REGENERON PHARMACEUTICALS, INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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(Mark One) |
þ
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QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the quarterly period ended
June 30, 2005 |
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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 |
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For the transition period from
to
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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
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(I.R.S. Employer Identification No.) |
incorporation or organization) |
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777 Old Saw Mill River Road |
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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 an accelerated filer (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 29, 2005:
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Class of Common Stock
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Number of Shares |
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Class A Stock, $0.001 par value
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2,358,373 |
Common Stock, $0.001 par value
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53,767,633 |
REGENERON PHARMACEUTICALS, INC.
Table of Contents
June 30, 2005
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS AT JUNE 30, 2005 AND DECEMBER 31, 2004 (Unaudited)
(In thousands, except share data)
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June 30, |
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December 31, |
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2005 |
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2004 |
ASSETS |
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Current assets |
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Cash and cash equivalents |
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$ |
145,201 |
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$ |
95,229 |
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Marketable securities |
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190,612 |
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200,753 |
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Accounts receivable |
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16,830 |
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43,102 |
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Prepaid expenses and other current assets |
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2,923 |
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1,642 |
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Inventory |
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3,746 |
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3,229 |
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Total current assets |
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359,312 |
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343,955 |
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Marketable securities |
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15,798 |
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52,930 |
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Property, plant, and equipment, at cost, net of accumulated
depreciation and amortization |
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67,366 |
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71,239 |
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Other assets |
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4,472 |
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4,984 |
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Total assets |
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$ |
446,948 |
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$ |
473,108 |
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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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$ |
17,043 |
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$ |
18,872 |
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Deferred revenue, current portion |
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12,906 |
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15,267 |
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Total current liabilities |
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29,949 |
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34,139 |
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Deferred revenue |
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51,939 |
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56,426 |
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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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281,888 |
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290,565 |
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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;
2,358,373 shares issued and outstanding in 2005 and 2004 |
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2 |
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2 |
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Common Stock, $.001 par value; 160,000,000 shares authorized;
shares issued and outstanding 53,762,428 in 2005 and 53,502,004 in
2004 |
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54 |
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54 |
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Additional paid-in capital |
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687,965 |
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675,389 |
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Unearned compensation |
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(1,296 |
) |
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(2,299 |
) |
Accumulated deficit |
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(520,956 |
) |
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(489,834 |
) |
Accumulated other comprehensive loss |
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(709 |
) |
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(769 |
) |
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Total stockholders equity |
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165,060 |
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182,543 |
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Total liabilities and stockholders equity |
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$ |
446,948 |
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$ |
473,108 |
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The accompanying notes are an integral part of the financial statements.
3
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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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2005 |
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2004 |
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2005 |
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2004 |
Revenues |
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Contract research and
development |
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$ |
13,545 |
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$ |
27,146 |
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$ |
27,047 |
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$ |
68,756 |
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Research progress payments |
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17,770 |
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Contract manufacturing |
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2,821 |
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1,272 |
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5,528 |
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3,882 |
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16,366 |
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28,418 |
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32,575 |
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90,408 |
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Expenses |
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Research and development |
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40,642 |
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36,297 |
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76,554 |
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68,478 |
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Contract manufacturing |
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1,675 |
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529 |
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4,166 |
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2,754 |
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General and administrative |
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6,216 |
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4,235 |
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12,362 |
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8,025 |
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48,533 |
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41,061 |
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93,082 |
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79,257 |
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Income (loss) from operations |
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(32,167 |
) |
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(12,643 |
) |
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(60,507 |
) |
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11,151 |
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Other income (expense) |
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Other contract income |
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5,640 |
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30,640 |
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42,750 |
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Investment income |
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2,539 |
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1,105 |
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4,769 |
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2,229 |
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Interest expense |
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(3,011 |
) |
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(3,011 |
) |
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(6,024 |
) |
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(6,147 |
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5,168 |
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(1,906 |
) |
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29,385 |
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38,832 |
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Net income (loss) |
( |
$ |
26,999 |
) |
( |
$ |
14,549 |
) |
( |
$ |
31,122 |
) |
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$ |
49,983 |
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Net income (loss) per share: |
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Basic |
( |
$ |
0.48 |
) |
( |
$ |
0.26 |
) |
( |
$ |
0.56 |
) |
|
$ |
0.90 |
|
Diluted |
( |
$ |
0.48 |
) |
( |
$ |
0.26 |
) |
( |
$ |
0.56 |
) |
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$ |
0.88 |
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Weighted average shares outstanding: |
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Basic |
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55,917 |
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55,383 |
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55,866 |
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|
55,333 |
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Diluted |
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55,917 |
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55,383 |
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55,866 |
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|
63,209 |
|
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, 2005
(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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Unearned |
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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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Compensation |
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Deficit |
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Loss |
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Equity |
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Loss |
Balance, December 31, 2004 |
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|
2,358 |
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|
$ |
2 |
|
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|
53,502 |
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|
$ |
54 |
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|
$ |
675,389 |
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($2,299 |
) |
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($489,834 |
) |
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|
($769 |
) |
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$ |
182,543 |
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Issuance of Common Stock in connection with
exercise of stock options |
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172 |
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1,032 |
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1,032 |
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Issuance of Common Stock in connection with
Company 401(k) Savings
Plan contribution |
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90 |
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|
632 |
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632 |
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Forfeitures of restricted Common Stock under
Long-Term Incentive Plan |
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(2 |
) |
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(27 |
) |
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27 |
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Stock-based compensation expense |
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|
10,939 |
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|
976 |
|
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|
11,915 |
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Net loss |
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(31,122 |
) |
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(31,122 |
) |
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($31,122 |
) |
Change in net unrealized loss on
marketable securities |
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|
60 |
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|
|
60 |
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|
60 |
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Balance, June 30, 2005 |
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|
2,358 |
|
|
$ |
2 |
|
|
|
53,762 |
|
|
$ |
54 |
|
|
$ |
687,965 |
|
|
|
($1,296 |
) |
|
|
($520,956 |
) |
|
|
($709 |
) |
|
$ |
165,060 |
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|
|
($31,062 |
) |
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|
The accompanying notes are an integral part of the financial statements.
5
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
(In thousands)
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|
Six months ended June 30, |
|
|
2005 |
|
2004 |
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net income (loss) |
|
($ |
31,122 |
) |
|
$ |
49,983 |
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net income (loss) to net cash provided
by (used in) operating activities |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
7,689 |
|
|
|
7,570 |
|
Non-cash compensation expense |
|
|
11,703 |
|
|
|
1,299 |
|
Non-cash expense related to a license agreement |
|
|
|
|
|
|
347 |
|
Forgiveness of loan payable to Novartis Pharma AG,
inclusive of accrued interest |
|
|
|
|
|
|
(17,770 |
) |
Changes in assets and liabilities |
|
|
|
|
|
|
|
|
Decrease (increase) in accounts receivable |
|
|
26,272 |
|
|
|
(9,868 |
) |
Increase in prepaid expenses and other assets |
|
|
(1,246 |
) |
|
|
(1,708 |
) |
Decrease (increase) in inventory |
|
|
141 |
|
|
|
(1,260 |
) |
Decrease in deferred revenue |
|
|
(6,848 |
) |
|
|
(26,776 |
) |
Decrease in accounts payable, accrued expenses,
and other liabilities |
|
|
(2,040 |
) |
|
|
(2,941 |
) |
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
35,671 |
|
|
|
(51,107 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
4,549 |
|
|
|
(1,124 |
) |
|
|
|
|
|
|
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Cash flows from investing activities |
|
|
|
|
|
|
|
|
Purchases of marketable securities |
|
|
(60,392 |
) |
|
|
(87,669 |
) |
Purchases of restricted marketable securities |
|
|
|
|
|
|
(5,538 |
) |
Sales or maturities of marketable securities |
|
|
107,680 |
|
|
|
88,940 |
|
Maturities of restricted marketable securities |
|
|
|
|
|
|
11,038 |
|
Capital expenditures |
|
|
(2,897 |
) |
|
|
(2,533 |
) |
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
44,391 |
|
|
|
4,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Net proceeds from the issuance of stock |
|
|
1,032 |
|
|
|
603 |
|
Borrowings under loan payable |
|
|
|
|
|
|
3,827 |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,032 |
|
|
|
4,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
49,972 |
|
|
|
7,544 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
95,229 |
|
|
|
97,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
145,201 |
|
|
$ |
105,021 |
|
|
|
|
|
|
|
|
|
|
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, 2004
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, 2004.
2. Per Share Data
The Companys basic net income (loss) per share amounts have been computed by dividing net income
or loss by the weighted average number of shares of Common Stock and Class A Stock outstanding.
Diluted net income per share is based upon the weighted average number of shares of Common Stock
and Class A Stock and the common stock equivalents outstanding when dilutive. Common stock
equivalents include: (i) outstanding stock options and restricted stock awards under the Companys
Long-Term Incentive Plans, which are included under the treasury stock method when dilutive, and
(ii) Common Stock to be issued under the assumed conversion of the Companys outstanding
convertible senior subordinated notes, which are included under the if-converted method when
dilutive. For the three and six months ended June 30, 2005 and the three months ended June 30,
2004, the Company reported a net loss and, therefore, no common stock equivalents were included in
the computation of diluted net loss per share for such periods, since such inclusion would have
been antidilutive. The calculations of basic and diluted net income (loss) per share are as
follows:
7
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
2005 |
|
2004 |
Net loss (Numerator) |
|
($ |
26,999 |
) |
|
($ |
14,549 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares, in thousands
(Denominator) |
|
|
55,917 |
|
|
|
55,383 |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
($ |
0.48 |
) |
|
($ |
0.26 |
) |
|
|
|
Six Months Ended June 30, |
|
|
2005 |
|
2004 |
Net income (loss) (Numerator): |
|
|
|
|
|
|
|
|
Net income (loss) for basic per share calculations |
|
($ |
31,122 |
) |
|
$ |
49,983 |
|
Adjustment for interest expense on convertible
notes |
|
|
|
|
|
|
5,500 |
|
|
|
|
|
|
|
|
|
|
Adjusted net income (loss) for diluted per
share calculations |
|
($ |
31,122 |
) |
|
$ |
55,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares, in thousands (Denominator): |
|
|
|
|
|
|
|
|
Weighted-average shares for basic per share
calculations |
|
|
55,866 |
|
|
|
55,333 |
|
Effect of stock options |
|
|
|
|
|
|
1,209 |
|
Effect of restricted stock awards |
|
|
|
|
|
|
56 |
|
Effect of convertible notes |
|
|
|
|
|
|
6,611 |
|
|
|
|
|
|
|
|
|
|
Adjusted weighted-average shares for diluted
per share calculations |
|
|
55,866 |
|
|
|
63,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
|
($ |
0.56 |
) |
|
$ |
0.90 |
|
Diluted net income (loss) per share |
|
($ |
0.56 |
) |
|
$ |
0.88 |
|
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, 2005 and 2004 diluted
per share amounts because their effect would have been antidilutive, include the following:
8
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
2005 |
|
2004 |
Stock Options: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
13,295 |
|
|
|
13,122 |
|
Weighted average exercise price |
|
$ |
14.55 |
|
|
$ |
20.33 |
|
|
|
|
|
|
|
|
|
|
Restricted Stock: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
204 |
|
|
|
282 |
|
|
|
|
|
|
|
|
|
|
Convertible Debt: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
6,611 |
|
|
|
6,611 |
|
Conversion price |
|
$ |
30.25 |
|
|
$ |
30.25 |
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
2005 |
|
2004 |
Stock Options: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
13,385 |
|
|
|
7,515 |
|
Weighted average exercise price |
|
$ |
14.64 |
|
|
$ |
27.75 |
|
|
|
|
|
|
|
|
|
|
Restricted Stock: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Debt: |
|
|
|
|
|
|
|
|
Weighted average number, in thousands |
|
|
6,611 |
|
|
|
|
|
Conversion price |
|
$ |
30.25 |
|
|
|
|
|
3. Stock-based Employee Compensation
Effective January 1, 2005, the Company adopted the fair value based method of accounting for
stock-based employee compensation under the provisions of Statement of Financial Accounting
Standards No. (SFAS) 123, Accounting for Stock-Based Compensation, using the modified prospective
method as described in SFAS 148, Accounting for Stock-Based Compensation- Transition and
Disclosure. As a result, the Company has begun recognizing expense, in an amount equal to the fair
value of share-based payments (including stock option awards) on their date of grant, over the
vesting period of the awards. Under the modified prospective method, compensation expense for the
Company is recognized for (a) all share based payments granted on or after January 1, 2005,
(including replacement options granted under the Companys stock option exchange program which
concluded on January 5, 2005 (see Note 11)) and (b) all awards granted to employees prior to
January 1, 2005 that were unvested on that date. Prior to the adoption of the fair value method,
the Company accounted for stock-based compensation to employees under the intrinsic value method of
accounting set forth in Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to
Employees,
9
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
and related interpretations. Therefore, compensation expense related to employee stock options was
not reflected in operating expenses in any period prior to the first quarter of 2005 and prior
period results have not been restated. For the three months ended June 30, 2005, non-cash
stock-based employee compensation expense related to stock option awards (Stock Option Expense)
totaled $5,398, of which $5,348 was recognized in operating expenses and $50 was capitalized in
inventory. For the six months ended June 30, 2005, Stock Option Expense totaled $10,939, of which
$10,727 was recognized in operating expenses and $212 was capitalized in inventory. For the three
and six months ended June 30, 2004, had the Company adopted the fair value based method of
accounting for stock-based employee compensation under the provisions of SFAS 123, Stock Option
Expense would have totaled $8,584 and $17,510, respectively, and the effect on the Companys net
income (loss) and net income (loss) per share would have been as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, 2004 |
|
June 30, 2004 |
Net income (loss), as reported |
|
($ |
14,549 |
) |
|
$ |
49,983 |
|
Add: Stock-based employee
compensation
expense included in reported
net income (loss) |
|
|
628 |
|
|
|
1,299 |
|
Deduct: Total stock-based employee
compensation expense determined
under fair value based method
for all awards |
|
|
(9,212 |
) |
|
|
(18,809 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net income (loss), basic |
|
($ |
23,133 |
) |
|
$ |
32,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net income (loss), diluted |
|
($ |
23,133 |
) |
|
$ |
37,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share
amounts: |
|
|
|
|
|
|
|
|
As reported |
|
($ |
0.26 |
) |
|
$ |
0.90 |
|
Pro forma |
|
($ |
0.42 |
) |
|
$ |
0.59 |
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share
amounts: |
|
|
|
|
|
|
|
|
As reported |
|
($ |
0.26 |
) |
|
$ |
0.88 |
|
Pro forma |
|
($ |
0.42 |
) |
|
$ |
0.60 |
|
The fair value of each option granted under the Regeneron Pharmaceuticals, Inc. 2000 Long-Term
Incentive Plan (2000 Incentive Plan) during the three and six months ended June 30, 2005 and 2004
was estimated on the date of grant using the Black-Scholes
10
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
option-pricing model. Using this model, fair value is calculated based on assumptions with respect
to (i) expected volatility of the Companys Common Stock price, (ii) the periods of time over which
employees and Board Directors are expected to hold their options prior to exercise (expected
lives), (iii) expected dividend yield on the Companys Common Stock, and (iv) risk-free interest
rates, which are based on quoted U.S. Treasury rates for securities with maturities approximating
the options expected lives. Expected volatility has been estimated based on actual movements in
the Companys stock price over the most recent historical periods equivalent to the options
expected lives. Expected lives are principally based on the Companys limited historical exercise
experience with option grants with similar exercise prices. The expected dividend yield is zero as
the Company has never paid dividends and does not currently anticipate paying any in the
foreseeable future. The weighted-average fair value of the options granted during the three months
ended June 30, 2005 and 2004 was $4.04 and $8.62 per option, respectively. The weighted-average
fair value of the options granted during the six months ended June 30, 2005 and 2004 was $5.81 and
$10.30 per option, respectively. The following table summarizes the weighted average values of the
assumptions used in computing the fair value of option grants.
