-----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, P65UXaY71oW4Oq5VEnI1CdfN4Obrx7HlYiy8eCSCcBF4JYUujzhb5lQ2kPC5/RjX SAhuqhI17DzDq1V7gxZFeA== 0000950135-00-001761.txt : 20000411 0000950135-00-001761.hdr.sgml : 20000411 ACCESSION NUMBER: 0000950135-00-001761 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 17 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000329 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: 583096 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 BIOGEN INC. 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 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 16, 2000 (excludes shares held by directors): $12,913,220,996. 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 16, 2000: 150,926,556 shares. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant's definitive Proxy Statement for its 2000 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report, and portions of the Registrant's 1999 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 and recently added by Standard & Poor's to the benchmark S&P 500 Index, 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 1999 were approximately $620.6 million, making AVONEX(R) the worldwide market leader among multiple sclerosis therapies. The Company's royalty revenues in 1999 were approximately $173.8 million. Biogen continues to have an active development program related to AVONEX(R), and is conducting several important clinical trials of the product. In 1999, Biogen completed a clinical study of AVONEX(R) in patients who had experienced only one confirmed demyelinating event (multiple sclerosis-type exacerbation). The study showed a highly statistically significant beneficial effect of AVONEX(R) in delaying the development of clinically definite multiple sclerosis. The study was stopped early following positive results. The Company intends to file an application for a broadened prescribing label for AVONEX(R) with regulatory agencies worldwide. Biogen also continues to devote significant resources to its ongoing research and development efforts. The Company focuses its efforts on areas where it has particular scientific strengths such as: multiple sclerosis, inflammatory diseases, cardiovascular diseases, developmental biology and gene therapy. In 1999, the Company completed a Phase 2b clinical study of its AMEVIVE(TM) (Human LFA-3/IgG1 fusion protein) product, also known as LFA3TIP, in patients with moderate to severe chronic plaque psoriasis. Based on the encouraging Phase 2b data, the Company began a Phase 3 clinical trial in North America, and is moving forward with planning for a Phase 3 clinical trial in Europe. Biogen anticipates beginning Phase 2 clinical trials of AMEVIVE(TM) in a second indication during 2000. The Company also recently announced that it had successfully completed an early-stage Phase 2 study of an adenosine A(1) antagonist small molecule product being studied as a treatment for congestive heart failure. Additional studies using the lead back-up molecule for this pathway are planned. A third Biogen product candidate in clinical trials experienced a set back in 1999. In November 1999, the Company announced that it had halted all ongoing clinical trials of ANTOVA(TM) (Humanized anti-CD40 ligand monoclonal antibody), also known as humanized 5c8, until it has completed a review of issues relating to adverse incidents involving thrombo-embolic events. Work to identify the reasons for the adverse events is ongoing. Biogen also has many earlier-stage research programs. These include: a program directed toward developing a novel inhibitor of a particular immune response pathway as a potential therapy for several autoimmune diseases; a program focused on finding oral small molecule drug candidates to inhibit the migration of white blood cells into tissue as a potential treatment for multiple sclerosis and 2 3 certain chronic inflammatory diseases; a program in which the Company is exploring ways to treat certain central nervous system disorders through use of proteins involved in inducing the formation and regeneration of tissue; and a program directed at developing products based on human gene therapy technology. The Company is also exploring the use of functional genomics technology to find novel therapeutics. 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 among 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 is currently conducting several clinical studies of AVONEX(R). These include: a dose comparison study, initiated in 1996, comparing the approved dosage of AVONEX(R) with a higher dose; an open-label follow-up study initiated in 1995 to obtain long-term safety and antigenicity data; a clinical study of AVONEX(R) in patients with secondary progressive multiple sclerosis, initiated in 1998; and a Phase 2 clinical study of AVONEX(R) in the treatment of idiopathic pulmonary fibrosis which also commenced in 1998. Biogen also recently completed a clinical study of AVONEX(R) in patients who had experienced only one confirmed demyelinating event (multiple sclerosis-type exacerbation). The study, which was initiated in 1996, showed a highly statistically significant beneficial effect of AVONEX(R) in delaying the development of clinically definite multiple sclerosis. Clinically definite multiple sclerosis is identified by the presence of at least two demyelinating events, separated by time and location in the central nervous system. The study was stopped early following positive results. The Company intends to file an application for a broadened prescribing label for AVONEX(R) with regulatory agencies worldwide. 3 4 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 1999 were $620.6 million or approximately 78% of total revenues. Revenues from sales of AVONEX(R) in 1998 and 1997 were $394.9 million and $240.0 million, respectively, or approximately 71% and 58% of total revenues, respectively. Approximately 71% of AVONEX(R) sales in 1999, 77% of AVONEX(R) sales in 1998, and 92% of AVONEX(R) sales in 1997, were generated in the United States. Sales to three major wholesale distributors and a specialty distributor in the United States accounted for 13%, 11%, 11% and 15%, respectively, of total revenues in 1999. 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) (LFA3TIP) 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) (LFA3TIP) 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 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 a Phase 3 study in North America and is moving forward with planning for a Phase 3 study in Europe. 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 anticipates beginning Phase 2 clinical trials of AMEVIVE(TM) in a second indication during 2000. ADENOSINE A(1) 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 A(1) 4 5 receptor. The adenosine A(1) 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 A(1) antagonists as a 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 1999, Biogen successfully completed an early-stage Phase 2 study comparing CVT-124, a particular small molecule product, with existing therapies in the acute treatment of congestive heart failure. Additional studies using the lead back-up molecule for this pathway are planned. ANTOVA(TM) (HUMANIZED 5C8) The human immune system generates two types of responses: humoral (also known as antibody) responses and cell-mediated responses. When CD40 ligand ("CD40L") on the surface of an activated T-cell binds to CD40 on the surface of a B-cell, the production of antibodies is triggered. When CD40L on the surface of an activated T-cell binds to CD40 on the surface of a variety of other cells, such as macrophages and dendritic cells, the cells become activated, triggering an inflammatory response. The inhibition of the CD40-CD40L pathway offers a unique target for modulating both types of immune responses. Biogen is developing ANTOVA(TM), a humanized monoclonal antibody that binds to CD40L, as a treatment for a variety of autoimmune diseases and as a therapy for preventing organ and cellular transplant rejection. During 1999, the Company was involved in an ongoing Phase 2 safety study of ANTOVA(TM) in patients with immune thrombocytopenic purpura, as well as Phase 2 studies of ANTOVA(TM) in lupus nephritis, renal transplantation, pancreatic islet cell transplantation, Factor VIII inhibitor syndrome and multiple sclerosis. In November 1999, the Company announced that it had halted all existing clinical trials of ANTOVA(TM) until it has completed a review of issues relating to adverse incidents involving thrombo-embolic events. Work to identify the reasons for the adverse events is ongoing. 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 as a potential treatment for certain autoimmune diseases and expects to start Phase 1 safety studies in 2001. VLA-4 INHIBITORS VLA-4 (Very Late Antigen-4) is a receptor that appears on the surface of white blood cells and binds to VCAM-1, a protein found on the surface of vascular endothelial cells, as well as extracellular matrix proteins, fibronectin and osteopontin. The VLA-4 pathway facilitates migration of white blood cells into tissue as part of the body's normal response during inflammation. This inflammatory response 5 6 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 such as asthma. Biogen scientists have developed VLA-4-specific small molecule inhibitors designed to interrupt the cell adhesion activity of VLA-4 as a means of blocking the inflammation process in a highly specific manner. In December 1997, Biogen entered into a collaborative research, development and license agreement with Merck & Co., Inc. ("Merck") under which Biogen and Merck are collaborating on developing small molecule inhibitors of VLA-4. Under the agreement with Merck, Biogen has rights to develop, market and sell small molecule inhibitors of VLA-4 for the treatment of multiple sclerosis, kidney diseases and disorders, inflammatory bowel disease and most diseases with small patient populations. Merck has rights to develop, market and sell small molecule inhibitors of VLA-4 in all other indications, including asthma. Early in 1999, Merck completed a Phase 2a study in asthmatic patients using an aerosolized small molecule inhibitor of VLA-4, known as BIO-1211. Merck subsequently determined that the results of the trial did not support continued development of that particular compound. Collaborative efforts to identify a suitable oral small molecule inhibitor drug candidate continue at Merck and Biogen. HEDGEHOG PROTEINS Hedgehog proteins are a class of novel human proteins that are responsible for inducing the formation or regeneration of tissue. In 1996, the Company entered into a research collaboration and license agreement with Ontogeny, Inc. ("Ontogeny") for the development of three specific "hedgehog" proteins. Under its agreement with Ontogeny, Biogen has access to exclusive worldwide rights to develop therapeutics directly based on Ontogeny's proprietary family of sonic, indian and desert hedgehogs for most disease indications. In 1998, Biogen and Ontogeny extended the hedgehog research program and broadened the collaboration to include gene therapy. The Company's current focus is the study of the hedgehog proteins for the treatment of certain central nervous system disorders. GENE THERAPY In 1995, the Company entered into a collaborative research agreement with Genovo, Inc. ("Genovo") for the development of certain human gene therapy treatments. Under this agreement, Biogen received rights related to certain diseases of the liver and lung. Genovo has also granted to Biogen rights under Genovo's gene therapy technology for development of certain gene therapy products in connection with the treatment of cancer. OTHER RESEARCH PROGRAMS As part of its further research efforts, Biogen is exploring the use of growth factors to prevent or treat the degeneration of organs following damage. The Company is also investigating new ways to modify immune responses more specifically in order to treat diseases of the immune system. In addition, through its collaborations with CuraGen Corporation, Incyte Pharmaceuticals, Inc. and Genetica Incorporated, Biogen is exploring the use of functional genomics technology to find novel therapeutics. 6 7 RESEARCH AND DEVELOPMENT COSTS For the years ended December 31, 1999, 1998 and 1997, Biogen's research and development costs were approximately $221.2 million, $177.2 million and $145.5 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 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 1999 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. In late 1998, Biogen filed for arbitration against Schering-Plough in a dispute over the amount of royalties payable to Biogen on sales of REBETRON(R), a combination product containing the Intron(R) A injection product and REBETOL(R) (ribavirin, USP capsules). Schering-Plough sells REBETRON(R) in the United States as a treatment for 7 8 chronic hepatitis C. A hearing in connection with the arbitration was conducted in January 2000. In March 2000, the arbitration panel found in favor of Schering-Plough, and rejected Biogen's claim that royalty payments should be based on the higher rate for combination products called for under the 1979 agreement between the parties, and not on the Intron(R) A component alone. Biogen does not expect to suffer any financial impact as a result of the arbitration panel's decision since Schering-Plough is presently paying royalties only on the Intron(R) A component, and the decision will have no effect on those royalties. Royalties from Schering-Plough on sales of Intron(R)A accounted for approximately 13%, 16% and 19% of Biogen's revenues in 1999, 1998 and 1997, respectively. For a discussion of the length of Schering-Plough's royalty obligation to Biogen on sales of alpha interferon products, 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. 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. SmithKline Beecham Biologicals s.a. ("SmithKline") and 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. Royalties from SmithKline and Merck together accounted for approximately 6%, 9% and 14% of Biogen's revenues in 1999, 1998 and 1997, respectively. 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. 8 9 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 Under a license agreement with Eli Lilly and Company ("Lilly"), Biogen has granted Lilly rights under certain of Biogen's patents related to gene expression. Lilly uses the patented vectors and methods in several products that are on the market or in development. Under the license agreement, Biogen receives royalties on sales of these products. See "Patents and Other Proprietary Rights - Other Patents". 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 October 1999, TMC received marketing clearance for ANGIOMAX(TM) in New Zealand for use as an anticoagulant in patients undergoing coronary angioplasty. In the United States and Europe, bivalirudin is an investigational drug currently under regulatory review for marketing approval by both the FDA and the European Agency for the Evaluation of Medicinal Products. Financial information about foreign operations and export sales is included in the Company's 1999 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. 9 10 RECOMBINANT ALPHA INTERFERON Biogen has 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 brand of alpha interferon. See "Principal Products Being Marketed or Developed by Biogen's Licensees - Alpha Interferon". Schering-Plough's royalty obligation to Biogen on sales of alpha interferon in Japan and Europe will terminate 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 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 July 2002 (when Biogen's existing United States alpha interferon patent expires) 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. 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 federal judge in the case issued a narrow pre-trial interpretation of the claims of the Biogen patent. This decision was appealed. A hearing in connection with the appeal was held in December 1999. A decision is expected in the first half of 2000. During the arbitration proceedings between Biogen and Schering-Plough related to REBETRON(R) royalties, Schering-Plough alleged that the federal judge's decision in the Amgen case narrowed the scope of the claims in Biogen's United States alpha interferon patent such that the patent no longer covers Schering-Plough's Intron(R) A product. If the Amgen appeal is unsuccessful, Schering-Plough might argue that royalties on sales of Intron(R) A are not payable during the period commencing after expiration of the EU patent in January 2001 (which currently covers all product manufactured in the EU, including all product sold in the United States) until commencement in July 2002 of the royalty obligation tied to the term of the Roche/Genentech patent. Biogen intends to vigorously oppose any attempt by Schering-Plough to discontinue payment of royalties during any period. 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 10 11 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 or is able to obtain supplemental protection certificates. To date, Biogen has received supplemental protection certificates in Austria, Belgium, France, Ireland, Italy, Luxembourg, The Netherlands, Sweden and Switzerland, and has a number of additional applications pending. The additional coverage afforded by the supplemental protection certificates ranges from two to six 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. Although no formal appeal procedure exists, Biogen asked the European Patent Office to overturn the revocation. A recent decision in another case denied that such a right of appeal exists. Consequently, Biogen's appeal will be dismissed and the patent will stand revoked. Biogen also has a patent with similar claims in Israel. In July 1997, Biogen sued InterPharm Laboratories Ltd. ("InterPharm"), an affiliate of Ares Serono, S.A. ("Serono"), and related defendants, claiming that the manufacture by InterPharm of Serono's Rebif(R) (Interferon Beta-1a) infringes Biogen's Israeli patent. 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. 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 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 pretrial purposes with a related declaratory judgment action previously filed by Biogen. In August 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. In September 1998, the cases were consolidated for pretrial and trial purposes. Berlex seeks a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from alleged infringement. A hearing on the parties' summary judgment motions was completed in March 2000. No decisions have been rendered to date. The Company expects a trial to occur in the second half of 2000. For a further discussion, see Item 3 hereof - Legal Proceedings, and the Company's 1999 Annual Report to Shareholders --- Notes to Consolidated Financial Statements --- Note 9, incorporated herein by reference under Item 8 hereof. 