UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
(X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 1998
-------------------- ------------
OR
( ) 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
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REGENERON PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
New York 13-3444607
--------------------------------- -------------------------------------
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
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(Address of principal executive offices) (Zip code)
(914) 347-7000
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(Registrant's telephone number, including area code)
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 the number of shares outstanding of each of the issuer's classes
of common stock as of May 8, 1998:
Class of Common Stock Number of Shares
------------------------------- ------------------
Class A Stock, $0.001 par value 27,110,100
Common Stock, $0.001 par value 3,896,274
REGENERON PHARMACEUTICALS, INC.
Table of Contents
March 31, 1998
Page Numbers
PART I FINANCIAL INFORMATION
Item 1 Financial Statements
Condensed balance sheets (unaudited) at March 31, 1998
and December 31, 1997 3
Condensed statements of operations (unaudited) for the three
months ended March 31, 1998 and 1997 4
Condensed statement of stockholders' equity (unaudited) for
three months ended March 31, 1998 5
Condensed statements of cash flows (unaudited) for the
three months ended March 31, 1998 and 1997 6
Notes to condensed financial statements 7-9
Item 2 Management's Discussion and Analysis of Financial Condition
and Results of Operations 10-17
PART II OTHER INFORMATION
Item 6 Exhibits and Reports on Form 8-K 18
SIGNATURE PAGE 19
Exhibit 27 Financial data schedule
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT MARCH 31, 1998 AND DECEMBER 31, 1997
(Unaudited) (In thousands, except share data)
March 31, December 31,
ASSETS 1998 1997
---- ----
Current assets
Cash and cash equivalents $19,258 $28,921
Marketable securities 65,813 63,602
Receivable due from The Procter & Gamble Company 2,306 2,403
Receivable due from Merck & Co., Inc. 1,896 1,707
Receivable due from Amgen-Regeneron Partners 429 356
Receivable due from Sumitomo Pharmaceuticals Company, Ltd. 2,115
Prepaid expenses and other current assets 1,204 536
--------------- ----------------
Total current assets 90,906 99,640
Marketable securities 37,401 35,518
Investment in Amgen-Regeneron Partners 707 364
Property, plant and equipment, at cost, net of accumulated depreciation
and amortization 32,200 32,713
Other assets 218 145
--------------- ----------------
Total assets $161,432 $168,380
=============== ================
LIABILITIES and STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $3,683 $4,663
Capital lease obligations, current portion 1,284 1,770
Note payable, current portion 73 73
Deferred revenue, current portion 2,431 4,182
--------------- ----------------
Total current liabilities 7,471 10,688
Capital lease obligations 1,813 2,077
Note payable 1,658 1,675
Other liabilities 252 242
Deferred revenue 14,802 14,801
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;
4,024,870 shares issued and outstanding in 1998
4,117,540 shares issued and outstanding in 1997 4 4
Common Stock, $.001 par value; 60,000,000 shares authorized;
26,968,234 shares issued and outstanding in 1998
26,804,941 shares issued and outstanding in 1997 27 27
Additional paid-in capital 308,426 308,109
Unearned compensation (630) (720)
Accumulated deficit (172,437) (168,608)
Accumulated other comprehensive income 46 85
--------------- ----------------
Total stockholders' equity 135,436 138,897
--------------- ----------------
Total liabilities and stockholders' equity $161,432 $168,380
=============== ================
The accompanying notes are an integral part of the financial statements.
3
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
Three months ended March 31,
1998 1997
---- ----
Revenues
Contract research and development $4,574 $4,238
Contract manufacturing 1,886 696
Investment income 1,790 1,279
----- -----
8,250 6,213
----- -----
Expenses
Research and development 8,150 7,076
Loss in Amgen-Regeneron Partners 687 1,700
General and administrative 1,384 1,464
Depreciation and amortization 869 1,201
Contract manufacturing 868 493
Interest 121 208
------ ------
12,079 12,142
------ ------
Net loss ($3,829) ($5,929)
======== ========
Net loss per share, basic and diluted ($0.12) ($0.23)
======= =======
The accompanying notes are an integral part of the financial statements.
