Neurocrine Biosciences, Inc.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-22705
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
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33-0525145 |
(State or other jurisdiction of
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(IRS Employer Identification No.) |
incorporation or organization) |
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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):
Large accelerated filer þ Accelerated filer o 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 $0.001 per share,
was 37,866,858 as of July 28, 2006.
NEUROCRINE BIOSCIENCES, INC.
FORM 10-Q INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except for share information)
(unaudited)
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June 30, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
86,168 |
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$ |
49,948 |
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Short-term investments, available-for-sale |
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148,151 |
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223,120 |
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Receivables under collaborative agreements |
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406 |
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858 |
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Other current assets |
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5,902 |
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5,384 |
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Total current assets |
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240,627 |
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279,310 |
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Property and equipment, net |
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96,693 |
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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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5,448 |
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4,731 |
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Total assets |
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$ |
442,543 |
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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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$ |
17,233 |
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$ |
21,342 |
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Deferred revenues |
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1,453 |
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6,537 |
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Current portion of long-term debt |
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5,246 |
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5,814 |
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Total current liabilities |
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23,932 |
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33,693 |
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Long-term debt |
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51,205 |
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53,590 |
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Other liabilities |
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5,634 |
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5,736 |
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Total liabilities |
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80,771 |
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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, $0.001 par value; 110,000,000 shares
authorized; issued and outstanding shares were 37,866,858
as of June 30, 2006 and 37,132,478 as of December 31, 2005 |
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38 |
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37 |
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Additional paid-in capital |
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716,540 |
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691,717 |
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Accumulated other comprehensive loss |
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(1,310 |
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(1,504 |
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Accumulated deficit |
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(353,496 |
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(300,146 |
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Total stockholders equity |
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361,772 |
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390,104 |
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Total liabilities and stockholders equity |
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$ |
442,543 |
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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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Six Months Ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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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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$ |
277 |
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$ |
2,721 |
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$ |
6,155 |
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$ |
7,137 |
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License fees and milestones |
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727 |
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25,448 |
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6,085 |
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31,896 |
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Sales force allowance |
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8,240 |
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5,000 |
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16,480 |
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6,000 |
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Total revenues |
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9,244 |
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33,169 |
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28,720 |
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45,033 |
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Operating expenses: |
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Research and development |
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26,112 |
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29,633 |
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53,847 |
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55,236 |
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Sales, general and administrative |
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12,396 |
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9,788 |
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31,731 |
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15,396 |
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Total operating expenses |
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38,508 |
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39,421 |
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85,578 |
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70,632 |
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Loss from operations |
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(29,264 |
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(6,252 |
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(56,858 |
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(25,599 |
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Other income and (expenses): |
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Interest income |
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2,758 |
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1,713 |
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5,420 |
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3,314 |
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Interest expense |
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(943 |
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(1,054 |
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(1,912 |
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(2,138 |
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Other income and (expense), net |
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(11 |
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(11 |
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Total other income, net |
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1,815 |
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648 |
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3,508 |
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1,165 |
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Net loss |
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$ |
(27,449 |
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$ |
(5,604 |
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$ |
(53,350 |
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$ |
(24,434 |
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Net loss per common share: |
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Basic and diluted |
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$ |
(0.73 |
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$ |
(0.15 |
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$ |
(1.42 |
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$ |
(0.67 |
) |
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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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37,764 |
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36,647 |
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37,560 |
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36,623 |
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See accompanying notes to the condensed consolidated financial statements.
4
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Six Months Ended |
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June 30, |
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2006 |
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2005 |
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CASH FLOW FROM OPERATING ACTIVITIES |
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Net loss |
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$ |
(53,350 |
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$ |
(24,434 |
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Adjustments to reconcile net loss to net cash
used in operating activities: |
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Depreciation and amortization |
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5,356 |
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4,947 |
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Deferred revenues |
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(5,084 |
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(11,330 |
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Loan forgiveness on notes receivable from stockholder |
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50 |
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50 |
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Share-based compensation expense |
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9,478 |
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|
314 |
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Change in operating assets and liabilities: |
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Accounts receivable and other current assets |
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(66 |
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(15,571 |
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Other non-current assets |
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(713 |
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(388 |
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Accounts payable and accrued liabilities |
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(4,109 |
) |
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(7,521 |
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Other non-current liabilities |
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(355 |
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446 |
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Net cash used in operating activities |
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(48,793 |
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(53,487 |
) |
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CASH FLOW FROM INVESTING ACTIVITIES |
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Purchases of short-term investments |
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(62,838 |
) |
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(19,970 |
) |
Sales/maturities of short-term investments |
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137,947 |
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64,987 |
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Restricted cash |
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(525 |
) |
Purchases of property and equipment |
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(2,742 |
) |
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(2,592 |
) |
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Net cash provided by investing activities |
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72,367 |
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41,900 |
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CASH FLOW FROM FINANCING ACTIVITIES |
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Issuance of common stock |
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15,599 |
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2,551 |
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Principal payments on debt |
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(2,953 |
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(3,492 |
) |
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Net cash provided by (used in) financing activities |
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12,646 |
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(941 |
) |
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Net increase (decrease) in cash and cash equivalents |
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36,220 |
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(12,528 |
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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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$ |
86,168 |
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$ |
48,499 |
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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. ORGANIZATION AND SUMMARY OF BUSINESS
Neurocrine Biosciences, Inc. (the Company or Neurocrine) was incorporated in California in
1992 and reincorporated in Delaware in 1996. The Company discovers, develops and intends to
commercialize drugs for the treatment of neurological and endocrine-related diseases and disorders.
The Companys product candidates address some of the largest pharmaceutical markets in the world,
including insomnia, anxiety, depression, diabetes, endometriosis, irritable bowel syndrome, pain,
Parkinsons disease, and other neurological and endocrine related diseases and disorders. The
Company currently has eight programs in various stages of research and development, including six
programs in clinical development. While the Company independently develops many of its product
candidates, they are in a collaboration for two of its programs. The lead clinical development
program, indiplon, is a drug candidate for the treatment of insomnia. The Company submitted two
New Drug Applications (NDAs) to the United States Food and Drug Administration (FDA) with respect
to indiplon.
On May 15, 2006, the Company received two complete responses from the FDA regarding the
indiplon capsule and tablet NDAs. These responses indicated that indiplon 5 mg and 10 mg capsules
were approvable (FDA Approvable Letter) and that the 15 mg tablets were not approvable (FDA Not
Approvable Letter). The FDA Approvable Letter requested that the Company reanalyze data from
certain preclinical and clinical studies to support approval of indiplon 5 mg and 10 mg capsules
for sleep initiation and middle of the night dosing. The FDA Approvable Letter also requested
reexamination of the safety analysis for the elderly population. The FDA may require additional
clinical and/or preclinical safety data. The FDA Not Approvable Letter requested that the Company
reanalyze certain safety and efficacy data and questioned the sufficiency of the objective sleep
maintenance clinical data with the 15 mg tablet in view of the fact that the majority of our
indiplon tablet studies were conducted with doses higher than 15 mg. Additional clinical data will
likely be required.
The Company has requested a meeting with the FDA to discuss the FDA Approvable Letter and this
meeting is scheduled to occur in August 2006. Additionally, the
Company has requested a separate
meeting with the FDA to discuss the FDA Not Approvable Letter. Until these discussions are
completed, the Company cannot estimate the scope of additional analyses and/or data the FDA may
require to address the issues and comments raised in each of the FDA
letters, nor can the
Company estimate a timeline for resubmission of the capsule and tablet NDAs. The process of
preparing and resubmitting the NDAs may require significant resources and could be time consuming
and subject to unanticipated delays and cost. Upon resubmission, the FDA may still require
additional data analysis or clinical trials, which would require substantial expenditures by the
Company and could further delay the approval process.
