*
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, 1997
---------------
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.
------------------------------------------------------
(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
----------------------------------------------------
(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 April 30, 1997:
Class of Common Stock Number of Shares
- ------------------------------- ----------------
Class A Stock, $0.001 par value 4,335,824
Common Stock, $0.001 par value 22,166,169
Page 1 of 17
REGENERON PHARMACEUTICALS, INC.
Table of Contents
March 31, 1997
Page Numbers
------------
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed balance sheets (unaudited) at March 31, 1997
and December 31, 1996 3
Condensed statements of operations (unaudited) for the three
months ended March 31, 1997 and 1996 4
Condensed statements of cash flows (unaudited) for the
three months ended March 31, 1997 and 1996 5
Notes to condensed financial statements 6
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations 7-13
PART II- OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K 14
SIGNATURE PAGE 15
Exhibit 11 Statement of computation of net loss per share for the three
months ended March 31, 1997 and 1996. 16
Exhibit 27 Financial data schedule. 17
2
PART 1. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT MARCH 31, 1997 AND DECEMBER 31, 1996 (Unaudited)
March 31, December 31,
ASSETS 1997 1996
------------- -------------
Current assets
Cash and cash equivalents $ 27,914,539 $ 34,475,060
Marketable securities 40,141,043 45,587,404
Receivable due from Sumitomo Pharmaceuticals Company, Ltd. 2,072,473 2,072,455
Receivable due from Merck & Co., Inc. 793,581 1,816,056
Receivable due from Amgen-Regeneron Partners 446,269 446,269
Prepaid expenses and other current assets 528,087 611,435
------------- -------------
Total current assets 71,895,992 85,008,679
Marketable securities 23,223,159 16,965,302
Investment in Amgen-Regeneron Partners 1,205,299
Property, plant and equipment, at cost, net of accumulated depreciation
and amortization 33,846,173 34,297,843
Other assets 102,935 104,731
------------- -------------
Total assets $ 129,068,259 $ 137,581,854
============= =============
LIABILITIES and STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $ 3,416,852 $ 4,357,145
Capital lease obligations, current portion 3,291,977 3,505,221
Note payable, current portion 76,532 77,684
Capital contribution due to Amgen-Regeneron Partners 485,700
Deferred revenue, current portion 2,426,326 4,108,412
------------- -------------
Total current liabilities 9,697,387 12,048,462
Capital lease obligations 2,726,546 3,400,015
Note payable 1,730,031 1,748,082
Other liabilities 198,337 183,426
Deferred revenue 13,673,302 13,270,870
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;
4,345,824 shares issued and outstanding in 1997
4,355,994 shares issued and outstanding in 1996 4,346 4,356
Common Stock, $.001 par value; 60,000,000 shares authorized;
22,152,619 shares issued and outstanding in 1997
21,319,896 shares issued and outstanding in 1996 22,153 21,320
Additional paid-in capital 264,848,892 264,742,236
Unearned compensation (990,000) (1,080,000)
Accumulated deficit (162,957,961) (157,029,112)
Net unrealized gain on marketable securities 115,226 272,199
------------- -------------
Total stockholders' equity 101,042,656 106,930,999
------------- -------------
Total liabilities and stockholders' equity $ 129,068,259 $ 137,581,854
============= =============
The accompanying notes are an integral part of the financial statements.
3
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
Three months
ended March 31,
1997 1996
------------ ------------
Revenues
Contract research and development $ 4,238,438 $ 4,182,896
Investment income 1,278,741 600,422
Contract manufacturing 696,456 405,351
------------ ------------
6,213,635 5,188,669
------------ ------------
Expenses
Research and development 7,076,471 6,926,403
Loss in Amgen-Regeneron Partners 1,700,000 2,661,900
General and administrative 1,463,927 1,510,945
Depreciation and amortization 1,201,497 1,490,954
Contract manufacturing 492,862 115,336
Interest 207,727 250,629
------------ ------------
12,142,484 12,956,167
------------ ------------
Net loss ($ 5,928,849) ($ 7,767,498)
============ ============
Net loss per share ($0.23) ($0.35)
============ ============
Weighted average number of Common
and Class A shares outstanding 25,798,971 22,007,864
============ ============
The accompanying notes are an integral part of the financial statements.
