Neurocrine Biosciences, Inc.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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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 March 31, 2006
OR
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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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12790 EL CAMINO REAL
SAN DIEGO, CALIFORNIA 92130
(Address of principal executive offices)
(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,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer
in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o |
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 $0.001 per share,
was 37,721,802 as of April 21, 2006.
\
NEUROCRINE BIOSCIENCES, INC.
FORM 10-Q INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except for share information)
(unaudited)
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March 31, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
101,494 |
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$ |
49,948 |
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Short-term investments, available-for-sale |
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162,995 |
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223,120 |
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Receivables under collaborative agreements |
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5,930 |
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858 |
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Other current assets |
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4,303 |
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5,384 |
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Total current assets |
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274,722 |
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279,310 |
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Property and equipment, net |
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97,363 |
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99,307 |
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Restricted cash |
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5,775 |
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5,775 |
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Prepaid royalty |
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94,000 |
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94,000 |
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Other non-current assets |
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5,543 |
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4,731 |
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Total assets |
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$ |
477,403 |
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$ |
483,123 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
16,791 |
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$ |
21,342 |
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Deferred revenues |
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10,419 |
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6,537 |
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Current portion of long-term debt |
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5,547 |
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5,814 |
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Total current liabilities |
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32,757 |
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33,693 |
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Long-term debt |
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52,403 |
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53,590 |
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Other liabilities |
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8,413 |
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5,736 |
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Total liabilities |
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93,573 |
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93,019 |
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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, $0.001 par value; 50,000,000 shares
authorized; issued and outstanding shares were 37,711,572
as of March 31, 2006 and 37,132,478 as of December 31, 2005 |
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38 |
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37 |
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Additional paid-in capital |
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711,023 |
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691,717 |
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Accumulated other comprehensive loss |
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(1,184 |
) |
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(1,504 |
) |
Accumulated deficit |
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(326,047 |
) |
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(300,146 |
) |
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Total stockholders equity |
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383,830 |
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390,104 |
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Total liabilities and stockholders equity |
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$ |
477,403 |
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$ |
483,123 |
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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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March 31, |
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2006 |
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2005 |
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Revenues: |
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Sponsored research and development |
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$ |
5,878 |
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$ |
4,416 |
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License fees and milestones |
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5,358 |
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6,448 |
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Sales force allowance |
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8,240 |
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1,000 |
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Total revenues |
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19,476 |
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11,864 |
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Operating expenses: |
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Research and development |
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27,735 |
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25,603 |
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Sales, general and administrative |
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19,335 |
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5,608 |
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Total operating expenses |
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47,070 |
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31,211 |
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Loss from operations |
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(27,594 |
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(19,347 |
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Other income and (expenses): |
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Interest income |
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2,662 |
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1,601 |
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Interest expense |
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(969 |
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(1,084 |
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Total other income |
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1,693 |
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517 |
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Net loss |
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$ |
(25,901 |
) |
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$ |
(18,830 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(0.69 |
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$ |
(0.51 |
) |
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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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37,355 |
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36,598 |
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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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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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OPERATING ACTIVITIES |
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Net loss |
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$ |
(25,901 |
) |
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$ |
(18,830 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation and amortization |
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2,666 |
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2,442 |
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Deferred revenues |
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(4,358 |
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(5,683 |
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Share-based compensation expense |
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6,788 |
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209 |
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Change in operating assets and liabilities: |
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Accounts receivable and other current assets |
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(3,991 |
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2,559 |
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Other non-current assets |
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(529 |
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(335 |
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Sales force
allowance prepayment |
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8,240 |
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Accounts payable and accrued liabilities |
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(4,551 |
) |
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(6,504 |
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Other non-current liabilities |
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1,286 |
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163 |
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Net cash used in operating activities |
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(20,350 |
) |
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(25,979 |
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INVESTING ACTIVITIES |
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Purchases of short-term investments |
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(61,021 |
) |
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(20,550 |
) |
Sales/maturities of short-term investments |
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121,183 |
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33,033 |
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Restricted cash |
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(525 |
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Purchases of property and equipment |
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(722 |
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(1,514 |
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Net cash provided by investing activities |
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59,440 |
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10,444 |
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FINANCING ACTIVITIES |
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Issuance of common stock |
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13,910 |
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|
796 |
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Principal payments on debt |
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(1,454 |
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(1,718 |
) |
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Net cash provided by (used in) financing activities |
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12,456 |
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(922 |
) |
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Net increase (decrease) in cash and cash equivalents |
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51,546 |
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(16,457 |
) |
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Cash and cash equivalents at beginning of the period |
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49,948 |
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61,027 |
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Cash and cash equivalents at end of the period |
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$ |
101,494 |
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$ |
44,570 |
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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 periods 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
audited financial statements and notes thereto for the year ended December 31, 2005 included in our
Annual Report on Form 10-K for the year ended December 31, 2005, filed with the SEC.
The terms Company and we and our are used in this report to refer collectively to
Neurocrine Biosciences, Inc. and its subsidiaries.
Stock-Based Compensation
Prior to January 1, 2006, the Company accounted for stock-based compensation under the
recognition and measurement principles of Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees (APB 25). Therefore, the Company measured compensation expense for
its stock-based compensation using the intrinsic value method, that is, as the excess, if any, of
the fair market value of the Companys stock at the grant date over the amount required to be paid
to acquire the stock, and provided the disclosures required by Statement of Financial Accounting
Standards (SFAS) 123, Accounting for Stock-Based Compensation (SFAS 123) and SFAS 148,
Accounting for Stock-Based Compensation-Transition and Disclosure (SFAS 148).
Effective January 1, 2006, the Company began recording compensation expense associated with
stock options and other equity-based compensation in accordance with SFAS 123 (revised 2004),
Share-Based Payment (SFAS 123R), using the modified prospective transition method and therefore
has not restated results for prior periods. Under the modified prospective transition method,
stock-based compensation expense for the first quarter of 2006
includes: 1) compensation expense for
all stock-based awards granted on or after January 1, 2006 as determined based on the grant-date
fair value estimated in accordance with the provisions of SFAS 123R and 2) stock-based compensation
awards granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair
value estimated in accordance with the original provisions of SFAS
123. The Company recognizes these compensation costs on a straight-line
basis over the requisite service period of the award, which is generally four years; however,
certain provisions in the Companys equity compensation plans provide for shorter vesting periods
under certain circumstances. As a result of the adoption of SFAS 123R, the Companys net loss for
the three months ended March 31, 2006, includes approximately $6.8 million of compensation expense.
See Note 2 for additional information regarding stock-based compensation.
2. STOCK-BASED COMPENSATION
The Company grants stock options, restricted stock units and stock bonuses (collectively,
share-based compensation) to its employees and directors under the 2003 Incentive Stock Plan and
certain Employment Commencement Nonstatutory Stock Options. Eligible employees can also purchase
shares of our common stock at 85% of the fair market value on the last day of each six-month
offering period under our Employee Stock Purchase Plan. Effective
January 1, 2006, the benefits provided under these Plans are
share-based compensation subject to the provisions of SFAS 123R. Prior to January 1, 2006, the Company
accounted for share-based compensation related to stock options under the recognition and
measurement principles of Accounting Principles Board Opinion No. 25; therefore, the Company
measured compensation expense for its stock options using the intrinsic value method, that is, as
the excess, if any, of the fair market value of the Companys stock at the grant date over the
amount required to be paid to acquire the stock, and provided the pro forma disclosures required by
SFAS 123 and 148.
6
As a result of the adoption of SFAS 123R, the Companys net loss for the three months
ended March 31, 2006 includes $6.8 million of compensation expense related to the Companys
share-based compensation awards. The compensation expense related to the Companys share-based
compensation arrangements is recorded as components of sales, general and administrative expense
($4.7 million) and research and development expense ($2.1 million). SFAS 123R requires that cash
flows resulting from tax deductions in excess of the cumulative compensation cost recognized for
options exercised (excess tax benefits) be classified as cash inflows from financing activities and
cash outflows from operating activities. Due to the Companys net loss position, no tax benefits
have been recognized in the cash flow statement.
The Company issues new shares upon the exercise of stock options and the issuance of stock
bonus awards.
Share-Based Compensation Plans
Since 1992, the Company has authorized a total of 12.7 million shares of common stock for
issuance upon exercise of stock options or stock purchase rights granted under the 1992 Incentive
Stock Plan, 1996 Director Option Plan, 1997 Northwest Neurologic, Inc. Restated Incentive Stock
Plan, 2001 Stock Option Plan, several Employment Commencement Nonstatutory Stock Option Agreements
and the 2003 Incentive Stock Plan (collectively, the Option Plans). The Option Plans provide for
the grant of stock options, restricted stock, restricted stock units, and stock bonuses to
officers, directors, and employees of the Company. Currently, all grants of stock options are made
from the 2003 Incentive Stock Plan and through Employment Commencement Nonstatutory Stock Option
Agreements. Of the 12.7 million reserved for issuance under the Option Plans, 0.8 million of these
shares were originally reserved for issuance pursuant to the terms of the Companys 1992 Incentive
Stock Plan, 1996 Director Stock Option Plan and 2001 Stock Option Plan and would currently be
available for issuance but for the Companys determination in 2003 not to make further grants under
these plans, 5.6 million had been issued upon exercise of stock options previously granted or
pursuant to restricted stock or stock bonus awards, 6.3 million shares were subject to
outstanding options and restricted stock units and 76,000 remained available for future grant under
the 2003 Incentive Stock Plan. Options cancelled due to forfeiture or expiration return to the pool
available for future grants.
Vesting Provisions of Share-Based Compensation
Stock options granted under the Option Plans primarily have terms of up to ten years from the
date of grant, and generally vest over a four-year period. Stock bonuses granted under the Option
Plans generally have vesting periods ranging from two to four years, restricted stock units granted
under the Option Plans have vesting periods of three years. The expense recognized under SFAS 123R
is generally recognized ratably over the vesting period. However, certain retirement provisions in
the Option Plans provide that employees who are age 55 or older and have five or more years of
service with the Company will be entitled to accelerated vesting of all of the unvested share-based
compensation awards upon retirement from the Company. In these cases, 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. Effective
January 1, 2006, the maximum term for all options granted
subsequent to this date was
reduced to seven years.
