expected future financial results, the size and growth of the markets for our products, and plans for our product development programs. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include our continued dependence on our two principal products, AVONEX® and RITUXAN®, the uncertainty of success in commercializing other products, including TYSABRI® , the occurrence of adverse safety events with our products, the consequences of the nomination of directors for election to our Board by an activist shareholder, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed in February 2008 and our quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date of this Annual Report, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise. All of the Company’s SEC filings are available at the SEC’s website, www.sec.gov, or upon request from the Company’s Investor Relations Department (617.679.2812). Product Pipeline DRUG INDICATION PRECLINICAL PHASE ONE PHASE TWO PHASE THREE FILING APPROVED ONCOLOGY RITUXAN® (rituximab) Non-Hodgkin’s Lymphoma RITUXAN® (rituximab) Chronic Lymphocytic Leukemia Anti-CD80 (galiximab) Non-Hodgkin’s Lymphoma Anti-CD23 (lumiliximab) Chronic Lymphocytic Leukemia M200 / anti-α5β1 (volociximab) Solid Tumors (Ovarian, NSCLC, Melanoma) HSP90 Inhibitors Solid Tumors (FDG-PET GIST) TYSABRI® (natalizumab) Multiple Myeloma Anti-Cripto-DM4 Solid Tumors Anti-IGF-1R Solid Tumors Renée Shapiro Raf Inhibitor Solid Tumors Molecular Discovery IMMUNOLOGY RITUXAN® (rituximab) Rheumatoid Arthritis (TNF-IR) FUMADERM® (fumaric acid esters) Psoriasis TYSABRI® (natalizumab) Crohn’s Disease RITUXAN® (rituximab) Rheumatoid Arthritis (DMARD-IR) RITUXAN® (rituximab) Lupus 2nd gen Anti-CD20 (ocrelizumab) Rheumatoid Arthritis LTβR-Ig (baminercept alfa) Rheumatoid Arthritis Anti-CD40L Systemic Lupus Erythematosus Megan Weaver Anti-TWEAK Rheumatoid Arthritis Leadership Award Winner NEUROLOGY AVONEX® (interferon beta-1a) Multiple Sclerosis – Relapsing Remitting TYSABRI® (natalizumab) Multiple Sclerosis – Relapsing Remitting BG-12 Multiple Sclerosis – Relapsing Remitting RITUXAN® (rituximab) Multiple Sclerosis – Primary Progressive RITUXAN® (rituximab) Multiple Sclerosis – Relapsing Remitting Anti-IL2R (daclizamub) Multiple Sclerosis – Relapsing Remitting CDP323 Multiple Sclerosis – Relapsing Remitting BIIB014 Parkinson’s Disease Neublastin Neuropathic Pain Livia Carvalho LINGO Multiple Sclerosis Manufacturing CARDIOPULMONARY Lixivaptan Acute Heart Failure with Hyponatremia & EMERGING ADENTRI® Acute Heart Failure – IV THERAPEUTIC AREAS ADENTRI® Chronic Heart Failure – Oral Aviptadil Pulmonary Arterial Hypertension Long-Acting rFactor IX Hemophilia B Michaela Lerner Long-Acting rFactor VIII Hemophilia A Leadership Award Winner Product Pipeline DRUG INDICATION PRECLINICAL PHASE ONE PHASE TWO PHASE THREE FILING APPROVED ONCOLOGY RITUXAN® (rituximab) Non-Hodgkin’s Lymphoma RITUXAN® (rituximab) Chronic Lymphocytic Leukemia Anti-CD80 (galiximab) Non-Hodgkin’s Lymphoma Anti-CD23 (lumiliximab) Chronic Lymphocytic Leukemia M200 / anti-α5β1 (volociximab) Solid Tumors (Ovarian, NSCLC, Melanoma) HSP90 Inhibitors Solid Tumors (FDG-PET GIST) TYSABRI® (natalizumab) Multiple Myeloma Anti-Cripto-DM4 Solid Tumors Anti-IGF-1R Solid Tumors Renée Shapiro Raf Inhibitor Solid Tumors Molecular Discovery IMMUNOLOGY RITUXAN® (rituximab) Rheumatoid Arthritis (TNF-IR) FUMADERM® (fumaric acid esters) Psoriasis TYSABRI® (natalizumab) Crohn’s Disease RITUXAN® (rituximab) Rheumatoid Arthritis (DMARD-IR) RITUXAN® (rituximab) Lupus 2nd gen Anti-CD20 (ocrelizumab) Rheumatoid Arthritis LTβR-Ig (baminercept alfa) Rheumatoid Arthritis Anti-CD40L Systemic Lupus Erythematosus Megan Weaver Anti-TWEAK Rheumatoid Arthritis Leadership Award Winner NEUROLOGY AVONEX® (interferon beta-1a) Multiple Sclerosis – Relapsing Remitting TYSABRI® (natalizumab) Multiple Sclerosis – Relapsing Remitting BG-12 Multiple Sclerosis – Relapsing Remitting RITUXAN® (rituximab) Multiple Sclerosis – Primary Progressive RITUXAN® (rituximab) Multiple Sclerosis – Relapsing Remitting Anti-IL2R (daclizamub) Multiple Sclerosis – Relapsing Remitting CDP323 Multiple Sclerosis – Relapsing Remitting BIIB014 Parkinson’s Disease Neublastin Neuropathic Pain Livia Carvalho LINGO Multiple Sclerosis Manufacturing CARDIOPULMONARY Lixivaptan Acute Heart Failure with Hyponatremia & EMERGING ADENTRI® Acute Heart Failure – IV THERAPEUTIC AREAS ADENTRI® Chronic Heart Failure – Oral Aviptadil Pulmonary Arterial Hypertension Long-Acting rFactor IX Hemophilia B Michaela Lerner Long-Acting rFactor VIII Hemophilia A Leadership Award Winner Letter to our Shareholders Page 1 Page 2 2007 Annual Report By the end of 2007, TYSABRI had been RITUXAN, already the world’s leading approved in more than 30 countries and cancer drug, continued its expansion into more than 21,000 patients worldwide autoimmune disorders with growing sales were receiving this therapy. TYSABRI’s in rheumatoid arthritis and positive clinical market share is currently growing faster trial results in multiple sclerosis. than any other multiple sclerosis therapy. Mike Lynch TYSABRI Patient Natasha Williams RITUXAN RA Patient Fellow Shareholders: 2007 was a year of significant accomplishment for Biogen During this four-year period, we delivered on our revenue • Leveraging our core capabilities to expand development into recently approved a label expansion to reflect clinical trial Idec, as we continued to pursue our important mission of and earnings goals, generating 14 percent compound promising new therapeutic areas, including cardiovascular data showing that RITUXAN slows the progression of joint developing innovative treatments for patients with high annual revenue growth and 22 percent compound annual disease and hemophilia. damage in RA patients. We announced positive results from unmet medical needs. non-GAAP earnings growth. We were able to combine this a Phase III clinical trial of RITUXAN in patients who had an Reflecting these accomplishments over the past four years, strong financial performance with significant commercial inadequate response to prior treatment with methotrexate, During the year, we generated strong financial performance Biogen Idec’s market capitalization has increased by more and operating achievements including: a disease modifying antirheumatic drug, and based on that significantly advanced and expanded our product pipeline than $4.7 billion, from $12 billion on Dec. 31, 2003, to $16.7 data, we plan to file for approval to market RITUXAN as a and returned $3 billion to shareholders