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 June 30, 1998
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OR
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from to
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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
- ---------------------------------------- ----------
(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 August 10, 1998:
Class of Common Stock Number of Shares
--------------------- ----------------
Class A Stock, $0.001 par value 3,639,625
Common Stock, $0.001 par value 27,374,769
REGENERON PHARMACEUTICALS, INC.
Table of Contents
June 30, 1998
Page Numbers
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PART I FINANCIAL INFORMATION
Item 1 Financial Statements
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Condensed balance sheets (unaudited) at June 30, 1998
and December 31, 1997 3
Condensed statements of operations (unaudited) for the three
months and six months ended June 30, 1998 and 1997 4
Condensed statement of stockholders' equity (unaudited) for the
six months ended June 30, 1998 5
Condensed statements of cash flows (unaudited) for the
three months and six months ended June 30, 1998 and 1997 6
Notes to condensed financial statements 7-11
Item 2 Management's Discussion and Analysis of Financial Condition
- ------ ------------------------------------------------------------
and Results of Operations 12-21
-------------------------
PART II OTHER INFORMATION
Item 4 Submission of Matters to a Vote of Security Holders 22
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Item 6 Exhibits and Reports on Form 8-K 23
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SIGNATURE PAGE 24
Exhibit 27 Financial data schedule
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT JUNE 30, 1998 AND DECEMBER 31, 1997 (Unaudited)
(In thousands, except share data)
June 30, December 31,
ASSETS 1998 1997
---- ----
Current assets
Cash and cash equivalents $22,538 $28,921
Marketable securities 52,453 63,602
Receivable due from The Procter & Gamble Company 9,782 2,403
Receivable due from Merck & Co., Inc. 1,290 1,707
Receivable due from Amgen-Regeneron Partners 474 356
Receivable due from Sumitomo Pharmaceuticals Co., Ltd. 935 2,115
Prepaid expenses and other current assets 926 536
---------------- ---------------
Total current assets 88,398 99,640
Marketable securities 42,431 35,518
Investment in Amgen-Regeneron Partners 1,914 364
Property, plant and equipment, at cost, net of accumulated depreciation
and amortization 32,160 32,713
Other assets 216 145
---------------- ---------------
Total assets $165,119 $168,380
================ ===============
LIABILITIES and STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $5,079 $4,663
Capital lease obligations, current portion 1,157 1,770
Note payable, current portion 72 73
Deferred revenue, current portion 2,205 4,182
---------------- ---------------
Total current liabilities 8,513 10,688
Capital lease obligations 1,961 2,077
Note payable 1,640 1,675
Other liabilities 262 242
Deferred revenue 14,971 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;
3,643,720 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;
27,363,854 shares issued and outstanding in 1998
26,804,941 shares issued and outstanding in 1997 27 27
Additional paid-in capital 308,516 308,109
Unearned compensation (540) (720)
Accumulated deficit (170,297) (168,608)
Accumulated other comprehensive income 62 85
---------------- ---------------
Total stockholders' equity 137,772 138,897
---------------- ---------------
Total liabilities and stockholders' equity $165,119 $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 June 30, Six months ended June 30,
1998 1997 1998 1997
--------------- --------------- -------------- -------------
Revenues
Contract research and development $6,202 $4,377 $10,776 $8,616
Research progress payments 5,000 5,000
Contract manufacturing 2,281 858 4,167 1,555
Investment income 1,712 1,381 3,502 2,659
--------------- --------------- -------------- -------------
15,195 6,616 23,445 12,830
--------------- --------------- -------------- -------------
Expenses
Research and development 9,054 6,881 17,204 13,957
Loss in Amgen-Regeneron Partners 186 479 873 2,179
General and administrative 1,693 1,688 3,077 3,152
Depreciation and amortization 780 1,165 1,649 2,367
Contract manufacturing 1,235 476 2,103 969
Interest 107 197 228 405
--------------- --------------- -------------- -------------
13,055 10,886 25,134 23,029
--------------- --------------- -------------- -------------
Net income (loss) $2,140 ($4,270) ($1,689) ($10,199)
=============== =============== ============== =============
Net income (loss) per share,
basic and diluted $0.07 ($0.16) ($0.05) ($0.38)
=============== =============== ============== =============
The accompanying notes are an integral part of the financial statements.