On November 7, 2005, the Company accelerated vesting of all unvested stock options to purchase
shares of common stock that were held by then-current employees and had an exercise price per share
equal to or greater than $50.00. Stock options to purchase approximately 472,000 shares of common
stock were subject to this acceleration. The exercise prices and number of shares subject to the
accelerated stock options were unchanged. The acceleration was effective November 7, 2005, and the
expense was included in the pro forma results of the fourth quarter of 2005 disclosed in our notes
to financial statements pursuant to SFAS 123. The acceleration of these stock options was
undertaken to eliminate the future compensation expense of approximately $10.5 million that the
Company would have otherwise recognized under SFAS 123R in its future consolidated statements of
operations.
7
Stock Options
The exercise price of all options granted during the three-month periods ended March 31, 2006
and 2005 was equal to the market value on the date of grant and, accordingly, no share-based
compensation expense for such options is reflected in operating
results for the first three-months of
fiscal year 2005. 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 months ended March 31, 2006 and 2005:
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Three Months Ended |
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March 31, |
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2006 |
|
2005 |
Risk-free interest rate |
|
|
4.31 |
% |
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|
4.18 |
% |
Expected volatility of common stock |
|
|
32.16 |
% |
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|
34.00 |
% |
Dividend yield |
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|
0.0 |
% |
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|
0.0 |
% |
Expected option term |
|
4.75 years |
|
5.8 years |
The risk-free interest rate assumption is based upon observed interest rates appropriate
for the expected term of the Companys employee stock options. The expected volatility is based on
the historical volatility of the Companys stock. The Company has not paid any dividends on common
stock since its inception and does not anticipate paying dividends on its common stock in the
foreseeable future. The computation of the expected option term is based on a weighted-average
calculation combining the average life of options that have already been exercised or cancelled
with the estimated life of all unexercised options. The decrease in the expected option term
period-to-period is due to the decrease in the maximum term of the options granted after January 1,
2006 from ten years to seven years.
As share-based compensation expense recognized in the Condensed Consolidated Statement of
Operations for the first quarter of fiscal 2006 is based on awards ultimately expected to vest, it
should be reduced for estimated forfeitures. 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. Pre-vesting forfeitures were estimated to be 0% in the first quarter of fiscal
2006 based on historical experience. The effect of pre-vesting forfeitures on the Companys
recorded expense has historically been negligible due to the predominant monthly vesting of option
grants. If pre-vesting forfeitures occur in the future, the Company will record the benefit related
to such forfeitures as the forfeitures occur. In the Companys pro forma information required under
SFAS 123 for the periods prior to fiscal 2006, the Company also accounted for forfeitures as they
occurred. The Companys determination of fair value is affected by the Companys stock price as
well as a number of assumptions that require judgment. The weighted-average fair value of each
option granted during the three months ended March 31, 2006 and 2005, estimated as of the grant
date using the Black-Scholes option valuation model, was $21.69 per option and $16.47 per option,
respectively.
A summary of the status of the Companys stock option plans as of March 31, 2006 and of
changes in options outstanding under the plans during the three months ended March 31, 2006 is as
follows (in thousands, except for weighted average exercise price and weighted average remaining
contractual term data):
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Weighted- |
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Weighted- |
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Average |
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Number |
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Average |
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Remaining |
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Aggregate |
|
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of |
|
Exercise Price |
|
Contractual |
|
Intrinsic |
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Shares |
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per Share |
|
Term (in years) |
|
Value |
Options outstanding at December 31, 2005 |
|
|
6,544 |
|
|
$ |
38.32 |
|
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|
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|
Options granted |
|
|
187 |
|
|
$ |
61.76 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(433 |
) |
|
$ |
32.13 |
|
|
|
|
|
|
|
|
|
Options forfeited or expired |
|
|
(38 |
) |
|
$ |
45.58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at March 31, 2006 |
|
|
6,260 |
|
|
$ |
39.00 |
|
|
|
6.5 |
|
|
$ |
157,723 |
|
Options vested and exercisable at
March 31, 2006 |
|
|
4,561 |
|
|
$ |
37.00 |
|
|
|
6.0 |
|
|
$ |
124,638 |
|
8
For the three months ended March 31, 2006, share-based compensation expense related to
stock options was $5.3 million. As of March 31, 2006, there was $29.6 million of unamortized
compensation cost related to unvested
stock option awards, which is expected to be recognized over a remaining weighted-average
vesting period of 2.7 years. The total intrinsic value of stock option exercises during the three
months ended March 31, 2006, was $15.4 million. Cash received from stock option exercises for the
three months ended March 31, 2006 and 2005 was $13.9 million and $0.8 million, respectively.
For stock options granted prior to the adoption of SFAS 123R, the following table
illustrates the pro forma effect on net loss and loss per common share as if the Company had
applied the fair value recognition provisions of SFAS 123 in determining stock-based compensation
for awards under the plan (in thousands, except loss per share data):
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2005 |
|
Net loss, as reported |
|
$ |
(18,830 |
) |
Stock option expense |
|
|
(5,341 |
) |
|
|
|
|
Pro forma net loss |
|
$ |
(24,171 |
) |
Loss per share: |
|
|
|
|
Basic and diluted as reported |
|
$ |
(0.51 |
) |
|
|
|
|
Basic and diluted pro forma |
|
$ |
(0.66 |
) |
|
|
|
|
Restricted Stock Units
Effective January 2006, certain employees are eligible to receive restricted stock units under
the Companys 2003 Incentive Stock Plan. In accordance with SFAS 123R, the fair value of
restricted stock units is estimated based on the closing sale price of the Companys common stock
on the Nasdaq National Market on the date of issuance. The total number of restricted stock awards
expected to vest is adjusted by estimated forfeiture rates, which has been estimated at zero based
on historical experience of stock bonus awards. For the three months ended March 31, 2006,
share-based compensation expense related to restricted stock units was $1.4 million. As of March
31, 2006, there was approximately $1.1 million of unamortized compensation cost related to
restricted stock units, which is expected to be recognized over a remaining weighted-average
vesting period of 2.5 years. The restricted stock units are placed into the Companys deferred
compensation plan upon vesting and recorded as other long-term liabilities in the consolidated
balance sheet. Once in the deferred compensation plan, the restricted stock units are adjusted to
market value of the Companys stock for each reporting period.
A summary of the status of the Companys restricted stock units as of March 31, 2006 and
of changes in restricted stock units outstanding under the plan during the three months ended March
31, 2006 is as follows (in thousands, except for weighted average grant date fair value per unit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
Number of |
|
|
Grant Date Fair |
|
|
Fair
Value |
|
|
|
Shares |
|
|
Value per Unit |
|
|
at
March 31, 2006 |
|
Restricted stock units outstanding at December 31, 2005 |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
Restricted stock units granted |
|
|
40 |
|
|
|
60.95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units outstanding at March 31, 2006 |
|
|
40 |
|
|
$ |
60.95 |
|
|
$ |
|
|
Restricted stock units vested at March 31, 2006 |
|
|
2 |
|
|
$ |
60.95 |
|
|
$ |
143 |
|
Stock Bonus Awards
The Company granted approximately 39,000 stock bonus awards at various market prices between
2003 and 2005. As of March 31, 2006, there was approximately $0.6 million of unamortized
compensation cost related to these stock bonus awards, representing approximately 10,000 shares of
common stock, which are expected to be recognized over a remaining weighted-average vesting period
of approximately two years. The Company common stock related to these awards has been placed into
the Companys deferred compensation plan and recorded as other long-term liabilities in the
consolidated balance sheet. Once in the deferred compensation plan, the related liability is
adjusted to market value of the Companys stock for each reporting period.
9
Employee Stock Purchase Plan
The Company has reserved 625,000 shares of common stock for issuance under the 1996 Employee
Stock Purchase Plan (the Purchase Plan). Effective January 1, 2006, the Purchase Plan was amended
such that the purchase price of common stock would be at 85% of the fair market value per share of
common stock on the date on which the shares are purchased. As of March 31, 2006, 592,000 shares
have been issued pursuant to the Purchase Plan.
The Purchase Plan has a six-month contribution period with purchase dates of June 30 and
December 31 each year. As of March 31, 2006, employees have contributed approximately $0.7 million
to the Purchase Plan, and the Company has recognized approximately $0.1 million in share-based
compensation expense related to the anticipated purchase on June 30, 2006.
3. 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.
4. 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.
5. IMPAIRMENT OF LONG-LIVED ASSETS
In accordance with SFAS 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 impairment is indicated, the Company measures the
amount of such impairment by comparing the carrying value of the asset to the estimated fair value
of the related asset, which is generally determined based on the present value of the expected
future cash flows. While the Companys current and historical operating and cash flow losses are
indicators of impairment, the Company believes the future cash flows to be received from the
long-lived assets will exceed the assets carrying value, and accordingly the Company has not
recognized any impairment losses through March 31, 2006.
6. LOSS PER COMMON SHARE
The Company computes net loss per share in accordance with SFAS 128, Earnings Per Share.
Under the provisions of SFAS 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 assumed exercise
of stock options and warrants, are excluded from historical diluted loss per share because of their
anti-dilutive effect. Potentially dilutive securities totaled 2.5 million and 1.4 million for the
period ended March 31, 2006 and 2005, respectively.
7. COMPREHENSIVE LOSS
Comprehensive loss is calculated in accordance with SFAS 130, Comprehensive Income. SFAS 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 short-term investments.
For the three months ended March 31, 2006 and 2005, comprehensive loss was $25.6 million and
$20.1 million, respectively.
10
8. REVENUE RECOGNITION
Revenue under collaborative research and development agreements and grants is 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 and 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. Up-front, nonrefundable
payments for license fees 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. 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. Revenue related to the sales allowance is
recognized based on the related costs incurred to build the sales function.
9. RESEARCH AND DEVELOPMENT EXPENSES
Research and development (R&D) expenses are recognized as incurred and include related
salaries, contractor fees, facilities costs, administrative expenses and allocations of certain
other costs. All such costs are charged to R&D expenses 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, the Company funds R&D, conducted on our behalf, at other companies and
research institutions under agreements, which are generally cancelable. The Company reviews and
accrues clinical trials expense based on work performed. Accrued clinical costs are subject to
revisions as trials progress to completion. Revisions to accruals are recorded in the period in
which the facts that give rise to the revision become known.
