-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, HRq1J2v/IIjgwKD/MdhfUKiEzq8AAZUcJwvrBEwGsf1KhcaGtHHPxnwauNvQWgL4 lGoBSUqqZkuPUjgvu4k5+Q== 0000950135-01-001092.txt : 20010409 0000950135-01-001092.hdr.sgml : 20010409 ACCESSION NUMBER: 0000950135-01-001092 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 8 CONFORMED PERIOD OF REPORT: 20001231 FILED AS OF DATE: 20010330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOGEN INC CENTRAL INDEX KEY: 0000714655 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043002117 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 000-12042 FILM NUMBER: 1588475 BUSINESS ADDRESS: STREET 1: 14 CAMBRIDGE CTR CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 6176792000 MAIL ADDRESS: STREET 1: 14 CAMBRIDGE CTR CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: BIOGEN NV DATE OF NAME CHANGE: 19880622 10-K 1 b38146bge10-k.txt BIOGEN INC. 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2000 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-12042 BIOGEN, INC. (Exact name of Registrant as specified in its charter) Massachusetts 04-3002117 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 14 Cambridge Center, Cambridge, Massachusetts 02142 (Address of principal executive offices) (zip code) Registrant's telephone number, including area code: (617) 679-2000 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.01 par value (Title of class) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No --- --- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] Aggregate market value of Common Stock held by nonaffiliates of the Registrant at March 29, 2001 (excludes shares held by directors): $9,485,799,873. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, direct or indirect, to direct or cause the direction of management or policies of the Registrant, or that such person is controlled by or under common control with the Registrant. Common Stock outstanding at March 29, 2001: 150,270,097 shares. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant's definitive Proxy Statement for its 2001 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report, and portions of the Registrant's 2000 Annual Report to Shareholders are incorporated by reference into Parts II and IV of this Report. 2 PART I ITEM 1 - BUSINESS OVERVIEW Biogen, Inc. ("Biogen" or the "Company") is a biopharmaceutical company principally engaged in the business of developing, manufacturing and marketing drugs for human health care. Biogen, which was founded in 1978, currently derives revenues from sales of its AVONEX(R) (Interferon beta-1a) product for the treatment of relapsing forms of multiple sclerosis and from royalties on worldwide sales by the Company's licensees of a number of products covered under patents controlled by the Company. Such products include certain forms of alpha interferon, hepatitis B vaccines and hepatitis B diagnostic test kits, among others. The Company's revenues from sales of AVONEX(R) in 2000 were approximately $761.1 million, making AVONEX(R) the worldwide market leader among multiple sclerosis therapies. The Company's royalty revenues in 2000 were approximately $165.4 million. Biogen continues to have an active development program related to AVONEX(R), and is conducting several important clinical trials of the product. In 2000, Biogen announced the results of its CHAMPS trial, begun in 1996, to study the effect of AVONEX(R) in delaying the development of clinically definite multiple sclerosis in patients who had experienced an isolated, well-defined neurologic event consistent with MS. The study showed a highly statistically significant beneficial effect of AVONEX(R) on delaying the development of clinically definite multiple sclerosis as compared to the placebo. A follow-on open label trial is ongoing. In 2000, Biogen also completed a small Phase 2 pilot study of the use of AVONEX(R) in the treatment of patients with primary progressive multiple sclerosis. In the study the patient group treated with AVONEX(R) experienced a significant reduction in the size of brain lesions seen on MRI, a measure of the extent of damage the disease has caused to the brain, as compared to the placebo group. In January 2001, Biogen announced preliminary results of a study of the use of AVONEX(R) in the treatment of patients with secondary progressive multiple sclerosis. In the study the patient group treated with AVONEX(R) showed a statistically significant reduction in the rate of disability accumulation compared to the placebo group as measured by the multiple sclerosis functional composite (MSFC) endpoint. Biogen also continues to devote significant resources to its other ongoing development efforts. In 2000, the Company completed dosing in its Phase 3 clinical studies of its AMEVIVE(TM) (alafacept) product in patients with moderate to severe chronic plaque psoriasis. Biogen anticipates that the results of these studies will be made available during the second quarter of 2001. In January 2001, the Company announced positive results from two large Phase 2 studies of the use of Antegren(R) (natalizumab) in the treatment of multiple sclerosis and Crohn's Disease. Antegren(R) is being developed in a collaboration between Biogen and Elan Corporation, plc ("Elan"). Based on the Phase 2 results, Biogen and Elan plan to proceed with Phase 3 clinical studies of Antegren(R) in both MS and Crohn's Disease in 2001. Biogen also plans to begin Phase 1 clinical trials of several products in 2001, including its small molecule adenosine A1 receptor antagonist which is being developed as a potential treatment for congestive heart failure and its soluble lymphotoxin beta receptor Ig fusion protein being developed as a potential treatment for several autoimmune diseases. 2 3 In addition to its development programs, Biogen also has many earlier-stage research programs. Biogen's research strategy is to direct its efforts toward finding therapeutics in four major research focus areas: Fibrosis, oncology, immunomodulation, and neurodegeneration. The Company believes that this focused research effort along with the leveraging of its traditional strengths in biologics research, protein chemistry and protein manufacturing will allow the Company to be in a position to capitalize on the potential of the genomics era. The Company is exploring the use of functional genomics tools and technology to find novel therapeutics through its collaborations with Eos Biotechnology, Inc., Lexicon Genetics Incorporated, MorphoSys AG, Gene Logic, Inc., Incyte Genomics, Inc. and Genetica Incorporated. AVONEX(R) (INTERFERON BETA-1A) Biogen currently markets and sells AVONEX(R) (Interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis. Multiple sclerosis is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. Patients with active relapsing multiple sclerosis experience an uneven pattern of disease progression characterized by periods of stability interrupted by flareups of the disease after which the patient returns to a new baseline of functioning. AVONEX(R) is a recombinant form of a protein produced by fibroblast cells in response to viral infection. AVONEX(R) has been shown in a pivotal clinical trial both to slow the accumulation of disability and to reduce the frequency of exacerbations in patients with relapsing forms of multiple sclerosis. Biogen began selling AVONEX(R) in the United States in 1996, and in the European Union ("EU") in 1997. AVONEX(R) is on the market in over 50 countries, including Argentina, Australia, Brazil, Canada, Chile, Columbia, Cyprus, the Czech Republic, the countries of the EU, Hungary, Israel, Mexico, Norway, Slovakia, South Africa, Switzerland, Turkey and the United States. In the United States, Canada and most of the major countries of the EU, Biogen uses its own sales force to market AVONEX(R). In those countries, Biogen distributes AVONEX(R) principally through wholesale distributors of pharmaceutical products, mail order, specialty distributors or shipping service providers. In other countries, Biogen sells AVONEX(R) to distribution partners who are then responsible for most marketing and distribution activities. The Company has entered into distribution agreements covering Australia, Eastern Europe, Greece, Israel, Italy, Japan, Latin America, the Middle East, New Zealand, Portugal, South Africa, Spain and Turkey. Under most of these agreements, the distribution partners are responsible for marketing and distributing AVONEX(R). Biogen continues to have an active development program related to AVONEX(R). In February 2000, Biogen announced results of a clinical study of AVONEX(R) in patients who had experienced only one confirmed demyelinating event (multiple sclerosis-type exacerbation). The study, called the Controlled High Risk AVONEX(R) Multiple Sclerosis Prevention Study (CHAMPS), which was initiated in 1996, showed a highly statistically significant beneficial effect of AVONEX(R) in delaying the development of clinically definite multiple sclerosis compared to placebo. The CHAMPS study was stopped early following positive results. Biogen also completed in 2000 a dose comparison study, initiated in 1996, comparing the approved dosage of AVONEX(R) with a higher dose. The study confirmed that the higher dose provided no additional benefit as compared to the currently marketed 30 mcg dose, and that the two doses were equally effective in reducing disability progression in patients with relapsing/remitting MS. Biogen also completed in 2000 a small Phase 2 pilot study of AVONEX(R) 3 4 in the treatment of primary progressive multiple sclerosis. In the study, the patient group treated with AVONEX(R) experienced a significant reduction in the size of brain lesions seen on MRI as compared to the placebo group. In 2001, Biogen announced completion of a double blinded, randomized clinical study of AVONEX(R) in patients with secondary progressive multiple sclerosis. In the study, initiated in 1998, treatment with AVONEX(R) was shown to reduce the progression of disability in secondary progressive MS by 27% as compared to treatment with the placebo and as measured by the multiple sclerosis functional composite (MSFC) endpoint. Biogen is currently conducting several other clinical studies of AVONEX(R). These include: an open-label follow-up study initiated in 1995 to obtain long-term safety and antigenicity data and an open label follow-up study initiated in 2000 to study the long-term effect of AVONEX(R) on patients who participated in the CHAMPS study. Biogen is also exploring new ways to improve the formulation and delivery of AVONEX(R). In February 1999, Biogen entered into a collaborative agreement with Inhale Therapeutic Systems, Inc. under which the parties are working towards development of a dry powder formulation of AVONEX(R) for pulmonary delivery using Inhale's deep-lung delivery system. Biogen is also continuing to work towards development of a pre-filled syringe formulation of AVONEX(R). Revenues from sales of AVONEX(R) in 2000 were $761.1 million or approximately 82% of total revenues. Revenues from sales of AVONEX(R) in 1999 and 1998 were $620.6 million and $394.9 million, respectively, or approximately 78% and 71% of total revenues, respectively. Approximately 73% of AVONEX(R) sales in 2000, 71% of AVONEX(R) sales in 1999 and 77% of AVONEX(R) sales in 1998 were generated in the United States. Sales to three major wholesale distributors and a specialty distributor in the United States accounted for 18%, 13%, 12% and 11%, respectively, of total revenues in 2000. MAJOR RESEARCH AND DEVELOPMENT PROGRAMS Biogen's research is focused on biological systems and processes where its scientific expertise in molecular biology, cell biology, immunology and protein chemistry can lead to a greater understanding of disease processes and, as a result, to the creation of new pharmaceuticals. Biogen selects product candidates from its research programs to test in clinical trials, focusing its efforts on those agents which it believes have the greatest potential competitive advantages and large commercial markets. Described below are Biogen's major research programs. AMEVIVE(TM) (ALAFACEPT) Inflammation is the result of the body's immune response to infection and injury. In many autoimmune diseases, the inflammation process is directed inappropriately against the body's own tissues, causing temporary or permanent damage. Biogen has focused the efforts of its inflammation programs on developing drugs to inhibit specific cellular interactions critical to the inflammation process. Central to inflammation is the activation of T-cells, specialized white blood cells which initiate and control the immune response. One of the cellular pathways which is important for the activation of T-cells is the LFA-3/CD2 pathway. AMEVIVE(TM) (alafacept) is a recombinantly engineered protein designed to modulate immune responses by binding to the CD2 receptor. Biogen is developing AMEVIVE(TM) as a treatment for certain autoimmune diseases. In 1999, the Company completed a Phase 4 5 2b clinical study of AMEVIVE(TM) in patients with moderate to severe chronic plaque psoriasis. Based on positive data from the Phase 2b study, the Company began Phase 3 studies in North America and Europe. The Company has completed dosing of the Phase 3 studies, and expects that results of the studies will be made available in the second quarter of 2001. Psoriasis is a chronic autoimmune disease that is characterized by inflammation and thickening of the skin. An estimated 500,000 psoriasis patients in the United States have a severe enough form of the disease to need systemic therapies. Biogen also has begun initial work for clinical trials of AMEVIVE(TM) in other indications. ANTEGREN(R) (NATALIZUMAB) Antegren(R) (natalizumab) is a humanized monoclonal antibody, the first of a new class of potential therapeutics known as alpha 4 integrin inhibitors. Antegren(R) is designed to block cell adhesion to blood vessel walls and subsequent migration of white blood cells into tissue, by binding to the cell surface receptors known as alpha-4-beta-1 (VLA-4) and alpha-4-beta-7 which are found on most types of white blood cells. The migration of white blood cells into tissue is part of the body's normal response during inflammation. This inflammatory response can be severely damaging or even life threatening when it is directed against the body's own tissue in autoimmune diseases and may cause serious collateral injury in chronic immune inflammatory diseases. In August of 2000, Biogen entered into a collaborative research, development and license agreement with Elan Corporation, plc ("Elan") under which Biogen and Elan are working together to develop, manufacture and commercialize Antegren(R) worldwide. In January of 2001, Biogen and Elan announced positive results from two large Phase 2 clinical studies of Antegren(R) in multiple sclerosis and Crohn's Disease. The companies expect to initiate Phase 3 clinical studies of Antegren(R) in both of these diseases in 2001. ADENOSINE A1 RECEPTOR ANTAGONISTS In March 1997, Biogen entered into a research collaboration and license agreement with CV Therapeutics, Inc. ("CVT") pursuant to which the Company obtained rights under CVT's patents and know-how to develop and market molecules that act as highly selective antagonists of the adenosine A1 receptor. The adenosine A1 receptor is expressed principally in the heart, brain and kidney, and in the kidney mediates vasoconstriction, renal function and reabsorption of fluids. Biogen is developing small molecule adenosine A1 receptor antagonists as a potential treatment for congestive heart failure. Congestive heart failure is a chronic progressive disease that affects four to five million people in the United States. Patients with the disease experience both a chronic course as well as acute episodes of heart failure that usually require hospitalization. Reduction in kidney function and the formation of edema, or fluid retention, in lungs and extremities are significant symptoms of chronic heart failure, leading to increased morbidity, hospitalization and death. In early 2000, Biogen announced that it had successfully completed a Phase 2 study of a proof-of-concept adenosine A1 receptor antagonist molecule in patients with moderate to severe congestive heat failure. Since then, the Company has been working on the development of a possible commercial compound and anticipates commencing a Phase 1 study with the commercial compound in 2001 in both oral and intravenous forms. 5 6 LT-BETA RECEPTOR The lymphotoxin-beta receptor ("LT-Beta Receptor") pathway is involved in controlling the maintenance of proper immune interactions and the correct positioning of key cell types in the immune system. Both elements are crucial for the immune system to function properly. The LT-Beta Receptor pathway serves as a novel access point to modulate autoimmune disease. Biogen is developing its LT-Beta Receptor Ig fusion protein as a potential treatment for certain autoimmune diseases via various routes of administration and completed dosing in healthy patients for Phase 1 safety studies in March, 2001. GENE THERAPY In August 2000, the Company entered into a collaborative research agreement with Targeted Genetics Corporation, successor in interest to Genovo, Inc. ("Genovo") continuing Biogen's agreement with Genovo for the development of certain human gene therapy treatments. OTHER RESEARCH PROGRAMS Biogen's research strategy is to direct its efforts toward finding therapeutics in four major research focus areas: fibrosis, oncology, immunomodulation, and neurodegeneration. The Company believes that this focused research effort along with the leveraging of its traditional strengths in biologics research, protein chemistry and protein manufacturing will allow the Company to be in a position to capitalize on the potential of the genomics era. The Company is exploring the use of functional genomics tools and technology to find novel therapeutics through its collaborations with Eos Biotechnology, Inc., Lexicon Genetics Incorporated, MorphoSys AG, Gene Logic, Inc., Incyte Genomics, Inc. and Genetica Incorporated. As part of its further research efforts, Biogen is also exploring the use of growth factors to prevent or treat the degeneration of organs following damage and investigating new ways to modify immune responses more specifically in order to treat diseases of the immune system. RESEARCH AND DEVELOPMENT COSTS For the years ended December 31, 2000, 1999 and 1998, Biogen's research and development costs were approximately $302.8 million, $221.2 million and $177.2 million, respectively. RISKS ASSOCIATED WITH DRUG DEVELOPMENT AND COMMERCIALIZATION Certain of the statements set forth above regarding the Company's research and development programs, such as statements regarding the anticipated commencement of clinical trials of drugs in development, are forward-looking, and are based upon the Company's current belief as to the outcome and timing of such future events. These events are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Many important factors affect the Company's ability to successfully develop and commercialize drugs, including the need to demonstrate the safety and efficacy of drug candidates at each stage of the clinical trial process, to overcome technical hurdles that may arise, to meet applicable regulatory standards, to receive required regulatory approvals, to be capable of producing drug candidates in commercial quantities at reasonable costs, to obtain and maintain all necessary patents or licenses, to compete successfully against other products, and to market products successfully. There can 6 7 be no assurance that any of the products described in this section or resulting from Biogen's research and development programs will be successfully developed, prove to be safe and efficacious at each stage of clinical trials, meet applicable regulatory standards, be capable of being produced in commercial quantities at reasonable costs, be successfully marketed or successfully meet challenges from competitive products. For a detailed discussion of the risks associated with the Company's drug development and commercialization program, see the Company's 2000 Annual Report to Shareholders --- "Management's Discussion and Analysis of Financial Condition and Results of Operations --- Outlook," which is incorporated herein by reference under Item 7 hereof. PRINCIPAL PRODUCTS BEING MARKETED OR DEVELOPED BY BIOGEN'S LICENSEES ALPHA INTERFERON Alpha interferon is a naturally occurring protein produced by normal white blood cells. Biogen has been granted patents covering the production of alpha interferon through recombinant DNA techniques. See "Patents and Other Proprietary Rights." Biogen's worldwide licensee for recombinant alpha interferon, Schering-Plough Corporation ("Schering-Plough"), first began commercial sales of its INTRON(R) A brand of alpha interferon in the United States in 1986 for hairy-cell leukemia. Schering-Plough now sells INTRON(R) A worldwide for as many as 16 indications. The United States Food and Drug Administration (the "FDA") has approved INTRON(R) A for the treatment of chronic hepatitis B and hepatitis C, hairy-cell leukemia, AIDS-related Kaposi's sarcoma, condylomata acuminata, for injection as an adjuvant treatment to surgery in patients at high risk for systemic recurrence of malignant melanoma, and for use in conjunction with anthracycline-containing combination chemotherapy for the initial treatment of patients with clinically aggressive non-Hodgkin's lymphoma. Schering-Plough also sells alpha interferon in two other forms, REBETRON(R), a combination product containing INTRON(R) A and REBETROL(R) (ribavirin, USP capsules) and PEG-INTRON(R), a pegylated form of alpha interferon recently approved by the FDA and approved in May 2000 by European Union regulatory authorities for use in the treatment of hepatitis C. Royalties from Schering-Plough on sales of INTRON(R) A accounted for approximately 10%, 13% and 16% of Biogen's revenues in 2000, 1999 and 1998, respectively. For a discussion of the length of Schering-Plough's royalty obligation to Biogen on sales of alpha interferon products and a current dispute with Schering-Plough related to royalty amounts, see "Patents and Other Proprietary Rights - Recombinant Alpha Interferon." HEPATITIS B VACCINES AND DIAGNOSTICS Hepatitis B is a blood-borne disease which causes a serious infection of the liver and substantially increases the risk of liver cancer. More than 250 million people worldwide have chronic hepatitis B virus infections. Biogen holds several important patents related to hepatitis B antigens produced by genetic engineering techniques. See "Patents and Other Proprietary Rights - Recombinant Hepatitis B Antigens." These antigens are used in recombinant hepatitis B vaccines and in diagnostic test kits used to detect hepatitis B infection. 7 8 Hepatitis B Vaccines Approximately 100 countries around the world, including the United States, have added the vaccination against hepatitis B to their routine immunization programs for all children. The United States Centers for Disease Control and the American Academy of Pediatrics have also recommended universal immunization of ten-year-old children and at-risk adolescents. The United States Occupational Safety and Health Administration has recommended that all persons with an occupational exposure to blood and other infectious material receive the hepatitis B vaccine. GlaxoSmithKline plc ("SmithKline") and Merck and Co, Inc. ("Merck") are the two major worldwide marketers of hepatitis B vaccines. Biogen has licensed to SmithKline exclusive rights under Biogen's hepatitis B patents to market hepatitis B vaccines in the major countries of the world, excluding Japan. SmithKline currently pays Biogen royalties based on sales of SmithKline's vaccine in the United States and in over 15 other countries. In 1990, SmithKline and Biogen entered into a sublicense arrangement with Merck under which Biogen currently receives royalties. Biogen has also licensed rights relating to hepatitis B vaccines under its hepatitis B patents to Merck and The Green Cross Corporation on a non-exclusive basis in Japan. Hepatitis B Diagnostics Biogen has licensed its proprietary hepatitis B rights, on an antigen-by-antigen and nonexclusive basis, to diagnostic kit manufacturers. Biogen currently has hepatitis B license or license and supply agreements for diagnostic use with more than 15 companies, including Abbott Laboratories, the major worldwide marketer of hepatitis B diagnostic kits, Ortho-Clinical Diagnostics, Organon Teknika B.V. and Roche Diagnostic Systems, Inc. For a discussion of the length of the royalty obligation of SmithKline and Merck on sales of hepatitis B vaccines and the obligation of Biogen's other licensees on sales of hepatitis B-related diagnostic products, see "Patents and Other Proprietary Rights - Recombinant Hepatitis B Antigens." OTHER PRODUCTS In 1996, Biogen granted a sublicense to Pharmacia & Upjohn AB ("Pharmacia & Upjohn") under certain patent rights to proprietary protein secretion technology exclusively licensed to Biogen by Harvard University. Under the terms of the license agreement, Biogen receives ongoing royalties on sales of Pharmacia & Upjohn's recombinant human growth hormone product, Genotropin(R), in the United States, Canada and Japan. In March 1997, Biogen granted to The Medicines Company ("TMC") exclusive worldwide rights to develop and market Biogen's bivalirudin product, a direct thrombin inhibitor now known as ANGIOMAX(TM). Biogen will receive milestone and royalty payments from TMC if TMC is successful in its efforts to develop and commercialize the drug. In December 2000, TMC received clearance from the FDA to market and sell ANGIOMAX(TM) in the United States for use as an anticoagulant in patients undergoing coronary angioplasty. TMC currently markets ANGIOMAX(TM) in New Zealand for this use. In Europe, the filing for marketing approval of ANGIOMAX(TM) is under regulatory review by the European Agency for the Evaluation of Medicinal Products. 