On June 22, 2006, Pfizer and the Company agreed to terminate their collaboration and license
agreements to develop and co-promote indiplon effective December 19, 2006. As a result, the Company
will reacquire all worldwide rights for indiplon capsules and tablets. The Company will receive
reimbursement of certain indiplon expenses incurred or committed prior to the June 22, 2006 notice
date as well as certain ongoing expenses until December 19, 2006, the effective date of
termination. The Company will be responsible for any costs associated with additional data or
clinical trials that may be required for resubmission of the indiplon NDAs.
Pursuant to the Companys collaboration agreement with Pfizer, the Companys sales force
ceased detailing Pfizers antidepressant Zoloft® to psychiatrists as of June 30, 2006, the date of
expiration of Zoloft® patent exclusivity. Pfizer notified the Company that as of July 1, 2006,
Pfizer will no longer reimburse or support the Companys sales force. Consequently, the Company
terminated the entire sales force during July 2006. Additionally, the Company also reduced its
research and development, and general and administrative staff based in San Diego by approximately
100 employees, in August 2006. The Company estimates incurring expenses of approximately $9.5
million in the third quarter of 2006 for salary continuation, outplacement services, and other
costs related to these reductions in force. Substantially all of these expenses will be paid in
cash.
6
2. 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.
3. SHARE-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
grants stock options to certain employees pursuant to Employment Commencement Nonstatutory Stock
Options. Until June 30, 2006, eligible employees could 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 Amended
and Restated Employee Stock Purchase Plan. The benefits provided under these Plans are share-based
compensation subject to the provisions of Statement of Financial Accounting Standards (SFAS) 123
(revised 2004), Share-Based Payment (SFAS 123R).
Prior to January 1, 2006, the Company accounted for share-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 share-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 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 123R, using the modified
prospective transition method and therefore has not restated results for prior periods. Under the
modified prospective transition method, share-based compensation expense for 2006 includes 1)
compensation expense for all share-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)
compensation expense for share-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 compensation expense 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 and six
months ended June 30, 2006 includes $2.7 million and $9.5 million, respectively, 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 ($0.8 million and $5.6 million for the three and six months ended June
30, 2006, respectively) and research and development expense ($1.8 million and $3.9 million for the
three and six months ended June 30, 2006, respectively). 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 provided by
financing activities and cash outflows used in 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.
7
Share-Based Compensation Plans
Since 1992, the Company has authorized a total of 13.7 million shares of common stock for
issuance pursuant to its 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. As of June 30, 2006, of the 13.7
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 were issued upon exercise of stock options previously granted or pursuant to restricted
stock or stock bonus awards; 6.3 million were subject to outstanding options and restricted stock
units; and 1.0 million remained available for future grant under the 2003 Incentive Stock Plan.
Share awards made under the 2003 Incentive Stock Plan that are later 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 from the 2003 Incentive Stock Plan 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 operations for the fourth quarter of 2005 which
were disclosed in the notes to Companys consolidated financial statements for the year ended
December 31, 2005 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.
8
Stock Options
The exercise price of all options granted during the six months ended June 30, 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 net income for the first six months of fiscal year 2005 in
accordance with APB 25. The estimated fair value of each option award granted was determined on the
date of grant using the Black-Scholes option valuation model with the following weighted-average
assumptions for option grants during the three and six months ended June 30, 2006 and 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
5.1 |
% |
|
|
4.18 |
% |
|
|
4.59 |
% |
|
|
4.18 |
% |
Expected volatility of common stock |
|
|
64.51 |
% |
|
|
34.00 |
% |
|
|
43.64 |
% |
|
|
34.00 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected option term |
|
4.75 years |
|
5.8 years |
|
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 from
2005 to 2006 is due to the decrease in the maximum term of the options granted after January 1,
2006 from ten years to seven years.
Share-based compensation expense recognized in the Condensed Consolidated Statement of
Operations for the six months ended June 30, 2006 is based on awards ultimately expected to vest,
net of 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 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 options granted during the six months ended June 30,
2006 and 2005, estimated as of the grant date using the Black-Scholes option valuation model, was
$16.55 per option and $15.96 per option, respectively.
A summary of the status of the Companys stock option plans as of June 30, 2006 and of changes
in options outstanding under the plans during the six months ended June 30, 2006 is as follows (in
thousands, except for weighted average exercise price and weighted average remaining contractual
term data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
Weighted- |
|
Average |
|
|
|
|
Number |
|
Average |
|
Remaining |
|
Aggregate |
|
|
of |
|
Exercise Price |
|
Contractual |
|
Intrinsic |
|
|
Shares |
|
per Share |
|
Term (in years) |
|
Value |
Options outstanding at December 31, 2005 |
|
|
6,544 |
|
|
$ |
38.32 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
288 |
|
|
$ |
44.49 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(539 |
) |
|
$ |
28.09 |
|
|
|
|
|
|
|
|
|
Options forfeited or expired |
|
|
(84 |
) |
|
$ |
46.20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at June 30, 2006 |
|
|
6,209 |
|
|
$ |
39.39 |
|
|
|
6.3 |
|
|
$ |
2,092 |
|
Options vested and exercisable at
June 30, 2006 |
|
|
4,680 |
|
|
$ |
37.80 |
|
|
|
5.9 |
|
|
$ |
2,092 |
|
9
For the three and six months ended June 30, 2006, share-based compensation expense
related to stock options was $3.9 million and $9.1 million, respectively. As of June 30, 2006,
there was approximately $25.3 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 six months ended June
30, 2006, was $17.9 million. Cash received from stock option exercises for the six months ended
June 30, 2006 and 2005 was $15.1 million and $1.5 million, respectively.
For stock options granted prior to the adoption of SFAS 123R, the following table
illustrates the pro forma effect on net income and earnings per common share as if the Company had
applied the fair value recognition provisions of SFAS 123 in determining stock-based compensation
(in thousands, except loss per share data):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 |
|
Net loss, as reported |
|
$ |
(5,604 |
) |
|
$ |
(24,434 |
) |
Stock option expense |
|
|
(5,131 |
) |
|
|
(10,472 |
) |
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(10,735 |
) |
|
$ |
(34,906 |
) |
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted as reported |
|
$ |
(0.15 |
) |
|
$ |
(0.67 |
) |
|
|
|
|
|
|
|
Basic and diluted pro forma |
|
$ |
(0.29 |
) |
|
$ |
(0.95 |
) |
|
|
|
|
|
|
|
Restricted Stock Units
Beginning in 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 0% based on historical experience of stock bonus awards. Based upon the Companys closing stock
price as of June 30, 2006, there is approximately $0.2 million of unamortized compensation cost
related to restricted stock units, which is expected to be recognized over a remaining
weighted-average vesting period of 2.2 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 liability and expense
for restricted stock units are adjusted to reflect the market value of the Companys stock for each
reporting period. For the three and six months ended June 30, 2006, the adjustment to share-based
compensation expense related to restricted stock units was $(1.1) million and $0.3 million,
respectively.
