10-K 1 b38146bge10-k.txt BIOGEN INC. 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2000 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 0-12042 BIOGEN, INC. (Exact name of Registrant as specified in its charter) Massachusetts 04-3002117 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 14 Cambridge Center, Cambridge, Massachusetts 02142 (Address of principal executive offices) (zip code) Registrant's telephone number, including area code: (617) 679-2000 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.01 par value (Title of class) Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No --- --- Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] Aggregate market value of Common Stock held by nonaffiliates of the Registrant at March 29, 2001 (excludes shares held by directors): $9,485,799,873. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, direct or indirect, to direct or cause the direction of management or policies of the Registrant, or that such person is controlled by or under common control with the Registrant. Common Stock outstanding at March 29, 2001: 150,270,097 shares. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant's definitive Proxy Statement for its 2001 Annual Meeting of Stockholders are incorporated by reference into Part III of this Report, and portions of the Registrant's 2000 Annual Report to Shareholders are incorporated by reference into Parts II and IV of this Report. 2 PART I ITEM 1 - BUSINESS OVERVIEW Biogen, Inc. ("Biogen" or the "Company") is a biopharmaceutical company principally engaged in the business of developing, manufacturing and marketing drugs for human health care. Biogen, which was founded in 1978, currently derives revenues from sales of its AVONEX(R) (Interferon beta-1a) product for the treatment of relapsing forms of multiple sclerosis and from royalties on worldwide sales by the Company's licensees of a number of products covered under patents controlled by the Company. Such products include certain forms of alpha interferon, hepatitis B vaccines and hepatitis B diagnostic test kits, among others. The Company's revenues from sales of AVONEX(R) in 2000 were approximately $761.1 million, making AVONEX(R) the worldwide market leader among multiple sclerosis therapies. The Company's royalty revenues in 2000 were approximately $165.4 million. Biogen continues to have an active development program related to AVONEX(R), and is conducting several important clinical trials of the product. In 2000, Biogen announced the results of its CHAMPS trial, begun in 1996, to study the effect of AVONEX(R) in delaying the development of clinically definite multiple sclerosis in patients who had experienced an isolated, well-defined neurologic event consistent with MS. The study showed a highly statistically significant beneficial effect of AVONEX(R) on delaying the development of clinically definite multiple sclerosis as compared to the placebo. A follow-on open label trial is ongoing. In 2000, Biogen also completed a small Phase 2 pilot study of the use of AVONEX(R) in the treatment of patients with primary progressive multiple sclerosis. In the study the patient group treated with AVONEX(R) experienced a significant reduction in the size of brain lesions seen on MRI, a measure of the extent of damage the disease has caused to the brain, as compared to the placebo group. In January 2001, Biogen announced preliminary results of a study of the use of AVONEX(R) in the treatment of patients with secondary progressive multiple sclerosis. In the study the patient group treated with AVONEX(R) showed a statistically significant reduction in the rate of disability accumulation compared to the placebo group as measured by the multiple sclerosis functional composite (MSFC) endpoint. Biogen also continues to devote significant resources to its other ongoing development efforts. In 2000, the Company completed dosing in its Phase 3 clinical studies of its AMEVIVE(TM) (alafacept) product in patients with moderate to severe chronic plaque psoriasis. Biogen anticipates that the results of these studies will be made available during the second quarter of 2001. In January 2001, the Company announced positive results from two large Phase 2 studies of the use of Antegren(R) (natalizumab) in the treatment of multiple sclerosis and Crohn's Disease. Antegren(R) is being developed in a collaboration between Biogen and Elan Corporation, plc ("Elan"). Based on the Phase 2 results, Biogen and Elan plan to proceed with Phase 3 clinical studies of Antegren(R) in both MS and Crohn's Disease in 2001. Biogen also plans to begin Phase 1 clinical trials of several products in 2001, including its small molecule adenosine A1 receptor antagonist which is being developed as a potential treatment for congestive heart failure and its soluble lymphotoxin beta receptor Ig fusion protein being developed as a potential treatment for several autoimmune diseases. 2 3 In addition to its development programs, Biogen also has many earlier-stage research programs. Biogen's research strategy is to direct its efforts toward finding therapeutics in four major research focus areas: Fibrosis, oncology, immunomodulation, and neurodegeneration. The Company believes that this focused research effort along with the leveraging of its traditional strengths in biologics research, protein chemistry and protein manufacturing will allow the Company to be in a position to capitalize on the potential of the genomics era. The Company is exploring the use of functional genomics tools and technology to find novel therapeutics through its collaborations with Eos Biotechnology, Inc., Lexicon Genetics Incorporated, MorphoSys AG, Gene Logic, Inc., Incyte Genomics, Inc. and Genetica Incorporated. AVONEX(R) (INTERFERON BETA-1A) Biogen currently markets and sells AVONEX(R) (Interferon beta-1a) for the treatment of relapsing forms of multiple sclerosis. Multiple sclerosis is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. Patients with active relapsing multiple sclerosis experience an uneven pattern of disease progression characterized by periods of stability interrupted by flareups of the disease after which the patient returns to a new baseline of functioning. AVONEX(R) is a recombinant form of a protein produced by fibroblast cells in response to viral infection. AVONEX(R) has been shown in a pivotal clinical trial both to slow the accumulation of disability and to reduce the frequency of exacerbations in patients with relapsing forms of multiple sclerosis. Biogen began selling AVONEX(R) in the United States in 1996, and in the European Union ("EU") in 1997. AVONEX(R) is on the market in over 50 countries, including Argentina, Australia, Brazil, Canada, Chile, Columbia, Cyprus, the Czech Republic, the countries of the EU, Hungary, Israel, Mexico, Norway, Slovakia, South Africa, Switzerland, Turkey and the United States. In the United States, Canada and most of the major countries of the EU, Biogen uses its own sales force to market AVONEX(R). In those countries, Biogen distributes AVONEX(R) principally through wholesale distributors of pharmaceutical products, mail order, specialty distributors or shipping service providers. In other countries, Biogen sells AVONEX(R) to distribution partners who are then responsible for most marketing and distribution activities. The Company has entered into distribution agreements covering Australia, Eastern Europe, Greece, Israel, Italy, Japan, Latin America, the Middle East, New Zealand, Portugal, South Africa, Spain and Turkey. Under most of these agreements, the distribution partners are responsible for marketing and distributing AVONEX(R). Biogen continues to have an active development program related to AVONEX(R). In February 2000, Biogen announced results of a clinical study of AVONEX(R) in patients who had experienced only one confirmed demyelinating event (multiple sclerosis-type exacerbation). The study, called the Controlled High Risk AVONEX(R) Multiple Sclerosis Prevention Study (CHAMPS), which was initiated in 1996, showed a highly statistically significant beneficial effect of AVONEX(R) in delaying the development of clinically definite multiple sclerosis compared to placebo. The CHAMPS study was stopped early following positive results. Biogen also completed in 2000 a dose comparison study, initiated in 1996, comparing the approved dosage of AVONEX(R) with a higher dose. The study confirmed that the higher dose provided no additional benefit as compared to the currently marketed 30 mcg dose, and that the two doses were equally effective in reducing disability progression in patients with relapsing/remitting MS. Biogen also completed in 2000 a small Phase 2 pilot study of AVONEX(R) 3 4 in the treatment of primary progressive multiple sclerosis. In the study, the patient group treated with AVONEX(R) experienced a significant reduction in the size of brain lesions seen on MRI as compared to the placebo group. In 2001, Biogen announced completion of a double blinded, randomized clinical study of AVONEX(R) in patients with secondary progressive multiple sclerosis. In the study, initiated in 1998, treatment with AVONEX(R) was shown to reduce the progression of disability in secondary progressive MS by 27% as compared to treatment with the placebo and as measured by the multiple sclerosis functional composite (MSFC) endpoint. Biogen is currently conducting several other clinical studies of AVONEX(R). These include: an open-label follow-up study initiated in 1995 to obtain long-term safety and antigenicity data and an open label follow-up study initiated in 2000 to study the long-term effect of AVONEX(R) on patients who participated in the CHAMPS study. Biogen is also exploring new ways to improve the formulation and delivery of AVONEX(R). In February 1999, Biogen entered into a collaborative agreement with Inhale Therapeutic Systems, Inc. under which the parties are working towards development of a dry powder formulation of AVONEX(R) for pulmonary delivery using Inhale's deep-lung delivery system. Biogen is also continuing to work towards development of a pre-filled syringe formulation of AVONEX(R). Revenues from sales of AVONEX(R) in 2000 were $761.1 million or approximately 82% of total revenues. Revenues from sales of AVONEX(R) in 1999 and 1998 were $620.6 million and $394.9 million, respectively, or approximately 78% and 71% of total revenues, respectively. Approximately 73% of AVONEX(R) sales in 2000, 71% of AVONEX(R) sales in 1999 and 77% of AVONEX(R) sales in 1998 were generated in the United States. Sales to three major wholesale distributors and a specialty