e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF
1934 |
For the transition period from _________ to _________
Commission file number 0-22705
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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33-0525145 |
(State or other jurisdiction of
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(IRS Employer Identification No.) |
incorporation or organization) |
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12780 EL CAMINO REAL, SAN DIEGO, CALIFORNIA
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92130 |
(Address of principal executive office)
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(Zip Code) |
(858) 617-7600
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days: Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Act). Yes o No þ
The number of outstanding shares of the registrants common stock, par value $0.001 per
share, was 38,438,123 as of July 25, 2008.
NEUROCRINE BIOSCIENCES, INC.
FORM 10-Q INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except for share information)
(unaudited)
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June 30, |
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December 31, |
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2008 |
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2007 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
91,917 |
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$ |
99,664 |
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Short-term investments, available-for-sale |
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19,984 |
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79,721 |
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Receivables under collaborative agreements |
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2 |
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27 |
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Other current assets |
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1,726 |
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3,536 |
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Total current assets |
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113,629 |
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182,948 |
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Property and equipment, net |
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79,434 |
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82,598 |
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Longterm investments |
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21,593 |
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Restricted cash |
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6,568 |
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6,399 |
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Other non-current assets |
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4,446 |
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4,709 |
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Total assets |
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$ |
225,670 |
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$ |
276,654 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,739 |
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$ |
3,776 |
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Accrued liabilities |
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13,235 |
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21,717 |
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Deferred revenues |
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2,919 |
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2,928 |
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Current portion of long-term debt |
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601 |
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1,486 |
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Total current liabilities |
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19,494 |
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29,907 |
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Long-term deferred revenues |
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13,135 |
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14,595 |
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Leaseback financing obligation |
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108,745 |
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108,745 |
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Other liabilities |
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4,455 |
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4,710 |
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Total liabilities |
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145,829 |
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157,957 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding |
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Common stock, $0.001 par value; 110,000,000 shares authorized; issued and outstanding shares
were 38,437,623 as of June 30, 2008 and 38,273,979 as of December 31, 2007 |
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38 |
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38 |
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Additional paid-in capital |
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738,011 |
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733,542 |
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Accumulated other comprehensive income |
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(1,510 |
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(233 |
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Accumulated deficit |
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(656,698 |
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(614,650 |
) |
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Total stockholders equity |
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79,841 |
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118,697 |
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Total liabilities and stockholders equity |
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$ |
225,670 |
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$ |
276,654 |
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See accompanying notes to the condensed consolidated financial statements.
3
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except loss per share data)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues: |
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Sponsored research and development |
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$ |
4 |
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$ |
21 |
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$ |
16 |
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$ |
107 |
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License fees and milestones |
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730 |
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2,460 |
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Grant revenue |
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27 |
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9 |
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45 |
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Total revenues |
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734 |
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48 |
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2,485 |
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152 |
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Operating expenses: |
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Research and development |
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16,186 |
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18,789 |
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30,413 |
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37,850 |
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General and administrative |
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4,665 |
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8,807 |
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12,951 |
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17,124 |
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Total operating expenses |
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20,851 |
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27,596 |
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43,364 |
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54,974 |
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Loss from operations |
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(20,117 |
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(27,548 |
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(40,879 |
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(54,822 |
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Other income and (expense): |
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Interest income and other income |
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1,060 |
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2,032 |
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2,666 |
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4,456 |
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Interest expense |
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(1,914 |
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(848 |
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(3,835 |
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(1,718 |
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Total other (expense) income, net |
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(854 |
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1,184 |
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(1,169 |
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2,738 |
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Net loss |
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$ |
(20,971 |
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$ |
(26,364 |
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$ |
(42,048 |
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$ |
(52,084 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(0.55 |
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$ |
(0.69 |
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$ |
(1.10 |
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$ |
(1.37 |
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Shares used in the calculation of net loss per common share: |
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Basic and diluted |
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38,421 |
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37,969 |
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38,376 |
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37,938 |
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See accompanying notes to the condensed consolidated financial statements.
4
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Six Months Ended |
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June 30, |
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2008 |
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2007 |
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CASH FLOW FROM OPERATING ACTIVITIES |
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Net loss |
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$ |
(42,048 |
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$ |
(52,084 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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4,067 |
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5,027 |
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Gain on sale of assets |
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(198 |
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Deferred revenues |
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(1,469 |
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9 |
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Share-based compensation expense |
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4,436 |
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5,203 |
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Change in operating assets and liabilities: |
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Accounts receivable and other current assets |
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1,835 |
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7,756 |
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Other non-current assets |
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(27 |
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94 |
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Accounts payable and accrued liabilities |
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(9,519 |
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36 |
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Other non-current liabilities |
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(255 |
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352 |
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Net cash used in operating activities |
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(43,178 |
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(33,607 |
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CASH FLOW FROM INVESTING ACTIVITIES |
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Purchases of investments |
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(19,042 |
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(48,647 |
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Sales/maturities of investments |
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56,187 |
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54,795 |
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Restricted cash |
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(157 |
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Sale of property and equipment |
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450 |
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Purchases of property and equipment |
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(1,155 |
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(173 |
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Net cash provided by investing activities |
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36,283 |
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5,975 |
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CASH FLOW FROM FINANCING ACTIVITIES |
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Issuance of common stock |
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33 |
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573 |
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Principal payments on debt |
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(885 |
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(2,437 |
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Net cash used in financing activities |
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(852 |
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(1,864 |
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Net decrease in cash and cash equivalents |
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(7,747 |
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(29,496 |
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Cash and cash equivalents at beginning of the period |
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99,664 |
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80,981 |
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Cash and cash equivalents at end of the period |
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$ |
91,917 |
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$ |
51,485 |
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See accompanying notes to the condensed consolidated financial statements.
5
NEUROCRINE BIOSCIENCES, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. BASIS OF PRESENTATION
The condensed consolidated financial statements included herein are unaudited. These
statements have been prepared in accordance with accounting principles generally accepted in the
United States for interim financial information and with the instructions of the Securities and
Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not
include all of the information and disclosures required by accounting principles generally accepted
in the United States for complete financial statements. In the opinion of management, these
financial statements include all adjustments (consisting of normal recurring adjustments) necessary
for a fair presentation of the financial position, results of operations, and cash flows for the
periods presented. The results of operations for the interim period shown in this report are not
necessarily indicative of results expected for the full year. These financial statements should be
read in conjunction with the Managements Discussion and Analysis of Financial Condition and
Results of Operations, Quantitative and Qualitative Disclosures About Market Risk and the
financial statements and notes thereto for the year ended December 31, 2007 and the three months
ended March 31, 2008 included in the Companys Annual Report on Form 10-K for the year ended
December 31, 2007 and the Companys Quarterly Report on Form 10-Q for the three months ended March
31, 2008, respectively, filed with the SEC.
The terms Company and Neurocrine are used in this report to refer collectively to
Neurocrine Biosciences, Inc. and its subsidiaries.
2. ORGANIZATION AND SUMMARY OF BUSINESS
Neurocrine Biosciences, Inc. discovers, develops and intends to commercialize drugs for the
treatment of neurological and endocrine-related diseases and disorders. The Companys product
candidates address some of the largest pharmaceutical markets in the world, including
endometriosis, irritable bowel syndrome, anxiety, depression, pain, diabetes, insomnia and other
neurological and endocrine-related diseases and disorders. The Company currently has eight programs
in various stages of research and development, including five programs in clinical development.
While the Company independently develops many of its own product candidates, Neurocrine is in
collaborations with pharmaceutical companies for two of its programs. The Companys lead clinical
development program, elagolix, is a drug candidate for the treatment of endometriosis.
3. IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards (SFAS) No. 159, The Fair Value Option for Financial Assets and
Financial Liabilitiesincluding an amendment of FASB Statement No. 115 (SFAS 159). SFAS 159
expands the use of fair value accounting but does not affect existing standards which require
assets or liabilities to be carried at fair value. Under SFAS 159, a company may elect to use fair
value to measure accounts and loans receivable, available-for-sale and held-to-maturity securities,
equity method investments, accounts payable, guarantees and issued debt. Other eligible items
include firm commitments for financial instruments that otherwise would not be recognized at
inception and non-cash warranty obligations where a warrantor is permitted to pay a third party to
provide the warranty goods or services. If the use of fair value is elected, any upfront costs and
fees related to the item must be recognized in earnings and cannot be deferred, e.g., debt issue
costs. The fair value election is irrevocable and generally made on an instrument-by-instrument
basis, even if a company has similar instruments that it elects not to measure based on fair value.
At the adoption date, unrealized gains and losses on existing items for which fair value has been
elected are reported as a cumulative adjustment to beginning retained earnings. Subsequent to the
adoption of SFAS 159, changes in fair value are recognized in earnings. SFAS 159 is effective for
fiscal years beginning after November 15, 2007 and was adopted by the Company in the first quarter
of 2008. The adoption of SFAS 159 did not have a material impact on the Companys consolidated
results of operations and financial condition as the fair value option was not elected for any of
the Companys financial assets or financial liabilities.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 provides guidance for using fair value to measure assets and liabilities. It also responds to
investors requests for expanded information about the extent to which a company measures assets
and liabilities at fair value, the information used to measure fair value, and the effect of fair
value measurements on earnings. SFAS 157 applies whenever other standards require (or permit)
assets or liabilities to be measured at fair
value, and does not expand the use of fair value in any new circumstances. SFAS 157 is
effective for financial statements issued for fiscal years beginning after November 15, 2007 and
was adopted by the Company in the first quarter of 2008. The adoption of SFAS 157 did not have a
material impact on the Companys consolidated results of operations and financial condition.
6
In June 2007, the FASB ratified Emerging Issues Task Force (EITF) Issue No. 07-3, Accounting for Non-Refundable Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities (EITF No. 07-3), which requires nonrefundable advance payments for goods and
services that will be used or rendered for future research and development activities to be
deferred and capitalized. These amounts will be recognized as expense in the period that the
related goods are delivered or the related services are performed. EITF No. 07-3 is effective for
fiscal years beginning after December 15, 2007. The Company adopted the provisions of EITF No. 07-3
on January 1, 2008 and the adoption of EITF No. 07-3 did not have a material impact on its
consolidated results of operations and financial condition.
4. SHARE-BASED COMPENSATION
The Companys net loss for the three months ended June 30, 2008 and 2007 includes $2.2 million
and $2.8 million, respectively, of compensation expense related to the Companys share-based
compensation awards. The Companys net loss for the six months ended June 30, 2008 and 2007
includes $4.4 million and $5.2 million, respectively, of compensation expense related to the
Companys share-based compensation awards. As of June 30, 2008, total unrecognized estimated
compensation cost related to non-vested stock options and non-vested restricted stock units (RSUs)
granted prior to that date was $5.5 million and $9.5 million, respectively, which is expected to be
recognized over a weighted average period of approximately 2.1 and 2.3 years, respectively. The
compensation expense related to the Companys share-based compensation arrangements is recorded as
components of general and administrative expense and research and development expense. The
following is a summary of the components of the Companys compensation expense related to
share-based compensation (in millions):
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
|
2007 |
General and administrative |
|
$ |
1.2 |
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$ |
1.5 |
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$ |
2.5 |
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$ |
2.8 |
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Research and development |
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1.0 |
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1.3 |
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1.9 |
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2.4 |
|
Cash received from stock option exercises for the six months ended June 30, 2008 and 2007 was
$33,000 and $0.6 million, respectively. The Company issued approximately 164,000 shares of common
stock pursuant to stock option exercises, the vesting of RSUs, and distributions of stock awards
from the Companys deferred compensation plan during the six months ended June 30, 2008.
Stock Option Assumptions
The exercise price of all options granted during the six month periods ended June 30, 2008 and
2007 was equal to the closing price of the Companys common stock on the date of grant. The
estimated fair value of each option award granted was determined on the date of grant using the
Black-Scholes option valuation model with the following weighted-average assumptions for option
grants during the three and six months ended June 30, 2008 and 2007:
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
|
2007 |
|
2008 |
|
2007 |
Risk-free interest rate |
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3.36 |
% |
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4.97 |
% |
|
|
2.65 |
% |
|
|
4.82 |
% |
Expected volatility of common stock |
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67.99 |
% |
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62.91 |
% |
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68.60 |
% |
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65.36 |
% |
Dividend yield |
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0.0 |
% |
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0.0 |
% |
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0.0 |
% |
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0.0 |
% |
Expected option term |
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4.75 |
years |
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4.75 |
years |
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4.75 |
years |
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4.75 |
years |
The Company estimates forfeiture rates for options based on past behavior for similar options
with further consideration given to the class of employees to whom the options were granted.
7
5. USE OF ESTIMATES
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires management to make estimates and assumptions that affect the
amounts reported in the financial statements and the accompanying notes. Actual results could
differ from those estimates.
6. FAIR VALUE MEASUREMENTS
As described in Note 3, the Company adopted SFAS 157 on January 1, 2008. SFAS 157, among other
things, defines fair value, establishes a consistent framework for measuring fair value and expands
disclosure for each major asset and liability category measured at fair value on either a recurring
or nonrecurring basis. SFAS 157 clarifies that fair value is an exit price, representing the amount
that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants. As such, fair value is a market-based measurement that should be
determined based on assumptions that market participants would use in pricing an asset or
liability. As a basis for considering such assumptions, SFAS 157 establishes a three-tier fair
value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices in active markets;
Level 2: Inputs, other than the quoted prices in active markets, that are observable either
directly or indirectly; and
Level 3: Unobservable inputs in which there is little or no market data, which require the
reporting entity to develop its own assumptions.
The Companys long-term investments at June 30, 2008 include (at par value) $22.6 million of
auction rate securities. With the liquidity issues experienced in global credit and capital
markets, these auction rate securities have experienced multiple failed auctions as the amount of
securities submitted for sale has exceeded the amount of purchase orders, and as a result, these
affected securities are currently not liquid. However, the Company now earns a higher interest rate
according to the terms of these securities. All of the Companys auction rate securities are
secured by student loans, which are backed by the full faith and credit of the federal government
(up to approximately 98% of the value of the student loan). Additionally, all of the Companys
auction rate securities maintain the highest credit rating of AAA. All of these securities continue
to pay interest according to their stated terms (generally 120 basis points over the ninety-one day
United States Treasury Bill rate) with interest rates resetting every 7 to 28 days. While it is not
the Companys intent to hold these securities until their stated ultimate maturity dates, these
investments are scheduled to ultimately mature between 2030 and 2047.
At present, in the event the Company needs to access the funds that are in an illiquid state,
it may not be able to do so without the possible loss of principal, until a future auction for
these investments is successful, another secondary market evolves for these securities, they are
redeemed by the issuer or they mature. If the Company is unable to sell these securities in the
market or they are not redeemed, then the Company could be required to hold them to maturity. The
Company does not have a need to access these funds for operational purposes in the foreseeable
future. The Company will continue to monitor and evaluate these investments on an ongoing basis for
impairment. Although the auction rate security investments continue to pay interest according to
their stated terms, based on valuation models the Company has recorded an unrealized loss of
approximately $1.0 million in accumulated other comprehensive loss as a reduction in shareholders
equity, reflecting adjustments to auction rate security holdings that the Company has concluded
have a temporary decline in value due to a lack of liquidity in the global credit markets. The
carrying value in long-term investments for these auction rate securities at June 30, 2008 is
approximately $21.6 million.
The valuation of the Companys auction rate securities investment portfolio is subject to
uncertainties that are difficult to predict. The fair values of these securities are estimated
utilizing a discounted cash flow analysis valuation model as of June 30, 2008. The key driver of
this valuation model is the expected term to redemption. Changes to this assumption one year in
either direction did not have a material impact on the valuation of the Companys auction rate
securities portfolio at June 30, 2008. Other items this analysis considers are the
collateralization underlying the security investments, the creditworthiness of the counterparty,
the timing of expected future cash flows, and the expected term to liquidity. The significant
assumptions of this valuation model were discount margins ranging from 166 to 230 basis points and
an estimated term to liquidity of 2.5 years. These securities were also compared, when possible, to
other observable market data with similar characteristics to the securities held by the Company.
8
Factors that may impact the valuation of the Companys auction rate securities portfolio
include changes to credit ratings of the securities as well as to the underlying assets supporting
those securities, rates of default of the underlying assets, underlying collateral value, discount
rates, counterparty risk and ongoing strength and quality of market credit and liquidity.
Assets measured at fair value as of June 30, 2008 are classified below based on the three fair
value hierarchy tiers described above (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at June 30, 2008 Using |
|
|
|
|
|
|
|
Quoted Prices in |
|
|
|
|
|
|
|
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Significant |
|
|
|
|
|
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Unobservable Inputs |
|
Description |
|
6/30/2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Money market funds |
|
$ |
78,616 |
|
|
$ |
78,616 |
|
|
|
|
|
|
|
|
|
Commercial paper |
|
|
19,870 |
|
|
|
19,870 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
10,981 |
|
|
|
10,981 |
|
|
|
|
|
|
|
|
|
U.S. Government securities |
|
|
9,002 |
|
|
|
9,002 |
|
|
|
|
|
|
|
|
|
Auction rate securities (1) |
|
|
21,593 |
|
|
|
|
|
|
|
|
|
|
$ |
21,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
140,062 |
|
|
$ |
118,469 |
|
|
$ |
|
|
|
$ |
21,593 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Activity for assets measured at fair value during the six month period ended June 30, 2008
using significant unobservable inputs (Level 3) is presented in the table below (in thousands):
|
|
|
|
|
|
|
Fair Value |
|
|
|
Measurements Using |
|
|
|
Significant |
|
|
|
Unobservable Inputs |
|
|
|
(Level 3) |
|
Beginning balance as of March 31, 2008 |
|
$ |
21,625 |
|
Total unrealized gains or losses included in other comprehensive income |
|
|
(32 |
) |
Transfers in and/or out of Level 3 |
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
21,593 |
|
|
|
|
|
Amount of total gains or losses for the period included in earnings
attributable to the change in unrealized gains or losses relating to
assets still held at the reporting date |
|
$ |
|
|
|
|
|
|
|
|
|
(1) |
|
The Company estimated the fair value of these auction rate securities based on the following:
(i) the underlying structure of each security; (ii) the present value of future principal and
interest payments discounted at rates considered to reflect current market conditions; (iii)
consideration of the probabilities of default, auction failure, or repurchase at par for each
period; (iv) the expected term to liquidity; and (v) its market required rate of return. |
7. SHORT-TERM INVESTMENTS AVAILABLE FOR SALE
Available-for-sale securities are carried at fair value, with the unrealized gains and losses
reported in comprehensive income. The amortized cost of debt securities in this category is
adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is
included in interest income. Realized gains and losses and declines in value judged to be
other-than-temporary, if any, on available-for-sale securities are included in interest income or
expense. The cost of securities sold is based on the specific identification method. Interest and
dividends on securities classified as available-for-sale are included in interest income.
8. IMPAIRMENT OF LONG-LIVED ASSETS
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, if indicators of impairment exist, the Company assesses the recoverability of the affected
long-lived assets by determining whether the carrying value of such assets can be recovered through
undiscounted future operating cash flows. If the carrying amount is not recoverable, the Company
measures the amount of any impairment by comparing the carrying value of the asset to the present
value of the expected future cash flows associated with the use of the asset.
9
9. RESTRUCTURING CHARGES
In December 2007, the Company announced a restructuring program to implement cost containment
measures and to focus research and development efforts. As a result, the Company reduced its
research and development and general and administrative staff in San Diego by approximately 125
employees. Restructuring charges are comprised of salary continuation, outplacement services, and
other miscellaneous costs related to this reduction in force. Substantially all of these expenses
were paid in cash during the first quarter of 2008. During 2008, the Company recorded an additional
net charge of $2.0 million (primarily all general and administrative expense) for severance related
to certain executives and other personnel departing the Company. The Company expects this
restructuring to reduce annual expenses by approximately $19.0 million.
As of June 30, 2008, the Company had a remaining balance of approximately $2.7 million of
accrued restructuring expenses included in the Condensed Consolidated Balance Sheet. This liability
will be paid over the remaining contractual period of certain severance agreements. The changes to
the accrued liability for the first six months of 2008 are as follows (in thousands):
|
|
|
|
|
Accrual balance as of December 31, 2007 |
|
$ |
6,924 |
|
Payments |
|
|
(6,216 |
) |
Additional accruals |
|
|
2,357 |
|
Adjustments |
|
|
(405 |
) |
|
|
|
|
Accrual balance as of June 30, 2008 |
|
$ |
2,660 |
|
|
|
|
|
The Company is in the process of relocating all of its operations into one of the two
buildings it currently leases, while actively marketing the other, to be vacated building to
potential tenants. Upon completion of this relocation and certain other events, it is anticipated
that a cease-use date will occur as defined under the provisions of SFAS No. 146, Accounting for
Costs Associated with Exit or Disposal Activities. On that date, the Company will record a present
value liability and a corresponding charge based on the remaining lease rentals offset by any
potential sublease rentals. The Company is currently analyzing the impact that such a cease-use
date event would have on its financial statements.
