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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, 1993
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) 252-9200
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 Warrants
(Title of class)(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 25, 1994: $1,133,288,049 (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 March
25, 1994: 32,412,707 shares.
Documents Incorporated by Reference
Portions of the Registrant's definitive Proxy Statement for its
1994 Annual Meeting of Stockholders are incorporated by reference into
Part III of this Report, and portions of the Registrant's 1993 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 five products sold by licensees
around the world. During 1993, Biogen's licensees generated total sales
of approximately $1.5 billion from these products. In the future,
Biogen expects to derive additional revenues from sales of proprietary
products which Biogen will market. One of Biogen's two leading product
candidates, its Hirulog(TM) thrombin inhibitor, is in Phase III clinical
trials for two indications and in Phase II trials for certain other
indications. Hirulog(TM) is a rationally designed antithrombotic being
tested for use in the treatment of a number of arterial cardiovascular
conditions. Biogen's other leading product candidate, recombinant beta
interferon, is in Phase III clinical trials for one indication and in
Phase II clinical trials for certain other indications. Recombinant
beta interferon is a protein being tested for use as a therapy for
multiple sclerosis and certain viruses and cancers.
Biogen focuses its research and development efforts on areas where
it has particular scientific and competitive strengths: cardiovascular
disease, inflammatory diseases, AIDS 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 new immune system modulators,
antithrombotic agents, virus inhibitors and drug delivery agents.
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 with the greatest potential competitive advantages and large
commercial markets. Described below are Biogen's proprietary products
in clinical trials and its major research programs.
Products in Clinical Trials
Hirulog(TM) Thrombin Inhibitor
Hirulog(TM) is a rationally designed antithrombotic which directly
inhibits thrombin, a central component in the cascade that leads to clot
formation in arteries and veins. Biogen believes that Hirulog(TM) may
have broad therapeutic applications and is focusing its initial clinical
efforts on the use of Hirulog(TM) during coronary balloon angioplasty,
for the treatment of unstable angina and as an adjunctive with
thrombolytic agents for treating myocardial infarction (heart attack).
Each of these indications often requires expensive and invasive surgical
procedures, and Biogen believes there is a significant need for better
treatments which is not met by currently available medications. To
date, Hirulog(TM) has been administered to more than 2,500 patients in
Phase I, Phase II and Phase III clinical trials conducted in North
America and Europe. The results of Phase I and Phase II clinical trials
to date have shown that Hirulog(TM) is well tolerated and has a
dose-related antithrombotic effect in humans. A clinical trial of
Hirulog(TM) in the treatment of unstable angina conducted by the
Thrombolysis in Myocardial Infarction (TIMI) group at the Brigham and
Women's Hospital has been completed. A second, larger Phase III
clinical trial of Hirulog(TM) in unstable angina recently began. A Phase
III clinical trial of Hirulog(TM) in angioplasty and additional Phase II
trials are ongoing. Biogen presently expects the Phase III trials of
Hirulog(TM)in angioplasty to be completed in 1994. Because of the
mechanism of action and results of in vitro, in vivo and clinical
testing of Hirulog(TM), Biogen believes Hirulog(TM) has the potential
for use in many situations where an anticoagulant is needed.
Hirulog(TM) is the product of Biogen research which began on
hirudin, the anticoagulant protein found in the saliva of the medicinal
leech. Based on their knowledge of the structure and function of
hirudin and thrombin, Biogen's scientists designed a smaller molecule
which may have different therapeutic effects from those of hirudin.
Hirulog(TM) is a chemically synthesized, twenty amino acid peptide.
Biogen has contracted with a major chemical company to provide Biogen
with the quantities of Hirulog(TM) necessary to meet its anticipated
needs for clinical trials and commercial sale.
Biogen is developing Hirulog(TM) as a proprietary therapeutic
product which it intends to market itself, assuming the successful
completion of clinical studies and receipt of applicable regulatory
approvals. In 1991, Biogen licensed to Commonwealth Serum Laboratories
Limited, Australia's largest domestic pharmaceutical company, the rights
to market Hirulog(TM) as a therapeutic in Australia and New Zealand.
