10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2007
OR
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o |
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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)
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New York
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13-3444607 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
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777 Old Saw Mill River Road
Tarrytown, New York
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10591-6707 |
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(Address of principal executive offices)
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(Zip Code) |
(914) 347-7000
(Registrants 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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock as of July 31, 2007:
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Class of Common Stock |
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Number of Shares |
Class A Stock, $0.001 par value
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2,260,266 |
Common Stock, $0.001 par value
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63,798,205 |
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REGENERON PHARMACEUTICALS, INC.
Table of Contents
June 30, 2007
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT JUNE 30, 2007 AND DECEMBER 31, 2006 (Unaudited)
(In thousands, except share data)
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June 30, |
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December 31, |
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2007 |
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2006 |
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ASSETS |
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Current assets |
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Cash and cash equivalents |
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$ |
109,643 |
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$ |
237,876 |
|
Marketable securities |
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351,054 |
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|
221,400 |
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Accounts receivable |
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20,478 |
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7,493 |
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Prepaid expenses and other current assets |
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15,806 |
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|
3,215 |
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|
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Total current assets |
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496,981 |
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469,984 |
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Restricted cash |
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1,600 |
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|
1,600 |
|
Marketable securities |
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49,985 |
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61,983 |
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Property, plant, and equipment, at cost, net of accumulated
depreciation and amortization |
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47,647 |
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49,353 |
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Other assets |
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1,645 |
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|
2,170 |
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Total assets |
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$ |
597,858 |
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$ |
585,090 |
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LIABILITIES and STOCKHOLDERS EQUITY |
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Current liabilities |
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Accounts payable and accrued expenses |
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$ |
34,905 |
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$ |
21,471 |
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Deferred revenue, current portion |
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69,926 |
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23,543 |
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Total current liabilities |
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104,831 |
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45,014 |
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Deferred revenue |
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113,691 |
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123,452 |
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Notes payable |
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200,000 |
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200,000 |
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Total liabilities |
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418,522 |
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368,466 |
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Commitments and contingencies |
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Stockholders equity |
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Preferred stock, $.01 par value; 30,000,000 shares authorized; issued and
outstanding-none |
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Class A
Stock, convertible, $.001 par value; 40,000,000 shares authorized;
shares issued and outstanding - 2,270,353 in 2007 and 2006 |
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2 |
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2 |
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Common
Stock, $.001 par value; 160,000,000 shares authorized;
shares issued and outstanding - 63,783,564 in 2007 and 63,130,962 in
2006 |
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64 |
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63 |
|
Additional paid-in capital |
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924,094 |
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904,407 |
|
Accumulated deficit |
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(744,308 |
) |
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(687,617 |
) |
Accumulated other comprehensive loss |
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|
(516 |
) |
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(231 |
) |
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|
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Total stockholders equity |
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|
179,336 |
|
|
|
216,624 |
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|
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Total liabilities and stockholders equity |
|
$ |
597,858 |
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$ |
585,090 |
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|
The accompanying notes are an integral part of the financial statements.
3
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
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Three months ended June 30, |
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Six months ended June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues |
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Contract research and development |
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$ |
15,917 |
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$ |
14,991 |
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$ |
29,562 |
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$ |
29,578 |
|
Contract manufacturing |
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4,267 |
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7,899 |
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Technology licensing |
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6,278 |
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|
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8,421 |
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22,195 |
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19,258 |
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37,983 |
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37,477 |
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Expenses |
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Research and development |
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43,864 |
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34,398 |
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|
85,099 |
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66,482 |
|
Contract manufacturing |
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|
2,810 |
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4,662 |
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General and administrative |
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8,935 |
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6,299 |
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17,137 |
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12,245 |
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|
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|
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|
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|
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52,799 |
|
|
|
43,507 |
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|
102,236 |
|
|
|
83,389 |
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|
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|
|
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|
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|
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|
|
|
|
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|
|
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Loss from operations |
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|
(30,604 |
) |
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|
(24,249 |
) |
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|
(64,253 |
) |
|
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(45,912 |
) |
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Other income (expense) |
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Investment income |
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6,841 |
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3,684 |
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|
13,584 |
|
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|
7,165 |
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Interest expense |
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|
(3,011 |
) |
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|
(3,011 |
) |
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(6,022 |
) |
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|
(6,022 |
) |
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
3,830 |
|
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|
673 |
|
|
|
7,562 |
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|
|
1,143 |
|
|
|
|
|
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|
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|
|
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|
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|
|
|
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|
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Net loss before cumulative effect of a change in accounting principle |
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|
(26,774 |
) |
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|
(23,576 |
) |
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|
(56,691 |
) |
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|
(44,769 |
) |
Cumulative effect of adopting Statement of Financial
Accounting Standards No. 123R (SFAS 123R) |
|
|
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|
|
|
|
|
|
|
|
|
|
|
813 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net loss |
|
$ |
(26,774 |
) |
|
$ |
(23,576 |
) |
|
$ |
(56,691 |
) |
|
$ |
(43,956 |
) |
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|
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Net loss per share amounts, basic and diluted: |
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|
|
|
|
|
|
|
|
|
|
|
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|
Net loss before cumulative effect of a change in
accounting principle |
|
$ |
(0.41 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.79 |
) |
Cumulative effect of adopting SFAS 123R |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(0.41 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.86 |
) |
|
$ |
(0.77 |
) |
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average shares outstanding, basic and diluted |
|
|
65,950 |
|
|
|
56,915 |
|
|
|
65,757 |
|
|
|
56,821 |
|
The accompanying notes are an integral part of the financial statements.
4
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS EQUITY (Unaudited)
For the six months ended June 30, 2007
(In thousands)
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Accumulated |
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Additional |
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Other |
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Total |
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Class A Stock |
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Common Stock |
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Paid-in |
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Accumulated |
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Comprehensive |
|
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Stockholders |
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Comprehensive |
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Shares |
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Amount |
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Shares |
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|
Amount |
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Capital |
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|
Deficit |
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|
Loss |
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|
Equity |
|
|
Loss |
|
Balance, December 31, 2006 |
|
|
2,270 |
|
|
$ |
2 |
|
|
|
63,131 |
|
|
$ |
63 |
|
|
$ |
904,407 |
|
|
$ |
(687,617 |
) |
|
$ |
(231 |
) |
|
$ |
216,624 |
|
|
|
|
|
Issuance of Common Stock in connection with
exercise of stock options, net of shares tendered |
|
|
|
|
|
|
|
|
|
|
588 |
|
|
|
1 |
|
|
|
4,823 |
|
|
|
|
|
|
|
|
|
|
|
4,824 |
|
|
|
|
|
Issuance of Common Stock in connection with
Company 401(k) Savings Plan contribution |
|
|
|
|
|
|
|
|
|
|
65 |
|
|
|
|
|
|
|
1,367 |
|
|
|
|
|
|
|
|
|
|
|
1,367 |
|
|
|
|
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,497 |
|
|
|
|
|
|
|
|
|
|
|
13,497 |
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(56,691 |
) |
|
|
|
|
|
|
(56,691 |
) |
|
$ |
(56,691 |
) |
Change in net unrealized loss on
marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(285 |
) |
|
|
(285 |
) |
|
|
(285 |
) |
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2007 |
|
|
2,270 |
|
|
$ |
2 |
|
|
|
63,784 |
|
|
$ |
64 |
|
|
$ |
924,094 |
|
|
$ |
(744,308 |
) |
|
$ |
(516 |
) |
|
$ |
179,336 |
|
|
$ |
(56,976 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
The accompanying notes are an integral part of the financial statements.
5
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(56,691 |
) |
|
$ |
(43,956 |
) |
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in
operating activities |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
5,729 |
|
|
|
7,488 |
|
Non-cash compensation expense |
|
|
13,497 |
|
|
|
8,779 |
|
Cumulative effect of a change in accounting principle |
|
|
|
|
|
|
(813 |
) |
Changes in assets and liabilities |
|
|
|
|
|
|
|
|
(Increase) decrease in accounts receivable |
|
|
(12,985 |
) |
|
|
24,380 |
|
(Increase) decrease in prepaid expenses and other assets |
|
|
(13,241 |
) |
|
|
627 |
|
Increase in inventory |
|
|
|
|
|
|
1,279 |
|
Increase (decrease) in deferred revenue |
|
|
36,622 |
|
|
|
(8,063 |
) |
Increase (decrease) in accounts payable, accrued expenses,
and other liabilities |
|
|
14,324 |
|
|
|
(5,118 |
) |
|
|
|
|
|
|
|
Total adjustments |
|
|
43,946 |
|
|
|
28,559 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(12,745 |
) |
|
|
(15,397 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
Purchases of marketable securities |
|
|
(371,007 |
) |
|
|
(152,660 |
) |
Sales or maturities of marketable securities |
|
|
253,719 |
|
|
|
95,292 |
|
Capital expenditures |
|
|
(3,024 |
) |
|
|
(986 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(120,312 |
) |
|
|
(58,354 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Net proceeds from the issuance of Common Stock |
|
|
4,824 |
|
|
|
3,813 |
|
Other |
|
|
|
|
|
|
390 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
4,824 |
|
|
|
4,203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(128,233 |
) |
|
|
(69,548 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
237,876 |
|
|
|
184,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
109,643 |
|
|
$ |
114,960 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial statements.
6
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, 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 Companys financial position, results of operations, and cash flows in
conformity with accounting principles generally accepted in the United States of America. In the
opinion of management, these financial statements reflect all adjustments, consisting only of
normal recurring accruals, necessary for a fair presentation of the Companys 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, 2006
Condensed Balance Sheet data were derived from audited financial statements, but do not include all
disclosures required by accounting principles generally accepted in the United States of America.
These financial statements should be read in conjunction with the financial statements and notes
thereto contained in the Companys Annual Report on Form 10-K for the year ended December 31, 2006.
2. Per Share Data
The Companys basic and diluted net loss per share amounts have been computed by dividing net
loss by the weighted average number of shares of Common Stock and Class A Stock outstanding. Net
loss per share is presented on a combined basis, inclusive of Common Stock and Class A Stock
outstanding, as each class of stock has equivalent economic rights. For the three and six months
ended June 30, 2007 and 2006, the Company reported net losses; therefore, no common stock
equivalents were included in the computation of diluted net loss per share for these periods, since
such inclusion would have been antidilutive. The calculations of basic and diluted net loss per
share are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
2007 |
|
2006 |
Net loss (Numerator) |
|
$ |
(26,774 |
) |
|
$ |
(23,576 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares, in thousands
(Denominator) |
|
|
65,950 |
|
|
|
56,915 |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.41 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2007 |
|
2006 |
Net loss (Numerator) |
|
$ |
(56,691 |
) |
|
$ |
(43,956 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares, in thousands
(Denominator) |
|
|
65,757 |
|
|
|
56,821 |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.86 |
) |
|
$ |
(0.77 |
) |
7
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
Shares issuable upon the exercise of stock options, vesting of restricted stock awards, and
conversion of convertible debt, which have been excluded from the June 30, 2007 and 2006 diluted
per share amounts because their effect would have been antidilutive, include the following:
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
2007 |
|
2006 |
Stock Options: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
15,228 |
|
|
|
14,181 |
|
Weighted average exercise price |
|
$ |
15.91 |
|
|
$ |
14.32 |
|
|
|
|
|
|
|
|
|
|
Restricted Stock: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
|
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
Convertible Debt: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
6,611 |
|
|
|
6,611 |
|
Conversion price |
|
$ |
30.25 |
|
|
$ |
30.25 |
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
2007 |
|
2006 |
Stock Options: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
15,388 |
|
|
|
14,291 |
|
Weighted average exercise price |
|
$ |
15.78 |
|
|
$ |
14.29 |
|
|
|
|
|
|
|
|
|
|
Restricted Stock: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
|
|
|
|
47 |
|
|
|
|
|
|
|
|
|
|
Convertible Debt: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
6,611 |
|
|
|
6,611 |
|
Conversion price |
|
$ |
30.25 |
|
|
$ |
30.25 |
|
3. Statement of Cash Flows
Supplemental disclosure of noncash investing and financing activities:
Included in accounts payable and accrued expenses at June 30, 2007 and December 31, 2006 are
$1.3 million and $0.8 million, respectively, of accrued capital expenditures. Included in accounts
payable and accrued expenses at both June 30, 2006 and December 31, 2005 are $0.2 million of
accrued capital expenditures.
Included in accounts payable and accrued expenses at December 31, 2006 and 2005 are $1.4
million and $1.9 million, respectively, of accrued Company 401(k) Savings Plan contribution
expense. In the first quarter of 2007 and 2006, the Company contributed 64,532 and 120,960
8
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
shares, respectively, of Common Stock to the 401(k) Savings Plan in satisfaction of these
obligations.
Included in marketable securities at June 30, 2007 and December 31, 2006 are $2.2 million and
$1.5 million, respectively, of accrued interest income. Included in marketable securities at June
30, 2006 and December 31, 2005 are $0.8 million and $1.2 million, respectively, of accrued interest
income.
4. Accounts Receivable
Accounts receivable as of June 30, 2007 and December 31, 2006 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Receivable from the sanofi-aventis Group |
|
$ |
11,410 |
|
|
$ |
6,900 |
|
Receivable from Bayer HealthCare LLC |
|
|
7,463 |
|
|
|
|
|
Other |
|
|
1,605 |
|
|
|
593 |
|
|
|
|
|
|
|
|
|
|
$ |
20,478 |
|
|
$ |
7,493 |
|
|
|
|
|
|
|
|
5. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses as of June 30, 2007 and December 31, 2006 consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Accounts payable |
|
$ |
18,546 |
|
|
$ |
4,349 |
|
Accrued payroll and related costs |
|
|
7,222 |
|
|
|
9,932 |
|
Accrued clinical trial expense |
|
|
4,316 |
|
|
|
2,606 |
|
Accrued expenses, other |
|
|
2,529 |
|
|
|
2,292 |
|
Interest payable on convertible notes |
|
|
2,292 |
|
|
|
2,292 |
|
|
|
|
|
|
|
|
|
|
$ |
34,905 |
|
|
$ |
21,471 |
|
|
|
|
|
|
|
|
6. 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 (loss) on
marketable securities. The net effect of income taxes on comprehensive loss is immaterial. For
the three and six months ended June 30, 2007 and 2006, the components of comprehensive loss are:
9
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(26,774 |
) |
|
$ |
(23,576 |
) |
Change in net unrealized gain (loss) on
marketable securities |
|
|
(357 |
) |
|
|
(102 |
) |
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(27,131 |
) |
|
$ |
(23,678 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(56,691 |
) |
|
$ |
(43,956 |
) |
Change in net unrealized gain (loss) on
marketable securities |
|
|
(285 |
) |
|
|
(3 |
) |
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(56,976 |
) |
|
$ |
(43,959 |
) |
|
|
|
|
|
|
|
7. Accounting for Collaboration with Bayer HealthCare
In October 2006, the Company entered into a license and collaboration agreement with
Bayer HealthCare LLC to globally develop, and commercialize outside the United States, the
Companys VEGF Trap for the treatment of eye disease by local administration (VEGF Trap-Eye).
Under the terms of the agreement, Bayer made a non-refundable up-front payment to the Company of
$75.0 million. In 2007, agreed upon VEGF Trap-Eye development expenses incurred by both companies
under a global development plan will be shared as follows: Up to the first $50.0 million will be
shared equally; Regeneron is solely responsible for the next $40.0 million; over $90.0 million will
be shared equally. Through June 30, 2007, reimbursements from Bayer HealthCare of the Companys
VEGF Trap-Eye development expenses totaled $10.6 million, of which $7.5 million was receivable at
June 30, 2007. Neither party was reimbursed for any development expenses that it incurred prior to
2007.
The Company and Bayer HealthCare are currently formalizing the global development plans for
the VEGF Trap-Eye in the collaborations two initial eye disease indications. The plans will
include estimated development steps, timelines and costs, as well as the projected responsibilities
of and costs to be incurred by each of the companies. Pending completion of these plans, all
payments received or receivable by the Company from Bayer HealthCare through June 30, 2007,
totaling $85.6 million, have been fully deferred and included in deferred revenue for financial
statement purposes. When the plans are formalized later this year, the Company will determine the
appropriate accounting policy for payments from Bayer HealthCare and the financial statement
classifications and periods in which past and future payments (including the $75.0 million up-front
payment, development and regulatory milestone payments, and reimbursements of Regeneron development
expenses) will be recognized in the Companys Statement of Operations. In the period when the
Company commences recognizing previously deferred payments from Bayer HealthCare, the Company
anticipates recording a cumulative catch-up for the period since inception of the collaboration in
October 2006, which can not be quantified at this time.
10
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
8. 2007 License Agreements
AstraZeneca
In February 2007, the Company entered into a non-exclusive license agreement with AstraZeneca
UK Limited that allows AstraZeneca to utilize the Companys VelocImmune® technology in its internal
research programs to discover human monoclonal antibodies. Under the terms of the agreement,
AstraZeneca made a $20.0 million non-refundable up-front payment to the Company which was deferred
and is being recognized as revenue ratably over the twelve month period beginning in February 2007.
AstraZeneca also will make up to five additional annual payments of $20.0 million, subject to its
ability to terminate the agreement after making the first three additional payments or earlier if
the technology does not meet minimum performance criteria. These additional payments will be
recognized as revenue ratably over their respective annual license periods. The Company is
entitled to receive a mid-single-digit royalty on any future sales of antibody products discovered
by AstraZeneca using the Companys VelocImmune technology. For the six months ended June 30, 2007,
the Company recognized $7.1 million of revenue in connection with the AstraZeneca license
agreement. At June 30, 2007, deferred revenue was $12.9 million.
Astellas
In March 2007, the Company entered into a non-exclusive license agreement with Astellas Pharma
Inc. that allows Astellas to utilize the Companys VelocImmune technology in its internal research
programs to discover human monoclonal antibodies. Under the terms of the agreement, Astellas made
a $20.0 million non-refundable up-front payment to the Company, which was deferred and is being
recognized as revenue ratably over the twelve month period beginning in June 2007. Astellas also
will make up to five additional annual payments of $20.0 million, subject to its ability to
terminate the agreement after making the first three additional payments or earlier if the
technology does not meet minimum performance criteria. These additional payments will be
recognized as revenue ratably over their respective annual license periods. The Company is
entitled to receive a mid-single-digit royalty on any future sales of antibody products discovered
by Astellas using the Companys VelocImmune technology. For the six months ended June 30, 2007,
the Company recognized $1.3 million of revenue in connection with the Astellas license agreement.