4
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
Increase (Decrease) in Cash and Cash Equivalents
Three months ended March 31,
1997 1996
------------ ------------
Cash flows from operating activities
Net loss ($ 5,928,849) ($ 7,767,498)
------------ ------------
Adjustments to reconcile net loss to net cash
used in operating activities
Share of net loss of Amgen-Regeneron Partners 1,700,000 2,661,900
Depreciation and amortization 1,201,497 1,490,954
Stock issued in consideration for services rendered 90,000 90,000
Changes in assets and liabilities
Decrease in amounts due from Amgen-Regeneron Partners 162,410
(Increase) in amounts due from Sumitomo
Pharmaceuticals Co. Ltd. (18) (216,769)
Decrease (increase) in amounts due from Merck & Co., Inc. 1,022,475 (1,493,359)
(Increase) in investment in Amgen-Regeneron Partners (9,001) (2,670,000)
Decrease in prepaid expenses and other assets 85,144 10,823
(Decrease) increase in deferred revenue (1,279,654) 899,634
(Decrease) in accounts payable, accrued expenses,
and other liabilities (240,643) (507,183)
------------ ------------
Total adjustments 2,569,800 428,410
------------ ------------
Net cash (used in) operating activities (3,359,049) (7,339,088)
------------ ------------
Cash flows from investing activities
Purchase of marketable securities (20,561,837) (18,387,003)
Sale of marketable securities 19,593,368 9,483,152
Capital expenditures (1,184,566) (4,758,580)
------------ ------------
Net cash (used in) investing activities (2,153,035) (13,662,431)
------------ ------------
Cash flows from financing activities
Net proceeds from the issuance of equity securitie 107,479 1,000,283
Principal payments on note payable (19,203) (20,694)
Capital lease payments (1,136,713) (789,904)
------------ ------------
Net cash (used in) provided by financing act (1,048,437) 189,685
------------ ------------
Net (decrease) in cash and cash equivalents (6,560,521) (20,811,834)
------------ ------------
Cash and cash equivalents at beginning of year 34,475,060 32,736,026
------------ ------------
Cash and cash equivalents at end of year $ 27,914,539 $ 11,924,192
============ ============
Supplemental disclosure of cash flow information
Cash paid for interest $ 192,816 $ 230,282
============ ============
The accompanying notes are an integral part of the financial statements.
5
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements
1. Interim Financial Statements
In the opinion of management of the Company, the accompanying
unaudited interim financial statements reflect all adjustments,
consisting only of normal recurring accruals, necessary to present
fairly the Company's financial position as of March 31, 1997 and
December 31, 1996 and the results of operations for the three months
ended March 31, 1997 and 1996. The results of operations for such
interim periods are not necessarily indicative of the results to be
expected for the full year.
2. Statement of Cash Flows
Supplemental disclosure of noncash investing and financing activities:
There were capital lease obligations of $250,000 incurred in the first
three months of 1997.
Included in accounts payable and accrued expenses at March 31, 1997
and December 31, 1996 were approximately $104,000 and $800,000,
respectively, of accrued capital expenditures.
3. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses as of March 31, 1997 and
December 31, 1996 consist of the following:
March 31, December 31,
1997 1996
---------- ----------
Accounts payable $1,586,646 $2,178,308
Accrued payroll and related costs 776,755 1,047,812
Accrued clinical trial expense 319,500 319,500
Accrued expenses, other 311,488 389,062
Deferred compensation 422,463 422,463
---------- ----------
$3,416,852 $4,357,145
========== ==========
6
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 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 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.
During the first quarter of 1997, Amgen Inc. ("Amgen"), on behalf of
Amgen-Regeneron Partners, continued to conduct a further clinical trial of
neurotrophin-3 ("NT-3") for the treatment of peripheral neuropathies caused by
diabetes. Amgen also continued to conduct a trial of BDNF in Europe for the
treatment of neuropathies caused by diabetes. The Company continued to develop
and manufacture BDNF for use by Sumitomo Pharmaceuticals Co., Ltd. ("Sumitomo
Pharmacteuticals") in Japan and continued the development of a series of
preclinical research programs in the areas of inflammatory and muscle disease,
angiogenesis, hematopoiesis, and cancer.
In January 1997, Amgen and Regeneron announced that the Phase
III clinical trial of BDNF delivered subcutaneously did not demonstrate
clinical efficacy in patients with ALS and that the trial confirmed the safety
and tolerability of BDNF seen in earlier trials. The failure of the Phase III
trial to achieve its primary end points had a materially adverse effect on the
price of the Company's Common Stock (which declined more than 50% immediately
after the announcement of the results of the trial). After the Phase III
clinical trial results were announced, the Company retained independent experts
in the fields of neurology and gastroenterology, as well as independent
statisticians, to conduct further examination of the data. This review by the
Company and the outside panels indicated 1) that a subset of ALS patients in
the trial may have received a benefit from BDNF treatment and 2) that BDNF
appeared to have an effect on the gastrointestinal system and might have a
therapeutic role in treating constipating conditions, among other disorders.
