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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(MARK ONE)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2000
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER 0-19034
REGENERON PHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
NEW YORK 13-3444607
(STATE OR OTHER JURISDICTION OF INCORPORATION OR (I.R.S. EMPLOYER IDENTIFICATION NO.)
ORGANIZATION)
777 OLD SAW MILL RIVER ROAD, TARRYTOWN, NEW YORK 10591-6707
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
(914) 347-7000
(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
NONE
(TITLE OF CLASS)
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK -- PAR VALUE $.001 PER SHARE
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(TITLE OF CLASS)
PREFERRED SHARE PURCHASE RIGHTS EXPIRING OCTOBER 18, 2006
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(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 (sec.229.405 of this chapter) 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. [ ]
At February 23, 2001, the aggregate market value of voting stock held by
non-affiliates of the Registrant totaled approximately $684,560,000 based on the
last sale price as reported by The Nasdaq Stock Market.
Indicate the number of shares outstanding of each of Registrant's classes
of common stock as of February 23, 2001:
CLASS OF COMMON STOCK NUMBER OF SHARES
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CLASS A STOCK, $.001 PAR VALUE 2,575,165
COMMON STOCK, $.001 PAR VALUE 34,259,851
DOCUMENTS INCORPORATED BY REFERENCE:
The Registrant's definitive proxy statement to be filed in connection with
solicitation of proxies for its Annual Meeting of Shareholders to be held on
June 8, 2001, is incorporated by reference into Part III of this Form 10-K.
Exhibit index is located on pages 26 to 28 of this filing.
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PART I
This Annual Report on Form 10-K contains forward-looking statements that
involve risks and uncertainties relating to the future financial performance of
Regeneron Pharmaceuticals, Inc. and actual events or results may differ
materially. These statements concern, among other things, the possible
therapeutic applications of our product candidates and research programs, the
timing and nature of the clinical and research programs now underway or planned,
and the future sources and uses of capital and our financial needs. These
statements are made by us based on management's current beliefs and judgment. In
evaluating such statements, stockholders and potential investors should
specifically consider the various factors identified under the caption "Factors
That May Affect Future Operating Results" which could cause actual results to
differ materially from those indicated by such forward-looking statements. We do
not undertake any obligation to update publicly any forward-looking statement,
whether as a result of new information, future events, or otherwise, except as
required by law.
ITEM 1. BUSINESS
GENERAL
Regeneron Pharmaceuticals, Inc., which may be referred to as "we", "us", or
"our", is a biopharmaceutical company that discovers, develops, and intends to
commercialize therapeutic drugs for the treatment of serious medical conditions.
Our product pipeline includes product candidates for the treatment of obesity,
rheumatoid arthritis and other inflammatory conditions, cancer and related
disorders, allergies, asthma, and other diseases and disorders. Since inception
we have not generated sales or any profits from the commercialization of any of
our product candidates.
Our core business strategy is to combine our strong foundation in science
and technology with state-of-the-art manufacturing and clinical development
capabilities to build a successful, integrated biopharmaceutical company. Our
efforts have yielded a diverse and growing pipeline of product candidates that
have the potential to address a variety of unmet medical needs. Our ability to
develop product candidates results from the application of our technology
platforms. Our technology platforms, in contrast to basic genomics approaches
which attempt to identify every gene in a cell or genome, are designed to
discover specific genes of therapeutic interest for a particular disease or cell
type. We will continue to invest in the development of enabling technologies to
assist in our efforts to identify, develop, and commercialize new product
candidates.
A key aspect of our strategy is to retain significant ownership and
commercialization rights to our pipeline. Below is a summary of our leading
clinical programs, as well as several product candidates that are expected to
enter clinical trials over the next two years. We retain sole ownership and
marketing rights for each of these programs and currently are developing them
independent of any corporate partners.
- AXOKINE(R): Acts on the brain region regulating food intake and energy
expenditure and is being developed for the treatment of obesity. In
November 2000, we announced the preliminary results of a twelve-week
Phase II dose-ranging trial of AXOKINE in 170 severely obese patients. In
the trial, AXOKINE was generally well tolerated and patients treated with
AXOKINE showed medically meaningful and statistically significant weight
loss compared to those receiving placebo. Subject to discussions with the
FDA, we intend to initiate Phase III testing of AXOKINE in severely obese
patients in mid-2001.
- PEGYLATED AXOKINE: Chemically modified version of AXOKINE that is being
developed as a more potent, longer-acting form of the protein. Pegylated
AXOKINE currently is in late-stage preclinical development and we
anticipate initiating a Phase I clinical trial in mid-2001.
- INTERLEUKIN-1 CYTOKINE TRAP (IL-1 TRAP): Protein-based antagonist for
the interleukin-1 (called IL-1) cytokine. IL-1 is thought to play a major
role in rheumatoid arthritis and other inflammatory diseases. In December
2000, we initiated a Phase I study to assess the safety and tolerability
of the IL-1 Trap in patients with rheumatoid arthritis. We expect the
study to be completed in the second half of 2001.
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- INTERLEUKIN-4/INTERLEUKIN-13 CYTOKINE TRAP (IL-4/IL-13
TRAP): Protein-based antagonist for the interleukin-4 and interleukin-13
(called IL-4 and IL-13) cytokines which are thought to play a major role
in diseases such as asthma, allergic disorders, and other inflammatory
diseases. We expect to initiate a Phase I clinical trial of a dual
IL-4/IL-13 Trap for asthma/allergy-related conditions in late 2001.
- VEGF TRAP: Protein-based antagonist to Vascular Endothelial Growth
Factor (called VEGF, also known as Vascular Permeability Factor or VPF),
which is required for the growth of blood vessels that are needed for
tumors to grow and is a potent regulator of vascular permeability and
leak. The VEGF Trap is expected to enter Phase I clinical trials in
mid-2001.
- ANGIOPOIETINS: A new family of growth factors that act specifically on
the endothelium cells that line blood vessels and may be useful for
growing blood vessels in diseased hearts and other tissues with decreased
blood flow and for repairing blood vessel leaks that cause swelling and
edema in many different diseases such as stroke, diabetic retinopathy,
and inflammatory diseases. Selected Angiopoietins, including engineered
forms of these growth factors, are in preclinical development.
In addition to the above programs which we are conducting solely on our
own, we have formed collaborations to advance other research and development
efforts. We are conducting research with The Procter & Gamble Company in muscle
diseases and other fields. We are also collaborating with Medarex, Inc. to
discover, develop, and commercialize certain human antibodies as therapeutics.
In partnership with Amgen Inc., we are conducting clinical trials with
Neurotrophin-3, or NT-3, for the treatment of constipating conditions. In all of
these research collaborations, we retain 50% of the commercialization rights.
OUR INDEPENDENT PROGRAMS
The following table lists the programs and product candidates for which we
retain sole ownership and marketing rights.
PROGRAM AND PRODUCT CANDIDATE TARGETED INDICATION STAGE
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AXOKINE(R) Obesity Clinical
PEGYLATED AXOKINE Obesity Preclinical
IL-1 TRAP Rheumatoid arthritis Clinical
IL-4/13 TRAP Asthma and allergic disorders Preclinical
TRAPS FOR IL-2, IL-3, IL-4, IL-5, IL-6, Multiple diseases Research
IL-15, GAMMA-INTERFERON, TGF-BETA AND
OTHERS
VEGF TRAP Cancer and related conditions Preclinical
ANGIOPOIETIN-1 Vascular leak and edema Preclinical
EPHRINS, ANGIOPOIETIN-2 Cancer and ischemia Research
REGENERON ORPHAN RECEPTORS (RORS) Osteoarthritis and other cartilage diseases Research
AXOKINE. AXOKINE is our patented second generation ciliary neurotrophic
factor, called CNTF. We are developing AXOKINE for the treatment of obesity.
Obesity is a major health problem in all developed countries. The
prevalence of obesity in the United States has increased substantially during
the past decade. A 1999 Congressional Report funded by the National Institutes
of Health confirmed that obesity significantly increases a number of health
risks, including Type II diabetes. Obesity-related conditions, such as stroke
and myocardial infarct are estimated to contribute to about 300,000 deaths
yearly, ranking second only to smoking as a cause of preventable death. Current
treatment of obesity consists of diet, exercise, and other lifestyle changes,
and a limited number of drugs. There are two approved drugs currently indicated
for the treatment of obesity -- sibutramine (Meridia(R), a registered trademark
of Knoll Pharmaceutical Company) and orlistat (Xenical(R), a registered
trademark of Hoffmann-La Roche, Inc.). According to their approved product
labels, over a twelve month treatment period, these drugs, at their approved
starting doses, have produced weight loss of between approximately five and nine
pounds as compared to patients taking placebo.
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In November 2000, we announced the preliminary results of a Phase II
clinical trial, which tested the safety and efficacy of AXOKINE in severely
obese patients. This Phase II trial was a randomized, double-blind,
placebo-controlled, out-patient study conducted at seven sites in the United
States. Following an initial two week "run-in period," all subjects received
twelve weeks of daily treatment, administered under the skin by patient
self-injection. A total of 170 patients were divided into five patient groups.
The first four patient groups comprised the pre-specified population for the
primary analyses and received placebo, a daily dose of 0.3 micrograms (mcg) of
AXOKINE per kilogram (kg), a daily dose of 1.0 mcg/kg, or a daily dose of 2.0
mcg/kg, in each case, over the twelve week treatment period. A fifth group
received a daily dose of 1.0 mcg/kg for eight weeks, followed by a blinded
withdrawal period in which they received placebo for four weeks. The
pre-specified end points of the study were change in weight for the patients who
completed the full twelve weeks of treatment ("Completer Analysis"), and change
in weight for all patients, whether or not they completed the full twelve weeks
of treatment ("Last Observed Value Analysis"). All AXOKINE-treated groups showed
medically meaningful and statistically significant weight loss compared to
placebo. Summarized below are the results of the four groups comprising the
primary analyses.
COMPLETER ANALYSIS
MEAN WEIGHT CHANGE
FROM BASELINE P VALUE
(POUNDS) (RELATIVE TO PLACEBO)
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Placebo
(n=19) +1.3 --
0.3 mcg/kg
(n=23) -3.4 p = 0.01
1.0 mcg/kg
(n=26) -8.9 p < 0.0001
2.0 mcg/kg
(n=19) -7.5 p < 0.0001
LAST OBSERVED VALUE ANALYSIS
MEAN WEIGHT CHANGE
FROM BASELINE P VALUE
(POUNDS) (RELATIVE TO PLACEBO)
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Placebo
(n=31) +0.6 --
0.3 mcg/kg
(n=31) -2.4 p = 0.04
1.0 mcg/kg
(n=37) -7.5 p < 0.0001
2.0 mcg/kg
(n=33) -5.8 p < 0.0001
As used in the table above, "n" refers to the number of patients in each
patient group. The reference to "p" value (relative to placebo) means the
probability of being wrong when asserting that a true difference exists between
the results for the patient group in question and the placebo group. For
example, a p-value of less than 0.0001 indicates that there is a less than one
in ten thousand chance that the mean weight loss observed in the group treated
with drug and the mean weight loss observed in the group treated with placebo
are the same.
The trial established the optimal dose of AXOKINE to be 1.0 mcg/kg daily.
Patients who received the optimal dose of AXOKINE over the twelve week treatment
period averaged 10 pounds more weight loss than patients on placebo. Moreover,
46% of these patients in the optimal dose group lost at least 10 pounds,
compared to just 5% of the patients who received placebo. Nausea was shown not
to be a factor that determined average weight loss in this Phase II study.
The 38 patients in the fifth group who received 1.0 mcg/kg of AXOKINE daily
for eight weeks followed by the four week blinded withdrawal period lost weight
during the treatment period and did not regain weight while taking placebo
during the withdrawal period.
On February 28, 2001 we announced that based on a preliminary analysis of
interim data, patients who received AXOKINE therapy during the Phase II study
maintained their average weight loss during the three months following their
last AXOKINE treatment, relative to patients who received placebo. Moreover,
patients in the fifth group who were treated with AXOKINE for only eight weeks
continued to maintain their average weight loss for an additional four months
following their last treatment. This preliminary analysis is based on a total of
87 patients, comprised of patients from all five groups, who completed the full
twelve weeks of treatment in the study and the twelve week follow-up.
No serious adverse events associated with the drug were reported during the
trial and the drug was generally well tolerated, as reflected by the following
ratio of patients in each treatment group completing the
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full twelve weeks of treatment according to the protocol: placebo, 61%; 0.3
mcg/kg, 74%; 1.0 mcg/kg, 70%, and 2.0 mcg/kg, 58%. The most common side effect
was dose-dependent injection site reactions (skin redness), which occurred in
all patient groups, including placebo, and were generally mild. Other side
effects associated with the drug included cough and vomiting, which were notable
only in the 2.0 mcg/kg dose group, and nausea, which occurred most frequently in
the 2.0 mcg/kg dose group. There was no increase compared to placebo in the
incidence of herpes simplex infections in patients taking AXOKINE. Neutralizing
antibodies, based on a laboratory test, were not dose-related and occurred in
less than 10% of all patients receiving AXOKINE.
Subject to discussions with the FDA, we intend to initiate Phase III
testing of AXOKINE in severely obese patients in mid-2001. This Phase III
program likely will involve the enrollment of several thousand severely obese
patients with a primary double-blind treatment period of approximately one year
and an additional one year follow-up treatment period.
In March 2000, we established a research and development collaboration with
Emisphere Technologies, Inc. to utilize Emisphere's oral drug delivery
technology for AXOKINE. In preliminary preclinical pharmacokinetic studies, the
Emisphere technology was able to achieve measurable blood levels of AXOKINE.
PEGYLATED AXOKINE. We are developing a pegylated version of AXOKINE
(pegAXOKINE) as a more potent, longer-acting form of the protein. PegAXOKINE may
allow for less frequent and/or lower dosing in patients. PegAXOKINE currently is
in late-stage preclinical development and we anticipate initiating a Phase I
clinical trial in mid-2001. Shearwater Corporation has contracted with us to
develop and supply the pegylated reagent for this product candidate.
CYTOKINE TRAPS. Our research on the CNTF class of neurotrophic factors led
to the discovery that CNTF, although it is a neurotrophic factor, belongs to the
"superfamily" of signaling molecules referred to as cytokines. Cytokines are
soluble proteins secreted by the cells of the body. In many cases, cytokines act
as messengers to help regulate immune and inflammatory responses. In excess,
cytokines can be harmful and have been linked to a variety of diseases. Blocking
cytokines and growth factors is a proven therapeutic approach with a number of
drugs already approved or in clinical development. The cytokine superfamily
includes factors such as erythropoietin, thrombopoietin, granulocyte-colony
stimulating factor, and the interleukins (or ILs).
In the early 1990's, our scientists made a breakthrough in understanding
how receptors work for an entire class of interleukins in the human body. Based
on this finding, we developed a family of antagonists referred to as "Cytokine
Traps." This family includes Cytokine Traps for IL-1, IL-4, and IL-6 and a
single Trap that blocks both IL-4 and IL-13. Because these Traps mimic the
body's natural receptors, they are effective at catching and holding the
cytokines. With the cytokines trapped, the immune system responds as if the
perceived threat is under control.
In preclinical studies, these Cytokine Traps are more potent than other
antagonists, potentially allowing lower levels of the drug to be used. Moreover,
because these Cytokine Traps are comprised entirely of natural human-derived
protein sequences they may be less likely to induce an immune reaction in
humans. Because pathological levels of IL-1, IL-4, IL-6, and IL-13 seem to
contribute to a variety of disease states, these Cytokine Traps have the
potential to be important therapeutic agents.
IL-1 Trap. In December 2000, we initiated a Phase I study of the IL-1
Trap to assess its safety and tolerability in patients with rheumatoid
arthritis. The placebo-controlled, double-blind, dose-escalation study is being
conducted at several centers in the United States and includes a single dose
phase and a multiple dose phase. We expect the study to be completed in the
second half of 2001. The IL-1 Trap is also being evaluated for potential uses in
treating other inflammatory diseases.
Rheumatoid arthritis is a chronic disease in which the immune system
attacks the tissue that lines and cushions joints. Over time, the cartilage,
bone, and ligaments of the joint erode, leading to progressive joint deformity
and joint destruction, generally in the hand, wrist, knee, and foot. Joints
become painful and swollen and motion is limited. Over time, the cartilage
erodes, resulting in structural damage to the joint. Over two
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million people, 1% of the U.S. population, are estimated to have rheumatoid
arthritis, and 10% of those eventually become disabled. Women account for
roughly two-thirds of these patients.
Rheumatoid arthritis involves an excess of certain cytokines, including
IL-1 and tumor necrosis factor (TNF). Drugs that block TNF have already been
approved for the treatment of rheumatoid arthritis, while animal studies
indicate that IL-1 is also an attractive target for drug development in this
disease. In animal models, our IL-1 Trap is a potent blocker of IL-1 activity,
has a long half-life in the blood, penetrates into the inflamed joint, and
blocks cartilage erosion.
While both TNF and IL-1 can induce arthritis, IL-1 more potently induces
cartilage destruction in animal models. In addition, the arthritis caused by TNF
in some animals can be prevented by blocking the action of IL-1, indicating that
the arthritogenic action of TNF may be mediated, in part, through IL-1. Even
stronger evidence for the role of IL-1 in rheumatoid arthritis is that mice that
are deficient in the interleukin-1 receptor antagonist (IL-1-ra), a naturally
occurring blocker of IL-1 action, develop spontaneously occurring arthritis. The
validation of IL-1 blockade as a target for drugs to treat rheumatoid arthritis
also appears to have been demonstrated by the positive results reported by
another company with administration of IL-1ra in clinical trials in patients
with rheumatoid arthritis.
IL-4/IL-13 Trap. Antagonists for IL-4 and IL-13 may be therapeutically
useful in a number of allergy and asthma-related conditions, including as
adjuncts to vaccines where blocking IL-4 and IL-13 may help to elicit more of
the desired type of immune response to the vaccine. We have developed both an
IL-4 Trap and an IL-4/IL-13 Trap, which is a single molecule that can block both
interleukin-4 and interleukin-13. We expect to initiate a clinical trial of a
dual IL-4/IL-13 Trap to assess its safety and tolerability for the treatment of
asthma/allergy-related conditions late in 2001.
One in 13 Americans suffers from allergies and one in 18 suffers from
asthma. The number of people afflicted with these diseases has been growing at
an alarming rate. It is believed that IL-4 and IL-13 play a role in these
diseases. These two cytokines are essential to the normal functioning of the
immune system, creating a vital communication link between white blood cells. In
the case of asthma and allergies, however, there are too many interleukins
present, causing the immune system to overact. Our IL-4/IL-13 Trap may offer
unique advantages over other products and product candidates for asthma and
allergy-related conditions because of its ability to block both of the cytokines
thought to be at the root of these disorders.
Other Cytokine Traps. We have a late stage research program underway for
an IL-6 Cytokine Trap. IL-6 has been implicated in the pathology and progression
of multiple myeloma, certain solid tumors, AIDS, lymphomas (both AIDS-related
and non-AIDS-related), osteoporosis, and other conditions. We also have patents
covering additional Cytokine Traps for IL-2, IL-3, IL-5, IL-15,
gamma-interferon, transforming growth factor beta, and others, which are being
pursued at the research level. Our research regarding protein-based cytokine
antagonists currently includes molecular and cellular research to improve or
modify Cytokine Trap technology, process development efforts to produce
experimental and clinical research supplies, and in vivo and in vitro studies to
further understand and demonstrate the efficacy of the Cytokine Traps.
VEGF TRAP AND ANGIOPOIETINS. A plentiful blood supply is required to
nourish every tissue and organ of the body. Diseases such as diabetes and
atherosclerosis wreak their havoc, in part, by destroying blood vessels
(arteries, veins, and capillaries) and compromising blood flow. Decreases in
blood flow (known as ischemia) can result in non-healing skin ulcers and
gangrene, painful limbs that cannot tolerate exercise, loss of vision, and heart
attacks. In other cases, disease processes can damage blood vessels by breaking
down vessel walls, resulting in defective and leaky vessels. Leaking vessels can
lead to swelling and edema, as occurs in brain tumors following ischemic stroke,
in diabetic retinopathy, and in arthritis and other inflammatory diseases.
Finally, some disease processes, such as tumor growth, depend on the induction
of new blood vessels.
Depending on the clinical situation, positively or negatively regulating
blood vessel growth could have important therapeutic benefits, as could the
repair of damaged and leaky vessels. Thus, building new vessels, by a process
known as angiogenesis, can improve circulation to ischemic limbs and heart, aid
in healing of skin ulcers or other chronic wounds, and in establishing tissue
grafts. Reciprocally, blocking tumor-induced angiogenesis can blunt tumor
growth. In addition, repairing leaky vessels can reverse swelling and edema.
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Vascular endothelial growth factor (VEGF) was the first growth factor shown
to be specific for blood vessels, by virtue of having its receptor specifically
expressed on blood vessel cells. Our scientists discovered a second family of
angiogenic growth factors, termed the Angiopoietins, and we have received
patents for the members of this family. The Angiopoietins include naturally
occurring positive and negative regulators of angiogenesis, as described in
numerous scientific manuscripts published by our scientists and their
collaborators.
Our studies have revealed that VEGF and the Angiopoietins normally function
in a coordinated and collaborative manner during blood vessel growth. Thus, the
growth of new blood vessels to nourish ischemic tissue appears to require use of
both these agents. In addition, Angiopoietin-1 seems to play a critical role in
stabilizing the vessel wall, and the use of this growth factor can prevent or
repair leaky vessels in animal models. In terms of blocking vessel growth,
manipulation of both VEGF and Angiopoietin seems to be of value.
Currently, we have a highly potent VEGF antagonist, termed the VEGF Trap,
in preclinical development as an anti-angiogenic agent for cancer. We expect to
begin a clinical trial of the VEGF Trap as a potential treatment for harmful
angiogenesis or vascular leak in settings of cancer and/or other conditions in
mid-2001. In addition, we are evaluating Angiopoietin-1 and engineered designer
versions of Angiopoietins in preclinical studies to determine their utility for
repairing blood vessel leak and for growing blood vessels in ischemia.
We and others have identified a family of growth factors termed the Ephrins
and their receptors termed the Ephs. Members of this family have specific roles
in angiogenesis and hemopoiesis, which are being pursued in preclinical studies.
