1
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, 2001
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
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, 2001:
Class of Common Stock Number of Shares
--------------------- ----------------
Class A Stock, $0.001 par value 2,573,665
Common Stock, $0.001 par value 40,972,694
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REGENERON PHARMACEUTICALS, INC.
TABLE OF CONTENTS
MARCH 31, 2001
PAGE NUMBERS
------------
PART I FINANCIAL INFORMATION
Item 1 Financial Statements
Condensed balance sheets (unaudited) at March 31, 2001 and
December 31, 2000 3
Condensed statements of operations (unaudited) for the three
months ended March 31, 2001 and 2000 4
Condensed statement of stockholders' equity (unaudited) for the
three months ended March 31, 2001 5
Condensed statements of cash flows (unaudited) for the
three months ended March 31, 2001 and 2000 6
Notes to condensed financial statements 7-13
Item 2 Management's Discussion and Analysis of Financial Condition
and Results of Operations 14-24
Item 3 Quantitative & Qualitative Disclosure About Market Risk 24
PART II OTHER INFORMATION
Item 6 Exhibits and Reports on Form 8-K 25
SIGNATURE PAGE 26
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT MARCH 31, 2001 AND DECEMBER 31, 2000 (Unaudited)
(In thousands, except share data)
March 31, December 31,
ASSETS 2001 2000
--------- ------------
Current assets
Cash and cash equivalents $ 183,620 $ 30,978
Marketable securities 90,383 86,634
Receivable due from The Procter & Gamble Company 2,500 6,907
Receivable due from Merck & Co., Inc. 207 1,447
Receivable due from Amgen-Regeneron Partners 1,894 1,604
Receivable due from Sumitomo Pharmaceuticals Co., Ltd. 4,007 3,877
Prepaid expenses and other current assets 1,357 780
Inventory 2,668 1,915
--------- ---------
Total current assets 286,636 134,142
Marketable securities 25,210 36,758
Investment in Amgen-Regeneron Partners 267
Property, plant, and equipment, at cost, net of accumulated
depreciation and amortization 37,166 36,934
Other assets 173 173
--------- ---------
Total assets $ 349,185 $ 208,274
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable and accrued expenses $ 9,404 $ 9,446
Deferred revenue, current portion 3,682 3,728
Due to Amgen-Regeneron Partners 232
Capital lease obligations, current portion 470 545
Note payable, current portion 67 67
--------- ---------
Total current liabilities 13,855 13,786
Deferred revenue 8,713 9,995
Capital lease obligations 464 603
Note payable 1,450 1,466
Other liabilities 292 294
Commitments and contingencies
Stockholders' equity
Preferred stock, $.01 par value; 30,000,000 shares authorized; issued and
outstanding - none
Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized;
2,575,165 shares issued and outstanding in 2001
2,612,845 shares issued and outstanding in 2000 3 3
Common Stock, $.001 par value; 60,000,000 shares authorized;
40,827,224 shares issued and outstanding in 2001
34,197,104 shares issued and outstanding in 2000 41 34
Additional paid-in capital 560,985 406,391
Unearned compensation (1,296) (1,314)
Accumulated deficit (236,555) (223,518)
Accumulated other comprehensive income 1,233 534
--------- ---------
Total stockholders' equity 324,411 182,130
--------- ---------
Total liabilities and stockholders' equity $ 349,185 $ 208,274
========= =========
The accompanying notes are an integral part of the financial statements.
================================================================================
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REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
Three months ended March 31,
2001 2000
-------- --------
Revenues
Contract research and development $ 3,414 $ 9,215
Contract manufacturing 2,899 1,376
-------- --------
6,313 10,591
-------- --------
Expenses
Research and development 16,805 12,876
Contract manufacturing 2,188 3,051
General and administrative 2,031 1,780
-------- --------
21,024 17,707
-------- --------
Loss from operations (14,711) (7,116)
-------- --------
Other income (expense)
Investment income 2,772 1,226
Loss in Amgen-Regeneron Partners (1,051) (1,271)
Interest expense (47) (64)
-------- --------
1,674 (109)
-------- --------
Net loss before cumulative effect of a change
in accounting principle (13,037) (7,225)
Cumulative effect of adopting Staff Accounting
Bulletin 101 ("SAB 101") (1,563)
-------- --------
Net loss ($13,037) ($ 8,788)
======== ========
Net loss per share amounts, basic and diluted:
Net loss before cumulative effect of a
change in accounting principle ($ 0.35) ($ 0.23)
Cumulative effect of adopting SAB 101 (0.05)
-------- --------
Net loss ($ 0.35) ($ 0.28)
======== ========
The accompanying notes are an integral part of the financial statements.
================================================================================
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REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS' EQUITY (Unaudited)
For the three months ended March 31, 2001
(In thousands)
Class A Stock Common Stock Additional
--------------------------- ------------------------- Paid-in
Shares Amount Shares Amount Capital
------------- ------------ ---------- ------------ -------------
Balance, December 31, 2000 2,613 $3 34,197 $34 $406,391
Issuance of Common Stock in a public offering
at $25.00 per share 6,500 7 162,493
Cost associated with issuance of equity
securities (8,826)
Issuance of Common Stock in connection with
exercise of stock options 33 287
Issuance of restricted Common Stock under
Long-Term Incentive Plan 5 163
Issuance of Common Stock to Medtronic, Inc. in
connection with a cashless exercise of warrants 37
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution 17 477
Conversion of Class A Stock to Common Stock (38) 38
Amortization of unearned compensation
Net loss
Change in net unrealized gain on
marketable securities
-----------------------------------------------------------------------
Balance, March 31, 2001 2,575 $3 40,827 $41 $560,985
=======================================================================
Accumulated
other Total
Unearned Accumulated Comprehensive Stockholders' Comprehensive
Compensation Deficit Income Equity Loss
-------------- ------------ ------------- ------------- -------------
Balance, December 31, 2000 ($1,314) ($223,518) $534 $182,130
Issuance of Common Stock in a public offering
at $25.00 per share 162,500
Cost associated with issuance of equity
securities (8,826)
Issuance of Common Stock in connection with
exercise of stock options 287
Issuance of restricted Common Stock under
Long-Term Incentive Plan (163)
Issuance of Common Stock to Medtronic, Inc. in
connection with a cashless exercise of warrants
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution 477
Conversion of Class A Stock to Common Stock
Amortization of unearned compensation 181 181
Net loss (13,037) (13,037) ($13,037)
Change in net unrealized gain on
marketable securities 699 699 699
-------------------------------------------------------------------------
Balance, March 31, 2001 ($1,296) ($236,555) $1,233 $324,411 ($12,338)
=========================================================================
The accompanying notes are an integral part of the financial statements.