distributor in the United States accounted for 18%, 13%, 12% and 11%, respectively, of total revenues in 2000. MAJOR RESEARCH AND DEVELOPMENT PROGRAMS Biogen's research is focused on biological systems and processes where its scientific expertise in molecular biology, cell biology, immunology and protein chemistry can lead to a greater understanding of disease processes and, as a result, to the creation of new pharmaceuticals. Biogen selects product candidates from its research programs to test in clinical trials, focusing its efforts on those agents which it believes have the greatest potential competitive advantages and large commercial markets. Described below are Biogen's major research programs. AMEVIVE(TM) (ALAFACEPT) Inflammation is the result of the body's immune response to infection and injury. In many autoimmune diseases, the inflammation process is directed inappropriately against the body's own tissues, causing temporary or permanent damage. Biogen has focused the efforts of its inflammation programs on developing drugs to inhibit specific cellular interactions critical to the inflammation process. Central to inflammation is the activation of T-cells, specialized white blood cells which initiate and control the immune response. One of the cellular pathways which is important for the activation of T-cells is the LFA-3/CD2 pathway. AMEVIVE(TM) (alafacept) is a recombinantly engineered protein designed to modulate immune responses by binding to the CD2 receptor. Biogen is developing AMEVIVE(TM) as a treatment for certain autoimmune diseases. In 1999, the Company completed a Phase 4 5 2b clinical study of AMEVIVE(TM) in patients with moderate to severe chronic plaque psoriasis. Based on positive data from the Phase 2b study, the Company began Phase 3 studies in North America and Europe. The Company has completed dosing of the Phase 3 studies, and expects that results of the studies will be made available in the second quarter of 2001. Psoriasis is a chronic autoimmune disease that is characterized by inflammation and thickening of the skin. An estimated 500,000 psoriasis patients in the United States have a severe enough form of the disease to need systemic therapies. Biogen also has begun initial work for clinical trials of AMEVIVE(TM) in other indications. ANTEGREN(R) (NATALIZUMAB) Antegren(R) (natalizumab) is a humanized monoclonal antibody, the first of a new class of potential therapeutics known as alpha 4 integrin inhibitors. Antegren(R) is designed to block cell adhesion to blood vessel walls and subsequent migration of white blood cells into tissue, by binding to the cell surface receptors known as alpha-4-beta-1 (VLA-4) and alpha-4-beta-7 which are found on most types of white blood cells. The migration of white blood cells into tissue is part of the body's normal response during inflammation. This inflammatory response can be severely damaging or even life threatening when it is directed against the body's own tissue in autoimmune diseases and may cause serious collateral injury in chronic immune inflammatory diseases. In August of 2000, Biogen entered into a collaborative research, development and license agreement with Elan Corporation, plc ("Elan") under which Biogen and Elan are working together to develop, manufacture and commercialize Antegren(R) worldwide. In January of 2001, Biogen and Elan announced positive results from two large Phase 2 clinical studies of Antegren(R) in multiple sclerosis and Crohn's Disease. The companies expect to initiate Phase 3 clinical studies of Antegren(R) in both of these diseases in 2001. ADENOSINE A1 RECEPTOR ANTAGONISTS In March 1997, Biogen entered into a research collaboration and license agreement with CV Therapeutics, Inc. ("CVT") pursuant to which the Company obtained rights under CVT's patents and know-how to develop and market molecules that act as highly selective antagonists of the adenosine A1 receptor. The adenosine A1 receptor is expressed principally in the heart, brain and kidney, and in the kidney mediates vasoconstriction, renal function and reabsorption of fluids. Biogen is developing small molecule adenosine A1 receptor antagonists as a potential treatment for congestive heart failure. Congestive heart failure is a chronic progressive disease that affects four to five million people in the United States. Patients with the disease experience both a chronic course as well as acute episodes of heart failure that usually require hospitalization. Reduction in kidney function and the formation of edema, or fluid retention, in lungs and extremities are significant symptoms of chronic heart failure, leading to increased morbidity, hospitalization and death. In early 2000, Biogen announced that it had successfully completed a Phase 2 study of a proof-of-concept adenosine A1 receptor antagonist molecule in patients with moderate to severe congestive heat failure. Since then, the Company has been working on the development of a possible commercial compound and anticipates commencing a Phase 1 study with the commercial compound in 2001 in both oral and intravenous forms. 5 6 LT-BETA RECEPTOR The lymphotoxin-beta receptor ("LT-Beta Receptor") pathway is involved in controlling the maintenance of proper immune interactions and the correct positioning of key cell types in the immune system. Both elements are crucial for the immune system to function properly. The LT-Beta Receptor pathway serves as a novel access point to modulate autoimmune disease. Biogen is developing its LT-Beta Receptor Ig fusion protein as a potential treatment for certain autoimmune diseases via various routes of administration and completed dosing in healthy patients for Phase 1 safety studies in March, 2001. GENE THERAPY In August 2000, the Company entered into a collaborative research agreement with Targeted Genetics Corporation, successor in interest to Genovo, Inc. ("Genovo") continuing Biogen's agreement with Genovo for the development of certain human gene therapy treatments. OTHER RESEARCH PROGRAMS Biogen's research strategy is to direct its efforts toward finding therapeutics in four major research focus areas: fibrosis, oncology, immunomodulation, and neurodegeneration. The Company believes that this focused research effort along with the leveraging of its traditional strengths in biologics research, protein chemistry and protein manufacturing will allow the Company to be in a position to capitalize on the potential of the genomics era. The Company is exploring the use of functional genomics tools and technology to find novel therapeutics through its collaborations with Eos Biotechnology, Inc., Lexicon Genetics Incorporated, MorphoSys AG, Gene Logic, Inc., Incyte Genomics, Inc. and Genetica Incorporated. As part of its further research efforts, Biogen is also exploring the use of growth factors to prevent or treat the degeneration of organs following damage and investigating new ways to modify immune responses more specifically in order to treat diseases of the immune system. RESEARCH AND DEVELOPMENT COSTS For the years ended December 31, 2000, 1999 and 1998, Biogen's research and development costs were approximately $302.8 million, $221.2 million and $177.2 million, respectively. RISKS ASSOCIATED WITH DRUG DEVELOPMENT AND COMMERCIALIZATION Certain of the statements set forth above regarding the Company's research and development programs, such as statements regarding the anticipated commencement of clinical trials of drugs in development, are forward-looking, and are based upon the Company's current belief as to the outcome and timing of such future events. These events are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. Many important factors affect the Company's ability to successfully develop and commercialize drugs, including the need to demonstrate the safety and efficacy of drug candidates at each stage of the clinical trial process, to overcome technical hurdles that may arise, to meet applicable regulatory standards, to receive required regulatory approvals, to be capable of producing drug candidates in commercial quantities at reasonable costs, to obtain and maintain all necessary patents or licenses, to compete successfully against other products, and to market products successfully. There can 6 7 be no assurance that any of the products described in this section or resulting from Biogen's research and development programs will be successfully developed, prove to be safe and efficacious at each stage of clinical trials, meet applicable regulatory standards, be capable of being produced in commercial quantities at reasonable costs, be successfully marketed or successfully meet challenges from competitive products. For a detailed discussion of the risks associated with the Company's drug development and commercialization program, see the Company's 2000 Annual Report to Shareholders --- "Management's Discussion and Analysis of Financial Condition and Results of Operations --- Outlook," which is incorporated herein by reference under Item 7 hereof. PRINCIPAL PRODUCTS BEING MARKETED OR DEVELOPED BY BIOGEN'S LICENSEES ALPHA INTERFERON Alpha interferon is a naturally occurring protein produced by normal white blood cells. Biogen has been granted patents covering the production of alpha interferon through recombinant DNA techniques. See "Patents and Other Proprietary Rights." Biogen's worldwide licensee for recombinant alpha interferon, Schering-Plough Corporation ("Schering-Plough"), first began commercial sales of its INTRON(R) A brand of alpha interferon in the United States in 1986 for hairy-cell leukemia. Schering-Plough now sells INTRON(R) A worldwide for as many as 16 indications. The United States Food and Drug Administration (the "FDA") has approved INTRON(R) A for the treatment of chronic hepatitis B and hepatitis C, hairy-cell leukemia, AIDS-related Kaposi's sarcoma, condylomata acuminata, for injection as an adjuvant treatment to surgery in patients at high risk for systemic recurrence of malignant melanoma, and for use in conjunction with anthracycline-containing combination chemotherapy for the initial treatment of patients with clinically aggressive non-Hodgkin's lymphoma. Schering-Plough also sells alpha interferon in two other forms, REBETRON(R), a combination product containing INTRON(R) A and REBETROL(R) (ribavirin, USP capsules) and PEG-INTRON(R), a pegylated form of alpha interferon recently approved by the FDA and approved in May 2000 by European Union regulatory authorities for use in the treatment of hepatitis C. Royalties from Schering-Plough on sales of INTRON(R) A accounted for approximately 10%, 13% and 16% of Biogen's revenues in 2000, 1999 and 1998, respectively. For a discussion of the length of Schering-Plough's royalty obligation to Biogen on sales of alpha interferon products and a current dispute with Schering-Plough related to royalty amounts, see "Patents and Other Proprietary Rights - Recombinant Alpha Interferon." HEPATITIS B VACCINES AND DIAGNOSTICS Hepatitis B is a blood-borne disease which causes a serious infection of the liver and substantially increases the risk of liver cancer. More than 250 million people worldwide have chronic hepatitis B virus infections. Biogen holds several important patents related to hepatitis B antigens produced by genetic engineering techniques. See "Patents and Other Proprietary Rights - Recombinant Hepatitis B Antigens." These antigens are used in recombinant hepatitis B vaccines and in diagnostic test kits used to detect hepatitis B infection. 