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
2005 |
|
2004 |
Expected volatility |
|
|
70 |
% |
|
|
80 |
% |
Expected lives from grant date |
|
5.0 years |
|
7.5 years |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Risk-free interest rate |
|
|
3.78 |
% |
|
|
4.07 |
% |
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
2005 |
|
2004 |
Expected volatility |
|
|
75 |
% |
|
|
80 |
% |
Expected lives from grant date |
|
6.2 years |
|
7.3 years |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Risk-free interest rate |
|
|
3.96 |
% |
|
|
3.83 |
% |
Under the 2000 Incentive Plan, the Company also awards shares of restricted stock. In accordance
with generally accepted accounting principles, the Company records unearned compensation in
Stockholders Equity related to these awards. The amount is based on the fair market value of
shares of Common Stock on the grant date of the restricted stock award and is expensed, on a pro
rata basis, over the period that the restrictions lapse. For the three months ended June 30, 2005
and 2004, the Company recognized compensation expense related to restricted stock awards of $474
and $628, respectively. For the six months ended June 30, 2005 and 2004, the Company recognized
compensation expense related to restricted stock awards of $976 and $1,299, respectively.
11
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
4. Statement of Cash Flows
Supplemental disclosure of noncash investing and financing activities:
Included in accounts payable and accrued expenses at June 30, 2005 and December 31, 2004 are $1,393
and $550, respectively, of accrued capital expenditures. Included in accounts payable and accrued
expenses at June 30, 2004 and December 31, 2003 are $1,114 and $752, respectively, of accrued
capital expenditures.
Included in accounts payable and accrued expenses at December 31, 2004 and 2003 are $632 and $917,
respectively, of accrued Company 401(k) Savings Plan contribution expense. In the first quarter of
both 2005 and 2004, the Company contributed 90,385 and 64,333 shares, respectively, of Common Stock
to the 401(k) Savings Plan in satisfaction of these obligations.
Included in marketable securities at June 30, 2005 and December 31, 2004 are $2,562 and $2,607,
respectively, of accrued interest income. Included in marketable securities at June 30, 2004 and
December 31, 2003 are $1,422 and $878, respectively, of accrued interest income.
5. Marketable Securities
The Company has revised the classification of its investments in auction rate securities from cash
and cash equivalents to short-term investments on its balance sheets at December 31, 2004 and 2003,
and June 30, 2004. Auction rate securities are securities that have stated maturities beyond three
months, but are priced and traded as short-term investments due to the liquidity provided through
the auction mechanism that generally resets interest rates every 28 or 35 days. The change in
classification resulted in decreases in cash and cash equivalents and corresponding increases in
short-term marketable securities of $6,005 and $20,808 at December 31, 2004 and 2003, respectively,
and $17,812 at June 30, 2004. The Company held no auction rate securities at June 30, 2005. In
addition, the Company revised its statements of cash flows to reflect the purchases and sales of
these securities as investing activities rather than as a component of cash and cash equivalents,
resulting in increases in cash flows from investing activities of $14,803 and $14,230 for the years
ended December 31, 2004 and 2003, respectively, and $2,996 for the six months ended June 30, 2004.
This change in classification had no impact on the Companys previously reported current assets,
net income (loss), or cash flows from operations.
12
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
6. Accounts Receivable
Accounts receivable as of June 30, 2005 and December 31, 2004 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2005 |
|
2004 |
Receivable from the sanofi-aventis Group |
|
$ |
7,782 |
|
|
$ |
39,362 |
|
Receivable from The Procter & Gamble Company |
|
|
8,393 |
|
|
|
2,345 |
|
Receivable from Merck & Co., Inc. |
|
|
575 |
|
|
|
1,315 |
|
Other |
|
|
80 |
|
|
|
80 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,830 |
|
|
$ |
43,102 |
|
|
|
|
|
|
|
|
|
|
7. Inventories
Inventories consist of raw materials, work-in process, and finished products associated with the
production of an intermediate for a Merck & Co., Inc. pediatric vaccine under a long-term
manufacturing agreement which is scheduled to expire in October 2006.
Inventories as of June 30, 2005 and December 31, 2004 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2005 |
|
2004 |
Raw materials |
|
$ |
390 |
|
|
$ |
310 |
|
Work-in-process |
|
|
543 |
|
|
|
692 |
(2) |
Finished products |
|
|
2,813 |
(1) |
|
|
2,227 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,746 |
|
|
$ |
3,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Net of reserves of $427. |
|
(2) |
|
Net of reserves of $256. |
8. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses as of June 30, 2005 and December 31, 2004 consist of the
following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2005 |
|
2004 |
Accounts payable |
|
$ |
3,297 |
|
|
$ |
4,407 |
|
Accrued payroll and related costs |
|
|
4,835 |
|
|
|
7,972 |
|
Accrued clinical trial expense |
|
|
3,692 |
|
|
|
2,083 |
|
Accrued expenses, other |
|
|
2,927 |
|
|
|
2,118 |
|
Interest payable on convertible notes |
|
|
2,292 |
|
|
|
2,292 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,043 |
|
|
$ |
18,872 |
|
|
|
|
|
|
|
|
|
|
13
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
9. Comprehensive Income (Loss)
Comprehensive income (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
income (loss) of the Company includes net income (loss) adjusted for the change in net unrealized
gain (loss) on marketable securities. The net effect of income taxes on comprehensive income
(loss) is immaterial. For the three months ended June 30, 2005 and 2004, the components of
comprehensive loss are:
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
2005 |
|
2004 |
Net loss |
|
($ |
26,999 |
) |
|
($ |
14,549 |
) |
Change in net unrealized gain (loss) on
marketable securities |
|
|
401 |
|
|
|
(384 |
) |
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
($ |
26,598 |
) |
|
($ |
14,933 |
) |
|
|
|
|
|
|
|
|
|
For the six months ended June 30, 2005 and 2004, the components of comprehensive income (loss) are:
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
2005 |
|
2004 |
Net income (loss) |
|
($ |
31,122 |
) |
|
$ |
49,983 |
|
Change in net unrealized gain (loss) on
marketable securities |
|
|
60 |
|
|
|
(315 |
) |
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
($ |
31,062 |
) |
|
$ |
49,668 |
|
|
|
|
|
|
|
|
|
|
10. Research and Development Agreements
a. The sanofi-aventis Group
In September 2003, the Company entered into a collaboration agreement (the s-a Agreement) with
Aventis Pharmaceuticals Inc., now a member of the sanofi-aventis Group, to jointly develop and
commercialize the Companys Vascular Endothelial Growth Factor (VEGF) Trap. In connection with
this agreement, Aventis Pharmaceuticals made a non-refundable up-front payment of $80.0 million and
purchased $45.0 million of newly issued, unregistered shares of the Companys Common Stock.
In January 2005, the Company and the sanofi-aventis Group amended the s-a Agreement to exclude rights to
develop and commercialize the VEGF Trap for eye diseases through local delivery systems, and these
VEGF Trap product rights reverted to Regeneron. In
14
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
connection with this amendment, the sanofi-aventis Group made a one-time $25.0 million payment to Regeneron
in January 2005. Under the
s-a Agreement, as amended, Regeneron and the sanofi-aventis Group will share
co-promotion rights for and profits on sales, if any, from the VEGF Trap, for disease indications
included in the companies collaboration.
Under the s-a Agreement, as amended, agreed upon development expenses incurred by both companies
during the term of the agreement will be funded by the sanofi-aventis Group. If the collaboration becomes
profitable, Regeneron will reimburse the sanofi-aventis Group for 50 percent of the VEGF Trap development
expenses, including 50 percent of the $25.0 million payment received in connection with the January
2005 amendment to the collaboration agreement, in accordance with a formula based on the amount of
development expenses and Regenerons share of the collaboration profits, or at a faster rate at
Regenerons option. In addition, if the first commercial sale of a VEGF Trap product for diseases
of the eye through local delivery systems predates the first commercial sale of a VEGF Trap product
under the collaboration, Regeneron will begin reimbursing the sanofi-aventis Group for up to $7.5 million of
VEGF Trap development expenses commencing two years after such initial commercialization outside
the collaboration in accordance with a defined formula, until the first commercial VEGF Trap sale
under the collaboration occurs.
b. The Procter & Gamble Company
On June 30, 2005, the Company and The Procter & Gamble Company agreed to amend their collaboration
agreement (the Collaboration Agreement) entered into as of December 31, 2000. Pursuant to the
terms of the amendment and agreement (the Amendment) entered into by the parties on June 30,
2005, the Company and Procter & Gamble agreed that the research activities of the parties under the
Collaboration Agreement were completed on June 30, 2005, six months prior to the December 31, 2005
expiration date in the Collaboration Agreement. In connection with the Amendment, Procter & Gamble
agreed to make a one-time $5.6 million payment to Regeneron, which was received in July 2005, and
the Company agreed to pay $950 to Procter & Gamble to acquire certain capital equipment owned by
Procter & Gamble and located at the Companys facilities. Procter & Gamble also funded Regenerons
research for the second quarter of 2005 under the terms of the Collaboration Agreement. Procter &
Gamble and the Company divided rights to research programs and pre-clinical product candidates that
were developed during the research term of the Collaboration Agreement. Neither party has the
right to participate in the development or commercialization of the other partys product
candidates. The Company is entitled to receive royalties based on any future product sales of a
Procter & Gamble pre-clinical candidate arising from the collaboration. Neither party is entitled
to receive royalties or other payments based on any other products arising from the collaboration.
15
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
11. Stock Option Exchange Program
In December 2004, the Companys shareholders approved a stock option exchange program. Under the
program, Company regular employees who worked an average of 20 hours per week, other than the
Companys chairman and the Companys president and chief executive officer, were provided the
opportunity to make a one-time election to surrender options granted under the Companys Long-Term
Incentive Plans that had an exercise price per share of at least $18.00 and exchange them for
replacement options granted under the 2000 Incentive Plan in accordance with the following exchange
ratios:
|
|
|
|
|
|
|
Exchange Ratio |
|
|
(Number of Eligible Options |
|
|
Surrendered and Cancelled for Each |
Exercise Price of Eligible Options |
|
Replacement Option) |
$18.00 to $28.00 |
|
|
1.50 |
|
$28.01 to $37.00 |
|
|
2.00 |
|
$37.01 and up |
|
|
3.00 |
|
Participation in the stock option exchange program was voluntary, and non-employee directors,
consultants, former employees, and retirees were not eligible to participate. The participation
deadline for the program was January 5, 2005. Eligible employees elected to exchange options with
a total of 3,665,819 underlying shares of Common Stock, and on January 5, 2005, the Company issued
replacement options with respect to a total of 1,977,840 underlying shares of Common Stock at an
exercise price of $8.50 per share.
12. Segment Reporting
The Companys operations are managed in two business segments: research and development, and
contract manufacturing.
Research and development: Includes all activities related to the discovery of potential
therapeutics for human medical conditions, and the development and commercialization of these
discoveries. Also includes revenues and expenses related to (i) the development of manufacturing
processes prior to commencing commercial production of a product under contract manufacturing
arrangements, and (ii) the supply of specified, ordered research materials using
Regeneron-developed proprietary technology.
Contract manufacturing: Includes all revenues and expenses related to the commercial
production of products under contract manufacturing arrangements. The Company produces an
intermediate for a Merck & Co., Inc. pediatric vaccine under a long-term manufacturing agreement.
16
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
The table below presents information about reported segments for the three and six months ended
June 30, 2005 and 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2005 |
|
|
Research & |
|
Contract |
|
Reconciling |
|
|
|
|
Development |
|
Manufacturing |
|
Items |
|
Total |
Revenues |
|
$ |
13,545 |
|
|
$ |
2,821 |
|
|
|
|
|
|
$ |
16,366 |
|
Depreciation and
amortization |
|
|
3,570 |
|
|
|
|
(1) |
|
$ |
261 |
|
|
|
3,831 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
3,011 |
|
|
|
3,011 |
|
Other contract income |
|
|
5,640 |
|
|
|
|
|
|
|
|
|
|
|
5,640 |
|
Net income (loss) |
|
|
(27,673 |
) |
|
|
1,146 |
|
|
|
(472 |
)(2) |
|
|
(26,999 |
) |
Capital expenditures |
|
|
2,115 |
|
|
|
|
|
|
|
|
|
|
|
2,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2004 |
|
|
Research & |
|
Contract |
|
Reconciling |
|
|
|
|
Development |
|
Manufacturing |
|
Items |
|
Total |
Revenues |
|
$ |
27,146 |
|
|
$ |
1,272 |
|
|
|
|
|
|
$ |
28,418 |
|
Depreciation and
amortization |
|
|
3,536 |
|
|
|
|
(1) |
|
$ |
261 |
|
|
|
3,797 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
3,011 |
|
|
|
3,011 |
|
Net income (loss) |
|
|
(13,386 |
) |
|
|
743 |
|
|
|
(1,906 |
)(2) |
|
|
(14,549 |
) |
Capital expenditures |
|
|
2,214 |
|
|
|
|
|
|
|
|
|
|
|
2,214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, 2005 |
|
|
Research & |
|
Contract |
|
Reconciling |
|
|
|
|
Development |
|
Manufacturing |
|
Items |
|
Total |
Revenues |
|
$ |
27,047 |
|
|
$ |
5,528 |
|
|
|
|
|
|
$ |
32,575 |
|
Depreciation and
amortization |
|
|
7,167 |
|
|
|
|
(1) |
|
$ |
522 |
|
|
|
7,689 |
|
Interest expense |
|
|
|
|
|
|
|
|
|
|
6,024 |
|
|
|
6,024 |
|
Other contract income |
|
|
30,640 |
|
|
|
|
|
|
|
|
|
|
|
30,640 |
|
Net income (loss) |
|
|
(31,229 |
) |
|
|
1,362 |
|
|
|
(1,255 |
)(2) |
|
|
(31,122 |
) |
Capital expenditures |
|
|
3,752 |
|
|
|
|
|
|
|
|
|
|
|
3,752 |
|
Total assets |
|
|
81,936 |
|
|
|
6,006 |
|
|
|
359,006 |
(3) |
|
|
446,948 |
|
17
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, 2004 |
|
|
Research & |
|
Contract |
|
Reconciling |
|
|
|
|
Development |
|
Manufacturing |
|
Items |
|
Total |
Revenues |
|
$ |
86,526 |
|
|
$ |
3,882 |
|
|
|
|
|
|
$ |
90,408 |
|
Depreciation and
amortization |
|
|
7,048 |
|
|
|
- |
(1) |
|
$ |
522 |
|
|
|
7,570 |
|
Interest expense |
|
|
126 |
|
|
|
|
|
|
|
6,021 |
|
|
|
6,147 |
|
Other contract income |
|
|
42,750 |
|
|
|
|
|
|
|
|
|
|
|
42,750 |
|
Net income (loss) |
|
|
52,647 |
|
|
|
1,128 |
|
|
|
(3,792 |
)(2) |
|
|
49,983 |
|
Capital expenditures |
|
|
2,899 |
|
|
|
|
|
|
|
|
|
|
|
2,899 |
|
Total assets |
|
|
96,816 |
|
|
|
15,417 |
|
|
|
375,941 |
(3) |
|
|
488,174 |
|
|
|
|
(1) |
|
Depreciation and amortization related to contract manufacturing is capitalized into
inventory and included in contract manufacturing expense when the product is shipped. |
|
(2) |
|
Represents investment income, net of interest expense related primarily to
convertible notes issued in October 2001. |
|
(3) |
|
Includes cash and cash equivalents, marketable securities, restricted marketable
securities, prepaid expenses and other current assets, and other assets. |
13. Legal Matters
In May 2003, securities class action lawsuits were commenced against Regeneron and certain of the
Companys officers and directors in the United States District Court for the Southern District of
New York. A consolidated amended class action complaint was filed in October 2003. The complaint,
which purports to be brought on behalf of a class consisting of investors in the Companys publicly
traded securities between March 28, 2000 and March 30, 2003, alleges that the defendants misstated
or omitted material information concerning the safety and efficacy of AXOKINE, a product then being
developed by the Company for the treatment of obesity, in violation of Sections 10(b) and 20(a) of
the Securities and Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.