At June 30, 2007, deferred revenue was $18.7 million.
9. Commitment Purchase of Building
In June 2007, the Company exercised a purchase option on a building in Rensselaer, New York,
totaling approximately 270,000 square feet, in which the Company currently leases approximately
75,000 square feet of manufacturing, office, and warehouse space. The Company anticipates
completing the purchase of this building in the third quarter of 2007 at a cost of approximately
$10 million.
11
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
10. Income Taxes
Effective January 1, 2007, the Company adopted the provisions of Financial Accounting
Standards Board (FASB) Interpretation No. 48 (FIN 48), Accounting for Uncertainty in Income
Taxes an interpretation of FASB Statement No. 109. The implementation of FIN 48 had no impact on
the Companys financial statements.
The Company is primarily subject to U.S. federal and New York State income tax. Tax years
subsequent to 1991 remain open to examination by U.S. federal and state tax authorities.
The Companys policy is to recognize interest and penalties related to income tax matters in
income tax expense. As of January 1 and June 30, 2007, the Company had no accruals for interest or
penalties related to income tax matters.
11. Legal Matters
From time to time, the Company is a party to legal proceedings in the course of the Companys
business. The Company does not expect any such current legal proceedings to have a material
adverse effect on the Companys business or financial condition.
12. Segment Information
Through 2006, the Companys operations were managed in two business segments: research and
development, and contract manufacturing.
Research and development: Includes all activities related to the discovery of pharmaceutical
products for the treatment of serious medical conditions, and the development and commercialization
of these discoveries. Also includes revenues and expenses related to activities conducted under
contract research and technology licensing agreements.
Contract manufacturing: Includes all revenues
and expenses related to the commercial
production of products under contract manufacturing arrangements. During 2006, the Company
produced a vaccine intermediate for Merck & Co., Inc. under
a manufacturing agreement, which expired in October 2006.
Due to the expiration of the Companys manufacturing agreement with Merck in
October 2006, beginning in 2007, the Company only has a research and development business segment.
Therefore, segment information has not been provided for 2007 in the table below.
The following table presents information about reported segments for the three and six months
ended June 30, 2006.
12
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2006 |
|
|
Research & |
|
Contract |
|
Reconciling |
|
|
|
|
|
Development |
|
Manufacturing |
|
Items |
|
|
Total |
Revenues |
|
$ |
14,991 |
|
|
$ |
4,267 |
|
|
|
|
|
|
|
$ |
19,258 |
|
Depreciation and
amortization |
|
|
3,429 |
|
|
|
|
(1) |
|
$ |
261 |
|
|
|
|
3,690 |
|
Non-cash
compensation
expense |
|
|
4,603 |
|
|
|
97 |
|
|
|
|
|
|
|
|
4,700 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
3,011 |
|
|
|
|
3,011 |
|
Net (loss) income |
|
|
(25,706 |
) |
|
|
1,457 |
|
|
|
673 |
(2) |
|
|
|
(23,576 |
) |
Capital expenditures |
|
|
323 |
|
|
|
|
|
|
|
|
|
|
|
|
323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, 2006 |
|
|
Research & |
|
Contract |
|
Reconciling |
|
|
|
|
|
Development |
|
Manufacturing |
|
Items |
|
|
Total |
Revenues |
|
$ |
29,578 |
|
|
$ |
7,899 |
|
|
|
|
|
|
|
$ |
37,477 |
|
Depreciation and
amortization |
|
|
6,966 |
|
|
|
|
(1) |
|
$ |
522 |
|
|
|
|
7,488 |
|
Non-cash
compensation
expense |
|
|
8,587 |
|
|
|
192 |
|
|
|
(813 |
)(4) |
|
|
|
7,966 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
6,022 |
|
|
|
|
6,022 |
|
Net (loss) income |
|
|
(49,149 |
) |
|
|
3,237 |
|
|
|
1,956 |
(2) |
|
|
|
(43,956 |
) |
Capital expenditures |
|
|
968 |
|
|
|
|
|
|
|
|
|
|
|
|
968 |
|
Total assets |
|
|
64,543 |
|
|
|
3,580 |
|
|
|
310,209 |
(3) |
|
|
|
378,332 |
|
|
|
|
(1) |
|
Depreciation and amortization related to contract manufacturing was capitalized into
inventory and included in contract manufacturing expense when the product was shipped. |
|
(2) |
|
Represents investment income, net of interest expense related primarily to
convertible notes issued in October 2001. For the six months ended June 30, 2006, also
includes the cumulative effect of adopting Statement of Financial Accounting Standards No.
(SFAS) 123R, Share-Based Payment. |
|
(3) |
|
Includes cash and cash equivalents, marketable securities, restricted cash (where
applicable), prepaid expenses and other current assets, and other assets. |
|
(4) |
|
Represents the cumulative effect of adopting SFAS 123R. |
13. Future Impact of Recently Issued Accounting Standards
In February 2007, the FASB issued SFAS 159, The Fair Value Option for Financial Assets and
Financial Liabilities. SFAS 159 permits entities to choose to measure many financial instruments
and certain other items at fair value. The objective is to improve financial reporting by
providing entities with the opportunity to mitigate volatility in reported earnings caused by
measuring related assets and liabilities differently without having to apply complex hedge
accounting provisions. SFAS 159 is effective for financial statements issued for fiscal years
beginning after November 15, 2007. The Company will be required to adopt SFAS 159 effective
13
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
for the fiscal year beginning January 1, 2008. Management is currently evaluating the
potential impact of adopting SFAS 159 on the Companys financial statements.
In June 2007, the Emerging Issues Task Force issued Statement No. 07-3, Accounting for
Non-refundable Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities (EITF 07-3). EITF 07-3 addresses how entities involved in research and development
activities should account for the non-refundable portion of an advance payment made for future
research and development activities and requires that such payments be deferred and capitalized,
and recognized as an expense when the goods are delivered or the related services are performed.
EITF 07-3 is effective for fiscal years beginning after December 15, 2007, including interim
periods within those fiscal years. The Company will be required to adopt EITF 07-3 effective for
the fiscal year beginning January 1, 2008. Management believes that the future adoption of EITF
07-3 will not have a material impact on the Companys financial statements.
14
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The discussion below contains forward-looking statements that involve risks and uncertainties
relating to future events and the future financial performance of Regeneron Pharmaceuticals, Inc.
and actual events or results may differ materially. These statements concern, among other things,
the possible success and therapeutic applications of our product candidates and research programs,
the timing and nature of the clinical and research programs now underway or planned, and the future
sources and uses of capital and our financial needs. These statements are made by us based on
managements current beliefs and judgment. In evaluating such statements, stockholders and
potential investors should specifically consider the various factors identified under the caption
Risk Factors 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.
Overview
Regeneron Pharmaceuticals, Inc. is a biopharmaceutical company that discovers, develops, and
intends to commercialize pharmaceutical products for the treatment of serious medical conditions.
We are currently focused on three development programs: rilonacept (IL-1 Trap) in various
inflammatory indications, the VEGF Trap (aflibercept) in oncology, and the VEGF Trap-Eye
formulation in eye diseases using intraocular delivery. The VEGF Trap is being developed in
oncology in collaboration with the sanofi-aventis Group. The VEGF Trap-Eye is being developed in
collaboration with Bayer HealthCare LLC. Our preclinical research programs are in the areas of
oncology and angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and
disorders, inflammation and immune diseases, bone and cartilage, pain, and cardiovascular diseases.
We expect that our next generation of product candidates will be based on our proprietary
technologies for developing human monoclonal antibodies. Developing and commercializing new
medicines entails significant risk and expense. Since inception we have not generated any sales or
profits from the commercialization of any of our product candidates.
Our core business strategy is to maintain a strong foundation in basic scientific research and
discovery-enabling technology and combine that foundation with our manufacturing and clinical
development capabilities to build a successful, integrated biopharmaceutical company. We believe
that our ability to develop product candidates is enhanced by the application of our technology
platforms. Our discovery platforms are designed to identify specific genes of therapeutic interest
for a particular disease or cell type and validate targets through high-throughput production of
mammalian models. Our human monoclonal antibody technology (VelocImmune®) and cell line
expression technologies may then be utilized to design and produce new product candidates directed
against the disease target. Based on the VelocImmune platform which we believe, in conjunction
with our other proprietary technologies, can accelerate the development of fully human monoclonal
antibodies, we plan to move our first new antibody product candidate into clinical trials in the
fourth quarter of 2007. We plan to introduce two new antibody product candidates into clinical
development each year. We continue to invest in the development of enabling technologies to assist
in our efforts to identify, develop, and commercialize new product candidates.
15
Clinical Programs:
Below is a summary of the status of our clinical candidates as of June 30, 2007:
1. Rilonacept Inflammatory Diseases
Rilonacept (IL-1 Trap) is a protein-based product candidate designed to bind the interleukin-1
(called IL-1) cytokine and prevent its interaction with cell surface receptors. We are evaluating
rilonacept in a number of diseases and disorders where IL-1 may play an important role, including a
spectrum of rare diseases called Cryopyrin-Associated Periodic Syndromes (CAPS) and other diseases
associated with inflammation.
We recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for rilonacept in CAPS. The FDA has previously
granted Orphan Drug status and Fast Track designation to rilonacept for the treatment of CAPS. In
July 2007, rilonacept also received Orphan Drug designation in the European Union for the treatment
of CAPS.
In October 2006, we announced positive data from our Phase 3 clinical trial, which was
designed to provide two separate demonstrations of efficacy for rilonacept within a single group of
adult patients suffering from CAPS. This Phase 3 trial included two studies (Part A and Part B).
Both studies met their primary endpoints (Part A: p < 0.0001 and Part B: p < 0.001). The
primary endpoint of both studies was the change in disease activity, which was measured using a
composite symptom score composed of a daily evaluation of fever/chills, rash, fatigue, joint pain,
and eye redness/pain.
The first study (Part A) was a double-blind and placebo-controlled 6-week trial, in which
patients randomized to receive rilonacept had an approximately 85% reduction in their mean symptom
score compared to an approximately 13% reduction in patients treated with placebo (p<0.0001).
Following a 9-week interval during which all patients received rilonacept, a randomized
withdrawal study (Part B) was performed, in which the patients in Part A were re-randomized to
either switch to placebo or continue treatment with rilonacept in a double-blind manner. During
the 9-week randomized withdrawal period, patients who were switched to placebo had a five-fold
increase in their mean symptom score, compared with those remaining on rilonacept who had no
significant change (p<0.001). Both the Part A and Part B studies achieved statistical
significance in all of their pre-specified secondary and exploratory endpoints.
Preliminary analysis of the safety data from both studies indicated that there were no
drug-related serious adverse events. Injection site reactions and upper respiratory tract
infections, all mild to moderate in nature, occurred more frequently in patients while on
rilonacept than on placebo. In these studies, rilonacept appeared to be well tolerated; 46 of 47
randomized patients completed the Part A study, and 44 of 45 randomized patients completed the Part
B study. See Item 1A, Risk Factors under Risks Related to Development of Our Product
Candidates.
16
CAPS is a spectrum of rare inherited inflammatory conditions, including Familial Cold
Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem
Inflammatory Disease (NOMID). These syndromes are characterized by spontaneous systemic
inflammation and are termed autoinflammatory disorders. A novel feature of these conditions
(particularly FCAS and MWS) is that exposure to mild degrees of cold temperature can provoke a
major inflammatory episode that occurs within hours. CAPS are caused by a range of mutations in
the gene CIAS1 (also known as NALP3) which encodes a protein named cryopyrin. Currently, there are
no medicines approved for the treatment of CAPS.
We are also evaluating the potential use of rilonacept in other indications in which IL-1 may
play a role. We are completing an exploratory proof of concept study of rilonacept in ten patients
with chronic gout, and plan to begin a safety and efficacy study of rilonacept in gout patients in
the third quarter of 2007. We are also preparing to initiate exploratory proof of concept studies
of rilonacept in other indications, the first of which is planned to begin in the fourth quarter of
2007.
Under a March 2003 collaboration agreement with Novartis Pharma AG, we retain the right to
elect to collaborate in the future development and commercialization of a Novartis IL-1 antibody,
which is in clinical development. Following completion of Phase 2 development and submission to us
of a written report on the Novartis IL-1 antibody, we have the right, in consideration for an
opt-in payment, to elect to co-develop and co-commercialize the Novartis IL-1 antibody in North
America. If we elect to exercise this right, we are responsible for paying 45% of post-election
North American development costs for the antibody product. In return, we are entitled to
co-promote the Novartis IL-1 antibody and to receive 45% of net profits on sales of the antibody
product in North America. Under certain circumstances, we are also entitled to receive royalties
on sales of the Novartis IL-1 antibody in Europe.
In addition, under the collaboration agreement, Novartis has the right to elect to collaborate
in the development and commercialization of a second generation rilonacept following completion of
its Phase 2 development, should we decide to clinically develop such a second generation product
candidate. Novartis does not have any rights or options with respect to our rilonacept currently
in clinical development.
2. VEGF Trap Oncology
The VEGF Trap is a protein-based product candidate designed to bind all forms of Vascular
Endothelial Growth Factor-A (called VEGF-A, also known as Vascular Permeability Factor or VPF) and
the related Placental Growth Factor (called PlGF), and prevent their interaction with cell surface
receptors. VEGF-A (and to a less validated degree, PlGF) is required for the growth of new blood
vessels that are needed for tumors to grow and is a potent regulator of vascular permeability and
leakage.
The VEGF Trap (aflibercept) is being developed in cancer indications in collaboration with
sanofi-aventis. We and sanofi-aventis are preparing to initiate a large Phase 3 program that will
evaluate the safety and efficacy of the VEGF Trap in combination with standard chemotherapy
regimens in five different cancer types. The first trial is planned to begin in the third quarter
of 2007. The Phase 3 trials are planned in the following indications:
17
|
|
|
first-line metastatic hormone resistant prostate cancer in combination with Taxotere®
(Aventis), |
|
|
|
|
first-line metastatic pancreatic cancer in combination with gemcitabine-based regimen, |
|
|
|
|
first-line gastric cancer in combination with Taxotere® (Aventis), |
|
|
|
|
second-line non-small cell lung cancer in combination with Taxotere® (Aventis), and |
|
|
|
|
second-line metastatic colorectal cancer in combination with FOLFIRI (Folinic Acid
(leucovorin), 5-fluorouracil, and irinotecan). |
Currently, the collaboration is conducting Phase 2 single-agent studies in advanced ovarian
cancer (AOC), non-small cell lung adenocarcinoma (NSCLA), and AOC patients with symptomatic
malignant ascites (SMA). In 2004, the FDA granted Fast Track designation to the VEGF Trap for the
treatment of SMA.
In June 2007, at the annual meeting of the American Society of Clinical Oncology (ASCO), we
and sanofi-aventis announced interim results from the Phase 2 studies in AOC and NSCLA. The AOC
study, selected for an oral presentation at ASCO, was an interim analysis of a Phase 2 randomized,
double-blind, multi-center trial investigating two doses of the VEGF Trap used as a single agent in
patients with recurrent platinum-resistant epithelial ovarian cancer. While the study remains
blinded with regard to dose, the combined preliminary results of the two dose levels for 162 of a
planned 200 patients demonstrated anti-tumor activity as evidenced by an 8.0% partial response rate
and 77% achievement of stable disease at 4 weeks in heavily pre-treated patients who had failed
multiple other treatments. The VEGF Trap has been well tolerated, and the most common adverse
events have been the typical class effect of anti-angiogenic agents. Of the 23 patients in the AOC
study with evaluable baseline ascites, 7 patients (30%) experienced complete disappearance of the
ascites, and 13 patients (57%) experienced no increase in ascites during treatment. The AOC study
is ongoing and is now fully enrolled.
The NSCLA study, presented as a poster at ASCO, is a Phase 2 single-arm study conducted in
patients with platinum-resistant and erlotinib-resistant adenocarcinoma of the lung (a common type
of non-small cell lung cancer). In this study, the preliminary results presented at ASCO
demonstrated activity in this heavily pre-treated patient base, as evidenced by a 3.7% partial
response rate and 63% of patients achieving stable disease. The VEGF Trap has been well-tolerated
in this trial as well. This study is ongoing and is now fully enrolled.
Sanofi-aventis has indicated that a first registration submission to a regulatory agency for
the VEGF Trap is possible as early as 2008.
In addition, eight clinical studies have begun in conjunction with the National Cancer
Institute (NCI) Cancer Therapy Evaluation Program (CTEP). We and sanofi-aventis are working to
finalize plans with NCI/CTEP to conduct additional trials in different cancer types.
Five safety and tolerability studies of the VEGF Trap in combination with standard
chemotherapy regimens are continuing in a variety of cancer types to support the planned Phase 3
clinical program. In addition, sanofi-aventis has initiated the first trial of the VEGF Trap in
18
Japan, a Phase 1 safety and tolerability study in combination with S-1 in patients with advanced
solid malignancies.
Cancer is a heterogeneous set of diseases and one of the leading causes of death in the
developed world. A mutation in any one of dozens of normal genes can eventually result in a cell
becoming cancerous; however, a common feature of cancer cells is that they need to obtain nutrients
and remove waste products, just as normal cells do. The vascular system normally supplies
nutrients to and removes waste from normal tissues. Cancer cells can use the vascular system
either by taking over preexisting blood vessels or by promoting the growth of new blood vessels (a
process known as angiogenesis). VEGF is secreted by many tumors to stimulate the growth of new
blood vessels to supply nutrients and oxygen to the tumor. VEGF blockers have been shown to
inhibit new vessel growth; and, in some cases, can cause regression of existing tumor vasculature.
Countering the effects of VEGF, thereby blocking the blood supply to tumors, has demonstrated
therapeutic benefits in clinical trials. This approach of inhibiting angiogenesis as a mechanism of
action for an oncology medicine was validated in February 2004, when the FDA approved Genentech,
Inc.s VEGF inhibitor, Avastin®. Avastin® (Genentech) is an antibody product
designed to inhibit VEGF and interfere with the blood supply to tumors.