10. RETENTION PROGRAM
On February 27, 2008, the Board of Directors of the Company approved an employee retention
program (Retention Program) to provide the Company with a mechanism to retain its non-officer and
executive officer employees who were not subject to the Companys December 2007 restructuring
program. As part of the Retention Program, the Board approved a one-time cash retention payment
totaling $3.2 million, 60% of which was paid in the first quarter of 2008 and the remaining 40% of
which is payable at the end of 2008, assuming such individual remains in good standing as an
employee at such time. In addition, the Board approved the issuance of RSUs covering an aggregate
of 1,203,000 shares and stock options covering an aggregate of 501,000 shares to its executive
officers and certain employees, all of which were issued in the first quarter of 2008.
11. LOSS PER COMMON SHARE
The Company computes net loss per share in accordance with SFAS No. 128, Earnings Per Share.
Under the provisions of SFAS No. 128, basic net loss per share is computed by dividing the net loss
for the period by the weighted average number of common shares outstanding during the period.
Diluted net loss per share is computed by dividing the net loss for the period by the weighted
average number of common and common equivalent shares outstanding during the period. Additionally,
potentially dilutive securities, composed of incremental common shares issuable upon the exercise
of stock options and warrants, are excluded from historical diluted loss per share because of their
anti-dilutive effect. Potentially dilutive securities totaled 0.1 million and 1.8 million for the
three months ended June 30, 2008 and 2007, respectively, and 0.1 million and 1.6 million for the six
months ended June 30, 2008 and 2007, respectively.
12. COMPREHENSIVE LOSS
Comprehensive loss is calculated in accordance with SFAS No. 130, Comprehensive Income. SFAS
No. 130 requires the disclosure of all components of comprehensive loss, including net loss and
changes in equity during a period from transactions and other events and circumstances generated
from non-owner sources. The Companys components of comprehensive loss consist of the net loss and
unrealized gains and losses on investments. For the three months ended June 30, 2008 and 2007,
comprehensive loss was
$21.1 million and $26.1 million, respectively. For the six months ended June 30, 2008 and
2007, comprehensive loss was $43.3 million and $51.5 million, respectively.
10
13. REVENUE RECOGNITION
Revenues under collaborative research agreements and grants are recognized as research costs
are incurred over the period specified in the related agreement or as the services are performed.
These agreements are on a best-efforts basis, do not require scientific achievement as a
performance obligation and provide for payment to be made when costs are incurred or the services
are performed. All fees are nonrefundable to the collaborators. Upfront, nonrefundable payments for
license fees, grants, and advance payments for sponsored research revenues received in excess of
amounts earned are classified as deferred revenue and recognized as income over the contract or
development period. Estimating the duration of the development period includes continual assessment
of development stages and regulatory requirements. Milestone payments are recognized as revenue
upon achievement of pre-defined scientific events, which require substantive effort, and for which
achievement of the milestone was not readily assured at the inception of the agreement.
14. RESEARCH AND DEVELOPMENT
Research and development (R&D) expenses are recognized as incurred and include related
salaries, contractor fees, clinical trial costs, facilities costs, administrative expenses and
allocations of certain other costs. These expenses result from the Companys independent R&D
efforts as well as efforts associated with collaborations and in-licensing arrangements. In
addition, the Company funds R&D at other companies and research institutions under agreements,
which are generally cancelable. The Company reviews and accrues clinical trial expenses based on
work performed, a method that relies on estimates of total costs incurred based on patient
enrollment, completion of patient studies and other events. The Company follows this method since
reasonably dependable estimates of the costs applicable to various stages of a research agreement
or clinical trial can be made. Accrued clinical costs are subject to revisions as trials progress
to completion. Revisions are charged to expense in the period in which the facts that give rise to
the revision become known.
15. INCOME TAXES
On July 13, 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes, an interpretation of FASB No. 109. Under FIN 48, the impact of an
uncertain income tax position on the income tax return must be recognized at the largest amount
that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An
uncertain income tax position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal
years beginning after December 15, 2006.
The Company adopted the provisions of FIN 48 on January 1, 2007. There were no unrecognized
tax benefits as of the date of adoption. As a result of the implementation of FIN 48, the Company
did not recognize an increase in the liability for unrecognized tax benefits. There are no
unrecognized tax benefits included in the balance sheet that would, if recognized, affect the
effective tax rate.
The Companys practice is to recognize interest and/or penalties related to income tax matters
in income tax expense. The Company had no accrual for interest or penalties on the Companys
balance sheets at December 31, 2007 and at June 30, 2008, and has not recognized interest and/or
penalties in the statement of operations for the first six months of 2008.
The Company is subject to taxation in the United States and various state jurisdictions. The
Companys tax years for 1993 and forward are subject to examination by the United States and
California tax authorities due to the carryforward of unutilized net operating losses and R&D
credits.
The adoption of FIN 48 did not impact the Companys financial condition, results of operations
or cash flows. At January 1, 2008, the Company had net deferred tax assets of $65.8 million. Due to
uncertainties surrounding the Companys ability to generate future taxable income to realize these
assets, a full valuation allowance has been established to offset the net deferred tax assets.
Additionally, the future utilization of the Companys net operating loss and research and
development credit carryforwards to offset future taxable income may be subject to a substantial
annual limitation, pursuant to Internal Revenue Code Sections 382 and 383, as a result of ownership
changes that may have occurred previously or that could occur in the future. Although the Company
determined that an ownership change had not occurred through January 31, 2007, it is possible that
an ownership change occurred subsequent to
11
that date. The Company has not completed an update of its Section 382 analysis subsequent to
January 31, 2007. Until this analysis has been updated the Company has removed the deferred tax
assets for net operating losses of $194.4 million and research and development credits of $37.1
million generated through 2007 from its deferred tax asset schedule and has recorded a
corresponding decrease to its valuation allowance. When this analysis is finalized, the Company
plans to update its unrecognized tax benefits under FIN 48. Due to the existence of the valuation
allowance, future changes in the Companys unrecognized tax benefits will not impact the Companys
effective tax rate.
16. LITIGATION
On June 19, 2007, Construction Laborers Pension Trust of Greater St. Louis filed a purported
class action lawsuit in the United States District Court for the Southern District of California
under the caption Construction Laborers Pension Trust of Greater St. Louis v. Neurocrine
Biosciences, Inc., et al., 07-cv-1111-IEG-RBB. On June 26, 2007, a second purported class action
lawsuit with similar allegations was also filed. On October 16, 2007, both lawsuits were
consolidated into one purported class action under the caption In re Neurocrine Biosciences, Inc.
Securities Litigation, 07-cv-1111-IEG-RBB. The court also selected lead plaintiffs and ordered
them to file a consolidated complaint. On November 30, 2007, lead plaintiffs filed the
Consolidated Amended Complaint (CAC), which alleged, among other things, that the Company and
certain of its officers and directors violated federal securities laws by making allegedly false
and misleading statements regarding the progress toward FDA approval and the potential for market
success of indiplon in the 15 mg dosage unit. On January 11, 2008, the Company and the individual
defendants filed a motion to dismiss the CAC. Following a hearing on April 22, 2008, the court
granted the motion to dismiss but gave the lead plaintiffs leave to file an amended complaint. On
June 11, 2008, the lead plaintiffs filed the Second Consolidated Amended Complaint (SAC), which is
now the operative complaint in the litigation. On July 8, 2008, the Company and the individual
defendants filed a motion to dismiss the SAC. A hearing on the motion to dismiss the SAC is
scheduled to occur on September 2, 2008.
In addition, on June 25, 2007, a shareholder derivative complaint was filed in the Supreme
Court of the State of California for the County of San Diego by Ralph Lipeles under the caption,
Lipeles v. Lyons. The complaint was brought purportedly on the Companys behalf against certain
current and former officers and directors and alleges, among other things, that the named officers
and directors breached their fiduciary duties by directing us to make allegedly false statements
about the progress toward FDA approval and the potential for market success of indiplon in the 15
mg dosage unit. All proceedings in this matter have been stayed pending resolution of the motion to
dismiss the SAC.
The Company intends to take all appropriate action in responding to all of the complaints. Due
to the uncertainty of the ultimate outcome of these matters, the impact, if any, on the Companys
future financial results is not subject to reasonable estimate as of June 30, 2008.
ITEM 2: MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following Managements Discussion and Analysis of Financial Condition and Results of
Operations section contains forward-looking statements, which involve risks and uncertainties. Our
actual results could differ materially from those anticipated in these forward-looking statements
as a result of various factors, including those set forth below in Part II, Item 1A under the
caption Risk Factors. The interim financial statements and this Managements Discussion and
Analysis of Financial Condition and Results of Operations should be read in conjunction with the
Financial Statements and Notes thereto for the year ended December 31, 2007 and the three months
ended March 31, 2008 and the related Managements Discussion and Analysis of Financial Condition
and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the
year ended December 31, 2007 and our Quarterly Report on Form 10-Q for the three months ended March
31, 2008, respectively.
OVERVIEW
We discover, develop and intend to commercialize drugs for the treatment of neurological and
endocrine-related diseases and disorders. Our product candidates address some of the largest
pharmaceutical markets in the world, including endometriosis, irritable bowel syndrome, anxiety,
depression, pain, diabetes, insomnia and other neurological and endocrine-related diseases and
disorders. We currently have eight programs in various stages of research and development,
including five programs in clinical development. While we independently develop many of our product
candidates, we are in collaborations with pharmaceutical companies for two of our programs. Our
lead clinical development program, elagolix, is a drug candidate for the treatment of
endometriosis.
12
In December 2007, we announced a restructuring program to implement cost containment measures
and to focus research and development efforts. As a result, we reduced our research and development
and general and administrative staff in San Diego by approximately 125 employees. In connection
with this restructuring, we recorded a one-time charge of approximately $6.9 million in the fourth
quarter of 2007, of which $4.9 million was included in research and development expense and $2.0
million was included in general and administrative expense. Restructuring charges are comprised of
salary continuation, outplacement services, and other miscellaneous costs related to this reduction
in force. Substantially all of these expenses were paid in cash during the first quarter of 2008.
During the first six months of 2008, we incurred an additional $2.0 million charge (net) for
severance related to certain executives and other personnel departing the Company. We expect this
restructuring to reduce annual expenses by approximately $19.0 million.
On February 27, 2008, we approved an employee retention program (Retention Program) to provide
us with a mechanism to retain our non-officer and executive officer employees who were not subject
to our December 2007 restructuring program. As part of the Retention Program, we approved a
one-time cash retention payment totaling $3.2 million, 60% of which was paid in the first quarter
of 2008 and the remaining 40% of which is payable at the end of 2008, assuming such individual
remains in good standing as an employee at such time. In addition, we approved the issuance of
restricted stock units (RSUs) covering an aggregate of 1,203,000 shares and stock options covering
an aggregate of 501,000 shares to our executive officers and certain employees, all of which were
issued in the first quarter of 2008.
We are in the process of relocating all of our operations into one of the two buildings we
currently lease, while actively marketing the other, to be vacated building to potential tenants.
Upon completion of this relocation and certain other events, it is anticipated that a cease-use
date will occur as defined under the provisions of SFAS No. 146, Accounting for Costs Associated
with Exit or Disposal Activities. On that date, we will record a present value liability and
corresponding charge based on the remaining lease rentals offset by any potential sublease rentals.
We are currently analyzing the impact that such a cease-use date event would have on our financial
statements.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our discussion and analysis of our financial condition and results of operations is based upon
financial statements that we have prepared in accordance with accounting principles generally
accepted in the United States. The preparation of these financial statements requires management to
make estimates and judgments that affect the reported amounts of assets, liabilities and expenses,
and related disclosures. On an on-going basis, we evaluate these estimates, including those related
to revenues under collaborative research agreements and grants, clinical trial accruals (research
and development expense), debt, share-based compensation, investments, and fixed assets. Estimates
are based on historical experience, information received from third parties and on various other
assumptions that are believed to be reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions. The items in our financial statements requiring significant estimates
and judgments are as follows:
Revenues under collaborative research and development agreements are recognized as costs are
incurred over the period specified in the related agreement or as the services are performed. These
agreements are on a best-efforts basis, do not require scientific achievement as a performance
obligation, and provide for payment to be made when costs are incurred or the services are
performed. All fees are nonrefundable to the collaborators. Upfront, nonrefundable payments for
license fees, grants, and advance payments for sponsored research revenues received in excess of
amounts earned are classified as deferred revenue and recognized as income over the contract or
development period. Estimating the duration of the development period includes continual assessment
of development stages and regulatory requirements. Milestone payments are recognized as revenue
upon achievement of pre-defined scientific events, which requires substantive effort, and for which
achievement of the milestone was not readily assured at the inception of the agreement.
Research and development (R&D) expenses include related salaries, contractor fees, facilities
costs, administrative expenses and allocations of corporate costs. All such costs are charged to
R&D expense as incurred. These expenses result from our independent R&D efforts as well as efforts
associated with collaborations, grants and in-licensing arrangements. In addition, we fund R&D and
clinical trials at other companies and research institutions under agreements, which are generally
cancelable. We review and accrue clinical trials expense based on work performed, a method that
relies on estimates of total costs incurred based on patient enrollment, completion of studies and
other events. We follow this method since reasonably dependable estimates of the costs applicable
to various stages of a research agreement or clinical trial can be made. Accrued clinical costs are
subject to revisions as trials progress to
completion. Revisions are charged to expense in the period in which the facts that give rise
to the revision become known. Historically, revisions have not resulted in material changes to R&D
costs; however a modification in the protocol of a clinical trial or cancellation of a trial could
result in a charge to our results of operations.
13
In accordance with Statement of Financial Accounting Standards No. 144 (SFAS 144), Accounting
for the Impairment or Disposal of Long-Lived Assets, if indicators of impairment exist, we assess
the recoverability of the affected long-lived assets by determining whether the carrying value of
such assets can be recovered through undiscounted future operating cash flows. If impairment is
indicated, we measure the amount of such impairment by comparing the carrying value of the asset to
the estimated fair value of the asset, which is generally determined based on the present value of
the expected future cash flows.
We grant stock options to purchase our common stock to our employees and directors under the
2003 Incentive Stock Plan, as amended (the 2003 Plan) and grant stock options to certain employees
pursuant to Employment Commencement Nonstatutory Stock Option Agreements. We also grant certain
employees stock bonuses and RSUs under the 2003 Plan. Additionally, we have outstanding options
that were granted under option plans from which we no longer make grants. The benefits provided
under all of these plans are subject to the provisions of revised Statement of Financial Accounting
Standards No. 123, Share-Based Payment (SFAS 123R). Share-based compensation expense recognized
under SFAS 123R for the three months ended June 30, 2008 and 2007 was $2.2 million and $2.8
million, respectively. Share-based compensation expense recognized under SFAS 123R for the six
months ended June 30, 2008 and 2007 was $4.4 million and $5.2 million, respectively.
Stock option awards and RSUs generally vest over a three to four year period and expense is
ratably recognized over those same time periods. However, due to certain retirement provisions in
our stock plans, share-based compensation expense may be recognized over a shorter period of time,
and in some cases the entire share-based compensation expense may be recognized upon grant of the
share-based compensation award. Employees who are age 55 or older and have five or more years of
service with us are entitled to accelerated vesting of certain unvested share-based compensation
awards upon retirement. This retirement provision leads to variability in the quarterly expense
amounts recognized under SFAS 123R, and therefore individual share-based compensation awards may
impact earnings disproportionately in any individual fiscal quarter.
The determination of fair value of stock-based payment awards on the date of grant using the
Black-Scholes model is affected by our stock price, as well as the input of other subjective
assumptions. These assumptions include, but are not limited to, the expected term of stock options
and our expected stock price volatility over the term of the awards. Our stock options have
characteristics significantly different from those of traded options, and changes in the
assumptions can materially affect the fair value estimates.
SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary,
in subsequent periods if actual forfeitures differ from those estimates. If actual forfeitures vary
from our estimates, we will recognize the difference in compensation expense in the period the
actual forfeitures occur or when options vest.
Available-for-sale securities are carried at fair value, with the unrealized gains and losses
reported in comprehensive income. The amortized cost of debt securities in this category is
adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is
included in interest income. Realized gains and losses and declines in value judged to be
other-than-temporary, if any, on available-for-sale securities are included in interest income or
expense. The cost of securities sold is based on the specific identification method. Interest and
dividends on securities classified as available-for-sale are included in interest income.
THREE MONTHS ENDED JUNE 30, 2008 AND 2007
Revenues were $0.7 million for the three months ended June 30, 2008 compared with $48,000 for
the respective period last year. The increase in revenues for the three months ended June 30, 2008,
compared with the respective period in 2007, is primarily from revenues recognized in 2008 under
our collaboration agreement with Dainippon Sumitomo Pharma Co. Ltd (DSP). During the second quarter
of 2008, we recognized $0.7 million in revenue under our collaboration agreement with DSP from
amortization of up-front licensing fees. We recognized $21,000 in revenue in the form of sponsored
development funding from GlaxoSmithKline (GSK) during the second quarter of 2007.
Research and development expenses decreased to $16.2 million for the second quarter of 2008
compared with $18.8 million for the respective period in 2007. This decrease in research and
development expenses is primarily due to cost savings related to our restructuring during the
fourth quarter of 2007. The decrease in staff levels reduced personnel costs by $2.9 million, from
$8.2 million in the second quarter of 2007 to $5.3 million in the second quarter of 2008.
Additionally, laboratory costs decreased by $0.9 million in
the second quarter of 2008 compared to the same period in 2007. These reductions were offset
by an increase in external development costs of $2.5 million. External development spending in our
elagolix program increased from $2.2 million in the second quarter of 2007 to $5.7 million in the
second quarter of 2008. The increase in our elagolix external development spending was partially
offset by decreased external development costs in other programs. We currently have eight programs
in various stages of research and development, including five programs in clinical development.
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General and administrative expenses were $4.7 million for the second quarter of 2008 compared
with $8.8 million during the same period last year. This decrease in general and administrative
expenses is primarily due to cost savings related to our restructuring implemented in the fourth
quarter of 2007.
Other income (expense) decreased from $1.2 million during the second quarter of 2007 to $(0.9)
million for the second quarter of 2008. The decrease resulted primarily from rental payments made
under our facilities sale-leaseback agreement that are recorded as interest expense under
sale-leaseback accounting rules. Additionally, investment income for the second quarter of 2008 is
lower than in the prior year period, primarily due to lower cash balances and interest rates.
Net loss for the second quarter of 2008 was $21.0 million, or $0.55 per share, compared to
$26.4 million, or $0.69 per share, for the same period in 2007. This decrease in net loss was
primarily due to a reduction in expenses as a result of our restructuring program implemented in
the fourth quarter of 2007.
SIX MONTHS ENDED JUNE 30, 2008 AND 2007
Revenues were $2.5 million for the six months ended June 30, 2008 compared with $0.2 million
for the respective period last year. During the six months ended June 30, 2008, we recognized a
$1.0 million milestone from GSK related to clinical advancements of our CRF program and $1.5
million in revenue under our collaboration agreement with DSP from amortization of up-front
licensing fees. We recognized $95,000 in revenue in the form of sponsored development funding from
GSK during the six months ended June 30, 2007.
Research and development expenses decreased to $30.4 million for the first half of 2008
compared with $37.9 million for the respective period in 2007. This decrease in research and
development expenses is primarily due to cost savings related to our restructuring implemented in
the fourth quarter of 2007. The decrease in staff levels reduced personnel costs by $6.2 million,
from $16.7 million in the first six months of 2007 to $10.5 million in the first six months of
2008. Additionally, laboratory costs decreased by $1.9 million in the first half of 2008 compared
to the same period in 2007. External development costs increased by $1.6 million to $11.0 million
in the first half of 2008 compared to $9.4 million in the same period last year. External
development spending in our elagolix program increased from $5.6 million in the first six months of
2007 to $9.4 million in the first six months of 2008. The increase in our elagolix external
development spending was offset by decreased costs in other external development programs.
General and administrative expenses were $13.0 million for the six months ended June 30, 2008
compared with $17.1 million during the same period last year. We incurred a $2.0 million
restructuring charge (net) in the first half of 2008. This charge was offset by cost savings
related to the restructuring implemented in the fourth quarter of 2007.
Other income (expense) decreased from $2.7 million during the first six months of 2007 to
$(1.2) million for the first six months of 2008. The decrease resulted primarily from rent payments
made under our facilities sale-leaseback agreement that are recorded as interest expense under
sale-leaseback accounting rules. Additionally, investment income for the first half of 2008 was
lower than in the prior year period, primarily due to lower cash balances and interest rates.
Net loss for the first half of 2008 was $42.0 million, or $1.10 per share, compared to $52.1
million, or $1.37 per share, for the same period in 2007. This decrease in net loss was primarily
due to a reduction in expenses as a result of our restructuring program implemented in the fourth
quarter of 2007.
To date, our revenues have been derived primarily from funded research and development,
achievements of milestones under corporate collaborations, and licensing of product candidates. The
nature and amount of these revenues from period to period may lead to substantial fluctuations in
the results of quarterly revenues and earnings. Accordingly, results and earnings for one period
are not predictive of future periods. Collaborations, including grant revenue, accounted for 100%
of our revenue for the six months ended June 30, 2008 and 2007.