11 12 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 has appealed that decision and the appeal is still pending. 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 decision on the Rentschler II Patent has not been issued to date. For a more detailed discussion, see the Company's 1999 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 Biogen has granted Lilly a non-exclusive license under certain of Biogen's patents for gene expression. Lilly uses the patented vectors and methods in certain products that are on the market or in development. 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 has appealed the decision. 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 that to make Neupogen(R) Amgen uses technology claimed in certain of Biogen's gene expression patents. In 1998, the court made a decision as to interpretation of the claims of the Biogen patent in such a way as to preclude Amgen's literal infringement of the patent. Amgen has filed a motion for summary judgment based on the court's decision. The parties filed briefs on whether Amgen is entitled to summary judgment on its claim that its vector is not an infringing equivalent. The matter was argued to the court in November 1999. A decision on this motion is expected in the first half of 2000. 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. In March 1999, Biogen was added as a plaintiff in a lawsuit filed by Plant Genetic Systems, N.V. ("PGS") against Dekalb Genetics Corporation ("Dekalb") in the United States District Court in Connecticut. PGS, the licensee of certain Biogen plant gene patents, is claiming that DeKalb infringes the patents in its production of genetically-engineered seeds. 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 12 13 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. Schering-Plough, Biogen's exclusive licensee for recombinant alpha interferon, is licensed under certain of Genentech's patents for the manufacture, use and sale of recombinant alpha interferon. 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 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. Much competition is directed towards establishing proprietary positions through research and development. 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. Biogen believes that leadership in the industry will be based on managerial and technological superiority and may be influenced significantly by patents and other forms of protection of proprietary information. See "Patents and Other Proprietary Rights". 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. 13 14 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. 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, 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 other countries, 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 to recently 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). The results of this study may help Serono in its attempts to get the orphan drug status of AVONEX(R) removed. Biogen expects Serono to release the results of the study in the first quarter of 2001. 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. For example, Immunex Corporation, a majority-owned subsidiary of American Home Products Corporation, recently received a non-binding recommendation for approval of Novantrone(R) in the United States from an advisory panel of the FDA. Novantrone(R) was recommended for approval to slow the worsening of neurologic disability and to reduce the relapse rate in patients with clinically worsening forms of relapsing-remitting and secondary progressive multiple sclerosis. The FDA will consider the recommendation in its final review of the Novantrone(R) new drug application. 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. 14 15 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 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 15 16 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, 1999, Biogen employed 1,351 full-time employees worldwide, of whom 1,150 were located in the United States. Of the 1,351 employees, 344 were engaged in, or directly supported, research and process development, 474 were involved in, or directly supported, manufacturing, quality assurance/quality control, regulatory, medical operations and preclinical and clinical development, and 306 were involved in sales 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 nine 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 301,002 square feet of additional office, manufacturing, and research and development space in all or part of four 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 150,848 square feet of office space, and a 17,000 square foot building housing office space and distribution facilities. The lease expiration dates for the leased sites range from 2000 to 2015. The Company has also leased additional space in Cambridge that it is not currently utilizing, but plans to use in the near term. In addition, in 1999, Biogen commenced construction of a new 224,000 square foot facility in Cambridge primarily to house 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 an additional 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. 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 1999 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. The lease for this 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, 950 square meters of office 16 17 space in Germany, and small offices in Austria, Canada, Denmark, England, Finland, Norway and Sweden. In addition, Dompe-Biogen AG, a minority-owned subsidiary of Biogen, leases a small office in Switzerland. 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 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 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 pretrial purposes with a related declaratory judgment action previously filed by Biogen. In August 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. In September 1998, the cases were consolidated for pretrial and trial purposes. Berlex seeks a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from alleged infringement. An unfavorable ruling in the Berlex suit could have a material adverse effect on the Company's results of operations and financial position. The Company believes that it has meritorious defenses to the Berlex claims, but the ultimate outcome is not currently determinable. A hearing on the parties' summary judgment motions was completed in March 2000. No decisions have been rendered to date. The Company expects a trial to occur in the second half of 2000. 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 EXECUTIVE OFFICERS OF THE REGISTRANT The following is a list of each executive officer of the Company, their respective age as of December 31, 1999 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........... 60 Chairman of the Board of Directors and Chief Executive Officer James C. Mullen............ 41 President, Chief Operating Officer and Director
17 18
Burt A. Adelman............ 47 Vice President - Medical Research Cornelis "Kees" Been....... 41 Vice President - Business and Market Development Michael W. Bonney.......... 41 Vice President - Sales and Marketing Thomas J. Bucknum.......... 53 Vice President - General Counsel, Secretary and Clerk Frank A. Burke, Jr......... 56 Vice President - Human Resources Joseph M. Davie ........... 60 Senior Vice President - Research Sylvie L. Gregoire......... 38 Vice President - Regulatory Affairs Robert A. Hamm............. 48 Vice President - Manufacturing Timothy M. Kish ........... 48 Vice President - Finance and Chief Financial Officer Mark W. Leuchtenberger..... 43 Vice President - International David D. Pendergast........ 51 Vice President - Product Development and Quality Assurance
The background of these officers is as follows: James L. Vincent has been Chairman of the Board of Directors since October 1985. Mr. Vincent's current term as Chief Executive Officer began in December 1998. He previously served as Chief 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 Operating Officer in January 1999, after serving as Vice President - International since August 1996. Mr. Mullen was appointed a Director of the Company in April 1999. Mr. Mullen was the Company's 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 SmithKline Beecham Corporation), most recently as 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 18 19 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 in the most recent years he was a 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. Michael W. Bonney was appointed Vice President - Sales and Marketing in January 1999, after serving as Vice President - Sales since September 1995. Prior to joining the Company, Mr. Bonney served as National Business Director for the United States pharmaceutical business of Zeneca Inc. from October 1994 to September 1995 and as Director of Core Business Systems and Re-engineering of Zeneca Inc.'s United States pharmaceutical business from January 1993 until January 1995. 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 that, 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., most recently as Director of Compensation and Employee Benefits of the Engineered Materials Sector. Joseph M. Davie, M.D., Ph.D. was appointed Senior Vice President - Research in January 1999 after serving as Vice President - Research since April 1993. Prior to joining the Company, Dr. Davie was employed by Searle Corporation where he served as Senior Vice President - Science and Technology from January 1993 to April 1993, President - Research and Development from July 1987 to January 1993 and Senior Vice President - Discovery Research from January 1987 to July 1987. Dr. Davie is a director of Genovo, Inc. Sylvie L. Gregoire, Pharm.D. was appointed Vice President - Regulatory Affairs in January 1999. From July 1998 to January 1999, Dr. Gregoire was the Program Executive for the Company's LT-Beta Receptor program. From 1995 until July 1998, Dr. Gregoire 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 - Manufacturing in June 1999 after serving as Director, Northern Europe and Distributors since November 1996. Mr. Hamm served 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. 19 20 Timothy M. Kish was appointed Vice President - Finance and Chief Financial Officer in August 1993 after serving as Corporate Controller of the Company since 1986. Prior to joining Biogen, Mr. Kish was Director of Finance for Allied Health & Scientific Products Company, a subsidiary of Allied Corporation. Before joining Allied, Mr. Kish served in various capacities at Bendix Corp., most recently as Executive Assistant to the President. In February 2000, Mr. Kish announced his intention to resign from Biogen to become involved in an earlier-stage technology-based organization. Mr. Kish will remain with the Company to assist it in the transition to a successor. 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. 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. PART II ITEM 5 - MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The section entitled "Market for Securities" in the Company's 1999 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 1999 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 1999 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations - Outlook - Market Risk" in the Company's 1999 Annual Report to Shareholders is hereby incorporated herein by reference. 20 21 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 1999 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 2000 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 29, 2000, 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 2000 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 29, 2000, 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 2000 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 29, 2000, 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 2000 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 29, 2000, is hereby incorporated herein by reference. 21 22 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 1999 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 1999 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 1999 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 22 23 (3) Exhibits 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)** (10.8) Consulting Agreement dated as of April 1, 1991, as amended, between the Registrant and Alexander G. Bearn (e)** (10.9) Letter Agreement dated March 24, 1998 with Alexander G. Bearn relating to renewal of Independent Consulting Agreement (q)** (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)** 23 24 (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)** (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)** (10.16) Letter dated April 7, 1993 regarding employment of Dr. Joseph M. Davie (g)** (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 20, 1998 and restated, with form of Option Agreement (p)** 24 25 (10.27) 1985 Non-Qualified Stock Option Plan, as amended through June 10, 1999 and restated and updated on June 25, 1999 to reflect stock split *, ** (10.28) 1987 Scientific Board Stock Option Plan, as amended through September 12, 1997 (o)** (10.29) Voluntary Executive Supplemental Savings Plan (k)** (10.30) Amendment No. 1 dated April 25, 1997 to Voluntary Executive Supplemental Savings Plan (o)** (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 *, ** (10.33) Amendment No. 4 dated December 13, 1999 to Voluntary Executive Supplemental Savings Plan *, ** (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 *, ** (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 *, ** (10.40) Amendment No. 4 dated December 13, 1999 to Voluntary Board of Directors Savings Plan *, ** (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) 25 26 (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) (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 *, ** (10.52) Letter amending employment arrangement between the Registrant and James C. Mullen dated January 7, 1999 *, ** (10.53) Letter regarding employment of Burt Adelman, M.D. dated April 2, 1996 *, ** (10.54) Letter regarding employment of Mark Leuchtenberger dated November 14, 1996 *, ** (10.55) Letter agreement amending employment arrangement between the Registrant and Mark Leuchtenberger dated May 12, 1999 *, ** (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 * (27) Financial Data Schedule * - ------------- 26 27 (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. (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. 27 28 (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. (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. * 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 1999. 28 29 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 L. Vincent ------------------------------------------ James L. Vincent, Chairman of the Board and Chief Executive Officer Dated March 29, 2000 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 L. Vincent Chairman of the Board and March 29, 2000 - --------------------- Chief Executive Officer James L. Vincent (principal executive officer) /s/ James C. Mullen President, Chief Operating March 29, 2000 - ------------------- Officer and Director James C. Mullen /s/ Timothy M. Kish Vice President - Finance and Chief March 29, 2000 - ------------------- Financial Officer (principal Timothy M. Kish financial and accounting officer) /s/ Alexander G. Bearn Director March 29, 2000 - ----------------------- Alexander G. Bearn /s/ Alan Belzer Director March 29, 2000 - ----------------- Alan Belzer /s/ Harold W. Buirkle Director March 29, 2000 - --------------------- Harold W. Buirkle /s/ Mary L. Good Director March 29, 2000 - ----------------- Mary L. Good /s/ Thomas F. Keller Director March 29, 2000 - --------------------- Thomas F. Keller /s/ Roger H. Morley Director March 29, 2000 - -------------------- Roger H. Morley
29 30
/s/ Kenneth Murray Director March 29, 2000 - ------------------- Kenneth Murray /s/ Phillip A. Sharp Director March 29, 2000 - --------------------- Phillip A. Sharp /s/ Alan K. Simpson Director March 29, 2000 - -------------------- Alan K. Simpson /s/ James W. Stevens Director March 29, 2000 - --------------------- James W. Stevens