Collaboration with the sanofi-aventis Group
In September 2003, we entered into a collaboration agreement with Aventis Pharmaceuticals,
Inc. (predecessor to sanofi-aventis U.S.) to collaborate on the development and commercialization
of the VEGF Trap in all countries other than Japan, where we retained the exclusive right to
develop and commercialize the VEGF Trap. In January 2005, we and sanofi-aventis amended the
collaboration agreement to exclude from the scope of the collaboration the development and
commercialization of the VEGF Trap for intraocular delivery to the eye. In December 2005, we and
sanofi-aventis amended our collaboration agreement to expand the territory in which the companies
are collaborating on the development of the VEGF Trap to include Japan. Under the collaboration
agreement, as amended, we and sanofi-aventis will share co-promotion rights and profits on sales,
if any, of the VEGF Trap outside of Japan for disease indications included in our collaboration.
In Japan, we are entitled to a royalty of approximately 35% on annual sales of the VEGF Trap,
subject to certain potential adjustments. We may also receive up to $400.0 million in milestone
payments upon receipt of specified marketing approvals. This total includes up to $360.0 million
in milestone payments related to receipt of marketing approvals for up to eight VEGF Trap oncology
and other indications in the United States or the European Union. Another $40.0 million of
milestone payments relate to receipt of marketing approvals for up to five VEGF Trap oncology
indications in Japan.
Under the collaboration agreement, as amended, agreed upon worldwide development expenses
incurred by both companies during the term of the agreement will be funded by sanofi-aventis. If
the collaboration becomes profitable, we will be obligated to reimburse sanofi-aventis for 50% of
the VEGF Trap development expenses in accordance with a formula based on the amount of development
expenses and our share of the collaboration profits and Japan royalties, or at a faster rate at our
option.
19
3. VEGF Trap Eye Diseases
The VEGF Trap-Eye is a form of the VEGF Trap that has been purified and formulated with
excipients and at concentrations suitable for direct injection into the eye. The VEGF Trap-Eye
currently is being tested in a Phase 2 trial in patients with the neovascular form of age-related
macular degeneration (wet AMD) and in a small pilot study in patients with diabetic macular edema
(DME).
In the clinical development program for the VEGF Trap-Eye, we and Bayer HealthCare announced that we have initiated a Phase 3 study of the VEGF Trap-Eye in wet AMD. This first
trial will compare the VEGF Trap-Eye and Genentech, Inc.s Lucentisâ
(ranibizumab), an anti-angiogenic agent approved for use in wet AMD. This Phase 3 trial is
evaluating dosing intervals of four and eight weeks for the VEGF Trap-Eye compared with ranibizumab
dosing according to its label every four weeks. Regeneron and Bayer HealthCare plan to initiate a
second Phase 3 trial in wet AMD around the end of 2007.
In May 2007, at the annual meeting of the Association for Research in Vision and Ophthalmology
(ARVO), we and Bayer HealthCare reported positive interim data from a pre-planned interim analysis
of the Phase 2 study in wet AMD. The Phase 2 trial is a 150 patient, 12 week, study that is
evaluating the safety and biological effect of treatment with multiple doses of the VEGF Trap-Eye
using different doses and different dosing regimens. In the interim data analysis, the VEGF
Trap-Eye met its primary endpoint of a statistically significant reduction in retinal thickness
after 12 weeks compared with baseline (all groups combined, decrease of 135 microns, p <
0.0001). Mean change from baseline in visual acuity, a key secondary endpoint of the study, also
demonstrated statistically significant improvement (all groups combined, increase of 5.9 letters, p
< 0.0001). Moreover, patients in the dose groups that received only a single dose, on average,
compared to baseline, demonstrated a decrease in excess retinal thickness (p < 0.0001) and an
increase in visual acuity (p = 0.012) at 12 weeks. There were no drug-related serious adverse
events, and treatment with the VEGF Trap-Eye was generally well-tolerated. The most common adverse
events were those typically associated with intravitreal injections. Detailed data from this
interim analysis is scheduled for presentation at an upcoming scientific conference. All patients
have now completed 12 weeks of treatment, and we and Bayer HealthCare expect to report the results
at a scientific conference in the third quarter of 2007. We are also conducting a Phase 1 safety
and tolerability trial of a new formulation of the VEGF Trap-Eye in wet AMD.
We are also developing the VEGF Trap-Eye in DME. In May 2007, at the ARVO meeting, the
companies reported results from a small pilot study of the VEGF Trap-Eye in patients with DME. In
the study, the VEGF Trap was well tolerated and demonstrated activity in five patients, with
decreases in retinal thickness and improvement in visual acuity. We expect to initiate a safety
and efficacy study in DME in the second half of 2007.
VEGF-A both stimulates angiogenesis and increases vascular permeability. It has been shown in
preclinical studies to be a major pathogenic factor in both wet AMD and diabetic retinopathy, and
it is believed to be involved in other medical problems affecting the eyes. In clinical trials,
blocking VEGF-A has been shown to be effective in patients with wet AMD, and
20
Macugen® (OSI
Pharmaceuticals, Inc.) and Lucentis® (Genentech, Inc.) have been approved to treat
patients with this condition.
Wet AMD and diabetic retinopathy (DR) are two of the leading causes of adult blindness in the
developed world. In both conditions, severe visual loss is caused by a combination of retinal
edema and neovascular proliferation. DR is a major complication of diabetes mellitus that can lead
to significant vision impairment. DR is characterized, in part, by vascular leakage, which results
in the collection of fluid in the retina. When the macula, the central area of the retina that is
responsible for fine visual acuity, is involved, loss of visual acuity occurs. This is referred to
as diabetic macular edema (DME). DME is the most prevalent cause of moderate visual loss in
patients with diabetes.
Collaboration with Bayer HealthCare
In October 2006, we entered into a collaboration agreement with Bayer HealthCare for the
global development and commercialization outside the United States of the VEGF Trap-Eye. Under the
agreement we and Bayer HealthCare will collaborate on, and share the costs of, the development of
the VEGF Trap-Eye through an integrated global plan that encompasses wet AMD, diabetic eye
diseases, and other diseases and disorders. The companies will share equally in profits from any
future sales of the VEGF Trap-Eye outside the United States. If the VEGF Trap-Eye is granted
marketing authorization in a major market country outside the United States, we will be obligated
to reimburse Bayer HealthCare for 50% of the development costs that it has incurred under the
agreement from our share of the collaboration profits. Within the United States, we retained
exclusive commercialization rights to the VEGF Trap-Eye and are entitled to all profits from any
such sales. We received an up-front payment of $75.0 million from Bayer HealthCare and can earn up
to $110.0 million in total development and regulatory milestones related to the development of the
VEGF Trap-Eye and marketing approvals in major market countries outside the United States. We can
also earn up to $135.0 million in sales milestones if total annual sales of the VEGF Trap-Eye
outside the United States achieve certain specified levels starting at $200.0 million.
General
Developing and commercializing new medicines entails significant risk and expense. Since
inception we have not generated any sales or profits from the commercialization of any 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 research and development and obtaining regulatory
approval from the FDA and regulatory authorities in other countries. In addition, the
biotechnology and pharmaceutical industries are rapidly evolving and highly competitive, and new
developments may render our products and technologies uncompetitive or obsolete.
From inception on January 8, 1988 through June 30, 2007, we had a cumulative loss of $744.3
million. In the absence of revenues from the commercialization of our product candidates or other
sources, the amount, timing, nature, and source of which cannot be predicted, our losses will
continue as we conduct our research and development activities. We expect to incur
21
substantial losses over the next several years as we continue the clinical development of the
VEGF Trap-Eye and rilonacept; advance new product candidates into clinical development from our
existing research programs utilizing our technology for designing fully human monoclonal
antibodies; continue our research and development programs; and commercialize product candidates
that receive regulatory approval, if any. Also, our activities may expand over time and require
additional resources, and we expect our operating losses to be substantial over at least the next
several years. Our losses may fluctuate from quarter to quarter and will depend on, among other
factors, the progress of our research and development efforts, the timing of certain expenses, and
the amount and timing of payments that we receive from collaborators.
The planning, execution, and results of our clinical programs are significant factors that can
affect our operating and financial results. In our clinical programs, key events for 2007 and
plans over the next 12 months are as follows:
|
|
|
|
|
Clinical Program |
|
2007 Events to Date |
|
2007-8 Plans |
VEGF Trap -
Oncology
|
|
NCI/CTEP
initiated eight
Phase 2 studies of
the VEGF Trap as a
single agent
Reported
interim results from
two Phase 2
single-agent trials
- - in advanced
ovarian cancer and
in non-small cell
lung adenocarcinoma
Initiated
Japanese Phase 1
trial of VEGF Trap
in combination with
S-1 in patients with
solid malignancies
|
|
Sanofi-aventis to initiate three of five Phase 3 studies of
the VEGF Trap in combination with standard chemotherapy regimens in specific cancer indications
NCI/CTEP to initiate
additional new exploratory
safety and efficacy studies |
|
|
|
|
|
|
VEGF Trap-Eye
(intravitreal injection)
|
|
Reported
positive interim
results of Phase 2
trial in wet AMD
Reported
positive results in
Phase 1 trial in DME Initiated first Phase 3 trial in
wet AMD
|
|
Report final
results of Phase 2
trial in wet AMD
Initiate
second Phase 3 trial
in wet AMD
Initiate
safety and efficacy
trial in DME
Explore
additional eye
disease indications |
|
22
|
|
|
|
|
Clinical Program |
|
2007 Events to Date |
|
2007-8 Plans |
Rilonacept (IL-1 Trap)
|
|
Completed
the 24 week
open-label safety
extension phase of
the Phase 3 trial in
CAPS
Submitted
BLA to the FDA for
CAPS
Orphan Drug
designation in CAPS
granted in European
Union
|
|
FDA acceptance of BLA submission for CAPS and establishment of target
completion date for FDA review of BLA
Report results of exploratory proof of concept study in
patients with chronic gout
Initiate safety and efficacy trial in gout
Evaluate rilonacept in other disease indications in which IL-1 may play an important role
|
|
VelocImmune®
|
|
|
|
Initiate
first trial for
antibody product
candidate
Finalize
plans to initiate
clinical trials for
two additional
antibody candidates
in 2008 |
|
|
|
|
License Agreements
AstraZeneca
In February 2007, we entered into a non-exclusive license agreement with AstraZeneca UK
Limited that allows AstraZeneca to utilize our VelocImmune® technology in its internal
research programs to discover human monoclonal antibodies. Under the terms of the agreement,
AstraZeneca made a $20.0 million non-refundable up-front payment to us. AstraZeneca also will make
up to five additional annual payments of $20.0 million, subject to its ability to terminate the
agreement after making the first three additional payments or earlier if the technology does not
meet minimum performance criteria. We are entitled to receive a mid-single-digit royalty on any
future sales of antibody products discovered by AstraZeneca using our VelocImmune technology.
Astellas
In March 2007, we entered into a non-exclusive license agreement with Astellas Pharma Inc.
that allows Astellas to utilize our VelocImmune technology in its internal research programs to
discover human monoclonal antibodies. Under the terms of the agreement, Astellas made a $20.0
million non-refundable up-front payment to us. Astellas also will make up to five additional
annual payments of $20.0 million, subject to its ability to terminate the agreement after making
the first three additional payments or earlier if the technology does not meet minimum performance
criteria. We are entitled to receive a mid-single-digit royalty on any future sales of antibody
products discovered by Astellas using our VelocImmune technology.
Accounting for Collaboration with Bayer HealthCare
As described above, in October 2006 we entered into a VEGF Trap-Eye license and collaboration
agreement with Bayer HealthCare. Under the terms of the agreement, Bayer HealthCare made a
non-refundable up-front payment to us of $75.0 million. In 2007, agreed upon VEGF Trap-Eye
development expenses incurred by both companies under a global development plan will be shared as
follows: Up to the first $50.0 million will be shared equally;
23
Regeneron is solely responsible for
the next $40.0 million; over $90.0 million will be shared
equally. Through June 30, 2007, reimbursements from Bayer HealthCare of our VEGF Trap-Eye
development expenses total $10.6 million, of which $7.5 million was receivable at June 30, 2007.
Neither party was reimbursed for any development expenses that it incurred prior to 2007.
We and Bayer HealthCare are currently formalizing our global development plans for the VEGF
Trap-Eye in wet AMD and DME. The plans will include estimated development steps, timelines, and
costs, as well as the projected responsibilities of and costs to be incurred by each of the
companies. Pending completion of these plans, all payments received or receivable from Bayer
HealthCare through June 30, 2007, totaling $85.6 million, have been fully deferred and included in
deferred revenue for financial statement purposes. When the plans are formalized later this year,
we will determine the appropriate accounting policy for payments from Bayer HealthCare and the
financial statement classifications and periods in which past and future payments from Bayer
(including the $75.0 million up-front payment, development and regulatory milestone payments, and
reimbursements of Regeneron development expenses) will be recognized in our Statement of
Operations. In the period when we commence recognizing previously deferred payments from Bayer
HealthCare, we anticipate recording a cumulative catch-up for the
period since inception of the collaboration in October 2006, which can not be quantified at this
time.
Results of Operations
Three Months Ended June 30, 2007 and 2006
Net Loss:
Regeneron reported a net loss of $26.8 million, or $0.41 per share (basic and diluted), for
the second quarter of 2007 compared to a net loss of $23.6 million, or $0.41 per share (basic and
diluted), for the second quarter of 2006.
Revenues:
Revenues for the three months ended June 30, 2007 and 2006 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
(In millions) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
Contract research & development revenue |
|
|
|
|
|
|
|
|
|
|
|
|
The sanofi-aventis Group |
|
$ |
13.5 |
|
|
$ |
14.8 |
|
|
$ |
(1.3 |
) |
Other |
|
|
2.4 |
|
|
|
0.2 |
|
|
|
2.2 |
|
|
|
|
|
|
|
|
|
|
|
Total contract research &
development revenue |
|
|
15.9 |
|
|
|
15.0 |
|
|
|
0.9 |
|
Contract manufacturing revenue |
|
|
|
|
|
|
4.3 |
|
|
|
(4.3 |
) |
Technology licensing revenue |
|
|
6.3 |
|
|
|
|
|
|
|
6.3 |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
22.2 |
|
|
$ |
19.3 |
|
|
$ |
2.9 |
|
|
|
|
|
|
|
|
|
|
|
We recognize revenue from sanofi-aventis, in connection with the companies VEGF Trap
collaboration, in accordance with Staff Accounting Bulletin
No. 104, Revenue Recognition (SAB 104) and FASB
Emerging Issue Task Force Issue No. 00-21, Accounting for
Revenue Arrangements with Multiple Deliverables (EITF 00-21). We earn contract research and
development revenue from sanofi-aventis which, as detailed below, consists partly of
24
reimbursement
for research and development expenses and partly of the recognition of revenue
related to a total of $105.0 million of non-refundable, up-front payments received in 2003 and
2006. Non-refundable up-front license payments are recorded as deferred revenue and recognized
over the period over which we are obligated to perform services. We estimate our performance
period based on the specific terms of each agreement, and adjust the performance periods, if
appropriate, based on the applicable facts and circumstances.
|
|
|
|
|
|
|
|
|
Sanofi-aventis
Contract Research & Development Revenue (In millions) |
|
Three months ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
Regeneron expense reimbursement |
|
$ |
11.3 |
|
|
$ |
11.8 |
|
Recognition of deferred revenue related to up-front payments |
|
|
2.2 |
|
|
|
3.0 |
|
|
|
|
|
|
|
|
Total |
|
$ |
13.5 |
|
|
$ |
14.8 |
|
|
|
|
|
|
|
|
Sanofi-aventis reimbursement of Regeneron VEGF Trap expenses decreased in the second
quarter of 2007 from the same period in 2006, primarily due to higher costs in 2006 related to the
Companys manufacture of VEGF Trap clinical supplies. Recognition of deferred revenue related to
sanofi-aventis up-front payments decreased in the second quarter of 2007 from the same period in
2006, due to an extension of the estimated performance period over which this deferred revenue is
being recognized. As of June 30, 2007, $65.5 million of the original $105.0 million of up-front
payments was deferred and will be recognized as revenue in future periods.
Other contract research and development revenue includes $1.6 million recognized in connection
with our five-year grant from the National Institutes of Health (NIH), which we were awarded in
September 2006 as part of the NIHs Knockout Mouse Project.
Contract manufacturing revenue for the second quarter of 2006 related to our long-term
agreement with Merck & Co., Inc., which expired in October 2006, to manufacture a vaccine
intermediate at our Rensselaer, New York facility. Revenue and the related manufacturing expense
were recognized as product was shipped, after acceptance by Merck. Included in contract
manufacturing revenue in the second quarter of 2006 was $0.4 million of deferred revenue associated
with capital improvement reimbursements paid by Merck prior to commencement of production. We do
not expect to receive any further contract manufacturing revenue from Merck.
In connection with our license agreement with AstraZeneca, as described above, the $20.0
million non-refundable up-front payment, which we received in February 2007, was deferred and is
being recognized as revenue ratably over the twelve month period beginning in February 2007. In
connection with our license agreement with Astellas, as described above, the $20.0 million
non-refundable up-front payment, which we received in April 2007, was deferred and is being
recognized as revenue ratably over the twelve month period beginning in June 2007. In the second
quarter of 2007, we recognized $6.3 million of technology licensing revenue related to these
agreements.