CARTILAGE GROWTH FACTOR SYSTEM AND OSTEOARTHRITIS. Osteoarthritis results
from the wearing down of the articular cartilage surfaces that cover joints.
Thus, growth factors that specifically act on cartilage cells could have utility
in osteoarthritis. Our scientists have discovered a growth factor receptor
system selectively expressed by cartilage cells, termed Regeneron Orphan
Receptor 2 (ROR2). Furthermore, our scientists have demonstrated that this
growth factor receptor system is required for normal cartilage development in
mice. In addition, together with collaborators, our scientists have proven that
mutations in this growth factor receptor system cause inherited defects in
cartilage development in humans. Thus, this growth factor receptor system is a
promising new target for cartilage diseases such as osteoarthritis.
OUR COLLABORATIVE PROGRAMS
MUSCLE ATROPHY AND RELATED DISORDERS. Muscle atrophy occurs in many
neuromuscular diseases and also when muscle is unused, as often occurs during
prolonged hospital stays and during convalescence. Currently, physicians have
few options to prescribe for patients with muscle atrophy or other muscle
conditions which afflict millions of patients globally. Thus, a factor that
might have beneficial effects on skeletal muscle could have significant clinical
benefit. Our muscle program is currently focused on conducting in vivo and in
vitro experiments with the objective of demonstrating and further understanding
the molecular mechanisms involved in muscle atrophy and hypertrophy. This work
is being conducted in collaboration with scientists at Procter & Gamble as part
of our collaboration.
NT-3. Amgen-Regeneron Partners' clinical development of NT-3 is currently
focused on the treatment of constipating conditions. In 1998, we, on behalf of
Amgen-Regeneron Partners, completed a small clinical study that included healthy
volunteers and patients suffering from severe idiopathic constipation. We also
conducted additional small studies in patients who suffer from constipation
associated with conditions such as spinal cord injury and the use of narcotic
analgesics. In 2000, we initiated double-blind, placebo-controlled Phase II
studies of NT-3 in patients with functional constipation and in spinal cord
injury patients with bowel dysfunction. These studies currently are underway and
we expect them to be completed in mid-2001. Amgen-Regeneron Partners is
developing NT-3 in the United States under a license from Takeda Chemical
Industries, Ltd.
OTHER EARLY STAGE PROGRAMS: FIBROSIS AND G-PROTEIN COUPLED
RECEPTORS. Fibrotic diseases, such as cirrhosis, result from the excess
production of fibrous extracellular matrix by certain cell types that are
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inappropriately activated in these diseases. We and our collaborators identified
orphan receptors, termed Discoidin Domain Receptors 1 and 2 (DDR1 and DDR2),
that are expressed by the activated cell types in fibrotic disease. We have
further shown that these receptors bind and are activated by the fibrous matrix
they produce. Thus, these receptors are important new targets in fibrotic
disease.
Our work in this area is currently focused on determining whether selective
inhibition or activation of DDR1 and DDR2 would be beneficial in the setting of
fibrotic disease. Further, we are studying key signaling pathways which allow
particular fibrosis-inducing cells to multiply. Inhibition of such pathways may
be useful in preventing the development of fibrosis. These research activities
are being conducted in collaboration with scientists at Procter & Gamble.
We also have a research program focused on the discovery and
characterization of G-Protein Coupled Receptors, which have historically been
among the most useful targets for pharmaceuticals. We use a genomics approach to
discover new receptors and then we characterize these receptors in our disease
models by examining their expression. Early stage research work on selected
G-Protein Coupled Receptors is being conducted in collaboration with scientists
at Procter & Gamble.
OUR TECHNOLOGY PLATFORMS
Our ability to discover and develop product candidates for a wide variety
of serious medical conditions results from the leveraging of our powerful
technology platforms, many of which were developed or enhanced by us. Although
the primary use of these technology platforms is for our own research and
development programs, we are also exploring the possibilities of exploiting
these technologies commercially through, for example, direct licensing or sale
of technology, or the establishment of research collaborations to discover and
develop drug targets.
TARGETED GENOMICS(TM): In contrast to basic genomics approaches, which
attempt to identify every gene in a cell or genome, we use Targeted Genomics
approaches to identify specific genes likely to be of therapeutic interest.
These approaches do not depend on random gene sequencing, but rather on
function-based approaches to specifically target the discovery of genes for
growth factors, peptides, and their receptors that are most likely to have use
for developing drug candidates. This technology has already led to our discovery
of the Angiopoietin and Ephrin growth factor families for angiogenesis and
vascular disorders, the MuSK growth factor receptor system for muscle disorders,
and the Regeneron Orphan Receptor (ROR) growth factor receptor system that
regulates cartilage formation.
HIGH THROUGHPUT FUNCTIONOMICS(TM): A major challenge facing the
biopharmaceutical industry in the post-genomic era involves the efficient
assignment of function to random gene sequences to enable the identification of
validated drug targets. One way to help determine the function of a gene is to
generate mice in which the gene is removed (referred to as "knockout mice"), or
is over-produced (referred to as "transgenic mice"), or in which a
color-producing gene is substituted for the gene of interest (referred to as
"reporter knockin mice") to identify which cells in the body are expressing the
gene. Until recently, technical hurdles involved in the generation of mouse
models restricted the ability to produce multiple models quickly and
efficiently. We have developed proprietary technology that we believe will allow
for the rapid and efficient production of genetically modified mice on a high
throughput scale enabling rapid assignment of function to gene sequences.
DESIGNER PROTEIN THERAPEUTICS(TM): In cases in which the natural gene
product is itself not a product candidate, we utilize our Designer Protein
Therapeutics platform to genetically engineer product candidates with the
desired properties. We use these technologies to develop derivatives of growth
factors and their receptors, which can allow for modified agonistic or
antagonistic properties that may prove to be therapeutically useful. Examples
include the generation of AXOKINE and the development of Cytokine Traps and the
VEGF Trap. This technology platform has already produced more than 10 patented
proteins, including the IL-1 Trap currently in Phase I clinical testing, and
several others in preclinical development.
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COLLABORATIVE RELATIONSHIPS
In addition to our independent programs, we currently conduct programs in
collaboration with academic and corporate partners. We have entered into
research collaboration and licensing agreements with various corporate partners,
including Procter & Gamble, Medarex, Amgen, and Sumitomo Pharmaceuticals.
PROCTER & GAMBLE. In May 1997, we entered into a long-term collaboration
agreement with Procter & Gamble to discover, develop, and commercialize
pharmaceutical products. Procter & Gamble agreed over the first five years of
the 1997 collaboration to purchase up to $60.0 million of our equity, of which
$42.9 million was purchased in June 1997 and $17.1 million was purchased in
August 2000. These equity purchases were in addition to a purchase by Procter &
Gamble of $10.0 million of our common stock that was completed in March 1997.
Procter & Gamble also agreed over the first five years of the 1997 collaboration
to provide funding in support of our research efforts related to the
collaboration, of which we had received $44.9 million through December 31, 2000.
In September 1997, we and Procter & Gamble amended the 1997 collaboration
agreement to include AXOKINE and related molecules. Procter & Gamble paid us
research progress payments of $5.0 million in 1997 and $5.0 million in 1998 upon
the achievement of defined milestones related to AXOKINE. During the third
quarter of 1999, Procter & Gamble returned the product rights to AXOKINE to us
and ended related research support for our AXOKINE program. However, Procter &
Gamble will be entitled to receive a small royalty on any sales of AXOKINE.
In August 2000, Procter & Gamble made two non-recurring research progress
payments to us totaling $3.5 million. In addition, in August 2000, we and
Procter & Gamble agreed through a binding memorandum of understanding to enter
into a new collaboration agreement, replacing the companies' 1997 collaboration
agreement. The new agreement extends Procter & Gamble's obligation to fund our
research under the new collaboration through December 2005, with no further
research obligations by either party thereafter, and focuses the companies'
collaborative research on therapeutic areas that are of particular interest to
Procter & Gamble, including muscle atrophy and muscle diseases, fibrotic
diseases, and selected G-Protein Coupled Receptors. For each of these program
areas, the parties contribute research activities and necessary intellectual
property rights pursuant to mutually agreed upon plans and budgets established
by operating committees. Neither party may independently perform research on
targets subject to research or development activities under the collaboration.
In addition, during the research term and for five years thereafter, neither
party may develop or commercialize a product that competes with a product
developed as part of the collaboration.
Pursuant to the August 2000 binding memorandum of understanding, we and
Procter & Gamble have divided rights to the programs from the 1997 collaboration
agreement that are no longer part of the companies' collaboration. Procter &
Gamble has obtained rights to certain early stage programs. We have rights to
all other research programs including exclusive rights to the VEGF Trap, the
Angiopoietins and Regeneron's Orphan Receptors (RORs). Any drugs that result
from the new collaboration will continue to be jointly developed and marketed
worldwide, with the companies equally sharing development costs and profits.
Under the new agreement, beginning in the first quarter of 2001, research
support from Procter & Gamble will be $2.5 million per quarter (before
adjustments for future inflation) through December 2005.
The new collaboration agreement will expire on the later of December 31,
2005 or the termination of research, development, or commercial activities
relating to compounds that meet predefined success criteria before that date. In
addition, if either party successfully develops a compound covered under the
agreement to a predefined development stage during the two-year period following
December 31, 2005, the parties shall meet to determine whether to reconvene
joint development of the compound under the agreement. The agreement is also
subject to termination if either party enters bankruptcy, breaches its material
obligations, or undergoes a change of control.
In addition to these termination rights, the agreement with Procter &
Gamble has an "opt-out" provision, whereby a party may decline to participate
further in a research or product development program. In such cases, the
opting-out party will generally not have any further funding obligation and will
not have any rights to the product or program in question (but may be entitled
to a royalty on any product sales). If Procter &
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Gamble opts out of a product development program, and we do not find a new
partner, we would bear the full cost of the program.
MEDAREX. In March 2000, we entered into a collaboration under a binding
memorandum of understanding with Medarex to discover, develop, and commercialize
human antibodies as therapeutics. We will contribute our expertise in
discovering and characterizing proteins as drug targets, and Medarex will
contribute its HuMAb-Mouse(TM) technology to create fully human antibody
products for those targets. Together we have selected more than twenty initial
targets, including growth factors, cytokines, and receptors, and plan to add
additional targets in the future. We and Medarex intend to prioritize targets
based upon a variety of criteria, including target validation, reagent
availability, market opportunity, competitive factors, intellectual property
position, and the expected feasibility of obtaining antibodies that have the
desired properties. The HuMAb-Mouse is a transgenic mouse whose genes for
creating mouse antibodies have been inactivated and replaced by human antibody
genes. This makes it possible to rapidly create and develop fully human
antibodies as drug candidates.
Under the agreement, Medarex and we will share equally all development,
manufacturing, and clinical costs of jointly developed products and all net
profits and losses. Each of us has the right to opt out of the joint development
of an antigen target and receive instead milestones and royalty payments on net
sales as may be negotiated by the parties. The agreement terminates upon the
later of three years or the date on which neither party is exploiting any
jointly developed products. During the term of the agreement, neither party may
independently develop any antibody-based products against any of the targets
included within the collaboration. In addition, we and Medarex have agreed not
to purchase more than twenty percent of each other's stock.
EMISPHERE. In March 2000, we signed an agreement with Emisphere to
establish a research and development collaboration to utilize Emisphere's oral
drug delivery technology for AXOKINE. In preliminary preclinical pharmacokinetic
studies, the Emisphere technology was able to achieve measurable blood levels of
AXOKINE. Under the terms of the agreement, we will support research at Emisphere
and make payments, including license and milestone payments, based on the
satisfaction of pre-determined criteria during the development of orally
delivered AXOKINE. The parties have established a steering committee to
determine these milestones, which trigger either payment obligations or
termination rights for us. The first of these milestones is based on the status
of the program as of March 31, 2001. The steering committee shall meet on at
least a quarterly basis to review the results of the program. In addition, the
agreement is also subject to termination if either party breaches its material
obligations thereunder. During the term of the agreement, we will receive
exclusive worldwide commercialization rights to oral products that result from
the collaboration and pay Emisphere a royalty on sales of any such products.
SHEARWATER. In December 2000, we entered into a license and supply
agreement with Shearwater Corporation under which Shearwater will develop and
supply a pegylated reagent that could be used to formulate a modified form of
AXOKINE. In preclinical studies, a pegylated AXOKINE was substantially longer
lasting than unmodified AXOKINE. This may allow less frequent and/or lower
dosing in patients. Under the terms of the agreement, Shearwater will develop
and supply the reagent and we will manufacture and have exclusive rights to
pegylated AXOKINE. Shearwater is entitled to receive milestone payments based on
the development of the modified AXOKINE and will be the exclusive supplier of
the reagent. We will pay Shearwater a royalty not to exceed 2.5% on sales of any
pegylated AXOKINE. The agreement remains in force until the later of ten years
from the grant of the first marketing approval for a pegylated AXOKINE or the
last to expire patent covering Shearwater's pegylated reagent. In addition, each
party shall have the right to terminate the agreement upon bankruptcy of the
other party or the other party's breach of a material obligation under the
agreement. We have additional termination rights if market or other conditions,
including regulatory restrictions, seriously inhibit the ability to develop or
market pegylated AXOKINE.
AMGEN. In August 1990, we entered into a collaboration agreement with
Amgen to develop and attempt to commercialize two proprietary products, BDNF and
NT-3, in the United States. Pursuant to the agreement with Amgen, we formed a
partnership with Amgen (Amgen-Regeneron Partners) to complete the development
and commercialization of these product candidates. We are required to fund 50%
of the development costs of Amgen-Regeneron Partners to maintain 50% of the
commercialization rights. Assuming equal capital
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contributions to Amgen-Regeneron Partners, we and Amgen share any profits or
losses of Amgen-Regeneron Partners equally. Under our agreement with Amgen we
are attempting to develop with Amgen and, if such effort is successful,
commercialize, market and distribute NT-3 in the United States through Amgen-
Regeneron Partners.
Our agreement with Amgen will continue for the longer of the life of the
patents covering NT-3 or BDNF or fifteen years from the date on which either
product candidate is approved for commercial marketing in any country. The
agreement is also subject to termination if either party enters into bankruptcy
or breaches its material obligations thereunder. During the term of the
agreement, there are restrictions on the ability of either party to
independently conduct research or development of NT-3 or BDNF without the other
party. Our aggregate capital contribution to Amgen-Regeneron Partners from the
partnership's inception in June 1993 through December 31, 2000 was $56.2
million. We expect that our capital contributions for 2001 will total at least
$2.2 million. These contributions could increase or decrease, depending upon,
among other things, the nature and cost of ongoing and additional NT-3 studies
that Amgen-Regeneron Partners may conduct, the outcomes of those studies, and
costs associated with the discontinuation of the BDNF studies.
The development and commercialization of NT-3 outside of the United States,
Japan, China, and certain other Pacific Rim countries, if any, will be conducted
solely by Amgen through a license from us and from Takeda Chemical Industries,
Ltd. In return, we will receive royalty payments based on Amgen's net sales of
any products in the licensed territory. In the licensed territory, Amgen is
solely responsible for funding clinical development and related costs of the
licensed products, as well as costs of their commercial exploitation, and has
sole discretion with respect to all such development, manufacturing, and
marketing of the products and sole responsibility for filing applications for
regulatory approvals.
Amgen-Regeneron Partners was conducting clinical trials of BDNF for the
treatment of amyotrophic lateral sclerosis (or ALS). Following notification that
BDNF did not provide any therapeutic advantage to ALS patients in the clinical
trials, we and Amgen discontinued the development of BDNF for ALS in January
2001.
During October 2000, we and Amgen entered into an agreement whereby we
acquired Amgen's patents and patent applications relating to CNTF and related
molecules for $1.0 million. As part of this agreement, we granted back to Amgen
exclusive, royalty free rights under these patents and patent applications
solely for human ophthalmic uses. In addition, we agreed not to sue Amgen under
our patents and patent applications relating to CNTF and related molecules
solely for human ophthalmic uses.
SUMITOMO. In March 1989, Sumitomo Chemical Company, Ltd. entered into a
Technology Development Agreement with us and paid us $5.6 million. In addition,
Sumitomo Chemical purchased $4.4 million of our equity. In connection with this
agreement, we granted Sumitomo Chemical a limited right of first negotiation,
over a fifteen year period, to license up to three of our product candidates to
commercialize in Japan on financial and commercial terms as we may offer. If
Sumitomo Chemical decides it does not wish to enter into a license agreement
with us on the terms we propose, we are free to license the product candidate to
any other third party in Japan on terms and conditions no more favorable to a
third party licensee than those offered to Sumitomo Chemical. We are obligated
periodically to inform and, if requested, to meet with Sumitomo Chemical
management about our progress in research and development. This agreement shall
expire on the earlier of March 20, 2004 or the date that Sumitomo Chemical
licenses three product candidates from us, provided that the parties may extend
the agreement for an additional five-year term.
BDNF is licensed to Sumitomo Pharmaceuticals Company, Ltd. (a subsidiary of
Sumitomo Chemical) for development in Japan. Under our agreement, we supply
Sumitomo Pharmaceuticals with BDNF for clinical and preclinical testing and
receive payments for manufacturing costs and research progress payments based on
the development of BDNF. In addition, we will receive a royalty based on any
potential BDNF sales in Japan. The agreement expires at the later of fifteen
years from the date of the first commercial sale of BDNF in Japan and the last
to expire patent covering BDNF in Japan. In addition, Sumitomo Pharmaceuticals
has the unilateral right to terminate the agreement at any time. In light of the
recent Amgen-Regeneron Partners' clinical trial results for BDNF, it is likely
that Sumitomo Pharmaceuticals will exercise its discretionary right to terminate
the license with us for BDNF and, other than amounts currently outstanding
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and any wind-down costs, we would not expect to receive further payments from
Sumitomo Pharmaceuticals for research progress payments, contract research and
development, or contract manufacturing. We recognized revenue from Sumitomo
Pharmaceuticals of $7.6 million in 2000, $0.1 million in 1999, and $8.8 million
in 1998.
MANUFACTURING
We maintain an 8,000 square foot manufacturing facility in Tarrytown, New
York. This facility, which was designed to comply with FDA current good
manufacturing practices (called GMP), produces preclinical and clinical supplies
of our product candidates.
In 1993, we purchased our 100,000 square foot Rensselaer, New York
manufacturing facility, which is being used to manufacture drugs for our own
preclinical and clinical studies. We also use the facility to manufacture a
product for Merck under a long-term contract.
Currently, we dedicate approximately 200 people to our manufacturing
operations at these facilities.
In 1995, we entered into a long-term manufacturing agreement with Merck &
Co., Inc. (called, as amended, the Merck Agreement) to produce an intermediate
for a Merck pediatric vaccine at our Rensselaer facility. We agreed to modify
portions of our facility for manufacture of the Merck intermediate and to assist
Merck in securing regulatory approval for manufacturing in the Rensselaer
facility. In December 1999, we announced that the FDA had approved us as a
contract manufacturer for the Merck intermediate. Under the Merck Agreement, we
will manufacture intermediate for Merck for six years, with certain minimum
order quantities each year. The Merck Agreement is expected to extend to 2005
and may be terminated at any time by Merck upon payment of a termination fee.
Merck agreed to reimburse us for the capital costs to modify the facility and
for the cost of our activities performed on behalf of Merck prior to the start
of production. Merck also agreed to pay an annual facility fee of $1.0 million,
subject to annual adjustment for inflation, reimburse us for certain
manufacturing costs, pay us a variable fee based on the quantity of intermediate
supplied to Merck, and make certain additional payments. We recognized contract
manufacturing revenue related to the Merck Agreement of $12.5 million in 2000,
$10.0 million in 1999, and $9.1 million in 1998. We cannot assure you that we
will be able to manufacture the Merck intermediate successfully for six years,
or that Merck will not terminate the Merck Agreement. Either of these events
could have a severe negative impact on our financial condition, results of
operations, and cash flow.
Among the conditions for regulatory marketing approval of a drug is the
requirement that the prospective manufacturer's quality control and
manufacturing procedures conform to the GMP regulations of the health authority.
In complying with standards set forth in these regulations, manufacturers must
continue to expend time, money, and effort in the area of production and quality
control to ensure full technical compliance. Manufacturing establishments, both
foreign and domestic, are also subject to inspections by or under the authority
of the FDA and by other federal, state, and local agencies. If our manufacturing
facilities fail to comply with FDA and other regulatory requirements, we will be
required to suspend manufacturing. This will have a material adverse effect on
our financial condition, results of operations, and cash flow.
COMPETITION
There is substantial competition in the biotechnology and pharmaceutical
industries from pharmaceutical, biotechnology, and chemical companies. Many of
our competitors have substantially greater research, preclinical, and clinical
product development and manufacturing capabilities, and financial, marketing,
and human resources than we do. Our smaller competitors may also be significant
if they acquire or discover patentable inventions, form collaborative
arrangements, or merge with large pharmaceutical companies. Even if we achieve
product commercialization, one or more of our competitors may achieve product
commercialization earlier than we do or obtain patent protection that dominates
or adversely affects our activities. Our ability to compete will depend on how
fast we can develop safe and effective product candidates, complete clinical
testing and approval processes and supply commercial quantities of the product
to the market. Competition among product candidates approved for sale will also
be based on efficacy, safety, reliability, availability, price, patent position,
and other factors.
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AXOKINE: There is substantial competition in the discovery and development
of treatments for obesity. In addition, there are well-established and
cost-effective prescription and over-the-counter treatments for this condition.
For example, Hoffmann-La Roche and Knoll Pharmaceuticals already market well-
established drugs for the treatment of obesity and Amgen and a number of other
pharmaceutical companies are developing leptin and related molecules. Clinical
trials of leptin are under way. Some of these drugs may offer competitive
advantages over AXOKINE. For example, AXOKINE currently is available only in
injectible form, while the currently available marketed drugs for the treatment
of obesity are delivered in oral dosage forms, which generally are favored by
patients over injectible drugs. Therefore, even if AXOKINE is approved for sale,
the fact that it must be delivered by injection may severely limit its market
acceptance among patients and physicians.