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 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, 2005 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, 2005.
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 insomnia, anxiety, depression, various female and
male health disorders, diabetes and other neurological and endocrine related diseases and
disorders. We currently have eight programs in various stages of research and development,
including six programs in clinical development. While we independently develop many of our product
candidates, we have entered into collaborations for three of our programs. Our lead clinical
development program, indiplon, is a drug candidate for the treatment of insomnia. We have submitted
two New Drug Applications (NDAs) to the United States Food and Drug Administration (FDA) with
respect to indiplon. We have funded our operations primarily through private and public offerings
of our common stock and payments received under licensing, collaboration and research and
development agreements. We expect to generate future net losses until one or more of our drug
candidates receive regulatory approval from the FDA and are successfully commercialized.
11
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 (which
affect research and development expense), 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 and grants 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 and 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. Up-front, nonrefundable
payments for license fees 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. Revenue related to the sales force is recognized based on the costs incurred to
initially build the sales function.
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 at
other companies and research institutions under agreements, which are generally cancelable. We
review and accrue clinical trials expenses based on work performed, which relies on estimates of
total hours and 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.
We grant stock options to purchase our common stock to our employees and directors under our
2003 Incentive Stock Plan and certain Employment Commencement Nonstatutory Stock Option Agreements.
We also grant certain employees stock bonuses and restricted stock units under our 2003 Incentive
Stock Plan. Additionally, we have outstanding options that were granted under option plans from
which we no longer make grants. Eligible employees also can purchase shares of our common stock at
85% of the fair market value on the last day of each six-month offering period under our employee
stock purchase plan. The benefits provided under all of these plans are subject to the provisions
of revised Statement of Financial Accounting Standards No. 123 (SFAS 123R), Share-Based Payment,
which we adopted effective January 1, 2006. We elected to use the modified prospective application
in adopting SFAS 123R and therefore have not restated results for prior periods. The valuation
provisions of SFAS 123R apply to new awards and to awards that are outstanding on the adoption date
and subsequently modified or cancelled. Our results of operations for the first quarter of 2006
were impacted by the recognition of non-cash expense related to the fair value of our stock-based
compensation awards. Stock based compensation expense recognized under SFAS 123R for the three
months ended March 31, 2006 was $6.8 million.
Stock option awards and restricted stock units generally vest over a four year and three year
period, respectively, and expense is ratably recognized over those same time periods. However, due
to certain retirement provisions in our stock plans, stock based compensation expense may be
recognized over a shorter period of time, and in some cases the entire stock based compensation
expense may be recognized upon grant of the stock based compensation award.
Employees who are age 55 or older and have five or more years of service with the Company are
entitled to accelerated vesting of all of the unvested stock based compensation awards upon
retirement from the Company. This retirement provision leads to variability in the quarterly
expense amounts recognized under SFAS 123R, and therefore individual stock compensation awards may
impact earnings disproportionately in any individual fiscal quarter.
12
At March 31, 2006, total unrecognized, estimated stock-based compensation expense related to
unvested stock options granted prior to that date was $29.6 million, which is expected to be
recognized over a weighted average period of 2.7 years. Net stock options and restricted stock
units, after forfeitures and cancellations, granted during each of the three months ended March 31,
2006 and 2005 represented 0.6% and 0.8%, respectively, of outstanding shares as of the beginning of
each fiscal quarter. Total stock options and restricted stock units granted during the three months
ended March 31, 2006 and 2005 represented 0.6% and 0.9% of outstanding shares as of the end of each
fiscal quarter, respectively. For more information about our accounting for stock-based
compensation expense, see Note 2 to the Consolidated Condensed Financial Statements in Item 1.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2006 AND 2005
The following table summarizes our primary sources of revenue:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
Ended March 31 |
|
|
|
2006 |
|
|
2005 |
|
|
|
(in thousands) |
|
Revenues under collaboration agreements: |
|
|
|
|
|
|
|
|
Pfizer |
|
$ |
18,463 |
|
|
$ |
10,410 |
|
GlaxoSmithKline |
|
|
1,013 |
|
|
|
1,454 |
|
|
|
|
Total revenue |
|
$ |
19,476 |
|
|
$ |
11,864 |
|
|
|
|
Revenues were $19.5 million for the first quarter of 2006 compared with $11.9 million for the
respective period last year. The increase in revenues for the three months ended March 31, 2006,
compared with the respective period in 2005, is primarily from revenues recognized under our
collaboration agreement with Pfizer, Inc (Pfizer). During the first quarter of 2006 we recognized
$5.9 million from Pfizer in the form of sponsored development funding, $4.4 million resulting from
amortization of up-front license fees, and $8.2 million related to the sales force allowance.
During the first quarter of 2005, we recognized $10.4 million in revenue from Pfizer, $4.0 million
in the form of sponsored development funding, $5.4 million resulting from amortization of up-front
license fees, and $1.0 million related to the sales allowance we received from Pfizer to commence
the building of our sales force. Under the GlaxoSmithKline (GSK) agreement, we recognized $1.0
million during the first quarter of 2006 related to a milestone for clinical advancements in the
CRF program. During the first quarter of 2005, we recognized $1.5 million under the GSK agreement,
which included a $1.5 million milestone for successful completion of the research portion of our
collaboration agreement.
Research and development expenses increased to $27.7 million for the first quarter 2006
compared with $25.6 million for the respective period in 2005. This increase in research and
development expenses is primarily due to personnel costs which have increased by $4.0 million, from
$8.6 million in the first quarter of 2005 to $12.6 million in the first quarter of 2006.
Approximately $1.9 million of this increase in personnel costs is related to the expansion of
research and development activities. Additionally, the adoption of SFAS 123R accounted for
approximately $2.1 million of the increase in research and development personnel expense in 2006.
External development costs for indiplon clinical programs have decreased by $3.2 million from $3.4
million in the first quarter of 2005 to $0.2 million in the first quarter of 2006. This decrease in
indiplon external development costs was offset by increased costs in our other external development
programs. External development spending on our GnRH compound for endometriosis and benign prostatic
hyperplasia increased from $2.0 million in the first quarter of 2005 to $2.7 million in the first
quarter of 2006 and external development spending on Urocortin 2 for congestive heart failure
increased from $0.3 million in the first quarter of 2005 to $1.6 million in the first quarter of
2006. We currently have eight programs in various stages of research and development, including six
programs in clinical development.
Additionally, we expect increases in non-indiplon related research and development expenses to
continue in the future as we advance and build our product portfolio focused on neurological and
endocrine-related diseases and disorders.
13
Sales, general and administrative expenses increased to $19.3 million for the first quarter
2006 compared with $5.6 million during the same period last year. The $13.7 million increase in
expenses from 2005 to 2006 resulted primarily from the activities surrounding the implementation of
our commercialization strategy. Direct costs related to our sales force were approximately $8.0
million in the first quarter of 2006 compared to $0.7 million in the first quarter of 2005. This
increase in sales costs is offset by revenue recognized under our sales force allowance from
Pfizer, which is obligated to pay for and support a 200-person sales force. We began to build our
sales force in the first quarter of 2005 and it is now fully operational and is currently detailing
Pfizers leading antidepressant Zoloft® to psychiatrists, and will detail indiplon to those same
psychiatrists upon approval of indiplon by the FDA. Additionally, non-sales related personnel costs
increased by approximately $6.2 million from the first quarter of 2005 to the first quarter of
2006. This was due primarily to the adoption of SFAS 123R which accounted for approximately $4.7
million of the increase in sales, general and administrative personnel costs. In addition, certain
bonus and deferred compensation expenses were higher in the first quarter of 2006 compared to the
first quarter of 2005.
Other income increased from $0.5 million during the first quarter of 2005 to $1.7 million for
the first quarter of 2006. The increase resulted primarily from higher interest income due to
higher interest rates on our investments.
Net loss for the first quarter of 2006 was $25.9 million, or $0.69 net loss per share,
compared to $18.8 million, or $0.51 net loss per share, for the same period in 2005. The primary
reason for the $7.1 million increase in net loss is the adoption of SFAS 123R which resulted in an
additional $6.8 million in expense in the first quarter of 2006. Profitability for 2006 is
dependent upon the approval of our NDA for indiplon by the FDA, and acceptance of indiplon by
prescribers and consumers; however, fluctuations in the quarterly results may occur due to the
timing of milestone achievements related to approval of indiplon, by the FDA, under our
collaboration agreement with Pfizer.
On April 14, 2005, we submitted an NDA to the FDA seeking clearance to market indiplon
capsules for the treatment of insomnia. On May 26, 2005, we submitted an NDA to the FDA seeking
clearance to market indiplon tablets for the treatment of insomnia. The FDA accepted both of these
NDA submissions and established the Prescription Drug User Fee Act (PDUFA) dates as February 15,
2006 for the capsule NDA filing and March 27, 2006 for the tablet NDA filing. The PDUFA action date
is the date by which the FDA is expected to have completed its review of the submissions and will
document its assessment through the issuance of an action letter. In January 2006, the FDA
requested submission of results from the driving study we completed in late 2005. We submitted the
final report of this study to the agency as requested. Based on feedback from the FDA, we
anticipate labeling that includes data from this study, which showed no impairment in next-day
driving performance. In addition, the FDA has stated its intent to issue a combined package insert
in lieu of individual package inserts for the capsule and tablet NDA. To complete review of the
driving study and the combined package insert, the FDA has advised us that the PDUFA dates for the
capsule and tablet NDAs have been moved to May 15, 2006 and June 27, 2006, respectively. However,
the FDA has committed to an action by May 15, 2006 for both NDAs.
To date, the Companys revenues have come 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 of one period are not
predictive of future periods. Collaborations accounted for all of our revenue for the quarters
ended March 31, 2006 and 2005, respectively.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 2006, our cash, cash equivalents, and short-term investments totaled $264.5
million compared with $273.1 million at December 31, 2005. The decrease in cash balances at March
31, 2006 resulted primarily from our net loss of $25.9 million
offset by a non cash share-based compensation charge of
$6.8 million and an increase in additional
paid in capital of $13.9 million as a result of stock option exercises.