7 8 Hepatitis B Vaccines Approximately 100 countries around the world, including the United States, have added the vaccination against hepatitis B to their routine immunization programs for all children. The United States Centers for Disease Control and the American Academy of Pediatrics have also recommended universal immunization of ten-year-old children and at-risk adolescents. The United States Occupational Safety and Health Administration has recommended that all persons with an occupational exposure to blood and other infectious material receive the hepatitis B vaccine. GlaxoSmithKline plc ("SmithKline") and Merck and Co, Inc. ("Merck") are the two major worldwide marketers of hepatitis B vaccines. Biogen has licensed to SmithKline exclusive rights under Biogen's hepatitis B patents to market hepatitis B vaccines in the major countries of the world, excluding Japan. SmithKline currently pays Biogen royalties based on sales of SmithKline's vaccine in the United States and in over 15 other countries. In 1990, SmithKline and Biogen entered into a sublicense arrangement with Merck under which Biogen currently receives royalties. Biogen has also licensed rights relating to hepatitis B vaccines under its hepatitis B patents to Merck and The Green Cross Corporation on a non-exclusive basis in Japan. Hepatitis B Diagnostics Biogen has licensed its proprietary hepatitis B rights, on an antigen-by-antigen and nonexclusive basis, to diagnostic kit manufacturers. Biogen currently has hepatitis B license or license and supply agreements for diagnostic use with more than 15 companies, including Abbott Laboratories, the major worldwide marketer of hepatitis B diagnostic kits, Ortho-Clinical Diagnostics, Organon Teknika B.V. and Roche Diagnostic Systems, Inc. For a discussion of the length of the royalty obligation of SmithKline and Merck on sales of hepatitis B vaccines and the obligation of Biogen's other licensees on sales of hepatitis B-related diagnostic products, see "Patents and Other Proprietary Rights - Recombinant Hepatitis B Antigens." OTHER PRODUCTS In 1996, Biogen granted a sublicense to Pharmacia & Upjohn AB ("Pharmacia & Upjohn") under certain patent rights to proprietary protein secretion technology exclusively licensed to Biogen by Harvard University. Under the terms of the license agreement, Biogen receives ongoing royalties on sales of Pharmacia & Upjohn's recombinant human growth hormone product, Genotropin(R), in the United States, Canada and Japan. In March 1997, Biogen granted to The Medicines Company ("TMC") exclusive worldwide rights to develop and market Biogen's bivalirudin product, a direct thrombin inhibitor now known as ANGIOMAX(TM). Biogen will receive milestone and royalty payments from TMC if TMC is successful in its efforts to develop and commercialize the drug. In December 2000, TMC received clearance from the FDA to market and sell ANGIOMAX(TM) in the United States for use as an anticoagulant in patients undergoing coronary angioplasty. TMC currently markets ANGIOMAX(TM) in New Zealand for this use. In Europe, the filing for marketing approval of ANGIOMAX(TM) is under regulatory review by the European Agency for the Evaluation of Medicinal Products. 8 9 Financial information about foreign operations and export sales is included in the Company's 2000 Annual Report to Shareholders --- Notes to Consolidated Financial Statements --- Note 11, incorporated herein by reference under Item 8 hereof. PATENTS AND OTHER PROPRIETARY RIGHTS Biogen has filed numerous patent applications in the United States and various other countries seeking protection of a number of its processes and products. Patents have been issued on many of these applications. The Company has also obtained rights to various patents and patent applications under licenses with third parties which provide for the payment of royalties by the Company. The ultimate degree of patent protection that will be afforded to biotechnology products and processes, including those of Biogen, in the United States and in other important markets remains uncertain and is dependent upon the scope of protection decided upon by the patent offices, courts and lawmakers in these countries. There is no certainty that Biogen's existing patents or others, if obtained, will afford substantial protection or commercial benefit to Biogen. Similarly, there is no assurance that the Company's pending patent applications or patent applications licensed from third parties will ultimately be granted as patents or that those patents that have been issued or are issued in the future will prevail if they are challenged in court. There has been, and Biogen expects that there may continue to be, significant litigation in the industry regarding patents and other intellectual property rights. Intellectual property litigation could therefore create uncertainty and consume substantial resources. RECOMBINANT ALPHA INTERFERON Biogen has obtained approximately 67 patents in countries around the world, including the United States and numerous other countries, covering the production of recombinant alpha interferons. Biogen has granted an exclusive worldwide license to Schering-Plough under Biogen's alpha interferon patents, and receives royalties from Schering-Plough on sales of its brands of alpha interferon, including INTRON(R) A. See "Principal Products Being Marketed or Developed by Biogen's Licensees - Alpha Interferon". Many of Biogen's alpha interferon patents have recently expired or will expire during 2001. Schering-Plough's royalty obligation to Biogen on sales of INTRON(R) A in Japan and Europe terminated upon expiration of Biogen's alpha interferon patent in such territories in January 2001, except in France and Italy where Biogen has obtained supplementary protection certificates extending the coverage in France until 2003 and in Italy until 2007. In December 1996, Schering-Plough filed suit in its own name, as Biogen's exclusive licensee, against Amgen, Inc. ("Amgen") to enforce Biogen's United States alpha interferon patent claiming it to be infringed by Amgen's consensus interferon product known as Infergen(R). In July 1998, the United States District Court for the District of Delaware construed the claims of the patent narrowly, which precluded finding Amgen's consensus interferon product to be an infringing product. Schering-Plough appealed the 1998 ruling and in a ruling by the Court of Appeals for the Federal Circuit in August 2000, the District Court's narrow claim construction was affirmed, resulting in a determination that Amgen's consensus interferon product did not infringe the Biogen patent. Schering-Plough has taken the position that as a result of the Court of Appeal's decision in the Amgen case narrowing the scope of Biogen's United States alpha interferon patent, the patent no longer covers Schering-Plough's alpha interferon product, and that, as a result, Schering-Plough no longer has an obligation to pay royalties under that patent on sales of its alpha interferon products in the United 9 10 States. Until January 2001 when Biogen's EU patent expired, Schering-Plough continued to pay royalties on sales of INTRON(R) A in the United States based on the manufacture of the product in the EU. The dispute related to the impact of the Amgen decision on Schering-Plough's royalty obligation does not affect its obligation to pay royalties on U.S. sales of its alpha interferon products after July 2002. In consideration of assignment to Schering-Plough by Biogen of a Biogen patent application claiming recombinant mature human alpha interferon, Schering-Plough has agreed to pay to Biogen certain sums on sales by Schering-Plough of alpha interferon products in the United States from the date when Biogen's existing United States alpha interferon patent expires (i.e., July 2002) until expiration of an alpha interferon patent expected to be issued to Hoffman-LaRoche Inc. ("Roche") and Genentech, Inc. ("Genentech"). The Roche/Genentech patent was the subject of a lawsuit brought by Biogen which was ultimately settled. Schering-Plough entered into an agreement with Roche as part of the settlement of the matter. Biogen is currently in discussions with Schering-Plough to work to resolve the twelve to eighteen month royalty issue and to resolve claims by Biogen related to underpayment of royalties by Schering- Plough. RECOMBINANT HEPATITIS B ANTIGENS Biogen has obtained numerous patents in countries around the world, including in the United States and in European countries, covering the recombinant production of hepatitis B surface, core and "e" antigens. Biogen has licensed its recombinant hepatitis B antigen patent rights to manufacturers and marketers of hepatitis B vaccines and diagnostic test kits, and receives royalties on sales of the vaccines and test kits by its licensees. See "Principal Products Being Marketed or Developed by Biogen's Licensees - Hepatitis B Vaccines and Diagnostics." The obligation of SmithKline and Merck to pay royalties on sales of hepatitis B vaccines and the obligation of Biogen's other licensees under its hepatitis B patents to pay royalties on sales of diagnostic products will terminate upon expiration of Biogen's hepatitis B patents in each licensed country. Biogen's existing United States hepatitis B patent will expire in 2004. Biogen's European hepatitis B patents expired at the end of 1999, except in those countries in which Biogen has obtained supplementary protection certificates. To date, Biogen has received supplementary protection certificates in Austria, Belgium, France, Great Britain, Ireland, Italy, Luxembourg, The Netherlands, Sweden and Switzerland, and has a number of granted or pending registrations of the Great Britain supplementary protection certificates in various British Territories. The additional coverage afforded by the supplementary protection certificates, or related registrations, ranges from two to eight years. RECOMBINANT BETA INTERFERON In 1997, the Technical Board of Appeal of the European Patent Office revoked Biogen's European patent covering the production of recombinant beta interferon. Biogen appealed the decision, but a recent decision in another case denied that such a right of appeal exists. Consequently, Biogen's appeal stands dismissed and the patent stands revoked. Biogen had sued InterPharm Laboratories Ltd. ("InterPharm"), an affiliate of Ares Serono, S.A. ("Serono"), and related defendants under a related Israeli patent claiming that the manufacture by InterPharm of Serono's Rebif(R) (Interferon Beta-1a) infringes Biogen's Israeli patent. In October 2000, Biogen reached a settlement with the defendants and the case was dismissed in Israel. In Germany, a patent with similar claims was the subject of a nullity proceeding instituted by Schering AG in the German Federal Patent Court. In March 1998, the German Federal Patent Court upheld the German patent but with substantially narrower claims. Biogen has appealed the decision but does not anticipate any decision until sometime during 2002. 