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FORM 10-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 [FEE REQUIRED]
For the fiscal year ended December 31, 1994
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 [NO FEE REQUIRED]
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 February 24, 1995: $1,339,203,910 (excludes shares held by
directors). 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 February 24, 1995: 33,176,843
shares.
Documents Incorporated by Reference
Portions of the Registrant's definitive Proxy Statement for its 1995
Annual Meeting of Stockholders are incorporated by reference into Part III
of this Report, and portions of the Registrant's 1994 Annual Report to
Shareholders are incorporated by reference into Parts II and IV of this
Report.
PART I
Item 1.
Business
Biogen, Inc. ("Biogen" or the "Company") is a
biopharmaceutical company principally engaged in the business of
developing and manufacturing drugs for human health care through
genetic engineering. Biogen currently derives revenues from a
number of products sold by licensees around the world. During
1994, Biogen's licensees generated total sales of approximately
$1.7 billion from these products. In the future, Biogen expects
to derive additional revenues from sales of proprietary products
which Biogen will market. Biogen's leading product candidate is
recombinant beta interferon, a protein being developed for use as
a therapy for multiple sclerosis. A Phase III clinical trial of
recombinant beta interferon in patients with multiple sclerosis
was completed in 1994. The Company intends to seek a license in
the United States and market approval in the countries of the
European Union for beta interferon in the first half of 1995.
Biogen focuses its research and development efforts on areas
where it has particular scientific and competitive strengths:
inflammatory diseases, respiratory diseases and certain cancers
and viruses. Biogen is conducting preclinical tests on three
anti-inflammatory product candidates from its T-cell activation,
T-cell/B-cell interaction and cell adhesion programs. These
product candidates are being tested for therapeutic uses in a
broad range of acute and chronic inflammatory and autoimmune
diseases. Biogen is also conducting preclinical tests on an
antimucolytic agent for treatment in cystic fibrosis and several
other pulmonary diseases. In addition, Biogen has earlier-stage
research programs directed toward finding therapies for renal
failure and restenosis and developing products for human gene
therapy.
Biogen Proprietary Products and Major Research 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 beta interferon product
and major research programs.
Recombinant Beta Interferon
Natural beta interferon is a protein produced by fibroblast
cells in response to viral infection. Biogen is developing
recombinant beta interferon for use as a therapy in 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. In July 1994, Biogen announced the results of a
Phase III clinical trial in the United States of recombinant beta
interferon for the treatment of multiple sclerosis. Based on the
data from the trial, which was sponsored by the National
Institutes of Health, recombinant beta interferon appeared to
slow the progression of disability and to reduce the number of
flareups of the disease in patients with active relapsing
multiple sclerosis. Biogen intends to seek a license in the
United States and market approval in the countries of the
European Union for recombinant beta interferon in the first half
of 1995. As part of its world-wide strategy to commercialize
recombinant beta interferon, Biogen transferred manufacture of
the product from its former joint venture in Europe to a
production facility in Cambridge. The Company uses a different
production process at the Cambridge facility and is conducting
bio-equivalency studies in a small number of healthy human
volunteers, comparing the drug manufactured in Europe and the
drug manufactured in Cambridge. See also "Patents and Other
Proprietary Rights."
Major Research Programs
Inflammation Program
Biogen scientists have been working to understand the
activities of white blood cells involved in the inflammation
process. Biogen has focused on two events central to
inflammation: (1) the activation of T-cells, specialized white
blood cells which initiate and control the immune response; and
(2) the adhesion of white blood cells to the endothelium (blood
vessel walls) and their migration through the endothelium into
surrounding tissues where they cause inflammation. Activation
and adhesion of white blood cells depend upon the binding of
pairs of receptor molecules which appear on the surface of white
blood cells and endothelial cells. When these pairs of receptors
bind together, their interactions create cellular "pathways" for
activation and adhesion events. Biogen has investigated several
of these cellular pathways and identified new receptors in
certain of these pathways.
Based on its research, Biogen has selected three cellular
pathways as the promising points of therapeutic intervention to
prevent inflammation: (1) the LFA-3/CD2 pathway, which activates
T-cells, (2) the VCAM-1/VLA-4 pathway, which is necessary for
the adhesion of several types of white blood cells to endothelial
cells, and (3) the CD40L/CD40 pathway, which activates B-cells
which produce antibodies. Biogen believes that products which
interrupt these pathways will block the inflammation process at
an early stage, thus preventing tissue damage more effectively
than currently available therapies. Moreover, such products
should result in selective inhibition of the immune system,
rather than the broad suppression associated with many therapies
currently available or under development. In in vitro and in
vivo experiments the product candidates from the inflammation
program have shown promising inhibitory effects. The Company
expects to commence Phase I clinical trials of at least one
product candidate from the inflammation program by 1996.
Gelsolin
Thick viscid secretions in the airways of cystic fibrosis
("CF") patients are believed to cause progressive pulmonary
destruction. A major contributor to the viscosity of CF mucus is
the release of a large amount of filamentous actin by
degenerating inflammatory cells which migrate in large numbers to
the airways of CF patients. Biogen and its collaborators believe
that severing actin filaments contaminating the CF airway mucus
may lead to clinical improvement in CF patients. Biogen is
developing a recombinant form of an actin severing agent, human
r-P gelsolin, for reducing airway obstruction in CF and several
other pulmonary diseases. The Company is presently conducting
preclinical studies of gelsolin product candidates.