Net cash used in operating activities during the first quarter of 2006 was $20.4 million
compared with $26.0 million during the same period last year.
This fluctuation resulted primarily from the prepayment by Pfizer of
$8.2 million sales force allowance for the second quarter of 2006 and
a decrease in development expense accruals of $2.7 million.
14
Net cash provided by investing activities during the first quarter of 2006 was $59.4 million
compared to $10.4 million for the first quarter of 2005. 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. In addition, purchases of property and equipment decreased from $1.5 million
in 2005 to $0.7 million in 2006. Capital equipment purchases for 2006 are expected to be
approximately $7.5 million.
Net cash provided by financing activities during the first quarter of 2006 was $12.5 million
compared with net cash used in financing activities of ($0.9) million for the respective period
last year. This fluctuation resulted primarily from cash proceeds from the issuance of common stock
under option programs which increased by $13.1 million in the current quarter compared to the same
quarter last year. We expect similar fluctuations to occur throughout the year, as the amount and
frequency of stock-related transactions are dependent upon the market performance of our common
stock.
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.
CAUTION ON FORWARD-LOOKING STATEMENTS
Our business is subject to significant risks, including but not limited to, the risks inherent
in our research and development activities, including the successful continuation of our strategic
collaborations, the successful completion of clinical trials, the lengthy, expensive and uncertain
process of seeking regulatory approvals, uncertainties associated both with the potential
infringement of patents and other intellectual property rights of third parties, and with obtaining
and enforcing our own patents and patent rights, uncertainties regarding government reforms and of
product pricing and reimbursement levels, technological change and competition, manufacturing
uncertainties and dependence on third parties. Even if our product candidates appear promising at
an early stage of development, they may not reach the market for numerous reasons. Such reasons
include the possibilities that the product will be ineffective or unsafe during clinical trials,
will fail to receive necessary regulatory approvals, will be difficult to manufacture on a large
scale, will be uneconomical to market or will be precluded from commercialization by proprietary
rights of third parties. For more information about the risks we face, see Risk Factors included
in Part II, Item IA of this report.
INTEREST RATE RISK
We are exposed to interest rate risk on our short-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
15
our exposure due to adverse shifts in
interest rates, we invest in short-term securities and ensure that the maximum average maturity of
our investments does not exceed 40 months. If a 10% change in interest rates were to have occurred
on March 31, 2006, 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, we have
concluded that we do not have a material financial market risk exposure.
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 the Companys
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 controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
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PART II: OTHER INFORMATION
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, 2005 other than revisions to the
first risk factor and the inclusion of new second and third risk factors to provide additional
information regarding the FDA approval process for, and factors that could impact the timing of
commercialization of, indiplon tablets and capsules and revisions to the fourth risk factor to
provide additional information about the possible impact on us of the expiration of our rights to
co-promote Zoloft®. 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 near-term success is dependent on the success of our lead product candidate, indiplon, and we
may not receive regulatory approvals for it or our other product candidates or approvals may be
delayed.
Based on the results of preclinical studies and Phase I, Phase II and Phase III clinical
trials on indiplon, as well as a non-clinical data package related to indiplon manufacturing,
formulation and commercial product development, we assembled and filed with the United States Food
and Drug Administration (FDA) New Drug Applications (NDAs) for both indiplon capsules and indiplon
tablets. Since the filing of the NDAs, we have engaged in an iterative process with the FDA in
which the FDA has raised questions and comments about the data and information included in our NDAs
to which we have responded. As part of the FDAs review of the NDAs, the FDA has inquired about
data analyses included in the NDAs, requested clarification of scientific and biostatical
procedures for non-clinical and clinical endpoints and requested re-analyses of subsets of data
submitted. While we believe that the complete data package included in both of the NDAs supports
the approvals and the labeling we requested, we cannot provide any assurances that the FDA will
accept or be satisfied with our responses to their inquires and requests for further analyses or
that it will not otherwise find either or both of our NDAs incomplete or insufficient. In such a
case, the FDA could refuse to approve one or both NDAs. If the FDA refuses to approve the NDAs for
any reason, our business and reputation would be harmed and our stock price would decline.
In addition, even if our indiplon NDAs are 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.
If the FDA issues an approvable or not approvable letter with respect to either or both of
our NDAs, our business and reputation would be harmed and our stock price would decline.
Once an NDA is accepted for filing, the FDA will review and act upon the application in
accordance with its established performance goals for priority and standard applications under the
Prescription Drug User Fee Act (PDUFA). The FDAs response to an NDA based on these PDUFA
performance goals consists of an approval letter, approvable letter or not approvable letter,
also referred to as an action letter or response letter. An approval letter states that the drug
is approved. An approvable letter is issued if the application substantially meets the FDAs
requirements and can be approved if certain conditions are met or additional information is
provided. A not approvable letter states that the application may not be approved and describes
the deficiencies that must be addressed in order for the product to be approved, which could
include, for example, new analyses of previously submitted data or conduct of an additional
clinical trial or trials. The FDA has set May 15, 2006 as the date by which it intends to take
action on our indiplon capsule NDA. This date is known as the PDUFA date. While the PDUFA date
for the tablet formulation of indiplon is June 27, 2006, the FDA has informed us that it intends to
take action on both the capsule and tablet formulations of indiplon on May 15, 2006. If the FDA
does not approve our NDAs on the action date and instead issues an approvable or not approvable
letter, commercialization and launch of indiplon will be delayed until we satisfy any conditions
set by the FDA. If the FDA requests that we
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submit additional data, the FDA could extend the review period for up to an additional six
months from the time the new data are submitted. If an additional clinical trial is required, a
much longer delay would be anticipated. Any such delay could harm our business and reputation and
cause our stock price to decline.
Even if we receive an approval letter for indiplon or any other product, we may be unable to
commercialize such products immediately upon receipt of such letter.
Commercialization of a product for which we have received an approval letter from the FDA
could be delayed for a number of reasons, some which are outside of our control, including delays
in the FDAs issuance of approvals for our trademarks or delays in the completion of required
procedures by agencies other than the FDA, such as the Drug Enforcement Administration (DEA). For
example, one of our competitors received an approval letter from the FDA for its proprietary
product. In connection with the approval, the FDA recommended that the competitors product be
classified as a Schedule IV controlled substance by the DEA. However, because the Federal
governments administrative process for formally classifying the product as a Schedule IV
controlled substance was not yet complete, the competitors product launch was delayed several
months. Indiplon, like the competitors product, and like all non-benzodiazepine hypnotics, is
expected to be a Schedule IV controlled substance requiring classification by the DEA. There can be
no assurance that we will receive DEA scheduling promptly. If we are unable to commercialize
indiplon promptly after receipt of an approval letter, our business and financial position may be
materially adversely affected due to reduced revenue from product sales during the period that
commercialization is delayed. In addition, the exclusivity period, or the time during which the
FDA will prevent generic pharmaceuticals from introducing a generic copy of the product, begins to
run upon receipt of the approval letter from the FDA and, therefore, to the extent we are unable
to commercialize a product upon receipt of an approval letter, our long-term product sales and
revenues could be adversely affected.
We expect to rely on our collaboration with Pfizer for the funding of the completion of our
indiplon clinical program and for commercialization of indiplon.
Pfizer has agreed to:
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fund substantially all third-party costs related to future indiplon development,
manufacturing and commercialization activities; |
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fund a 200-person Neurocrine sales force that will initially promote Zoloft® and, upon
approval of the indiplon NDAs, will co-promote indiplon in the United States; |
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be responsible for obtaining all regulatory approvals outside of the United States and
regulatory approvals in the United States after approval of the first indiplon NDA; and |
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be responsible for sales and marketing of indiplon worldwide. |
While our agreement with Pfizer requires them to use commercially reasonable efforts in the
development and commercialization of indiplon, we cannot control the amount and timing of resources
Pfizer may devote to our collaboration in the United States nor can we control when Pfizer will
seek regulatory approvals outside of the United States. In addition, if Pfizers development
activities in pursuing new indications and uses of indiplon are not successful or if Pfizers sales
and marketing activities for indiplon are not effective, indiplon sales and our business may be
harmed.
Under our agreement with Pfizer, our rights to co-promote Zoloft® will terminate upon
expiration of Zoloft® patent protection on June 30, 2006. If we do not receive FDA approval of
indiplon tablets prior to this expiration, Pfizer may seek to suspend further funding of the sales
force until such approval. In this event, we would seek to obtain rights to co-promote another
Pfizer product or to enter into a co-promotion arrangement with another party or would focus our
sales force on other activities. We cannot assure you that we would be able to enter into
alternative co-promotion or co-detailing arrangements on a timely basis or at all.
Decisions within our collaboration are made within a series of joint committees comprised of
Neurocrine and Pfizer representatives. In the event of disagreement at the committee level, the
agreement provides for elevation of the issue to a joint steering committee and thereafter to
senior executives at both companies. The agreement provides that
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certain decisions are Neurocrine
decisions, certain decisions are Pfizer decisions and certain decisions require
consensus among both parties before any action can be taken. We face the risk that decisions
may be delayed as a result of this resolution process. Pursuant to our agreement, as a result of
certain events, some decisions previously designated as Neurocrine decisions have become Pfizer
decisions.
Pfizer may terminate the collaboration at any time upon 180-days written notice, subject to
payment of specified amounts related to ongoing clinical development activities. If Pfizer elected
to terminate the collaboration prior to FDA approval, we would be responsible for regulatory and
commercialization expenses while we seek another partner to assist us in the worldwide development
and commercialization of indiplon. This could cause delays in obtaining marketing approvals and
sales, and negatively impact our business. If Pfizer elects to terminate the collaboration after
receipt of FDA approval and we would be forced to fund the Neurocrine sales force and/or seek new
marketing partners for indiplon, we would lose our rights to co-promote Zoloft® (if such rights
have not already expired). This could lead to loss of sales and negatively impact our business. In
the event the collaboration is terminated by Pfizer, we may not be successful in finding another
collaboration partner on favorable terms, or at all, and any failure to obtain a new partner on
favorable terms could adversely affect indiplon development and commercialization and our business.
Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates,
which could prevent or significantly delay their regulatory approval.