===============================================================================
4
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited)
For the six months ended June 30, 1998
(In thousands)
Class A Stock Common Stock Additional
------------------------ ----------------------- Paid-in Unearned
Shares Amount Shares Amount Capital Compensation
----------- ----------- ---------- --------- ------------ --------------
Balance, December 31, 1997 4,118 $4 26,805 $27 $308,109 ($720)
Amortization of unearned
compensation 180
Issuance of Common Stock in
connection with exercise
of stock options 85 407
Conversion of Class A Stock to
Common Stock (474) 474
Net loss
Change in net unrealized gain
on marketable securities
====================================================================================
Balance, June 30, 1998 3,644 $4 27,364 $27 $308,516 ($540)
====================================================================================
Accumulated Total
Accumulated Other Comprehensive Stockholders' Comprehensive
Deficit Income Equity Loss
------------ ---------------- --------------- ----------------
Balance, December 31, 1997 ($168,608) $85 $138,897
Amortization of unearned
compensation 180
Issuance of Common Stock in
connection with exercise
of stock options 407
Conversion of Class A Stock to
Common Stock
Net loss (1,689) (1,689) ($1,689)
Change in net unrealized gain
on marketable securities (23) (23) (23)
==========================================================================
Balance, June 30, 1998 ($170,297) $62 $137,772 ($1,712)
==========================================================================
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)
Six months ended June 30,
1998 1997
---- ----
Cash flows from operating activities
Net loss ($1,689) ($10,199)
------------------ ------------------
Adjustments to reconcile net loss to net cash
used in operating activities
Loss in Amgen-Regeneron Partners 873 2,179
Depreciation and amortization 1,649 2,367
Stock issued in consideration for services rendered 180 180
Changes in assets and liabilities
Increase in amounts due from The Procter & Gamble Company (7,379) (938)
Decrease (increase) in amounts due from Merck & Co., Inc. 417 (98)
Increase in amounts due from Amgen-Regeneron Partners (118) (359)
Decrease (increase) in amounts due from Sumitomo Pharmaceuticals Co., Ltd. 1,180 (255)
Increase in investment in Amgen-Regeneron Partners (2,423) (9)
(Increase) decrease in prepaid expenses and other assets (461) 221
Decrease in deferred revenue (1,807) (925)
Increase in accounts payable, accrued expenses,
and other liabilities 881 371
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Total adjustments (7,008) 2,734
------------------ ------------------
Net cash used in operating activities (8,697) (7,465)
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Cash flows from investing activities
Purchases of marketable securities (43,883) (46,078)
Sales of marketable securities 48,096 30,440
Capital expenditures (1,090) (1,085)
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Net cash provided by (used in) investing activities 3,123 (16,723)
------------------ ------------------
Cash flows from financing activities
Net proceeds from the issuance of stock 407 43,207
Principal payments on note payable (36) (38)
Capital lease payments (1,180) (2,011)
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Net cash (used in) provided by financing activities (809) 41,158
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Net (decrease) increase in cash and cash equivalents (6,383) 16,970
------------------ ------------------
Cash and cash equivalents at beginning of period 28,921 34,475
------------------ ------------------
Cash and cash equivalents at end of period $22,538 $51,445
================== ==================
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 $451 and $619 were incurred during the
first six months of 1998 and 1997, respectively, when the Company
leased new equipment.
Included in accounts payable and accrued expenses at June 30, 1998 and
December 31, 1997 were approximately $190 and $635, respectively, of
accrued capital expenditures. Included in accounts payable and accrued
expenses at June 30, 1997 and December 31, 1996 were approximately
$1,127 and $800, respectively, of accrued capital expenditures. In
addition, approximately $40 of costs incurred in connection with the
Company's issuance of equity securities were included in accounts
payable and accrued expenses at June 30, 1997.
3. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses as of June 30, 1998 and December
31, 1997 consist of the following:
June 30, December 31,
1998 1997
---- ----
Accounts payable $2,439 $2,947
Accrued payroll and related costs 1,343 654
Accrued clinical trial expense 320 320
Accrued expenses, other 690 392
Deferred compensation 287 350
----- ------
$5,079 $4,663
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7
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
4. Income Taxes
For the three months ended June 30, 1998, the Company did not record a
provision for income taxes. The Company was able to apply net
operating loss carry-forwards against its taxable net income, and the
effect of the alternative minimum tax was not material.