10 11 Other parties have pending patent applications or issued patents in the United States, Europe and other countries with claims to key intermediates in the production of beta interferon (the "Taniguchi patents") and to beta interferon itself (the "Roche patents"). Biogen has obtained non-exclusive rights in various countries of the world, including the United States, Japan and most European countries, to manufacture, use and sell AVONEX(R) under the Taniguchi patents and has obtained worldwide, non-exclusive rights under the Roche patents. On July 3, 1996, Berlex Laboratories, Inc. ("Berlex") filed suit against Biogen in the United States District Court for the District of New Jersey alleging infringement by Biogen of Berlex's "McCormick" patent (U.S. Patent No. 5,376,567) in the United States in the production AVONEX(R). In November 1996, Berlex's New Jersey action was transferred to the United States District Court in Massachusetts and consolidated for pre-trial purposes with a related declaratory judgment action previously filed by Biogen. On August 18, 1998, Berlex filed a second suit against Biogen alleging infringement by Biogen of a patent which was issued to Berlex in August 1998 and which is related to the McCormick patent (U.S. Patent No. 5,795,779). On September 23, 1998, the cases were consolidated for pre-trial and trial purposes. Berlex sought a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. A hearing on the parties' summary judgment motions in the case was completed in March 2000. In September 2000, the District Court rendered final judgment in favor of Biogen and against Berlex determining that Biogen's production of AVONEX(R) did not infringe any of the claims of the Berlex patents. Berlex has appealed this decision to the Court of Appeals for the Federal Circuit, and the parties are in the process of briefing the matter for oral argument before the court. For a further discussion, see Item 3 hereof - Legal Proceedings, and the Company's 2000 Annual Report to Shareholders --- Notes to Consolidated Financial Statements --- Note 9, incorporated herein by reference under Item 8 hereof. In 1995, the Company filed an opposition with the Opposition Division of the European Patent Office opposing a European patent (the "Rentschler I Patent") issued to Dr. Rentschler Biotechnologie GmbH ("Rentschler") relating to compositions of matter of beta interferon. In 1997, the European Patent Office issued a decision revoking the Rentschler I Patent. Rentschler appealed that decision. An oral hearing on the appeal took place in December 2000. At the oral hearing in order to gain reinstatment of the patent, Rentschler narrowed the patent claims so as to claim only a specific cell line. Biogen does not use the specific cell line now claimed. On October 13, 1998, the Company filed another opposition with the Opposition Division of the European Patent Office to oppose a second European patent issued to Rentschler (the "Rentschler II Patent") with certain claims regarding compositions of matter of beta interferon with specific regard to the structure of the glycosylated molecule. The parties are in the process of filing further evidence and arguments with the European Oppositon Division. A decision on the Rentschler II Patent has not been issued to date. For a more detailed discussion, see the Company's 2000 Annual Report to Shareholders --- "Management's Discussion and Analysis of Financial Condition and Results of Operations - Legal Matters" incorporated herein by reference under Item 7 hereof. OTHER PATENTS In March 1995, Biogen filed suit in the U.S. District Court for the District of Massachusetts seeking to enjoin Amgen from manufacturing and selling its Neupogen(R) human granulocyte colony stimulating factor in the United States and asking for damages for infringing activities. Biogen believes 11 12 that to make Neupogen(R) Amgen uses technology claimed in certain of Biogen's gene expression patents. In 1998, the court interpreted the broad vector claim of one of the Biogen patents in such a way as to preclude Amgen's literal infringement of the claim. Amgen thereafter filed a motion for summary judgment based on the court's 1998 claim construction as well as a motion for a declaration of noninfringement under the doctrine of equivalents. The matter was argued to the court in November 1999 and the Court issued a decision in September 2000 allowing Amgen's motions for a declaration of noninfringement. Amgen made a motion asking the court to apply its decisions with respect to noninfringement to the remaining Biogen patents in suit and arguing that Biogen may not assert infringement under the doctrine of equivalents as a result of arguments Biogen made in obtaining the patent. On March 1, 2001, the court ruled in favor of Amgen with respect to one of the patents in the suit and ordered a hearing on Amgen's arguments with respect to the remaining patents in the suit. Biogen intends to seek reconsideration of the court's ruling. In July 1997, Biogen filed suit in the U.S. District Court for the District of Massachusetts to enjoin Amgen from manufacturing and selling its Infergen(R) consensus interferon in the United States and asking for damages for infringing activities. Biogen believes that to make Infergen(R) Amgen uses technology claimed in certain of Biogen's gene expression patents. Biogen's request to have the case consolidated with the Neupogen(R) suit was denied by the court. The case has been stayed pending resolution of the Biogen suit pertaining to Neupogen(R). In the court's March 1, 2001 decision in the Neupogen(R) suit, the court ordered a hearing on Amgen's contention that the court's ruling in the Neupogen(R) suit compels dismissal of the Infergen(R) suit. In 1994, Biogen granted Eli Lilly and Company ("Lilly") a non-exclusive license under the same patents for gene expression involved in the Amgen case. Under the license, Biogen has received royalties from Lilly since 1994 on products which use the patented vectors and methods. Based on the court's claims construction decision in the Amgen case, Lilly recently has notified Biogen that Lilly believes that it no longer owes royalties to Biogen under the agreement on any of its products. Biogen's European patent relating to gene expression was opposed by Biotechnology General Corp. in December 1993. A hearing was held by the Opposition Division of the European Patent Office in March 1996. In March 1997, the Opposition Division decided to revoke Biogen's patent. Biogen appealed the decision and a hearing is scheduled on Biogen's appeal in June 2001. Biogen successfully defended a similar opposition against issuance of a counterpart patent in Japan. THIRD-PARTY PATENTS Biogen is aware that others, including various universities and companies working in the biotechnology field, have also filed patent applications and have been granted patents in the United States and in other countries claiming subject matter potentially useful or necessary to Biogen's business. Some of those patents and patent applications claim only specific products or methods of making such products, while others claim more general processes or techniques useful or now used in the biotechnology industry. For example, Genentech has been granted patents and is prosecuting other patent applications in the United States and certain other countries which it may allege are currently used by Biogen and the rest of the biotechnology industry to produce recombinant proteins in microbial hosts. Genentech has offered to Biogen and others in the industry non-exclusive licenses under those patents and patent applications for various proteins and in various fields of use, but not for others. The ultimate scope and validity of Genentech's patents, of other existing patents, or of patents which may be granted to third parties in the future, and the extent to which Biogen may wish or be required to acquire rights 12 13 under such patents and the availability and cost of acquiring such rights, currently cannot be determined by Biogen. TRADE SECRETS AND CONFIDENTIAL KNOW-HOW Trade secrets and confidential know-how are important to Biogen's scientific and commercial success. Although Biogen seeks to protect its proprietary information by generally requiring its employees, consultants, advisors and corporate partners to sign confidentiality agreements, there can be no assurance that third parties will not either independently develop the same or similar information or obtain access to Biogen's proprietary information. COMPETITION AND MARKETING IN GENERAL Competition in the biotechnology and pharmaceutical industries is intense and comes from many and varied sources. Biogen does not believe that it or any of the other industry leaders can be considered dominant in view of the rapid technological change in the industry. Biogen experiences significant competition from specialized biotechnology firms in the United States, Europe and elsewhere and from many large pharmaceutical, chemical and other companies. Certain of these companies have substantially greater financial, marketing, research and development and human resources than Biogen. Most pharmaceutical companies have considerable experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products. Biogen believes that competition and leadership in the