Expenses:
Total operating expenses increased to $52.8 million in the second quarter of 2007 from $43.5
million in the same period of 2006. Our average employee headcount in the second quarter of
25
2007
increased to 618 from 579 in the second quarter of 2006, primarily to support our expanded
development programs for the VEGF Trap-Eye and rilonacept and our plans to move our first
antibody candidate into clinical trials later this year. Operating expenses in the second quarter
of 2007 and 2006 include a total of $6.9 million and $4.6 million, respectively, of non-cash
compensation expense related to employee stock option awards (Stock Option Expense), as detailed
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
For the three months ended June 30, 2007 |
|
|
|
Expenses before |
|
|
|
|
|
|
|
|
|
inclusion of Stock |
|
|
Stock Option |
|
|
Expenses as |
|
Expenses |
|
Option Expense |
|
|
Expense |
|
|
Reported |
|
Research and development |
|
$ |
39.9 |
|
|
$ |
4.0 |
|
|
$ |
43.9 |
|
General and administrative |
|
|
6.0 |
|
|
|
2.9 |
|
|
|
8.9 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
45.9 |
|
|
$ |
6.9 |
|
|
$ |
52.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
For the three months ended June 30, 2006 |
|
|
|
Expenses before |
|
|
|
|
|
|
|
|
|
inclusion of Stock |
|
|
Stock Option |
|
|
Expenses as |
|
Expenses |
|
Option Expense |
|
|
Expense |
|
|
Reported |
|
Research and development |
|
$ |
31.8 |
|
|
$ |
2.6 |
|
|
$ |
34.4 |
|
Contract manufacturing |
|
|
2.7 |
|
|
|
0.1 |
|
|
|
2.8 |
|
General and administrative |
|
|
4.4 |
|
|
|
1.9 |
|
|
|
6.3 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
38.9 |
|
|
$ |
4.6 |
|
|
$ |
43.5 |
|
|
|
|
|
|
|
|
|
|
|
The increase in total Stock Option Expense in the second quarter of 2007 was primarily due to
the higher fair market value of our Common Stock on the date of our annual employee option grants
made in December 2006 in comparison to the fair market value of our Common Stock on the dates of
annual employee option grants made in recent prior years.
Research and Development Expenses:
Research and development expenses increased to $43.9 million in the second quarter of 2007
from $34.4 million in the same period of 2006. The following table summarizes the major categories
of our research and development expenses for the three months ended June 30, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
Three months ended June 30, |
|
Research and development expenses |
|
2007 |
|
|
2006 |
|
|
Increase |
|
Payroll and benefits (1) |
|
$ |
14.4 |
|
|
$ |
11.7 |
|
|
$ |
2.7 |
|
Clinical trial expenses |
|
|
6.5 |
|
|
|
4.4 |
|
|
|
2.1 |
|
Clinical manufacturing costs (2) |
|
|
11.5 |
|
|
|
9.1 |
|
|
|
2.4 |
|
Research and preclinical development costs |
|
|
6.1 |
|
|
|
4.3 |
|
|
|
1.8 |
|
Occupancy and other operating costs |
|
|
5.4 |
|
|
|
4.9 |
|
|
|
0.5 |
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
43.9 |
|
|
$ |
34.4 |
|
|
$ |
9.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes $3.3 million and $2.2 million of Stock Option Expense for the three months
ended June 30, 2007 and 2006, respectively. |
|
(2) |
|
Represents the full cost of manufacturing drug for use in research, preclinical
development, and clinical trials, including related payroll and benefits, Stock Option
Expense, manufacturing materials and supplies, depreciation, and occupancy costs of our
Rensselaer manufacturing facility. Includes $0.7 million and $0.4 million of Stock Option
Expense for the three months ended June 30, 2007 and 2006, respectively. |
26
Payroll and benefits increased primarily due to higher Stock Option Expense, as described
above, and higher compensation expense due, in part, to the increase in employee headcount, as
described above, and annual salary increases effective January 1, 2007. Clinical trial expenses
increased due primarily to (i) higher costs related to our ongoing Phase 1 and 2 studies of the
VEGF Trap-Eye in wet AMD, (ii) start-up costs related to our upcoming Phase 3 study of the VEGF
Trap-Eye in wet AMD, and (iii) higher rilonacept costs. Clinical manufacturing costs increased
primarily because capacity which had previously been dedicated to manufacture of a vaccine
intermediate for Merck, and whose cost had been included with Contract Manufacturing Expenses in
2006, has now been designated for, and the related costs included in, clinical manufacturing. In
addition, higher costs related to manufacturing rilonacept and preclinical and clinical supplies of
our first antibody drug candidate were partly offset by lower costs related to manufacturing VEGF
Trap. Research and preclinical development costs increased primarily due to higher costs related
to our human monoclonal antibody programs. In addition, higher preclinical development costs
related to VEGF Trap and VEGF Trap-Eye were partly offset by lower preclinical development costs
related to rilonacept.
We budget our research and development costs by expense category, rather than by project. We
also prepare estimates of research and development costs for projects in clinical development,
which include direct costs and allocations of certain costs such as indirect labor, non-cash
stock-based employee compensation expense related to stock option awards, and manufacturing and
other costs related to activities that benefit multiple projects. Our estimates of research and
development costs for clinical development programs are shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
Three months ended June 30, |
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
Project Costs |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
VEGF Trap Oncology |
|
$ |
10.0 |
|
|
$ |
10.1 |
|
|
$ |
(0.1 |
) |
VEGF Trap- Eye |
|
|
8.4 |
|
|
|
4.1 |
|
|
|
4.3 |
|
Rilonacept |
|
|
8.1 |
|
|
|
7.4 |
|
|
|
0.7 |
|
Other research programs & unallocated costs |
|
|
17.4 |
|
|
|
12.8 |
|
|
|
4.6 |
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses |
|
$ |
43.9 |
|
|
$ |
34.4 |
|
|
$ |
9.5 |
|
|
|
|
|
|
|
|
|
|
|
Drug development and approval in the United States is a multi-step process regulated by the
FDA. The process begins with discovery and preclinical evaluation, leading up to the submission of
an IND to the FDA which, if successful, allows the opportunity for study in humans, or clinical
study, of the potential new drug. Clinical development typically involves three phases of study:
Phase 1, 2 and 3. The most significant costs in clinical development are in Phase 3 clinical
trials, as they tend to be the longest and largest studies in the drug development process.
Following successful completion of Phase 3 clinical trials for a biological product, a biologics
license application (or BLA) must be submitted to, and accepted by, the FDA, and the FDA must
approve the BLA prior to commercialization of the drug. It is not uncommon for the FDA to request
additional data following its review of a BLA, which can significantly increase the drug
development timeline and expenses. We may elect either on our own, or at the request of the FDA,
to conduct further studies that are referred to as Phase 3B and 4 studies. Phase 3B studies are
initiated and either completed or substantially completed while the BLA is under FDA review. These
studies are conducted under an IND. Phase 4 studies, also referred to as post-marketing
studies, are studies that are initiated and conducted after the FDA has approved a product for
marketing. In addition, as discovery research, preclinical development, and clinical
27
programs
progress, opportunities to expand development of drug candidates into new disease indications can
emerge. We may elect to add such new disease indications to our development efforts (with the
approval of our collaborator for joint development programs), thereby extending the period in which
we will be developing a product. For example, we, and our collaborators, where applicable,
continue to explore further development of rilonacept, VEGF Trap, and VEGF Trap-Eye in different
disease indications.
There are numerous uncertainties associated with drug development, including uncertainties
related to safety and efficacy data from each phase of drug development, uncertainties related to
the enrollment and performance of clinical trials, changes in regulatory requirements, changes in
the competitive landscape affecting a product candidate, and other risks and uncertainties
described below in Item 1A, Risk Factors under Risks Related to Development of Our Product
Candidates, Regulatory and Litigation Risks, and Risks Related to Commercialization of
Products. The lengthy process of seeking FDA approvals, and subsequent compliance with applicable
statutes and regulations, require the expenditure of substantial resources. Any failure by us to
obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business.
For these reasons and due to the variability in the costs necessary to develop a product and
the uncertainties related to future indications to be studied, the estimated cost and scope of the
projects, and our ultimate ability to obtain governmental approval for commercialization, accurate
and meaningful estimates of the total cost to bring our product candidates to market are not
available. Similarly, we are currently unable to reasonably estimate if our product candidates
will generate product revenues and material net cash inflows. We submitted a BLA for our
rilonacept for the treatment of CAPS, a spectrum of rare genetic disorders, in the second quarter
of 2007. We cannot predict whether or when the commercialization of rilonacept in CAPS will result
in a material net cash inflow to the company.
Contract Manufacturing Expenses:
Contract manufacturing expenses decreased in the second quarter of 2007 compared to the same
period of 2006 due to the expiration of our manufacturing agreement with Merck in October 2006.
General and Administrative Expenses:
General and administrative expenses increased to $8.9 million in the second quarter of 2007
from $6.3 million in the same period of 2006 primarily due to (i) higher Stock Option Expense, as
described above, (ii) higher compensation expense due, in part, to increases in administrative
headcount in 2007 to support our expanded research and development activities and annual salary
increases effective January 1, 2007, (iii) higher recruitment and related costs associated with
expanding our headcount in 2007, (iv) higher fees for consultants and other professional services
on various corporate matters, and (v) marketing research and related expenses incurred in 2007 in
connection with our rilonacept and VEGF Trap-Eye programs.
28
Other Income and Expense:
Investment income increased to $6.8 million in the second quarter of 2007 from $3.7 million in
the same period of 2006 resulting primarily from higher balances of cash and marketable securities
(due, in part, to the up-front payment received from Bayer HealthCare in October 2006, as
described above, and the receipt of net proceeds from the November 2006 public offering of our
Common Stock). Interest expense was $3.0 million in the second quarter of 2007 and 2006. Interest
expense is attributable primarily to $200.0 million of convertible notes issued in October 2001,
which mature in October 2008 and bear interest at 5.5% per annum.
Six Months Ended June 30, 2007 and 2006
Net Loss:
Regeneron reported a net loss of $56.7 million, or $0.86 per share (basic and diluted), for
the first half of 2007 compared to a net loss of $44.0 million, or $0.77 per share (basic and
diluted), for the same period of 2006.
Revenues:
Revenues for the six months ended June 30, 2007 and 2006 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
(In millions) |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
Contract research & development revenue |
|
|
|
|
|
|
|
|
|
|
|
|
The sanofi-aventis Group |
|
$ |
25.3 |
|
|
$ |
28.7 |
|
|
$ |
(3.4 |
) |
Other |
|
|
4.3 |
|
|
|
0.9 |
|
|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
Total contract research &
development revenue |
|
|
29.6 |
|
|
|
29.6 |
|
|
|
|
|
Contract manufacturing revenue |
|
|
|
|
|
|
7.9 |
|
|
|
(7.9 |
) |
Technology licensing revenue |
|
|
8.4 |
|
|
|
|
|
|
|
8.4 |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
38.0 |
|
|
$ |
37.5 |
|
|
$ |
0.5 |
|
|
|
|
|
|
|
|
|
|
|
We recognize revenue from sanofi-aventis, in connection with the companies VEGF Trap
collaboration, in accordance with SAB 104 and EITF 00-21. We earn contract research and
development revenue from sanofi-aventis which, as detailed below, consists partly of reimbursement
for research and development expenses and partly of the recognition of revenue related to a total
of $105.0 million of non-refundable, up-front payments received in 2003 and 2006. Non-refundable
up-front license payments are recorded as deferred revenue and recognized over the period over
which we are obligated to perform services. We estimate our performance period based on the
specific terms of each agreement, and adjust the performance periods, if appropriate, based on the
applicable facts and circumstances.
|
|
|
|
|
|
|
|
|
Sanofi-aventis
Contract Research & Development Revenue
(In millions) |
|
Six months ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
Regeneron expense reimbursement |
|
$ |
20.8 |
|
|
$ |
22.6 |
|
Recognition of deferred revenue related to up-front payments |
|
|
4.5 |
|
|
|
6.1 |
|
|
|
|
|
|
|
|
Total |
|
$ |
25.3 |
|
|
$ |
28.7 |
|
|
|
|
|
|
|
|
29
Sanofi-aventis reimbursement of Regeneron VEGF Trap expenses decreased in the first half
of 2007 from the same period in 2006, primarily due to higher costs in 2006 related to the
Companys manufacture of VEGF Trap clinical supplies. Recognition of deferred revenue related to
sanofi-aventis up-front payments decreased in the first quarter of 2007 from the same period in
2006, due to an extension of the estimated performance period over which this deferred revenue is
being recognized. As of June 30, 2007, $65.5 million of the original $105.0 million of up-front
payments was deferred and will be recognized as revenue in future periods.
Other contract research and development revenue includes $2.3 million recognized in the first
half of 2007 related to our five-year grant from the National Institutes of Health (NIH), which we
were awarded in September 2006 as part of the NIHs Knockout Mouse Project.
Contract manufacturing revenue for the first six months of 2006 related to our long-term
manufacturing agreement with Merck, which expired in October 2006. Revenue and the related
manufacturing expense were recognized as product was shipped, after acceptance by Merck. Included
in contract manufacturing revenue in the second quarter of 2006 was $0.8 million of deferred
revenue associated with capital improvement reimbursements paid by Merck prior to commencement of
production. We do not expect to receive any further contract manufacturing revenue from Merck.
In connection with our license agreement with AstraZeneca, as described above, the $20.0
million non-refundable up-front payment, which we received in February 2007, was deferred and is
being recognized as revenue ratably over the twelve month period beginning in February 2007. In
connection with our license agreement with Astellas, as described above, the $20.0 million
non-refundable up-front payment, which we received in April 2007, was deferred and is being
recognized as revenue ratably over the twelve month period beginning in June 2007. In the first
six months of 2007, we recognized $8.4 million of technology licensing revenue related to these
agreements.
Expenses:
Total operating expenses increased to $102.2 million in the first half of 2007 from $83.4
million in the same period of 2006. Our average employee headcount in the first half of 2007
increased to 602 from 583 in the first half of 2006, primarily to support our expanded development
programs for the VEGF Trap-Eye and rilonacept and our plans to move our first antibody candidate
into clinical trials later this year. Operating expenses for the first six months of 2007 and 2006
include a total of $13.5 million and $8.5 million, respectively, of Stock Option Expense, as
detailed below:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
For the six months ended June 30, 2007 |
|
|
|
Expenses before |
|
|
|
|
|
|
|
|
|
inclusion of Stock |
|
|
Stock Option |
|
|
Expenses as |
|
Expenses |
|
Option Expense |
|
|
Expense |
|
|
Reported |
|
Research and development |
|
$ |
77.2 |
|
|
$ |
7.9 |
|
|
$ |
85.1 |
|
General and administrative |
|
|
11.5 |
|
|
|
5.6 |
|
|
|
17.1 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
88.7 |
|
|
$ |
13.5 |
|
|
$ |
102.2 |
|
|
|
|
|
|
|
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
For the six months ended June 30, 2006 |
|
|
|
Expenses before |
|
|
|
|
|
|
|
|
|
inclusion of Stock |
|
|
Stock Option |
|
|
Expenses as |
|
Expenses |
|
Option Expense |
|
|
Expense |
|
|
Reported |
|
Research and development |
|
$ |
61.9 |
|
|
$ |
4.6 |
|
|
$ |
66.5 |
|
Contract manufacturing |
|
|
4.5 |
|
|
|
0.2 |
|
|
|
4.7 |
|
General and administrative |
|
|
8.5 |
|
|
|
3.7 |
|
|
|
12.2 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
74.9 |
|
|
$ |
8.5 |
|
|
$ |
83.4 |
|
|
|
|
|
|
|
|
|
|
|
The increase in total Stock Option Expense in the first half of 2007 was primarily due to the
higher fair market value of our Common Stock on the date of our annual employee option grants made
in December 2006 in comparison to the fair market value of our Common Stock on the dates of annual
employee option grants made in recent prior years.
Research and Development Expenses:
Research and development expenses increased to $85.1 million in the first half of 2007 from
$66.5 million in the same period of 2006. The following table summarizes the major categories of
our research and development expenses for the six months ended June 30, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
Six months ended June 30, |
|
Research and development expenses |
|
2007 |
|
|
2006 |
|
|
Increase |
|
Payroll and benefits (1) |
|
$ |
28.1 |
|
|
$ |
21.7 |
|
|
$ |
6.4 |
|
Clinical trial expenses |
|
|
11.8 |
|
|
|
7.8 |
|
|
|
4.0 |
|
Clinical manufacturing costs (2) |
|
|
22.0 |
|
|
|
18.4 |
|
|
|
3.6 |
|
Research and preclinical development costs |
|
|
12.1 |
|
|
|
7.8 |
|
|
|
4.3 |
|
Occupancy and other operating costs |
|
|
11.1 |
|
|
|
10.8 |
|
|
|
0.3 |
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
85.1 |
|
|
$ |
66.5 |
|
|
$ |
18.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes $6.4 million and $3.8 million of Stock Option Expense for the six months ended
June 30, 2007 and 2006, respectively. |
|
(2) |
|
Represents the full cost of manufacturing drug for use in research, preclinical
development, and clinical trials, including related payroll and benefits, Stock Option
Expense, manufacturing materials and supplies, depreciation, and occupancy costs of our
Rensselaer manufacturing facility. Includes $1.5 million and $0.8 million of Stock Option
Expense for the six months ended June 30, 2007 and 2006, respectively. |
Payroll and benefits increased primarily due to higher Stock Option Expense, as described
above, and higher compensation expense due, in part, to the increase in employee headcount, as
described above, and annual salary increases effective January 1, 2007. Clinical trial expenses
increased due primarily to (i) higher costs related to our ongoing Phase 1 and 2 studies of the
VEGF Trap-Eye in wet AMD, (ii) start-up costs related to our upcoming Phase 3 study of the VEGF
Trap-Eye in wet AMD, and (iii) higher rilonacept costs. Clinical manufacturing costs increased
primarily because capacity which had previously been dedicated to manufacture of a vaccine
intermediate for Merck, and whose cost had been included with Contract Manufacturing Expenses in
2006, has now been designated for, and the related costs included in, clinical manufacturing.
Higher costs related to manufacturing rilonacept and preclinical and clinical supplies of our first
antibody drug candidate were offset by lower costs related to manufacturing VEGF Trap. Research
and preclinical development costs increased primarily due to higher costs related to our human
monoclonal antibody programs. In addition, higher preclinical development
31
costs related to VEGF Trap-Eye and VEGF Trap-Oncology were partly offset by lower preclinical
development costs related to rilonacept.