================================================================================
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REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands)
Three months ended March 31,
2001 2000
--------- --------
Cash flows from operating activities
Net loss ($ 13,037) ($ 8,788)
--------- --------
Adjustments to reconcile net loss to net cash
used in operating activities
Loss in Amgen-Regeneron Partners 1,051 1,271
Depreciation and amortization 1,329 926
Cumulative effect of a change in accounting principle 1,563
Non-cash compensation expense 181
Changes in assets and liabilities
Decrease (increase) in amounts due from The Procter & Gamble Company 4,407 (7,046)
Decrease (increase) in amounts due from Merck & Co., Inc. 1,240 (383)
Increase in amounts due from Amgen-Regeneron Partners (290) (783)
Increase in amounts due from Sumitomo Pharmaceuticals Co., Ltd. (130) (58)
Increase in investment in Amgen-Regeneron Partners (552) (1,627)
Increase in prepaid expenses and other assets (609) (1,402)
Increase in inventory (474) (700)
Decrease in deferred revenue (1,328) (553)
(Decrease) increase in accounts payable, accrued expenses,
and other liabilities (185) 919
--------- --------
Total adjustments 4,640 (7,873)
--------- --------
Net cash used in operating activities (8,397) (16,661)
--------- --------
Cash flows from investing activities
Purchases of marketable securities (15,378) (5,984)
Sales of marketable securities 23,908 10,338
Capital expenditures (1,643) (1,771)
--------- --------
Net cash provided by investing activities 6,887 2,583
--------- --------
Cash flows from financing activities
Net proceeds from the issuance of stock 154,382 2,983
Principal payments on note payable (16) (14)
Capital lease payments (214) (294)
--------- --------
Net cash provided by financing activities 154,152 2,675
--------- --------
Net increase (decrease) in cash and cash equivalents 152,642 (11,403)
--------- --------
Cash and cash equivalents at beginning of period 30,978 23,697
--------- --------
Cash and cash equivalents at end of period $ 183,620 $ 12,294
========= ========
The accompanying notes are an integral part of the financial statements.
================================================================================
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
1. INTERIM FINANCIAL STATEMENTS
The interim Condensed Financial Statements of Regeneron
Pharmaceuticals, Inc. ("Regeneron" or 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 operations, 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. The December
31, 2000 Condensed Balance Sheet data was derived from audited
financial statements, but does not include all disclosures required by
generally accepted accounting principles. 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, 2000. As discussed in Notes 2 and 12 below, the
operating results for the three months ended March 31, 2000 have been
restated from amounts previously reported to reflect the adoption of a
new accounting principle for revenue recognition and reclassification
of depreciation and amortization expense, respectively.
2. REVENUE RECOGNITION AND CHANGE IN ACCOUNTING PRINCIPLE
During the fourth quarter of 2000, the Company changed its method of
accounting for revenue recognition to conform with the guidance
provided by Staff Accounting Bulletin No. 101, Revenue Recognition in
Financial Statements ("SAB 101"). The change in accounting method was
effective January 1, 2000 and, accordingly, the previously issued
interim financial statements for the quarters ended March 31, June 30,
and September 30, 2000 have been restated to reflect the adoption of
SAB 101 as if it had occurred on January 1, 2000. The cumulative effect
of adopting SAB 101 at January 1, 2000 amounted to $1,563 of additional
loss as of that date, with a corresponding increase to deferred revenue
to be recognized in subsequent periods. $93 of that deferred revenue is
included in contract research and development revenue in both the first
quarter of 2000 and 2001. The $1,563 represents a portion of a 1989
payment received from Sumitomo Chemical Company, Ltd. in consideration
for a fifteen year limited right of first negotiation to license up to
three of the Company's product candidates in Japan. The effect of
income taxes on the cumulative effect adjustment was immaterial.
3. STATEMENT OF CASH FLOWS
Supplemental disclosure of noncash investing and financing
activities:
Included in accounts payable and accrued expenses at March 31, 2001 are
$869 of accrued capital expenditures and $421 of costs incurred in
connection with the Company's sale of Common Stock in a public
offering. Included in accounts payable and accrued expenses at December
31, 2000 are $672 of accrued capital expenditures. Included in accounts
payable and accrued expenses at March 31, 2000 and December 31, 1999
are $572 and $697, respectively, of accrued capital expenditures.
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
Included in accounts payable and accrued expenses at December 31, 2000
and 1999 are $477 and $421, respectively, of accrued Company 401(k)
Savings Plan contribution expense. In the first quarter of both 2001
and 2000, the Company contributed 17,484 and 54,003 shares,
respectively, of Common Stock to the 401(k) Savings Plan in
satisfaction of these obligations.
Included in marketable securities at March 31, 2001 and December 31,
2000 are $2,573 and $2,541 of accrued interest income, respectively.
Included in marketable securities at March 31, 2000 and December 31,
1999 are $1,333 and $1,259 of accrued interest, respectively.