A summary of the status of the Companys restricted stock units as of June 30, 2006 and
of changes in restricted stock units outstanding under the plan during the six months ended June
30, 2006 is as follows (in thousands, except for weighted average grant date fair value per unit):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Number of |
|
Grant Date Fair |
|
|
Shares |
|
Value per Unit |
Restricted stock units outstanding at December 31, 2005 |
|
|
|
$ |
|
|
Restricted stock units granted |
|
40 |
|
|
60.95 |
|
|
|
|
|
|
|
|
Restricted stock units outstanding at June 30, 2006 |
|
40 |
|
$ |
60.95 |
|
Restricted stock units vested at June 30, 2006 |
|
6 |
|
$ |
60.95 |
|
Stock Bonus Awards
The Company granted approximately 39,000 shares of its common stock pursuant to stock bonus
awards between 2003 and 2005 from the Companys 2003 Incentive Stock Plan. Based upon the Companys
closing stock price as of June 30, 2006, there was approximately $83,000 of unamortized
compensation cost related to these stock bonus awards, representing approximately 7,800 shares of
common stock, which is expected to be recognized over a
remaining weighted-average vesting period of approximately two years. The 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 and expense is adjusted to reflect the market value of the Companys stock
for each reporting period.
10
Employee Stock Purchase Plan
As of June 30, 2006, the Company had reserved 725,000 shares of common stock for issuance
under the Amended and Restated 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 June 30, 2006, 640,000 shares had 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. The Company recognized approximately $77,000 in share-based compensation
expense related to the purchase on June 30, 2006.
Effective July 1, 2006, the Company terminated the Purchase Plan. The termination was a result
of a review of the Purchase Plans effectiveness in providing long-term share ownership to the
Companys employees. In addition, the Purchase Plan had an insufficient amount of shares available
to allow full participation by employees.
4. 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.
5. 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.
6. 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 and
the action letters from the FDA are indicators of impairment for the prepaid royalty, the Company
believes the future cash flows to be realized from the prepaid royalty will exceed the assets
carrying value, and accordingly the Company has not recognized any impairment losses through June
30, 2006. . However, events both within and outside of the Companys control, such as competition
from other insomnia therapeutic agents, disease prevalence, further FDA actions related to
indiplon, and general market conditions may have an impact on the Companys ability to recover the
carrying value of this asset in the future.
7. 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 0.8 million and 1.2 million
for the three months ended June 30, 2006 and 2005, respectively and 1.5 million and 1.3 million for
the six months ended June 30, 2006 and 2005, respectively.
11
8. 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 June 30, 2006
and 2005, comprehensive loss was $27.6 million and $4.6 million, respectively. For the six months
ended June 30, 2006 and 2005, comprehensive loss was $53.2 million and $24.7 million, respectively.
9. 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 force
allowance is recognized based on the related costs incurred to build and operate the sales
function.
10. 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 the
Companys independent R&D efforts as well as efforts associated with collaborations and
in-licensing arrangements. In addition, the Company funds R&D, conducted on its 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.
12
|
|
|
ITEM 2: |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS |
The following Managements Discussion and Analysis of Financial Condition and Results of
Operations section contains forward-looking statements, which involve risks and uncertainties. Our
actual results could differ materially from those anticipated in these forward-looking statements
as a result of various factors, including those set forth below in Part II, Item 1A under the
caption Risk Factors. The interim financial statements and this Managements Discussion and
Analysis of Financial Condition and Results of Operations should be read in conjunction with the
Financial Statements and Notes thereto for the year ended December 31, 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, diabetes,
endometriosis, irritable bowel syndrome, pain, Parkinsons disease, 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 are in a collaboration for two of our programs. Our lead
clinical development program, indiplon, is a drug candidate for the treatment of insomnia. We
submitted two New Drug Applications (NDAs) to the United States Food and Drug Administration (FDA)
with respect to indiplon.
On May 15, 2006, we received two complete responses from the FDA regarding our indiplon
capsule and tablet NDAs. These responses indicated that indiplon 5 mg and 10 mg capsules were
approvable (FDA Approvable Letter) and that the 15 mg tablets were not approvable (FDA Not
Approvable Letter). The FDA Approvable Letter requested that we reanalyze data from certain
preclinical and clinical studies to support approval of indiplon 5 mg and 10 mg capsules for sleep
initiation and middle of the night dosing. The FDA Approvable Letter also requested reexamination
of the safety analysis for the elderly population. The FDA may require additional clinical and/or
preclinical safety data. The FDA Not Approvable Letter requested that we reanalyze certain safety
and efficacy data and questioned the sufficiency of the objective sleep maintenance clinical data
with the 15 mg tablet in view of the fact that the majority of our indiplon tablet studies were
conducted with doses higher than 15 mg. Additional clinical data will likely be required.
We have requested a meeting with the FDA to discuss the FDA Approvable Letter and this meeting
is scheduled to occur in August 2006. Additionally, we have
requested a separate meeting with the
FDA to discuss the FDA Not Approvable Letter. Until these discussions are completed, we cannot
estimate the scope of additional analyses and/or data the FDA may require to address the issues and
comments raised in each of the FDA Letters, nor can we estimate a timeline for resubmission of
the capsule and tablet NDAs. The process of preparing and resubmitting the NDAs may require
significant resources and could be time consuming and subject to unanticipated delays and
cost. Upon resubmission, the FDA may still require additional data analysis or clinical
trials, which would require substantial expenditures by us and could further delay the approval
process.
On June 22, 2006, the Company and Pfizer agreed to terminate our collaboration and license
agreements to develop and co-promote indiplon effective December 19, 2006. As a result, we will
reacquire all worldwide rights for indiplon capsules and tablets. We will receive reimbursement of
certain indiplon expenses incurred or committed prior to the June 22, 2006 notice date as well as
certain ongoing expenses until December 19, 2006, the effective date of termination. We will be
responsible for any costs associated with additional data or clinical trials that may be required
for resubmission of the indiplon NDAs.
13
Pursuant to the collaboration agreement with Pfizer, our sales force ceased detailing Pfizers
antidepressant Zoloft® to psychiatrists as of June 30, 2006, the date of expiration of Zoloft®
patent exclusivity. Pfizer notified us that as of July 1, 2006, Pfizer will no longer reimburse or
support our sales force. Consequently, we terminated the entire sales force during July 2006.
Additionally, we also reduced our research and development, and general and administrative staff
based in San Diego by approximately 100 employees, in August 2006. We estimate incurring expenses
of approximately $9.5 million in the third quarter of 2006 for salary continuation, outplacement
services, and other costs related to these reductions in force. Substantially all of these expenses
will be paid in cash.
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, 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 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.
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, 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 because 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.
In accordance with Statement of Financial Accounting Standards No. 144 (SFAS 144),
Accounting for the Impairment or Disposal of Long-Lived Assets, if indicators of impairment
exist, we assess the recoverability of the affected long-lived assets by determining whether the
carrying value of such assets can be recovered through undiscounted future operating cash flows. If
impairment is indicated, we measure the amount of such impairment by comparing the carrying value
of the asset to the estimated fair value of the related asset, which is generally determined based
on the present value of the expected future cash flows. While our current and historical operating
and cash flow losses and the action letters from the FDA are indicators of impairment, we believe
the future cash flows to be realized from our long-lived assets, i.e. prepaid royalty, will exceed
the assets carrying value, and accordingly we have not recognized any impairment losses through
June 30, 2006.