Recombinant Beta Interferon
Natural beta interferon is a protein produced by fibroblast cells
in response to viral infection. Biogen is investigating recombinant
beta interferon for use as an antiviral and anticancer agent and for the
treatment of multiple sclerosis. Dosing in a Phase III clinical trial
in the United States of recombinant beta interferon for the treatment of
multiple sclerosis, sponsored by the National Institutes of Health,
ended in February 1994. The Company is currently collecting and
analyzing data and information from the trial. Biogen is also
conducting and sponsoring clinical investigations for the use of
recombinant beta interferon in treating hepatitis B, hepatitis C, and
other diseases. Phase II clinical trials of beta interferon are ongoing
in Europe and the United States for several indications.
Compared to natural beta interferon, beta interferon produced
through recombinant technology is believed to be a purer and more
consistent product, and can be produced in recombinant form in large
quantities. Biogen's recombinant beta interferon is produced in
mammalian cells. Biogen believes that recombinant beta interferon has
greater activity in vivo than natural beta interferon. In addition,
Biogen believes that recombinant beta interferon can be administered by
routes, such as subcutaneous and intramuscular, which are limited for
natural beta interferon.
Biogen is developing recombinant beta interferon as a proprietary
product and, assuming the successful completion of clinical studies and
receipt of applicable regulatory approvals, intends to market the drug
in North America and Europe. In 1993, Bioferon Biochemische Substanzen
GmbH & Co. ("Bioferon"), a pharmaceutical company owned jointly by
Biogen and Dr. Rentschler Arzneimittal GmbH & Co. ("Rentschler"), was
liquidated and its assets sold to Rentschler. As a result, Biogen's
agreements with Bioferon and Asta Pharma AG relating to beta interferon
and the participation of Bioferon and Asta in the development of
Biogen's recombinant beta interferon have terminated.
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 best 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 TBAM/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 most 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 has delayed commencing
Phase I clinical trials of product candidates from the inflammation
program while resources are devoted to development of Hirulog* and beta
interferon.
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 a
number of different approaches for intervening in thrombotic processes,
targeting new approaches to the treatment of certain persistent viral
diseases, such as human papillomavirus infections, and developing
methods for delivering drug products directly to the inside of cells.
Additional efforts are being directed towards new strategies for
intervening in diseases where the normal pattern of growth regulation
has been disturbed. Abnormal growth is implicated in diseases as
diverse as cancer, which is characterized by the uncontrolled growth of
abnormal cells, and restenosis, in which the reclosure of blood vessels
may be associated with the growth of scar tissue. Biogen is also
exploring various avenues of therapeutic intervention in AIDS. One of
these avenues is a therapy that blocks entry of HIV into cells via CD4.
Biogen has identified a monoclonal antibody, known as 5A8, directed
against CD4, which has the potential to block HIV infection and HIV-
induced cell fusion or HIV/CD4 cell fusion.
Research Costs
During 1993, 1992 and 1991, Biogen's research and development costs
were approximately
$79.3 million, $60.4 million and $44.3 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.
Products Being Marketed or Developed by Biogen Licensees
Intron(R) 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(R) A brand of alpha interferon in the United States
in 1986 for hairy-cell leukemia. Schering-Plough now sells Intron(R) 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(R) A by Schering-Plough were $572 million in 1993,
the majority of which were generated outside the United States.
Currently the largest market for Intron(R) A is in Japan for the
treatment of hepatitis C. The United States Food and Drug
Administration ("FDA") has approved Intron(R) A for the treatment of
hepatitis B and hepatitis C in the United States. Schering-Plough has
undertaken studies using Intron(R) A for a number of additional
indications. These studies include Phase III trials of Intron(R) A for
the treatment of chronic myelogenous leukemia, bladder cancer, non-
Hodgkin's lymphoma, malignant melanoma, renal cell carcinoma, multiple
myeloma and head and neck cancer, and earlier phase trials for Crohn's
disease and, in combination with AZT or ddI, as a treatment for AIDS.
Royalties from Schering-Plough accounted for approximately 57% of
Biogen's revenues (excluding interest) in 1993.
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 $900 million in
1993.