5. Amgen-Regeneron Partners Research Collaboration Agreement
In August 1990, the Company and Amgen Inc. formed a partnership,
Amgen-Regeneron Partners (the "Partnership"), whereby the revenues
earned and expenses incurred by the Partnership for the research and
development of BDNF and NT-3 are shared equally. The Company accounts
for its investment in the Partnership in accordance with the equity
method of accounting.
Selected income statement data of the Partnership for the three and
six months ended June 30, 1998 and 1997 are as follows:
Three Months Ended June 30, Six Months Ended June 30,
--------------------------- -------------------------
1998 1997 1998 1997
---- ---- ---- ----
Total revenues $43 $37 $83 $187
Total expenses (416) (995) (1,829) (4,546)
----- ----- ------- -------
Net loss ($373) ($958) ($1,746) ($4,359)
====== ====== ======== ========
8
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
6. Earnings per Share
The Company's basic net income (loss) per share amounts have been
computed by dividing net income (loss) by the weighted average number
of Common and Class A shares outstanding. For the three months ended
June 30, 1998, the Company reported net income; therefore, common
stock equivalents were included in the computation of diluted net
income per share. For the three months ended June 30, 1997 and for the
six months ended June 30, 1998 and 1997, the Company reported net
losses; 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
income (loss) per share are as follows:
Three Months Ended June 30,
- -------------------------------------------------------------------------------
Net Income (Loss) Shares Net Income (Loss)
(Numerator) (Denominator) Per Share
----------- ------------- ---------
1998:
Basic $2,140 31,003 $0.07
Effect of dilutive
securities
Options -- 985 --
------
Diluted $2,140 31,988 $0.07
======
1997:
Basic and ($4,270) 27,193 ($0.16)
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 June 30,
- ------------------------------------------------------------------------------
1998 1997
------------------------- ---------------------------
Weighted Weighted
Weighted Average Weighted Average
Average Exercise Average Exercise
Number Price Number Price
------ ----- ------ -----
Options with exercise
prices below
the average fair
market value of
the Company's common
stock for the
respective period 1,890 $4.49
Options and warrants
with exercise
prices above the
average fair market
value of the Company's
common stock for
the respective period 4,002 $12.05 2,495 $13.34
----- ----- ------
Total 4,002 4,385
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9
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
6. Earnings per Share (continued)
Six Months Ended June 30,
- ---------------------------------------------------------------------------
Net Loss Shares Per Share
(Numerator) (Denominator) Amount
1998:
Basic and Diluted ($1,689) 30,968 ($0.05)
1997:
Basic and Diluted ($10,199) 26,496 ($0.38)
- ---------------------------------------------------------------------------
Options and warrants, which have been excluded from the diluted per
share amounts because their effect would have been antidilutive
include the following:
Six Months Ended June 30,
- -------------------------------------------------------------------------------
1998 1997
-----------------------------------------------------
Weighted Weighted
Weighted Average Weighted Average
Average Exercise Average Exercise
Number Price Number Price
------ ----- ------ -----
Options and warrants
with exercise prices
below the average fair
market value of the
Company's common stock
for the respective period 2,328 $5.43 2,298 $5.40
Options and warrants
with exercise prices
above the average fair
market value of the
Company's common stock
for the respective period 4,010 $12.04 1,831 $14.64
----- -----
Total 6,338 4,129
===== =====
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10
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
(In thousands, except per share data)
7. Adoption of Statement of Financial Accounting Standards No. 130
The Company has adopted Statement of Financial Accounting Standards
No. 130, Reporting Comprehensive Income ("SFAS No. 130").
Comprehensive loss represents the change in net assets of a business
enterprise during a period from transactions and other events and
circumstances from non-owner sources. Comprehensive loss of the
Company includes net loss adjusted for the change in net unrealized
gain or loss on marketable securities. The net effect of income taxes
on comprehensive loss is immaterial. The disclosures required by SFAS
No. 130 for the six months ended June 30, 1998 have been included in
the Statement of Stockholders' Equity. For the six months ended June
30, 1998 and 1997, the components of comprehensive loss were:
1998 1997
---- ----
Net loss ($ 1,689) ($10,199)
Change in net unrealized gain
on marketable securities (23) (136)
-------- --------
Total comprehensive loss ($1,712) ($10,335)
======== =========
8. Impact of the Future Adoption of Recently Issued Accounting Standard
In June 1998, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 133, Accounting for
Derivative and Hedging Activities ("SFAS No. 133"). SFAS No. 133
establishes a comprehensive standard on accounting for derivatives and
hedging activities and is effective for periods beginning after June
15, 1999. Management does not believe that the future adoption of SFAS
No. 133 will have a material effect on the Company's financial
position and results of operations.
