e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________ to _________
Commission file number: 001-34637
ANTHERA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
(State or Other Jurisdiction of Incorporation or Organization)
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20-1852016
(I.R.S. Employer Identification No.) |
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25801 Industrial Boulevard, Suite B |
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Hayward, California
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94545 |
(Address of Principal Executive Offices)
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(Zip Code) |
(510) 856-5600
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ Noo
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes o No þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer o |
Accelerated filer o |
Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of May 4, 2011, the number of outstanding shares of the registrants common stock, par
value $0.001 per share, was 32,974,267.
ANTHERA PHARMACEUTICALS, INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2011
INDEX
2
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ANTHERA PHARMACEUTICALS, INC
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(unaudited)
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March 31, |
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December 31, |
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2011 |
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2010 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
66,557,789 |
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$ |
40,029,972 |
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Short term investments |
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11,982,185 |
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23,350,922 |
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Prepaid expenses and other current assets |
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1,231,693 |
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1,864,883 |
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Total current assets |
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79,771,667 |
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65,245,777 |
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Property and equipment net |
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1,325,478 |
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17,285 |
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Debt issuance costs |
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348,230 |
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TOTAL |
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$ |
81,445,375 |
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$ |
65,263,062 |
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
7,664,486 |
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$ |
3,791,693 |
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Accrued
clinical studies |
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8,159,476 |
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3,136,786 |
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Accrued liabilities |
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475,473 |
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467,817 |
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Accrued payroll and related costs |
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471,276 |
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609,086 |
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Total current liabilities |
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16,770,711 |
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8,005,382 |
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Notes payable net of discount |
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23,719,801 |
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Total liabilities |
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40,490,512 |
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8,005,382 |
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Commitments and Contingencies |
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Stockholders equity (deficit) |
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Preferred stock, $0.001 par value, 5,000,000 shares
authorized, 0 shares issued and outstanding as of
March 31, 2011 and December 31, 2010 |
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Common stock, $0.001 par value, 95,000,000 shares
authorized; 32,909,914 and 32,853,032 shares issued
and outstanding as of March 31, 2011 and December
31, 2010, respectively |
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32,909 |
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32,853 |
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Additional paid-in capital |
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164,839,927 |
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162,919,216 |
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Accumulated comprehensive income (loss) |
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291,499 |
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(50,622 |
) |
Deficit accumulated the during the development stage |
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(124,209,472 |
) |
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(105,643,767 |
) |
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Total stockholders equity |
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40,954,863 |
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57,257,680 |
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TOTAL |
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$ |
81,445,375 |
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$ |
65,263,062 |
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See accompanying notes to condensed financial statements.
3
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
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Cumulative |
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Period from |
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September 9, |
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2004 |
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(Date of |
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Inception) to |
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Three Months Ended March 31, |
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March 31, |
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2011 |
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2010 |
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2011 |
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OPERATING EXPENSES: |
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Research and development |
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$ |
16,316,758 |
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$ |
5,241,814 |
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$ |
97,097,481 |
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General and administrative |
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2,339,882 |
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1,224,110 |
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18,558,298 |
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Total operating expenses |
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18,656,640 |
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6,465,924 |
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115,655,779 |
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LOSS FROM OPERATIONS |
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(18,656,640 |
) |
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(6,465,924 |
) |
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(115,655,779 |
) |
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OTHER INCOME (EXPENSE): |
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Other expense and interest income, net |
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90,935 |
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(841,377 |
) |
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(448,658 |
) |
Mark-to-market adjustment of warrant liability |
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(3,796,491 |
) |
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(3,796,491 |
) |
Beneficial conversion features |
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(4,308,544 |
) |
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Total other income (expense) |
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90,935 |
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(4,637,868 |
) |
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(8,553,693 |
) |
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NET LOSS |
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$ |
(18,565,705 |
) |
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$ |
(11,103,792 |
) |
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$ |
(124,209,472 |
) |
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Net loss per share basic and diluted |
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$ |
(0.56 |
) |
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$ |
(0.83 |
) |
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Weighted-average number of shares used in per
share calculation basic and diluted |
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32,895,152 |
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13,344,231 |
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See accompanying notes to condensed financial statements.
4
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
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September 9, |
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2004 |
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(Date of |
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Inception) to |
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Three Months Ended March 31, |
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March 31, |
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2011 |
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2010 |
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2011 |
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CASH FLOW FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
(18,565,705 |
) |
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$ |
(11,103,792 |
) |
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$ |
(124,209,472 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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4,556 |
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3,270 |
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94,164 |
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Amortization of premium/(discount) on short-term investments |
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74,061 |
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45,929 |
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Realized loss on short-term investments |
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8,682 |
|
Realized gain from disposal of property and equipment |
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(214 |
) |
Stock-based compensation expense |
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587,698 |
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52,616 |
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1,924,852 |
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Issuance of common stock for consulting service |
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41,366 |
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Issuance of preferred and common stock for service and license fee |
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3,500,000 |
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5,750,000 |
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Issuance of preferred stock in lieu of interest payment |
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173,194 |
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330,575 |
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Beneficial conversion feature |
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4,308,544 |
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Amortization of discount on convertible promissory notes |
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540,993 |
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677,715 |
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Amortization of discount on term loan |
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15,095 |
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15,095 |
|
Amortization of debt issuance costs |
|
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2,788 |
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|
227,955 |
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|
310,387 |
|
Mark-to-market adjustment on warrant liability |
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3,796,491 |
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3,795,776 |
|
Changes in assets and liabilities: |
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Prepaid expenses and other assets |
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633,190 |
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(339,427 |
) |
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(1,231,695 |
) |
Accounts payable |
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2,566,210 |
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(103,890 |
) |
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6,615,264 |
|
Accrued
clinical studies |
|
|
5,022,690 |
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|
(242,336 |
) |
|
|
8,159,476 |
|
Accrued liabilities |
|
|
(56,626 |
) |
|
|
(34,662 |
) |
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|
404,343 |
|
Accrued payroll and related costs |
|
|
(137,810 |
) |
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|
25,922 |
|
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|
471,276 |
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Net cash used in operating activities |
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(9,853,853 |
) |
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(3,503,666 |
) |
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(92,487,937 |
) |
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INVESTING ACTIVITIES: |
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Property and equipment purchases |
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(5,746 |
) |
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(107,079 |
) |
Proceeds from disposal of property and equipment |
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|
400 |
|
Purchase of short-term investments |
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(1,996,000 |
) |
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(41,745,256 |
) |
Proceeds from sale of short-term investments |
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13,318,014 |
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29,850,146 |
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Restricted cash |
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Net cash provided by (used in) investing activities |
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11,322,014 |
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(5,746 |
) |
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(12,001,789 |
) |
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FINANCING ACTIVITIES: |
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Proceeds from issuance of convertible notes |
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26,560,000 |
|
Proceeds from issuance of term loan |
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25,000,000 |
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|
25,000,000 |
|
Payment of debt issuance costs |
|
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(291,500 |
) |
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|
(2,572 |
) |
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|
(599,099 |
) |
Net proceeds from issuance of preferred stock |
|
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|
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|
32,210,278 |
|
Payment of
financing costs for initial public and private offering |
|
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(13,818 |
) |
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|
(850,416 |
) |
|
|
(3,533,957 |
) |
Proceeds from issuance of common stock |
|
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|
57,202,972 |
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|
90,789,015 |
|
Proceeds from issuance of common stock pursuant to employee stock purchase
plan |
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|
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|
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|
81,226 |
|
Proceeds from exercise of stock options |
|
|
50,192 |
|
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|
17,653 |
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|
|
390,236 |
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|
|
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|
Net cash provided by financing activities |
|
|
24,744,874 |
|
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|
56,367,637 |
|
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|
170,897,699 |
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|
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|
Effect of exchange rate changes on cash |
|
|
314,782 |
|
|
|
|
|
|
|
149,816 |
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
26,527,817 |
|
|
|
52,858,225 |
|
|
|
66,557,789 |
|
CASH AND CASH EQUIVALENTS Beginning of period |
|
|
40,029,972 |
|
|
|
3,803,384 |
|
|
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CASH AND CASH EQUIVALENTS End of period |
|
$ |
66,557,789 |
|
|
$ |
56,661,609 |
|
|
$ |
66,557,789 |
|
|
|
|
|
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|
SUPPLEMENTAL CASH DISCLOSURES OF CASH FLOW INFORMATION: |
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|
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Interest paid |
|
$ |
|
|
|
$ |
|
|
|
$ |
15,229 |
|
|
|
|
|
|
|
|
|
|
|
Taxes paid |
|
$ |
|
|
|
$ |
10,136 |
|
|
$ |
52,746 |
|
|
|
|
|
|
|
|
|
|
|
NONCASH INVESTING AND FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of convertible promissory notes and accrued interest into
common stock, Series A-2 convertible preferred stock and Series B-2
convertible preferred stock |
|
$ |
|
|
|
$ |
13,709,918 |
|
|
$ |
27,200,493 |
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature |
|
$ |
|
|
|
$ |
|
|
|
$ |
4,308,544 |
|
|
|
|
|
|
|
|
|
|
|
Unamortized debt discount charged to equity in conjunction with conversion
of promissory notes into common stock |
|
$ |
|
|
|
$ |
185,833 |
|
|
$ |
185,883 |
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrant and derivative liabilities to additional
paid-in capital |
|
$ |
|
|
|
$ |
406,130 |
|
|
$ |
406,130 |
|
|
|
|
|
|
|
|
|
|
|
Issuance costs charged to equity |
|
$ |
|
|
|
$ |
3,021,966 |
|
|
$ |
3,564,932 |
|
|
|
|
|
|
|
|
|
|
|
Accrued and deferred financing and debt issuance costs |
|
$ |
78,700 |
|
|
$ |
982,504 |
|
|
$ |
78,700 |
|
|
|
|
|
|
|
|
|
|
|
Liability accrued for equipment purchases |
|
$ |
1,312,748 |
|
|
$ |
|
|
|
$ |
1,312,748 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed financial statements.
5
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
NOTES TO THE CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES
Organization
Anthera Pharmaceuticals, Inc. (the Company or Anthera) was incorporated on September 9,
2004 in the state of Delaware. During 2006, the Company opened its headquarters in San Mateo,
California, and subsequently moved to Hayward, California. Anthera is a biopharmaceutical company
focused on developing and commercializing therapeutics to treat serious diseases associated with
inflammation, including cardiovascular and autoimmune diseases. Two of the Companys primary
product candidates, varespladib and A-001, are inhibitors of the family of human enzymes known as
secretory phospholipase A2, or sPLA2. The Companys other primary product
candidate, A-623, targets elevated levels of B-cell activating factor, or BAFF. The Companys
activities since inception have consisted principally of acquiring product and technology rights,
raising capital, and performing research and development. Accordingly, the Company is considered to
be in the development stage as of March 31, 2011. Successful completion of the Companys
development programs and, ultimately, the attainment of profitable operations are dependent on
future events, including, among other things, its ability to access potential markets; secure
financing; develop a customer base; attract, retain and motivate qualified personnel; generate
revenues; and develop strategic alliances. Although management believes that the Company will be
able to successfully fund its operations, there can be no assurance that the Company will be able
to do so or that the Company will ever operate profitably.
From September 9, 2004 (Date of Inception) through March 31, 2010, the Company had an
accumulated a deficit of $124.2 million. During the three months ended March 31, 2011, the Company
incurred a net loss of $18.6 million and had negative cash flows from operations of $9.9 million.
The Company expects to continue to incur substantial losses and negative cash flows over the next
several years during its clinical development phase. To fully execute its business plan, the
Company will need to complete certain research and development activities and clinical studies.
Further, the Companys product candidates will require regulatory approval prior to
commercialization. These activities may span many years and require substantial expenditures to
complete and may ultimately be unsuccessful. Any delays in completing these activities could
adversely impact the Company. The Company plans to meet its capital requirements primarily through
issuances of equity securities, debt financing, and in the longer term, revenue from product sales.
Failure to generate revenue or raise additional capital would adversely affect the Companys
ability to achieve its intended business objectives.
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in conformity
with accounting principles generally accepted in the United States (U. S. GAAP) for interim
financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not contain all of the information and footnotes required for complete
financial statements. In the opinion of management, the accompanying unaudited condensed financial
statements reflect all adjustments, which include only normal recurring adjustments necessary to
present fairly the Companys interim consolidated financial information. The results for the three
months ended March 31, 2011 are not necessarily indicative of the results to be expected for the
year ending December 31, 2011 or for any other period. The condensed balance sheet as of December
31, 2010 has been derived from the audited financial statements as of that date but it does not
include all of the information and notes required by U.S. GAAP. The accompanying unaudited
condensed financial statements and notes thereto should be read in conjunction with the audited
financial statements and notes thereto included in our Annual Report on Form 10-K for the year
ended December 31, 2010, filed with the Securities and Exchange Commission (SEC) on March 7,
2011.
Significant Accounting Policies
There have been no changes in our significant accounting policies for the three month period
ended March 31, 2011, as compared to the significant accounting policies described in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2010.
Use of Estimates
The preparation of these financial statements in conformity with U.S. GAAP requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and
related disclosures. On an ongoing basis, management evaluates its estimates, including critical
accounting policies or estimates related to clinical trial accruals, our tax provision and
stock-based compensation. The Company bases its estimates on historical experience and on various
other market specific and other relevant
6
assumptions that it believes 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 significantly from these
estimates.
2. NET LOSS PER SHARE
Basic net loss attributable to common stockholders per share is computed by dividing income
available to common stockholders by the weighted-average number of common shares outstanding during
the period. Shares issued during the period and shares reacquired during the period are weighted
for the portion of the period that they were outstanding. The computation of diluted net loss per
share is similar to the computation of basic net loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the
dilutive potential common shares had been issued. In addition, in computing the dilutive effect of
convertible securities, the numerator is adjusted to add back any convertible preferred dividends
and the after-tax amount of interest recognized in the period associated with any convertible debt.