Other Research Programs
As part of its further research efforts, Biogen is
investigating the use of growth factors to prevent or treat the
degeneration of the kidney which results from renal failure,
methods of preventing restenosis and various human gene
therapies.
Research Costs
During 1994, 1993 and 1992, Biogen's research and
development costs were approximately $91.2 million, $79.3 million
and $60.4 million, respectively.
There can be no assurance that any of the products described
above or resulting from Biogen's research 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 or be successfully marketed.
Principal Products Being Marketed or Developed by Biogen
Licensees
Intron A Alpha Interferon
Alpha interferon is a naturally occurring protein produced
by normal white blood cells. Biogen has been granted patents in
the United States and in Europe covering the production of alpha
interferons through recombinant DNA techniques and has
applications pending in numerous other countries. 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
A brand of alpha interferon in the United States in 1986 for
hairy-cell leukemia. Schering-Plough now sells Intron A in more
than 60 countries for more than 16 indications, including
hepatitis B, hepatitis C, genital warts and Kaposi's sarcoma.
Sales of Intron A by Schering-Plough were $426 million in
1994, the majority of which were generated outside the United
States. Currently the largest market for Intron A is in Japan
for the treatment of hepatitis C. In 1994, Japan instituted a
17% government-mandated decrease in the price of alpha interferon
and imposed restrictions on off-label use. The United States Food
and Drug Administration ("FDA") has approved Intron A for the
treatment of hepatitis B and hepatitis C in the United States.
Schering-Plough has undertaken studies using Intron A for a
number of additional indications. These include late phase
studies of Intron A for the treatment of chronic myelogenous
leukemia, bladder cancer, non-Hodgkin's lymphoma, malignant
melanoma, and head and neck cancer, and earlier phase trials for
Crohn's disease and as a therapy for patients with HIV infection.
Royalties from Schering-Plough accounted for approximately 40% of
Biogen's revenues (excluding interest) in 1994.
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." These antigens are used in recombinant
hepatitis B vaccines and in diagnostic test kits used to detect
hepatitis B infection. In total, sales of hepatitis B vaccines
and diagnostic products by Biogen licensees exceeded $1.0 billion
in 1994.
Hepatitis B Vaccines
At least 20 countries around the world, including the United
States, recommend vaccination against hepatitis B for all
infants. 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.
In 1994, France instituted a vaccination program for infants and
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
& 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's vaccine is approved in the United
States and in over 60 other countries. In 1990, SmithKline and
Biogen entered into a sublicense arrangement with Merck under
which Biogen currently receives royalties. Royalties from
SmithKline and Merck together accounted for approximately 42% of
Biogen's revenues (excluding interest) in 1994. Biogen has also
licensed rights under its hepatitis B patents to Merck and The
Green Cross Corporation non-exclusively in Japan.
In 1994, the English Chancery Court upheld the favorable
decision received by SmithKline in a foreign arbitration with
Biogen regarding the rate of royalties payable under the
agreement between the parties governing non-U.S. sales of
hepatitis B vaccines by SmithKline. As a result, Biogen made a
payment of $2.6 million to SmithKline in 1994. In 1993,
SmithKline initiated arbitration in the United States regarding
similar royalty provisions in a separate agreement governing
sales of hepatitis B vaccines by SmithKline in the United States.
The Company believes that a decision in the United States
similar to the foreign arbitration decision is not probable.
Hepatitis B Diagnostics
Biogen has licensed its proprietary hepatitis B rights
non-exclusively, on an antigen-by-antigen basis, to diagnostic
kit manufacturers. Biogen currently has hepatitis B license or
supply agreements for diagnostic use with more than a dozen
companies, including Abbott Laboratories, the major worldwide
marketer of hepatitis B diagnostic kits, Ortho Diagnostic
Systems, Inc., Roche Diagnostic Systems, Inc. and Organon Teknika
B.V.
Gamma Interferon
Gamma interferon is a protein produced by cells of the
immune system. Biogen developed a recombinant gamma interferon
for Biogen Medical Products Limited Partnership ("BMPLP") under a
development agreement with BMPLP. In Japan, Biogen's licensee,
Shionogi & Co., Ltd. ("Shionogi"), markets recombinant gamma
interferon under the trademark Imunomax -Gamma for renal cell
carcinoma. Biogen supplies Shionogi with its clinical and
commercial needs for recombinant gamma interferon. In general,
gamma interferon has experienced disappointing results in
clinical trials for tested indications.
Other Products
During the first quarter of 1994, Biogen entered into a
license agreement with Eli Lilly and Company ("Lilly") under
which Biogen 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. Upon execution of the
license agreement, Lilly paid Biogen approximately $10 million in
royalties related to sales which occurred prior to 1994.