We grant stock options to purchase our common stock to our employees and directors under our
2003 Incentive Stock Plan and grant stock options to certain employees pursuant to Employment
Commencement Nonstatutory Stock Option Agreements. We also grant certain employees stock bonuses
and restricted stock units under our 2003
14
Incentive Stock Plan. Additionally, we have outstanding
options that were granted under option plans from which we no longer make grants. The benefits
provided under all of these plans are subject to the provisions of revised Statement of Financial
Accounting Standards No. 123 (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 fiscal 2006 were impacted by the recognition of non-cash
expense related to the fair value of our share- based compensation awards. Share-based compensation
expense recognized under SFAS 123R for the three and six months ended June 30, 2006 was $2.7
million and $9.5 million, respectively.
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, share-based compensation expense may be
recognized over a shorter period of time, and in some cases the entire share-based compensation
expense may be recognized upon grant of the share-based compensation award. Employees who are age
55 or older and have five or more years of service with us are entitled to accelerated vesting of
all of the unvested share-based compensation awards upon retirement from us. This retirement
provision leads to variability in the quarterly expense amounts recognized under SFAS 123R, and
therefore individual share-based compensation awards may impact earnings disproportionately in any
individual fiscal quarter.
At June 30, 2006, total unrecognized, estimated share-based compensation expense related to
unvested stock options granted prior to that date was $25.3 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 and six months ended
June 30, 2006 and 2005 represented 0.6% and 0.9%, respectively, of outstanding shares as of the
beginning of each fiscal quarter. Total stock options and restricted stock units granted during the
six months ended June 30, 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 share-based
compensation expense, see Note 3 to the Condensed Consolidated Financial Statements in Part I, Item
1.
RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2006 AND 2005
The following table summarizes our primary sources of revenue:
|
|
|
|
|
|
|
|
|
|
|
Three months |
|
|
Ended June 30 |
|
|
2006 |
|
2005 |
|
|
(in thousands) |
Revenues under collaboration agreements: |
|
|
|
|
|
|
|
|
Pfizer |
|
$ |
9,230 |
|
|
$ |
33,163 |
|
GlaxoSmithKline |
|
|
14 |
|
|
|
6 |
|
|
|
|
Total revenue |
|
$ |
9,244 |
|
|
$ |
33,169 |
|
|
|
|
Revenues were $9.2 million for the three months ended June 30, 2006 compared with $33.2
million for the same period last year. The decrease in revenues for the three months ended June 30,
2006 compared with the same period in 2005 results primarily from a decrease in revenues recognized
under our former collaboration agreement with Pfizer, Inc (Pfizer). During the second quarter of
2006, we recognized $9.2 million of revenue under the Pfizer collaboration agreement, which is
comprised of $0.3 million from Pfizer in the form of sponsored development funding, $0.7 million
resulting from amortization of up-front license fees, and $8.2 million related to the sales force
allowance for the operation of our sales force. During the second quarter of 2005, we recognized
$33.2 million in revenue under the Pfizer collaboration agreement, of which $2.7 million came from
sponsored development funding, $5.4 million from amortization of up-front license fees, a $20.0
million milestone related to the FDAs accepting for review our NDA for indiplon capsules, and $5.0
million related to the sales force allowance.
Research and development expenses decreased to $26.1 million for the second quarter 2006
compared with $29.6 million for the respective period in 2005. The $3.5 million decrease in
research and development expenses is primarily due to lower external development costs for our
indiplon clinical program, which decreased to $0.2 million
15
in the second quarter of 2006 from $6.2
million in the second quarter of 2005. This decrease in indiplon development costs was partially
offset by an increase in personnel expense of $1.9 million, primarily due to our adoption of SFAS
123R in 2006. We currently have eight programs in various stages of research and development,
including six programs in clinical development.
Sales, general and administrative expenses increased to $12.4 million for the second quarter
2006 compared with $9.8 million during the same period last year. The $2.6 million increase in
expenses from 2005 to 2006 resulted primarily from sales force activities. Direct costs related to
our sales force were approximately $7.4 million in the second quarter of 2006 compared to $4.3
million in the second quarter of 2005. This increase in sales force cost was offset by revenue
recognized under our sales force allowance from Pfizer. Additionally, the adoption of SFAS 123R in
2006 resulted in an increase of approximately $0.8 million of expense. However, total compensation
expense for the second quarter of 2006 decreased by $2.0 million compared to the second quarter of
2005, as a result of a decline in fair value of company stock and restricted stock units held in
our deferred compensation program.
Other income increased from $0.6 million during the first quarter of 2005 to $1.8 million for
the second quarter of 2006. The increase resulted primarily from increased interest income due to
higher rates of return on our investments.
Net loss for the second quarter of 2006 was $27.4 million, or $(0.73) per share, compared to
$5.6 million, or $(0.15) per share, for the same period in 2005. The primary reason for the $21.8
million increase in net loss is the achievement of a $20.0 million milestone from Pfizer in the
second quarter of last year and our adoption of SFAS 123R which resulted in an additional $2.7
million in expense in the second quarter of 2006.
SIX MONTHS ENDED JUNE 30, 2006 AND 2005
The following table summarizes our primary sources of revenue:
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Ended June 30, |
|
|
2006 |
|
2005 |
|
|
(in thousands) |
Revenues under collaboration agreements: |
|
|
|
|
|
|
|
|
Pfizer |
|
$ |
27,693 |
|
|
$ |
43,573 |
|
GlaxoSmithKline |
|
|
1,027 |
|
|
|
1,460 |
|
|
|
|
Total revenues |
|
$ |
28,720 |
|
|
$ |
45,033 |
|
|
|
|
Revenues were $28.7 million for the six months ended June 30, 2006 compared with $45.0 million
for the respective period last year. The decrease in revenues during the first six months of 2006,
compared with the respective period in 2005, results primarily from the achievement of a $20.0
million milestone under the Pfizer collaboration agreement related to the FDAs accepting for
review our NDA for indiplon capsules in 2005. During the first half of 2006, we recognized $27.7
million in revenue from Pfizer, comprised of $6.1 million in the form of sponsored development
funding, $5.1 million resulting from amortization of up-front license fees, and $16.5 million
related to the sales force allowance for operating our sales force. During the first half of 2005,
we recognized $43.6 million in revenue from Pfizer, comprised of $6.7 million in the form of
sponsored development funding, $10.9 million resulting from amortization of up-front license fees,
the above mentioned $20.0 million milestone, and $6.0 million related to the sales force allowance
received from Pfizer. Under our GSK collaboration agreement, we recognized a $1.0 million
milestone during the first six months of 2006 for successfully enrolling the first patient in a
Phase II clinical trial for our CRF program. During the first half of 2005, we recognized $1.5
million in revenue under the GSK collaboration agreement, which included a $1.0 million milestone
for successful selection of two clinical candidate compounds.
Research and development expenses decreased to $53.8 million for the first half of 2006
compared with $55.2 million for the respective period in 2005. This decrease in research and
development expenses is comprised of a decrease in external development costs of $8.9 million,
which is partially offset by an increase in personnel costs of $6.0 million. External development
costs incurred related to indiplon for the first half of 2006 were $0.4 million compared to $10.2
million for the same period last year. This decrease in indiplon external development costs was
offset by increased costs in other external development programs. External development costs for
our GnRH
16
compound for endometriosis and benign prostatic hyperplasia increased to $5.4 million in
the first half of 2006 from $4.5 million in the first half of 2005 and external development costs
related to the H1 insomnia program increased to $3.2 million in the first half of 2006 from $1.8
million in the first half of 2005. External development costs related to the APL Diabetes program
decreased to $0.8 million in the first half of 2006 from $1.7 million in the first half of 2005.
Personnel costs have increased by $6.0 million from the first half of 2005 to the first half of
2006 primarily due to $3.9 million in SFAS 123R expense and expanded research and development
activities.