The numerator also is adjusted for any other changes in income or loss that would result from the
assumed conversion of those potential common shares, such as profit-sharing expenses. Diluted net
loss per share is identical to basic net loss per share since common equivalent shares are excluded
from the calculation, as their effect is anti-dilutive.
The following table summarizes the Companys calculation of net loss per common share for the
three months ended March 31, 2011 and 2010:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
Net loss per share |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(18,565,705 |
) |
|
$ |
(11,103,792 |
) |
Weighted-average common shares outstanding |
|
|
32,917,289 |
|
|
|
13,357,149 |
|
Less: Weighted-average shares subject to repurchase |
|
|
(22,137 |
) |
|
|
(12,918 |
) |
|
|
|
|
|
|
|
Total basic and diluted net loss per share |
|
|
32,895,152 |
|
|
|
13,344,231 |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.56 |
) |
|
$ |
(0.83 |
) |
|
|
|
|
|
|
|
The following table shows weighted-average historical dilutive common share equivalents
outstanding for the three months ended March 31, 2011 and 2010, which are not included in the above
calculation, as the effect of their inclusion is anti-dilutive during each period.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
Options to purchase common stock |
|
|
940,430 |
|
|
|
1,102,614 |
|
Common stock subject to repurchase |
|
|
22,137 |
|
|
|
12,918 |
|
Warrants to purchase common stock |
|
|
4,582,136 |
(2) |
|
|
493,268 |
(1) |
Restricted stock units |
|
|
302,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,844,903 |
|
|
|
1,608,800 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The warrants were exercised upon the closing of the Companys initial public offering (IPO) in March 2010. |
|
(2) |
|
Consists of 357,136 warrants which carry a contractual term of five years and terminate upon the earlier of
i) five years from the date of issuance, which will be July 17, 2014 or September 9, 2014, and ii) upon
certain corporate transactions; 4,200,000 warrants which carry a contractual term of five years expiring
September 24, 2015 and 25,000 warrants which carry a contractual term of seven years expiring March 25,
2018. Each of the warrants contains a customary net issuance feature, which allows the warrant holder to
pay the exercise price of the warrant by forfeiting a portion of the executed warrant shares with a value
equal to the aggregate exercise price. |
7
3. CASH EQUIVALENTS AND INVESTMENTS
At March 31, 2011 and December 31, 2010, the amortized cost and estimated fair value of
investments is set forth in the following tables:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Losses |
|
|
Fair Value |
|
Cash |
|
$ |
44,860,866 |
|
|
$ |
|
|
|
$ |
44,860,866 |
|
Money market funds |
|
|
16,514,928 |
|
|
|
|
|
|
|
16,514,928 |
|
Certificates of deposit |
|
|
11,989,000 |
|
|
|
(6,815 |
) |
|
|
11,982,185 |
|
Investments in foreign sovereign debt |
|
|
5,186,304 |
|
|
|
(4,309 |
) |
|
|
5,181,995 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
78,551,098 |
|
|
|
(11,124 |
) |
|
|
78,539,974 |
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash and cash equivalents |
|
|
(66,562,098 |
) |
|
|
4,309 |
|
|
|
(66,557,789 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
11,989,000 |
|
|
$ |
(6,815 |
) |
|
$ |
11,982,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Losses |
|
|
Fair Value |
|
Cash |
|
$ |
15,499,182 |
|
|
$ |
|
|
|
$ |
15,499,182 |
|
Money market funds |
|
|
19,467,096 |
|
|
|
|
|
|
|
19,467,096 |
|
Certificates of deposit |
|
|
14,478,000 |
|
|
|
(6,765 |
) |
|
|
14,471,235 |
|
Corporate bonds |
|
|
4,010,563 |
|
|
|
(83 |
) |
|
|
4,010,480 |
|
Investments in foreign sovereign debt |
|
|
10,017,010 |
|
|
|
(84,109 |
) |
|
|
9,932,901 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
63,471,851 |
|
|
|
(90,957 |
) |
|
|
63,380,894 |
|
|
|
|
|
|
|
|
|
|
|
Less amounts classified as cash and cash equivalents |
|
|
(40,045,129 |
) |
|
|
15,157 |
|
|
|
(40,029,972 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
23,426,722 |
|
|
$ |
(75,800 |
) |
|
$ |
23,350,922 |
|
|
|
|
|
|
|
|
|
|
|
4. FAIR VALUE OF INSTRUMENTS
Pursuant to the accounting guidance for fair value measurement and its subsequent updates,
fair value is defined as the price that would be received to sell an asset or paid to transfer a
liability (i.e., the exit price) in an orderly transaction between market participants at the
measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair
value that minimizes the use of unobservable inputs by requiring the use of observable market data
when available. Observable inputs are inputs that market participants would use in pricing the
asset or liability based on active market data. Unobservable inputs are inputs that reflect the
assumptions market participants would use in pricing the asset or liability based on the best
information available in the circumstances.
The fair value hierarchy is broken down into the three input levels summarized below:
|
|
|
Level 1 Valuations are based on quoted prices in active markets for identical assets
or liabilities, and readily accessible by us at the reporting date. Examples of assets and
liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and
trading securities with quoted prices on active markets. |
|
|
|
|
Level 2 Valuations based on inputs other than the quoted prices in active markets that
are observable either directly or indirectly in active markets. Examples of assets and
liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds,
commercial paper, certificates of deposit and over-the-counter derivatives. |
|
|
|
|
Level 3 Valuations based on unobservable inputs in which there is little or no market
data, which require us to develop our own assumptions. Examples of assets and liabilities
utilizing Level 3 inputs are cost method investments, auction rate securities (ARS) and the
Primary Fund. |
8
The following tables present the Companys fair value hierarchy for all its financial assets
(including those in cash and cash equivalents), by major security type measured at fair value on a
recurring basis as of March 31, 2011 and December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
|
|
Estimated |
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Money market funds |
|
$ |
16,514,928 |
|
|
$ |
16,514,928 |
|
|
$ |
|
|
|
$ |
|
|
Certificates of deposit |
|
|
11,982,185 |
|
|
|
|
|
|
|
11,982,185 |
|
|
|
|
|
Investments in foreign sovereign debt |
|
|
5,181,995 |
|
|
|
|
|
|
|
5,181,995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
33,679,108 |
|
|
$ |
16,514,928 |
|
|
$ |
17,164,180 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
|
Estimated |
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Money market funds |
|
$ |
19,467,096 |
|
|
$ |
19,467,096 |
|
|
$ |
|
|
|
$ |
|
|
Certificates of deposit |
|
|
14,471,235 |
|
|
|
|
|
|
|
14,471,235 |
|
|
|
|
|
Corporate bonds |
|
|
4,010,480 |
|
|
|
|
|
|
|
4,010,480 |
|
|
|
|
|
Investments in foreign sovereign debt |
|
|
9,932,901 |
|
|
|
|
|
|
|
9,932,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
47,881,712 |
|
|
$ |
19,467,096 |
|
|
$ |
28,414,616 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company did not have any non-financial assets or non-financial liabilities that were
required to be measured at fair value as of March 31, 2011 and December 31, 2010.
5. PROPERTY AND EQUIPMENT
Property and equipment are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
Computers and software |
|
$ |
77,318 |
|
|
$ |
77,318 |
|
Office equipment and furniture |
|
|
16,730 |
|
|
|
16,730 |
|
Leasehold improvements |
|
|
10,802 |
|
|
|
10,802 |
|
Construction in progress |
|
|
1,312,749 |
|
|
|
|
|
|
|
|
|
|
|
|
Total property and equipment |
|
|
1,417,599 |
|
|
|
104,850 |
|
Less accumulated depreciation |
|
|
(92,121 |
) |
|
|
(87,565 |
) |
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
1,325,478 |
|
|
$ |
17,285 |
|
|
|
|
|
|
|
|
6. COMMITMENTS AND CONTINGENCIES
In July 2006, the Company entered into a license agreement with Shionogi & Co., Ltd. and Eli
Lilly and Company, or Eli Lilly, to develop and commercialize certain sPLA2 inhibitors
for the treatment of inflammatory diseases. The agreement granted the Company commercialization
rights to Shionogi & Co., Ltd.s and Eli Lillys sPLA2 inhibitors, including varespladib
and A-001. Under the terms of the agreement, the Companys license is worldwide, with the exception
of Japan where Shionogi & Co., Ltd. has retained rights. Pursuant to this license agreement, the
Company paid Shionogi & Co., Ltd. and Eli Lilly a one-time license initiation fee of $250,000 in
the aggregate. Additionally, in consideration for the licensed technology, the Company issued an
aggregate of 257,744 shares of Series A-2 convertible preferred stock at $5.14 per share and an
aggregate of 127,297 shares of Series B-1 convertible preferred stock at $7.28 per share with a
total aggregate value of $2.3 million to Shionogi & Co., Ltd. and Eli Lilly. As there is no future
alternative use for the technology, the Company recorded the initiation and license fees in
research and development expenses during 2006. In March 2010, the Company paid $1.75 million each
to Eli Lilly and Shionogi & Co., Ltd. in the form of the Companys common stock upon the
commencement of the Companys Phase 3 VISTA-16 study of varespladib.
The Company is obligated to make additional milestone payments of up to $97.5 million upon the
achievement of certain development and regulatory milestones. The Company is also obligated to pay
tiered royalties, which increase as a percentage from the mid-single digits to the low double
digits as net sales increase, on future net sales of products that are developed and approved as
defined by this collaboration. The Companys obligation to pay royalties with respect to each
licensed product in each country will expire upon the later of (a) 10 years following the date of
the first commercial sale of such licensed product in such country and (b) the first date on which
generic version(s) of the applicable licensed product achieve a total market share, in the
aggregate, of 25% or more of the total unit sales of wholesalers to pharmacies of licensed product and all generic
versions combined in the applicable country.
9
On December 18, 2007, the Company entered into with Amgen, Inc. (Amgen), a worldwide,
exclusive license agreement, or the Amgen Agreement, to develop and commercialize A-623 for the
treatment of systemic lupus erythematosus (lupus). Under the terms of the Amgen Agreement, the
Company paid a nonrefundable, upfront license fee of $6.0 million. As there is no future
alternative use for the technology, the Company expensed the license fee in research and
development expenses during 2007.
Under the terms of the Amgen Agreement, the Company is obligated to make additional milestone
payments to Amgen of up to $33.0 million upon the achievement of certain development and regulatory
milestones. The Company is also obligated to pay tiered royalties on future net sales of products,
ranging from the high single digits to the low double digits, which are developed and approved as
defined by this collaboration. The Companys royalty obligations as to a particular licensed
product will be payable, on a country-by-country and licensed product-by-licensed product basis,
for the longer of (a) the date of expiration of the last to expire valid claim within the licensed
patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product
by the Company or a sublicense in such country or (b) 10 years after the first commercial sale of
the applicable licensed product in the applicable country. There were no outstanding obligations
due to Amgen as of March 31, 2011.
7. COMPREHENSIVE LOSS
Comprehensive loss is comprised of net loss and certain changes in equity that are excluded
from net loss. Components of comprehensive loss include unrealized gains on available-for-sale
securities, and unrealized gains related to foreign currency transactions. The components of
comprehensive loss are as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
Net loss |
|
$ |
(18,565,705 |
) |
|
$ |
(11,103,792 |
) |
Unrealized gain on available-for-sale securities |
|
|
1,268 |
|
|
|
|
|
Foreign currency translation adjustments |
|
|
340,852 |
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(18,223,585 |
) |
|
$ |
(11,103,792 |
) |
|
|
|
|
|
|
|
8. DEBT FINANCING
Term Loan Agreement
Hercules Technology Growth Capital
In March 2011, the Company entered into a Loan and Security Agreement (Loan Agreement) with
Hercules Technology Growth Capital, Inc. and Hercules Technology II, L.P. (together, Hercules).
Under the terms of the Loan Agreement, the Company borrowed $25.0 million at an interest rate of
the higher of (i) 10.55% or (ii) 7.30% plus the prime rate as reported in the Wall Street Journal,
and issued to Hercules a secured term promissory note evidencing the loan. The loan is secured by
the Companys assets, excluding intellectual property. The Company will make interest only payments
for the initial 12 months, which will be extended an additional three months if (a) positive
biomarker analysis results are obtained from VISTA-16 Phase III FDA Clinical Trial on or before
July 31, 2011, and (b) full enrollment of the PEARL-SC Phase 2b FDA Clinical Trial is obtained on
or before March 31, 2012. The Company obtained positive biomarker analysis results on April 18,
2011. Thereafter, the loan will be repaid in 30 equal monthly installments of approximately
$952,000, at the initial interest rate. The Company will also be obligated to pay an end of the
term charge of $937,500, which will be expensed over the term of the
Loan Agreement using the effective interest rate.
The Loan Agreement limits both the seniority and amount of future debt the Company may incur.
The Company may be required to prepay the loan in the event of a change in control. In conjunction
with the loan, the Company issued a seven-year warrant to purchase 321,429 shares of the Companys
common stock at an exercise price of $6.00 per share. The warrant is immediately exercisable and
expires March 2018. The Company estimated the fair value of this warrant using the Black-Scholes
option valuation model with the following assumptions: expected term of seven years, a risk-free
interest rate of 2.87%, expected volatility of 63% and 0% expected dividend yield.
The Company applied the relative fair value method, described in ASC 470-20-30-1, to
allocate the $25.0 million proceeds received under the Loan Agreement between the loan and warrant.