4. INVENTORIES
Inventories consist primarily of raw materials and other direct and
indirect costs associated with production of an intermediate for a
Merck & Co., Inc. pediatric vaccine under a long-term manufacturing
agreement.
Inventories as of March 31, 2001 and December 31, 2000 consist of the
following:
March 31, December 31,
2001 2000
---- ----
Raw materials $ 617(1) $ 535(3)
Work-in-process 499(2) 53(4)
Finished products 1,552 1,327
------ ------
$2,668 $1,915
====== ======
--------------------------------------
(1) Net of reserves of $247.
(2) Net of reserves of $283.
(3) Net of reserves of $255.
(4) Net of reserves of $830.
5. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses as of March 31, 2001 and December
31, 2000 consist of the following:
March 31, December 31,
2001 2000
---- ----
Accounts payable $2,704 $2,590
Accrued payroll and related costs 2,701 2,630
Accrued clinical trial expense 2,553 2,308
Accrued expenses, other 1,446 1,918
------ ------
$9,404 $9,446
====== ======
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
6. AMGEN-REGENERON PARTNERS RESEARCH COLLABORATION AGREEMENT
In August 1990, the Company entered into a collaboration with Amgen
Inc. ("Amgen") to develop and attempt to commercialize brain derived
neurotrophic factor ("BDNF") and neurotrophin-3 ("NT-3") in the United
States. Pursuant to that agreement, the Company and Amgen formed a
partnership, Amgen-Regeneron Partners (the "Partnership"). The Company
accounts for its investment in the Partnership in accordance with the
equity method of accounting.
In January 2001, the Partnership discontinued all clinical development
of BDNF for the potential treatment of amyotrophic lateral sclerosis
("ALS") following notification that BDNF did not provide a therapeutic
advantage to ALS patients in clinical trials. The Partnership continues
to develop NT-3.
Selected operating statement data of the Partnership for the three
months ended March 31, 2001 and 2000 is as follows:
Three Months Ended March 31,
2001 2000
---- ----
Interest income $ 69 $ 78
Total expenses (2,170) (2,619)
------- -------
Net loss ($2,101) ($2,541)
======== ========
7. COMPREHENSIVE LOSS
Comprehensive loss represents the change in net assets of a business
enterprise during a period from transactions and other events and
circumstances from non-owner sources. Comprehensive loss of the Company
includes net loss adjusted for the change in net unrealized gain or
loss on marketable securities. The net effect of income taxes on
comprehensive loss is immaterial. For the three months ended March 31,
2001 and 2000, the components of comprehensive loss are:
Three Months Ended March 31,
2001 2000
---- ----
Net loss ($13,037) ($8,788)
Change in net unrealized gain/loss
on marketable securities 699 (23)
-------- -------
Total comprehensive loss ($12,338) ($8,811)
========= ========
8. EQUITY TRANSACTIONS
On March 23, 2001 the Company completed a public offering in which it
issued 6.5 million shares of Common Stock at a price of $25.00 per
share and received proceeds, after commissions and estimated expenses,
of $153.7 million. On April 11, 2001, the Company sold an additional
130,000 shares of Common Stock pursuant to the underwriters'
over-allotment option from the
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
March 2001 public offering at a price of $25.00 per share for proceeds
to the Company, after commissions and estimated expenses, of $3.1
million.
In March 2001, Medtronic, Inc. exercised 107,400 warrants with an
exercise price of $21.72 per share on a "cashless" basis and received
37,306 shares of the Company's Common Stock.
9. PER SHARE DATA
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, 2001 and 2000,
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 loss per share are as follows:
Three Months Ended March 31,
-----------------------------
Net Loss, in Shares, in
thousands thousands Per Share
(Numerator) (Denominator) Amount
----------- ------------- ---------
2001:
Basic and Diluted ($13,037) 37,472 ($0.35)
2000:
Basic and Diluted ($8,788) 31,927 ($0.28)
Options and warrants which have been excluded from the diluted per
share amounts because their effect would have been antidilutive include
the following:
Three months ended March 31,
2001 2000
---- ----
Weighted Average Number, in thousands 7,621 7,544
Weighted Average Exercise Price $18.93 $9.97
10. SEGMENT REPORTING
The Company's operations are principally managed in two business
segments: research and development, and contract manufacturing.
Research and development: Includes all activities related to the
discovery of potential therapeutics for human medical conditions, and
the development and commercialization of these discoveries. Also
includes revenues and expenses related to the development of
manufacturing
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
processes prior to commencing commercial production of a product under
contract manufacturing arrangements.
Contract manufacturing: Includes all revenues and expenses related to
the commercial production of products under contract manufacturing
arrangements. The Company produces an intermediate for a Merck & Co.,
Inc. pediatric vaccine under a long-term manufacturing agreement and,
in 2000, produced BDNF for Sumitomo Pharmaceuticals Co., Ltd. under a
research and development agreement.
The tables below present information about reported segments for the
three months ended March 31, 2001 and 2000:
Three Months Ended March 31, 2001
---------------------------------
Research & Contract Reconciling
Development Manufacturing Items Total
----------- ------------- ----- -----
Revenues $ 3,414 $ 2,899 $ 2,772 (1) $ 9,085
Loss in Amgen-
Regeneron Partners 1,051 -- -- 1,051
Depreciation and
amortization 1,329 -- (2) -- 1,329
Interest expense 33 14 -- 47
Net (loss) income (16,506) 697 2,772 (13,037)
Capital expenditures 1,839 -- -- 1,839
Total assets 35,523 12,919 300,743 (3) 349,185
Three Months Ended March 31, 2000
---------------------------------
Research & Contract Reconciling
Development Manufacturing Items Total
----------- ------------- ----- -----
Revenues $ 9,215 $ 1,376 $ 1,226 (1) $ 11,817
Loss in Amgen-
Regeneron Partners 1,271 -- -- 1,271
Depreciation and
amortization 926 -- (2) -- 926
Interest expense 22 42 -- 64
Net (loss) income (8,297) (1,717) 1,226 (8,788)
Capital expenditures 1,616 31 -- 1,647
Total assets 15,050 35,837 81,147 (3) 132,034
(1) Represents investment income.