We expect to incur operating losses for the foreseeable future because of the expenses we
expect to incur related to progressing programs through our pipeline.
15
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2008, our cash, cash equivalents, and investments totaled $133.5 million compared
with $179.4 million at December 31, 2007. The decrease in cash and investment balances at June 30,
2008 resulted primarily from our net loss of $42.0 million, cash payments related to our December
2007 restructuring program of $6.2 million and a reduction in accounts payable from the prior year
of approximately $3.3 million.
Our long-term investments at June 30, 2008 included (at par value) $22.6 million of auction
rate securities. With the liquidity issues experienced in global credit and capital markets, these
auction rate securities have experienced multiple failed auctions as the amount of securities
submitted for sale has exceeded the amount of purchase orders, and as a result, these affected
securities are currently not liquid. However, we now earn a higher interest rate according to the
terms of these securities. All of our auction rate securities are secured by student loans, which
are backed by the full faith and credit of the federal government (up to approximately 98% of the
value of the student loan). Additionally, all of our auction rate securities maintain the highest
credit rating of AAA. All of these securities continue to pay interest according to their stated
terms (generally 120 basis points over the ninety-one day United States Treasury bill rate) with
interest rates resetting every 7 to 28 days. While it is not our intent to hold these securities
until their stated ultimate maturity dates, these investments are schedule to ultimately mature
between 2030 and 2047.
At present, in the event we need to access the funds that are in an illiquid state, we may not
be able to do so without the possible loss of principal, until a future auction for these
investments is successful, another secondary market evolves for these securities, until they are
redeemed by the issuer or they mature. If we are unable to sell these securities in
the market or they are not redeemed, we could be required to hold them to maturity. We do not have
a need to access these funds for operational purposes in the foreseeable future. We will continue
to monitor and evaluate these investments on an ongoing basis for impairment. Although the auction rate security investments continue
to pay interest according to their stated terms, based on valuation models of the individual
securities, we have recorded an unrealized loss of approximately $1.0 million in accumulated other
comprehensive loss as a reduction in shareholders equity, reflecting adjustments to auction rate
security holdings that we concluded have a temporary decline in value due to a lack of liquidity in
the global credit markets. The carrying value in long-term investments for these auction rate
securities at June 30, 2008 is $21.6 million.
The valuation of our auction rate securities investment portfolio is subject to uncertainties
that are difficult to predict. The fair values of these securities are estimated utilizing a
discounted cash flow analysis as of June 30, 2008. The key driver
of this valuation model is the expected term to redemption. Changes to this assumption one year in either
direction did not have a material impact on the valuation of our auction rate securities portfolio
at June 30, 2008. Other items this analysis considers are the collateralization underlying the
security investments, the creditworthiness of the counterparty, the timing of expected future cash
flows, and the expected term to liquidity. The significant assumptions of this valuation model were
discount margins ranging from 166 to 230 basis points and an estimated term to liquidity of 2.5
years. These securities were also compared, when possible, to other observable market data with
similar characteristics to the securities held by us.
Factors that may impact the valuation of our auction rate securities portfolio include changes
to credit ratings of the securities as well as to the underlying assets supporting those
securities, rates of default of the underlying assets, underlying collateral value, discount rates,
counterparty risk and ongoing strength and quality of market credit and liquidity.
Net cash used in operating activities during the first half of 2008 was $43.2 million compared
with $33.6 million during the same period last year. Net loss for the first half of 2008 was $42.0
million compared to $52.1 million for the same period in 2007. This decrease in net loss was
primarily due to a reduction in expenses as a result of our restructuring program implemented in
the fourth quarter of 2007. The fluctuation in cash used in operating activities also resulted from
$9.5 million in payments made to reduce accounts payable and accrued liabilities (including accrued
severance) in the first half of 2008 and by a reduction in accounts receivable and other current
assets in the first six months of 2007 of $7.8 million compared to a corresponding decrease of only
$1.8 million in the same period during 2008.
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Net cash provided by investing activities during the first six months of 2008 was $36.3
million compared to $6.0 million for the first six months of 2007. The fluctuation in net cash
provided by investing activities resulted primarily from the timing differences in investment
purchases, sales and maturities, and the fluctuation of our portfolio mix between cash equivalents
and short-term investment holdings.
Net cash used in financing activities during the first half of 2008 was $0.9 million compared
to $1.9 million for the respective period last year. This fluctuation resulted primarily from cash
payments made on outstanding debt obligations.
We believe that our existing capital resources, together with interest income and future
payments due under our strategic alliances, will be sufficient to satisfy our current and projected
funding requirements for at least the next 12 months. However, we cannot guarantee that these
capital resources and payments will be sufficient to conduct all of our research and development
programs as planned. The amount and timing of expenditures will vary depending upon a number of
factors, including progress of our research and development programs.
We will require additional funding to continue our research and product development programs,
to conduct preclinical studies and clinical trials, for operating expenses, to pursue regulatory
approvals for our product candidates, for the costs involved in filing and prosecuting patent
applications and enforcing or defending patent claims, if any, the cost of product in-licensing and
any possible acquisitions, and we may require additional funding to establish manufacturing and
marketing capabilities in the future. We intend to seek additional funding through strategic
alliances, and may seek additional funding through public or private sales of our securities,
including equity securities. In addition, we have financed capital purchases and may continue to
pursue opportunities to obtain additional debt financing in the future. However, additional equity
or debt financing might not be available on reasonable terms, if at all, and any additional equity
financings will be dilutive to our stockholders. If adequate funds are not available, we may be
required to curtail significantly one or more of our research or development programs or obtain
funds through arrangements with collaborators or others. This may require us to relinquish rights
to certain of our technologies or product candidates. To the extent that we are unable to obtain
third-party funding for such expenses, we expect that increased expenses will result in increased
losses from operations. We cannot assure you that we will be successful in the development of our
product candidates, or that, if successful; any products marketed will generate sufficient revenues
to enable us to earn a profit.
INTEREST RATE RISK
We are exposed to interest rate risk on our short and long term investments. The primary
objective of our investment activities is to preserve principal while at the same time maximizing
yields without significantly increasing risk. To achieve this objective, we invest in highly liquid
and high quality government and other debt securities. To minimize our exposure due to adverse
shifts in interest rates, we invest in short-term securities and ensure that the maximum initial
average maturity of our investments does not exceed 36 months. If a 10% change in interest rates
were to have occurred on June 30, 2008, this change would not have had a material effect on the
fair value of our investment portfolio as of that date. Due to the short holding period of our
investments and the nature of our investments, we have concluded that we do not have a material
financial market interest rate risk exposure.
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q and the information incorporated herein by reference
contain forward-looking statements that involve a number of risks and uncertainties. Although our
forward-looking statements reflect the good faith judgment of our management, these statements can
only be based on facts and factors currently known by us. Consequently, these forward-looking
statements are inherently subject to risks and uncertainties, and actual results and outcomes may
differ materially from results and outcomes discussed in the forward-looking statements.
Forward-looking statements can be identified by the use of forward-looking words such as
believes, expects, hopes, may, will, plan, intends, estimates, could, should,
would, continue, seeks, proforma, or anticipates, or other similar words (including their
use in the negative), or by discussions of future matters such as the development or regulatory
approval of new products, technology enhancements, possible changes in legislation and other
statements that are not historical. These statements include but are not limited to statements
under the captions Risk Factors, and Managements Discussion and Analysis of Financial Condition
and Results of Operations as well as other sections in this report. You should be aware that the
occurrence of any of the events discussed under the heading in Part II titled Item 1A. Risk
Factors and elsewhere in this report could substantially harm our business, results of operations
and financial condition and that if any of these events occurs, the trading price of our common
stock could decline and you could lose all or a part of the value of your shares of our common
stock.
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The cautionary statements made in this report are intended to be applicable to all related
forward-looking statements wherever they may appear in this report. We urge you not to place undue
reliance on these forward-looking statements, which speak only as of the date of this report.
Except as required by law, we assume no obligation to update our forward-looking statements, even
if new information becomes available in the future.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
A discussion of our exposure to, and management of, market risk appears in Part I, Item 2 of
this Quarterly Report on Form 10-Q under the heading Interest Rate Risk.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the timelines specified in the Securities and Exchange Commissions rules and
forms, and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decision
regarding required disclosure. In designing and evaluating the disclosure controls and procedures,
management recognized that any controls and procedures, no matter how well designed and operated,
can only provide reasonable assurance of achieving the desired control objectives, and in reaching
a reasonable level of assurance, management necessarily was required to apply its judgment in
evaluating the cost-benefit relationship of possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level.
There has been no change in our internal control over financial reporting during our most
recent fiscal quarter 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
On June 19, 2007, Construction Laborers Pension Trust of Greater St. Louis filed a purported
class action lawsuit in the United States District Court for the Southern District of California
under the caption Construction Laborers Pension Trust of Greater St. Louis v. Neurocrine
Biosciences, Inc., et al., 07-cv-1111-IEG-RBB. On June 26, 2007, a second purported class action
lawsuit with similar allegations was also filed. On October 16, 2007, both lawsuits were
consolidated into one purported class action under the caption In re Neurocrine Biosciences, Inc.
Securities Litigation, 07-cv-1111-IEG-RBB. The court also selected lead plaintiffs and ordered
them to file a consolidated complaint. On November 30, 2007, lead plaintiffs filed the
Consolidated Amended Complaint (CAC), which alleged, among other things, that the Company and
certain of its officers and directors violated federal securities laws by making allegedly false
and misleading statements regarding the progress toward FDA approval and the potential for market
success of indiplon in the 15 mg dosage unit. On January 11, 2008, we and the individual
defendants filed a motion to dismiss the CAC. Following a hearing on April 22, 2008, the court
granted the motion to dismiss but gave the lead plaintiffs leave to file an amended complaint. On
June 11, 2008, the lead plaintiffs filed the Second Consolidated Amended Complaint (SAC), which is
now the operative complaint in the litigation. On July 8, 2008, the Company and the individual
defendants filed a motion to dismiss the SAC. A hearing on the motion to dismiss the SAC is
scheduled to occur on September 2, 2008.
In addition, on June 25, 2007, a shareholder derivative complaint was filed in the Superior
Court of the State of California for the County of San Diego by Ralph Lipeles under the caption,
Lipeles v. Lyons. The complaint was brought purportedly on our behalf against certain current and
former officers and directors and alleges, among other things, that the named officers and
directors breached their fiduciary duties by directing us to make allegedly false statements about
the progress toward FDA approval and the potential for market success of indiplon in the 15mg
dosage unit. All proceedings in this matter have been stayed pending resolution of the motion to
dismiss the SAC.
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We intend to take all appropriate action in responding to all of the complaints. Due to the
uncertainty of the ultimate outcome of these matters, the impact, if any, on our future financial
results is not subject to reasonable estimate as of June 30, 2008.
ITEM 1A. RISK FACTORS
The following Risk Factors do not reflect any material changes to the Risk Factors set forth
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2007, other than the
revisions to the risk factors set forth below with an asterisk (*) next to the title. The following
information sets forth risk factors that could cause our actual results to differ materially from
those contained in forward-looking statements we have made in this Quarterly Report and those we
may make from time to time. If any of the following risks actually occur, our business, operating
results, prospects or financial condition could be harmed. Additional risks not presently known to
us, or that we currently deem immaterial, may also affect our business operations.
Risks Related to Our Company
*Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates,
which could prevent or significantly delay their regulatory approval.
Before obtaining regulatory approval for the sale of any of our potential products, we must
subject these product candidates to extensive preclinical and clinical testing to demonstrate their
safety and efficacy for humans. Clinical trials are expensive, time-consuming and may take years to
complete.
In connection with the clinical trials of our product candidates, we face the risks that:
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the product candidate may not prove to be effective; |
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we may discover that a product candidate may cause harmful side effects; |
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the results may not replicate the results of earlier, smaller trials; |
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we or the FDA or similar foreign regulatory authorities may suspend the trials; |
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the results may not be statistically significant; |
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patient recruitment may be slower than expected; and |
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patients may drop out of the trials. |
For example, there is uncertainty regarding future development of indiplon as described below
under the risk factor entitled There is uncertainty regarding future development of our product
candidate, indiplon, and we may not be able to meet the requirements to receive regulatory
approvals for it.
In addition, late stage clinical trials are often conducted with patients having the most
advanced stages of disease. During the course of treatment, these patients can die or suffer other
adverse medical effects for reasons that may not be related to the pharmaceutical agent being
tested but which can nevertheless adversely affect clinical trial results. Any failure or
substantial delay in completing clinical trials for our product candidates may severely harm our
business.
We depend on continuing our current collaborations and developing additional collaborations to
develop and commercialize our product candidates.
Our strategy for developing and commercializing our products is dependent upon maintaining our
current arrangements and establishing new arrangements with research collaborators, corporate
collaborators and others. We have active collaboration agreements with GlaxoSmithKline and
Dainippon Sumitomo Pharma Co. Ltd. and previously have had collaborations with Pfizer, Wyeth,
Johnson & Johnson, and Eli Lilly and Company. We historically have been dependent upon these
corporate collaborators to
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provide adequate funding for a number of our programs. Under these arrangements, our corporate
collaborators are typically responsible for:
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selecting compounds for subsequent development as drug candidates; |
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conducting preclinical studies and clinical trials and obtaining required regulatory
approvals for these drug candidates; and |
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manufacturing and commercializing any resulting drugs. |
Because we expect to continue to rely heavily on corporate collaborators, the development and
commercialization of our programs would be substantially delayed if one or more of our current or
future collaborators:
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failed to select a compound that we have discovered for subsequent development into
marketable products; |
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failed to gain the requisite regulatory approvals of these products; |
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did not successfully commercialize products that we originate; |
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did not conduct its collaborative activities in a timely manner; |
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did not devote sufficient time and resources to our partnered programs or potential
products; |
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terminated its alliance with us; |
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developed, either alone or with others, products that may compete with our products; |
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disputed our respective allocations of rights to any products or technology developed
during our collaborations; or |
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merged with a third party that wants to terminate the collaboration. |
These issues and possible disagreements with current or future corporate collaborators could
lead to delays in the collaborative research, development or commercialization of many of our
product candidates. Furthermore, disagreements with these parties could require or result in
litigation or arbitration, which would be time-consuming and expensive. If any of these issues
arise, it may delay the development and commercialization of drug candidates and, ultimately, our
generation of product revenues.
If we cannot raise additional funding, we may be unable to complete development of our product
candidates.
We may require additional funding to continue our research and product development programs,
to conduct preclinical studies and clinical trials, for operating expenses and to pursue regulatory
approvals for product candidates, for the costs involved in filing and prosecuting patent
application and enforcing or defending patent claims, if any, as well as costs associated with
litigation matters, product in-licensing and any possible acquisitions, and we may require
additional funding to establish manufacturing and marketing capabilities in the future. We believe
that our existing capital resources, together with interest income, and future payments due under
our strategic alliances, will be sufficient to satisfy our current and projected funding
requirements for at least the next 12 months. However, these resources might be insufficient to
conduct research and development programs as planned. If we cannot obtain adequate funds, we may be
required to curtail significantly one or more of our research and development programs or obtain
funds through additional arrangements with corporate collaborators or others that may require us to
relinquish rights to some of our technologies or product candidates.
Our future capital requirements will depend on many factors, including:
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continued scientific progress in our research and development programs; |
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the magnitude of our research and development programs; |
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progress with preclinical testing and clinical trials; |
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the time and costs involved in obtaining regulatory approvals; |
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the costs involved in filing and pursuing patent applications and enforcing patent
claims; |
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competing technological and market developments; |
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the establishment of additional strategic alliances; |
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the cost of commercialization activities and arrangements, including manufacturing of our
product candidates; and |
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the cost of product in-licensing and any possible acquisitions. |
We intend to seek additional funding through strategic alliances, and may seek additional
funding through public or private sales of our securities, including equity securities. For
example, we have an effective shelf registration statement on file with the Securities and Exchange
Commission which allows us to issue shares of our common stock from time to time for an aggregate
initial offering price of up to $150 million. In addition, we have previously financed capital
purchases and may continue to pursue opportunities to obtain additional debt financing in the
future. However, additional equity or debt financing might not be available on reasonable terms, if
at all. Any additional equity financings will be dilutive to our stockholders and any additional
debt financings may involve operating covenants that restrict our business.
*Our pending securities class action litigation could divert managements attention and harm our
business.
The market price of our common stock declined significantly following our May 16, 2006
announcement of the FDAs action letters with respect to indiplon. In June 2007, two class action
lawsuits (which have since been consolidated) were filed alleging, among other things, that we and
certain of our officers and directors violated federal securities laws by making allegedly false
and misleading statements regarding the progress toward FDA approval and the potential for market
success of indiplon in the 15mg dosage unit. Also in June 2007, a shareholder derivative lawsuit
was filed alleging, among other things, that certain of our current and former officers and
directors breached their fiduciary duties by directing us to make allegedly false statements about
such matters. In January 2008, we and the individual officers and directors filed a motion to
dismiss the consolidated class action lawsuit, which the court granted in April 2008 but gave the
lead plaintiffs leave to file an amended complaint. In June 2008, the lead plaintiffs filed an
amended complaint to which we and the individual defendants filed a motion to dismiss the amended
complaint. A hearing on the motion to dismiss the amended complaint is scheduled for September
2008. The shareholder derivative lawsuit has been stayed pending resolution of the motion to
dismiss the amended complaint. We cannot currently predict the outcome of this litigation, which
may be expensive and divert our managements attention and resources from operating the business.
Additionally, we may not be successful in having such litigation dismissed or settled within the
limits of our insurance.
Our restructuring activities could result in management distractions, operational disruptions and
other difficulties.
As a result of the uncertainty in the future development of indiplon capsules and tablets, we
have initiated restructuring activities in an effort to reduce operating costs, including a work
force reduction announced in December 2007. Employees whose positions were eliminated in connection
with this reduction may seek future employment with our competitors. Although all employees are
required to sign a confidentiality agreement with us at the time of hire, we cannot assure you that
the confidential nature of our proprietary information will be maintained in the course of such
future employment. Any additional restructuring efforts could divert the attention of our
management away from our operations, harm our reputation and increase our expenses. We cannot
assure you that we will not undertake additional restructuring activities, that any of our
restructuring efforts will be successful, or that we will be able to realize the cost savings and
other anticipated benefits from our previous or future restructuring plans. In addition, if we
continue to reduce our workforce, it may adversely impact our ability to respond rapidly to any new
growth opportunities.
*There is uncertainty regarding future development of our product candidate, indiplon, and we may
not be able to meet the requirements to receive regulatory approvals for it.
On December 12, 2007 we received an action letter from the FDA stating that indiplon 5mg and
10mg capsules are approvable (2007 FDA Approvable Letter). The 2007 FDA Approvable Letter
acknowledged that our resubmitted NDA for indiplon 5mg and 10mg capsules had addressed the issues
raised in a previous approvable letter, but set forth new requirements. The new requirements set forth
in the 2007 FDA Approvable Letter are the following: (i) an objective/subjective clinical trial in
the elderly, (ii) a safety study
assessing the rates of adverse events occurring with indiplon when compared to a marketed
product and (iii) a preclinical study to evaluate indiplon administration during the third
trimester of pregnancy. After receipt of the 2007 FDA Approvable Letter, we ceased all indiplon
clinical development activities in the United States as well as all pre-commercialization
activities. We met with the FDA in July 2008 to discuss the 2007 FDA Approvable Letter and we are
awaiting their written minutes of this meeting.
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The process of preparing and resubmitting the NDA for indiplon will require significant
resources and could be time consuming and subject to unanticipated delays and cost. As a result of
the 2007 FDA Approvable Letter, there is a significant amount of uncertainty regarding the future
development of indiplon. Should the NDA be refiled, the FDA could again refuse to approve the NDA,
or could still require additional data analysis or clinical trials, which would require substantial
expenditures by us and would further delay the approval process. Even if our indiplon NDA is
approved, the FDA may determine that our data do not support elements of the labeling we have
requested. In such a case, the labeling actually granted by the FDA could limit the commercial
success of the product. The FDA could also require Phase IV, or post-marketing, trials to study the
long-term effects of indiplon and could withdraw its approval based on the results of those trials.
We face the risk that for any of the reasons described above, as well as other reasons set forth
herein, indiplon may never be approved by the FDA or commercialized anywhere in the world.
If we determine that it is impractical or we are unable to refile the NDA, or the FDA refuses
to accept or approve the resubmitted NDA for any reason or we experience a further delay in
approval and subsequent commercialization of indiplon, our business and reputation would be harmed
and our stock price could decline.
We have a history of losses and expect to incur losses and negative operating cash flows for the
near future, and we may never achieve sustained profitability.
Since our inception, we have incurred significant net losses, including net losses of $207.3
million and $107.2 million for the years ended December 31, 2007 and 2006, respectively. As a
result of ongoing operating losses, we had an accumulated deficit of $614.7 million and $407.4
million as of December 31, 2007 and 2006, respectively. We do not expect to be profitable for the
year ended December 31, 2008 or the foreseeable future.