4
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited)
For the three months ended March 31, 1998
(In thousands)
Additional
Paid-in
Class A Stock Common Stock Capital
------------- ------------ ----------
Shares Amount Shares Amount
------ ------ ------ ------
Balance, December 31, 1997 4,118 $ 4 26,805 $ 27 $308,109
Amortization of unearned compensation
Issuance of Common Stock in connection
with exercise of stock options 71 317
Conversion of Class A Stock to
Common Stock (93) 93
Net loss
Change in net unrealized gain
on marketable securities
------ ------- ------ ------- --------
Balance, March 31, 1998 4,025 $ 4 26,969 $ 27 $308,426
====== ======= ====== ======= ========
Accumulated Total
Unearned Accumulated Other Comprehensive Stockholders' Comprehensive
Compensation Deficit Income Equity Loss
------------ ----------- ------------------- ------------ -------------
Balance, December 31, 1997 ($720) ($168,608) $ 85 $ 138,897
Amortization of unearned compensation 90 90
Issuance of Common Stock in connection
Conversion of Class A Stock to
with exercise of stock options 317
Common Stock
Net loss (3,829) (3,829) ($ 3,829)
Change in net unrealized gain
on marketable securities (39) (39) (39)
------ ---------- --------- --------- ---------
Balance, March 31, 1998 ($630) ($172,437) $ 46 $ 135,436 ($ 3,868)
====== ========== ========= ========= =========
The accompanying notes are an integral part of the financial statements.
5
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
Increase (Decrease) in Cash and Cash Equivalents
(In thousands)
Three months ended March 31,
1998 1997
---- ----
Cash flows from operating activities
Net loss ($3,829) ($5,929)
-------- --------
Adjustments to reconcile net loss to net cash
used in operating activities
Loss in Amgen-Regeneron Partners 687 1,700
Depreciation and amortization 869 1,201
Stock issued in consideration for services rendered 90 90
Changes in assets and liabilities
Decrease in amounts due from The Procter & Gamble Company 97
Decrease in amounts due from Sumitomo Pharmaceuticals Co., Ltd. 2,115
(Increase) decrease in amounts due from Merck & Co., Ltd. (189) 1,022
Increase in amounts due from Amgen-Regeneron Partners (73)
Increase in investment in Amgen-Regeneron Partners (1,030) (9)
(Increase) decrease in prepaid expenses and other assets (741) 85
Decrease in deferred revenue (1,750) (1,280)
Decrease in accounts payable, accrued expenses,
and other liabilities (452) (240)
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Total adjustments (377) 2,569
------- -------
Net cash used in operating activities (4,206) (3,360)
------- -------
Cash flows from investing activities
Purchases of marketable securities (26,475) (20,562)
Sales of marketable securities 22,342 19,593
Capital expenditures (874) (1,184)
-------- --------
Net cash used in investing activities (5,007) (2,153)
-------- --------
Cash flows from financing activities
Net proceeds from the issuance of stock 317 107
Principal payments on note payable (17) (19)
Capital lease payments (750) (1,136)
-------- --------
Net cash used in financing activities (450) (1,048)
-------- --------
Net decrease in cash and cash equivalents (9,663) (6,561)
-------- --------
Cash and cash equivalents at beginning of period 28,921 34,475
------- -------
Cash and cash equivalents at end of period $19,258 $27,914
======= =======
The accompanying notes are an integral part of the financial statements.