The initial carrying amount
assigned to the loan was $23.7 million and was recorded as the Notes payable net of
discount on the Companys balance sheets. The fair value allocated to the warrant of $1.3 million
was recorded as an increase to additional paid-in capital in the Companys balance sheets. The
resulting $1.3 million discount from the $25.0 million par value of the loan will be amortized as
an additional interest expense over the term of the loan using the
effective interest rate method. At
March 31, 2011, this warrant remained outstanding and exercisable.
10
In connection with the Loan Agreement, the Company incurred note issuance costs of
approximately $370,200, which are recorded as long-term assets on the Companys balance sheet. The
note issuance costs are being amortized to interest expense over the term of the Loan Agreement
using the effective interest rate method.
9. STOCKHOLDERS EQUITY
Option Plans
At March 31, 2011, the Company had the following plans that give rise to share-based
compensation: (i) two stock option plans, the 2005 Equity and Incentive Plan (the 2005 Plan),
and the 2010 Stock Option and Incentive Plan (the 2010 Plan), and (ii) the 2010 Employee Stock
Purchase Plan. The terms of awards granted during the three months ended March 31, 2011 and the
methods for determining grant-date fair value of the awards were consistent with those described in
the financial statements included in the Companys Annual Report on Form 10-K for the year ended
December 31, 2010.
On January 1, 2011, in accordance with the 2010 Plan annual increase provisions, the
authorized shares in the 2010 Plan increased by 1,315,214.
The following table summarizes stock option activity under the Companys share-based
compensation plans for the three months ended March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
Weighted- |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number of |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
Options |
|
Price |
|
Life in Years |
|
Value |
Balance at December 31, 2010 |
|
|
1,275,991 |
|
|
$ |
1.26 |
|
|
|
7.07 |
|
|
$ |
4,700,543 |
|
Granted |
|
|
988,000 |
|
|
$ |
5.03 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(35,747 |
) |
|
$ |
1.40 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(13,313 |
) |
|
$ |
2.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2011 |
|
|
2,214,931 |
|
|
$ |
2.93 |
|
|
|
8.02 |
|
|
$ |
8,471,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at March 31, 2011 |
|
|
1,080,275 |
|
|
$ |
1.08 |
|
|
|
6.50 |
|
|
$ |
6,141,662 |
|
Vested and expected to vest at March 31, 2011 |
|
|
2,214,931 |
|
|
$ |
2.93 |
|
|
|
8.02 |
|
|
$ |
8,471,231 |
|
The intrinsic value of stock options represents the difference between the exercise price of
stock options and the market price of our stock on that day for all in-the-money options.
Additional information related to our stock options is summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
September 9, |
|
|
|
|
|
|
|
|
|
|
2004 (Date of |
|
|
|
|
|
|
|
|
|
|
Inception) to |
|
|
Three Months Ended March 31, |
|
March 31, |
|
|
2011 |
|
2010 |
|
2011 |
Intrinsic value of options exercised |
|
$ |
151,680 |
|
|
$ |
126,868 |
|
|
$ |
979,879 |
|
Proceeds received from the exercise of stock options |
|
$ |
50,192 |
|
|
$ |
17,653 |
|
|
$ |
395,343 |
|
Grant date fair value of options vested |
|
$ |
130,465 |
|
|
$ |
36,683 |
|
|
$ |
953,099 |
|
As of March 31, 2011 there were 400,916 shares available for future issuance under the 2010
Plan.
Restricted Stock Units
The Company grants restricted stock unit awards under its 2010 Plan, as determined by the
Companys compensation committee, which are issued upon vesting. The restricted stock units granted
represent a right to receive shares of common stock at a future date determined in accordance with
the participants award agreement. An exercise price and monetary payment are not required for
receipt of restricted stock units or the shares issued in settlement of the award. Instead,
consideration is furnished in the form of the participants services to the Company. Substantially
all of the restricted stock units vest over four years.
11
The following table summarizes activity related to our restricted stock units:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant |
|
|
|
|
|
|
Date Fair |
|
|
Shares |
|
Value |
Outstanding at December 31, 2010 |
|
|
302,500 |
|
|
$ |
5.13 |
|
Restricted stock units granted |
|
|
10,000 |
|
|
$ |
4.88 |
|
Restricted stock units released |
|
|
(10,000 |
) |
|
$ |
4.88 |
|
Restricted stock units forfeitures and cancellations |
|
|
(4,500 |
) |
|
$ |
4.84 |
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2011 |
|
|
298,000 |
|
|
$ |
5.13 |
|
|
|
|
|
|
|
|
|
|
2010 Employee Stock Purchase Plan
Effective July 2010, under the 2010 Employee Stock Purchase Plan (the ESPP), eligible
employees of the Company may authorize the Company to deduct amounts from their compensation, which
amounts are used to enable the employees to purchase shares of the Companys common stock. The
Company initially reserved 100,000 shares of common stock for issuance thereunder plus on January
1, 2011 and each January 1 thereafter, the number of shares of stock reserved and available for
issuance under the Plan shall be cumulatively increased by the lesser of (i) one percent (1%) of
the number of shares of common stock issued and outstanding on the immediately preceding December
31 or (ii) 250,000 shares of common stock. On January 1, 2011, in accordance with the ESPPs
annual increase provisions, the authorized shares in the ESPP increased by 250,000.
The purchase price per share is 85% of the fair market value of the common stock as of the
first date or the ending date of the applicable semi-annual purchase period, whichever is less.
Purchases are generally made on the last trading day of each June and December. As of March 31,
2011, the Company received $27,723 in contributions for the ESPP. There were no shares issued
under the ESPP during the three month period ended March 31, 2011. As of March 31, 2011, 325,084
shares were available for future purchase under the ESPP.
Stock-Based Compensation
The employee stock-based compensation expense was determined using the Black-Scholes option
pricing model. Option pricing models require the input of subjective assumptions and these
assumptions can vary over time.
The estimated grant date fair values of the employee stock options and stock purchase rights
were calculated using the Black-Scholes option-pricing model with assumptions as follows:
Stock Option Plans
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
September 9, |
|
|
|
|
|
|
|
|
|
|
2004 (Date of |
|
|
|
|
|
|
|
|
|
|
Inception) to |
|
|
Three Months Ended March 31, |
|
March 31, |
|
|
2011 |
|
2010 |
|
2011 |
Expected Volatility |
|
|
63 |
% |
|
|
89 |
% |
|
|
74 |
% |
Dividend Yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
Risk-Free Interest Rate |
|
|
2.37 |
% |
|
|
3.02 |
% |
|
|
3.41 |
% |
Expected Term (years) |
|
|
6.25 |
|
|
|
6.25 |
|
|
|
6.25 |
|
12
ESPP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
September 9, |
|
|
|
|
|
|
2004 (Date of |
|
|
|
|
|
|
Inception) to |
|
|
Three Months ended |
|
March 31, |
|
|
March 31, 2011 |
|
2011 |
Expected Volatility |
|
|
54 |
% |
|
|
64 |
% |
Dividend Yield |
|
|
0 |
% |
|
|
0 |
% |
Risk-Free Interest Rate |
|
|
0.16 |
% |
|
|
0.16 |
% |
Expected Term (years) |
|
|
0.5 |
|
|
|
0.5 |
|
Restricted Stock Units
Compensation cost for these awards is based on the closing price of the Companys common stock on
the date of grant and recognized as compensation expense on a straight-line basis over the
requisite service period.
Stock-Compensation Summary
Compensation cost for stock options granted to employees is based on the grant-date fair value
and is recognized over the vesting period of the applicable option on a straight-line basis. The
estimated per share weighted-average fair value of stock options granted to employees during the
three months ended March 31, 2011 and 2010 and for the period from September 4, 2004 (Date of
Inception) to March 31, 2011 was $3.02, $5.30 and $1.31 respectively.
Total stock-based compensation expense for equity awards granted to employees and
non-employees recognized was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
September 9, |
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of |
|
|
|
|
|
|
|
|
|
|
|
Inception) to |
|
|
|
Three Months Ended March 31, |
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
Research and development |
|
$ |
235,890 |
|
|
$ |
20,231 |
|
|
$ |
678,391 |
|
General and administrative |
|
|
351,808 |
|
|
|
32,385 |
|
|
|
1,246,461 |
|
|
|
|
|
|
|
|
|
|
|
Total employee stock-based compensation |
|
$ |
587,698 |
|
|
$ |
52,616 |
|
|
$ |
1,924,852 |
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2011, there was $3.1 million of unrecognized compensation expense related to
options. The unrecognized compensation expense will be amortized on a straight-line basis over a
weighted-average remaining period of 3.35 years. As of March 31, 2011, the unrecognized
compensation cost related to restricted stock unit awards was $1.2 million which will be amortized
on a straight-line basis over 2.48 years.
Nonemployee Stock-Based Compensation
In connection with share based awards granted to consultants, the Company recorded $48,800
(relating to restricted stock awards), $4,204, and $215,144 for nonemployee stock-based
compensation during the three months ended March 31, 2011 and 2010 and for the period from
September 9, 2004 (Date of Inception) to March 31, 2011, respectively. These amounts were based
upon the fair value of the vested portion of the grants. Amounts expensed during the remaining
vesting period will be determined based on the fair value at the time of vesting.
13
10. RELATED PARTY TRANSACTIONS
The Company engaged an outside service provider whose chief executive officer is a founder of
the Company and spouse of an officer of the Company, for clinical management services. In
consideration for the services rendered, the Company paid the following fees:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
September 9, |
|
|
|
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
(Date of |
|
|
|
|
|
|
|
|
|
|
Inception) to |
|
|
Three Months Ended March 31, |
|
March 31, |
|
|
2011 |
|
2010 |
|
2011 |
Project management fees |
|
$ |
620,727 |
|
|
$ |
38,274 |
|
|
$ |
1,285,918 |
|
As of March 31, 2011, the Company had $828,935 payable to this organization for services
performed during the period compared to $519,386 payable as of December 31, 2010. We anticipate
this relationship to continue for the foreseeable future.
11. SUBSEQUENT EVENTS
In April 2011, the Company signed an extension and amendment to our lease agreement for our
operating facility. The lease commences August 2011 and will end September 2014. Total future
minimum lease payments over the life of the lease are $517,905.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended (the Exchange Act), which are subject to the safe harbor created by
those sections. Forward-looking statements are based on our managements beliefs and assumptions
and on information currently available to our management. All statements other than statements of
historical factors are forward-looking statements for purposes of theses provisions. In some
cases you can identify forward-looking statements by terms such as may, will, should,
could, would, expect, plan, anticipate, believe, estimate, project, predict, and
potential, and similar expressions intended to identify forward-looking statements. Such
forward-looking statements are subject to risks, uncertainties and other important factors that
could cause actual results and the timing of certain events to differ materially from future
results expressed or implied by such forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to, those identified below, and those
discussed in the section titled Risk Factors in this report. Furthermore, such forward-looking
statements speak only as of the date of this report. Except as required by law, we undertake no
obligation to update any forward-looking statements to reflect events or circumstances after the
date of such statements.
Overview
We are a biopharmaceutical company focused on developing and commercializing products to treat
serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. We
currently have one Phase 3 clinical program, varespladib, and two Phase 2 clinical programs, A-623
and A-001. Two of our product candidates, varespladib and A-001, are designed to inhibit a novel
enzyme target known as secretory phospholipase A2, or sPLA2. Elevated levels
of sPLA2 have been implicated in a variety of acute inflammatory conditions, including
acute coronary syndrome and acute chest syndrome associated with sickle cell disease, as well as in
chronic diseases, including stable coronary artery disease. In addition, our Phase 2 product
candidate, A-623, targets elevated levels of B-cell activating factor, or BAFF, which has been
associated with a variety of B-cell mediated autoimmune diseases, including systemic lupus
erythematosus, or lupus, lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjögrens
Syndrome, Graves Disease and others.
We were incorporated and commenced operations in September 2004. Since our inception, we have
generated significant losses. As of March 31, 2011, we had an accumulated deficit of approximately
$124.2 million. As of the date of this filing, we have never generated any revenue and have
generated only interest income from cash and cash equivalents and short-term investments. We expect
to incur substantial and increasing losses for at least the next several years as we pursue the
development and commercialization of our product candidates.
14
To date, we have funded our operations through equity offerings, private placements of
convertible debt and debt financings, raising net proceeds of approximately $170.4 million. We will
need substantial additional financing to continue to develop our product candidates, obtain
regulatory approvals and to fund operating expenses, which we will seek to raise through public or
private equity or debt financings, collaborative or other arrangements with third parties or
through other sources of financing. We cannot assure you that such funds will be available on terms
favorable to us, if at all. In addition to the normal risks associated with development-stage
companies, we may never successfully complete development of any of our product candidates, obtain
adequate patent protection for our technology, obtain necessary government regulatory approval for
our product candidates or achieve commercial viability for any approved product candidates. In
addition, we may not be profitable even if we succeed in commercializing any of our product
candidates.
Revenue
To date, we have not generated any revenue. We do not expect to generate revenue unless or
until we obtain regulatory approval of, and commercialize, our product candidates or in- license
additional products that generate revenue. We intend to seek to generate revenue from a combination
of product sales, up-front fees and milestone payments in connection with collaborative or
strategic relationships and royalties resulting from the licensing of the commercial rights to our
intellectual property. We expect that any revenue we generate will fluctuate from quarter to
quarter as a result of the nature, timing and amount of milestone payments we may receive upon the
sale of our products, to the extent any are successfully commercialized, as well as any revenue we
may receive from our collaborative or strategic relationships.