We budget our research and development costs by expense category, rather than by project. We
also prepare estimates of research and development cost for projects in clinical development, which
include direct costs and allocations of certain costs such as indirect labor, non-cash stock-based
employee compensation expense related to stock option awards, and manufacturing and other costs
related to activities that benefit multiple projects. Our estimates of research and development
costs for clinical development programs are shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
Six months ended June 30, |
|
|
|
|
|
|
|
|
|
|
|
Increase |
|
Project Costs |
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
VEGF Trap Oncology |
|
$ |
17.8 |
|
|
$ |
19.2 |
|
|
$ |
(1.4 |
) |
VEGF Trap- Eye |
|
|
14.2 |
|
|
|
7.8 |
|
|
|
6.4 |
|
Rilonacept |
|
|
15.9 |
|
|
|
14.3 |
|
|
|
1.6 |
|
Other research programs & unallocated costs |
|
|
37.2 |
|
|
|
25.2 |
|
|
|
12.0 |
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses |
|
$ |
85.1 |
|
|
$ |
66.5 |
|
|
$ |
18.6 |
|
|
|
|
|
|
|
|
|
|
|
For the reasons described above under Research and Development Expenses for the three
months ended June 30, 2007 and 2006, and due to the variability in the costs necessary to develop a
product and the uncertainties related to future indications to be studied, the estimated cost and
scope of the projects, and our ultimate ability to obtain governmental approval for
commercialization, accurate and meaningful estimates of the total cost to bring our product
candidates to market are not available. Similarly, we are currently unable to reasonably estimate
if our product candidates will generate product revenues and material net cash inflows.
Contract Manufacturing Expenses:
Contract manufacturing expenses decreased in the first half of 2007 compared to the same
period of 2006 due to the expiration of our manufacturing agreement with Merck in October 2006.
General and Administrative Expenses:
General and administrative expenses increased to $17.1 million in the first half of 2007 from
$12.2 million in the same period of 2006 primarily due to (i) higher Stock Option Expense, as
described above, (ii) higher compensation expense due, in part, to increases in administrative
headcount in 2007 to support our expanded research and development activities and annual salary
increases effective January 1, 2007, (iii) higher recruitment and related costs associated with
expanding our headcount in 2007, (iv) higher fees for consultants and other professional services
on various corporate matters, and (v) marketing research and related expenses incurred in 2007 in
connection with our rilonacept and VEGF Trap-Eye programs.
Other Income and Expense:
Investment income increased to $13.6 million in the first half of 2007 from $7.2 million in the
same period of 2006 resulting primarily from higher balances of cash and marketable securities
32
(due, in part, to the up-front payment received from Bayer HealthCare in October 2006, as described
above, and the receipt of net proceeds from the November 2006 public offering of our Common Stock).
Interest expense was $6.0 million in first half of 2007 and 2006. Interest expense is
attributable primarily to $200.0 million of convertible notes issued in October 2001, which mature
in October 2008 and bear interest at 5.5% per annum.
Liquidity and Capital Resources
Since our inception in 1988, we have financed our operations primarily through offerings of
our equity securities, a private placement of convertible debt, payments earned under our past and
present research and development and contract manufacturing agreements, including our agreements
with sanofi-aventis, Bayer HealthCare, and Merck, and investment income.
Six Months Ended June 30, 2007 and 2006
At June 30, 2007, we had $512.3 million in cash, cash equivalents, restricted cash, and
marketable securities, compared with $522.9 million at December 31, 2006. In connection with our
new non-exclusive license agreements with AstraZeneca and Astellas, as described above, AstraZeneca
and Astellas each made an up-front payment to us of $20.0 million in February and April 2007,
respectively.
Cash (Used in) Operations:
Net cash used in operations was $12.7 million in the first six months of 2007, compared to
$15.4 million in the first six months of 2006. Our net losses of $56.7 million in the first half
of 2007 and $44.0 million in the first half of 2006 included $13.5 million and $8.8 million,
respectively, of non-cash stock-based employee compensation costs, of which $13.5 million and $8.5
million, respectively, represented Stock Option Expense and, in the first half of 2006, $0.3
million represented non-cash compensation expense from Restricted Stock awards. At June 30, 2007,
accounts receivable balances increased by $13.0 million, compared to year end 2006, primarily due
to amounts receivable from sanofi-aventis and Bayer HealthCare for reimbursements of our VEGF
Trap-Oncology and VEGF Trap-Eye development costs, respectively. Also, our deferred revenue
balances at June 30, 2007 increased by $36.6 million, compared to year end 2006, primarily due to
the $20.0 million up-front payments received from each of AstraZeneca and Astellas, as described
above. In addition, for the first six months of 2007, reimbursements from Bayer HealthCare of our
2007 VEGF Trap-Eye development expenses, totaling $10.6 million, have been fully deferred and
included in deferred revenue for financial statement purposes, as discussed above. At June 30,
2006, accounts receivable balances decreased by $24.4 million, compared to year end 2005, primarily
due to the January 2006 receipt of a $25.0 million up-front payment from sanofi-aventis, which was
receivable at December 31, 2005, in connection with an amendment to our collaboration agreement to
include Japan. Also, our deferred revenue balances at June 30, 2006 decreased by $8.1 million,
compared to year end 2005, due primarily to first half 2006 revenue recognition of $6.1 million of
deferred revenue related to up-front payments from sanofi-aventis. The majority of our cash
expenditures in both the first half of 2007 and 2006 were to fund research and development,
primarily related to our
clinical programs and, in the first half of 2007, our preclinical human monoclonal antibody
programs.
33
Cash Used in Investing Activities:
Net cash used in investing activities was $120.3 million in the first half of 2007 compared to
$58.4 million in the same period of 2006, due primarily to an increase in purchases of marketable
securities net of sales or maturities. In the first half of 2007, purchases of marketable
securities exceeded sales or maturities by $117.3 million, whereas in the first half of 2006,
purchases of marketable securities exceeded sales or maturities by $57.4 million.
Cash Provided by Financing Activities:
Cash provided by financing activities increased to $4.8 million in the first half of 2007 from
$4.2 million in the same period in 2006 due primarily to an increase in the issuance of Common
Stock in connection with exercises of employee stock options.
License Agreements with AstraZeneca and Astellas:
Under these non-exclusive license agreements, AstraZeneca and Astellas each made a $20.0
million non-refundable, up-front payment to us in February and April 2007, respectively.
AstraZeneca and Astellas also will each make up to five additional annual payments of $20.0
million, subject to each licensees ability to terminate its license agreement with us after making
the first three additional payments or earlier if the technology does not meet minimum performance
criteria.
Capital Expenditures:
Our additions to property, plant, and equipment totaled $3.5 million and $1.0 million for the
first half of 2007 and 2006, respectively. During the remainder of 2007, we expect to incur
approximately $13 million in capital expenditures primarily to support our manufacturing,
development, and research activities.
During the second quarter of 2007, we exercised a purchase option on a building in Rensselaer,
totaling approximately 270,000 square feet, in which we currently lease approximately 75,000 square
feet of manufacturing, office and warehouse space. The acquisition of the building and related
costs are expected to approximate $10 million, which is included in our anticipated capital
expenditures for the remainder of 2007, as described above. We expect to complete the purchase of
this building in the third quarter of 2007. The space that we do not occupy in this building is
currently leased to another tenant.
Convertible Debt:
In 2001, we issued $200.0 million aggregate principal amount of convertible senior
subordinated notes, which bear interest at 5.5% per annum, payable semi-annually, and mature in
October 2008. The notes are convertible into shares of our Common Stock at a conversion price of
approximately $30.25 per share, subject to adjustment in certain circumstances. If the price per
share of our Common Stock is above $30.25 at maturity, we would expect the notes to convert into
shares of Common Stock. Otherwise, we will be required to repay the $200.0
34
million aggregate
principal amount of the notes or refinance the notes prior to maturity; however, we can provide no
assurance that we will be able to successfully arrange such refinancing.
Funding Requirements:
We expect to continue to incur substantial funding requirements primarily for research and
development activities (including preclinical and clinical testing). Before taking into account
reimbursements from collaborators, we currently anticipate that approximately 55%-65% of our
expenditures for 2007 will be directed toward the preclinical and clinical development of product
candidates, including rilonacept, VEGF Trap, VEGF Trap-Eye and monoclonal antibodies; approximately
10%-15% of our expenditures for 2007 will be applied to our basic research activities and the
continued development of our novel technology platforms; and the remainder of our expenditures for
2007 will be used for capital expenditures and general corporate purposes.
Under our collaboration with Bayer HealthCare, over the next several years we and Bayer
HealthCare are sharing agreed upon VEGF Trap-Eye development expenses incurred by both companies,
under a global development plan, as follows:
|
2007: |
|
Up to $50.0 million shared equally; we are solely responsible for up to the next $40.0
million; over $90.0 million shared equally. |
|
|
2008: |
|
Up to $70.0 million shared equally, we are solely responsible for up to the next $30.0
million; over $100.0 million shared equally. |
2009 and thereafter: All expenses shared equally.
In addition, under our collaboration agreements with sanofi-aventis and Bayer Healthcare, if
the applicable collaboration becomes profitable, we have contingent contractual obligations to
reimburse sanofi-aventis and Bayer Healthcare for 50% of agreed-upon development expenses incurred
by sanofi-aventis and Bayer Healthcare, respectively. Profitability under each collaboration will
be measured by calculating net sales less agreed-upon expenses. These reimbursements would be
deducted from our share of the collaboration profits (and, for sanofi-aventis, royalties on product
sales in Japan) otherwise payable to us unless we agree to reimburse these expenses at a faster
rate at our option. Given the uncertainties related to drug development (including the development
of the VEGF Trap-Oncology in collaboration with sanofi-aventis and the VEGF Trap-Eye in
collaboration with Bayer Healthcare) such as the variability in the length of time necessary to
develop a product candidate and the ultimate ability to obtain governmental approval for
commercialization, we are currently unable to reliably estimate if our collaborations with
sanofi-aventis and Bayer Healthcare will become profitable.
The amount we need to fund operations 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 our collaborations with sanofi-aventis and
Bayer HealthCare. Clinical trial costs are dependent, among other things, on the size and duration
of trials, fees charged for services provided by clinical trial investigators and other third
parties,
the costs for manufacturing the product candidate for use in the trials, supplies,
35
laboratory
tests, and other expenses. The amount of funding that will be required for our clinical programs
depends upon the results of our research and preclinical programs and early-stage clinical trials,
regulatory requirements, the clinical trials underway plus additional clinical trials that we
decide to initiate, and the various factors that affect the cost of each trial as described above.
In the future, if we are able to successfully develop, market, and sell certain of our product
candidates, we may be required to pay royalties or otherwise share the profits generated on such
sales in connection with our collaboration and licensing agreements.
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.
We believe that our existing capital resources will enable us to meet operating needs through
at least early 2010, without taking into consideration the $200.0 million aggregate principal
amount of convertible senior subordinated notes, which mature in October 2008. However, this is a
forward-looking statement based on our current operating plan, and there may be a 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. Other than the $1.6 million letter of credit issued to our landlord in
connection with our new operating lease for facilities in Tarrytown, New York, we have no
off-balance sheet arrangements. In addition, we do not guarantee the obligations of any other
entity. As of June 30, 2007, we had no established banking arrangements through which we could
obtain short-term financing or a line of credit. In the event we need additional financing for
the operation of our business, we will consider collaborative arrangements and additional public or
private financing, including additional equity financing. Factors influencing the availability of
additional financing include our progress in product development, investor perception of our
prospects, and the general condition of the financial markets. We may not be able to secure the
necessary funding through new collaborative arrangements or additional public or private offerings.
If we cannot raise adequate funds to satisfy our capital requirements, we may have to delay, scale
back, or eliminate certain of our research and development activities or future operations. This
could harm our business.
Critical Accounting Policies and Significant Judgments and Estimates
Revenue Recognition:
We recognize revenue from contract research and development and research progress payments in
accordance with Staff Accounting Bulletin No. 104, Revenue Recognition (SAB 104) and Emerging
Issues Task Force 00-21, Accounting for Revenue Arrangements with Multiple Deliverables (EITF
00-21). We earn contract research and development revenue and research progress payments in
connection with collaboration and other agreements to develop and commercialize product candidates
and utilize our technology platforms. The terms of these agreements typically include
non-refundable up-front licensing payments, research progress (milestone) payments, and payments
for development activities. Non-refundable up-front license payments, where continuing involvement
is required of us, are deferred and recognized over the
related performance period. We estimate our performance period based on the specific terms of
36
each agreement, and adjust the performance periods, if appropriate, based on the applicable facts
and circumstances. Payments which are based on achieving a specific substantive performance
milestone, involving a degree of risk, are recognized as revenue when the milestone is achieved and
the related payment is due and non-refundable, provided there is no future service obligation
associated with that milestone. Substantive performance milestones typically consist of
significant achievements in the development life-cycle of the related product candidate, such as
completion of clinical trials, filing for approval with regulatory agencies, and approvals by
regulatory agencies. In determining whether a payment is deemed to be a substantive performance
milestone, we take into consideration (i) the nature, timing, and value of significant achievements
in the development life-cycle of the related development product candidate, (ii) the relative
level of effort required to achieve the milestone, and (iii) the relative level of risk in
achieving the milestone, taking into account the high degree of uncertainty in successfully
advancing product candidates in a drug development program and in ultimately attaining an approved
drug product. Payments for achieving milestones which are not considered substantive are accounted
for as license payments and recognized over the related performance period. Payments for
development activities where Regeneron is not sharing costs are recognized as revenue as earned,
over the period of effort. In addition, we record revenue in connection with a government research
grant as we incur expenses related to the grant, subject to the grants terms and annual funding
approvals.
In connection with non-refundable licensing payments, our performance period estimates are
principally based on projections of the scope, progress, and results of our research and
development activities. Due to the variability in the scope of activities and length of time
necessary to develop a drug product, changes to development plans as programs progress, and
uncertainty in the ultimate requirements to obtain governmental approval for commercialization,
revisions to performance period estimates are possible, and could result in material changes to the
amount of revenue recognized each year in the future. In addition, performance periods may be
extended if we and our collaborators decide to expand our clinical plans for a drug candidate into
additional disease indications. Also, if a collaborator terminates an agreement in accordance with
the terms of the agreement, we would recognize any unamortized remainder of an up-front payment at
the time of the termination. For the year ended December 31, 2006, changes in estimates of our
performance periods, including an extension of our estimated performance period for our
collaboration with sanofi-aventis, did not have a material impact on contract research and
development revenue that we recognized. In 2007, we currently expect to recognize at least $2.4
million lower contract research and development revenue, compared to amounts recognized in 2006, in
connection with $105.0 million of non-refundable up-front payments previously received from
sanofi-aventis, due to an extension of our estimated performance period.
As described above, we and Bayer HealthCare are currently formalizing our global development
plans for the VEGF Trap-Eye in wet AMD and DME. Pending completion of these plans, all payments
received or receivable from Bayer HealthCare through June 30, 2007 have been fully deferred and
included in deferred revenue for financial statement purposes. When the plans are formalized later
this year, we will determine the appropriate accounting policy for payments from Bayer HealthCare
and the financial statement classifications and periods in which past and future payments from
Bayer (including the $75.0 million up-front payment, development and regulatory milestone payments,
and reimbursements of Regeneron development
37
expenses)
will be recognized in our Statement of Operations. In the period when we commence recognizing
previously deferred payments from Bayer HealthCare, we anticipate
recording a cumulative catch-up for the period since inception of the collaboration in October
2006, which can not be quantified at this time.
Clinical Trial Expenses:
Clinical trial costs are a significant component of research and development expenses and
include costs associated with third-party contractors. We outsource a substantial portion of our
clinical trial activities, utilizing external entities such as contract research organizations,
independent clinical investigators, and other third-party service providers to assist us with the
execution of our clinical studies. For each clinical trial that we conduct, certain clinical trial
costs are expensed immediately, while others are expensed over time based on the expected total
number of patients in the trial, the rate at which patients enter the trial, and the period over
which clinical investigators or contract research organizations are expected to provide services.
Clinical activities which relate principally to clinical sites and other administrative
functions to manage our clinical trials are performed primarily by contract research organizations
(CROs). CROs typically perform most of the start-up activities for our trials, including document
preparation, site identification, screening and preparation, pre-study visits, training, and
program management. On a budgeted basis, these start-up costs are typically 10% to 15% of the
total contract value. On an actual basis, this percentage range can be significantly wider, as
many of our contracts are either expanded or reduced in scope compared to the original budget,
while start-up costs for the particular trial may not change materially. These start-up costs
usually occur within a few months after the contract has been executed and are event driven in
nature. The remaining activities and related costs, such as patient monitoring and administration,
generally occur ratably throughout the life of the individual contract or study. In the event of
early termination of a clinical trial, we accrue and recognize expenses in an amount based on our
estimate of the remaining non-cancelable obligations associated with the winding down of the
clinical trial and/or penalties.
For clinical study sites, where payments are made periodically on a per-patient basis to the
institutions performing the clinical study, we accrue on an estimated cost-per-patient basis an
expense based on subject enrollment and activity in each quarter. The amount of clinical study
expense recognized in a quarter may vary from period to period based on the duration and progress
of the study, the activities to be performed by the sites each quarter, the required level of
patient enrollment, the rate at which patients actually enroll in and drop-out of the clinical
study, and the number of sites involved in the study. Clinical trials that bear the greatest risk
of change in estimates are typically those with a significant number of sites, require a large
number of patients, have complex patient screening requirements, and span multiple years. During
the course of a trial, we adjust our rate of clinical expense recognition if actual results differ
from our estimates. Our estimates and assumptions for clinical expense recognition could differ
significantly from our actual results, which could cause material increases or decreases in
research and development expenses in future periods when the actual results become known. No
material adjustments to our past clinical trial accrual estimates were made during the year ended
December 31, 2006 or the six months ended June 30, 2007.
38
During the three months ended June 30, 2007, there were no changes to any other Critical
Accounting Policies and Significant Judgments and Estimates described in our Annual Report on Form
10-K for the year ended December 31, 2006.
Future Impact of Recently Issued Accounting Standards
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. (SFAS) 159, The Fair Value Option for Financial Assets and
Financial Liabilities. SFAS 159 permits entities to choose to measure many financial instruments
and certain other items at fair value. The objective is to improve financial reporting by
providing entities with the opportunity to mitigate volatility in reported earnings caused by
measuring related assets and liabilities differently without having to apply complex hedge
accounting provisions. SFAS 159 is effective for financial statements issued for fiscal years
beginning after November 15, 2007. We will be required to adopt SFAS 159 effective for the fiscal
year beginning January 1, 2008. Our management is currently evaluating the potential impact of
adopting SFAS 159 on our financial statements.