Hirulog Thrombin Inhibitor
In October 1994, Biogen decided to discontinue its major
activities associated with development of its Hirulog thrombin
inhibitor, based on the results of the Phase III trial of
Hirulog in angioplasty. Although positive efficacy benefits
were seen in selected patient populations, the trial results
failed to demonstrate a significant positive effect, compared to
the heparin control, on the primary efficacy end- point in the
overall patient population. Hirulog appeared to demonstrate
efficacy equivalent to the heparin control, although patients
treated with Hirulog had a more than 50% lower incidence of
major bleeding complications. Biogen is seeking a marketing
partner for Hirulog .
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, and patents have issued on a
number of these applications. Issues remain as to the ultimate
degree of protection that will be afforded to Biogen by such
patents. There is no certainty that these patents or others, if
obtained, will be of substantial protection or commercial benefit
to Biogen. Furthermore, it is not known to what extent Biogen's
other pending patent applications will ultimately be granted as
patents or whether those patents that have been issued will
prevail if they are challenged in litigation.
Trade secrets and confidential know-how are important to
Biogen's scientific and commercial success. Although Biogen
seeks to protect its proprietary information, there can be no
assurance that others will not either develop independently the
same or similar information or obtain access to Biogen's
proprietary information.
Recombinant Alpha Interferon
Biogen has more than 50 patents in countries around the
world, including the United States and countries of the European
Patent Office, covering the production of recombinant alpha
interferons. Biogen continues to seek related patents in the
United States and other countries.
Four infringement suits have been filed in Biogen's name to
enforce its non-US alpha interferon patents. The first suit was
filed in Vienna, Austria against Boehringer Ingelheim Zentrale
GmbH ("BI") and two of its subsidiaries. The Austrian Court has
stayed Biogen's infringement case pending a decision by the
Austrian Patent Office on BI's petition to revoke Biogen's
European (Austrian) patent on grounds peculiar to Austrian law.
Biogen expects an initial decision from the Austrian Patent
Office in mid 1995. A final decision is unlikely before early
1996. The second suit was filed in Dusseldorf, Germany against
Dr. Karl Thomae GmbH and two other BI companies. The German
trial and appeal courts ruled in favor of Biogen and have
enjoined Thomae from the further manufacture, use or sale of
recombinant alpha-2(c) interferon. The third suit was filed in
Warsaw, Poland against Boehringer Ingelheim Pharma GmbH ("BI
Pharma"). Biogen expects a trial in early 1996 in Poland. The
fourth suit was filed in June 1994 in Tokyo, Japan against Amgen
Limited. The suit seeks to enjoin Amgen from its clinical
testing and planned commercialization of consensus interferon.
Biogen does not expect a decision in this case before 1997.
Recombinant Hepatitis B Antigens
Biogen has more than 75 patents in countries around the
world, including three in the United States and two in countries
of the European Patent Office, and several patent applications,
covering the recombinant production of hepatitis B surface, core
and "e" antigens. Biogen continues to seek related patents in
the United States and other countries.
Biogen's first European hepatitis B patent was opposed by
five companies. The Opposition Division of the European Patent
Office maintained the patent over those oppositions. Two of the
opponents appealed the Opposition Division's decision to the
Technical Board of Appeal, which is the final arbiter of European
oppositions. In June 1994, the Technical Board maintained
Biogen's patent in amended form.
Biogen's second European hepatitis B patent was opposed by
four companies. In 1992, the Opposition Division held that
Biogen's second European hepatitis B patent lacked inventive
step. Biogen appealed this decision to the Technical Board of
Appeal. In July 1994, the Technical Board reversed the
Opposition Division and maintained the Biogen patent.
Biogen has filed three infringement suits to enforce its
hepatitis B patents, in England against Medeva plc ("Medeva"), in
Israel against Bio-Technology General (Israel) Ltd. ("BTG"), and
in Singapore against Scitech Medical Products Pte Ltd. and
Scitech Genetics Pte Ltd. The action against Medeva seeks to
enjoin Medeva's planned production and distribution of a
hepatitis B vaccine. In November 1993, the United Kingdom High
Court of Justice ruled in favor of Biogen and enjoined Medeva
from infringement of one of Biogen's European (UK) patents. The
Court then stayed the injunction pending Medeva's appeal. In
October 1994, the United Kingdom Court of Appeal reversed the
High Court and held the Biogen patent to be invalid. Biogen has
received provisional leave from the United Kingdom House of Lords
to appeal this decision. If the House of Lords withdraws the
leave to appeal or does not reverse the decision of the Court of
Appeal and hold the Biogen patent valid and infringed, the Biogen
hepatitis B patent will no longer be enforceable in the United
Kingdom or in any of the various United Kingdom patent
registration countries. In 1992, BTG brought an action against
Biogen seeking a compulsory license under Biogen's Israeli
hepatitis B patent and Biogen filed an infringement suit against
BTG, seeking to enjoin BTG's planned production, sale and
distribution of hepatitis B vaccine. Both cases are continuing
in Israel. In 1993, Biogen sued Scitech Products and Scitech
Genetics in Singapore. Since Singapore is a United Kingdom
patent registration country, Biogen's continued prosecution of
this case depends on a favorable outcome in the United Kingdom
House of Lords on Biogen's appeal of the decision holding
Biogen's European (UK) patent invalid.