industry will be based on managerial and technological superiority and establishing proprietary positions through research and development. Leadership in the industry may also be influenced significantly by patents and other forms of protection of proprietary information. See "Patents and Other Proprietary Rights". A key aspect of such competition is recruiting and retaining qualified scientists and technicians. Biogen believes that it has been successful in attracting skilled and experienced scientific personnel. The achievement of a leadership position depends largely upon Biogen's continued ability to attract and retain skilled and experienced personnel, its ability to identify and exploit commercially the products resulting from research and the availability of adequate financial resources to fund facilities, equipment, personnel, clinical testing, manufacturing and marketing. Many of Biogen's competitors are working to develop products similar to those under development by Biogen. The timing of the entry of a new pharmaceutical product into the market can be an important factor in determining the product's eventual success and profitability. Early entry may have important advantages in gaining product acceptance and market share. Moreover, for certain diseases with limited patient populations, the FDA is prevented under the Orphan Drug Act, for a period of seven years, from approving more than one application for the "same" product for a single orphan drug designation, unless a later product is considered clinically superior. The EU and other jurisdictions have or are considering similar laws. Accordingly, the relative speed with which Biogen can develop products, complete the testing and approval process and supply commercial quantities of the product to the market will have an important impact on Biogen's competitive position. In addition, competition among products approved for sale may be based, among other things, on patent position, product efficacy, safety, reliability, availability and price. 13 14 AVONEX(R) (INTERFERON BETA - 1a) As a treatment for multiple sclerosis, AVONEX(R) competes with interferon beta-1b which is sold in the United States under the brand name Betaseron(R) by Berlex Laboratories, a United States affiliate of Schering AG, and is sold in Europe under the brand name Betaferon(R) by Schering AG. AVONEX(R) also faces competition from Copaxone(R) glatiramer acetate (also known as copolymer-1). In the United States, Copaxone(R) is marketed by a partnership between Teva Pharmaceutical Industries, Ltd. and Hoechst Marion Roussel, Inc. In most countries outside of the United States, AVONEX(R) also competes with Rebif(R), a recombinant interferon beta-1a product sold by Serono. In response to an application from Serono for approval of Rebif(R) in the United States for relapsing multiple sclerosis, the FDA, in March 1999, upheld its earlier ruling that, based on the data from existing clinical trials, Serono cannot market Rebif(R) in the United States for relapsing multiple sclerosis while the orphan drug status afforded to AVONEX(R) and Betaseron(R) for that indication is still in effect. AVONEX(R)'s orphan drug status for relapsing forms of the disease expires in 2003. The ruling by the FDA prompted Serono in 2000 to initiate a 12-month head-to-head study of Rebif(R) and AVONEX(R) to determine if Serono can show whether Rebif(R) is clinically superior to AVONEX(R). If positive, Serono will most likely use the results of this study in its attempts to overcome the orphan drug status of AVONEX(R) and to get Rebif(R) approved in the United States before 2003. Biogen expects Serono to release the results of the study in the third quarter of 2001. AVONEX(R) also competes in the United States with Novantrone(R) (mitoxantrone for injection) which is produced and marketed by Immunex Corporation, a majority-owned subsidiary of American Home Products Corporation. Novantrone(R) is approved for use in patients with clinically worsening forms of relapsing-remitting and secondary progressive multiple sclerosis. A number of other companies are working to develop products to treat multiple sclerosis which may in the future compete with AVONEX(R), the worldwide market leader among multiple sclerosis therapies. AVONEX(R) may also in the future face competition from off-label uses of drugs approved for other indications. Biogen believes that competition among treatments for multiple sclerosis will be based on product performance, service and price. REGULATION Biogen's current and contemplated activities and the products and processes that will result from such activities are, and will be, subject to substantial government regulation. Before new pharmaceutical products may be sold in the United States and other countries, clinical trials of the products must be conducted and the results submitted to appropriate regulatory agencies for approval. These clinical trial programs generally involve a three-phase process. Typically, in Phase 1, trials are conducted in volunteers or patients to determine the early side effect profile and, perhaps, the pattern of drug distribution and metabolism. In Phase 2, trials are conducted in groups of patients with a specific disease in order to determine appropriate dosages, expand evidence of the safety profile and, perhaps, determine preliminary efficacy. In Phase 3, large scale, comparative trials are conducted on patients with a target disease in order to generate enough data to provide the statistical proof of efficacy and safety required by national regulatory agencies. The receipt of regulatory approvals often takes a number of years, involving the expenditure of substantial resources and depends on a number of factors, including the severity of the disease in question, the availability of alternative 14 15 treatments and the risks and benefits demonstrated in clinical trials. On occasion, regulatory authorities may require larger or additional studies, leading to unanticipated delay or expense. In connection with the commercialization of products resulting from Biogen's research and development projects, it is necessary, in a number of countries, to comply with certain regulations relating to the manufacturing and marketing of such products and to the products themselves. For example, the commercial manufacturing, marketing and exporting of pharmaceutical products require the approval of the FDA in the United States and of comparable agencies in other countries. The FDA has established mandatory procedures and safety standards which apply to the manufacture, clinical testing and marketing of pharmaceutical products in the United States. The regulatory requirements and approval processes for new products in the EU operate under similar principles as those applied in the United States. The process of seeking and obtaining approval of the FDA or regulatory authorities in the EU or other regulatory authorities worldwide for a new product and licensing of the facilities in which the product is produced takes a number of years and involves the expenditure of substantial resources. In addition, the regulatory approval processes for products in the United States, the countries of the EU and other countries around the world are undergoing or may undergo changes. Biogen cannot determine what effect any changes in regulatory approval processes may have on its business. In the United States, the federal government regularly considers reforming health care coverage and costs. Resulting legislation or regulatory actions may have a significant effect on the Company's business. Biogen's ability to successfully commercialize human pharmaceutical products also may depend in part on the extent to which reimbursement for the costs of such products and related treatments will be available worldwide from government health administration authorities, private health insurers and other organizations. Currently, substantial uncertainty exists as to the reimbursement status of newly approved health care products by third-party payors. Biogen conducts relevant research in compliance with the current United States National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (the "NIH Guidelines") and all other applicable federal and state regulations. By local ordinance, Biogen is required, among other things, to comply with the NIH Guidelines in relation to its facilities in Cambridge, Massachusetts, and is required to operate pursuant to certain permits. Various laws, regulations and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import and export and use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with Biogen's research work are or may be applicable to its activities. The extent of government regulation which might result from future legislation or administrative action cannot accurately be predicted. Certain agreements entered into by Biogen involving exclusive license rights may be subject to national or supranational antitrust regulatory control, the effect of which also cannot be predicted. EMPLOYEES At December 31, 2000, Biogen employed 1,475 full-time employees worldwide, of whom 1,217 were located in the United States. Of the 1,475 employees, 424 were engaged in, or directly supported, research, including medical research, 454 were involved in, or directly supported, manufacturing, product and process development, and quality assurance/quality control, and 291 were involved in sales 15 16 and marketing. In addition, Biogen maintains consulting arrangements with a number of scientists at various universities and other research institutions in Europe and the United States, including the ten outside members of its Scientific Board. ITEM 2 - PROPERTIES Biogen's principal executive offices and a majority of its administrative, manufacturing and research and development facilities are located in Cambridge, Massachusetts. The Company owns a 150,000 square foot building in Cambridge that houses laboratories and office space. The Company also leases a total of approximately 482,987 square feet of additional office, manufacturing, and research and development space in all or part of six other buildings in Cambridge, consisting of: a 67,362 square foot building housing manufacturing facilities, laboratories and office space; a building with 65,792 square feet of space containing laboratories, purification and aseptic bottling facilities, and office space; a multi-tenant building where the Company leases approximately 156,069 square feet of office space; a 17,000 square foot building housing office space and distribution facilities; a 24,100 square foot warehouse facility; and