In June 2007, the Emerging Issues Task Force issued Statement No. 07-3, Accounting for
Non-refundable Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities (EITF 07-3). EITF 07-3 addresses how entities involved in research and development
activities should account for the non-refundable portion of an advance payment made for future
research and development activities and requires that such payments be deferred and capitalized,
and recognized as an expense when the goods are delivered or the related services are performed.
EITF 07-3 is effective for fiscal years beginning after December 15, 2007, including interim
periods within those fiscal years. We will be required to adopt EITF 07-3 effective for the fiscal
year beginning January 1, 2008. Our management believes that the future adoption of EITF 07-3 will
not have a material impact on our financial statements.
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. We estimated that a one percent change in interest rates would result in
approximately a $2.0 million and $0.9 million change in the fair market value of our investment
portfolio at June 30, 2007 and 2006, respectively. The increase in the potential impact of an
interest rate change at June 30, 2007, compared to June 30, 2006, is due primarily to increases in
our investment portfolios balance and duration at the end of June 2007 versus June 2006.
Item 4. Controls and Procedures
Our management, with the participation of our chief executive officer and chief financial
officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as
such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934
(the Exchange Act)), as of the end of the period covered by this report. Based on this
evaluation, our chief executive officer and chief financial officer each concluded that, as of the
39
end
of such period, our disclosure controls and procedures were effective in ensuring that
information required to be disclosed by us in the reports that we file or submit under the Exchange
Act is recorded, processed, summarized, and reported within the time periods specified in
applicable rules and forms of the Securities and Exchange Commission, and is accumulated and
communicated to our management, including our chief executive officer and chief financial officer,
as appropriate to allow timely decisions regarding required disclosure.
There has been no change in our internal control over financial reporting (as such term is
defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 30,
2007 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we are a party to legal proceedings in the course of our business. We do
not expect any such current legal proceedings to have a material adverse effect on our business or
financial condition.
Item 1A. Risk Factors
We operate in an environment that involves a number of significant risks and uncertainties. We
caution you to read the following risk factors, which have affected, and/or in the future could
affect, our business, operating results, financial condition, and cash flows. The risks described
below include forward-looking statements, and actual events and our actual results may differ
substantially from those discussed in these forward-looking statements. Additional risks and
uncertainties not currently known to us or that we currently deem immaterial may also impair our
business operations. Furthermore, additional risks and uncertainties are described under other
captions in this report and in our Annual Report on Form 10-K for the year ended December 31, 2006
and should be considered by our investors.
Risks Related to Our Financial Results and Need for Additional Financing
We have had a history of operating losses and we may never achieve profitability. If we continue to
incur operating losses, we may be unable to continue our operations.
From inception on January 8, 1988 through June 30, 2007, we had a cumulative loss of $744.3
million. If we continue to incur operating losses and fail to become a profitable company, we may
be unable to continue our operations. We have no products that are available for sale and do not
know when we will have products available for sale, if ever. In the absence of revenue from the
sale of products 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.
40
We will need additional funding in the future, which may not be available to us, and which may
force us to delay, reduce or eliminate our product development programs or commercialization
efforts.
We will need to expend substantial resources for research and development, including costs
associated with clinical testing of our product candidates. We believe our existing capital
resources will enable us to meet operating needs through at least early 2010, without taking into
consideration the $200.0 million aggregate principal amount of convertible senior subordinated
notes, which mature in October 2008; however, our projected revenue may decrease or our expenses
may increase and that would lead to our capital being consumed significantly before such time. We
will likely require additional financing in the future and we may not be able to raise such
additional funds. If we are able to obtain additional financing through the sale of equity or
convertible debt securities, such sales may be dilutive to our shareholders. Debt financing
arrangements may require us to pledge certain assets or enter into covenants that would restrict
our business activities or our ability to incur further indebtedness and may contain other terms
that are not favorable to our shareholders. If we are unable to raise sufficient funds to complete
the development of our product candidates, we may face delay, reduction or elimination of our
research and development programs or preclinical or clinical trials, in which case our business,
financial condition or results of operations may be materially harmed.
We have a significant amount of debt and may have insufficient cash to satisfy our debt service and
repayment obligations. In addition, the amount of our debt could impede our operations and
flexibility.
We have a significant amount of convertible debt and semi-annual interest payment obligations.
This debt, unless converted to shares of our common stock, will mature in October 2008. We may be
unable to generate sufficient cash flow or otherwise obtain funds necessary to make required
payments on our debt. Even if we are able to meet our debt service obligations, the amount of debt
we already have could hurt our ability to obtain any necessary financing in the future for working
capital, capital expenditures, debt service requirements, or other purposes. In addition, our debt
obligations could require us to use a substantial portion of cash to pay principal and interest on
our debt, instead of applying those funds to other purposes, such as research and development,
working capital, and capital expenditures.
Risks Related to Development of Our Product Candidates
Successful development of any of our product candidates is highly uncertain.
Only a small minority of all research and development programs ultimately result in
commercially successful drugs. We have never developed a drug that has been approved for marketing
and sale, and we may never succeed in developing an approved drug. Even if clinical trials
demonstrate safety and effectiveness of any of our product candidates for a specific disease and
the necessary regulatory approvals are obtained, the commercial success of any of our product
candidates will depend upon their acceptance by patients, the medical community, and third-party
payers and on our partners ability to successfully manufacture and commercialize our product
candidates. Our product candidates are delivered either by intravenous infusion or by intravitreal
or subcutaneous injections, which are generally less well received by patients than
41
tablet or capsule delivery. If our products are not successfully commercialized, we will not
be able to recover the significant investment we have made in developing such products and our
business would be severely harmed.
We are studying our lead product candidates, the VEGF Trap, VEGF Trap-Eye, and rilonacept, in
a wide variety of indications. We are studying the VEGF Trap in a variety of cancer settings, the
VEGF Trap-Eye in different eye diseases and ophthalmologic indications, and rilonacept in a variety
of systemic inflammatory disorders. Many of these current trials are exploratory studies designed
to identify what diseases and uses, if any, are best suited for our product candidates. It is
likely that our product candidates will not demonstrate the requisite efficacy and/or safety
profile to support continued development for most of the indications that are to be studied. In
fact, our product candidates may not demonstrate the requisite efficacy and safety profile to
support the continued development for any of the indications or uses.
Clinical trials required for our product candidates are expensive and time-consuming, and their
outcome is highly uncertain. If any of our drug trials are delayed or achieve unfavorable results,
we will have to delay or may be unable to obtain regulatory approval for our product candidates.
We must conduct extensive testing of our product candidates before we can obtain regulatory
approval to market and sell them. We need to conduct both preclinical animal testing and human
clinical trials. Conducting these trials is a lengthy, time-consuming, and expensive process. These
tests and trials may not achieve favorable results for many reasons, including, among others,
failure of the product candidate to demonstrate safety or efficacy, the development of serious or
life-threatening adverse events (or side effects) caused by or connected with exposure to the
product candidate, difficulty in enrolling and maintaining subjects in the clinical trial, lack of
sufficient supplies of the product candidate or comparator drug, and the failure of clinical
investigators, trial monitors and other consultants, or trial subjects to comply with the trial
plan or protocol. A clinical trial may fail because it did not include a sufficient number of
patients to detect the endpoint being measured or reach statistical significance. A clinical trial
may also fail because the dose(s) of the investigational drug included in the trial were either too
low or too high to determine the optimal effect of the investigational drug in the disease setting.
For example, we are studying higher doses of rilonacept in different diseases after a Phase 2
trial using lower doses of rilonacept in subjects with rheumatoid arthritis failed to achieve its
primary endpoint.
We will need to reevaluate any drug candidate that does not test favorably and either conduct
new trials, which are expensive and time consuming, or abandon the drug development program. Even
if we obtain positive results from preclinical or clinical trials, we may not achieve the same
success in future trials. Many companies in the biopharmaceutical industry, including us, have
suffered significant setbacks in clinical trials, even after promising results have been obtained
in earlier trials. The failure of clinical trials to demonstrate safety and effectiveness for the
desired indication(s) could harm the development of the product candidate(s), and our business,
financial condition, and results of operations may be materially harmed.
42
The data from the Phase 3 clinical program for rilonacept in CAPS (Cryopyrin Associated Periodic
Syndromes) may be inadequate to support regulatory approval for commercialization of rilonacept.
We recently submitted a BLA to the FDA for rilonacept in CAPS. However, the efficacy and safety data from
the Phase 3 clinical program included in the BLA may be inadequate to support approval for
commercialization of rilonacept. The FDA and other regulatory agencies may have varying
interpretations of our clinical trial data, which could delay, limit, or prevent regulatory
approval or clearance.
Further, before a product candidate is approved for marketing, our manufacturing facilities
must be inspected by the FDA and the FDA will not approve the product for marketing if we or our
third party manufacturers are not in compliance with current good manufacturing practices. Even if
the FDA and similar foreign regulatory authorities do grant marketing approval for rilonacept, they
may pose restrictions on the use or marketing of the product, or may require us to conduct
additional post-marketing trials. These restrictions and requirements would likely result in
increased expenditures and lower revenues and may restrict our ability to commercialize rilonacept
profitably.
In addition to the FDA and other regulatory agency regulations in the United States, we are
subject to a variety of foreign regulatory requirements governing human clinical trials, marketing
and approval for drugs, and commercial sales and distribution of drugs in foreign countries. The
foreign regulatory approval process includes all of the risks associated with FDA approval as well
as country-specific regulations. Whether or not we obtain FDA approval for a product in the United
States, we must obtain approval by the comparable regulatory authorities of foreign countries
before we can commence clinical trials or marketing of rilonacept in those countries.
The development of serious or life-threatening side effects with any of our product candidates
would lead to delay or discontinuation of development, which could severely harm our business.
During the conduct of clinical trials, patients report changes in their health, including
illnesses, injuries, and discomforts, to their study doctor. Often, it is not possible to determine
whether or not the drug candidate being studied caused these conditions. Various illnesses,
injuries, and discomforts have been reported from time-to-time during clinical trials of our
product candidates. Although our current drug candidates appeared to be generally well tolerated in
clinical trials conducted to date, it is possible as we test any of them in larger, longer, and
more extensive clinical programs, illnesses, injuries, and discomforts that were observed in
earlier trials, as well as conditions that did not occur or went undetected in smaller previous
trials, will be reported by patients. Many times, side effects are only detectable after
investigational drugs are tested in large scale, Phase 3 clinical trials or, in some cases, after
they are made available to patients after approval. If additional clinical experience indicates
that any of our product candidates has many side effects or causes serious or life-threatening side
effects, the development of the product candidate may fail or be delayed, which would severely harm
our business.
43
Our VEGF Trap is being studied for the potential treatment of certain types of cancer and our
VEGF Trap-Eye candidate is being studied in diseases of the eye. There are many potential safety
concerns associated with significant blockade of vascular endothelial growth factor, or VEGF.
These risks, based on the clinical and preclinical experience of systemically delivered VEGF
inhibitors, including the systemic delivery of the VEGF Trap, include bleeding, hypertension, and
proteinuria. These serious side effects and other serious side effects have been reported in our
systemic VEGF Trap studies in cancer and diseases of the eye. In addition, patients given infusions
of any protein, including the VEGF Trap delivered through intravenous administration, may develop
severe hypersensitivity reactions or infusion reactions. Other VEGF blockers have reported side
effects that became evident only after large scale trials or after marketing approval and large
number of patients were treated. These include side effects that we have not yet seen in our
trials such as heart attack and stroke. These and other complications or side effects could harm
the development of the VEGF Trap for the treatment of cancer or the VEGF Trap-Eye for the treatment
of diseases of the eye.
It is possible that safety or tolerability concerns may arise as we continue to test
rilonacept in patients with inflammatory diseases and disorders. Like cytokine antagonists such as
Kineret® (Amgen Inc.), EnbrelÒ (Immunex Corporation), and
RemicadeÒ (Centocor, Inc.), rilonacept affects the immune defense system of the
body by blocking some of its functions. Therefore, rilonacept may interfere with the bodys
ability to fight infections. Treatment with Kineret® (Amgen), a medication that works
through the inhibition of IL-1, has been associated with an increased risk of serious infections,
and serious infections have been reported in patients taking rilonacept. One subject with adult
Stills diseases in a study of rilonacept developed an infection in his elbow with mycobacterium
intracellulare. The patient was on chronic glucocorticoid treatment for Stills disease. The
infection occurred after an intraarticular glucocorticoid injection into the elbow and subsequent
local exposure to a suspected source of mycobacteria. One patient with polymayalgia rheumatica in
another study developed bronchitis/sinusitis, which resulted in hospitalization. One patient in an
open-label study of rilonacept in CAPS developed sinusitis and streptococcus pneumoniae meningitis
and subsequently died. In addition, patients given infusions of rilonacept have developed
hypersensitivity reactions or infusion reactions. These or other complications or side effects
could impede or result in us abandoning the development of rilonacept.
Our product candidates in development are recombinant proteins that could cause an immune response,
resulting in the creation of harmful or neutralizing antibodies against the therapeutic protein.
In addition to the safety, efficacy, manufacturing, and regulatory hurdles faced by our
product 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 patients own proteins, resulting in an auto-immune type disease. Whether antibodies
will be created can often not be predicted from preclinical or clinical experiments, and their
detection or appearance is often delayed, so that there can be no assurance that neutralizing
antibodies will not be detected at a later date in some cases even after pivotal clinical trials
have been completed. Of the clinical study subjects who received rilonacept for rheumatoid
arthritis and other
44
indications, fewer than
5% of patients developed antibodies and no side effects related to antibodies were observed.
Using a very sensitive test, approximately 40% of the patients in the CAPS pivotal study tested
positive at least once for low levels of antibodies to rilonacept. Again, no side effects related
to antibodies were observed and there were no observed effects on drug efficacy or drug levels.
However, it is possible that as we continue to test the VEGF Trap and VEGF Trap-Eye with more
sensitive assays in different patient populations and larger clinical trials, we will find that
subjects given the VEGF Trap and VEGF Trap-Eye develop antibodies to these product candidates, and
may also experience side effects related to the antibodies, which could adversely impact the
development of such candidates.
We may be unable to formulate or manufacture our product candidates in a way that is suitable for
clinical or commercial use.
Changes in product formulations and manufacturing processes may be required as product
candidates progress in clinical development and are ultimately commercialized. For example, we are
currently testing a new formulation of the VEGF Trap-Eye in a Phase 1 Trial. If we are unable to
develop suitable product formulations or manufacturing processes to support large scale clinical
testing of our product candidates, including the VEGF Trap, VEGF Trap-Eye, and rilonacept, we may
be unable to supply necessary materials for our clinical trials, which would delay the development
of our product candidates. Similarly, if we are unable to supply sufficient quantities of our
product or develop product formulations suitable for commercial use, we will not be able to
successfully commercialize our product candidates.
Risks Related to Intellectual Property
If we cannot protect the confidentiality of our trade secrets or our patents are insufficient to
protect our proprietary rights, our business and competitive position will be harmed.
Our business requires using sensitive and proprietary technology and other information that we
protect as trade secrets. We seek to prevent improper disclosure of these trade secrets through
confidentiality agreements. If our trade secrets are improperly exposed, either by our own
employees or our collaborators, it would help our competitors and adversely affect our business. We
will be able to protect our proprietary rights from unauthorized use by third parties only to the
extent that our rights are covered by valid and enforceable patents or are effectively maintained
as trade secrets. The patent position of biotechnology companies involves complex legal and factual
questions and, therefore, enforceability cannot be predicted with certainty. Our patents may be
challenged, invalidated, or circumvented. Patent applications filed outside the United States may
be challenged by third parties who file an opposition. Such opposition proceedings are increasingly
common in the European Union and are costly to defend. We have patent applications that are being
opposed and it is likely that we will need to defend additional patent applications in the future.
Our patent rights may not provide us with a proprietary position or competitive advantages against
competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our
intellectual property rights can be extremely expensive and time consuming.
45
We may be restricted in our development and/or commercialization activities by, and could be
subject to damage awards if we are found to have infringed, third party patents or other
proprietary rights.
Our commercial success depends significantly on our ability to operate without infringing the
patents and other proprietary rights of third parties. Other parties may allege that they have
blocking patents to our products in clinical development, either because they claim to hold
proprietary rights to the composition of a product or the way it is manufactured or used.
Moreover, other parties may allege that they have blocking patents to antibody products made using
our VelocImmune technology, either because of the way the antibodies are discovered or produced or
because of a proprietary position covering an antibody or the antibodys target.
We are aware of patents and pending applications owned by Genentech that claim certain
chimeric VEGF receptor compositions. Although we do not believe that the VEGF Trap or VEGF
Trap-Eye infringes any valid claim in these patents or patent applications, Genentech could
initiate a lawsuit for patent infringement and assert its patents are valid and cover the VEGF Trap
or VEGF Trap-Eye. Genentech may be motivated to initiate such a lawsuit at some point in an effort
to impair our ability to develop and sell the VEGF Trap or VEGF Trap-Eye, which represents a
potential competitive threat to Genentechs VEGF-binding products and product candidates. An
adverse determination by a court in any such potential patent litigation would likely materially
harm our business by requiring us to seek a license, which may not be available, or resulting in
our inability to manufacture, develop and sell the VEGF Trap or VEGF Trap-Eye or in a damage award.
Any patent holders could sue us for damages and seek to prevent us from manufacturing,
selling, or developing our drug candidates, and a court may find that we are infringing validly
issued patents of third parties. In the event that the manufacture, use, or sale of any of our
clinical candidates infringes on the patents or violates other proprietary rights of third parties,
we may be prevented from pursuing product development, manufacturing, and commercialization of our
drugs and may be required to pay costly damages. Such a result may materially harm our business,
financial condition, and results of operations. Legal disputes are likely to be costly and time
consuming to defend.