Research and Development Expenses
Since our inception, we have focused our activities on our product candidate development
programs. We expense research and development costs as they are incurred. Research and development
expenses consist of personnel costs, including salaries, benefits and stock-based compensation,
clinical studies performed by contract research organizations, or CROs, materials and supplies,
licenses and fees and overhead allocations consisting of various administrative and
facilities-related costs. Research and development activities are also separated into three main
categories: licensing, clinical development and pharmaceutical development. Licensing costs consist
primarily of fees paid pursuant to license agreements. Historically, our clinical development costs
have included costs for preclinical and clinical studies. We expect to incur substantial clinical
development costs for our Phase 3 clinical study named VISTA- 16 for varespladib and for our Phase
2b clinical study named PEARL-SC for A-623, as well as for the development of our other product
candidates. Pharmaceutical development costs consist of expenses incurred relating to clinical
studies and product formulation and manufacturing.
We expense both internal and external research and development costs as incurred. We are
developing our product candidates in parallel, and we typically use our employee and infrastructure
resources across several projects. Thus, some of our research and development costs are not
attributable to an individually named project, but rather are allocated across our clinical stage
programs. These unallocated costs include salaries, stock-based compensation charges and related
fringe benefit costs for our employees (such as workers compensation and health insurance
premiums), consulting fees and travel.
The following table shows our total research and development expenses for the three months
ended March 31, 2011 and 2010 and for the period from September 9, 2004 (Date of Inception) through
March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Period |
|
|
|
|
|
|
|
|
|
|
|
September 9, |
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of |
|
|
|
|
|
|
|
|
|
|
|
Inception) to |
|
|
|
Three Months Ended March 31, |
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
Allocated costs: |
|
|
|
|
|
|
|
|
|
|
|
|
A-001 |
|
$ |
24,255 |
|
|
$ |
91,729 |
|
|
$ |
6,532,613 |
(1) |
Varespladib |
|
|
9,323,210 |
|
|
|
4,252,849 |
(2) |
|
|
56,413,723 |
(1)(2)(4) |
A-623 |
|
|
5,680,193 |
|
|
|
304,950 |
|
|
|
17,650,085 |
(3)(5) |
Unallocated costs |
|
|
1,289,100 |
|
|
|
592,286 |
|
|
|
16,501,060 |
|
|
|
|
|
|
|
|
|
|
|
Total development |
|
$ |
16,316,758 |
|
|
$ |
5,241,814 |
|
|
$ |
97,097,481 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes Qualifying Therapeutic Discovery Project Credit under Section 48D of approximately $244,000. |
15
|
|
|
(2) |
|
Includes milestone payments of $3.5 million pursuant to amendments to the license agreements with
each of Eli Lilly and Shionogi & Co. Ltd., which were paid in the form of shares of common stock. |
|
(3) |
|
Includes Qualifying Therapeutic Discovery Project Credit under Section 48D of approximately $488,000. |
|
(4) |
|
Includes license fees of $4.0 million pursuant to a license agreement with each of Eli Lilly and
Shionogi & Co. Ltd., which were paid in cash and shares of preferred stock in 2006. |
|
(5) |
|
Includes a one-time license initiation fee of $6.0 million pursuant to a license agreement with Amgen. |
We expect our research and development expenses to increase significantly as we continue to
develop our product candidates. We began enrollment of patients in the VISTA-16 study of
varespladib for the treatment of patients experiencing acute coronary syndrome in June 2010. We
also initiated the PEARL-SC study of A-623 in July 2010. We intend to fund our clinical studies
with existing cash and proceeds from potential future debt and equity offerings.
We expect that a large percentage of our research and development expenses in the future will
be incurred in support of our current and future clinical development programs. These expenditures
are subject to numerous uncertainties in timing and cost to completion. As we obtain results from
clinical studies, we may elect to discontinue or delay clinical studies for certain product
candidates or programs in order to focus our resources on more promising product candidates or
programs. Completion of clinical studies may take several years or more, but the length of time
generally varies according to the type, complexity, novelty and intended use of a product
candidate. The cost of clinical studies may vary significantly over the life of a program as a
result of differences arising during clinical development, including:
|
|
|
the number of sites included in the studies; |
|
|
|
|
the length of time required to enroll suitable patient subjects; |
|
|
|
|
the number of patients that participate in the studies; |
|
|
|
|
the number of doses that patients receive; |
|
|
|
|
the drop-out or discontinuation rates of patients; and |
|
|
|
|
the duration of patient follow-up. |
Our expenses related to clinical studies are based on estimates of the services received and
efforts expended pursuant to contracts with multiple research institutions and clinical research
organizations that conduct and manage clinical studies on our behalf. The financial terms of these
agreements are subject to negotiation and vary from contract to contract and may result in uneven
payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed
fee or unit price. Payments under the contracts depend on factors such as the successful enrollment
of patients or the completion of clinical study milestones. Expenses related to clinical studies
generally are accrued based on contracted amounts and the achievement of milestones such as number
of patients enrolled. If timelines or contracts are modified based upon changes to the clinical
study design or scope of work to be performed, we modify our estimates of accrued expenses
accordingly on a prospective basis.
None of our product candidates has received U.S. Food and Drug Administration, or FDA, or
foreign regulatory marketing approval. In order to grant marketing approval, the FDA or foreign
regulatory agencies must conclude that clinical data establishes the safety and efficacy of our
product candidates and that the manufacturing facilities, processes and controls are adequate.
Despite our efforts, our product candidates may not offer therapeutic or other improvement over
existing, comparable drugs, be proven safe and effective in clinical studies, or meet applicable
regulatory standards.
As a result of the uncertainties discussed above, we are unable to determine the duration and
completion costs of our development projects or when and to what extent we will receive cash
inflows from the commercialization and sale of an approved product candidate, if ever.
16
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees in
executive and operational functions, including clinical, chemical manufacturing, regulatory,
finance and business development. Other significant costs include professional fees for legal
services, including legal services associated with obtaining and maintaining patents. We will
continue to incur significant general and administrative expenses as a public company, including
costs for insurance, costs related to the hiring of additional personnel, payment to outside
consultants, lawyers and accountants and complying with the corporate governance, internal controls
and similar requirements applicable to public companies.
Critical Accounting Policies and Estimates
Our managements discussion and analysis of our financial condition and results of operations
is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The
preparation of these financial statements requires us to make estimates and judgments that affect
the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these
estimates and judgments, including those described below. We base our estimates on our historical
experience and on various other assumptions that we believe to be reasonable under the
circumstances. These estimates and assumptions form the basis for making judgments about the
carrying values of assets and liabilities that are not readily apparent from other sources. Actual
results and experiences may differ materially from these estimates.
While our significant accounting policies are more fully described in the notes to the
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2010, we believe that the following accounting policies are the most critical to aid you in fully
understanding and evaluating our reported financial results and affect the more significant
judgments and estimates that we use in the preparation of our financial statements.
Accrued Clinical Expenses
We make estimates of our accrued expenses as of each balance sheet date in our financial
statements based on facts and circumstances known to us at that time. This process involves
reviewing open contracts and purchase orders, communicating with our applicable personnel to
identify services that have been performed on our behalf and estimating the level of service
performed and the associated cost incurred for the service when we have not yet been invoiced or
otherwise notified of actual cost. The majority of our service providers invoice us at least
monthly in arrears for services performed. We periodically confirm the accuracy of our estimates
with the service providers and make adjustments if necessary. Examples of estimated accrued
clinical expenses include:
|
|
|
fees paid to CROs in connection with clinical studies; |
|
|
|
|
fees paid to investigative sites in connection with clinical studies; |
|
|
|
|
fees paid to contract manufacturers in connection with the production of clinical study
materials; and |
|
|
|
|
fees paid to vendors in connection with the preclinical development activities. |
We base our expenses related to clinical studies on our estimates of the services received and
efforts expended pursuant to contracts with multiple research institutions and CROs that conduct
and manage clinical studies on our behalf. The financial terms of these agreements are subject to
negotiation, vary from contract to contract and may result in uneven payment flows. Payments under
some of these contracts depend on factors such as the successful enrollment of patients and the
completion of clinical study milestones. In accruing service fees, we estimate the time period over
which services will be performed and the level of effort to be expended in each period. If the
actual timing of the performance of services or the level of effort varies from our estimate, we
adjust the accrual accordingly. If we do not identify costs that we have begun to incur or if we
underestimate or overestimate the level of services performed or the costs of these services, our
actual expenses could differ from our estimates.
Stock-Based Compensation
Compensation costs related to all equity instruments are recognized at the grant-date fair
value of the awards. Additionally, we are required to include an estimate of the number of awards
that will be forfeited in calculating compensation costs, which are recognized over the requisite
service period of the awards on a straight-line basis. We account for stock-based compensation
using the Black-Scholes option pricing model to estimate the fair value of each option grant on the
date of grant. Black-Scholes option pricing model requires the input of highly subjective
assumptions, including the expected stock price volatility, expected term, and forfeiture rate. Any
changes in these highly subjective assumptions significantly impact stock-based compensation
expense.
17
Fair Value Measurements and Impairments
All of our available-for-sale investments are subject to periodic impairment review.
Investments are considered to be impaired when a decline in fair value is judged to be
other-than-temporary. This determination requires significant judgment. For publicly traded
investments, impairment is determined based upon the specific facts and circumstances present at
the time, including factors such as current economic and market conditions, the credit rating of
the securitys issuer, the length of time an investments fair value has been below our carrying
value, and our ability and intent to hold investments to maturity or for a period of time
sufficient to allow for any anticipated recovery in fair value. If an investments decline in fair
value, caused by factors other than changes in interest rates, is deemed to be
other-than-temporary, we reduce its carrying value to its estimated fair value, as determined based
on quoted market prices, liquidation values or other metrics.
Pursuant to the accounting guidance for fair value measurement and its subsequent updates,
fair value is defined as the price that would be received to sell an asset or paid to transfer a
liability (i.e., the exit price) in an orderly transaction between market participants at the
measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair
value that minimizes the use of unobservable inputs by requiring the use of observable market data
when available. Observable inputs are inputs that market participants would use in pricing the
asset or liability based on active market data. Unobservable inputs are inputs that reflect the
assumptions market participants would use in pricing the asset or liability based on the best
information available in the circumstances.
The fair value hierarchy is broken down into the three input levels summarized below:
|
|
|
Level 1 Valuations are based on quoted prices in active markets for identical assets
or liabilities, and readily accessible by us at the reporting date. Examples of assets and
liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and
trading securities with quoted prices on active markets. |
|
|
|
|
Level 2 Valuations based on inputs other than the quoted prices in active markets that
are observable either directly or indirectly in active markets. Examples of assets and
liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds,
commercial paper, certificates of deposit and over-the-counter derivatives. |
|
|
|
|
Level 3 Valuations based on unobservable inputs in which there is little or no market
data, which require us to develop our own assumptions. Examples of assets and liabilities
utilizing Level 3 inputs are cost method investments, auction rate securities (ARS) and the
Primary Fund. |
We measure our available-for-sale securities at fair value on a recurring basis.
Available-for-sale securities include U.S. Treasury securities, U.S. government agency bonds,
corporate bonds, commercial paper, money market funds and certificates of deposit. Where possible,
we utilize quoted market prices to measure and such items are classified as Level 1 in the
hierarchy. When quoted market prices for identical assets are unavailable, varying valuation
techniques are used. Such assets are classified as Level 2 or Level 3 in the hierarchy. We classify
items in Level 2 if investments are valued using observable inputs to quoted market prices,
benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with
reasonable levels of price transparency. We classify items in Level 3 if investments are valued
using a pricing model, based on unobservable inputs in the market or that require us to develop our
own assumptions. Our assessment of the significance of a particular input to the fair value
measurement in its entirety requires judgment and considers factors specific to the investment.
We are also exposed to market risk relating to our available-for-sale investments due to
uncertainties in the credit and capital markets. The fair value of our investments may change
significantly due to events and conditions in the credit and capital markets. These
securities/issuers could be subject to review for possible downgrade. Any downgrade in these credit
ratings may result in an additional decline in the estimated fair value of our investments. We
monitor and evaluate the accounting for our investment portfolio on a quarterly basis for
additional other-than-temporary impairment charges.
We actively review current investment ratings, company specific events, and general economic
conditions in managing our investments and determining whether there is a significant decline in
fair value that is other-than-temporary. As of March 31, 2011, our short-term in marketable
securities have been classified as available-for-sale and are carried at fair value.
Available-for-sale investments with original maturities of greater than three months at the date of
purchases are classified as short-term investments as these investments generally consist of
marketable securities that are intended to be available to meet current cash requirements.
Recognized gains and losses on available for sale investments during the three months ended
March 31, 2011 and 2010 were not material. Management determines the appropriate classification of
investments at the time of purchase and reevaluates the classification at each reporting date.
18
Results of Operations
Comparison of the three months ended March 31, 2011 and 2010
Research and development expenses. Research and development expenses consist of personnel
costs for employees in clinical, chemical manufacturing and regulatory functions, clinical studies
performed by CROs, pharmaceutical development costs including product formulation and
manufacturing, preclinical costs, license fees and overhead allocations consisting of various
administrative and facilities-related costs.
Change in research and development expenses from the three months ended March 31, 2010 to 2011
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Research and development expense |
|
$ |
16.3 |
|
|
$ |
5.2 |
|
|
$ |
11.1 |
|
|
|
213 |
% |
The increase in research and development expenses from 2010 to 2011 was primarily attributable
to increased patient enrollment, CRO and manufacturing cost related to the launch of our Phase 3
clinical study of varespladib and Phase 2 clinical study of A-623, as well as increased headcount
to support these clinical studies.
General and administrative expenses. General and administrative expenses consist of personnel
costs for employees in executive, business development and operational functions, professional
service fees including corporate legal fees, accountant fees and overhead allocations consisting of
various administrative and facilities-related costs.