Any failure or substantial delay in completing clinical trials for our product candidates may
severely harm our business. 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. We have submitted NDAs based on the results of our
clinical trials in our indiplon development program for insomnia. This is our most advanced
clinical program and represents a significant portion of our total clinical development activities
and expenditures, to date. If the FDA determines that we have failed to demonstrate that indiplon
is safe and efficacious for the targeted patient populations or if the FDA does not approve the
proposed indiplon product labeling, our business and reputation would be harmed and our stock price
would be negatively affected.
In connection with the clinical trials of indiplon and our other product candidates, we face the
risks that:
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the product 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 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, we announced in March 2006 that the results of our Phase II clinical trial using
our altered peptide ligand (APL) technology for Multiple Sclerosis (MS) did not meet its primary
endpoint and demonstrate efficacy, although the product was safe and well tolerated. Based on these
results, we discontinued the development of our APL-MS program.
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.
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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 $22.2
million and $45.8 million for the years ended December 31, 2005 and 2004, respectively. As a result
of ongoing operating losses, we had an accumulated deficit of $300.1 million and $278.0 million as
of December 31, 2005 and 2004, respectively. We were not profitable for the year ended December 31,
2005. Profitability in 2006 is contingent upon the timing of the approval of our NDA filings for
indiplon by the FDA, and acceptance of indiplon by prescribers and consumers. 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.
We depend on continuing our current strategic alliances and developing additional strategic
alliances to develop and commercialize our product candidates.
We depend upon our corporate collaborators to provide adequate funding for a number of our
programs. Under these arrangements, our corporate collaborators are 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. |
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 Pfizer and GlaxoSmithKline.
Because we rely heavily on our corporate collaborators, the development of our projects would be
substantially delayed if our collaborators:
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fail to select a compound that we have discovered for subsequent development into marketable products; |
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fail to gain the requisite regulatory approvals of these products; |
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do not successfully commercialize products that we originate; |
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do not conduct their collaborative activities in a timely manner; |
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do not devote sufficient time and resources to our partnered programs or potential products; |
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terminate their alliances with us; |
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develop, either alone or with others, products that may compete with our products; |
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dispute our respective allocations of rights to any products or technology developed
during our collaborations; or |
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merge with a third party that may wish to terminate the collaboration. |
These issues and possible disagreements with our 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.
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. 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, Urocortin 2, which we license from Research Development
Foundation and the adenosine 2A receptor antagonist we license from Almirall Prodesfarma, S.A.
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 GnRH program. If we were to default
on our obligations under any of our product licenses, we could lose some or all of our rights to
develop, market and sell the product. 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 and, while we expect indiplon to be commercially available in 2006, there is the
possibility that it will not be commercially available at all. 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 or fail to achieve market acceptance. |
If any of our products encounters any of these potential problems, we may never successfully
market that product.
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Since indiplon is our most advanced product program, our business and reputation would be
particularly harmed, and our stock price likely would be harmed, if we fail to receive necessary
regulatory approvals on a timely basis or achieve market acceptance.
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. In preparation
for marketing indiplon upon approval by the FDA, we have hired staff with experience in
pharmaceutical sales and marketing. We will rely on Pfizer to co-promote indiplon with us in the
United States and rely exclusively on Pfizer to market indiplon outside of the United States. We
will also rely on Pfizer to provide distribution, customer service, order entry, shipping, billing,
customer reimbursement assistance and managed care sales support related to indiplon.
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. If Pfizers
sales force or our sales force do not successfully promote indiplon to prescribers, sales of
indiplon and our royalty revenues will suffer. Further, if Pfizer does not provide the other
services it has agreed to provide in a satisfactory manner, sales of indiplon will be harmed and
our reputation may be damaged.
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, or 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 will delay 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.
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 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 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; |
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drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA,
the DEA, and corresponding state 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
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if the primary contract manufacturer for indiplon should be unable to manufacture
indiplon for any reason, or should fail to receive FDA or DEA approval, commercialization
of indiplon could be delayed, which would delay indiplon sales and negatively impact our
business. |
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.
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 and effective, we may not recover
our investment.
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,
including preclinical testing and clinical trials of our product candidates, for operating expenses
and to pursue regulatory approvals for product candidates. We also 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. 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.
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 National
Market rules, are creating uncertainty for companies such as ours. These new or changed laws,
regulations and standards are subject to varying interpretations
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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 and our external auditors audit of
that assessment 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 $34
per share to approximately $73 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; |
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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. |
If any of the risks described in this Risk Factors section occurs, it could cause our stock
price to fall dramatically and may expose us to class action securities lawsuits which, even if
unsuccessful, would be costly to defend and a distraction to management.
25
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.
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 insomnia, anxiety, depression, various female and male disorders, diabetes and other
neuro-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; |
26
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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. |
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, by 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 collaboration partners with respect to technologies used in
potential products. We are aware of a patent application controlled by another company, which if
granted in its broadest scope and held to be valid, could
impact the commercialization of our modified release insomnia formulation in the United States
unless we obtain a license, which may not be available to us. Based on information available from
the USPTO, we have learned that the
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USPTO has examined the pending claims of this application two
times and that both times it has rejected all the pending claims. We are also aware that the
corresponding patent application in Europe has issued as a patent, and we have filed an opposition
against the issued European patent. Even if we were to prevail, any litigation could be costly and
time-consuming and could divert the attention of our management and key personnel from our business
operations. If a patent infringement suit were brought against us or our collaboration partners,
we or our collaboration partners 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 collaboration partners 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 collaboration partners 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.
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.
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(A) EXHIBITS.
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3.1
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Restated Certificate of Incorporation (1) |
3.2
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Bylaws (1) |
3.3
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Certificate of Amendment of Bylaws (1) |
3.4
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Certificate of Amendment of Bylaws dated May 28, 2004 (2) |
10.1
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Neurocrine Biosciences, Inc. Amended and Restated Employee Stock Purchase Plan |
10.2
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Neurocrine Biosciences, Inc. 2003 Incentive Stock Plan, as amended
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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.
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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.
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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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Incorporated by reference to the Companys Report on Form 10-Q filed on August 9, 2004 |
*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.
(B) REPORTS ON FORM 8-K.
On January 19, 2006, the Company reported under Item 1.01 amendments to the Nonqualified
Deferred Compensation Plan and the 2003 Incentive Stock Plan.
On January 25, 2006, the Company reported under Item 1.01 the bonus program for 2006 and
bonus payouts under the 2005 Bonus Plan.
On February 2, 2006, the Company reported under Item 1.02 the resignation of Robert Little,
Senior Vice President Commercial Operations.
On February 13, 2006, the Company reported under Items 1.01 and 9.01 an amendment to the
Companys agreement with Glaxo Group Limited, a subsidiary of GlaxoSmithKline.
On March 13, 2006 the Company reported under Items 8.01 and 9.01 an update to the Companys
drug development program including the discontinuing of the development of the APL program
for Multiple Sclerosis.
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: April 28, 2006
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/s/ Paul W. Hawran |
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Paul W. Hawran |
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Executive Vice President and |
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Chief Financial Officer |
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(Duly authorized Officer and |
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Principal Financial Officer) |
29
exv10w1
EXHIBIT 10.1
NEUROCRINE BIOSCIENCES, INC.
AMENDED
AND RESTATED EMPLOYEE STOCK PURCHASE PLAN
(as amended May 24, 2001, June 15, 2001 and November 7, 2005)
The following constitute the provisions of the Employee Stock Purchase Plan of Neurocrine
Biosciences, Inc.
1. Purpose. The purpose of the Plan is to provide employees of the Company and its
Designated Subsidiaries with an opportunity to purchase Common Stock of the Company through
accumulated payroll deductions. It is the intention of the Company to have the Plan qualify as an
Employee Stock Purchase Plan under Section 423 of the Internal Revenue Code of 1986, as amended.
The provisions of the Plan, accordingly, shall be construed so as to extend and limit participation
in a manner consistent with the requirements of that section of the Code.
2. Definitions.
(a) Board shall mean the Board of Directors of the Company.
(b) Code shall mean the Internal Revenue Code of 1986, as amended.
(c) Common Stock shall mean the Common Stock of the Company.
(d) Company shall mean Neurocrine Biosciences, Inc. and any Designated Subsidiary of
the Company.
(e) Compensation shall mean all regular straight time gross earnings but shall
exclude variable compensation for field sales personnel, incentive bonuses, overtime, shift
premium, lead pay and automobile allowances and other compensation.
(f) Designated Subsidiaries shall mean the Subsidiaries which have been designated
by the Board from time to time in its sole discretion as eligible to participate in the Plan.
(g) Employee shall mean any individual who is an Employee of the Company for tax
purposes whose customary employment with the Company is at least twenty (20) hours per week and
more than five (5) consecutive months in any calendar year. For purposes of the Plan, the
employment relationship shall be treated as continuing intact while the individual is on sick leave
or other leave of absence approved by the Company. Where the period of leave exceeds 90 days and
the individuals right to reemployment is not guaranteed either by statute or by contract, the
employment relationship will be deemed to have terminated on the 91st day of such leave.
(h) Enrollment Date shall mean the first day of each Offering Period.
(i) Exercise Date shall mean the last Trading Day of each Purchase Period. The
first Exercise Date shall be the last Trading Day on or before December 31, 1996.
(j) Fair Market Value shall mean, as of any date, the value of Common Stock
determined as follows:
(1) If the Common Stock is listed on any established stock exchange or a national market
system, including without limitation the Nasdaq National Market of the National Association of
Securities Dealers, Inc. Automated Quotation (NASDAQ) System, its Fair Market Value shall be the
closing sale price for the Common Stock (or the mean of the closing bid and asked prices, if no
sales were reported), as quoted on such exchange (or the exchange with the greatest volume of
trading in Common Stock) or system on the date of such determination, as reported in The Wall
Street Journal or such other source as the Board deems reliable; or
(2) If the Common Stock is quoted on the NASDAQ System (but not on the National Market
thereof) or is regularly quoted by a recognized securities dealer but selling prices are not
reported, its Fair Market Value shall be the mean of the closing bid and asked prices for the
Common Stock on the date of such determination, as reported in The Wall Street Journal or such
other source as the Board deems reliable; or
(3) In the absence of an established market for the Common Stock, the Fair Market Value
thereof shall be determined in good faith by the Board.