6
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
1. Interim Financial Statements
The interim Condensed Financial Statements of Regeneron
Pharmaceuticals, Inc. (the "Company") have been prepared in accordance
with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all information and disclosures
necessary for a presentation of the Company's financial position,
results of operations and cash flows in conformity with generally
accepted accounting principles. In the opinion of management, these
financial statements reflect all adjustments, consisting only of normal
recurring accruals, necessary for a fair presentation of the Company's
financial position, results of operation, and cash flows for such
periods. The results of operations for any interim periods are not
necessarily indicative of the results for the full year. These
financial statements should be read in conjunction with the financial
statements and notes thereto contained in the Company's Annual Report
on Form 10-K for the year ended December 31, 1997.
2. Statement of Cash Flows
Supplemental disclosure of noncash investing and financing
activities:
Capital lease obligations of $250 were incurred during the first
three months of 1997, when the Company leased new equipment. No
such obligations were incurred for the three months ended March
31, 1998.
Included in accounts payable and accrued expenses at March 31,
1998 and December 31, 1997 were approximately $117 and $635 of
capital expenditures, respectively. Included in accounts payable
and accrued expenses at March 31, 1997 and December 31, 1996
were approximately $104 and $800, respectively, of accrued
capital expenditures.
3. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses as of March 31, 1998 and
December 31, 1997 consist of the following:
March 31, December 31,
1998 1997
--------- ------------
Accounts payable $1,763 $2,947
Accrued payroll and related costs 973 654
Accrued clinical trial expense 320 320
Accrued expenses, other 350 392
Deferred compensation 277 350
------ ------
$3,683 $4,663
====== ======
7
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
4. 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. For the three months
ended March 31, 1998 and 1997, 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 Per Share
(Numerator) (Denominator) Amount
----------- ------------- ------
1998:
Basic and ($3,829) 30,932 ($ 0.12)
Diluted
1997:
Basic and ($5,929) 25,799 ($ 0.23)
Diluted
Options and warrants, which have been excluded from the diluted
per share amounts because their effect would have been
antidilutive, include the following:
Three Months Ended March 31,
----------------------------------
1998 1997
--------------------------- ----------------------------
Weighted Weighted Weighted Weighted
Average Average Average Average
Number Exercise Price Number Exercise Price
------ -------------- -------- --------------
Options and warrants with
exercise prices below the average
fair market value of the
Company's common stock for
the respective period 1,848 $ 4.61 3,753 $ 7.07
Options and warrants with
exercise prices above the average
fair market value of the
Company's common stock for
the respective period 4,433 $11.72 1,665 $15.09
----- -----
6,281 5,418
===== =====
8
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
5. Adoption of Statement of Financial Accounting Standard No. 130
The Company has adopted Statement of Financial Accounting
Standard No. 130, Reporting Comprehensive Income ("SFAS No.
130"). 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. The disclosures required by SFAS No. 130 for the
three months ended March 31, 1998 have been included in the
Statement of Stockholders' Equity. For the three months ended
March 31, 1998 and 1997, the components of comprehensive loss
were:
1998 1997
---- ----
(in thousands)
Net Loss $(3,829) $(5,929)
Change in net unrealized gain on marketable securities (39) (157)
------- -------
Total comprehensive loss $(3,868) $(6,086)
======== ========
9
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
General
Overview. The discussion below contains forward-looking statements
that involve risks and uncertainties relating to the future financial
performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company")
and actual events or results may differ materially. These statements concern,
among other things, the possible therapeutic applications of the Company's
product candidates and research programs, the timing and nature of the Company's
clinical and research programs now underway or planned, a variety of items
described herein and in the footnotes to the Company's financial statements
(including the useful life of assets, the anticipated length of agreements, and
other matters), and the future uses of capital and financial needs of the
Company. These statements are made by the Company 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.
Regeneron is a leader in the application of molecular and cell
biology to discover novel potential therapeutics for human medical conditions
and is seeking to develop and commercialize these discoveries. The Company is
applying its technological expertise in protein growth factors, their receptors,
and their mechanisms of action to the discovery and development of protein-based
drugs and orally active, small molecule drugs.