Sales, general and administrative expenses increased to $31.8 million for the six months ended
June 30, 2006 compared with $15.4 million during the same period last year. The $16.4 million
increase in expenses from 2005 to 2006 resulted primarily from the sales force activities. Direct
costs related to our sales force were approximately $15.0 million in the first half of 2006
compared to $4.9 million in the same period during 2005. This increase in sales force costs was
offset by revenue recognized under our sales force allowance from Pfizer. Additionally, non-sales
force related personnel costs increased by approximately $5.0 million from the first half of 2005
to the first half of 2006. This was due primarily to the adoption of SFAS 123R which resulted in
expense of approximately $5.6 million during the first half of 2006.
Other income increased to $3.5 million for the first half of 2006 from $1.2 million during the
first half of 2005. The increase resulted primarily from increased interest income due to higher
rates of return on our investments.
Net loss for the first half of 2006 was $53.4 million, or $(1.42) per share, compared to $24.4
million, or $(0.67) per share, for the same period in 2005. The primary reason for the $29.0
million increase in net loss is the achievement of a $20.0 million milestone under our Pfizer
collaboration in the first half of 2005. Additionally, the adoption of SFAS 123R resulted in an
additional $9.5 million in expense in the first half of 2006.
To date, our revenues have come from funded research and development, achievements of
milestones under corporate collaborations, licensing of product candidates, and from the sales
force allowance from Pfizer. 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 100%
of our revenues for the six months ended June 30, 2006 and 2005.
During the second quarter of 2006, we received two letters from the FDA related to our NDA
submissions for indiplon. These letters indicated that indiplon capsules were approvable and that
indiplon tablets were not approvable. Additionally on June 22, 2006, we announced that the Company
and Pfizer had agreed to terminate our collaboration and license agreements to develop and
co-promote indiplon. These two events are indicators of impairment for our prepaid royalty, which
is carried as a long-lived asset on our balance sheet. This prepaid royalty arose out of our
acquisition, in February 2004, of Wyeths financial interest in indiplon for approximately $95.0
million, consisting of $50.0 million in cash and $45.0 million in our common stock. This
transaction decreased our overall royalty obligation on sales of indiplon from six percent to three
and one-half percent. In accordance with SFAS 144 we performed an analysis of the undiscounted cash
flows related to this prepaid royalty. Based on our
current expectations with respect to FDA approval and commercialization, we have determined
that the carrying value of this asset is fully recoverable, and we have not recognized any
impairment charge to date. However, events both within and outside of our control, such as
competition from other insomnia therapeutic agents, disease prevalence, further FDA actions related
to indiplon, and general market conditions may have an impact on our ability to recover the
carrying value of this asset in the future. In the event that either the tablet or capsule, or both
formulations of indiplon, are not eventually approved by the FDA or approved by the FDA and not
successfully commercialized, an impairment charge would likely occur. We will continue to monitor
this long-lived asset on a quarterly basis.
We
expect to incur a net loss of approximately $135.0 million during fiscal 2006, which includes
approximately $9.5 million in expense related to our reduction in force during the third quarter of
2006 and various non-cash expenses such as those associated with our adoption of FAS 123R and
depreciation. Additionally, we expect to incur operating losses for the foreseeable future because
of the decrease in revenues we will experience as a result of the termination of the Pfizer
collaboration agreement and because of the expenses we expect to incur for the clinical trials and
other costs related to refiling of the indiplon NDAs as well as costs to progress other programs
through our pipeline. Future profitability is dependent upon the approval of our NDAs for indiplon
by the FDA and upon acceptance of indiplon by prescribers and consumers.
17
LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2006, our cash, cash equivalents, and short-term investments totaled $234.3
million compared with $273.1 million at December 31, 2005. The decrease in cash balances at June
30, 2006 resulted primarily from our net loss of $53.4 million offset by an increase in additional
paid in capital of $15.6 million as a result of stock option exercises.
Net cash used in operating activities during the first half of 2006 was $48.8 million compared
with $53.5 million during the same period last year. This fluctuation resulted from our net loss of
$53.4 million in the first half of 2006 compared to our net loss of $24.4 million for the first
half of 2005, a decrease in accounts receivable from collaborators of $22.4 million, as well as
increases in share-based compensation expense totaling $9.2 million.
Net cash provided by investing activities during the first half of 2006 was $72.4 million
compared to $41.9 million for the first half 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.
Net cash provided by financing activities during the first half of 2006 was $12.6 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 $13.0 million in the first half of 2006 compared to the
same period 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 and the extent to which
additional clinical trials are necessary in connection with the resubmissions of our NDAs for
indiplon capsules and tablets.
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.
18
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 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 June 30, 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.
19
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 Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2006, except as
follows:
|
|
|
We revised the first risk factor to reflect the fact that we received two complete
responses from the United States Food and Drug Administration (FDA) which indicated that
indiplon 5 mg and 10 mg capsules were approvable, and that the 15 mg tablets were not
approvable, and the possible implications of these responses; |
|
|
|
|
We added a new second risk factor to address the impact on us of the termination of our
collaboration with Pfizer to develop and co-promote indiplon; |
|
|
|
|
We added a new third risk factor stating that we may become involved in securities
class action litigation that could divert managements attention and harm our business; |
|
|
|
|
We revised our sixth risk factor to address the impact the termination of our
collaboration with Pfizer will have on our revenues and profitability; |
|
|
|
|
We revised our eighth risk factor to address the state of our corporate collaborations
following termination of the Pfizer collaboration; and |
|
|
|
|
We added a new fourteenth risk factor stating that potential future impairments under
Statement of Financial Accounting Standards No. 144 could adversely affect our future
results of operations and financial position. |
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 FDA New Drug
Applications (NDAs) for both indiplon capsules and indiplon tablets. On May 15, 2006, we received
two complete responses from the FDA regarding our indiplon capsule and tablet NDAs. These
responses indicated that indiplon 5 mg and 10 mg capsules were approvable (FDA Approvable Letter)
and that the 15 mg tablets were not approvable (FDA Not Approvable Letter). The FDA Approvable
Letter requested that we reanalyze data from certain preclinical and clinical studies to support
approval of indiplon 5 mg and 10 mg capsules for sleep initiation and middle of the night dosing.
The FDA Approvable Letter also requested reexamination of the safety analysis for the elderly
population. The FDA may require additional clinical and/or preclinical safety data. The FDA Not
Approvable Letter requested that we reanalyze certain safety and efficacy data and questioned the
sufficiency of the objective sleep maintenance clinical data with the 15 mg tablet in view of the
fact that the majority of our indiplon tablet studies were conducted with doses higher than 15 mg.
Additional clinical data will likely be required.
We have requested a meeting with the FDA to discuss the FDA Approvable Letter and this meeting
is scheduled to occur in August 2006. Additionally, we have
requested a separate meeting with the
FDA to discuss the FDA Not Approvable Letter. Until these discussions are completed, we cannot
estimate the scope of additional analyses and/or data the FDA may require to address the issues and
comments raised in the each of the FDA Letters, nor can we estimate a timeline for resubmission of
the capsule and tablet NDAs. Based on the results of these meetings, we
will determine our strategy to move forward, which will include an evaluation of costs,
timelines and feasibility of additional data analyses and clinical data required by the FDA for
approval.