The panels recommended, among other things, that additional clinical and
preclinical investigations of subcutaneous BDNF for ALS and BDNF for
gastrointestinal conditions should be undertaken. The Company is reviewing
these recommendations and the Phase III data and is discussing with Amgen and
Sumitomo Pharmaceuticals whether to undertake these or other investigations of
BDNF. Further development of BDNF in the United States must be undertaken in
accordance with the terms of the Company's collaboration agreement with Amgen.
Although Sumitomo Pharmaceuticals had planned a Phase I safety assessment of
BDNF early in 1997, they are currently reviewing their BDNF development plan in
light of the recently available information.
7
The results of the Company's and its collaborators' past activities in
connection with the research and development of BDNF and NT-3 do not
necessarily predict the results or success of future activities including, but
not limited to, any additional preclinical or clinical studies of BDNF or NT-3.
The Company cannot predict whether, when, or under what conditions 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 BDNF or NT-3
to treat human conditions or to be approved for marketing would have a material
adverse impact on the Company.
The Company and Amgen are conducting a Phase I trial of BDNF for ALS
using intrathecal delivery. While intrathecal delivery may be more successful
in delivering BDNF to certain motor neurons (the nerve cells that degenerate in
ALS), it is not known whether intrathecal delivery will prove any more
successful in demonstrating safety and utility in patients with ALS than the
subcutaneous delivery used in the Phase III clinical trial that failed to
achieve its primary end points. If additional studies of BDNF for ALS are
undertaken, the time and expense required for such trials could be material to
the Company and the outcome will be uncertain. If subsequent trials are
conducted and such trials fail to demonstrate that BDNF is safe and effective
in the treatment of ALS, that failure could have a materially adverse effect on
the Company, the price of the Company's Common Stock, and the Company's ability
to raise additional capital.
No assurance can be given that extended administration of NT-3 will be
safe or effective. The Phase I study of NT-3 in normal human volunteers that
concluded in 1995 was a short term (seven day) treatment study. The current
NT-3 clinical study involves substantially longer treatment (six months or
longer). The treatment of peripheral neuropathy may present additional clinical
trial risks in light of the complex and not wholly understood mechanisms of
action that lead to the neuropathies, the presence of many other drugs to treat
the underlying conditions, the potential difficulty of achieving significant
clinical endpoints, and other factors. No assurance can be given that these or
any other studies of NT-3 will be successful or that NT-3 will be
commercialized.
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 United States Food and Drug
Administration ("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.
In the absence of revenues from commercial product sales or other
sources (the amount, timing, nature, or source of which can not 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.
8
Results of Operations
Three months ended March 31, 1997 and 1996. The Company's total revenue
increased to $6.2 million for the first quarter of 1997 from $5.2 million for
the same period in 1996. Contract research and development revenue remained the
same at $4.2 million for the first quarter of 1997 compared to the same period
in 1996. Contract research and development revenue earned from Sumitomo
Pharmaceuticals increased to $2.8 million in the first quarter of 1997 from
$2.7 million for the same period in 1996. Of the first quarter 1997 and 1996
Sumitomo Pharmaceuticals revenue, $0.7 million was for contract research for
both periods, and $2.1 million and $2.0 million was reimbursement for
developing manufacturing processes for BDNF and supplying BDNF, respectively.
Contract research and development revenue earned from Amgen-Regeneron Partners
("the Partnership") decreased to $0.5 million for the first quarter of 1997
from $1.5 million for the same period in 1996. This reflects less spending on
research conducted by Regeneron and Amgen on BDNF and NT-3. The Company entered
into a research collaboration agreement with Procter & Gamble Pharmaceuticals,
Inc. ("Procter & Gamble") in December of 1996, and contract research revenue
related to this agreement totaled $0.9 million for the first quarter 1997.
Contract manufacturing revenue related to the long-term manufacturing agreement
(the "Merck Agreement") with Merck & Co., Inc. ("Merck") for the first quarters
of 1997 and 1996 totaled $0.7 million and $0.4 million, respectively.