CYTOKINE TRAPS: Similarly, marketed products for the treatment of
rheumatoid arthritis and asthma are available as either oral or inhaled drugs,
whereas our Cytokine Traps currently are only planned for clinical trials as
injectibles. The markets for both rheumatoid arthritis and asthma are very
competitive. Several new, highly successful drugs recently became available for
these disease states. Examples include the TNF-antagonists Enbrel(R) (a
registered trademark of Immunex Corporation) and Remicade(R) (a registered
trademark of Centocor, Inc.) for rheumatoid arthritis and the
leukotriene-modifier Singulair(R) (a registered trademark of Merck & Co., Inc.),
as well as various inexpensive corticosteroid drugs for asthma.
VEGF TRAP: Many companies are developing drugs designed to block the
actions of VEGF specifically and angiogenesis in general. A variety of
approaches have been employed, including antibodies to VEGF, antibodies to the
VEGF receptor, small molecule antagonists to the VEGF receptor tyrosine kinase,
as well as multiple other anti-angiogenesis strategies. Many of these
alternative approaches may offer competitive advantages to our VEGF Trap in
efficacy, side-effect profile, cost, or form of delivery. Additionally, many of
these developmental drugs may be at a more advanced stage of development than
our product candidate.
NT-3: The treatment of constipating conditions is highly competitive, with
a number of companies providing over-the-counter remedies and other competitors
attempting to discover and develop improved over-the-counter or prescription
treatments. These products may offer competitive advantages over our NT-3
product candidate in efficacy, side-effect profile, cost, or form of delivery.
OTHER AREAS: Many pharmaceutical and biotechnology companies are
attempting to discover and develop small-molecule based therapeutics, similar in
at least certain respects to our program with Procter & Gamble. In these and
related areas, intellectual property rights have been sought and certain rights
have been granted to competitors and potential competitors of ours and we may be
at a substantial competitive disadvantage in such areas as a result of, among
other things, our lack of experience, trained personnel, and expertise. A number
of corporate and academic competitors are involved in the discovery and
development of novel therapeutics using tyrosine kinase receptors, orphan
receptors, and compounds that are the focus of other research or development
programs we are now conducting. These competitors include Amgen and Genentech,
Inc., as well as many others. Many firms and entities are engaged in research
and development in the areas of cytokines, interleukins, angiogenesis, and
muscle conditions. Some of these competitors are currently conducting advanced
preclinical and clinical research programs in these areas. These and other
competitors may have established substantial intellectual property and other
competitive advantages.
If a competitor announces a successful clinical study involving a product
that may be competitive with one of our product candidates or an approval by a
regulatory agency of the marketing of a competitive product, such announcement
may have a material adverse effect on our operations, or future prospects, or
the price of our common stock.
We also compete with academic institutions, governmental agencies, and
other public or private research organizations, which conduct research, seek
patent protection, and establish collaborative arrangements for the development
and marketing of products that would provide royalties for use of their
technology. These institutions are becoming more active in seeking patent
protection and licensing arrangements to collect royalties for use of the
technology that they have developed. Products developed in this manner may
compete directly with products we develop. We also compete with others in
acquiring technology from such institutions, agencies, and organizations.
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PATENTS, TRADEMARKS AND TRADE SECRETS
Our success depends, in part, on our ability to obtain patents, maintain
trade secret protection, and operate without infringing on the proprietary
rights of third parties. Our policy is to file patent applications to protect
technology, inventions, and improvements that are considered important to the
development of our business. We have been granted 55 U.S. patents and we have
more than 100 pending applications. We are the exclusive or nonexclusive
licensee of a number of additional U.S. patents and patent applications. We also
rely upon trade secrets, know-how, and continuing technological innovation to
develop and maintain our competitive position. We or our licensors or
collaborators have filed patent applications on products and processes relating
to AXOKINE, Cytokine Traps, VEGF Trap, Angiopoietins, and NT-3, as well as other
technologies and inventions in the United States and in certain foreign
countries. We intend to file additional patent applications, when appropriate,
relating to improvements in these technologies and other specific products and
processes. We plan to aggressively prosecute, enforce, and defend our patents
and other proprietary technology.
In September 2000, Immunex Corporation filed a request with the European
Patent Office seeking the declaration of an Opposition regarding our European
patent relating to Cytokine Traps. This is a legal challenge to the validity and
scope of our patent. Although we plan to defend the patent diligently, the scope
of the patent may be adversely affected following the outcome of the Opposition.
Patent law relating to the patentability and scope of claims in the
biotechnology field is evolving and our patent rights are subject to this
additional uncertainty. Others may independently develop similar products or
processes to those developed by us, duplicate any of our products or processes
or, if patents are issued to us, design around any products and processes
covered by our patents. We expect to continue to file product and process patent
applications with respect to our inventions. However, we cannot assure you that
we will file any such applications or, if filed, that the patents will be
issued. Patents issued to or licensed by us may be infringed by the products or
processes of others.
Defense and enforcement of our intellectual property rights can be
expensive and time consuming, even if the outcome is favorable to us. It is
possible that patents issued to or licensed to us will be successfully
challenged, that a court may find that we are infringing validly issued patents
of third parties, or that we may have to alter our products or processes or pay
licensing fees or cease certain activities to take into account patent right of
third parties, causing additional unexpected costs and delays which may have a
material adverse effect on us.
GOVERNMENT REGULATION
Regulation by government authorities in the United States and foreign
countries is a significant factor in the research, development, manufacture, and
marketing of our product candidates. All of our product candidates will require
regulatory approval before they can be commercialized. In particular, human
therapeutic products are subject to rigorous preclinical and clinical trials and
other premarket approval requirements by the FDA and foreign authorities. Many
aspects of the structure and substance of the FDA and foreign pharmaceutical
regulatory practices have been reformed during recent years, and continued
reform is under consideration in a number of forums. The ultimate outcome and
impact of such reforms and potential reforms cannot be reasonably predicted.
Clinical trials are conducted in accordance with certain standards under
protocols that detail the objectives of the study, the parameters to be used to
monitor safety, and the efficacy criteria to be evaluated. Each protocol must be
submitted to the FDA. The phases of clinical studies may overlap. The
designation of a clinical trial as being of a particular phase is not
necessarily indicative that such a trial will be sufficient to satisfy the
parameters of a particular phase, and a clinical trial may contain elements of
more than one phase notwithstanding the designation of the trial as being of a
particular phase. We cannot assure you that the results of preclinical studies
or early stage clinical trials will predict long-term safety or efficacy of our
compounds when they are tested or used more broadly in humans. Various federal
and state statutes and regulations also govern or influence the research,
manufacture, safety, labeling, storage, record keeping, marketing, transport, or
other aspects of such products. The lengthy process of seeking these approvals
and the
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compliance with applicable statutes and regulations require the expenditure of
substantial resources. Any failure by us or our collaborators or licensees to
obtain, or any delay in obtaining, regulatory approvals could adversely affect
the marketing of our products and our ability to receive product or royalty
revenue.
In addition to the foregoing, our present and future business will be
subject to regulation under the United States Atomic Energy Act, the Clean Air
Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation
and Liability Act, the National Environmental Policy Act, the Toxic Substances
Control Act, and the Resource Conservation and Recovery Act, national
restrictions, and other present and potential future local, state, federal, and
foreign regulations.
EMPLOYEES
As of December 31, 2000, we had 491 full-time employees, 85 of whom held a
Ph.D. or M.D. degree or both. We believe that we have been successful in
attracting skilled and experienced personnel in a highly competitive
environment; however, competition for these personnel is intense. None of our
personnel are covered by collective bargaining agreements and our management
considers its relations with our employees to be good.
ITEM 2. PROPERTIES
We conduct our research, development, manufacturing, and administrative
activities at our own facilities. We currently lease approximately 145,600
square feet, and sublease approximately 9,100 square feet, of office,
laboratory, and manufacturing space in Tarrytown, New York. The current monthly
base rental charge is $261,565 plus additional rental charges for utilities,
increases in taxes, and operating expenses, as defined. The lease and sublease
expire on June 30, 2003 and December 31, 2002, respectively, and we have renewal
options to extend the agreements for an additional five-year period. We own the
Rensselaer facility, consisting of two buildings totaling approximately 104,000
square feet of research, manufacturing, office, and warehouse space.
As our activities expand, additional space may be required. In the future,
we may locate, lease, operate, or purchase additional facilities in which to
conduct expanded research and development activities and manufacturing and
commercial operations.
ITEM 3. LEGAL PROCEEDINGS
In September 2000, Immunex filed a request with the European Patent Office
seeking the declaration of an Opposition regarding the scope of our European
patent relating to Cytokine Traps. This is a legal challenge to the validity and
scope of our patent. Although we plan to defend the patent diligently, the scope
of the patent may be adversely affected following the outcome of the Opposition.
In addition to this patent challenge, we have from time to time been subject to
legal claims arising in connection with our business. While the ultimate results
of the patent challenge and legal claims cannot be predicted with certainty, at
December 31, 2000, there were no asserted claims against us which, in the
opinion of management, if adversely decided, would have a material adverse
effect on our financial position or results of operations.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
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EXECUTIVE OFFICERS OF THE REGISTRANT
Listed below are our executive officers as of February 28, 2001. There are
no family relationships between any of the executive officers and there is no
arrangement or understanding between any executive officer and any other person
pursuant to which the executive officer was selected. At the annual meeting of
the Board of Directors, which follows the Annual Meeting of Shareholders,
executive officers are elected by the Board to hold office for one year and
until their respective successors are elected and qualified, or until their
earlier resignation or removal.
NAME AGE POSITION
- ---- --- --------
Leonard S. Schleifer, M.D., Ph.D. ........ 48 President, Chief Executive Officer, and Founder
George D. Yancopoulos, M.D., Ph.D. ....... 41 Executive Vice President and Chief Scientific
Officer, and President, Regeneron Research
Laboratories
Murray A. Goldberg........................ 56 Senior Vice President, Finance & Administration,
Chief Financial Officer, Treasurer, and Assistant
Secretary
Randall G. Rupp, Ph.D. ................... 53 Senior Vice President, Manufacturing and Process
Sciences
Neil Stahl, Ph.D. ........................ 44 Senior Vice President, Preclinical Development and
Biomolecular Science
Information with regard to our directors is incorporated by reference to
the Regeneron Pharmaceuticals, Inc. Proxy Statement to be filed in connection
with solicitation of proxies for our Annual Meeting of Shareholders to be held
on June 8, 2001.
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PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our Common Stock is quoted on The Nasdaq Stock Market under the symbol
"REGN." Our Class A Stock, par value $.001 per share, is not publicly quoted or
traded.
The following table sets forth, for the periods indicated, the range of
high and low bid quotations for the Common Stock as reported by The Nasdaq Stock
Market. The bid prices reflect inter-dealer quotations without retail mark-ups,
mark-downs, or commissions and do not necessarily represent actual transactions.
HIGH LOW
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1999
First Quarter............................................. $10.125 $ 6.375
Second Quarter............................................ 8.250 5.375
Third Quarter............................................. 9.938 6.875
Fourth Quarter............................................ 13.000 6.500
2000
First Quarter............................................. $57.375 $10.953
Second Quarter............................................ 32.625 15.125
Third Quarter............................................. 36.250 24.625
Fourth Quarter............................................ 41.688 19.625
As of February 23, 2001, there were 608 shareholders of record of our
Common Stock and 65 shareholders of record of our Class A Stock. The closing bid
price for the Common Stock on that date was $32.00.
We have never paid cash dividends and do not anticipate paying any in the
foreseeable future. In addition, under the terms of our financing from the New
York State Urban Development Corporation for the purchase and renovation of our
Rensselaer facility, we are not permitted to declare or pay cash dividends to
our shareholders.
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ITEM 6. SELECTED FINANCIAL DATA
The selected financial data set forth below for the years ended December
31, 2000, 1999, and 1998 and at December 31, 2000 and 1999 are derived from and
should be read in conjunction with our audited financial statements, including
the notes thereto, included elsewhere in this report. The selected financial
data for the years ended December 31, 1997 and 1996 and at December 31, 1998,
1997, and 1996 are derived from our audited financial statements not included in
this report.
YEAR ENDED DECEMBER 31,
-------------------------------------------------------
2000 1999 1998 1997 1996
-------- -------- ------- -------- --------
(IN THOUSANDS, EXCEPT PER SHARE DATA)
STATEMENT OF OPERATIONS DATA
Revenues
Contract research and
development..................... $ 36,478 $ 24,539 $19,714 $ 17,400 $ 17,303
Research progress payments......... 6,200 9,500 5,000
Contract manufacturing............. 16,598 9,960 9,113 4,458 2,451
-------- -------- ------- -------- --------
59,276 34,499 38,327 26,858 19,754
-------- -------- ------- -------- --------
Expenses
Research and development........... 56,256 44,940 37,047 27,770 28,269
General and administrative......... 8,309 6,355 5,838 5,765 5,880
Depreciation and amortization...... 4,421 3,426 3,019 4,389 6,084
Contract manufacturing............. 15,566 3,612 5,002 2,617 1,115
-------- -------- ------- -------- --------
84,552 58,333 50,906 40,541 41,348
-------- -------- ------- -------- --------
Loss from operations................. (25,276) (23,834) (12,579) (13,683) (21,594)
-------- -------- ------- -------- --------
Other income (expense)
Investment income.................. 8,480 5,207 6,866 6,242 4,360
Loss in Amgen-Regeneron Partners... (4,575) (4,159) (2,484) (3,403) (14,250)
Interest expense................... (281) (284) (428) (735) (940)
-------- -------- ------- -------- --------
3,624 764 3,954 2,104 (10,830)
-------- -------- ------- -------- --------
Net loss before cumulative effect of
a change in accounting principle... (21,652) (23,070) (8,625) (11,579) (32,424)
Cumulative effect of adopting Staff
Accounting Bulletin 101 ("SAB
101").............................. (1,563)
-------- -------- ------- -------- --------
Net loss............................. $(23,215) $(23,070) $(8,625) $(11,579) $(32,424)
======== ======== ======= ======== ========
Net loss per share, basic and
diluted:
Net loss before cumulative effect
of a change in accounting
principle....................... $ (0.62) $ (0.74) $ (0.28) $ (0.40) $ (1.33)
Cumulative effect of adopting
SAB 101......................... (0.04)
-------- -------- ------- -------- --------
Net loss per share................. $ (0.66) $ (0.74) $ (0.28) $ (0.40) $ (1.33)
======== ======== ======= ======== ========
AT DECEMBER 31,
------------------------------------------------------
2000 1999 1998 1997 1996
-------- ------- -------- -------- -------
(IN THOUSANDS)
BALANCE SHEET DATA
Cash, cash equivalents, and marketable
securities.......................... $154,370 $93,599 $113,530 $128,041 $97,028
Total assets.......................... 208,274 136,999 156,915 168,380 137,582
Capital lease obligations and note
payable, long-term portion.......... 2,069 2,731 3,066 3,752 5,148
Stockholders' equity.................. 182,130 109,532 131,227 138,897 106,931
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
GENERAL
We are a biopharmaceutical company that discovers, develops, and intends to
commercialize therapeutic drugs for the treatment of serious medical conditions.
Our product pipeline includes product candidates for the treatment of obesity,
rheumatoid arthritis and other inflammatory conditions, cancer and related
disorders, allergies, asthma, and other diseases and disorders. Since inception
we have not generated sales or any profits from the commercialization of any of
our product candidates.
Below is a summary of our leading clinical programs, as well as several
product candidates that are expected to enter clinical trials over the next two
years. We retain sole ownership and marketing rights for each of these programs
and currently are developing them independent of any corporate partners.
- AXOKINE(R): Acts on the brain region regulating food intake and energy
expenditure and is being developed for the treatment of obesity. In
November 2000, we announced the preliminary results of a twelve-week
Phase II dose-ranging trial of AXOKINE in 170 severely obese patients. In
the trial, AXOKINE was generally well tolerated and patients treated with
AXOKINE showed medically meaningful and statistically significant weight
loss compared to those receiving placebo. Subject to discussions with the
FDA, we intend to initiate Phase III testing of AXOKINE in severely obese
patients in mid-2001.
- PEGYLATED AXOKINE: Chemically modified version of AXOKINE that is being
developed as a more potent, longer-acting form of the protein. Pegylated
AXOKINE currently is in late-stage preclinical development and we
anticipate initiating a Phase I clinical trial in mid-2001.
- INTERLEUKIN-1 CYTOKINE TRAP (IL-1 TRAP): Protein-based antagonist for
the interleukin-1 (called IL-1) cytokine. IL-1 is thought to play a major
role in rheumatoid arthritis and other inflammatory diseases. In December
2000, we initiated a Phase I study to assess the safety and tolerability
of the IL-1 Trap in patients with rheumatoid arthritis. We expect the
study to be completed in the second half of 2001.
- INTERLEUKIN-4/INTERLEUKIN-13 CYTOKINE TRAP (IL-4/IL-13 TRAP): Protein-
based antagonist for the interleukin-4 and interleukin-13 (called IL-4
and IL-13) cytokines which are thought to play a major role in diseases
such as asthma, allergic disorders, and other inflammatory diseases. We
expect to initiate a Phase I clinical trial of a dual IL-4/IL-13 Trap for
asthma/allergy-related conditions in late 2001.
- VEGF TRAP: Protein-based antagonist to Vascular Endothelial Growth
Factor (called VEGF, also known as Vascular Permeability Factor or VPF),
which is required for the growth of blood vessels that are needed for
tumors to grow and is a potent regulator of vascular permeability and
leak. The VEGF Trap is expected to enter Phase I clinical trials in
mid-2001.
- ANGIOPOIETINS: A new family of growth factors that act specifically on
the endothelium cells that line blood vessels and may be useful for
growing blood vessels in diseased hearts and other tissues with decreased
blood flow and for repairing blood vessel leaks that cause swelling and
edema in many different diseases such as stroke, diabetic retinopathy,
and inflammatory diseases. Selected Angiopoietins, including engineered
forms of these growth factors are in preclinical development.
In addition to the above programs which we are conducting solely on our
own, we have formed collaborations to advance other research and development
efforts. We are conducting research with Procter & Gamble in muscle diseases and
other fields. We are also collaborating with Medarex to discover, develop, and
commercialize certain human antibodies as therapeutics. In partnership with
Amgen, we are conducting clinical trials with NT-3 for the treatment of
constipating conditions. In all of these research collaborations, we retain 50%
of the commercialization rights.
We have not received revenue from the commercialization of our product
candidates and may never receive such revenues. Before revenues from the
commercialization of our product candidates can be realized,
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we (or our collaborators) must overcome a number of hurdles which include
successfully completing our research and development efforts and obtaining
regulatory approval from the FDA or regulatory authorities in other countries.
In addition, the biotechnology and pharmaceutical industries are rapidly
evolving and highly competitive, and new developments may render our products
and technologies noncompetitive or obsolete.
From inception on January 8, 1988 through December 31, 2000, we had a
cumulative loss of $223.5 million. In the absence of revenues from the
commercialization of our product candidates or other sources, the amount,
timing, nature, or source of which cannot be predicted, our losses will continue
as we conduct our research and development activities. Our activities may expand
over time and may require additional resources and our operating losses may be
substantial over at least the next several years. Our losses may fluctuate from
quarter to quarter and will depend, among other factors, on the timing of
certain expenses and on the progress of our research and development efforts.
RESULTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 2000 AND 1999. Our total revenue increased to
$59.3 million in 2000 from $34.5 million in 1999. Contract research and
development revenue increased to $36.5 million in 2000 from $24.5 million in
1999. Contract research and development revenue from Procter & Gamble increased
to $28.3 million in 2000 from $20.8 million in 1999 as increased revenue under
the companies' collaboration agreement more than offset the termination of
Procter & Gamble payments related to AXOKINE research in the third quarter of
1999 after Procter & Gamble returned the product rights to AXOKINE to us.
Revenue from Amgen-Regeneron Partners increased to $6.2 million in 2000 from
$3.6 million in 1999 due to increased clinical trial activity on BDNF and NT-3.
In 2000, research progress payments consisted of two non-recurring payments
totaling $3.5 million from Procter & Gamble related to its long-term
collaboration agreement with us and a payment of $3.0 million (reduced by $0.3
million of Japanese withholding tax) from Sumitomo Pharmaceuticals related to
the development of BDNF in Japan. Contract manufacturing revenue increased to
$16.6 million in 2000, compared to $10.0 million in 1999. Contract manufacturing
revenue related to a long-term agreement with Merck to manufacture a vaccine
intermediate at the Company's Rensselaer, New York facility increased to $12.5
million in 2000 from $10.0 million in 1999. In 1999, Merck revenue was primarily
compensation for services rendered related to preparing for commercial
production, which began in the fourth quarter of 1999. In 2000, Merck revenue
primarily consisted of payments related to commercial production. In addition,
contract manufacturing revenue in 2000 included $4.1 million related to the
manufacture of clinical supplies of BDNF for Sumitomo Pharmaceuticals in
connection with a research and development agreement.
Our total operating expenses increased to $84.6 million in 2000 from $58.3
million in 1999. Research and development expenses increased to $56.3 million in
2000 from $44.9 million in 1999, primarily as a result of higher staffing and
increased activity in our preclinical and clinical research programs. Research
and development expenses were 67% of total operating expenses in 2000, compared
to 77% in 1999. General and administrative expenses increased to $8.3 million in
2000 from $6.4 million in 1999 due to higher administrative staffing and related
occupancy costs, and an increase in patent expenses related primarily to our
acquiring the patent rights to CNTF from Amgen. Depreciation and amortization
expense increased to $4.4 million in 2000 from $3.4 million in 1999, as a result
of improvements to, and purchases of equipment for, the Company's facilities in
Tarrytown, New York and Rensselaer, New York. Contract manufacturing expenses
increased to $15.6 million in 2000 from $3.6 million in 1999 due primarily to
costs associated with initiating commercial production at our Rensselaer
facility of both a vaccine intermediate for Merck and clinical supplies of BDNF
for Sumitomo Pharmaceuticals.
Our other income, net, increased to $3.6 million in 2000 from $0.8 million
in 1999. Investment income in 2000 increased to $8.5 million from $5.2 million
in 1999 due to interest earned on the proceeds of our public offering in April
2000 and our sale of Common Stock to Procter & Gamble in August 2000. The loss
in Amgen-Regeneron Partners increased to $4.6 million in 2000 from $4.2 million
in 1999 as a result of the partnership's increased clinical trial activity on
BDNF and NT-3. Interest expense was $0.3 million in both 2000 and 1999.