Hepatitis B Vaccines
The American Academy of Pediatrics and the United States Centers
for Disease Control and Prevention ("CDCP") have recommended that all
infants born in the United States receive inoculation against hepatitis
B as part of a universal vaccination program. At least 20 countries
around the world already recommend vaccination for all infants. CDCP
and the American Academy of Pediatrics have also recommended universal
immunization of ten-year-old children and at-risk adolescents. In
addition, the United States Occupational Safety and Health
Administration ("OSHA") has recommended that all persons with an
occupational exposure to blood and other infectious material receive the
hepatitis B vaccine. In 1992, OSHA instituted a program requiring
certain employers to offer the vaccine at no cost to all employees at
risk.
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 34% of
Biogen's revenues (excluding interest) in 1993. Biogen has also
licensed rights under its hepatitis B patents to Merck and The Green
Cross Corporation non-exclusively in Japan.
In 1993, SmithKline initiated arbitration in the United States
regarding the rate of royalties payable on sales of hepatitis B vaccines
by SmithKline in the United States. In the fourth quarter of 1992,
SmithKline received a favorable decision against Biogen in a foreign
arbitration regarding similar royalty provisions in a separate agreement
governing international sales of hepatitis B vaccines by SmithKline.
Biogen has received leave to appeal the foreign arbitration decision
from the English Chancery Court. 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.
Other Products
Gamma Interferon
Gamma interferon is a protein produced by cells of the immune
system. Biogen has developed a recombinant gamma interferon for Biogen
Medical Products Limited Partnership ("BMPLP"). In 1993, BMPLP
terminated its agreements with Bioferon under which Bioferon developed
gamma interferon and, under a distribution agreement with Rentschler,
marketed gamma interferon in Germany for the treatment of rheumatoid
arthritis as a second line therapy for patients who no longer benefit
from nonsteroidal anti-inflammatory drugs. See "Patents and Other
Proprietary Rights." In Japan, Biogen's licensee, Shionogi & Co., Ltd.
("Shionogi"), markets recombinant gamma interferon under the trademark
Imunomax(R)-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.
Porcine Somatotropin
Porcine somatotropin ("PST") is a protein normally produced in
young pigs which promotes their growth and development into adult
animals. Biogen believes that PST significantly increases feed
conversion efficiency and daily weight gain and improves the quality of
the meat product in pigs by reducing fat content. Biogen has been
granted a patent in the European Patent Office and has applications
pending in certain other countries, including the United States,
covering the production of PST through recombinant DNA techniques.
Until 1993, recombinant PST was being developed by Pitman-Moore, Inc.,
a subsidiary of the IMCERA Group, under an agreement with Biogen. In
1993, Pitman-Moore terminated its development agreement with Biogen and
the license to recombinant PST patent rights, citing changing market
conditions.
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 30 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.
Three infringement suits have been filed in Biogen's name to
enforce its European alpha interferon patent. 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. 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"). The Polish
court preliminarily enjoined BI Pharma from further infringement of
Biogen's patent. The court then stayed the injunction pending a decision
on BI Pharma's appeal.
Recombinant Hepatitis B Antigens
Biogen has more than 50 granted 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. Biogen expects an oral hearing on
this appeal in June 1994.
Biogen's second European hepatitis B patent was opposed by four
companies. In 1992, the Opposition Division decided to revoke Biogen's
second European hepatitis B patent alleging that it lacked inventive
step. Biogen has appealed this decision to the European Patent Office
Technical Board of Appeal. The patent will remain in force during the
appeal process. Although such matters can never be free from doubt,
Biogen believes that the decision of the Opposition Division will be
reversed on appeal.
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 hepatitis B vaccine. In November 1993, the United
Kingdom High Court of Justice ruled in favor of Biogen and enjoined
Medeva from further infringement of one of Biogen's European (UK)
patents. The Court then stayed the injunction pending decision on
Medeva's appeal. The appeal is expected to be heard in mid-1994. 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 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. The case is continuing in Singapore.
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. Biogen expects the opponent
to appeal this decision. 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.
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 the 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.
Hirulog(TM) Thrombin Inhibitor
In 1993, the United States Patent Office issued to Biogen a patent
covering Biogen's Hirulog(TM) thrombin inhibitor. Biogen has several
patent applications pending on Hirulog(TM) and continues to seek patents
covering Hirulog(TM) in the United States and other countries.