Change in general and administrative expenses from the three months ended March 31, 2010 to
2011 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
General and administrative expense |
|
$ |
2.3 |
|
|
$ |
1.2 |
|
|
$ |
1.1 |
|
|
|
92 |
% |
The increase in general and administrative expenses from 2010 to 2011 was primarily
attributable to increased headcount and professional services incurred in connection with our
financial audit and other costs associated with operating as a public company.
Other expense and interest income, net. Other expense for the three months ended March 31,
2010 consists of primarily non-cash charge related to the amortization of discounts, mark-to-market
adjustment relating to warrants and embedded derivative associated with our convertible promissory
notes issued in July and September of 2009, which were converted into shares of our common stock
upon the closing of our IPO in March 2010. Other expense for the three months ended March 31, 2011
consists primarily of interest expense, amortization of note discount and note issuance costs, and
an end of term charge associated with our note issued under a Loan and Security Agreement with
Hercules in March 2011. Interest income consists of interest earned on our cash, cash equivalents
and short-term investments.
Change in other expense and interest income, net, from the three months ended March 31, 2010
to 2011 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
2010 |
|
$ Change |
|
% Change |
Other expense and interest income, net |
|
$ |
0.1 |
|
|
$ |
(0.8 |
) |
|
$ |
0.9 |
|
|
|
113 |
% |
Mark-to-market adjustment of warrant liability |
|
|
|
|
|
|
(3.8 |
) |
|
$ |
(3.8 |
) |
|
|
100 |
% |
The decrease in other expense and interest income, net, from 2011 to 2010 was primarily
attributable to a non-cash charge of $4.5 million recorded for the amortization of discounts on our
convertible promissory notes and the mark-to-market adjustment relating to warrants and embedded
derivative connected to these convertible promissory notes in 2010. The balance was offset by an
increase in interest income from 2010 to 2011 attributable to higher cash and investment balances
in 2011, resulting from proceeds received from our private placement in September 2010 and the debt
financing with Hercules in March 2011.
Liquidity and Capital Resources
To date, we have funded our operations primarily through private placements of preferred stock
and common stock, convertible and nonconvertible debt and our IPO. As of March 31, 2011, we had
received net proceeds of approximately $119.5 million from the sale of equity securities,
approximately $26.2 million from the issuance of convertible promissory notes, and approximately
$24.7 million from issuance of note payable. As of March 31, 2011, we had cash, cash equivalents
and short-term investments of approximately $78.5 million.
19
Cash, cash equivalents and investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
|
December 31, 2010 |
|
Cash and cash equivalents |
|
$ |
66,557,789 |
|
|
$ |
40,029,972 |
|
Short-term investments |
|
|
11,982,185 |
|
|
|
23,350,922 |
|
|
|
|
|
|
|
|
Total |
|
$ |
78,539,974 |
|
|
$ |
63,380,894 |
|
|
|
|
|
|
|
|
Our principal liquidity requirements are primarily to meet our working capital needs, support
ongoing business activities, research and development, and our capital expenditure needs.
In March 2011, we filed a shelf registration statement with the Securities and Exchange
Commission (SEC) under which we may issue up to $75.0 million in shares of common stock,
preferred stock, debt securities and/or warrants. As of March 31, 2011, no securities have been
issued.
Cash Flows
Three months ended March 31, 2011
For the three months ended March 31, 2011, we incurred a net loss of approximately $18.6
million.
Net cash used in operating activities was approximately $9.9 million. The net loss is higher
than cash used in operating activities by $8.7 million. The primary drivers for the difference
include increase of $5.0 million in clinical trial accruals which is based upon our estimated
clinical trial performance to date, increase in other operating liabilities of $3.0 million, and
adjustments for non-cash charges such as stock-based compensation of approximately $588,000.
Net cash provided by investing activities was approximately $11.3 million and was primarily
driven by the maturities of short-term investments during the period.
Net cash provided by financing activities was approximately $24.7 million and consisted
primarily of proceeds of $25 million received from the issuance of note payable with Hercules.
Three Months Ended March 31, 2010
For the three months ended March 31, 2010, we incurred a net loss of approximately $11.1
million.
Net cash used in operating activities was approximately $3.5 million. The net loss is higher
than cash used in operating activities by $7.6 million. The primary drivers for the difference are
the issuance of $3.5 million worth of common stock in lieu of cash milestone payments due to Eli
Lilly and Shionogi & Co., Ltd., and mark-to-market adjustments relating to warrant and derivative
liability of $3.8 million.
Net cash provided by financing activities was approximately $56.3 million and consisted
primarily of proceeds of $57.2 million received from the issuance of common stock at our IPO.
Contractual Obligations and Commitments
The Company has lease obligations consisting of operating lease in connection with a sublease
for our operating facility that commenced in October 2008 and expires July 2011 (which was
subsequently extended through September 2014 in April 2011), for approximately 7,800 square feet of
office space, and office equipment leases that commenced in October 2007 and will expire in June
2013.
On March 25, 2011, the Company entered into a Loan and Security Agreement (Loan Agreement)
with Hercules Technology Growth Capital, Inc. and Hercules Technology II, L.P. (together,
Hercules). Under the terms of the Loan Agreement, the Company borrowed $25.0 million at an
interest rate of the higher of (i) 10.55% or (ii) 7.30% plus the prime rate as reported in the Wall
Street Journal, and issued to Hercules a secured term promissory note evidencing the loan. The loan
is secured by the Companys assets, excluding intellectual property. The Company will make interest
only payments for the initial 12 months, which will be extended an additional three months if (a)
positive biomarker analysis results are obtained from VISTA-16 Phase III FDA Clinical Trial on or
20
before July 31, 2011, and (b) full enrollment of the PEARL-SC Phase 2b FDA Clinical Trial is
obtained on or before March 31, 2012. The Company obtained positive biomarker analysis results on
April 18, 2011. Thereafter, the loan will be repaid in 30 equal monthly installments of
approximately $952,000, at the initial interest rate. The Company will also be obligated to pay an
end of the term charge of $937,500, which will be expensed over the term of the Loan Agreement
using the effective interest rate.
The following table summarizes our estimated scheduled future minimum contractual obligations
and commitments as of March 31, 2011:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less Than |
|
|
|
|
|
|
|
|
|
|
After |
|
|
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
3-5 Years |
|
|
5 Years |
|
Operating lease obligations |
|
$ |
30,402 |
|
|
$ |
26,502 |
|
|
$ |
3,900 |
|
|
$ |
|
|
|
$ |
|
|
Loan Agreement |
|
$ |
32,061,628 |
|
|
$ |
2,505,625 |
|
|
$ |
29,556,003 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
32,092,030 |
|
|
$ |
2,532,127 |
|
|
$ |
29,559,903 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The above amounts exclude potential payments to be made under our license agreements to our
licensors that are based on the progress of our product candidates in development, as these
payments are not determinable. Under our license agreement with Eli Lilly and Shionogi & Co., Ltd.
to develop and commercialize certain sPLA2 inhibitors, we are obligated to make
additional milestone payments upon the achievement of certain development, regulatory, and
commercial objectives. We are also obligated to pay royalties on future net sales of products that
are developed and approved as defined by this collaboration. Our obligation to pay royalties with
respect to each licensed product in each country will expire upon the later of (a) 10 years
following the date of the first commercial sale of such licensed product in such country, and (b)
the first date on which generic version(s) of the applicable licensed product achieve a total
market share, in the aggregate, of 25% or more of the total unit sales of wholesalers to pharmacies
of licensed product and all generic versions combined in the applicable country.
Also excluded from the table above
is the lease extension for the Companys facility and potential milestone payments on the development of
A-623. Under our license agreement with Amgen to develop and commercialize A-623, we are obligated
to make additional milestone payments upon the achievement of certain development, regulatory, and
commercial objectives. We are also obligated to pay royalties on future net sales of products that
are developed and approved as defined by this collaboration. Our royalty obligations as to a
particular licensed product will be payable, on a country-by-country and licensed
product-by-licensed product basis, for the longer of (a) the date of expiration of the last to
expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to
sell, or import of such licensed product by us or a sublicensee in such country, or (b) 10 years
after the first commercial sale of the applicable licensed product in the applicable country.
Funding Requirements
We expect to incur substantial expenses and generate significant operating losses as we
continue to advance our product candidates into preclinical studies and clinical studies and as we:
|
|
|
continue clinical development of varespladib; |
|
|
|
|
continue clinical development of A-623; |
|
|
|
|
hire additional clinical, scientific and management personnel; and |
|
|
|
|
implement new operational, financial and management information systems. |
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include the following:
|
|
|
the progress of preclinical development and clinical studies of our product candidates; |
|
|
|
|
the time and costs involved in obtaining regulatory approvals; |
|
|
|
|
delays that may be caused by evolving requirements of regulatory agencies; |
|
|
|
|
the costs involved in filing and prosecuting patent applications and enforcing or
defending patent claims; |
21
|
|
|
our ability to establish, enforce and maintain selected strategic alliances; and |
|
|
|
|
the acquisition of technologies, product candidates and other business opportunities that
require financial commitments. |
To date, we have not generated any revenue. We do not expect to generate commercial product
revenue unless or until we obtain regulatory approval of, and commercialize, our product
candidates. We expect our continuing operating losses to result in increases in cash used in
operations over the next several years. Our future capital requirements will depend on a number of
factors including the progress and results of our clinical studies, the costs, timing and outcome
of regulatory review of our product candidates, our revenue, if any, from successful development
and commercialization of our product candidates, the costs of commercialization activities, the
scope, progress, results and costs of preclinical development, laboratory testing and clinical
studies for other product candidates, the emergence of competing therapies and other market
developments, the costs of preparing, filing and prosecuting patent applications and maintaining,
enforcing and defending intellectual property rights, the extent to which we acquire or invest in
other product candidates and technologies, and our ability to establish collaborations and obtain
milestone, royalty or other payments from any collaborators.
We expect our existing resources as of the date of this report, to be sufficient to fund our
planned operations, including our continued product candidate development, for at least the next 12
months. However, we may require significant additional funds earlier than we currently expect to
conduct additional or extended clinical studies and seek regulatory approval of our product
candidates. Because of the numerous risks and uncertainties associated with the development and
commercialization of our product candidates, we are unable to estimate the amounts of increased
capital outlays and operating expenditures associated with our current and anticipated clinical
studies.
Additional funding may not be available to us on acceptable terms or at all. In addition, the
terms of any financing may adversely affect the holdings or the rights of our stockholders. For
example, if we raise additional funds by issuing equity securities or by selling debt securities,
if convertible, further dilution to our existing stockholders may result. To the extent our capital
resources are insufficient to meet our future capital requirements, we will need to finance our
future cash needs through public or private equity offerings, collaboration agreements, debt
financings or licensing arrangements.
If adequate funds are not available, we may be required to terminate, significantly modify or
delay our development programs, reduce our planned commercialization efforts, or obtain funds
through collaborators that may require us to relinquish rights to our technologies or product
candidates that we might otherwise seek to develop or commercialize independently. We may elect to
raise additional funds even before we need them if the conditions for raising capital are
favorable.
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever had, any relationships with unconsolidated entities
or financial partnerships, such as entities often referred to as structured finance or special
purpose entities, established for the purpose of facilitating off-balance sheet arrangements or
other contractually narrow or limited purposes. In addition, we do not engage in trading activities
involving non-exchange traded contracts.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our primary exposure to market risk is interest income sensitivity, which is affected by
changes in the general level of U.S. interest rates. We are exposed to market risk related to
fluctuations in interest rates, market prices, and foreign currency exchange rates. However, since
a majority of our investments are in short-term certificates of deposit, FDIC-insured corporate
bonds and money market funds, we do not believe we are subject to any material market risk
exposure. As of March 31, 2011, we did not have any material derivative financial instruments. The
fair value of our marketable securities, including those included in cash equivalents and
short-term investments, was $33.7 million as of March 31, 2011.
Our investment policy is to limit credit exposure through diversification and investment in
highly rated securities. We actively review, along with our investment advisors, current investment
ratings, company specific events and general economic conditions in managing our investments and in
determining whether there is a significant decline in fair value that is other-than-temporary. We
will monitor and evaluate the accounting for our investment portfolio on a quarterly basis for
additional other-than-temporary impairment charges.
22
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive and financial officers,
evaluated the effectiveness of our disclosures controls and procedures, as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act, as of March 31, 2011. The term disclosure controls
and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls
and other procedures of a company that are designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SECs rules and forms.
Disclosure controls and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed by a company in the reports that it files or
submits under the Exchange Act is accumulated and communicated to the companys management,
including its principal executive and principal financial officers, as appropriate, to allow timely
decisions regarding required disclosure. Management recognizes that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure
controls and procedures as of March 31, 2011, our principal executive officer and principal
financial officer concluded that, as of such date, our disclosure controls and procedures were
effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the quarter ended
March 31, 2011 identified in connection with the evaluation required by Rule 13a-15(d) and
15d-15(d) of the Exchange Act that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we may be involved in routine legal proceedings, as well as demands, claims
and threatened litigation, which arise in the normal course of our business.
We believe there is no litigation pending that could, individually or in the aggregate, have a
material adverse effect on our results of operations or financial condition.
ITEM 1A. RISK FACTORS
You should carefully consider the risks described below, together with the other information
contained in this Quarterly Report on Form 10-Q, including the financial statements and the related
notes that appear in this report. We believe the risks described below are the risks that are
material to us as of the date of this report. If any of the following risks occur, our business,
financial condition, results of operations and future growth prospects would like be materially and
adversely affected. In these circumstances, the market price of our common stock could decline,
and you may lose all or part of your investment.
Risks Related to Our Financial Condition and Capital Requirements
We have incurred significant losses since our inception and anticipate that we will incur
continued significant losses for the foreseeable future.