(2) Depreciation and amortization related to contract manufacturing is
capitalized into inventory.
(3) Includes cash and cash equivalents, marketable securities, prepaid
expenses and other current assets, and other assets.
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
11. LITIGATION
In September 2000, Immunex Corporation filed a request with the
European Patent Office seeking the declaration of an Opposition
regarding the scope of the Company's European patent relating to
Cytokine Traps. This is a legal challenge to the validity and scope of
the Company's patent. Although the Company plans to defend the patent
diligently, the scope of the patent may be adversely affected following
the outcome of the Opposition. In addition to this patent challenge,
the Company, from time to time, has been subject to legal claims
arising in connection with its business. While the ultimate results of
the patent challenge and legal claims cannot be predicted with
certainty, at March 31, 2001 there were no asserted claims against the
Company which, in the opinion of management, if adversely decided would
have a material adverse effect on the Company's financial position,
results of operations, and cash flows.
12. RECLASSIFICATIONS
Certain reclassifications have been made to the financial statements
for the three months ended March 31, 2000 to conform with the current
period's presentation.
Effective in 2001, the Company's financial statement presentation of
depreciation and amortization in the Statements of Operations has been
changed to allocate depreciation and amortization between research and
development expense and general and administrative expense.
Depreciation and amortization related to contract manufacturing expense
was already included in contract manufacturing expense in 2000. The
effect of this reclassification for the three months ended March 31,
June 30, and September 30, 2000 and for the year ended December 31,
2000 is presented in the following table.
First Quarter Ended Second Quarter Ended
March 31, 2000 June 30, 2000
(Unaudited) (Unaudited)
-------------------------------- -------------------------------------
As Previously As As Previously As
Reported Reclassified Reported Reclassified
-------- ------------ -------- ------------
Expenses
Research and development $11,975 $12,876 $14,410 $15,425
General and administrative 1,755 1,780 1,711 1,741
Depreciation and amortization 926 1,045
Contract manufacturing 3,051 3,051 1,265 1,265
------- ------- ------- -------
Total $17,707 $17,707 $18,431 $18,431
======= ======= ======= =======
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REGENERON PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(Dollars in thousands, except per share data)
Third Quarter Ended Year Ended
September 30, 2000 December 31, 2000
(Unaudited) (Unaudited)
--------------------------------- --------------------------------
As Previously As As Previously As
Reported Reclassified Reported Reclassified
-------- ------------ -------- ------------
Expenses
Research and development $14,085 $15,207 $56,256 $60,559
General and administrative 1,737 1,769 8,309 8,427
Depreciation and amortization 1,154 4,421
Contract manufacturing 2,512 2,512 15,566 15,566
------- ------- ------- -------
Total $19,488 $19,488 $84,552 $84,552
======= ======= ======= =======
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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. and actual events or results may differ
materially. These statements concern, among other things, the possible
therapeutic applications of our product candidates and research programs, the
timing and nature of the clinical and research programs now underway or planned,
and the future uses of capital and our financial needs. These statements are
made by us based on management's current beliefs and judgment. In evaluating
such statements, stockholders and potential investors should specifically
consider the various factors identified under the caption "Factors That May
Affect Future Operating Results" which could cause actual results to differ
materially from those indicated by such forward-looking statements. We do not
undertake any obligation to update publicly any forward-looking statement,
whether as a result of new information, future events, or otherwise, except as
required by law.
Regeneron Pharmaceuticals, Inc., which may be referred to as "we",
"us", or "our", is a biopharmaceutical company that discovers, develops, and
intends to commercialize therapeutic drugs for the treatment of serious medical
conditions. Our product pipeline includes product candidates for the treatment
of obesity, rheumatoid arthritis and other inflammatory conditions, cancer and
related disorders, allergies, asthma, and other diseases and disorders. Since
inception, we have not generated sales or any profits from the commercialization
of any of our product candidates.
Our core business strategy is to combine our strong foundation in
science and technology with state-of-the-art manufacturing and clinical
development capabilities to build a successful, integrated biopharmaceutical
company. Our efforts have yielded a diverse and growing pipeline of product
candidates that have the potential to address a variety of unmet medical needs.
Our ability to develop product candidates results from the application of our
technology platforms. In contrast to basic genomics approaches which attempt to
identify every gene in a cell or genome, our technology platforms are designed
to discover specific genes of therapeutic interest for a particular disease or
cell type. We will continue to invest in the development of enabling
technologies to assist in our efforts to identify, develop, and commercialize
new product candidates.
Below is a summary of our leading clinical programs, as well as several
product candidates that are expected to enter clinical trials over the next two
years. We retain sole ownership and marketing rights for each of these programs
and currently are developing them independent of any corporate partners.
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- AXOKINE(R): Acts on the brain region regulating food intake
and energy expenditure and is being developed for the
treatment of obesity. In November 2000, we announced the
preliminary results of a twelve-week Phase II dose-ranging
trial of AXOKINE in 170 severely obese patients. In the trial,
AXOKINE was generally well tolerated and patients treated with
AXOKINE showed medically meaningful and statistically
significant weight loss compared to those receiving placebo.
We intend to initiate Phase III testing of AXOKINE in
mid-2001.
- PEGYLATED AXOKINE: Chemically modified version of AXOKINE that
is being developed as a more potent, longer-acting form of the
protein. Pegylated AXOKINE currently is in late-stage
preclinical development and we anticipate initiating a Phase I
clinical trial in 2001.