30 31 EXHIBIT INDEX Exhibit No. Description - ----------- ----------- (10.27) 1985 Non-Qualified Stock Option Plan, as amended through June 10, 1999 and restated and updated on June 25, 1999 to reflect stock split (10.32) Amendment No. 3 dated September 27, 1999 to Voluntary Executive Supplemental Savings Plan (10.33) Amendment No. 4 dated December 13, 1999 to Voluntary Executive Supplemental Savings Plan (10.35) Amendment No. 1 dated September 27, 1999 to Amended and Restated Supplemental Executive Retirement Plan (10.39) Amendment No. 3 dated September 27, 1999 to Voluntary Board of Directors Savings Plan (10.40) Amendment No. 4 dated December 13, 1999 to Voluntary Board of Directors Savings Plan (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 (10.52) Letter amending employment arrangement between the Registrant and James C. Mullen dated January 7, 1999 (10.53) Letter regarding employment of Burt Adelman, M.D. dated April 2, 1996 (10.54) Letter regarding employment of Mark Leuchtenberger dated November 14, 1996 (10.55) Letter agreement amending employment arrangement between the Registrant and Mark Leuchtenberger dated May 12, 1999 (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 (27) Financial Data Schedule EX-10.27 2 1985 NON0QUALIFIED STOCK OPTION PLAN 1 EXHIBIT 10.27 BIOGEN, INC. 1985 NON-QUALIFIED STOCK OPTION PLAN (AS AMENDED THROUGH JUNE 10, 1999 AND RESTATED AND UPDATED ON JUNE 25, 1999 TO REFLECT STOCK SPLIT) I. PURPOSE OF THE PLAN The Plan is intended to encourage ownership of shares of Common Stock of the Company by certain employees and Directors of the Company and its Affiliates and to provide an additional incentive to those employees and Directors to promote the success of the Company and its Affiliates. II. DEFINITIONS 1. "Company" means Biogen, Inc., a Massachusetts corporation. 2. "Affiliate" means a corporation in respect of which the Company owns directly or indirectly fifty percent (50%) or more of the voting shares thereof or which is otherwise controlled by the Company. 3. "Committee" means the Stock and Option Plan Administration Committee of the Board of Directors of the Company. 4. "Option" means a stock option granted under this Plan. III. SHARES SUBJECT TO THE PLAN The aggregate number of shares as to which Options may be granted from time to time shall be 40,908,000 of the shares of Common Stock of the Company (par value $.01); provided, however that such aggregate number shall be reduced by the number of shares which has been sold under, or may be sold pursuant to options granted from time to time under, the Company's 1982 Incentive Stock Option Plan (the "ISO Plan"), to the same extent as if such sales had been made or options granted pursuant to this Plan. If any option granted under this Plan or the ISO Plan ceases to be "outstanding", in whole or in part, other than by reason of the exercise of such option, the shares which were subject to such option shall be available for the granting of other Options. Any option shall be treated as "outstanding" until such option is exercised in full, terminates under the provisions of this Plan or the ISO Plan, as the case may be, or expires by reason of lapse of time. The aggregate number of shares as to which Options may be granted shall be subject to change only by means of an amendment adopted in accordance with Article XI below, subject to the provisions of Article VIII. 2 IV. ADMINISTRATION OF THE PLAN The Plan shall be administered by the Committee. The membership of the Committee shall be determined, and shall be subject to change without cause and without notice from time to time, by the Board of Directors of the Company. The Committee is authorized to interpret the provisions of the Plan or of any Option and to make all rules and determinations necessary or advisable for the administration of the Plan. Subject to the provisions of the Plan, Options may be granted upon such terms and conditions as the Committee may prescribe. This Plan is intended to comply in all respects with Rule 16b-3 or its successors promulgated under the Securities Exchange Act of 1934 ("1934 Act") with respect to participants who are subject to Section 16 of the 1934 Act, and any provision in this Plan with respect to such persons contrary to Rule 16b-3 shall be deemed null and void to the extent permissible by law and deemed appropriate by the Committee. V. ELIGIBILITY FOR PARTICIPATION The Committee shall determine which employees and Directors shall be eligible to participate in the Plan. Without limiting the generality of the foregoing, Options may be awarded for reasons of performance, merit, promotion, bonus or upon new employees joining the Company or any Affiliate. The Committee may grant to one or more such employees or Directors one or more Options, and shall designate the number of shares to be optioned under each Option so granted; provided, however, that no Options shall be granted after December 31, 2002. In no event shall any employee be granted in any calendar year options to purchase or receive more than 2,400,000 shares of the Company's Common Stock pursuant to this Plan. VI. TERMS AND CONDITIONS OF OPTIONS No Option issued pursuant to this Plan shall be an incentive stock option under Section 422 of the Internal Revenue Code of 1986, as amended. Each Option shall be set forth in writing in an Option agreement, duly executed on behalf of the Company and by the person to whom such Option is granted. No Option shall be deemed to have been granted and no purported grant of any Option shall be effective until such Option shall have been approved by the Committee. The Committee may provide that Options be granted subject to such conditions as the Committee may deem appropriate, including without limitation, subsequent approval by the shareholders of the Company of this Plan or any amendments thereto. Each such Option agreement shall be subject to at least the following terms and conditions: 2 3 A. Option Price: Except as otherwise determined by the Committee, the Option price per share for Options granted under the Plan shall be equal to the fair market value per share of Common Stock on the date of grant of the Option; provided, however, that in no event shall the Option price be less than the par value per share of Common Stock. Fair market value shall be the average of the "high" and "low" sale prices as reported in the National Association of Securities Dealers Automated Quotation System ("NASDAQ") for the date of grant of the Option or, if none, for the most recent trading date thirty (30) days or less prior to the date of grant of the Option on which the Common Stock was traded. B. Term of Option: Each Option shall terminate not more than ten (10) years from the date of the grant thereof, or at such earlier or later time as the Committee shall expressly resolve. C. Date of Exercise: The Committee may prescribe the date or dates on which the Option becomes exercisable, and may provide that the Option rights accrue or become exercisable in installments over a period of months or years, or upon the attainment of stated goals. D. Cancellation and Repurchase Rights: The Committee may stipulate that any Option which becomes exercisable shall be subject to cancellation or that shares purchased upon the exercise of such Option shall be subject to repurchase rights in favor of the Company. In such event the Committee shall determine the date or dates, or event or events, upon which such cancellation or repurchase rights shall become effective or shall lapse, as the case may be. E. Medium of Payment: The Option price shall be payable upon the exercise of the Option. It shall be payable in cash, or, if permitted by the Committee, in shares or other consideration. F. Termination of Employment: An Option holder who ceases (for any reason other than death or total and permanent disability or termination of employment for cause) to be an employee or Director of the Company or of an Affiliate may exercise any Option granted to the extent that the right to purchase shares thereunder has accrued on the date of such termination. Such Option shall be exercisable only within three (3) months after such date of termination, or, if earlier, within the originally prescribed term of the Option, unless the Committee shall authorize a different period. Employment shall not be deemed terminated by reason of a transfer to another employer which is the Company or an Affiliate. An Option holder whose employment with the Company or an Affiliate is terminated by his/her employer for cause or a Director who is removed from the Board of Directors for cause shall forthwith upon such termination cease to have any right to exercise any Option. For purposes of this paragraph, "cause" shall be deemed to include dishonesty with respect to the employer, insubordination, substantial malfeasance or non-feasance of duty, unauthorized disclosure of confidential information, and conduct substantially prejudicial to the business of the Company or any Affiliate. The determination of the Committee as to the existence of cause shall be conclusive. 3 4 An Option holder to whom an Option has been granted under the Plan who is absent from work with the Company or with an Affiliate because of temporary disability, or who is on a permitted leave of absence for any purpose, shall not, during the period of any such absence, be deemed by virtue of such absence alone, to have terminated his employment with the Company or with an Affiliate except as the Committee may otherwise expressly provide. G. Total and Permanent Disability: If an Option holder ceases to be an employee or Director of the Company or of an Affiliate by reason of total and permanent disability, as determined by the Committee, any Option held by him or her on the date of disability shall be exercisable as to all or any part of the shares subject to the Option, all of which shares shall be fully vested as of the date of such disability. A disabled Option holder may exercise such Option only within a period of one (1) year after the date as of which the Committee determines that he or she became disabled or within such different period as may be determined by the Committee, or, if earlier, within the originally prescribed term of the Option. H. Death: If an Option holder dies while the Option holder is an employee or Director of the Company or of an Affiliate, any Option held by him or her at the date of death shall be exercisable as to all or any part of the shares subject to the Option, all of which shares shall be fully vested as of the date of the Option holder's death. A deceased Option holder's legal representatives or one who acquires the Option by will or by the laws of descent and distribution may exercise such Option only within a period of one (1) year after the date of death or within such different period as may be determined by the Committee, or, if earlier, within the originally prescribed term of the Option. I. Exercise of Option and Issue of Shares: Options shall be exercised by giving written notice to the Company, addressed to the Company at the address specified in the Option agreement, with which the Option holder shall tender the Option price. Such written notice shall be signed by the person exercising the Option, shall state the number of shares with respect to which the Option is being exercised, and shall contain any warranty required by Article VII of the Plan. The issuance of the Option shares may be delayed by the Company if any law or regulation requires the Company to take any action with respect to the Option shares prior to the issuance thereof. Without limiting the generality of the foregoing, nothing contained herein shall be deemed to require the Company to issue any Option shares if prohibited by law or applicable regulation. The shares shall, upon issuance, be evidenced by an appropriate certificate or certificates in respect of paid-up, non-assessable shares. J. Assignability and Transferability of Option: By its terms, an Option granted to an Option holder shall not be transferable by such Option holder other than (i) by will or by the laws of descent and distribution or (ii) pursuant to a qualified domestic relations order, as defined by the Code or Title 1 of the Employee Retirement Income Security Act or the rules thereunder, or (iii) as otherwise determined by the Committee and set forth in the applicable Option agreement. The designation of a beneficiary of an Option by an Option holder shall not be deemed a transfer prohibited by this paragraph. Except as provided in the preceding sentence, an Option shall be 4 5 exercisable, during an Option holder's lifetime, only by the Option holder (or by his or her legal representative) and shall not be assigned, pledged, or hypothecated in any way (whether by operation of law or otherwise) and shall not be subject to execution, attachment or similar process. Any attempted transfer, assignment, pledge, hypothecation, or other disposition of any Option or of any rights granted thereunder contrary to the provisions of this Paragraph, or the levy of any attachment or similar process upon an Option or other such rights, shall be null and void. K. Other Provisions: The Option agreements authorized under the Plan shall be subject to such other terms and conditions, including, without limitation, restrictions upon the exercise of the Option, as the Committee shall deem advisable. L. Non-Employee, Non-Scientific Board Directors' Options: Each Director who is not (i) an employee of the Company or any of its Affiliates, or (ii) a member of the Scientific Board of the Company, or (iii) elected pursuant to an agreement or arrangement between shareholders of the Company or between the Company and its shareholders, upon first being appointed or elected to the Board of Directors, and upon every third anniversary thereof, shall be granted an Option to purchase 30,000 shares of Common Stock. Each such Option shall have an exercise price equal to the fair market value per share of Common Stock on the date of grant, as determined under Section VI.A. above, and a term of ten (10) years, and shall be exercisable as to one-third (1/3) of the shares subject thereto upon completion of one full year of service on the Board of Directors after the date of grant, and as to an additional one-third (1/3) upon completion of each full year of service thereafter. For any such Director serving in office on December 6, 1991, the first such Option shall be granted on the date on which the most recent Option previously granted to him, the vesting of which is contingent upon continued service on the Board of Directors, becomes fully vested, and subsequent Options under this Paragraph shall be granted on every third anniversary of such date. Notwithstanding the provision of Section XI concerning amendment of the Plan, the provisions of this Section VI.L. shall not be amended more than once every six months, other than to comport with changes in the Internal Revenue Code of 1986, as amended, the Employee Retirement Income Security Act, or the rules thereunder. The grants of options under this Paragraph L are intended to be non-discretionary formula awards within the meaning of Rule 16b-3(c)(2)(ii). Paragraph F of Article VI, which cancels the Options of any Participant determined by the Committee to have been terminated for cause, shall not apply to the awards under this Paragraph L. M. Tax Withholding: In the event that any federal, state, or local income taxes, employment taxes, Federal Insurance Contributions Act ("F.I.C.A.") withholdings or other amounts are required by applicable law or governmental regulation to be withheld from the Option holder's salary in connection with the exercise of an Option, the Option holder shall advance in cash to the Company, or to any Affiliate of the Company which employs or employed the Option holder, the amount of such withholdings unless a different withholding arrangement, including the use of shares of the Company's Common Stock, is authorized by the Committee (and permitted by law), provided, however, that with respect to persons subject to Section 16 of the 1934 Act, any such withholding arrangement shall be in compliance with any applicable provisions of Rule 16b-3 promulgated under Section 16 of the 1934 Act. For purposes hereof, the fair market value of the 5 6 shares withheld for purposes of payroll withholding shall be determined in the manner provided in Section VI.A. above, as of the date of exercise. If the fair market value of the shares withheld is less than the amount of payroll withholdings required, the Option holder may be required to advance the difference in cash to the Company or the Affiliate employer. N. Reload Options: The Committee may authorize reload options ("Reload Options") to purchase for cash or shares a number of shares of Common Stock. The number of Reload Options shall equal (i) the number of shares of Common Stock used to exercise the underlying Options and (ii) to the extent authorized by the Committee, the number of shares of Common Stock used to satisfy any tax withholding requirement incident to the exercise of the underlying Options. The grant of a Reload Option will become effective upon the exercise of underlying Options through the use of shares of Common Stock held by the optionee for at least 6 months. Reload Options must be evidenced in Option agreements or amendments to those agreements. The Option price per share of Common Stock deliverable upon the exercise of a Reload Option shall be the fair market value of a share of Common Stock on the date the grant of the Reload Option becomes effective. The term of each Reload Option shall be equal to the remaining option term of the underlying Option. No additional Reload Options shall be granted to Option holders when Options and/or Reload Options are exercised pursuant to the terms of this Plan following termination of the Option holder's employment or on account of death or total and permanent disability. All other provisions of this Plan with respect to Options shall apply equally to Reload Options. O. Rights as a Shareholder: No Option holder shall have rights as a shareholder with respect to any shares covered by such Option except as to such shares as have been registered in the Company's share register in the name of such person upon the due exercise of the Option. VII. PURCHASE FOR INVESTMENT If and to the extent that the issuance of shares pursuant to the exercise of Options is deemed by the Company to be subject to the United States Securities Act of 1933, as now in force or hereafter amended ("1933 Act"), or to the securities law of any other jurisdiction, the Company shall be under no obligation to issue shares covered by such exercise unless the person or persons who exercises or who exercise such Option shall make such warranty or take such action as may be required by any applicable securities law of any applicable jurisdiction and shall, in the case of the applicability of the 1933 Act, in the absence of an effective registration under such Act with respect to such shares, warrant to the Company, at the time of such exercise, that such person is or that they are acquiring the shares to be issued to such person or to them, pursuant to such exercise of the Option, for investment and not with a view to, or for sale in connection with, the distribution of any such shares; and in such events the person or persons acquiring such shares shall be bound by the provisions of a legend endorsed upon any share certificates expressing the requirements of any applicable non-United States securities law, or, in cases deemed governed by the 1933 Act, substantially the following legend, which shall be endorsed upon the certificate or certificates evidencing the shares issued by the Company pursuant to such exercise: 6 7 "The shares have not been registered under the securities laws of any country, including the United States Securities Act of 1933, as amended, and the Company may refuse to permit the sale or transfer of all or any of the shares until (1) the Company has received an opinion of Counsel satisfactory to the Company that any such transfer is exempt from registration under all applicable securities laws or (2) in the case of sales or transfers to which the United States Securities Act of 1933 is applicable, unless a registration statement with respect to such shares shall be effective under such Act, as amended." Without limiting the generality of the foregoing, the Company may delay issuance of the shares until completion of any action or obtaining of any consent which the Company deems necessary under any applicable law (including without limitation state securities or "blue sky" laws). VIII. ADJUSTMENTS UPON CHANGES IN CAPITALIZATION In the event that the outstanding Common Stock, $.01 par value, of the Company is changed into or exchanged for a different number or kind of shares or other securities of the Company or of another corporation by reason of any reorganization, merger, consolidation, recapitalization, reclassification, change in par value, stock split-up, combination of shares or dividend payable in capital stock, or the like, appropriate adjustment shall be made in the number and kind of shares for the purchase of which Options may be granted under the Plan, including Options to be granted pursuant to Article VI L hereof, and, in addition, appropriate adjustment shall be made in the number and kind of shares and in the Option price per share subject to outstanding Options so that each Option holder shall be in a position equivalent to the position the Option holder would have been in had the Option holder exercised the Options immediately prior to the applicable event. IX. DISSOLUTION OR LIQUIDATION OF THE COMPANY Upon the dissolution or liquidation of the Company other than in connection with transactions to which the preceding Article VIII is applicable, all Options granted hereunder shall terminate and become null and void; provided, however, that if the rights hereunder of an Option holder or one who acquired an Option by will or by the laws of descent and distribution have not otherwise terminated and expired, the Option holder or such person shall have the right immediately prior to such dissolution or liquidation to exercise any Option granted hereunder to the extent that the right to purchase shares thereunder has accrued as of the date of exercise immediately prior to such dissolution or liquidation. X. TERMINATION OF THE PLAN Unless the Committee shall decide to reduce or, subject to shareholder approval, if required under Article XI, to extend the duration of the Plan, the Plan shall terminate on December 31, 2002. Termination of the Plan shall not affect any Options granted or any Option agreements executed prior to the effective date of termination. 