a 152,164 square foot office building. The lease expiration dates for the leased sites range from 2002 to 2015. In February 2001, Biogen completed construction of a new 224,000 square foot facility in Cambridge primarily to house research and development and process development operations. The Company also has development options for additional property in Cambridge. In addition to its Cambridge facilities, the Company has a 100,000 square foot biologics manufacturing facility in Research Triangle Park, North Carolina. The Company uses the Research Triangle Park facility as a site for the manufacture of AVONEX(R). In 1999, the Company commenced construction of a 250,000 square foot addition to the Research Triangle Park facility to add large scale cell culture manufacturing capacity which it expects to complete in the first half of 2001. In addition, in 2000, the Company commenced construction at the Research Triangle Park location of a 150,000 square foot office and laboratory facility. Biogen financed construction of the buildings which it owns in Cambridge, Massachusetts and Research Triangle Park, North Carolina with term loans. The loans are secured by the buildings. See the Company's 2000 Annual Report to Shareholders --- "Management's Discussion and Analysis of Financial Condition and Results of Operations" incorporated herein by reference under Item 7 hereof. The Company's European headquarters consists of 4,150 square meters of office space in a multi-tenant building in Nanterre, France and the company is currently negotiating for an additional 1,500 square meters. The lease for the Nanterre space terminates in 2008 with Biogen having the right to terminate the lease earlier under specified circumstances. The Company also leases 2,250 square meters of office and manufacturing space in The Netherlands, 1,400 square meters of office space in Germany, of which 450 square meters is subleased to a third party through the second quarter of 2001, 800 square meters of office space in England, 450 square meters of office space in Denmark and small offices in Austria, Canada, Finland, Norway and Sweden. The Company believes that its production plants in Cambridge, Massachusetts and Research Triangle Park, North Carolina and existing outside sources will allow it to meet, in the near term, its production needs for products in clinical trials and AVONEX(R). Biogen believes that its existing facilities are in compliance with applicable regulatory standards. The Company expects that additional 16 17 facilities and outside sources will be required to meet the Company's future research, development and commercial production needs. ITEM 3 - LEGAL PROCEEDINGS On July 3, 1996, Berlex Laboratories, Inc. ("Berlex") filed suit against Biogen in the United States District Court for the District of New Jersey alleging infringement by Biogen of Berlex's "McCormick" patent (U.S. Patent No. 5,376,567) in the United States in the production of AVONEX(R). In November 1996, Berlex's New Jersey action was transferred to the United States District Court in Massachusetts and consolidated for pre-trial purposes with a related declaratory judgment action previously filed by Biogen. On August 18, 1998, Berlex filed a second suit against Biogen alleging infringement by Biogen of a patent which was issued to Berlex in August 1998 and which is related to the McCormick patent (U.S. Patent No. 5,795,779). On September 23, 1998, the cases were consolidated for pre-trial and trial purposes. Berlex sought a judgment granting it damages, a trebling of any damages awarded and a permanent injunction restraining Biogen from the alleged infringement. A hearing on the parties' summary judgment motions in the case was completed in March 2000. In September 2000, the District Court rendered final judgment in favor of Biogen and against Berlex determining that Biogen's production of AVONEX(R) did not infringe any of the claims of the Berlex patents. Berlex has appealed this decision with the Court of Appeals for the Federal Circuit and the parties are in the process of briefing the appeal for oral argument. An unfavorable ruling on appeal would result in the case being remanded to the District Court for trial. If Berlex were to be successful in its appeal and the case were to be remanded, an unfavorable ruling in the remanded case could have a material adverse effect on the Company's results of operations and financial position. The Company believes that the decision of the District Court that Biogen does not infringe the Berlex patents is sound, but the ultimate outcome of the appeal is not currently determinable. As a result, an estimate of any potential loss or range of loss cannot be made at this time. For a description of legal proceedings relating to certain patent rights, see Item 1 hereof, "Business - Patents and Other Proprietary Rights." ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS Not Applicable 17 18 EXECUTIVE OFFICERS OF THE REGISTRANT The following is a list of each executive officer of the Company, their respective age as of December 31, 2000 and their principal positions with the Company. Officers are elected and may be removed by the Board of Directors.
Name Age Positions ---- --- --------- James L. Vincent........... 61 Chairman of the Board of Directors James C. Mullen............ 42 President, Chief Executive Officer and Director Burt A. Adelman............ 48 Vice President - Medical Research Cornelis "Kees" Been....... 42 Vice President - Business and Market Development Thomas J. Bucknum.......... 54 Vice President - General Counsel, Secretary and Clerk Frank A. Burke, Jr......... 57 Vice President - Human Resources Nadine D. Cohen............ 51 Vice President - Regulatory Affairs Michael Gilman ............ 45 Vice President - Research Sylvie L. Gregoire......... 39 Vice President - Manufacturing Robert A. Hamm............. 49 Vice President - Sales and Marketing Peter N. Kellogg .......... 44 Vice President - Finance and Chief Financial Officer Mark W. Leuchtenberger..... 44 Vice President - International Toshio Nakata.............. 57 President - Biogen Japan, Ltd., Vice President - Japan, Asia and Oceana John W. Palmer............. 49 Vice President - Program Management David D. Pendergast........ 52 Vice President - Product Development and Quality Assurance Patrick J. Purcell......... 40 Vice President - Information Systems and Chief Information Officer
The background of these officers is as follows: James L. Vincent has been Chairman of the Board of Directors since October 1985. Mr. Vincent served as Chief Executive Officer from December 1998 to June 2000. He previously served as Chief 18 19 Executive Officer of the Company from October 1985 until February 1997. He served in the additional capacities of Chief Operating Officer and President from April 1988 until February 1994. Before joining Biogen, Mr. Vincent served as Group Vice President, Allied Corporation and as President, Allied Health & Scientific Products Company, a subsidiary of Allied Corporation. Before joining Allied Corporation, Mr. Vincent was with Abbott Laboratories, Inc. where he served in various capacities, including Executive Vice President, Chief Operating Officer and Director of the parent corporation. James C. Mullen was appointed President and Chief Executive Officer in June 2000 after serving as President and Chief Operating Officer since January 1999. He was appointed as a Director of the Company in April 1999. Mr. Mullen previously served as Vice President - International from August 1996 until January 1999, and Vice President - Operations from December 1991 until August 1996 and served as Senior Director - Operations from February 1991 to December 1991. Mr. Mullen joined the Company in 1989. Before coming to Biogen, Mr. Mullen held various positions of responsibility from 1984 through 1988 at SmithKline-Beckman Corporation (now GlaxoSmithKline plc), including Director, Engineering, SmithKline and French Laboratories, Worldwide. Burt A. Adelman, M.D. was appointed Vice President - Medical Research in January 1999 after serving as Vice President - Development Operations since August 1996. Dr. Adelman served as Vice President - Regulatory Affairs of the Company from May 1995 until August 1996. From 1991 until May 1995, Dr. Adelman was Director of Medical Research at Biogen. Dr. Adelman has served as Lecturer of Medicine at Harvard Medical School and Brigham and Women's Hospital since 1992. Cornelis "Kees" Been was appointed Vice President - Business and Market Development in August 1999. Prior to joining the Company, Mr. Been held a variety of management positions from 1996 until April 1999 with Monsanto Life Sciences, most recently as Vice President - Global Strategy. From 1988 through 1995, Mr. Been worked at Gemini Consulting, where his positions included Vice President, responsible for building Gemini's pharmaceuticals practice. Mr. Been began his career in 1983 as a Trade and Licensing Manager with Biogen, based in Geneva, Switzerland. Thomas J. Bucknum was appointed Vice President - General Counsel, Secretary and Clerk in July 1999, after serving as the Company's Chief Corporate Counsel since 1996. Prior to joining the Company, Mr. Bucknum was Senior Vice President and General Counsel of DuPont Merck Pharmaceutical Company from 1990 to 1995 with responsibility for legal, government and public affairs matters. Prior to joining DuPont Merck, Mr. Bucknum held a number of domestic and international positions with E.I. DuPont de Nemours & Company, Inc in the legal, marketing and regulatory affairs departments. Frank A. Burke, Jr., was appointed Vice President - Human Resources in May 1986 after serving for 12 years in various human resource management positions at Allied-Signal, Inc., including Director of Compensation and Employee Benefits of the Engineered Materials Sector. Nadine D. Cohen, Ph.D., was appointed Vice President - Regulatory Affairs in October 2000 after serving as Director of Regulatory Affairs since September 1999. Dr. Cohen joined Biogen in 1999 from the Massachusetts Biologics Laboratories, where she was Senior Director of Quality Control and Technical Services. Prior to that, she was Vice President of Regulatory Affairs and Quality at Alpha Beta Technology, Inc. 19 20 Michael Gilman, Ph.D., was appointed Vice President - Research in April 2000. Dr. Gilman joined Biogen in 1999 as Director, Molecular Biology from ARIAD Pharmaceuticals, Inc., where he served as Executive Vice President and Chief Scientific Officer. From 1986-1994, Dr. Gilman worked at Cold Spring Harbor Laboratory. Sylvie L. Gregoire, Pharm.D., was