11
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 associated with Type II diabetes and
possibly for uncomplicated obesity,
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, that occurs in a variety of clinical settings
following disuse or denervation of muscle, and
12
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 Second Quarter 1998 Activities. In the second quarter of
1998, the Company continued to develop AXOKINE under the Company's
collaboration agreement ("the P&G Agreement") with The Procter and Gamble
Company ("Procter & Gamble"). The Company and Procter & Gamble plan to file an
Investigational New Drug application ("IND") with the United States Food and
Drug Administration ("FDA") in early 1999 in order to conduct early stage
clinical studies of AXOKINE for the treatment of obesity associated with Type
II diabetes and possibly for uncomplicated obesity. No assurance can be made
regarding the timing or nature of such IND in light of the need successfully to
complete substantial preclinical development activities, the timing of which is
partially not in the control of the Company or Procter & Gamble, before filing
an IND. In addition, no assurance can be made regarding the timing, nature, or
result of any clinical trial of AXOKINE. AXOKINE has never been administered to
people. Its safety and efficacy to treat any condition have not been
established and can not be predicted. Previous clinical studies of ciliary
neurotrophic factor ("CNTF"), the parent molecule of AXOKINE, resulted in the
creation of antibodies and adverse events (side effects) in patients, including
weight loss, cough, nausea, malaise, and others. While certain aspects of the
development of AXOKINE by the Company and Procter & Gamble have focused on
attempting to avoid or minimize antibody production or adverse events, no
assurance may be given that these problems will be avoided or minimized or that
they will not lead to the failure, delay, or additional difficulty in
conducting AXOKINE clinical trials.
In June 1998, the Company and Procter & Gamble executed a development
agreement for AXOKINE and other potential drug candidates which resulted in a
$5.0 million research progress payment to the Company from Procter & Gamble.
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 early 1999. In July 1998, the Company and Medtronic, Inc. terminated their
1996 collaborative development agreement to conduct an exploratory research
program using Medtronic delivery systems to deliver AXOKINE to the central
nervous system, initially as a potential treatment for Huntington's disease, due
to obstacles in formulation and delivery.
During the second 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.
13
During the second quarter of 1998, Amgen-Regeneron Partners, the
partnership equally owned by Regeneron and Amgen Inc. ("Amgen"), continued to
develop BDNF and NT-3. BDNF is currently being developed by Amgen-Regeneron
Partners for potential use in treating ALS through two routes of
administration: intrathecal (infusion into the spinal fluid through an
implanted pump) and subcutaneous (injection under the skin). Amgen, on behalf
of Amgen-Regeneron Partners, has completed a Phase I safety study of BDNF
delivered intrathecally and is planning to begin a Phase II clinical trial
later this year. 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.
The Company and Sumitomo Pharmaceuticals Co., Ltd. ("Sumitomo
Pharmaceuticals") are collaborating in the development of BDNF in Japan,
initially for the treatment of ALS. In March 1998, Sumitomo Pharmaceuticals
initiated a Phase I clinical trial in Japan to assess the safety of BDNF
delivered subcutaneously to normal volunteers. In August 1998, Sumitomo
Pharmaceuticals signed a license agreement for the development of BDNF in
Japan. Pursuant to the license agreement, Sumitomo Pharmaceuticals is expected
to make a $5.0 million milestone payment to Regeneron in the third quarter of
1998 and will make additional payments upon the achievement of specified
milestones. Sumitomo Pharmaceuticals will also pay a royalty on sales of BDNF
in Japan.
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 gastrointestinal motility. In June 1998,
Regeneron, on behalf of Amgen-Regeneron Partners, began 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.