We have not yet obtained regulatory approvals of any products and, consequently, have not
generated revenues from the sale of products. Even if we succeed in developing and commercializing
one or more of our drugs, we may not be profitable. We also expect to continue to incur significant
operating and capital expenditures as we:
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seek regulatory approvals for our product candidates; |
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develop, formulate, manufacture and commercialize our drugs; |
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in-license or acquire new product development opportunities; |
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implement additional internal systems and infrastructure; and |
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hire additional clinical, scientific and marketing personnel. |
We also expect to experience negative cash flow for the near future as we fund our operating
losses, in-licensing or acquisition opportunities, and capital expenditures. We will need to
generate significant revenues to achieve and maintain profitability and positive cash flow. We may
not be able to generate these revenues, and we may never achieve profitability in the future. Our
failure to achieve or maintain profitability could negatively impact the market price of our common
stock. Even if we become profitable, we cannot assure you that we would be able to sustain or
increase profitability on a quarterly or annual basis.
Because our operating results may vary significantly in future periods, our stock price may
decline.
Our quarterly revenues, expenses and operating results have fluctuated in the past and are
likely to fluctuate significantly in the future. Our revenues are unpredictable and may fluctuate,
among other reasons, due to our achievement of product development objectives and milestones,
clinical trial enrollment and expenses, research and development expenses and the timing and nature
of contract manufacturing and contract research payments. A high portion of our costs are
predetermined on an annual basis, due in part to our significant research and development costs.
Thus, small declines in revenue could disproportionately affect operating results in
a quarter. Because of these factors, our operating results in one or more future quarters may
fail to meet the expectations of securities analysts or investors, which could cause our stock
price to decline.
22
We license some of our core technologies and drug candidates from third parties. If we default on
any of our obligations under those licenses, we could lose our rights to those technologies and
drug candidates.
We are dependent on licenses from third parties for some of our key technologies. These
licenses typically subject us to various commercialization, reporting and other obligations. If we
fail to comply with these obligations, we could lose important rights. For example, we have
licensed indiplon from DOV Pharmaceutical, Inc. (DOV). In addition, we license some of the core
technologies used in our collaborations from third parties, including the CRF receptor we license
from The Salk Institute and use in our CRF program, and urocortin 2 which we license from Research
Development Foundation. Other in-licensed technologies, such as the GnRH receptor we license from
Mount Sinai School of Medicine, will be important for future collaborations for our elagolix
program. If we were to default on our obligations under any of our licenses, we could lose some or
all of our rights to develop, market and sell products covered by these licenses. Likewise, if we
were to lose our rights under a license to use proprietary research tools, it could adversely
affect our existing collaborations or adversely affect our ability to form new collaborations. We
also face the risk that our licensors could, for a number of reasons, lose patent protection or
lose their rights to the technologies we have licensed, thereby impairing or extinguishing our
rights under our licenses with them.
Because the development of our product candidates is subject to a substantial degree of
technological uncertainty, we may not succeed in developing any of our product candidates.
All of our product candidates are in research, clinical development or in registration with
the FDA. Only a small number of research and development programs ultimately result in commercially
successful drugs. Potential products that appear to be promising at early stages of development may
not reach the market for a number of reasons. These reasons include the possibilities that the
potential products may:
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be found ineffective or cause harmful side effects during preclinical studies or clinical
trials; |
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fail to receive necessary regulatory approvals on a timely basis or at all; |
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be precluded from commercialization by proprietary rights of third parties; |
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be difficult to manufacture on a large scale; or |
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be uneconomical to commercialize or fail to achieve market acceptance. |
If any of our products encounters any of these potential problems, we may never successfully
market that product.
We have limited marketing experience, sales force or distribution capabilities, and if our
products are approved, we may not be able to commercialize them successfully.
Although we do not currently have any marketable products, our ability to produce revenues
ultimately depends on our ability to sell our products if and when they are approved by the FDA. We
currently have limited experience in marketing and selling pharmaceutical products. If we fail to
establish successful marketing and sales capabilities or fail to enter into successful marketing
arrangements with third parties, our product revenues will suffer.
The independent clinical investigators and contract research organizations that we rely upon to
conduct our clinical trials may not be diligent, careful or timely, and may make mistakes, in the
conduct of our trials.
We depend on independent clinical investigators and contract research organizations (CROs) to
conduct our clinical trials under their agreements with us. The investigators are not our
employees, and we cannot control the amount or timing of resources that they devote to our
programs. If independent investigators fail to devote sufficient time and resources to our drug
development programs, or if their performance is substandard, it may delay or prevent the approval
of our FDA applications and our introduction of new drugs. The CROs we contract with for execution
of our clinical trials play a significant role in the conduct of the trials and the subsequent
collection and analysis of data. Failure of the CROs to meet their obligations could adversely
affect clinical development of our
products. Moreover, these independent investigators and CROs may also have relationships with
other commercial entities, some of which may compete with us. If independent investigators and CROs
assist our competitors at our expense, it could harm our competitive position.
23
We have no manufacturing capabilities. If third-party manufacturers of our product candidates fail
to devote sufficient time and resources to our concerns, or if their performance is substandard,
our clinical trials and product introductions may be delayed and our costs may rise.
We have in the past utilized, and intend to continue to utilize, third-party manufacturers to
produce the drug compounds we use in our clinical trials and for the potential commercialization of
our future products. We have no experience in manufacturing products for commercial purposes and do
not currently have any manufacturing facilities. Consequently, we depend on, and will continue to
depend on, several contract manufacturers for all production of products for development and
commercial purposes. If we are unable to obtain or retain third-party manufacturers, we will not be
able to develop or commercialize our products. The manufacture of our products for clinical trials
and commercial purposes is subject to specific FDA regulations. Our third-party manufacturers might
not comply with FDA regulations relating to manufacturing our products for clinical trials and
commercial purposes or other regulatory requirements now or in the future. Our reliance on contract
manufacturers also exposes us to the following risks:
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contract manufacturers may encounter difficulties in achieving volume production, quality
control and quality assurance, and also may experience shortages in qualified personnel. As
a result, our contract manufacturers might not be able to meet our clinical schedules or
adequately manufacture our products in commercial quantities when required; |
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switching manufacturers may be difficult because the number of potential manufacturers is
limited. It may be difficult or impossible for us to find a replacement manufacturer quickly
on acceptable terms, or at all; |
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our contract manufacturers may not perform as agreed or may not remain in the contract
manufacturing business for the time required to successfully produce, store or distribute
our products; and |
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drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the
DEA, and other agencies to ensure strict compliance with good manufacturing practices and
other government regulations and corresponding foreign standards. We do not have control
over third-party manufacturers compliance with these regulations and standards. |
Our current dependence upon third parties for the manufacture of our products may harm our
profit margin, if any, on the sale of our future products and our ability to develop and deliver
products on a timely and competitive basis.
If we are unable to retain and recruit qualified scientists or if any of our key senior executives
discontinues his or her employment with us, it may delay our development efforts.
We are highly dependent on the principal members of our management and scientific staff. The
loss of any of these people could impede the achievement of our development objectives.
Furthermore, recruiting and retaining qualified scientific personnel to perform research and
development work in the future is critical to our success. We may be unable to attract and retain
personnel on acceptable terms given the competition among biotechnology, pharmaceutical and health
care companies, universities and non-profit research institutions for experienced scientists. In
addition, we rely on a significant number of consultants to assist us in formulating our research
and development strategy. All of our consultants are employed by employers other than us. They may
have commitments to, or advisory or consulting agreements with, other entities that may limit their
availability to us.
We may be subject to claims that we or our employees have wrongfully used or disclosed alleged
trade secrets of their former employers.
As is commonplace in the biotechnology industry, we employ individuals who were previously
employed at other biotechnology or pharmaceutical companies, including our competitors or potential
competitors. Although no claims against us are currently pending, we may be subject to claims that
these employees or we have inadvertently or otherwise used or disclosed trade secrets or other
proprietary information of their former employers. Litigation may be necessary to defend against
these claims. Even if we are successful in defending against these claims, litigation could result
in substantial costs and be a distraction to management.
24
Governmental and third-party payors may impose sales and pharmaceutical pricing controls on our
products that could limit our product revenues and delay profitability.
The continuing efforts of government and third-party payors to contain or reduce the costs of
health care through various means may reduce our potential revenues. These payors efforts could
decrease the price that we receive for any products we may develop and sell in the future. In
addition, third-party insurance coverage may not be available to patients for any products we
develop. If government and third-party payors do not provide adequate coverage and reimbursement
levels for our products, or if price controls are enacted, our product revenues will suffer.
If physicians and patients do not accept our products, we may not recover our investment.
The commercial success of our products, if they are approved for marketing, will depend upon
the acceptance of our products as safe and effective by the medical community and patients.
The market acceptance of our products could be affected by a number of factors, including:
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the timing of receipt of marketing approvals; |
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the safety and efficacy of the products; |
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the success of existing products addressing our target markets or the emergence of
equivalent or superior products; and |
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the cost-effectiveness of the products. |
In addition, market acceptance depends on the effectiveness of our marketing strategy, and, to
date, we have very limited sales and marketing experience or capabilities. If the medical community
and patients do not ultimately accept our products as being safe, effective, superior and/or
cost-effective, we may not recover our investment.
Compliance with changing regulation of corporate governance and public disclosure may result in
additional expenses.
Changing laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and Nasdaq rules, are
creating uncertainty for companies such as ours. These new or changed laws, regulations and
standards are subject to varying interpretations in many cases due to their lack of specificity,
and as a result, their application in practice may evolve over time as new guidance is provided by
regulatory and governing bodies, which could result in continuing uncertainty regarding compliance
matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
We are committed to maintaining high standards of corporate governance and public disclosure. As a
result, our efforts to comply with evolving laws, regulations and standards have resulted in, and
are likely to continue to result in, increased general and administrative expenses and management
time related to compliance activities. In particular, our efforts to comply with Section 404 of the
Sarbanes-Oxley Act of 2002 and the related regulations regarding our required assessment of our
internal controls over financial reporting requires the commitment of significant financial and
managerial resources. We expect these efforts to require the continued commitment of significant
resources. If we fail to comply with new or changed laws, regulations and standards, our reputation
may be harmed and we might be subject to sanctions or investigation by regulatory authorities, such
as the Securities and Exchange Commission. Any such action could adversely affect our financial
results and the market price of our common stock.
The price of our common stock is volatile.
The market prices for securities of biotechnology and pharmaceutical companies historically
have been highly volatile, and the market has from time to time experienced significant price and
volume fluctuations that are unrelated to the operating performance of particular companies. Over
the course of the last 12 months, the price of our common stock has ranged from approximately $4
per share to approximately $13 per share. The market price of our common stock may fluctuate in
response to many factors, including:
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developments related to the FDA approval process for indiplon; |
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the results of our clinical trials; |
25
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developments concerning our strategic alliance agreements; |
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announcements of technological innovations or new therapeutic products by us or others; |
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developments in patent or other proprietary rights; |
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future sales of our common stock by existing stockholders; |
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comments by securities analysts; |
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general market conditions; |
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fluctuations in our operating results; |
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government regulation; |
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health care reimbursement; |
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failure of any of our product candidates, if approved, to achieve commercial success; and |
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public concern as to the safety of our drugs. |
*Negative conditions in the global credit markets may impair the liquidity of a portion of our
investment portfolio.
Our investment securities consist of auction rate securities, corporate debt securities and
government agency securities. As of June 30, 2008, our long-term investments included $22.6 million
of high-grade (AAA rated) auction rate securities issued by student loan providers. All of these
auction rate securities have experienced failed auctions due to lack of liquidity at the time their
interest rates were to reset. The recent negative conditions in the global credit markets have
prevented some investors from liquidating their holdings, including their holdings of auction rate
securities. As a result, certain of these types of securities are not fully liquid and we could be
required to hold them until they are redeemed by the issuer, a future auction for these securities
is successful, another secondary market evolves for these securities, or they mature. In the event
we need to access the funds that are in an illiquid state, we may not be able to do so without a
potential loss of principal. As of June 30, 2008, the carrying value of all auction rate securities
had been reduced by $1.0 million, from $22.6 million to $21.6 million, reflecting an estimated
change in fair market value due solely to a lack of liquidity. Although the auction rate securities
continue to pay interest according to their stated terms, based on valuation models, we have
recorded an unrealized loss of approximately $1.0 million in accumulated other comprehensive loss
as a reduction in shareholders equity. If the credit ratings of the security issuers deteriorate
or if uncertainties in these markets continue and any decline in market value is determined to be
other-than-temporary, we would be required to adjust the carrying value of the investment through
an impairment charge, which could negatively affect our financial condition, cash flow and reported
earnings.
Risks Related to Our Industry
We may not receive regulatory approvals for our product candidates or approvals may be delayed.
Regulation by government authorities in the United States and foreign countries is a
significant factor in the development, manufacture and marketing of our proposed products and in
our ongoing research and product development activities. Any failure to receive the regulatory
approvals necessary to commercialize our product candidates would harm our business. The process of
obtaining these approvals and the subsequent compliance with federal and state statutes and
regulations require spending substantial time and financial resources. If we fail or our
collaborators or licensees fail to obtain or maintain, or encounter delays in obtaining or
maintaining, regulatory approvals, it could adversely affect the marketing of any products we
develop, our ability to receive product or royalty revenues, our recovery of prepaid royalties, and
our liquidity and capital resources. All of our products are in research and development, and we
have not yet received regulatory approval to commercialize any product from the FDA or any other
regulatory body. In addition, we have limited experience in filing and pursuing applications
necessary to gain regulatory approvals, which may impede our ability to obtain such approvals.
26
In particular, human therapeutic products are subject to rigorous preclinical testing and
clinical trials and other approval procedures of the FDA and similar regulatory authorities in
foreign countries. The FDA regulates, among other things, the development, testing, manufacture,
safety, efficacy, record keeping, labeling, storage, approval, advertising, promotion, sale and
distribution of biopharmaceutical products. Securing FDA approval requires the submission of
extensive preclinical and clinical data and supporting information to the FDA for each indication
to establish the product candidates safety and efficacy. The approval process may take many years
to complete and may involve ongoing requirements for post-marketing studies. Any FDA or other
regulatory approval of our product candidates, once obtained, may be withdrawn. If our potential
products are marketed abroad, they will also be subject to extensive regulation by foreign
governments.
We face intense competition, and if we are unable to compete effectively, the demand for our
products, if any, may be reduced.
The biotechnology and pharmaceutical industries are subject to rapid and intense technological
change. We face, and will continue to face, competition in the development and marketing of our
product candidates from academic institutions, government agencies, research institutions and
biotechnology and pharmaceutical companies.
Competition may also arise from, among other things:
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other drug development technologies; |
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methods of preventing or reducing the incidence of disease, including vaccines; and |
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new small molecule or other classes of therapeutic agents. |
Developments by others may render our product candidates or technologies obsolete or
noncompetitive.
We are performing research on or developing products for the treatment of several disorders
including endometriosis, irritable bowel syndrome, anxiety, depression, pain, diabetes, insomnia,
and other neurological and endocrine related diseases and disorders, and there are a number of
competitors to products in our research pipeline. If one or more of our competitors products or
programs are successful, the market for our products may be reduced or eliminated.
Compared to us, many of our competitors and potential competitors have substantially greater:
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capital resources; |
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research and development resources, including personnel and technology; |
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regulatory experience; |
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preclinical study and clinical testing experience; |
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manufacturing and marketing experience; and |
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production facilities. |
If we are unable to protect our intellectual property, our competitors could develop and market
products based on our discoveries, which may reduce demand for our products.
Our success will depend on our ability to, among other things:
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obtain patent protection for our products; |
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preserve our trade secrets; |
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prevent third parties from infringing upon our proprietary rights; and |
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operate without infringing upon the proprietary rights of others, both in the United
States and internationally. |
27
Because of the substantial length of time and expense associated with bringing new products
through the development and regulatory approval processes in order to reach the marketplace, the
pharmaceutical industry places considerable importance on obtaining patent and trade secret
protection for new technologies, products and processes. Accordingly, we intend to seek patent
protection for our proprietary technology and compounds. However, we face the risk that we may not
obtain any of these patents and that the breadth of claims we obtain, if any, may not provide
adequate protection of our proprietary technology or compounds.
We also rely upon unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation to develop and maintain our competitive position, which we seek
to protect, in part, through confidentiality agreements with our commercial collaborators,
employees and consultants. We also have invention or patent assignment agreements with our
employees and some, but not all, of our commercial collaborators and consultants. However, if our
employees, commercial collaborators or consultants breach these agreements, we may not have
adequate remedies for any such breach, and our trade secrets may otherwise become known or
independently discovered by our competitors.
In addition, although we own a number of patents, the issuance of a patent is not conclusive
as to its validity or enforceability, and third parties may challenge the validity or
enforceability of our patents. We cannot assure you how much protection, if any, will be given to
our patents if we attempt to enforce them and they are challenged in court or in other proceedings.
It is possible that a competitor may successfully challenge our patents or that challenges will
result in limitations of their coverage. Moreover, competitors may infringe our patents or
successfully avoid them through design innovation. To prevent infringement or unauthorized use, we
may need to file infringement claims, which are expensive and time-consuming. In addition, in an
infringement proceeding a court may decide that a patent of ours is not valid or is unenforceable,
or may refuse to stop the other party from using the technology at issue on the grounds that our
patents do not cover its technology. Interference proceedings declared by the United States Patent
and Trademark Office (USPTO) may be necessary to determine the priority of inventions with respect
to our patent applications or those of our licensors. Litigation or interference proceedings may
fail and, even if successful, may result in substantial costs and be a distraction to management.
We cannot assure you that we will be able to prevent misappropriation of our proprietary rights,
particularly in countries where the laws may not protect such rights as fully as in the United
States.
The technologies we use in our research as well as the drug targets we select may infringe the
patents or violate the proprietary rights of third parties.
We cannot assure you that third parties will not assert patent or other intellectual property
infringement claims against us or our collaborators with respect to technologies used in potential
products. If a patent infringement suit were brought against us or our collaborators, we or our
collaborators could be forced to stop or delay developing, manufacturing or selling potential
products that are claimed to infringe a third partys intellectual property unless that party
grants us or our collaborators rights to use its intellectual property. In such cases, we could be
required to obtain licenses to patents or proprietary rights of others in order to continue to
commercialize our products. However, we may not be able to obtain any licenses required under any
patents or proprietary rights of third parties on acceptable terms, or at all. Even if our
collaborators or we were able to obtain rights to the third partys intellectual property, these
rights may be non-exclusive, thereby giving our competitors access to the same intellectual
property. Ultimately, we may be unable to commercialize some of our potential products or may have
to cease some of our business operations as a result of patent infringement claims, which could
severely harm our business.
We face potential product liability exposure far in excess of our limited insurance coverage.
The use of any of our potential products in clinical trials, and the sale of any approved
products, may expose us to liability claims. These claims might be made directly by consumers,
health care providers, pharmaceutical companies or others selling our products. We have obtained
limited product liability insurance coverage for our clinical trials in the amount of $10 million
per occurrence and $10 million in the aggregate. However, our insurance may not reimburse us or may
not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance
coverage is becoming increasingly expensive, and we may not be able to maintain insurance coverage
at a reasonable cost or in sufficient amounts to protect us against losses due to liability. We
intend to expand our insurance coverage to include the sale of commercial products if we obtain
marketing approval for product candidates in development, but we may be unable to obtain
commercially reasonable product liability insurance for any products approved for marketing. On
occasion, juries have awarded large judgments in class action lawsuits based on drugs that had
unanticipated side effects. A successful product liability claim or series of claims brought
against us would decrease our cash reserves and could cause our stock price to fall.
28
Our activities involve hazardous materials, and we may be liable for any resulting contamination
or injuries.
Our research activities involve the controlled use of hazardous materials. We cannot eliminate
the risk of accidental contamination or injury from these materials. If an accident occurs, a court
may hold us liable for any resulting damages, which may harm our results of operations and cause us
to use a substantial portion of our cash reserves, which would force us to seek additional
financing.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Incorporated by reference to Item 8.01 of our Current Report on Form 8-K filed on May 28,
2008.
ITEM 6. EXHIBITS
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3.1
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Restated Certificate of Incorporation (1) |
3.2
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Certificate of Amendment to Certificate of Incorporation (2) |
3.3
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Bylaws (1) |
3.4
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Certificate of Amendment of Bylaws (3) |
3.5
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Certificate of Amendment of Bylaws (4) |
10.1
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Neurocrine Biosciences, Inc. 2003 Incentive Stock Plan, as amended,
and form of stock option agreement and restricted stock unit
agreement. |
31.1
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Certification of Chief Executive Officer pursuant to Rules 13a-14(a)
and 15d-14(a) promulgated under the Securities Exchange Act of 1934. |
31.2
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Certification of Chief Financial Officer pursuant to Rules 13a-14(a)
and 15d-14(a) promulgated under the Securities Exchange Act of 1934. |
32*
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Certifications of Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002. |
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(1) |
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Incorporated by reference to the Companys Registration Statement on Form S-1 (Registration
No. 333-03172) |
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(2) |
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Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed on August 9,
2006 |
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(3) |
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Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended December 31, 1997 filed on April 10, 1998 |
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(4) |
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Incorporated by reference to the Companys Quarterly Report on Form 10-Q filed on August 9,
2004 |
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These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Neurocrine Biosciences, Inc., whether made before or after the date hereof, regardless of any
general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities and 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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Dated: July 31, 2008
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/s/ Timothy P. Coughlin
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Timothy P. Coughlin |
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Vice President and Chief Financial Officer |
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(Duly authorized officer and Principal Financial Officer) |
30
exv10w1
EXHIBIT 10.1
NEUROCRINE BIOSCIENCES, INC.