7 8 XI. AMENDMENT OF THE PLAN The Plan may be amended by the Committee or the Board of Directors of the Company provided, however, that if the scope of any amendment is such as to require shareholder approval in order to comply with Rule 16b-3 under the 1934 Act such amendment shall require approval by the shareholders. Any amendment shall not affect any Options theretofore granted and any Option agreements theretofore executed by the Company and any Option holder unless such amendment shall expressly so provide. No amendment shall adversely affect any Option holder with respect to an outstanding Option without the written consent of such Option holder. With the consent of the Option holder affected, the Committee may amend any outstanding Option agreement in a manner not inconsistent with the Plan, including, without limitation, to accelerate the date of exercise of any installment of any Option. XII. EMPLOYMENT RELATIONSHIP Nothing herein contained shall be deemed to prevent the Company or an Affiliate from terminating the employment of any employee, nor to prevent any employee from terminating his/her employment with the Company or an Affiliate. XIII. EFFECTIVE DATE This Plan first became effective on January 2, 1985. 8 EX-10.32 3 AMENDMENT NO. 3 DATED 9/27/99 1 EXHIBIT 10.32 BIOGEN, INC. VOLUNTARY EXECUTIVE SUPPLEMENTAL SAVINGS PLAN THIRD AMENDMENT The Biogen, Inc. Voluntary Executive Supplemental Savings Plan, as heretofore amended ("Plan"), is hereby further amended as follows: Section 3.1 is amended by inserting the following new sentence at the end of the Section: An individual will not be considered an employee for purposes of this plan if the individual is classified as a consultant or contractor under Biogen's (or a subsidiary's) regular personnel classifications and practices, or he is a party to an agreement to provide services to Biogen (or a subsidiary) without participating in this plan, notwithstanding that such individual may be treated as a common law employee for payroll tax or other legal purposes. Section 6.5 is amended in its entirety to read as follows: 6.5 Installment Distributions in Certain Cases. (a) PARTICIPANT. Notwithstanding the provisions of Section 6.2, 6.3 and 6.4, a participant may, at the time of filing an enrollment form under Section 4.1(b), designate that the amount payable to him hereunder will be paid in a number (minimum of two and maximum of ten) of annual installment payments, as specified by the participant. (b) BENEFICIARY. A participant may designate that, if the participant dies before receiving the entire amount payable to him hereunder, the beneficiary will receive either: (i) A number of annual installment payments equal to (A) the number the participant elected for himself under subsection (a) above (if the participant dies before receiving any installment payments), or (B) the number of remaining installment payments due to the participant under subsection (a) above (if the participant dies after receiving one or more installment payments); or (ii) a single payment. Page 1 of 2 2 Payment to the beneficiary will commence as provided herein as soon as practicable after the committee's receipt of satisfactory evidence of the death of the participant. If the participant fails to designate the form of payment to the beneficiary, the default form will be installments under (i) above. If installment payments are payable to the beneficiary, with the consent of the committee, a participant may subsequently change the form of payment to his beneficiary (but not the form of payment to himself under Section 6.2 or 6.4) to a single payment by filing a written instrument so specifying with the committee. (c) INSTALLMENT PAYMENTS. Where installment payments are due, the first annual installment payment will be paid out on the date specified in Section 6.2, 6.3 or 6.4 (whichever is applicable) and subsequent annual installments will be paid on succeeding anniversaries of the first payment date. The amount of each annual installment payment will be determined by multiplying the vested amount in the participant's account by a fraction whose numerator is one and whose denominator is the number of remaining annual installment payments. (d) DEATH OF BENEFICIARY. If a participant's designated beneficiary is receiving installment payments and dies before receiving payment of all the annual installments, the designated beneficiary's estate will receive a lump-sum payment of the amount remaining to be distributed to such deceased beneficiary. Such payment will be made as soon as practicable after the committee's receipt of satisfactory evidence of the death of the designated beneficiary. Section 6.3(b) is amended by inserting the following new sentence at the end of the Section: In the event that a participant does not participate in the Savings Plan, the participant may designate one or more beneficiaries to receive a distribution payable under subsection (a) above and may revoke or change such a designation at any time. If the participant names two or more beneficiaries, distribution to them will be in such proportions as the participant designates or, if the participant does not so designate, in equal shares. Any designation of beneficiary will be in writing on such form as the committee may prescribe or deem acceptable, and will be effective upon filing with the committee. BIOGEN, INC. Date: September 27, 1999 By: /s/ Frank A. Burke, Jr. -------------------------------- Frank A. Burke, Jr. Vice President - Human Resources Page 2 of 2 EX-10.33 4 AMENDMENT NO. 4 DATED 12/13/99 1 EXHIBIT 10.33 Biogen, Inc. Voluntary Executive Supplemental Savings Plan FOURTH AMENDMENT The Biogen, Inc. Voluntary Executive Supplemental Savings Plan ("Plan"), as heretofore amended, is hereby further amended as follows: 1. Section 4.2 is amended in it entirety to read as follows: 4.2 EMPLOYER CREDITS. (a) AMOUNT OF MATCHING EMPLOYER CREDITS. For each calendar quarter (or a shorter period of time specified by the committee) during a plan year, each employer will credit a matching contribution amount to the account of each participant employed by such employer who makes matchable savings deposits during such calendar quarter (or such shorter period of time). The employer's matching contribution credits will be equal to 25% of the participant's matchable savings deposits during the calendar quarter (or such shorter period of time). (b) TIME FOR MAKING EMPLOYER MATCHING CREDITS. The employer's matching amounts under subsection (a) will be credited to participants' accounts as soon as practicable after each calendar quarter (or such shorter period of time specified by the committee). 2. Section 5.1(c) is amended by inserting at the end of the first paragraph the parenthetical phrase "(other than the Biogen stock fund)", thereby not allowing participants to chose the Biogen stock fund as an investment option. 3. Section 5.1(c) is further amended by inserting at the end of the third paragraph and immediately after the phrase "calendar quarter" in the fourth paragraph the parenthetical phrase "(or such shorter period of time specified by the committee)". 4. Section 5.2(b) is amended in its entirety to read as follows: "A participant will have a fully vested interest in his employer matching credits account at all times." 5. Section 6.2 is amended in its entirety to read as follows: "Upon retirement from his employer, the participant will receive a single sum payment equal to his account balance, payable as soon as practicable after the committee's receipt of satisfactory evidence of the occurrence of his retirement." 6. Section 6.3(a) is amended by deleting the word "vested" each time it appears in the second sentence of said Section and by deleting the phrase "the end of the calendar quarter in which" in the third sentence of said Section. Page 1 of 2 2 7. Section 6.4 is amended in its entirety to read as follows: "Upon a participant's termination of employment for any reason other than retirement or death, the participant will receive a single sum payment equal to his account balance as soon as practicable after the committee's receipt of satisfactory evidence of the termination of the participant's employment." 8. Except as expressly set forth herein, the Plan shall remain in full force and effect. BIOGEN, INC. Date: December 13, 1999 By: /s/ Frank A. Burke, Jr. --------------------------------- Frank A. Burke, Jr. Vice President - Human Resources Page 2 of 2 EX-10.35 5 AMEND. #1 TO AMENDED & RESTATED SUPPLEMENTAL 1 EXHIBIT 10.35 BIOGEN, INC. Supplemental Executive Retirement Plan FIRST AMENDMENT TO THE 4/1/96 RESTATEMENT The Biogen, Inc. Supplemental Executive Retirement Plan ("Plan"), as heretofore amended, is hereby further amended as follows: Section 3.4 is inserted and shall state: "An individual is not considered a Participant for purposes of this Plan if the individual is classified as a consultant or contractor under the Company's or the Company's affiliate's regular personnel classifications and practices, or he is a party to an agreement to provide services to the Company or the Company's affiliate without participating in the Plan, notwithstanding that such individual may be treated as a common law employee for payroll tax or other legal purposes." Date: September 27, 1999 BIOGEN, INC. By: /s/ Frank A. Burke, Jr. --------------------------------- Frank A. Burke, Jr. Vice President - Human Resources EX-10.39 6 AMENDMENT NO. 3 DATED 9/27/99 1 EXHIBIT 10.39 Biogen, Inc. Voluntary Board of Directors Savings Plan THIRD AMENDMENT The Biogen, Inc. Voluntary Board of Directors Savings Plan, as heretofore amended (the "Plan"), is hereby further amended as follows: Section 6.4 is amended in its entirety to read as follows: 6.4 INSTALLMENT DISTRIBUTIONS IN CERTAIN CASES. (a) PARTICIPANT. Notwithstanding the provisions of Section 6.2, 6.3 and 6.4, a participant may, at the time of filing an enrollment form under Section 4.1(b), designate that the amount payable to him hereunder will be paid in a number (minimum of two and maximum of ten) of annual installment payments, as specified by the participant. (b) BENEFICIARY. A participant may designate that, if the participant dies before receiving the entire amount payable to him hereunder, the beneficiary will receive either: (i) a number of annual installment payments equal to (A) the number the participant elected for himself under subsection (a) above (if the participant dies before receiving any installment payments), or (B) the number of remaining installment payments due to the participant under subsection (a) above (if the participant dies after receiving one or more installment payments); or (ii) a single payment. Payment to the beneficiary will commence as provided herein as soon as practicable after the committee's receipt of satisfactory evidence of the death of the participant. If the participant fails to designate the form of payment to the beneficiary, the default form will be installments under (i) above. If installment payments are payable to the beneficiary, with the consent of the committee, a participant may subsequently change the form of payment to his beneficiary (but not the form of Page 1 of 2 2 payment to himself under Section 6.2 or 6.4) to a single payment by filing a written instrument so specifying with the committee. (c) INSTALLMENT PAYMENTS. Where installment payments are due, the first annual installment payment will be paid out on the date specified in Section 6.2, 6.3 or 6.4 (whichever is applicable) and subsequent annual installments will be paid on succeeding anniversaries of the first payment date. The amount of each annual installment payment will be determined by multiplying the vested amount in the participant's account by a fraction whose numerator is one and whose denominator is the number of remaining annual installment payments. (d) DEATH OF BENEFICIARY. If a participant's designated beneficiary is receiving installment payments and dies before receiving payment of all the annual installments, the designated beneficiary's estate will receive a lump-sum payment of the amount remaining to be distributed to such deceased beneficiary. Such payment will be made as soon as practicable after the committee's receipt of satisfactory evidence of the death of the designated beneficiary. BIOGEN, INC. Date: September 27, 1999 By: /s/ Frank A. Burke, Jr. --------------------------------- Frank A. Burke, Jr. Vice President - Human Resources Page 2 of 2 EX-10.40 7 AMENDMENT NO. 4 TO VOLUNTARY BOARD PLAN 1 EXHIBIT 10.40 Biogen, Inc. Voluntary Board of Directors Savings Plan FOURTH AMENDMENT The Biogen, Inc. Voluntary Board of Directors Savings Plan ("Plan"), as heretofore amended, is hereby further amended as follows: 1. Section 5.1(b) is amended by inserting at the end of the first paragraph the parenthetical phrase "(other than the Biogen stock fund)", thereby not allowing participants to chose the Biogen stock fund as an investment option. 2. Section 6.2(a) is amended by deleting the phrase "the end of the calendar quarter in which" in the second sentence of said Section. 3. Section 6.3 is amended by deleting the second sentence of said Section in its entirety and substituting in place thereof the following sentence: "Distribution will be made in a single lump sum payment as soon as practicable after the committee's receipt of satisfactory evidence of the occurrence of the event causing distribution." 4. Except as expressly set forth herein, the Plan shall remain in full force and effect. BIOGEN, INC. Date: December 13, 1999 By: /s/ Frank A. Burke, Jr. --------------------------------- Frank A. Burke, Jr. Vice President - Human Resources EX-10.50 8 LETTER AGREEMENT WITH JAMES VINCENT 1 [BIOGEN, INC. LETTERHEAD] 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 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"), provided, that, notwithstanding the extension term specified in the Letter Agreement, your chairmanship will continue after the end of the Initial Chairmanship Term on February 14, 2001 until the Annual Meeting to be held in 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. Date: March 10, 2000 By: /s/ Roger H. Morley ------------------ ------------------------------- Roger H. Morley Chairman, Compensation and Management Resources Committee Date: March 10, 2000 By: /s/ Harold W. Buirkle ------------------ --------------------------- Harold W. Buirkle Member, Compensation and Management Resources Committee 2 Date: March 10, 2000 By: /s/ Phillip A. Sharp ------------------ ------------------------------- Phillip A. Sharp Member, Compensation and Management Resources Committee Date: March 10, 2000 By: /s/ Mary L. Good ------------------ ------------------------------- Mary L. Good Member, Compensation and Management Resources Committee Acknowledged and agreed /s/ James L. Vincent - -------------------------- James L. Vincent Date: March 10, 2000 --------------------- EX-10.51 9 LETTER REGARDING EMPLOYMENT OF JAMES MULLEN 1 [BIOGEN, INC. LETTERHEAD] EXHIBIT 10.51 March 18, 1993 Mr. James C. Mullen Vice President, Operations Biogen, Inc. 14 Cambridge Center Cambridge, MA 02142 Dear Jim: To confirm our recent discussions, your employment letter is hereby amended to include the following additional provisions, in recognition of your position as Vice President, Operations and an executive officer of Biogen: 1. LIFE INSURANCE: You will be provided with Biogen's Executive Life Insurance coverage of $1,000,000, which combines the existing group term insurance provisions with the provisions of an individual term insurance policy. 2. 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 Price Waterhouse. The cost of this service is covered by Biogen. 3. 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 12 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 EX-10.52 10 LETTER AMENDING AGREEMENT DATED 1/7/99 1 [BIOGEN, INC. LETTERHEAD] EXHIBIT 10.52 PERSONAL AND CONFIDENTIAL January 7, 1999 Mr. James C. Mullen Biogen, Inc. 14 Cambridge Center Cambridge, MA 02142 Dear Jim: This confirms your discussion with Jim Vincent related to your new role in the organization. Effective January 1, 1999, your new title is President and Chief Operating Officer with a base salary of $400,000 and a target bonus of 60%. Additionally, you have been granted 175,000 stock options as of January 4, 1999 with a grant value of $14,525,000 (175,000 shares at $83.00). Sincerely, /s/ Frank A. Burke, Jr. Frank A. Burke, Jr. Vice President, Human Resources cc: Personnel File EX-10.53 11 LETTER REGARDING EMPLOYMENT OF BURT ADELMAN 1 [BIOGEN, INC. LETTERHEAD] EXHIBIT 10.53 PERSONAL AND CONFIDENTIAL April 2, 1996 Burt Adelman, M.D. Vice President, Regulatory Affairs Biogen Inc. 14 Cambridge Center Cambridge, MA 02142 Dear Burt: To confirm our recent discussions, your employment letter is hereby amended to include the following additional provisions, in recognition of your position as Vice President, Regulatory Affairs and an executive officer of Biogen. 1. PERFORMANCE BONUS: Your performance bonus target is 25%. 2. SUPPLEMENTAL SAVINGS PLAN: You are eligible to participate in the Voluntary Executive Supplemental Savings Plan. 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 Price Waterhouse. 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 "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., 2 April 2, 1996 Burt Adelman, M.D. Page 2 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 12 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 cc: Personnel File EX-10.54 12 LETTER REGARDING EMPLOYMENT OF MARK LEUCHTENBERGER 1 [BIOGEN, INC. LETTERHEAD] EXHIBIT 10.54 PERSONAL AND CONFIDENTIAL November 14, 1996 Mr. M. W. Leuchtenberger Vice President, Marketing and Sales Biogen Inc. 14 Cambridge Center Cambridge, MA 02142 Dear Mark: To confirm our recent discussions, your employment letter is hereby amended to include the following additional provisions, in recognition of your position as Vice President, Marketing and Sales and an executive officer of Biogen. 