14
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 June 30, 1998, Regeneron had
a cumulative loss of $170.3 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 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 June 30, 1998 and 1997. The Company's total revenue
increased to $15.2 million for the second quarter of 1998 from $6.6 million for
the same period in 1997. Contract research and development revenue increased to
$6.2 million for the second quarter of 1998 from $4.4 million for the same
period in 1997, as higher revenue related to the P&G Agreement more than offset
a decrease in revenue from Sumitomo Pharmaceuticals. A research progress
payment of $5.0 million was received in the second quarter of 1998 from Procter
& Gamble in connection with a collaboration to develop AXOKINE for obesity
associated with Type II diabetes and possibly for uncomplicated obesity.
Contract manufacturing revenue related to the long-term manufacturing agreement
(the "Merck Agreement") with Merck & Co., Inc. ("Merck") increased to $2.3
million for the second quarter of 1998 compared to $0.9 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 second quarter of 1998 increased to $1.7 million from
$1.4 million for the same period in 1997, due mainly to higher levels of
interest-bearing investments resulting primarily from
15
the proceeds of a private placement of equity securities with Procter & Gamble
in June 1997.
The Company's total operating expenses increased to $13.1 million in
the second quarter 1998 from $10.9 million for the same period in 1997.
Research and development expenses increased to $9.1 million in the second
quarter of 1998 from $6.9 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 $0.2 million in the second quarter of 1998 from $0.5 million for
the same period in 1997, as the level of research activity declined. Research
and development expenses (including loss in Amgen-Regeneron Partners) were
approximately 71% of total operating expenses in the second quarter of 1998,
compared to 68% for the same period in 1997.
General and administrative expenses were $1.7 million in both the
second quarters of 1998 and 1997. Depreciation and amortization expense
decreased to $0.8 million in the second quarter of 1998 from $1.2 million in
the second quarter of 1997, as certain laboratory equipment and leasehold
improvements became fully depreciated. Contract manufacturing expenses, which
are direct expenses related to the Merck Agreement and are reimbursed by Merck,
increased to $1.2 million in the second quarter of 1998 from $0.5 million in
the same period of 1997, primarily due to increased activity in preparation for
manufacturing a product for Merck. Interest expense decreased to $0.1 million
from $0.2 million in the second quarters of 1998 and 1997, respectively, as the
amount of outstanding obligations in connection with capital leases declined.
The Company's net income for the second quarter of 1998 was $2.1
million, or $0.07 per share (basic and diluted), compared to a net loss of $4.3
million, or $0.16 per share (basic and diluted), for the same period in 1997.
Six months ended June 30, 1998 and 1997. The Company's total revenue
increased to $23.4 million for the six months ended June 30, 1998 from $12.8
million for the same period in 1997. Contract research and development revenue
increased to $10.8 million for the six months ended June 30, 1998 from $8.6
million for the same period in 1997, as higher revenue related to the P&G
Agreement more than offset a decrease in revenue from Sumitomo Pharmaceuticals.
A research progress payment of $5.0 million was received in the second quarter
of 1998 from Procter & Gamble in connection with a collaboration to develop
AXOKINE for obesity associated with Type II diabetes and possibly for
uncomplicated obesity. Contract manufacturing revenue related to the Merck
Agreement increased to $4.2 million for the first six months of 1998 compared
to $1.6 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 for the six months ended June 30, 1998
increased to $3.5 million from $2.7 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 increased to $25.1 million for
the six months ended June 30, 1998 from $23.0 million for the same period in
1997. Research and development expenses increased to $17.2 million in the first
six months of 1998 from $14.0 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 $0.9 million in the first half of 1998 from $2.2 million for the
same period in 1997, as the level of research activity declined.
16
Research and development expenses (including loss in Amgen-Regeneron Partners)
were approximately 72% of total operating expenses in the first six months of
1998, compared to 70% for the same period in 1997.
General and administrative expenses decreased slightly to $3.1 million
for the six months ended June 30, 1998 from $3.2 million for the same period in
1997. Depreciation and amortization expense decreased to $1.6 million for the
six months ended June 30, 1998 from $2.4 million for the same period in 1997,
as certain laboratory equipment and leasehold improvements became fully
depreciated. Contract manufacturing expenses, which are direct expenses related
to the Merck Agreement and are reimbursed by Merck, increased to $2.1 million
in the first half of 1998 from $1.0 million in the same period of 1997,
primarily due to increased activity in preparation for manufacturing a product
for Merck. Interest expense decreased to $0.2 million from $0.4 million for the
six months ended June 30, 1998 and 1997, respectively, as the amount of
outstanding obligations in connection with capital leases declined.