2003 INCENTIVE STOCK PLAN
as amended May 25, 2005, November 7, 2005, January 12, 2006,
March 2, 2006, May 31, 2007, August 1, 2007 and
May 28,2008
1. Purpose of the Plan. The purposes of this Incentive Stock Plan are to attract and
retain the best available personnel, to provide additional incentive to the employees of Neurocrine
Biosciences, Inc. (the Company) and to promote the success of the Companys business.
Options granted hereunder may be either Incentive Stock Options or Nonstatutory Stock Options, at
the discretion of the Board and as reflected in the terms of the written option agreement. The
Board also has the discretion to grant Restricted Stock awards, Restricted Stock Unit awards and
Stock Bonus awards.
2. Definitions.
(a) Award shall mean any right granted under the Plan, including an Option, a
Restricted Stock award, Restricted Stock Unit award, and a Stock Bonus award.
(b) Award Agreement shall mean any written or electronic agreement, contract, or
other instrument or document evidencing an Award.
(c) Board shall mean the Committee, if one has been appointed, or the Board of
Directors of the Company, if no Committee is appointed.
(d) Change in Control has the meaning set forth in Section 15(c) of the Plan.
(e) Code shall mean the Internal Revenue Code of 1986, as amended.
(f) Committee shall mean the Committee appointed by the Board in accordance with
Section 4(a) of the Plan, if one is appointed.
(g) Common Stock shall mean the common stock of the Company, par value $.001 per
share.
(h) Company shall mean Neurocrine Biosciences, Inc.
(i) Consultant shall mean any natural person who is engaged by the Company or any
Parent or Subsidiary to render bona fide consulting services and is compensated for such consulting
services, and any Director whether compensated for such services or not.
(j) Continuous Status as an Employee or Consultant shall mean the absence of any
interruption or termination of service as an Employee or Consultant, as applicable. Continuous
Status as an Employee or Consultant shall not be considered interrupted in the case of sick leave,
military leave, or any other leave of absence approved by the Board; provided, that
1.
such leave is for a period of not more than ninety (90) days or reemployment upon the
expiration of such leave is guaranteed by contract or statute.
(k) Director means a member of the Board of Directors of the Company.
(l) Disability means total and permanent disability (as defined in Section 22(e)(3)
of the Code).
(m) Employee shall mean any persons, including officers and directors, employed by
the Company or any Parent or Subsidiary of the Company. The payment of a directors fee by the
Company shall not be sufficient to constitute employment by the Company.
(n) Holder shall mean a person who has been granted or awarded an Award pursuant to
the Plan.
(o) Incentive Stock Option shall mean an Option intended to qualify as an incentive
stock option within the meaning of Section 422 of the Code.
(p) Nonstatutory Stock Option shall mean an Option not intended to qualify as an
Incentive Stock Option.
(q) Option shall mean a stock option granted pursuant to the Plan. An Option may be
either an Incentive Stock Option or a Nonstatutory Stock Option.
(r) Option Agreement shall mean any written or electronic agreement, contract, or
other instrument or document evidencing an Option.
(s) Optioned Stock shall mean the Common Stock subject to an Option.
(t) Optionee shall mean an Employee or Consultant who receives an Option.
(u) Outside Director means a Director who is not an Employee.
(v) Parent shall mean a parent corporation, whether now or hereafter existing, as
defined in Section 424(e) of the Code.
(w) Performance Award shall mean an Award that vests based upon the acheivement of
performance goals related to one or more Performance Criteria.
(x) Performance Criteria shall mean the following business criteria with respect to
the Company, any Subsidiary or any division or operating unit: (a) net income, (b) pre-tax income,
(c) operating income, (d) cash flow, (e) earnings per share, (f) return on equity, (g) return on
invested capital or assets, (h) cost reductions or savings, (i) funds from operations, (j)
appreciation in the fair market value of Common Stock, and (k) earnings before any one or more of
the following items: interest, taxes, depreciation or amortization; each as determined in
accordance with generally accepted accounting principles or subject to such adjustments as may be
specified by the Board.
2.
(y) Plan shall mean this 2003 Incentive Stock Plan, as amended.
(z) Restricted Stock shall mean a right to purchase Common Stock pursuant to Section
11 of the Plan.
(aa) Restricted Stock Unit shall mean a right to receive a specified number of
shares of Common Stock during specified time periods pursuant to Section 12 of the Plan.
(bb) Retirement has the meaning set forth in Section 9(d) of the Plan.
(cc) Section 162(m) Participant shall mean any key Employee designated by the Board
as a key Employee whose compensation for the fiscal year in which the key Employee is so designated
or a future fiscal year may be subject to the limit on deductible compensation imposed by Section
162(m) of the Code.
(dd) Share shall mean a share of the Common Stock, as adjusted in accordance with
Section 15 of the Plan.
(ee) Stock Bonus shall mean the right to receive a bonus of Common Stock for past
services pursuant to Section 13 of the Plan.
(ff) Subsidiary shall mean a subsidiary corporation, whether now or hereafter
existing, as defined in Section 424(f) of the Code.
3. Stock Subject to the Plan.
(a) Subject to the provisions of Section 15 of the Plan, the maximum aggregate number of
shares available for issuance under the Plan is five million three
hundred thousand (5,300,000)
shares of Common Stock. The Shares may be authorized but unissued, or reacquired Common Stock. If
an Award should expire or become unexercisable for any reason without having been exercised in
full, then the unpurchased Shares which were subject thereto shall, unless the Plan shall have been
terminated, become available for future grant or sale under the Plan. Notwithstanding any other
provision of the Plan, shares issued under the Plan and later repurchased by the Company shall not
become available for future grant or sale under the Plan.
(b) The following limitations shall apply to grants of Awards to Employees:
(i) No Employee shall be granted, in any fiscal year of the Company, Awards
pursuant to which more than an aggregate of two hundred and fifty thousand (250,000)
Shares are issuable to such Employee.
(ii) In connection with his or her initial employment, an Employee may be
granted Awards to purchase and/or receive up to an additional two hundred and fifty
thousand (250,000) Shares which shall not count against the limit set forth in
subsection (i) above.
(iii) The foregoing limitations shall be adjusted proportionately in connection
with any change in the Companys capitalization as described in Section 15.
3.
(iv) If an Option is canceled in the same fiscal year of the Company in which
it was granted (other than in connection with a transaction described in Section
15), the canceled Option shall be counted against the limit set forth in subsection
(i) above.
(c) Shares Available. Subject to adjustment as provided in Section 15, the
aggregate number of shares of Common Stock with respect to which awards of Restricted Stock,
Restricted Stock Units, Stock Bonuses or a combination thereof shall be made under this Plan shall
not exceed fifty percent (50%) of the aggregate number of shares of Common Stock available under
this Plan, as set forth in Section 3(a).
(d) Limited Exception to Minimum Vesting Restrictions. Up to five percent (5%) of
the total number of shares of Common Stock available for issuance under the Plan pursuant to
Section 3(a) may in the aggregate be issued as awards of Restricted Stock, Restricted Stock Units,
Stock Bonuses or a combination thereof that are not subject to the minimum vesting requirements set
forth in Sections 11(d), 12(b) and 13(d) of the Plan.
4. Administration of the Plan.
(a) Procedure.
(i) Multiple Administrative Bodies. The Plan may be administered by
different Committees with respect to different groups of Employees and Consultants.
(ii) Section 162(m). To the extent that the Board determines it to be
desirable to qualify Awards granted hereunder as performance-based compensation
within the meaning of Section 162(m) of the Code, the Plan shall be administered by
a Committee of two or more outside directors within the meaning of Section 162(m)
of the Code.
(iii) Discretionary Awards to Directors. Except for Options granted
automatically at the time and manner set forth in Section 10, any Award granted to a
Director shall be administered by a committee consisting solely of Outside Directors
and such Outside Directors may administer and grant discretionary Awards to
themselves.
(iv) Rule 16b-3. To the extent desirable to qualify transactions
hereunder as exempt under Rule 16b-3, the transactions contemplated hereunder shall
be structured to satisfy the requirements for exemption under Rule 16b-3.
(v) Other Administration. Other than as provided above, the Plan shall
be administered by (A) the Board or (B) a Committee, which committee shall be
constituted to satisfy applicable laws.
(b) Powers of the Board. Subject to the provisions of the Plan, the Board shall have
the authority, in its discretion: (i) to grant Incentive Stock Options, Nonstatutory Stock Options,
Restricted Stock awards, Restricted Stock Unit awards, or Stock Bonus awards; (ii) to determine,
upon review of relevant information and in accordance with Section 7 of the Plan, the fair market
4.
value of the Common Stock; (iii) to determine the exercise price per share of each Award to be
granted, if any, which exercise price shall be determined in accordance with Section 7 of the Plan;
(iv) to determine the Employees or Consultants to whom, and the time or times at which, Awards
shall be granted and, subject to the limitations of Section 3 above, the number of shares to be
represented by each Award; (v) to interpret the Plan; (vi) to prescribe, amend and rescind rules
and regulations relating to the Plan; (vii) to determine the terms and provisions of each Award
granted (which need not be identical) and, with the consent of the holder thereof, modify or amend
any provisions (including provisions relating to exercise price) of any Award; (viii) to accelerate
or defer (with the consent of the Optionee) the exercise date of any Option, consistent with the
provisions of Section 6 of the Plan; (ix) to authorize any person to execute on behalf of the
Company any instrument required to effectuate the grant of an Award previously granted by the
Board; (x) to allow Optionees to satisfy withholding tax obligations by electing to have the
Company withhold from the Shares to be issued upon exercise of an Award that number of Shares
having a fair market value equal to the statutory minimum amount required to be withheld (the fair
market value of the Shares to be withheld shall be determined on the date that the amount of tax to
be withheld is to be determined; and, all elections by an Award holder to have Shares withheld for
this purpose shall be made in such form and under such conditions as the Board may deem necessary
or advisable); and (xi) to make all other determinations deemed necessary or advisable for the
administration of the Plan. Except to the extent prohibited by Sections 11(d), 12(b) and 13(d) of
the Plan, the Board shall have the power to accelerate the time at which an Award may first be
exercised or the time during which an Award or any part thereof will vest in accordance with the
Plan, notwithstanding the provisions in the Award stating the time at which it may first be
exercised or the time during which it will vest.
(c) Effect of Boards Decision. All decisions, determinations and interpretations of
the Board shall be final and binding on all Holders of any Awards granted under the Plan.
(d) Provisions Applicable to Section 162(m) Participants.
(i) The Board, in its discretion, may determine whether an Award is to qualify
as performance-based compensation as described in Section 162(m)(4)(C) of the Code.
(ii) Notwithstanding anything in the Plan to the contrary, the Board may grant
any Award to a Section 162(m) Participant, including a Restricted Stock award,
Restricted Stock Unit award, or Stock Bonus award the restrictions with respect to
which lapse upon the attainment of performance goals which are related to one or
more of the Performance Criteria.
(iii) To the extent necessary to comply with the performance-based compensation
requirements of Section 162(m)(4)(C) of the Code, with respect to any Restricted
Stock award, Restricted Stock Unit award, or Stock Bonus award granted under the
Plan to one or more Section 162(m) Participants, no later than ninety (90) days
following the commencement of any fiscal year in question or any other designated
fiscal period or period of service (or such other time as may be required or
permitted by Section 162(m) of the Code), the Board shall, in writing, (i) designate
one or more Section 162(m) Participants, (ii) select the Performance Criteria
applicable to the fiscal year or other designated fiscal period
5.
or period of service, (iii) establish the various performance targets, in terms
of an objective formula or standard, and amounts of such Restricted Stock awards,
Restricted Stock Unit awards, and Stock Bonus awards, as applicable, which may be
earned for such fiscal year or other designated fiscal period or period of service,
and (iv) specify the relationship between Performance Criteria and the performance
targets and the amounts of such Restricted Stock awards, Restricted Stock Unit
awards, and Stock Bonus awards, as applicable, to be earned by each Section 162(m)
Participant for such fiscal year or other designated fiscal period or period of
service. Following the completion of each fiscal year or other designated fiscal
period or period of service, the Board shall certify in writing whether the
applicable performance targets have been achieved for such fiscal year or other
designated fiscal period or period of service. In determining the amount earned by
a Section 162(m) Participant, the Board shall have the right to reduce (but not to
increase) the amount payable at a given level of performance to take into account
additional factors that the Board may deem relevant to the assessment of individual
or corporate performance for the fiscal year or other designated fiscal period or
period of service.
(iv) Furthermore, notwithstanding any other provision of the Plan, any Award
which is granted to a Section 162(m) Participant and is intended to qualify as
performance-based compensation as described in Section 162(m)(4)(C) of the Code
shall be subject to any additional limitations set forth in Section 162(m) of the
Code (including any amendment to Section 162(m) of the Code) or any regulations or
rulings issued thereunder that are requirements for qualification as
performance-based compensation as described in Section 162(m)(4)(C) of the Code, and
the Plan shall be deemed amended to the extent necessary to conform to such
requirements.
5. Eligibility.
(a) Awards may be granted to Employees and Consultants; provided, that Incentive Stock Options
may only be granted to Employees. An Employee or Consultant who has been granted an Award may, if
such Employee or Consultant is otherwise eligible, be granted additional Awards. Each Outside
Director shall be eligible to be automatically granted Options at the times and in the manner set
forth in Section 10.
(b) Each Option shall be designated in the written Option Agreement as either an Incentive
Stock Option or a Nonstatutory Stock Option. However, notwithstanding such designation, to the
extent that the aggregate fair market value of the Shares with respect to which Options designated
as Incentive Stock Options are exercisable for the first time by any Optionee during any calendar
year (under all plans of the Company) exceeds one hundred thousand dollars ($100,000), such Options
shall be treated as Nonstatutory Stock Options.
(c) For purposes of Section 5(b), Options shall be taken into account in the order in which
they were granted, and the fair market value of the Shares shall be determined as of the time the
Option with respect to such Shares is granted.
(d) The Plan shall not confer upon any Holder any right with respect to continuation of
employment by or the rendition of consulting services to the Company, nor shall it interfere in
6.
any way with his or her right or the Companys right to terminate his or her employment or
services at any time, with or without cause.
6. Term of Plan. The Plan shall become effective upon the earlier to occur of its adoption
by the Board or its approval by vote of holders of a majority of the outstanding shares of the
Company entitled to vote on the adoption of the Plan. It shall continue in effect until terminated
under Section 17 of the Plan. Notwithstanding the foregoing, no Incentive Stock Option may be
granted under this Plan after the first to occur of (a) the expiration of ten (10) years from the
date the Plan is adopted by the Board or (b) the expiration of ten (10) years from the date the
Plan is approved by the Companys stockholders under Section 21.
7. Exercise Price and Consideration.
(a) The per Share exercise price for the Shares to be issued pursuant to exercise of an Option
shall be no less than one hundred percent (100%) of the fair market value per Share on the date of
grant; provided, however, that in the case of an Incentive Stock Option granted to an Employee who,
at the time of grant of such Incentive Stock Option, owns stock representing more than ten percent
(10%) of the voting power of all classes of stock of the Company or any Parent or Subsidiary, the
per Share exercise price shall be no less than one hundred and ten percent (110%) of the fair
market value per Share on the date of grant. Notwithstanding the foregoing, Options may be granted
with a per Share exercise price of less than one hundred percent (100%) of the fair market value
per Share on the date of grant pursuant to a merger or other corporate transaction.
(b) The fair market value shall be determined by the Board in its discretion; provided,
however, that where there is a public market for the Common Stock, the fair market value per Share
shall be the closing price per share (or the closing bid, if no sales were reported) of the Common
Stock for the date of grant, as reported in the Wall Street Journal (or, if not so reported, as
otherwise reported by the NASDAQ Stock Market) or, in the event the Common Stock is listed on
another stock exchange, the fair market value per Share shall be the closing price per share (or
the closing bid, if no sales were reported) on such exchange on the date of grant, as reported in
the Wall Street Journal (or if not so reported, as otherwise reported
by such exchange). If there is no closing price per share for the
Common Stock on the date of the grant, then the fair market value
shall be the closing price per share on the last preceding date for
which such quotation exists.
(c) The consideration to be paid for the Shares to be issued upon exercise of an Award,
including the method of payment, shall be determined by the Board (and in the case of an Incentive
Stock Option, shall be determined at the time of grant) and to the extent permitted under
applicable laws may consist entirely of cash, check, other Shares of Common Stock which (i) either
have been owned by the Optionee for more than six (6) months on the date of surrender or were not
acquired directly or indirectly, from the Company, and (ii) have a fair market value on the date of
surrender equal to the aggregate exercise price of the Shares as to which said Award shall be
exercised, or any combination of such methods of payment, or such other consideration and method of
payment for the issuance of Shares to the extent permitted under applicable law.
8. Term of Option. The term of each Option shall be the term stated in the Option
Agreement; provided, however, that the term shall be no more than seven (7) years from the date of
grant thereof. In the case of an Incentive Stock Option granted to an Optionee who, at the time
the Option is granted, owns stock representing more than ten percent (10%) of the voting
7.
power of all classes of stock of the Company or any Parent or Subsidiary, the term of the Option
shall be five (5) years from the date of grant thereof or such shorter term as may be provided in
the Option Agreement.
9. Exercise of Option.
(a) Procedure for Exercise; Rights as a Stockholder.
(i) Any Option granted hereunder shall be exercisable at such times and under
such conditions as determined by the Board, including performance criteria with
respect to the Company and/or the Optionee, and as shall be permissible under the
terms of the Plan.
(ii) An Option may not be exercised for a fraction of a Share.
(iii) An Option shall be deemed to be exercised when written notice of such
exercise has been given to the Company in accordance with the terms of the Option by
the person entitled to exercise the Option and full payment for the Shares with
respect to which the Option is exercised has been received by the Company. Full
payment may, as authorized by the Board, consist of any consideration and method of
payment allowable under Section 7 of the Plan. Until the issuance (as evidenced by
the appropriate entry on the books of the Company or of a duly authorized transfer
agent of the Company) of the stock certificate evidencing such Shares, no right to
vote or receive dividends or any other rights as a stockholder shall exist with
respect to the Optioned Stock, notwithstanding the exercise of the Option. Upon an
Optionees request, the Company shall issue (or cause to be issued) such stock
certificate promptly upon exercise of the Option. To the extent an Option
designated as an Incentive Stock Option at grant that is treated as the exercise of
a Nonstatutory Stock Option pursuant to Section 5(b), the Company shall issue a
separate stock certificate evidencing the Shares treated as acquired upon exercise
of an Incentive Stock Option and a separate stock certificate evidencing the Shares
treated as acquired upon exercise of a Nonstatutory Stock Option and shall identify
each such certificate accordingly in its stock transfer records. No adjustment will
be made for a dividend or other right for which the record date is prior to the date
the stock certificate is issued, except as provided in Section 15 of the Plan.
(iv) Exercise of an Option in any manner shall result in a decrease in the
number of Shares which thereafter may be available, both for purposes of the Plan
and for sale under the Option, by the number of Shares as to which the Option is
exercised.
(b) Termination of Status as an Employee or Consultant. In the event of termination
of an Optionees Continuous Status as an Employee or Consultant (as the case may be), such Optionee
may, but only within such period of time as is determined by the Board, with such determination in
the case of an Incentive Stock Option not exceeding three (3) months and in the case of
Nonstatutory Stock Option not exceeding six (6) months after the date of termination (provided,
that such period shall be three (3) months in the case of an Option granted to an Outside Director
pursuant to Section 10), with such determination in the case of an Incentive
8.
Stock Option being made at the time of grant of the Option, exercise the Option to the extent
that such Employee or Consultant was entitled to exercise it at the date of such termination (but
in no event later than the date of expiration of the term of such Option as set forth in the Option
Agreement). To the extent that such Employee or Consultant was not entitled to exercise the Option
at the date of such termination, or if such Employee or Consultant does not exercise such Option
(which such Employee or Consultant was entitled to exercise) within the time specified herein, the
Option shall terminate.
(c) Disability of Optionee. Notwithstanding the provisions of Section 9(b) above, in
the event of termination of an Optionees Continuous Status as an Employee or Consultant as a
result of such Employees or Consultants Disability, such Employee or Consultant may, but only
within six (6) months (twelve (12) months in the case of an Option granted to an Outside Director
pursuant to Section 10) (or such other period of time not exceeding twelve (12) months as is
determined by the Board, with such determination in the case of an Incentive Stock Option being
made at the time of grant of the Option) from the date of such termination (but in no event later
than the date of expiration of the term of such Option as set forth in the Option Agreement),
exercise the Option to the extent the right to exercise would have accrued had the Optionee
continued Continuous Status as an Employee or Consultant for a period of six (6) months following
termination of Continuous Status as an Employee or Consultant by reason of Disability. To the
extent that such Employee or Consultant was not entitled to exercise an Option in this period, or
if such Employee or Consultant does not exercise such Option (which such Employee or Consultant was
entitled to exercise) within the time specified herein, the Option shall terminate.