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 has maintained
the Genentech patent in a decision that cannot be appealed. If
Genentech's European gamma interferon patents continue in force in
Europe with their present scope and Biogen does not obtain a license
under such patents, Biogen will likely be prevented from selling
recombinant gamma interferon in Europe.
Other Patents
In January 1994, Biogen filed suit in the District Court 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.
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. 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 and testing 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 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. The commercial manufacture and marketing of
pharmaceutical products for animal use require approval of either the
FDA or the USDA and of comparable agencies in other countries. 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 is currently
undertaking a complete review and reformation of 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, 1994, Biogen employed 380 full-time employees, of
whom 55 held Ph.D. and/or M.D. degrees. Of the 380 employees, 167 were
engaged in, or directly supported, research and process development and 111
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 six outside
members of its Scientific Board.
Item 2.
Properties
Substantially all of Biogen's facilities are located in Cambridge,
Massachusetts, where the Company leases all or part of five buildings
containing a total of approximately 220,000 square feet of office and
research and development space. 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 a combined
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 $40 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.
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 Hirulog(TM) thrombin inhibitor and 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
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 . 54 Chairman of the Board of Directors, Chief
Executive Officer
James R. Tobin . . 49 President and Chief Operating Officer
Michael J. Astrue. 37 Vice President - General Counsel,
Secretary and Clerk
Kenneth M. Bate. . 43 Vice President - Marketing and Sales
Frank A. Burke, Jr. 50 Vice President - Human Resources
Lawrence S. Daniels 51 Vice President - Strategic Planning
Joseph M. Davie. . 54 Vice President - Research
Irving H. Fox. . . 50 Vice President - Medical Affairs
Timothy M. Kish . 42 Vice President - Finance, Chief Financial
Officer and Treasurer
James C. Mullen. . 35 Vice President - Operations
Michael R. Slater. 47 Vice President - Regulatory Affairs
Irvin D. Smith.... 61 Vice President - QA/QC and Drug
Development
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, Chairman of the
Executive Board of Wharton Graduate School of the University of
Pennsylvania and is a member of the Board of Directors of Continental
Bank, Continental Corporation and Millipore Corporation.
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.
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, 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.
Michael R. Slater was appointed Vice President - Regulatory
Affairs in 1991. Mr. Slater has been with Biogen since 1983, serving
first as Head of Regulatory Affairs and then as Director of Regulatory
Affairs of Biogen, S.A., the Company's former Swiss subsidiary. From
1985 to 1988, Mr. Slater served as Director of Corporate Regulatory
Affairs of Biogen Research Corp. From 1988 to 1991, Mr. Slater served
as Vice President - Quality Assurance and Regulatory Affairs of the
Company.
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. 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
1993 Annual Report to Shareholders is hereby incorporated by reference.
Item 6.
Selected Financial Data
The section entitled "Selected Financial Data" in the
Company's 1993 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 1993
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 1993 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 "Other
Matters" in the Company's definitive proxy statement for its 1994 Annual
Meeting of Stockholders, which the Company intends to file with the
Commission no later than April 30, 1994, 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 "Executive Compensation", "Board of
Directors and Committees", "Employment Arrangements", "Statement of
Compensation Philosophy" and "Performance Graph" in the Company's
definitive proxy statement for its 1994 Annual Meeting of Stockholders,
which the Company intends to file with the Commission no later than
April 30, 1994, 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 1994 Annual Meeting of Stockholders,
which the Company intends to file with the Commission no later than
April 30, 1994, is hereby incorporated by reference.
Item 13.
Certain Relationships and Related Transactions
The section entitled "Certain Transactions" in the Company's
definitive proxy statement for its 1994 Annual Meeting of Stockholders,
which the Company intends to file with the Commission no later than
April 30, 1994, 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 1993 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 Page 25 of this Report;
Annual Report under the caption
"Report of Independent
Accountants."
With the exception of the portions of the 1993 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:
Item Location
Report of Independent Accountants Page 25 of this Report
Consent of Independent Accountants Page 26 of this Report
Schedule I, Marketable Securities Page 27 of this Report
Schedule X, Supplementary Income Page 28 of this Report
Statement Information
Schedules not included herein are omitted because they are not
applicable or the required information appears in the Consolidated
Financial Statements or Notes thereto.