- INTERLEUKIN-1 CYTOKINE TRAP (IL-1 TRAP): Protein-based
antagonist for the interleukin-1 (called IL-1) cytokine. IL-1
is thought to play a major role in rheumatoid arthritis and
other inflammatory diseases. In December 2000, we initiated a
Phase I study to assess the safety and tolerability of the
IL-1 Trap in patients with rheumatoid arthritis. We expect the
study to be completed in the second half of 2001.
- INTERLEUKIN-4/INTERLEUKIN-13 CYTOKINE TRAP (IL-4/IL-13 TRAP):
Protein-based antagonist for the interleukin-4 and
interleukin-13 (called IL-4 and IL-13) cytokines which are
thought to play a major role in diseases such as asthma,
allergic disorders, and other inflammatory diseases. We expect
to initiate a Phase I clinical trial of a dual IL-4/IL-13 Trap
for asthma in late 2001.
- VEGF TRAP: Protein-based antagonist to Vascular Endothelial
Growth Factor (called VEGF, also known as Vascular
Permeability Factor or VPF). VEGF is required for the growth
of blood vessels that are needed for tumors to grow and is a
potent regulator of vascular permeability and leak. The VEGF
Trap is expected to enter Phase I clinical trials in mid-2001.
- ANGIOPOIETINS: A new family of growth factors that act
specifically on the endothelium cells that line blood vessels.
Angiopoietins may be useful for growing blood vessels in
diseased hearts and other tissues with decreased blood flow
and for repairing blood vessel leaks that cause swelling and
edema in many different diseases such as stroke, diabetic
retinopathy, and inflammatory diseases. Selected
Angiopoietins, including engineered forms of these growth
factors, are in preclinical development.
In addition to the above programs which we are conducting independent
of any corporate partners, we have formed collaborations to advance other
research and development efforts. We are conducting research with The Procter &
Gamble Company in muscle diseases and other fields. We are also collaborating
with Medarex, Inc. to discover, develop, and commercialize certain human
antibodies as therapeutics. In
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partnership with Amgen Inc., we are conducting clinical trials with
Neurotrophin-3, or NT-3, for the treatment of constipating conditions. In all of
these research collaborations, we retain 50% of the commercialization rights.
DISCUSSION OF FIRST QUARTER 2001 ACTIVITIES
In November 2000, we announced the preliminary results of a Phase II
clinical trial, which tested the safety and efficacy of AXOKINE in severely
obese patients. The Phase II trial was a randomized, double-blind,
placebo-controlled, out-patient study conducted with 170 patients at seven sites
in the United States. The trial established an optimal daily dose of AXOKINE of
1.0 mcg/kg. Patients who received the optimal dose over the twelve-week
treatment period averaged 10 pounds more weight loss than patients on placebo.
Moreover, 46% of the patients in the optimal dose group lost at least 10 pounds,
compared to just 5% of the patients who received placebo. In February 2001, we
announced that based on a preliminary analysis of interim data, patients who
received AXOKINE therapy during the Phase II study maintained their average
weight loss during the three months following their last AXOKINE treatment,
relative to patients who received placebo. No serious adverse events associated
with the drug were reported during the trial and the drug was generally well
tolerated. In April 2001, we began end-of-Phase II discussions with the FDA. We
plan to initiate Phase III testing of AXOKINE in mid-2001. This Phase III
program likely will involve the enrollment of several thousand patients with a
double-blind treatment period of approximately one year and an additional
follow-up period.
We are continuing to develop a pegylated version of AXOKINE
(pegAXOKINE) as a more potent, longer-acting form of the protein. PegAXOKINE may
allow for less frequent and/or lower dosing in patients. PegAXOKINE currently is
in late-stage preclinical development and we anticipate initiating a Phase I
clinical trial in 2001.
During the first quarter of 2001, we continued a Phase I study of the
IL-1 Trap to assess its safety and tolerability in patients with rheumatoid
arthritis. The placebo-controlled, double-blind, dose-escalation study is being
conducted at several centers in the United States. Single dose and multiple dose
phases are both currently underway, and results of the trial are expected in the
second half of 2001. The IL-1 Trap is also being evaluated for potential uses in
treating other inflammatory diseases.
In the first quarter of 2001, we continued the development of an
IL-4/IL-13 Trap, which is a single molecule that can block both interleukin-4
and interleukin-13. Antagonists for IL-4 and IL-13 may be therapeutically useful
in a number of allergy and asthma-related conditions, including as adjuncts to
vaccines where blocking IL-4 and IL-13 may help to elicit more of the desired
type of immune response to the vaccine. We expect to initiate a clinical trial
of a dual IL-4/IL-13 Trap to assess its safety and tolerability for the
treatment of asthma late in 2001.
In the first quarter of 2001, we continued the preclinical development
of a highly potent Vascular Endothelial Growth Factor (VEGF) antagonist, termed
VEGF Trap. We
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expect to begin a clinical trial of the VEGF Trap as a potential treatment for
harmful angiogenesis or vascular leak in settings of cancer and/or other
conditions in mid-2001. In addition, we continue to evaluate Angiopoietin-1 and
engineered designer versions of Angiopoietins in preclinical studies to
determine their utility for repairing blood vessel leak and for growing blood
vessels in ischemia.
During the first quarter of 2001, we and The Procter & Gamble Company
continued our collaborative research and development activities in muscle
atrophy and muscle diseases, fibrotic diseases, and certain G-Protein Coupled
Receptors.
Amgen-Regeneron Partners, the partnership equally owned by Amgen Inc.
and us, is currently developing NT-3 for the treatment of constipating
conditions. In 2000, we, on behalf of Amgen-Regeneron Partners, initiated
double-blind, placebo-controlled Phase II studies of NT-3 in patients with
functional constipation and spinal cord injury patients with bowel dysfunction.
These studies continued in the first quarter of 2001 and we expect them to be
completed by the end of the year.
In January 2001, we and Amgen discontinued the development of brain
derived neurotrophic factor (called BDNF) for the treatment of amyotrophic
lateral sclerosis (or ALS), following notification that BDNF did not provide any
therapeutic advantage to ALS patients in clinical trials.