Recombinant Beta Interferon
The European Patent Office and certain countries have
granted patents to Biogen covering the recombinant production of
beta interferon. In other countries, including the United
States, Biogen has filed patent applications and continues to
seek patents covering the recombinant production of beta
interferon and related technology.
Biogen's European patent was opposed by one company. In
December 1993, the European Patent Office's Opposition Division
dismissed the opposition and maintained Biogen's patent. The
opponent appealed this decision to the Technical Board of Appeal.
Biogen expects a decision on the appeal in early 1996. In the
United States, Biogen's claims to key intermediates in the
recombinant production of beta interferon were involved in an
interference to determine who was the first to invent those
intermediates in the United States. Priority of invention was
awarded to another party in the interference. Biogen's pending
United States claims to the production of recombinant beta
interferon were not part of that interference. Prosecution of
these claims continues.
Other parties have also filed patent applications in various
countries covering the recombinant production of beta interferon,
and, in particular, key intermediates in that production, as well
as beta interferon itself. One such party has been granted
several patents in the European Patent Office and in certain
countries on these key intermediates. The same party was awarded
priority to those intermediates in the United States
interference. Biogen has obtained non-exclusive rights to
manufacture, use and sell recombinant beta interferon under these
patents in various countries of the world, including the United
States, Japan and most European countries. Another party has
been granted various patents in the United States and in other
countries on beta interferon itself. Biogen has obtained
worldwide, non-exclusive rights under these patents to make, use
and sell recombinant beta interferon. Two other patents issued
in 1994 to competitors of Biogen with claims related to beta
interferon; one in the United States and one in the European
Patent Office. With respect to the United States patent, Biogen
believes there are substantial issues of validity, enforceability
and scope of claims. With respect to the European patent, Biogen
has been aware of it for many years and believes that it has no
applicability to Biogen's recombinant beta interferon product.
Biogen does not believe that either patent will prevent its
commercialization of recombinant beta interferon for the
treatment of multiple sclerosis.
Recombinant Gamma Interferon
In 1988 and 1990, Genentech, Inc. ("Genentech") was granted
several patents in the United States and Europe claiming
recombinant gamma interferon and intermediates and methods for
the production of recombinant gamma interferon. In January
1990, Genentech and Biogen and BMPLP entered into a cross-license
agreement under which Genentech and Biogen/BMPLP each licensed to
the other its United States patent rights relating to certain
gamma interferons and their intermediates and processes of
production for certain fields of use. At the same time, Biogen
granted Genentech a non-exclusive worldwide sublicense for
certain proteins under certain of its licensed process patents
relating to the secretion of proteins. Biogen opposed the
Genentech European gamma interferon patent in the European Patent
Office. The European Patent Office maintained the Genentech
patent in a decision that cannot be appealed.
Other Patents
In January 1994, Biogen filed suit in Osaka, Japan, against
Sumitomo Pharmaceutical Co., Ltd. ("Sumitomo"). The suit seeks
to enjoin Sumitomo from importing and selling its recombinant
human growth hormone products in Japan. Biogen believes that
these products are made by a process that infringes certain of
its licensed patents relating to the secretion of proteins.
Biogen does not expect a decision in the case until 1997.
In January 1994, Biogen granted Eli Lilly and Company
("Lilly") a non-exclusive license under certain of Biogen's
patents for gene expression. Lilly uses the patented vectors and
methods in several products that are on the market or in
development.
Third Party Patents
Biogen is aware that others, including various universities
and companies working in biotechnology, 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
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.
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 these 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, 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.
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.
Competition and Marketing
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 and
human resources than Biogen. The pharmaceutical companies have
considerable experience in undertaking clinical trials and in
obtaining regulatory approval to market pharmaceutical products.
In addition, certain of Biogen's products may be subject to
competition from products developed using alternatives to
biotechnology techniques.
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 such a position depends upon Biogen's
ability to attract and retain skilled and experienced personnel,
its ability to identify and exploit commercially the products
resulting from biotechnology 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. 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 is expected to 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.
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 I, 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 II, 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 III, 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 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 process of seeking and obtaining FDA approval for a new
product and the facilities in which it can be produced is likely
to take a number of years and involve the expenditure of
substantial resources. In addition, the regulatory approval
processes for products in the United States, Canada and Europe
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 commercialize
successfully 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 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's policy is to conduct 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 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. These include, among
others, the United States Atomic Energy Act, the Clean Air Act,
the Clean Water Act, the Occupational Safety and Health Act, the
National Environmental Policy Act, the Toxic Substances Control
Act and the Resource Conservation and Recovery Act, national
restrictions on technology transfer and import, export and
customs regulations. 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 January 1, 1995, Biogen employed 433 full-time employees,
of whom 78 held Ph.D. and/or M.D. degrees. Of the 433 employees,
169 were engaged in, or directly supported, research and
development and 128 were involved in, or directly supported,
manufacturing, quality assurance/quality control, regulatory,
medical operations and preclinical and clinical development.
Biogen maintains consulting arrangements with a number of
scientists at various universities and other research
institutions in Europe and the United States, including the eight
outside members of its Scientific Board.
Item 2.