(3) Exhibits
Exhibit No. Description
(3.1) Articles of Organization, as amended (k)
(3.2) By-Laws, as amended (o)
(4.1) Form of Common Stock Share Certificate (q)
(4.2) Form of Warrant Certificate (f)
(4.3) Certificate of Designation of Series A Junior
Participating Preferred Stock (j)
(4.4) Rights Agreement dated as of May 8, 1989 between
Registrant and The First National Bank of Boston, as
Rights Agent (j)
(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 (o)**
(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 (o)**
(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 (m)**
(10.9) Form of Amendment dated July 1, 1988 to Independent
Consulting Agreement between Registrant and Scientific
Board Members (h)**
(10.10) Form of Extension of Independent Consulting Agreement
between Registrant and Scientific Board Members (k)**
(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 (d)**
(10.13) Letter regarding employment of James L. Vincent dated
September 23, 1985 (c)**
(10.14) Form of Stock Option Agreement with James L. Vincent
under 1985 Non-Qualified Stock Option Plan (o)**
(10.15) Letter dated December 13, 1989 regarding employment of
Dr. Irving H. Fox (l)**
(10.16) Letter dated August 13, 1990 regarding employment of Mr.
Kenneth M. Bate (m)**
(10.17) Letter dated October 23, 1991 regarding employment of Mr.
Lawrence S. Daniels (o)**
(10.18) Letter dated April 7, 1993 regarding employment of Dr.
Joseph M. Davie (p)**
(10.19) Letter dated January 12, 1994 regarding employment of
James R. Tobin *,**
(10.20) Letter dated August 30, 1993 regarding employment of
Irvin D. Smith, Ph.D.*,**
(10.21) Form of Indemnification Agreement between Registrant and
each Director and Executive Officer (h)**
(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 (k)
(10.23) First Amendment dated December 22, 1986 to Agreement and
Certificate of Limited Partnership (d)
(10.24) Technology License Agreement dated May 15, 1984 between
Biogen B.V. and Biogen Medical Products Limited
Partnership (k)
(10.25) Development Contract dated May 15, 1984 between Biogen
B.V. and Biogen Medical Products Limited Partnership (k)
(10.26) Amendment dated December 22, 1986 to Development Contract
(d)
(10.27) Amendment dated January 1, 1987 to Development Contract
(g)
(10.28) Extension Agreement dated October 10, 1989 relating to
Development Contract (k)
(10.29) Extension Agreement dated December 31, 1993 relating to
Development Contract *
(10.30) Joint Venture Option Agreement dated May 15, 1984 between
Biogen Inc. and Biogen Medical Products Limited
Partnership (k)
(10.31) Purchase Option Agreement dated May 15, 1984 between
Biogen B.V. and the limited partners of Biogen Medical
Products Limited Partnership (k)
(10.32) 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 (k)
(10.33) Demand Loan Agreement dated October 1, 1989 between
Biogen Medical Products Limited Partnership and Biogen
Medical Products, Inc. (k)
(10.34) 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. (k)
(10.35) Letter of May 24, 1989 exercising option under Standard
Form Commercial Lease dated January 29, 1981 (k)
(10.36) Lease Extension Agreement dated February 20, 1990 between
Eastern Realty Trust and Registrant (k)
(10.37) Standard Form Commercial Lease dated June 1, 1989 between
Eastern Realty Trust and Registrant (k)
(10.38) 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)
(10.39) First Amendment to Lease dated January 19, 1989 amending
Cambridge Center Lease dated October 4, 1982 (o)
(10.40) Second Amendment to Lease dated March 8, 1990 amending
Cambridge Center Lease dated October 4, 1982 (o)
(10.41) Third Amendment to Lease dated September 25, 1991
amending Cambridge Center Lease dated October 4, 1982 (o)
(10.42) Lease dated October 6, 1993 between North Parcel Limited
Partnership and Biogen Realty Limited Partnership*.