A minority of all research and development programs ultimately results
in commercially successful drugs; it is not possible to predict whether any
program will succeed until it actually produces a drug that is commercially
marketed for a significant period of time. In addition, in each of the areas of
our 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, cancer,
abnormal bone growth, muscle atrophy, small molecules, NT-3, and other programs
or areas of research or development do not necessarily predict the results or
success of current or future activities including, but not limited to, any
additional preclinical or clinical studies. We cannot predict whether, when, or
under what conditions any of our research or product candidates, including
without limitation AXOKINE, IL-1, 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 its product candidates to treat human conditions or to be
approved for marketing could have a material adverse impact on Regeneron. We
discuss the risks associated with drug development in the section of this report
titled "Factors That May Affect Future Operating Results."
We have not received revenue from the commercialization of our product
candidates and may never receive such revenues. Before revenues from the
commercialization of our product candidates can be realized, we (or our
collaborators) must overcome a number of hurdles which include successfully
completing our research and development efforts and obtaining regulatory
approval from the FDA or regulatory
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authorities in other countries. In addition, the biotechnology and
pharmaceutical industries are rapidly evolving and highly competitive, and new
developments may render our products and technologies noncompetitive or
obsolete.
From inception on January 8, 1988 through March 31, 2001, we had a
cumulative loss of $236.6 million. In the absence of revenues from the
commercialization of our product candidates or other sources, the amount,
timing, nature, or source of which cannot be predicted, our losses will continue
as we conduct our research and development activities. Our activities may expand
over time and may require additional resources and our operating losses may be
substantial over at least the next several years. Our losses may fluctuate from
quarter to quarter and will depend, among other factors, on the timing of
certain expenses and on the progress of our research and development efforts.
RESULTS OF OPERATIONS
Three months ended March 31, 2001 and 2000. Our total revenue decreased
to $6.3 million for the first quarter of 2001 from $10.6 million for the same
period in 2000, as higher contract manufacturing revenue was more than offset by
a decrease in contract research and development revenue. Contract research and
development revenue decreased to $3.4 million for the first quarter of 2001 from
$9.2 million for the same period in 2000. Under our long-term collaboration
agreement with Procter & Gamble, research payments decreased effective in the
first quarter of 2001 to $2.5 million per quarter versus $7.1 million for the
same period of 2000. In addition, revenue from Amgen-Regeneron Partners
decreased to $0.8 million for the first quarter of 2001 from $1.9 million for
the same period in 2000 due to the cessation of clinical trial activity on BDNF
in January 2001. Contract manufacturing revenue, related primarily to a
long-term agreement with Merck & Co., Inc. (Merck) to manufacture a vaccine
intermediate, increased to $2.9 million in the first quarter of 2001 from $1.4
million for the same period in 2000, principally due to an increase in shipments
of intermediate to Merck.
Our total operating expenses increased to $21.0 million in the first
quarter of 2001 from $17.7 million for the same period in 2000. Research and
development expenses increased to $16.8 million in the first quarter of 2001
from $12.9 million for the same period in 2000, primarily as a result of higher
staffing and increased activity in our preclinical and clinical research
programs. Research and development expenses were 80% of total operating expenses
in the first quarter of 2001, compared to 73% for the same period in 2000.
Contract manufacturing expenses decreased to $2.2 million in the first quarter
of 2001 from $3.1 million for the same period in 2000 due, in part, to higher
costs in 2000 associated with initiating commercial production at the Company's
Rensselaer, New York facility of both vaccine intermediate for Merck and BDNF
for clinical use by Sumitomo Pharmaceuticals Co., Ltd. We stopped producing
clinical supplies of BDNF for Sumitomo Pharmaceuticals at the end of 2000.
General and administrative expenses increased to $2.0 million in the first
quarter of 2001 from $1.8 million for the same period of 2000, due primarily to
higher administrative staffing and related occupancy costs.
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Investment income increased to $2.8 million for the first quarter of
2001 from $1.2 million for the same period in 2000 due to interest earned on the
proceeds of our public offerings in March 2001 and April 2000 and our sale of
Common Stock to Procter & Gamble in August 2000. The loss in Amgen-Regeneron
Partners decreased to $1.1 million for the first quarter of 2001 from $1.3
million for the same period in 2000 due primarily to the cessation of clinical
trial activity on BDNF in January 2001.
During the fourth quarter of 2000, we changed our method of accounting
for revenue recognition to conform with the guidance provided by Staff
Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, (SAB
101). The change in accounting method was effective January 1, 2000 and, as a
result, we restated the previously issued interim financial statements for the
quarter ended March 31, 2000 to reflect the adoption of SAB 101 as if it had
occurred on January 1, 2000. The cumulative effect of adopting SAB 101 as of
January 1, 2000 was to increase our net loss by $1.6 million as of that date, or
$0.05 per share, with a corresponding increase to deferred revenue to be
recognized in subsequent periods. The SAB 101 adjustment relates to a portion of
a 1989 payment received from Sumitomo Chemical Company, Ltd. in consideration
for a fifteen year limited right of first negotiation to license up to three of
our product candidates in Japan. In the first quarter of both 2001 and 2000, we
recognized contract research and development revenue of $0.1 million that was
included in the cumulative effect adjustment as of January 1, 2000.
The Company's net loss for the first quarter of 2001 was $13.0 million,
or $0.35 per share (basic and diluted), compared to a net loss of $8.8 million,
or $0.28 per share (basic and diluted), for the same period in 2000.
LIQUIDITY AND CAPITAL RESOURCES
Since our inception in 1988, we have financed our operations primarily
through private placements and public offerings of our equity securities,
revenue earned under our agreements with Amgen, Sumitomo Chemical, Sumitomo
Pharmaceuticals, Merck, and Procter & Gamble, and investment income.