The Company is pursuing research and development programs in the
following areas:
o AXOKINE(R), a second generation ciliary neurotrophic
factor, for the treatment of obesity (and diseases related
to obesity such as Type II diabetes),
o AXOKINE for the treatment of retinitis pigmentosa and other
retinal diseases,
o Brain-derived neurotrophic factor ("BDNF") for the
treatment of amyotrophic lateral sclerosis ("ALS," commonly
known as Lou Gehrig's disease),
o Neurotrophin-3 ("NT-3") for the treatment of enteric
neuropathies (constipating conditions),
o Angiopoietins, a new family of ligands (and their receptors,
called the TIE family of receptors) that appears to regulate
blood vessel formation, or angiogenesis,
o Protein antagonists for cytokines such as interleukin-4
("IL-4") and interleukin-6 ("IL-6") as potential treatment
of inflammatory diseases, allergic disorders, and cancer,
o Noggin, a naturally occurring protein, for potential use
in treating abnormal bone formation and related diseases
and conditions,
o Muscle atrophy, based on a receptor (called MuSK) of the
tyrosine kinases type that is specifically expressed in
skeletal muscle and a protein ligand (agrin) for this
receptor, and
10
o Research programs to discover orally active, small
molecule-based drugs, some of which may mimic or antagonize
protein- or receptor-based drug candidates that the Company
is developing.
Discussion of First Quarter 1998 Activities. In the first quarter of
1998, the Company continued to develop AXOKINE under the Company's collaboration
agreement ("the Procter & Gamble Agreement") with The Procter and Gamble Company
("Procter & Gamble"). Subject to completion of planned preclinical and related
development activities and regulatory review, the Company expects that an
Investigational New Drug application will be filed with the United States Food
and Drug Administration (the "FDA") by the end of 1998 or in early 1999 pursuant
to which clinical studies of AXOKINE for obesity and related conditions,
including Type II diabetes, would begin. The Company and Procter & Gamble also
continued to collaborate in research and development in the fields of
angiogenesis, bone growth, and muscle injury and atrophy, as well as small
molecule (orally active) drugs. The majority of the Company's scientific
resources are devoted to its collaborative activities with Procter & Gamble.
The Company continued independently to develop AXOKINE for use in
treating degenerative retinal diseases. The Company is collaborating with
academic investigators, government agencies, and private foundations in the
development of AXOKINE for retinal disease. Subject to completion of appropriate
preclinical experiments and regulatory approval, the Company plans to commence a
Phase I clinical study of AXOKINE to treat retinitis pigmentosa in late 1998 or
early 1999.
During the first quarter of 1998, the Company continued to develop
independent of any corporate collaboration its proprietary cytokine traps for
the potential treatment of inflammatory disease, asthma, cancer, and rheumatoid
arthritis. In addition, the Company continued to conduct research with
Pharmacopeia, Inc. and Glaxo Wellcome plc in the area of small molecule (orally
active) drugs.
During the first quarter of 1998, Amgen-Regeneron Partners, the
partnership equally owned by Regeneron and Amgen Inc. ("Amgen"), continued to
develop brain derived neurotrophic factor ("BDNF") and neurotrophin-3 (NT-3").
BDNF is currently being developed by Amgen-Regeneron Partners for potential use
in treating amyotrophic lateral sclerosis ("ALS," commonly known as Lou Gehrig's
disease) through two routes of administration: intrathecal (infusion into the
spinal fluid through an implanted pump) and subcutaneous (injection under the
skin). An intrathecal study in ALS patients is ongoing. Subcutaneous studies
conducted by Regeneron on behalf of the partnership began in the first quarter
of 1998. The subcutaneous studies are based on an analysis of the
Amgen-Regeneron Partners' Phase III trial of BDNF for ALS that was completed in
1996. That trial failed to achieve its predetermined end points, but subsequent
analyses indicated that a retrospectively-defined subset of ALS patients in the
trial may have received a survival benefit from BDNF treatment.