8 9 Financial information about foreign operations and export sales is included in the Company's 2000 Annual Report to Shareholders --- Notes to Consolidated Financial Statements --- Note 11, incorporated herein by reference under Item 8 hereof. PATENTS AND OTHER PROPRIETARY RIGHTS Biogen has filed numerous patent applications in the United States and various other countries seeking protection of a number of its processes and products. Patents have been issued on many of these applications. The Company has also obtained rights to various patents and patent applications under licenses with third parties which provide for the payment of royalties by the Company. The ultimate degree of patent protection that will be afforded to biotechnology products and processes, including those of Biogen, in the United States and in other important markets remains uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in these countries. There is no certainty that Biogen's existing patents or others, if obtained, will afford substantial protection or commercial benefit to Biogen. Similarly, there is no assurance that the Company's pending patent applications or patent applications licensed from third parties will ultimately be granted as patents or that those patents that have been issued or are issued in the future will prevail if they are challenged in court. There has been, and Biogen expects that there may continue to be, significant litigation in the industry regarding patents and other intellectual property rights. Intellectual property litigation could therefore create uncertainty and consume substantial resources. RECOMBINANT ALPHA INTERFERON Biogen has obtained approximately 67 patents in countries around the world, including the United States and numerous other countries, covering the production of recombinant alpha interferons. Biogen has granted an exclusive worldwide license to Schering-Plough under Biogen's alpha interferon patents, and receives royalties from Schering-Plough on sales of its brands of alpha interferon, including INTRON(R) A. See "Principal Products Being Marketed or Developed by Biogen's Licensees - Alpha Interferon". Many of Biogen's alpha interferon patents have recently expired or will expire during 2001. Schering-Plough's royalty obligation to Biogen on sales of INTRON(R) A in Japan and Europe terminated upon expiration of Biogen's alpha interferon patent in such territories in January 2001, except in France and Italy where Biogen has obtained supplementary protection certificates extending the coverage in France until 2003 and in Italy until 2007. In December 1996, Schering-Plough filed suit in its own name, as Biogen's exclusive licensee, against Amgen, Inc. ("Amgen") to enforce Biogen's United States alpha interferon patent claiming it to be infringed by Amgen's consensus interferon product known as Infergen(R). In July 1998, the United States District Court for the District of Delaware construed the claims of the patent narrowly, which precluded finding Amgen's consensus interferon product to be an infringing product. Schering-Plough appealed the 1998 ruling and in a ruling by the Court of Appeals for the Federal Circuit in August 2000, the District Court's narrow claim construction was affirmed, resulting in a determination that Amgen's consensus interferon product did not infringe the Biogen patent. Schering-Plough has taken the position that as a result of the Court of Appeal's decision in the Amgen case narrowing the scope of Biogen's United States alpha interferon patent, the patent no longer covers Schering-Plough's alpha interferon product, and that, as a result, Schering-Plough no longer has an obligation to pay royalties under that patent on sales of its alpha interferon products in the United 9 10 States. Until January 2001 when Biogen's EU patent expired, Schering-Plough continued to pay royalties on sales of INTRON(R) A in the United States based on the manufacture of the product in the EU. The dispute related to the impact of the Amgen decision on Schering-Plough's royalty obligation does not affect its obligation to pay royalties on U.S. sales of its alpha interferon products after July 2002. In consideration of assignment to Schering-Plough by Biogen of a Biogen patent application claiming recombinant mature human alpha interferon, Schering-Plough has agreed to pay to Biogen certain sums on sales by Schering-Plough of alpha interferon products in the United States from the date when Biogen's existing United States alpha interferon patent expires (i.e., July 2002) until expiration of an alpha interferon patent expected to be issued to Hoffman-LaRoche Inc. ("Roche") and Genentech, Inc. ("Genentech"). The Roche/Genentech patent was the subject of a lawsuit brought by Biogen which was ultimately settled. Schering-Plough entered into an agreement with Roche as part of the settlement of the matter. Biogen is currently in discussions with Schering-Plough to work to resolve the twelve to eighteen month royalty issue and to resolve claims by Biogen related to underpayment of royalties by Schering- Plough. RECOMBINANT HEPATITIS B ANTIGENS Biogen has obtained numerous patents in countries around the world, including in the United States and in European countries, covering the recombinant production of hepatitis B surface, core and "e" antigens. Biogen has licensed its recombinant hepatitis B antigen patent rights to manufacturers and marketers of hepatitis B vaccines and diagnostic test kits, and receives royalties on sales of the vaccines and test kits by its licensees. See "Principal Products Being Marketed or Developed by Biogen's Licensees - Hepatitis B Vaccines and Diagnostics." The obligation of SmithKline and Merck to pay royalties on sales of hepatitis B vaccines and the obligation of Biogen's other licensees under its hepatitis B patents to pay royalties on sales of diagnostic products will terminate upon expiration of Biogen's hepatitis B patents in each licensed country. Biogen's existing United States hepatitis B patent will expire in 2004. Biogen's European hepatitis B patents expired at the end of 1999, except in those countries in which Biogen has obtained supplementary protection certificates. To date, Biogen has received supplementary protection certificates in Austria, Belgium, France, Great Britain, Ireland, Italy, Luxembourg, The Netherlands, Sweden and Switzerland, and has a number of granted or pending registrations of the Great Britain supplementary protection certificates in various British Territories. The additional coverage afforded by the supplementary protection certificates, or related registrations, ranges from two to eight years. RECOMBINANT BETA INTERFERON In 1997, the Technical Board of Appeal of the European Patent Office revoked Biogen's European patent covering the production of recombinant beta interferon. Biogen appealed the decision, but a recent decision in another case denied that such a right of appeal exists. Consequently, Biogen's appeal stands dismissed and the patent stands revoked. Biogen had sued InterPharm Laboratories Ltd. ("InterPharm"), an affiliate of Ares Serono, S.A. ("Serono"), and related defendants under a related Israeli patent claiming that the manufacture by InterPharm of Serono's Rebif(R) (Interferon Beta-1a) infringes Biogen's Israeli patent. In October 2000, Biogen reached a settlement with the defendants and the case was dismissed in Israel. In Germany, a patent with similar claims was the subject of a nullity proceeding instituted by Schering AG in the German Federal Patent Court. In March 1998, the German Federal Patent Court upheld the German patent but with substantially narrower claims. Biogen has appealed the decision but does not anticipate any decision until sometime during 2002. 10 11 Other parties have pending patent applications or issued patents in the United States, Europe and other countries with claims to key intermediates in the production of beta interferon (the "Taniguchi patents") and to beta interferon itself (the "Roche patents"). Biogen has obtained non-exclusive rights in various countries of the world, including the United States, Japan and most European countries, to manufacture, use and sell AVONEX(R) under the Taniguchi patents and has obtained worldwide, non-exclusive rights under the Roche patents. On July 3, 1996, Berlex Laboratories, Inc. ("Berlex") filed suit against Biogen in the United States District Court for the District of New Jersey alleging infringement by Biogen of Berlex's "McCormick" patent (U.S. Patent No. 5,376,567) in the United States in the production AVONEX(R). In November 1996, Berlex's New Jersey action was transferred to the United States District Court in Massachusetts and consolidated for pre-trial purposes with a related declaratory judgment action previously filed by Biogen. On August 18, 1998, Berlex filed a second suit against Biogen alleging infringement by Biogen of a patent which was issued to Berlex in August 1998 and which is related to the McCormick patent (U.S. Patent No. 5,795,779). On September 23, 1998, the cases were consolidated for pre-trial and trial purposes. Berlex sought a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. A hearing on the parties' summary judgment motions in the case was completed in March 2000. In September 2000, the District Court rendered final judgment in favor of Biogen and against Berlex determining that Biogen's production of AVONEX(R) did not infringe any of the claims of the Berlex patents. Berlex has appealed this decision to the Court of Appeals for the Federal Circuit, and the parties are in the process of briefing the matter for oral argument before the court. For a further discussion, see Item 3 hereof - Legal Proceedings, and the Company's 2000 Annual Report to Shareholders --- Notes to Consolidated Financial Statements --- Note 9, incorporated herein by reference under Item 8 hereof. In 1995, the Company filed an opposition with the Opposition Division of the European Patent Office opposing a European patent (the "Rentschler I Patent") issued to Dr. Rentschler Biotechnologie GmbH ("Rentschler") relating to compositions of matter of beta interferon. In 1997, the European Patent Office issued a decision revoking the Rentschler I Patent. Rentschler appealed that decision. An oral hearing on the appeal took place in December 2000. At the oral hearing in order to gain reinstatment of the patent, Rentschler narrowed the patent claims so as to claim only a specific cell line. Biogen does not use the specific cell line now claimed. On October 13, 1998, the Company filed another opposition with the Opposition Division of the European Patent Office to oppose a second European patent issued to Rentschler (the "Rentschler II Patent") with certain claims regarding compositions of matter of beta interferon with specific regard to the structure of the glycosylated molecule. The parties are in the process of filing further evidence and arguments with the European Oppositon Division. A decision on the Rentschler II Patent has not been issued to date. For a more detailed discussion, see the Company's 2000 Annual Report to Shareholders --- "Management's Discussion and Analysis of Financial Condition and Results of Operations - Legal Matters" incorporated herein by reference under Item 7 hereof. OTHER PATENTS In March 1995, Biogen filed suit in the U.S. District Court for the District of Massachusetts seeking to enjoin Amgen from manufacturing and selling its Neupogen(R) human granulocyte colony stimulating factor in the United States and asking for damages for infringing activities. Biogen believes 11 12 that to make Neupogen(R) Amgen uses technology claimed in certain of Biogen's gene expression patents. In 1998, the court interpreted the broad vector claim of one of the Biogen patents in such a way as to preclude Amgen's literal infringement of the claim. Amgen thereafter filed a motion for summary judgment based on the court's 1998 claim construction as well as a motion for a declaration of noninfringement under the doctrine of equivalents. The matter was argued to the court in November 1999 and the Court issued a decision in September 2000 allowing Amgen's motions for a declaration of noninfringement. Amgen made a motion asking the court to apply its decisions with respect to noninfringement to the remaining Biogen patents in suit and arguing that Biogen may not assert infringement under the doctrine of equivalents as a result of arguments Biogen made in obtaining the patent. On March 1, 2001, the court ruled in favor of Amgen with respect to one of the patents in the suit and ordered a hearing on Amgen's arguments with respect to the remaining patents in the suit. Biogen intends to seek reconsideration of the court's ruling. In July 1997, Biogen filed suit in the U.S. District Court for the District of Massachusetts to enjoin Amgen from manufacturing and selling its Infergen(R) consensus interferon in the United States and asking for damages for infringing activities. Biogen believes that to make Infergen(R) Amgen uses technology claimed in certain of Biogen's gene expression patents. Biogen's request to have the case consolidated with the Neupogen(R) suit was denied by the court. The case has been stayed pending resolution of the Biogen suit pertaining to Neupogen(R). In the court's March 1, 2001 decision in the Neupogen(R) suit, the court ordered a hearing on Amgen's contention that the court's ruling in the Neupogen(R) suit compels dismissal of the Infergen(R) suit. In 1994, Biogen granted Eli Lilly and Company ("Lilly") a non-exclusive license under the same patents for gene expression involved in the Amgen case. Under the license, Biogen has received royalties from Lilly since 1994 on products which use the patented vectors and methods. Based on the court's claims construction decision in the Amgen case, Lilly recently has notified Biogen that Lilly believes that it no longer owes royalties to Biogen under the agreement on any of its products. Biogen's European patent relating to gene expression was opposed by Biotechnology General Corp. in December 1993. A hearing was held by the Opposition Division of the European Patent Office in March 1996. In March 1997, the Opposition Division decided to revoke Biogen's patent. Biogen appealed the decision and a hearing is scheduled on Biogen's appeal in June 2001. Biogen successfully defended a similar opposition against issuance of a counterpart patent in Japan. THIRD-PARTY PATENTS Biogen is aware that others, including various universities and companies working in the biotechnology field, have also filed patent applications and have been granted patents in the United States and in other countries claiming subject matter potentially useful or necessary to Biogen's business. Some of those patents and patent applications claim only specific products or methods of making such products, while others claim more general processes or techniques useful or now used in the biotechnology industry. For example, Genentech has been granted patents and is prosecuting other patent applications in the United States and certain other countries which it may allege are currently used by Biogen and the rest of the biotechnology industry to produce recombinant proteins in microbial hosts. Genentech has offered to Biogen and others in the industry non-exclusive licenses under those patents and patent applications for various proteins and in various fields of use, but not for others. The ultimate scope and validity of Genentech's patents, of other existing patents, or of patents which may be granted to third parties in the future, and the extent to which Biogen may wish or be required to acquire rights 12 13 under such patents and the availability and cost of acquiring such rights, currently cannot be determined by Biogen. TRADE SECRETS AND CONFIDENTIAL KNOW-HOW Trade secrets and confidential know-how are important to Biogen's scientific and commercial success. Although Biogen seeks to protect its proprietary information by generally requiring its employees, consultants, advisors and corporate partners to sign confidentiality agreements, there can be no assurance that third parties will not either independently develop the same or similar information or obtain access to Biogen's proprietary information. COMPETITION AND MARKETING IN GENERAL Competition in the biotechnology and pharmaceutical industries is intense and comes from many and varied sources. Biogen does not believe that it or any of the other industry leaders can be considered dominant in view of the rapid technological change in the industry. Biogen experiences significant competition from specialized biotechnology firms in the United States, Europe and elsewhere and from many large pharmaceutical, chemical and other companies. Certain of these companies have substantially greater financial, marketing, research and development and human resources than Biogen. Most pharmaceutical companies have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products. Biogen believes that competition and leadership in the industry will be based on managerial and technological superiority and establishing proprietary positions through research and development. Leadership in the industry may also be influenced significantly by patents and other forms of protection of proprietary information. See "Patents and Other Proprietary Rights". A key aspect of such competition is recruiting and retaining qualified scientists and technicians. Biogen believes that it has been successful in attracting skilled and experienced scientific personnel. The achievement of a leadership position depends largely upon Biogen's continued ability to attract and retain skilled and experienced personnel, its ability to identify and exploit commercially the products resulting from research and the availability of adequate financial resources to fund facilities, equipment, personnel, clinical testing, manufacturing and marketing. Many of Biogen's competitors are working to develop products similar to those under development by Biogen. The timing of the entry of a new pharmaceutical product into the market can be an important factor in determining the product's eventual success and profitability. Early entry may have important advantages in gaining product acceptance and market share. Moreover, for certain diseases with limited patient populations, the FDA is prevented under the Orphan Drug Act, for a period of seven years, from approving more than one application for the "same" product for a single orphan drug designation, unless a later product is considered clinically superior. The EU and other jurisdictions have or are considering similar laws. Accordingly, the relative speed with which Biogen can develop products, complete the testing and approval process and supply commercial quantities of the product to the market will have an important impact on Biogen's competitive position. In addition, competition among products approved for sale may be based, among other things, on patent position, product efficacy, safety, reliability, availability and price. 13 14 AVONEX(R) (INTERFERON BETA - 1a) As a treatment for multiple sclerosis, AVONEX(R) competes with interferon beta-1b which is sold in the United States under the brand name Betaseron(R) by Berlex Laboratories, a United States affiliate of Schering AG, and is sold in Europe under the brand name Betaferon(R) by Schering AG. AVONEX(R) also faces competition from Copaxone(R) glatiramer acetate (also known as copolymer-1). In the United States, Copaxone(R) is marketed by a partnership between Teva Pharmaceutical Industries, Ltd. and Hoechst Marion Roussel, Inc. In most countries outside of the United States, AVONEX(R) also competes with Rebif(R), a recombinant interferon beta-1a product sold by Serono. In response to an application from Serono for approval of Rebif(R) in the United States for relapsing multiple sclerosis, the FDA, in March 1999, upheld its earlier ruling that, based on the data from existing clinical trials, Serono cannot market Rebif(R) in the United States for relapsing multiple sclerosis while the orphan drug status afforded to AVONEX(R) and Betaseron(R) for that indication is still in effect. AVONEX(R)'s orphan drug status for relapsing forms of the disease expires in 2003. The ruling by the FDA prompted Serono in 2000 to initiate a 12-month head-to-head study of Rebif(R) and AVONEX(R) to determine if Serono can show whether Rebif(R) is clinically superior to AVONEX(R). If positive, Serono will most likely use the results of this study in its attempts to overcome the orphan drug status of AVONEX(R) and to get Rebif(R) approved in the United States before 2003. Biogen expects Serono to release the results of the study in the third quarter of 2001. AVONEX(R) also competes in the United States with Novantrone(R) (mitoxantrone for injection) which is produced and marketed by Immunex Corporation, a majority-owned subsidiary of American Home Products Corporation. Novantrone(R) is approved for use in patients with clinically worsening forms of relapsing-remitting and secondary progressive multiple sclerosis. A number of other companies are working to develop products to treat multiple sclerosis which may in the future compete with AVONEX(R), the worldwide market leader among multiple sclerosis therapies. AVONEX(R) may also in the future face competition from off-label uses of drugs approved for other indications. Biogen believes that competition among treatments for multiple sclerosis will be based on product performance, service and price. REGULATION Biogen's current and contemplated activities and the products and processes that will result from such activities are, and will be, subject to substantial government regulation. Before new pharmaceutical products may be sold in the United States and other countries, clinical trials of the products must be conducted and the results submitted to appropriate regulatory agencies for approval. These clinical trial programs generally involve a three-phase process. Typically, in Phase 1, trials are conducted in volunteers or patients to determine the early side effect profile and, perhaps, the pattern of drug distribution and metabolism. In Phase 2, trials are conducted in groups of patients with a specific disease in order to determine appropriate dosages, expand evidence of the safety profile and, perhaps, determine preliminary efficacy. In Phase 3, large scale, comparative trials are conducted on patients with a target disease in order to generate enough data to provide the statistical proof of efficacy and safety required by national regulatory agencies. The receipt of regulatory approvals often takes a number of years, involving the expenditure of substantial resources and depends on a number of factors, including the severity of the disease in question, the availability of alternative 14 15 treatments and the risks and benefits demonstrated in clinical trials. On occasion, regulatory authorities may require larger or additional studies, leading to unanticipated delay or expense. In connection with the commercialization of products resulting from Biogen's research and development projects, it is necessary, in a number of countries, to comply with certain regulations relating to the manufacturing and marketing of such products and to the products themselves. For example, the commercial manufacturing, marketing and exporting of pharmaceutical products require the approval of the FDA in the United States and of comparable agencies in other countries. The FDA has established mandatory procedures and safety standards which apply to the manufacture, clinical testing and marketing of pharmaceutical products in the United States. The regulatory requirements and approval processes for new products in the EU operate under similar principles as those applied in the United States. The process of seeking and obtaining approval of the FDA or regulatory authorities in the EU or other regulatory authorities worldwide for a new product and licensing of the facilities in which the product is produced takes a number of years and involves the expenditure of substantial resources. In addition, the regulatory approval processes for products in the United States, the countries of the EU and other countries around the world are undergoing or may undergo changes. Biogen cannot determine what effect any changes in regulatory approval processes may have on its business. In the United States, the federal government regularly considers reforming health care coverage and costs. Resulting legislation or regulatory actions may have a significant effect on the Company's business. Biogen's ability to successfully commercialize human pharmaceutical products also may depend in part on the extent to which reimbursement for the costs of such products and related treatments will be available worldwide from government health administration authorities, private health insurers and other organizations. Currently, substantial uncertainty exists as to the reimbursement status of newly approved health care products by third-party payors. Biogen conducts relevant research in compliance with the current United States National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (the "NIH Guidelines") and all other applicable federal and state regulations. By local ordinance, Biogen is required, among other things, to comply with the NIH Guidelines in relation to its facilities in Cambridge, Massachusetts, and is required to operate pursuant to certain permits. Various laws, regulations and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import and export and use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with Biogen's research work are or may be applicable to its activities. The extent of government regulation which might result from future legislation or administrative action cannot accurately be predicted. Certain agreements entered into by Biogen involving exclusive license rights may be subject to national or supranational antitrust regulatory control, the effect of which also cannot be predicted. EMPLOYEES At December 31, 2000, Biogen employed 1,475 full-time employees worldwide, of whom 1,217 were located in the United States. Of the 1,475 employees, 424 were engaged in, or directly supported, research, including medical research, 454 were involved in, or directly supported, manufacturing, product and process development, and quality assurance/quality control, and 291 were involved in sales 15 16 and marketing. In addition, Biogen maintains consulting arrangements with a number of scientists at various universities and other research institutions in Europe and the United States, including the ten outside members of its Scientific Board. ITEM 2 - PROPERTIES Biogen's principal executive offices and a majority of its administrative, manufacturing and research and development facilities are located in Cambridge, Massachusetts. The Company owns a 150,000 square foot building in Cambridge that houses laboratories and office space. The Company also leases a total of approximately 482,987 square feet of additional office, manufacturing, and research and development space in all or part of six other buildings in Cambridge, consisting of: a 67,362 square foot building housing manufacturing facilities, laboratories and office space; a building with 65,792 square feet of space containing laboratories, purification and aseptic bottling facilities, and office space; a multi-tenant building where the Company leases approximately 156,069 square feet of office space; a 17,000 square foot building housing office space and distribution facilities; a 24,100 square foot warehouse facility; and a 152,164 square foot office building. The lease expiration dates for the leased sites range from 2002 to 2015. In February 2001, Biogen completed construction of a new 224,000 square foot facility in Cambridge primarily to house research and development and process development operations. The Company also has development options for additional property in Cambridge. In addition to its Cambridge facilities, the Company has a 100,000 square foot biologics manufacturing facility in Research Triangle Park, North Carolina. The Company uses the Research Triangle Park facility as a site for the manufacture of AVONEX(R). In 1999, the Company commenced construction of a 250,000 square foot addition to the Research Triangle Park facility to add large scale cell culture manufacturing capacity which it expects to complete in the first half of 2001. In addition, in 2000, the Company commenced construction at the Research Triangle Park location of a 150,000 square foot office and laboratory facility. Biogen financed construction of the buildings which it owns in Cambridge, Massachusetts and Research Triangle Park, North Carolina with term loans. The loans are secured by the buildings. See the Company's 2000 Annual Report to Shareholders --- "Management's Discussion and Analysis of Financial Condition and Results of Operations" incorporated herein by reference under Item 7 hereof. The Company's European headquarters consists of 4,150 square meters of office space in a multi-tenant building in Nanterre, France and the company is currently negotiating for an additional 1,500 square meters. The lease for the Nanterre space terminates in 2008 with Biogen having the right to terminate the lease earlier under specified circumstances. The Company also leases 2,250 square meters of office and manufacturing space in The Netherlands, 1,400 square meters of office space in Germany, of which 450 square meters is subleased to a third party through the second quarter of 2001, 800 square meters of office space in England, 450 square meters of office space in Denmark and small offices in Austria, Canada, Finland, Norway and Sweden. The Company believes that its production plants in Cambridge, Massachusetts and Research Triangle Park, North Carolina and existing outside sources will allow it to meet, in the near term, its production needs for products in clinical trials and AVONEX(R). Biogen believes that its existing facilities are in compliance with applicable regulatory standards. The Company expects that additional 16 17 facilities and outside sources will be required to meet the Company's future research, development and commercial production needs. ITEM 3 - LEGAL PROCEEDINGS On July 3, 1996, Berlex Laboratories, Inc. ("Berlex") filed suit against Biogen in the United States District Court for the District of New Jersey alleging infringement by Biogen of Berlex's "McCormick" patent (U.S. Patent No. 5,376,567) in the United States in the production of AVONEX(R). In November 1996, Berlex's New Jersey action was transferred to the United States District Court in Massachusetts and consolidated for pre-trial purposes with a related declaratory judgment action previously filed by Biogen. On August 18, 1998, Berlex filed a second suit against Biogen alleging infringement by Biogen of a patent which was issued to Berlex in August 1998 and which is related to the McCormick patent (U.S. Patent No. 5,795,779). On September 23, 1998, the cases were consolidated for pre-trial and trial purposes. Berlex sought a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. A hearing on the parties' summary judgment motions in the case was completed in March 2000. In September 2000, the District Court rendered final judgment in favor of Biogen and against Berlex determining that Biogen's production of AVONEX(R) did not infringe any of the claims of the Berlex patents. Berlex has appealed this decision with the Court of Appeals for the Federal Circuit and the parties are in the process of briefing the appeal for oral argument. An unfavorable ruling on appeal would result in the case being remanded to the District Court for trial. If Berlex were to be successful in its appeal and the case were to be remanded, an unfavorable ruling in the remanded case could have a material adverse effect on the Company's results of operations and financial position. The Company believes that the decision of the District Court that Biogen does not infringe the Berlex patents is sound, but the ultimate outcome of the appeal is not currently determinable. As a result, an estimate of any potential loss or range of loss cannot be made at this time. For a description of legal proceedings relating to certain patent rights, see Item 1 hereof, "Business - Patents and Other Proprietary Rights." ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS Not Applicable 17 18 EXECUTIVE OFFICERS OF THE REGISTRANT The following is a list of each executive officer of the Company, their respective age as of December 31, 2000 and their principal positions with the Company. Officers are elected and may be removed by the Board of Directors.