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During the fourth quarter of 2000, we changed our method of accounting for
revenue recognition to conform with the guidance provided by Staff Accounting
Bulletin No. 101, Revenue Recognition in Financial Statements, (SAB 101),
effective as of January 1, 2000. The cumulative effect of adopting SAB 101 as of
January 1, 2000 was to increase our net loss by $1.6 million, or $0.04 per
share, with a corresponding increase to deferred revenue which will be
recognized in future periods. The SAB 101 adjustment relates to a portion of a
1989 payment received from Sumitomo Chemical in consideration for a fifteen year
limited right of first negotiation to license up to three of our product
candidates in Japan. In 2000, we recognized contract research and development
revenue of $0.4 million that was included in the cumulative effect adjustment as
of January 1, 2000.
Our net loss in 2000 was $23.2 million, or $0.66 per share (basic and
diluted), compared to a net loss of $23.1 million, or $0.74 per share (basic and
diluted), in 1999.
YEARS ENDED DECEMBER 31, 1999 AND 1998. Our total revenue decreased to
$34.5 million in 1999 from $38.3 million in 1998, as higher contract research
and development revenue and higher contract manufacturing revenue were more than
offset by non-recurring research progress payments. Contract research and
development revenue increased to $24.5 million in 1999 from $19.7 million in
1998, as revenue from Procter & Gamble increased to $20.8 million in 1999 from
$13.5 million in 1998. Effective in the third quarter of 1999, research support
under our collaboration agreement with Procter & Gamble increased from $1.1
million per quarter to $7.0 million per quarter. However, Procter & Gamble
payments related to AXOKINE research declined in 1999 as AXOKINE progressed into
clinical trials and because Procter & Gamble stopped funding AXOKINE research in
the third quarter of 1999 after it returned the product rights to AXOKINE to us.
We also earned nominal revenue in 1999 from Sumitomo Pharmaceuticals, compared
to $4.3 million in 1998, as research payments under our research and development
agreement with Sumitomo Pharmaceuticals ended in 1998 and because we did not
supply any BDNF to Sumitomo Pharmaceuticals in 1999 for preclinical and clinical
use. In addition, in 1998 we received non-recurring research progress payments
totaling $9.5 million, consisting of $5.0 million from Sumitomo Pharmaceuticals
related to the development of BDNF in Japan (reduced by $0.5 million of Japanese
withholding tax) and $5.0 million from Procter & Gamble in connection with the
AXOKINE collaboration. Contract manufacturing revenue related to the long-term
agreement with Merck increased to $10.0 million in 1999, compared to $9.1
million in 1998, as a result of increased activity in preparation for
manufacturing Merck's vaccine intermediate.
Our total operating expenses increased to $58.3 million in 1999 from $50.9
million in 1998. Research and development expenses increased to $44.9 million in
1999 from $37.0 million in 1998, primarily as a result of higher staffing and
increased activity in our preclinical and clinical research programs. Research
and development expenses were 77% of total operating expenses in 1999, compared
to 73% in 1998. General and administrative expenses increased to $6.4 million in
1999 from $5.8 million in 1998 due primarily to an increase in patent expenses
related to U.S. and foreign patent filings and higher administrative staffing.
Depreciation and amortization expense increased to $3.4 million in 1999 from
$3.0 million in 1998, resulting primarily from improvements made to our leased
research facilities and offices in Tarrytown, New York. Contract manufacturing
expenses, which relate directly to our manufacturing agreement with Merck,
decreased to $3.6 million in 1999 from $5.0 million in 1998. During the fourth
quarter of 1999, the United States Food and Drug Administration approved
Regeneron as a contract manufacturer for the Merck intermediate, and we
commenced commercial production and began capitalizing manufacturing costs into
inventory. This resulted in a decrease in contract manufacturing expenses, as we
discontinued the expensing of pre-commercial production costs and began
capitalizing inventory costs.
Our other income, net, decreased to $0.8 million in 1999 from $4.0 million
in 1998. Investment income in 1999 decreased to $5.2 million from $6.9 million
in 1998 due mainly to lower levels of interest-bearing investments as we funded
our operations. The loss in Amgen-Regeneron Partners increased to $4.2 million
in 1999 from $2.5 million in 1998 as a result of the partnership's increased
clinical trial activity on BDNF and NT-3. Interest expense was $0.3 million in
1999 and $0.4 million in 1998.
Our net loss in 1999 was $23.1 million, or $0.74 per share (basic and
diluted), compared to a net loss of $8.6 million, or $0.28 per share (basic and
diluted), in 1998.
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LIQUIDITY AND CAPITAL RESOURCES
Since our inception in 1988, we have financed our operations primarily
through private placements and public offerings of our equity securities,
revenue earned under our agreements with Amgen, Sumitomo Chemical, Sumitomo
Pharmaceuticals, Merck, and Procter & Gamble, and investment income.
In May 1997, we entered into a long-term collaboration agreement with
Procter and Gamble. Procter & Gamble agreed over the first five years of the
1997 collaboration to purchase up to $60.0 million in Regeneron equity, of which
$42.9 million was purchased in June 1997 and $17.1 million was purchased in
August 2000, and provide funding in support of our research efforts related to
the collaboration, of which we have received $44.9 million through December 31,
2000. In August 2000, Procter & Gamble made two non-recurring research progress
payments to us totaling $3.5 million. In addition, in August 2000, we and
Procter & Gamble agreed through a binding memorandum of understanding to enter
into a new long-term collaboration agreement, replacing the companies' 1997
agreement. The new agreement will extend Procter & Gamble's obligation to fund
Regeneron's research through December 2005, with no further research obligations
by either party thereafter, and focus the companies' collaborative research on
therapeutic areas that are of particular interest to Procter & Gamble. Under the
original 1997 collaboration agreement, research support from Procter & Gamble
would have been $6.8 million per quarter, before adjustments for future
inflation, for the period from July 2000 through June 2002. Under the new
agreement, beginning in the first quarter of 2001, research support from Procter
& Gamble will be $2.5 million per quarter, before adjustments for future
inflation, through December 2005.
Our activities relating to BDNF and NT-3, as agreed upon by Amgen and us,
are being compensated by Amgen-Regeneron Partners for services rendered, and we
recognize these amounts as revenue. In January 2001, Amgen-Regeneron Partners
discontinued all development of BDNF for the potential treatment of ALS. We and
Amgen fund Amgen-Regeneron Partners through capital contributions, and must make
equal payments in order to maintain equal ownership and equal sharing of any
profits or losses from the partnership. Our aggregate capital contribution to
Amgen-Regeneron Partners from the partnership's inception in June 1993 through
December 31, 2000 was $56.2 million. We expect that our capital contributions
for 2001 will total at least $2.2 million. These contributions could increase or
decrease, depending upon, among other things, the nature and cost of ongoing and
additional NT-3 studies that Amgen-Regeneron Partners may conduct, the outcomes
of those studies, and costs associated with the discontinuation of the BDNF
studies.
In connection with our agreement to collaborate with Sumitomo
Pharmaceuticals in the research and development of BDNF in Japan, Sumitomo
Pharmaceuticals paid us $25.0 million through December 1997. We also received
research progress payments from Sumitomo Pharmaceuticals of $5.0 million
(reduced by $0.5 million of Japanese withholding tax) in August 1998 and $3.0
million (reduced by $0.3 million Japanese withholding tax) in April 2000. In
addition, Sumitomo Pharmaceuticals has paid us $27.9 million through December
31, 2000 in connection with supplying BDNF for preclinical and clinical use and
is obligated to pay us another $3.9 million for materials shipped at the end of
2000. In light of the recent BDNF clinical trial results, it is likely that
Sumitomo Pharmaceuticals will exercise its discretionary right to terminate the
license with us for BDNF and, other than amounts outstanding at December 31,
2000 and any wind-down costs, we would not expect to receive further payments
from Sumitomo Pharmaceuticals for research progress payments, contract research
and development, or contract manufacturing.
We invested $6.5 million in 2000, $5.9 million in 1999, and $3.3 million in
1998 in property, plant, and equipment. In addition, we leased $1.1 million of
equipment in 1999. In connection with the purchase and renovation of our
Rensselaer facility, we obtained financing of $2.0 million from the New York
State Urban Development Corporation in 1994, of which $1.5 million is
outstanding. Under the terms of this UDC financing, we are not permitted to
declare or pay dividends on our equity securities.
We expect that expenses related to the filing, prosecution, defense, and
enforcement of patent and other intellectual property claims will continue to be
substantial as a result of patent filings and prosecutions in the United States
and foreign countries. In September 2000, Immunex filed a request with the
European Patent Office seeking the declaration of an Opposition regarding our
European patent relating to Cytokine Traps.
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This is a legal challenge to the validity and scope of our patent and we may
incur substantial expenses in defending the patent.
As of December 31, 2000, we had no established banking arrangements through
which we could obtain short-term financing or a line of credit. We may seek
additional funding through, among other things, future collaboration agreements
and public or private financing. We cannot assure you that additional financing
will be available to us or, if available, that it will be available on
acceptable terms. In April 2000, we completed a public offering of 2.6 million
shares of Common Stock at a price of $29.75 per share and received proceeds,
after commissions and expenses, of $72.9 million. In August 2000, we sold
573,630 shares of Common Stock to Procter & Gamble at a price of $29.75 per
share and received total proceeds of $17.1 million. The sale of stock to Procter
& Gamble was made pursuant to a 1997 securities purchase agreement. In January
2001, we filed a registration statement with the Securities and Exchange
Commission (SEC) for a proposed offering of 4.0 million shares of our Common
Stock, with an additional 600,000 shares available to cover an over-allotment
option. We cannot assure you that our proposed offering will be declared
effective or, if declared effective, how many shares of our Common Stock will be
sold, what the stock's selling price per share will be, or what our net proceeds
will be from the offering.
At December 31, 2000, we had $154.4 million in cash, cash equivalents, and
marketable securities. We expect to incur substantial funding requirements for,
among other things, research and development activities (including preclinical
and clinical testing), expansion and validation of manufacturing facilities, and
the acquisition of equipment. We currently anticipate that for 2001 and 2002,
approximately 50-70% of our expenditures will be directed toward the preclinical
and clinical development of product candidates, including AXOKINE, pegylated
AXOKINE, IL-1 Trap, IL-4/IL-13 Trap, VEGF Trap, NT-3, and the Angiopoietins;
approximately 10-30% of our expenditures will cover our basic research
activities; approximately 5-15% of our expenditures will be directed toward the
continued development of our novel technology platforms, including potential
efforts to commercialize these technologies; and the remainder of our
expenditures will be for general corporate purposes, including capital
expenditures and working capital. The amount we need to fund operations and the
allocation of our resources will depend on various factors, including the status
of competitive products, the success of our research and development programs,
the potential future need to expand our professional and support staff and
facilities, the status of patents and other intellectual property rights, the
delay or failure of a clinical trial of any of our potential drug candidates,
and the continuation, extent, and success of any collaborative research
arrangements (including those with Procter & Gamble, Medarex, Emisphere, and
Amgen). We believe that our existing capital resources will enable us to meet
operating needs through the third quarter of 2002. However, this is a
forward-looking statement based on our current operating plan, and we cannot
assure you that there will be no change in projected revenues or expenses that
would lead to our capital being consumed significantly before such time. If
there is insufficient capital to fund all of our planned operations and
activities, we believe we would prioritize available capital to fund preclinical
and clinical development of our product candidates.
FUTURE IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
There are a number of recently issued accounting standards, including
Statement of Financial Accounting Standards No. 133, Accounting for Derivative
Financial Instruments and for Hedging Activities, which we will be required to
adopt in future periods. Our management believes that the future adoption of
these accounting standards will not have a material impact on our financial
statements.
FACTORS THAT MAY AFFECT FUTURE OPERATING RESULTS
We caution stockholders and potential investors that the following
important factors, among others, in some cases have affected, and in the future
could affect, our actual results and could cause our actual results to differ
materially from those expressed in any forward-looking statements made by, or on
behalf of, us. The statements under this caption are intended to serve as
cautionary statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The following information is not intended to limit in any
way the
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characterization of other statements or information under other captions as
cautionary statements for such purpose:
- Delay, difficulty, or failure of our research and development programs to
produce product candidates that are scientifically or commercially
appropriate for further development by us or others.
- Cancellation or termination of material collaborative or licensing
agreements (including in particular, but not limited to, those with
Procter & Gamble and Amgen) and the resulting loss of research or other
funding could have a material adverse effect on us and our operations. A
change of control of one or more of our material collaborators or
licensees could also have a material adverse effect on us.
- Delay, difficulty, or failure of a clinical trial of any of our product
candidates. A clinical trial can fail or be delayed as a result of many
causes, including, among others, failure of the product candidate to
demonstrate safety or efficacy, the development of serious or
life-threatening adverse events (side effects) caused by or connected
with exposure to the product candidate, difficulty in enrolling and
maintaining patients, lack of sufficient supplies of the product
candidate, and the failure of clinical investigators, trial monitors and
other consultants, or trial subjects to comply with the trial plan or
protocol.
- In addition to the safety, efficacy, manufacturing, and regulatory
hurdles faced by our drug candidates, the administration of recombinant
proteins frequently causes an immune response, resulting in the creation
of antibodies against the therapeutic protein. The antibodies can have no
effect or can totally neutralize the effectiveness of the protein, or
require that higher doses be used to obtain a therapeutic effect. In some
cases, the antibody can cross react with the patient's own proteins,
resulting in an "auto-immune type" disease. Whether antibodies will be
created can often not be predicted from preclinical experiments and their
appearance is often delayed, so that there can be no assurance that
neutralizing antibodies will not be created at a later date -- in some
cases even after pivotal clinical trials have been successfully
completed. Patients who have been treated with AXOKINE and NT-3 have
developed antibodies, though we have no information that indicates that
these antibodies are neutralizing antibodies.
- Delay, difficulty, or failure in obtaining regulatory approval (including
approval of our facilities for production) for our products, including
delays or difficulties in development because of insufficient proof of
safety or efficacy.
- Increased and irregular costs of development, manufacture, regulatory
approval, sales, and marketing associated with the introduction of
products in the late stage of development.
- Competitive or market factors that may cause use of our products to be
limited or otherwise fail to achieve broad acceptance.
- The ability to obtain, maintain, and prosecute intellectual property
rights and the cost of acquiring in-process technology and other
intellectual property rights, either by license, collaboration, or
purchase of another entity.
- Difficulties or high costs of obtaining adequate financing to fund the
cost of developing product candidates.
- Amount and rate of growth of our general and administrative expenses, and
the impact of unusual charges resulting from our ongoing evaluation of
our business strategies and organizational structure.
- Failure of corporate partners to develop or commercialize successfully
our products or to retain and expand the markets served by the commercial
collaborations; conflicts of interest, priorities, and commercial
strategies which may arise between our corporate partners and us.
- Delays or difficulties in developing and acquiring production technology
and technical and managerial personnel to manufacture novel biotechnology
product in commercial quantities at reasonable costs and in compliance
with applicable quality assurance and environmental regulations and
governmental permitting requirements.
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- Difficulties in obtaining key raw materials and supplies for the
manufacture of our product candidates.
- The costs and other effects of legal and administrative cases and
proceedings (whether civil, such as product- or employment-related, or
environmental, or criminal), settlements, and investigations;
developments or assertions by or against us relating to intellectual
property rights and licenses; the issuance and use of patents and
proprietary technology by us and our competitors, including the possible
negative effect on our ability to develop, manufacture, and sell our
products in circumstances where we are unable to obtain licenses to
patents which may be required for our products.
- Underutilization of our existing or new manufacturing facilities or of
any facility expansions, resulting in inefficiencies and higher costs;
start-up costs, inefficiencies, delays, and increased depreciation costs
in connection with the start of production in new plants and expansions.
- Health care reform, including reductions or changes in reimbursement
available for prescription medications or other reforms.
- Difficulties in attracting and retaining key personnel.
As our scientific efforts lead to potentially promising new directions,
both outside of recombinant protein therapies and into conditions or diseases
outside of our current areas of experience and expertise, we will require
additional internal expertise or external collaborations in areas in which we
currently do not have substantial resources and personnel.
To date, we have received revenues from (1) our licensees and collaborators
for research and development efforts, (2) Merck and Sumitomo Pharmaceuticals for
contract manufacturing, and (3) investment income. We may not continue to
receive these revenues from our licensees, collaborators, or contract
manufacturing customers. In the absence of revenues from the commercialization
of our product candidates or other sources, our losses will continue as we
conduct our research and development activities. Our activities may expand over
time and may require additional resources, and our operating losses may be
substantial over at least the next several years. Our losses may fluctuate from
quarter to quarter and will depend, among other factors, on the timing of
certain expenses and on the progress of our research and development efforts. We
do not know if we will ever have an approved product or achieve significant
revenues or profitable operations. We do not expect to receive any revenue from
the commercialization of our product candidates for several years and we intend
to continue to invest significantly in our research and development activities.
Even if we do successfully develop products that can be marketed and sold
commercially, we will need to generate significant revenue from products to
achieve and maintain profitability.
Most drug research and development programs never lead to the development
of commercially successful products. Only a small minority of all research and
development programs ultimately result in commercially successful drugs. We are
attempting to develop drugs for human therapeutic uses, and our research and
development activities may not be successful and none of our potential product
candidates may ever complete clinical trials. Even if clinical trials
demonstrate safety and efficacy of our product candidates and the necessary
regulatory approvals are obtained, the commercial success of any of our product
candidates will depend upon their acceptance by patients, the medical community,
and third-party payors and on our ability to successfully develop, manufacture,
and market our product candidates. If our products are not successfully
commercialized, we will not be able to recover the significant investment we
have made in developing such products and our business would be severely harmed.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK.
Our earnings and cash flows are subject to fluctuations due to changes in
interest rates primarily from our investment of available cash balances in
investment grade corporate and U.S. government securities. We do not believe we
are materially exposed to changes in interest rates. Under our current policies
we do not use interest rate derivative instruments to manage exposure to
interest rate changes.
24
26
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Our financial statements required by this item are included herein as
exhibits and listed under Item 14.(A)1.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
Not applicable.
25
27
PART III
ITEM 10. DIRECTORS AND OFFICERS OF THE REGISTRANT
Information with respect to directors and executive officers is
incorporated by reference to the material captioned "Election of Directors,"
"Executive Officers of the Registrant," and "Compliance with Section 16(b) of
the Securities Exchange Act of 1934" in the Regeneron Pharmaceuticals, Inc.
Proxy Statement to be filed in connection with solicitation of proxies for our
Annual Meeting of Shareholders to be held on June 8, 2001.
ITEM 11. EXECUTIVE COMPENSATION
The information called for by this item is incorporated by reference to the
material captioned "Executive Compensation" and "Election of Directors" in the
Regeneron Pharmaceuticals, Inc. Proxy Statement to be filed in connection with
solicitation of proxies for our Annual Meeting of Shareholders to be held on
June 8, 2001.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The information called for by this item is incorporated by reference to the
material captioned "Security Ownership of Management" and "Security Ownership of
Certain Beneficial Owners" in the Regeneron Pharmaceuticals, Inc. Proxy
Statement to be filed in connection with solicitation of proxies for our Annual
Meeting of Shareholders to be held on June 8, 2001.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information called for by this item is incorporated by reference to the
material captioned "Certain Relationships and Related Transactions" in the
Regeneron Pharmaceuticals, Inc. Proxy Statement to be filed in connection with
solicitation of proxies for our Annual Meeting of Shareholders to be held on
June 8, 2001.
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(A) 1. Financial Statements
The financials statements filed as part of this report are listed on the
Index to Financial Statements on page F-1.
2. Financial Statement Schedules
All schedules for which provision is made in the applicable accounting
regulations of the Securities and Exchange Commission are not required under the
related instructions or are inapplicable and therefore have been omitted.
3. Exhibits
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
3.1(a) Restated Certificate of Incorporation of Regeneron
Pharmaceuticals, Inc. as of June 21, 1991.
3.2(f) By-Laws of the Company, currently in effect (amended as of
January 22, 1995).
10.1(b) Certificate of Amendment of the Restated Certificate of
Incorporation of Regeneron Pharmaceuticals, Inc., as of
October 18, 1996.
10.2(c)* Technology Development Agreement dated as of March 20, 1989,
between the Company and Sumitomo Chemical Company, Limited.
26
28
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
10.3(c)* Neurotrophic Factor Agreement (License Agreement) dated as
of May 10, 1988, between the Company and Max Planck
Institute fur Psychiatric.
10.4(c)* Collaboration Agreement dated August 31, 1990, between the
Company and Amgen Inc.
10.5(c) 1990 Amended and Restated Long-Term Incentive Plan.
10.6(d)* License Agreement dated as of October 7, 1992, between the
Company and The Regents of the University of California.
10.7(e)* Research and Development Agreement dated as of June 2, 1994,
between the Company and Sumitomo Pharmaceuticals Company,
Ltd.
10.8(g)* Manufacturing Agreement dated as of September 18, 1995,
between the Company and Merck & Co., Inc.
10.9(h) Warrant Agreement dated as of April 15, 1996, between the
Company and Amgen Inc.
10.10(h) Registration Rights Agreement dated as of April 15, 1996,
between the Company and Amgen Inc.
10.11(h) Warrant Agreement dated as of June 27, 1996, between the
Company and Medtronic, Inc.
10.12(h) Registration Rights Agreement dated as of June 27, 1996,
between the Company and Medtronic, Inc.
10.13(i) Rights Agreement, dated as of September 20, 1996, between
Regeneron Pharmaceuticals, Inc. and Chase Mellon Shareholder
Services LLC, as Rights Agent, including the form of Rights
Certificate as Exhibit B thereto.
10.14(j) Stock Purchase Agreement dated as of December 11, 1996,
between the Company and Procter & Gamble Pharmaceuticals,
Inc.
10.15(j) Registration Rights Agreement dated as of December 11, 1996,
between the Company and Procter & Gamble Pharmaceuticals,
Inc.
10.16(k) Securities Purchase Agreement dated as of May 13, 1997,
between the Company and The Procter & Gamble Company.
10.17(k) Warrant Agreement dated as of May 13, 1997, between the
Company and The Procter & Gamble Company.
10.18(k) Registration Rights Agreement dated as of May 13, 1997,
between the Company and The Procter & Gamble Company.