Properties
Substantially all of Biogen's facilities are located in
Cambridge, Massachusetts, where the Company leases a total of
approximately 220,000 square feet of office and research and
development space in all or part of five buildings. Most of the
Company's operations are contained in a 67,000 square foot
building housing a pilot production plant, laboratories and
office space, in a building with 64,000 square feet of space
containing laboratories, purification and aseptic bottling
facilities and office space, in a multitenant building where the
Company occupies approximately 54,000 square feet of office space
and in a 17,000 square foot building designed for specialized
research laboratories. The leases for these sites terminate in
1998 (with the right to renew), 2004, 1998 (with the right to
renew) and 2004, respectively.
In 1993, the Company began construction of a 150,000 square
foot building in Cambridge, Massachusetts which will house
laboratories and office space. The anticipated cost of
construction, including the land, is approximately $36 million.
Upon completion of the building, the Company has the option,
subject to certain conditions, to obtain a secured term loan with
a bank for up to $25 million for a period of up to ten years.
The building is scheduled for completion in 1995.
In 1994, the Company opened its European headquarters which
consists of 1,450 square meters of office space in a multitenant
building in Nanterre, France. The lease for this space
terminates in 2003.
The Company believes that its pilot production plant in
Cambridge, Massachusetts and existing outside sources will allow
it to meet its production needs for clinical trials and its
initial commercial production needs for its beta interferon
product. Biogen believes that the facilities are in compliance
with appropriate regulatory standards. The Company expects that
additional facilities and outside sources will be required to
meet the Company's future research and production needs.
Item 3.
Legal Proceedings
During the fourth quarter of 1994, a total of six class
action lawsuits were initiated against the Company and several of
its directors and officers. On March 3, 1995, these cases were
consolidated into a single proceeding in the United States
District Court for the District of Massachusetts. The lawsuits
generally allege that the Company and the named directors and
officers violated federal securities laws in connection with the
Company's public disclosures, including disclosures relating to
its Hirulog thrombin inhibitor and other disclosures made in
connection with patent matters related to beta interferon. The
plaintiffs seek damages in unspecified amounts.
For a description of legal proceedings relating to patent
rights, see Item 1, "Business-Patents and Other Proprietary
Rights."
Item 4.
Submission of Matters to a Vote of Security Holders
None
Executive Officers
The following is a list of the executive officers of the
Company and their principal positions with the Company. Each
individual officer serves at the pleasure of the Board of
Directors.
Name Age Positions
James L. Vincent 55 Chairman of the Board of Directors,
Chief Executive Officer
James R. Tobin 50 President and Chief Operating Officer
Michael J. Astrue 38 VicePresident-GeneralCounsel,Secretary
andClerk
Kenneth M. Bate 44 Vice President - Marketing and Sales
Frank A. Burke, Jr. 51 Vice President - Human Resources
Lawrence S. Daniels 52 Vice President - Strategic Planning
Joseph M. Davie 55 Vice President - Research
Irving H. Fox. 51 Vice President - Medical Affairs
Timothy M. Kish 43 Vice President - Finance, Chief
Financial Officer and Treasurer
James C. Mullen 36 Vice President - Operations
R. Maurice Powell, Jr.39 Vice President - QA/QC
Irvin D. Smith 62 Vice President - Development Operations
The background of these officers is as follows:
James L. Vincent joined the Company as its Chief Executive
Officer in October 1985. He also served as Chief Operating
Officer and President from April 1988 until February 1994. He is
also Chairman of the Board of Directors of the Company. 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. Mr. Vincent is, in addition,
on the Board of Trustees of Duke University and the Board of
Trustees of the University of Pennsylvania, as well as a member
of the Board of Overseers of Wharton Graduate Business School of
the University of Pennsylvania.
James R. Tobin joined the Company as its President and Chief
Operating Officer in February 1994. Prior to joining the
Company, Mr. Tobin served in various capacities at Baxter
International, including Executive Vice President from 1988 until
1992 and President and Chief Operating Officer from 1992 until
1993. Mr. Tobin is a director of Creative BioMolecules, Inc. and
Medisense Inc.
Michael J. Astrue was appointed Vice President - General
Counsel, Secretary and Clerk of the Company in June 1993. Prior
to joining the Company, Mr. Astrue was a partner in the Boston
law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
and a managing director of its wholly-owned consulting firm, ML
Strategies, from November 1992 to June 1993. From June 1989
through November 1992, Mr. Astrue served as General Counsel of
the United States Department of Health and Human Services. From
April 1988 through June 1989, Mr. Astrue served as Associate
Counsel to the President of the United States.
Kenneth M. Bate was appointed Vice President - Marketing and
Sales in August 1993 after serving as Vice President - Finance
and Chief Financial Officer since August 1990 and as Treasurer of
the Company since December 1991. From 1978 until 1990, Mr. Bate
was employed by Peter Kiewit & Sons, Inc. and its subsidiaries in
various financial capacities, most recently as Vice President -
Treasurer.
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.
Lawrence S. Daniels was appointed Vice President - Strategic
Planning of the Company in August 1993 after serving as Vice
President - Marketing and Business Development since November
1991. Prior to joining the Company, Mr. Daniels served for nine
years in planning and administrative functions for Allied-Signal,
Inc., most recently as Vice President, Corporate Strategy
Development.