20
If we are unable to perform the required analyses or conduct the clinical trials or if these
data analyses or clinical trials do not demonstrate the safety and efficacy of indiplon capsules or
indiplon tablets, we may not be able to resubmit the NDA for either or both formulations. If we do
obtain positive results from these data analyses and clinical trials, we would then refile the
NDAs. The process of preparing and resubmitting the NDAs may require significant resources and
could be time consuming and subject to unanticipated delays and cost. Upon resubmission, the FDA
could again refuse to approve one or both NDAs, or could still require additional data analysis or
clinical trials, which would require substantial expenditures by us and could further delay the
approval process. 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. We face the risk that for any of the reasons
described above, as well as other reasons set forth herein, indiplon may never be approved by the
FDA or commercialized anywhere in the world.
If we are unable to refile one or both NDAs, or the FDA refuses to accept or approve the
resubmitted NDAs for any reason or we experience a significant delay in approval and subsequent
commercialization of indiplon, our business and reputation would be harmed and our stock price
would decline.
Because of the termination of our collaboration with Pfizer to develop and co-promote indiplon, we
must identify a new partner and enter into a collaboration agreement with them or develop,
commercialize, market and sell indiplon by ourselves.
On June 22, 2006, we announced that the Company and Pfizer had agreed to terminate our
collaboration and license agreements to develop and co-promote indiplon. Under the collaboration,
Pfizer had agreed to:
|
|
|
fund substantially all third-party costs related to future indiplon development,
manufacturing and commercialization activities; |
|
|
|
|
fund a 200-person Neurocrine sales force that would initially promote Zoloft® and, upon
approval of the indiplon NDAs, co-promote indiplon in the United States; |
|
|
|
|
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 |
|
|
|
|
be responsible for sales and marketing of indiplon worldwide. |
As a result of termination of this collaboration, we will reacquire all worldwide rights for
indiplon capsules and tablets. We will receive reimbursement of certain indiplon expenses incurred
or committed prior to the June 22, 2006 notice date as well as certain ongoing expenses until
December 19, 2006, the effective date of termination. We will be responsible for any costs
associated with additional data or clinical trials that may be required for resubmission of the
indiplon NDAs.
We may seek another partner or partners, at an appropriate time, to assist us in the worldwide
development and commercialization of indiplon or develop, commercialize, market and sell indiplon
by ourselves. We face competition in our search for partners with whom we may collaborate. As a
result, 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, commercialization and future sales, which would harm our business. Identifying a new
partner and entering into a collaboration agreement with them or developing the necessary
infrastructure to commercialize, market and sell indiplon ourselves could cause delays in obtaining
regulatory approvals and commercialization of indiplon, which would negatively impact our business.
If we choose to commercialize, market and sell indiplon ourselves, we will be required to
substantially increase our internal sales,
distribution and marketing capabilities. The development of the infrastructure necessary to
commercialize, market and sell indiplon will require substantial resources and may divert the
attention of our management and key personnel and negatively impact our product development
efforts. Moreover, we may not be able to hire a sales force that is sufficient in size or has
adequate expertise.
21
Pursuant to the collaboration agreement with Pfizer, our sales force ceased detailing Pfizers
antidepressant Zoloft® to psychiatrists as of June 30, 2006, the date of expiration of Zoloft®
patent exclusivity. Pfizer notified us that as of July 1, 2006, Pfizer will no longer reimburse or
support our sales force. Consequently, we terminated the entire sales force in July 2006 and
estimate incurring expenses of approximately $5.9 million in the third quarter of 2006 related to
salary continuation, outplacement services, and other costs related to eliminating the sales force.
We cannot assure you that we will be able to successfully rebuild the sales force in a timely
manner, or at all, should indiplon be approved by the FDA.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The market price of our common stock has declined significantly since our May 16, 2006
announcement of the FDAs action letters with respect to indiplon. In the past, following periods
of volatility in the market price of a particular companys securities, securities class action
litigation has often been brought against the company. We may become involved in this type of
litigation in the future, which would be expensive and divert managements attention and resources
from operating the business. Additionally, we may not be successful in having any such suit
dismissed or settled within the limits of our insurance.
Even if we ultimately 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 of 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.
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.
In connection with the clinical trials of indiplon and our other product candidates, we face the
risks that:
|
|
|
the product may not prove to be effective; |
|
|
|
|
we may discover that a product candidate may cause harmful side effects; |
|
|
|
|
the results may not replicate the results of earlier, smaller trials; |
|
|
|
|
we or the FDA may suspend the trials; |
22
|
|
|
the results may not be statistically significant; |
|
|
|
|
patient recruitment may be slower than expected; and |
|
|
|
|
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.
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 do not expect to be profitable for the year ended
December 31, 2006. During the third quarter of 2006, we estimate incurring expenses of
approximately $9.5 million related to salary continuation, outplacement services and other costs
related to our reduction in force. Additionally, we will be responsible for any costs associated
with additional data or clinical trials that may be required for resubmission of the indiplon NDAs.
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.
23
We depend on continuing our current collaboration and developing additional collaborations to
develop and commercialize our product candidates.
Our strategy for developing and commercializing our products is dependent upon maintaining our
current arrangements and establishing new arrangements with research collaborators, corporate
collaborators and others. We have an active collaboration agreement with GlaxoSmithKline and
previously have had collaborations with Pfizer, Wyeth, Johnson & Johnson, and Eli Lilly and
Company. We historically have been dependent upon these corporate collaborators to provide
adequate funding for a number of our programs. Under these arrangements, our corporate
collaborators are typically responsible for:
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selecting compounds for subsequent development as drug candidates; |
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conducting preclinical studies and clinical trials and obtaining required regulatory
approvals for these drug candidates; and |
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manufacturing and commercializing any resulting drugs. |
Because we expect to continue to rely heavily on corporate collaborators, the development of
our projects would be substantially delayed if one or more of our current or future collaborators:
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failed to select a compound that we have discovered for subsequent development into marketable products; |
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failed to gain the requisite regulatory approvals of these products; |
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did not successfully commercialize products that we originate; |
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did not conduct its collaborative activities in a timely manner; |
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did not devote sufficient time and resources to our partnered programs or potential products; |
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terminated its alliance with us; |
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developed, either alone or with others, products that may compete with our products; |
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disputed our respective allocations of rights to any products or technology developed
during our collaborations; or |
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merged with a third party that wants to terminate the collaboration. |
These issues and possible disagreements with current or future corporate collaborators could
lead to delays in the collaborative research, development or commercialization of many of our
product candidates. Furthermore, disagreements with these parties could require or result in
litigation or arbitration, which would be time-consuming and expensive. If any of these issues
arise, it may delay the development and commercialization of drug candidates and, ultimately, our
generation of product revenues.
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
24
collaborations or adversely affect our ability to form new collaborations. We also face
the risk that our licensors could, for a number of reasons, lose patent protection or lose their
rights to the technologies we have licensed, thereby impairing or extinguishing our rights under
our licenses with them.
Because the development of our product candidates is subject to a substantial degree of
technological uncertainty, we may not succeed in developing any of our product candidates.
All of our product candidates are in research, clinical development or in registration with
the FDA. Only a small number of research and development programs ultimately result in commercially
successful drugs. Potential products that appear to be promising at early stages of development may
not reach the market for a number of reasons. These reasons include the possibilities that the
potential products may:
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be found ineffective or cause harmful side effects during preclinical studies or clinical trials; |
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fail to receive necessary regulatory approvals on a timely basis or at all; |
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be precluded from commercialization by proprietary rights of third parties; |
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be difficult to manufacture on a large scale; or |
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be uneconomical or fail to achieve market acceptance. |
If any of our products encounters any of these potential problems, we may never successfully
market that product.