On August
3, 2005, the plaintiffs and the Company entered into a Stipulation and Agreement of
Settlement settling all claims against the Company in this lawsuit. The settlement requires no
payment by the Company or any of the individual defendants named in
the lawsuit. The Companys primary insurance carrier agreed to
make the required payment under the settlement, which is in an immaterial
amount to the Company. The
settlement includes no admission of wrongdoing by the Company or any
of the individual in defendants.
The settlement must be finally approved by the United States
District Court for the Southern District of New York following notice and hearing.
18
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
Separately, the plaintiffs and the individual defendants named in the lawsuit entered into a
Stipulation of Voluntary Dismissal, dismissing all claims against the individuals. This voluntary
dismissal shall automatically become a dismissal with prejudice, without costs, upon the court
entering an order and final judgment approving the settlement.
The Company, from time to time, has been subject to other legal claims arising in connection with
its business. While the ultimate results of the legal claims cannot be predicted with certainty, at
June 30, 2005 there were no asserted claims against the Company which, in the opinion of
management, if adversely decided would have a material adverse effect on the Companys financial
position, results of operations, and cash flows.
14. Future Impact of Recently Issued Accounting Standards
In December 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 123R, Share-Based Payment. SFAS 123R is a revision of SFAS 123,
Accounting for Stock-Based Compensation (which we adopted effective January 1, 2005 see Note 3),
and supersedes APB Opinion No. 25, Accounting for Stock Issued to Employees, and its related
implementation guidance. SFAS 123R focuses primarily on accounting for transactions in which an
entity obtains employee services in share-based payment transactions, and requires the recognition
of compensation expense in an amount equal to the fair value of the share-based payment (including
stock options and restricted stock) issued to employees. SFAS 123R is effective for fiscal years
beginning after June 15, 2005. In March 2005, the U.S. Securities and Exchange Commission (SEC)
issued Staff Accounting Bulletin No. 107 (SAB 107) which expresses views of the SEC staff
regarding the application of SFAS 123R. Among other things, SAB 107 provides interpretive guidance
related to the interaction between SFAS 123R and certain SEC rules and regulations as well as the
SEC staffs views regarding the valuation of share-based payment arrangements for public companies.
The Company will be required to adopt SFAS 123R effective for the fiscal year beginning January 1,
2006, and intends to do so using the modified prospective method. Under the modified prospective
method, compensation cost is recognized beginning with the effective date based on (a) the
requirements of SFAS 123R for all share-based payments granted after the effective date and (b) the
requirements of SFAS 123 for all awards granted to employees prior to the effective date of SFAS
123R that remain unvested on the effective date. In addition, the Company will consider the
guidance of SAB 107 as it adopts SFAS 123R. Although the impact of adopting SFAS 123R has not yet
been quantified, management believes that the future adoption of this standard may have a material
impact on the Companys financial statements.
In March 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections. SFAS 154
replaces APB Opinion No. 20, Accounting Changes, and SFAS 3, Reporting Accounting Changes in
Interim Financial Statements, and requires retrospective
19
REGENERON PHARMACEUTICALS, INC.
Notes to Condensed Financial Statements (Unaudited)
(Unless otherwise noted, dollars in thousands, except per share data)
application to prior-period financial statements of changes in accounting principle, unless it is
impracticable to determine either the period-specific effects or the cumulative effect of a change.
SFAS 154 also redefines restatement as the revising of previously issued financial statements to
reflect the correction of an error. SFAS 154 is effective for accounting changes and corrections
of errors made in fiscal years beginning after December 15, 2005. The Company is required to adopt
the provisions of SFAS 154, as applicable, effective for the fiscal year beginning January 1, 2006.
In March 2005, the FASB issued Interpretation No. 47, Accounting for Conditional Asset Retirement
Obligations (FIN 47), which clarifies that the term conditional asset retirement, as used in
SFAS 143, Accounting for Asset Retirement Obligations, refers to a legal obligation to perform an
asset retirement activity in which the timing and/or method of settlement are conditional on a
future event that may or may not be within the control of the entity. FIN 47 requires that a
liability be recognized for the fair value of a conditional asset retirement obligation when
incurred, if the fair value of the liability can be reasonably estimated. Uncertainty about the
timing and method of settlement of a conditional asset retirement obligation would be factored into
the measurement of the liability when sufficient information exists. FIN 47 is effective no later
than the end of fiscal years ending after December 15, 2005. Management believes that the future
adoption of FIN 47 will not have a material impact on the Companys financial statements.
20
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Overview
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.
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 strategically focused in 2005 on the development of the VEGF Trap in oncology, the VEGF Trap
in eye diseases, and the IL-1 Trap in various indications in which interleukin-1 is believed to
play a role, including rheumatoid arthritis and other inflammatory conditions. Our clinical and
preclinical pipeline also includes product candidates for the treatment of allergies, asthma, and
other diseases and disorders. 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. Our efforts
have yielded a diverse pipeline of product candidates that we believe has the potential to address
a variety of serious medical conditions. We believe that our ability to develop product candidates
is enhanced by the application of our technology platforms. These platforms are designed to
discover specific genes of therapeutic interest for a particular disease or cell type and validate
targets through high-throughput production of mammalian models. We continue to invest in the
development of enabling technologies to assist in our efforts to identify, develop, and
commercialize new product candidates.
Here is a summary of the clinical status of our clinical candidates as of June 30, 2005:
|
|
|
VEGF TRAP Oncology: Protein-based product candidate designed to bind Vascular
Endothelial Growth Factor (called VEGF, 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 (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. |
21
In April 2004, we initiated a phase 1 trial designed to evaluate the safety, tolerability,
and pharmacokinetics of intravenous VEGF Trap in advanced cancer patients. A total of 27
patients were enrolled and were given one of five dose levels in this ongoing study.
Preliminary results of this trial, which were announced at the annual meeting of the
American Society of Clinical Oncology (ASCO) in May 2005, indicated that:
|
|
|
the VEGF Trap was generally well-tolerated at the dose levels evaluated, |
|
|
|
|
preliminary analyses of tumor blood flow and volume by dynamic contrast-enhanced
Magnetic Resonance Imaging (MRI) scans suggest that the VEGF Trap rapidly induces a
tumor vascular response, and |
|
|
|
|
preliminary efficacy analyses show evidence of tumor size reduction and prolonged
stable disease in some patients after receiving the VEGF Trap as a single agent. |
The VEGF Trap is being developed in collaboration with the sanofi-aventis Group, as
described below. In May 2005, we and the sanofi-aventis Group initiated a safety and tolerability
study of the VEGF Trap in combination with a standard chemotherapy regimen in
patients with advanced solid malignancies. The study includes patients with solid
malignancies that are metastatic or unresectable. In July 2005, we and the sanofiaventis Group initiated a second Phase 1 study of the VEGF Trap in combination with another standard chemotherapy regimen in advanced cancer patients.
We and the sanofi-aventis Group plan to initiate
additional clinical studies in 2005 to evaluate the VEGF Trap as a single-agent and in
combination with other therapies in various cancer indications. During the third quarter of
2004, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the VEGF
Trap for a specific niche cancer indication. As a result of the FDAs decision, we and
the sanofiaventis Group plan to initiate a clinical trial in that indication.
In September 2003, we entered into a collaboration agreement with Aventis Pharmaceuticals,
Inc. (now a member of the sanofi-aventis Group) to jointly develop and commercialize the
VEGF Trap throughout the world with the exception of Japan, where product rights remain with
us. Under the collaboration agreement, as amended in January 2005, we and the sanofi-aventis Group
will share co-promotion rights and profits on sales, if any, of the VEGF Trap for disease
indications included in our collaboration. In December 2004, we earned a $25.0 million
payment from the sanofi-aventis Group, which was received in January 2005, upon the achievement of an
early stage clinical milestone. We may also receive up to $360.0 million in additional
milestone payments upon receipt of specified marketing approvals for up to eight VEGF Trap
indications in Europe or the United States
Under the collaboration agreement, agreed upon development expenses incurred by both
companies during the term of the agreement will be funded by the sanofi-aventis Group. If the
collaboration becomes profitable, we will reimburse the sanofi-aventis Group 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 profit, or at a faster rate at our option.
22
|
|
VEGF TRAP Eye Diseases: VEGF both stimulates angiogenesis and increases vascular
permeability. It has been shown in preclinical studies to be a major pathogenic factor in
diabetic retinopathy, diabetic macular edema, and age-related macular degeneration, and is
believed to be involved in other medical problems affecting the eyes. In January 2005, we
and the sanofi-aventis Group amended our collaboration agreement to exclude rights to develop and
commercialize the VEGF Trap for eye diseases through local delivery systems. |
|
|
|
We now have the exclusive right to develop and commercialize the VEGF Trap for eye diseases
through local administration to the eye; and, in June 2005, we initiated a clinical trial of
the VEGF Trap delivered through intravitreal injection. This phase 1 trial is a
dose-escalating study designed to assess the safety and tolerability of the VEGF Trap in
patients with the neovascular form of age-related macular degeneration (wet AMD). In the
initial part of the trial, patients will receive a single dose of the VEGF Trap delivered by
intravitreal injection into the eye, after which they will be evaluated for three months to
measure the durability of effects and provide guidance for dosing regimens to be used in
future trials. |
|
|
|
Two phase 1 clinical trials of the VEGF Trap delivered systemically in patients with wet AMD
and diabetic macular edema (DME) were completed in 2004. The results of the study of the
VEGF Trap in 25 patients with advanced wet AMD were discussed at the annual meeting of the
Association for Research in Vision and Ophthalmology (ARVO) in May 2005. The trial
successfully met its pre-specified efficacy endpoint as preliminary results from the trial
indicated that the VEGF Trap demonstrated a statistically significant decrease in excess
retinal thickness in treated patients, which increased in both magnitude and duration with
higher doses. The trial results also showed that the VEGF Trap caused a dose-dependent
increase in blood pressure (hypertension), which appears to be a class-effect of
systemically administered anti-VEGF agents. While use of the VEGF Trap for eye diseases
using systemic delivery remains part of our collaboration with the sanofi-aventis Group, we and
the sanofi-aventis Group do not currently intend to pursue further clinical development using systemic
delivery of the VEGF Trap for eye diseases. |
|
|
|
INTERLEUKIN-1 TRAP (IL-1 Trap): Protein-based product candidate designed to bind the
interleukin-1 (called IL-1) cytokine and prevent its interaction with cell surface
receptors. IL-1 may play an important role in a number of rheumatological and other
diseases and disorders, including diseases associated with inflammation in blood vessels. |
|
|
|
In October 2003, we announced that the IL-1 Trap demonstrated evidence of clinical activity
and safety in patients with rheumatoid arthritis in a phase 2 dose-ranging study in
approximately 200 patients. Patients treated with the highest dose, 100 milligrams of the
IL-1 Trap, exhibited non-statistically significant improvements in the proportion of
American College of Rheumatology (ACR) 20 responses versus placebo, the primary endpoint of
the trial. Patients treated with the IL-1 Trap also exhibited improvements in secondary
endpoints of the trial. Patients in this trial experienced statistically significant
reductions in C-reactive protein (CRP) levels, and the improvements in CRP levels
demonstrated a clear dose response to the IL-1 Trap. The IL-1 Trap was generally well
tolerated and no serious drug-related adverse events were reported. |
23
|
|
In July 2005, we initiated a phase 2b study to further evaluate the safety and efficacy of
the IL-1 Trap in rheumatoid arthritis in a double blind, placebo-controlled, multi-center
trial. This trial will enroll 600 patients in clinical sites in North America, Latin
America, and Europe. Patients will be treated with doses of 160 milligrams and 320
milligrams of IL-1 Trap delivered in two subcutaneous injections once a week for 14 weeks.
The primary endpoint of the study will be to measure the efficacy of the IL-1 Trap compared
with placebo in patients with moderately or severely active rheumatoid arthritis who are
being treated concomitantly with methotrexate. Following the initial 14-week period,
patients will continue to receive weekly injections of the IL-1 Trap in a 14-week follow-on
safety evaluation phase. Additional trials of the IL-1 Trap may be required to support an
application seeking approval to market the IL-1 Trap for rheumatoid arthritis. |
|
|
|
In the fourth quarter of 2004, we initiated a pilot study of the IL-1 Trap in patients with
CIAS1-Associated Periodic Syndrome (CAPS), a spectrum of rare diseases associated with
mutations in the CIAS1 gene. IL-1 appears to play a significant role in these diseases
and, in December 2004, the FDA granted orphan drug status to the IL-1 Trap for the treatment
of CAPS. In June 2005, we reported positive preliminary results from this ongoing study in
CAPS. All four patients enrolled in the study as of that date demonstrated a positive
response both to a subcutaneous loading dose of the IL-1 Trap (including a sizable reduction
in daily diary scores and acute reactant levels) and in the ongoing chronic dosing phase of
the study. We expect to initiate an advanced trial in CAPS in 2005. |
|
|
|
We believe blocking IL-1 could also be useful in a number of other potential indications
where inflammation plays a role. Examples include such indications as osteoarthritis,
Stills disease, and cardiovascular diseases. In April 2005, we initiated a
proof-of-concept study of the IL-1 Trap in osteoarthritis. Later this year, we plan to
initiate several other proof-of-concept studies to identify indications where the IL-1 Trap
demonstrates evidence of efficacy and safety. |
|
|
|
Under the terms of our 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, and Novartis has the right to
elect to collaborate in the development and commercialization of our second generation IL-1
Trap, should we decide to develop this product candidate. |
|
|
|
INTERLEUKIN-4/INTERLEUKIN-13 TRAP (IL-4/13 Trap): Protein-based product candidate
designed to bind both the interleukin-4 and interleukin-13 (called IL-4 and IL-13)
cytokines and prevent their interaction with cell surface receptors. Based on preclinical
data, IL-4 and IL-13 are thought to play a role in diseases such as asthma, allergic
disorders, and other inflammatory diseases. At a scientific conference during the second
quarter of 2004, we presented the results of a placebo-controlled, double-blind, dose
escalation phase 1 trial of the IL-4/13 Trap using subcutaneous injections in adult
subjects with mild to moderate asthma. The IL-4/13 Trap was generally safe and well
tolerated at the doses tested. We plan to initiate a phase 2 trial in the next twelve
months |
24
|
|
to evaluate the safety and potential efficacy of the IL-4/13 Trap in asthma or allergy
indications. |
In addition to our clinical programs, we have research programs focused on angiogenesis,
metabolic diseases, muscle atrophy and related disorders, inflammatory conditions, and other
diseases and disorders. We also use our Velocigene® and Trap technology platforms to discover and
develop new product candidates and are developing our VelocimmuneTM platform to
create fully human, therapeutic antibodies.