(4) For purposes of the Enrollment Date of the first Offering Period, the Fair Market Value
of the Common Stock shall be the Price to Public as set forth in the final prospectus filed with
the Securities and Exchange Commission pursuant to Rule 424 under the Securities Act of 1933, as
amended.
(k)
Offering Period shall mean the period of
approximately six (6) months during
which an option granted pursuant to the Plan may be exercised, commencing on the first Trading Day
on or after January 1 and July 1 of each year and terminating on the last Trading Day in the
periods ending up to six-months later (provided, however, that any employee with an Offering Period
beginning before January 1, 2001, shall have an initial Offering Period of up to two-years). The
first day of the first Offering Period shall be the effective date of the Companys initial public
offering of its Common Stock that is registered with the Securities and Exchange Commission. The
duration and timing of Offering Periods may be changed pursuant to Section 4 of this Plan.
(l) Plan shall mean this Neurocrine Biosciences, Inc. Employee Stock Purchase
Plan as amended hereby.
(m) Purchase Price shall mean an amount equal to 85% of the Fair Market Value of a
share of Common Stock on the Enrollment Date or on the Exercise Date, whichever is lower. For
purposes of Offering Periods commencing on or after January 1, 2006, Purchase Price shall mean an
amount equal to 85% of the Fair Market Value of a share of Common Stock on the Exercise Date.
(n) Purchase Period shall mean the approximately six-month period commencing after
one Exercise Date and ending with the next Exercise Date, except that the first Purchase Period
-2-
of any Offering Period shall begin on the Enrollment Date and end with the next Exercise Date.
The first Purchase Period of the first Offering Period shall begin on the first day of the first
Offering Period and shall end on the first Exercise Date.
(o) Reserves shall mean the number of shares of Common Stock covered by each option
under the Plan which have not yet been exercised and the number of shares of Common Stock which
have been authorized for issuance under the Plan but not yet placed under option.
(p) Subsidiary shall mean a corporation, domestic or foreign, of which not less than
50% of the voting shares are held by the Company or a Subsidiary, whether or not such corporation
now exists or is hereafter organized or acquired by the Company or a Subsidiary.
(q) Trading Day shall mean a day on which national stock exchanges and the National
Association of Securities Dealers Automated Quotation (NASDAQ) System are open for trading.
3. Eligibility.
(a) Any Employee (as defined in Section 2(g)), who shall be employed by the Company on a given
Enrollment Date shall be eligible to participate in the Plan.
(b) Any provisions of the Plan to the contrary notwithstanding, no Employee shall be granted
an option under the Plan (i) if, immediately after the grant, such Employee (or any other person
whose stock would be attributed to such Employee pursuant to Section 424(d) of the Code) would own
capital stock of the Company and/or hold outstanding options to purchase such stock possessing five
percent (5%) or more of the total combined voting power or value of all classes of the capital
stock of the Company or of any Subsidiary, or (ii) if such option permits his or her rights to
purchase stock under all employee stock purchase plans of the Company and its Subsidiaries to
accrue at a rate which exceeds twenty-five thousand dollars ($25,000) worth of stock (determined at
the fair market value of the shares at the time such option is granted) for each calendar year in
which such option is outstanding at any time.
4. Offering Periods. The Plan shall be implemented by consecutive Offering
Periods with a new Offering Period beginning on the first Trading Day on or after July 1 and
January 1, or on such other date as the Board shall determine, and continuing thereafter
until terminated in accordance with Section 19 hereof. The first day of the first Offering Period
shall be the effective date of the Companys initial public offering of its Common Stock that is
registered with the Securities and Exchange Commission. The Board shall have the power to change
the duration of Offering Periods (including the commencement dates thereof) with respect to future
offerings without stockholder approval if such change is announced at least five (5) days prior to
the scheduled beginning of the first Offering Period to be affected thereafter.
-3-
5. Participation.
(a) An eligible Employee may become a participant in the Plan by completing a subscription
agreement authorizing payroll deductions in the form of Exhibit A to this Plan and filing it with
the Companys payroll office prior to the applicable Enrollment Date.
(b) Payroll deductions for a participant shall commence on the first payroll date following
the Enrollment Date and shall end on the last payroll date in the Offering Period to which such
authorization is applicable, unless sooner terminated by the participant as provided in Section 10
hereof.
6. Payroll Deductions.
(a) At the time a participant files his or her subscription agreement, he or she shall elect
to have payroll deductions made on each pay day during the Offering Period in an amount not
exceeding fifteen percent (15%) of the Compensation which he or she receives on each pay day during
the Offering Period, and the aggregate of such payroll deductions during the Offering Period shall
not exceed fifteen percent (15%) of the participants Compensation during said Offering Period.
(b) All payroll deductions made for a participant shall be credited to his or her account
under the Plan and will be withheld in whole percentages only. A participant may not make any
additional payments into such account.
(c) A participant may discontinue his or her participation in the Plan as provided in Section
10 hereof, or may increase or decrease the rate of his or her payroll deductions during the
Offering Period by completing or filing with the Company a new subscription agreement authorizing a
change in payroll deduction rate. The Board may, in its discretion, limit the number of
participation rate changes during any Offering Period. The change in rate shall be effective with
the first full payroll period following five (5) business days after the Companys receipt of the
new subscription agreement unless the Company elects to process a given change in participation
more quickly. A participants subscription agreement shall remain in effect for successive
Offering Periods unless terminated as provided in Section 10 hereof.
(d) Notwithstanding the foregoing, to the extent necessary to comply with Section 423(b)(8) of
the Code and Section 3(b) hereof, a participants payroll deductions may be decreased to 0% at such
time during any Purchase Period which is scheduled to end during the current calendar year (the
Current Purchase Period) that the aggregate of all payroll deductions which were previously used
to purchase stock under the Plan in a prior Purchase Period which ended during that calendar year
plus all payroll deductions accumulated with respect to the Current Purchase Period equal $21,250.
Payroll deductions shall recommence at the rate provided in such participants subscription
agreement at the beginning of the first Purchase Period which is scheduled to end in the following
calendar year, unless terminated by the participant as provided in Section 10 hereof.
(e) At the time the option is exercised, in whole or in part, or at the time some or all of
the Companys Common Stock issued under the Plan is disposed of, the participant must make adequate
provision for the Companys federal, state, or other tax withholding obligations, if any,
-4-
which arise upon the exercise of the option or the disposition of the Common Stock. At any
time, the Company may, but will not be obligated to, withhold from the participants compensation
the amount necessary for the Company to meet applicable withholding obligations, including any
withholding required to make available to the Company any tax deductions or benefits attributable
to sale or early disposition of Common Stock by the Employee.
7. Grant of Option. On the Enrollment Date of each Offering Period, each eligible Employee
participating in such Offering Period shall be granted an option to purchase on each Exercise Date
during such Offering Period (at the Purchase Price) up to a number of shares of the Companys
Common Stock determined by dividing such Employees payroll deductions accumulated prior to such
Exercise Date and retained in the Participants account as of the Exercise Date by the Purchase
Price; provided, that in no event shall an Employee be permitted to purchase during each Purchase
Period more than a number of Shares determined by dividing $12,500 by the Fair Market Value of a
share of the Companys Common Stock on the Enrollment Date; and provided, further, that such
purchase shall be subject to the limitations set forth in Sections 3(b) and 12 hereof. Exercise of
the option shall occur as provided in Section 8 hereof, unless the participant has withdrawn
pursuant to Section 10 hereof, and shall expire on the last day of the Offering Period.
8. Exercise of Option. Unless a participant withdraws from the Plan as provided in Section
10 hereof, his or her option for the purchase of shares will be exercised automatically on the
Exercise Date, and the maximum number of full shares subject to the option shall be purchased for
such participant at the Purchase Price with the accumulated payroll deductions in his or her
account. No fractional shares will be purchased; any payroll deductions accumulated in a
participants account which are not sufficient to purchase a full share shall be retained in the
participants account for the subsequent Purchase Period or Offering Period, subject to earlier
withdrawal by the participant as provided in Section 10 hereof. Any other monies left over in a
participants account after the Exercise Date shall be returned to the participant. During a
participants lifetime, a participants option to purchase shares hereunder is exercisable only by
him or her.
9. Delivery. As promptly as practicable after each Exercise Date on which a purchase of
shares occurs, the Company shall arrange the delivery to each participant, as appropriate, of a
certificate representing the shares purchased upon exercise of his or her option.
10. Withdrawal; Termination of Employment.
(a) A participant may withdraw all but not less than all the payroll deductions credited to
his or her account and not yet used to exercise his or her option under the Plan at any time by
giving written notice to the Company in the form of Exhibit B to this Plan. All of the
participants payroll deductions credited to his or her account will be paid to such participant
promptly after receipt of notice of withdrawal and such participants option for the Offering
Period will be automatically terminated, and no further payroll deductions for the purchase of
shares will be made for such Offering Period. If a participant withdraws from an Offering Period,
payroll deductions will not resume at the beginning of the succeeding Offering Period unless the
participant delivers to the Company a new subscription agreement.
-5-
(b) Upon a participants ceasing to be an Employee (as defined in Section 2(g) hereof), for
any reason, he or she will be deemed to have elected to withdraw from the Plan and the payroll
deductions credited to such participants account during the Offering Period but not yet used to
exercise the option will be returned to such participant or, in the case of his or her death, to
the person or persons entitled thereto under Section 14 hereof, and such participants option will
be automatically terminated. The preceding sentence notwithstanding, a participant who receives
payment in lieu of notice of termination of employment shall be treated as continuing to be an
Employee for the participants customary number of hours per week of employment during the period
in which the participant is subject to such payment in lieu of notice.
11. Interest. No interest shall accrue on the payroll deductions of a participant in
the Plan.
12. Stock.
(a) The maximum number of shares of the Companys Common Stock which shall be made available
for sale under the Plan shall be six hundred and twenty five
thousand (625,000), subject to
adjustment upon changes in capitalization of the Company as provided in Section 18 hereof. If, on
a given Exercise Date, the number of shares with respect to which options are to be exercised
exceeds the number of shares then available under the Plan, the Company shall make a pro rata
allocation of the shares remaining available for purchase in as uniform a manner as shall be
practicable and as it shall determine to be equitable.
(b) The participant will have no interest or voting right in shares covered by his option
until such option has been exercised.