In March 1998, Sumitomo Pharmaceuticals Co., Ltd. ("Sumitomo
Pharmaceuticals"), the Company's collaborator in the development of BDNF in
Japan, began a Phase I safety assessment of BDNF delivered subcutaneously to
normal volunteers. Sumitomo Pharmaceuticals is initially developing BDNF to
treat ALS.
Amgen-Regeneron Partners' clinical development of NT-3 is currently
focused on enteric neuropathies (constipating conditions). The enteric nervous
system is a complex collection of nerves that control the
function of the gastrointestinal system, including
11
gastrointestinal motility. Regeneron, on behalf of Amgen-Regeneron Partners,
plans to commence by mid-1998, the first of a series of small clinical studies
of NT-3 in enteric neuropathies. The initial study includes patients suffering
from severe idiopathic constipation. Later studies may be in patients who suffer
from constipation associated with Parkinson's disease, spinal cord injury, use
of opiate pain-killers, and other conditions.
No assurance can be given that extended administration of BDNF or
NT-3 will be safe or effective. The treatment of ALS has been shown, in a number
of clinical settings using a variety of treatment modalities (including
Amgen-Regeneron Partners' earlier clinical studies), to present significant
difficulties. The design of an ALS clinical study presents special difficulties
and risks, as do the facts that ALS is a progressive disease that afflicts
individual patients differently and other ALS treatments are approved or have
been or are currently being tested, creating the possibility that patients in
any BDNF study may also receive other therapeutics during all or part of the
BDNF trial. The treatment of various constipating conditions may present
additional clinical trial risks in light of the complex and not wholly
understood mechanisms of action that lead to the conditions, the concurrent use
of other drugs to treat the underlying illnesses as well as the gastrointestinal
condition, the potential difficulty of designing and achieving significant
clinical end points, and other factors. No assurance can be given that these or
any other studies of BDNF or NT-3 will be successful or that BDNF or NT-3 will
be commercialized.
Substantial risk is inherent in the research, development, and
commercialization of drugs. In addition, in each of the areas of the Company's
independent and collaborative activities, other companies and entities are
actively pursuing competitive paths toward similar objectives. The results of
the Company's and its collaborators' past activities in connection with the
research and development of AXOKINE, cytokine traps, angiopoietins, abnormal
bone growth, muscle atrophy, small molecules, BDNF, and NT-3 do not necessarily
predict the results or success of current or future activities including, but
not limited to, any additional preclinical or clinical studies. The Company
cannot predict whether, when, or under what conditions any of its research or
product candidates, including without limitation AXOKINE, BDNF, or NT-3, will be
shown to be safe or effective to treat any human condition or be approved for
marketing by any regulatory agency. The delay or failure of current or future
studies to demonstrate the safety or efficacy of the Company's product
candidates to treat human conditions or to be approved for marketing could have
a material adverse impact on the Company.
To date, Regeneron has not received any revenues from the commercial
sale of products and may never receive such revenues. Before such revenues can
be realized, the Company (or its collaborators) must overcome a number of
hurdles which include successfully completing its 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 the
Company's products and technologies noncompetitive and obsolete.
From inception on January 8, 1988 through March 31, 1998, Regeneron
had a cumulative loss of $172.4 million. In the absence of revenues from
commercial product sales or other sources (the amount, timing, nature, or source
of which cannot be predicted), the Company's losses will continue as the Company
conducts its research and development activities. The Company's activities may
expand over time and may require additional resources, and the Company's
operating losses may be substantial over at least
12
the next several years. The Company's losses may fluctuate from quarter to
quarter and will depend, among other factors, on the timing of certain expenses
and on the progress of the Company's research and development efforts.