In June 2005, we and The Procter & Gamble Company amended our Focused Collaboration Agreement
entered into as of December 31, 2000. Under the terms of the modified agreement, the two companies
agreed that the research activities being pursued under the collaboration agreement were completed
on June 30, 2005, six months prior to the December 31, 2005 expiration date in the original
agreement. Procter & Gamble agreed to make a one-time $5.6 million payment to Regeneron, which was
received in July 2005, and to fund Regenerons research for the second quarter of 2005 under the
terms of the collaboration agreement. We agreed to pay Procter & Gamble $950,000 to acquire certain capital
equipment located at our facilities. We and Procter & Gamble divided rights to research programs
and pre-clinical product candidates that were developed during the research term of the
collaboration. Neither party has the right to participate in the development or commercialization
of the other partys product candidates. We are entitled to receive royalties based on any future
product sales of a Procter & Gamble pre-clinical candidate arising from the collaboration. Neither
party is entitled to receive royalties or other payments based on any other products arising from
the collaboration.
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 U.S. Food and Drug Administration (or 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, 2005, we had a cumulative loss of $521.0
million. In the absence of revenues from the commercialization of our product candidates or other
sources, the amount, timing, nature, or source of which cannot be predicted, our losses will
continue as we conduct our research and development activities. We expect to incur substantial
losses over the next several years as we continue the clinical development of the VEGF Trap, IL-1
Trap, and IL-4/13 Trap; advance new product candidates into clinical development from our existing
research programs; continue our research and development programs; and commercialize product
candidates that receive regulatory approval, if any.
Our activities may expand over time and may 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, among other factors, on the progress of our research and
25
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 first half of 2005
clinical events and plans for the remainder of 2005 are as follows:
|
|
|
|
|
|
|
|
|
Product Candidate |
|
|
|
2005 Events to Date |
|
|
|
Additional 2005 Plans |
VEGF
Trap Oncology
|
|
|
|
The sanofi-aventis Group reaffirmed their commitment to the collaborative
development of the VEGF Trap in oncology
|
|
|
|
Initiate additional single-agent and combination trials in cancer |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reported positive preliminary results of phase 1 trial utilizing
intravenous injections |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Initiated two phase 1 studies of the VEGF Trap in combination with
standard chemotherapy regimens |
|
|
|
|
|
|
|
|
|
|
|
|
|
VEGF Trap Eye Diseases
|
|
|
|
Reported positive results from phase 1 trial in patients with wet AMD
utilizing subcutaneous injections
|
|
|
|
Initiate phase 2 clinical trial in eye disease utilizing
intravitreal injections |
|
|
|
|
|
|
|
|
|
|
|
|
|
Initiated phase 1 study in patients with wet AMD utilizing local
delivery by intravitreal injections |
|
|
|
|
|
|
|
|
|
|
|
|
|
IL-1 Trap
|
|
|
|
Completed safety and tolerability studies of IL-1 Trap at higher doses
|
|
|
|
Initiate exploratory proof-of-concept trials in other indications |
|
|
|
|
|
|
|
|
|
|
|
|
|
Initiated clinical trial in osteoarthritis
|
|
|
|
Complete CAPS proof-of-concept study and commence additional trial in this indication |
|
|
|
|
|
|
|
|
|
|
|
|
|
Successfully completed initial treatment phase of proof-of-concept study in CAPS
|
|
|
|
Evaluate IL-1 Trap in other inflammatory conditions |
|
|
|
|
|
|
|
|
|
|
|
|
|
Initiated phase 2b study in rheumatoid arthritis |
|
|
|
|
Accounting for Stock-based Employee Compensation
Effective January 1, 2005, we adopted the fair value based method of accounting for
stock-based employee compensation under the provisions of Statement of Financial Accounting
Standards No. (SFAS) 123, Accounting for Stock-Based Compensation, using the modified prospective
method as described in SFAS 148, Accounting for Stock-Based Compensation- Transition and
Disclosure. As a result, we have begun recognizing expense, in an amount equal
26
to the fair value of share-based payments (including stock option awards) on their date of grant,
over the vesting period of the awards. Under the modified prospective method, we recognize
compensation expense for (a) all share based payments granted on or after January 1, 2005,
(including replacement options granted under our stock option exchange program which concluded on
January 5, 2005) and (b) all awards granted to employees prior to January 1, 2005 that were
unvested on that date. Prior to the adoption of the fair value method, we accounted for
stock-based compensation to employees under the intrinsic value method of accounting set forth in
Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25), and
related interpretations. Therefore, compensation expense related to employee stock options was not
reflected in operating expenses in any period prior to the first quarter of 2005 and prior period
operating results have not been restated. For the three months ended June 30, 2005, non-cash
stock-based employee compensation expense related to stock options awards (Stock Option Expense)
totaled $5.4 million, of which $5.3 million was recognized in operating expenses and $0.1 million
was capitalized in inventory. For the six months ended June 30, 2005, Stock Option Expense totaled
$10.9 million, of which $10.7 million was recognized in operating expenses and $0.2 million was
capitalized in inventory.
Assumptions
We use the Black-Scholes model to estimate the fair value of each option granted under the
Regeneron Pharmaceuticals, Inc. 2000 Long-Term Incentive Plan. Using this model, fair value is
calculated based on assumptions with respect to (i) expected volatility of our Common Stock price,
(ii) the periods of time over which employees and Board Directors are expected to hold their
options prior to exercise (expected lives), (iii) expected dividend yield on our Common Stock, and
(iv) risk-free interest rates, which are based on quoted U.S. Treasury rates for securities with
maturities approximating the options expected lives. Expected volatility has been estimated based
on actual movements in our stock price over the most recent historical periods equivalent to the
options expected lives. Expected lives are principally based on our limited historical exercise
experience with option grants with similar exercise prices. The expected dividend yield is zero as
we have never paid dividends and do not currently anticipate paying any in the foreseeable future.
The following table summarizes the weighted average values of the assumptions we used in computing
the fair value of option grants during the three and six months ended June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, 2005 |
|
June 30, 2005 |
Expected volatility |
|
|
70 |
% |
|
|
75 |
% |
Expected lives |
|
5.0 years |
|
6.2 years |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Risk-free interest rate |
|
|
3.78 |
% |
|
|
3.96 |
% |
Changes in any of these estimates may materially affect the fair value of stock options granted and
the amount of stock-based compensation recognized in any period.
27
Results of Operations
Non-GAAP Financial Measures:
As described above, effective January 1, 2005, Regeneron began recognizing Stock Option
Expense in accordance with SFAS 123 in each of the categories of expense in our Statement of
Operations. Prior to the adoption of SFAS 123, Stock Option Expense was not reflected in operating
expenses and prior period operating results have not been restated.
The discussion of our results of operations for the three and six months ended June 30, 2005
and 2004 includes certain financial measures that are calculated in a manner different from
generally accepted accounting principles (GAAP) and are considered non-GAAP financial measures
under United States Securities and Exchange Commission (SEC) rules. These non-GAAP financial
measures for the three and six months ended June 30, 2005 are: (1) pro forma net income and pro
forma net income per share (basic and diluted), exclusive of Stock Option Expense and (2) research
and development expenses, general and administrative expenses, and contract manufacturing expenses,
all exclusive of Stock Option Expense. Our management does not intend that the presentation of
non-GAAP financial measures be considered in isolation or as a substitute for results prepared in
accordance with GAAP.
Our management believes that the non-GAAP financial measures described above present helpful
information to investors and other users of Regenerons financial statements by providing greater
transparency about the nature of and trends in our operating expenses and net income and a more
useful basis for comparing our operating results for the three and six months ended June 30, 2005
and 2004. In addition, Regenerons management uses non-GAAP financial measures which exclude Stock
Option Expense internally for operating, budgeting, and financial planning purposes. In our
discussion below we have included tables which provide a reconciliation of the differences between
these non-GAAP financial measures and the most directly comparable financial measures calculated
and presented in accordance with GAAP.
Three Months Ended June 30, 2005 and 2004
Net Income (Loss):
Regeneron reported a net loss of $27.0 million, or $0.48 per share (basic and diluted) for the
second quarter of 2005 compared with net loss of $14.5 million, or $0.26 per share (basic and
diluted) for the second quarter of 2004. Excluding Stock Option Expense, Regeneron had a pro forma
net loss of $ 21.7 million, or $0.38 per share (basic and diluted), in the second quarter of 2005
as follows:
For the three months ended June 30, 2005
(in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss per Share |
|
|
Net Loss |
|
Basic and Diluted |
Net loss, as reported |
|
($ |
27.0 |
) |
|
($ |
0.48 |
) |
Add: Stock Option Expense |
|
|
5.3 |
|
|
|
0.10 |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss, exclusive of Stock
Option Expense |
|
($ |
21.7 |
) |
|
($ |
0.38 |
) |
|
|
|
|
|
|
|
|
|
28
Revenues:
Revenues for the three months ended June 30, 2005 and 2004 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
|
2005 |
|
2004 |
Contract research & development revenue |
|
|
|
|
|
|
|
|
The sanofi-aventis Group |
|
$ |
9.4 |
|
|
$ |
23.4 |
|
The Procter & Gamble Company |
|
|
2.9 |
|
|
|
2.7 |
|
Other |
|
|
1.3 |
|
|
|
1.0 |
|
|
|
|
|
|
|
|
|
|
Total contract research & development revenue |
|
|
13.6 |
|
|
|
27.1 |
|
Contract manufacturing revenue |
|
|
2.8 |
|
|
|
1.3 |
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
16.4 |
|
|
$ |
28.4 |
|
|
|
|
|
|
|
|
|
|
Our total revenue decreased to $16.4 million in the second quarter of 2005 from $28.4 million in
the same period of 2004 due primarily to lower revenues related to our collaboration with
the sanofi-aventis Group on the VEGF Trap. Contract research and development revenue, as detailed below,
consists partly of reimbursement for research and development expenses and partly of the
recognition of revenue related to a non-refundable, up-front payment received from the sanofi-aventis Group
in September 2003. Non-refundable, up-front payments are recorded as deferred revenue and
recognized ratably over the period over which we are obligated to perform services in accordance
with Staff Accounting Bulletin No. 104, Revenue Recognition (SAB 104).
Contract research & development revenues earned from the sanofi-aventis Group for the three months ended June 30,
2005 and 2004 were as follows:
For the three months ended June 30, 2005
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front Payment to Regeneron |
|
|
|
|
2005 Regeneron |
|
|
|
|
|
Amount |
|
|
|
|
|
Total Revenue |
|
|
Expense |
|
Total |
|
Recognized |
|
Deferred Revenue |
|
Recognized |
|
|
Reimbursement |
|
Payment |
|
in 2005 |
|
at June 30, 2005 |
|
in 2005 |
The sanofi-aventis Group |
|
$ |
7.1 |
|
|
$ |
80.0 |
|
|
$ |
2.3 |
|
|
$ |
61.1 |
|
|
$ |
9.4 |
|
For the three months ended June 30, 2004
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front Payment to Regeneron |
|
|
|
|
2004 Regeneron |
|
|
|
|
|
Amount |
|
|
|
|
|
Total Revenue |
|
|
Expense |
|
Total |
|
Recognized |
|
Deferred Revenue |
|
Recognized |
|
|
Reimbursement |
|
Payment |
|
in 2004 |
|
at June 30, 2004 |
|
in 2004 |
The sanofi-aventis Group |
|
$ |
20.7 |
|
|
$ |
80.0 |
|
|
$ |
2.7 |
|
|
$ |
70.9 |
|
|
$ |
23.4 |
|
The sanofi-aventis Group reimbursement of Regeneron VEGF Trap expenses decreased in the second quarter
of 2005 from the same period in 2004, primarily due to lower costs in 2005 related to our
29
manufacture of VEGF Trap clinical supplies. We manufactured clinical supplies of VEGF Trap during
the second quarter of 2004, but not during the second quarter of 2005.
Contract manufacturing revenue relates to our long-term agreement with Merck & Co., Inc. to
manufacture a vaccine intermediate at our Rensselaer, New York facility. Contract manufacturing
revenue increased to $2.8 million in the second quarter of 2005 from $1.3 million in the same
period of 2004 as we shipped more product to Merck. Revenue and the related manufacturing expense
are recognized as product is shipped, after acceptance by Merck. Included in contract
manufacturing revenue in the second quarter of 2005 and 2004 was $0.3 million and $0.1 million,
respectively, of deferred revenue associated with capital improvement reimbursements paid by Merck
prior to commencement of production. This deferred revenue is being recognized as product is
shipped to Merck based on the total amount of product expected to be shipped over the life of the
agreement. In February 2005, we agreed to extend the manufacturing agreement by one year through
October 2006 and provide Merck an opportunity, upon twelve months prior notice, to extend the
agreement for an additional year through October 2007. As a result, we are recognizing the
remaining $2.7 million deferred balance of Mercks capital improvement reimbursements as of
December 31, 2004 as revenue as product is shipped to Merck, based upon our estimate of Mercks
order quantities through October 2006.
Expenses:
Total operating expenses increased to $48.5 million in the second quarter of 2005 from $41.0
million in the same period of 2004. Operating expenses in the second quarter of 2005 include a
total of $5.3 million of Stock Option Expense, as follows:
For the three months ended June 30,
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
2004 |
|
|
Expenses as |
|
Stock Option |
|
Expenses exclusive of |
|
Expenses as |
Expenses |
|
Reported |
|
Expense |
|
Stock Option Expense |
|
Reported |
Research and development |
|
$ |
40.6 |
|
|
$ |
3.3 |
|
|
$ |
37.3 |
|
|
$ |
36.3 |
|
Contract manufacturing |
|
|
1.7 |
|
|
|
0.1 |
|
|
|
1.6 |
|
|
|
0.5 |
|
General and administrative |
|
|
6.2 |
|
|
|
1.9 |
|
|
|
4.3 |
|
|
|
4.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
48.5 |
|
|
$ |
5.3 |
|
|
$ |
43.2 |
|
|
$ |
41.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In addition, $0.1 million of Stock Option Expense was capitalized into inventory, for a total
of $5.4 million of Stock Option Expense recognized in the second quarter of 2005. Stock Option
Expense was not included in operating expenses in the second quarter of 2004, as reported in our
Statement of Operations. In the second quarter of 2004, had we adopted the fair value based method
of accounting for stock-based employee compensation under the provisions of SFAS 123, Stock Option
Expense would have totaled $8.6 million. The decrease in total Stock Option Expense of $3.2
million in the second quarter of 2005 was partly due to lower exercise prices of annual employee
option grants made by us in December 2004 in comparison to the exercise prices of annual grants in
recent prior years. Exercise prices of these option grants were generally equal to the fair market
value of our Common Stock on the date of grant. The decrease in Stock Option Expense in the second
quarter of 2005 was also due, in part, to the exchange of options by eligible employees in
connection with our stock option exchange program in January 2005, as the unamortized fair value of
the surrendered options on the date of the exchange is
30
being recognized as Stock Option Expense over a longer time period (the vesting period of the
replacement options) in accordance with SFAS 123.