We are a development stage company with only six years of operating history. We have focused
primarily on developing our three product candidates, varespladib, A-623 and varespladib sodium
(A-001). We have financed our operations exclusively through equity offerings, private placements
of convertible debt, and debt financings and we have incurred losses in each year since our
inception in September 2004. Our net losses were approximately $8.7 million in 2006, $25.7 million
in 2007, $18.1 million in 2008, $12.2 million in 2009, and $40.4 million in 2010 and $18.6 million
for the three months ended March 31, 2011. As of March 31, 2011, we had an accumulated deficit of
approximately $124.2 million. Substantially all of our losses resulted from costs incurred in
connection with our product development programs and from general and administrative costs
associated with our operations.
We expect to incur additional losses over the next several years, and these losses may
increase if we cannot generate revenues. Our historical losses, combined with expected future
losses, have had and will continue to have an adverse effect on our stockholders
equity and working capital. We expect our development expenses, as well as our clinical
product manufacturing expenses, to increase in connection with our pivotal Phase 3 clinical study
named VISTA-16 for varespladib, our Phase 2b clinical study named PEARL-SC for A-623 and other
clinical studies related to the development of A-623. In addition, we will incur additional costs
of operating as a
23
public company and, if we obtain regulatory approval for any of our product candidates, we may
incur significant sales, marketing, in-licensing and outsourced manufacturing expenses as well as
continued product development expenses. As a result, we expect to continue to incur significant and
increasing losses for the foreseeable future.
We have never generated any revenue and may never be profitable.
Our ability to generate revenue and achieve profitability depends on our ability, alone or
with collaborators, to successfully complete the development of our product candidates, conduct
preclinical tests in animals and clinical studies in human beings, obtain the necessary regulatory
approvals for our product candidates and commercialize any approved products. We have not generated
any revenue from our development-stage product candidates, and we do not know when, or if, we will
generate any revenue. The commercial success of our development-stage product candidates will
depend on a number of factors, including, but not limited to, our ability to:
|
|
|
obtain favorable results for and advance the development of our lead product candidate,
varespladib, for the treatment of acute coronary syndrome, including successfully launching
and completing the VISTA-16 study; |
|
|
|
|
obtain favorable results for and advance the development of our product candidate A-623
for the treatment of B-cell mediated autoimmune diseases, including successfully launching
and completing PEARL-SC or other clinical studies in patients with systemic lupus
erythematosus, or lupus, or other indications related to the development of A-623; |
|
|
|
|
obtain favorable results for and advance the development of our product candidate A-001
for the prevention of acute chest syndrome associated with sickle cell disease, including
completing a multi-center Phase 2 clinical study; |
|
|
|
|
successfully execute our planned preclinical studies in animals and clinical studies in
human beings for our other product candidates; |
|
|
|
|
obtain regulatory approval for varespladib, A-623, A-001 and our other product
candidates; |
|
|
|
|
if regulatory approvals are obtained, begin the commercial manufacturing of our product
candidates with our third-party manufacturers; |
|
|
|
|
launch commercial sales and effectively market our product candidates, either
independently or in strategic collaborations with third parties; and |
|
|
|
|
achieve broad market acceptance of our product candidates in the medical community and
with third-party payors. |
All of our product candidates are subject to the risks of failure inherent in the development
of therapeutics based on new technologies. Currently, we have three product candidates in clinical
development: varespladib, A-623 and A-001. These product candidates could fail in clinical studies
if we are unable to demonstrate that they are effective or if they cause unacceptable adverse
effects in the patients we treat. Failure of our product candidates in clinical studies would have
a material adverse effect on our ability to generate revenue or become profitable. If we are not
successful in achieving regulatory approval for our product candidates or are significantly delayed
in doing so, our business will be materially harmed.
Additionally, all of our other product candidates are in preclinical development. Our drug
discovery efforts may not produce any other viable or marketable product candidates. We do not
expect any of our potential product candidates to be commercially available until at least 2013.
Even if our product candidates are approved for commercial sale, the approved product
candidate may not gain market acceptance or achieve commercial success. Physicians, patients,
payors or the medical community in general may be unwilling to accept, utilize or recommend any of
our products. We would anticipate incurring significant costs associated with commercializing any
approved product. Even if we are able to generate product sales, which we cannot guarantee, we may
not achieve profitability soon thereafter, if ever. If we are unable to generate product revenues,
we will not become profitable and may be unable to continue operations without additional funding.
24
We will need substantial additional capital in the future to fund our operations. If additional
capital is not available, we will have to delay, reduce or cease operations.
We will need to raise substantial additional capital to fund our operations and to develop our
product candidates. Our future capital requirements could be substantial and will depend on many
factors including:
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the rate of progress of our Phase 3 clinical study named VISTA-16 study for varespladib
and our Phase 2b clinical study named PEARL-SC or other studies for A-623; |
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the scope, size, rate of progress, results and costs of our preclinical studies, clinical
studies and other development activities for one or more of our other product candidates; |
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manufacturing campaign of A-623 clinical matters, including formulation development and
enhancement; |
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non-clinical activities that we may pursue parallel to clinical trials for each clinical
compound; |
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the cost, timing and outcomes of regulatory proceedings; |
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payments received under any strategic collaborations; |
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the filing, prosecution and enforcement of patent claims; |
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the costs associated with commercializing our product candidates if they receive
regulatory approval, including the cost and timing of developing sales and marketing
capabilities, or entering into strategic collaboration with others relating to the
commercialization of our product candidates; and |
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revenues received from approved products, if any, in the future. |
As of the date of this report, we anticipate that our existing cash, cash equivalents and
short-term investments, will enable us to maintain our currently planned operations through at
least the next 12 months. Changing circumstances may cause us to consume capital significantly
faster than we currently anticipate. Additional financing may not be available when we need it or
may not be available on terms that are favorable to us. If adequate funds are not available to us
on a timely basis, or at all, we may be required to:
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terminate, reduce or delay preclinical studies, clinical studies or other development
activities for one or more of our product candidates; or |
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terminate, reduce or delay our (i) establishment of sales and marketing capabilities,
(ii) pursuit of strategic collaborations with others relating to the sales, marketing and
commercialization of our product candidates or (iii) other activities that may be necessary
to commercialize our product candidates, if approved for sale. |
The timing of the milestone and royalty payments we are required to make to each of Eli Lilly and
Company, Shionogi & Co., Ltd. and Amgen Inc. is uncertain and could adversely affect our cash
flows and results of operations.
In July 2006, we entered into a license agreement with Eli Lilly and Company, or Eli Lilly,
and Shionogi & Co., Ltd. to develop and commercialize certain secretory phospholipase
A2, or sPLA2, inhibitors for the treatment of cardiovascular disease and
other diseases. Pursuant to our license agreement with them, we have an obligation to pay to each
of Eli Lilly and Shionogi & Co., Ltd. significant milestone and royalty payments based upon how we
develop and commercialize certain sPLA2 inhibitors, including varespladib and A-001, and
our achievement of certain significant corporate, clinical and financial events. For varespladib,
we are required to pay up to $32.0 million upon achievement of certain approval and post-approval
sales milestones. For A-001, we are required to pay up to $3.0 million upon achievement of certain
clinical development milestones and up to $25.0 million upon achievement of certain approval and
post-approval sales milestones. For other product formulations that we are not currently
developing, we would be required to pay up to $2.0 million upon achievement of certain clinical
development milestones and up to $35.5 million upon achievement of certain approval and
post-approval sales milestones.
In addition, in December 2007, we entered into a license agreement with Amgen Inc., or Amgen,
pursuant to which we obtained an exclusive worldwide license to certain technology and compounds
relating to A-623. Pursuant to our license agreement with Amgen,
we are required to make various milestone payments upon our achievement of certain
development, regulatory and commercial objectives for any A-623 formulation. We are required to pay
up to $10.0 million upon achievement of certain pre-approval clinical
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development milestones and up to $23.0 million upon achievement of certain post-approval
milestones. We are also required to make tiered quarterly royalty payments on net sales, which
increase as a percentage from the high single digits to the low double digits as net sales
increase. The timing of our achievement of these events and corresponding milestone payments
becoming due to Eli Lilly, Shionogi & Co., Ltd. and Amgen is subject to factors relating to the
clinical and regulatory development and commercialization of certain sPLA2 inhibitors or
A-623, as applicable, many of which are beyond our control. We may become obligated to make a
milestone payment during a period in which we do not have the cash on hand to make such payment,
which could require us to delay our clinical studies, curtail our operations, scale back our
commercialization and marketing efforts, seek funds to meet these obligations at terms unfavorable
to us or default on our license agreements, which could result in license termination.
Our limited operating history makes it difficult to evaluate our business and prospects.
We were incorporated in September 2004. Our operations to date have been limited to organizing
and staffing our company, acquiring product and technology rights, conducting product development
activities for our primary product candidates, varespladib, A-623 and A-001, and performing
research and development. We have not yet demonstrated an ability to obtain regulatory approval for
or commercialize a product candidate. Consequently, any predictions about our future performance
may not be as accurate as they could be if we had a history of successfully developing and
commercializing pharmaceutical products.
Risks Associated with Development and Commercialization of Our Product Candidates
We depend substantially on the success of our three primary product candidates, varespladib, A-623
and A-001, which are still under clinical development. We cannot assure you that these product
candidates or any of our other product candidates will receive regulatory approval or be
successfully commercialized.
To date, we have not obtained marketing approval for, or marketed, distributed or sold any
product candidates. The success of our business depends primarily upon our ability to develop and
commercialize our three primary product candidates successfully. Our lead product candidate is
varespladib, which has completed its Phase 2 clinical studies and for which we have received (i) an
agreement from the U.S. Food and Drug Administration, or FDA, on a Special Protocol Assessment, or
SPA, for the VISTA-16 Phase 3 study protocol, and (ii) scientific advice from the European
Medicines Agency on our European development strategy for varespladib. We initiated the VISTA-16
study for varespladib in June 2010.
Our next product candidate is A-623, which has completed several Phase 1 clinical studies and
recently began enrollment for our Phase 2b clinical study. In July 2010, we received clearance from
the FDA to begin recruitment of lupus patients into the PEARL-SC Phase 2b clinical study. In
November 2010, we placed a voluntary hold on the PEARL-SC study due to problems found with vials.
Patient enrollment in the study was temporarily suspended and dosing was discontinued in patients
who were enrolled in the study while we conducted an analysis of the problem. We resolved the
issues found with the vials in December 2010. After analysis, simulation and consultation with
industry experts, we determined that shipping on dry ice was the root cause of the issue. Shipping
logistics were modified and we reinitiated enrollment in PEARL-SC and dosing in January 2011. We
have received no reports of patient-related side effects or problems with drug administration that
could be attributed to the vial problem.
Our third product candidate, varespladib sodium (A-001), is an intravenously administered
inhibitor of sPLA2. We have completed a Phase 2 clinical study for the prevention of
acute chest syndrome associated with sickle cell disease. A pre-specified interim review of our
Phase 2 clinical study results by a Data Safety Monitoring Board, or DSMB, indicated A-001, at a
certain dose, reduced sPLA2 activity by more than 80% from baseline within 48 hours.
Furthermore, the incidence of acute chest syndrome appeared to be related to the level of
sPLA2 activity.
Our product candidates are prone to the risks of failure inherent in drug development. Before
obtaining regulatory approvals for the commercial sale of any product candidate for a target
indication, we must demonstrate with substantial evidence gathered in preclinical and
well-controlled clinical studies, and, with respect to approval in the United States, to the
satisfaction of the FDA and, with respect to approval in other countries, similar regulatory
authorities in those countries, that the product candidate is safe and effective for use for that
target indication and that the manufacturing facilities, processes and controls are adequate.
Despite our efforts, our product candidates may not:
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offer therapeutic or other improvement over existing, comparable therapeutics; |
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be proven safe and effective in clinical studies; |
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meet applicable regulatory standards; |
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be capable of being produced in sufficient quantities at acceptable costs; |
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be successfully commercialized; or |
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obtain favorable reimbursement. |
We are not permitted to market our varespladib and A-001 product candidates in the United
States until we receive approval of a new drug application, or NDA, or with respect to our A-623
product candidate, approval of a biologics license application, or BLA, from the FDA, or in any
foreign countries until we receive the requisite approval from such countries. We have not
submitted an NDA or BLA or received marketing approval for any of our product candidates.
Preclinical testing and clinical studies are long, expensive and uncertain processes. We may
spend several years completing our testing for any particular product candidate, and failure can
occur at any stage. Negative or inconclusive results or adverse medical events during a clinical
study could also cause the FDA or us to terminate a clinical study or require that we repeat it or
conduct additional clinical studies. Additionally, data obtained from a clinical study are
susceptible to varying interpretations and the FDA or other regulatory authorities may interpret
the results of our clinical studies less favorably than we do. The FDA and equivalent foreign
regulatory agencies have substantial discretion in the approval process and may decide that our
data are insufficient to support a marketing application and require additional preclinical,
clinical or other studies.
Any termination or suspension of, or delays in the commencement or completion of, clinical testing
of our product candidates could result in increased costs to us, delay or limit our ability to
generate revenue and adversely affect our commercial prospects.