10.19(k)* Multi-Project Collaboration Agreement dated as of May 13,
1997, between the Company and The Procter & Gamble Company.
10.20(l)* First Amendment to the Multi-Project Collaboration Agreement
dated May 13, 1997, between the Company and The Procter &
Gamble Company, dated as of September 29, 1997.
10.21(m) Employment Agreement, dated as of February 12, 1998 between
the Company and Leonard S. Schleifer, M.D., Ph.D.
23.1 Consent of PricewaterhouseCoopers LLP, Independent
Accountants.
23.2 Consent of Ernst & Young LLP, Independent Auditors.
24 Power of Attorney. Included in the signature page of this
Registration Statement.
- ---------------
DESCRIPTION:
(a) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended June 30, 1991, filed August 13, 1991.
(b) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1996, filed November 5, 1996.
27
29
(c) Incorporated by reference from the Company's registration statement on Form
S-1 (file number 33-39043).
(d) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1992, filed March 30, 1993.
(e) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1994, filed November 14, 1994.
(f) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1994, filed March 30, 1995.
(g) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1995, filed November 14, 1995.
(h) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended June 30, 1996, filed August 14, 1996.
(i) Incorporated by reference from the Form 8-A for Regeneron Pharmaceuticals,
Inc. filed October 15, 1996.
(j) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1996, filed March 26, 1997.
(k) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended June 30, 1997, filed August 12, 1997.
(l) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1997, filed November 10, 1997.
(m) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1997, filed March 26, 1998.
* Portions of this document have been omitted and filed separately with the
Commission pursuant to requests for confidential treatment pursuant to Rule
24b-2.
(B) Reports on Form 8-K
On March 29, 2000, we filed a report on Form 8-K regarding the fact that we
issued a press release entitled "Regeneron Initiates Phase II Obesity Clinical
Trial", a copy of which was included as an exhibit to that filing.
On April 4, 2000, we filed a report on Form 8-K covering the filing of the
underwriting agreement related to our sale of 2.6 million shares of Common Stock
with total proceeds to us after commissions but before expenses of $73.5
million.
28
30
SIGNATURE
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
REGENERON PHARMACEUTICALS, INC.
By: /s/ LEONARD S. SCHLEIFER
------------------------------------
Leonard S. Schleifer, M.D., Ph.D.
President and Chief Executive
Officer
Dated: New York, New York
March 2, 2001
KNOW ALL PERSONS BY THESE PRESENTS, that I the undersigned, a director of
Regeneron Pharmaceuticals, Inc., a New York corporation, do hereby constitute
and appoint Leonard S. Schleifer, Murray A. Goldberg and Stuart Kolinski, and
each of them severally to be my true and lawful attorneys-in-fact and agents
each acting alone with full power of substitution and revocation, to sign my
name to the Regeneron Pharmaceuticals, Inc. Annual Report on Form 10-K for the
year ended December 31, 2000 and any and all amendments to such Annual Report,
and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, and I hereby
grant unto said attorneys-in-fact and agents full power and authority to do and
perform each and every act and thing requisite and necessary to be done, as full
as to all intents and purposes as such person might or could do in person,
hereby ratifying and confirming all that said attorney-in-fact and agent or his
substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following person on behalf of the registrant
in the capacities indicated on March 2, 2001.
SIGNATURE TITLE
--------- -----
/s/ LEONARD S. SCHLEIFER President, Chief Executive Officer, and Director
- --------------------------------------------------- (Principal Executive Officer)
Leonard S. Schleifer, M.D., Ph.D.
/s/ MURRAY A. GOLDBERG Senior Vice President, Finance & Administration,
- --------------------------------------------------- Chief Financial Officer, Treasurer, and
Murray A. Goldberg Assistant Secretary (Principal Financial
Officer)
/s/ DOUGLAS S. MCCORKLE Controller and Assistant Treasurer (Principal
- --------------------------------------------------- Accounting Officer)
Douglas S. McCorkle
/s/ P. ROY VAGELOS Chairman of the Board
- ---------------------------------------------------
P. Roy Vagelos, M.D.
* Director
- ---------------------------------------------------
Charles A. Baker
Director
- ---------------------------------------------------
Michael S. Brown, M.D.
29
31
SIGNATURE TITLE
--------- -----
* Director
- ---------------------------------------------------
Alfred G. Gilman, M.D., Ph.D.
* Director
- ---------------------------------------------------
Joseph L. Goldstein, M.D.
Director
- ---------------------------------------------------
Fred A. Middleton
* Director
- ---------------------------------------------------
Eric M. Shooter, Ph.D.
Director
- ---------------------------------------------------
George L. Sing
*By: /s/ STUART A. KOLINSKI
---------------------------------------------
Stuart A. Kolinski, Esq.
(Attorney-in-Fact)
30
32
REGENERON PHARMACEUTICALS, INC.
INDEX TO FINANCIAL STATEMENTS
PAGE
NUMBERS
------------
REGENERON PHARMACEUTICALS, INC.
Report of Independent Accountants......................... F-2
Balance Sheets at December 31, 2000 and 1999.............. F-3
Statements of Operations for the years ended December 31,
2000, 1999, and 1998................................... F-4
Statements of Stockholders' Equity for the years ended
December 31, 2000, 1999, and 1998...................... F-5 to F-6
Statements of Cash Flows for the years ended December 31,
2000, 1999, and 1998................................... F-7
Notes to Financial Statements............................. F-8 to F-27
AMGEN-REGENERON PARTNERS
Report of Ernst & Young LLP, Independent Auditors......... F-28
Balance Sheets at December 31, 2000 and 1999.............. F-29
Statements of Operations for the years ended December 31,
2000, 1999, and 1998................................... F-30
Statements of Changes in Partners' Capital (Deficit) for
the years ended December 31, 2000, 1999, and 1998...... F-31
Statements of Cash Flows for the years ended December 31,
2000, 1999, and 1998................................... F-32
Notes to Financial Statements............................. F-33 to F-34
F-1
33
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors and Stockholders of
Regeneron Pharmaceuticals, Inc.:
In our opinion, based upon our audits and the report of other auditors, the
accompanying balance sheets and the related statements of operations,
stockholders' equity and cash flows present fairly, in all material respects,
the financial position of Regeneron Pharmaceuticals, Inc. (the "Company") at
December 31, 2000 and 1999, and the results of its operations and its cash flows
for each of the three years in the period ended December 31, 2000, in conformity
with generally accepted accounting principles in the United States of America.
These financial statements are the responsibility of the Company's management;
our responsibility is to express an opinion on these financial statements based
on our audits. We did not audit the financial statements of Amgen-Regeneron
Partners (the "Partnership"), an entity which is fifty percent owned by the
Company, as of December 31, 2000 and 1999 and for each of the three years in the
period ended December 31, 2000. The Company's investment in the Partnership is
accounted for in accordance with the equity method of accounting. At December
31, 2000, its investment constitutes less than one percent of the Company's
assets. At December 31, 1999, its obligation to the Partnership constituted less
than two percent of the Company's liabilities. For the years ended December 31,
2000, 1999 and 1998, the Company recorded its pro rata share of the
Partnership's net loss of approximately $4.6 million, $4.2 million, and $2.5
million, respectively. The Partnership's financial statements were audited by
other auditors whose report thereon has been furnished to us, and our opinion
expressed herein, insofar as it relates to the amounts included for the
Partnership, is based solely on the report of the other auditors. We conducted
our audits of these statements in accordance with generally accepted auditing
standards in the United States of America which require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant estimates made by
management, and evaluating the overall financial statement presentation. We
believe that our audits and the report of other auditors provide a reasonable
basis for the opinion expressed above.
As discussed in Note 2 to the financial statements, during the year ended
December 31, 2000, the Company changed its method of accounting for revenue
recognition, effective January 1, 2000.
PricewaterhouseCoopers LLP
New York, New York
February 7, 2001
F-2
34
REGENERON PHARMACEUTICALS, INC.
BALANCE SHEETS
DECEMBER 31, 2000 AND 1999
2000 1999
--------- ---------
(IN THOUSANDS,
EXCEPT SHARE DATA)
ASSETS
Current assets
Cash and cash equivalents................................. $ 30,978 $ 23,697
Marketable securities..................................... 86,634 42,463
Receivable due from The Procter & Gamble Company.......... 6,907
Receivable due from Merck & Co., Inc. .................... 1,447
Receivable due from Amgen-Regeneron Partners.............. 1,604 473
Receivable due from Sumitomo Pharmaceuticals Company,
Ltd. .................................................. 3,877 151
Prepaid expenses and other current assets................. 780 1,708
Inventory................................................. 1,915 4,552
--------- ---------
Total current assets................................... 134,142 73,044
Marketable securities....................................... 36,758 27,439
Investment in Amgen-Regeneron Partners...................... 267
Property, plant, and equipment, at cost, net of accumulated
depreciation and amortization............................. 36,934 36,298
Other assets................................................ 173 218
--------- ---------
Total assets........................................... $ 208,274 $ 136,999
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses..................... $ 9,446 $ 6,551
Deferred revenue, current portion......................... 3,728 4,686
Due to Merck & Co., Inc. ................................. 334
Due to Amgen-Regeneron Partners........................... 300
Capital lease obligations, current portion................ 545 1,380
Note payable, current portion............................. 67 68
--------- ---------
Total current liabilities.............................. 13,786 13,319
Deferred revenue............................................ 9,995 11,130
Capital lease obligations................................... 603 1,204
Note payable................................................ 1,466 1,527
Other liabilities........................................... 294 287
Commitments and contingencies
Stockholders' equity
Preferred stock, $.01 par value; 30,000,000 shares
authorized; issued and outstanding -- none
Class A Stock, convertible, $.001 par value; 40,000,000
shares authorized;
2,612,845 shares issued and outstanding in 2000
3,605,133 shares issued and outstanding in 1999........ 3 4
Common Stock, $.001 par value; 60,000,000 shares
authorized;
34,197,104 shares issued and outstanding in 2000
27,817,636 shares issued and outstanding in 1999....... 34 28
Additional paid-in capital................................ 406,391 310,296
Unearned compensation..................................... (1,314)
Accumulated deficit....................................... (223,518) (200,303)
Accumulated other comprehensive income (loss)............. 534 (493)
--------- ---------
Total stockholders' equity............................. 182,130 109,532
--------- ---------
Total liabilities and stockholders' equity............. $ 208,274 $ 136,999
========= =========
The accompanying notes are an integral part of the financial statements.
F-3
35
REGENERON PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999, AND 1998
2000 1999 1998
---------- ---------- ----------
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Revenues
Contract research and development........................ $ 36,478 $ 24,539 $ 19,714
Research progress payments............................... 6,200 9,500
Contract manufacturing................................... 16,598 9,960 9,113
-------- -------- --------
59,276 34,499 38,327
-------- -------- --------
Expenses
Research and development................................. 56,256 44,940 37,047
General and administrative............................... 8,309 6,355 5,838
Depreciation and amortization............................ 4,421 3,426 3,019
Contract manufacturing................................... 15,566 3,612 5,002
-------- -------- --------
84,552 58,333 50,906
-------- -------- --------
Loss from operations....................................... (25,276) (23,834) (12,579)
-------- -------- --------
Other income, net
Investment income........................................ 8,480 5,207 6,866
Loss in Amgen-Regeneron Partners......................... (4,575) (4,159) (2,484)
Interest expense......................................... (281) (284) (428)
-------- -------- --------
3,624 764 3,954
-------- -------- --------
Net loss before cumulative effect of a change in accounting
principle................................................ (21,652) (23,070) (8,625)
Cumulative effect of adopting Staff Accounting Bulletin 101
("SAB 101").............................................. (1,563)
-------- -------- --------
Net loss................................................... $(23,215) $(23,070) $ (8,625)
======== ======== ========
Net loss per share amounts, basic and diluted:
Net loss before cumulative effect of a change in
accounting principle.................................. $ (0.62) $ (0.74) $ (0.28)
Cumulative effect of adopting SAB 101.................... (0.04)
-------- -------- --------
Net loss.............................................. $ (0.66) $ (0.74) $ (0.28)
======== ======== ========
Pro forma amounts assuming SAB 101 is applied
retroactively:
Net loss.............................................. $(22,699) $ (8,254)
Net loss per share, basic and diluted................. $ (0.73) $ (0.27)
The accompanying notes are an integral part of the financial statements.
F-4
36
REGENERON PHARMACEUTICALS, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999, AND 1998
CLASS A STOCK COMMON STOCK ADDITIONAL
--------------- --------------- PAID-IN UNEARNED ACCUMULATED
SHARES AMOUNT SHARES AMOUNT CAPITAL COMPENSATION DEFICIT
------ ------ ------ ------ ---------- ------------ -----------
(IN THOUSANDS)
BALANCE, DECEMBER 31, 1997..................... 4,118 $ 4 26,805 $27 $308,109 $ (720) $(168,608)
Amortization of unearned compensation.......... 360
Issuance of Common Stock in connection with
exercise of stock options.................... 95 452
Conversion of Class A Stock to Common Stock.... (487) 487
Net loss, 1998................................. (8,625)
Change in net unrealized gain on marketable
securities...................................
----- --- ------ --- -------- ------- ---------
BALANCE, DECEMBER 31, 1998..................... 3,631 4 27,387 27 308,561 (360) (177,233)
Amortization of unearned compensation.......... 360
Issuance of Common Stock in connection with
exercise of stock options.................... 367 1 1,427
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution..... 38 308
Conversion of Class A Stock to Common Stock.... (26) 26
Net loss, 1999................................. (23,070)
Change in net unrealized gain/loss on
marketable securities........................
----- --- ------ --- -------- ------- ---------
BALANCE, DECEMBER 31, 1999..................... 3,605 4 27,818 28 310,296 (200,303)
ACCUMULATED
OTHER
COMPREHENSIVE TOTAL
INCOME STOCKHOLDERS' COMPREHENSIVE
(LOSS) EQUITY LOSS
------------- ------------- -------------
(IN THOUSANDS)
BALANCE, DECEMBER 31, 1997..................... $ 85 $138,897
Amortization of unearned compensation.......... 360
Issuance of Common Stock in connection with
exercise of stock options.................... 452
Conversion of Class A Stock to Common Stock....
Net loss, 1998................................. (8,625) $ (8,625)
Change in net unrealized gain on marketable
securities................................... 143 143 143
------ -------- --------
BALANCE, DECEMBER 31, 1998..................... 228 131,227 $ (8,482)
========
Amortization of unearned compensation.......... 360
Issuance of Common Stock in connection with
exercise of stock options.................... 1,428
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution..... 308
Conversion of Class A Stock to Common Stock....
Net loss, 1999................................. (23,070) $(23,070)
Change in net unrealized gain/loss on
marketable securities........................ (721) (721) (721)
------ -------- --------
BALANCE, DECEMBER 31, 1999..................... (493) 109,532 $(23,791)
========
F-5
37
REGENERON PHARMACEUTICALS, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY -- (CONTINUED)
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999, AND 1998
CLASS A STOCK COMMON STOCK ADDITIONAL
--------------- --------------- PAID-IN UNEARNED ACCUMULATED
SHARES AMOUNT SHARES AMOUNT CAPITAL COMPENSATION DEFICIT
------ ------ ------ ------ ---------- ------------ -----------
(IN THOUSANDS)
Issuance of Common Stock in a public offering
at $29.75 per share.......................... 2,600 3 77,347
Cost associated with issuance of equity
securities................................... (4,496)
Issuance of Common Stock in connection with
exercise of stock options.................... 707 1 4,445
Net issuance of Common Stock to Amgen Inc. in
connection with a cashless exercise of
warrants..................................... 478
Issuance of Common Stock to The Procter &
Gamble Company............................... 574 17,065
Net issuance of Common Stock to The Procter &
Gamble Company in connection with a cashless
exercise of warrants......................... 939 1 (1)
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution..... 54 421
Conversion of Class A Stock to Common Stock.... (992) (1) 992 1
Issuance of restricted Common Stock under Long-
Term Incentive Plan.......................... 35 1,314 (1,314)
Net loss, 2000................................. (23,215)
Change in net unrealized gain/loss on
marketable securities........................
----- --- ------ --- -------- ------- ---------
BALANCE, DECEMBER 31, 2000..................... 2,613 $ 3 34,197 $34 $406,391 $(1,314) $(223,518)
===== === ====== === ======== ======= =========
ACCUMULATED
OTHER
COMPREHENSIVE TOTAL
INCOME STOCKHOLDERS' COMPREHENSIVE
(LOSS) EQUITY LOSS
------------- ------------- -------------
(IN THOUSANDS)
Issuance of Common Stock in a public offering
at $29.75 per share.......................... 77,350
Cost associated with issuance of equity
securities................................... (4,496)
Issuance of Common Stock in connection with
exercise of stock options.................... 4,446
Net issuance of Common Stock to Amgen Inc. in
connection with a cashless exercise of
warrants.....................................
Issuance of Common Stock to The Procter &
Gamble Company............................... 17,065
Net issuance of Common Stock to The Procter &
Gamble Company in connection with a cashless
exercise of warrants.........................
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution..... 421
Conversion of Class A Stock to Common Stock....
Issuance of restricted Common Stock under Long-
Term Incentive Plan..........................
Net loss, 2000................................. (23,215) $(23,215)
Change in net unrealized gain/loss on
marketable securities........................ 1,027 1,027 1,027
------ -------- --------
BALANCE, DECEMBER 31, 2000..................... $ 534 $182,130 $(22,188)
====== ======== ========
The accompanying notes are an integral part of the financial statements.
F-6
38
REGENERON PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999, AND 1998
2000 1999 1998
-------- -------- -------
(IN THOUSANDS)
Cash flows from operating activities
Net loss.................................................. $(23,215) $(23,070) $(8,625)
-------- -------- -------
Adjustments to reconcile net loss to net cash used in
operating activities
Loss in Amgen-Regeneron Partners....................... 4,575 4,159 2,484
Depreciation and amortization.......................... 4,421 3,426 3,019
Stock issued in consideration for services rendered.... 360 360
Cumulative effect of a change in accounting
principle............................................ 1,563
Changes in assets and liabilities
(Increase) decrease in amounts due from The Procter &
Gamble Company.................................... (6,907) 3,169 (766)
(Increase) decrease in amounts due from Merck & Co.,
Inc............................................... (1,781) 1,999 42
(Increase) decrease in amounts due from
Amgen-Regeneron Partners.......................... (1,131) 236 (353)
(Increase) decrease in amounts due from Sumitomo
Pharmaceuticals Co., Ltd.......................... (3,726) 16 1,948
Increase in investment in Amgen-Regeneron Partners... (5,142) (768) (5,211)
Increase in prepaid expenses and other assets........ (309) (232) (704)
Decrease (increase) in inventory..................... 4,050 (4,033) (196)
(Decrease) increase in deferred revenue.............. (3,656) 143 (3,310)
Increase in accounts payable, accrued expenses, and
other liabilities................................. 3,348 1,085 1,094
-------- -------- -------
Total adjustments................................. (4,695) 9,560 (1,593)
-------- -------- -------
Net cash used in operating activities............. (27,910) (13,510) (10,218)
-------- -------- -------
Cash flows from investing activities
Purchases of marketable securities........................ (104,898) (60,067) (87,973)
Sales of marketable securities............................ 53,717 82,892 93,479
Capital expenditures...................................... (6,495) (5,682) (3,049)
-------- -------- -------
Net cash (used in) provided by investing
activities...................................... (57,676) 17,143 2,457
-------- -------- -------
Cash flows from financing activities
Net proceeds from the issuance of stock................... 94,365 1,428 452
Principal payments on note payable........................ (62) (79) (74)
Capital lease payments.................................... (1,436) (1,042) (1,781)
-------- -------- -------
Net cash provided by (used in) financing
activities...................................... 92,867 307 (1,403)
-------- -------- -------
Net increase (decrease) in cash and cash
equivalents..................................... 7,281 3,940 (9,164)
Cash and cash equivalents at beginning of period............ 23,697 19,757 28,921
-------- -------- -------
Cash and cash equivalents at end of period........ $ 30,978 $ 23,697 $19,757
======== ======== =======
Supplemental disclosure of cash flow information
Cash paid for interest.................................... $ 274 $ 265 $ 388
======== ======== =======
The accompanying notes are an integral part of the financial statements.
F-7
39
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2000, 1999, AND 1998
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
1. ORGANIZATION AND BUSINESS
Regeneron Pharmaceuticals, Inc. (the "Company" or "Regeneron") was
incorporated in January 1988 in the State of New York. The Company is engaged in
research and development programs to discover and commercialize therapeutics to
treat human disorders and conditions. The Company's facilities are located in
New York. The Company's business is subject to certain risks including, but not
limited to, uncertainties relating to conducting pharmaceutical research,
obtaining regulatory approvals, commercializing products, and obtaining and
enforcing patents.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Property, Plant, and Equipment
Property, plant, and equipment are stated at cost. Depreciation is provided
on a straight-line basis over the estimated useful lives of the assets.
Expenditures for maintenance and repairs which do not materially extend the
useful lives of the assets are charged to expense as incurred. The cost and
accumulated depreciation or amortization of assets retired or sold are removed
from the respective accounts, and any gain or loss is recognized in operations.
The estimated useful lives of property, plant, and equipment are as follows:
Building and improvements.............................. 6-30 years
Leasehold improvements................................. Life of lease
Laboratory and computer equipment...................... 3-5 years
Furniture and fixtures................................. 5 years
Cash and Cash Equivalents
For purposes of the statement of cash flows and the balance sheet, the
Company considers all highly liquid debt instruments with a maturity of three
months or less when purchased to be cash equivalents. The carrying amount
reported in the balance sheet for cash and cash equivalents approximates its
fair value.
Inventories
Inventories are stated at the lower of cost or market. Cost is determined
based on standards that approximate the first-in, first-out method. Inventories
are shown net of applicable reserves.
Revenue Recognition and Change in Accounting Principle
a. Contract Research and Development and Research Progress Payments
On January 1, 2000, the Company changed its method of accounting for
revenue recognition to conform with the guidance provided by Staff Accounting
Bulletin No. 101, Revenue Recognition in Financial Statements ("SAB 101").