Research and Development Expenses:
Research and development expenses, exclusive of Stock Option Expense, increased slightly to
$37.3 million in the second quarter of 2005 from $36.3 million in the same period of 2004. The
following table summarizes the major categories of our research and development expenses for the
three months ended June 30, 2005 and 2004:
For the three months ended June 30,
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
2004 |
|
|
Expenses as |
|
Stock Option |
|
Expenses exclusive of |
|
Expenses as |
Research and development expenses |
|
Reported |
|
Expense |
|
Stock Option Expense |
|
Reported (2) |
Payroll and benefits |
|
$ |
14.0 |
|
|
$ |
2.9 |
|
|
$ |
11.1 |
|
|
$ |
10.8 |
|
Clinical trial expenses |
|
|
6.4 |
|
|
|
|
|
|
|
6.4 |
|
|
|
2.4 |
|
Clinical manufacturing costs (1) |
|
|
8.2 |
|
|
|
0.4 |
|
|
|
7.8 |
|
|
|
10.5 |
|
Research and preclinical
development costs |
|
|
5.8 |
|
|
|
|
|
|
|
5.8 |
|
|
|
6.8 |
|
Occupancy and other operating costs |
|
|
6.2 |
|
|
|
|
|
|
|
6.2 |
|
|
|
5.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
40.6 |
|
|
$ |
3.3 |
|
|
$ |
37.3 |
|
|
$ |
36.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents the full cost of manufacturing drug for use in research, preclinical
development and clinical trials, including related payroll and benefits, manufacturing
materials and supplies, depreciation, and occupancy costs of our Rensselaer manufacturing
facility. |
|
(2) |
|
In 2004, research and development expenses as reported in our Statement of Operations
did not include Stock Option Expense. |
Payroll and benefits, exclusive of Stock Option Expense, increased $0.3 million in the
second quarter of 2005 compared to the same period in 2004 as we added research and development
personnel to support our clinical and research programs, especially for the VEGF Trap and IL-1
Trap. Clinical trial expenses increased $4.0 million in the second quarter of 2005 compared to the
same period in 2004 as we both initiated and prepared to initiate new trials in our VEGF Trap and
IL-1 Trap clinical programs in 2005. Clinical manufacturing costs, exclusive of Stock Option
Expense, decreased $2.7 million in the second quarter of 2005 compared to the same period in 2004
as higher costs in 2004 related to manufacturing clinical supplies of VEGF Trap were partly offset
in 2005 by costs to manufacture clinical supplies of IL-1 Trap. Research and preclinical
development costs decreased by $1.0 million in the second quarter of 2005 compared to the same
period in 2004, due primarily to higher preclinical VEGF Trap development costs in 2004. Occupancy
and other operating costs increased by $0.4 million in the second quarter of 2005 compared to the
same period in 2004.
Contract Manufacturing Expenses:
Contract manufacturing expenses, exclusive of Stock Option Expense, increased to $1.6 million
in the second quarter of 2005 compared to $0.5 million in the same period of 2004, primarily
because we shipped more product to Merck.
31
General and Administrative Expenses:
General and administrative expenses, exclusive of Stock Option Expense, increased to $4.3
million in the second quarter of 2005 from $4.2 million in the same period of 2004.
Other Income and Expense:
In June 2005, we and Procter & Gamble amended our collaboration agreement and agreed that the
research activities of both companies under the collaboration agreement were completed. In
connection with the amendment, Procter & Gamble agreed to make a one-time $5.6 million payment to
us, which we recognized as other contract income in the second quarter of 2005.
Investment income increased to $2.5 million in the second quarter of 2005 from $1.1 million in
the same period of 2004 due primarily to higher effective interest rates on investment securities
in 2005. Interest expense was $3.0 million for both the second quarter of 2005 and 2004. Interest
expense is attributable primarily to $200.0 million of convertible notes issued in October 2001,
which mature in 2008 and bear interest at 5.5% per annum.
Six Months Ended June 30, 2005 and 2004
Net Income (Loss):
Regeneron reported a net loss of $31.1 million, or $0.56 per share (basic and diluted) for the
first half of 2005 compared with net income of $50.0 million, or $0.90 per basic share and $0.88
per diluted share, for the same period of 2004. Excluding Stock Option Expense, Regeneron had pro
forma net loss of $20.4 million, or $0.37 per share (basic and diluted), in the first half of 2005
as follows:
For the six months ended June 30, 2005
(in millions, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss per Share - |
|
|
|
Net Loss |
|
|
Basic and Diluted |
|
Net loss, as reported |
|
($ |
31.1 |
) |
|
($ |
0.56 |
) |
Add: Stock Option Expense |
|
|
10.7 |
|
|
|
0.19 |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss, exclusive of
Stock Option Expense |
|
($ |
20.4 |
) |
|
($ |
0.37 |
) |
|
|
|
|
|
|
|
|
|
32
Revenues:
Revenues for the six months ended June 30, 2005 and 2004 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
(In millions) |
|
|
2005 |
|
2004 |
Contract research & development revenue |
|
|
|
|
|
|
|
|
The sanofi-aventis Group |
|
$ |
19.2 |
|
|
$ |
39.8 |
|
Novartis Pharma AG |
|
|
|
|
|
|
22.1 |
|
Procter & Gamble |
|
|
6.0 |
|
|
|
5.4 |
|
Other |
|
|
1.9 |
|
|
|
1.4 |
|
|
|
|
|
|
|
|
|
|
Total contract research & development revenue |
|
|
27.1 |
|
|
|
68.7 |
|
Research progress payment |
|
|
|
|
|
|
17.8 |
|
Contract manufacturing revenue |
|
|
5.5 |
|
|
|
3.9 |
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
32.6 |
|
|
$ |
90.4 |
|
|
|
|
|
|
|
|
|
|
Our total revenue decreased to $32.6 million in the first half of 2005 from $90.4 million in the
same period of 2004 due primarily to lower revenues related to our collaboration with
the sanofi-aventis Group on the VEGF Trap and the absence in the 2005 period of revenues related to our
collaboration with Novartis on the IL-1 Trap which ended in 2004. Collaboration revenue earned
from the sanofi-aventis Group and Novartis is comprised of contract research and development revenue and
research progress payments. Contract research and development revenue, as detailed below, consists
partly of reimbursement for research and development expenses and partly of the recognition of
revenue related to non-refundable, up-front payments. Non-refundable, up-front payments are
recorded as deferred revenue and recognized ratably over the period over which we are obligated to
perform services in accordance with SAB 104.
Contract research & development revenues earned from the sanofi-aventis Group and Novartis for the six months ended
June 30, 2005 and 2004 were as follows:
For the six months ended June 30, 2005
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front Payment to Regeneron |
|
|
|
|
2005 Regeneron |
|
|
|
|
|
Amount |
|
|
|
|
|
Total Revenue |
|
|
Expense |
|
Total |
|
Recognized |
|
Deferred Revenue |
|
Recognized |
|
|
Reimbursement |
|
Payment |
|
in 2005 |
|
at June 30, 2005 |
|
in 2005 |
The sanofi-aventis Group |
|
$ |
14.5 |
|
|
$ |
80.0 |
|
|
$ |
4.7 |
|
|
$ |
61.1 |
|
|
$ |
19.2 |
|
For the six months ended June 30, 2004
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front Payment to Regeneron |
|
|
|
|
2004 Regeneron |
|
|
|
|
|
Amount |
|
|
|
|
|
Total Revenue |
|
|
Expense |
|
Total |
|
Recognized |
|
Deferred Revenue |
|
Recognized |
|
|
Reimbursement |
|
Payment |
|
in 2004 |
|
at June 30, 2004 |
|
in 2004 |
The sanofi-aventis Group |
|
$ |
34.3 |
|
|
$ |
80.0 |
|
|
$ |
5.5 |
|
|
$ |
70.9 |
|
|
$ |
39.8 |
|
Novartis |
|
|
|
|
|
|
27.0 |
|
|
|
22.1 |
|
|
|
|
|
|
|
22.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
34.3 |
|
|
$ |
107.0 |
|
|
$ |
27.6 |
|
|
$ |
70.9 |
|
|
$ |
61.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33
The
sanofi-aventis Group reimbursement of Regeneron VEGF Trap expenses decreased in the first half of
2005 from the same period in 2004, primarily due to lower costs in 2005 related to our manufacture
of VEGF Trap clinical supplies. We manufactured clinical supplies of VEGF Trap during the first
six months of 2004, but not during the first six months of 2005. In the first quarter of 2004,
Novartis provided notice of its intention not to proceed with the joint development of the IL-1
Trap and the remaining balance of the $27.0 million up-front payment received from Novartis in
March 2003 was recognized as contract research and development revenue. Since the first quarter of
2004, we have not received, and do not expect to receive, any further contract research and
development revenue from Novartis.
In March 2004, Novartis forgave all of its outstanding loans, including interest, to us,
totaling $17.8 million, based upon our achievement of a pre-defined IL-1 Trap development
milestone, which was recognized as a research progress payment.
Contract manufacturing revenue increased to $5.5 million in the first half of 2005 from $3.9
million in the same period of 2004 as we shipped more product to Merck in 2005. Included in
contract manufacturing revenue in both the first six months of 2005 and 2004 was $0.6 million of
deferred revenue associated with capital improvement reimbursements paid by Merck prior to
commencement of production. This deferred revenue is being recognized as product is shipped to
Merck based on the total amount of product expected to be shipped over the term of the agreement.
Expenses:
Total operating expenses increased to $93.1 million in the first half of 2005 from $79.3
million in the same period of 2004. Operating expenses in the first half of 2005 include a total
of $10.7 million of Stock Option Expense, as follows:
For the six months ended June 30,
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
Expenses as |
|
Stock Option |
|
Expenses exclusive of |
|
Expenses as |
Expenses |
|
Reported |
|
Expense |
|
Stock Option Expense |
|
Reported |
Research and development |
|
$ |
76.5 |
|
|
$ |
6.7 |
|
|
$ |
69.8 |
|
|
$ |
68.5 |
|
Contract manufacturing |
|
|
4.2 |
|
|
|
0.1 |
|
|
|
4.1 |
|
|
|
2.8 |
|
General and administrative |
|
|
12.4 |
|
|
|
3.9 |
|
|
|
8.5 |
|
|
|
8.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
$ |
93.1 |
|
|
$ |
10.7 |
|
|
$ |
82.4 |
|
|
$ |
79.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In addition, $0.2 million of Stock Option Expense was capitalized into inventory, for a total
of $10.9 million of Stock Option Expense recognized in the first half of 2005. Stock Option
Expense was not included in operating expenses in the first half of 2004, as reported in our
Statement of Operations. In the first half of 2004, had we adopted the fair value based method of
accounting for stock-based employee compensation under the provisions of SFAS 123, Stock Option
Expense would have totaled $17.5 million. The decrease in total Stock Option Expense of $6.6
million in the first half of 2005 was partly due to lower exercise prices of annual employee option
grants made by us in December 2004 in comparison to the exercise prices of annual grants in recent
prior years. Exercise prices of these option grants were generally equal to the fair market value
of our Common Stock on the date of grant. The decrease in Stock Option Expense in the first half
of 2005 was also due, in part, to the exchange of options by eligible
34
employees in connection with our stock option exchange program in January 2005, as the unamortized
fair value of the surrendered options on the date of the exchange is being recognized as Stock
Option Expense over a longer time period (the vesting period of the replacement options) in
accordance with SFAS 123.
Research and Development Expenses:
Research and development expenses, exclusive of Stock Option Expense, increased to $69.8
million in the first half of 2005 from $68.5 million in the same period of 2004. The following
table summarizes the major categories of our research and development expenses for the six months
ended June 30, 2005 and 2004:
For the six months ended June 30,
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
Expenses as |
|
Stock Option |
|
Expenses exclusive of |
|
Expenses as |
Research and development expenses |
|
Reported |
|
Expense |
|
Stock Option Expense |
|
Reported (2) |
Payroll and benefits |
|
$ |
28.4 |
|
|
$ |
5.9 |
|
|
$ |
22.5 |
|
|
$ |
20.9 |
|
Clinical trial expenses |
|
|
8.5 |
|
|
|
|
|
|
|
8.5 |
|
|
|
5.8 |
|
Clinical manufacturing costs (1) |
|
|
17.3 |
|
|
|
0.8 |
|
|
|
16.5 |
|
|
|
18.9 |
|
Research and preclinical
development costs |
|
|
10.7 |
|
|
|
|
|
|
|
10.7 |
|
|
|
11.8 |
|
Occupancy and other operating costs |
|
|
11.6 |
|
|
|
|
|
|
|
11.6 |
|
|
|
11.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
76.5 |
|
|
$ |
6.7 |
|
|
$ |
69.8 |
|
|
$ |
68.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents the full cost of manufacturing drug for use in research, preclinical
development and clinical trials, including related payroll and benefits, manufacturing
materials and supplies, depreciation, and occupancy costs of our Rensselaer manufacturing
facility. |
|
(2) |
|
In 2004, research and development expenses as reported in our Statement of Operations
did not include Stock Option Expense. |
Payroll and benefits, exclusive of Stock Option Expense, increased $1.6 million in the
first half of 2005 compared to the same period in 2004 as we added research and development
personnel to support our clinical and research programs, especially for the VEGF Trap and IL-1
Trap. Clinical trial expenses increased $2.7 million in the first half of 2005 compared to the
same period in 2004 as we both initiated and prepared to initiate new trials in our VEGF Trap and
IL-1 Trap clinical programs in 2005. Clinical manufacturing costs, exclusive of Stock Option
Expense, decreased $2.4 million in the first half of 2005 compared to the same period in 2004 as
higher costs in 2004 related to manufacturing clinical supplies of VEGF Trap were partly offset in
2005 by costs to manufacture clinical supplies of IL-1 Trap. Research and preclinical development
costs decreased by $1.1 million in the first half of 2005 compared to the same period in 2004 due
primarily to higher preclinical VEGF Trap development costs in 2004. Occupancy and other operating
costs increased by $0.5 million in the first half of 2005 compared to the same period in 2004.
Contract Manufacturing Expenses:
Contract manufacturing expenses, exclusive of Stock Option Expense, increased to $4.1 million
in the first half of 2005 from $2.8 million in the same period of 2004, primarily because we
shipped more product to Merck in 2005.
35
General and Administrative Expenses:
General and administrative expenses, exclusive of Stock Option Expense, increased to $8.5
million in the first half of 2005 from $8.0 million in the same period of 2004 due primarily to
higher administrative personnel and facility costs.
Other Income and Expense:
In June 2005, we and Procter & Gamble amended our collaboration agreement and agreed that the
research activities of both companies under the collaboration agreement were completed. In
connection with the amendment, Procter & Gamble agreed to make a one-time $5.6 million payment to
us, which we recognized as other contract income in the second quarter of 2005. In January 2005,
we and the sanofi-aventis Group amended our collaboration agreement to exclude rights to develop and
commercialization the VEGF Trap for eye diseases through local delivery systems. In connection
with the amendment, the sanofi-aventis Group made a one-time $25.0 million payment to us, which was
recognized as other contract income in the first quarter of 2005. In the first quarter of 2004,
Novartis notified us of its decision to forgo its right under the collaboration to jointly develop
the IL-1 Trap and agreed to pay us $42.75 million to satisfy its obligation to fund development
costs for the IL-1 Trap for the nine-month period following its notification and for the two months
prior to that notice. The $42.75 million was included in other contract income in the first
quarter of 2004.
Investment income increased to $4.8 million in the first half of 2005 from $2.2 million in the
same period of 2004 due primarily to higher effective interest rates on investment securities in
2005. Interest expense decreased slightly to $6.0 million in the first half of 2005 from $6.1
million in the same period of 2004. Interest expense is attributable primarily to $200.0 million
of convertible notes issued in October 2001, which mature in 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, revenue earned under our past and
present research and development and contract manufacturing agreements, including our agreements
with the sanofi-aventis Group, Novartis, Procter & Gamble, and Merck, and investment income.
Change in Classification
We have revised the classification of our investments in auction rate securities from cash and
cash equivalents to short-term investments in our previously issued financial statements. Auction
rate securities are securities that have stated maturities beyond three months, but are priced and
traded as short-term investments due to the liquidity provided through the auction mechanism that
generally resets interest rates every 28 or 35 days. The change in classification resulted in a
decrease in cash and cash equivalents and corresponding increase in short-term marketable
securities at each balance sheet date. In addition, we revised our statements of cash flows to
reflect the purchases and sales of these securities as investing activities rather than as a
component of cash and cash equivalents. This change in classification had no impact on our
36
previously reported current assets, net income (loss), or cash flows from operations. We held
no auction rate securities at June 30, 2005.