(c) Shares to be delivered to a participant under the Plan will be registered in the name of
the participant or in the name of the participant and his or her spouse.
13. Administration.
(a) Administrative Body. The Plan shall be administered by the Board or a committee
of members of the Board appointed by the Board. The Board or its committee shall have full and
exclusive discretionary authority to construe, interpret and apply the terms of the Plan, to
determine eligibility and to adjudicate all disputed claims filed under the Plan. Every finding,
decision and determination made by the Board or its committee shall, to the full extent permitted
by law, be final and binding upon all parties.
(b) Rule 16b-3 Limitations. Notwithstanding the provisions of Subsection (a) of this
Section 13, in the event that Rule 16b-3 promulgated under the Securities Exchange Act of 1934, as
amended (the Exchange Act), or any successor provision (Rule 16b-3) provides specific
requirements for the administrators of plans of this type, the Plan shall be only administered by
such a body and in such a manner as shall comply with the applicable requirements of Rule 16b-3.
Unless permitted by Rule 16b-3, no discretion concerning decisions regarding the Plan shall be
afforded to any committee or person that is not disinterested as that term is used in Rule 16b-3.
14. Designation of Beneficiary.
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(a) A participant may file a written designation of a beneficiary who is to receive any shares
and cash, if any, from the participants account under the Plan in the event of such participants
death subsequent to an Exercise Date on which the option is exercised but prior to delivery to such
participant of such shares and cash. In addition, a participant may file a written designation of
a beneficiary who is to receive any cash from the participants account under the Plan in the event
of such participants death prior to exercise of the option. If a participant is married and the
designated beneficiary is not the spouse, spousal consent shall be required for such designation to
be effective.
(b) Such designation of beneficiary may be changed by the participant at any time by written
notice. In the event of the death of a participant and in the absence of a beneficiary validly
designated under the Plan who is living at the time of such participants death, the Company shall
deliver such shares and/or cash to the executor or administrator of the estate of the participant,
or if no such executor or administrator has been appointed (to the knowledge of the Company), the
Company, in its discretion, may deliver such shares and/or cash to the spouse or to any one or more
dependents or relatives of the participant, or if no spouse, dependent or relative is known to the
Company, then to such other person as the Company may designate.
15. Transferability. Neither payroll deductions credited to a participants account
nor any rights with regard to the exercise of an option or to receive shares under the Plan may be
assigned, transferred, pledged or otherwise disposed of in any way (other than by will, the laws of
descent and distribution or as provided in Section 14 hereof) by the participant. Any such attempt
at assignment, transfer, pledge or other disposition shall be without effect, except that the
Company may treat such act as an election to withdraw funds from an Offering Period in accordance
with Section 10 hereof.
16. Use of Funds. All payroll deductions received or held by the Company under the
Plan may be used by the Company for any corporate purpose, and the Company shall not be obligated
to segregate such payroll deductions.
17. Reports. Individual accounts will be maintained for each participant in the Plan.
Statements of account will be given to participating Employees at least annually, which statements
will set forth the amounts of payroll deductions, the Purchase Price, the number of shares
purchased and the remaining cash balance, if any.
18. Adjustments Upon Changes in Capitalization, Dissolution, Liquidation, Merger or Asset
Sale.
(a)
Changes in Capitalization. Subject to any required action by the stockholders of
the Company, the Reserves as well as the price per share of Common Stock covered by each option
under the Plan which has not yet been exercised shall be proportionately adjusted for any increase
or decrease in the number of issued shares of Common Stock resulting from a stock split, reverse
stock split, stock dividend, combination or reclassification of the Common Stock, or any other
increase or decrease in the number of shares of Common Stock effected without receipt of
consideration by the Company; provided, however, that conversion of any convertible securities of
the Company shall not be deemed to have been effected without receipt of consideration. Such
adjustment shall be made by the Board, whose determination in that respect shall be final, binding
and conclusive. Except as
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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
option.
(b) Dissolution or Liquidation. In the event of the proposed dissolution or
liquidation of the Company, the Offering Periods will terminate immediately prior to the
consummation of such proposed action, unless otherwise provided by the Board.
(c) Merger or Asset Sale. In the event of a proposed sale of all or substantially all
of the assets of the Company, or the merger of the Company with or into another corporation, each
option under the Plan shall be assumed or an equivalent option shall be substituted by such
successor corporation or a parent or subsidiary of such successor corporation, unless the Board
determines, in the exercise of its sole discretion and in lieu of such assumption or substitution,
to shorten the Offering Periods then in progress by setting a new Exercise Date (the New Exercise
Date). If the Board shortens the Offering Periods then in progress in lieu of assumption or
substitution in the event of a merger or sale of assets, the Board shall notify each participant in
writing, at least ten (10) business days prior to the New Exercise Date, that the Exercise Date for
his option has been changed to the New Exercise Date and that his option will be exercised
automatically on the New Exercise Date, unless prior to such date he has withdrawn from the
Offering Period as provided in Section 10 hereof. For purposes of this paragraph, an option
granted under the Plan shall be deemed to be assumed if, following the sale of assets or merger,
the option confers the right to purchase, for each share of option stock subject to the option
immediately prior to the sale of assets or merger, the consideration (whether stock, cash or other
securities or property) received in the sale of assets or merger by holders of Common Stock for
each share of Common Stock held on the effective date of the transaction (and if such holders were
offered a choice of consideration, the type of consideration chosen by the holders of a majority of
the outstanding shares of Common Stock); provided, however, that if such consideration received in
the sale of assets or merger was not solely common stock of the successor corporation or its parent
(as defined in Section 424(e) of the Code), the Board may, with the consent of the successor
corporation, provide for the consideration to be received upon exercise of the option 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 and the sale of assets or merger.
19. Amendment or Termination.
(a) The Board may at any time and for any reason terminate or amend the Plan. Except as
provided in Section 18 hereof, no such termination can affect options previously granted; provided,
that an Offering Period may be terminated by the Board on any Exercise Date if the Board determines
that the termination of the Plan is in the best interests of the Company and its stockholders.
Except as provided in Section 18 hereof, no amendment may make any change in any option theretofore
granted which adversely affects the rights of any participant. To the extent necessary to comply
with Rule 16b-3 or under Section 423 of the Code (or any successor rule or provision or any other
applicable law or regulation), the Company shall obtain stockholder approval in such a manner and
to such a degree as required.
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(b) Without stockholder consent and without regard to whether any participant rights may be
considered to have been adversely affected, the Board (or its committee) shall be entitled to
change the Offering Periods, limit the frequency and/or number of changes in the amount withheld
during an Offering Period, establish the exchange ratio applicable to amounts withheld in a
currency other than U.S. dollars, permit payroll withholding in excess of the amount designated by
a participant in order to adjust for delays or mistakes in the Companys processing of properly
completed withholding elections, establish reasonable waiting and adjustment periods and/or
accounting and crediting procedures to ensure that amounts applied toward the purchase of Common
Stock for each participant properly correspond with amounts withheld from the participants
Compensation, and establish such other limitations or procedures as the Board (or its committee)
determines in its sole discretion advisable which are consistent with the Plan.
20. Notices. All notices or other communications by a participant to the Company
under or in connection with the Plan shall be deemed to have been duly given when received in the
form specified by the Company at the location, or by the person, designated by the Company for the
receipt thereof.
21. Conditions Upon Issuance of Shares. Shares shall not be issued with respect to an
option unless the exercise of such option and the issuance and delivery of such shares pursuant
thereto shall comply with all applicable provisions of law, domestic or foreign, including, without
limitation, the Securities Act of 1933, as amended, the Exchange Act, the rules and regulations
promulgated thereunder, and the requirements of any stock exchange upon which the shares may then
be listed, and shall be further subject to the approval of counsel for the Company with respect to
such compliance.
As a condition to the exercise of an option, the Company may require the person exercising
such option 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 applicable provisions of law.
22. Term of Plan.
The Plan shall become effective upon the earlier to occur of its
adoption by the Board or its approval by the stockholders of the Company. It shall continue in
effect until December 31, 2015 unless sooner terminated under Section 19 hereof.
23. Automatic Transfer to Low Price Offering Period. To the extent permitted by Rule
16b-3 of the Exchange Act, if the Fair Market Value of the Common Stock on any Exercise Date in an
Offering Period is lower than the Fair Market Value of the Common Stock on the Enrollment Date of
such Offering Period, then all participants in such Offering Period shall be automatically
withdrawn from such Offering Period immediately after the exercise of their option on such Exercise
Date and automatically re-enrolled in the immediately following Offering Period as of the first day
thereof.
24. 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.
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Such stockholder approval shall be obtained in the degree and manner required under applicable
state and federal law.
25. Financial Reports. The Company shall provide to each Optionee, not less
frequently than annually during the period such Optionee has one or more Options outstanding,
copies of annual financial statements. The Company shall not be required to provide such
statements to key employees whose duties in connection with the Company assure their access to
equivalent information.
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EXHIBIT A
NEUROCRINE BIOSCIENCES, INC.