Effective January 1, 2000, the Company recognizes revenue from contract research
and development and research progress payments as services are performed,
provided a contractual arrangement exists, the contract price is fixed or
determinable, and the collection of the resulting receivable is probable. In
situations where the Company receives payment in advance of the performance of
services, such amounts are deferred and recognized as revenue as the related
services are performed. Non-refundable fees, including payments for services,
up-front licensing fees, technology fees, and research progress payments
(collectively, "Non-refundable Fees"), are recognized as revenue based on the
percentage of costs incurred to date, estimated costs to complete, and total
expected contract revenue. However, revenue recognized is limited to the amount
of Non-refundable Fees received. Non-refundable Fees received in consideration
for
F-8
40
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
granting collaborators the right to license product candidates developed by the
Company are recognized as revenue on a straight-line basis over the term of the
underlying agreements.
Prior to January 1, 2000, the Company recognized revenue as described
above, except that certain Non-refundable Fees were recognized as revenue when
there were no additional contractual services to be provided or costs to be
incurred by the Company in connection with the Non-refundable Fee.
The cumulative effect of adopting SAB 101 at January 1, 2000 amounted to
$1.6 million of additional loss, with a corresponding increase to deferred
revenue that will be recognized in future periods, of which $0.4 million was
included in contract research and development revenue in 2000. The $1.6 million
represents a portion of a 1989 payment received from Sumitomo Chemical Co., Ltd.
in consideration for a fifteen year limited right of first negotiation to
license up to three of the Company's product candidates in Japan (see Note 9b).
The effect of income taxes on the cumulative effect adjustment was immaterial.
Prior period financial statements have not been restated to apply SAB 101
retroactively; however, the pro forma amounts included in the Statement of
Operations show the net loss and per share net loss assuming the Company had
retroactively applied SAB 101 to all prior periods.
b. Contract Manufacturing
The Company has entered into contract manufacturing agreements under which
it manufactures products and performs services for third parties. Contract
manufacturing revenue is recognized as products are shipped and as services are
performed.
Investment Income
Interest income, which is included in investment income, is recognized as
earned.
Accounting for the Impairment of Long-Lived Assets
Long-lived assets, such as fixed assets are reviewed for impairment when
events or circumstances indicate that their carrying value may not be
recoverable. Estimated undiscounted expected future cash flows are used to
determine if an asset is impaired in which case the asset's carrying value would
be reduced to fair value. For all periods presented, no impairment losses were
recorded.
Net Loss Per Share
Net loss per share, basic and diluted, is computed on the basis of the net
loss for the period divided by the weighted average number of shares of Common
Stock and Class A Stock outstanding during the period. The diluted net loss per
share for all periods presented excludes the number of shares issuable upon
exercise of outstanding stock options and warrants, since such inclusion would
be antidilutive. Disclosures required by Statement of Financial Accounting
Standards No. 128, Earnings per Share, have been included in Note 15.
Income Taxes
The Company recognizes deferred tax liabilities and assets for the expected
future tax consequences of events that have been included in the financial
statements or tax returns. Under this method, deferred tax liabilities and
assets are determined on the basis of the difference between the tax basis of
assets and liabilities and their respective financial reporting amounts
("temporary differences") at enacted tax rates in effect for the years in which
the differences are expected to reverse. A valuation allowance is established
for deferred tax assets for which realization is not likely.
F-9
41
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
Comprehensive Loss
Comprehensive loss represents the change in net assets of a business
enterprise during a period from transactions and other events and circumstances
from non-owner sources. Comprehensive loss of the Company includes net loss
adjusted for the change in net unrealized gain or loss on marketable securities.
The net effect of income taxes on comprehensive loss is immaterial.
Comprehensive losses for the years ended December 31, 2000, 1999, and 1998 have
been included in the Statements of Stockholders' Equity.
Concentrations of Credit Risk
Financial instruments which potentially subject the Company to
concentrations of credit risk consist of cash, cash equivalents, marketable
securities, and receivables from The Procter & Gamble Company, Amgen-Regeneron
Partners, Sumitomo Pharmaceuticals Company, Ltd., and Merck & Co., Inc. The
Company generally invests its excess cash in obligations of the U.S. government
and its agencies, bank deposits, investment grade debt securities issued by
corporations, governments, and financial institutions, and money market funds
that invest in these instruments. The Company has established guidelines that
relate to credit quality, diversification, and maturity, and that limit exposure
to any one issue of securities.
Risks and Uncertainties
Regeneron has had no sales of its products and there is no assurance that
the Company's research and development efforts will be successful, that the
Company will ever have commercially approved products, or that the Company will
achieve significant sales of any such products. In January 2001, Amgen-Regeneron
Partners, a partnership equally owned by the Company and Amgen Inc.,
discontinued all clinical development of one product following notification that
the product did not provide a therapeutic advantage to patients in clinical
trials (see Note 9a). The Company has incurred net losses and negative cash
flows from operations since its inception, and revenues to date have been
limited to payments for research from four collaborators and for contract
manufacturing from two pharmaceutical companies and investment income (see Notes
9 and 10). The Company operates in an environment of rapid change in technology
and is dependent upon the services of its employees, consultants, collaborators,
and certain third-party suppliers of materials. Regeneron, as licensee, licenses
certain technologies which impose various obligations on the Company. If
Regeneron fails to comply with these requirements, licensors may have the right
to terminate our licenses.
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates.
Stock-based Employee Compensation
The accompanying financial position and results of operations of the
Company have been prepared in accordance with APB Opinion No. 25, Accounting for
Stock Issued to Employees ("APB No. 25"). Under APB No. 25, generally, no
compensation expense is recognized in the accompanying financial statements in
connection with the awarding of stock option grants to employees provided that,
as of the grant date, all terms associated with the award are fixed and the
quoted market price of the Company's stock, as of the grant date, is equal to or
less than the amount an employee must pay to acquire the stock as defined.
Disclosures required by Statement of Financial Accounting Standards No.
123, Accounting for Stock-Based Compensation ("SFAS No. 123"), including pro
forma operating results had the Company prepared its financial statements in
accordance with the fair value based method of accounting for stock-based
compensation, have been included in Note 11.
F-10
42
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
Statement of Cash Flows
Supplemental disclosure of noncash investing and financing activities:
Capital lease obligations of $1.1 million and $0.4 million were incurred
when the Company acquired new equipment in 1999 and 1998, respectively.
During January 1995, the Company issued 600,000 restricted shares of Common
Stock ("Restricted Shares"), in consideration for $0.3 million and services to
be rendered, in connection with an agreement with the Chairman of the Board of
Directors. The difference between the fair market value of the Common Stock on
the date the agreement was signed and the purchase price of the Restricted
Shares was $1.8 million which the Company has recognized as compensation expense
on a pro rata basis over five years as the restriction on the Restricted Shares
lapsed.
Included in accounts payable and accrued expenses at December 31, 2000,
1999, and 1998 were $0.7 million, $0.7 million, and $0.5 million of capital
expenditures, respectively.
Included in accounts payable and accrued expenses at December 31, 1999 and
1998 were $0.4 million and $0.3 million, respectively, of accrued 401(k) Savings
Plan contribution expense. During January 2000 and 1999, the Company contributed
54,003 and 37,653 shares, respectively, of Common Stock to the 401(k) Savings
Plan in satisfaction of these obligations.
Included in marketable securities at December 31, 2000, 1999, and 1998 were
$2.5 million, $1.3 million, and $1.6 million of accrued interest income,
respectively.
Reclassifications
Certain reclassifications have been made to the financial statements for
1999 and 1998 to conform with the current year's presentation.
Future Impact of Recently Issued Accounting Standards
There are a number of recently issued accounting standards, including
Statement of Financial Accounting Standards No. 133, Accounting for Derivative
Financial Instruments and for Hedging Activities, which the Company will be
required to adopt in future periods. Management believes that the future
adoption of these accounting standards will not have a material impact on the
Company's financial statements.
3. MARKETABLE SECURITIES
The Company considers its marketable securities to be "available-for-sale,"
as defined by Statement of Financial Accounting Standards No. 115, Accounting
for Certain Investments in Debt and Equity Securities. Gross unrealized holding
gains and losses are reported as a net amount in a separate component of
stockholders' equity entitled Accumulated Other Comprehensive Income (Loss). The
net change in unrealized holding gains and losses is excluded from operations
and included in stockholders' equity as a separate component of comprehensive
loss.
F-11
43
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
The following tables summarize the amortized cost basis of marketable
securities, the aggregate fair value of marketable securities, and gross
unrealized holding gains and losses at December 31, 2000 and 1999:
UNREALIZED HOLDING
AMORTIZED FAIR --------------------------
COST BASIS VALUE GAINS (LOSSES) NET
---------- -------- ----- -------- -----
AT DECEMBER 31, 2000
Maturities within one year
Corporate debt securities.................. $ 31,155 $ 31,196 $ 44 $ (3) $ 41
U.S. Government securities................. 55,218 55,438 254 (34) 220
-------- -------- ---- ----- -----
86,373 86,634 298 (37) 261
-------- -------- ---- ----- -----
Maturities between one and three years
Corporate debt securities.................. 6,302 6,357 55 55
U.S. Government securities................. 30,183 30,401 256 (38) 218
-------- -------- ---- ----- -----
36,485 36,758 311 (38) 273
-------- -------- ---- ----- -----
$122,858 $123,392 $609 $ (75) $ 534
======== ======== ==== ===== =====
AT DECEMBER 31, 1999
Maturities within one year
Corporate debt securities.................. $ 28,366 $ 28,343 $ 8 $ (31) $ (23)
U.S. Government securities................. 14,184 14,120 (64) (64)
-------- -------- ---- ----- -----
42,550 42,463 8 (95) (87)
-------- -------- ---- ----- -----
Maturities between one and three years
Corporate debt securities.................. 10,337 10,264 (73) (73)
U.S. Government securities................. 17,508 17,175 (333) (333)
-------- -------- ----- -----
27,845 27,439 (406) (406)
-------- -------- ---- ----- -----
$ 70,395 $ 69,902 $ 8 $(501) $(493)
======== ======== ==== ===== =====
Realized gains and losses are included as a component of investment income.
For the years ended December 31, 2000, 1999, and 1998, gross realized gains and
losses were not significant. In computing realized gains and losses, the Company
computes the cost of its investments on a specific identification basis. Such
cost includes the direct costs to acquire the securities, adjusted for the
amortization of any discount or premium. The fair value of marketable securities
has been estimated based on quoted market prices.
4. INVENTORIES
Inventory balances at December 31, 2000 consist primarily of raw materials
and other direct and indirect costs associated with the production of an
intermediate for a Merck & Co., Inc. pediatric vaccine under a long-term
manufacturing agreement ("Merck Costs") (see Note 10). At December 31, 1999,
inventory balances consist of Merck Costs and raw materials and other direct and
indirect costs associated with the production of brain-derived neurotrophic
factor ("BDNF") for Sumitomo Pharmaceuticals Company, Ltd. under a research and
development agreement (see Note 9b).
F-12
44
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
Inventories as of December 31, 2000 and 1999 consist of the following:
2000 1999
------ ------
Raw materials...................................... $ 535(1) $1,042
Work-in process.................................... 53(2) 165(3)
Finished products.................................. 1,327 3,345
------ ------
$1,915 $4,552
====== ======
- ---------------
(1) Net of reserves of $0.3 million.
(2) Net of reserves of $0.8 million.
(3) Net of reserves of $0.7 million.
5. PROPERTY, PLANT, AND EQUIPMENT
Property, plant, and equipment as of December 31, 2000 and 1999 consist of
the following:
2000 1999
-------- --------
Land........................................... $ 475 $ 475
Building and improvements...................... 32,182 30,562
Leasehold improvements......................... 11,689 10,364
Construction in progress....................... 1,119
Laboratory and other equipment................. 25,113 21,017
Furniture, fixtures, and computer equipment.... 3,672 3,124
-------- --------
73,131 66,661
Less, accumulated depreciation and
amortization................................. (36,197) (30,363)
-------- --------
$ 36,934 $ 36,298
======== ========
Depreciation and amortization expense on property, plant, and equipment
amounted to $5.8 million, $3.7 million, and $3.0 million, for the years ended
December 31, 2000, 1999, and 1998, respectively. Included in these amounts were
$1.4 million and $0.3 million of depreciation and amortization expense related
to contract manufacturing that was capitalized into inventory for the years
ended December 31, 2000 and 1999, respectively.
6. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses as of December 31, 2000 and 1999
consist of the following:
2000 1999
------ ------
Accounts payable................................... $2,590 $2,642
Accrued payroll and related costs.................. 2,630 1,977
Accrued clinical trial expense..................... 2,308 1,005
Accrued expenses, other............................ 1,918 643
Deferred compensation.............................. 284
------ ------
$9,446 $6,551
====== ======
F-13
45
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
7. STOCKHOLDERS' EQUITY
The Company's Amended Certificate of Incorporation provides for the
issuance of up to 40 million shares of Class A Stock, par value $0.001 per
share, and 60 million shares of Common Stock, par value $0.001 per share. Shares
of Class A Stock are convertible, at any time, at the option of the holder into
shares of Common Stock on a share-for-share basis. Holders of Class A Stock have
rights and privileges identical to Common Stockholders except that Class A
Stockholders are entitled to ten votes per share, while Common Stockholders are
entitled to one vote per share. Class A Stock may only be transferred to
specified Permitted Transferees, as defined. The Company's Board of Directors
(the "Board") is authorized to issue up to 30 million shares of preferred stock,
in series, with rights, privileges, and qualifications of each series determined
by the Board.
During January 1995, the Company entered into an agreement with the
Chairman of the Board. As partial consideration for services to be rendered, the
agreement provided for the Company to sell the Chairman 600,000 restricted
shares of Common Stock ("Restricted Shares"), in consideration for $0.3 million,
and to grant 285,000 stock options. The Restricted Shares were nontransferable
with such restriction lapsing ratably over a five-year period. In accordance
with generally accepted accounting principles, the Company recognized
compensation expense for the difference between the fair market value of the
Common Stock on the date the agreement was signed and the purchase price of the
Restricted Shares on a pro rata basis over five years as the restriction on the
Restricted Shares lapsed. The unearned compensation was fully amortized at
December 31, 1999. For the years ended December 31, 1999 and 1998, the Company
recognized compensation expense of $0.4 million in each year. The stock options,
which were issued under the Company's Amended and Restated 1990 Long-Term
Incentive Plan, entitle the holder to purchase an equal number of shares of
Common Stock at a per share price of $3.50, the fair market value of the Common
Stock on the date of grant. The options vested over a five year period.
During 1996, the Company adopted a Shareholder Rights Plan in which Rights
were distributed as a dividend at the rate of one Right for each share of Common
Stock and Class A Stock (collectively, "Stock") held by shareholders of record
as of the close of business on October 18, 1996. Each Right initially entitles
the registered holder to buy a unit ("Unit") consisting of one-one thousandth of
a share of Series A Junior Participating Preferred Stock ("A Preferred Stock")
at a purchase price of $120 per Unit (the "Purchase Price"). Initially the
Rights were attached to all Stock certificates representing shares then
outstanding, and no separate Rights certificates were distributed. The Rights
will separate from the Stock and a "distribution date" will occur upon the
earlier of (i) ten days after a public announcement that a person or group of
affiliated or associated persons, excluding certain defined persons, (an
"Acquiring Person") has acquired, or has obtained the right to acquire,
beneficial ownership of 20% or more of the outstanding shares of Stock or (ii)
ten business days following the commencement of a tender offer or exchange offer
that would result in a person or group beneficially owning 20% or more of such
outstanding shares of Stock. The Rights are not exercisable unless a
distribution date occurs and will expire at the close of business on October 18,
2006 unless earlier redeemed by the Company, subject to certain defined
restrictions, for $.01 per Right. In the event that an Acquiring Person becomes
the beneficial owner of 20% or more of the then outstanding shares of Stock
(unless such acquisition is made pursuant to a tender or exchange offer for all
outstanding shares of the Company, at a price determined by a majority of the
independent directors of the Company who are not representatives, nominees,
affiliates, associates of an Acquiring Person to be fair and otherwise in the
best interest of the Company and its shareholders after receiving advice from
one or more investment banking firms), each Right will entitle the holder to
purchase, at the Right's then current exercise price, common shares (or, in
certain circumstances, cash, property or other securities of the Company) having
a value twice the Right's Exercise Price. The Right's Exercise Price is the
Purchase Price times the number of shares of Common Stock associated with each
Right (initially, one). Upon the occurrence of any such events, the Rights held
by an Acquiring Person become null and void. In certain circumstances, a Right
entitles the
F-14
46
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
holder to receive, upon exercise, shares of common stock of an acquiring company
having a value equal to two times the Right's Exercise Price.
As a result of the Shareholder Rights Plan, the Company's Board designated
100,000 shares of preferred stock as A Preferred Stock. The A Preferred Stock
has certain preferences, as defined.
On April 4, 2000, the Company completed a public offering of 2.6 million
shares of Common Stock at a price of $29.75 per share for net proceeds, after
commissions and expenses, of $72.9 million.
As of December 31, 2000, a former collaborator holds 107,400 warrants to
purchase shares of the Company's Common Stock. The warrants have an exercise
price of $21.72 per share, are fully exercisable, expire on June 26, 2001, and
are subject to anti-dilution provisions and other defined adjustments.
8. COMMITMENTS AND CONTINGENCIES
a. Operating Leases
The Company leases and subleases laboratory and office space under
operating lease agreements which expire through June 30, 2003. The leases
provide for base rent plus additional rental charges for utilities, increases in
taxes and operating expenses, as defined. The Company has renewal options to
extend their leases for an additional five years.
The Company leases certain laboratory and office equipment under operating
leases which expire at various times through 2003.
At December 31, 2000, the future minimum noncancelable lease commitments
under operating leases were as follows:
LABORATORY AND
DECEMBER 31, OFFICE SPACE EQUIPMENT TOTAL
- ------------ -------------- --------- ------
2001.............................................. $3,172 $ 89 $3,261
2002.............................................. 3,139 49 3,188
2003.............................................. 1,456 7 1,463
------ ---- ------
$7,767 $145 $7,912
====== ==== ======
Rent expense under operating leases was:
LABORATORY AND
YEAR ENDING DECEMBER 31, OFFICE SPACE EQUIPMENT TOTAL
- ------------------------ -------------- --------- ------
2000.............................................. $2,898 $186 $3,084
1999.............................................. 2,826 156 2,982
1998.............................................. 2,466 194 2,660
In addition to its rent expense for laboratory and office space, the
Company paid additional rental charges for utilities, real estate taxes, and
operating expenses of $2.1 million, $1.0 million, and $0.1 million for the years
ended December 31, 2000, 1999, and 1998, respectively.
b. Capital Leases
The Company leases equipment under noncancelable capital leases. Lease
terms are generally four years after which, for certain leases, the Company may
extend the lease for eight additional months at defined monthly payments, or is
required to purchase the equipment at amounts defined by the agreements.
F-15
47
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
As of December 31, 2000, minimum rental payments under all capital leases,
including payments to acquire leased equipment, were as follows:
MINIMUM
YEAR ENDING DECEMBER 31, RENTAL PAYMENTS
- ------------------------ ---------------
2001........................................................ $ 643
2002........................................................ 464
2003........................................................ 153
------
1,260
Less, amounts representing interest......................... (112)
------
Present value of net minimum capital lease payments......... $1,148
======
Leased equipment and building improvements included in property, plant, and
equipment was $2.4 million and $5.3 million at December 31, 2000 and 1999,
respectively; related accumulated depreciation was $1.4 million and $3.1 million
for the same respective periods.
In connection with one capital lease, the Company entered into a 38-month
equipment maintenance agreement which requires equal quarterly payments which
commenced during the second quarter of 2000. The total amount due over the term
of the agreement is $0.2 million.
c. Note Payable
In 1994, the Company borrowed $2.0 million from the New York State Urban
Development Corporation ("NYS UDC"). The terms of the note provide for monthly
payments of principal and interest through December 2014. Outstanding borrowings
accrue interest at an effective interest rate of approximately 6.4%. The note is
collateralized by a first mortgage on the Company's land, building, and
improvements in Rensselaer, New York (book value at December 31, 2000 was $26.4
million). The note also has various financial covenants which include a minimum
ratio of current assets over current liabilities, as defined, and a minimum
level of tangible net worth, as defined, of $35.0 million. In addition, the
Company is not permitted to declare or pay dividends to its stockholders. The
provisions of the note require the Company to meet certain defined levels of
employment; otherwise, the interest rate on outstanding borrowings will increase
to 2.0% above the prime rate (as defined) until the defined levels of employment
are attained. As of January 1, 1998, 1999, 2000, and 2001, the Company had not
met the defined levels of employment; however, for the years ended December 31,
1998, 1999, and 2000, the NYS UDC elected either not to increase the interest
rate, or to only increase the rate by a nominal amount, the effects of which
were not material to the financial statements. The estimated fair value of the
Company's note payable to the NYS UDC at December 31, 2000 was $1.7 million. The
fair value was estimated based on the current rate offered to the Company for
debt with similar terms.
Principal payments under the note during each of the next five years, and
thereafter, are as follows:
2001................................................ $ 67
2002................................................ 67
2003................................................ 68
2004................................................ 74
2005................................................ 81
Thereafter.......................................... 1,176
------
$1,533
======
F-16
48
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
d. Research Collaboration and Licensing Agreements
As part of the Company's research and development efforts, the Company
enters into research collaboration and licensing agreements with related and
unrelated scientific collaborators, universities, or consultants. The Company
also has research collaborations with Medarex, Inc. and Emisphere Technologies,
Inc., and a license and supply agreement with Shearwater Corporation. These
agreements contain varying terms and provisions which include fees and
milestones to be paid by the Company, services to be provided, and ownership
rights to certain proprietary technology developed under the agreements. Some of
the agreements contain provisions which require the Company to pay royalties, as
defined, at rates that range from 0.5% to 12%, in the event the Company sells or
licenses any proprietary products developed under the respective agreements.
Certain agreements, where the Company is required to pay fees, provide for
the Company, upon 30 to 90-day written notice, to terminate such agreements.
With respect to payments associated with these agreements, the Company incurred
expenses of $0.6 million, $0.6 million, and $0.7 million for the years ended
December 31, 2000, 1999, and 1998, respectively.
9. COLLABORATION AGREEMENTS
a. Amgen Inc.