Name Age Positions - ---- --- --------- James L. Vincent........... 61 Chairman of the Board of Directors James C. Mullen............ 42 President, Chief Executive Officer and Director Burt A. Adelman............ 48 Vice President - Medical Research Cornelis "Kees" Been....... 42 Vice President - Business and Market Development Thomas J. Bucknum.......... 54 Vice President - General Counsel, Secretary and Clerk Frank A. Burke, Jr......... 57 Vice President - Human Resources Nadine D. Cohen............ 51 Vice President - Regulatory Affairs Michael Gilman ............ 45 Vice President - Research Sylvie L. Gregoire......... 39 Vice President - Manufacturing Robert A. Hamm............. 49 Vice President - Sales and Marketing Peter N. Kellogg .......... 44 Vice President - Finance and Chief Financial Officer Mark W. Leuchtenberger..... 44 Vice President - International Toshio Nakata.............. 57 President - Biogen Japan, Ltd., Vice President - Japan, Asia and Oceana John W. Palmer............. 49 Vice President - Program Management David D. Pendergast........ 52 Vice President - Product Development and Quality Assurance Patrick J. Purcell......... 40 Vice President - Information Systems and Chief Information Officer
The background of these officers is as follows: James L. Vincent has been Chairman of the Board of Directors since October 1985. Mr. Vincent served as Chief Executive Officer from December 1998 to June 2000. He previously served as Chief 18 19 Executive Officer of the Company from October 1985 until February 1997. He served in the additional capacities of Chief Operating Officer and President from April 1988 until February 1994. Before joining Biogen, Mr. Vincent served as Group Vice President, Allied Corporation and as President, Allied Health & Scientific Products Company, a subsidiary of Allied Corporation. Before joining Allied Corporation, Mr. Vincent was with Abbott Laboratories, Inc. where he served in various capacities, including Executive Vice President, Chief Operating Officer and Director of the parent corporation. James C. Mullen was appointed President and Chief Executive Officer in June 2000 after serving as President and Chief Operating Officer since January 1999. He was appointed as a Director of the Company in April 1999. Mr. Mullen previously served as Vice President - International from August 1996 until January 1999, and Vice President - Operations from December 1991 until August 1996 and served as Senior Director - Operations from February 1991 to December 1991. Mr. Mullen joined the Company in 1989. Before coming to Biogen, Mr. Mullen held various positions of responsibility from 1984 through 1988 at SmithKline-Beckman Corporation (now GlaxoSmithKline plc), including Director, Engineering, SmithKline and French Laboratories, Worldwide. Burt A. Adelman, M.D. was appointed Vice President - Medical Research in January 1999 after serving as Vice President - Development Operations since August 1996. Dr. Adelman served as Vice President - Regulatory Affairs of the Company from May 1995 until August 1996. From 1991 until May 1995, Dr. Adelman was Director of Medical Research at Biogen. Dr. Adelman has served as Lecturer of Medicine at Harvard Medical School and Brigham and Women's Hospital since 1992. Cornelis "Kees" Been was appointed Vice President - Business and Market Development in August 1999. Prior to joining the Company, Mr. Been held a variety of management positions from 1996 until April 1999 with Monsanto Life Sciences, most recently as Vice President - Global Strategy. From 1988 through 1995, Mr. Been worked at Gemini Consulting, where his positions included Vice President, responsible for building Gemini's pharmaceuticals practice. Mr. Been began his career in 1983 as a Trade and Licensing Manager with Biogen, based in Geneva, Switzerland. Thomas J. Bucknum was appointed Vice President - General Counsel, Secretary and Clerk in July 1999, after serving as the Company's Chief Corporate Counsel since 1996. Prior to joining the Company, Mr. Bucknum was Senior Vice President and General Counsel of DuPont Merck Pharmaceutical Company from 1990 to 1995 with responsibility for legal, government and public affairs matters. Prior to joining DuPont Merck, Mr. Bucknum held a number of domestic and international positions with E.I. DuPont de Nemours & Company, Inc in the legal, marketing and regulatory affairs departments. Frank A. Burke, Jr., was appointed Vice President - Human Resources in May 1986 after serving for 12 years in various human resource management positions at Allied-Signal, Inc., including Director of Compensation and Employee Benefits of the Engineered Materials Sector. Nadine D. Cohen, Ph.D., was appointed Vice President - Regulatory Affairs in October 2000 after serving as Director of Regulatory Affairs since September 1999. Dr. Cohen joined Biogen in 1999 from the Massachusetts Biologics Laboratories, where she was Senior Director of Quality Control and Technical Services. Prior to that, she was Vice President of Regulatory Affairs and Quality at Alpha Beta Technology, Inc. 19 20 Michael Gilman, Ph.D., was appointed Vice President - Research in April 2000. Dr. Gilman joined Biogen in 1999 as Director, Molecular Biology from ARIAD Pharmaceuticals, Inc., where he served as Executive Vice President and Chief Scientific Officer. From 1986-1994, Dr. Gilman worked at Cold Spring Harbor Laboratory. Sylvie L. Gregoire, Pharm.D., was appointed Vice President - Manufacturing in October 2000 after serving as Vice President - Regulatory Affairs from January 1999 to October 2000. From July 1998 to January 1999, Dr. Gregoire was the Program Executive for the Company's LT-Beta Receptor program and from 1995 until July 1998, served as Director, European Regulatory Affairs of the Company. Prior to joining Biogen, Dr. Gregoire was Associate Director of European Regulatory Affairs for Merck Sharp and Dohme (Europe) Inc. from 1991 until the end of 1994. Robert A. Hamm was appointed Vice President - Sales and Marketing in October 2000 after serving as Vice President - Manufacturing from June 1999 to October 2000. Mr. Hamm served as Director, Northern Europe and Distributors of the Company from November 1996 until June 1999 and as the Company's Associate Director, Logistics from April 1994 until November 1996. From 1987 until April 1994, Mr. Hamm held a variety of management positions at Syntex Laboratories Corporation, including Director of Operations and New Product Planning, and Manager of Materials, Logistics and Contract Manufacturing. Peter N. Kellogg was appointed Vice President - Finance and Chief Financial Officer in July 2000. Mr. Kellogg joined Biogen from PepsiCo where from 1987 to 2000, he served in a variety of senior financial, international and general management positions, including Senior Vice President, PepsiCo. E-Commerce from March to July 2000. From March 1998 to March 2000, he served as Senior Vice President and Chief Financial Officer, Frito-Lay International; from November 1996 to March 1998 as Vice President and Chief Financial Officer, Frito-Lay Latin America; from March 1994 to November 1996 as Vice President and Chief Financial Officer, Central/Eastern Europe and Russia, Pepsi-Cola International; and from February 1993 through March 1994 as Vice President and General Manager-Pepsi, South Franchise Business Unit. Prior to joining PepsiCo, Mr. Kellogg was a senior consultant with Booz Allen & Hamilton and Arthur Andersen & Co. Mark W. Leuchtenberger was appointed Vice President - International in January 1999 after serving as Vice President - Sales, Marketing and Business Development since January 1998. Mr. Leuchtenberger was the Company's Vice President - Marketing and Sales from October 1996 until January 1998, Director of Distributor Operations, Europe from September 1996 until October 1996, Director of Marketing and the Program Executive for AVONEX(R) from 1993 until September 1996, a Product Manager from 1992 to 1993, and a Market Development Manager from 1990 to 1992. Prior to joining Biogen, Mr. Leuchtenberger worked for the consulting firm of Bain & Company from 1987 to 1990. Toshio Nakata was appointed President - Biogen Japan, Ltd. and Vice President - Japan, Asia and Oceana in October 2000. Mr. Nakata joined Biogen from Mitsui & Co., Ltd. where he served as: Associate Director and General Manager of the Global Environment Department, Corporate Planning Division, from January 2000 to October 2000; General Manager of New Business and Technology Development Department and Global Environment Department, Corporate Planning Division, from April 1997 to January 2000; and General Manager of Technology Planning and Development 20 21 Department and Global Environment Department, Corporate Planning Division, from May 1994 to April 1997. John W. Palmer was appointed as Vice President - Program Management in May 2000, after serving as Program Executive for Biogen's Adensoine A1 antagonist program since 1997. From 1993 until 1997, Mr. Palmer was the Company's Director of Operations, and from 1989 until 1993 served as Director of Marketing and Business Development. Prior to joining Biogen, Mr. Palmer was a Marketing and Business Development Director at General Foods Corporation. He was also previously Founder, President and Chief Operating Officer of Caribbean Emergency Medical Air Transport, Inc., a novel air ambulance service operating throughout the Caribbean market, and a managing consultant with Strategic Planning Associates in Washington, D.C. David D. Pendergast, Ph.D. was appointed Vice President - Product Development and Quality Assurance in January 1998 after serving as Vice President - Quality Assurance and Quality Control of the Company since April 1996. Dr. Pendergast joined Biogen from Fisons Pharmaceuticals, Manchester U.K. where he served as Director, Quality Assurance/Quality Control of Fisons PLC from 1992 to 1996. Prior to joining Fisons, Dr. Pendergast served, over a twenty-year period, in various capacities at The Upjohn Company, including Vice President - Quality Assurance from 1989 to 1992. Patrick J. Purcell was appointed Vice President - Information Systems and Chief Information Officer in February 2000. Mr. Purcell joins Biogen from Sprint PCS, where he worked from 1992 to 2000 in a variety of finance and information technology management capacities, most recently serving as Vice President, IT Planning, Resource & Performance Management. Prior to joining Sprint, Mr. Purcell worked at Deloitte & Touche Management Consulting from 1988 to 1992, as a consulting manager with primary focus on business and financial planning, financing and operations analysis, and change management in a variety of industries. PART II ITEM 5 - MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The section entitled "Market for Securities" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 6 - SELECTED FINANCIAL DATA The section entitled "Selected Financial Data" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 7 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 21 22 The section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations - Outlook - Market Risk" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The sections entitled "Consolidated Statements of Income," "Consolidated Balance Sheets," "Consolidated Statements of Cash Flows," "Consolidated Statements of Shareholders' Equity," "Notes to Consolidated Financial Statements" and "Report of Independent Accountants" in the Company's 2000 Annual Report to Shareholders are hereby incorporated herein by reference. ITEM 9 - CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE Not Applicable PART III ITEM 10 - DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The sections entitled "Election of Directors" and "Section 16(a) Beneficial Ownership Reporting Compliance" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, are hereby incorporated herein by reference. Information concerning the Company's Executive Officers is set forth in Item 4 of Part I of this Annual Report on Form 10-K. ITEM 11 - EXECUTIVE COMPENSATION The sections entitled "Election of Directors" and "Executive Compensation" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, are hereby incorporated herein by reference. ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The section entitled "Share Ownership" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, is hereby incorporated herein by reference. ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The section entitled "Executive Compensation - Employment Arrangements with the Company and Certain Transactions" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, is hereby incorporated herein by reference. 22 23 PART IV ITEM 14 - EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a) The following documents are filed as a part of this report: (1) The Company's Financial Statements are incorporated herein by reference from the Company's 2000 Annual Report to Shareholders attached hereto as Exhibit 13. The specific items and the locations of such items are set forth below:
Item Location - ---- -------- Consolidated Statements of Income Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Statements of Income." Consolidated Balance Sheets Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Balance Sheets." Consolidated Statements of Cash Flows Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Statements of Cash Flows." Consolidated Statements of Shareholders' Equity Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Statements of Shareholders' Equity." Notes to Consolidated Financial Statements Annual Report under the caption "Biogen, Inc. and Subsidiaries Notes to Consolidated Financial Statements." Report of Independent Accountants Annual Report under the caption "Report of Independent Accountants."
With the exception of the portions of the Company's 2000 Annual Report to Shareholders specifically incorporated herein by reference, such report shall not be deemed filed as part of this Annual Report on Form 10-K. (2) The Company's Financial Statement Schedules, as required by Item 8 of this Form 10-K, are incorporated herein by reference from the Company's 2000 Annual Report to Shareholders attached hereto as Exhibit 13. A list of such Financial Statement Schedules is set forth below: Report of Independent Accountants on Financial Statement Schedule. Schedule II - Valuation and Qualifying Accounts and Reserves (3) Exhibits 23 24 Exhibit No. Description - ----------- ----------- (3.1) Articles of Organization, as amended (m) (3.2) By-Laws, as amended (f) (4.1) Form of Common Stock Share Certificate (h) (4.2) Certificate of Designation of Series A Junior Participating Preferred Stock (d) (4.3) Rights Agreement dated as of May 8, 1989 between the Registrant and The First National Bank of Boston, as Rights Agent (d) (10.1) Independent Consulting and Project Agreement dated as of June 29, 1979 between the Registrant and Kenneth Murray (a)** (10.2) Letter Agreement dated September 11, 1998 with Kenneth Murray related to renewal of Independent Consulting Agreement (q) ** (10.3) Minute of Agreement dated February 5, 1981 among the Registrant, The University Court of the University of Edinburgh and Kenneth Murray (a)** (10.4) Independent Consulting Agreement dated as of June 29, 1979 between the Registrant and Phillip A. Sharp (a)** (10.5) Letter Agreement dated December 11, 1998 with Phillip A. Sharp related to chairmanship of Scientific Board and renewal of Independent Consulting Agreement (q)** (10.6) Project Agreement dated as of December 15, 1979 between the Registrant and Phillip A. Sharp (a)** (10.7) Share Restriction and Repurchase Agreement dated as of December 15, 1979 between the Registrant and Phillip A. Sharp (a)** (10.10) Form of Amendment dated July 1, 1988 to Independent Consulting Agreement between the Registrant and Scientific Board Members (c)** (10.11) Letter regarding employment of James L. Vincent dated September 23, 1985 (b)** (10.12) Letter agreement amending employment arrangement between the Registrant and James L. Vincent dated as of November 21, 1996 (n)** (10.13) Form of Stock Option Agreement with James L. Vincent under 1985 Non-Qualified Stock Option Plan (f)** 24 25 (10.14) Form of Stock Option Agreement with James L. Vincent under 1985 Non-Qualified Stock Option Plan (1995) (l)** (10.15) Form of Stock Option Agreement with James L. Vincent under 1985 Non-Qualified Stock Option Plan (1997) (o)** (10.17) Form of Indemnification Agreement between the Registrant and each Director and Executive Officer (c)** (10.18) Cambridge Center Lease dated October 4, 1982 between Mortimer Zuckerman, Edward H. Linde and David Barrett, as Trustees of Fourteen Cambridge Center Trust, and B. Leasing, Inc. (a) (10.19) First Amendment to Lease dated January 19, 1989, amending Cambridge Center Lease dated October 4, 1982 (f) (10.20) Second Amendment to Lease dated March 8, 1990, amending Cambridge Center Lease dated October 4, 1982 (f) (10.21) Third Amendment to Lease dated September 25, 1991, amending Cambridge Center Lease dated October 4, 1982 (f) (10.22) Fourth Amendment to Lease dated October 6, 1993, amending Cambridge Center Lease dated October 4, 1982 (o) (10.23) Fifth Amendment to Lease dated October 9, 1997, amending Cambridge Center Lease dated October 4, 1982 (o) (10.24) Lease dated October 6, 1993 between North Parcel Limited Partnership and Biogen Realty Limited Partnership (i) (10.25) 1983 Employee Stock Purchase Plan, as amended and restated through September 12, 1997 (o)** (10.26) 1982 Incentive Stock Option Plan, as amended through June 15, 2000 and restated, with form of Option Agreement (s)** (10.27) 1985 Non-Qualified Stock Option Plan, as amended through June 15, 2000 and restated (s)** (10.28) 1987 Scientific Board Stock Option Plan, as amended through June 15, 2000 and restated (s)** (10.29) Voluntary Executive Supplemental Savings Plan (k)** (10.30) Amendment No. 1 dated April 25, 1997 to Voluntary Executive Supplemental Savings Plan (o)** 25 26 (10.31) Amendment No. 2 dated March 11, 1998 to Voluntary Executive Supplemental Savings Plan (q)** (10.32) Amendment No. 3 dated September 27, 1999 to Voluntary Executive Supplemental Savings Plan (r) ** (10.33) Amendment No. 4 dated December 13, 1999 to Voluntary Executive Supplemental Savings Plan (r)** (10.34) Amended and Restated Supplemental Executive Retirement Plan (o)** (10.35) Amendment No. 1 dated September 27, 1999 to Amended and Restated Supplemental Executive Retirement Plan (r), ** (10.36) Voluntary Board of Directors Savings Plan (k)** (10.37) Amendment No. 1 dated April 25, 1997 to Voluntary Board of Directors Savings Plan (o)** (10.38) Amendment No. 2 dated March 11, 1998 to Voluntary Board of Directors Savings Plan (q)** (10.39) Amendment No. 3 dated September 27, 1999 to Voluntary Board of Directors Savings Plan (r)** (10.40) Amendment No. 4 dated December 13, 1999 to Voluntary Board of Directors Savings Plan (r)** (10.41) Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (a) (10.42) Amendatory Agreement dated May 14, 1985 to Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (b) (10.43) Amendment and Settlement Agreement dated September 29, 1988 to Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (f) (10.44) Amendment dated March 20, 1989 to Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (f) (10.45) License Agreement (United States) dated March 28, 1988 between the Registrant and SmithKline Beecham Biologicals, s.a. (as successor to Smith Kline-R.I.T, s.a.) (f) (10.46) License Agreement (International) dated March 28, 1988 between the Registrant and SmithKline Beecham Biologicals, s.a. (as successor to Smith Kline-R.I.T., s.a.) (f) 26 27 (10.47) Sublicense Agreement dated as of February 15, 1990 among the Registrant, SmithKline Beecham Biologicals, s.a (as successor to SmithKline Biologicals, s.a.) and Merck and Co., Inc. (f) (10.48) Supplemental Amendment and Agreement dated as of March 1, 1994 between the Registrant and Schering Corporation (j) (10.49) Agreement and Amendment between the Registrant and Schering Corporation dated May 1, 1998 (p) (10.50) Letter agreement amending employment arrangement between the Registrant and James L. Vincent dated March 10, 2000 * ** (10.51) Letter regarding employment of James C. Mullen dated March 18, 1993 (r)** (10.52) Letter amending employment arrangement between the Registrant and James C. Mullen dated January 7, 1999 (r)** (10.53) Letter regarding employment of Burt Adelman, M.D. dated April 2, 1996 (r)** (10.54) Letter regarding employment of Mark Leuchtenberger dated November 14, 1996 (r)** (10.55) Letter agreement amending employment arrangement between the Registrant and Mark Leuchtenberger dated May 12, 1999 (r)** (10.56) Letter regarding employment of Thomas J. Bucknum, dated June 11, 1999 * ** (10.57) Letter agreement regarding employment arrangement between the Registrant and Cornelis Been, dated July 19, 1999 * ** (10.58) Letter amending employment arrangement between the Registrant and James C. Mullen, dated May 3, 2000 * ** (13) Incorporated portions of the Registrant's Financial Statements from its 2000 Annual Report to Shareholders * (21) Subsidiaries of the Registrant * (23) Consent of PricewaterhouseCoopers LLP * - ------------- (a) Previously filed with the Commission as an exhibit to the Registrant's Registration Statement on Form S-1, File No. 2-81689, and incorporated herein by reference. (b) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1985, as amended, File No. 0-12042, and incorporated herein by reference. (c) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1988, File No. 0-12042, and incorporated herein by reference. 27 28 (d) Previously filed with the Commission as an exhibit to the Registrant's Registration Statement on Form 8-A, File No. 0-12042, filed May 26, 1989, and incorporated herein by reference. (e) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1991, File No. 0-12042, and incorporated herein by reference. (f) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1992, File No. 0-12042, and incorporated herein by reference. (g) Previously filed with the Commission as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1993, File No. 0-12042, and incorporated herein by reference. (h) Previously filed with the Commission as an exhibit to the Registrant's Registration Statement on Form S-3, File No. 33-51639 filed December 21, 1993, and incorporated herein by reference. (i) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1993, File No. 0-12042, and incorporated herein by reference. (j) Previously filed with the Commission as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 1994, File No. 0-12042, and incorporated herein by reference. (k) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1994, File No. 0-12042, and incorporated herein by reference. (l) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1995, File No. 0-12042, and incorporated herein by reference. (m) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1996, File No. 0-12042, and incorporated herein by reference. (n) Previously filed with the Commission as an exhibit to an amendment to the Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 1996, File No. 0-12042, and incorporated herein by reference. (o) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1997, File No. 0-12042, and incorporated herein by reference. 28 29 (p) Previously filed with the Commission as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1998, File No. 0-12042, and incorporated herein by reference. (q) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1998, File No. 0-12042, and incorporated herein by reference. (r) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-k for the fiscal year ended December 31, 1999, File No. 0-12042, and incorporated herein by reference * Filed herewith ** Management contract or compensatory plan or arrangement (b) Reports on Form 8-K The Company did not file any reports on Form 8-K during the fourth quarter of 2000. 29 30 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BIOGEN, INC. By: /s/ James C. Mullen ------------------------------------ James C. Mullen, President and Chief Executive Officer Dated March 30, 2001 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURES TITLE DATE - ---------- ----- ---- /s/ James C. Mullen President, Chief Executive March 30, 2001 - --------------------------- Officer and Director James C. Mullen (principal executive officer) /s/ James L. Vincent Chairman of the Board of March 30, 2001 - --------------------------- Directors James L. Vincent /s/ Peter N. Kellogg Vice President - Finance and Chief March 30, 2001 - --------------------------- Financial Officer (principal Peter N. Kellogg financial and accounting officer) /s/ Alan Belzer Director March 30, 2001 - --------------------------- Alan Belzer /s/ Harold W. Buirkle Director March 30, 2001 - --------------------------- Harold W. Buirkle /s/ Mary L. Good Director March 30, 2001 - --------------------------- Mary L. Good /s/ Thomas F. Keller Director March 30, 2001 - --------------------------- Thomas F. Keller /s/ Roger H. Morley Director March 30, 2001 - --------------------------- Roger H. Morley /s/ Kenneth Murray Director March 30, 2001 - --------------------------- Kenneth Murray
31 /s/ Phillip A. Sharp Director March 30, 2001 - --------------------------- Phillip A. Sharp /s/ Alan K. Simpson Director March 30, 2001 - --------------------------- Alan K. Simpson /s/ James W. Stevens Director March 30, 2001 - --------------------------- James W. Stevens
32 EXHIBIT INDEX Exhibit No. Description - ----------- ----------- (13) Incorporated portions of the Registrant's Financial Statements from its 1999 Annual Report to Shareholders (21) Subsidiaries of the Registrant (23) Consent of PricewaterhouseCoopers LLP (10.50) Letter agreement amending employment arrangement between the Registrant and James L. Vincent dated March 10, 2000 (10.56) Letter regarding employment of Thomas J. Bucknum, dated June 11, 1999 (10.57) Letter agreement regarding employment arrangement between the Registrant and Cornelis Been, dated July 19, 1999 (10.58) Letter amending employment arrangement between the Registrant and James C. Mullen, dated May 3, 2000