Delays in the commencement or completion of clinical testing could significantly affect our
product development costs. We do not know whether planned clinical studies will begin on time or be
completed on schedule, if at all. The commencement and completion of clinical studies can be
delayed for a number of reasons, including delays related to:
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obtaining regulatory approval to commence a clinical study or complying with conditions
imposed by a regulatory authority regarding the scope or design of a clinical study; |
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reaching agreement on acceptable terms with prospective clinical research organizations,
or CROs, and study sites, the terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and study sites; |
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manufacturing, including manufacturing sufficient quantities of a product candidate or
other materials for use in clinical studies; |
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obtaining institutional review board, or IRB, approval or the approval of other reviewing
entities to conduct a clinical study at a prospective site; |
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recruiting and enrolling patients to participate in clinical studies for a variety of
reasons, including size of patient population, nature of clinical study protocol, the
availability of approved effective treatments for the relevant disease and competition from
other clinical study programs for similar indications; |
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severe or unexpected drug-related adverse effects experienced by patients in a clinical
study; and |
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retaining patients who have initiated a clinical study, but may withdraw due to treatment
protocol, adverse effects from the therapy, lack of efficacy from the treatment, personal
issues or who are lost to further follow-up. |
Clinical studies may also be delayed, suspended or terminated as a result of ambiguous or
negative interim results, or results that are inconsistent with earlier results. For example, while
an independent statistician has completed an analysis of various biomarkers of cardiovascular risk
and determined that treatment with once-daily varespladib met the pre-specified criteria for the
VISTA-16 study to proceed, an independent DSMB reviewing the clinical data from the VISTA-16 study
may recommend the clinical study discontinue based on safety and tolerability. In addition, a
clinical study may be suspended or terminated by us, the FDA, the IRB or other reviewing entity
overseeing the clinical study at issue, any of our clinical study sites with respect to that site,
or other regulatory authorities due to a number of factors, including:
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failure to conduct the clinical study in accordance with regulatory requirements or our
clinical protocols; |
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inspection of the clinical study operations or study sites by the FDA or other regulatory
authorities resulting in the imposition of a clinical hold; |
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unforeseen safety issues or any determination that a clinical study presents unacceptable
health risks; and |
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lack of adequate funding to continue the clinical study, including the incurrence of
unforeseen costs due to enrollment delays, requirements to conduct additional clinical
studies and increased expenses associated with the services of our CROs and other third
parties. |
Product development costs to us and our collaborators will increase if we have delays in
testing or approval of our product candidates or if we need to perform more or larger clinical
studies than planned. For example, we may need to increase our sample size for our VISTA-16 study
for varespladib if the overall major adverse cardiovascular event, or MACE, rate is lower than
expected. We typically rely on third-party clinical investigators at medical institutions and
health care facilities to conduct our clinical studies and, as a result, we may face additional
delaying factors outside our control.
Additionally, changes in regulatory requirements and policies may occur and we may need to
amend clinical study protocols to reflect these changes. Amendments may require us to resubmit our
clinical study protocols to IRBs for reexamination, which may impact the costs, timing or
successful completion of a clinical study. If we experience delays in completion of, or if we, the
FDA or other regulatory authorities, the IRB or other reviewing entities, or any of our clinical
study sites suspend or terminate any of our clinical studies, the commercial prospects for our
product candidates may be harmed and our ability to generate product revenues will be delayed. In
addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in
the commencement or completion of, clinical studies may also ultimately lead to the denial of
regulatory approval of a product candidate. Also, if one or more clinical studies are delayed, our
competitors may be able to bring products to market before we do, and the commercial viability of
our product candidates could be significantly reduced.
The results of biomarker assays in earlier clinical studies in varespladib are not necessarily
predictive of future results, and therefore the results of biomarker assays in the VISTA-16 study
may not be similar to those observed previously.
Success in our Phase 2 clinical studies in lowering low-density lipoprotein cholesterol, or
LDL-C, C-reactive protein, or CRP, sPLA2 and interleukin-6, or IL-6, during treatment
with varespladib does not ensure that later clinical studies, such as our VISTA-16 study, will
demonstrate similar reductions in these biomarkers. Each of these biomarkers has been associated
with an increased risk for secondary MACE following an acute coronary syndrome. Our inability to
demonstrate similar biomarker effects in our VISTA-16 study may reduce our ability to achieve our
primary endpoint to reduce MACE and to achieve regulatory approval of varespladib. Recently, an
independent statistician completed an analysis of various biomarkers of cardiovascular risk and
determined that treatment with once-daily varespladib met the pre-specified criteria for the study
to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment
effects versus placebo at relevant time points on a collection of biomarkers including: secretory
phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP),
interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less
than 70 mg/dL and CRP below 1.0 mg/L. Despite these interim results on biomarkers from VISTA-16,
those results do not necessarily equate with reductions in MACE.
Because the results of preclinical testing or earlier clinical studies are not necessarily
predictive of future results, varespladib, A-623, A-001 or any other product candidate we advance
into clinical studies may not have favorable results in later clinical studies or receive
regulatory approval.
Success in preclinical testing and early clinical studies does not ensure that later clinical
studies will generate adequate data to demonstrate the efficacy and safety of an investigational
drug or biologic. A number of companies in the pharmaceutical and biotechnology industries,
including those with greater resources and experience, have suffered significant setbacks in Phase
3 clinical studies, even after seeing promising results in earlier clinical studies. Despite the
results reported in earlier clinical studies for our product candidates, including varespladib,
A-623 and A-001, we do not know whether any Phase 3 or other clinical studies we may conduct will
demonstrate adequate efficacy and safety to result in regulatory approval to market any of our
product candidates. If later stage clinical studies do not produce favorable results, our ability
to achieve regulatory approval for any of our product candidates may be adversely impacted. Even if
we believe that our product candidates have performed satisfactorily in preclinical testing and
clinical studies, we may nonetheless fail to obtain FDA approval for our product candidates.
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If we breach the license agreements for our primary product candidates, we could lose the ability
to continue the development and commercialization of our primary product candidates.
We are party to an agreement with Eli Lilly and Shionogi & Co., Ltd. containing exclusive,
worldwide licenses, except for Japan, of the composition of matter, methods of making and methods
of use for certain sPLA2 inhibitors. We are also party to an agreement with Amgen
containing exclusive, worldwide licenses of the composition of matter and methods of use for A-623.
These agreements require us to make timely milestone and royalty payments, provide regular
information, maintain the confidentiality of and indemnify Eli Lilly, Shionogi & Co., Ltd. and
Amgen under the terms of the agreements.
If we fail to meet these obligations, our licensors may terminate our exclusive licenses and
may be able to re-obtain licensed technology and aspects of any intellectual property controlled by
us that relate to the licensed technology that originated from the licensors. Our licensors could
effectively take control of the development and commercialization of varespladib, A-623 and A-001
after an uncured, material breach of our license agreements by us or if we voluntarily terminate
the agreements. While we would expect to exercise all rights and remedies available to us,
including seeking to cure any breach by us, and otherwise seek to preserve our rights under the
patents licensed to us, we may not be able to do so in a timely manner, at an acceptable cost or at
all. Any uncured, material breach under the licenses could result in our loss of exclusive rights
and may lead to a complete termination of our product development and any commercialization efforts
for varespladib, A-623 or A-001.
Our industry is subject to intense competition. If we are unable to compete effectively, our
product candidates may be rendered non-competitive or obsolete.
The pharmaceutical industry is highly competitive and subject to rapid and significant
technological change. Our potential competitors include large pharmaceutical and more established
biotechnology companies, specialty pharmaceutical and generic drug companies, academic
institutions, government agencies and other public and private research organizations that conduct
research, seek patent protection and establish collaborative arrangements for research,
development, manufacturing and commercialization. All of these competitors currently engage in,
have engaged in or may engage in the future in the development, manufacturing, marketing and
commercialization of pharmaceuticals and biotechnologies, some of which may compete with our
present or future product candidates. It is possible that any of these competitors could develop
technologies or products that would render our product candidates obsolete or non-competitive,
which could adversely affect our revenue potential. Key competitive factors affecting the
commercial success of our product candidates are likely to be efficacy, safety profile,
reliability, convenience of dosing, price and reimbursement.
The market for inflammatory disease therapeutics is especially large and competitive. All of
the sPLA2 inhibitor compounds we are currently developing, if approved, will face
intense competition, either as monotherapies or in combination therapies. We are aware of other
companies with products in development that are being tested for anti-inflammatory benefits in
patients with acute coronary syndrome, such as Via Pharmaceuticals, Inc. and its 5-lipoxygenase, or
5-LO, inhibitor, which has been evaluated in Phase 2 clinical studies; and GlaxoSmithKline plc and
its product candidate, darapladib, which is a lipoprotein associated phospholipase A2,
or Lp-PLA2, inhibitor currently being evaluated in Phase 3 clinical studies. Although
there are no sPLA2 inhibitor compounds currently approved by the FDA for the treatment
of acute chest syndrome associated with sickle cell disease, Droxia, or hydroxyurea, is approved
for the prevention of vaso-occlusive crisis, or VOC, in sickle cell disease and thus could reduce
the pool of patients with VOC at risk for acute chest syndrome. For lupus, Human Genome Sciences,
Inc.s and GlaxoSmithKline plcs BAFF antagonist monoclonal antibody, Benlysta, was recently
approved by the FDA for treatment of lupus. Further, we are aware of companies with other
products in development that are being tested for potential treatment of lupus, ZymoGenetics, Inc.
and Merck Serono S.A., whose dual BAFF/APRIL antagonist fusion protein, Atacicept, is in a Phase 3
clinical study for lupus; and Immunomedics, Inc. and UCB S.A., who recently reported favorable
results for their CD-22 antagonist humanized antibody, epratuzumab, which completed a Phase 2b
clinical study in lupus and has begun a Phase 3 study, and Eli Lillys anti-BLYS monoclonal
antibody, LY2127399, which has begun two Phase 3 studies.
Many of our potential competitors have substantially greater financial, technical and human
resources than we do and significantly greater experience in the discovery and development of drug
candidates, obtaining FDA and other regulatory approvals of products and the commercialization of
those products. Accordingly, our competitors may be more successful than we may be in obtaining FDA
approval for drugs and achieving widespread market acceptance. Our competitors drugs may be more
effective, have fewer adverse effects, be less expensive to develop and manufacture or be more
effectively marketed and sold than any product candidate we may commercialize and may render our
product candidates obsolete or non-competitive before we can recover the expenses of developing and
commercializing any of our product candidates. We anticipate that we will face intense and
increasing competition as new drugs enter the market and advanced technologies become available.
These entities may also establish collaborative or licensing
relationships with our competitors. Finally, the development of new treatment methods for the
diseases we are targeting could render our drugs non-competitive or obsolete. All of these factors
could adversely affect our business.
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Our product candidates may cause undesirable adverse effects or have other properties that could
delay or prevent their regulatory approval or limit the commercial profile of any approved label.
Undesirable adverse effects caused by our product candidates could cause us, IRBs or other
reviewing entities, clinical study sites, or regulatory authorities to interrupt, delay or halt
clinical studies and could result in the denial of regulatory approval by the FDA or other
regulatory authorities. Phase 2 clinical studies conducted by us with our product candidates have
generated differences in adverse effects and serious adverse events. The most common adverse
effects seen with any of our product candidates versus placebo include diarrhea, headache, nausea
and increases in alanine aminotransferase, which is an enzyme that indicates liver cell injury. The
most common serious adverse events seen with any of our product candidates include death, VOC and
congestive heart failure. While none of these serious adverse events were considered related to the
administration of our product candidates by the clinical investigators, if serious adverse events
that are considered related to our product candidates are observed in any Phase 3 clinical studies,
our ability to obtain regulatory approval for our product candidates may be adversely impacted.
Further, if any of our product candidates receives marketing approval and we or others later
discover, after approval and use in an increasing number of patients, that our products could have
adverse effect profiles that limit their usefulness or require their withdrawal (whether or not the
therapies showed the adverse effect profile in Phase 1 through Phase 3 clinical studies), a number
of potentially significant negative consequences could result, including:
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regulatory authorities may withdraw their approval of the product; |
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regulatory authorities may require the addition of labeling statements, such as warnings
or contraindications; |
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we may be required to change the way the product is administered, conduct additional
clinical studies or change the labeling of the product; |
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we could be sued and held liable for harm caused to patients; and |
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our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining market acceptance of the
affected product candidate and could substantially increase the costs of commercializing our
product candidates.
After the completion of our clinical studies, we cannot predict whether or when we will obtain
regulatory approval to commercialize our product candidates and we cannot, therefore, predict the
timing of any future revenue from these product candidates.
Even if we project positive clinical results and file for regulatory approval, we cannot
commercialize any of our product candidates until the appropriate regulatory authorities have
reviewed and approved the applications for such product candidates. We cannot assure you that the
regulatory agencies will complete their review processes in a timely manner or that we will obtain
regulatory approval for any product candidate we develop. Satisfaction of regulatory requirements
typically takes many years, is dependent upon the type, complexity and novelty of the product and
requires the expenditure of substantial resources. In addition, we may experience delays or
rejections based upon additional government regulation from future legislation or administrative
action or changes in FDA policy during the period of product development, clinical studies and FDA
regulatory review.
Our agreement with the FDA on a SPA for our VISTA-16 study of varespladib for the potential
treatment of acute coronary syndrome does not guarantee any particular outcome from regulatory
review of the study or the product candidate.
The FDAs SPA process creates a written agreement between the sponsoring company and the FDA
regarding clinical study design and other clinical study issues that can be used to support
approval of a product candidate. The SPA is intended to provide assurance that if the agreed upon
clinical study protocols are followed and the clinical study endpoints are achieved, the data may
serve as the primary basis for an efficacy claim in support of an NDA. However, the SPA agreement
is not a guarantee of an approval of a product or any permissible claims about the product. In
particular, the SPA is not binding on the FDA if public health concerns unrecognized at the time of
the SPA agreement is entered into become evident, other new scientific concerns regarding product
safety or efficacy arise or if the sponsor company fails to comply with the agreed upon clinical
study protocols. Although we have an agreement with the FDA on an SPA for our VISTA-16 clinical
study of varespladib for the potential short-term (16-week) treatment of acute coronary syndrome,
we do not know how the FDA will interpret the commitments under our agreed upon SPA, how it will
interpret the data and results or whether it will approve our varespladib product candidate for the
short-term (16-week) treatment of acute coronary
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syndrome. Regardless of our SPA agreement, we cannot guarantee any particular outcome from
regulatory review of our VISTA-16 study.