In August 1990, the Company entered into a collaboration agreement (the
"Amgen Agreement") with Amgen Inc. ("Amgen") to develop and attempt to
commercialize two proprietary products (BDNF and NT-3, individually the
"Product," collectively the "Products") in the United States. The Amgen
Agreement, among other things, provided for Amgen and the Company to form a
partnership ("Amgen-Regeneron Partners" or the "Partnership") to complete the
development and to commercialize the Products. Amgen and the Company hold equal
ownership interests (subject to adjustment for any future inequities in capital
contributions, as defined). The Partnership is the exclusive distributor of
Products in the United States, and Amgen has received a license from the Company
to market the Products outside the United States and outside Japan and certain
Pacific Rim countries. The Company accounts for its investment in the
Partnership in accordance with the equity method of accounting. Since the
Partnership's inception, the Company has contributed capital to the Partnership
of $56.2 million. In 2000, 1999, and 1998, the Company recognized its share of
the Partnership net loss in the amounts of $4.6 million, $4.2 million, and $2.5
million, respectively, which represents 50% of the total Partnership net loss.
As of December 31, 2000, the Company continues to be an equal partner in the
Partnership.
Payments the Company receives from the Partnership in connection with
services provided to the Partnership, are recognized as contract research and
development revenue as earned. Such revenue for the years ended December 31,
2000, 1999, and 1998 totaled $6.2 million, $3.6 million, and $1.9 million,
respectively. In addition, the Amgen Agreement contains a provision whereby the
Company will receive defined amounts ("Research Progress Payments") from Amgen
if and when each Product reaches certain levels of development.
In January 2001, Amgen-Regeneron Partners discontinued all clinical
development of BDNF for the potential treatment of amyotrophic lateral sclerosis
("ALS") following notification that BDNF did not provide a therapeutic advantage
to ALS patients in clinical trials. The Partnership continues to develop NT-3.
F-17
49
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
Selected financial data of the Partnership as of December 31, 2000 and 1999
and for the years ended December 31, 2000, 1999 and 1998, are as follows:
BALANCE SHEET DATA 2000 1999
- ------------------ ------ ------
Cash and cash equivalents................................... $5,169 $3,700
Accounts payable and accrued expenses due to partners(1).... 4,635 4,300
Partners' capital accounts
Amgen..................................................... 267 (300)
The Company............................................... 267 (300)
- ---------------
(1) At December 31, 2000 and 1999, includes $1.6 million and $0.5 million due
the Company, respectively.
STATEMENT OF OPERATIONS DATA 2000 1999 1998
- ---------------------------- ------- ------- -------
Interest income..................................... $ 347 $ 366 $ 316
Total expenses(2)................................... (9,497) (8,684) (5,284)
------- ------- -------
Net loss............................................ $(9,150) $(8,318) $(4,968)
======= ======= =======
- ---------------
(2) Includes $6.2 million, $3.6 million, and $1.9 million related to services
provided by the Company in 2000, 1999, and 1998, respectively.
During 1990, Amgen purchased 767,656 shares of Series D convertible
preferred stock for $15.0 million. Such shares converted into 788,766 shares of
Class A Stock in April 1991 at the time of the Company's initial public
offering. During April 1996, Amgen purchased from the Company 3.0 million shares
of Common Stock and 700,000 warrants for $48.0 million. During March 2000, in
accordance with the terms of their warrant agreement, as amended, Amgen
exercised their 700,000 warrants with an exercise price of $16.00 per share. As
consideration for the exercise price, Amgen tendered 221,958 shares of the
Company's Common Stock, which had an aggregate fair market value at the time of
exercise equal to the aggregate exercise price of the warrants. The shares of
Common Stock delivered to the Company by Amgen were retired upon receipt.
During October 2000, Amgen and Regeneron entered into an agreement whereby
Regeneron acquired Amgen's patents and patent applications relating to ciliary
neurotrophic factor ("CNTF") and related molecules for $1.0 million. As part of
this agreement, Regeneron granted back to Amgen exclusive, royalty free rights
under these patents and patent applications solely for human ophthalmic uses. In
addition, Regeneron entered into a covenant not to sue Amgen under Regeneron's
patents and patent applications relating to CNTF and related molecules solely
for human ophthalmic uses.
b. Sumitomo Pharmaceuticals Company, Ltd.
In June 1994, the Company entered into a research and development agreement
(the "R&D Agreement") with Sumitomo Pharmaceuticals Company, Ltd. ("Sumitomo
Pharmaceuticals") to collaborate in the research and development of BDNF in
Japan. Sumitomo Pharmaceuticals paid the Company $13.0 million in June 1994 and
agreed to pay $3.0 million annually on each January 1 from 1995 to 1998
(inclusive) for research payments. In connection with the R&D Agreement,
Sumitomo Pharmaceuticals also makes payments to the Company for its activities
in developing and validating manufacturing processes for BDNF, and manufacturing
and supplying BDNF and other research materials to Sumitomo Pharmaceuticals. In
2000, 1999, and 1998, Regeneron recognized contract research and development
revenue from Sumitomo Pharmaceuticals of $0.8 million, $0.1 million, and $4.3
million, respectively. In addition, the Company recognized contract
manufacturing revenue of $4.1 million in 2000 for supplying BDNF to Sumitomo
Pharmaceuticals.
F-18
50
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
In connection with the R&D Agreement, in March 1998, Sumitomo
Pharmaceuticals initiated a Phase I clinical trial of BDNF in Japan and, in
August 1998, signed a license agreement with the Company for the development of
BDNF in Japan. Pursuant to the license agreement, Sumitomo Pharmaceuticals made
research progress payments of $5.0 million (reduced by $0.5 million of Japanese
withholding tax) in August 1998 and $3.0 million (reduced by $0.3 million of
Japanese withholding tax) in April 2000. The amounts received in 2000 and 1998
are included in research progress payments.
Sumitomo Pharmaceuticals has the discretionary right to terminate the
license for BDNF with the Company. If Sumitomo Pharmaceuticals were to exercise
this discretionary right, in light of the January 2001 BDNF clinical trial
results (see Note 9a), the Company would not receive any further revenue from
Sumitomo Pharmaceuticals for research progress payments, contract research and
development, or contract manufacturing.
During 1989, Sumitomo Chemical Co., Ltd. ("Sumitomo Chemical"), an
affiliate of Sumitomo Pharmaceuticals, entered into a Technology Development
Agreement ("TDA") with Regeneron and paid the Company $5.6 million. In
consideration for this payment, Sumitomo Chemical received a fifteen year
limited right of first negotiation to license up to three of the Company's
product candidates in Japan. In connection with the Company's implementation of
SAB 101 (see Note 1), the Company is recognizing this payment as revenue on a
straight-line basis over the term of the TDA.
In addition, Sumitomo Chemical also entered into a stock purchase agreement
whereby it purchased, for $4.4 million, 885,062 shares of Class C Preferred
Stock. Such shares converted into 909,401 shares of Class A Stock in April 1991
at the time of the Company's initial public offering.
c. Glaxo Wellcome plc
During 1993, the Company entered into a collaborative research agreement
with Glaxo Wellcome plc ("Glaxo"). Products that are developed by the joint
efforts of Glaxo and the Company will be commercialized by one or more equally
owned joint ventures. Glaxo also purchased 500,000 shares of the Company's
Common Stock at a price of $20 per share.
d. The Procter & Gamble Company
In May 1997, the Company entered into a ten-year multi-project
collaboration agreement with The Procter & Gamble Company ("P&G") to discover,
develop, and commercialize pharmaceutical products (the "P&G Agreement"), as
well as a securities purchase agreement and other agreements. The P&G Agreement
expanded and superseded a collaboration agreement that the Company and Procter &
Gamble Pharmaceuticals, Inc. ("P&G Pharmaceuticals") entered into in December
1996 to jointly discover and develop therapeutics for muscle diseases and
disorders. P&G agreed over the first five years of the various agreements to
provide funding for Regeneron's research efforts related to the collaboration,
of which the Company had received $44.9 million as of December 31, 2000, and to
purchase up to $60.0 million in Regeneron equity.
In September 1997, the Company and P&G amended the P&G Agreement to include
AXOKINE(R) second generation ciliary neurotrophic factor and related molecules.
P&G paid the Company research progress payments of $5.0 million in 1997 and $5.0
million in 1998 upon the achievement of defined milestones related to AXOKINE.
During the third quarter of 1999, P&G returned to the Company the product rights
to AXOKINE and ended related research support for the Company's AXOKINE program.
However, Procter & Gamble will be entitled to receive a small royalty on any
sales of AXOKINE.
In August 2000, P&G made two research progress payments to Regeneron
totaling $3.5 million. In addition, in August 2000, the Company and P&G agreed
through a binding memorandum of understanding to enter into a new collaboration
agreement, replacing the P&G Agreement. The new agreement extends
F-19
51
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
P&G's obligation to fund Regeneron research through December 2005, with no
further research obligations by either party thereafter, and focuses their
collaborative research on therapeutic areas that are of particular interest to
P&G. Under the new agreement, P&G's research funding from 2001 through 2005 is
expected to total approximately $50 million (before adjustments for future
inflation). Any drugs that result from the collaboration will continue to be
jointly developed and marketed worldwide, with the companies equally sharing
development costs and profits. P&G and the Company have divided rights to
programs from the P&G Agreement that are no longer part of the companies'
collaboration.
Contract research and development revenue related to the P&G Agreement,
including payments from P&G related to AXOKINE, was $28.3 million, $20.8
million, and $13.5 million in 2000, 1999, and 1998, respectively. At December
31, 2000 and 1998, the P&G contract research revenue receivable was $6.9 million
and $3.2 million, respectively. There was no P&G receivable balance at December
31, 1999.
In December 1996, P&G Pharmaceuticals paid $10.0 million and in March 1997
received 800,000 shares of the Company's Common Stock. In June 1997, P&G
completed the purchase of 4.35 million shares of the Company's Common Stock at
$9.87 per share for a total of $42.9 million and received five year warrants to
purchase an additional 1.45 million shares of the Company's stock at $9.87 per
share. In August 2000, P&G purchased 573,630 shares of the Company's Common
Stock at $29.75 per share for a total of $17.1 million. In addition, in August
2000, in accordance with the terms of their warrant agreement, as amended, P&G
exercised 1.45 million warrants at $9.87 per share. As consideration for the
exercise price, P&G tendered 511,125 shares of the Company's Common Stock which
had an aggregate value at the time of exercise, based upon the average market
price of the Company's Common Stock over approximately the prior 30 trading
days, equal to the aggregate exercise price of the warrants. The net result of
this warrant exercise was that P&G acquired an additional 938,875 shares of the
Company's Common Stock. The 511,125 shares of Common Stock delivered to the
Company by P&G were retired upon receipt.
10. MANUFACTURING AGREEMENT
During 1995, the Company entered into a long-term manufacturing agreement
with Merck & Co., Inc., as amended, (the "Merck Agreement") to produce an
intermediate (the "Intermediate") for a Merck pediatric vaccine at the Company's
Rensselaer, New York facility. The Company agreed to modify portions of its
facility for manufacture of the Intermediate and to assist Merck in securing
regulatory approval for such manufacture in the Company's facility. The Merck
Agreement calls for the Company to manufacture Intermediate for Merck for six
years (the "Production Period"), with certain minimum order quantities each
year. The Production Period commenced in November of 1999. The Merck Agreement
is expected to extend into 2005 and may be terminated at any time by Merck upon
the payment by Merck of a termination fee.
Merck agreed to reimburse the Company for the capital costs to modify the
facility ("Capital Costs"). Merck also agreed to pay an annual facility fee (the
"Facility Fee") of $1.0 million beginning March 1995, subject to annual
adjustment for inflation. During the Production Period, Merck agreed to
reimburse the Company for certain manufacturing costs, pay the Company a
variable fee based on the quantity of Intermediate supplied to Merck, and make
additional bi-annual payments ("Additional Payments"), as defined. In addition,
Merck agreed to reimburse the Company for the cost of Company activities
performed on behalf of Merck prior to the Production Period and for
miscellaneous costs during the Production Period ("Internal Costs"). These
payments are recognized as contract manufacturing revenue as follows: (i)
payments for Internal Costs are recognized as the activities are performed, (ii)
the Facility Fee and Additional Payments are recognized over the period to which
they relate, (iii) payments for Capital Costs were deferred and are recognized
as Intermediate is shipped to Merck, and (iv) payments related to the
manufacture of Intermediate during the Production Period ("Manufacturing
Payments") are recognized as Intermediate is shipped to Merck.
F-20
52
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
In 2000, 1999, and 1998, Merck contract manufacturing revenue includes $0.7
million, $7.1 million, and $8.0 million of Internal Costs, respectively, and
$2.3 million, $1.9 million, and $1.1 million of Facility Fee and Additional
Payments, respectively. In addition, contract manufacturing revenue includes
previously deferred Capital Costs of $2.9 million in 2000 and $0.4 million in
1999, Manufacturing Payments of $6.6 million in 2000, and other variable fees of
$0.6 million in 1999 related to the manufacture of Intermediate prior to
commencement of the Production Period.
11. INCENTIVE AND STOCK PURCHASE PLANS
a. Long-Term Incentive Plans
During 2000, the Company established the Regeneron Pharmaceuticals, Inc.
2000 Long-Term Incentive Plan ("2000 Incentive Plan") which provides for the
issuance of up to 6,000,000 shares of Common Stock in respect of awards.
Employees of the Company, including officers, and nonemployees, including
consultants and nonemployee members of the Board of Directors, (collectively,
"Participants") may receive awards as determined by a committee of independent
directors ("Committee"). The awards that may be made under the 2000 Incentive
Plan include: (a) Incentive Stock Options ("ISOs") and Nonqualified Stock
Options, (b) shares of Restricted Stock, (c) shares of Phantom Stock, (d) Stock
Bonuses, and (e) Other Awards.
Stock Option awards grant Participants the right to purchase shares of
Common Stock at prices determined by the Committee; however, in the case of an
ISO, the option exercise price will not be less than the fair market value of a
share of Common Stock on the date the Option is granted. Options vest over a
period of time determined by the Committee, generally on a pro rata basis over a
three or five year period. The Committee also determines the expiration date of
each Option; however, no ISO is exercisable more than ten years after the date
of grant.
Restricted Stock awards grant Participants shares of restricted Common
Stock or allow Participants to purchase such shares at a price determined by the
Committee. Such shares are nontransferable for a period determined by the
Committee ("vesting period"). Should employment terminate, as defined by the
2000 Incentive Plan, the ownership of the Restricted Stock will be transferred
to the Company, except under defined circumstances with Committee approval, in
consideration of amounts, if any, paid by the Participant to acquire such
shares. In addition, if the Company requires a return of the Restricted Shares,
it also has the right to require a return of all dividends paid on such shares.
Phantom Stock awards provide the Participant the right to receive, within
30 days of the date on which the share vests, an amount, in cash and/or shares
of the Company's Common Stock as determined by the Committee, equal to the sum
of the fair market value of a share of Common Stock on the date such share of
Phantom Stock vests and the aggregate amount of cash dividends paid with respect
to a share of Common Stock during the period from the grant date of the share of
Phantom Stock to the date on which the share vests.
Stock Bonus awards are bonuses payable in shares of Common Stock which are
granted at the discretion of the Committee.
Other Awards are other forms of awards which are valued based on the
Company's Common Stock. Subject to the provisions of the 2000 Incentive Plan,
the terms and provisions of such Other Awards are determined solely on the
authority of the Committee.
During 1990, the Company established the Regeneron Pharmaceuticals, Inc.
1990 Long-Term Incentive Plan ("1990 Incentive Plan") which, as amended,
provided for a maximum of 6,900,000 shares of Common Stock in respect of awards.
Employees of the Company, including officers, and nonemployees, including
consultants and nonemployee members of the Board of Directors, received awards
as determined by a
F-21
53
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
committee of independent directors. Under the provisions of the 1990 Incentive
Plan, there will be no future awards from the plan. Awards under the 1990
Incentive Plan consisted of Incentive Stock Options and Nonqualified Stock
Options which generally vest on a pro rata basis over a three or five year
period and have a term of ten years.
The 1990 and 2000 Incentive Plans contain provisions that allow for the
Committee to provide for the immediate vesting of awards upon a change in
control of the Company, as defined.
In accordance with APB No. 25 and related interpretations, the Company will
record compensation expense from employee stock-based awards under certain
conditions. Generally, when the terms of the award and the amount the employee
must pay to acquire the stock are fixed, compensation expense for options,
restricted stock, and stock bonus awards will total the grant date intrinsic
value, if any, amortized over the vesting period. For other awards, including
phantom stock, compensation expense will be recognized over the life of the
award based on the cash remitted to settle the award or the intrinsic value of
the award on the date of exercise.
Transactions involving stock option awards during 1998, 1999, and 2000,
under the 1990 and 2000 Incentive Plans, are summarized in the table below.
Option exercise prices were equal to the fair market value of the Company's
Common Stock on the date of grant. The total number of options exercisable at
December 31, 1998, 1999, and 2000 was 1,994,848, 2,366,180, and 2,533,662,
respectively, with weighted average exercise prices of $7.49, $8.00, and $8.31,
respectively.
NUMBER OF WEIGHTED-AVERAGE
SHARES EXERCISE PRICE
--------- ----------------
Stock options outstanding at December 31, 1997........... 3,616,436 $ 8.00
1998:
Stock options granted.................................. 1,006,240 $ 8.61
Stock options canceled................................. (353,888) $ 9.62
Stock options exercised................................ (95,163) $ 4.75
---------
Stock options outstanding at December 31, 1998......... 4,173,625 $ 8.08
1999:
Stock options granted.................................. 2,112,345 $ 8.08
Stock options canceled................................. (96,704) $10.14
Stock options exercised................................ (367,470) $ 3.89
---------
Stock options outstanding at December 31, 1999......... 5,821,796 $ 8.29
2000:
Stock options granted.................................. 2,633,850 $36.55
Stock options canceled................................. (267,531) $ 9.23
Stock options exercised................................ (757,056) $ 7.28
---------
Stock options outstanding at December 31, 2000......... 7,431,059 $18.37
=========
F-22
54
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
The following table summarizes stock option information as of December 31,
2000:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE
------------------------------------------------- ------------------------------
WEIGHTED AVERAGE
RANGE OF NUMBER REMAINING WEIGHTED AVERAGE NUMBER WEIGHTED AVERAGE
EXERCISE PRICES OUTSTANDING CONTRACTUAL LIFE EXERCISE PRICE EXERCISABLE EXERCISE PRICE
--------------- ----------- ---------------- ---------------- ----------- ----------------
$3.00 to $7.41 1,794,954 5.61 $ 5.86 1,132,335 $ 5.03
$7.44 to $8.77 1,588,847 8.23 $ 8.55 385,879 $ 8.46
$8.78 to $14.75 1,360,178 5.21 $11.21 951,448 $11.55
$14.94 to $37.53 730,980 8.95 $25.88 64,000 $17.39
$37.78 1,613,354 9.97 $37.78
$38.97 to $51.56 342,746 9.18 $50.53
--------- ---------
$3.00 to $51.56 7,431,059 7.54 $18.37 2,533,662 $ 8.31
========= =========
The following table summarizes the pro forma operating results of the
Company had compensation costs for the Incentive Plans been determined in
accordance with the fair value based method of accounting for stock based
compensation as prescribed by SFAS No. 123. Since option grants awarded during
2000, 1999, and 1998 vest over several years and additional awards are expected
to be issued in the future, the pro forma results shown below are not likely to
be representative of the effects on future years of the application of the fair
value based method.
2000 1999 1998
-------- -------- --------
Pro forma net loss................................. $(33,131) $(27,739) $(13,114)
======== ======== ========
Pro forma net loss per share, basic and diluted.... $ (0.95) $ (0.89) $ (0.42)
======== ======== ========
For the purpose of the above pro forma calculation, the fair value of each
option granted from the Incentive Plans during 2000, 1999, and 1998 was
estimated on the date of grant using the Black-Scholes option-pricing model. The
weighted-average fair value of the options granted during 2000, 1999, and 1998
was $24.35, $5.27, and $5.84, respectively. The following table summarizes the
assumptions used in computing the fair value of option grants.
2000 1999 1998
----------- ----------- -----------
Expected volatility...................... 75% 65% 85%
Expected lives........................... 3.5 years 3.5 years 3 years
Dividend yield........................... 0% 0% 0%
Risk-free interest rate.................. 5.90%-6.00% 6.02%-6.26% 5.30%-5.44%
During December 2000, 34,785 shares of Restricted Stock were awarded under
the 2000 Incentive Plan. These shares are nontransferable with such restriction
lapsing with respect to 25% of the shares every six months over a two-year
period beginning in January 2001. In accordance with generally accepted
accounting principles, the Company recorded unearned compensation of $1.3
million within Stockholders' Equity related to these awards. This amount was
based on the fair market value of shares of the Company's Common Stock on the
date of the Restricted Stock award and will be expensed, on a pro rata basis,
over the two year period that the restriction on these shares lapses.
For the years ended December 31, 1999 and 1998, the Company recognized
compensation expense from stock-based awards of $0.4 million in each year (see
Note 7). No stock-based compensation expense was recognized during the year
ended December 31, 2000.
F-23
55
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
As of December 31, 2000, there were 3,774,615 shares available for future
grants under the 2000 Incentive Plan.
b. Executive Stock Purchase Plan
In 1989, the Company adopted an Executive Stock Purchase Plan (the "Plan")
under which 1,027,500 shares of Class A Stock were reserved for restricted stock
awards. The Plan provides for the compensation committee of the Board of
Directors to award employees, directors, consultants, and other individuals
("Plan participants") who render service to the Company the right to purchase
Class A Stock at a price set by the compensation committee. The Plan provides
for the vesting of shares as determined by the compensation committee and,
should the Company's relationship with a Plan participant terminate before all
shares are vested, unvested shares will be repurchased by the Company at a price
per share equal to the original amount paid by the Plan participant. During 1989
and 1990, a total of 983,254 shares were issued, all of which vested as of
December 31, 1999. As of December 31, 2000, there were 44,246 shares available
for future grants under the Plan.