EX-10.50 2 b38146bgex10-50.txt LETTER AGREEMENT-JAMES L VINCENT 1 Exhibit 10.50 March 10, 2000 Mr. James L. Vincent 7 Audubon Road Weston, MA 02193 Dear Jim: This letter will serve as notice that Biogen, Inc. would like to extend your chairmanship of the Board of Directors for an additional three years under the terms of the letter agreement dated November 21, 1996 (the "Letter Agreement") amending your Employment Agreement dated as of September 23, 1985 (the "Employment Agreement") such that your chairmanship will continue after the end of the Initial Chairmanship Term, as defined in the Letter Agreement, on February 14, 2001 until February 14, 2004 (the "Extended Term") unless earlier terminated by your resignation or earlier removal. During the Extended Term, after appointment of a successor Chief Executive Officer, your duties as Chairman will once again consist of those activities specified under Section 1 of the Letter Agreement. All other terms of the Letter Agreement and the Employment Agreement, as amended by the Letter Agreement and this letter, shall apply during the Extended Term. If you agree with extension of your chairmanship on the above terms, please execute this letter and the enclosed copy in the space provided below. Sincerely, Biogen, Inc. By: /s/ Roger H. Morley Chairman, Compensation and Management Resources Committee By: /s/ Harold W. Buirkle Member, Compensation and Management Resources Committee By: /s/ Phillip A. Sharp Member, Compensation and Management Resources Committee 2 By: /s/ Mary L. Good Member, Compensation and Management Resources Committee Acknowledged and agreed /s/ James L. Vincent EX-10.56 3 b38146bgex10-56.txt LETTER EMPLOYMENT- THOMAS J. BUCKNUM 1 Exhibit 10.56 PERSONAL AND CONFIDENTIAL June 11, 1999 Mr. Thomas J. Bucknum 381 Beacon Street Boston, MA 02116 Dear Tom: This confirms your discussion with Jim Vincent and me related to your new role in the organization. Effective June 10, 1999, your new title is Vice President and General Counsel with a base salary of $225,000 and a target bonus of 30%. Additionally, you have been granted 25,000 stock options as of June 10, 1999 with a grant value of $2,710,938 (25,000 shares at $108.4375). As an officer of the company, you will be required to participate in our program for executive stock ownership. We believe it is very important that our key leaders have personal stock ownership. I will outline the program to you. Additionally, in your new role you are now eligible for the following: 1. VACATION - You are entitled to four (4) weeks vacation. 2. SUPPLEMENTAL SAVINGS PLAN: You are entitled to participate in the Voluntary Executive Supplemental Savings Plan. This plan allows you to defer from your current taxation up to 50% of your base salary and 100% of your 1999 bonus, if there is one. Rick Fisher can outline the details of the program if you are interested in participating. 3. LIFE INSURANCE: You will be provided Biogen's Executive Term Life Insurance coverage for a total of $1,000,000. This coverage is based on your successfully meeting the medical standards as stated in the Executive Term insurance policy. 4. TAX REVIEW/PREPARATION: You are entitled to the preparation and/or review, including review of estimated taxes of your annual Federal and State tax returns, which is currently administered through PricewaterhouseCoopers. The cost of this service is covered by Biogen. 5. INVOLUNTARY TERMINATION: If you are involuntarily terminated from employment with Biogen (other than for cause), Biogen will protect you by paying you a supplementary amount (the 2 Mr. Thomas J. Bucknum June 11, 1999 Page 2 "Supplementary Amount") equal to your then present base salary for a period (the "Extra Period") ending on the earlier of (i) the date twelve months from your termination and (ii) the date you start another job. During such period, Biogen will also pay to continue your health benefits (i.e., health and dental plan coverage), provided such benefits are accorded employees generally and Biogen can obtain the relevant coverage. If you need continued coverage to prevent a gap in health coverage between your Biogen coverage and that at your new job, Biogen will extend such coverage for up to 30 days (to the extent that the Extra Period is less than twelve months) after you start your new job. The Supplementary Amount will be paid on the same schedule as your salary would have been paid. You will not be an employee of Biogen during the time of such payments and will not accrue any benefits or other rights (such as, but not limited to, pension plan vesting or accrual, stock option vesting, vacation pay, etc.) during such period except health benefits as described above. You agree to notify us when you accept a new job. Sincerely, /s/ Frank A. Burke Jr. Frank A. Burke, Jr. Vice President, Human Resources FAB:bk EX-10.57 4 b38146bgex10-57.txt LETTER AGREEMENT-CORNELIS BEEN 1 Exhibit 10.57 July 19, 1999 Mr. Kees Been 121 Whitebridge Meadows Lane St. Louis, MO 63141 Dear Kees: This letter supersedes my previous letter to you dated July 9, 1999 and represents Jim Vincent's amended offer to you on behalf of Biogen. You are offered the position of Vice President, Business Development at an annual salary of $250,000. You will report directly to Jim Vincent. Consistent with Biogen's compensation policy, you will be eligible for a pro-rated merit salary review at year-end 1999 and annually thereafter. You will be eligible to participate in Biogen's annual incentive compensation plan with a 30% target bonus beginning in the year ending December 31, 2000. Upon employment you will receive $200,000 as a one-time special cash bonus, which will be treated as a forgivable loan. The bonus will be forgiven over a thirty-six month, straight-line schedule. In the event you voluntarily terminate your employment or your employment is terminated for performance prior to the thirty-six months from the date of the loan, the unforgiven portion of the loan would be payable to Biogen within six months of your termination date. Upon employment you will be granted an option to purchase up to 100,000 shares of the common stock of Biogen, Inc. This option grant is subject to the approval of the Stock and Option Plan Administration Committee of the Board of Directors, which we expect to be forthcoming. The exercise price per share will be the average of the high and low sale prices as reported in the National Association of Securities Dealers Automated Quotation System ("NASDAQ") on the date you commence employment. The option will have a ten-year term and vest over a five-year period at the rate of 20% per year starting on the anniversary of the date you commence employment. You will be able to choose from a menu of benefit options through our flexible benefits program, BioChoice. These include health care, life, dependent life, and disability insurance as well as two flexible spending accounts, Med-Flex and D-Flex, for eligible medical or dependent care expenses. At the beginning of the calendar quarter following your date of hire you will be eligible to participate in Biogen's pension and 401(k) savings plans. You are also entitled to twenty vacation days per year accrued on a monthly pro-rated basis. Biogen also offers a variety of additional benefits including tuition reimbursement, childcare and elder care referral service, educational matching gifts, credit union, and group homeowners and automobile insurance. You will receive more detailed information regarding your benefits on your first day at work. 2 Mr. Kees Been Page 2 July 19, 1999 Biogen will provide relocation benefits to facilitate your move from St. Louis, MO. A relocation counselor will contact you to discuss the relocation program, and will send you a package detailing the relocation policy to you. Please read the policy carefully as it will outline the parameters of these benefits and detail the reimbursement process. These benefits will include the reimbursement of many of the costs associated with both the sale of your current house and the purchase of a new house in the Boston area; home-finding; and movement of your household goods. As an additional provision of your relocation benefits, Biogen will pay you a lump sum of $40,000 on employment to be used for your temporary living in Boston and to also allow you round trip flights to St. Louis pending your family's eventual relocation to the Boston area. In the event your family relocates to the Boston area prior to your fully expending the $40,000, any unused amount of this lump sum payment will be yours to retain with no repayment obligation to Biogen. In the event you voluntarily terminate your employment or your employment is terminated for performance within two years from the date that you start your new job, you will be required to repay to Biogen some or all of the relocation expenses that you have incurred. As an officer of the company, you will be required to participate in our program for executive stock ownership. We believe it is very important that our key leaders have personal stock ownership. I will outline the program to you. Additionally, in your new role you will be eligible for the following: - - SUPPLEMENTAL SAVINGS PLAN: You are entitled to participate in the Voluntary Executive Supplemental Savings Plan. This plan allows you to defer from your current taxation up to 50% of your base salary and 100% of your bonus, if there is one. I can outline the details of the program if you are interested in participating. - - LIFE INSURANCE: You will be provided Biogen's Executive Term Life Insurance coverage for a total of $1,000,000. This coverage is based on your successfully meeting the medical standards as stated in the Executive Term insurance policy. - - TAX REVIEW/PREPARATION: You are entitled to the preparation and/or review, including review of estimated taxes of your annual Federal and State tax returns, which is currently administered through PricewaterhouseCoopers. The cost of this service is covered by Biogen. In the event you choose to continue the services provided by your current tax advisor, Biogen will reimburse you the cost of these services up to but not exceeding the amount incurred by Biogen through PricewaterhouseCoopers. 3 Mr. Kees Been Page 3 July 19, 1999 - - INVOLUNTARY TERMINATION: If you are involuntarily terminated from employment with Biogen (other than for cause), Biogen will protect you by paying you a supplementary amount (the "Supplementary Amount") equal to your then present BASE salary for a period (the "Extra Period") ending on the earlier of (i) the date twelve months from your termination and (ii) the date you start another job. During such period, Biogen will also pay to continue your health benefits (i.e., health and dental plan coverage), provided such benefits are accorded employees generally and Biogen can obtain the relevant coverage. If you need continued coverage to prevent a gap in health coverage between your Biogen coverage and that at your new job, Biogen will extend such coverage for up to 30 days (to the extent that the Extra Period is less than twelve months) after you start your new job. The Supplementary Amount will be paid on the same schedule as your salary would have been paid. You will not be an employee of Biogen during the time of such payments and will not accrue any benefits or other rights (such as, but not limited to, pension plan vesting or accrual, stock option vesting, vacation pay, etc.) during such period except health benefits as described above. You agree to notify us when you accept a new job. Employment with Biogen is contingent on the satisfactory completion of a pre-employment drug screening test at least five business days prior to your start date. We require all new employees to sign an Intellectual Property/Confidentiality Agreement on the first day of employment. You will also be required to complete a medical history review with our occupational health department, which is scheduled after your first day of employment. It is Biogen's policy to comply with federal, state and local guidelines applicable to its facilities and to take all reasonable steps to ensure the health and safety of Biogen employees. Consistent with this policy, your normal duties may require you from time to time to attend meetings or perform functions in any or all of Biogen's facilities. The Federal Government requires you to provide proper identification verifying your eligibility to work in the United States. Please bring the appropriate identification with you on your first day of employment. On behalf of Jim Vincent, we very much look forward to your positive response and to your joining us as early as practical. We are confident that you will make a significant contribution to Biogen's future success. 4 Mr. Kees Been Page 4 July 19, 1999 Please confirm your acceptance by signing this offer letter and noting your preferred start date. Also, please sign the enclosed drug screen authorization form and then return both signed documents to me in the enclosed self addressed, stamped envelope. The other original offer letter is for your records. Sincerely, /s/ Frank A. Burke, Jr. Frank A. Burke, Jr. FAB:bk cc: Mr. James L. Vincent I am pleased to accept the offer of employment described above. ACCEPTED: /s/ Kees Been - ------------------------------------------------------------------------ Kees Been Preferred Start Date EX-10.58 5 b38146bgex10-58.txt LETTER AGREEMENT-JAMES C. MULLEN 1 Exhibit 10.58 PERSONAL AND CONFIDENTIAL May 3, 2000 Mr. James C. Mullen 138 Richardson Drive Needham, MA 02492 Dear Jim: As a follow-up to our conversation last Friday, I am pleased to confirm that the Board of Directors has approved your appointment as President and Chief Executive Officer of Biogen, Inc., effective June 16, 2000. Concurrent with the effective date of your appointment, the Board of Directors has also approved an adjustment in your annual base salary to $700,000, and has established a target of 90% of your base salary for your cash bonus in 2000. In addition, you will be granted an option to purchase 250,000 shares of Biogen Common Stock, effective June 16, 2000, with a seven-year, straight-line vesting schedule. Jim, on behalf of the other members of the Board, I wish you the best of success as you take over the leadership of Biogen next month. In the interim, please let me know how I can assist you in the transition to your new role. Sincerely, /s/ James L. Vincent James L. Vincent Chairman and Chief Executive Officer JLV:bk EX-13 6 b38146bgex13.txt ANNUAL REPORT TO SHAREHOLDERS 1 Exhibit 13 Financials Biogen, Inc. and Subsidiaries 20 Selected Financial Data 21 Management's Discussion and Analysis of Financial Condition and Results of Operations 33 Consolidated Statements of Income 34 Consolidated Balance Sheets 35 Consolidated Statements of Cash Flows 36 Consolidated Statements of Shareholders' Equity 37 Notes to Consolidated Financial Statements 54 Report of Independent Accountants 55 Senior Executives and Board Members 56 Shareholder Information 2 Selected Financial Data Biogen, Inc. and Subsidiaries (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
YEARS ENDED DECEMBER 31, 2000 1999 1998 1997 1996 - ------------------------------------------------------------------------------------------------------------- Product revenue $ 761,079 $ 620,636 $ 394,863 $ 239,988 $ 78,202 Royalty revenue 165,373 173,799 162,724 171,921 181,502 Total revenues 926,452 794,435 557,587 411,909 259,704 Total costs and expenses 598,096 478,184 366,948 285,787 234,541 Income before income taxes 487,105 329,016 210,193 148,968 40,829 Net income 333,577 220,450 138,697 89,167 40,530 Diluted earnings per share 2.16 1.40 0.90 0.58 0.28 Cash, cash equivalents and short- term marketable securities 682,412 654,539 516,914 440,088 321,381 Total assets 1,431,856 1,277,973 924,715 813,825 634,572 Long-term debt, less current portion 47,185 52,073 56,960 61,846 62,254 Shareholders' equity 1,106,402 979,530 718,613 536,293 484,370 Shares used in calculating diluted earnings per share 154,602 157,788 154,270 152,999 146,442
20 3 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW Biogen, Inc. (the "Company" or "Biogen") is a biopharmaceutical company principally engaged in the business of developing, manufacturing and marketing drugs for human health care. The Company currently derives revenues from sales of its AVONEX(R) (Interferon beta-1a) product for the treatment of relapsing forms of multiple sclerosis ("MS"). The Company also derives revenue from royalties on worldwide sales by the Company's licensees of a number of products covered under patents controlled by the Company, including alpha interferon and hepatitis B vaccines and diagnostic products. RESULTS OF OPERATIONS 2000 AS COMPARED TO 1999 REVENUES Total revenues in 2000 were $926.5 million, as compared to $794.4 million in 1999, an increase of $132.1 million or approximately 17%. Product sales in 2000 were $761.1 million as compared to $620.6 million in 1999, an increase of $140.5 million or approximately 23%. Product sales from AVONEX(R) represent approximately 82% of the Company's total revenues in 2000 as compared to 78% in 1999. The growth in 2000 was primarily attributable to an increase in the sales volume of AVONEX(R) in the United States and in the fifteen member countries of the European Union ("EU"). AVONEX(R) sales outside of the United States were approximately $208.5 million in 2000 as compared to $178.4 million in 1999. Revenues from royalties in 2000 were $165.4 million, a decrease of $8.4 million or approximately 5% as compared to $173.8 million of royalty revenue in 1999. Revenues from royalties represented approximately 18% of total revenues in 2000 as compared to 22% in 1999. The decrease in royalty revenues in 2000 over the comparable period in 1999 is primarily the result of reductions attributable to patent expirations and lower licensee sales. See "Outlook - Royalty Revenue" and "Outlook - Patents and Other Proprietary Rights". In the near and long term, the Company expects to experience declining royalty revenues as a result of patent expirations, other patent-related events and a potential decrease in sales by licensees of licensed products. In the near term, Biogen's royalty revenues may also be significantly affected as a result of a dispute with Schering-Plough Corporation ("Schering-Plough") over twelve to eighteen months of royalties payable by Schering-Plough on U.S. sales of its alpha interferon products, including INTRON(R) A. See "Outlook - Royalty Revenue." In addition, sales levels of products sold by the Company's licensees may fluctuate from quarter to quarter due to the timing and extent of major events such as new indication approvals or government sponsored programs. For a discussion of some of the factors that may affect royalty revenues in the future, see "Outlook - Royalty Revenue" and "Outlook - Patents and Other Proprietary Rights". The Company expects product sales as a percentage of total revenues to continue to increase in the near and long term as the Company continues to market AVONEX(R) worldwide, and as royalty revenues continue to decline, the Company also expects sales from AVONEX(R) outside the United States to continue to increase as a percentage of total product sales. The Company, however, expects to face increasing competition in the MS marketplace in and outside the United States from existing and new MS treatments that may impact sales of AVONEX(R). See "Outlook - Competition". COSTS AND EXPENSES Total costs and expenses in 2000 were $598.1 million as compared to $478.2 million in 1999, an increase of approximately 25%. 21 4 Cost of revenues in 2000 totaled $125.2 million, an increase of $14.2 million or 13% as compared to 1999. The increase in cost of revenues was attributable to the higher sales volume of AVONEX(R). Included in cost of revenues in 2000 and 1999 is $112.9 million and $96.9 million, respectively, from product sales and $12.3 million and $14.1 million, respectively, relating to royalty revenue. Gross margins on product sales increased to approximately 85% for the period ended December 31, 2000 compared to 84% for the same period in 1999. Gross margins on royalty revenue increased to approximately 93% for the period ended December 31, 2000 compared to 92% for the same period in 1999. The Company expects that gross margins on royalty revenue will fluctuate in the future based on changes in sales volumes for specific products. Research and development expenses in 2000 were $302.8 million, an increase of $81.6 million or 37% as compared to $221.2 million in 1999. The increase was primarily due to an increase in clinical trial costs of $35.9 million, the costs associated with an increase in the Company's other development efforts related to its ongoing research and development programs of $14 million and the funding of collaboration agreements of $12.4 million. The Company expects that, in the near and long-term, research and development expenses will increase as the Company continues to expand its development efforts with respect to new products, conducts clinical trials of these products and continues work on new formulations and delivery methods for AVONEX(R). Selling, general and administrative expenses in 2000 were $170.1 million, an increase of $24.1 million or 17% as compared to 1999. This increase was primarily due to an increase in selling and marketing expenses related to the sale of AVONEX(R). The Company expects that selling, general and administrative expenses will continue to increase in the near term as the Company continues to expand its sales and marketing organizations necessary to sell AVONEX(R) worldwide and as the Company expands in anticipation of additional products. OTHER INCOME, NET Other income, net consists of interest income, partially offset by interest expenses and other non-operating income and expenses. Other income, net in 2000 was $158.7 million as compared to $12.8 million in 1999, an increase of $145.9 million. Interest income in 2000 was $43 million compared $35.4 million in 1999, an increase of $7.6 million or 21% due to higher average yields and an increase in funds invested. The Company expects interest income to vary based on changes in the amount of funds invested and fluctuations in interest rates. Interest expense decreased $0.3 million or 7% in 2000 from 1999. Other income (expense) increased by $138.1 million in 2000 from 1999. Other income (expense) for the period ended December 31, 2000 included gains on the sale of certain non-current marketable securities totaling approximately $101.1 million. Additionally, the Company realized gains of approximately $24.1 million upon the acquisition of two of its investees by third parties. Other income (expense) for the period ended December 31, 1999 included a $15 million write-down of certain non-current marketable securities. Other income, net consists of the following (in thousands): December 31, ------------------------- 2000 1999 --------- -------- Interest income $ 42,965 $ 35,407 Interest expense (4,310) (4,639) Other income (expense) 120,094 (18,003) -------- -------- Total other income, net $158,749 $ 12,765 ======== ======== 22 5 INCOME TAXES The Company's effective tax rate in 2000 was 31.5%. Income tax expense for 2000 varied from the amount computed at the U.S. federal statutory rates primarily due to higher sales in European jurisdictions with lower tax rates and to the utilization of research and development tax credits. The Company's effective tax rate outside the U.S. is lower than the U.S. tax rate, and the Company expects that the U.S. tax rate will decline as a percentage of its total tax rate as international sales increase. RESULTS OF OPERATIONS 1999 AS COMPARED TO 1998 REVENUES Total revenues in 1999 were $794.4 million, as compared to $557.6 million in 1998, an increase of $236.8 million or approximately 42%. Product sales in 1999 were $620.6 million as compared to $394.9 million in 1998, an increase of $225.7 million or approximately 57%. Product sales from AVONEX(R) represent approximately 78% of the Company's total revenues in 1999 as compared to 71% in 1998. The growth in 1999 was primarily attributable to an increase in the sales volume of AVONEX(R) in the United States and in the fifteen member countries of the European Union ("EU"). AVONEX(R) sales outside of the United States were approximately $178.4 million in 1999 as compared to $92 million in 1998. Revenues from royalties in 1999 were $173.8 million, an increase of $11.1 million or approximately 7% as compared to $162.7 million of royalty revenue in 1998. Revenues from royalties represented approximately 22% of total revenues in 1999 as compared to 29% in 1998. The increase in royalty revenues in 1999 over the comparable period in 1998 is primarily the result of royalties received on increased sales of alpha interferon. COSTS AND EXPENSES Total costs and expenses in 1999 were $478.2 million as compared to $366.9 million in 1998, an increase of approximately 30%. Cost of revenues in 1999 totaled $111 million, an increase of $36.5 million or 49% as compared to 1998. The increase in cost of revenues was attributable to the higher sales volume of AVONEX(R). Included in cost of revenues in 1999 and 1998 is $96.9 million and $62.1 million, respectively, from product sales and $14.1 million and $12.4 million, respectively, relating to royalty revenue. Gross margins on product sales remained constant at approximately 84% for the period ended December 31, 1999 compared to the same period in 1998. Gross margins on royalty revenue remained constant at approximately 92% for the period ended December 31, 1999 compared to the same period in 1998. Research and development expenses in 1999 were $221.2 million, an increase of $44 million or 25% as compared to $177.2 million in 1998. The increase was primarily due to an increase in clinical trial costs, the costs associated with an increase in the Company's other development efforts related to its ongoing research and development programs and the funding of collaboration agreements. Selling, general and administrative expenses in 1999 were $146 million, an increase of $30.8 million or 27% as compared to 1998. This increase was primarily due to an increase in selling and marketing expenses related to the sale of AVONEX(R). 