(d) Retirement of Employee. Notwithstanding the provisions of Section 9(b) above, in
the event of termination of an Employees Continuous Status as an Employee as a result of such
Employees retirement from the Company at age fifty-five (55) or greater after having Continuous
Status as an Employee for (5) years or more (Retirement), all Awards held by such Employee shall
vest and such Employee may, but only within three (3) years from the date of such termination (but
in no event later than the date of expiration of the term of such Award), exercise the Award to the
extent such Employee was entitled to exercise it at the date of such termination.
(e) Death of Optionee. In the event of the death of an Optionee:
(i) during the term of the Option who is at the time of his or her death an
Employee or Consultant of the Company and who shall have been in Continuous Status
as an Employee or Consultant since the date of grant of the Option, the Option may
be exercised, at any time within six (6) months (twelve (12) months in the case of
an Option granted to an Outside Director pursuant to Section 10) (or at such later
time as may be determined by the Board but in no event later than the date of
expiration of the term of such Option as set forth in the Option Agreement), by the
Optionees estate or by a person who acquired the right to exercise the Option by
bequest or inheritance, but only to the extent that the right to exercise would have
accrued had the Optionee continued living and remained in Continuous Status as an
Employee or Consultant six (6) months (or such other period of time as is determined
by the Board) after the date of death; or
9.
(ii) within thirty (30) days (or such other period of time not exceeding three
(3) months as is determined by the Board, with such determination in the case of an
Incentive Stock Option being made at the time of grant of the Option) after the
termination of Continuous Status as an Employee or Consultant, the Option may be
exercised, at any time within six (6) months (twelve (12) months in the case of an
Option granted to an Outside Director pursuant to Section 10) (or such other period
of time as is determined by the Board at the time of grant of the Option) following
the date of death (but in no event later than the date of expiration of the term of
such Option as set forth in the Option Agreement), by the Optionees estate or by a
person who acquired the right to exercise the Option by bequest or inheritance, but
only to the extent that the right to exercise that had accrued at the date of
termination.
10. Automatic Granting of Options to Outside Directors.
(a) First Option Grants. Unless otherwise determined by the Board, each new Outside
Director shall be automatically granted an Option to purchase thirty thousand (30,000) Shares (a
First Option) on the date on which such person first becomes a Director, whether through
election by the stockholders of the Company or appointment by the Board to fill a vacancy.
(b) Subsequent Option Grants. Unless otherwise determined by the Board, each Outside
Director and the Chairman of the Board of Directors of the Company shall be automatically granted
an annual Option (a Subsequent Option) to purchase, in the case of an Outside Director,
fifteen thousand (15,000) Shares, and in the case of the Chairman of the Board of Directors of the
Company, twenty thousand (20,000) Shares, each on the date of each annual meeting of the
stockholders of the Company, if on such date, he or she shall have served on the Board for at least
six (6) months.
(c) Terms of Options Granted to Outside Directors. Options granted to Outside
Directors pursuant to this Section 10 shall have a per Share exercise price of no less than one
hundred percent (100%) of the fair market value per Share on the date of grant. Subject to Section
9, the term of each Option granted to an Outside Director pursuant to this Section 10 shall be
seven (7) years from the date of grant thereof. First Options and Subsequent Options shall become
exercisable in cumulative monthly installments of 1/12 of the Shares subject to such Option on each
of the monthly anniversaries of the date of grant of the Option, commencing with the first such
monthly anniversary, such that each such Option shall be one hundred percent (100%) vested on the
first anniversary of its date of grant.
11. Restricted Stock Awards.
(a) Rights to Purchase. After the Board determines that it will offer an Employee or
Consultant a Restricted Stock award, it shall deliver to the offeree a stock purchase agreement
setting forth the terms, conditions and restrictions relating to the offer. Such agreement shall
further specify the number of Shares which such person shall be entitled to purchase, and the time
within which such person must accept such offer, which shall in no event exceed six (6) months from
the date upon which the Board made the determination to grant the Restricted Stock
10.
award. The offer shall be accepted by execution of a stock purchase agreement in the form
determined by the Board.
(b) Purchase Price. The Board shall establish the purchase price, if any, and form of
payment for each Restricted Stock award; provided, however, that such purchase price shall be no
less than one hundred percent (100%) of the fair market value per Share on the date of grant;
provided, further, however, that the purchase price per Share may be reduced on a dollar-for-dollar
basis to the extent the Restricted Stock award is granted to the Holder in lieu of cash
compensation otherwise payable to the Holder. In all cases, legal consideration shall be required
for each issuance of a Restricted Stock award.
(c) Issuance of Shares. Forthwith after payment therefor, the Shares purchased shall
be duly issued; provided, however, that the Board may require that the Holder make adequate
provision for any Federal and State withholding obligations of the Company as a condition to the
Holder purchasing such Shares.
(d) Vesting. Subject to the following minimum vesting requirements and the
requirements of Section 4(d) of the Plan with respect to Restricted Stock awards granted to Section
162(m) Participants, at the time of the grant of a Restricted Stock award, the Board may impose
such restrictions or conditions to the vesting of such Restricted Stock award as it, in its sole
discretion, deems appropriate. No Restricted Stock award that is not a Performance Award shall
vest at a rate more favorable to the Holder than in pro-rata installments over a three (3) year
period measured from the date of grant. The vesting of all Restricted Stock Performance Awards
shall be subject to the completion of at least one (1) year of Continuous Status as an Employee or
Consultant measured from the date of the grant of the Award. Notwithanding the foregoing minimum
vesting requirements, vesting of Restricted Stock awards may occur earlier in the event of (A)
death, (B) Disability, (C) Retirement, or (D) a Change in Control. Additionally, Restricted Stock
awards granted pursuant to the exception set forth in Section 3(d) of the Plan are not subject to
the foregoing minimum vesting requirements.
(e) Unvested Share Repurchase Option. The stock purchase agreement shall grant the
Company an unvested share repurchase option exercisable upon the voluntary or involuntary
termination of the Holders employment with the Company for any reason (including death or
Disability). Subject to applicable laws, if the Board so determines, the purchase price for shares
repurchased may be paid by cancellation of any indebtedness of the Holder to the Company.
(f) Other Provisions. The stock purchase agreement shall contain such other terms,
provisions and conditions not inconsistent with the Plan as may be determined by the Board.
12. Restricted Stock Unit Awards.
(a) Grant of Restricted Stock Units. Any Employee or Consultant selected by the Board
may be granted an Award of Restricted Stock Units in the manner determined from time to time by the
Board.
(b) Vesting of Restricted Stock Units. Subject to the following minimum vesting
requirements and the requirements of Section 4(d) with respect to Restricted Stock Unit awards
granted to Section 162(m) Participants, at the time of the grant of a Restricted Stock Unit award,
the Board may impose such restrictions or conditions to the vesting of such Restricted Stock Unit
11.
award as it, in its sole discretion, deems appropriate. No Restricted Stock Unit award that
is not a Performance Award shall vest at a rate more favorable to the Holder than in pro-rata
installments over a three (3) year period measured from the date of grant. The vesting of all
Restricted Stock Unit Performance Awards shall be subject to the completion of at least one (1)
year of Continuous Status as an Employee or Consultant measured from the date of the grant of the
Award. Notwithanding the foregoing minimum vesting requirements, vesting of Restricted Stock Unit
awards may occur earlier in the event of (A) death, (B) Disability, (C) Retirement, or (D) a Change
in Control. Additionally, Restricted Stock Unit awards granted pursuant to the exception set forth
in Section 3(d) of the Plan are not subject to the foregoing minimum vesting requirements. Common
Stock underlying a Restricted Stock Unit award will not be issued until the Restricted Stock Unit
award has vested, pursuant to a vesting schedule or Performance Criteria set by the Board.
(c) No Rights as a Stockholder. Unless otherwise provided by the Board, a Holder
awarded Restricted Stock Units shall have no rights as a Company stockholder with respect to such
Restricted Stock Units until such time as the Restricted Stock Units have vested and the Common
Stock underlying the Restricted Stock Units has been issued.
(d) Purchase Price. The Board shall establish the purchase price, if any, and form of
payment for each Restricted Stock Unit award; provided, however, that such purchase price shall be
no less than one hundred percent (100%) of the fair market value per Share on the date of grant;
provided, further, however, that the purchase price per Share may be reduced on a dollar-for-dollar
basis to the extent the Restricted Stock Unit award is granted to the Holder in lieu of cash
compensation otherwise payable to the Holder. In all cases, legal consideration shall be required
for each issuance of a Restricted Stock Unit award.
(e) Other Provisions. The restricted stock unit award agreements shall contain such
other terms, provisions and conditions not inconsistent with the Plan as may be determined by the
Board.
13. Stock Bonus Awards.
(a) Terms of Award. After the Board determines that it will offer an Employee or
Consultant a Stock Bonus award, it shall deliver to the offeree a stock bonus agreement setting
forth the terms, conditions and restrictions relating to the offer and the number of shares to be
awarded. The offer shall be accepted by execution of a stock bonus agreement in the form
determined by the Board.
(b) Purchase Price. The Board shall establish the purchase price, if any, and form of
payment for each Stock Bonus award; provided, however, that such purchase price shall be no less
than one hundred percent (100%) of the fair market value per Share on the date of grant; provided,
further, however, that the purchase price per Share may be reduced on a dollar-for-dollar basis to
the extent the Stock Bonus award is granted to the Holder in lieu of cash compensation otherwise
payable to the Holder.
(c) Issuance of Shares. Forthwith after payment therefor, the Shares purchased shall
be duly issued; provided, however, that the Board may require that the Holder make adequate
provision for any Federal and State withholding obligations of the Company as a condition to the
Holder purchasing such Shares.
12.
(d) Vesting. Subject to the following minimum vesting requirements and the
requirements of Section 4(d) with respect to Stock Bonus awards granted to Section 162(m)
Participants, at the time of the grant of a Stock Bonus award, the Board may impose such
restrictions or conditions to the vesting of such Stock Bonus award as it, in its sole discretion,
deems appropriate. No Stock Bonus award that is not a Performance Award shall vest at a rate more
favorable to the Holder than in pro-rata installments over a three (3) year period measured from
the date of grant. The vesting of all Stock Bonus Performance Awards shall be subject to the
completion of at least one (1) year of Continuous Status as an Employee or Consultant measured from
the date of the grant of the Award. Notwithanding the foregoing minimum vesting requirements,
vesting of Stock Bonus awards may occur earlier in the event of (A) death, (B) Disability, (C)
Retirement, or (D) a Change in Control. Additionally, Stock Bonus awards granted pursuant to the
exception set forth in Section 3(d) of the Plan are not subject to the foregoing minimum vesting
requirements.
(e) Unvested Share Repurchase/Reacquisition Option. The Stock Bonus award agreement
shall grant the Company an unvested share repurchase/reacquisition option exercisable upon the
voluntary or involuntary termination of the Holders employment with the Company for any reason
(including death or Disability). Subject to applicable laws, if the Board so determines, the
purchase price (if any) for shares repurchased may be paid by cancellation of any indebtedness of
the Holder to the Company. If no purchase price was paid for the shares, the unvested shares may
be reacquired by the Company for no consideration.
(e) Other Provisions. The stock bonus agreement shall contain such other terms,
provisions and conditions not inconsistent with the Plan as may be determined by the Board.
14. Non-Transferability of Awards. Unless determined otherwise by the Board, an Award may
not be sold, pledged, assigned, hypothecated, transferred, or disposed of in any manner other than
by will or by the laws of descent or distribution and may be exercised, during the lifetime of the
Holder, only by the Holder. If the Board makes an Award transferable, such Award shall contain
such additional terms and conditions as the Board deems appropriate.
15. Adjustments upon Changes in Capitalization or Merger.
(a) Changes in Capitalization. Subject to any action by the Company required by
applicable law or regulations or the requirements of the NASDAQ Stock Market or another established
stock exchange on which the Companys securities are traded, and subject to Section 15(d), the
number and kind of shares of Common Stock (or other securities or property) covered by each
outstanding Award, and the number and kind of shares of Common Stock (or other securities or
property) which have been authorized for issuance under the Plan but as to which no Awards have yet
been granted or which have been returned to the Plan upon cancellation or expiration of an Award,
as well as the price per share of Common Stock (or other securities or property) covered by each
such outstanding Award, shall be adjusted proportionately to the extent the Board determines that
any increase, decrease or adjustment in the number or kind of issued shares of Common Stock (or
other securities or property), dividend, distribution, stock split, reverse stock split, stock
dividend, combination or reclassification of the Common Stock, reorganization, merger,
consolidation, split-up, repurchase, liquidation, dissolution, or sale, transfer, exchange or other
disposition of all or substantially all of the assets of the Company, exchange of Common Stock or
other securities of the Company, or other similar corporate
13.
transaction or event, in the Boards sole discretion, affects the Common Stock such that an
adjustment is determined by the Board to be appropriate in order to prevent dilution or enlargement
of the benefits or potential benefits intended to be made available under the Plan or with respect
to an Award. Such adjustment shall be made by the Board, whose determination in that respect shall
be final, binding and conclusive. Except as expressly provided herein, no issuance by the Company
of shares of stock of any class, or securities convertible into shares of stock of any class, shall
affect, and no adjustment by reason thereof shall be made with respect to, the number or price of
shares of Common Stock subject to an Award.
(b) Dissolution or Liquidation. In the event of the proposed dissolution or
liquidation of the Company, the Board shall notify the Holder at least fifteen (15) days prior to
such proposed action. To the extent it has not been previously exercised, the Award shall
terminate immediately prior to the consummation of such proposed action.
(c) Merger or Asset Sale. Unless otherwise provided in the Award Agreement, in the
event of a merger, sale of all or substantially all of the assets of the Company, tender offer or
other transaction or series of related transactions resulting in a change of ownership of more than
fifty percent (50%) of the voting securities of the Company (Change in Control) approved
by the majority of the members of the Board on the Board prior to the commencement of such Change
in Control, each outstanding Award shall be assumed or an equivalent award substituted by the
successor corporation or a Parent or Subsidiary of the successor corporation; provided, however, in
the event that within one year of the date of the completion of the Change in Control, the
successor corporation or a Parent or Subsidiary of the successor corporation terminates the
employment of a Holder that is an Employee without Cause (as defined below), such Holder shall
fully vest in and, if applicable, have the right to exercise the award assumed or substituted for
the Award as to all of the Shares subject to the Award, including Shares as to which it would not
otherwise be exercisable. In the event that the successor corporation refuses to assume or
substitute the Award, the Holder shall fully vest in and, if applicable, have the right to exercise
the Award as to all of the Shares subject to the Award, including Shares as to which it would not
otherwise be exercisable. If an Award becomes fully vested and exercisable in lieu of assumption
or substitution in the event of a Change in Control, the Board shall notify the Holder in writing
or electronically that the Award shall be fully vested and exercisable for a period of fifteen (15)
days from the date of such notice, and the Award shall terminate upon the expiration of such
period, if applicable.
For the purposes of this paragraph, the Award shall be considered assumed if, following the
Change in Control, the Award confers the same acquisition rights for each Share subject to the
Award immediately prior to the Change in Control, the consideration (whether stock, cash, or other
securities or property) received in the Change in Control by holders of Common Stock for each Share
held on the effective date of the transaction (and if holders were offered a choice of
consideration, the type of consideration chosen by the holders of a majority of the outstanding
Shares); provided, however, that if such consideration received in the Change in Control is not
solely common stock of the successor corporation or its Parent, the Board may, with the consent of
the successor corporation, provide for the consideration to be received pursuant to the Award, for
each Share subject to the Award, to be solely common stock of the successor corporation or its
Parent equal in fair market value to the per share consideration received by holders of Common
Stock in the Change in Control.
14.
For purposes of this paragraph, termination shall be for Cause in the event of the
occurrence of any of the following: (a) any intentional action or intentional failure to act by
Employee which was performed in bad faith and to the material detriment of the successor
corporation or its Parent or Subsidiary; (b) Employee willfully and habitually neglects the duties
of employment; or (c) Employee is convicted of a felony crime involving moral turpitude; provided,
that in the event that any of the foregoing events is capable of being cured, the successor
corporation or its Parent or Subsidiary shall provide written notice to the Employee describing the
nature of such event and the Employee shall thereafter have five (5) business days to cure such
event.
In the event of a Change in Control which is not approved by the majority of the members of
the Board on the Board prior to the commencement of a Change in Control, each Holder shall fully
vest in and, if applicable, have the right to exercise all outstanding Awards as to all of the
Shares subject to such Award, including Shares as to which it would not otherwise be exercisable.
(d) With respect to Awards which are granted to Section 162(m) Participants and are intended
to qualify as performance-based compensation under Section 162(m)(4)(C), no adjustment or action
described in this Section 15 or in any other provision of the Plan shall be authorized to the
extent that such adjustment or action would cause such Award to fail to so qualify under Section
162(m)(4)(C), or any successor provisions thereto.
16. Date of Granting Awards. The date of grant of an Award shall, for all purposes, be the
date on which the Board makes the determination granting such Award. Notice of the determination
shall be given to each Employee or Consultant to whom an Award is so granted within a reasonable
time after the date of such grant.
17. Amendment and Termination of the Plan.
(a) Amendment and Termination. The Board may at any time amend, alter,
suspend or discontinue the Plan, but no amendment, alteration, suspension or discontinuation shall
be made which would impair the rights of any Holder under any grant theretofore made, without his
or her consent. In addition, to the extent necessary and desirable to comply with Section 422 of
the Code (or any other applicable laws or regulation, the requirements of the NASDAQ Stock Market
or another established stock exchange), the Company shall obtain stockholder approval of any Plan
amendment in such a manner and to such a degree as required.
(b) Effect of Amendment or Termination. Any such amendment or termination of the Plan
shall not affect Awards already granted, and such Awards shall remain in full force and effect as
if this Plan had not been amended or terminated, unless mutually agreed otherwise between the
Holder, as applicable, and the Board, which agreement must be in writing and signed by the Holder,
as applicable, and the Company.
18. Conditions upon Issuance of Shares. Shares shall not be issued pursuant to the
exercise of an Award unless the exercise of such Award and the issuance and delivery of such Shares
pursuant thereto shall comply with all relevant provisions of law, including, without limitation,
the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, the rules
and regulations promulgated thereunder, and the requirements of the NASDAQ Stock Market or any
other stock exchange upon which the Shares may then be listed, and shall be
15.
further subject to the approval of counsel for the Company with respect to such compliance. As a
condition to the exercise of an Award, the Company may require the person exercising such Award to
represent and warrant at the time of any such exercise that the Shares are being purchased only for
investment and without any present intention to sell or distribute such Shares if, in the opinion
of counsel for the Company, such a representation is required by any of the aforementioned relevant
provisions of law.
19. Reservation of Shares. The Company, during the term of this Plan, will at all times
reserve and keep available such number of Shares as shall be sufficient to satisfy the requirements
of the Plan. The inability of the Company to obtain authority from any regulatory body having
jurisdiction, which authority is deemed by the Companys counsel to be necessary to the lawful
issuance and sale of any Shares hereunder, shall relieve the Company of any liability in respect of
the failure to issue or sell such Shares as to which such requisite authority shall not have been
obtained.
20. Award Agreements. Options shall be evidenced by written Option Agreements in such form
as the Board shall approve. Restricted Stock awards, Restricted Stock Unit awards, or Stock Bonus
awards shall be evidenced by written restricted stock award agreements, a restricted stock unit
award agreements, or stock bonus agreements, respectively, in such form as the Board shall approve.
21. Stockholder Approval. Continuance of the Plan shall be subject to approval by the
stockholders of the Company within twelve (12) months before or after the date the Plan is adopted.
Such stockholder approval shall be obtained in the degree and manner required under applicable
laws and the rules of the NASDAQ Stock Market or any other stock exchange upon which the Common
Stock is listed.
22. Section 409A of the Code. In the event any provision of the Plan, or the application
thereof, is or becomes inconsistent with Section 409A of the Code and any regulations promulgated
thereunder, such provision shall be void or unenforceable or in the sole discretion of the Board
shall be deemed amended to comply with Section 409A and any regulations promulgated thereunder.
The other provisions of the Plan shall remain in full force and effect.
16.
STOCK OPTION AGREEMENT
Unless
otherwise defined herein, the terms defined in the 2003 Stock Option
Plan as amended, (the Plan)
shall have the same defined meanings in this Option Agreement.
I. NOTICE OF STOCK OPTION GRANT
NAME
ADDRESS
CITY, STATE ZIP
As
part of [your Employment Agreement or the Companys
Performance Options Policy] you have been granted an option to
purchase Common Stock of the Company, subject to the terms and conditions of the Plan and this Option
Agreement, as follows:
Date of Grant:
Vesting Commencement Date
Exercise Price per Share:
Total Number of Shares Granted:
Total Exercise Price:
Type of Option:
NQ Nonstatutory Stock Option
Term/Expiration Date:
Vesting Schedule:
This Option may be exercised, in whole or in part, in accordance with the following schedule:
[25%
of the Shares subject to the Option shall vest twelve months after the
Vesting Commencement Date, and 1/48 of the Shares subject to the Option shall vest
each month thereafter, subject to the Optionee continuing to be an Employee or Consultant on such
dates.
or
One
third (1/3) of the Shares subject to the Option shall vest annually
beginning one year after the Vesting Commencement Date, subject to
the Optionee continuing to be an Employee or Consultant on such
dates.]