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. If we fail to
establish successful marketing and sales capabilities or fail to enter into successful marketing
arrangements with third parties, our product revenues will suffer.
The independent clinical investigators and contract research organizations that we rely upon to
conduct our clinical trials may not be diligent, careful or timely, and may make mistakes, in the
conduct of our trials.
We depend on independent clinical investigators and contract research organizations, 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
25
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; and |
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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
regulations and standards. |
Our current dependence upon third parties for the manufacture of our products may harm our
profit margin, if any, on the sale of our future products and our ability to develop and deliver
products on a timely and competitive basis.
Potential future impairments under SFAS 144 could adversely affect our future results of
operations and financial position.
In accordance with Statement of Financial Accounting Standards No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, we assess our long-lived assets for impairment
quarterly or whenever events or changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. If indicators of impairment exist, we assess the recoverability of
the affected long-lived assets by determining whether the carrying value of such assets can be
recovered through undiscounted future operating cash flows. If the carrying amount is not
recoverable, we measure the amount of any impairment by comparing the carrying value of the asset
to the present value of the expected future cash flows (fair value) associated with the use of the
asset. If the carrying amount of the asset were determined to be impaired, an impairment loss to
write-down the carrying value of the asset to fair value would be required.
For example, our June 30, 2006 balance sheet reflects $94 million of prepaid royalties related
to our acquisition in February 2004 of Wyeths financial interest in indiplon for approximately
$95.0 million, consisting of $50.0 million in cash and $45.0 million in our common stock. This
transaction decreased our overall royalty obligation on sales of indiplon from six percent to three
and one-half percent. This transaction has been recorded as a long-term asset and will be
amortized over the commercialization period of indiplon, based primarily upon indiplon sales.
Given the FDA letters we received on our NDA submissions for indiplon and the subsequent
cancellation of
the collaboration agreement with Pfizer, we determined that indicators of impairment existed.
We performed the undiscounted cash flow analysis and determined that the carrying value of the
prepaid royalty was recoverable as of June 30, 2006. However, events both within and outside of our
control, such as competition from other insomnia therapeutic agents, disease prevalence, further
FDA actions related to indiplon, and general market conditions may have an impact on our ability to
recover the carrying value of this asset in the future.
If we determine that the sum of the expected future undiscounted cash flows relating to this
prepaid royalty is less than the carrying amount of the asset, the asset would be impaired, and we
would be required to take an impairment loss to write-down the carrying value of the asset to fair
value. A material reduction in earnings resulting from such a charge could cause us to fail to be
profitable in the period in which the charge is taken or otherwise to fail to meet the expectations
of investors and securities analysts, which could cause the price of our stock to decline.
26
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
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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 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.
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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 $9
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. |
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
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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, diabetes, endometriosis, irritable bowel syndrome, pain,
Parkinsons Disease, 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; |
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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. |
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Because of the substantial length of time and expense associated with bringing new products
through the development and regulatory approval processes in order to reach the marketplace, the
pharmaceutical industry places considerable importance on obtaining patent and trade secret
protection for new technologies, products and processes. Accordingly, we intend to seek patent
protection for our proprietary technology and compounds. However, we face the risk that we may not
obtain any of these patents and that the breadth of claims we obtain, if any, may not provide
adequate protection of our proprietary technology or compounds.
We also rely upon unpatented trade secrets and improvements, unpatented know-how and
continuing technological innovation to develop and maintain our competitive position, which we seek
to protect, in part, through confidentiality agreements with our commercial collaborators,
employees and consultants. We also have invention or patent assignment agreements with our
employees and some, but not all, of our commercial collaborators and consultants. However, if our
employees, commercial collaborators or consultants breach these agreements, we may not have
adequate remedies for any such breach, and our trade secrets may otherwise become known or
independently discovered by our competitors.
In addition, although we own a number of patents, the issuance of a patent is not conclusive
as to its validity or enforceability, and third parties may challenge the validity or
enforceability of our patents. We cannot assure you how much protection, if any, will be given to
our patents if we attempt to enforce them and they are challenged in court or in other proceedings.
It is possible that a competitor may successfully challenge our patents or that challenges will
result in limitations of their coverage. Moreover, competitors may infringe our patents or
successfully avoid them through design innovation. To prevent infringement or unauthorized use, we
may need to file infringement claims, which are expensive and time-consuming. In addition, in an
infringement proceeding a court may decide that a patent of ours is not valid or is unenforceable,
or may refuse to stop the other party from using the technology at issue on the grounds that our
patents do not cover its technology. Interference proceedings declared by the United States Patent
and Trademark Office (USPTO) may be necessary to determine the priority of inventions with respect
to our patent applications or those of our licensors. Litigation or interference proceedings may
fail and, even if successful, may result in substantial costs and be a distraction to management.
We cannot assure you that we will be able to prevent misappropriation of our proprietary rights,
particularly in countries where the laws may not protect such rights as fully as in the United
States.
The technologies we use in our research as well as the drug targets we select may infringe the
patents or violate the proprietary rights of third parties.
We cannot assure you that third parties will not assert patent or other intellectual property
infringement claims against us or our 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 indiplon tablets 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 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.
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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 4. SUBMISSIONS OF MATTERS TO A VOTE OF SECURITY HOLDERS
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The Companys Annual Meeting of stockholders was held on June 30, 2006 (the Annual
Meeting). |
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The following Class I Directors were elected at the Annual Meeting: |
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|
|
|
|
Name |
|
Position |
|
Term Expires |
Joseph A. Mollica, Ph.D. |
|
Class I Director |
|
2009 |
Wylie W. Vale, Ph.D. |
|
Class I Director |
|
2009 |
W. Thomas Mitchell |
|
Class I Director |
|
2009 |
The
following Class II and III Directors continue to serve their respective terms which expire on
the Companys Annual Meeting of Stockholders in the years noted:
|
|
|
|
|
Name |
|
Position |
|
Term Expires |
Corinne H. Lyle |
|
Class II Director |
|
2007 |
Richard F. Pops |
|
Class II Director |
|
2007 |
Stephen A. Sherwin, M.D. |
|
Class II Director |
|
2007 |
Gary A. Lyons |
|
Class III Director |
|
2008 |
Adrian Adams |
|
Class III Director |
|
2008 |
|
C. |
|
At the Annual Meeting, stockholders voted on five matters: (i) the election of three
Class I Directors for a term of three years expiring in 2009, (ii) the approval of an
amendment to the Companys Certificate of Incorporation, as amended, to increase the
authorized number of shares of common stock from 50,000,000 shares to 110,000,000 shares,
(iii) the approval of an amendment to the Companys 2003 Incentive Stock Plan, as
amended, and the reservation of an additional 1,000,000 shares of common stock for issuance
thereunder, (iv) the approval of an amendment to the Companys Amended and Restated
Employee Stock Purchase Plan and the reservation of an additional 100,000 shares of common
stock for issuance thereunder, and (v) the ratification of the appointment of Ernst & Young
LLP as the Companys registered independent public accounting firm for the fiscal year
ending December 31, 2006. The stockholders approved all five matters and the voting results
were as follows: |
|
(i) |
|
Election of three Class I Directors |
|
|
|
|
|
Joseph A. Mollica, Ph.D. |
|
For 30,453,120 |
|
Withheld 970,560 |
Wylie W. Vale, Ph.D. |
|
For 30,753,210 |
|
Withheld 670,470 |
W. Thomas Mitchell |
|
For 30,672,705 |
|
Withheld 750,975 |
|
(ii) |
|
Approval of an amendment to the Companys Certificate of Incorporation, as
amended, to increase the authorized number of shares of common stock from 50,000,000 to
110,000000 |
|
|
|
|
|
For 25,351,239 |
|
Against 4,560,323 |
|
Abstain 1,512,117 |
|
(iii) |
|
Approval of an amendment to the Companys 2003 Incentive Stock Plan, as
amended, which increased the number of shares of common stock reserved for issuance
from 3,300,000 to 4,300,000 shares |
|
|
|
|
|
For 16,581,535 |
|
Against 8,126,338 |
|
Abstain 1,483,368 |
|
(iv) |
|
Approval of an amendment to the Companys Amended and Restated Employee Stock
Purchase Plan, which increased the number of shares of common stock reserved for
issuance from 625,000 to 725,000 |
|
|
|
|
|
For 23,537,041 |
|
Against 1,173,348 |
|
Abstain 1,480,852 |
|
(v) |
|
Ratification of the appointment of Ernst and Young LLP as the Companys
independent registered public accounting firm for the fiscal year ending December 31,
2006 |
|
|
|
|
|
For 29,364,431 |
|
Against 554,161 |
|
Abstain 1,505,087 |
33
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(A) EXHIBITS.