Joseph M. Davie, M.D., Ph.D. was appointed Vice President -
Research of the Company in 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.
Irving H. Fox, M.D. was appointed Vice President - Medical
Affairs in February 1990. Dr. Fox joined Biogen following a
14-year career at the University of Michigan, where he held
professorships in internal medicine and biological chemistry, and
from 1978 to 1990, was program director of the Clinical Research
Center at the University of Michigan Hospital.
Timothy M. Kish was appointed Vice President - Finance,
Treasurer and Chief Financial Officer of the Company 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.
James C. Mullen became Biogen's Vice President - Operations
in December 1991 after serving as Senior Director - Operations
since February 1991. Mr. Mullen joined the Company in 1989 as
Director - Facilities and Engineering and then served as Acting
Director - Manufacturing and Engineering. Before coming to
Biogen, Mr. Mullen held various positions of responsibility from
1984 through 1988 at SmithKline-Beckman Corporation, most
recently as Director, Engineering - SmithKline and French
Laboratories, Worldwide.
R. Maurice Powell, Jr. was appointed Vice President-QA/QC in
November 1994. Prior to joining Biogen, Mr. Powell served in
various capacities from 1978 to 1994 at Baxter Healthcare
Corporation, most recently as Vice President of Manufacturing,
Quality and Regulatory Management from 1993 to 1994 and Vice
President of Regulatory Affairs and Quality Assurance from 1992
to 1993.
Irvin D. Smith, Ph.D. was appointed Vice President - Quality
Assurance/Quality Control and Drug Development in August 1993
after serving as General Manager of Bioferon, Biogen's former
joint venture in Germany, since July 1991. The name of his
position was changed to Vice President-Development Operations in
1994. Dr. Smith was a private consultant from March 1990 to July
1991 and President and Chief Executive Officer of Applied
BioSystems from October 1987 to March 1990.
PART II
Item 5.
Market for Registrant's Common Equity and Related Stockholder
Matters
The section entitled "Market for Securities" in the
Company's 1994 Annual Report to Shareholders is hereby
incorporated by reference.
Item 6.
Selected Financial Data
The section entitled "Selected Financial Data" in the
Company's 1994 Annual Report to Shareholders is hereby
incorporated 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 1994 Annual Report to Shareholders is hereby
incorporated by reference.
Item 8.
Financial Statements and Supplementary Data
The sections entitled "Consolidated Balance Sheets,"
"Consolidated Statements of Income," "Consolidated Statements of
Cash Flows," "Consolidated Statements of Shareholders' Equity,"
"Notes to Consolidated Financial Statements" and "Report of
Independent Accountants" in the Company's 1994 Annual Report to
Shareholders are hereby incorporated 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, Promoters and
Control Persons
Directors
The sections entitled "Election of Directors" and "Trading
Reports" in the Company's definitive proxy statement for its 1995
Annual Meeting of Stockholders, which the Company intends to file
with the Commission no later than April 30, 1995, are hereby
incorporated by reference.
Executive Officers
Information concerning the Company's Executive Officers is
set forth in Part I of this Annual Report on Form 10-K.
Item 11.
Executive Compensation
The sections entitled "Election of Directors", "Executive
Compensation", "Joint Report on Compensation Philosophy" and
"Performance Graph" in the Company's definitive proxy statement
for its 1995 Annual Meeting of Stockholders, which the Company
intends to file with the Commission no later than April 30, 1995,
are hereby incorporated 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 1995 Annual Meeting of
Stockholders, which the Company intends to file with the
Commission no later than April 30, 1995, is hereby incorporated
by reference.
Item 13.
Certain Relationships and Related Transactions
The section entitled "Employment Arrangements with the
Company and Certain Transactions" in the Company's definitive
proxy statement for its 1995 Annual Meeting of Stockholders,
which the Company intends to file with the Commission no later
than April 30, 1995, is hereby incorporated by reference.
PART IV
Item 14.
Exhibits, Financial Statement Schedules and Reports on Form 8-K.
(a) Financial Statements and Financial Statement Schedules.
The following documents are filed as a part of this report:
1. Financial Statements, as required by Item 8 of this Form,
incorporated by reference herein from the 1994 Annual Report to
Shareholders attached hereto as Exhibit 13:
Item Location
Consolidated Balance Sheets Annual Report under the
caption "Biogen, Inc. and
Subsidiaries Consolidated
Balance Sheets."
Consolidated Statements of Income Annual Report under the
caption "Biogen, Inc. and
Subsidiaries Consolidated
Statements of Income."
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."
Reports of Independent Accountants Annual Report under the
caption "Report of Independent
Accountants."