In May 1997, we entered into a long-term collaboration agreement with
Procter and Gamble. Procter & Gamble agreed over the first five years of the
1997 collaboration to purchase up to $60.0 million in Regeneron equity, of which
$42.9 million was purchased in June 1997 and $17.1 million was purchased in
August 2000, and provide funding in support of our research efforts related to
the collaboration, of which we have received $51.7 million through March 31,
2001. In August 2000, Procter & Gamble made two non-recurring research progress
payments to us totaling $3.5 million. In addition, in August 2000, we and
Procter & Gamble agreed through a binding memorandum of understanding to enter
into a new long-term collaboration agreement, replacing the companies' 1997
agreement. The new agreement will extend Procter & Gamble's obligation to fund
Regeneron's research through December 2005, with no further research obligations
by either party thereafter, and focus the companies' collaborative research on
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therapeutic areas that are of particular interest to Procter & Gamble. Under the
new agreement, beginning in the first quarter of 2001, research support from
Procter & Gamble is $2.5 million per quarter, before adjustments for future
inflation, through December 2005.
Our activities relating to BDNF and NT-3, as agreed upon by Amgen and us,
are being compensated by Amgen-Regeneron Partners for services rendered, and we
recognize these amounts as revenue. In January 2001, Amgen-Regeneron Partners
discontinued all development of BDNF for the potential treatment of ALS. We and
Amgen fund Amgen-Regeneron Partners through capital contributions, and must make
equal payments in order to maintain equal ownership and equal sharing of any
profits or losses from the partnership. Our aggregate capital contribution to
Amgen-Regeneron Partners from the partnership's inception in June 1993 through
March 31, 2001 was $56.8 million. We expect that our capital contributions for
the remainder of 2001 will total at least $1.6 million. These contributions
could increase or decrease, depending upon, among other things, the nature and
cost of ongoing and additional NT-3 studies that Amgen-Regeneron Partners may
conduct, the outcomes of those studies, and costs associated with the
discontinuation of the BDNF studies.
In connection with our agreement to collaborate with Sumitomo
Pharmaceuticals in the research and development of BDNF in Japan, we received a
research progress payment from Sumitomo Pharmaceuticals of $3.0 million (reduced
by $0.3 million Japanese withholding tax) in April 2000. In addition, Sumitomo
Pharmaceuticals has paid us $27.9 million through March 31, 2001 in connection
with supplying BDNF for preclinical and clinical use and paid us another $3.8
million in April 2001 for materials shipped at the end of 2000. In light of the
recent BDNF clinical trial results, we would not expect to receive further
payments from Sumitomo Pharmaceuticals for research progress payments, contract
research and development, or contract manufacturing, other than amounts
outstanding and any wind-down costs.
We invested $1.8 million and $1.6 million for the three months ended March
31, 2001 and 2000, respectively, in property, plant, and equipment. In
connection with the purchase and renovation of our Rensselaer facility, we
obtained financing of $2.0 million from the New York State Urban Development
Corporation in 1994, of which $1.5 million is outstanding. Under the terms of
this UDC financing, we are not permitted to declare or pay dividends on our
equity securities.
We expect that expenses related to the filing, prosecution, defense, and
enforcement of patent and other intellectual property claims will continue to be
substantial as a result of patent filings and prosecutions in the United States
and foreign countries. In September 2000, Immunex Corporation filed a request
with the European Patent Office seeking the declaration of an Opposition
regarding our European patent relating to Cytokine Traps. This is a legal
challenge to the validity and scope of our patent and we may incur substantial
expenses in defending the patent.
As of March 31, 2001, we had no established banking arrangements
through which we could obtain short-term financing or a line of credit. We may
seek additional
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funding through, among other things, future collaboration agreements and public
or private financing. We cannot assure you that additional financing will be
available to us or, if available, that it will be available on acceptable terms.
In April 2000, we completed a public offering of 2.6 million shares of Common
Stock at a price of $29.75 per share and received proceeds, after commissions
and expenses, of $72.9 million. In August 2000, we sold 573,630 shares of Common
Stock to Procter & Gamble at a price of $29.75 per share and received total
proceeds of $17.1 million. The sale of stock to Procter & Gamble was made
pursuant to a 1997 securities purchase agreement. In March 2001, we completed a
public offering in which we issued 6.5 million shares of Common Stock at a price
of $25.00 per share and received proceeds, after commissions and expenses, of
$153.7 million. In April 2001, we sold an additional 130,000 shares of Common
Stock pursuant to the underwriters' over-allotment option from the March 2001
public offering at a price of $25.00 per share and received proceeds, after
commissions and estimated expenses, of $3.1 million.
At March 31, 2001, we had $299.2 million in cash, cash equivalents, and
marketable securities. We expect to incur substantial funding requirements for,
among other things, research and development activities (including preclinical
and clinical testing), expansion and validation of manufacturing facilities, and
the acquisition of equipment. We currently anticipate that for the remainder of
2001 and 2002, approximately 50-70% of our expenditures will be directed toward
the preclinical and clinical development of product candidates, including
AXOKINE, Pegylated AXOKINE, IL-1 Trap, IL-4/13 Trap, VEGF Trap, NT-3, and the
Angiopoietins; approximately 10-30% of our expenditures will cover our basic
research activities; approximately 5-15% of our expenditures will be directed
toward the continued development of our novel technology platforms, including
potential efforts to commercialize these technologies; and the remainder of our
expenditures will be for general corporate purposes, including capital
expenditures and working capital. The amount we need to fund operations and the
allocation of our resources will depend on various factors, including the status
of competitive products, the success of our research and development programs,
the potential future need to expand our professional and support staff and
facilities, the status of patents and other intellectual property rights, the
delay or failure of a clinical trial of any of our potential drug candidates,
and the continuation, extent, and success of any collaborative research
arrangements (including those with Procter & Gamble, Medarex, Emisphere
Technologies, Inc., and Amgen). We believe that our existing capital resources
will enable us to meet operating needs through at least 2002. However, this is a
forward-looking statement based on our current operating plan, and we cannot
assure you that there will be no change in projected revenues or expenses that
would lead to our capital being consumed significantly before such time. If
there is insufficient capital to fund all of our planned operations and
activities, we believe we would prioritize available capital to fund preclinical
and clinical development of our product candidates.