We seek to obtain licenses to patents when, in our judgment, such licenses are needed. If any
licenses are required, we may not be able to obtain such licenses on commercially reasonable terms,
if at all. The failure to obtain any such license could prevent us from developing or
commercializing any one or more of our product candidates, which could severely harm our business.
Regulatory and Litigation Risks
If we do not obtain regulatory approval for our product candidates, we will not be able to market
or sell them.
We cannot sell or market products without regulatory approval. If we do not obtain and
maintain regulatory approval for our product candidates, the value of our company and our results
of operations will be harmed. In the United States, we must obtain and maintain approval
46
from the United States Food and Drug Administration (FDA) for each drug we intend to sell.
Obtaining FDA approval is typically a lengthy and expensive process, and approval is highly
uncertain. Foreign governments also regulate drugs distributed in their country and approval in any
country is likely to be a lengthy and expensive process, and approval is highly uncertain. None of
our product candidates has ever received regulatory approval to be marketed and sold in the United
States or any other country. We may never receive regulatory approval for any of our product
candidates.
Before approving a new drug or biologic product, the FDA requires that the facilities at which
the product will be manufactured be in compliance with current good manufacturing practices, or
cGMP requirements. Manufacturing product candidates in compliance with these regulatory
requirements is complex, time-consuming, and expensive. To be successful, our products must be
manufactured for development, following approval, in commercial quantities, in compliance with
regulatory requirements, and at competitive costs. If we or any of our product collaborators or
third-party manufacturers, product packagers, or labelers are unable to maintain regulatory
compliance, the FDA can impose regulatory sanctions, including, among other things, refusal to
approve a pending application for a new drug or biologic product, or revocation of a pre-existing
approval. As a result, our business, financial condition, and results of operations may be
materially harmed.
If the testing or use of our products harms people, we could be subject to costly and damaging
product liability claims. We could also face costly and damaging claims arising from employment
law, securities law, environmental law, or other applicable laws governing our operations.
The testing, manufacturing, marketing, and sale of drugs for use in people expose us to
product liability risk. Any informed consent or waivers obtained from people who sign up for our
clinical trials may not protect us from liability or the cost of litigation. Our product liability
insurance may not cover all potential liabilities or may not completely cover any liability arising
from any such litigation. Moreover, we may not have access to liability insurance or be able to
maintain our insurance on acceptable terms.
Our operations may involve hazardous materials and are subject to environmental, health, and safety
laws and regulations. We may incur substantial liability arising from our activities involving the
use of hazardous materials.
As a biopharmaceutical company with significant manufacturing operations, we are subject to
extensive environmental, health, and safety laws and regulations, including those governing the use
of hazardous materials. Our research and development and manufacturing activities involve the
controlled use of chemicals, viruses, radioactive compounds, and other hazardous materials. The
cost of compliance with environmental, health, and safety regulations is substantial. If an
accident involving these materials or an environmental discharge were to occur, we could be held
liable for any resulting damages, or face regulatory actions, which could exceed our resources or
insurance coverage.
Changes in the securities laws and regulations have increased, and are likely to continue to
increase, our costs.
47
The Sarbanes-Oxley Act of 2002, which became law in July 2002, has required changes in some of
our corporate governance, securities disclosure and compliance practices. In response to the
requirements of that Act, the SEC and the NASDAQ Stock Market have promulgated new rules and
listing standards covering a variety of subjects. Compliance with these new rules and listing
standards has increased our legal costs, and significantly increased our accounting and auditing
costs, and we expect these costs to continue. These developments may make it more difficult and
more expensive for us to obtain directors and officers liability insurance. Likewise, these
developments may make it more difficult for us to attract and retain qualified members of our board
of directors, particularly independent directors, or qualified executive officers.
In future years, if we or our independent registered public accounting firm are unable to conclude
that our internal control over financial reporting is effective, the market value of our common
stock could be adversely affected.
As directed by Section 404 of the Sarbanes-Oxley Act of 2002, the SEC adopted rules requiring
public companies to include a report of management on the Companys internal control over financial
reporting in their annual reports on Form 10-K that contains an assessment by management of the
effectiveness of our internal control over financial reporting. In addition, the independent
registered public accounting firm auditing our financial statements must attest to and report on
managements assessment and on the effectiveness of our internal control over financial reporting.
Our independent registered public accounting firm provided us with an unqualified report as to our
assessment and the effectiveness of our internal control over financial reporting as of December
31, 2006, which report was included in our Annual Report on Form 10-K. However, we cannot assure
you that management or our independent registered public accounting firm will be able to provide
such an assessment or unqualified report as of future year-ends. In this event, investors could
lose confidence in the reliability of our financial statements, which could result in a decrease in
the market value of our common stock. In addition, if it is determined that deficiencies in the
design or operation of internal controls exist and that they are reasonably likely to adversely
affect our ability to record, process, summarize, and report financial information, we would likely
incur additional costs to remediate these deficiencies and the costs of such remediation could be
material.
Risks Related to Our Dependence on Third Parties
If our collaboration with sanofi-aventis for the VEGF Trap is terminated, our business operations
and our ability to develop, manufacture, and commercialize the VEGF Trap in the time expected, or
at all, would be harmed.
We rely heavily on sanofi-aventis to assist with the development of the VEGF Trap oncology
program. Sanofi-aventis funds all of the development expenses incurred by both companies in
connection with the VEGF Trap oncology program. If the VEGF Trap oncology program continues, we
will rely on sanofi-aventis to assist with funding the VEGF Trap program, provide commercial
manufacturing capacity, enroll and monitor clinical trials, obtain regulatory approval,
particularly outside the United States, and provide sales and marketing support. While we cannot
assure you that the VEGF Trap will ever be successfully developed and commercialized, if
sanofi-aventis does not perform its obligations in a timely manner, or at all, our ability to
48
develop,
manufacture, and commercialize the VEGF Trap in cancer indications will be significantly
adversely affected. Sanofi-aventis has the right to terminate its collaboration agreement with us
at any time upon twelve months advance notice. If sanofi-aventis were to terminate its
collaboration agreement with us, we would not have the resources or skills to replace those of our
partner, which could cause significant delays in the development and/or manufacture of the VEGF
Trap and result in substantial additional costs to us. We have no sales, marketing, or distribution
capabilities and would have to develop or outsource these capabilities. Termination of the
sanofi-aventis collaboration agreement would create substantial new and additional risks to the
successful development of the VEGF Trap oncology program.
If our collaboration with Bayer HealthCare for the VEGF Trap-Eye is terminated, our business
operations and our ability to develop, manufacture, and commercialize the VEGF Trap-Eye in the time
expected, or at all, would be harmed.
We rely heavily on Bayer HealthCare to assist with the development of the VEGF Trap-Eye. Under
our agreement with them, Bayer HealthCare is required to fund approximately half of the development
expenses incurred by both companies in connection with the global VEGF Trap-Eye development
program. If the VEGF Trap-Eye program continues, we will rely on Bayer HealthCare to assist with
funding the VEGF Trap-Eye development program, provide assistance with the enrollment and
monitoring of clinical trials conducted outside the United States, obtaining regulatory approval
outside the United States, and provide sales, marketing and commercial support for the product
outside the United States. In particular, Bayer HealthCare has responsibility for selling VEGF
Trap-Eye outside the United States using its sales force. While we cannot assure you that the VEGF
Trap-Eye will ever be successfully developed and commercialized, if Bayer HealthCare does not
perform its obligations in a timely manner, or at all, our ability to develop, manufacture, and
commercialize the VEGF Trap-Eye outside the United States will be significantly adversely affected.
Bayer HealthCare has the right to terminate its collaboration agreement with us at any time upon
six or twelve months advance notice, depending on the circumstances giving rise to termination. If
Bayer HealthCare were to terminate its collaboration agreement with us, we would not have the
resources or skills to replace those of our partner, which could cause significant delays in the
development and/or commercialization of the VEGF Trap-Eye outside the United States and result in
substantial additional costs to us. We have no sales, marketing, or distribution capabilities and
would have to develop or outsource these capabilities outside the United States. Termination of the
Bayer HealthCare collaboration agreement would create substantial new and additional risks to the
successful development of the VEGF Trap-Eye development program.
Our collaborators and service providers may fail to perform adequately in their efforts to support
the development, manufacture, and commercialization of our drug candidates.
We depend upon third-party collaborators, including sanofi-aventis, Bayer HealthCare, and
service providers such as clinical research organizations, outside testing laboratories, clinical
investigator sites, and third-party manufacturers and product packagers and labelers, to assist us
in the development of our product candidates. If any of our existing collaborators or service
providers breaches or terminates its agreement with us or does not perform its development or
manufacturing services under an agreement in a timely manner or at all, we could experience
49
additional costs, delays, and difficulties in the development or ultimate commercialization of
our product candidates.
Risks Related to the Manufacture of Our Product Candidates
We have limited manufacturing capacity, which could inhibit our ability to successfully develop or
commercialize our drugs.
Our manufacturing facility is likely to be inadequate to produce sufficient quantities of
product for commercial sale. We intend to rely on our corporate collaborators, as well as contract
manufacturers, to produce the large quantities of drug material needed for commercialization of our
products. We rely entirely on third-party manufacturers for filling and finishing services. We will
have to depend on these manufacturers to deliver material on a timely basis and to comply with
regulatory requirements. If we are unable to supply sufficient material on acceptable terms, or if
we should encounter delays or difficulties in our relationships with our corporate collaborators or
contract manufacturers, our business, financial condition, and results of operations may be
materially harmed.
We may expand our own manufacturing capacity to support commercial production of active
pharmaceutical ingredients, or API, for our product candidates. This will require substantial
additional funds, and we will need to hire and train significant numbers of employees and
managerial personnel to staff our facility. Start-up costs can be large and scale-up entails
significant risks related to process development and manufacturing yields. We may be unable to
develop manufacturing facilities that are sufficient to produce drug material for clinical trials
or commercial use. In addition, we may be unable to secure adequate filling and finishing services
to support our products. As a result, our business, financial condition, and results of operations
may be materially harmed.
We may be unable to obtain key raw materials and supplies for the manufacture of our product
candidates. In addition, we may face difficulties in developing or acquiring production technology
and managerial personnel to manufacture sufficient quantities of our product candidates at
reasonable costs and in compliance with applicable quality assurance and environmental regulations
and governmental permitting requirements.
If any of our clinical programs are discontinued, we may face costs related to the unused capacity
at our manufacturing facilities.
We have large-scale manufacturing operations in Rensselaer, New York. We use our facilities to
produce bulk product for clinical and preclinical candidates for ourselves and our collaborations.
If our clinical candidates are discontinued, we will have to absorb one hundred percent of related
overhead costs and inefficiencies.
Certain of our raw materials are single-sourced from third parties; third-party supply failures
could adversely affect our ability to supply our products.
Certain raw materials necessary for manufacturing and formulation of our product candidates
are provided by single-source unaffiliated third-party suppliers. We would be unable to obtain
50
these raw materials for an indeterminate period of time if these third-party single-source
suppliers were to cease or interrupt production or otherwise fail to supply these materials or
products to us for any reason, including due to regulatory requirements or action, due to adverse
financial developments at or affecting the supplier, or due to labor shortages or disputes. This,
in turn, could materially and adversely affect our ability to manufacture our product candidates
for use in clinical trials, which could materially and adversely affect our business and future
prospects.
Also, certain of the raw materials required in the manufacturing and the formulation of our
clinical candidates may be derived from biological sources, including mammalian tissues, bovine
serum, and human serum albumin. There are certain European regulatory restrictions on using these
biological source materials. If we are required to substitute for these sources to comply with
European regulatory requirements, our clinical development activities may be delayed or
interrupted.
Risks Related to Commercialization of Products
If we are unable to establish sales, marketing, and distribution capabilities, or enter into
agreements with third parties to do so, we will be unable to successfully market and sell future
products.
We have no sales or distribution personnel or capabilities and have only a small staff with
marketing capabilities. If we are unable to obtain those capabilities, either by developing our own
organizations or entering into agreements with service providers, we will not be able to
successfully sell any products that we may obtain regulatory approval for and bring to market in
the future. In that event, we will not be able to generate significant revenue, even if our product
candidates are approved. We cannot guarantee that we will be able to hire the qualified sales and
marketing personnel we need or that we will be able to enter into marketing or distribution
agreements with third-party providers on acceptable terms, if at all. Under the terms of our
collaboration agreement with sanofi-aventis, we currently rely on sanofi-aventis for sales,
marketing, and distribution of the VEGF Trap in cancer indications, should it be approved in the
future by regulatory authorities for marketing. We will have to rely on a third party or devote
significant resources to develop our own sales, marketing, and distribution capabilities for our
other product candidates, including the VEGF Trap-Eye in the United States, and we may be
unsuccessful in developing our own sales, marketing, and distribution organization.
Even if our product candidates are approved for marketing, their commercial success is highly
uncertain because our competitors have received approval for products with the same mechanism of
action, and competitors may get to the marketplace before we do with better or lower cost drugs or
the market for our product candidates may be too small to support commercialization or sufficient
profitability.
There is substantial competition in the biotechnology and pharmaceutical industries from
pharmaceutical, biotechnology, and chemical companies. Many of our competitors have substantially
greater research, preclinical and clinical product development and manufacturing capabilities, and
financial, marketing, and human resources than we do. Our smaller competitors may also enhance
their competitive position if they acquire or discover patentable inventions,
51
form collaborative
arrangements, or merge with large pharmaceutical companies. Even if we achieve
product commercialization, our competitors have achieved, and may continue to achieve, product
commercialization before our products are approved for marketing and sale.
Genentech has an approved VEGF antagonist, Avastin® (Genentech), on the market for
treating certain cancers and many different pharmaceutical and biotechnology companies are working
to develop competing VEGF antagonists, including Novartis, OSI Pharmaceuticals, and Pfizer. Many of
these molecules are farther along in development than the VEGF Trap and may offer competitive
advantages over our molecule. Novartis has an ongoing Phase 3 clinical development program
evaluating an orally delivered VEGF tyrosine kinase inhibitor in different cancer settings. Each
of Pfizer and Onyx Pharmaceuticals (together with its partner Bayer HealthCare) has received
approval from the FDA to market and sell an oral medication that targets tumor cell growth and new
vasculature formation that fuels the growth of tumors. The marketing approvals for Genentechs
VEGF antagonist, Avastin® (Genentech), and their extensive, ongoing clinical development
plan for Avastin® (Genentech) in other cancer indications, may make it more difficult
for us to enroll patients in clinical trials to support the VEGF Trap and to obtain regulatory
approval of the VEGF Trap in these cancer settings. This may delay or impair our ability to
successfully develop and commercialize the VEGF Trap. In addition, even if the VEGF Trap is ever
approved for sale for the treatment of certain cancers, it will be difficult for our drug to
compete against Avastin® (Genentech) and the FDA approved kinase inhibitors, because
doctors and patients will have significant experience using these medicines. In addition, an oral
medication may be considerably less expensive for patients than a biologic medication, providing a
competitive advantage to companies that market such products.
The market for eye disease products is also very competitive. Novartis and Genentech are
collaborating on the commercialization and further development of a VEGF antibody fragment
(Lucentis®) for the treatment of age-related macular degeneration (wet AMD) and other
eye indications that was approved by the FDA in June 2006. OSI Pharmaceuticals and Pfizer are
marketing an approved VEGF inhibitor for wet AMD. Many other companies are working on the
development of product candidates for the potential treatment of wet AMD that act by blocking VEGF,
VEGF receptors, and through the use of soluble ribonucleic acids (sRNAs) that modulate gene
expression. In addition, ophthalmologists are using off-label a third-party reformatted version of
Genentechs approved VEGF antagonist, Avastin®, with success for the treatment of wet
AMD. The National Eye Institute recently has received funding for a Phase 3 trial to compare
Lucentis® (Genentech) to Avastin® (Genentech) in the treatment of wet AMD.
The marketing approval of Lucentis® (Genentech) and the potential off-label use of
Avastin® (Genentech) make it more difficult for us to enroll patients in our clinical
trials and successfully develop the VEGF Trap-Eye. Even if the VEGF Trap-Eye is ever approved for
sale for the treatment of eye diseases, it may be difficult for our drug to compete against
Lucentis® (Genentech), because doctors and patients will have significant experience
using this medicine. Moreover, the relatively low cost of therapy with Avastin®
(Genentech) in patients with wet AMD presents a further competitive challenge in this indication.
The availability of highly effective FDA approved TNF-antagonists such as Enbrel®
(Immunex), Remicade® (Centocor), and Humira® (Abbott Biotechnology Ltd.), and
the IL-1 receptor antagonist Kineret® (Amgen), and other marketed therapies makes it
more difficult to successfully develop and commercialize rilonacept. This is one of the reasons we
discontinued
52
the development of rilonacept in adult rheumatoid arthritis. In addition, even if
rilonacept is ever
approved for sale, it will be difficult for our drug to compete against these FDA approved
TNF-antagonists in indications where both are useful because doctors and patients will have
significant experience using these effective medicines. Moreover, in such indications these
approved therapeutics may offer competitive advantages over rilonacept, such as requiring fewer
injections.
There are both small molecules and antibodies in development by third parties that are
designed to block the synthesis of interleukin-1 or inhibit the signaling of interleukin-1. For
example, Eli Lilly and Company and Novartis are each developing antibodies to interleukin-1 and
Amgen is developing an antibody to the interleukin-1 receptor. It has been reported that Novartis
has commenced advanced clinical testing of its IL-1 antibody in Muckle-Wells Syndrome, which is
part of the spectrum of rare genetic diseases called CAPS. Novartis IL-1 antibody and these other
drug candidates could offer competitive advantages over rilonacept. The successful development of
these competing molecules could delay or impair our ability to successfully develop and
commercialize rilonacept. For example, we may find it difficult to enroll patients in clinical
trials for rilonacept if the companies developing these competing interleukin-1 inhibitors commence
clinical trials in the same indications.
We are developing rilonacept for the treatment of a spectrum of rare diseases associated with
mutations in the CIAS1 gene. These rare genetic disorders affect a small group of people, estimated
to be between several hundred and a few thousand. There may be too few patients with these genetic
disorders to profitably commercialize rilonacept in this indication.
The successful commercialization of our product candidates will depend on obtaining coverage and
reimbursement for use of these products from third-party payers and these payers may not agree to
cover or reimburse for use of our products.