12. EMPLOYEE SAVINGS PLAN
In 1993, the Company adopted the provisions of the Regeneron
Pharmaceuticals, Inc. 401(k) Savings Plan (the "Savings Plan"). The terms of the
Savings Plan provide for employees who have met defined service requirements to
participate in the Savings Plan by electing to contribute to the Savings Plan a
percentage of their compensation to be set aside to pay their future retirement
benefits, as defined. The Savings Plan, as amended and restated during 1998,
provides for the Company to make discretionary contributions ("Contribution"),
as defined. The Company recorded Contribution expense of $0.5 million in 2000,
$0.4 million in 1999, and $0.3 million in 1998; such amounts were accrued as
liabilities at December 31, 2000, 1999 and 1998, respectively. During the first
quarter of 2001, 2000, and 1999, the Company contributed 17,484, 54,003, and
37,653 shares, respectively, of Common Stock to the Savings Plan in satisfaction
of these obligations.
13. INCOME TAXES
There is no provision (benefit) for federal or state income taxes, since
the Company has incurred operating losses since inception and has established a
valuation allowance equal to the total deferred tax asset.
The tax effect of temporary differences, net operating loss carry-forwards,
and research and experimental tax credit carry-forwards as of December 31, 2000
and 1999 was as follows:
2000 1999
--------- --------
Deferred tax assets
Net operating loss carry-forward.......................... $ 86,935 $ 74,043
Fixed assets.............................................. 1,159 1,240
Deferred revenue.......................................... 5,620 4,865
Research and experimental tax credit carry-forward........ 14,101 10,309
Other..................................................... 2,497 1,586
Valuation allowance....................................... (110,312) (92,043)
--------- --------
-- --
========= ========
For all years presented, the Company's effective income tax rate is zero.
The difference between the Company's effective income tax rate and the Federal
statutory rate of 35% is attributable to state tax benefits and tax credit
carry-forwards offset by an increase in the deferred tax valuation allowance.
F-24
56
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
As of December 31, 2000, the Company had available for tax purposes unused
net operating loss carry-forwards of $212.3 million which will expire in various
years from 2004 to 2020. The Company's research and experimental tax credit
carry-forwards expire in various years from 2004 to 2020. Future changes in the
ownership of the Company could limit the future utilization of these net
operating loss and tax credit carry-forwards, as defined by the Federal and
state tax codes.
14. LITIGATION
In September 2000, Immunex Corporation filed a request with the European
Patent Office seeking the declaration of an Opposition regarding the scope of
the Company's European patent relating to Cytokine Traps. This is a legal
challenge to the validity and scope of the Company's patent. Although the
Company plans to defend the patent diligently, the scope of the patent may be
adversely affected following the outcome of the Opposition. In addition to this
patent challenge, the Company, from time to time, has been subject to legal
claims arising in connection with its business. While the ultimate results of
the patent challenge and legal claims cannot be predicted with certainty, at
December 31, 2000 there were no asserted claims against the Company which, in
the opinion of management, if adversely decided would have a material adverse
effect on the Company's financial position, results of operations, and cash
flows.
15. NET LOSS PER SHARE
The Company's basic net loss per share amounts have been computed by
dividing net loss by the weighted average number of Common and Class A shares
outstanding. In 2000, 1999, and 1998, the Company reported net losses and,
therefore, no common stock equivalents were included in the computation of
diluted net loss per share since such inclusion would have been antidilutive.
The calculations of basic and diluted net loss per share are as follows:
NET LOSS SHARES
(NUMERATOR, (DENOMINATOR, PER SHARE
IN THOUSANDS) IN THOUSANDS) AMOUNT
------------- ------------- ---------
2000:
Basic and Diluted............................. $(23,215) 34,950 $(0.66)
1999:
Basic and Diluted............................. $(23,070) 31,308 $(0.74)
1998:
Basic and Diluted............................. $ (8,625) 30,992 $(0.28)
Options and warrants which have been excluded from the diluted per share
amounts because their effect would have been antidilutive include the following:
DECEMBER 31,
--------------------------
2000 1999 1998
------ ------ ------
Weighted Average Number, in thousands.................... 6,819 7,146 6,429
Weighted Average Exercise Price.......................... $11.95 $ 9.31 $ 9.57
16. SEGMENT INFORMATION
Beginning in 2000, the Company's operations have been principally managed
in two business segments: research and development, and contract manufacturing.
F-25
57
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
RESEARCH AND DEVELOPMENT: Includes all activities related to the discovery
of potential therapeutics for human medical conditions, and the development and
commercialization of these discoveries. Also includes revenues and expenses
related to the development of manufacturing processes prior to commencing
commercial production of a product under contract manufacturing arrangements.
CONTRACT MANUFACTURING: Includes all revenues and expenses related to the
commercial production of products under contract manufacturing arrangements.
During 2000, the Company produced Intermediate under the Merck Agreement (see
Note 10) and BDNF for Sumitomo Pharmaceuticals under the R&D Agreement (see Note
9b).
Prior to 2000, the Company's operations were all conducted under the
research & development business segment.
The table below presents information about reported segments for the year
ended December 31, 2000:
RESEARCH & CONTRACT RECONCILING
DEVELOPMENT MANUFACTURING ITEMS TOTAL
----------- ------------- ----------- --------
Revenues......................... $ 42,678 $16,598 $ 8,480(1) $ 67,756
Loss in Amgen-Regeneron
Partners....................... 4,575 4,575
Depreciation and amortization.... 4,421 (2) 4,421
Interest expense................. 195 86 281
Net (loss) income................ (32,641) 946 8,480 (23,215)
Capital expenditures............. 6,404 65 6,469
Total assets..................... 18,336 34,615 155,323(3) 208,274
- ---------------
(1) Represents investment income.
(2) Depreciation and amortization related to contract manufacturing was
capitalized into inventory.
(3) Includes cash and cash equivalents, marketable securities, prepaid expenses
and other current assets, and other assets.
17. UNAUDITED QUARTERLY RESULTS
Effective January 1, 2000, the Company changed its method of accounting for
revenue recognition to conform with the guidance provided by SAB 101 (see Note
2). The cumulative effect of adopting SAB 101 at January 1, 2000 amounted to
$1.6 million of additional loss, with a corresponding increase to deferred
revenue that will be recognized in future periods, of which $0.4 million was
included in contract research and development revenue in 2000. The Company's
unaudited financial results for the quarters ended March 31, June 30, and
September 30, 2000 have been restated to apply SAB 101 retroactively, resulting
in the recognition of additional revenue of $0.1 million per quarter.
F-26
58
REGENERON PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA)
Summarized quarterly financial data for the years ended December 31, 2000
and 1999 are displayed in the following tables.
FIRST QUARTER ENDED
MARCH 31, 2000
(UNAUDITED)}
----------------------------
AS PREVIOUSLY
REPORTED AS RESTATED
------------- -----------
Revenues.................................................... $11,724 $11,817
======= =======
Net loss before cumulative effect of change in accounting
principle................................................. $(7,318) $(7,225)
Cumulative effect of adopting SAB 101....................... (1,563)
------- -------
Net loss.................................................... $(7,318) $(8,788)
======= =======
Net loss per share, basic and diluted:
Net loss before cumulative effect of change in accounting
principle.............................................. $ (0.23) $ (0.23)
Cumulative effect of adopting SAB 101..................... (0.04)
------- -------
Net loss per share........................................ $ (0.23) $ (0.27)
======= =======
SECOND QUARTER ENDED THIRD QUARTER ENDED
JUNE 30, 2000 SEPTEMBER 30, 2000
(UNAUDITED) (UNAUDITED) FOURTH QUARTER
---------------------------- ---------------------------- ENDED
AS PREVIOUSLY AS PREVIOUSLY DECEMBER 31, 2000
REPORTED AS RESTATED REPORTED AS RESTATED (UNAUDITED)
------------- ----------- ------------- ----------- -----------------
Revenues.................. $16,667 $16,760 $17,436 $17,529 $21,650
Net loss.................. (2,947) (2,854) (3,211) (3,118) (8,455)
Net loss per share, basic
and diluted............. $ (0.08) $ (0.08) $ (0.09) $ (0.09) $ (0.23)
FIRST QUARTER SECOND QUARTER THIRD QUARTER FOURTH QUARTER
ENDED ENDED ENDED ENDED
MARCH 31, 1999 JUNE 30, 1999 SEPTEMBER 30, 1999 DECEMBER 31, 1999
(UNAUDITED) (UNAUDITED) (UNAUDITED) (UNAUDITED)
-------------- -------------- ------------------ -----------------
Revenues..................... $ 6,918 $ 7,170 $12,536 $13,082
Net loss..................... (8,930) (7,833) (4,925) (1,382)
Net loss per share, basic and
diluted.................... $ (0.29) $ (0.25) $ (0.16) $ (0.04)
F-27
59
REPORT OF INDEPENDENT AUDITORS
The Partners
Amgen-Regeneron Partners
We have audited the accompanying balance sheets of Amgen-Regeneron
Partners, a Delaware general partnership, as of December 31, 2000 and 1999, and
the related statements of operations, changes in partners' capital (deficit),
and cash flows for each of the three years in the period ended December 31,
2000. These financial statements are the responsibility of the Partnership's
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with auditing standards generally
accepted in the United States. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements. An
audit also includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our opinion, the financial statements referred to above present fairly,
in all material respects, the financial position of Amgen-Regeneron Partners at
December 31, 2000 and 1999, and the results of its operations and its cash flows
for each of the three years in the period ended December 31, 2000, in conformity
with accounting principles generally accepted in the United States.
/s/ Ernst & Young LLP
Los Angeles, California
February 2, 2001
F-28
60
AMGEN-REGENERON PARTNERS
BALANCE SHEETS
DECEMBER 31
----------------
2000 1999
------ ------
(IN THOUSANDS)
ASSETS
Total current assets -- cash and cash equivalents........... $5,169 $3,700
====== ======
LIABILITIES AND PARTNERS' CAPITAL (DEFICIT)
Total current liabilities -- accounts payable and accrued
expenses due to partners.................................. $4,635 $4,300
------ ------
Partners' capital (deficit):
Amgen..................................................... 267 (300)
Regeneron................................................. 267 (300)
------ ------
Total partners' capital (deficit)........................... 534 (600)
------ ------
Total liabilities and partners' capital (deficit)........... $5,169 $3,700
====== ======
See accompanying notes.
F-29
61
AMGEN-REGENERON PARTNERS
STATEMENTS OF OPERATIONS
YEAR ENDED DECEMBER 31
-----------------------------
2000 1999 1998
------- ------- -------
(IN THOUSANDS)
Interest income............................................. $ 347 $ 366 $ 316
------- ------- -------
Total income................................................ 347 366 316
------- ------- -------
Expenses:
Research and development performed by partners............ 9,436 8,631 5,235
General and administrative................................ 61 53 49
------- ------- -------
Total expenses.............................................. 9,497 8,684 5,284
------- ------- -------
Net loss.................................................... $(9,150) $(8,318) $(4,968)
======= ======= =======
See accompanying notes.
F-30
62
AMGEN-REGENERON PARTNERS
STATEMENTS OF CHANGES IN PARTNERS' CAPITAL (DEFICIT)
AMGEN REGENERON
------- ---------
(IN THOUSANDS)
Balance at December 31, 1997................................ $ 364 $ 364
Capital contributions..................................... 5,211 5,211
Net loss.................................................. (2,484) (2,484)
------- -------
Balance at December 31, 1998................................ 3,091 3,091
Capital contributions..................................... 768 768
Net loss.................................................. (4,159) (4,159)
------- -------
Balance at December 31, 1999................................ (300) (300)
Capital contributions..................................... 5,142 5,142
Net loss.................................................. (4,575) (4,575)
------- -------
Balance at December 31, 2000................................ $ 267 $ 267
======= =======
See accompanying notes.
F-31
63
AMGEN-REGENERON PARTNERS
STATEMENTS OF CASH FLOWS
YEAR ENDED DECEMBER 31
-----------------------------
2000 1999 1998
------- ------- -------
(IN THOUSANDS)
Cash flows from operating activities:
Net loss.................................................. $(9,150) $(8,318) $(4,968)
Increase in accounts payable and accrued expenses......... 335 521 1,955
------- ------- -------
Net cash used in operating activities....................... (8,815) (7,797) (3,013)
Cash flows from financing activities -- capital
contributions............................................. 10,284 1,536 10,422
------- ------- -------
Increase (decrease) in cash and cash equivalents............ 1,469 (6,261) 7,409
Cash and cash equivalents at beginning of period............ 3,700 9,961 2,552
------- ------- -------
Cash and cash equivalents at end of period.................. $ 5,169 $ 3,700 $ 9,961
======= ======= =======
See accompanying notes.
F-32
64
AMGEN-REGENERON PARTNERS
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2000
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Business and Organization
Amgen-Regeneron Partners (the Partnership), a general partnership, was
formed on June 21, 1991, under the laws of the state of Delaware between Amgen
Inc. (Amgen) and Regeneron Pharmaceuticals, Inc. (Regeneron). The Partnership
was formed to develop and commercialize in the United States brain-derived
neurotrophic factor (BDNF) and Neurotrophin-3 (NT-3, together with BDNF, the
Products) for human pharmaceutical use, in conformity with a collaboration
agreement (the Collaboration Agreement) (Note 3).
In January 1997, Amgen and Regeneron announced that the Phase 3 clinical
trial of BDNF did not demonstrate clinical efficacy in the end points measured
in patients with amyotrophic lateral sclerosis (ALS), commonly known as Lou
Gehrig's Disease. The trial was designed to evaluate the effects of subcutaneous
delivery of BDNF for ALS. On behalf of the Partnership, Amgen continued to
conduct clinical trials of intrathecal delivery of BDNF for ALS, and Regeneron
continued to conduct clinical trials of subcutaneous delivery of BDNF for ALS.
In January 2001, Amgen and Regeneron were notified that clinical trials for both
intrathecal and subcutaneous delivery of BDNF did not provide a therapeutic
advantage to ALS patients. As a result, the Partnership has discontinued
clinical development of BDNF for the treatment of ALS and will incur additional
expenses during 2001 to wind up the related clinical trials. Regeneron continues
to conduct clinical trials with NT-3 for the treatment of chronic constipation
on behalf of the Partnership.
Under the Collaboration Agreement, Amgen will be primarily responsible for
the manufacture and commercialization of the Products in the United States if
successfully developed by the Partnership. Amgen's costs in connection with such
activities will be reimbursed at agreed-to rates. Unless terminated earlier, the
Partnership will continue in effect, with respect to each Product, until the
later of the expiration of the last United States patent of each Product, or 15
years from the date on which each Product was approved for sale in the United
States.
A Joint Management Committee (the Committee) is responsible for the overall
management of the business and affairs of the Partnership as well as activities
performed under the Collaboration Agreement. Each partner has appointed three
representatives to the Committee. One additional representative may be appointed
by a partner if the balance of their capital account becomes more than twice the
amount of the balance of the other partner's capital account (Note 2).
Cash Equivalents
The Partnership considers only those investments which are highly liquid,
readily convertible to cash and which mature within three months of the date of
purchase as cash equivalents. At December 31, 2000 and 1999, cash and cash
equivalents consisted of a single interest bearing money market account.
Research and Development
Research and development costs are expensed as incurred. Clinical trial
costs, which are a component of research and development costs, are recognized
based upon the estimated levels of effort expended on those trials.
Income Taxes
The Partnership's financial statements do not include a provision (credit)
for income taxes. Income taxes, if any, are the liability of the individual
partners.
F-33
65
AMGEN-REGENERON PARTNERS
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates.
2. CAPITAL CONTRIBUTIONS, ALLOCATION OF PROFITS AND LOSSES AND CASH
DISTRIBUTIONS
Capital contributions are recorded in the capital account of each partner.
Capital account contributions are generally made quarterly in advance based upon
capital calls made by the Committee pursuant to projected cash requirements of
the Partnership. Cash distributions, if any, and profits or losses are allocated
to each partner's capital account in proportion to their respective capital
account contributions.
3. COLLABORATION AGREEMENT
In August 1990, Amgen and Regeneron entered into the Collaboration
Agreement to develop and commercialize BDNF and NT-3, compounds for which
Regeneron possesses substantial scientific, technical and proprietary
information. Each party has agreed to perform research and development on the
Products under product development programs approved by the Committee. Upon
Amgen's notification in writing to Regeneron that the preparation of an
Investigational New Drug Application for each Product was to commence, the
licenses granted by the partners to the Partnership for the underlying
technologies, discussed below, became effective on a Product-by-Product basis.
Also, upon such notification, further research and development of the Products
under the licenses became the obligation of the Partnership. These licenses
grant the Partnership an exclusive royalty-free right to develop, make, have
made, use, sell and distribute each Product for human pharmaceutical use in the
United States. The Partnership has, in turn, granted to Amgen and Regeneron
exclusive royalty-free sublicenses for the underlying technologies to the extent
necessary to fulfill their obligations under the Collaboration Agreement. These
sublicenses became effective at the same time the related licenses granted the
Partnership became effective.
Pursuant to the terms of the Collaboration Agreement, Amgen and Regeneron
conduct certain research and development activities on behalf of the
Partnership, including contracting with third parties to conduct clinical
trials. Amgen also provides on behalf of the Partnership certain quantities of
materials, primarily for clinical testing. Amgen and Regeneron are paid for such
services and materials at amounts approved by the Committee. During the years
ended December 31, 2000, 1999 and 1998, the Partnership incurred expenses
(including accrued expenses) of $3,204,000, $5,044,000 and $3,379,000,
respectively, from Amgen and $6,232,000, $3,587,000 and $1,856,000,
respectively, from Regeneron for such services and materials. These amounts are
included in research and development expense in the accompanying statements of
operations. In addition, certain other costs associated with the development of
the Products have been incurred by the partners but not charged to the
Partnership or reflected in the accompanying financial statements as the related
development activities are not billable to the Partnership under the terms of
the Collaboration Agreement. At December 31, 2000, accounts payable and accrued
expenses due to partners was composed of $869,000 of accounts payable and
$2,162,000 of accrued clinical costs due to Amgen and $234,000 of accounts
payable and $1,370,000 of accrued clinical costs due to Regeneron. At December
31, 1999, accounts payable and accrued expenses due to partners was composed of
$888,000 of accounts payable and $2,939,000 of accrued clinical costs due to
Amgen and $236,000 of accounts payable and $237,000 of accrued clinical costs
due to Regeneron.
F-34
66
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
3.1(a) Restated Certificate of Incorporation of Regeneron
Pharmaceuticals, Inc. as of June 21, 1991.
3.2(f) By-Laws of the Company, currently in effect (amended as of
January 22, 1995).
10.1(b) Certificate of Amendment of the Restated Certificate of
Incorporation of Regeneron Pharmaceuticals, Inc., as of
October 18, 1996.
10.2(c)* Technology Development Agreement dated as of March 20, 1989,
between the Company and Sumitomo Chemical Company, Limited.
10.3(c)* Neurotrophic Factor Agreement (License Agreement) dated as
of May 10, 1988, between the Company and Max Planck
Institute fur Psychiatric.
10.4(c)* Collaboration Agreement dated August 31, 1990, between the
Company and Amgen Inc.
10.5(c) 1990 Amended and Restated Long-Term Incentive Plan.
10.6(d)* License Agreement dated as of October 7, 1992, between the
Company and The Regents of the University of California.
10.7(e)* Research and Development Agreement dated as of June 2, 1994,
between the Company and Sumitomo Pharmaceuticals Company,
Ltd.
10.8(g)* Manufacturing Agreement dated as of September 18, 1995,
between the Company and Merck & Co., Inc.
10.9(h) Warrant Agreement dated as of April 15, 1996, between the
Company and Amgen Inc.
10.10(h) Registration Rights Agreement dated as of April 15, 1996,
between the Company and Amgen Inc.
10.11(h) Warrant Agreement dated as of June 27, 1996, between the
Company and Medtronic, Inc.
10.12(h) Registration Rights Agreement dated as of June 27, 1996,
between the Company and Medtronic, Inc.
10.13(i) Rights Agreement, dated as of September 20, 1996, between
Regeneron Pharmaceuticals, Inc. and Chase Mellon Shareholder
Services LLC, as Rights Agent, including the form of Rights
Certificate as Exhibit B thereto.
10.14(j) Stock Purchase Agreement dated as of December 11, 1996,
between the Company and Procter & Gamble Pharmaceuticals,
Inc.
10.15(j) Registration Rights Agreement dated as of December 11, 1996,
between the Company and Procter & Gamble Pharmaceuticals,
Inc.
10.16(k) Securities Purchase Agreement dated as of May 13, 1997,
between the Company and The Procter & Gamble Company.
10.17(k) Warrant Agreement dated as of May 13, 1997, between the
Company and The Procter & Gamble Company.
10.18(k) Registration Rights Agreement dated as of May 13, 1997,
between the Company and The Procter & Gamble Company.
10.19(k)* Multi-Project Collaboration Agreement dated as of May 13,
1997, between the Company and The Procter & Gamble Company.
10.20(l)* First Amendment to the Multi-Project Collaboration Agreement
dated May 13, 1997, between the Company and The Procter &
Gamble Company, dated as of September 29, 1997.
10.21(m) Employment Agreement, dated as of February 12, 1998 between
the Company and Leonard S. Schleifer, M.D., Ph.D.
67
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
23.1 Consent of PricewaterhouseCoopers LLP, Independent
Accountants.
23.2 Consent of Ernst & Young LLP, Independent Auditors.
24 Power of Attorney. Included in the signature page of this
Registration Statement.
- ---------------
DESCRIPTION:
(a) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended June 30, 1991, filed August 13, 1991.
(b) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1996, filed November 5, 1996.
(c) Incorporated by reference from the Company's registration statement on Form
S-1 (file number 33-39043).
(d) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1992, filed March 30, 1993.
(e) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1994, filed November 14, 1994.
(f) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1994, filed March 30, 1995.
(g) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1995, filed November 14, 1995.
(h) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended June 30, 1996, filed August 14, 1996.
(i) Incorporated by reference from the Form 8-A for Regeneron Pharmaceuticals,
Inc. filed October 15, 1996.
(j) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1996, filed March 26, 1997.
(k) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended June 30, 1997, filed August 12, 1997.
(l) Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals,
Inc. for the quarter ended September 30, 1997, filed November 10, 1997.
(m) Incorporated by reference from the Form 10-K for Regeneron Pharmaceuticals,
Inc. for the fiscal year ended December 31, 1997, filed March 26, 1998.
* Portions of this document have been omitted and filed separately with the
Commission pursuant to requests for confidential treatment pursuant to Rule
24b-2.