The impact of the revision to the classification of our investments in auction rate securities
on previously reported amounts for cash and cash equivalents and short-term marketable securities
at December 31, 2004 and 2003, and cash flows provided by (used in) investing activities for the
three month, six month, and nine month periods ended March 31, 2004, June 30, 2004, and September
30, 2004, respectively, and the years ended December 31, 2004 and 2003, is as follows:
Balance Sheet Impact at December 31, 2004 and 2003
|
|
|
|
|
|
|
|
|
(in millions) |
|
2004 |
|
|
2003 |
|
As originally reported: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
101.2 |
|
|
$ |
118.3 |
|
Short-term marketable securities |
|
|
194.8 |
|
|
|
164.6 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
296.0 |
|
|
$ |
282.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revised to reflect auction rate securities as short-term investments: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
95.2 |
|
|
$ |
97.5 |
|
Short-term marketable securities |
|
|
200.8 |
|
|
|
185.4 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
296.0 |
|
|
$ |
282.9 |
|
|
|
|
|
|
|
|
|
|
Statement of Cash Flows Impact for the three month, six month, and nine month periods ended
March 31, June 30, and September 30, 2004, respectively, and the years ended December 31, 2004 and
2003
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
September 30, |
|
|
December 31, |
|
|
|
2004 |
|
|
2004 |
|
|
2004 |
|
|
2004 |
|
|
2003 |
|
As originally reported: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in)
investing activities |
|
$ |
70.2 |
|
|
$ |
1.2 |
|
|
|
($12.1 |
) |
|
($ |
4.6 |
) |
|
|
($63.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revised to reflect auction rate securities
as short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in)
investing activities |
|
$ |
73.2 |
|
|
$ |
4.2 |
|
|
|
($4.7 |
) |
|
$ |
10.2 |
|
|
|
($49.6 |
) |
These revised amounts, as applicable, are reflected in this Quarterly Report on Form 10-Q for
the period ended June 30, 2005, and will be included in our Quarterly Report on Form 10-Q for the
period ended September 30, 2005 and our Annual Report on Form 10-K for the year ended December 31,
2005.
Six Months Ended June 30, 2005 and 2004
Cash Provided by (Used in) Operations:
At June 30, 2005, we had $351.6 million in cash, cash equivalents, and marketable securities
compared with $348.9 million at December 31, 2004. In January 2005, we received two $25.0 million
payments from the sanofi-aventis Group. One payment was related to a VEGF Trap clinical milestone that was
earned in December 2004. The second payment related to changes to our collaboration agreement with
the sanofi-aventis Group that were made in January 2005.
37
In the first half of 2005, our net loss was $31.1 million but cash provided by our operations
was $4.5 million, principally due to receipts during this period from the sanofi-aventis Group for (i)
reimbursement of VEGF Trap development expenses incurred by us and (ii) the $25.0 million clinical
milestone payment earned in December 2004. In addition, our net loss in the first half of 2005
included $11.7 million of non-cash stock-based employee compensation costs, of which $10.7 million
represents Stock Option Expense resulting from our adoption of SFAS 123 in January 2005. In the
first half of 2004, our net income was $50.0 million but we used $1.1 million of cash in
operations. The difference between net income and cash usage was primarily due to the recognition
of $39.9 million of non-cash deferred and research progress payment revenue pursuant to our
collaboration agreement with Novartis.
Cash Provided by Investing Activities:
Net cash provided by investing activities increased to $44.4 million in the first half of 2005
from $4.2 million in the same period in 2004, due primarily to an increase in sales or maturities
of marketable securities, net of purchases. In the first half of 2005, sales or maturities of
marketable securities exceeded purchases by $47.3 million, whereas in the first half of 2004, sales
or maturities of marketable securities exceeded purchases by $6.8 million.
Cash Provided by Financing Activities:
Cash provided by financing activities decreased to $1.0 million in the first half of 2005 from
$4.4 million in the same period in 2004. In accordance with our collaboration agreement with
Novartis, we elected to fund our share of 2003 IL-1 Trap development expenses through a loan from
Novartis that was forgiven in March 2004 upon our achievement of a pre-defined IL-1 Trap
development milestone. In the first quarter of 2004, we drew $3.8 million, excluding interest,
against this loan facility for expenses incurred during 2003.
The sanofi-aventis Group Agreement:
In January 2005, we and the sanofi-aventis Group amended our collaboration agreement to exclude rights
to develop and commercialize the VEGF Trap for eye diseases through local delivery systems. In
connection with this amendment, the sanofi-aventis Group made a one-time $25.0 million payment to us. Under
the collaboration agreement, as amended, we and the sanofi-aventis Group will share co-promotion rights for
and profits on sales, if any, of the VEGF Trap for disease indications included in our
collaboration. We will manufacture clinical supplies of the VEGF Trap at our plant in Rensselaer,
New York and the sanofi-aventis Group is responsible for providing commercial scale manufacturing capacity
for the VEGF Trap.
Under the collaboration agreement, as amended, agreed upon development expenses incurred by
both companies during the term of the agreement, including costs associated with the manufacture of
clinical drug supply, will be funded by the sanofi-aventis Group. If the collaboration becomes profitable,
we will reimburse the sanofi-aventis Group for 50% of these development expenses, including 50% of the $25.0
million payment received in connection with the January 2005 amendment to our collaboration
agreement, in accordance with a formula based on the amount of development expenses and our share
of the collaboration profits, or at a faster rate at our option. In addition, if the first
commercial sale of a VEGF Trap product for diseases of the eye through
38
local delivery systems predates the first commercial sale of a VEGF Trap product under the
collaboration, we will begin reimbursing the sanofi-aventis Group for up to $7.5 million of VEGF Trap
development expenses commencing two years after such initial commercialization outside the
collaboration in accordance with a formula until the first commercial VEGF Trap sale under the
collaboration occurs.
Capital Expenditures:
Our additions to property, plant, and equipment totaled $3.8 million and $2.9 million for the
first six months of 2005 and 2004, respectively. During the remainder of 2005, we expect to incur
approximately $4 million to $6 million in capital expenditures which primarily consists of
equipment for our manufacturing, research, and development activities.
Funding Requirements:
We expect to continue to incur substantial funding requirements primarily for research and
development activities (including preclinical and clinical testing). We currently anticipate that
for all of 2005, approximately 55%-65% of our expenditures will be directed toward the preclinical
and clinical development of product candidates, including the VEGF Trap for oncology, VEGF Trap for
eye diseases, IL-1 Trap, and IL-4/13 Trap; approximately 20%-30% of our expenditures will be
applied to our basic research activities and the continued development of our novel technology
platforms; and the remainder of our expenditures for 2005 will be used for capital expenditures and
general corporate purposes.
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 any collaborative research and development
collaborations. 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,
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.
Also, under the terms of the the sanofi-aventis Group collaboration agreement, if the collaboration
becomes profitable, we will reimburse the sanofi-aventis Group for 50% of the VEGF Trap development expenses,
including 50% of the $25.0 million payment received in connection with amending our collaboration
agreement in January 2005, in accordance with a formula based on the amount of development expenses
and our share of the collaboration profits, or at a faster rate at our option. In addition, if the
first commercial sale of a VEGF Trap product for diseases of the eye through local delivery systems
predates the first commercial sale of a VEGF Trap product under the
39
collaboration, we will begin reimbursing the sanofi-aventis Group for up to $7.5 million of VEGF Trap
development expenses commencing two years after such initial commercialization outside the
collaboration in accordance with a formula until the first commercial VEGF Trap sale under the
collaboration occurs. The sanofi-aventis Group has the right to terminate the agreement without cause with at
least twelve months advance notice. Upon termination of the agreement for any reason, any remaining
obligation to reimburse the sanofi-aventis Group for 50% of the VEGF Trap development expenses will terminate
and we will retain all rights to the VEGF Trap.
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 mid-2007. 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. We have no off-balance sheet
arrangements and do not guarantee the obligations of any other entity. As of June 30, 2005, 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. In January 2005, we filed a shelf registration statement on Form S-3
to sell, in one or more offerings, up to $200.0 million of equity or debt securities, together or
separately, which registration statement was declared effective in February 2005. However, there
is no assurance that we will be able to complete any such offerings of securities. 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
During the six months ended June 30, 2005, there were no changes to our critical accounting
policies and significant judgments and estimates, as described in our Annual Report on Form 10-K
for the year ended December 31, 2004.
Future Impact of Recently Issued Accounting Standards
In December 2004, the Financial Accounting Standards Board issued SFAS 123R, Share-Based
Payment. SFAS 123R is a revision of SFAS 123, Accounting for Stock-Based Compensation (which we
adopted effective January 1, 2005), and supersedes APB 25, Accounting for Stock Issued to
Employees, and its related implementation guidance. SFAS 123R focuses primarily on accounting for
transactions in which an entity obtains employee services in share-based payment transactions, and
requires the recognition of compensation expense in an
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amount equal to the fair value of the share-based payment (including stock options and
restricted stock) issued to employees. SFAS 123R is effective for fiscal years beginning after
June 15, 2005. In March 2005, the U.S. Securities and Exchange Commission (SEC) issued Staff
Accounting Bulletin No. 107 (SAB 107) which expresses views of the SEC staff regarding the
application of SFAS 123R. Among other things, SAB 107 provides interpretive guidance related to
the interaction between SFAS 123R and certain SEC rules and regulations as well as the SEC staffs
views regarding the valuation of share-based payment arrangements for public companies. We will be
required to adopt SFAS 123R effective for the fiscal year beginning January 1, 2006, and intend to
do so using the modified prospective method. Under the modified prospective method, compensation
cost is recognized beginning with the effective date based on (a) the requirements of SFAS 123R for
all share-based payments granted after the effective date and (b) the requirements of SFAS 123 for
all awards granted to employees prior to the effective date of SFAS 123R that remain unvested on
the effective date. In addition, we will consider the guidance of SAB 107 as we adopt SFAS 123R.
Although the impact of adopting SFAS 123R has not yet been quantified, management believes that the
future adoption of this standard may have a material impact on our financial statements.
In March 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections. SFAS 154
replaces APB Opinion No. 20, Accounting Changes, and SFAS 3, Reporting Accounting Changes in
Interim Financial Statements, and requires retrospective application to prior-period financial
statements of changes in accounting principle, unless it is impracticable to determine either the
period-specific effects or the cumulative effect of a change. SFAS 154 also redefines
restatement as the revising of previously issued financial statements to reflect the correction
of an error. SFAS 154 is effective for accounting changes and corrections of errors made in fiscal
years beginning after December 15, 2005. We are required to adopt the provisions of SFAS 154, as
applicable, effective for the fiscal year beginning January 1, 2006.
In March 2005, the FASB issued Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations (FIN 47) which clarifies that the term conditional asset retirement, as
used in SFAS 143, Accounting for Asset Retirement Obligations, refers to a legal obligation to
perform an asset retirement activity in which the timing and/or method of settlement are
conditional on a future event that may or may not be within the control of the entity. FIN 47
requires that a liability be recognized for the fair value of a conditional asset retirement
obligation when incurred, if the fair value of the liability can be reasonably estimated.
Uncertainty about the timing and method of settlement of a conditional asset retirement obligation
would be factored into the measurement of the liability when sufficient information exists. FIN 47
is effective no later than the end of fiscal years ending after December 15, 2005. Management
believes that the future adoption of FIN 47 will not have a material impact on our financial
statements.
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
41
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 our Annual Report on Form 10-K 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, 2005, we had a cumulative loss of $521.0
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. We
currently receive contract manufacturing revenue from our agreement with Merck and, until June 30,
2005, we received contract research and development revenue from our agreement with Procter &
Gamble. Our agreement with Merck is scheduled to expire before the end of 2006, unless extended
for one additional year by Merck. Our agreement with Procter & Gamble expired in June 2005. The
expiration of these agreements will result in a significant loss of revenue to the Company, which
may negatively affect our business, operating results, and financial condition.
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 mid-2007; 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.
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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.
We have adopted, effective January 1, 2005, the fair market value based method of accounting for
stock-based employee compensation. This will materially increase operating expenses in our
Statement of Operations, primarily due to non-cash compensation costs related to stock options.
We have adopted, effective January 1, 2005, the fair value based method of accounting for
stock-based employee compensation under the provisions of SFAS 123, Accounting for Stock Based
Compensation, using the modified prospective method as described in SFAS 148, Accounting for Stock
Based Compensation Transition and Disclosure. As a result, we have begun recognizing expense in
an amount equal to the fair value of share-based payments (including stock option awards) on their
date of grant over the vesting period of the awards. Although the impact of adopting SFAS 123 has
not been quantified for the full year 2005, in the first half of 2005, non-cash stock-based
employee compensation expense of $10.7 million related to stock options awards was recognized in
operating expenses in our Statement of Operations, which decreased our basic net income per share
by $0.19 per share. Also, if we had adopted SFAS 123 effective January 1, 2004, our net income for
the full year 2004 would have decreased by approximately $33.6 million and our basic net income per
share in 2004 would have been $0.15 per share instead of $0.75 per share.
In addition, in December 2004, the FASB issued SFAS 123R, Share-Based Payment, which is a
revision of SFAS 123 and supersedes APB 25, Accounting for Stock Issued to Employees. SFAS 123R
requires the recognition of compensation expense in an amount equal to the fair value of
share-based payments (including stock options) issued to employees. We will be required to adopt
SFAS 123R effective for the fiscal year beginning January 1, 2006. The impact of adopting SFAS
123R has not yet been quantified.
The negative impact on our income (loss) as a result of adopting SFAS 123 as of January 1,
2005, and subsequently adopting SFAS 123R commencing January 1, 2006, may negatively affect our
stock price.
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
43
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 payors and on our and 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 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.
In October 2003, we reported results from the first phase 2 trial of our IL-1 Trap in
rheumatoid arthritis. We have initiated a large-scale rheumatoid arthritis trial of the IL-1 Trap
in a larger patient population, testing higher doses than were tested in the previous phase 2 trial
for a longer period of time. However, higher doses may not lead to better results than were
demonstrated in the previous phase 2 trial. In addition, safety or tolerability concerns may arise
which limit our ability to deliver higher doses of the IL-1 Trap to patients. The dose levels that
are being tested are substantially higher than the dose levels of other biological therapeutics
currently approved for the treatment of rheumatoid arthritis. The higher doses may affect the
safety and/or tolerability of the IL-1 Trap, which could delay or prevent its being approved for
marketing and sale and could limit its commercial potential if the product candidate is ever
approved.
We intend to study our lead product candidates, the VEGF Trap and IL-1 Trap, in a wide variety
of indications. We intend to study the VEGF Trap in a variety of cancer settings and
ophthalmologic indications and the IL-1 Trap in a wide variety of inflammatory disorders. The
specific indications were selected based on available preclinical and clinical data from medical
publications, our product candidates, and competitive agents. The purpose of these exploratory
studies is to identify what diseases, if any, are best suited for treatment with these product
candidates. However, 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 these studies. In fact, our product candidates may not demonstrate the
requisite efficacy and safety profile to support the continued development for any of the
indications studied in these early-stage trials.
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, and the failure of clinical investigators, trial
44
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 the IL-1 Trap after a previous phase 2 trial of the IL-1 Trap 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.
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.
Our VEGF Trap is being studied for the potential treatment of certain types of cancer and
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 VEGF Trap, include bleeding,
hypertension, and proteinuria. These serious side effects and other serious side effects have been
reported in our 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, referred to as infusion reactions. These and other
complications or side effects could harm the development of the VEGF Trap for either the treatment
of cancer or diseases of the eye.
45
Although the IL-1 Trap was generally well tolerated and was not associated with any
drug-related serious adverse events in the phase 2 rheumatoid arthritis study completed in 2003,
safety or tolerability concerns may arise as we test higher doses of the IL-1 Trap in patients with
rheumatoid arthritis and other inflammatory diseases and disorders. Like TNF-antagonists such as
EnbrelÒ (a registered trademark of Amgen) and RemicadeÒ (a registered trademark of
Centocor), the IL-1 Trap affects the immune defense system of the body by blocking some of its
functions. Therefore, there may be an increased risk for infections to develop in patients treated
with the IL-1 Trap. In addition, patients given infusions of the IL-1 Trap have developed
hypersensitivity reactions, referred to as infusion reactions. These and other complications or
side effects could harm the development of the IL-1 Trap.