Our products, if commercialized, may be significantly more expensive than traditional drug
treatments. Our future revenues and profitability will be adversely affected if United States and
foreign governmental, private third-party insurers and payers, and other third-party payers,
including Medicare and Medicaid, do not agree to defray or reimburse the cost of our products to
the patients. If these entities refuse to provide coverage and reimbursement with respect to our
products or provide an insufficient level of coverage and reimbursement, our products may be too
costly for many patients to afford them, and physicians may not prescribe them. Many third-party
payers cover only selected drugs, making drugs that are not preferred by such payer more expensive
for patients, and require prior authorization or failure on another type of treatment before
covering a particular drug. Payers may especially impose these obstacles to coverage on
higher-priced drugs, as our product candidates are likely to be.
We are seeking approval to market rilonacept for the treatment of a spectrum of rare genetic
disorders called CAPS. There may be too few patients with CAPS to profitably commercialize
rilonacept. Physicians may not prescribe rilonacept and CAPS patients may not be able to afford
rilonacept if third party payers do not agree to reimburse the cost of rilonacept therapy and this
would adversely affect our ability to commercialize rilonacept profitably.
In addition to potential restrictions on coverage, the amount of reimbursement for our
53
products may also reduce our profitability. In the United States, there have been, and we expect
will continue to be, actions and proposals to control and reduce healthcare costs. Government and
other third-party payers are challenging the prices charged for healthcare products and
increasingly limiting, and attempting to limit, both coverage and level of reimbursement for
prescription drugs.
Since our products, including rilonacept, will likely be too expensive for most patients to
afford without health insurance coverage, if our products are unable to obtain adequate coverage
and reimbursement by third-party payers our ability to successfully commercialize our product
candidates may be adversely impacted. Any limitation on the use of our products or any decrease in
the price of our products will have a material adverse effect on our ability to achieve
profitability.
In certain foreign countries, pricing, coverage and level of reimbursement of prescription
drugs are subject to governmental control, and we may be unable to negotiate coverage, pricing, and
reimbursement on terms that are favorable to us. In some foreign countries, the proposed pricing
for a drug must be approved before it may be lawfully marketed. The requirements governing drug
pricing vary widely from country to country. For example, the European Union provides options for
its member states to restrict the range of medicinal products for which their national health
insurance systems provide reimbursement and to control the prices of medicinal products for human
use. A member state may approve a specific price for the medicinal product or it may instead adopt
a system of direct or indirect controls on the profitability of the company placing the medicinal
product on the market. Our results of operations may suffer if we are unable to market our products
in foreign countries or if coverage and reimbursement for our products in foreign countries is
limited.
Risk Related to Employees
We are dependent on our key personnel and if we cannot recruit and retain leaders in our research,
development, manufacturing, and commercial organizations, our business will be harmed.
We are highly dependent on certain of our executive officers. If we are not able to retain any
of these persons or our Chairman, our business may suffer. In particular, we depend on the services
of P. Roy Vagelos, M.D., the Chairman of our board of directors, Leonard Schleifer, M.D., Ph.D.,
our President and Chief Executive Officer, George D. Yancopoulos, M.D., Ph.D., our Executive Vice
President, Chief Scientific Officer and President, Regeneron Research Laboratories, and Neil Stahl,
Ph.D., our Senior Vice President, Research and Development Sciences. There is intense competition
in the biotechnology industry for qualified scientists and managerial personnel in the development,
manufacture, and commercialization of drugs. We may not be able to continue to attract and retain
the qualified personnel necessary for developing our business.
Risks Related to Our Common Stock
Our stock price is extremely volatile.
54
There has been significant volatility in our stock price and generally in the market prices of
biotechnology companies securities. Various factors and events may have a significant impact on
the market price of our common stock. These factors include, by way of example:
|
|
|
progress, delays, or adverse results in clinical trials; |
|
|
|
|
announcement of technological innovations or product candidates by us or competitors; |
|
|
|
|
fluctuations in our operating results; |
|
|
|
|
public concern as to the safety or effectiveness of our product candidates; |
|
|
|
|
developments in our relationship with collaborative partners; |
|
|
|
|
developments in the biotechnology industry or in government regulation of healthcare; |
|
|
|
|
large sales of our common stock by our executive officers, directors, or significant
shareholders; |
|
|
|
|
arrivals and departures of key personnel; and |
|
|
|
|
general market conditions. |
The trading price of our common stock has been, and could continue to be, subject to wide
fluctuations in response to these and other factors, including the sale or attempted sale of a
large amount of our common stock in the market. Broad market fluctuations may also adversely affect
the market price of our common stock.
Future sales of our common stock by our significant shareholders or us may depress our stock price
and impair our ability to raise funds in new share offerings.
A small number of our shareholders beneficially own a substantial amount of our common stock.
As of April 12, 2007, our seven largest shareholders beneficially owned 44.1% of our outstanding
shares of Common Stock, assuming, in the case of Leonard S. Schleifer, M.D. Ph.D., our Chief
Executive Officer, and P. Roy Vagelos, M.D., our Chairman, the conversion of their Class A Stock
into Common Stock and the exercise of all options held by them which are exercisable within 60 days
of April 12, 2007. As of April 12, 2007, sanofi-aventis owned 2,799,552 shares of Common Stock,
representing approximately 4.4% of the shares of Common Stock then outstanding. Under our stock
purchase agreement with sanofi-aventis, sanofi-aventis may sell no more than 500,000 of these
shares in any calendar quarter. If sanofi-aventis, or our other significant shareholders or we,
sell substantial amounts of our Common Stock in the public market, or the perception that such
sales may occur exists, the market price of our Common Stock could fall. Sales of Common Stock by
our significant shareholders, including sanofi-aventis, also might make it more difficult for us to
raise funds by selling equity or equity-related securities in the future at a time and price that
we deem appropriate.
Our existing shareholders may be able to exert significant influence over matters requiring
shareholder approval.
Holders of Class A Stock, who are generally the shareholders who purchased their stock from us
before our initial public offering, are entitled to ten votes per share, while holders of Common
Stock are entitled to one vote per share. As of April 12, 2007, holders of Class A Stock held
26.4% of the combined voting power of all of Common Stock and Class A Stock then outstanding.
These shareholders, if acting together, would be in a position to significantly
55
influence the election of our directors and to effect or prevent certain corporate
transactions that require majority or supermajority approval of the combined classes, including
mergers and other business combinations. This may result in our company taking corporate actions
that you may not consider to be in your best interest and may affect the price of our Common Stock.
As of April 12, 2007:
|
|
|
our current executive officers and directors beneficially owned 13.2% of our outstanding
shares of Common Stock, assuming conversion of their Class A Stock into Common Stock and
the exercise of all options held by such persons which are exercisable within 60 days of
April 12, 2007, and 30.4% of the combined voting power of our outstanding shares of Common
Stock and Class A Stock, assuming the exercise of all options held by such persons which
are exercisable within 60 days of April 12, 2007; and |
|
|
|
|
our seven largest shareholders beneficially owned 44.1% of our outstanding shares of
Common Stock, assuming, in the case of Leonard S. Schleifer, M.D., Ph.D., our Chief
Executive Officer, and P. Roy Vagelos, M.D., our Chairman, the conversion of their Class A
Stock into Common Stock and the exercise of all options held by them which are exercisable
within 60 days of April 12, 2007. In addition, these seven shareholders held 51.0% of the
combined voting power of our outstanding shares of Common Stock and Class A Stock, assuming
the exercise of all options held by our Chief Executive Officer and our Chairman which are
exercisable within 60 days of April 12, 2007. |
The anti-takeover effects of provisions of our charter, by-laws, and of New York corporate law,
could deter, delay, or prevent an acquisition or other change in control of us and could
adversely affect the price of our common stock.
Our amended and restated certificate of incorporation, our by-laws and the New York Business
Corporation Law contain various provisions that could have the effect of delaying or preventing a
change in control of our company or our management that shareholders may consider favorable or
beneficial. Some of these provisions could discourage proxy contests and make it more difficult for
you and other shareholders to elect directors and take other corporate actions. These provisions
could also limit the price that investors might be willing to pay in the future for shares of our
common stock. These provisions include:
|
|
|
authorization to issue blank check preferred stock, which is preferred stock that can
be created and issued by the board of directors without prior shareholder approval, with
rights senior to those of our common shareholders; |
|
|
|
|
a staggered board of directors, so that it would take three successive annual meetings
to replace all of our directors; |
|
|
|
|
a requirement that removal of directors may only be effected for cause and only upon the
affirmative vote of at least eighty percent (80%) of the outstanding shares entitled to
vote for directors, as well as a requirement that any vacancy on the board of directors may
be filled only by the remaining directors; |
|
|
|
|
any action required or permitted to be taken at any meeting of shareholders may be taken
without a meeting, only if, prior to such action, all of our shareholders consent, the
effect |
56
|
|
|
of which is to require that shareholder action may only be taken at a duly convened meeting; |
|
|
|
any shareholder seeking to bring business before an annual meeting of shareholders must
provide timely notice of this intention in writing and meet various other requirements; and |
|
|
|
|
under the New York Business Corporation Law, a plan of merger or consolidation of the
Company must be approved by two-thirds of the votes of all outstanding shares entitled to
vote thereon. See the risk factor immediately above captioned Our existing shareholders
may be able to exert significant influence over matters requiring shareholder approval. |
In addition, we have a Change in Control Severance Plan and our chief executive officer has an
employment agreement that provides severance benefits in the event our officers are terminated as a
result of a change in control of the Company. Many of our stock options issued under our 2000
Long-Term Incentive Plan may become fully vested in connection with a change in control of our
company, as defined in the plan.
Item 4. Submission of Matters to a Vote of Security Holders
On June 8, 2007, we conducted our Annual Meeting of Shareholders pursuant to due notice. A
quorum being present either in person or by proxy, the shareholders voted on the following matters:
1. To elect three Directors to hold office for a three-year term as Class I directors, and
until their successors are duly elected and qualified.
2. To ratify the appointment of PricewaterhouseCoopers LLP as the Companys independent
registered public accounting firm for our fiscal year ending December 31, 2007.
No other matters were voted on. The number of votes cast was:
|
|
|
|
|
|
|
|
|
|
|
For |
|
Withheld |
1. Election of Class I Directors |
|
|
|
|
|
|
|
|
Leonard S. Schleifer, M.D., Ph.D. |
|
|
78,309,187 |
|
|
|
1,546,154 |
|
Eric M. Shooter, Ph.D. |
|
|
78,754,194 |
|
|
|
1,110,147 |
|
George D. Yancopoulos, M.D.. Ph.D. |
|
|
78,751,885 |
|
|
|
1,103,456 |
|
The terms of office of Alfred G. Gilman, M.D., Ph.D., Joseph L. Goldstein, M.D., P. Roy
Vagelos, M.D., Charles A. Baker, Michael S. Brown, M.D., Arthur F. Ryan, and George L. Sing continued
after the meeting.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
2. Ratification of the Appointment
of Independent Registered
Public Accounting Firm |
|
|
79,244,209 |
|
|
|
217,182 |
|
|
|
393,949 |
|
57
Item 6. Exhibits
(a) Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
12.1
|
|
- Statement re: computation of ratio of earnings to combined fixed charges. |
|
|
|
31.1
|
|
- Certification of CEO pursuant to Rule 13a-14(a) under the Securities and Exchange Act
of 1934. |
|
|
|
31.2
|
|
- Certification of CFO pursuant to Rule 13a-14(a) under the Securities and Exchange Act
of 1934. |
|
|
|
32
|
|
- Certification of CEO and CFO pursuant to 18 U.S.C. Section 1350. |
58
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
Regeneron Pharmaceuticals, Inc. |
|
|
|
|
|
Date: August 3, 2007
|
|
By:
|
|
/s/ Murray A. Goldberg |
|
|
|
|
|
|
|
|
|
|
|
|
Murray A. Goldberg |
|
|
Senior Vice President, Finance & Administration, |
|
|
Chief Financial Officer, Treasurer, and |
|
|
Assistant Secretary |
|
|
(Principal Financial Officer and |
|
|
Duly Authorized Officer) |
59
EX-12.1
Exhibit 12.1
Regeneron Pharmaceuticals, Inc.
Computation of Ratio of Earnings to Combined Fixed Charges
(Dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ended |
|
|
Years ended December 31, |
|
June 30, |
|
|
2002 |
|
2003 |
|
2004 |
|
2005 |
|
2006 |
|
2007 |
Earnings: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
before income (loss) from equity investee |
|
$ |
(124,350 |
) |
|
$ |
(107,395 |
) |
|
$ |
41,565 |
|
|
$ |
(95,456 |
) |
|
$ |
(103,150 |
) |
|
$ |
(56,691 |
) |
Fixed charges |
|
|
13,685 |
|
|
|
14,108 |
|
|
|
14,060 |
|
|
|
13,687 |
|
|
|
13,643 |
|
|
|
6,854 |
|
Amortization of capitalized interest |
|
|
|
|
|
|
33 |
|
|
|
78 |
|
|
|
78 |
|
|
|
73 |
|
|
|
12 |
|
Interest capitalized |
|
|
(222 |
) |
|
|
(276 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted earnings |
|
$ |
(110,887 |
) |
|
$ |
(93,530 |
) |
|
$ |
55,703 |
|
|
$ |
(81,691 |
) |
|
$ |
(89,434 |
) |
|
$ |
(49,825 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fixed charges: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
$ |
11,859 |
|
|
$ |
11,932 |
|
|
$ |
12,175 |
|
|
$ |
12,046 |
|
|
$ |
12,043 |
|
|
$ |
6,022 |
|
Interest capitalized |
|
|
222 |
|
|
|
276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumed interest component of rental charges |
|
|
1,604 |
|
|
|
1,900 |
|
|
|
1,885 |
|
|
|
1,641 |
|
|
|
1,600 |
|
|
|
832 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total fixed charges |
|
$ |
13,685 |
|
|
$ |
14,108 |
|
|
$ |
14,060 |
|
|
$ |
13,687 |
|
|
$ |
13,643 |
|
|
$ |
6,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ratio of earnings to fixed charges |
|
|
(A |
) |
|
|
(A |
) |
|
|
3.96 |
|
|
|
(A |
) |
|
|
(A |
) |
|
|
(A |
) |
|
|
|
(A) |
|
Due to the registrants losses for the years ended December 31, 2002,
2003, 2005, and 2006, and for the six months ended June 30, 2007, the
ratio coverage was less than 1:1. To achieve a coverage ratio of 1:1,
the registrant must generate additional earnings of the amounts shown
in the table below. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ended |
|
|
Years ended December 31, |
|
June 30, |
|
|
2002 |
|
2003 |
|
2005 |
|
2006 |
|
2007 |
Coverage deficiency |
|
$ |
124,572 |
|
|
$ |
107,638 |
|
|
$ |
95,378 |
|
|
$ |
103,077 |
|
|
$ |
56,679 |
|
EX-31.1
Exhibit 31.1
Certification of CEO Pursuant to
Rule 13a-14(a) under the Securities Exchange Act
of 1934, as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Leonard S. Schleifer, certify that:
1. |
|
I have reviewed this quarterly report on Form 10-Q of Regeneron Pharmaceuticals, Inc.; |
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
|
3. |
|
Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations, and cash flows of the registrant as of, and for, the periods presented in this
report; |
|
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused
such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of
financial reporting and preparation of financial statements for external purposes
in accordance with generally accepted accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure controls
and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
|
d) |
|
Disclosed in this report any change in the registrants internal
control over financial reporting that occurred during the registrants most recent
fiscal quarter (the registrants fourth fiscal quarter in the case of an annual
report) that has materially affected, or is reasonably likely to materially
affect, the registrants internal control over financial reporting; and |
5. |
|
The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions): |
|
a) |
|
All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrants ability to record, process, summarize and
report financial information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrants internal control over
financial reporting. |
|
|
|
|
|
|
|
|
Date: August 3, 2007 |
/s/ Leonard S. Schleifer
|
|
|
Leonard S. Schleifer, M.D., Ph.D. |
|
|
President and Chief Executive Officer |
|
EX-31.2
Exhibit 31.2
Certification of CFO Pursuant to
Rule 13a-14(a) under the Securities Exchange Act
of 1934, as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
I, Murray A. Goldberg, certify that:
1. |
|
I have reviewed this quarterly report on Form 10-Q of Regeneron Pharmaceuticals, Inc.; |
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
|
Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations, and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly
during the period in which this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused
such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of
financial reporting and preparation of financial statements for external purposes
in accordance with generally accepted accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure controls
and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
|
d) |
|
Disclosed in this report any change in the registrants internal
control over financial reporting that occurred during the registrants most recent
fiscal quarter (the registrants fourth fiscal quarter in the case of an annual
report) that has materially affected, or is reasonably likely to materially
affect, the registrants internal control over financial reporting; and |
5. |
|
The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions): |
|
a) |
|
All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrants ability to record, process, summarize and
report financial information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrants internal control over
financial reporting. |
|
|
|
|
|
|
|
|
Date: August 3, 2007 |
/s/ Murray A. Goldberg
|
|
|
Murray A. Goldberg |
|
|
Senior Vice President, Finance &
Administration, Chief Financial Officer,
Treasurer, and Assistant Secretary |
|
|
EX-32
Exhibit 32
Certification of CEO and CFO Pursuant to
18 U.S.C. Section 1350,
As Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report of Regeneron Pharmaceuticals, Inc. (the Company) on Form
10-Q for the quarterly period ended June 30, 2007 as filed with the Securities and Exchange
Commission on the date hereof (the Report), Leonard S. Schleifer, M.D., Ph.D., as Chief Executive
Officer of the Company, and Murray A. Goldberg, as Chief Financial Officer of the Company, each
hereby certifies, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley
Act of 2002, to the best of his knowledge, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
|
|
|
/s/ Leonard S. Schleifer |
|
|
Leonard S. Schleifer, M.D., Ph.D.
|
|
|
Chief Executive Officer |
|
|
August 3, 2007 |
|
|
|
|
|
/s/ Murray A. Goldberg |
|
|
|
|
|
Chief Financial Officer |
|
|
August 3, 2007 |
|
|