Results of Operations
Three months ended March 31,1998 and 1997. The Company's total
revenue increased to $8.3 million for the first quarter of 1998 from $6.2
million for the same period in 1997. Contract research and development revenue
increased to $4.6 million for the first quarter of 1998 from $4.2 million for
the same period in 1997, as higher revenue related to the P&G Agreement more
than offset a decrease in revenue from Amgen-Regeneron Partners and Sumitomo
Pharmaceuticals. Contract manufacturing revenue related to the long-term
manufacturing agreement (the "Merck Agreement") with Merck & Co., Inc. ("Merck")
increased to $1.9 million for the first quarter of 1998 compared to $0.7 million
for the same period in 1997 as a result of increased activity in preparation for
manufacturing a product for Merck at the Company's Rensselaer facility.
Investment income in the first quarter of 1998 increased to $1.8 million from
$1.3 million for the same period in 1997, due mainly to higher levels of
interest-bearing investments resulting primarily from the proceeds of a private
placement of equity securities with Procter & Gamble in June 1997.
The Company's total operating expenses were $12.1 million in the first
quarters of both 1998 and 1997. Research and development expenses increased to
$8.2 million in the first quarter of 1998 from $7.1 million for the same period
in 1997, primarily as a result of additional employees and increased activity in
the Company's preclinical and clinical research programs. Loss in
Amgen-Regeneron Partners decreased to $0.7 million in the first quarter of 1998
from $1.7 million for the same period in 1997, as the level of clinical trial
activity declined. Research and development expenses (including loss in
Amgen-Regeneron Partners) were approximately 73% of total operating expenses in
the first quarter of 1998, compared to 72% for the same period in 1997.
General and administrative expenses decreased slightly to $1.4 million
in the first quarter 1998 from $1.5 million for the same period in 1997.
Depreciation and amortization expense decreased to $0.9 million in the first
quarter of 1998 from $1.2 million in the first quarter of 1997, as certain
laboratory equipment became fully depreciated. Contract manufacturing expenses,
which are direct expenses related to the Merck Agreement and are reimbursed by
Merck, increased to $0.9 million in the first quarter of 1998 from $0.5 million
in the same period of 1997, primarily from increased manufacturing support by
Company personnel. Interest expense decreased to $0.1 million from $0.2 million
in the first quarters of 1998 and 1997, respectively, as the amount of
outstanding obligations in connection with capital leases declined.
The Company's net loss for the first quarter of 1998 was $3.8 million,
or $0.12 per share (basic and diluted), compared to a net loss of $5.9 million,
or $0.23 per share (basic and diluted), for the same period in 1997.
Liquidity and Capital Resources
Since its inception in 1988, the Company has financed its operations
primarily through private placements and public offerings of its equity
securities, revenue earned under the several agreements between the Company and
each of Amgen, Sumitomo
13
Chemical Company, Ltd., Sumitomo Pharmaceuticals, Merck, and Procter & Gamble
and investment income.
In May 1997, the Company and Procter & Gamble entered into the P&G
Agreement. Procter & Gamble agreed over the first five years of the P&G
Agreement to purchase up to $60.0 million in Regeneron equity (of which $42.9
was purchased in June 1997) and provide up to $94.7 million in support of
Regeneron's research efforts related to the collaboration. During the second
five years of the P&G Agreement, the companies will share all research costs
equally. Clinical testing and commercialization expenses for jointly developed
products will be shared equally throughout the ten years of the collaboration.
The companies expect jointly to develop and market worldwide any products
resulting from the collaboration and share equally in profits. Either company
may terminate the P&G Agreement at the end of five years with at least one year
prior notice or earlier in the event of a default (as defined in the P&G
Agreement). In September 1997, the Company and Procter & Gamble expanded the P&G
Agreement to include AXOKINE and related molecules (delivered systemically), and
agreed to develop AXOKINE initially to treat obesity associated with Type II
diabetes. Procter & Gamble agreed to reimburse the Company for certain research
and development costs and pay as much as $15.0 million in additional funding,
partly subject to achieving certain milestones related to AXOKINE. Of the $15.0
million, $5.0 million was paid in 1997 and an additional $5.0 million is
expected in 1998.