1. BASE SALARY: Your base salary will be $200,000 (through 1997), and will be reviewed at year-end 1997. 2. PERFORMANCE BONUS: Your performance bonus target is 30% (effective January 1, 1997). 3. SUPPLEMENTAL SAVINGS PLAN: You are eligible to participate in the Voluntary Executive Supplemental Savings Plan. 4. 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. 5. 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 Price Waterhouse. The cost of this service is covered by Biogen. 6. INVOLUNTARY TERMINATION: If you are involuntarily terminated from employment with Biogen (other than for cause), Biogen will protect you by paying you a 2 November 14, 1996 Mr. M. W. Leuchtenberger Page 2 supplementary amount (the "Supplementary Amount") equal to your then present BASE salary for a 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. In the event you have not obtained alternative medical and dental insurance coverage at the earlier of twelve months from your termination or the commencement of your new job, you shall have the right to continue your medical and dental coverages at your sole expense to the extent required by the provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985 ("COBRA"). The COBRA period shall be deemed to have commenced on the date of your involuntary termination from employment with Biogen. 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 /bk cc: Personnel File EX-10.55 13 LETTER AMENDING AGREEMENT DATED MAY 12, 1999 1 [BIOGEN, INC. LETTERHEAD] EXHIBIT 10.55 May 12, 1999 Mr. Mark Leuchtenberger 20 Old Farm Road Newton, MA 02459 Dear Mark: On behalf of Biogen, I am pleased to outline the details of a proposed secondment to the Paris office, whereby you will assume the position of Vice President - International. This secondment is intended to be a minimum of two years in duration, after which you will be repatriated back to Boston, Massachusetts. At the end of the two-year period, an option to extend for additional time will be by mutual agreement only. As this is an international secondment, your employment is subject to foreign government entry documents and work visas and your acceptance of the terms and conditions outlined in this letter. Your foreign secondment will begin as soon as the appropriate documentation can be completed and approved. Your point of origin will be Boston, Massachusetts. Your compensation and benefits package is designed to provide you with a level of income and benefits that is comparable with individuals at the same level and experience as yourself working in the United States. We have also taken into consideration the additional costs you may reasonably anticipate as a result of living in France. The terms and conditions outlined in this letter will be in effect for the period of your secondment. At the conclusion of this secondment and upon your return to the United States, the provisions of the letters will cease and you will return to United States compensation and benefits programs. COMPENSATION: Your base salary for this position will be increased to $ 245,000 (paid in US dollars) effective May 17, 1999. Typically, we can arrange to have your salary paid in local currency and/or in US dollars, for your convenience. You will continue to participate in the Executive Bonus Plan with a maximum bonus payment of 30% of base pay. The plan payments are determined by a combination of corporate and individual results. GOODS AND SERVICES ALLOWANCE In addition to your base salary, you will receive a goods and services allowance in addition to base salary if the cost of living at the location is in excess of comparable United States costs. Such cost relationships are measured by indices established by an independent consulting firm engaged by Biogen. Human Resources will establish the allowance with data provided by the consulting firm. This allowance is tied to income level and family size. Your 1999 allowance will be $3,250 per month. 2 Mr. Mark Leuchtenberger May 12, 1999 This allowance is paid on a monthly basis along with base salary and will be reviewed and possibly adjusted annually (or more frequently, in the event of a significant change) due to changes in host country costs and /or currency values. HOUSING Based upon our conversations, it was decided that it is in the best interest of Biogen and yourself for you to retain ownership of your US residence during your period of expatriation. You will be expected to maintain your current residence here in the US while on foreign assignment. You will be using your Newton residence and your personal vehicle during trips to Cambridge. The company will provide an apartment for you while you are in Paris. The company agrees to provide a management firm to watch over your Newton home while you are on foreign assignment. This will include mail forwarding, bill paying, and walk throughs. If repairs are to be made to your home, you will be financial responsible for such repairs. TAX EQUALIZATION Our philosophy is such that the Company will provide you with an after-tax income equivalent to that which you would have received had you remained in the US. This is done by hypothetical US Federal and actual state tax deductions from your total salary. Your withholding tax may also fluctuate according to changes in compensation or tax rates. A tax advisor from a well-respected accounting firm selected by the Company will be made available to help you prepare your U.S. and foreign income tax returns; the fees for these services will be borne by the Company. Filings of tax returns and payment of tax owed in the US or abroad is entirely your responsibility and the Company assumes no responsibility for your taxes. Additionally, appropriate and reasonable tax consulting sessions with the accounting firm selected by the Company will be provided before and after your secondment. DOCUMENT ASSISTANCE: The Company will advise you on appropriate documentation and will pay for those and other associated costs incurred in obtaining papers for travel to, or establishing residence in the France and/or countries to which you will be travelling in conjunction with the secondment abroad. CULTURAL ORIENTATION We will engage our relocation firm to provide you both a preview of the new country that you will visit as well as a cultural orientation. TRANSFER ALLOWANCE: Upon leaving the United States, you will be paid a one-time payment of $5,000 to pay for such things as appliance purchases, telephone installation, auto registration, driver's license, and other personal and miscellaneous expenses not specifically mentioned in this letter. 2 3 Mr. Mark Leuchtenberger May 12, 1999 SHIPMENT OF PERSONAL HOUSEHOLD GOODS: We will move personal goods and furniture up to 5,000 pounds to France. Additional items can be stored at the company's expense. All items to be moved would be fully insured by the Company. You will also be entitled to store personal and household goods. Biogen will also pay for any import duties and other expenses necessary for actual delivery of these goods. This does not include certain unusual or special items such as automobiles, antiques, trailers, campers, boats, etc. The selection of the storage company and the carrier will be at the discretion of the Company. AUTO SALES AND LEASE: Biogen will not pay for shipment of automobiles to the foreign location. If you decide to sell your present vehicle(s), we will reimburse you for the costs associated with the sale. While on foreign secondment, the Company will provide a leased automobile for you. Due to your unique situation, you will be provided a Mercedes E320. The costs of the leased vehicle and insurance will be at the company expense; the cost of fuel and repairs will be your expense. Should you choose to want to lease a second automobile, the company will arrange for the vehicle to be leased through the company, at your expense. VACATION: You will be eligible for vacation under the U.S. policy. HOLIDAYS: You will be eligible to observe the local policy for holidays in France. EMPLOYEE BENEFITS: You shall continue to be eligible to receive benefits that, in general, are substantially similar to those that US employees receive. For your medical coverage, you will be in the Tufts out of area plan. Your children in the US will continue to be covered locally through COBRA insurance. To the extent you are required by local laws and regulations to participate in Foreign benefit plans which are in addition to those you would have normally received in the US, the Company will pay for your contributions. Where possible the Company will help you obtain a waiver from participation in such local benefit plans programs. LANGUAGE INSTRUCTION: If required, the Company will pay for reasonable language instruction to be arranged upon your arrival in France. EMERGENCY LEAVE: The Company will grant up to seven days off plus travel time for personal emergencies such as serious illness or death of an immediate family member. Round trip air transportation will be granted. 3 4 Mr. Mark Leuchtenberger May 12, 1999 HOME LEAVE: Biogen encourages you and your family to return to the United States to renew business, professional, personal, and family contacts on an annual basis. For that purpose, the Company will provide the following home leave back to the United States during each twelve-month period of the secondment: - - A period of time above and beyond eligible vacation time, not to exceed fourteen calendar days or ten working days will be granted. - - Actual living expenses will be your responsibility. - - Expenses for the rental of a car in the United States will be reimbursed for a maximum period of fourteen days. - - Pay in any form will not be granted in lieu of home leave, nor will payment be authorized if travel is not to the point of origin. Additionally, based upon your unique situation, you and Jim have agreed that your children will be entitled to 5 visits to Paris during the year. In order to manage the expenses related to these trips, these trips will be reimbursed at a 30-day advanced nonrefundable coach rate. Additionally, it is expected that with the extensive travel you and the children have, you will use frequent flyer miles accumulated toward these trips, before requesting reimbursement from Biogen. Additionally, you, Tracey and Sara Grace will be reimbursed for 1 roundtrip for each 12-month period. Also, there is an expectation that certain business functions (such as the year end holiday party) will require the attendance of your and Tracey. The company agrees to reimburse you for such trips. TERMINATION: In the event of involuntary termination, the Company will arrange to return you to the United States. This will also include your household and personal effects, limited to the same weight and size of your shipment at the beginning of your secondment. The expenses will be borne by the Company only if the move out of France occurs within thirty days of termination. You agree that all rights and obligations in the event of an involuntary termination shall be determined based on the laws of the US and the Commonwealth of Massachusetts, and you hereby waive any rights you may have under the laws and regulations of France and the European Union. REPATRIATION: Although an expected secondment duration of approximately two years has been planned, further extensions may be negotiated. However, after two years, should you remain in the France, your overall compensation situation will be reviewed. If it is determined that your status will not remain that of an expatriate, you will be considered a local national and specifically, the following allowance/benefits may be discontinued: - - Commodities and Service Allowance - - Company arranged housing - - Company paid home leave - - Tax equalization 4 5 Mr. Mark Leuchtenberger May 12, 1999 Approximately six months before conclusion of your secondment, discussions will begin regarding your repatriation and a suitable position back in the United States upon successful completion of the foreign secondment. Every attempt will be made to find a position within the Company which suitably utilizes your skills and experience and which fits your career interests. At that point, I will generate a letter that will detail all terms and conditions of your repatriation. On behalf of Jim Mullen, it is with great pleasure that I present the terms and conditions of your appointment. I trust that you will find your experiences in your new capacity in Paris to be professionally rewarding, and that all the daily experiences of living in France will be personally fulfilling for you. Please countersign and date your acceptance below. Sincerely, /s/ Richard W. Fisher Richard W. Fisher Director - Human Resources Accepted: /s/ Mark Leuchtenberger Date: 9/10/99 ----------------------- Name 5 EX-13 14 PORTIONS OF FINANCIAL STATEMENTS 1 FINANCIALS Biogen, Inc. and Subsidiaries 20 Selected Financial Data 21 Management's Discussion and Analysis of Financial Condition and Results of Operations 32 Consolidated Statements of Income 33 Consolidated Balance Sheets 34 Consolidated Statements of Cash Flows 35 Consolidated Statements of Shareholders' Equity 36 Notes to Consolidated Financial Statements 52 Report of Independent Accountants 53 Senior Executives and Board Members 54 Shareholder Information 2 SELECTED FINANCIAL DATA Biogen, Inc. and Subsidiaries (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
YEARS ENDED DECEMBER 31, 1999 1998 1997 1996 1995 - ------------------------------------------------------------------------------------------------------------------------ Product revenue $ 620,636 $ 394,863 $ 239,988 $ 78,202 $ -- Royalty revenue 173,799 162,724 171,921 181,502 134,653 Total revenues 794,435 557,587 411,909 259,704 134,653 Total costs and expenses 478,184 366,948 285,787 234,541 138,245 Income before income taxes 329,016 210,193 148,968 40,829 7,445 Net income 220,450 138,697 89,167 40,530 5,660 Diluted earnings per share 1.40 0.90 0.58 0.28 0.04 Cash, cash equivalents and short- term marketable securities 654,539 516,914 440,088 321,381 307,948 Total assets 1,277,973 924,715 813,825 634,572 469,201 Long-term debt, less current portion 52,073 56,960 61,846 62,254 32,826 Shareholders' equity 979,530 718,613 536,293 484,370 382,980 Shares used in calculating diluted earnings per share 157,788 154,270 152,999 146,442 145,780
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 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. The Company expects product sales as a percentage of total revenues to continue to increase in the near term as the Company continues to market AVONEX(R) worldwide, and 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 from existing and new MS treatments that may impact sales of AVONEX(R). Commencing in 2000, the Company expects to experience declining royalty revenues as a result of patent expirations. In 2000, the Company expects the decline in royalty revenues to be partially offset by increasing overall sales of licensed products. In addition, sales levels of products sold by the Company's licensees may also 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 - Competition", "Outlook - Royalty Revenue" and "Outlook - Patents and Other Proprietary Rights". 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 21 4 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. 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 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. 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 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). 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. 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 $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. The Company expects interest income to vary based on changes in the amount of funds invested and fluctuations in interest rates. 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. 22 5 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, 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 1998 AS COMPARED TO 1997 REVENUES Total revenues in 1998 were $557.6 million, as compared to $411.9 million in 1997, an increase of $145.7 million or approximately 35%. Product sales in 1998 were $394.9 million as compared to $240 million in 1997, an increase of $154.9 million or approximately 65%. Product sales from AVONEX(R) represented approximately 71% of the Company's total revenues in 1998 as compared to 58% in 1997. AVONEX(R) sales outside of the United States were approximately $92 million in 1998 as compared to $19.1 million in 1997. The Company began selling AVONEX(R) in the United States in May 1996. In March 1997, the Company received regulatory approval to market AVONEX(R) in the EU. By the end of 1997, AVONEX(R) had received reimbursement approval and was on the market in all of the EU countries. In April of 1998, the Company received approval and began marketing AVONEX(R) in Canada. Revenues from royalties in 1998 were $162.7 million, a decrease of $9.2 million or 5% as compared to $171.9 million of royalty revenue in 1997. Revenues from royalties represented approximately 29% of total revenues in 1998 as compared to 42% in 1997. In May 1998, the Company and Schering Corporation, a subsidiary of Schering-Plough Corporation ("Schering-Plough"), amended the terms of the license agreement under which Schering-Plough pays the Company royalties on worldwide sales of Schering-Plough's alpha interferon product, Intron(R) A. Under the terms of the amendment, Schering-Plough acquired the Biogen alpha interferon patent application which was the subject of a lawsuit filed by the Company against Hoffman-LaRoche Inc. and Genentech Inc. related to an interference involving the Biogen patent application and a patent application jointly-owned by the two defendants. The lawsuit has since been settled. As consideration for the acquisition of the Biogen patent application, Schering-Plough agreed to pay certain sums on U.S. sales of alpha interferon products from July 2002 until the expiration of the alpha interferon patent expected to be issued to Hoffman-LaRoche Inc. and Genentech Inc. as a result of the settlement. See "Outlook - Royalty Revenue". COSTS AND EXPENSES Total costs and expenses in 1998 were $366.9 million as compared to $285.8 million in 1997, an increase of approximately 28%. Cost of revenues in 1998 totaled $74.5 million, an increase of $24.3 million or 48% as compared to 1997. The increase in cost of revenues was attributable to the higher sales volume of AVONEX(R). Included in cost of revenues in 1998 and 1997 is $62.1 million and $37.1 million, respectively, from product sales and $12.4 million and $13.1 million, respectively, relating to royalty revenue. Research and development expenses in 1998 were $177.2 million, an increase of $31.7 million or 22% as compared to $145.5 million in 1997. The increase was primarily due to the costs associated with the funding of collaboration agreements, an increase in clinical trial costs and an increase in the Company's other development efforts related to its ongoing research and development programs. 