(10.43) 1983 Employee Stock Purchase Plan as amended through
April 3, 1992 and restated (n)**
(10.44) 1982 Incentive Stock Option Plan as amended through March
25, 1993 and restated with form of Option Agreement (p)**
(10.45) 1985 Non-Qualified Stock Option Plan as amended through
March 25, 1993 and restated with form of Option Agreement
(p)**
(10.46) 1987 Scientific Board Stock Option Plan as amended
through April 3, 1992 and restated with form of Option
Agreement (n)**
(10.47) Exclusive License and Development Agreement dated
December 8, 1979 between Registrant and Schering
Corporation (a)
(10.48) Amendatory Agreement dated May 14, 1985 to Exclusive
License and Development Agreement dated December 8, 1979
(c)
(10.49) Amendment and Settlement Agreement dated September 29,
1988 to Exclusive License and Development Agreement dated
December 8, 1979 (o)
(10.50) Amendment dated March 20, 1989 to Exclusive License and
Development Agreement dated December 8, 1979 (o )
(10.51) 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.) (o)
(10.52) 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.) (o)
(10.53) 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. (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
Registration Statement on Form S-8, File No. 2-87550 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, 1985, 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, 1986, as amended, File No. 0-12042 and
incorporated herein by reference.
(e) Previously filed with the Commission as an exhibit to
Report on Form 8-K, File No. 0-12042, dated September 30,
1988 and incorporated herein by reference.
(f) Previously filed with the Commission as an exhibit to
Registration Statement on Form 8-B, File No. 0-12042,
dated December 12, 1988 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, 1987, 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, 1988, File No. 0-12042 and
incorporated herein by reference.
(i) Previously filed with the Commission as an exhibit to
Registration Statement on Form S-3, File No. 33-28612 and
incorporated herein by reference.
(j) 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.
(k) 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.
(l) 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.
(m) 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.
(n) 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.
(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, 1993, File No. 0-12042, and
incorporated herein by reference.
(p) Previously filed with the Commission as an exhibit to the
Registrant's Quarterly Report on Form 10-Q for the
quarter ended June 30, 1993, File No. 0-12042, and
incorporated herein by reference.
(q) Previously filed with the Commission as an exhibit to
Registration Statement on Form S-3, File No. 33-51639,
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 18, 1994
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 DirectorsMarch 18, 1994
James L. Vincent (principal executive officer)
/s/ Timothy M. Kish Vice President - Finance March 18, 1994
(principal
Timothy M. Kish financial and accounting officer)
/s/ Alexander Bearn Director March 18, 1994
Alexander Bearn
/s/ Harold W. Buirkle Director March 18, 1994
Harold W. Buirkle
/s/ Alan Belzer Director March 18, 1994
Alan Belzer
/s/ Roger H. Morley Director March 18, 1994
Roger H. Morley
/s/ Kenneth Murray Director March 18, 1994
Kenneth Murray
/s/ Phillip A. Sharp Director March 18, 1994
Phillip A. Sharp
/s/ James W. Stevens Director March 18, 1994
James W. Stevens
Report of Independent Accountants on
Financial Statement Schedules
To the Board of Directors
of Biogen, Inc.
Our audits of the consolidated financial statements referred to in our
report dated January 20, 1994 appearing on page 32 of the 1993 Annual
Report to Shareholders of Biogen, Inc. and its subsidiaries (which
report and consolidated financial statements are incorporated by
reference in this Annual Report on Form 10-K) also included an audit of
the Financial Statement Schedules listed in Item 14(a) of this Form 10-
K. In our opinion, these Financial Statement Schedules present fairly,
in all material respects, the information set forth therein when read in
conjunction with the related consolidated financial statements.
Price Waterhouse
Boston, Massachusetts
January 20, 1994
Consent of Independent Accountants
We hereby consent to the incorporation by reference in the Prospectus
constituting part of its Registration Statements on Form S-8, as amended
(Nos. 2-87550, 2-96157, 33-9827, 33-14742, 33-37312, 33-22378, 33-41077
and as filed on September 21, 1993) and on Form S-3, as amended (Nos.
33-14741, 33-14743, 33-20183, and 33-51639) of Biogen, Inc. and its
subsidiaries of our report dated January 20, 1994 appearing on page 32
of the 1993 Annual Report to Shareholders which is incorporated in this
Annual Report on Form 10-K. We also consent to the incorporation by
reference of our report on the Financial Statement Schedules, which
appears in this Form 10-K.