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
appearance is often delayed, so that there can be no assurance that neutralizing antibodies will
not be created at a later date in some cases even after pivotal clinical trials have been
completed. Subjects who received the IL-1 Trap in clinical trials have developed antibodies. It is
possible that as we test the VEGF Trap with more sensitive assays in different patient populations
and larger clinical trials, we will find that subjects given the VEGF Trap develop antibodies to
the product candidate.
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 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.
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
46
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. We are currently involved in a product liability lawsuit brought by a
subject who participated in a clinical trial of one of our drug candidates. 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.
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 increased 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
47
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, 2004, which report was included in our Annual Report on Form
10-K for the year ended December 31, 2004. 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.
Risks Related to Our Dependence on Third Parties
On February 27, 2004, Novartis Pharma AG provided notice to us that they would not participate in
the continued development and commercialization of the IL-1 Trap under our collaboration agreement.
This may harm our ability to develop and commercialize the IL-1 Trap.
We relied heavily on Novartis to provide their expertise, resources, funding, manufacturing
capacity, clinical expertise, and commercial infrastructure to support the IL-1 Trap program.
Novartis decision to withdraw from participating in the development and commercialization of the
IL-1 Trap may delay or disrupt the IL-1 Trap program. We do not have the resources and skills to
replace those of Novartis, which could result in significant delays in the development and
potential commercialization of the IL-1 Trap. In addition, we will have to fund the development and
commercialization of the IL-1 Trap without Novartis long-term commitment, which will require
substantially greater expenditures on our part.
If our collaboration with the sanofi-aventis Group 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 the sanofi-aventis Group to assist with the development of the VEGF Trap oncology
program. If the VEGF Trap oncology program continues, we will rely on the sanofi-aventis Group to assist with
funding the VEGF Trap program, providing commercial manufacturing capacity, enrolling and
monitoring clinical trials, obtaining regulatory approval, particularly outside the United States,
and providing sales and marketing support. While we cannot assure you that the VEGF Trap will ever
be successfully developed and commercialized, if the sanofi-aventis Group does not perform its obligations in
a timely manner, or at all, our ability to develop, manufacture, and commercialize the VEGF Trap in
cancer indications will be significantly adversely affected. The
sanofi-aventis Group has the right to
terminate its collaboration agreement with us at any time. If the sanofi-aventis Group were to terminate its
collaboration agreement with us, we might 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
the sanofi-aventis Group collaboration agreement would create new and additional risks to the successful
development of the VEGF Trap oncology program.
48
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 the sanofi-aventis Group 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 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.
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.
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.
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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. Under a long-term
manufacturing agreement with Merck, which expires in October 2006 unless extended for one
additional year by Merck, we produce an intermediate for a Merck pediatric vaccine at our facility
in Rensselaer, New York. We also use our facilities to produce API for our own clinical and
preclinical candidates. If we no longer use our facilities to manufacture the Merck intermediate or
clinical candidates are discontinued, we would have to absorb 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
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
50
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 the sanofi-aventis Group, we currently rely on the sanofi-aventis Group for sales,
marketing, and distribution of the VEGF Trap, 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,
and we may be unsuccessful in developing our own sales, marketing, and distribution organization.
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. 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, IL-1 Trap, and IL-4/13 Trap, 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.
Even if our product candidates are ever approved, their commercial success is highly uncertain
because our 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, 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, on the market for treating certain
cancers and many different pharmaceutical and biotechnology companies are working to develop
competing VEGF antagonists, including Novartis, Eyetech 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. Onyx Pharmaceuticals
and Bayer have filed an New Drug Application with the FDA for approval to market the first oral
medication that targets tumor cell growth and new vasculature formation that fuels the growth of
tumors. The marketing approval for Genentechs VEGF antagonist, Avastin,
51
and their extensive, ongoing clinical development plan for Avastin 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 and, if approved by the FDA, the Onyx/Bayer
kinase inhibitor and the Novartis phase 3 tyrosine kinase, 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 diseases is also very competitive. Eyetech Pharmaceuticals and Pfizer are
marketing an approved VEGF inhibitor for age-related macular degeneration (wet AMD). Novartis and
Genentech are collaborating on another VEGF inhibitor for the treatment of wet AMD that is in phase
3 development. In July 2005, Genentech announced positive results from its phase 3 clinical trial
of this VEGF inhibitor in patients with wet AMD. The marketing approval of the Eyetech/Pfizer VEGF
inhibitor and the potential approval of the Novartis/Genentech VEGF antibody fragment makes it more
difficult for us to successfully develop the VEGF Trap in eye diseases. In addition, even if the
VEGF Trap is ever approved for sale for the treatment of eye diseases, it will be difficult for our
drug to compete against the Eyetech/Pfizer drug and, if approved by the FDA, the Novartis/Genentech
phase 3 VEGF inhibitor, because doctors and patients will have significant experience using these
medicines
The markets for both rheumatoid arthritis and asthma are very competitive. Several highly
successful medicines are available for these diseases. Examples in rheumatoid arthritis include the
TNF-antagonists Enbrel® (a registered trademark of Amgen), Remicade® (a registered trademark of
Centocor), and Humira® (a registered trademark of Abbott Laboratories), and the IL-1 receptor
antagonist Kineret® (a registered trademark of Amgen). Examples in asthma include the
leukotriene-modifier Singulair® (a registered trademark of Merck), as well as various inexpensive
corticosteroid medicines for asthma.
The availability of highly effective FDA approved TNF-antagonists and other marketed therapies
makes it more difficult to successfully develop the IL-1 Trap for the treatment of rheumatoid
arthritis, since it will be difficult to enroll patients with rheumatoid arthritis to participate
in clinical trials of the IL-1 Trap. This may delay or impair our ability to successfully develop
the drug candidate. In addition, even if the IL-1 Trap is ever approved for sale, it will be
difficult for our drug to compete against these FDA approved TNF-antagonists because doctors and
patients will have significant experience using these effective medicines. Moreover, these approved
therapeutics may offer competitive advantages over the IL-1 Trap, such as requiring fewer
injections. In addition, 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, Novartis is developing an antibody to interleukin-1, Amgen is
developing an antibody to the interleukin-1 receptor, and Vertex Pharmaceuticals Incorporated is
developing an oral cytokine inhibitor of interleukin-1 beta converting enzyme (ICE). These drug
candidates could offer competitive advantages over the IL-1 Trap. The successful development of
these competing molecules could delay or impair our ability to successfully develop and
commercialize the IL-1 Trap.
52
We are developing the IL-1 Trap for the treatment of a spectrum of rare diseases associated
with mutations in the CIAS-1 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 the IL-1 Trap 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 payors.
Sales of biopharmaceutical products largely depend on the reimbursement of patients medical
expenses by government health care programs and private health insurers. Without the financial
support of the governments or third-party payors, the market for any biopharmaceutical product will
be limited. These third-party payors increasingly challenge the price and examine the
cost-effectiveness of products and services. Significant uncertainty exists as to the reimbursement
status of any new therapeutic, particularly if there exist lower-cost standards of care.
Third-party payors may not reimburse sales of our products, which would harm our business.
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 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 Roy
Vagelos, M.D., the Chairman of our Board of Directors, Leonard Schleifer, M.D., Ph.D., our
President and Chief Executive Officer, and George D. Yancopoulos, M.D., Ph.D., our Executive Vice
President, Chief Scientific Officer and President, Regeneron Research Laboratories. 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 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
53
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 expensive and time consuming.
We may be restricted in our development and/or commercialization activities by third party patents.
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 Trap products in clinical development, either because they claim to hold
proprietary rights to fusion proteins or proprietary rights to components of the Trap or the way it
is manufactured. We are aware of certain United States and foreign patents relating to particular
IL-4 and IL-13 receptors. Our IL-4/13 Trap includes portions of the IL-4 and IL-13 receptors. In
addition, we are aware of a broad patent held by Genentech relating to proteins fused to certain
immunoglobulin domains. Our Trap product candidates include proteins fused to immunoglobulin
domains. Although we do not believe that we are infringing valid and enforceable third party
patents, the holders of these patents may sue us for infringement and a court may find that we are
infringing one or more validly issued patents, which may materially harm our business.
We are aware of patents, allowed patent applications, and pending applications owned by
Genentech that claim certain chimeric VEGF receptor compositions. Although we do not believe that
the VEGF Trap 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. 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, 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 could materially harm our business either by requiring us to
seek a license or resulting in our inability to develop and sell the VEGF Trap.
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.
54
Risks Related to Our Common Stock
Our stock price is extremely volatile.
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:
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progress, delays, or adverse results in clinical trials; |
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announcement of technological innovations or product candidates by us or competitors; |
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fluctuations in our operating results; |
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public concern as to the safety or effectiveness of our product candidates; |
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developments in our relationship with collaborative partners; |
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developments in the biotechnology industry or in government regulation of healthcare; |
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large sales of our common stock by our executive officers, directors, or significant
shareholders; |
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arrivals and departures of key personnel; and |
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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 15, 2005, our eight largest shareholders, which include the sanofi-aventis Group and Novartis,
beneficially owned 58.6% 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 15, 2005. As of that date, Novartis
owned 7,527,050 shares of Common Stock, representing approximately 14.0% of the shares of Common
Stock then outstanding. These shares owned by Novartis are eligible to be sold pursuant to Rule
144(k) under the Securities Act of 1933, as amended, without registration, without regard to the
volume, manner-of-sale, or other limitations set forth in Rule 144 under such Act, and without any
contractual restrictions on sale. As of April 15, 2005, the sanofi-aventis Group owned 2,799,552 shares of
Common Stock, representing approximately 5.2% of the shares of Common Stock then outstanding.
Under our stock purchase agreement with the sanofi-aventis Group, these shares may generally not be sold or
otherwise transferred until after September 5, 2005, and for one year after that date,
the sanofi-aventis Group may sell no more than 250,000 shares in any calendar quarter. After September 5,
2006, the sanofi-aventis Group may sell no more than 500,000 shares in any calendar quarter. If Novartis or
the sanofi-aventis Group, 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
55
Stock by our significant shareholders, including the sanofi-aventis Group and Novartis, 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 15, 2005, holders of Class A Stock held 4.2%
of all shares of Common Stock and Class A Stock then outstanding, and had 30.5% of the combined
voting power of all of Common Stock and Class A Stock then outstanding, assuming, in each case, the
exercise of all options held by such persons which are exercisable within 60 days of April 15,
2005. These shareholders, if acting together, would be in a position to significantly 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 15, 2005:
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our current officers and directors beneficially owned 13.8% 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 15, 2005
and 34.7% 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 15, 2005; and |
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our eight largest shareholders beneficially owned 58.6% 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 15, 2005. In addition, these eight shareholders held 63.9% 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 15, 2005. |
The anti-takeover effects of provisions of our charter, by-laws, and rights agreement, 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, our rights agreement 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:
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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; |
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a staggered board of directors, so that it would take three successive annual meetings
to replace all of our directors; |
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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; |
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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 of which is to require that shareholder action may only be taken at a duly convened
meeting; |
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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 |
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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. |
We have a shareholder rights plan which could make it more difficult for a third party to
acquire us without the support of our board of directors and principal shareholders. In addition,
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 the Company, as defined in the plan.
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 an
approximately $1.1 million and $1.0 million change in the fair market value of our investment
portfolio at June 30, 2005 and 2004, respectively.
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
57
the 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,
2005 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
In May 2003, securities class action lawsuits were commenced against Regeneron and certain of
the Companys officers and directors in the United States District Court for the Southern District
of New York. A consolidated amended class action complaint was filed in October 2003. The
complaint, which purports to be brought on behalf of a class consisting of investors in the
Companys publicly traded securities between March 28, 2000 and March 30, 2003, alleges that the
defendants misstated or omitted material information concerning the safety and efficacy of AXOKINE,
in violation of Sections 10(b) and 20(a) of the Securities and Exchange Act of 1934 and Rule 10b-5
promulgated thereunder.
On
August 3, 2005, the plaintiffs and the Company entered into a Stipulation and Agreement
of Settlement settling all claims against the Company in this
lawsuit. The settlement requires no
payment by the Company or any of the individual defendants named in the lawsuit. The Companys primary insurance carrier agreed to
make the required payment under the settlement, which is in an immaterial
amount to the Company. The
settlement includes no admission of wrongdoing by the Company or any of the individual defendants.
The settlement must be finally approved by the United States
District Court for the Southern District of New York following notice and hearing.
Separately, the plaintiffs and the individual defendants named in the lawsuit entered into a
Stipulation of Voluntary Dismissal, dismissing all claims against the individuals. This voluntary
dismissal shall automatically become a dismissal with prejudice, without costs, upon the court
entering an order and final judgment approving the settlement.
We cannot assure investors that the settlement of the lawsuit will be approved by the court
following notice and hearing. If the settlement is not approved by the court, the lawsuit would
continue.
From time to time, we are a party to other legal proceedings in the course of our business.
We do not expect any such other current legal proceedings to have a material adverse effect on our
business or financial condition.
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Item 4. Submission of Matters to a Vote of Security Holders
On June 10, 2005, 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 II 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, 2005.
No other matters were voted on. The number of votes cast was:
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For |
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Withheld |
1. Election of Class II Directors |
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Alfred G. Gilman, M.D., Ph.D. |
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63,930,014 |
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5,103,538 |
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Joseph L. Goldstein, M.D. |
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67,419,359 |
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1,614,193 |
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P. Roy Vagelos, M.D. |
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64,541,190 |
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4,492,362 |
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The terms of office of Leonard S. Schleifer, M.D., Ph.D., Eric M. Shooter, Ph.D., George D.
Yancopoulos, M.D., Ph.D., Charles A Baker, Michael S. Brown, M.D., Arthur F. Ryan, and George L.
Sing continued after the meeting.
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For |
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Against |
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Abstain |
2. |
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Ratification of the Appointment of |
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Independent Registered Public |
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Accounting Firm |
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68,731,884 |
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274,121 |
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27,547 |
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Item 6. Exhibits
(a) Exhibits
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Exhibit |
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Number |
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Description |
10.10.1*
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Amendment and Agreement made as of June 30, 2005 by and between Regeneron
Pharmaceuticals, Inc. and The Procter & Gamble Company |
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12.1
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Statement re: computation of ratio of earnings to combined fixed charges. |
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31.1
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Certification of CEO pursuant to Rule 13a-14(a) under the Securities and Exchange Act
of 1934. |
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31.2
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Certification of CFO pursuant to Rule 13a-14(a) under the Securities and Exchange Act
of 1934. |
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Certification of CEO and CFO pursuant to 18 U.S.C. Section 1350. |
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* |
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Portions of this document have been omitted and filed separately with the Commission
pursuant to requests for confidential treatment pursuant to Rule 24b-2 |
60
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.
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Regeneron Pharmaceuticals, Inc. |
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Date: August 8, 2005
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By:
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/s/ Murray A. Goldberg |
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Murray A. Goldberg |
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Senior Vice President, Finance & Administration,
Chief Financial Officer, Treasurer, and
Assistant Secretary |
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Execution Copy
EXHIBIT 10.10.1
AMENDMENT AND AGREEMENT
This Amendment and Agreement (this "Amendment") is made as of the 30th of
June, 2005.
BETWEEN:
REGENERON PHARMACEUTICALS, INC. a New York corporation having its principal
office at 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707,
(hereinafter with its Affiliates, "Regeneron")
AND:
THE PROCTER & GAMBLE COMPANY, an Ohio corporation having its principal offices
at One Procter & Gamble Plaza, Cincinnati, Ohio 45202, (hereinafter together
with its Affiliate Procter & Gamble Pharmaceuticals, Inc., "P&G").