In connection with the Company's agreement to collaborate with
Sumitomo Pharmaceuticals in the research and development of BDNF in Japan, the
Company continues to be reimbursed in connection with supplying Sumitomo
Pharmaceuticals with BDNF for preclinical and clinical use. The Company expects
to receive a $5.0 million milestone payment during 1998 in connection with the
start of Sumitomo's Phase I clinical study of BDNF.
The Company's activities relating to BDNF and NT-3, as agreed upon by
Amgen and Regeneron, are being reimbursed by Amgen-Regeneron Partners, and the
Company recognizes such reimbursement as revenue. The funding of Amgen-Regeneron
Partners is through capital contributions from Amgen and Regeneron, who must
make equal payments in order to maintain equal ownership and equal sharing of
any profits or losses from the partnership. The Company has made capital
contributions totaling approximately $45.2 million to Amgen-Regeneron Partners
from the partnership's inception in June 1993 through December 31, 1997. The
Company expects that its capital contributions in 1998 will total $5.7 million
for the full year, of which $2.4 million has been funded through May 1998. These
contributions could increase or decrease, depending upon the cost of
Amgen-Regeneron Partners' conducting additional BDNF and NT-3 studies and the
outcomes of those and other ongoing studies.
From its inception in January 1988 through March 31, 1998, the Company
invested approximately $56.7 million in property, plant, and equipment. This
includes $16.8 million to acquire and renovate the Rensselaer facility and $14.1
million of completed construction at the facility related to the Merck
Agreement. In connection with the purchase and renovation of the Rensselaer
facility, the Company obtained financing of $2.0 million from the New York State
Urban Development Corporation, of which $1.7 million is outstanding. Under the
terms of such financing, the Company is not permitted to declare or pay
dividends to its stockholders.
14
The Company expects 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. The Company is currently involved in
interference proceedings in the Patent and Trademark Office between Regeneron's
patent applications and patents relating to ciliary neurotrophic factor ("CNTF")
issued to Synergen, Inc. ("Synergen"). Amgen acquired all outstanding shares of
Synergen in 1994. In March 1998, the Company and Amgen entered into a covenant
not to sue each other which, among other things, resolved their patent
interference and related opposition and other patent proceedings relating to
CNTF and AXOKINE. The Company also granted Amgen a license to use CNTF and
second generation CNTFs other than AXOKINE to treat retinal degenerative
conditions. Neither party will pay royalties or make other payments to the other
party in consideration of this agreement.
As of March 31, 1998, the Company had no established banking
arrangements through which it could obtain short-term financing or a line of
credit. Additional funds may be raised through, among other things, the issuance
of additional securities, other financing arrangements, and future collaboration
agreements. No assurance can be given that additional financing will be
available or, if available, that it will be available on acceptable terms. In
addition, the Company estimates that through mid-2002 it could receive
additional payments from Procter & Gamble in the form of research funding,
milestones, and equity purchases of as much as $100 million or more.
At March 31, 1998, the Company had $122.5 million in cash, cash
equivalents, and marketable securities. The Company expects to incur substantial
funding requirements for, among other things, research and development
activities (including preclinical and clinical testing), validation of
manufacturing facilities, and the acquisition of equipment. The Company expects
to incur ongoing funding requirements for capital contributions to
Amgen-Regeneron Partners to support the continued development and clinical
trials of BDNF and NT-3. The amount needed to fund operations will also depend
on other factors, including the status of competitive products, the success of
the Company's research and development programs, the status of patents and other
intellectual property rights developments, and the continuation, extent, and
success of any collaborative research programs (including those with Amgen and
Procter & Gamble). The Company believes that its existing capital resources will
enable it to meet operating needs for at least several years. No assurance can
be given that there will be no change in projected revenues or expenses that
would lead to the Company's capital being consumed significantly before such
time.