23 6 Selling, general and administrative expenses in 1998 were $115.2 million, an increase of $25.1 million or 28% as compared to 1997. This increase was primarily due to a rise in selling and marketing expenses related to the sale of AVONEX(R) and an increase in legal fees. OTHER INCOME, NET Other income, net consists primarily of interest income, partially offset by interest and other financing expenses, and other non-operating income and expenses. Interest income increased $6.2 million from $22.1 million in 1997 to $28.3 million 1998. This increase was offset by increases in financing related and other non-operating expenses. The increase in interest income was a result of increased funds invested. INCOME TAXES The Company's effective tax rate in 1998 was 34%. Income tax expense for 1998 varied from the amount computed at the U.S. federal statutory rates primarily due to the benefit of research and development and investment 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, 1999, cash, cash equivalents and short-term marketable securities were $654.5 million compared with $516.9 million at December 31, 1998, an increase of $137.6 million. Working capital increased $156.5 million to $720 million. Net cash from operating activities for the year ended December 31, 1999 was $272.3 million compared with $167.8 million in 1998. Cash outflows during 1999 included investments in property and equipment and patents of $86.3 million and investments in collaborative partners of $10 million. Significant cash outflows from financing activities included $197.7 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 included $149.8 million from common stock option exercises and related tax benefits and employee stock purchase plan activity and $22.1 million in proceeds from written put warrants. 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, 1999, the Company had $39.5 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, 1999, the Company also had $17.5 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 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 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 2000. The stock repurchase program may be discontinued at any time. During 1999, the Company repurchased approximately 3.4 million shares of its common stock at a cost of $197.7 million. Under a previous stock repurchase program, the Company in 1998 repurchased 1.8 million shares of its common stock at a cost of $65.6 million. 24 7 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. 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. All of the Company's put warrants outstanding are exercisable only at the date of expiration, with expiration dates ranging from January through November of 2000. The outstanding put warrants permit 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. 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 $35 million had been committed at December 31, 1999. 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 $67 million had been committed at December 31, 1999. 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. In March of 1998, under the terms of the CuraGen Agreement, the Company purchased approximately 435,000 shares of CuraGen common stock at the then fair value for a total of $5 million. Additionally, 100,000 shares of CuraGen Series E Preferred Stock purchased by Biogen in 1997 for $1 million were automatically converted into 100,000 shares of CuraGen common stock. In October 1999, CuraGen drew down $10 million on a line of credit, previously extended to CuraGen pursuant to the terms of the CuraGen Agreement and simultaneously converted the borrowings into approximately 611,000 shares of Curagen common stock at the then fair value of $16.37 per share. The investment in CuraGen common stock is classified as available-for-sale and is included in long-term marketable securities as of December 31, 1999. The Company provided CuraGen with research and development funding of $1.1 million and $1.9 million in 1999 and 1998, respectively. The Company expects to fund research activities of CuraGen related to the collaboration of up to $750,000 in 2000, and in return, has an option to acquire an exclusive license to certain discoveries arising out of the collaborative efforts. During the first quarter of 2000, the Company partially liquidated its holdings in CuraGen common stock generating proceeds of $70.5 million. 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. In addition, pursuant to the terms of the CVT Agreement, the Company established a $12 million line of credit that CVT may use for operating purposes. At December 31, 1999, the Company had advanced $8 million under the line of credit to CVT. 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. As of December 31, 1999, the investment is classified as available-for-sale and is 25 8 included in long term marketable securities. 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. During the first quarter of 2000 the Company liquidated its holdings of CBM common stock, generating proceeds of $7.5 million. 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. The Company accounts for its investment in Ontogeny, which is included in other assets, using the cost method of accounting. 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 Company provided $2.8 million and $3.6 million of research funding to Ontogeny in 1999 and 1998, respectively. The Company has agreed to fund up to an additional $6 million in research funding over the next two years unless the agreement is terminated. If the Company exercises its option to proceed with development and commercialization of a hedgehog protein, the Company would be committed to additional funding in the form of license fees, equity investments and lines of credit. 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 accounts for this investment, which is 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 $7.6 million, $9 million, and $7.7 million in 1999, 1998 and 1997, respectively. At December 31, 1999, the Company had remaining research funding commitments to Genovo of approximately $2.4 million. 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). 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 seeks a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. An unfavorable ruling in the Berlex suit could have a material adverse effect on the Company's results of operations and financial position. The Company believes that it has meritorious defenses to the Berlex claims, but the ultimate outcome is not currently determinable. As a result, an estimate of any potential loss or range of loss cannot be made at this time. A hearing on the parties' summary judgment motions was completed in March 2000. Biogen moved for summary judgement of non-infringement of certain claims of the `567 patent, non-infringement of the `779 patent, as well as a determination of the invalidity of certain claims of the `567 patent and all of the claims of the `779 patent. Berlex moved to dismiss Biogen's inequitable conduct defenses and counterclaims. Berlex also moved for a declaration of literal infringement of certain 26 9 claims of the `567 and the `779 patents. No decisions have been rendered to date. The Company expects a trial to occur in the second half of 2000. 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 has appealed that decision and the appeal is still pending. 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. 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 PRONOUNCEMENTS 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 is currently assessing the impact, if any, however, the Company does not currently anticipate that SAB 101 will 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 and predictions as to the anticipated outcome of pending litigation 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) receives 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". 27 10 COMPETITION The Company faces increasing competition from other products for the treatment of relapsing forms of MS. AVONEX(R) competes with interferon beta-1b which is sold in the United States under the brand name Betaseron(R) by Berlex Laboratories, Inc., a United States affiliate of Schering AG, Germany ("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 addition, in most other countries, AVONEX(R) also competes with Rebif(R), a recombinant interferon beta-1a product sold by Ares Serono S.A. ("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 to recently initate 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). The results of this study may help Serono in its attempts to get the orphan drug status of AVONEX(R) removed. Biogen expects Serono to release the results of the study in the first quarter of 2001. ROYALTY REVENUE The Company receives royalty revenues which contribute a significant amount to its overall profitability. Commencing in 2000, the Company expects to experience declining royalty revenues as a result of patent expirations. In 2000, the Company expects the decline in royalty revenues to be partially offset by increasing overall sales of licensed products. 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. See "Outlook - Patents and Other Proprietary Rights". In 1998, Schering-Plough received marketing clearance in the United States from the FDA for REBETRON(R) for the treatment of chronic hepatitis C. REBETRON(R) is a combination product containing the Intron(R) A injection product and REBETOL(R) (ribavirin, USP capsules). In late 1998, Biogen filed for arbitration against Schering-Plough in a dispute over the amount of royalties payable to Biogen on sales of REBETRON(R). A hearing in connection with the arbitration was conducted in January 2000. In March 2000, the arbitration panel found in favor of Schering-Plough, and rejected Biogen's claim that royalty payments should be based on the higher rate for combination products called for under the 1979 agreement between the parties, and not on the Intron(R) A component alone. Biogen does not expect to suffer any financial impact as a result of the arbitration panel's decision since Schering-Plough is presently paying royalties only on the Intron(R) A component, and the decision will have no effect on those royalties. 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 inteferon patent claiming it to be infringed by Amgen's consensus interferon product known as Infergen(R). In July 1998, the federal judge in the case issued a narrow pre-trial interpretation of the claims of the Biogen patent. This decision was appealed. A hearing in connection with the appeal was held in December 1999. A decision is expected in the first half of 2000. During the arbitration proceedings between Biogen and Schering-Plough related to REBETRON(R) royalties, Schering-Plough alleged that the federal judge's decision in the Amgen case narrowed the scope of the claims in Biogen's United States alpha interferon patent such that the patent no longer covers Schering-Plough's Intron(R) A product. If the Amgen appeal is unsuccessful, Schering-Plough might argue that royalties on sales of Intron(R) A are not payable during the period commencing after expiration of the EU patent in January 2001 (which currently covers all product manufactured in the EU, including all product sold in the United States) until commencement in July 2002 of the royalty obligation tied to the term of the Roche/Genetech alpha interferon patent rights. See "Outlook - Patents and Other Proprietary Rights". Biogen intends to vigorously oppose any attempt by Schering-Plough to discontinue payment of royalties during any period. 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 will not be granted patents claiming subject matter necessary to Biogen's business. 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 Intron(R) A brand of alpha interferon. 28 11 Schering-Plough's royalty obligation to Biogen on sales of alpha interferon in Japan and Europe will terminate upon expiration of Biogen's alpha interferon patent in such territories in 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 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 July 2002 (when Biogen's existing United States alpha interferon patent expires) 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 matter. 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 SmithKline Beecham 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 supplemental protection certificates. To date, Biogen has received supplemental protection certificates in Austria, Belgium, France, Ireland, Italy, Luxembourg, The Netherlands, Sweden, and Switzerland, and has a number of additional applications pending. The additional coverage afforded by supplemental protection certificates ranges from two to six years. There can be no assurance as to the extent of coverage available under the supplemental protection certificates, or that protection will be available in additional countries. 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 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. 29 12 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 $13 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, 1999, 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 is 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, 1999, representing the cash the Company would receive to settle the agreements, was approximately $366,000. 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 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. 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. YEAR 2000 ISSUES The Year 2000 problem resulted from the use of a two-digit date field to identify the year in computer software. Consequently, there was concern that certain computer programs would not accurately reflect the appropriate date after December 31, 1999, confusing 30 13 "00" as the year 1900 rather than the year 2000. The Year 2000 problem was a pervasive issue affecting many information technology systems and embedded technologies (e.g. microprocessors in communications systems) in all companies, in all industries. The Company developed a plan to address the Year 2000 issues. The plan was segregated into four phases: 1. Information Collection - Identify all Year 2000 risk areas and assign accountability. 2. Assess Risk - Assign each item a category of risk: - Commercial Risk - Has a significant impact on sale, delivery and support of AVONEX(R) or a significant impact on the Company's financial position or results of operations. - Operational Risk - Has a significant impact on productivity but does not materially impact the Company's financial position or results of operations. - Convenience Risk - Has a minor impact on productivity. 3. Remediate - Fix or replace, test and implement changes required for Year 2000 compliance. 4. Contingency Plan - Define procedures to be implemented should a disruption due to Year 2000 occur. The Company completed all phases of the project by December 31, 1999, including the testing and upgrading of all individual software applications and equipment that fell within the Commercial Risk category. Additionally, approximately 100% of the software applications and equipment in the Operational and Convenience Risk categories had been remediated. All of the Company's major software applications have been purchased from major software vendors and the Company performs only minor customizations to those applications. The Company's major software providers have attested to Year 2000 compliance. Subsequent to December 31, 1999, the Company has not experienced any significant problems related to the Year 2000 issue. The Company therefore believes that its principal information technology systems correctly define the Year 2000. The Company's Year 2000 costs were immaterial and the Company believes that future costs will also be immaterial. 31 14 CONSOLIDATED STATEMENTS OF INCOME - -------------------------------------------------------------------------------- Biogen, Inc. and Subsidiaries
- --------------------------------------------------------------------------------------------------------------------------- (in thousands, except per share amounts) - --------------------------------------------------------------------------------------------------------------------------- For the years ended December 31, 1999 1998 1997 - --------------------------------------------------------------------------------------------------------------------------- Revenues: Product $ 620,636 $ 394,863 $ 239,988 Royalty 173,799 162,724 171,921 - --------------------------------------------------------------------------------------------------------------------------- Total Revenues 794,435 557,587 411,909 - --------------------------------------------------------------------------------------------------------------------------- Costs and expenses: Cost of revenues 111,005 74,509 50,188 Research and development 221,153 177,228 145,501 Selling, general & administrative 146,026 115,211 90,098 - --------------------------------------------------------------------------------------------------------------------------- Total costs and expenses 478,184 366,948 285,787 - --------------------------------------------------------------------------------------------------------------------------- Income from operations 316,251 190,639 126,122 Other income, net 12,765 19,554 22,846 - --------------------------------------------------------------------------------------------------------------------------- Income before income taxes 329,016 210,193 148,968 Income taxes 108,566 71,496 59,801 - --------------------------------------------------------------------------------------------------------------------------- Net Income $ 220,450 $ 138,697 $ 89,167 - --------------------------------------------------------------------------------------------------------------------------- Basic earnings per share $ 1.47 $ 0.94 $ 0.60 - --------------------------------------------------------------------------------------------------------------------------- Diluted earnings per share $ 1.40 $ 0.90 $ 0.58 - --------------------------------------------------------------------------------------------------------------------------- Shares used in calculating: Basic earnings per share 149,921 147,537 147,624 - --------------------------------------------------------------------------------------------------------------------------- Diluted earnings per share 157,788 154,270 152,999 - ---------------------------------------------------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements. 32 15 CONSOLIDATED BALANCE SHEETS Biogen, Inc. and Subsidiaries (in thousands, except share amounts)