Price Waterhouse
Boston, Massachusetts
March 28, 1994
SCHEDULE I
BIOGEN, INC. AND SUBSIDIARIES
MARKETABLE SECURITIES AT DECEMBER 31, 1993
(in thousands)
PRINCIPAL MARKET VALUE BALANCE
NAME OF ISSUER AND AMOUNTS OF AT BALANCE SHEET
TITLE OF EACH ISSUE BONDS & NOTES COST SHEET DATE AMOUNT
Corporate Bonds and Notes:
Aluminum Co America $ 300 $ 300 $ 296 $ 300
American Brands Inc. 2,000 2,029 2,017 2,023
Associates Corp of NA 2,840 2,855 2,927 2,852
Bank America Corp 1,300 1,373 1,369 1,359
Bankers TR NY Corp 2,675 2,668 2,670 2,669
Beneficial Corp 1,500 1,696 1,686 1,668
BNY Master CR Card TR 2,500 2,555 2,560 2,543
Boeing Co 300 301 301 301
Chase Manhattan CR Corp 1,250 1,277 1,275 1,272
Commercial CR Group Inc 300 296 297 296
Discover Card TR 6,583 6,876 6,862 6,865
Discover Card TR 625 635 631 632
First Chicago Master TR 2,833 2,890 2,906 2,879
Fleet MTG Secs Inc. 2,000 2,040 2,046 2,036
Ford Motor CR CO 6,500 6,915 6,875 6,772
Ford Motor CR CO 554 579 575 577
General Motors Accep Corp 3,964 3,989 4,013 3,980
Gillette Co 300 300 298 300
Golden West Finl Corp DEl 900 1,029 998 1,021
Household Fin Corp 2,752 2,935 2,921 2,914
Korea Dev BK 2,000 2,184 2,134 2,168
MMCA Auto Grantor TR 1,862 1,859 1,849 1,859
Nissan Auto Receivables 799 798 804 798
Norwest Corp 1,925 1,908 1,916 1,915
Premier Auto TR 4,190 4,179 4,187 4,179
Reebok INTL LTD 1,082 1,196 1,161 1,183
Republic NATL BK New York 2,000 2,000 2,050 2,000
Ryland MTG Secs Corp 5,516 5,517 5,566 5,517
Saxon MTG Secs Corp 1,890 1,952 1,952 1,951
Security Pac Corp 1,000 1,051 1,092 1,040
Shawmut Natl Remic TR 241 248 246 248
Smith Barney Shearson HLDGS IN 1,000 1,000 1,009 1,000
Standard CR Card Master TR 1 1,250 1,266 1,275 1,260
Structured Asset Secs Corp 926 924 945 924
Syntex USA Inc. 1,000 995 996 996
Tennessee Valley Auth 300 296 299 296
TMS Home Equity LN TR 1,529 1,572 1,548 1,572
WMX Technologies 2,000 2,010 2,002 2,009
Computer Industry Bonds 530 528 552 528
Retail Industry Bonds 2,600 2,602 2,600 2,602
Utility Industry Bonds 5,605 5,920 5,912 5,843
U.S. Government Securities 115,548 112,633 113,886 112,658
TOTAL MARKETABLE SECURITIES $ 195,805
SCHEDULE X
BIOGEN, INC. AND SUBSIDIARIES
SUPPLEMENTARY INCOME STATEMENT INFORMATION
(in thousands)
The amounts shown below are included in costs and expenses in the
consolidated statements of income.
1993 1992 1991
Maintenance and repairs. . . . . . . . . . 1,883 1,4531,410
Patent amortization. . . . . . . . . . . . 2,258 3,6601,689
Royalties. . . . . . . . . . . . . . . . . 11,588 9,3843,768
There were no material charges for advertising and taxes, other than
payroll and income taxes, for the periods noted above.
EXHIBIT INDEX
Exhibit No. Description
(10.19) Letter dated January 12, 1994 regarding employment of
James R. Tobin
(10.20) Letter dated August 30, 1993 regarding employment of
Irvin D. Smith, Ph.D.
(10.29) Extension Agreement dated December 31, 1993 relating to
Development Contract.
(10.42) Lease dated October 6, 1993 between North Parcel Limited
Partnership and Biogen Realty Limited Partnership.
(11) Computation of Earnings per Share
(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).