Factors That May Affect Future Operating Results
Regeneron cautions stockholders and potential investors that the
following important factors, among others, in some cases have affected, and in
the future could affect, Regeneron's actual results and could cause Regeneron's
actual results to differ materially from those expressed in any forward-looking
statements made by, or on behalf of, Regeneron. 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 characterization of other statements or
information under other captions as cautionary statements for such purpose:
15
o Delay, difficulty, or failure of the Company's research and
development programs to produce product candidates that are
scientifically or commercially appropriate for further
development by the Company or others.
o 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 the Company and its operations. A change of control
of one or more of the Company's material collaborators or
licensees could also have a material adverse effect on the
Company.
o Delay, difficulty, or failure in obtaining regulatory approval
(including approval of its facilities for production) for the
Company's products (including vaccine intermediate for Merck),
including delays or difficulties in development because of
insufficient proof of safety or efficacy.
o Increased and irregular costs of development, manufacture,
regulatory approval, sales, and marketing associated with the
introduction of products in the late stage of development.
o Competitive or market factors that may cause use of the
Company's products to be limited or otherwise fail to achieve
broad acceptance.
o 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.
o Difficulties or high costs of obtaining adequate financing to
meet the Company's obligations under its collaboration and
licensing agreements or to fund 50 percent of the cost of
developing product candidates in order to retain 50 percent of
the commercialization rights.
o Amount and rate of growth of Regeneron's general and
administrative expenses, and the impact of unusual or
infrequent charges resulting from Regeneron's ongoing
evaluation of its business strategies and organizational
structure.
o Failure of corporate partners to develop or commercialize
successfully the Company's products or to retain and expand the
markets served by the commercial collaborations; conflicts of
interest, priorities, and commercial strategies which may arise
between the Company and such corporate partners.
o Delays or difficulties in developing and acquiring production
technology and technical and managerial personnel to
manufacture novel biotechnology products in commercial
quantities at reasonable costs and in compliance with
applicable quality assurance and environmental regulations and
governmental permitting requirements.
o Difficulties in obtaining key raw materials and supplies for
the manufacture of the Company's product candidates.
16
o 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
Regeneron relating to intellectual property rights and
licenses; the issuance and use of patents and proprietary
technology by Regeneron and its competitors, including the
possible negative effect on the Company's ability to develop,
manufacture, and sell its products in circumstances where it is
unable to obtain licenses to patents which may be required for
such products.
o Underutilization of the Company's 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.
o Health care reform, including reductions or changes in
reimbursement available for prescription medications or other
reforms.
o The ability to attract and retain key personnel. As Regeneron's
scientific efforts lead to potentially promising new
directions, both outside of recombinant protein therapies (into
orally active, small molecule pharmaceuticals) and outside of
treatments for neurological and neurodegenerative conditions
(into, for example, potential programs in obesity, diabetes,
cancer, inflammation, muscle disease, bone growth disorders,
and angiogenesis), the Company will require additional internal
expertise or external collaborations in areas in which it
currently does not have substantial resources and personnel.
The Company is evaluating the need to modify its computer
systems and software to properly handle information and transactions
relating to the year 2000. Presently the Company believes that with
modifications to some existing software, the year 2000 issue can be
mitigated. The Company plans to complete the year 2000 project not later
than December 31, 1998, and does not expect the cost of such
modifications to be material.
17
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
27 Financial Data Schedule
(b) Reports
No reports on Form 8-K were filed by the registrant
during the quarter ended March 31, 1998.
18
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Regeneron Pharmaceuticals, Inc.
Date: May 8, 1998 By: /s/ Murray A. Goldberg
-------------------------- ---------------------------------
Murray A. Goldberg
Vice President, Finance & Administration,
Chief Financial Officer, and Treasurer
19
5
1,000
3-MOS
DEC-31-1998
JAN-01-1998
MAR-31-1998
19,258
103,214
4,631
0
0
90,906
56,664
24,464
161,432
7,471
0
0
0
31
135,405
161,432
0
8,250
0
0
11,958
0
121
(3,829)
0
(3,829)
0
0
0
(3,829)
(0.12)
(0.12)