Investment income in the first quarter of 1997 increased to $1.3 million from
$0.6 million for the same period in 1996, due primarily to higher levels of
interest-bearing investments resulting from the private placements of equity
securities with Amgen, Medtronic, Inc. ("Medtronic"), and Procter & Gamble in
April, June, and December 1996, respectively.
The Company's total operating expenses decreased to $12.1 million in
the first quarter of 1997 from $13.0 million for the same period in 1996.
Research and development expense increased to $7.1 million in the first quarter
of 1997 from $6.9 million for the same period in 1996 as a result of increased
activity in the Company's Rensselaer, New York manufacturing facility related
to the Company's agreement with Merck. Loss in Amgen-Regeneron Partners
decreased to $1.7 million in the first quarter of 1997 from $2.7 million for
the same period in 1996, as the Partnership completed the Phase III clinical
trial of BDNF in 1996. Research and development expenses (including Loss in
Amgen-Regeneron Partners) were approximately 72% of total operating expenses in
the first quarter of 1997 compared to 74% for the same period in 1996.
General and administrative expenses totaled $1.5 million in the first
quarters of 1997 and 1996, as a decrease in legal and patent expenses in 1997
offset increases in salary and employee benefit expenses. Depreciation and
amortization decreased from $1.5 million in the first quarter of 1996 to $1.2
million in the first quarter of 1997 as older lab equipment became fully
depreciated and because capitalized patent costs were fully amortized in 1996.
Interest expense decreased to $0.2 million in the first quarter of 1997 from
$0.3 million for the same period in 1996, resulting from the expiration of
equipment leases during 1996. Contract manufacturing expenses are direct
expenses related to the long-term manufacturing agreement with Merck.
The Company's net loss for the first quarter of 1997 was $5.9 million,
or $0.23 per share, compared to a net loss of $7.8 million, or $0.35 per share,
for the same period in 1996.
9
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, Medtronic, and Procter & Gamble and investment income. In connection
with the Company's agreement to collaborate with Procter & Gamble in the
research and development of skeletal muscle disease and injury, Procter &
Gamble paid the Company $1.0 million in December 1996, and has agreed to pay
the Company an additional $3.75 million per year through at least December
1999. In connection with the Company's agreement to collaborate with Sumitomo
Pharmaceuticals in the research and development of BDNF in Japan, Sumitomo
Pharmaceuticals paid the Company $22.0 million through December 1996 (which
includes a payment of $3.0 million for 1997) and agreed to pay the Company an
additional $3.0 million in 1998. Sumitomo Pharmaceuticals has the option to
cancel the 1998 payment; however, if such a cancellation were to occur,
Sumitomo Pharmaceutical's rights to develop and commercialize BDNF in Japan
would revert to the Company. In addition, the Company is being reimbursed in
connection with supplying Sumitomo Pharmaceuticals with BDNF for preclinical
use.
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 $42.6 million to
Amgen-Regeneron Partners from the partnership's inception in June 1993 through
March 31, 1997. The Company expects that its capital contributions in 1997 will
total approximately $3.0 million to $5.0 million. These contributions could
increase or decrease, depending upon the cost of Amgen-Regeneron Partners'
conducting additional BDNF and NT-3 preclinical and clinical studies and the
outcomes of those and other ongoing studies. Capital contributions beyond 1997
are also anticipated to be significant.
From its inception in January 1988 through March 31, 1997, the Company
invested approximately $54.2 million in property, plant and equipment,
including $16.8 million to acquire and renovate the Rensselaer facility, $6.3
million of newly completed construction, and $6.6 million of new construction
that is in progress related to the modification of the facility in connection
with 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 $1.8 million is
outstanding. Under the terms of such financing the Company is not permitted to
declare or pay dividends to its stockholders.
During 1996, the Company entered into a series of new leasing
agreements (the "New Lease Line") which provides up to $4.0 million to finance
equipment acquisitions and certain building improvements, as defined,
(collectively, the "Equipment"). The Company may utilize the New Lease Line in
increments ("leases"). Lease terms are for four years after which the Company
is required to purchase the Equipment at defined amounts. Certain of the leases
may be renewed for eight months at defined monthly payments after which the
Company will own the Equipment. At March 31, 1997, the Company had available
approximately $0.8 million of the New Lease Line.
10
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
two interference proceedings in the Patent and Trademark Office between
Regeneron's patent applications and patents relating to CNTF issued to
Synergen, Inc. Amgen acquired all outstanding shares of Synergen in 1994.
As of March 31, 1997, 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.