23 6 OTHER INCOME, NET Other income, net consists primarily of interest income, partially offset by interest expenses and other non-operating income and expenses. Other income, net in 1999 was $12.8 million as compared to $19.6 million in 1998, a decrease of $6.8 million or approximately 35%. Interest income in 1999 was $35.4 million compared to $28.3 million in 1998, an increase of $7.1 million or 25% due to an increase in funds invested. Interest expense decreased $1.3 million or 22% in 1999 from 1998. Other expense increased by $15.2 million in 1999 from 1998, due primarily to a $15 million write-down related to certain non-current marketable securities in the second quarter of 1999. As part of its strategic product development efforts, the Company invests in equity securities of certain biotechnology companies with which it has collaborative agreements. In December of 1996, Biogen purchased approximately 1.5 million shares of Creative BioMolecules, Inc. common stock for $18 million. In March of 1997, Biogen purchased approximately 670,000 shares of CV Therapeutics, Inc. common stock for $7 million. In March of 1998, the Company purchased approximately 435,000 shares of CuraGen common stock for $5 million and converted 100,000 shares of CuraGen Series E Preferred Stock valued at $1 million to CuraGen common stock. Each of these small emerging companies is principally engaged in researching, developing or manufacturing drugs for human health care. As a matter of policy, Biogen determines on a quarterly basis whether a decline in the fair value of a marketable security is other than temporary. Unrealized gains and losses on marketable securities are included in other comprehensive income in shareholders' equity, net of related tax effects. If a decline in the fair value of a marketable security below the Company's cost basis is determined to be other than temporary, such marketable security is written down to its estimated fair value with a charge to current earnings. Up through and including the assessment at June 30, 1999, the Company concluded that substantial evidence existed suggesting that the value of the investments described above would recover to at least the Company's purchase price. Such evidence included the prospects for favorable clinical trial results, new product initiatives and new collaborative agreements. However, given the lack of any substantial price recovery during the quarter ended June 30, 1999, and the amount of time elapsed since the decline in value began, the Company concluded that it had become unclear over what period such price recovery would take place. As a result, it was determined that the positive evidence suggesting that the investments would recover to at least the Company's purchase price was not sufficient to overcome the presumption that the current market price of the investments was the best indicator of value at June 30, 1999. Accordingly, the related unrealized losses of approximately $15 million were recognized as other expense in the second quarter of 1999. INCOME TAXES The Company's effective tax rate in 1999 was 33%. Income tax expense for 1999 varied from the amount computed at the U.S. federal statutory rates primarily due to increased European sales and to the utilization of research and development tax credits. The Company's effective tax rate outside the U.S. is lower than the U.S. tax rate. FINANCIAL CONDITION At December 31, 2000, cash, cash equivalents and short-term marketable securities were $682.4 million compared with $654.5 million at December 31, 1999, an increase of $27.9 million. Working capital decreased $12.7 million to $707.3 million. Net cash from operating activities for the year ended December 31, 2000 was $365.9 million compared with $363.6 million in 1999. Cash outflows from investing activities during 2000 included investments in property and equipment and patents of $199.1 million and investments in collaborative partners of $5 million. Net cash inflows from investing activities related to 24 7 marketable securities was $99.1 million. Significant cash outflows from financing activities included $300.2 million for purchases of the Company's common stock under its stock repurchase program and $4.9 million for repayments on loan agreements with banks. Cash inflows from financing activities included $36 million from common stock option exercises and employee stock purchase plan activity. In August 1995, the Company entered into a loan agreement with a bank for financing the construction of its biological manufacturing facility in North Carolina (the "Construction Loan"). During 1997, the Company completed construction of the facility and the funds advanced under the Construction Loan were converted to a floating rate ten-year term loan with principal and interest payable quarterly. As of December 31, 2000, the Company had $36.2 million outstanding under the Construction Loan. The Construction Loan is secured by the underlying building. The Company also entered into an interest rate swap agreement with the same bank, fixing its interest rate on the Construction Loan at 7.75% during the remaining term of the loan with interest payable quarterly. In addition, as of December 31, 2000, the Company had $15.8 million outstanding under a floating rate loan with a bank (the "Term Loan"). The Term Loan is secured by the Company's laboratory and office building in Cambridge, Massachusetts. The Company has fixed its interest rate on the Term Loan at 7.5% under the terms of an interest rate swap agreement. Terms of the Company's loan agreements include various covenants, including financial covenants which require the Company to maintain minimum net worth, cash flow and various financial ratios. On December 18, 2000, the Company announced that its Board of Directors had authorized the repurchase of up to 4 million shares of the Company's common stock. The repurchased stock will provide the Company with treasury shares for general corporate purposes, such as stock to be issued under employee stock option and stock purchase plans. Stock purchases are expected to occur from time to time through 2001. The stock repurchase program may be discontinued at any time. In November of 2000, the Company completed a previous stock repurchase program. During 2000, the Company repurchased approximately 4.6 million shares of its common stock under this program at a cost of $300.2 million. On October 4, 1999, the Company began construction of its new research and development center in Cambridge, Massachusetts. The new 224,000 square foot building is expected to be completed in the spring of 2001 at a total cost of approximately $95 million, of which $81.4 million had been committed at December 31, 2000. Additionally, the Company is completing plans to build a large scale manufacturing plant in Raleigh, North Carolina. The Company expects that construction will be completed at the end of 2001 at a total cost of approximately $175 million of which $141.9 million had been committed at December 31, 2000. In September 2000, the Company signed a research and development agreement (the "Eos Agreement") with Eos Biotechnology, Inc. ("Eos"), under which the Company and Eos will collaborate in the research and development of novel targets for antibody and protein therapeutics in the area of breast cancer. Under the Eos Agreement, the Company purchased 1.9 million shares of preferred stock of Eos for $5 million. In addition, the Company paid a one-time non-refundable license fee of $6 million, which was charged to research and development expense and acquired certain exclusive, worldwide rights related to breast cancer-specific molecules for the use in the development of new antibody and secreted protein therapeutics. The Company accounts for its investment in Eos, which is included in other assets, using the cost method of accounting. The Company provided Eos with research and development funding of $250,000 in 2000. The Company expects to fund research activities of Eos related to the collaboration of up to $1.5 million in 2001. In August 2000, the Company signed a development and marketing collaboration agreement (the "Antegren Agreement") with Elan Corporation, plc ("Elan") under which the Company and Elan collaborate in the development, manufacture and commercialization of Antegren(R), a humanized monoclonal antibody and alpha 4 integrin inhibitor. Under the terms of the Antegren Agreement, Biogen and Elan will share costs for on-going development activities. The Company paid a one-time non-refundable license fee of $15 million, which was charged to research and development expense. 25 8 In October 1997, the Company signed a research and option agreement (the "CuraGen Agreement") with CuraGen Corporation ("CuraGen") under which the Company and CuraGen collaborate in the discovery of novel genes using CuraGen's functional genomics technologies. The Company provided CuraGen with research and development funding of $1.5 million, $1.1 million and $1.9 million in 2000, 1999 and 1998, respectively. The Curagen Agreement was terminated in September 2000 and all investments in CuraGen common stock were sold during 2000. In March 1997, the Company signed a research collaboration and license agreement (the "CVT Agreement") with CV Therapeutics, Inc. ("CVT") under which Biogen obtained rights under CVT's patents and know-how to develop and market molecules that act as highly selective antagonists of the adenosine A1 receptor, for the treatment of congestive heart failure. Under the terms of the CVT Agreement, the Company purchased approximately 670,000 shares of CVT common stock at the then fair value for $7 million and paid a one-time license fee of $5 million, which was charged to research and development expense. The investment in CVT is classified as available-for-sale and is included in long-term marketable securities. At December 31, 2000 the Company retained approximately 670,000 shares of CVT common stock. In December 1996, the Company signed a research collaboration and license agreement (the "CBM Agreement") with Creative BioMolecules, Inc. ("CBM") under which Biogen obtained rights to develop and market CBM's morphogenic protein, OP-1, for the treatment of renal disorders. Under the CBM Agreement, the Company purchased 1.5 million shares of CBM common stock for $18 million. The payment for the common stock included a $1.2 million premium over the fair value of the common stock which was charged to research and development expense. The Company provided $10 million in research and development funding, which was charged to expense as provided in 1998. The CBM Agreement terminated at the end of 1999 and all investments in CBM common stock were sold during 2000. In July 1996, the Company signed a collaborative research and commercialization agreement (the "Ontogeny Agreement") with Ontogeny, Inc. ("Ontogeny"), a private biotechnology company, for the development and commercialization of three specific hedgehog cell proteins, a class of novel human proteins, that are responsible for reducing the formation or regeneration of tissue. Under the Ontogeny Agreement, the Company purchased 400,000 shares of preferred stock of Ontogeny for $1 million and acquired certain exclusive, worldwide rights related to products based on the hedgehog proteins for most disease areas. In November 1998, the Company extended and expanded its collaboration with Ontogeny and provided to Ontogeny a $4 million convertible loan. In June 1999, the loan was converted into 800,000 shares of Ontogeny Convertible Preferred Stock. The Ontogeny Agreement was terminated in July 2000. In August 2000, Ontogeny merged with two other biotechnology companies to form Curis Inc. ("Curis"). As a shareholder in Ontogeny, Biogen received Curis common stock in exchange for the Company's shares in Ontogeny. The Company provided $1 million, $2.8 million and $3.6 million of research funding to Ontogeny in 2000, 1999 and 1998, respectively. Additionally, the Company provided $1.5 million upon conclusion of the Ontogeny Agreement, which was charged to research and development expense. At December 31, 2000 the investment in Curis is classified as available-for-sale and is included in long-term marketable securities. At December 31, 2000 the Company retained approximately 308,000 shares of Curis common stock. In August 1995, the Company signed a collaborative research agreement (the "Genovo Agreement") for the development of human gene therapy treatments with Genovo, Inc. ("Genovo"), a gene therapy research company. Under the Genovo Agreement, the Company acquired 380,000 shares of Genovo Series A Preferred stock for $4.5 million and acquired certain licensing rights. The Company accounted for this investment, which was included in other assets, using the equity method of accounting. The Company recorded its proportion of Genovo's net losses as research and development expense in the amounts of $3.9 million, $7.6 million, and $9 million in 2000, 1999, and 1998, respectively. In August 2000, Genovo entered into a merger agreement ("Targeted Merger Agreement") with Targeted Genetics Corporation ("Targeted"). As a shareholder in Genovo, Biogen received Targeted common stock in exchange for the Company's shares in Genovo. Additionally, concurrently with the Targeted Merger Agreement, the Company entered into a development and marketing agreement and a funding agreement (the "Targeted 26 9 Agreements") for gene therapy research and development in oncology. The Targeted Agreements provide for a $10 million credit facility. Targeted also has an option to sell to the Company an additional $10 million of Targeted common stock at fair value. As of December 31, 2000, there were no borrowings outstanding under the credit facility and the Company provided $250,000 in research funding to Targeted in 2000. The Company believes that existing funds and cash generated from operations are adequate to satisfy its working capital and capital expenditure requirements in the foreseeable future. However, the Company may raise additional capital to take advantage of favorable conditions in the market or in connection with the Company's development activities. LEGAL MATTERS On July 3, 1996, Berlex Laboratories, Inc. ("Berlex") filed suit against Biogen in the United States District Court for the District of New Jersey alleging infringement by Biogen of Berlex's "McCormick" patent (U.S. Patent No. 5,376,567) in the United States in the production of Biogen's AVONEX(R) (Interferon beta-1a) product. In November 1996, Berlex's New Jersey action was transferred to the United States District Court in Massachusetts and consolidated for pre-trial purposes with a related declaratory judgment action previously filed by Biogen. On August 18, 1998, Berlex filed a second suit against Biogen alleging infringement by Biogen of a patent which was issued to Berlex in August 1998 and which is related to the McCormick patent (U.S. Patent No. 5,795,779). On September 23, 1998, the cases were consolidated for pre-trial and trial purposes. Berlex sought a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. A hearing on the parties' summary judgment motions in the case was completed in March 2000. In September 2000, the District Court rendered final judgment in favor of Biogen and against Berlex determining that Biogen's production of AVONEX(R) did not infringe any of the claims of the Berlex patents. Berlex has appealed this decision with the Court of Appeals for the Federal Circuit and the parties are in the process of briefing the appeal for oral argument. An unfavorable ruling on appeal would result in the case being remanded to the District Court for trial. If Berlex were to be successful in its appeal and the case were remanded, an unfavorable ruling in the remanded case could have a material adverse effect on the Company's results of operations and financial position. The Company believes that the decision of the District Court that Biogen does not infringe the Berlex patents is sound, but the ultimate outcome of the appeal is not currently determinable. As a result, an estimate of any potential loss or range of loss cannot be made at this time. In 1995, the Company filed an opposition with the Opposition Division of the European Patent Office to oppose a European patent (the "Rentschler I Patent") issued to Dr. Rentschler Biotechnologie GmbH ("Rentschler") relating to compositions of matter of beta interferon. In 1997, the European Patent Office issued a decision to revoke the Rentschler I Patent. Rentschler appealed that decision and an oral hearing on the appeal took place in December 2000. At the oral hearing in order to gain reinstatement of the patent, Rentschler narrowed the patent claims so as to claim only a specific cell line. Biogen does not use the specific cell line now claimed. On October 13, 1998, the Company filed another opposition with the Opposition Division of the European Patent Office to oppose a second European patent issued to Rentschler (the "Rentschler II Patent") with certain claims regarding compositions of matter of beta interferon with specific regard to the structure of the glycosylated molecule. A hearing on the Company's opposition previously scheduled for October 2000 has been postponed, and will likely be held in 2001. While Biogen believes that the Rentschler II Patent will be revoked and that the revocation of the Rentschler I Patent will be upheld on appeal, if either the Rentschler I Patent or the Rentschler II Patent were to be upheld and if Rentschler were to obtain, through legal proceedings, a determination that the Company's sale of AVONEX(R) in Europe infringes a valid Rentschler patent, such result could have a material adverse effect on the Company's results of operation and financial position. NEW ACCOUNTING PRONOUNCEMENT In December 1999, the United States Securities and Exchange Commission issued Staff Accounting Bulletin 101, "Revenue Recognition in Financial Statements" ("SAB 101"). SAB 101 provides the staff's views in applying generally accepted accounting principles to selected revenue recognition issues, as well 27 10 as examples of how the staff applies revenue recognition guidance to specific circumstances. The Company adopted SAB 101 in 2000. Adoption of SAB 101 did not have a material effect on the Company's financial position and results of operations. OUTLOOK SAFE HARBOR STATEMENT UNDER PRIVATE SECURITIES LITIGATION REFORM ACT OF 1996 In addition to historical information, this annual report contains forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward-looking statements. Reference is made in particular to forward-looking statements regarding the anticipated level of future product sales, royalty revenues, expenses and profits, statements regarding the timing of clinical trials, statements regarding the potential outcome of clinical programs, the marketing of additional products and predictions as to the anticipated outcome of pending or anticipated litigation, arbitration and patent-related proceedings and the Company's expectations as to the value of its investments in certain marketable securities. These and all other forward-looking statements are made based on the Company's current belief as to the outcome and timing of such future events. Factors which could cause actual results to differ from the Company's expectations and which could negatively impact the Company's financial condition and results of operations are discussed below. DEPENDENCE ON AVONEX(R) SALES The Company's ability to sustain increases in revenues and profitability for the next several years will be primarily dependent on the level of revenues and profitability from AVONEX(R) sales. The Company's ability to sustain profitability from sales of AVONEX(R) will depend on a number of factors, including: continued market acceptance of AVONEX(R) worldwide; the Company's ability to maintain a high level of patient satisfaction with AVONEX(R); the nature of regulatory and pricing decisions related to AVONEX(R) worldwide; the extent to which AVONEX(R) continues to receive reimbursement coverage; the impact of competitive products; and the impact of adverse decisions in patent-related proceedings. The extent of the profitability from AVONEX(R) sales is also dependent on the successful resolution of the Berlex suit, which is described above under "Legal Matters". COMPETITION The Company faces increasing competition from other products for the treatment of relapsing forms of MS. As a treatment for multiple sclerosis, AVONEX(R) competes with interferon beta-1b which is sold in the United States under the brand name Betaseron(R) by Berlex Laboratories, a United States affiliate of Schering AG, and is sold in Europe under the brand name Betaferon(R) by Schering AG. AVONEX(R) also faces competition from Copaxone(R) glatiramer acetate (also known as copolymer-1). In the United States, Copaxone(R) is marketed by a partnership between Teva Pharmaceutical Industries, Ltd. and Hoechst Marion Roussel, Inc. In most countries outside of the United States, AVONEX(R) also competes with Rebif(R), a recombinant interferon beta-1a product sold by Serono. In response to an application from Serono for approval of Rebif(R) in the United States for relapsing multiple sclerosis, the FDA, in March 1999, upheld its earlier ruling that, based on the data from existing clinical trials, Serono cannot market Rebif(R) in the United States for relapsing multiple sclerosis while the orphan drug status afforded to AVONEX(R) and Betaseron(R) for that indication is still in effect. AVONEX(R)'s orphan drug status for relapsing forms of the disease expires in 2003. The ruling by the FDA prompted Serono in 2000 to initiate a 12-month head-to-head study of Rebif(R) and AVONEX(R) to determine if Serono can show whether Rebif(R) is clinically superior to AVONEX(R). If positive, Serono will most likely use the results of this study in its attempts to overcome the orphan drug status of AVONEX(R) and to get Rebif(R) approved before expiration of AVONEX's orphan drug status. Biogen expects Serono to release the results of the study in the third quarter of 2001. AVONEX(R) also competes in the United States with Novantrone(R) (mitoxantrone for injection) which is produced and marketed by Immunex Corporation, a majority-owned subsidiary of American Home Products Corporation. Novantrone(R) is approved for use in patients with clinically worsening forms of relapsing-remitting and secondary progressive multiple sclerosis. 28 11 A number of other companies are working to develop products to treat multiple sclerosis which may in the future compete with AVONEX(R), the worldwide market leader among multiple sclerosis therapies. AVONEX(R) may also in the future face competition from off-label uses of drugs approved for other indications. Biogen believes that competition among treatments for multiple sclerosis will be based on product performance, service and price. ROYALTY REVENUE The Company receives royalty revenues which contribute to its overall profitability. The Company expects to continue to experience a decline in royalty revenues as a result of patent expirations and other patent-related events in the range of up to approximately $10 million per quarter for 2001 (not including amounts that are subject to a dispute with Schering-Plough as discussed below). See "Outlook - Patents and Other Proprietary Rights." The Company expects the most significant decline to be in the amount of royalties received from Schering-Plough on sales of INTRON(R) A as the result of patent expirations in the EU and Japan. The extent of the decline in royalties related to United States sales of INTRON(R) A will depend on the outcome of a dispute with Schering-Plough related to its royalty obligations. Schering-Plough has taken the position that a Court of Appeal's decision affirming a District Court's ruling which narrowed the scope of the claims of Biogen's United States alpha interferon patent has caused the patent to no longer cover Schering-Plough's alpha interferon products, and, that, as a result, Schering-Plough no longer has an obligation to pay royalties under that patent. Until expiration of Biogen's EU (Irish) patent in January 2001, Schering-Plough continued to pay royalties on sales of product in the United States based on manufacture of the product in Ireland. Biogen is currently in discussions with Schering-Plough to work to resolve the royalty issue and to resolve claims by Biogen related to underpayment of royalties by Schering-Plough. In any event, commencing in July 2002, Schering-Plough is obligated to pay royalties on sales of its alpha interferon products in the U.S., including INTRON(R)A, during the term of a certain Roche/Genentech U.S. alpha interferon patent right under an agreement between Biogen and Schering-Plough in connection with settlement of a lawsuit with Roche/Genentech related to the Roche/Genentech patent right. Biogen intends to vigorously oppose any attempt by Schering-Plough to discontinue payment of royalties. If the dispute with Schering-Plough results in arbitration and Schering-Plough were to prevail in the arbitration, the resulting decline in royalties on United States sales of alpha interferon products could range up to approximately an additional $10 million per quarter in the eighteen month period. There are a number of other factors which could also cause the actual level of royalty revenue to differ from the Company's expectations. For example, pricing reforms, health care reform initiatives, other legal and regulatory developments and the introduction of competitive products may have an impact on product sales by the Company's licensees. In addition, sales levels of products sold by the Company's licensees may fluctuate from quarter to quarter due to the timing and extent of major events such as new indication approvals or government sponsored programs. Since the Company is not involved in the development or sale of products by its licensees, the Company can not be certain of the timing or potential impact of factors which may affect sales by the Company's licensees. In the long term, the Company expects its royalty revenue to be affected most significantly by patent expirations and a potential decrease in sales by licensees of licensed products. See "Outlook - Patents and Other Proprietary Rights." PATENTS AND OTHER PROPRIETARY RIGHTS The Company has numerous issued patents and patent applications pending on a number of its processes and products. The Company has also obtained rights to certain patents under licenses with third parties which provide for the payment of royalties. There can be no assurances that Biogen's existing patents or others, if obtained, will be of substantial protection or commercial benefit to Biogen. In addition, it is not known to what extent Biogen's pending patent applications or patent applications licensed from third parties will be granted or whether any of the Company's patents will prevail if they are challenged in litigation. There is also no assurance that third parties have not or will not be granted patents claiming subject matter necessary to Biogen's business. 29 12 Biogen has granted an exclusive worldwide license to Schering-Plough under Biogen's alpha interferon patents. Schering-Plough's royalty obligation to Biogen on sales of Schering-Plough's INTRON(R) A brand of alpha interferon in Japan and Europe terminated upon expiration of Biogen's alpha interferon patent in such territories in January 2001, except in France and Italy where Biogen has obtained supplemental protection certificates extending the coverage in France until 2003 and in Italy until 2007. In 2000, a Court of Appeals decision affirmed a District Court's decision narrowing the scope of Biogen's United States alpha interferon patents. For a discussion of a dispute with Schering-Plough over the implications of the decision on the amount of royalties owed to Biogen on sales of alpha interferon products in the United States, see "Outlook - Royalty Revenue". In consideration of assignment to Schering-Plough by Biogen of a Biogen patent application claiming recombinant mature human alpha interferon, Schering-Plough has agreed to pay to Biogen certain sums on sales by Schering-Plough of alpha interferon products in the United States from the date when Biogen's existing United States alpha interferon patent expires (i.e. July 2002) until expiration of an alpha interferon patent expected to be issued to Hoffman-LaRoche Inc. ("Roche") and Genentech, Inc. ("Genentech"). The Roche/Genentech patent was the subject of a lawsuit brought by Biogen which was ultimately settled. Schering-Plough entered into an agreement with Roche as part of the settlement. Biogen has licensed its recombinant hepatitis B antigen patent rights to manufacturers and marketers of hepatitis B vaccines and diagnostic test kits, and receives royalties on sales of the vaccines and test kits by its licensees. The obligation of GlaxoSmithKline plc and Merck & Co., Inc. to pay royalties on sales of hepatitis B vaccines and the obligation of Biogen's other licensees under its hepatitis B patents to pay royalties on sales of diagnostic products will terminate upon expiration of Biogen's existing hepatitis B patents. Biogen's existing United States hepatitis B patents will expire in 2004. Biogen's European hepatitis B patents expired at the end of 1999, except in those countries in which Biogen has or is able to obtain supplementary protection certificates. To date, Biogen has received supplementary protection certificates in Austria, Belgium, France, Great Britain, Ireland, Italy, Luxembourg, The Netherlands, Sweden, and Switzerland, and has a number of granted or pending registrations of the Great Britain supplementary protection certificates in various British Territories. The additional coverage afforded by the supplementary protection certificates, or related registrations, ranges from two to eight years. There can be no assurance as to the extent of coverage available under the supplementary protection certificates, or that protection will be available in additional countries. In 1994, Biogen granted Eli Lilly and Company ("Lilly") a non-exclusive license under certain patents for gene expression. Under the license, Biogen has received royalties from Lilly since 1994 on products which use the patented vectors and methods. Based on a District Court's claims construction decision in an infringement action brought by Biogen against Amgen, Inc. involving the same patents as are licensed to Lilly, Lilly recently notified Biogen that Lilly believes that it no longer owes royalties to Biogen under the agreement on any of its products. There has been, and Biogen expects that there may continue to be significant litigation in the industry regarding patents and other intellectual property rights. Such litigation could create uncertainty and consume substantial resources. See also "Legal Matters". PRODUCTS AVONEX(R) is currently the only product sold by the Company. The Company's long-term viability and growth will depend on the successful development and commercialization of other products from its research activities and collaborations. The Company continues to expand its development efforts related to other potential products in its pipeline. The expansion of the pipeline may include increases in spending on internal projects, the acquisition of third-party technologies or products or other types of investments. Product development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Success in preclinical and early clinical trials does not ensure that later stage or large scale clinical trials will be successful. Many important factors affect the Company's ability to successfully develop and commercialize drugs, including the ability to obtain and maintain necessary patents and licenses, to demonstrate safety and efficacy of drug candidates at each stage of the clinical trial process, to overcome technical hurdles that may arise, to meet applicable regulatory 30 13 standards and to receive required regulatory approvals, to be capable of producing drug candidates in commercial quantities at reasonable costs, to compete successfully against other products and to market products successfully. There can be no assurance that the Company will be successful in its efforts to develop and commercialize new products. MARKET RISK The Company has exposure to financial risk in several areas including changes in foreign exchange rates and interest rates. The Company attempts to minimize its exposures by using certain financial instruments, for purposes other than trading, in accordance with the Company's overall risk management guidelines. Further information regarding the Company's accounting policies for financial instruments and disclosures of financial instruments can be found in Notes 1, 2 and 3 to the Company's Consolidated Financial Statements. FOREIGN EXCHANGE The Company has operations in several European countries in connection with the sale of its product AVONEX(R). The Company also receives royalty revenues based on worldwide product sales by its licensees. As a result, the Company's financial position, results of operations and cash flows can be affected by fluctuations in foreign currency exchange rates (primarily the Euro, British pound, Japanese yen and Canadian dollar). The Company uses foreign currency forward contracts to manage foreign currency risk and does not engage in currency speculation. The Company uses these forward contracts to hedge certain forecasted transactions denominated in foreign currencies. A hypothetical adverse 10% movement in foreign exchange rates compared to the U.S. dollar across all maturities would result in a hypothetical loss in fair value of approximately $11 million. The Company's use of this methodology to quantify the market risk of such instruments should not be construed as an endorsement of its accuracy or the accuracy of the related assumptions. The quantitative information about market risk is necessarily limited because it does not take into account operating transactions. INTEREST RATES The Company is exposed to risk of interest rate fluctuations in connection with its variable rate long-term debt. The Term Loan requires annual principal payments of $1.7 million through 2004, with the balance due in 2005. The Construction Loan requires annual principal payments of $3.2 million through 2006, with the balance due in 2007. At December 31, 2000, the carrying values of the Term Loan and the Construction Loan approximated fair value. The Company has fixed its interest rates on the Term Loan and Construction Loan by entering interest rate swap agreements under which the Company exchanges the difference between 7.5% and 7.75%, respectively, and a floating rate. The notional principal balances on the interest rate swap agreements are exactly equal to the principal on the underlying debt agreements. All other relevant terms of the interest rate swap agreements (including the index rate, reset period, etc.) exactly match the underlying loan agreements. The fair value of the interest rate swap agreements at December 31, 2000, representing the cash requirements of the Company to settle the agreements, was approximately $1.7 million. Terms of the Company's loan agreements include various covenants, including financial covenants which require the Company to maintain minimum net worth, cash flow and various financial ratios. The fair value of the Company's cash, cash equivalents, marketable securities, long-term debt and interest rate swap agreements are subject to change as a result of potential changes in market interest rates. The potential change in fair value for interest rate sensitive instruments has been assessed on a hypothetical 100 basis point adverse movement across all maturities. The Company estimates that such hypothetical adverse 100 basis point movement would not have materially impacted net income or materially affected the fair value of interest rate sensitive instruments. 