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FACTORS THAT MAY AFFECT FUTURE OPERATING RESULTS
We caution shareholders and potential investors that the following
important factors, among others, in some cases have affected, and in the future
could affect, our actual results and could cause our actual results to differ
materially from those expressed in any forward-looking statements made by, or on
behalf of, us. The statements under this caption are intended to serve as
cautionary statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The following information is not intended to limit in any
way the characterization of other statements or information under other captions
as cautionary statements for such purpose:
- Delay, difficulty, or failure of our research and development
programs to produce product candidates that are scientifically
or commercially appropriate for further development by us or
others.
- Cancellation or termination of material collaborative or
licensing agreements (including in particular, but not limited
to, those with Procter & Gamble and Amgen) and the resulting
loss of research or other funding could have a material
adverse effect on us and our operations. A change of control
of one or more of our material collaborators or licensees
could also have a material adverse effect on us.
- Delay, difficulty, or failure of a clinical trial of any of
our product candidates. A clinical trial can fail or be
delayed as a result of many causes, including, among others,
failure of the product candidate to demonstrate safety or
efficacy, the development of serious or life-threatening
adverse events (side effects) caused by or connected with
exposure to the product candidate, difficulty in enrolling and
maintaining patients, lack of sufficient supplies of the
product candidate, and the failure of clinical investigators,
trial monitors and other consultants, or trial subjects to
comply with the trial plan or protocol.
- In addition to the safety, efficacy, manufacturing, and
regulatory hurdles faced by our drug candidates, the
administration of recombinant proteins frequently causes an
immune response, resulting in the creation of antibodies
against the therapeutic protein. The antibodies can have no
effect or can totally neutralize the effectiveness of the
protein, or require that higher doses be used to obtain a
therapeutic effect. In some cases, the antibody can cross
react with the patient's own proteins, resulting in an
"auto-immune type" disease. Whether antibodies will be created
can often not be predicted from preclinical experiments and
their appearance is often delayed, so that there can be no
assurance that neutralizing antibodies will not be created at
a later date -- in some cases even after pivotal clinical
trials have been successfully completed. Patients who have
been treated with AXOKINE and NT-3 have developed antibodies.
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- Delay, difficulty, or failure in obtaining regulatory approval
(including approval of our facilities for production) for our
products, including delays or difficulties in development
because of insufficient proof of safety or efficacy.
- Increased and irregular costs of development, manufacture,
regulatory approval, sales, and marketing associated with the
introduction of products in the late stage of development.
- Competitive or market factors that may cause use of our
products to be limited or otherwise fail to achieve broad
acceptance.
- The ability to obtain, maintain, and prosecute intellectual
property rights and the cost of acquiring in-process
technology and other intellectual property rights, either by
license, collaboration, or purchase of another entity.
- Difficulties or high costs of obtaining adequate financing to
fund the cost of developing product candidates.
- Amount and rate of growth of our general and administrative
expenses, and the impact of unusual charges resulting from our
ongoing evaluation of our business strategies and
organizational structure.
- Failure of corporate partners to develop or commercialize
successfully our products or to retain and expand the markets
served by the commercial collaborations; conflicts of
interest, priorities, and commercial strategies which may
arise between our corporate partners and us.
- Delays or difficulties in developing and acquiring production
technology and technical and managerial personnel to
manufacture novel biotechnology product in commercial
quantities at reasonable costs and in compliance with
applicable quality assurance and environmental regulations and
governmental permitting requirements.
- Difficulties in obtaining key raw materials and supplies for
the manufacture of our product candidates.
- The costs and other effects of legal and administrative cases
and proceedings (whether civil, such as product- or
employment-related, or environmental, or criminal),
settlements, and investigations; developments or assertions by
or against us relating to intellectual property rights and
licenses; the issuance and use of patents and proprietary
technology by us and our competitors, including the possible
negative effect on our ability to develop, manufacture, and
sell our products in circumstances where we are unable to
obtain licenses to patents which may be required for our
products.
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- Underutilization of our existing or new manufacturing
facilities or of any facility expansions, resulting in
inefficiencies and higher costs; start-up costs,
inefficiencies, delays, and increased depreciation costs in
connection with the start of production in new plants and
expansions.
- Health care reform, including reductions or changes in
reimbursement available for prescription medications or other
reforms.
- Difficulties in attracting and retaining key personnel.
As our scientific efforts lead to potentially promising new directions,
both outside of recombinant protein therapies and into conditions or diseases
outside of our current areas of experience and expertise, we will require
additional internal expertise or external collaborations in areas in which we
currently do not have substantial resources and personnel.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK.
Our earnings and cash flows are subject to fluctuations due to changes
in interest rates primarily from our investment of available cash balances in
investment grade corporate and U.S. government securities. We do not believe we
are materially exposed to changes in interest rates. Under our current policies
we do not use interest rate derivative instruments to manage exposure to
interest rate changes.
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PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
None
(b) Reports
Form 8-K: On January 25, 2001, we issued a press release
announcing our operating results for the fourth quarter and year ended
December 31, 2000.
Form 8-K/A: On January 25, 2001, we issued a revised press
release to correct a minor typographical error contained in the press
release issued earlier in the day.
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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 11, 2001 By: /s/ Murray A. Goldberg
------------------------------------------------
Murray A. Goldberg
Senior Vice President, Finance & Administration,
Chief Financial Officer, Treasurer, and
Assistant Secretary
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