appointed Vice President - Manufacturing in October 2000 after serving as Vice President - Regulatory Affairs from January 1999 to October 2000. From July 1998 to January 1999, Dr. Gregoire was the Program Executive for the Company's LT-Beta Receptor program and from 1995 until July 1998, served as Director, European Regulatory Affairs of the Company. Prior to joining Biogen, Dr. Gregoire was Associate Director of European Regulatory Affairs for Merck Sharp and Dohme (Europe) Inc. from 1991 until the end of 1994. Robert A. Hamm was appointed Vice President - Sales and Marketing in October 2000 after serving as Vice President - Manufacturing from June 1999 to October 2000. Mr. Hamm served as Director, Northern Europe and Distributors of the Company from November 1996 until June 1999 and as the Company's Associate Director, Logistics from April 1994 until November 1996. From 1987 until April 1994, Mr. Hamm held a variety of management positions at Syntex Laboratories Corporation, including Director of Operations and New Product Planning, and Manager of Materials, Logistics and Contract Manufacturing. Peter N. Kellogg was appointed Vice President - Finance and Chief Financial Officer in July 2000. Mr. Kellogg joined Biogen from PepsiCo where from 1987 to 2000, he served in a variety of senior financial, international and general management positions, including Senior Vice President, PepsiCo. E-Commerce from March to July 2000. From March 1998 to March 2000, he served as Senior Vice President and Chief Financial Officer, Frito-Lay International; from November 1996 to March 1998 as Vice President and Chief Financial Officer, Frito-Lay Latin America; from March 1994 to November 1996 as Vice President and Chief Financial Officer, Central/Eastern Europe and Russia, Pepsi-Cola International; and from February 1993 through March 1994 as Vice President and General Manager-Pepsi, South Franchise Business Unit. Prior to joining PepsiCo, Mr. Kellogg was a senior consultant with Booz Allen & Hamilton and Arthur Andersen & Co. Mark W. Leuchtenberger was appointed Vice President - International in January 1999 after serving as Vice President - Sales, Marketing and Business Development since January 1998. Mr. Leuchtenberger was the Company's Vice President - Marketing and Sales from October 1996 until January 1998, Director of Distributor Operations, Europe from September 1996 until October 1996, Director of Marketing and the Program Executive for AVONEX(R) from 1993 until September 1996, a Product Manager from 1992 to 1993, and a Market Development Manager from 1990 to 1992. Prior to joining Biogen, Mr. Leuchtenberger worked for the consulting firm of Bain & Company from 1987 to 1990. Toshio Nakata was appointed President - Biogen Japan, Ltd. and Vice President - Japan, Asia and Oceana in October 2000. Mr. Nakata joined Biogen from Mitsui & Co., Ltd. where he served as: Associate Director and General Manager of the Global Environment Department, Corporate Planning Division, from January 2000 to October 2000; General Manager of New Business and Technology Development Department and Global Environment Department, Corporate Planning Division, from April 1997 to January 2000; and General Manager of Technology Planning and Development 20 21 Department and Global Environment Department, Corporate Planning Division, from May 1994 to April 1997. John W. Palmer was appointed as Vice President - Program Management in May 2000, after serving as Program Executive for Biogen's Adensoine A1 antagonist program since 1997. From 1993 until 1997, Mr. Palmer was the Company's Director of Operations, and from 1989 until 1993 served as Director of Marketing and Business Development. Prior to joining Biogen, Mr. Palmer was a Marketing and Business Development Director at General Foods Corporation. He was also previously Founder, President and Chief Operating Officer of Caribbean Emergency Medical Air Transport, Inc., a novel air ambulance service operating throughout the Caribbean market, and a managing consultant with Strategic Planning Associates in Washington, D.C. David D. Pendergast, Ph.D. was appointed Vice President - Product Development and Quality Assurance in January 1998 after serving as Vice President - Quality Assurance and Quality Control of the Company since April 1996. Dr. Pendergast joined Biogen from Fisons Pharmaceuticals, Manchester U.K. where he served as Director, Quality Assurance/Quality Control of Fisons PLC from 1992 to 1996. Prior to joining Fisons, Dr. Pendergast served, over a twenty-year period, in various capacities at The Upjohn Company, including Vice President - Quality Assurance from 1989 to 1992. Patrick J. Purcell was appointed Vice President - Information Systems and Chief Information Officer in February 2000. Mr. Purcell joins Biogen from Sprint PCS, where he worked from 1992 to 2000 in a variety of finance and information technology management capacities, most recently serving as Vice President, IT Planning, Resource & Performance Management. Prior to joining Sprint, Mr. Purcell worked at Deloitte & Touche Management Consulting from 1988 to 1992, as a consulting manager with primary focus on business and financial planning, financing and operations analysis, and change management in a variety of industries. PART II ITEM 5 - MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The section entitled "Market for Securities" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 6 - SELECTED FINANCIAL DATA The section entitled "Selected Financial Data" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 7 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 21 22 The section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations - Outlook - Market Risk" in the Company's 2000 Annual Report to Shareholders is hereby incorporated herein by reference. ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The sections entitled "Consolidated Statements of Income," "Consolidated Balance Sheets," "Consolidated Statements of Cash Flows," "Consolidated Statements of Shareholders' Equity," "Notes to Consolidated Financial Statements" and "Report of Independent Accountants" in the Company's 2000 Annual Report to Shareholders are hereby incorporated herein by reference. ITEM 9 - CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE Not Applicable PART III ITEM 10 - DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The sections entitled "Election of Directors" and "Section 16(a) Beneficial Ownership Reporting Compliance" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, are hereby incorporated herein by reference. Information concerning the Company's Executive Officers is set forth in Item 4 of Part I of this Annual Report on Form 10-K. ITEM 11 - EXECUTIVE COMPENSATION The sections entitled "Election of Directors" and "Executive Compensation" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, are hereby incorporated herein by reference. ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The section entitled "Share Ownership" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, is hereby incorporated herein by reference. ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The section entitled "Executive Compensation - Employment Arrangements with the Company and Certain Transactions" in the Company's definitive proxy statement for its 2001 Annual Meeting of Stockholders, which the Company intends to file with the Commission no later than April 30, 2001, is hereby incorporated herein by reference. 22 23 PART IV ITEM 14 - EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K (a) The following documents are filed as a part of this report: (1) The Company's Financial Statements are incorporated herein by reference from the Company's 2000 Annual Report to Shareholders attached hereto as Exhibit 13. The specific items and the locations of such items are set forth below:
Item Location ---- -------- Consolidated Statements of Income Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Statements of Income." Consolidated Balance Sheets Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Balance Sheets." Consolidated Statements of Cash Flows Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Statements of Cash Flows." Consolidated Statements of Shareholders' Equity Annual Report under the caption "Biogen, Inc. and Subsidiaries Consolidated Statements of Shareholders' Equity." Notes to Consolidated Financial Statements Annual Report under the caption "Biogen, Inc. and Subsidiaries Notes to Consolidated Financial Statements." Report of Independent Accountants Annual Report under the caption "Report of Independent Accountants."
With the exception of the portions of the Company's 2000 Annual Report to Shareholders specifically incorporated herein by reference, such report shall not be deemed filed as part of this Annual Report on Form 10-K. (2) The Company's Financial Statement Schedules, as required by Item 8 of this Form 10-K, are incorporated herein by reference from the Company's 2000 Annual Report to Shareholders attached hereto as Exhibit 13. A list of such Financial Statement Schedules is set forth below: Report of Independent Accountants on Financial Statement Schedule. Schedule II - Valuation and Qualifying Accounts and Reserves (3) Exhibits 23 24 Exhibit No. Description ----------- ----------- (3.1) Articles of Organization, as amended (m) (3.2) By-Laws, as amended (f) (4.1) Form of Common Stock Share Certificate (h) (4.2) Certificate of Designation of Series A Junior Participating Preferred Stock (d) (4.3) Rights Agreement dated as of May 8, 1989 between the Registrant and The First National Bank of Boston, as Rights Agent (d) (10.1) Independent Consulting and Project Agreement dated as of June 29, 1979 between the Registrant and Kenneth Murray (a)** (10.2) Letter Agreement dated September 11, 1998 with Kenneth Murray related to renewal of Independent Consulting Agreement (q) ** (10.3) Minute of Agreement dated February 5, 1981 among the Registrant, The University Court of the University of Edinburgh and Kenneth Murray (a)** (10.4) Independent Consulting Agreement dated as of June 29, 1979 between the Registrant and Phillip A. Sharp (a)** (10.5) Letter Agreement dated December 11, 1998 with Phillip A. Sharp related to chairmanship of Scientific Board and renewal of Independent Consulting Agreement (q)** (10.6) Project Agreement dated as of December 15, 1979 between the Registrant and Phillip A. Sharp (a)** (10.7) Share Restriction and Repurchase Agreement dated as of December 15, 1979 between the Registrant and Phillip A. Sharp (a)** (10.10) Form of Amendment dated July 1, 1988 to