With the exception of the portions of the 1994 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) Financial Statement Schedules: None
(3) Exhibits
Exhibit No. Description
(3.1) Articles of Organization, as amended (g)
(3.2) By-Laws, as amended (k)
(4.1) Form of Common Stock Share Certificate (m)
(4.2) Certificate of Designation of Series A Junior
Participating Preferred Stock (f)
(4.3) Rights Agreement dated as of May 8, 1989 between
Registrant and The First National Bank of Boston, as
Rights Agent (f)
(10.1) Independent Consulting and Project Agreement dated as
of June 29, 1979 between Registrant and Kenneth Murray
(a)**
(10.2) Letter Agreement dated March 12, 1993 with Dr. Kenneth
Murray relating to renewal of Independent Consulting
Agreement (k)**
(10.3) Minute of Agreement dated February 5, 1981 among
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 Registrant and Phillip A. Sharp (a)**
(10.5) Letter Agreement dated December 10, 1992 with Phillip
Sharp relating to chairmanship of Scientific Board and
renewal of Independent Consulting Agreement (k)**
(10.6) Project Agreement dated as of December 14, 1979 between
Registrant and Phillip A. Sharp (a)**
(10.7) Share Restriction and Repurchase Agreement dated as of
December 15, 1979 between Registrant and Phillip A.
Sharp (a)**
(10.8) Consulting Agreement dated as of April 1, 1991, as
amended, between Registrant and Alexander G. Bearn
(i)**
(10.9) Form of Amendment dated July 1, 1988 to Independent
Consulting Agreement between Registrant and Scientific
Board Members (e)**
(10.10) Form of Extension of Independent Consulting Agreement
between Registrant and Scientific Board Members (g)**
(10.11) Form of Share Purchase Agreement between Registrant and
Scientific Board Members (a)**
(10.12) Form of Stock Option Agreement between Registrant and
each of Alan Belzer, Harold W. Buirkle, James W.
Stevens and Roger H. Morley (c)**
(10.13) Letter regarding employment of James L. Vincent dated
September 23, 1985 (b)**
(10.14) Form of Stock Option Agreement with James L. Vincent
under 1985 Non-Qualified Stock Option Plan (k)**
(10.15) Letter dated December 13, 1989 regarding employment of
Dr. Irving H. Fox (h)**
(10.16) Letter dated August 13, 1990 regarding employment of
Mr. Kenneth M. Bate (i)**
(10.17) Letter dated October 23, 1991 regarding employment of
Mr. Lawrence S. Daniels (k)**
(10.18) Letter dated April 7, 1993 regarding employment of Dr.
Joseph M. Davie (l)**
(10.19) Letter dated January 12, 1994 regarding employment of
James R. Tobin (n)**
(10.20) Letter dated August 30, 1993 regarding employment of
Irvin D. Smith, Ph.D. (n)**
(10.21) Form of Indemnification Agreement between Registrant
and each Director and Executive Officer (e)**
(10.22) Second Amended and Restated Agreement and Certificate
of Limited Partnership dated as of May 15, 1984 among
Biogen Medical Products, Inc. as General Partner and
certain limited partners (g)
(10.23) First Amendment dated December 22, 1986 to Agreement
and Certificate of Limited Partnership (c)
(10.24) Technology License Agreement dated May 15, 1984 between
Biogen B.V. and Biogen Medical Products Limited
Partnership (g)
(10.25) Development Contract dated May 15, 1984 between Biogen
B.V. and Biogen Medical Products Limited Partnership
(g)
(10.26) Amendment dated December 22, 1986 to Development
Contract (c)
(10.27) Amendment dated January 1, 1987 to Development Contract
(d)
(10.28) Extension Agreement dated October 10, 1989 relating to
Development Contract (g)
(10.29) Extension Agreement dated December 31, 1993 relating to
Development Contract (n)
(10.30) Extension Agreement dated December 31, 1994 relating to
Development Contract *
(10.31) Joint Venture Option Agreement dated May 15, 1984
between Biogen Inc. and Biogen Medical Products Limited
Partnership (g)
(10.32) Purchase Option Agreement dated May 15, 1984 between
Biogen B.V. and the limited partners of Biogen Medical
Products Limited Partnership (g)
(10.33) Guaranty dated May 15, 1984 to Biogen Medical Products
Limited Partnership by Registrant guaranteeing certain
obligations of Biogen Medical Products, Inc., Biogen
B.V. and Biogen Inc. to the Partnership (g)
(10.34) Demand Loan Agreement dated October 1, 1989 between
Biogen Medical Products Limited Partnership and Biogen
Medical Products, Inc. (g)
(10.35) Standard Form Commercial Lease dated January 29, 1981
between Ira C. Foss and Ira C. Foss, Jr., as Trustees
of Eastern Realty Trust, and B. Leasing, Inc. (g)
(10.36) Letter of May 24, 1989 exercising option under Standard
Form Commercial Lease dated January 29, 1981 (g)
(10.37) Lease Extension Agreement dated February 20, 1990
between Eastern Realty Trust and Registrant (g)
(10.38) Standard Form Commercial Lease dated June 1, 1989
between Eastern Realty Trust and Registrant (g)
(10.39) 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)
(10.40) First Amendment to Lease dated January 19, 1989
amending Cambridge Center Lease dated October 4, 1982
(k)
(10.41) Second Amendment to Lease dated March 8, 1990 amending
Cambridge Center Lease dated October 4, 1982 (k)
(10.42) Third Amendment to Lease dated September 25, 1991
amending Cambridge Center Lease dated October 4, 1982
(k)
(10.43) Lease dated October 6, 1993 between North Parcel
Limited Partnership and Biogen Realty Limited
Partnership (n)
(10.44) 1983 Employee Stock Purchase Plan as amended through