EMPLOYEE STOCK PURCHASE PLAN
SUBSCRIPTION AGREEMENT
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Original Application
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Enrollment Date: |
Change in Payroll Deduction Rate |
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Change of Beneficiary(ies) |
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hereby elects to participate in the Neurocrine Biosciences, Inc. Employee Stock Purchase Plan (the Employee Stock Purchase Plan) and subscribes to purchase
shares of the Companys Common Stock in accordance with this Subscription Agreement and the
Employee Stock Purchase Plan. |
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I hereby authorize payroll deductions from each paycheck in the amount of % of my
Compensation on each payday (1-15%) during the Offering Period in accordance with the Employee
Stock Purchase Plan. (Please note that no fractional percentages are permitted.) |
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I understand that said payroll deductions shall be accumulated for the purchase of shares of
Common Stock at the Purchase Price determined in accordance with the Employee Stock Purchase
Plan. I understand that if I do not withdraw from an Offering Period, any accumulated payroll
deductions will be used to automatically exercise my option. |
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I have received a copy of the complete Neurocrine Biosciences, Inc. Employee Stock
Purchase Plan. I understand that my participation in the Employee Stock Purchase Plan is in
all respects subject to the terms of the Employee Stock Purchase Plan. I understand that my
ability to exercise the option under this Subscription Agreement is subject to obtaining
stockholder approval of the Employee Stock Purchase Plan. |
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Shares purchased for me under the Employee Stock Purchase Plan should be issued in the
name(s) of (Employee or Employee and spouse only): . |
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I understand that if I dispose of any shares received by me pursuant to the Plan within 2
years after the Enrollment Date (the first day of the Offering Period during which I purchased
such shares) or one year after the Exercise Date, I will be treated for federal income tax
purposes as having received ordinary income at the time of such disposition in an amount equal
to the excess of the fair market value of the shares at the time such shares were purchased
over the price which I paid for the shares. I hereby agree to notify the Company in
writing within 30 days after the date of any disposition of my shares and I will make adequate
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provision for Federal, state or other tax withholding obligations, if any, which arise
upon the disposition of the Common Stock. The Company may, but will not be obligated to,
withhold from my compensation the amount necessary to meet any applicable withholding
obligation including any withholding necessary to make available to the Company any tax
deductions or benefits attributable to sale or early disposition of Common Stock by me. If I
dispose of such shares at any time after the expiration of the 2-year and 1-year holding
periods, I understand that I will be treated for federal income tax purposes as having
received income only at the time of such disposition, and that such income will be taxed as
ordinary income only to the extent of an amount equal to the lesser of (1) the excess of the
fair market value of the shares at the time of such disposition over the purchase price
which I paid for the shares, or (2) 15% of the fair market value of the shares on the first
day of the Offering Period. The remainder of the gain, if any, recognized on such
disposition will be taxed as capital gain. |
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I hereby agree to be bound by the terms of the Employee Stock Purchase Plan. The
effectiveness of this Subscription Agreement is dependent upon my eligibility to participate
in the Employee Stock Purchase Plan. |
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In the event of my death, I hereby designate the following as my beneficiary(ies) to receive
all payments and shares due me under the Employee Stock Purchase Plan: |
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NAME: (Please print) |
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Employees Social |
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Security Number:
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Employees Address:
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I UNDERSTAND THAT THIS SUBSCRIPTION AGREEMENT SHALL REMAIN IN EFFECT THROUGHOUT SUCCESSIVE OFFERING
PERIODS UNLESS TERMINATED BY ME.
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Dated: |
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Signature of Employee
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Spouses Signature (If beneficiary other than spouse)
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EXHIBIT B
NEUROCRINE BIOSCIENCES, INC.
EMPLOYEE STOCK PURCHASE PLAN
NOTICE OF WITHDRAWAL
The undersigned participant in the Offering Period of the Neurocrine Biosciences, Inc. Employee Stock Purchase Plan which began on , 19 (the Enrollment Date) hereby
notifies the Company that he or she hereby withdraws from the Offering Period. He or she hereby
directs the Company to pay to the undersigned as promptly as practicable all the payroll deductions
credited to his or her account with respect to such Offering Period. The undersigned understands
and agrees that his or her option for such Offering Period will be automatically terminated. The
undersigned understands further that no further payroll deductions will be made for the purchase of
shares in the current Offering Period and the undersigned shall be eligible to participate in
succeeding Offering Periods only by delivering to the Company a new Subscription Agreement.
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Name and Address of Participant: |
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Signature: |
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Date: |
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exv10w2
EXHIBIT 10.2
NEUROCRINE BIOSCIENCES, INC.
2003 INCENTIVE STOCK PLAN
as amended May 25, 2005, November 7, 2005 and January 12, 2006
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) Board shall mean the Committee, if one has been appointed, or the Board of
Directors of the Company, if no Committee is appointed.
(c) Code shall mean the Internal Revenue Code of 1986, as amended.
(d) Committee shall mean the Committee appointed by the Board in accordance with
Section 4(a) of the Plan, if one is appointed.
(e) Common Stock shall mean the common stock of the Company, par value $.001 per
share.
(f) Company shall mean Neurocrine Biosciences, Inc.
(g) 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.
(h) 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 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.
(i) Director means a member of the Board of Directors of the Company.
(j) 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.
(k) Holder shall mean a person who has been granted or awarded an Award pursuant to
the Plan.
(l) Incentive Stock Option shall mean an Option intended to qualify as an incentive
stock option within the meaning of Section 422 of the Code.
(m) Nonstatutory Stock Option shall mean an Option not intended to qualify as an
Incentive Stock Option.
(n) 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.
(o) Option Agreement shall mean any written or electronic agreement, contract, or
other instrument or document evidencing an Option.
(p) Optioned Stock shall mean the Common Stock subject to an Option.
(q) Optionee shall mean an Employee or Consultant who receives an Option.
(r) Outside Director means a Director who is not an Employee.
(s) Parent shall mean a parent corporation, whether now or hereafter existing, as
defined in Section 424(e) of the Code.
(t) 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.
(u) Plan shall mean this 2003 Incentive Stock Plan, as amended.
(v) Restricted Stock shall mean a right to purchase Common Stock pursuant to Section
11 of the Plan.
(w) 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.
(x) 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
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designated or a future fiscal year may be subject to the limit on deductible compensation
imposed by Section 162(m) of the Code.
(y) Share shall mean a share of the Common Stock, as adjusted in accordance with
Section 15 of the Plan.
(z) Stock Bonus shall mean the right to receive a bonus of Common Stock for past
services pursuant to Section 13 of the Plan.
(aa) 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 under the Plan is three million three hundred thousand (3,300,000) 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.
(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.
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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) 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.
(iv) 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
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(b) 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.
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(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 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
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(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 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
-6-
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 mean of the bid and asked prices (or the closing price per share if the Common Stock
is listed on the National Association of Securities Dealers Automated Quotation (NASDAQ)
National Market System) 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 System) or, in the event the
Common Stock is listed on a stock exchange, the fair market value per Share shall be the closing
price on such exchange on the date of grant of the Option, Restricted Stock award, Restricted Stock
Unit award or Stock Bonus award, as reported in the Wall Street Journal.
(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, promissory note, 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 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
-7-
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 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 total and permanent disability (as defined in Section
22(e)(3) of the Code), 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
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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, 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
(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 twenty five thousand (25,000) Shares
-9-
(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,
twelve thousand (12,000) Shares, and in the case of the Chairman of the Board of Directors of the
Company, fifteen thousand (15,000) 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 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.
-10-
(d) Repurchase Option. Unless the Board determines otherwise, the stock purchase
agreement shall grant the Company a 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. Subject to Section 4(d) with respect to Restricted Stock awards granted to Section 162(m)
Participants, the repurchase option shall lapse at such rate as the Board may determine.
(e) 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. The vesting of Restricted Stock Units shall be
determined by the Board and may be linked to specific performance criteria determined to be
appropriate by the Board, in each case on a specified date or dates or over any period or periods
determined by the Board. 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.
-11-
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.
(d) Repurchase Option. Unless the Board determines otherwise, the stock bonus
agreement shall grant the Company a 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. Subject
to Section 4(d) with respect to Stock Bonus awards granted to Section 162(m) Participants, the
repurchase option shall lapse at such rate as the Board may determine.
(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 an 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
-12-
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 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. 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 Option shall be assumed
or an equivalent option 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 employment of an Optionee without Cause (as defined below),
such Optionee shall fully vest in and have the right to exercise the options assumed or substituted
for the Option as to all of the Optioned Stock, including Shares as to which it would not otherwise
be exercisable. In the event that the successor corporation refuses to assume or substitute for
the Option, the Optionee shall fully vest in and have the right to exercise the Option as to all of
the Optioned Stock, including Shares as to which it would not otherwise be exercisable. If an
Option becomes fully vested and exercisable in lieu of assumption or substitution in the event of a
Change in Control, the Board shall notify the Optionee in writing or electronically that the Option
shall be fully vested and exercisable for a period of fifteen (15) days from the date of such
notice, and the Option shall terminate upon the expiration of such period. For the purposes of
this paragraph, the Option shall be considered assumed if, following the Change in Control, the
option confers the right to purchase, for each Share of Optioned Stock subject to the Option
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 upon the exercise of the
Option, for each Share of Optioned Stock subject to the Option, to be solely common stock of the
successor corporation or its Parent equal in fair market
-13-
value to the per share consideration
received by holders of Common Stock in the Change in Control. 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 Optionee shall fully
vest in and have the right to exercise all outstanding Options as to all of the Optioned Stock,
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 an
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
-14-
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
stock exchange upon which the Shares may then be listed, and shall be 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 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.
-15-
exv31w1
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO SECITON 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Gary A. Lyons, 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.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
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4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f) for the registrant and have: |
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a) |
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Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during 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 the internal control over financial reporting, to the registrants auditors and
the audit committee of registrants board of directors (or persons performing the equivalent
function): |
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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: April 28, 2006
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/s/ Gary A. Lyons
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Gary A. Lyons |
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President and Chief Executive Officer |
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exv31w2
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT
TO SECITON 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Paul W. Hawran, Executive Vice President and Chief Financial 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.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
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4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
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a) |
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Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during 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 the internal control over financial reporting, to the registrants
auditors and the audit committee of registrants board of directors (or persons performing
the equivalent function): |
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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: April 28, 2006
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/s/ Paul W. Hawran
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Paul W. Hawran |
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Executive Vice President and |
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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. (the Company) on
Form 10-Q for the period ended March 31, 2006 as filed with the Securities and Exchange Commission
on the date hereof (the Report), I, Gary A. Lyons, 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) |
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The Report fully complies with the requirements of Section 13(a) or 15(d), of the
Securities Exchange Act of 1934; and |
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(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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April 28, 2006
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By: /s/ Gary A. Lyons |
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Name: Gary A. Lyons |
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Title: President and Chief |
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Executive Officer |
In connection with the Quarterly Report of Neurocrine Biosciences, Inc. (the Company) on
Form 10-Q for the period ended March 31, 2006 as filed with the Securities and Exchange Commission
on the date hereof (the Report), I, Paul W. Hawran, Executive 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:
(3) |
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The Report fully complies with the requirements of Section 13(a) or 15(d), of the
Securities Exchange Act of 1934; and |
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(4) |
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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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April 28, 2006
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By: /s/ Paul W. Hawran |
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Name: Paul W. Hawran |
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Title: Executive Vice President and |
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Chief Financial Officer |