|
|
|
3.1
|
|
Restated Certificate of
Incorporation (1) |
|
|
|
3.2
|
|
Certificate of Amendment to Certificate of Incorporation |
|
|
|
3.3
|
|
Bylaws (1) |
|
|
|
3.4
|
|
Certificate of Amendment of Bylaws (1) |
|
|
|
3.5
|
|
Certificate of Amendment of Bylaws dated May 28, 2004 (2) |
|
|
|
10.1
|
|
Neurocrine Biosciences, Inc. 2003 Incentive Stock Plan, as amended,
and Form of Stock Option Agreement (3) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Rules 13a-14(a)
and 15d-14(a) promulgated under the Securities Exchange Act of 1934. |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Rules 13a-14(a)
and 15d-14(a) promulgated under the Securities Exchange Act of 1934. |
|
|
|
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. |
|
|
|
(1) |
|
Incorporated by reference to the Companys Registration Statement on Form S-1
(Registration No. 333-03172) |
|
(2) |
|
Incorporated by reference to the Companys Report on Form 10-Q filed on August 9, 2004 |
|
(3) |
|
Incorporated by reference to the Companys Registration Statement on Form S-8
(Registration No. 333-135909) filed July 21, 2006 |
|
* |
|
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 May 16, 2006, the Company reported under Item 8.01 and 9.01 the status of the Companys
new drug application for indiplon tablets and capsules with the U.S. Food and Drug
Administration.
On June 16, 2006, the Company reported under Item 8.01 and 9.01 to provide an update on the
Companys review of the indiplon action letters and communicate that the Company has
requested a meeting with the Food and Drug Administration.
On June 23, 2006 the Company reported under Items 1.02 and 9.01 to announce that the Company
and Pfizer have agreed to terminate the collaboration agreement to develop and co-promote
indiplon.
34
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.
|
|
|
|
|
|
|
|
Dated: August 7, 2006 |
/s/ Paul W. Hawran
|
|
|
Paul W. Hawran |
|
|
Executive Vice President and
Chief Financial Officer
(Duly authorized Officer and
Principal Financial Officer) |
|
35
Exhibit 3.2
EXHIBIT 3.2
CERTIFICATE OF AMENDMENT
OF
CERTIFICATE OF INCORPORATION
OF
NEUROCRINE BIOSCIENCES, INC.
NEUROCRINE BIOSCIENCES, INC., a corporation organized and existing under and by virtue of the
General Corporation Law of the State of Delaware (the Corporation), DOES HEREBY CERTIFY:
FIRST: That the Board of Directors of the Corporation, by action taken at a duly noticed
meeting, adopted a resolution proposing and declaring advisable that the first paragraph of
Article IV of the Certificate of Incorporation of the Corporation be amended to read in its
entirety as follows:
The Corporation is authorized to issue two classes of shares of stock to be
designated, respectively, Common Stock, $0.001 par value, and Preferred Stock,
$0.001 par value. The total number of shares that the Corporation is authorized to
issue is 115,000,000. The number of shares of Common Stock authorized is
110,000,000. The number of shares of Preferred Stock authorized is 5,000,000.
SECOND: That pursuant to resolutions of its Board of Directors, the amendment proposed was
considered at the next annual meeting of the stockholders of the Corporation. Such meeting
was duly called and held upon notice in accordance with Section 222 of the Delaware General
Corporation Law at which meeting the necessary number of shares as required by statute were
voted in favor of the amendment.
THIRD: That the aforesaid amendment has been duly adopted in accordance with the applicable
provisions of Sections 242 and 222 of the Delaware General Corporation Law.
IN WITNESS WHEREOF, the Corporation has caused this certificate to be signed this 19th day of
July, 2006.
|
|
|
|
|
|
|
|
|
By: |
/s/ MARGARET E. VALUER-JENSEN
|
|
|
|
Margaret E. Valeur-Jensen |
|
|
|
Executive Vice President, Secretary and General Counsel |
|
|
Exhibit 31.1
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences, Inc., certify
that:
1. |
|
I have reviewed this quarterly report on Form 10-Q of Neurocrine Biosciences, Inc.; |
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
|
3. |
|
Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
|
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during this period in which this report is being
prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused such internal control
over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting
principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
d) |
|
Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over financial
reporting; and |
5. |
|
The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of 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): |
|
a) |
|
All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other employees who have
a significant role in the registrants internal controls over financial reporting. |
|
|
|
|
|
|
|
|
Dated: August 7, 2006 |
/s/ Gary A. Lyons
|
|
|
Gary A. Lyons |
|
|
President and Chief Executive Officer |
|
Exhibit 31.2
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT
TO SECTION 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. |
|
I have reviewed this quarterly report on Form 10-Q of Neurocrine Biosciences, Inc.; |
|
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
|
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods
presented in this report; |
|
|
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
|
a) |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during this period in which
this report is being prepared; |
|
|
b) |
|
Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
|
|
c) |
|
Evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
d) |
|
Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and |
|
5. |
|
The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of 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): |
|
a) |
|
All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
|
|
b) |
|
Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal controls over financial reporting. |
|
|
|
|
|
|
|
|
Dated: August 7, 2006 |
/s/ Paul W. Hawran
|
|
|
Paul W. Hawran |
|
|
Executive Vice President and
Chief Financial Officer |
|
Exhibit 32
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 June 30, 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) |
|
The Report fully complies with the requirements of Section 13(a) or 15(d), of the
Securities Exchange Act of 1934; and |
|
|
(2) |
|
That information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company. |
|
|
|
|
|
|
|
|
August 7, 2006 |
By: |
/s/ Gary A. Lyons
|
|
|
|
Name: |
Gary A. Lyons |
|
|
|
Title: |
President and Chief Executive Officer |
|
|
In connection with the Quarterly Report of Neurocrine Biosciences, Inc. (the Company) on
Form 10-Q for the period ended June 30, 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) |
|
The Report fully complies with the requirements of Section 13(a) or 15(d), of the
Securities Exchange Act of 1934; and |
|
|
(4) |
|
That information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company. |
|
|
|
|
|
|
|
|
August 7, 2006 |
By: |
/s/ Paul W. Hawran
|
|
|
|
Name: |
Paul W. Hawran |
|
|
|
Title: |
Executive Vice President and
Chief Financial Officer |
|
|