Termination Period:
This Option may be exercised for ninety (90) days (or such other period of time not exceeding
six (6) months, as is determined by the Board) after Optionees Continuous Status as an Employee or
Consultant terminates. Upon the death or Disability of the Optionee, this Option may be
exercised for six (6) months after Optionees Continuous Status as an Employee or Consultant. In no
event shall this Option be exercised later than the Term/Expiration Date as provided above.
II. AGREEMENT
1. Grant of Option. The Plan Administrator of the Company hereby grants to the Optionee named
in the Notice of Grant attached as Part I of this Agreement (the Optionee) an option (the
Option) to purchase the number of Shares, as set forth in the Notice of Grant, at the exercise
price per share set forth in the Notice of Grant (the Exercise Price), subject to the terms and
conditions of the Plan, which is incorporated herein by reference. Subject to Section 13(b) of the
Plan, in the event of a conflict between the terms and conditions of the Plan and the terms and
conditions of this Option Agreement, the terms and conditions of the Plan shall prevail.
If designated in the Notice of Grant as an Incentive Stock Option (ISO), this Option is
intended to qualify as an Incentive Stock Option under Section 422 of the Code. However, if this
Option is intended to be an Incentive Stock Option, to the extent that it exceeds the $100,000 rule
of Code Section 422(d) it shall be treated as a Nonstatutory Stock Option (NSO).
2. Exercise of Option.
(a) Right to Exercise. This Option is exercisable during its term in accordance with the
Vesting Schedule set out in the Notice of Grant and the applicable provisions of the Plan and this
Option Agreement.
(b) Method of Exercise. This Option is exercisable by delivery of an exercise notice, in the
form attached as Exhibit A (the Exercise Notice), which shall state the election to exercise the
Option, the number of Shares in respect of which the Option is being exercised (the Exercised
Shares), and such other representations and agreements as may be required by the Company pursuant
to the provisions of the Plan. The Exercise Notice shall be completed by the Optionee and
delivered to the President, the Chief Financial Officer or Secretary of the Company. The Exercise
Notice shall be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares.
This Option shall be deemed to be exercised upon receipt by the Company of such fully executed
Exercise Notice accompanied by such aggregate Exercise Price.
No Shares shall be issued pursuant to the exercise of this Option unless such issuance and
exercise complies with Applicable Laws. Assuming such compliance, for income tax purposes the
Exercised Shares shall be considered transferred to the Optionee on the date the Option is
exercised with respect to such Exercised Shares.
3. Method of Payment. Payment of the aggregate Exercise Price shall be by any of the
following, or a combination thereof, at the election of the Optionee:
(a) cash; or
(b) check; or
(c) consideration received by the Company under a cashless exercise program implemented by
the Company in connection with the Plan; or
(d) surrender of other Shares which (i) in the case of Shares acquired upon exercise of an
option, have been owned by the Optionee for more than six (6) months on the date of surrender, and
(ii) have a Fair Market Value on the date of surrender equal to the aggregate Exercise Price of the
Exercised Shares.
4. Non-Transferability of Option. This Option may not be transferred in any manner otherwise
than by will or by the laws of descent or distribution and may be exercised during the lifetime of
Optionee only by the
Optionee. The terms of the Plan and this Option Agreement shall be binding upon the executors,
administrators, heirs, successors and assigns of the Optionee.
5. Term of Option. This Option may be exercised only within the term set out in the Notice
of Grant, and may be exercised during such term only in accordance with the Plan and the terms of
this Option Agreement.
6. Tax Consequences. Some of the federal tax consequences relating to this Option, as of the
date of this Option, are set forth below. THIS SUMMARY IS NECESSARILY INCOMPLETE, AND THE TAX LAWS
AND REGULATIONS ARE SUBJECT TO CHANGE. THE OPTIONEE SHOULD CONSULT A TAX ADVISER BEFORE EXERCISING
THIS OPTION OR DISPOSING OF THE SHARES.
(a) Exercising the Option.
(i) Nonstatutory Stock Option. The Optionee may incur regular federal income tax liability
upon exercise of a NSO. The Optionee will be treated as having received compensation income
(taxable at ordinary income tax rates) equal to the excess, if any, of the Fair Market Value of the
Exercised Shares on the date of exercise over their aggregate Exercise Price. If the Optionee is
an Employee or a former Employee, the Company will be required to withhold from his or her
compensation or collect from Optionee and pay to the applicable taxing authorities an amount in
cash equal to a percentage of this compensation income at the time of exercise, and may refuse to
honor the exercise and refuse to deliver Shares if such withholding amounts are not delivered at
the time of exercise.
(ii) Incentive Stock Option. If this Option qualifies as an ISO, the Optionee will have no
regular federal income tax liability upon its exercise, although the excess, if any, of the Fair
Market Value of the Exercised Shares on the date of exercise over their aggregate Exercise Price
will be treated as an adjustment to alternative minimum taxable income for federal tax purposes and
may subject the Optionee to alternative minimum tax in the year of exercise. In the event that the
Optionee ceases to be an Employee but continues to provide services to the Company, any Incentive
Stock Option of the Optionee that remains unexercised shall cease to qualify as an Incentive Stock
Option and will be treated for tax purposes as a Nonstatutory Stock Option on the date three (3)
months and one (1) day following such change of status.
(b) Disposition of Shares.
(i) NSO. If the Optionee holds NSO Shares for at least one year, any gain realized on
disposition of the Shares will be treated as long-term capital gain for federal income tax purposes
(holding the Shares for more than eighteen (18) months may lower the long-term capital gains rate).
(ii) ISO. If the Optionee holds ISO Shares for at least one year after exercise and two years
after the grant date, any gain realized on disposition of the Shares will be treated as long-term
capital gain for federal income tax purposes. If the Optionee disposes of ISO Shares within one
year after exercise or two years after the grant date, any gain realized on such disposition will
be treated as compensation income (taxable at ordinary income rates) to the extent of the excess,
if any, of the lesser of (A) the difference between the Fair Market Value of the Shares acquired on
the date of exercise and the aggregate Exercise Price, or (B) the difference between the sale price
of such Shares and the aggregate Exercise Price. Any additional gain will be taxed as capital
gain, short-term or long-term depending on the period that the ISO Shares were held.
(c) Notice of Disqualifying Disposition of ISO Shares. If the Optionee sells or otherwise
disposes of any of the Shares acquired pursuant to an ISO on or before the later of (i) two years
after the grant date, or (ii) one year after the exercise date, the Optionee shall immediately
notify the Company in writing of such disposition. The Optionee agrees that he or she may be
subject to income tax withholding by the Company on the compensation
income recognized from such early disposition of ISO Shares by payment in cash or out of the
current earnings paid to the Optionee.
7. Entire Agreement; Governing Law. The Plan is incorporated herein by reference. The Plan
and this Option Agreement constitute the entire agreement of the parties with respect to the
subject matter hereof and supersede in their entirety all prior undertakings and agreements of the
Company and Optionee with respect to the subject matter hereof, and may not be modified adversely
to the Optionees interest except by means of a writing signed by the Company and Optionee. This
agreement is governed by the internal substantive laws, but not the choice of law rules, of
California.
8. NO GUARANTEE OF CONTINUED SERVICE. OPTIONEE ACKNOWLEDGES AND AGREES THAT THE VESTING OF
SHARES PURSUANT TO THE VESTING SCHEDULE HEREOF IS EARNED ONLY BY CONTINUING AS AN EMPLOYEE OR
CONSULTANT AT THE WILL OF THE COMPANY (AND NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED AN
OPTION OR PURCHASING SHARES HEREUNDER).
OPTIONEE FURTHER ACKNOWLEDGES AND AGREES THAT THIS AGREEMENT, THE TRANSACTIONS CONTEMPLATED
HEREUNDER AND THE VESTING SCHEDULE SET FORTH HEREIN DO NOT CONSTITUTE AN EXPRESS OR IMPLIED PROMISE
OF CONTINUED ENGAGEMENT AS AN EMPLOYEE OR CONSULTANT FOR THE VESTING PERIOD, FOR ANY PERIOD, OR AT
ALL, AND SHALL NOT INTERFERE WITH OPTIONEES RIGHT OR THE COMPANYS RIGHT TO TERMINATE OPTIONEES
RELATIONSHIP AS AN EMPLOYEE OR CONSULTANT AT ANY TIME, WITH OR WITHOUT CAUSE.
By your signature and the signature of the Companys representative below, you and the Company
agree that this Option is granted under and governed by the terms and conditions of the Plan and
this Option Agreement. Optionee has reviewed the Plan and this Option Agreement in their entirety,
has had an opportunity to obtain the advice of counsel prior to executing this Option Agreement and
fully understands all provisions of the Plan and Option Agreement. Optionee hereby agrees to
accept as binding, conclusive and final all decisions or interpretations of the Administrator upon
any questions relating to the Plan and Option Agreement. Optionee further agrees to notify the
Company upon any change in the residence address indicated below.
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OPTIONEE:
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NEUROCRINE BIOSCIENCES, INC. |
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Signature
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Date
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Name:
NAME
ADDRESS
CITY, STATE ZIP
CONSENT OF SPOUSE
The undersigned spouse of Optionee has read and hereby approves the terms and conditions of
the Plan and this Option Agreement. In consideration of the Companys granting his or her spouse
the right to purchase Shares as set forth in the Plan and this Option Agreement, the undersigned
hereby agrees to be irrevocably bound by the terms and conditions of the Plan and this Option
Agreement and further agrees that any community property interest shall be similarly bound. The
undersigned hereby appoints the undersigneds spouse as attorney-in-fact for the undersigned with
respect to any amendment or exercise of rights under the Plan or this Option Agreement.
EXHIBIT A
NEUROCRINE BIOSCIENCES, INC.
2003
Stock Option Plan as amended
EXERCISE NOTICE
Neurocrine Biosciences, Inc.
12790 El Camino Real
San Diego, CA 92130
Attention: Secretary
1. Exercise of Option. Effective as of today, , 20___, the undersigned
(Purchaser) hereby elects to purchase shares (the Shares) of the Common Stock of
Neurocrine Biosciences, Inc. (the Company) under and
pursuant to the 2003 Stock Option
Plan as amended (the Plan) and the Stock Option Agreement dated , 20___(the Option Agreement).
The purchase price for the Shares shall be $ , as required by the Option
Agreement.
2. Delivery of Payment. Purchaser herewith delivers to the Company the full purchase price
for the Shares.
3. Representations of Purchaser. Purchaser acknowledges that Purchaser has received, read and
understood the Plan and the Option Agreement and agrees to abide by and be bound by their terms and
conditions.
4. Rights as Shareholder. Until the issuance (as evidenced by the appropriate entry on the
books of the Company or of a duly authorized transfer agent of the Company) of the Shares, no right
to vote or receive dividends or any other rights as a shareholder shall exist with respect to the
Optioned Stock, notwithstanding the exercise of the Option. The Shares so acquired shall be issued
to the Optionee as soon as practicable after exercise of the Option. No adjustment will be made
for a dividend or other right for which the record date is prior to the date of issuance, except as
provided in Section 11 of the Plan.
5. Tax Consultation. Purchaser understands that Purchaser may suffer adverse tax consequences
as a result of Purchasers purchase or disposition of the Shares. Purchaser represents that
Purchaser has consulted with any tax consultants Purchaser deems advisable in connection with the
purchase or disposition of the Shares and that Purchaser is not relying on the Company for any tax
advice.
6. Entire Agreement; Governing Law. The Plan and Option Agreement are incorporated herein by
reference. This Agreement, the Plan and the Option Agreement constitute the entire agreement of
the parties with respect to the subject matter hereof and supersede in their entirety all prior
undertakings and agreements of the Company and Purchaser with respect to the subject matter hereof,
and may not be modified adversely to the Purchasers interest except by means of a writing signed
by the Company and Purchaser. This agreement is governed by the internal substantive laws, but not
the choice of law rules, of California.
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Submitted by:
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PURCHASER: |
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NEUROCRINE BIOSCIENCES, INC. |
Neurocrine Biosciences, Inc.
12790 El Camino Real
San Diego, CA 92130
Date Received
NEUROCRINE BIOSCIENCES, INC.
2003 INCENTIVE STOCK PLAN
Restricted Stock Unit Agreement
Grant Notice
Neurocrine Biosciences, Inc. (the Company) hereby grants you, [ ] (the
Employee), an award of Restricted Stock Units (RSUs) under the Companys 2003 Incentive Stock
Plan, as amended (the Plan), the terms of which are hereby incorporated by reference. The date
of this Restricted Stock Unit Agreement, which includes Appendix A attached hereto and incorporated
herein (the Agreement), is September 26, 2006 (the Effective Date). Subject to the remaining
terms of this Agreement and of the Plan, the principal features of this award are as follows:
Number of RSUs:
Vesting of RSUs: The RSUs will vest according to the following schedule:
So long as you remain in Continuous Status as an Employee or Consultant through each such date,
1/3rd of the RSUs shall vest on each of the thirteen (13), twenty-four (24) and
thirty-six (36) month anniversaries of the Effective Date, so that the RSUs will become fully
vested on the thirty-six (36) month anniversary of the Effective Date (the Vesting Schedule).
The RSUs are also subject to the vesting conditions set forth in paragraph 4 of the attached
Appendix A.
Unless otherwise defined herein or in Appendix A, capitalized terms herein or in
Appendix A shall have the defined meanings ascribed to them in the Plan.
Your signature below indicates your agreement and understanding that this award is subject to all
of the terms and conditions contained in this Agreement (including Appendix A) and the
Plan. For example, important additional information on vesting and forfeiture of the RSUs is
contained in Paragraphs 4 through 6 of Appendix A. PLEASE BE SURE TO READ ALL OF APPENDIX
A, WHICH CONTAINS THE SPECIFIC TERMS AND CONDITIONS OF THIS AGREEMENT.
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EMPLOYEE |
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Tim Coughlin |
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[NAME] |
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VP and CFO |
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Date:
9/26/06
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APPENDIX A
TERMS AND CONDITIONS OF RESTRICTED STOCK UNITS
1. Grant. The Company hereby grants to the Employee under the Plan an award of that
number of RSUs set forth on the first page of this Agreement, subject to all of the terms and
conditions in this Agreement and the Plan.
2. Plan Governs. The RSUs are issued pursuant to, and the terms of this Agreement are
subject to, all terms and provisions of the Plan, including without limitation Section 15 of the
Plan. Except as provided in paragraph 4(b) below, in the event of a conflict between one or more
provisions of this Agreement and one or more provisions of the Plan, the provisions of the Plan
will govern.
3. Companys Obligation to Pay. Each RSU has a value equal to the fair market value
of a share of Common Stock on the date the shares subject thereto are distributed. Unless and
until the RSUs will have vested in the manner set forth in paragraphs 4 and 5, the Employee will
have no right to payment of any such RSUs. Prior to actual payment of any vested RSUs, such RSUs
will represent an unsecured obligation of the Company, payable (if at all) only from the general
assets of the Company. Nothing contained in this Agreement, and no action taken pursuant to its
provisions, shall create or be construed to create a trust of any kind or fiduciary relationship
between Employee and the Company or any other person.
4. Vesting.
(a) Subject to paragraph 5, the RSUs awarded by this Agreement will vest in the Employee
according to the Vesting Schedule set forth on the first page of this Agreement, subject to the
Employees remaining in Continuous Status as an Employee or Consultant through such vesting periods
or dates.
(b) Notwithstanding anything to the contrary set forth in the Plan, the vesting of the RSUs
awarded by this Agreement shall not accelerate in accordance with Section 9(d) of the Plan in
connection with a termination of Employees Continuous Status as an Employee as a result of
Employees retirement from the Company.
(c) In the event of a Change in Control of the Company approved by the majority of the members
of the Board on the Board prior to the commencement of such Change in Control, the RSUs shall be
assumed or an equivalent award or right substituted by the successor corporation or a Parent or
Subsidiary of the successor corporation; provided, however, in the event that within one year of
the date of the completion of the Change in Control, the successor corporation or a Parent or
Subsidiary of the successor corporation terminates the Employee without Cause, the RSUs shall
become immediately fully vested. In the event that the successor corporation refuses to assume or
substitute the RSUs, the RSUs shall become immediately fully vested and the shares subject to the
RSUs shall be issued to Employee immediately prior to the Change in Control, provided that such
transaction also qualifies as a change in the ownership or effective control of the Company, or in
the ownership of a substantial portion of the assets of the Company, in each case for purposes of
Section 409A(a)(2)(A)(v) of the Internal Revenue Code and the regulations and other guidance
thereunder (Section 409A Change of Control).
(d) In the event of a Change in Control which is not approved by the majority of the members
of the Board on the Board prior to the commencement of a Change in Control, the RSUs shall
immediately fully vest. In the event that the successor corporation refuses to assume or
substitute the RSUs, the shares subject to the RSUs shall be issued to Employee immediately prior
to the Change in Control , provided that such transaction also qualifies as a Section 409A Change
of Control.
(e) The RSUs shall be considered assumed if, following the Change in Control, the RSUs confer
the right to receive, for each Share of Common Stock subject to the RSUs immediately prior to the
Change in Control, the consideration (whether stock, cash, or other securities or property)
received in the Change in Control by holders of Common Stock for each Share held on the effective
date of the transaction (and if holders were offered a choice of consideration, the type of
consideration chosen by the holders of a majority of the outstanding Shares); provided, however,
that if such consideration received in the Change in Control is not solely common stock of the
successor corporation or its Parent, the Board may, with the consent of the successor corporation,
provide for the consideration to be issued pursuant to the RSUs, for each Share of Common Stock
subject to the RSUs, to be solely common stock of the successor corporation or its Parent equal in
fair market value to the per share consideration received by holders of Common Stock in the Change
in Control.
5. Forfeiture upon Termination as Service Provider. Notwithstanding any contrary
provision of this Agreement, if the Employee terminates Continuous Status as an Employee or
Consultant for any or no reason, the then-unvested RSUs awarded by this Agreement will thereupon be
forfeited at no cost to the Company and the Employee shall have no further rights thereunder. To
the extent not already paid, RSUs that vest in accordance with the Vesting Schedule shall be paid
following the Employees termination of Continuous Status as an Employee or Consultant in
accordance with paragraph 6 or 8 below, as applicable.
6. Issuance after Vesting. If Employee does not elect to defer his or her
distribution of the shares subject to the RSUs in accordance with paragraph 8 below, shares of
Common Stock subject to any RSUs that vest in accordance with the Vesting Schedule will be issued
to the Employee (or in the event of the Employees death, to his or her estate) in whole shares of
Common Stock on each of the thirteen (13), twenty-four (24) and thirty-six (36) month anniversaries
of the Effective Date (each a Vesting Distribution Date), in each case not later than ten (10)
days following each Vesting Distribution Date, with respect to shares of Common Stock subject to
those RSUs that have vested on each such date.
7. Tax Withholding. On or before the time Employee receives a distribution of shares
of Common Stock pursuant to the RSUs, or at any time thereafter as requested by the Company, the
Employee must make adequate provision, as determined by the Company, for any sums required to
satisfy the federal, state, local and foreign tax withholding obligations of the Company or a
Subsidiary, if any, which arise in connection with the vesting and/or issuance of the shares
subject to the RSUs. Unless the tax withholding obligations of the Company and/or any Subsidiary
are satisfied, the Company shall have no obligation to issue the shares of Common Stock subject to
the RSU. If the Employee does not satisfy the tax withholding obligations of the Company and/or
any Subsidiary within thirty (30) days following receipt of notice from the Company, then the RSU
will automatically terminate and the Employee will not be issued any shares pursuant to the RSU.
8. Deferral Election.
(a) Election Whether to Defer Distribution of RSU Shares. Each Employee must elect
whether to defer his or her distribution of the RSU shares to a date following the Vesting
Distribution Date in accordance with paragraph 8(b) or 8(c) below, as applicable. Employees who
are not eligible to participate in the Amended and Restated Neurocrine Biosciences, Inc.
Nonqualified Deferred Compensation Plan (the Deferred Compensation Plan), as amended, must make
an election pursuant to paragraph 8(b) below. Employees who are eligible to participate in the
Deferred Compensation Plan (Selected Employees) must make an election pursuant to paragraph 8(c)
below. If an Employee does not make a valid, timely election pursuant to paragraph 8(b) or 8(c)
below, as applicable, the Employee will be deemed to have affirmatively elected not to defer his or
her distribution of the RSU shares, and the shares will be delivered to Employee in accordance with
paragraph 6.