The Company's net loss for the six months ended June 30, 1998 was $1.7
million, or $0.05 per share (basic and diluted), compared to a net loss of
$10.2 million, or $0.38 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 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
million 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
$5.0 million was paid in July 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 also
expects to receive a $5.0 million milestone payment from Sumitomo
Pharmaceuticals in the third quarter of 1998.
17
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 $47.6 million to
Amgen-Regeneron Partners from the partnership's inception in June 1993 through
June 30, 1998. 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 June 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 June 30, 1998, the Company
invested approximately $57.4 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.
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 June 30, 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 June 30, 1998, the Company had $117.4 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
18
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:
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 of a clinical trial of any of the
Company's 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, the creation of
antibodies (in the case of protein-based therapeutics) that weaken or
neutralize the effect of the product candidate (and possibly could
have other adverse effects on patients), the failure of clinical
investigators, trial monitors and other consultants, or trial subjects
to comply with the trial plan or protocol.
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.
19
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 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.
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.
20
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 its operations to determine the impact, if
any, Year 2000 issues may have. The Company's review includes its computer
systems and software, embedded systems in non-computer equipment, and vendor
operations. The Company has appointed a Year 2000 task force with
representatives from each operation of the Company and has retained independent
consultants to facilitate its review. To date, the Company believes that no
material Year 2000 issue exists with respect to its computer systems and
software. The Company is in the process of analyzing its laboratory and
manufacturing equipment with embedded systems. This analysis is incomplete. The
Company is also in the process of surveying its vendors to determine their
level of readiness with respect to Year 2000 issues. The analysis of the
Company's embedded systems and the information collected regarding vendor
readiness will be used to formulate a contingency plan with respect to
reasonably identifiable items of equipment and supply of materials that are
critical to the Company's operations. The costs of addressing Year 2000 issues
have been minor to date, but may increase if substantial consultant or
personnel resources are required or if operationally-important equipment must
be remediated or replaced. The risks that Year 2000 issues could present to the
Company include, without limitation, disruption, delay, or cessation of
manufacturing or other operations, including operations that are subject to
regulatory compliance. In each case the correction of the problem could result
in substantial expense and disruption or delay of the Company's operations.
Impact of the Future Adoption of Recently Issued Accounting Standard
In June 1998, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 133, Accounting for Derivative
and Hedging Activities ("SFAS No. 133"). SFAS No. 133 establishes a
comprehensive standard on accounting for derivatives and hedging activities and
is effective for periods beginning after June 15, 1999. Management does not
believe that the future adoption of SFAS No. 133 will have a material effect on
the Company's financial position and results of operations.
21
PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On June 12, 1998, the Company conducted its Annual Meeting of
Shareholders pursuant to due notice. A quorum being present either in person or
by proxy, the shareholders voted on the following matters:
1. To elect three Directors to hold office for a three-year term as
Class I directors and until their successors are duly elected and qualified.
2. To approve the selection of Coopers & Lybrand L.L.P. as independent
accountants for the Company's fiscal year ending December 31, 1998.
No other matters were voted on. The number of votes cast was:
Withhold
For Authority
--- ---------
1. Election of Class I Directors
Leonard S. Schleifer, M.D., Ph.D. 52,390,382 277,081
Eric M. Shooter, Ph.D. 52,397,662 269,801
Fred A. Middleton 52,397,662 269,801
The terms of office of P. Roy Vagelos, M.D., Alfred G. Gilman, M.D.,
Ph.D., Joseph L. Goldstein, M.D., Michael S. Brown, M.D., George Sing, and
Charles A. Baker continued after the meeting.
For Against Abstain
--- ------- -------
2. Selection of accountants 52,608,041 38,480 20,942
22
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 June 30, 1998.
23
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: August 14, 1998 By: /s/ Murray A. Goldberg
----------------------- -------------------------------
Murray A. Goldberg
Vice President, Finance & Administration,
Chief Financial Officer, and Treasurer
24
5
1000
6-MOS
DEC-31-1998
JAN-01-1998
JUN-30-1998
22,538
94,884
12,481
0
0
88,398
60,464
28,304
165,119
8,513
0
0
0
31
137,741
165,119
0
23,445
0
0
24,906
0
228
(1,689)
0
(1,689)
0
0
0
(1,689)
(0.05)
(0.05)