Independent Consulting Agreement between the Registrant and Scientific Board Members (c)** (10.11) Letter regarding employment of James L. Vincent dated September 23, 1985 (b)** (10.12) Letter agreement amending employment arrangement between the Registrant and James L. Vincent dated as of November 21, 1996 (n)** (10.13) Form of Stock Option Agreement with James L. Vincent under 1985 Non-Qualified Stock Option Plan (f)** 24 25 (10.14) Form of Stock Option Agreement with James L. Vincent under 1985 Non-Qualified Stock Option Plan (1995) (l)** (10.15) Form of Stock Option Agreement with James L. Vincent under 1985 Non-Qualified Stock Option Plan (1997) (o)** (10.17) Form of Indemnification Agreement between the Registrant and each Director and Executive Officer (c)** (10.18) Cambridge Center Lease dated October 4, 1982 between Mortimer Zuckerman, Edward H. Linde and David Barrett, as Trustees of Fourteen Cambridge Center Trust, and B. Leasing, Inc. (a) (10.19) First Amendment to Lease dated January 19, 1989, amending Cambridge Center Lease dated October 4, 1982 (f) (10.20) Second Amendment to Lease dated March 8, 1990, amending Cambridge Center Lease dated October 4, 1982 (f) (10.21) Third Amendment to Lease dated September 25, 1991, amending Cambridge Center Lease dated October 4, 1982 (f) (10.22) Fourth Amendment to Lease dated October 6, 1993, amending Cambridge Center Lease dated October 4, 1982 (o) (10.23) Fifth Amendment to Lease dated October 9, 1997, amending Cambridge Center Lease dated October 4, 1982 (o) (10.24) Lease dated October 6, 1993 between North Parcel Limited Partnership and Biogen Realty Limited Partnership (i) (10.25) 1983 Employee Stock Purchase Plan, as amended and restated through September 12, 1997 (o)** (10.26) 1982 Incentive Stock Option Plan, as amended through June 15, 2000 and restated, with form of Option Agreement (s)** (10.27) 1985 Non-Qualified Stock Option Plan, as amended through June 15, 2000 and restated (s)** (10.28) 1987 Scientific Board Stock Option Plan, as amended through June 15, 2000 and restated (s)** (10.29) Voluntary Executive Supplemental Savings Plan (k)** (10.30) Amendment No. 1 dated April 25, 1997 to Voluntary Executive Supplemental Savings Plan (o)** 25 26 (10.31) Amendment No. 2 dated March 11, 1998 to Voluntary Executive Supplemental Savings Plan (q)** (10.32) Amendment No. 3 dated September 27, 1999 to Voluntary Executive Supplemental Savings Plan (r) ** (10.33) Amendment No. 4 dated December 13, 1999 to Voluntary Executive Supplemental Savings Plan (r)** (10.34) Amended and Restated Supplemental Executive Retirement Plan (o)** (10.35) Amendment No. 1 dated September 27, 1999 to Amended and Restated Supplemental Executive Retirement Plan (r), ** (10.36) Voluntary Board of Directors Savings Plan (k)** (10.37) Amendment No. 1 dated April 25, 1997 to Voluntary Board of Directors Savings Plan (o)** (10.38) Amendment No. 2 dated March 11, 1998 to Voluntary Board of Directors Savings Plan (q)** (10.39) Amendment No. 3 dated September 27, 1999 to Voluntary Board of Directors Savings Plan (r)** (10.40) Amendment No. 4 dated December 13, 1999 to Voluntary Board of Directors Savings Plan (r)** (10.41) Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (a) (10.42) Amendatory Agreement dated May 14, 1985 to Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (b) (10.43) Amendment and Settlement Agreement dated September 29, 1988 to Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (f) (10.44) Amendment dated March 20, 1989 to Exclusive License and Development Agreement dated December 8, 1979 between the Registrant and Schering Corporation (f) (10.45) License Agreement (United States) dated March 28, 1988 between the Registrant and SmithKline Beecham Biologicals, s.a. (as successor to Smith Kline-R.I.T, s.a.) (f) (10.46) License Agreement (International) dated March 28, 1988 between the Registrant and SmithKline Beecham Biologicals, s.a. (as successor to Smith Kline-R.I.T., s.a.) (f) 26 27 (10.47) Sublicense Agreement dated as of February 15, 1990 among the Registrant, SmithKline Beecham Biologicals, s.a (as successor to SmithKline Biologicals, s.a.) and Merck and Co., Inc. (f) (10.48) Supplemental Amendment and Agreement dated as of March 1, 1994 between the Registrant and Schering Corporation (j) (10.49) Agreement and Amendment between the Registrant and Schering Corporation dated May 1, 1998 (p) (10.50) Letter agreement amending employment arrangement between the Registrant and James L. Vincent dated March 10, 2000 * ** (10.51) Letter regarding employment of James C. Mullen dated March 18, 1993 (r)** (10.52) Letter amending employment arrangement between the Registrant and James C. Mullen dated January 7, 1999 (r)** (10.53) Letter regarding employment of Burt Adelman, M.D. dated April 2, 1996 (r)** (10.54) Letter regarding employment of Mark Leuchtenberger dated November 14, 1996 (r)** (10.55) Letter agreement amending employment arrangement between the Registrant and Mark Leuchtenberger dated May 12, 1999 (r)** (10.56) Letter regarding employment of Thomas J. Bucknum, dated June 11, 1999 * ** (10.57) Letter agreement regarding employment arrangement between the Registrant and Cornelis Been, dated July 19, 1999 * ** (10.58) Letter amending employment arrangement between the Registrant and James C. Mullen, dated May 3, 2000 * ** (13) Incorporated portions of the Registrant's Financial Statements from its 2000 Annual Report to Shareholders * (21) Subsidiaries of the Registrant * (23) Consent of PricewaterhouseCoopers LLP * ------------- (a) Previously filed with the Commission as an exhibit to the Registrant's Registration Statement on Form S-1, File No. 2-81689, and incorporated herein by reference. (b) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1985, as amended, File No. 0-12042, and incorporated herein by reference. (c) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1988, File No. 0-12042, and incorporated herein by reference. 27 28 (d) Previously filed with the Commission as an exhibit to the Registrant's Registration Statement on Form 8-A, File No. 0-12042, filed May 26, 1989, and incorporated herein by reference. (e) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1991, File No. 0-12042, and incorporated herein by reference. (f) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1992, File No. 0-12042, and incorporated herein by reference. (g) Previously filed with the Commission as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1993, File No. 0-12042, and incorporated herein by reference. (h) Previously filed with the Commission as an exhibit to the Registrant's Registration Statement on Form S-3, File No. 33-51639 filed December 21, 1993, and incorporated herein by reference. (i) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1993, File No. 0-12042, and incorporated herein by reference. (j) Previously filed with the Commission as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended March 31, 1994, File No. 0-12042, and incorporated herein by reference. (k) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1994, File No. 0-12042, and incorporated herein by reference. (l) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1995, File No. 0-12042, and incorporated herein by reference. (m) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1996, File No. 0-12042, and incorporated herein by reference. (n) Previously filed with the Commission as an exhibit to an amendment to the Registrant's Annual Report on Form 10-K/A for the fiscal year ended December 31, 1996, File No. 0-12042, and incorporated herein by reference. (o) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1997, File No. 0-12042, and incorporated herein by reference. 28 29 (p) Previously filed with the Commission as an exhibit to the Registrant's Quarterly Report on Form 10-Q for the quarter ended June 30, 1998, File No. 0-12042, and incorporated herein by reference. (q) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1998, File No. 0-12042, and incorporated herein by reference. (r) Previously filed with the Commission as an exhibit to the Registrant's Annual Report on Form 10-k for the fiscal year ended December 31, 1999, File No. 0-12042, and incorporated herein by reference * Filed herewith ** Management contract or compensatory plan or arrangement (b) Reports on Form 8-K The Company did not file any reports on Form 8-K during the fourth quarter of 2000. 29 30 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. BIOGEN, INC. By: /s/ James C. Mullen ------------------------------------ James C. Mullen, President and Chief Executive Officer Dated March 30, 2001 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
SIGNATURES TITLE DATE ---------- ----- ---- /s/ James C. Mullen President, Chief Executive March 30, 2001 --------------------------- Officer and Director James C. Mullen (principal executive officer) /s/ James L. Vincent Chairman of the Board of March 30, 2001 --------------------------- Directors James L. Vincent /s/ Peter N. Kellogg Vice President - Finance and Chief March 30, 2001 --------------------------- Financial Officer (principal Peter N. Kellogg financial and accounting officer) /s/ Alan Belzer Director March 30, 2001 --------------------------- Alan Belzer /s/ Harold W. Buirkle Director March 30, 2001 --------------------------- Harold W. Buirkle /s/ Mary L. Good Director March 30, 2001 --------------------------- Mary L. Good /s/ Thomas F. Keller Director March 30, 2001 --------------------------- Thomas F. Keller /s/ Roger H. Morley Director March 30, 2001 --------------------------- Roger H. Morley /s/ Kenneth Murray Director March 30, 2001 --------------------------- Kenneth Murray
31 /s/ Phillip A. Sharp Director March 30, 2001 --------------------------- Phillip A. Sharp /s/ Alan K. Simpson Director March 30, 2001 --------------------------- Alan K. Simpson /s/ James W. Stevens Director March 30, 2001 --------------------------- James W. Stevens
32 EXHIBIT INDEX Exhibit No. Description ----------- ----------- (13) Incorporated portions of the Registrant's Financial Statements from its 1999 Annual Report to Shareholders (21) Subsidiaries of the Registrant (23) Consent of PricewaterhouseCoopers LLP (10.50) Letter agreement amending employment arrangement between the Registrant and James L. Vincent dated March 10, 2000 (10.56) Letter regarding employment of Thomas J. Bucknum, dated June 11, 1999 (10.57) Letter agreement regarding employment arrangement between the Registrant and Cornelis Been, dated July 19, 1999 (10.58) Letter amending employment arrangement between the Registrant and James C. Mullen, dated May 3, 2000