As of December 31, 1999 1998 - -------------------------------------------------------------------------------------------------------------------- Assets Current Assets Cash and cash equivalents $ 56,920 $ 25,445 Marketable securities 597,619 491,469 Accounts receivable, less allowances of $1,642 137,363 101,281 Deferred tax asset 50,565 26,584 Other current assets 67,759 49,365 - -------------------------------------------------------------------------------------------------------------------- Total current assets 910,226 694,144 - -------------------------------------------------------------------------------------------------------------------- Property and equipment 239,777 182,551 Patents 13,871 15,869 Marketable securities 98,017 12,668 Other assets 16,082 19,483 - -------------------------------------------------------------------------------------------------------------------- $ 1,277,973 $ 924,715 - -------------------------------------------------------------------------------------------------------------------- Liabilities and Shareholders' Equity Current liabilities Accounts payable $ 30,125 $ 24,896 Current portion of long-term debt 4,888 4,888 Accrued expenses and other 155,257 100,879 - -------------------------------------------------------------------------------------------------------------------- Total current liabilities 190,270 130,663 - -------------------------------------------------------------------------------------------------------------------- Long-term debt, less current portion 52,073 56,960 Other long-term liabilities 56,100 18,479 Commitments and contingencies -- -- Shareholders' equity Common stock, par value $0.01 per share (375,000,000 shares authorized; 150,684,586 and 148,298,782 shares issued in 1999 and 1998, respectively) 1,507 1,483 Additional paid-in capital 676,673 538,105 Retained earnings 352,016 213,507 Accumulated other comprehensive income 45,618 (13,165) Treasury stock, at cost, 669,651 and 579,931 shares in 1999 and 1998, respectively (96,284) (21,317) - -------------------------------------------------------------------------------------------------------------------- Total shareholders' equity 979,530 718,613 - -------------------------------------------------------------------------------------------------------------------- $ 1,277,973 $ 924,715 - --------------------------------------------------------------------------------------------------------------------
See accompanying notes to consolidated financial statements. 33 16 CONSOLIDATED STATEMENTS OF CASH FLOWS Biogen, Inc. and Subsidiaries (in thousands)
For the years ended December 31, 1999 1998 1997 ----------------------------------------------- CASH FLOWS FROM OPERATING ACTIVITIES Net Income $ 220,450 $ 138,697 $ 89,167 Adjustments to reconcile net income to net cash provided from operating activities Depreciation and amortization 31,099 24,590 19,296 Other 5,162 (888) 2,695 Deferred income taxes (23,981) 7,486 22,462 Write-down of non-current marketable securities 15,287 -- -- Changes in: Accounts receivable (36,082) (14,479) (43,850) Other current and other assets (41,372) (25,638) (8,643) Accounts payable, accrued expenses and other current and long-term liabilities 101,725 38,077 16,505 ----------------------------------------------- Net cash flows from operating activities 272,288 167,845 97,632 ----------------------------------------------- CASH FLOWS FROM INVESTING ACTIVITIES Purchases of marketable securities (1,120,218) (574,021) (481,783) Proceeds from sales and maturities of marketable securities 1,006,465 453,952 373,130 Investment in collaborative partners (10,000) (5,000) (11,000) Acquisitions of property and equipment (82,528) (29,049) (28,896) Additions to patents (3,799) (4,562) (6,654) ----------------------------------------------- Net cash flows from investing activities (210,080) (158,680) (155,203) ----------------------------------------------- CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from note payable -- -- 24,817 Repayments on note payable -- (24,817) -- Proceeds from issuance of long-term debt -- -- 4,545 Repayments on long-term debt (4,887) (4,886) (4,082) Purchases of treasury stock (197,717) (65,550) (7,000) Proceeds from put warrants 22,086 -- -- Issuance of common stock, and option exercises and related tax benefits 149,785 41,175 47,617 ----------------------------------------------- Net cash flows from financing activities (30,733) (54,078) 65,897 ----------------------------------------------- Net increase (decrease) in cash and cash equivalents 31,475 (44,913) 8,326 Cash and cash equivalents, beginning of the year 25,445 70,358 62,032 ----------------------------------------------- Cash and cash equivalents, end of the year $ 56,920 $ 25,445 $ 70,358 =============================================== SUPPLEMENTAL CASH FLOW DATA Cash paid during the year for: Interest $ 4,598 $ 5,909 $ 5,940 Income taxes $ 4,787 $ 35,828 $ 3,783
See accompanying notes to consolidated financial statements. 34 17 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, 1996 $ 1,451 $ 470,897 $ -- $ 12,831 $ (809) $ 484,370 ------------------------------------------------------------------------------------------ Net income 89,167 89,167 Unrealized losses on marketable securities, net of tax of $ 942 (1,490) (1,490) Translation adjustment 29 29 ---------- Total comprehensive income 87,706 ---------- Reclassification of put option obligation (76,671) (76,671) Treasury stock purchased (7,000) (7,000) Exercise of options and related tax benefits 32 43,989 2,548 46,569 Issuance of common stock 981 67 1,048 Compensation expense related to stock options 271 271 ------------------------------------------------------------------------------------------ Balance, December 31, 1997 $ 1,483 $ 516,138 $ (4,385) $ 25,327 $ (2,270) $ 536,293 ------------------------------------------------------------------------------------------ Net income 138,697 138,697 Unrealized losses on marketable securities, net of tax of $4,476 (7,072) (7,072) Unrealized 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 ON MARKETABLE SECURITIES, NET OF TAX OF $25,013 48,555 48,555 UNREALIZED GAINS ON FOREIGN CURRENCY FORWARD CONTRACTS, NET OF TAX OF $2,490 6,654 6,654 UNREALIZED GAINS 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 ==========================================================================================
See accompanying notes to consolidated financial statements. 35 18 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 $2.5 million, $2.5 million and $8.2 million in 1999, 1998 and 1997, 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. 36 19 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) 1999 1998 -------------- ------------ Raw materials $ 5,679 $ 4,878 Work in process 15,110 17,585 Finished goods 19,242 13,402 -------------- ------------ $ 40,031 $ 35,865 ============== ============ MARKETABLE SECURITIES The Company invests its excess cash balances in short-term marketable securities, principally corporate notes and government securities. At December 31, 1999, 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, 1999 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 $4.7 million and $5 million at December 31, 1999 and 1998, respectively. The validation costs are amortized over the life of the related equipment. 37 20 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 $20.1 million and $15.5 million as of December 31, 1999 and 1998, 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. The Consolidated Statements of Shareholders' Equity reflect comprehensive income for years ended December 31, 1999, 1998 and 1997 which were $279.2 million, $127.8 million and $87.7 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. 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. 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. 38 21 The Company's 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. 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 are 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. 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 276,000 shares were outstanding at December 31, 1999 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) 1999 1998 1997 --------------------- ---------------- ----------------- Weighted average number of shares of common stock outstanding 149,921 147,537 147,624 Dilutive stock options 7,867 6,733 5,375 --------------------- ---------------- ----------------- Shares used in calculating diluted earnings per share 157,788 154,270 152,999 ===================== ================ =================
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 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. 39 22 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, 1999 and 1998 was 24 months and 21 months, respectively. Proceeds from maturities and other sales of marketable securities, which were primarily reinvested, for the years ended December 31, 1999, 1998 and 1997 were approximately $1,007 million, $454 million and $373 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, 1999, 1998 and 1997 were $(1,442,000), $645,000 and $(510,000), respectively. The following is a summary of marketable securities:
Unrealized -------------------------------- Amortized (in thousands) Fair Value Gains Losses Cost -------------- -------------- ---------- ------------ 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 ============================================================================= December 31, 1998: U.S. Government securities $ 259,411 $ 627 $ 57 $ 258,841 Corporate debt securities 232,058 3,810 -- 228,248 ----------------------------------------------------------------------------- $ 491,469 $ 4,437 $ 57 $ 487,089 ============================================================================= Marketable securities, noncurrent $ 12,668 $ -- $ 16,192 $ 28,860 =============================================================================
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, 1999, representing the cash the Company would receive to settle the agreements, was approximately $366,000. The fair value of the interest rate swap agreements at December 31, 1998, representing the cash requirements of the Company to settle the agreements, approximated $4.1 million. 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 1999 and 1998, 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 $376,000 in losses related to its interest rate swaps to affect earnings in 2000. 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 21 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 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, 1999 was approximately $181.3 million. These contracts had a fair value of approximately 40 23 $6.7 million, representing an unrealized gain, and were included in other current assets at December 31, 1999. 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. The Company expects approximately $5.3 million of unrealized gains at December 31, 1999 to affect earnings in 2000 related to its foreign currency forward contracts. 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, 1999, the Company had $17.5 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, 1999, the Company had $39.5 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) 1999 1998 - -------------------------------------------------------------- ------------------- ------------------ Term Loan due 2005 $ 17,501 $ 19,167 Construction Loan due 2007 39,460 42,681 ------------------- ------------------ 56,961 61,848 Current portion (4,888) (4,888) ------------------- ------------------ $ 52,073 $ 56,960 =================== ==================
4. CONSOLIDATED BALANCE SHEETS DETAILS
Property and equipment: December 31 (in thousands) 1999 1998 - -------------------------------------------------------------- ------------------- ------------------ Land $ 12,349 $ 8,359 Buildings 92,462 87,190 Leasehold improvements 54,946 52,602 Equipment 191,809 120,887 ------------------- ------------------ Total cost 351,566 269,038 Less accumulated depreciation 111,789 86,487 ------------------- ------------------ $ 239,777 $ 182,551 =================== ==================
41 24 Depreciation expense was $25.9 million, $21.4 million and $15.9 million for 1999, 1998 and 1997, respectively. Accrued expenses and other:
December 31 (in thousands) 1999 1998 - ---------------------------------------------------------- --------------------- ------------------ Royalties and licensing fees $ 34,914 $ 23,029 Income taxes 64,545 28,056 Other 55,798 49,794 --------------------- ------------------ $ 155,257 $ 100,879 ===================== ==================
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) 1999 1998 1997 ----------------- ----------------- -------------- Service cost $ 2,923 $ 2,225 $ 1,873 Interest cost 1,307 1,041 876 Expected return on plan assets (994) (722) (497) Amortization of transition asset -- (21) (21) Amortization of prior service cost 43 43 43 Amortization of net actuarial loss 22 -- 40 ----------------- ----------------- -------------- Net pension cost $ 3,301 $ 2,566 $ 2,314 ================= ================= ==============
42 25 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) 1999 1998 - ---------------------------------------------------------------- ------------------ ------------------ Net projected benefit obligation at the beginning of the year $ (16,003) $ (12,727) Service cost (2,923) (2,225) Interest cost (1,307) (1,041) Actuarial gain (loss) 697 (341) Gross benefits paid 159 331 ------------------ ------------------ Net projected benefit obligation at the end of the year (19,377) (16,003) ------------------ ------------------ Change in plan assets (in thousands) - ---------------------------------------------------------------- Fair value of plan assets at the beginning of the year 11,773 8,393 Actual return on plan assets 2,021 2,142 Employer contributions 1,500 1,557 Gross benefits paid (43) (213) Administrative expenses (190) (106) ------------------ ------------------ Fair value of plan assets at the end of the year 15,061 11,773 ------------------ ------------------ Funded status at the end of the year (in thousands) - ---------------------------------------------------------------- Funded status at the end of the year (4,316) (4,230) Unrecognized net actuarial (gain) loss (1,833) (173) Unrecognized prior service cost 315 358 Unrecognized net transition asset 0 0 ------------------ ------------------ Net amount recognized at the end of the year $ (5,834) $ (4,045) ================== ================== Weighted average assumptions at the end of the year - ---------------------------------------------------------------- Discount rate 7.50% 6.75% 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, 1999 the projected benefit and the accumulated benefit obligations was $3.8 million and $2.8 million, respectively. As of December 31, 1998 the projected benefit and the accumulated benefit obligations was $3.2 million and $2.3 million, respectively. 6. OTHER INCOME, NET Other income, net consists of the following (in thousands):
December 31, ----------------------------------------------------------- 1999 1998 1997 ------------------ ---------------- --------------- Interest income $ 35,407 $ 28,339 $ 22,135 Interest expense (4,639) (5,944) (5,309) Other income (expense) (18,003) (2,841) 6,020 ------------------ ---------------- --------------- Total other income, net $ 12,765 $ 19,554 $ 22,846 ================== ================ ===============
Other income (expense) for the period ended December 31, 1999 included a $15 million write-down of certain non-current marketable securities. 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 43 26 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 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. 7. INCOME TAXES The components of income (loss) before income taxes and of income tax expense (benefit) for each of the three years ended December 31, are as follows:
(in thousands) 1999 1998 1997 ------------------ ---------------- ---------------- Income (loss) before income taxes: Domestic $ 253,303 $ 200,181 $ 172,973 Foreign 75,713 10,012 (24,005) ------------------ ---------------- ---------------- $ 329,016 $ 210,193 $ 148,968 ================== ================ ================ Income tax expense: Current Federal $ 112,499 $ 58,152 $ 33,688 State 15,587 3,937 2,735 Foreign 4,206 887 916 ------------------ ---------------- ---------------- $ 132,292 $ 62,976 $ 37,339 ------------------ ---------------- ---------------- Deferred Federal $ (20,863) $ 8,314 $ 21,416 State (2,863) 206 1,046 ------------------ ---------------- ---------------- (23,726) 8,520 22,462 ------------------ ---------------- ---------------- Total income tax expense $ 108,566 $ 71,496 $ 59,801 ================== ================ ================
The Company's foreign subsidiaries generated operating losses in 1997 reflecting the costs of building a commercial infrastructure in Europe and the foreign subsidiaries' investment in the Company's research and development efforts. 44 27 Deferred tax assets (liabilities) are comprised of the following at December 31:
(in thousands) 1999 1998 --------------------- -------------------- Tax credits $ 35,089 $ 13,454 Inventory and other reserves 14,927 10,762 Other 549 2,368 --------------------- -------------------- Deferred tax asset 50,565 26,584 --------------------- -------------------- Depreciation, amortization and other (9,943) (7,095) Unrealized gain on investments (27,640) -- --------------------- -------------------- Deferred tax liabilities (37,583) (7,095) --------------------- -------------------- $ 12,982 $ 19,489 ===================== ====================
A reconciliation of the U.S. federal statutory tax rate to the effective tax rate for the periods ending December 31 is as follows:
1999 1998 1997 -------------- ---------------- ------------- Statutory rate 35.0 % 35.0 % 35.0 % State taxes 3.3 3.0 2.7 Foreign taxes (2.6) -- 6.3 Credits and net operating loss utilization (2.6) (4.2) (3.8) Other (0.1) 0.2 (0.1) -------------- ---------------- ------------- Effective tax rate 33.0 % 34.0 % 40.1 % ============== ================ =============