WHEREAS Regeneron and P&G entered into the Focused Collaboration Agreement on
December 31, 2000 ,as amended by the Parties on August 11, 2004 (the
"Agreement");
WHEREAS the Parties have mutually agreed that the activities contemplated by the
Parties during the Research Term have been completed;
NOW THEREFORE in consideration of the mutual promises contained herein, the
parties agree as follows:
1) Because the activities contemplated during the Research Term have been
completed, the Term shall expire effective as of June 30, 2005 (the
"Expiration Date").
2) P&G shall forthwith:
i. deliver promptly to Regeneron any and all confidential
information and materials relating to ******************
(including, without limitation, a **********************
*************************************** ***************, the
GPCR Field, and the DDR Field, whether
-1-
Execution Copy
provided by Regeneron or generated by P&G during the term of
the Agreement. Such confidential information shall now be
considered Regeneron's Information. Regeneron may use and
disclose such information without restriction and P&G shall
treat such Information in accordance with the confidentiality
and non-use obligations set forth in Article VIII of the
Agreement; and
ii. grant to Regeneron an exclusive, royalty free, worldwide,
fully paid up license, with the right to grant sublicenses, to
any Inventions (including any P&G Patent Right included
therein) and Know-how in, to or claiming*********************
**********, the GPCR Field and/or the DDR Field (including the
manufacture, use, offer for sale or sale thereof) that P&G (or
its Affiliate) might have at the Expiration Date and any
Patents filed after the Expiration Date which claim any such
Invention. Notwithstanding the license granted above, P&G
shall only grant to Regeneron a non-exclusive, royalty free
license under Procter & Gamble Know-how and P&G Patent Rights,
with the right to sublicense, to make, have made, and use
Procter & Gamble Compounds solely for research purposes. For
clarity, this non-exclusive license to Procter & Gamble
Compounds does not include the right to have sold or sell
Procter & Gamble Compounds, under Procter & Gamble Know-how
and P&G Patent Rights.
iii. at any time prior to************, promptly notify Regeneron of
any decision to not advance the Hercules Compound (as defined
below) to the next stage of development. Upon such
notification the obligations under Section 2.11(b) of the
Agreement shall no longer be applicable to the Hercules
Compound.
3) Regeneron shall forthwith:
i. grant to P&G an exclusive, worldwide license, with the right
to grant sublicenses, to any Inventions (including any
Regeneron Patent Rights included therein) and Know-how in, to
or claiming ***************************("Hercules Project"),
including the Development
Compound***********************************************, the
-2-
Execution Copy
"Hercules Compound") (including the manufacture, use, offer
for sale or sale thereof) that Regeneron might have at the
Expiration Date and any Patents filed after the Expiration
Date which claim any such Invention; and
ii. deliver promptly to P&G any and all confidential information
and materials relating to the Hercules Project or the Hercules
Compound whether provided by P&G or generated by Regeneron
during the term of the Agreement. Such confidential
information shall now be considered P&G's Information. P&G may
use and disclose such information without restrictions and
Regeneron shall treat such Information in accordance with the
confidentiality and non-use obligations set forth in Article
VIII of the Agreement.
4) All references to the Tail Period in the Agreement (and the respective
rights and obligations of the Parties during the Tail Period) are deleted.
Except as set forth herein, all obligations of, and licenses and rights
granted by, the Parties under the Agreement shall automatically terminate
as of the Expiration Date. However, neither Party shall be relieved of any
obligations (including payment obligations) arising prior to the
Expiration Date, including, without limitation, any payment obligations
pursuant to Section 3.2 of the Agreement for activities prior to June 30,
2005. P&G shall pay to Regeneron the sum of Two Million Seven Hundred
Fifty-two Thousand Four Hundred Eighty-five dollars ($2,752,485.00) upon
the Expiration Date for activities performed under the Agreement in the
second Fiscal Quarter of 2005.
5) Each Party shall forthwith:
i. deliver promptly to the other Party copies or samples of any
and all confidential information and materials relating to the
New Target Field, whether provided by the delivering Party or
generated by the other Party during the term of the Agreement.
Such information may be used and disclosed by both Parties
without regard to any of the confidentiality and non-use
obligations in Article VIII of the Agreement; and
ii. grant to the other Party a non-exclusive, royalty free,
worldwide, fully paid up license, with the right to grant
sublicenses, to any Inventions (including any P&G Patent Right
or Regeneron Patent Right included therein) and
-3-
Execution Copy
Know-how having utility in the New Target Field (including the
manufacture, use, offer for sale or sale thereof) that the
granting Party (or its Affiliate) might have at the Expiration
Date and any Patents filed after the Expiration Date which
claim any such Invention. Notwithstanding the above, P&G shall
only grant to Regeneron a non-exclusive, royalty free license
under Procter & Gamble Know-how and P&G Patent Rights, with
the right to sublicense, to make, have made, and use Procter &
Gamble Compounds in the New Target Field solely for research
purposes. For clarity, this non-exclusive license to Procter &
Gamble Compounds does not include the right to have sold or
sell Procter & Gamble Compounds, under Procter & Gamble
Know-how and P&G Patent Rights. P&G agrees that it shall not,
directly or indirectly, sell or have sold any Procter & Gamble
Compounds discovered during the Term in the New Target Field.
6) With respect to all other Inventions having utility in the Muscle Field
not covered by paragraphs 2, 3, and 5 of this Amendment, each Party grants
to the other Party a non-exclusive, royalty free, worldwide, fully paid up
license, without the right to grant sublicenses, to make, have made, and
use P&G Technology or Regeneron Technology, as the case may be, for
research purposes in the Muscle Field.
7) Without limiting anything in paragraphs 2, 3, 5, and 6 of this Amendment,
within thirty (30) days following the Expiration Date, each Party shall be
responsible for providing the other Party with the materials and
information set forth in Attachment I hereto.
8) P&G shall pay Regeneron Five Million Six Hundred Thirty-nine Thousand Nine
Hundred Sixty Dollars ($5,639,960) upon the Expiration Date
9) Regeneron shall pay P&G Nine Hundred Fifty Thousand Dollars ($950,000.00)
upon the Expiration Date to acquire all right, title and interest in all
capital equipment bought by or on behalf of P&G during the Term and
residing at Regeneron's facilities. P&G represents and warrants that it
has good and marketable title to such capital equipment, free and clear of
liens and encumbrances.
10) All payments due upon the Expiration Date shall be paid within thirty (30)
days of receipt of an invoice for such amount. Once the payments in
Sections 4, 8, and 9 of
-4-
\
Execution Copy
this Amendment are made in full, each Party shall release and discharge
the other Party from any and all claims, counterclaims, causes of actions,
liabilities or charges asserted or which could have been asserted, with
respect to such matters or the payments made by the Parties under the
Agreement during the Research Term.
11) P&G shall pay Regeneron, as an Opting Out Party, the following royalty on
the Hercules Compound:
i. P&G shall pay to Regeneron a royalty based on P&G's Net Sales
of a Hercules Compound in all countries in the Territory. Such
royalty will be calculated by multiplying the Net Sales by the
applicable rates listed below: ****************of Net Sales in
any Fiscal Year up to and including ***************(Threshold
I); and
****************of Net Sales in any Fiscal Year above
Threshold 1 and up to and including ****************; and
**************** of Net Sales in any Fiscal Year greater than
*************.
Such royalty will be paid on a quarterly basis for a period of **********
from the date of first sale to a customer of such Hercules Compound in a
particular country, or for so long as the manufacture, use, importation or sale
of the Hercules Compound would infringe a Valid Claim of a Patent in such
country, whichever is longer.
ii. If P&G licenses the Hercules Compound to a Third Party or
Parties, Regeneron's share of the royalty received from such
Third Parties shall be a percentage of the total royalty from
each such licensee(s). Such percentage will be based on when
in the development by P&G of the Hercules Compound, the Third
Party license is completed according to the following
schedule:
% of Third Party % of Third Party
Time of License Royalties to Regeneron Royalties to P&G
- ------------------ ---------------------- ----------------
****************** ****** *****
-5-
Execution Copy
****************** ****** *****
****************** ****** *****
****************** ****** *****
P&G may receive, without sharing with Regeneron, reimbursement from such
licensee for reasonable, ****************************** costs of research,
development and/or marketing costs (whether internal or Third Party) incurred by
P&G for work conducted on behalf of the licensee. Any amounts in excess of such
reimbursement plus any other payments or income received by P&G from a licensee,
including, but not limited to, upfront, milestone and termination payments and
licensing fees, shall be shared with Regeneron in the proportion outlined in the
above table.
All amounts from licensees received by P&G shall be fully disclosed to Regeneron
and be subject to audit (including without limitation the calculation of
fully-loaded costs) pursuant to Section 6.5 of the Agreement.
iii. If P&G elects to distribute or sublicense a Hercules Compound in any
country, and a license must be obtained from a Third Party to
manufacture and/or market such Hercules Compound to avoid a
non-frivolous claim of patent infringement, P&G shall offset *****
of the Third Party license fee, royalty or other similar payments
solely in connection with the license of such patent for use to
manufacture, use or sell a Hercules Compound ("Licensee Fees")
against Regeneron's royalty. Any portion of Licensee Fees paid by
P&G that is to be offset against Regeneron's royalty but that
exceeds Regeneron's royalty payable, shall be carried forward and
accrue interest pursuant to Section 6.4 of the Agreement and be
offset against future royalties as such royalties become payable.
12) Except as set forth herein with respect to the Tail Period, sections 2.1,
2.2, 2.11(b), 5.1, 5.3(a), each of 6.2, 6.3, 6.4 and 6.5 (in the case of 6.2,
6.3, 6.4, and 6.5, solely with respect to royalty payments made to Regeneron
under this Amendment), 8.1, 8.2, 9.3, 11.2, 11.3, 11.5, 11.6, 11.7, and Article
1 of the Agreement shall survive the expiration of the Agreement. For the
avoidance of doubt, this paragraph 11 shall replace Section 11.8 of the
Agreement in its entirety.
13) Capitalized terms not defined herein shall have the meaning ascribed to them
in the Agreement.
-6-
Execution Copy
14) This Amendment and, to the extent specifically referenced herein, the
Agreement constitute the entire agreement between the Parties hereto with
respect to the subject matter hereof. Said agreements supersede all other
agreements and understanding between the Parties with respect to the subject
matter hereof and thereof, whether written or oral. If there is a direct
conflict between the provisions of the Agreement and this Amendment, this
Amendment shall govern. This Amendment may be amended only by a written
instrument executed by both Parties. This Amendment shall be binding upon and
inure to the benefit of the Parties and their respective Affiliates, successors
and assigns.
15) This Amendment may be executed in one or more counterparts, all of which
shall be considered one and the same agreement, and shall become a binding
agreement when one counterpart has been signed by each Party and delivered
to the other Party.
16) This Amendment shall be governed by the laws of the Sate of Delaware, as
such laws are applied to contracts entered into and to be performed within
such state. Regeneron shall have the right to file or register this
Amendment with the United States Securities and Exchange Commission.
17) Regeneron represents to P&G that it has made available to P&G during the
Term the results of all material preclinical studies using its
****************. P&G represents to Regeneron that it has made available
to Regeneron during the Term the results of all material preclinical
studies in the Hercules Project.
-7-
Execution Copy
IN WITNESS WHEREOF the Parties have executed this Amendment as of the date first
written above.
THE PROCTER & GAMBLE COMPANY REGENERON PHARMACEUTICALS, INC.
/s/ Mark A. Collar /s/ Leonard Schleifer
- ---------------------------------------- -------------------------------
Name: Mark A. Collar Name: Leonard S. Schleifer
Title: President, Global Pharmaceuticals Title: President & CEO
-8-
Execution Copy
ATTACHMENT I INFORMATION TRANSFER
Information/Materials to be transferred to Regeneron by P&G
- -----------------------------------------------------------------------------
Information/Materials to be Transferred to P&G by Regeneron
Reagents
- -----------------------------------------------------------------------------
- -----------------------------------------------------------------------------
- -----------------------------------------------------------------------------
Information
**************************************************
The Parties need to provide the Information above only to the extent it is
available.
-9-
EX-12.1
Exhibit 12.1
Regeneron Pharmaceuticals, Inc.
Computation of Ratio of Earnings to Combined Fixed Charges
(Dollars in thousands)
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Six months |
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ended |
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Years ended December 31, |
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June 30, |
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2000 |
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2001 |
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2002 |
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2003 |
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2004 |
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2005 |
Earnings: |
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Income (loss) from continuing operations
before income (loss) from equity investee |
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($17,077 |
) |
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($75,178 |
) |
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($124,350 |
) |
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($107,395 |
) |
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$ |
41,565 |
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($31,125 |
) |
Fixed charges |
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1,309 |
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3,888 |
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13,685 |
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14,108 |
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14,060 |
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6,846 |
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Amortization of capitalized interest |
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33 |
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78 |
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39 |
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Interest capitalized |
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(222 |
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(276 |
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Adjusted earnings |
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($15,768 |
) |
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($71,290 |
) |
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($110,887 |
) |
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($93,530 |
) |
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$ |
55,703 |
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($24,240 |
) |
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Fixed charges: |
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Interest expense |
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$ |
281 |
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$ |
2,657 |
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$ |
11,859 |
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$ |
11,932 |
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$ |
12,175 |
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$ |
6,024 |
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Interest capitalized |
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222 |
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276 |
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Assumed interest component of rental charges |
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1,028 |
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1,231 |
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1,604 |
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1,900 |
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1,885 |
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822 |
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Total fixed charges |
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$ |
1,309 |
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$ |
3,888 |
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$ |
13,685 |
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$ |
14,108 |
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$ |
14,060 |
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$ |
6,846 |
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Ratio of earnings to fixed charges |
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(A |
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(A |
) |
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(A |
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(A |
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3.96 |
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(A |
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(A) |
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Due to the registrants losses for the years ended December 31, 2000,
2001, 2002, and 2003, and for the six months ended June 30, 2005, the
ratio coverage was less than 1:1. To achieve a coverage ration of
1:1, the registrant must generate additional earnings of the amounts
shown in the table below. |
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Six months |
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ended |
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Years ended December 31, |
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June 30, |
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2000 |
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2001 |
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2002 |
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2003 |
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2004 |
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2005 |
Coverage deficiency |
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$ |
17,077 |
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$ |
75,178 |
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$ |
124,572 |
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$ |
107,638 |
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$ |
31,086 |
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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. |
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I have reviewed this quarterly report on Form 10-Q of Regeneron Pharmaceuticals, Inc.; |
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2. |
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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; |
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3. |
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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; |
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4. |
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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: |
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a) |
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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; |
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b) |
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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 principals; |
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c) |
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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 |
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d) |
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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. |
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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): |
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a) |
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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 |
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b) |
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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. |
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Date: August 8, 2005
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/s/ Leonard S. Schleifer |
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Leonard S. Schleifer, M.D., Ph.D. |
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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. |
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I have reviewed this quarterly report on Form 10-Q of Regeneron Pharmaceuticals, Inc.; |
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2. |
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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; |
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3. |
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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; |
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4. |
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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: |
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a) |
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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; |
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b) |
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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 principals; |
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c) |
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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 |
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d) |
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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. |
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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): |
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a) |
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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 |
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b) |
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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. |
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Date: August 8, 2005
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/s/ Murray A. Goldberg |
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Murray A. Goldberg |
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Senior Vice President, Finance & |
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Administration, Chief Financial Officer, |
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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, 2005 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.
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/s/ Leonard S. Schleifer
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Leonard S. Schleifer, M.D., Ph.D. |
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Chief Executive Officer |
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August 8, 2005 |
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/s/ Murray A. Goldberg
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Murray A. Goldberg |
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Chief Financial Officer |
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August 8, 2005 |
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