April 3, 1992 and restated (j)**
(10.45) 1982 Incentive Stock Option Plan as amended through
March 25, 1993 and restated with form of Option
Agreement (l)**
(10.46) 1985 Non-Qualified Stock Option Plan as amended through
March 25, 1993 and restated with form of Option
Agreement (l)**
(10.47) 1987 Scientific Board Stock Option Plan as amended
through April 3, 1992 and restated with form of Option
Agreement (j)**
(10.48) Voluntary Executive Supplemental Savings Plan *,**
(10.49) Supplemental Executive Retirement Plan *,**
(10.50) Voluntary Board of Directors Savings Plan *,**
(10.51) Exclusive License and Development Agreement dated
December 8, 1979 between Registrant and Schering
Corporation (a)
(10.52) Amendatory Agreement dated May 14, 1985 to Exclusive
License and Development Agreement dated December 8,
1979 (b)
(10.53) Amendment and Settlement Agreement dated September 29,
1988 to Exclusive License and Development Agreement
dated December 8, 1979 (k)
(10.54) Amendment dated March 20, 1989 to Exclusive License and
Development Agreement dated December 8, 1979 (k)
(10.55) License Agreement (United States) dated March 28, 1988
between Registrant and SmithKline Beecham Biologicals,
s.a. (as successor to Smith Kline-R.I.T, s.a.) (k)
(10.56) License Agreement (International) dated March 28, 1988
between Registrant and SmithKline Beecham Biologicals,
s.a. (as successor to Smith Kline-R.I.T., s.a.) (k)
(10.57) Sublicense Agreement dated as of February 15, 1990
among Registrant, SmithKline Beecham Biologicals, s.a
(as successor to SmithKline Biologicals, s.a.) and
Merck and Co., Inc. (k)
(10.58) Supplemental Amendment and Agreement dated as of March
1, 1994 between the Registrant and Schering
Corpotration (o)
(11) Computation of Earnings per Share *
(12) None
(13) Incorporated portions from Biogen, Inc. 1993 Annual
Report to Shareholders *
(22) Subsidiaries of the Registrant *
(24.1) Consent of Price Waterhouse (Included in Part IV
hereof)
(29) None
(a) Previously filed with the Commission as an exhibit to
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
Registrant's Annual Report on Form 10-K for the 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
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1986, as amended, File No. 0-12042
and incorporated herein by reference.
(d) Previously filed with the Commission as an exhibit to
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1987, File No. 0-12042 and
incorporated herein by reference.
(e) Previously filed with the Commission as an exhibit to
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1988, File No. 0-12042 and
incorporated herein by reference.
(f) Previously filed with the Commission as an exhibit to
Registration Statement on Form 8-A, File No. 0-12042,
filed May 26, 1989 and incorporated herein by
reference.
(g) Previously filed with the Commission as an exhibit to
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1989, File No. 0-12042, and
incorporated herein by reference.
(h) Previously filed with the Commission as an exhibit to
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1990, File No. 0-12042, and
incorporated herein by reference.
(i) Previously filed with the Commission as an exhibit to
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1991, File No. 0-12042, and
incorporated herein by reference.
(j) Previously filed with the Commission as an exhibit to
Registrant's Quarterly Report on Form 10-Q for the
quarter ended June 30, 1992, 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, 1993, File No. 0-12042,
and incorporated herein by reference.
(l) 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.
(m) Previously filed with the Commission as an exhibit to
Registration Statement on Form S-3, File No. 33-51639,
and incorporated herein by reference.
(n) Previously filed with the Commission as an exhibit to
Registrant's Annual Report on Form 10-K for the year
ended December 31, 1994, File No. 0-12042, and
incorporated herein by reference.
(o) 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.
* Filed herewith
** Management contract or compensatory plan or arrangement
(b) Reports on Form 8-K
None.
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 6, 1995
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, Board of Directors March 6,
1995
James L. Vincent (principal executive officer)
/s/ Timothy M. Kish Vice President-Finance(principal
March 6, 1995
Timothy M. Kish financial and accounting officer)
/s/ Alexander Bearn Director March 6, 1995
Alexander Bearn
/s/ Harold W. Buirkle Director March 6, 1995
Harold W. Buirkle
/s/ Alan Belzer Director March 6, 1995
Alan Belzer
/s/ Roger H. Morley Director March 6, 1995
Roger H. Morley
/s/ Kenneth Murray Director March 6, 1995
Kenneth Murray
/s/ Phillip A. Sharp Director March 6, 1995
Phillip A. Sharp
/s/ James W. Stevens Director March 6, 1995
James W. Stevens
/s/ James R. Tobin Director March 6, 1995
James R. Tobin
EXHIBIT INDEX
Exhibit No. Description
(10.30) Extension Agreement dated December 31, 1994 relating to
Development Contract.
(10.48) Voluntary Executive Supplemental Savings Plan.
(10.49) Supplemental Executive Retirement Plan.
(10.50) Voluntary Board of Directors Savings Plan
(11) Computation of Earnings per Share.
(13) Incorporated portions from Biogen, Inc. 1994 Annual
Report to Shareholders.
(22) Subsidiaries of the Registrant.
(24.1) Consent of Price Waterhouse LLP