At March 31, 1997, the Company had $91.3 million in cash, cash
equivalents, and marketable securities. 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
Company also expects to incur substantial funding requirements for, among other
things, its research and development activities (including preclinical and
clinical testing), validation of its manufacturing facilities, and the
acquisition of equipment, and may incur substantial funding requirements for
expenses related to the patent interference proceedings and other patent
matters. 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 extent and success of any
collaborative research programs. The Company expects to incur additional
capital expenditures in connection with the renovation and validation of its
Rensselaer facility pursuant to its manufacturing agreement with Merck.
However, the Company also expects that such expenditures will be substantially
reimbursed by Merck, subject to certain conditions. The Company believes that
its existing capital resources will enable it to meet operating needs into
1999. 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 at
a faster rate than currently expected. In order to continue to attempt to
assure Regeneron's financial condition and maximize its technological
developments for the long-term benefit of shareholders, the Company from time
to time seeks additional corporate partners and explores other opportunities to
obtain research and development funding. No assurance can be given that such
partners or funding will be available or, if available, will be on terms
favorable or acceptable to the Company.
Factors That May Affect Future Operating Results
Regeneron cautions stockholders and 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:
11
o Delay, difficulty, or failure of the Company's preclinical drug research
and development programs to produce product candidates that are
scientifically or commercially appropriate for further development by the
Company or others.
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, regulatory approval,
manufacture, sales, and marketing associated with the introduction of
products in the late stage of development.
o Cancellation or termination of material collaborative or licensing
agreements and resulting loss of research or other funding and have other
material adverse effects 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 Competitive or market factors 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 in Regeneron's selling, 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 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 Difficulties in launching or marketing the Company's products by the
Company or its licensees, especially when such products are novel products
based on biotechnology, and unpredictability of customer acceptance of
such products.
o Inability to maintain or initiate third party arrangements which generate
revenues, in the form of license fees, research and development support,
royalties, and other payments, in return for rights to technology or
products under development by the Company.
12
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-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
cancer, inflammation, muscle disease, angiogenesis, and hematopoiesis),
the Company will require additional internal expertise or external
collaborations in areas in which it currently does not have substantial
resources and personnel.
Impact of the Adoption of Recently Issued Accounting Standards
In February 1997, the Financial Accounting Standards Board issued
Financial Accounting Standard No. 128, "Earnings Per Share" ("SFAS 128"). SFAS
128 will require the Company to replace the current presentation of "primary"
per share data with "basic" and "diluted" per share data. Currently,
outstanding common stock equivalents are antidilutive and therefore management
estimates that the future adoption of SFAS 128 currently will not have a
material impact on the Company's per share data. SFAS 128 will be adopted by
the Company for periods ending after December 15, 1997.
13
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
11 Statement of computation of loss per share for the
three months ended March 31, 1997 and 1996.
27 Financial Data Schedule
(b) Reports
No reports on Form 8-K were filed by the registrant during
the quarter ended March 31, 1997.
14
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 7, 1997 By: /s/ Murray A. Goldberg
----------------- -----------------------------------------
Murray A. Goldberg
Vice President, Finance & Administration,
Chief Financial Officer, and Treasurer
15
Exhibit 11
REGENERON PHARMACEUTICALS, INC.
STATEMENT OF COMPUTATION OF NET LOSS PER SHARE
Three months ended March 31,
----------------------------
1997 1996
Primary:
Net loss ($ 5,928,849) ($ 7,767,498)
============ ============
Per share data
Weighted average number of Class A and
Common shares outstanding during the period 25,798,971 22,007,864
============ ============
Net loss per share ($0.23) ($0.35)
============ ============
Fully diluted:
Net loss ($ 5,928,849) ($ 7,767,498)
============ ============
Per share data
Weighted average number of Class A and
Common shares outstanding during the period 25,798,971 22,007,864
Shares issuable upon exercise of options 2,301,301 2,866,962
Shares assumed to be repurchased under
the treasury stock method (1,154,685) (1,356,882)
------------ ------------
26,945,587 23,517,944
============ ============
Net loss per share ($0.22) ($0.33)
============ ============
16
5
3-MOS
DEC-31-1997
JAN-01-1997
MAR-31-1997
27,914,539
63,364,202
3,312,323
0
0
71,895,992
54,251,454
20,405,281
129,068,259
9,697,387
0
0
0
4,346
101,042,656
129,068,259
0
6,213,635
0
0
11,934,757
0
207,727
(5,928,849)
0
(5,928,849)
0
0
0
(5,928,849)
(0.23)
(0.22)