31 14 STOCK PRICE The stock prices of biotechnology companies are subject to significant fluctuations. The stock price may be affected by a number of factors including, but not limited to clinical trial results and other product development events, the outcome of litigation, the financial impact of changes in the value of investments, including investments in other biotechnology companies, the decisions relating to intellectual property rights and the entrance of competitive products into the market, changes in reimbursement policies or other practices related to the pharmaceutical industry or other industry and market changes or trends. In addition, if revenues or earnings in any quarter fail to meet the investment community's expectations, there could be an immediate adverse impact on the Company's stock price. 32 15 CONSOLIDATED STATEMENTS OF INCOME - -------------------------------------------------------------------------------- Biogen, Inc. and Subsidiaries
- -------------------------------------------------------------------------------------------------- (in thousands, except per share amounts) - -------------------------------------------------------------------------------------------------- For the years ended December 31, 2000 1999 1998 - -------------------------------------------------------------------------------------------------- Revenues: Product $761,079 $620,636 $394,863 Royalties 165,373 173,799 162,724 - -------------------------------------------------------------------------------------------------- Total revenues 926,452 794,435 557,587 - -------------------------------------------------------------------------------------------------- Costs and expenses: Cost of revenues 125,198 111,005 74,509 Research and development 302,840 221,153 177,228 Selling, general & administrative 170,058 146,026 115,211 - -------------------------------------------------------------------------------------------------- Total costs and expenses 598,096 478,184 366,948 - -------------------------------------------------------------------------------------------------- Income from operations 328,356 316,251 190,639 Other income, net 158,749 12,765 19,554 - -------------------------------------------------------------------------------------------------- Income before income taxes 487,105 329,016 210,193 Income taxes 153,528 108,566 71,496 - -------------------------------------------------------------------------------------------------- Net Income $333,577 $220,450 $138,697 - -------------------------------------------------------------------------------------------------- Basic earnings per share $ 2.24 $ 1.47 $ 0.94 - -------------------------------------------------------------------------------------------------- Diluted earnings per share $ 2.16 $ 1.40 $ 0.90 - -------------------------------------------------------------------------------------------------- Shares used in calculating: Basic earnings per share 148,743 149,921 147,537 - -------------------------------------------------------------------------------------------------- Diluted earnings per share 154,602 157,788 154,270 - -------------------------------------------------------------------------------------------------- - --------------------------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements. 33 16 CONSOLIDATED BALANCE SHEETS Biogen, Inc. and Subsidiaries
(in thousands, except share amounts) As of December 31, 2000 1999 - --------------------------------------------------------------------------------------------------- Assets Current assets Cash and cash equivalents $ 48,737 $ 56,920 Marketable securities 633,675 597,619 Accounts receivable, less allowances of $2,436 and $1,642, respectively 143,178 137,363 Deferred tax assets 40,047 50,565 Other current assets 62,634 67,759 - --------------------------------------------------------------------------------------------------- Total current assets 928,271 910,226 - --------------------------------------------------------------------------------------------------- Property and equipment, net 400,429 239,777 Patents 13,510 13,871 Marketable securities 71,982 98,017 Other assets 17,664 16,082 - --------------------------------------------------------------------------------------------------- $ 1,431,856 $ 1,277,973 =================================================================================================== Liabilities and Shareholders' Equity Current liabilities Accounts payable $ 37,869 $ 30,125 Current portion of long-term debt 4,888 4,888 Accrued expenses and other 178,264 155,257 - --------------------------------------------------------------------------------------------------- Total current liabilities 221,021 190,270 - --------------------------------------------------------------------------------------------------- Long-term debt, less current portion 47,185 52,073 Other long-term liabilities 57,248 56,100 Commitments and contingencies -- -- Shareholders' equity Common stock, par value $0.01 per share (375,000,000 shares authorized; 151,705,636 and 150,684,586 shares issued in 2000 and 1999, respectively) 1,517 1,507 Additional paid-in capital 772,172 676,673 Retained earnings 543,913 352,016 Accumulated other comprehensive income 22,376 45,618 Treasury stock, at cost, 3,882,979 and 669,651 shares in 2000 and 1999, respectively (233,576) (96,284) - --------------------------------------------------------------------------------------------------- Total shareholders' equity 1,106,402 979,530 - --------------------------------------------------------------------------------------------------- $ 1,431,856 $ 1,277,973 ===================================================================================================
See accompanying notes to consolidated financial statements. 34 17 CONSOLIDATED STATEMENTS OF CASH FLOWS Biogen, Inc. and Subsidiaries
(IN THOUSANDS) For the years ended December 31, 2000 1999 1998 ---------------------------------------------------- CASH FLOWS FROM OPERATING ACTIVITIES Net Income $ 333,577 $ 220,450 $ 138,697 Adjustments to reconcile net income to net cash provided from operating activities Depreciation and amortization 38,824 31,099 24,590 Other (569) 5,162 (888) Deferred income taxes 25,203 (23,981) 7,486 Gain on sale of non-current marketable securities (101,129) -- -- Tax benefit of stock options 81,023 91,295 19,595 Write-down of non-current marketable securities -- 15,287 -- Changes in: Accounts receivable (5,815) (36,082) (14,479) Other current and other assets (35,329) (41,372) (25,638) Accounts payable, accrued expenses and other current and long-term liabilities 30,154 101,725 38,077 ---------------------------------------------------- Net cash flows from operating activities 365,939 363,583 187,440 ---------------------------------------------------- CASH FLOWS FROM INVESTING ACTIVITIES Purchases of marketable securities (627,168) (1,120,218) (574,021) Proceeds from sales and maturities of marketable securities 606,087 1,006,465 453,952 Proceeds from sales of non-current marketable securities 120,199 -- -- Investment in collaborative partners (5,000) (10,000) (5,000) Acquisitions of property and equipment (194,402) (82,528) (29,049) Additions to patents (4,713) (3,799) (4,562) ---------------------------------------------------- Net cash flows from investing activities (104,997) (210,080) (158,680) ---------------------------------------------------- CASH FLOWS FROM FINANCING ACTIVITIES Repayments on note payable -- -- (24,817) Repayments on long-term debt (4,888) (4,887) (4,886) Purchases of treasury stock (300,192) (197,717) (65,550) Proceeds from put warrants -- 22,086 -- Issuance of common stock and option exercises 35,955 58,490 21,580 ---------------------------------------------------- Net cash flows from financing activities (269,125) (122,028) (73,673) ---------------------------------------------------- Net increase (decrease) in cash and cash equivalents (8,183) 31,475 (44,913) Cash and cash equivalents, beginning of the year 56,920 25,445 70,358 ---------------------------------------------------- Cash and cash equivalents, end of the year $ 48,737 $ 56,920 25,445 ==================================================== SUPPLEMENTAL CASH FLOW DATA Cash paid during the year for: Interest $ 4,314 $ 4,598 $ 5,909 Income taxes $ 42,683 $ 4,787 $ 35,828
See accompanying notes to consolidated financial statements. 35 18 CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY Biogen, Inc. and Subsidiaries (in thousands)
ACCUMULATED ADDITIONAL OTHER TOTAL COMMON PAID-IN TREASURY RETAINED COMPREHENSIVE SHAREHOLDERS' STOCK CAPITAL STOCK EARNINGS INCOME EQUITY - ------------------------------------------------------------------------------------------------------------------------------------ Balance, December 31, 1997 $1,483 $516,138 $ (4,385) $ 25,327 $ (2,270) $ 536,293 ------------------------------------------------------------------------------ Net income 138,697 138,697 Unrealized gains/losses on marketable securities, net of tax of $ 4,476 (7,072) (7,072) Unrealized gains/losses on interest rate swaps, net of transition adjustment (see Note 1) (4,132) (4,132) Translation adjustment 309 309 ---------- Total comprehensive income 127,802 ---------- Exercise of options and related tax benefits 19,745 48,618 (27,188) 41,175 Reclassification of put option obligation 76,671 76,671 Treasury stock purchased (65,550) (65,550) Compensation expense related to stock options 2,222 2,222 ------------------------------------------------------------------------------ BALANCE, DECEMBER 31, 1998 $1,483 $538,105 $ (21,317) $ 213,507 $(13,165) $ 718,613 ------------------------------------------------------------------------------ Net income 220,450 220,450 Unrealized gains/losses on marketable securities, net of tax of $25,013 48,555 48,555 Unrealized gains/losses on foreign currency forward contracts, net of tax of $2,490 6,654 6,654 Unrealized gains/losses on interest rate swaps, net of tax of $137 4,501 4,501 Translation adjustment (927) (927) ---------- Total comprehensive income 279,233 ---------- Exercise of options and related tax benefits 24 108,952 122,750 (81,941) 149,785 Proceeds from sale of put warrants 22,086 22,086 Treasury stock purchased (197,717) (197,717) Compensation expense related to stock options 7,530 7,530 ------------------------------------------------------------------------------ BALANCE, DECEMBER 31, 1999 $1,507 $676,673 $(96,284) $352,016 $45,618 $ 979,530 ------------------------------------------------------------------------------ NET INCOME 333,577 333,577 UNREALIZED GAINS/LOSSES ON MARKETABLE SECURITIES, NET OF TAX OF $6,791 (16,152) (16,152) UNREALIZED GAINS/LOSSES ON FOREIGN CURRENCY FORWARD CONTRACTS, NET OF TAX OF $1,686 (5,311) (5,311) UNREALIZED GAINS/LOSSES ON INTEREST RATE SWAPS, NET OF TAX OF $789 (1,458) (1,458) TRANSLATION ADJUSTMENT (321) (321) ---------- TOTAL COMPREHENSIVE INCOME 310,335 ---------- EXERCISE OF OPTIONS AND RELATED TAX BENEFITS 10 95,748 162,900 (141,680) 116,978 TREASURY STOCK PURCHASED (300,192) (300,192) COMPENSATION EXPENSE RELATED TO STOCK OPTIONS (249) (249) ------------------------------------------------------------------------------ BALANCE, DECEMBER 31, 2000 $1,517 $772,172 $(233,576) $ 543,913 $ 22,376 $1,106,402 ==============================================================================
See accompanying notes to consolidated financial statements. 36 19 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Biogen, Inc. and Subsidiaries 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES BUSINESS Biogen, Inc. ("Biogen" or the "Company") is a biopharmaceutical company principally engaged in the business of developing, manufacturing and marketing drugs for human health care. The Company currently derives revenues from sales of its AVONEX(R) (Interferon beta-la) product for the treatment of relapsing forms of multiple sclerosis and from royalties on worldwide sales by the Company's licensees of a number of products covered under patents controlled by the Company, including alpha interferon and hepatitis B vaccines and diagnostic products. PRINCIPLES OF CONSOLIDATION The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All material intercompany balances and transactions have been eliminated. Certain items in prior years' financial statements have been reclassified to conform with the current year's presentation. USE OF ESTIMATES The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and use assumptions that affect certain reported amounts and disclosures; actual amounts may differ. TRANSLATION OF FOREIGN CURRENCIES The functional currency for most of the Company's foreign subsidiaries is the local currency. Assets and liabilities are translated at current rates of exchange. Income and expense items are translated at the average exchange rates for the year. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into U.S. dollars are excluded from the determination of net income and are accumulated in a separate component of shareholders' equity. The U.S. dollar is the functional currency for certain foreign subsidiaries. The Company's subsidiaries which have the U.S. dollar as the functional currency are remeasured into U.S. dollars using current rates of exchange for monetary assets and liabilities and historical rates of exchange for nonmonetary assets. Foreign exchange transaction gains and losses are included in the results of operations in other income, net. Foreign exchange gains totaled $2.8 million, $2.5 million and $2.5 million in 2000, 1999, and 1998, respectively. CASH AND CASH EQUIVALENTS The Company considers only those investments which are highly liquid, readily convertible to cash and which mature within three months from date of purchase to be cash equivalents. FAIR VALUE OF FINANCIAL INSTRUMENTS The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other current assets, accounts payable, and accrued expenses and other approximate fair value due to the short-term maturities of these instruments. Marketable securities are carried at fair value based on quoted market prices, consistent with the requirements of Statement of Financial Accounting Standards No. 115, "Accounting for Certain Investments in Debt and Equity Securities". The fair values of trading securities, interest rate swaps, foreign currency forward contracts and options on non-marketable instruments are based on quoted market prices or pricing models using current market rates. The Company's long-term debt approximates fair value based on dealer quotes. 37 20 INVENTORIES Inventories are stated at the lower of cost or market with cost determined under the first-in/first-out ("FIFO") method and are included in other current assets. Included in inventory are raw materials used in the production of pre-clinical and clinical products which are expensed as research and development costs when consumed. The components of inventories for the periods ending December 31, are as follows: (in thousands) 2000 1999 ------- ------- Raw materials $ 7,775 $ 5,679 Work in process 17,582 15,110 Finished goods 14,172 19,242 ------- ------- $39,529 $40,031 ======= ======= MARKETABLE SECURITIES The Company invests its excess cash balances in short-term marketable securities, principally corporate notes and government securities. At December 31, 2000, substantially all of the Company's securities were classified as "available-for-sale". All available-for-sale securities are recorded at fair market value and unrealized gains and losses are included in accumulated other comprehensive income in shareholders' equity, net of related tax effects. Realized gains and losses and declines in value, if any, judged to be other than temporary on available-for-sale securities are reported in other income or expense. As part of its strategic product development efforts, the Company also invests in equity securities of certain biotechnology companies with which it has collaborative agreements. Such investments, which are included in long-term marketable securities and other assets, are classified as available-for-sale if a readily determinable market value exists. These investments are accounted for under the cost or equity method, depending on the facts and circumstances of the investment, and are reviewed regularly for impairment. On a quarterly basis, as of the end of the quarter, the Company determines whether a decline in fair value of a marketable security is other than temporary. Unrealized gains and losses on marketable securities are included in other comprehensive income in shareholders' equity, net of related tax effects. If a decline in the fair value of a marketable security below the Company's cost basis is determined to be other than temporary, such marketable security is written down to its estimated fair value with a charge to current earnings. The Company has concluded that all unrealized losses on marketable securities at December 31, 2000 are temporary in nature. The Company expects that the market value of such investments will recover to at least the Company's cost basis within a reasonable period of time. Should any portion of these unrealized losses subsequently be determined to be other than temporary, the Company would be required to record the related amount as a charge to current earnings. PROPERTY AND EQUIPMENT Property and equipment is carried at cost, subject to review of impairment for significant assets whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Depreciation is calculated on the straight-line basis over the estimated useful lives of the assets. Leasehold improvements are amortized over the lesser of the useful life or the term of the respective lease. Maintenance of computer systems, including maintenance to make software Year 2000 compliant, is expensed as incurred. Buildings and equipment are depreciated over estimated useful lives ranging from 30 to 40 and 3 to 10 years, respectively. The Company capitalizes certain incremental costs associated with the validation effort required for licensing by the FDA of manufacturing equipment for the production of a commercially approved drug. These costs include primarily direct labor and material and are incurred in preparing the equipment for its intended use. Net capitalized validation costs were $4.3 million and $4.7 million at December 31, 2000 and 1999, respectively. The validation costs are amortized over the life of the related equipment. 38 21 PATENTS The costs associated with successful patent defenses and patent applications are capitalized and amortized on a straight-line basis over estimated useful lives up to 15 years. Accumulated amortization of patent costs was $25.2 million and $20.1 million as of December 31, 2000 and 1999, respectively. The carrying value of patents is regularly reviewed by the Company and impairments are recognized when the expected future operating cash flows derived from the patent are less than their carrying value. DERIVATIVES AND HEDGING ACTIVITIES On June 15, 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities", ("SFAS 133"). The Company elected to adopt SFAS 133 in the fourth quarter of 1998. All derivatives are recognized on the balance sheet at their fair value. Changes in the fair value of derivatives are recorded each period in current earnings or other comprehensive income, depending on whether a derivative is designated as part of a hedge transaction and, if it is, the type of hedge transaction. The Company assesses, both at its inception and on an on-going basis, whether the derivatives that are used in hedging transactions are highly effective in offsetting the changes in cash flows of hedged items. The Company assesses hedge ineffectiveness on a quarterly basis and records the gain or loss related to the ineffective portion to current earnings to the extent significant. If the Company determines that a cash flow hedge is no longer probable of occurring, the Company discontinues hedge accounting for the affected portion of the forecasted transaction, and any unrealized gain or loss on the contract is recognized in current earnings. COMPREHENSIVE INCOME Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income", ("SFAS 130") requires the display of comprehensive income and its components as part of the Company's full set of financial statements. Comprehensive income is comprised of net income and other comprehensive income. Other comprehensive income includes certain changes in equity that are excluded from net income, such as translation adjustments and unrealized holding gains and losses on available-for-sale marketable securities and certain derivative instruments, net of tax. The Consolidated Statements of Shareholders' Equity reflect comprehensive income for years ended December 31, 2000, 1999 and 1998 which were $310.3 million, $279.2 million and $127.8 million, respectively. Upon adoption of SFAS 133, on October 1, 1998, the Company recorded an adjustment to other comprehensive income to recognize at fair value all derivatives that were designated as cash flow hedging instruments, which comprised unrealized losses related to the Company's interest rate swaps of $5.4 million. This unrealized loss decreased by $1.3 million during the fourth quarter of 1998 and as of December 31, 1998, the cumulative unrealized losses on the Company's interest rate swaps were $4.1 million. During 1999, the Company recorded $4.5 million of unrealized gains to other comprehensive income reflecting the increase in the fair value of the interest rate swaps and at December 31, 1999 had a cumulative unrealized gain of $366,000. During 2000, the Company recorded $1.5 million of unrealized losses to other comprehensive income reflecting the decrease in the fair value of the interest rate swaps and at December 31, 2000 had a cumulative unrealized loss of $1.1 million. The Company entered into foreign currency forward contracts in October 1998. At December 31, 1998, these contracts had unrealized gains of $3,000, which were aggregated with the unrealized losses associated with the Company's interest rate swaps in comprehensive income. During 1999, the fair value of the Company's foreign currency forward contracts increased by $6.7 million in unrealized gains. At December 31, 1999, the Company had cumulative unrealized gains of $6.7 million on its foreign currency forward contracts. During 2000, the fair value of the Company's foreign currency forward contracts decreased by $5.3 million. At December 31, 2000, the Company had cumulative unrealized gains of $1.4 million on its foreign currency forward contracts. SEGMENT INFORMATION Statement of Financial Accounting Standards No. 131, "Disclosures about Segments of an Enterprise and Related Information", ("SFAS 131") establishes standards for reporting information on operating segments in interim and annual financial statements. The Company's chief operating decision makers review the 39 22 profit and loss of the Company on an aggregate basis and manage the operations of the Company as a single operating segment. Accordingly, the Company operates in one segment, which is the business of developing, manufacturing and marketing drugs for human health care. REVENUES Revenues from product sales are recognized when product is shipped and title and risk of loss has passed. Revenues are recorded net of applicable allowances for returns, rebates and other applicable discounts and allowances. The Company prepares its estimates for sales returns and allowances, discounts and rebates quarterly based primarily on historical experience updated for changes in facts and circumstances, as appropriate. The Company receives royalty revenues under license agreements with a number of third parties that sell products based on technology developed by the Company or to which the Company has rights. The license agreements provide for the payment of royalties to the Company based on sales of the licensed product. The Company records these revenues based on estimates of the sales that occurred during the relevant period. The relevant period estimates of sales are based on interim data provided by licensees and analysis of historical royalties paid to the Company (adjusted for any changes in facts and circumstances, as appropriate). The Company maintains regular communication with its licensees in order to gauge the reasonableness of its estimates. Differences between actual royalty revenues and estimated royalty revenues are reconciled and adjusted for in the following quarter. Historically, adjustments have not been material based on actual amounts paid by licensees. There are no future performance obligations on the part of the Company under these license agreements. Revenue is not recognized in any circumstances unless collectibility is reasonably assured. RESEARCH AND DEVELOPMENT EXPENSES Research and development costs, including amounts funded in research collaborations, are expensed as incurred. EARNINGS PER SHARE The Company calculates earnings per share in accordance with Statement of Financial Accounting Standards No. 128, "Earnings per Share" ("SFAS 128"). SFAS 128 requires the presentation of "basic" earnings per share and "diluted" earnings per share. Basic earnings per share is computed by dividing the net income available to common shareholders by the weighted average number of shares of common stock outstanding. For purposes of calculating diluted earnings per share the denominator includes both the weighted average number of shares of common stock outstanding and the number of dilutive common stock equivalents such as stock options and warrants. Dilutive securities include outstanding options under the Company's stock option plans. Options to purchase 2.7 million shares were outstanding at December 31, 2000 but not included in the computation of diluted earnings per share because the options' exercise prices were greater than the average market price during the period. The put warrants sold in connection with the Company's stock repurchase program in 1999 did not have a significant additional dilutive effect. Shares used in calculating basic and diluted earnings per share for the periods ending December 31, are as follows: (in thousands) 2000 1999 1998 -------- -------- -------- Weighted average number of shares of common stock outstanding 148,743 149,921 147,537 Dilutive stock options 5,859 7,867 6,733 -------- -------- -------- Shares used in calculating diluted earnings per share 154,602 157,788 154,270 ======== ======== ======== On June 11, 1999, the Board of Directors declared a two-for-one stock split to be effected in the form of a stock dividend of one share of common stock for each share outstanding. The stock dividend was payable on June 25, 1999 to shareholders of record at the close of business on June 11, 1999. All references to 40 23 number of shares and per share amounts in the financial statements have been restated to give effect to the stock split for all periods presented. 2. FINANCIAL INSTRUMENTS Financial instruments that potentially subject the Company to concentrations of credit risk are accounts receivable and marketable securities. Wholesale distributors and large pharmaceutical companies account for the majority of the accounts receivable and collateral is generally not required. To mitigate the risk, the Company monitors the financial performance and credit worthiness of its customers. The Company invests its excess cash balances in marketable debt securities, primarily U.S. government securities and corporate bonds and notes, with strong credit ratings. The Company limits the amount of investment exposure as to institution, maturity and investment type. The average maturity of the Company's marketable securities as of December 31, 2000 and 1999 was 30 months and 24 months, respectively. Proceeds from maturities and other sales of marketable securities, which were primarily reinvested, for the years ended December 31, 2000, 1999 and 1998 were approximately $606 million, $1,006 million and $454 million, respectively. The cost of securities sold is determined based on the specific identification method. Realized gains and (losses) on these sales for the years ended December 31, 2000, 1999 and 1998 were $(1,846,000), $(1,442,000) and $645,000, respectively. The following is a summary of marketable securities:
Unrealized ---------------------- Amortized (in thousands) Fair Value Gains Losses Cost ---------- -------- -------- --------- December 31, 2000: U.S. Government securities $288,214 $ 5,284 $ -- $282,930 Corporate debt securities 345,461 2,444 -- 343,017 ---------------------------------------------------- $633,675 $ 7,728 $ -- $625,947 ==================================================== Marketable securities, noncurrent $ 71,982 $ 28,174 $ -- $ 43,808 ==================================================== December 31, 1999: U.S. Government securities $295,046 $ -- $ 4,656 $299,702 Corporate debt securities 302,573 -- 3,717 306,290 ---------------------------------------------------- $597,619 $ -- $ 8,373 $605,992 ==================================================== Marketable securities, noncurrent $ 98,017 $ 75,263 $ -- $ 22,754 ====================================================
The Company uses interest rate swap agreements to mitigate the risk associated with its floating rate debt. The fair value of the interest rate swap agreements at December 31, 2000, representing the cash requirements of the Company to settle the agreements, approximated $1.7 million. The fair value of the interest rate swap agreements at December 31, 1999, representing the cash the Company would receive to settle the agreements, was approximately $366,000. The Company has designated the interest rate swaps as cash flow hedges. There were no amounts of hedge ineffectiveness related to the Company's interest rate swaps during 2000 and 1999, and no gains or losses were excluded from the assessment of hedge effectiveness. The Company records the differential to be paid or received on the interest rate swaps as incremental interest expense. The Company expects approximately $619,000 in losses related to its interest rate swaps to affect earnings in 2001. The Company has foreign currency forward contracts to hedge specific transactions denominated in foreign currencies. All foreign currency forward contracts have durations of ninety days to 12 months. These contracts have been designated as cash flow hedges and accordingly, to the extent effective, any unrealized gains or losses on these foreign currency forward contracts are reported in other comprehensive income. Realized gains and losses for the effective portion are recognized with the underlying hedge transaction. The Company assesses hedge ineffectiveness on a quarterly basis and records the gain or loss related to the ineffective portion to current earnings to the extent significant. If the Company determines that a cash flow hedge is no longer probable of occurring, the Company discontinues hedge accounting for the affected 41 24 portion of the forecasted transaction and any unrealized gain or loss on the contract is recognized in current earnings. The notional settlement amount of the foreign currency forward contracts outstanding at December 31, 2000 was approximately $111.7 million. These contracts had a fair value of approximately $2.2 million, representing an unrealized gain, and were included in other current assets at December 31, 2000. In 2000, there were no significant amounts recognized in earnings due to hedge ineffectiveness. During 2000, the Company recognized $977,000 in other income as a result of the discontinuance of cash flow hedges upon determining that it was no longer probable that the original forecasted transaction would occur. The Company recognized $12.7 million of gains in product revenue and $3.7 million of gains in royalty revenue for the settlement of certain effective cash flow hedge instruments during the year ended December 31, 2000. These settlements were recorded in the same period as the related forecasted transactions affecting earnings. The Company expects approximately $2.2 million of unrealized gains at December 31, 2000 to affect earnings in 2001 related to its foreign currency forward contracts. In 1999, there were no significant amounts recognized in earnings due to hedge ineffectiveness or as a result of the discontinuance of cash flow hedge accounting because it was probable that the original transaction would not occur. The Company recognized $7.4 million of gains in product revenue and $2.7 million of gains in royalty revenue for the settlement of certain effective cash flow hedge instruments during the year ended December 31, 1999. These settlements were recorded in the same period as the related forecasted transactions affecting earnings. During 1998, the Company recognized $686,000 in other expense as a result of the discontinuance of cash flow hedges upon determining that it was no longer probable that the original forecasted transaction would occur. The Company also recognized a $322,000 gain in product revenue and a $485,000 loss in royalty revenue for the settlement of certain cash flow hedge instruments during the period. These settlements were recorded in the same period as the related forecasted transactions affecting earnings. 3. BORROWINGS As of December 31, 2000, the Company had $15.8 million outstanding under a floating rate loan with a bank (the "Term Loan"). The Term Loan is secured by the Company's laboratory and office building in Cambridge, Massachusetts. The Term Loan provides for annual principal payments of $1.7 million in each of the years 1996 through 2004 with the balance due May 8, 2005. The Company also entered into an interest rate swap agreement, with the same bank, fixing its interest rate at 7.5% during the remaining term of the loan, payable semi-annually. As of December 31, 2000, the Company had $36.2 million outstanding under a floating rate loan agreement with a bank for financing the construction of its biological manufacturing facility in North Carolina (the "Construction Loan"). The Construction Loan is secured by the facility. Payments of $805,000 are due quarterly through 2006 with the balance due in 2007. The Company also entered into an interest rate swap agreement, with the same bank, fixing its interest rate at 7.75% during the remaining term of the loan, payable quarterly. The Term Loan and Construction Loan agreements include various covenants, including financial covenants, which require the Company to maintain minimum net worth, cash flow and various financial ratios. The Company's long-term debt obligations are carried at face value, which approximates fair market value. Long-term debt at December 31, consists of the following: (in thousands) 2000 1999 - -------------------------- -------- -------- Term Loan due 2005 $ 15,836 $ 17,501 Construction Loan due 2007 36,237 39,460 -------- -------- 52,073 56,961 Current portion (4,888) (4,888) -------- -------- $ 47,185 $ 52,073 ======== ======== 42 25 4. CONSOLIDATED BALANCE SHEETS DETAILS Property and equipment: December 31 (in thousands) 2000 1999 - ----------------------------- -------- -------- Land $ 12,349 $ 12,349 Buildings 84,119 92,462 Leasehold improvements 63,845 54,946 Equipment 185,404 191,809 Construction in Progress 191,355 -- -------- -------- Total cost 537,072 351,566 Less accumulated depreciation 136,643 111,789 -------- -------- $400,429 $239,777 ======== ======== Depreciation expense was $27.8 million, $25.9 million and $21.4 million for 2000, 1999 and 1998, respectively. Accrued expenses and other: December 31 (in thousands) 2000 1999 - ------------------------------ -------- -------- Royalties and licensing fees $ 32,188 $ 34,914 Income taxes 69,494 64,545 Clinical trial costs 24,694 15,746 Other 51,888 40,052 -------- -------- $178,264 $155,257 ======== ======== 5. PENSIONS The Company has a defined benefit pension plan which provides benefits to substantially all of its employees. The Company also has a supplemental retirement benefit plan which covers certain employees. The pension plans are noncontributory with benefit formulas based on employee earnings and credited years of service. The Company's funding policy for its pension plans is to contribute amounts deductible for federal income tax purposes. Funds contributed to the plans are invested in fixed income and equity securities. The components of net periodic pension cost for each of the three years ended December 31 are summarized below: (in thousands) 2000 1999 1998 ------- ------- ------- Service cost $ 3,314 $ 2,923 $ 2,225 Interest cost 1,799 1,307 1,041 Expected return on plan assets (1,258) (994) (722) Amortization of transition asset -- -- (21) Amortization of prior service cost 43 43 43 Amortization of net actuarial loss 86 22 -- ------- ------- ------- Net pension cost $ 3,984 $ 3,301 $ 2,566 ======= ======= ======= 43 26 Reconciliations of projected benefit obligations, fair value of plan assets and the funded status of the plans as of December 31, are presented below:
Change in projected benefit obligation (in thousands) 2000 1999 - ------------------------------------------------------------- -------- -------- Net projected benefit obligation at the beginning of the year $(19,377) $(16,003) Service cost (3,314) (2,923) Interest cost (1,799) (1,307) Actuarial gain (loss) (935) 697 Gross benefits paid 991 159 -------- -------- Net projected benefit obligation at the end of the year (24,434) (19,377) -------- -------- Change in plan assets (in thousands) - ------------------------------------------------------------- Fair value of plan assets at the beginning of the year 15,061 11,773 Actual return on plan assets (934) 2,021 Employer contributions 2,000 1,500 Gross benefits paid (752) (43) Administrative expenses (119) (190) -------- -------- Fair value of plan assets at the end of the year 15,256 15,061 -------- -------- Funded status at the end of the year (in thousands) - ------------------------------------------------------------- Funded status at the end of the year (9,178) (4,316) Unrecognized net actuarial (gain) loss 1,224 (1,833) Unrecognized prior service cost 271 315 Unrecognized net transition asset 0 0 -------- -------- Net amount recognized at the end of the year $ (7,683) $ (5,834) ======== ======== Weighted average assumptions at the end of the year - ------------------------------------------------------------- Discount rate 7.50% 7.50% Expected return on plan assets 8.00% 8.00% Rates of compensation increase 5.00% 5.00%
The Company has an unfunded supplemental retirement plan. As of December 31, 2000 the projected benefit and the accumulated benefit obligations were $5.7 million and $3.7 million, respectively. As of December 31, 1999 the projected benefit and the accumulated benefit obligations were $3.8 million and $2.8 million, respectively. 6. OTHER INCOME, NET Other income, net consists of the following (in thousands): December 31, ----------------------------------------- 2000 1999 1998 --------- --------- --------- Interest income $ 42,965 $ 35,407 $ 28,339 Interest expense (4,310) (4,639) (5,944) Other income (expense) 120,094 (18,003) (2,841) --------- --------- --------- Total other income, net $ 158,749 $ 12,765 $ 19,554 ========= ========= ========= Other income (expense) for the period ended December 31, 2000 included gains on the sale of certain non-current marketable securities totaling approximately $101.1 million. Additionally, the Company realized gains of approximately $24.1 million upon the acquisition of two of its investees by third parties. Other income (expense) for the period ended December 31, 1999 included a $15 million write-down of certain non-current marketable securities. 44 27 As part of its strategic product development efforts, the Company invests in equity securities of certain biotechnology companies with which it has collaborative agreements. In December of 1996, Biogen purchased approximately 1.5 million shares of Creative BioMolecules, Inc. common stock for $18 million. In March of 1997, Biogen purchased approximately 670,000 shares of CV Therapeutics, Inc. common stock for $7 million. In March of 1998, the Company purchased approximately 435,000 shares of CuraGen common stock for $5 million and converted 100,000 shares of CuraGen Series E Preferred Stock valued at $1 million into CuraGen common stock. Each of these small emerging companies was principally engaged in researching, developing or manufacturing drugs for human health care. As a matter of policy, Biogen determines on a quarterly basis whether a decline in the fair value of a marketable security is other than temporary. Unrealized gains and losses on marketable securities are included in other comprehensive income in shareholders' equity, net of related tax effects. If a decline in the fair value of a marketable security below the Company's cost basis is determined to be other than temporary, such marketable security is written down to its estimated fair value with a charge to current earnings. Up through and including the assessment at June 30, 1999, the Company concluded that substantial evidence existed suggesting that the value of the investments described above would recover to at least the Company's purchase price. Such evidence included the prospects for favorable clinical trial results, new product initiatives and new collaborative agreements. However, given the lack of any substantial price recovery during the quarter ended June 30, 1999 and the amount of time elapsed since the decline in value began, the Company concluded that it had become unclear over what period such price recovery would take place. As a result, it was determined that the positive evidence suggesting that the investments would recover to at least the Company's purchase price was not sufficient to overcome the presumption that the current market price of the investments was the best indicator of value at June 30, 1999. Accordingly, the related unrealized losses of approximately $15 million were recognized as other expense in the second quarter of 1999. 7. INCOME TAXES The components of income before income taxes and of income tax expense (benefit) for each of the three years ended December 31, are as follows:
(in thousands) 2000 1999 1998 --------- --------- --------- Income before income taxes: Domestic $ 379,489 $ 253,303 $ 200,181 Foreign 107,616 75,713 10,012 --------- --------- --------- $ 487,105 $ 329,016 $ 210,193 ========= ========= ========= Income tax expense: Current Federal $ 115,696 $ 112,499 $ 58,152 State 11,969 15,587 3,937 Foreign 1,098 4,206 887 --------- --------- --------- $ 128,763 $ 132,292 $ 62,976 --------- --------- --------- Deferred Federal $ 25,344 $ (20,863) $ 8,314 State (579) (2,863) 206 --------- --------- --------- 24,765 (23,726) 8,520 --------- --------- --------- Total income tax expense $ 153,528 $ 108,566 $ 71,496 ========= ========= =========
45 28 Deferred tax assets (liabilities) are comprised of the following at December 31: (in thousands) 2000 1999 -------- -------- Tax credits $ 28,135 $ 35,089 Inventory and other reserves 11,532 14,927 Other 379 549 -------- -------- Deferred tax asset 40,046 50,565 -------- -------- Depreciation, amortization and other (24,189) (9,943) Unrealized gain on investments (12,956) (27,640) -------- -------- Deferred tax liabilities (37,145) (37,583) -------- -------- $ 2,901 $ 12,982 ======== ======== A reconciliation of the U.S. federal statutory tax rate to the effective tax rate for the periods ending December 31 is as follows: 2000 1999 1998 ---- ---- ---- Statutory rate 35.0% 35.0% 35.0% State taxes 3.2 3.3 3.0 Foreign taxes (2.6) (2.6) -- Credits and net operating loss utilization (3.3) (2.6) (4.2) Other (0.8) (0.1) 0.2 ---- ---- ---- Effective tax rate 31.5% 33.0% 34.0% ==== ==== ==== At December 31, 2000, the Company had tax credits of $28.1 million, most of which expire at various dates through 2015. As of December 31, 2000, undistributed foreign earnings of non-U.S. subsidiaries included in consolidated retained earnings aggregated $117 million, exclusive of earnings that would result in little or no tax under current U.S. tax law. The Company intends to reinvest these earnings indefinitely in operations outside the United States. It is not practicable to estimate the amount of additional tax that might be payable if such earnings were remitted to the United States. 8. RESEARCH COLLABORATIONS In September 2000, the Company signed a research and development agreement (the "Eos Agreement") with Eos Biotechnology, Inc. ("Eos"), under which the Company and Eos will collaborate in the research and development of novel targets for antibody and protein therapeutics in the area of breast cancer. Under the Eos Agreement, the Company purchased 1.9 million shares of preferred stock of Eos for $5 million. In addition, the Company paid a one-time non-refundable license fee of $6 million, which was charged to research and development expense and acquired certain exclusive, worldwide rights related to breast cancer-specific molecules for the use in the development of new antibody and secreted protein therapeutics. The Company accounts for its investment in Eos, which is included in other assets, using the cost method of accounting. The Company provided Eos with research and development funding of $250,000 in 2000. The Company expects to fund research activities of Eos related to the collaboration of up to $1.5 million in 2001. In August 2000, the Company signed a development and marketing collaboration agreement (the "Antegren Agreement") with Elan Corporation, plc ("Elan") under which the Company and Elan collaborate in the development, manufacture and commercialization of Antegren(R), a humanized monoclonal antibody and alpha 4 integrin inhibitor. Under the terms of the Antegren Agreement, Biogen and Elan will share costs for on-going development activities. The Company paid a one-time non-refundable license fee of $15 million, which was charged to research and development expense. In October 1997, the Company signed a research and option agreement (the "CuraGen Agreement") with CuraGen Corporation ("CuraGen") under which the Company and CuraGen collaborate in the discovery of novel genes using CuraGen's functional genomics technologies. The Company provided CuraGen with research and development funding of $1.5 million, $1.1 million and $1.9 million in 2000, 1999 and 1998, 46 29 respectively. The Curagen Agreement was terminated in September 2000 and all investments in CuraGen common stock were sold during 2000. In March 1997, the Company signed a research collaboration and license agreement (the "CVT Agreement") with CV Therapeutics, Inc. ("CVT") under which Biogen obtained rights under CVT's patents and know-how to develop and market molecules that act as highly selective antagonists of the adenosine A1 receptor, for the treatment of congestive heart failure. Under the terms of the CVT Agreement, the Company purchased approximately 670,000 shares of CVT common stock at the then fair value for $7 million and paid a one-time license fee of $5 million, which was charged to research and development expense. The investment in CVT is classified as available-for-sale and is included in long-term marketable securities. At December 31, 2000 the Company retained approximately 670,000 shares of CVT common stock. In December 1996, the Company signed a research collaboration and license agreement (the "CBM Agreement") with Creative BioMolecules, Inc. ("CBM") under which Biogen obtained rights to develop and market CBM's morphogenic protein, OP-1, for the treatment of renal disorders. Under the CBM Agreement, the Company purchased 1.5 million shares of CBM common stock for $18 million. The payment for the common stock included a $1.2 million premium over the fair value of the common stock which was charged to research and development expense. The Company provided $10 million in research and development funding, which was charged to expense as provided in 1998. The CBM Agreement terminated at the end of 1999 and all investments in CBM common stock were sold during 2000. In July 1996, the Company signed a collaborative research and commercialization agreement (the "Ontogeny Agreement") with Ontogeny, Inc. ("Ontogeny"), a private biotechnology company, for the development and commercialization of three specific hedgehog cell proteins, a class of novel human proteins, that are responsible for reducing the formation or regeneration of tissue. Under the Ontogeny Agreement, the Company purchased 400,000 shares of preferred stock of Ontogeny for $1 million and acquired certain exclusive, worldwide rights related to products based on the hedgehog proteins for most disease areas. In November 1998, the Company extended and expanded its collaboration with Ontogeny and provided to Ontogeny a $4 million convertible loan. In June 1999, the loan was converted into 800,000 shares of Ontogeny Convertible Preferred Stock. The Ontogeny Agreement was terminated in July 2000. In August 2000, Ontogeny merged with two other biotechnology companies to form Curis Inc. ("Curis"). As a shareholder in Ontogeny, Biogen received Curis common stock in exchange for the Company's shares in Ontogeny. The Company provided $1 million, $2.8 million and $3.6 million of research funding to Ontogeny in 2000, 1999 and 1998, respectively. Additionally, the Company provided $1.5 million upon conclusion of the Ontogeny Agreement, which was charged to research and development expense. At December 31, 2000 the investment in Curis is classified as available-for-sale and is included in long-term marketable securities. At December 31, 2000 the Company retained approximately 308,000 shares of Curis common stock. In August 1995, the Company signed a collaborative research agreement (the "Genovo Agreement") for the development of human gene therapy treatments with Genovo, Inc. ("Genovo"), a gene therapy research company. Under the Genovo Agreement, the Company acquired 380,000 shares of Genovo Series A Preferred stock for $4.5 million and acquired certain licensing rights. The Company accounted for this investment, which was included in other assets, using the equity method of accounting. The Company recorded its proportion of Genovo's net losses as research and development expense in the amounts of $3.9 million, $7.6 million, and $9 million in 2000, 1999, and 1998, respectively. In August 2000, Genovo entered into a merger agreement ("Targeted Merger Agreement") with Targeted Genetics Corporation ("Targeted"). As a shareholder in Genovo, Biogen received Targeted common stock in exchange for the Company's shares in Genovo. Additionally, concurrently with the Targeted Merger Agreement, the Company entered into a development and marketing agreement and a funding agreement (the "Targeted Agreements") for gene therapy research and development in oncology. The Targeted Agreements provide for a $10 million credit facility. Targeted also has an option to sell to the Company an additional $10 million of Targeted common stock at fair value. As of December 31, 2000, there were no borrowings outstanding under the credit facility and the Company provided $250,000 in research funding to Targeted in 2000. 