(b) Standard Deferral Election. Employees who are not Selected Employees must make an
election whether to defer receipt of the RSU shares pursuant to the terms and conditions of the
Standard Deferral Election Agreement attached hereto as Exhibit A. Subject to a valid
deferral election made within thirty (30) days following the Effective Date, the Employee may elect
to defer the timing of the receipt of shares under this Agreement and have such shares issued at a
later date pursuant to the terms and conditions of the Standard Deferral Election Agreement. Such
deferral elections must also comply with the requirements of Section 409A of the Internal Revenue
Code of 1986, as amended (the Code), and the related Treasury Regulations or other guidance
issued thereunder.
(c) Deferral Election Under Deferred Compensation Plan by Selected Employees.
Selected Employees must make an election whether to defer receipt of the RSU shares pursuant to the
terms and conditions of the Deferred Compensation Plan Deferral Election Agreement attached hereto
as Exhibit B. Subject to a valid deferral election made within thirty (30) days following
the Effective Date, Selected Employees may elect to defer the timing of the receipt of the shares
under this Agreement and have such shares issued at a later date pursuant to the terms and
conditions of the Deferred Compensation Plan and the Deferred Compensation Plan Deferral Election
Agreement. Such deferral elections must also comply with the requirements of Section 409A of the
Internal Revenue Code of 1986, as amended (the Code), and the related Treasury Regulations or
other guidance issued thereunder. To make a valid deferral election pursuant to this paragraph
8(c), Employee must also complete a Deferred Compensation Plan Beneficiary Designation form, in
substantially the form attached hereto as Exhibit C.
(d) Deferred Distribution Date. The date upon which the shares of Common Stock are
scheduled to be delivered pursuant to any deferral election made under this paragraph 8 is the
Deferred Distribution Date. Shares of Common Stock subject to any RSUs that are subject to any
deferral election made under this paragraph 8 will be issued to the Employee (or in the event of
the Employees death, to his or her estate) in whole shares of Common Stock in each case not later
than ten (10) days following the Deferred Distribution Date
9. Delay in Issuance of Shares. Notwithstanding anything to the contrary set forth
herein, if the Company determines that the Employees sale of shares of Common Stock on the date
the shares subject to the RSUs are scheduled to be delivered, whether on the Vesting Distribution
Date or a Deferred Distribution Date selected pursuant to paragraph 8 above (in either case, the
Original Distribution Date) would violate its policy regarding insider trading of the Companys
stock, as determined by the Company in accordance with such policy, then such shares shall not be
delivered on such Original Distribution Date and shall instead be delivered as soon as practicable
on or after the earliest date on which the Employee could sell such shares pursuant to such policy;
provided, however, that in no event shall the delivery of the shares be delayed pursuant to this
provision beyond the later of: (1) December 31st of the same calendar year of the Original
Distribution Date, or (2) the 15th day of the third calendar month following the Original
Distribution Date.
10. Rights as Stockholder. Neither the Employee nor any person claiming under or
through the Employee will have any of the rights or privileges of a stockholder of the Company in
respect of any shares of Common Stock deliverable hereunder unless and until certificates
representing such shares of Common Stock will have been issued, recorded on the records of the
Company or its transfer agents or registrars, and delivered to the Employee.
11. No Effect on Employment. This Agreement is not an employment contract, and
nothing herein shall be deemed to create in any way whatsoever any obligation on the Employees
part to continue in the employ of the Company, or of the Company to continue the Employees
employment with the Company. The Employees employment with the Company is on an at will basis
only. The Company will have the right, which is hereby expressly reserved, to terminate or change
the terms of the employment of the Employee at any time for any reason whatsoever, with or without
good cause.
12. Address for Notices. Any notice to be given to the Company under the terms of
this Agreement will be addressed to the Company at its principal place of business (attention:
General Counsel), or at such other address as the Company may hereafter designate in writing. Any
notices provided for in this Agreement or the Plan shall be given in writing and shall be deemed
effectively given upon receipt or, in the case of notices delivered by the Company to the Employee,
five (5) days after deposit in the United States mail, postage prepaid, addressed to the Employee
at the address specified on the first page of this Agreement or at such other address as the
Employee may hereafter designate by written notice to the Company.
13. Transferability. Unless determined otherwise by the Board, this grant and the
rights and privileges conferred hereby, including without limitation the shares of Common Stock
issuable following the vesting of the RSUs, will not be sold, pledged, assigned, hypothecated,
transferred, or disposed of in any manner (whether by operation of law or otherwise) and will not
be subject to sale under execution, attachment or similar process until, with respect to whole
shares of Common Stock issuable following the vesting of the RSUs, such shares are issued pursuant
to paragraph 6 or 8 above. Upon any attempt to sell, pledge, assign, hypothecate, transfer, or
dispose of this grant, or any right or privilege conferred hereby, or upon any attempted sale under
any execution, attachment or similar process, this grant and the rights and privileges conferred
hereby immediately will become null and void.
14. Binding Agreement. Subject to the limitations on the transferability of this
grant contained herein, this Agreement will be binding upon and inure to the benefit of the heirs,
legatees, legal representatives, successors and assigns of the parties hereto.
15. Additional Conditions to Issuance of Stock. If at any time the Company will
determine, in its discretion, that the listing, registration or qualification of the shares of
Common Stock upon any securities exchange or under any state or federal law, or the consent or
approval of any governmental regulatory authority, is necessary or desirable as a condition to the
issuance of shares of Common Stock to the Employee (or his or her estate), such issuance will not
occur unless and until such listing, registration, qualification, consent or approval will have
been effected or obtained free of any conditions not acceptable to the Company. The Company will
make all reasonable efforts to meet the requirements of any such state or federal law or securities
exchange and to obtain any such consent or approval of any such governmental authority.
16. Committee Authority. The Committee will have the power to interpret the Plan and
this Agreement and to adopt such rules for the administration, interpretation and application of
the Plan and this Agreement as are consistent therewith and to interpret or revoke any such rules.
All actions taken and all interpretations and determinations made by the Committee in good faith
will be final and binding upon Employee, the Company and all other interested persons. No member
of the Committee will be personally liable for any action, determination or interpretation made in
good faith with respect to the Plan or this Agreement.
17. Captions. Captions provided herein are for convenience only and are not to serve
as a basis for interpretation or construction of this Agreement.
18. Agreement Severable. In the event that any provision in this Agreement will be
held invalid or unenforceable, such provision will be severable from, and such invalidity or
unenforceability will not be construed to have any effect on, the remaining provisions of this
Agreement.
19. Amendment. The Committee may amend, terminate or revoke this Agreement in any
respect to the extent determined necessary or desirable by the Committee in its discretion to
comply with the requirements of Section 409A of the Code and the Treasury Regulations or other
guidance issued thereunder. Employee expressly understands and agrees that no additional consent
of Employee shall be required in connection with such amendment, termination or revocation.
EXHIBIT A
Standard Deferral Election Agreement
Please complete this Standard Deferral Election Agreement (Election Agreement) and return a
signed copy to Steve Zug no later than the thirtieth (30th) day following the Effective
Date as indicated on your Restricted Stock Unit Agreement.
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Deferral Election (check one) |
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Election to Defer: |
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Employee hereby irrevocably elects to defer receipt of the shares of Common
Stock associated with the RSUs provided for in the Grant Notice and Appendix A thereto,
to which this Exhibit A is attached, until the fifth anniversary of the Effective
Date. |
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Employee hereby irrevocably elects not to defer receipt of the shares of Common
Stock associated with the RSUs provided for in the Grant Notice and Appendix A thereto,
to which this Exhibit A is attached (shares will be issued to Employee as the RSU award
vests in accordance with the Restricted Stock Unit Agreement). |
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Terms and Conditions of Deferral Election |
If Employee elects to defer receipt of the shares subject to the RSU pursuant to this Election
Agreement, by signing this Election Agreement, Employee hereby acknowledges his or her
understanding and acceptance of each of the following:
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Acceleration of Issuance of Shares Upon Termination of Continuous Status as an Employee
or Consultant. In the event of Employees termination of Continuous Status as an Employee
or Consultant prior to the fifth anniversary of the Effective Date that qualifies as a
separation from service within the meaning of Code Section 409A(a)(2)(A)(i) and the
regulations and other guidance promulgated thereunder, then any vested shares of Common Stock
subject to the RSUs shall instead be delivered to Employee on the date of his or her
termination of Continuous Status as an Employee or Consultant. |
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Acceleration of Issuance of Shares Upon Change in Control. Notwithstanding
Employees deferral election pursuant to this Election Agreement, in the event that a
successor corporation refuses to assume or substitute the RSUs in connection with a Change in
Control, the shares subject to the RSUs shall instead be issued to Employee immediately prior
to the Change in Control to the extent provided in paragraph 4 of the Appendix. |
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Delay in Distribution for Specified Employees. Notwithstanding anything to the
contrary set forth herein, if at the time the shares of Common Stock would otherwise be issued
to Employee as a result of termination of Continuous Status as an Employee or Consultant,
Employee is subject to the distribution limitations contained in Section 409A of the Code
applicable to specified employees, share issuances resulting from a termination of
Continuous Status as an Employee or Consultant shall not be made before the date which is six
(6) months following the date of termination of Continuous Status as an Employee or
Consultant, or, if earlier, the date of Employees death that occurs within such six (6) month
period. |
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Delay in Distribution for Insiders. Notwithstanding the foregoing election, as
described in paragraph 9 of the Appendix to the RSU Agreement, the distribution of shares may
be delayed if the Company determines that Employees sale of the shares on such date would
violate the Companys policy regarding insider trading of the Companys stock, as determined
by the Company in accordance with such policy. |
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Effective Election. In order for the foregoing deferral election to become
effective, this Election Agreement must be submitted by Employee to Steve Zug on or before
thirty (30) days following the Effective Date of the RSUs. |
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Withholding. The Company shall require that Employee make adequate provision for any
federal, state, or local tax required by law to be withheld prior to the issuance of the
shares of Common Stock. |
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Nonassignable. Employees rights and interests under this Election Agreement may not
be assigned, pledged, or transferred. |
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Termination of this Election Agreement. The Company reserves the right to terminate
this Election Agreement at any time. In such case, any vested shares of Common Stock granted
to Employee pursuant to the Restricted Stock Unit Agreement may be issued to Employee
immediately, to the extent permitted by Section 409A of the Code and the regulations and other
guidance promulgated thereunder. |
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Bookkeeping Account. The Company will establish a bookkeeping account to reflect the
number of shares of Common Stock that Employee may acquire pursuant to the RSUs and the fair
market value of such shares of Common Stock that are subject to this Election Agreement. |
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Governing Law. This Election Agreement shall be construed and administered according
to the internal laws of the State of California, without regard to its conflicts of laws
principles. |
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Authorization and Signature |
By completing and executing this Election Agreement, Employee authorizes the Company to defer or
not defer, as applicable, the issuance of the shares subject to the RSU award. Employee
acknowledges that the Company has not made any representations concerning future performance of the
Companys Common Stock. Further, Employee has not relied upon advice from the Company in making
Employees election. By executing this Election Agreement, the Employee hereby acknowledges his or
her understanding of and agreement with all the terms and provisions set forth herein.
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Neurocrine Biosciences, Inc. |
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By: |
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Name: |
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Title: |
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Date:
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Date: |
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EXHIBIT B
Deferred Compensation Plan Deferral Election Agreement (RSU Awards)
Please complete this Deferred Compensation Plan Deferral Election Agreement (Election Agreement)
and return a signed copy to Steve Zug no later than the thirtieth (30th) day following
the Effective Date as indicated on your Restricted Stock Unit Agreement (RSU Agreement).
Defined terms not explicitly defined in this Election Agreement but defined in the Companys 2003
Incentive Stock Plan (Plan), the Companys Amended and Restated Nonqualified Deferred
Compensation Plan (Deferred Compensation Plan), or your RSU Agreement shall have the same
definitions as in such documents.
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Deferral Election (check one) |
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Election to Defer: |
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Employee hereby irrevocably elects to defer receipt of the shares of Common
Stock associated with the RSUs provided for in the Grant Notice and Appendix A thereto,
to which this Exhibit B is attached, in accordance with the terms of the Deferred
Compensation Plan. |
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Employee hereby irrevocably elects not to defer receipt of the shares of Common
Stock associated with the RSUs provided for in the Grant Notice and Appendix A thereto,
to which this Exhibit B is attached (shares will be issued to Employee as the RSU award
vests in accordance with the RSU Agreement). |
If Employee elects above to defer receipt of the shares subject to the RSUs, Employee must complete
Deferral Alternative #1 (Termination of Service). Selecting Deferral Alternative #2 is optional.
If Employee selects Deferral Alternative #2, Employee must also complete the applicable portion
that follows such selection.
All Employees Who Elect To Defer Receipt Of Their RSUs Must Complete This Section
Deferral Alternative #1 (Termination of Service):
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Employee elects to receive the vested shares of Common Stock associated with the
RSUs upon his or her termination of service. |
PLEASE NOTE: The above election will apply in the event of Employees termination of
service for any reason, including due to Employees Death, Disability or Retirement. The
shares subject to the RSUs will be issued in a single lump sum upon termination of
service. However, for termination of service distributions Employee may (but is not
required to) instead elect annual installment distribution of the shares, as follows:
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Employee elects to receive the vested shares of Common Stock
associated with the RSUs upon his or her termination of service in
substantially equal annual installments as follows: |
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annual installments (elect 2-15) |
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PLEASE NOTE: The above election to receive a distribution of
shares in annual installments instead of a lump sum will only
apply if the number of shares subject to each annual installment
is at least 2,500 shares. If the number of shares to be
distributed pursuant to any annual installment would be less
than 2,500 shares, the shares subject to the RSUs will be issued
in a single lump sum upon termination of service. |
Completion Of This Section Is Optional
Deferral Alternative #2: (Specified Date(S) Check boxes that apply)
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Employee elects to receive the vested shares of Common Stock associated
with the RSUs on the following specified dates (must be year 2013 or later) for
the following number of shares: |
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A.
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Number of shares
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Number of shares
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PLEASE NOTE: If Employees Retirement, Death, Disability, or
Termination of Employment occurs before the elected specified date(s), the
shares will not be issued to Employee on the specified date(s) elected above,
but will instead be issued to Employee in accordance with Employees deferral
election under Alternative #1 (Termination of Service). Employee may elect up
to four separate specified dates, and may not elect that fewer than 5,000 shares
be issued to Employee on any specified date.
II. Election Conditions
The following conditions apply to the foregoing deferral election:
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Employee may elect a Deferred Distribution Date that occurs after the date of vesting
of the RSUs. The Deferred Distribution Date is the date as of which Employee will
receive the shares of vested Common Stock associated with the RSUs that Employee elects to
defer. Unless Employee timely elects otherwise on this Election Agreement, such shares
will be issued to Employee on or about the date or dates upon which they vest as indicated
in the RSU Agreement. Notwithstanding the foregoing, as described in paragraph 9 of the
Appendix to the RSU Agreement, the distribution of such shares may be delayed if the
Company determines that Employees sale of the shares on such date would violate the
Companys policy regarding insider trading of the Companys stock, as determined by the
Company in accordance with such policy. |
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Employee may elect as the Deferred Distribution Date a termination of Employees
service that qualifies as a separation from service for purposes of Section 409A of the
Code. |
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As an alternative to 2 above, Employee may elect up to four different specified dates
as Deferred Distribution Dates. However, if prior to such Deferred Distribution Date,
there is a termination of Employees service with the Company that is a separation from
service for purposes of Section 409A of the Code, Employee will receive all shares of
vested Common Stock associated with the RSUs in accordance with Employees election under
Deferral Alternative #1, notwithstanding any deferral election Employee makes on this
Election Agreement under Alternative #2 to receive shares on a specified date. |
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If no Deferred Distribution Date is elected, then the issuance of vested Common Stock
will occur upon or about the vesting date(s) as indicated in the RSU Agreement. |
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Notwithstanding anything to the contrary set forth herein, if at the time the shares of
Common Stock would otherwise be issued to Employee as a result of termination of service,
Employee is subject to the distribution limitations contained in Section 409A of the Code
applicable to specified employees, share issuances resulting from a termination of
service shall not be made before the date which is six (6) months following the date of
termination of Employees service, or, if earlier, the date of Employees death that occurs
within such six (6) month period. |
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Notwithstanding anything to the contrary that may be set forth in Section 4.6 of the
Deferred Compensation Plan, and notwithstanding Employees deferral election pursuant to
this Election Agreement, in the event that a successor corporation refuses to assume or
substitute the RSUs in connection with a Change in Control (as defined in the 2003
Incentive Stock Plan), the shares subject to the RSUs shall instead be issued to Employee
immediately prior to the Change in Control to the extent provided in paragraph 4 of the
Appendix. |
III. Acknowledgement
Employee further acknowledges and agrees as follows:
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In order for the foregoing deferral election to become effective, this Election
Agreement must be submitted by Employee to Steve Zug on or before thirty (30) days
following the Effective Date of the RSUs. |
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The Company shall require that Employee make adequate provision for any federal, state,
or local tax required by law to be withheld prior to the issuance of the shares of Common
Stock. |
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Employees rights and interests under this Election Agreement may not be assigned,
pledged, or transferred. |
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The Company reserves the right to terminate this Election Agreement at any time. In
such case, any vested shares of Common Stock granted to Employee pursuant to the RSU
Agreement may be issued to Employee immediately, to the extent permitted by Section 409A of
the Code and the regulations and other guidance promulgated thereunder. |
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The Company will establish a bookkeeping account to reflect the number of shares of
Common Stock that Employee may acquire pursuant to the RSUs and the fair market value of
such shares of Common Stock that are subject to this Election Agreement. |
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This Election Agreement shall be construed and administered according to the internal
laws of the State of California, without regard to its conflicts of laws principles. |
IV. Authorization and Signature
By completing and executing this Election Agreement, Employee authorizes the Company to defer or
not defer, as applicable, the issuance of the shares subject to the RSU award. Employee
acknowledges that the Company has not made any representations concerning future performance of the
Companys Common Stock. Further, Employee has not relied upon advice from the Company in making
Employees election. Additionally, Employee acknowledges that the terms of the Deferred
Compensation Plan document, as reasonably interpreted by the Company, governs all aspects of this
election. By executing this Election Agreement, the Employee hereby acknowledges his or her
understanding of and agreement with all the terms and provisions set forth herein.
Exhibit C
Beneficiary Designation
Personal Information
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Last
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First
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Middle Initial
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Social Security Number |
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I hereby designate the following Beneficiary(ies) to receive any benefit payable under the Plan
by reason of my death, as provided in the Plan document. |
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Primary Beneficiary(ies) |
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Beneficiary
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Percentage |
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Relationship to Participant
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Social Security Number |
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Beneficiary
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Percentage |
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Relationship to Participant
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Social Security Number |
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Beneficiary
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Percentage |
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Relationship to Participant
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Beneficiary
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Relationship to Participant
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Please Sign Below |
If no percentage is indicated, all beneficiaries will be deemed to have an equal interest in
the benefits payable under the Plan.
exv31w1
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences, Inc., certify
that:
1. |
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I have reviewed this quarterly report on Form 10-Q of Neurocrine Biosciences, Inc.; |
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; |
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; |
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 this 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 the preparation of financial
statements for external purposes in accordance with generally accepted accounting
principles; |
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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 controls over financial reporting. |
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Dated: July 31, 2008
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/s/ Kevin C. Gorman
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Kevin C. Gorman |
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President and Chief Executive Officer |
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exv31w2
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Timothy P. Coughlin, Vice President and Chief Financial Officer of Neurocrine Biosciences, Inc.,
certify that:
1. |
|
I have reviewed this quarterly report on Form 10-Q of Neurocrine Biosciences, Inc.; |
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
3. |
|
Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)), for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during this period in which this report is being
prepared; |
|
|
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 the preparation of financial
statements for external purposes in accordance with generally accepted accounting
principles; |
|
|
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): |
|
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 controls over financial reporting. |
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Dated: July 31, 2008
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/s/ Timothy P. Coughlin
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Timothy P. Coughlin |
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Vice President and Chief Financial Officer |
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exv32
EXHIBIT 32
CERTIFICATIONS OF
CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
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 Neurocrine Biosciences, Inc. (Company) on Form 10-Q
for the period ended June 30, 2008 as filed with the Securities and Exchange Commission on the date
hereof (Report), I, Kevin C. Gorman, President and Chief Executive Officer of the Company, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, that to my knowledge:
(1) |
|
The Report fully complies with the requirements of Section 13(a) or 15(d), of the Securities
Exchange Act of 1934; and |
(2) |
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That 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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July 31, 2008 |
By: |
/s/ Kevin C. Gorman
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Name: Kevin C. Gorman |
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Title: President and Chief Executive Officer |
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In connection with the Quarterly Report of Neurocrine Biosciences, Inc. (Company) on Form 10-Q
for the period ended June 30, 2008 as filed with the Securities and Exchange Commission on the date
hereof (Report), I, Timothy P. Coughlin, Vice President and Chief Financial Officer of the Company,
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) |
|
The Report fully complies with the requirements of Section 13(a) or 15(d), of the Securities
Exchange Act of 1934; and |
(2) |
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That 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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July 31, 2008 |
By: |
/s/ Timothy P. Coughlin
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Name: Timothy P. Coughlin |
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Title: Vice President and Chief Financial Officer |
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