At December 31, 1999, the Company had tax credits of $35.1 million, most of which expire at various dates through 2014. As of December 31, 1999, undistributed foreign earnings of non-U.S. subsidiaries included in consolidated retained earnings aggregated $113 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 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. In March of 1998, under the terms of the CuraGen Agreement, the Company purchased approximately 435,000 shares of CuraGen common stock at the then fair value for a total of $5 million. Additionally, 100,000 shares of CuraGen Series E Preferred Stock purchased by Biogen in 1997 for $1 million were automatically converted into 100,000 shares of CuraGen common stock. In October 1999, CuraGen drew down $10 million on a line of credit, previously extended to CuraGen pursuant to the terms of the CuraGen Agreement and simultaneously converted the borrowings into approximately 611,000 shares of Curagen common stock at the then fair value of $16.37 per share. The investment in CuraGen common stock is classified as available-for-sale and is included in long-term marketable securities as of December 31, 1999. The Company provided CuraGen with research and development funding of $1.1 million and $1.9 million in 1999 and 1998, respectively. The Company expects to fund research activities of CuraGen related to the 45 28 collaboration of up to $750,000 in 2000, and in return, has an option to acquire an exclusive license to certain discoveries arising out of the collaborative efforts. 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. In addition, pursuant to the terms of the CVT Agreement, the Company established a $12 million line of credit that CVT may use for operating purposes. At December 31, 1999, the Company had advanced $8 million under the line of credit to CVT. 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. As of December 31, 1999, the investment is classified as available-for-sale and is included in long term marketable securities. 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. 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. The Company accounts for its investment in Ontogeny, which is included in other assets, using the cost method of accounting. 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 Company provided $2.8 million and $3.6 million of research funding to Ontogeny in 1999 and 1998, respectively. The Company has agreed to fund up to an additional $6 million in research funding over the next two years unless the agreement is terminated. If the Company exercises its option to proceed with development and commercialization of a hedgehog protein, the Company would be committed to additional funding in the form of license fees, equity investments and lines of credit. 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 accounts for this investment, which is 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 $7.6 million, $9 million, and $7.7 million in 1999, 1998 and 1997, respectively. At December 31, 1999, the Company had remaining research funding commitments to Genovo of approximately $2.4 million. 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 $11.9 million in 1999, $9.4 million in 1998 and $7.5 million in 1997. 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. 46 29 At December 31, 1999, minimum annual rental commitments under noncancellable leases were as follows:
Year (in thousands) ---------------------------------------------------------------------- 2000 $ 12,984 2001 10,245 2002 10,009 2003 8,447 2004 7,910 Thereafter 66,657 -------------------- Total minimum lease payments $ 116,252 ====================
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, 1999, $35 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, 1999, $67 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). 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 seeks a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. An unfavorable ruling in the Berlex suit could have a material adverse effect on the Company's results of operations and financial position. The Company believes that it has meritorious defenses to the Berlex claims, but the ultimate outcome is not currently determinable. As a result, an estimate of any potential loss or range of loss cannot be made at this time. A hearing on the parties' summary judgment motions was completed in March 2000. Biogen moved for summary judgment of non-infringement of certain claims of the `567 patent, non-infringement of the `779 patent, as well as a determination of the invalidity of certain claims of the `567 patent and all of the claims of the `779 patent. Berlex moved to dismiss Biogen's inequitable conduct defenses and counterclaims. Berlex also moved for a declaration of literal infringement of certain claims of the `567 and the `779 patents. No decisions have been rendered to date. The Company expects a trial to occur in the second half of 2000. 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 has appealed that decision and the appeal is still pending. 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. 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. 10. SHAREHOLDERS' EQUITY CONVERTIBLE EXCHANGEABLE PREFERRED STOCK The Company has authority to issue 20,000,000 shares of $.01 par value preferred stock. 47 30 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, 1999, 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, 1999, 1998 and 1997 were approximately $7.5 million, $2.2 million and $271,000, 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, aproximately 47 million optons 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. 48 31 Activity under these plans for the periods ending December 31, is as follows (shares are in thousands):
1999 1998 1997 ---------------------------------------------------------------------------------------------- Weighted Weighted Weighted Average Average Average Exercise Exercise Exercise Shares Price Shares Price Shares Price ---------- ------------- ----------- --------------- ------------ ------------ Outstanding, Jan. 1 22,376 $ 15.97 22,304 $ 11.98 23,496 $ 10.39 Granted 3,099 60.24 3,618 33.88 3,112 18.83 Exercised (5,435) 10.45 (2,612) 7.65 (3,304) 7.04 Canceled (2,102) 22.41 (934) 13.33 (1,000) 12.20 ---------- ------------- ----------- --------------- ------------ ------------ Outstanding, Dec. 31 17,938 $ 24.53 22,376 $ 15.97 22,304 $ 11.98 ========== ============= =========== =============== ============ ============ Options exercisable 9,384 10,998 10,416 Available for grant 2,828 3,824 2,270 Weighted average fair value of options granted $ 26.23 $ 14.63 $ 8.39
The table below summarizes options outstanding and exercisable at December 31, 1999 (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 3,809 3.53 $ 7.77 3,359 $ 7.72 $10.01-$20.00 8,163 6.15 15.51 4,586 14.76 $20.01-$30.00 976 8.00 22.93 180 22.38 $30.01-$40.00 281 8.77 33.85 69 33.52 $40.01-$50.00 2,703 8.98 41.25 890 41.12 $50.01-$60.00 352 9.39 54.27 -- -- $60.01-$70.00 17 9.63 66.14 -- -- $70.01-$80.00 1,485 9.91 72.27 300 71.63 Over $80.00 152 9.72 85.37 -- -- --------------- -------------- -------------- Total 17,938 $ 24.53 9,384 =============== ============== ==============
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, 1999, 365,690 shares have been issued under the stock purchase plans. If compensation cost for the Company's 1999, 1998 and 1997 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):
1999 1998 1997 ----------------- -------------- -------------- Pro forma net income $ 196,965 $ 122,342 $ 83,244 Pro forma diluted earnings per share $ 1.25 $ 0.79 $ 0.54
49 32 The fair value of options granted is estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions:
1999 1998 1997 -------------- ------------- ------------ Expected dividend yield 0 % 0 % 0 % Expected stock price volatility 36 % 36 % 36 % Risk-free interest rate 5.5 % 5.5 % 5.5-5.9 % Expected option term in years 5.6 5.6 5.8
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 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 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 2000. The stock repurchase program may be discontinued at any time. During 1999, the Company repurchased approximately 3.4 million shares of its common stock at a cost of $197.7 million. Under a previous stock repurchase program, the Company in 1998 repurchased 1.8 million shares of its common stock at a cost of $65.6 million. 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. 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. All of the Company's put warrants outstanding are exercisable only at the date of expiration, with expiration dates ranging from January through November of 2000. The outstanding put warrants permit 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. As of December 31, 1999, 1998, and 1997, respectively, no material amounts of product or royalty revenue could be attributable to an individual foreign country. 50 33 The Company's geographic information is as follows (in thousands):
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 270,179 20,910 -- 131 291,220 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 213,053 15,912 -- 105 229,070 December 31, 1997: US EUROPE ASIA OTHER TOTAL - ----------------------------------- ------------ ----------- ------------ ---------------- ----------- Product revenue from external customers $ 220,385 $ 17,885 $ -- $ 1,718 $ 239,988 Royalty revenue from external customers 88,424 50,279 15,362 17,856 171,921 Long-lived assets 204,800 11,888 -- -- 216,688
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. The Company received revenue from four unrelated parties in 1997 accounting for a total of 19%, 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 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 1998 Total revenues $ 114,472 $ 128,812 $ 145,904 $ 168,399 $ 557,587 Product revenue 76,100 87,073 107,492 124,198 394,863 Royalties revenue 38,372 41,739 38,412 44,201 162,724 Total expenses and taxes 93,623 103,602 114,024 127,195 438,444 Other income, net 6,922 6,239 5,685 708 19,554 Net income 27,771 31,449 37,565 41,912 138,697 Basic earnings per share 0.19 0.21 0.25 0.28 0.94 Diluted earnings per share 0.18 0.20 0.24 0.27 0.90
51 34 52 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, 1999 and 1998, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 1999, in conformity with accounting principles generally accepted in the United States. 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, 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 the opinion expressed above. PricewaterhouseCoopers LLP Boston, Massachusetts January 14, 2000 52 35 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 and Chairman of the Board and Chairman of the Scientific Board Chief Executive Officer Chief Executive Officer Institute Professor and Director of the Biogen, Inc. McGovern Institute for Brain Research, Massachusetts Institute of Technology; James C. Mullen Nobel Laureate President and Alexander G. Bearn, M.D. 5 Chief Operating Officer Executive Officer, American Philosophical Society Adjunct Professor, The Rockefeller University Sir Kenneth Murray, Ph.D. Burt A. Adelman, M.D. Professor Emeritus, Vice Chairman of the Scientific Board Vice-President - Medical Research Cornell University Medical College Biogen Professor of Molecular Biology, Emeritus University of Edinburgh; Cornelis "Kees" Been Alan Belzer 1, 5 Fellow of The Royal Society Vice President - Business and President, Chief Operating Officer and Director, Market Development Allied-Signal, Inc. (retired) Alexander G. Bearn, M.D. Executive Officer, American Philosophical Michael W. Bonney Harold W. Buirkle 1,2,4 Society Vice President - Sales and Marketing Managing Director, Adjunct Professor, The Rockefeller The Henley Group, Inc. (retired) University Professor Emeritus, Thomas J. Bucknum, Esq. Cornell University Medical College Vice President - General Counsel, Mary L. Good, Ph.D. 2 Secretary and Clerk Former Undersecretary for Technology, U.S. Department of Commerce Max D. Cooper, M.D. Management Member, Investigator, Frank A. Burke, Jr. Venture Capital Investors, LLC, Howard Hughes Medical Institute; Vice President - Human Resources Donaghey University Professor at University of Professor of Medicine, Pediatrics, Arkansas at Little Rock Microbiology and Pathology, University of Alabama at Birmingham Joseph M. Davie, M.D., Ph.D. Senior Vice President - Research Thomas F. Keller, Ph.D. 1 R.J. Reynolds Professor and Dean, Joseph M. Davie, M.D., Ph.D. Sylvie L. Gregoire, Pharm. D. Fuqua School of Business Europe, Senior Vice President - Research, Vice President - Regulatory Affairs Duke University Biogen, Inc. Robert A. Hamm Vice President - Manufacturing Roger H. Morley 2,4 Richard A. Flavell, Ph.D. Vice President, Schiller International Professor and Chairman, University Immunobiology Section, Timothy M. Kish Co-Managing Director, R&R Inventions Ltd.; Howard Hughes Medical Institute, Vice President - Finance and Former President, American Express Co. Yale University School of Medicine; Chief Financial Officer Fellow of The Royal Society Mark W. Leuchtenberger James C. Mullen 1 Vice President - International President and Chief Operating Officer, Daniel H. Rich, Ph.D. Biogen, Inc. Professor of Medicinal Chemistry David D. Pendergast, Ph.D. and Organic Chemistry, Vice President - Product Development University of Wisconsin - Madison and Quality Assurance Sir Kenneth Murray, Ph.D. 3,5 Biogen Professor of Molecular Biology, Emeritus University of Edinburgh; Kai L. Simons, M.D., Ph.D. Fellow of The Royal Society Professor of Cell Biology European Molecular Biology Lab, Heidelberg, Germany Phillip A. Sharp, Ph.D. 2, 3 Institute Professor and Director of the McGovern Institute Thomas P. Stossel, M.D. for Brain Research, Co-Director, 1 Member of the Finance and Audit Massachusetts Institute of Technology; Nobel Division of Hematology, Committee Laureate Brigham and Women's Hospital 2 Member of the Compensation and Management Resources Committee 3 Member of the Project Share Committee Alan K. Simpson 5 Daniel I.C. Wang, Ph.D. 4 Member of the Stock and Option Plan Director of the Institute of Politics and Institute Professor of Chemical Administration Committee Visiting Lecturer, Engineering 5 Member of the Nominating Committee John F. Kennedy School of Government Massachusetts Institute of Technology Harvard University; Former U.S. Senator James W. Stevens 1, 5 Former Chairman, Prudential Asset Management Group
53 36 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 16, 2000 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 20, 2000 there were approximately 2,667 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 1999 and 1998 Boston, MA 02111 are as follows: News Releases High Low As a service to our shareholders and prospective Fiscal 1999 investors, copies of Biogen news releases issued in the - --------------------- last 12 months are now available almost immediately First Quarter 58 19/32 39 19/32 24 hours a day, seven days a week, on the Internet's Second Quarter 64 5/16 46 3/16 World Wide Web at http://www.prnewswire.com and Third Quarter 89 3/16 63 1/16 via automated fax by calling "Company News On Call" Fourth Quarter 88 1/16 64 3/8 at 1-800-758-5804, ext. 101550. Biogen news releases are usually posted on both systems within one Fiscal 1998 hour of being issued are available at no cost. First Quarter 24 27/32 16 5/8 Second Quarter 24 27/32 20 17/32 Third Quarter 34 23 1/8 Fourth Quarter 43 7/16 31 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.
54 37 Biogen, Inc. and Subsidiaries Offices Worldwide
Biogen, Inc. Biogen GmbH Biogen Limited 14 Cambridge Center Effingergasse 21 5d Roxborough Way Cambridge, MA 02142 1160 Vienna Foundation Park United States Austria Maidenhead, Berkshire SL6 2UD Tel 617 679-2000 Tel 43 1 48 44 61 3 United Kingdom Fax 617 679-2617 Fax 43 1 48 44 61 311 Tel 44 1628 501000 Fax 44 1628 501010 Biogen Europe Biogen Belgium S.A. Le Capitole Avenue de Tyras 111 55 avenue des Champs Pierreux 1120 Neder-Over-Heembeek 92012 Nanterre Belgium France Tel 33 1 41 37 95 95 Biogen Canada, Inc. Fax 33 1 41 37 24 00 3-Robert Speck Parkway Mississauga, Ontario L4Z2G5 RTP - Biogen, Inc. Canada P.O. Box 14627 Tel 1 888 456-2263 5000 Davis Drive Research Triangle Park Biogen France S.A. NC 27709-4627 Le Capitole Tel 919 941-1100 55 avenue des Champs Pierreux Fax 919 941-1112 92012 Nanterre France Biogen (Denmark) A/S Tel 33 1 41 37 95 95 Lyngbyvej 28 Fax 33 1 40 97 00 53 2100 Copenhagen Denmark Biogen GmbH Tel 45 39 16 91 91 Carl-Zeiss Ring 6 Fax 45 39 16 91 99 85737 Ismaning Germany Biogen Sweden AB Tel 49 89 99 61 70 Kanalvagen 10C/12 Fax 49 89 99 61 71 99 S-194 61 Upplands Vasby Stockholm, Sweden Biogen International B.V. Tel 46 8 590 041 70 Robijnlaan 8 Fax 46 8 590 042 02 2132 WX Hoofddorp The Netherlands Biogen Norway AS Tel 31 23 566 81 81 Karenslyst Alle 8b Fax 31 23 566 81 82 N-0277 oslo Norway Biogen Finland Oy Tel 47 23 12 06 38 Pakkalankuja 6 Fax 47 23 12 05 98 SF-0150 Vantaa Finland Tel 358 9 77 43 700 Fax 358 9 77 43 70 40
55 38 Biogen, Inc. Schedule II Valuation and Qualifying Accounts and Reserves Years Ended December 31, 1999, 1998, 1997 (in thousands)
ADDITIONS 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, 1999 $ 1,642 $ -- $ -- $ 1,642 ------------------- ------------------- ------------------- ------------------- Year Ended December 31, 1998 $ 1,645 $ -- $ 3 $ 1,642 ------------------- ------------------- ------------------- ------------------- Year Ended December 31, 1997 $ 1,480 $ 1,196 $ 1,031 $ 1,645 ------------------- ------------------- ------------------- ------------------- Sales Returns & Allowances, Discounts and Rebates 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 ------------------- ------------------- ------------------- ------------------- Year Ended December 31, 1997 $ 1,350 $ 18,387 $ 15,948 $ 3,789 ------------------- ------------------- ------------------- -------------------
39 REPORT OF INDEPENDENT ACCOUNTANTS ON FINANCIAL STATEMENT SCHEDULE To the Board of Directors of Biogen, Inc. Our audits of the consolidated financial statements referred to in our report dated January 14, 2000 appearing in the 1999 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. PricewaterhouseCoopers LLP Boston, Massachusetts January 14, 2000 EX-21 15 SUBSIDIARIES 1 EXHIBIT 21 BIOGEN, INC. Subsidiaries
Name Jurisdiction of Incorporation - ---- ----------------------------- 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 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 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 16 CONSENT OF PRICEWATERHOUSECOOPERS 1 CONSENT OF INDEPENDENT ACCOUNTANTS We hereby consent to the incorporation by reference in the Registration Statements on Form S-3, as amended (Nos. 33-14741, 33-14743, 33-20183, 33-51639, and 333-71695) and in the Registration Statements on Form S-8, as amended (Nos. 2-87550, 2-96157, 33-9827, 33-14742, 33-37312, 33-22378, 33-41077, 33-69174, 33-63013, 33-63015, 333-42887, and 333-70701) of Biogen, Inc. and its subsidiaries of our report dated January 14, 2000 appearing in the 1999 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 on the Financial Statement Schedule, which appears in this Annual Report on Form 10-K. PricewaterhouseCoopers LLP Boston, Massachusetts March 28, 2000 EX-27 17 FINANCIAL DATA SCHEDULE
5 THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE CONSOLIDATED FINANCIAL STATEMENTS OF BIOGEN, INC. AND SUBSIDIARIES FOR THE YEAR ENDED DECEMBER 31, 1999 AND IS QUALIFIED IN ITS ENTIRETY TO SUCH ANNUAL REPORT ON FORM 10K FOR THE PERIOD ENDED DECEMBER 31, 1999. 1,000 U.S. DOLLARS YEAR DEC-31-1999 JAN-01-1999 DEC-31-1999 1 56,920 597,619 139,005 1,642 40,031 910,226 351,566 111,789 1,277,973 190,270 52,073 0 0 1,507 978,023 1,277,973 620,636 794,435 96,903 111,005 367,179 0 4,639 329,016 108,566 220,450 0 0 0 220,450 1.47 1.40
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