47 30 9. COMMITMENTS AND CONTINGENCIES The Company rents laboratory and office space and certain equipment under noncancellable operating leases. The rental expense under these leases, which terminate at various dates through 2015, amounted to $14.9 million in 2000, $11.9 million in 1999 and $9.4 million in 1998. The lease agreements contain various clauses for renewal at the option of the Company and, in certain cases, escalation clauses linked generally to rates of inflation. At December 31, 2000, minimum annual rental commitments under noncancellable leases were as follows: Year (in thousands) -------------------------------------------------------------- 2001 $ 17,365 2002 15,123 2003 13,338 2004 12,261 2005 11,993 Thereafter 60,220 ----------- Total minimum lease payments $ 130,300 =========== On October 4, 1999 the Company began construction of its new research and development center in Cambridge, Massachusetts. The new 224,000 square foot building is expected to be completed in the spring of 2001. At December 31, 2000, $81.4 million had been committed for construction costs. Additionally, the Company is completing plans to build a large scale manufacturing plant in Raleigh, North Carolina. The Company expects that construction will be completed at the end of 2001. At December 31, 2000, $141.9 million had been committed for construction costs. On July 3, 1996, Berlex Laboratories, Inc. ("Berlex") filed suit against Biogen in the United States District Court for the District of New Jersey alleging infringement by Biogen of Berlex's "McCormick" patent (U.S. Patent No. 5,376,567) in the United States in the production of Biogen's AVONEX(R) (Interferon beta-1a) product. In November 1996, Berlex's New Jersey action was transferred to the United States District Court in Massachusetts and consolidated for pre-trial purposes with a related declaratory judgment action previously filed by Biogen. On August 18, 1998, Berlex filed a second suit against Biogen alleging infringement by Biogen of a patent which was issued to Berlex in August 1998 and which is related to the McCormick patent (U.S. Patent No. 5,795,779). On September 23, 1998, the cases were consolidated for pre-trial and trial purposes. Berlex sought a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. A hearing on the parties' summary judgment motions in the case was completed in March 2000. In September 2000, the District Court rendered final judgment in favor of Biogen and against Berlex determining that Biogen's production of AVONEX(R) did not infringe any of the claims of the Berlex patents. Berlex has appealed this decision with the Court of Appeals for the Federal Circuit and the parties are in the process of briefing the appeal for oral argument. An unfavorable ruling on appeal would result in the case being remanded to the District Court for trial. If Berlex were to be successful in its appeal and the case were remanded, an unfavorable ruling in the remanded case could have a material adverse effect on the Company's results of operations and financial position. The Company believes that the decision of the District Court that Biogen does not infringe the Berlex patents is sound, but the ultimate outcome of the appeal is not currently determinable. As a result, an estimate of any potential loss or range of loss cannot be made at this time. In 1995, the Company filed an opposition with the Opposition Division of the European Patent Office to oppose a European patent (the "Rentschler I Patent") issued to Dr. Rentschler Biotechnologie GmbH ("Rentschler") relating to compositions of matter of beta interferon. In 1997, the European Patent Office issued a decision to revoke the Rentschler I Patent. Rentschler appealed that decision and an oral hearing on the appeal took place in December 2000. At the oral hearing in order to gain reinstatement of the patent, Rentschler narrowed the patent claims so as to claim only a specific cell line. Biogen does not use the specific cell line now claimed. On October 13, 1998, the Company filed another opposition with the Opposition Division of the European Patent Office to oppose a second European patent issued to Rentschler (the "Rentschler II Patent") with certain claims regarding compositions of matter of beta interferon with specific regard to the structure of the glycosylated molecule. A hearing on the Company's opposition previously scheduled for October 2000 has been postponed, and will likely be held in 2001. While Biogen believes that the Rentschler II Patent will be revoked and that the revocation of the Rentschler I Patent will be upheld on appeal, if either the Rentschler I Patent or the Rentschler II Patent 48 31 were to be upheld and if Rentschler were to obtain, through legal proceedings, a determination that the Company's sale of AVONEX(R) in Europe infringes a valid Rentschler patent, such result could have a material adverse effect on the Company's results of operation and financial position. 10. SHAREHOLDERS' EQUITY CONVERTIBLE EXCHANGEABLE PREFERRED STOCK The Company has authority to issue 20,000,000 shares of $.01 par value preferred stock. SHAREHOLDER RIGHTS PLAN In 1989, the Company's Board of Directors declared a dividend to holders of the Company's common stock of rights (the "Old Rights") to purchase shares of Series A Junior Participating Preferred Stock (the "Old Preferred Stock"). Each Old Right entitled the registered holder to purchase from the Company one one-hundredth of a share of Old Preferred Stock upon the terms and subject to the conditions set forth in a Rights Agreement, dated as of May 8, 1989, between the Company and The First National Bank of Boston (the "Old Plan"). The Old Plan and the Old Rights expired on May 8, 1999. Consequently, on April 16, 1999, the Board of Directors declared a dividend to holders of the Company's common stock of one new preferred share purchase right (a "New Right") for each outstanding share of common stock. The New Rights were granted on May 8, 1999 pursuant to a new Rights Agreement, dated May 8, 1999, between the Company and State Street Bank and Trust Company, as Rights Agent (the "New Plan"). Each New Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series A-1 Junior Participating Preferred Stock, par value $.01 per share ("New Preferred Stock"), at a price of $850 per one one-thousandth of a share of New Preferred Stock, subject to adjustment. Each one one-thousandth of a share of New Preferred Stock has rights, privileges and preferences which make its value approximately equal to the value of one share of the Company's common stock. The New Rights are exercisable only if a person or group acquires 20% or more of the outstanding common stock of the Company or commences a tender or exchange offer, the consummation of which would result in the ownership of 20% or more of the outstanding common stock of the Company. Once the New Rights become exercisable, and in some circumstances if additional conditions are met, each New Right will entitle the Company's shareholders (other than the acquiror) to, among other things, purchase common stock at a substantial discount. Unless earlier redeemed or exchanged by the Company, the New Rights expire on May 8, 2009. The Company is entitled to redeem the New Rights at a price of $.001 per New Right. The Old Preferred Stock has been eliminated and replaced with the New Preferred Stock. At December 31, 2000, the Company had 250,000 shares of New Preferred Stock authorized for use in connection with the New Plan. SHARE OPTION AND PURCHASE PLANS The Company has several stock-based compensation plans. The Company applies APB Opinion No. 25 "Accounting for Stock Issued to Employees" in accounting for its plans and applies Statement of Financial Accounting Standards No. 123 "Accounting for Stock Issued to Employees" ("SFAS 123") for disclosure purposes only. The SFAS 123 disclosures include pro forma net income and earnings per share as if the fair value-based method of accounting had been used. Stock issued to non-employees is accounted for in accordance with SFAS 123 and related interpretations. Included in compensation expense for the periods ending December 31, 2000, 1999 and 1998 were approximately $(249,000), $7.5 million, and $2.2 million, respectively, related to stock based compensation plans. The Company has several plans and arrangements under which it may grant options to employees, Directors and Scientific Board members to purchase common stock. Under the terms of the Company's stock-based compensation plans, approximately 47 million options may be granted. Option grants are typically made under the 1985 Non-Qualified Stock Option Plan and the 1987 Scientific Board Stock Option Plan (the "Plans"). Options under the Plans are granted at no less than 100% of the fair market value on the date of grant. Options generally become exercisable over various periods, typically 5 to 7 years for employees and 3 years for Directors and Scientific Board members, and have a maximum term of 10 years. 49 32 Activity under these plans for the periods ending December 31, is as follows (shares are in thousands):
2000 1999 1998 ------------------------------------------------------------------------------------- Weighted Weighted Weighted Average Average Average Exercise Exercise Exercise Shares Price Shares Price Shares Price ------ --------- -------- --------- -------- ---------- Outstanding, Jan. 1 17,938 $24.53 22,376 $15.97 22,304 $11.98 Granted 2,731 55.34 3,099 60.24 3,618 33.88 Exercised (3,250) 11.61 (5,435) 10.45 (2,612) 7.65 Canceled (502) 34.17 (2,102) 22.41 (934) 13.33 ------ ------ ------ ------ ------ ------ Outstanding, Dec. 31 16,917 $31.70 17,938 $24.53 22,376 $15.97 ====== ====== ====== ====== ====== ====== Options exercisable 9,093 9,384 10,998 Available for grant 1,578 3,807 4,804 Weighted average fair value of options granted $24.34 $26.23 $14.63
The table below summarizes options outstanding and exercisable at December 31, 2000 (shares are in thousands):
Options Outstanding Options Exercisable ----------------------------------------------------- --------------------------------- Weighted Average Weighted Weighted Remaining Average Average Range of Number Contractual Exercise Number Exercise Exercise Price Outstanding Life Price Exercisable Price - --------------------------- --------------- --------------- -------------- -------------- --------------- $0.00-$10.00 2,086 2.78 $ 8.10 2,030 $ 8.07 $10.01-$20.00 6,711 5.25 15.69 4,622 15.24 $20.01-$30.00 784 7.00 22.81 312 22.70 $30.01-$40.00 232 7.76 33.23 115 33.28 $40.01-$50.00 2,555 7.98 41.26 1,269 41.14 $50.01-$60.00 2,626 9.31 54.69 173 53.11 $60.01-$70.00 281 9.35 65.00 13 68.70 $70.01-$80.00 1,453 8.93 72.34 521 71.98 Over $80.00 189 8.80 85.85 38 85.89 ---------- --------- -------- Total 16,917 $ 31.70 9,093 ========== ========= ========
The Company also has two employee stock purchase plans covering substantially all of its employees. The plans allow employees to purchase common stock at 85% of the lower of the fair market value at either the date of the beginning of the plan period or the purchase date. Purchases under the plans are subject to certain limitations and may not exceed an aggregate of 1,120,000 shares during the term of the plans; no shares may be issued after December 31, 2007. Through December 31, 2000, 409,102 shares have been issued under the stock purchase plans. If compensation cost for the Company's 2000, 1999 and 1998 grants under the stock-based compensation plans had been determined based on SFAS 123, the Company's pro forma net income, and pro forma diluted earnings per share for the years ending December 31, would have been as follows (in thousands except per share data):
2000 1999 1998 -------- -------- -------- Pro forma net income $294,412 $196,965 $122,342 Pro forma diluted earnings per share $ 1.90 $ 1.25 $ 0.79
50 33 The fair value of options granted is estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions: 2000 1999 1998 ---- ---- ---- Expected dividend yield 0% 0% 0% Expected stock price volatility 45% 36% 36% Risk-free interest rate 6.9% 5.5% 5.5% Expected option term in years 5.5 5.6 5.6 The effects of applying SFAS 123 in this pro forma disclosure are not indicative of future amounts. SFAS 123 did not apply to awards prior to 1995, and additional awards in future years are anticipated. STOCK REPURCHASE PROGRAM On December 18, 2000, the Company announced that its Board of Directors had authorized the repurchase of up to 4 million shares of the Company's common stock. The repurchased stock will provide the Company with treasury shares for general corporate purposes, such as stock to be issued under employee stock option and stock purchase plans. Stock purchases are expected to occur from time to time through 2001. The stock repurchase program may be discontinued at any time. On February 22, 1999, the Company announced that its Board of Directors had authorized the repurchase of up to 8 million shares of the Company's common stock. The repurchased stock provided the Company with treasury shares for general corporate purposes, such as stock to be issued under employee stock option and stock purchase plans. During 1999, the Company repurchased approximately 3.4 million shares of its common stock at a cost of $197.7 million. During 2000, the Company repurchased approximately 4.6 million shares of its common stock at a cost of $300.2 million, completing this program. To enhance the 1999 stock repurchase program, the Company sold put warrants to and purchased call options from independent third parties for a total of 4 million shares of which 2.2 million shares were outstanding at December 31, 1999, at a strike price of $49.47. None of the put warrants and call options were outstanding at December 31, 2000. Additionally, during 1999 in a separate put warrant program to facilitate its purchase of common stock, the Company sold put warrants for total proceeds of $22.1 million. The Company had put warrants to purchase 1.6 million shares outstanding at December 31, 1999, at an average strike price of $68.99 relating to this put warrant program. None of the put warrants were outstanding at December 31, 2000. The outstanding put warrants permitted a net-share settlement at the Company's option and, therefore, did not result in a put obligation liability on the Company's Consolidated Balance Sheets. The put warrants sold in connection with the Company's stock repurchase program did not have a significant additional dilutive effect. 11. SEGMENT INFORMATION The Company operates in one segment, which is the business of developing, manufacturing and marketing drugs for human health care. The chief operating decision makers review the profit and loss of the Company on an aggregate basis and manage the operations of the Company as a single operating segment. The Company currently derives product revenues from sales of its AVONEX(R) (Interferon beta-1a) product for the treatment of relapsing forms of multiple sclerosis. The Company also derives revenue from royalties on worldwide sales by the Company's licensees of a number of products covered under patents controlled by the Company, including alpha interferon and hepatitis B vaccines and diagnostic products. Revenues are primarily attributed from external customers to individual countries where earned based on location of the customer or licensee. At December 31, 2000, product and royalty revenues from external customers in The Netherlands were approximately 10% of total revenues. As of December 31, 1999, and 1998, respectively, no material amounts of product or royalty revenue could be attributable to an individual foreign country. 51 34 The Company's geographic information is as follows (in thousands):
December 31, 2000: US EUROPE ASIA OTHER TOTAL - -------------------------------- -------- --------- -------- -------- -------- Product revenue from external customers $552,591 $199,714 $ -- $ 8,774 $761,079 Royalty revenue from external customers 120,578 26,414 16,479 1,902 165,373 Long-lived assets 497,347 6,125 -- 113 503,585 December 31, 1999: US EUROPE ASIA OTHER TOTAL - -------------------------------- -------- --------- -------- -------- -------- Product revenue from external customers $442,278 $173,640 $ -- $ 4,718 $620,636 Royalty revenue from external customers 117,182 38,391 15,871 2,355 173,799 Long-lived assets 346,706 20,910 -- 131 367,747 December 31, 1998: US EUROPE ASIA OTHER TOTAL - -------------------------------- -------- --------- -------- -------- -------- Product revenue from external customers $303,591 $ 91,237 $ -- $ 35 $394,863 Royalty revenue from external customers 108,177 37,573 13,940 3,034 162,724 Long-lived assets 214,554 15,912 -- 105 230,571
The Company received revenue from five unrelated parties in 2000 accounting for a total of 18%, 13%, 12%, 11% and 10% of total product and royalty revenue. The Company received revenue from five unrelated parties in 1999 accounting for a total of 15%, 13%, 13%, 11% and 11% of total product and royalty revenue. The Company received revenue from five unrelated parties in 1998 accounting for a total of 16%, 13%, 11%, 11% and 10% of total product and royalty revenue. 12. QUARTERLY FINANCIAL DATA (UNAUDITED) (in thousands, except per share amounts)
First Second Third Fourth Total Quarter Quarter Quarter Quarter Year 2000 Total revenues $216,848 $230,514 $233,754 $245,336 $926,452 Product revenue 174,596 190,009 193,242 203,232 761,079 Royalties revenue 42,252 40,505 40,512 42,104 165,373 Total expenses and taxes 194,506 175,191 198,577 183,350 751,624 Other income, net 99,024 16,737 33,204 9,784 158,749 Net income 121,366 72,060 68,381 71,770 333,577 Basic earnings per share 0.81 0.48 0.46 0.49 2.24 Diluted earnings per share 0.77 0.47 0.44 0.47 2.16 1999 Total revenues $171,720 $188,929 $208,431 $225,355 $794,435 Product revenue 131,320 145,852 163,448 180,016 620,636 Royalties revenue 40,400 43,077 44,983 45,339 173,799 Total expenses and taxes 132,220 136,271 154,494 163,765 586,750 Other income, net 6,184 (9,270) 8,092 7,759 12,765 Net income 45,684 43,388 62,029 69,349 220,450 Basic earnings per share 0.31 0.29 0.41 0.46 1.47 Diluted earnings per share 0.29 0.28 0.39 0.44 1.40
13. NEW ACCOUNTING PRONOUNCEMENT In December 1999, the United States Securities and Exchange Commission issued Staff Accounting Bulletin 101, "Revenue Recognition in Financial Statements" ("SAB 101"). SAB 101 provides the staff's views in applying generally accepted accounting principles to selected revenue recognition issues, as well as examples of how the staff applies revenue recognition guidance to specific circumstances. The Company 52 35 adopted SAB 101 in 2000. Adoption of SAB 101 did not have a material effect on the Company's financial position and results of operations. 53 36 REPORT OF INDEPENDENT ACCOUNTANTS To the Board of Directors and Shareholders of Biogen, Inc. In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of income, of cash flows and of shareholders' equity present fairly, in all material respects, the financial position of Biogen, Inc. and its subsidiaries at December 31, 2000 and 1999, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2000 in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Company's management; our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America, which require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. /s/ PricewaterhouseCoopers LLP Boston, Massachusetts January 11, 2001 54 37 SENIOR EXECUTIVES AND BOARD MEMBERS Biogen, Inc. and Subsidiaries Senior Biogen Executives Board of Directors Scientific Board James L. Vincent James L. Vincent (2)(3)(5) Phillip A. Sharp, Ph.D. Chairman of the Board Chairman of the Board and Chairman of the Scientific Board Chief Executive Officer Institute Professor and Director of the James C. Mullen Biogen, Inc. McGovern Institute for Brain Research, President and Massachusetts Institute of Technology; Chief Executive Officer Alan Belzer (1)(5) Nobel Laureate President, Chief Operating Officer and Director, Burt A. Adelman, M.D. Allied-Signal, Inc. (retired) Sir Kenneth Murray, Ph.D. Vice-President - Medical Research Vice Chairman of the Scientific Board Harold W. Buirkle (1)(2)(4) Biogen Professor of Molecular Biology, Cornelis "Kees" Been Managing Director, Emeritus Vice President - Business and The Henley Group, Inc. (retired) University of Edinburgh; Market Development Fellow of The Royal Society Mary L. Good, Ph.D. (2) Thomas J. Bucknum, Esq. Former Undersecretary for Technology, Alexander G. Bearn, M.D. Vice President - General Counsel, U.S. Department of Commerce Executive Officer, American Secretary and Clerk Management Member, Philosophical Society Venture Capital Investors, LLC, Adjunct Professor, The Rockefeller Frank A. Burke, Jr. Donaghey University Professor at University Vice President - Human Resources University of Arkansas Professor Emeritus, at Little Rock Cornell University Medical College Nadine D. Cohen, Ph.D. Vice President - Regulatory Affairs Thomas F. Keller, Ph.D. (1) Max D. Cooper, M.D. R. J. Reynolds Professor and Dean, Investigator, Michael Gilman, Ph.D. Fuqua School of Business Europe, Howard Hughes Medical Institute; Vice President - Research Duke University Professor of Medicine, Pediatrics, Microbiology and Pathology, Sylvie L. Gregoire, Pharm. D. Roger H. Morley (2)(4) University of Alabama at Birmingham Vice President - Manufacturing Vice President, Schiller International University Joseph M. Davie, M.D., Ph.D. Robert A. Hamm Co-Managing Director, R&R Inventions Ltd.; Senior Vice President - Research, Vice President - Sales and Marketing Former President, American Express Co. Biogen, Inc. Peter N. Kellogg James C. Mullen Richard A. Flavell, Ph.D. Vice President - Finance and President and Chief Operating Officer, Professor and Chairman, Chief Financial Officer Biogen, Inc. Immunoiology Section, Howard Hughes Medical Institute, Mark W. Leuchtenberger Sir Kenneth Murray, Ph.D. (3)(5) Vice President - International Biogen Professor of Molecular Biology, Yale University School of Medicine; Emeritus University of Edinburgh; Fellow of The Royal Society Toshio Nakata Fellow of The Royal Society President - Biogen Japan, Ltd. and Daniel H. Rich, Ph.D. Vice President - Japan, Asia and Phillip A. Sharp, Ph.D. (2)(3) Professor of Medicinal Chemistry Oceana Institute Professor and Director of the and Organic Chemistry, McGovern Institute for Brain Research, University of Wisconsin - Madison John W. Palmer Massachusetts Institute of Technology; Nobel Vice President - Program Management Laureate Kai L. Simons, M.D., Ph.D. Professor of Cell Biology David D. Pendergast, Ph.D. Alan K. Simpson 5 European Molecular Biology Lab, Vice President - Product Development Director of the Institute of Politics Heidelberg, Germany and Visiting Lecturer, Patrick J. Purcell John F. Kennedy School of Government Thomas P. Stossel, M.D. Vice President - Information Systems Harvard University; Former U.S. Senator Co-Director, and Chief Information Officer Division of Hematology, James W. Stevens 1, 5 Brigham and Women's Hospital Former Chairman, Prudential Asset (1) Member of the Finance and Audit Management Group Daniel I.C. Wang, Ph.D. Committee Institute Professor of Chemical (2) Member of the Compensation and Engineering Management Resources Committee Massachusetts Institute of Technology (3) Member of the Project Share Committee (4) Member of the Stock and Option Plan Administration Committee (5) Member of the Nominating Committee
55 38 SHAREHOLDER INFORMATION Biogen, Inc. and Subsidiaries Corporate Headquarters: SEC Form 10-K Biogen, Inc. A copy of the Company's annual report to the 14 Cambridge Center Securities and Exchange Commission on Cambridge, MA 02142 Form 10-K is available upon written request to the: Telephone: (617) 679-2000 Corporate Communications Department Fax: (617) 679-2617 Biogen, Inc. 14 Cambridge Center Annual Meeting Cambridge, MA 02142. Friday, June 15, 2001 at 10:00 a.m. at the Company's offices at 12 Cambridge Center Transfer Agent All shareholders are welcome. For shareholder questions regarding lost certificates, address changes and changes of ownership or name Market for Securities in which the shares are held, direct inquiries to: Biogen's securities are quoted on the State Street Bank and Trust Company NASDAQ National Market System. P.O. Box 8200 Common stock symbol: BGEN. Boston, MA 02266-8200 Telephone: (800) 426-5523 As of March 7, 2001 there were approximately 2,654 holders of record of the Company's Common Independent Accountants Stock. The Company has not paid any cash dividends PricewaterhouseCoopers LLP on its Common Stock since its inception, and does not 160 Federal Street intend to pay any dividends in the foreseeable future. Boston, MA 02110 On June 25, 1999 the Company effected a two-for-one stock split of its Common Stock. The quarterly high U.S. Legal Counsel and low closing prices (adjusted to reflect the stock Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. split) of the Company's Common Stock on the One Financial Center NASDAQ National Market System for 2000 and 1999 Boston, MA 02111 are as follows: News Releases High Low As a service to our shareholders and prospective Fiscal 2000 investors, copies of Biogen news releases issued in the - --------------------- last 12 months are now available almost immediately First Quarter 119 1/2 69 7/8 24 hours a day, seven days a week, on the Internet's Second Quarter 72 3/4 49 3/4 World Wide Web at http://www.prnewswire.com and Third Quarter 74 3/4 53 via automated fax by calling "Company News On Call" Quarter 64 1/4 51 1/2 at 1-800-758-5804, ext. 101550. Biogen news releases are usually posted on both systems within one Fiscal 1999 hour of being issued are available at no cost. - --------------------- First Quarter 58 19/32 39 19/32 Second Quarter 64 5/16 46 3/16 Third Quarter 89 3/16 63 1/16 Fourth Quarter 88 1/16 64 3/8 The Biogen logo and AVONEX(R)are registered Trademarks of Biogen, Inc. AMEVIVE(TM) and ANTOVA(TM) Are trademarks of Biogen, Inc. Intron(R)A, REBETOL(R), and REBETRON(R) are registered trademarks of Schering-Plough Corporation. Betaseron(R)is a registered trademark of Berlex Laboratories, Inc. Betaferon(R)is a registered trademark of Schering AG, Germany. Copaxone(R)is a registered trademark of Teva Pharmaceutical Industries, Ltd. Infergen(R)is a registered trademark of Amgen.
56 39 BIOGEN, INC. Schedule II Valuation and Qualifying Accounts and Reserves Years Ended December 31, 2000, 1999 and 1998 (in thousands)
ADDITIONAL BALANCE AT CHARGED TO BEGINNING OF COSTS AND BALANCE AT END DESCRIPTION PERIOD EXPENSES DEDUCTIONS OF PERIOD Allowance for Doubtful Accounts Year Ended December 31, 2000 1,642 $ 794 $ -- $ 2,436 ------- ------- ------- ------- Year Ended December 31, 1999 $ 1,642 $ -- $ -- $ 1,642 ------- ------- ------- ------- Year Ended December 31, 1998 $ 1,645 $ -- $ 3 $ 1,642 ------- ------- ------- ------- Sales Returns & Allowances, Discounts and Rebates Year Ended December 31, 2000 8,654 $58,666 $58,280 $ 9,040 ------- ------- ------- ------- Year Ended December 31, 1999 $ 5,592 $42,090 $39,028 $ 8,654 ------- ------- ------- ------- Year Ended December 31, 1998 $ 3,789 $26,172 $24,369 $ 5,592 ------- ------- ------- -------
S-1 40 Report of Independent Accountants on Financial Statement Schedule To the Board of Directors and Shareholders of Biogen, Inc.: Our audits of the consolidated financial statements referred to in our report dated January 11, 2001 appearing in the 2000 Annual Report to Shareholders of Biogen, Inc. (which report and consolidated financial statements are incorporated by reference in this Annual Report on Form 10-K) also included an audit of the financial statement schedule listed in Item 14(a)(2) of this Form 10-K. In our opinion, this financial statement schedule presents fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements. /s/ PricewaterhouseCoopers LLP Boston, Massachusetts January 11, 2001 S-2
EX-21 7 b38146bgex21.txt SUBSIDIARIES 1 Exhibit 21 Subsidiaries of the Registrant Biogen Canada, Inc. Delaware Bio Holding I, Inc. Delaware Bio Holding II, Inc. Delaware Biogen Realty Corporation Massachusetts Biogen Realty Limited Partnership Massachusetts Biogen Technologies, Inc. Delaware Biogen Australi Pty Ltd Australia Biogen Belgium S.A./NV Belgium Biogen B.V. The Netherlands Biogen France S.A. France Biogen GmbH Austria Biogen GmbH Germany Biogen International B.V. The Netherlands Biogen Investments, Ltd. Bermuda Biogen Japan Ltd. Japan Biogen Limited United Kingdom Biotech Manufacturing CV The Netherlands Biotech Manufacturing Limited Channel Islands Biogen Norway AS Norway Biogen Sweden AB Sweden Biogen (Denmark) A/S Denmark Biogen Finland Oy Finland Biogen Foreign Sales Company, Ltd Barbados EX-23 8 b38146bgex23.txt CONSENT OF PRICEWATERHOUSECOOPERS LLP 1 Exhibit 23 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-71695) and in the Registration Statements on Form S-8 (Nos. 33-37312, 33-69174, 33-63015, 333-42887, 333-70701, and 333-53598) of Biogen, Inc. of our report dated January 11, 2001 relating to the financial statements, which appear in the Annual Report to Shareholders, which is incorporated in this Annual Report on Form 10-K. We also consent to the incorporation by reference of our report dated January 11, 2001 relating to the financial statement schedule, which appears in this Form 10-K. /s/ PricewaterhouseCoopers LLP Boston, Massachusetts March 30, 2001
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