Even if our product candidates receive regulatory approval, they may still face future development
and regulatory difficulties.
Even if U.S. regulatory approval is obtained, the FDA may still impose significant
restrictions on a products indicated uses or marketing or impose ongoing requirements for
potentially costly post-approval studies or post-market surveillance. For example, the label
ultimately approved for varespladib, if any, may include restrictions on use. Further, the FDA has
indicated that long-term safety data on varespladib may need to be obtained as a post-market
requirement. Our product candidates will also be subject to ongoing FDA requirements governing the
labeling, packaging, storage, distribution, safety surveillance, advertising, promotion,
recordkeeping and reporting of safety and other post-market information. In addition, manufacturers
of drug products and their facilities are subject to continual review and periodic inspections by
the FDA and other regulatory authorities for compliance with current good manufacturing practices,
or cGMP, regulations. If we or a regulatory agency discovers previously unknown problems with a
product, such as adverse events of unanticipated severity or frequency, or problems with the
facility where the product is manufactured, a regulatory agency may impose restrictions on that
product, the manufacturing facility or us, including requiring recall or withdrawal of the product
from the market or suspension of manufacturing. If we, our product candidates or the manufacturing
facilities for our product candidates fail to comply with applicable regulatory requirements, a
regulatory agency may:
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issue warning letters or untitled letters; |
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seek an injunction or impose civil or criminal penalties or monetary fines; |
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suspend or withdraw regulatory approval; |
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suspend any ongoing clinical studies; |
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refuse to approve pending applications or supplements to applications filed by us; |
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suspend or impose restrictions on operations, including costly new manufacturing
requirements; or |
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seize or detain products, refuse to permit the import or export of products, or require
us to initiate a product recall. |
The occurrence of any event or penalty described above may inhibit our ability to
commercialize our products and generate revenue.
New legal and regulatory requirements could make it more difficult for us to obtain approvals for
our product candidates and could limit or make more burdensome our ability to commercialize any
approved products.
New federal legislation or regulatory requirements could affect the requirements for obtaining
regulatory approvals of our product candidates or otherwise limit our ability to commercialize any
approved products or subject our products to more rigorous post-approval requirements. For example,
the FDA Amendments Act of 2007, or FDAAA, granted the FDA new authority to impose post-approval
clinical study requirements, require safety-related changes to product labeling and require the
adoption of risk management plans, referred to in the legislation as risk evaluation and mitigation
strategies, or REMS. The REMS may include requirements for special labeling or medication guides
for patients, special communication plans to health care professionals, and restrictions on
distribution and use. Pursuant to the FDAAA, if the FDA makes the requisite findings, it might
require that a new product be used only by physicians with specified specialized training, only in
specified designated health care settings, or only in conjunction with special patient testing and
monitoring. The legislation also included the following: requirements for providing the public
information on ongoing clinical studies through a clinical study registry and for disclosing
clinical study results to the public through such registry; renewed requirements for conducting
clinical studies to generate information on the use of products in pediatric patients; and
substantial new penalties, for example, for false or misleading consumer advertisements. Other
proposals have been made to impose additional requirements on drug approvals, further expand
post-approval requirements, and restrict sales and promotional activities. The new legislation, and
the additional proposals if enacted, may make it more difficult or burdensome for us to obtain
approval of our product candidates, any approvals we receive may be more restrictive or be subject
to onerous post-approval requirements, our ability to successfully commercialize approved products
may be hindered and our business may be harmed as a result.
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If any of our product candidates for which we receive regulatory approval does not achieve broad
market acceptance, the revenue that we generate from its sales, if any, will be limited.
The commercial success of our product candidates for which we obtain marketing approval from
the FDA or other regulatory authorities will depend upon the acceptance of these products by the
medical community, including physicians, patients and health care payors. The degree of market
acceptance of any of our approved products will depend on a number of factors, including:
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demonstration of clinical safety and efficacy compared to other products; |
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the relative convenience, ease of administration and acceptance by physicians and payors
of varespladib in the treatment of acute coronary syndrome, A-623 in the treatment of lupus
and A-001 in the prevention of acute chest syndrome associated with sickle cell disease; |
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the prevalence and severity of any adverse effects; |
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limitations or warnings contained in a products FDA-approved labeling; |
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availability of alternative treatments, including, in the case of varespladib, a number
of competitive products being studied for anti-inflammatory benefits in patients with acute
coronary syndrome or expected to be commercially launched in the near future; |
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pricing and cost-effectiveness; |
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the effectiveness of our or any future collaborators sales and marketing strategies; |
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our ability to obtain and maintain sufficient third-party coverage or reimbursement from
government health care programs, including Medicare and Medicaid; and |
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the willingness of patients to pay out-of-pocket in the absence of third-party coverage. |
If our product candidates are approved but do not achieve an adequate level of acceptance by
physicians, health care payors and patients, we may not generate sufficient revenue from these
products, and we may not become or remain profitable. In addition, our efforts to educate the
medical community and third-party payors on the benefits of our product candidates may require
significant resources and may never be successful.
Our future success depends on our ability to retain our chief executive officer and other key
executives and to attract, retain and motivate qualified personnel.
We are highly dependent on Mr. Paul F. Truex, our President and Chief Executive Officer, Dr.
Colin Hislop, our Senior Vice President and Chief Medical Officer and the other principal members
of our executive team. The loss of the services of any of these persons might impede the
achievement of our research, development and commercialization objectives. Recruiting and retaining
qualified scientific personnel and possibly sales and marketing personnel will also be critical to
our success. We may not be able to attract and retain these personnel on acceptable terms given the
competition among numerous pharmaceutical and biotechnology companies for similar personnel. We
also experience competition for the hiring of scientific personnel from universities and research
institutions. Failure to succeed in clinical studies may make it more challenging to recruit and
retain qualified scientific personnel. In addition, we rely on consultants and advisors, including
scientific and clinical advisors, to assist us in formulating our research and development and
commercialization strategy. Our consultants and advisors may be employed by employers other than us
and may have commitments under consulting or advisory contracts with other entities that may limit
their availability to us.
Recently enacted and future legislation or regulatory reform of the health care system in the
United States and foreign jurisdictions may affect our ability to sell our products profitably.
Our ability to commercialize our future products successfully, alone or with collaborators,
will depend in part on the extent to which reimbursement for the products will be available from
government and health administration authorities, private health insurers and other third-party
payors. The continuing efforts of the U.S. and foreign governments, insurance companies, managed
care organizations and other payors of health care services to contain or reduce health care costs
may adversely affect our ability to set prices for our products which we believe are fair, and our
ability to generate revenues and achieve and maintain profitability.
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Specifically, in both the United States and some foreign jurisdictions, there have been a
number of legislative and regulatory proposals to change the health care system in ways that could
affect our ability to sell our products profitably. In March 2010, President Obama signed into law
the Patient Protection and Affordable Care Act, as amended by the Health Care and Education
Reconciliation Act, or collectively, the Health Care Reform Law, a sweeping law intended to broaden
access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies
against fraud and abuse, add new transparency requirements for healthcare and health insurance
industries, impose new taxes and fees on the health industry and impose additional health policy
reforms.
We will not know the full effects of the Health Care Reform Law until applicable federal and
state agencies issue regulations or guidance under the new law. Although it is too early to
determine the effect of the Health Care Reform Law, the new law appears likely to continue the
pressure on pharmaceutical pricing, especially under the Medicare program, and also may increase
our regulatory burdens and operating costs. We expect further federal and state proposals and
health care reforms to continue to be proposed by legislators, which could limit the prices that
can be charged for the products we develop and may limit our commercial opportunity.
Also in the United States, the Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, also called the Medicare Modernization Act, or MMA, changed the way Medicare covers and
pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by
the elderly and introduced a new reimbursement methodology based on average sales prices for drugs.
In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies
where they can limit the number of drugs that will be covered in any therapeutic class. As a result
of this legislation and the expansion of federal coverage of drug products, we expect that there
will be additional pressure to contain and reduce costs. These cost reduction initiatives and other
provisions of this legislation could decrease the coverage and price that we receive for any
approved products and could seriously harm our business. While the MMA applies only to drug
benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and
payment limitations in setting their own reimbursement rates, and any reduction in reimbursement
that results from the MMA may result in a similar reduction in payments from private payors.
The continuing efforts of government and other third-party payors to contain or reduce the
costs of health care through various means may limit our commercial opportunity. It will be
time-consuming and expensive for us to go through the process of seeking reimbursement from
Medicare and private payors. Our products may not be considered cost-effective, and government and
third-party private health insurance coverage and reimbursement may not be available to patients
for any of our future products or sufficient to allow us to sell our products on a competitive and
profitable basis. Our results of operations could be adversely affected by the MMA, the Health Care
Reform Law, and additional prescription drug coverage legislation, by the possible effect of this
legislation on amounts that private insurers will pay and by other health care reforms that may be
enacted or adopted in the future. In addition, increasing emphasis on managed care in the United
States will continue to put pressure on the pricing of pharmaceutical products. Cost control
initiatives could decrease the price that we or any potential collaborators could receive for any
of our future products and could adversely affect our profitability.
In some foreign countries, including major markets in the European Union and Japan, the
pricing of prescription pharmaceuticals is subject to governmental control. In these countries,
pricing negotiations with governmental authorities can take six to 12 months or longer after the
receipt of regulatory marketing approval for a product. To obtain reimbursement or pricing approval
in some countries, we may be required to conduct a clinical study that compares the
cost-effectiveness of our product candidates to other available therapies. Such pharmacoeconomic
studies can be costly and the results uncertain. Our business could be harmed if reimbursement of
our products is unavailable or limited in scope or amount or if pricing is set at unsatisfactory
levels.
We face potential product liability exposure, and, if successful claims are brought against us, we
may incur substantial liability.
The use of our product candidates in clinical studies and the sale of any products for which
we obtain marketing approval expose us to the risk of product liability claims. Product liability
claims might be brought against us by consumers, health care providers, pharmaceutical companies or
others selling or otherwise coming into contact with our products. If we cannot successfully defend
ourselves against product liability claims, we could incur substantial liabilities. In addition,
regardless of merit or eventual outcome, product liability claims may result in:
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impairment of our business reputation; |
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withdrawal of clinical study participants; |
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costs of related litigation; |
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distraction of managements attention from our primary business; |
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substantial monetary awards to patients or other claimants; |
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the inability to commercialize our product candidates; and |
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decreased demand for our product candidates, if approved for commercial sale. |
Our product liability insurance coverage for our clinical studies may not be sufficient to
reimburse us for all expenses or losses we may suffer. Moreover, insurance coverage is becoming
increasingly expensive, and, in the future, 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. If and when
we obtain marketing approval for any of our product candidates, we intend to expand our insurance
coverage to include the sale of commercial products; however, we may be unable to obtain this
product liability insurance on commercially reasonable terms. On occasion, large judgments have
been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. A
successful product liability claim or series of claims brought against us could cause our stock
price to decline and, if judgments exceed our insurance coverage, could decrease our cash and
adversely affect our business.
If we use hazardous and biological materials in a manner that causes injury or violates applicable
law, we may be liable for damages.
Our research and development activities involve the controlled use of potentially hazardous
substances, including toxic chemical and biological materials. We could be held liable for any
contamination, injury or other damages resulting from these hazardous substances. In addition, our
operations produce hazardous waste products. While third parties are responsible for disposal of
our hazardous waste, we could be liable under environmental laws for any required cleanup of sites
at which our waste is disposed. Federal, state, foreign and local laws and regulations govern the
use, manufacture, storage, handling and disposal of these hazardous materials. If we fail to comply
with these laws and regulations at any time, or if they change, we may be subject to criminal
sanctions and substantial civil liabilities, which may harm our business. Even if we continue to
comply with all applicable laws and regulations regarding hazardous materials, we cannot eliminate
the risk of accidental contamination or discharge and our resultant liability for any injuries or
other damages caused by these accidents.
We rely on third parties to conduct, supervise and monitor our clinical studies, and those third
parties may perform in an unsatisfactory manner, such as by failing to meet established deadlines
for the completion of these clinical studies, or may harm our business if they suffer a
catastrophic event.
We rely on third parties such as CROs, medical institutions and clinical investigators to
enroll qualified patients and conduct, supervise and monitor our clinical studies. Our reliance on
these third parties for clinical development activities reduces our control over these activities.
Our reliance on these third parties, however, does not relieve us of our regulatory
responsibilities, including ensuring that our clinical studies are conducted in accordance with
good clinical practices, or GCP, and the investigational plan and protocols contained in the
relevant regulatory application, such as the investigational new drug application, or IND. In
addition, the CROs with whom we contract may not complete activities on schedule, or may not
conduct our preclinical studies or clinical studies in accordance with regulatory requirements or
our clinical study design. If these third parties do not successfully carry out their contractual
duties or meet expected deadlines, our efforts to obtain regulatory approvals for, and to
commercialize, our product candidates may be delayed or prevented. In addition, if a catastrophe
such as an earthquake, fire, flood or power loss should affect one of the third parties on which we
rely, our business prospects could be harmed. For example, if a central laboratory holding all of
our clinical study samples were to suffer a catastrophic loss of their facility, we would lose all
of our samples and would have to repeat our studies.
Any failure by our third-party manufacturers on which we rely to produce our preclinical and
clinical drug supplies and on which we intend to rely to produce commercial supplies of any
approved product candidates may delay or impair our ability to commercialize our product
candidates.
We have relied upon a small number of third-party manufacturers and active pharmaceutical
ingredient formulators for the manufacture of our material for preclinical and clinical testing
purposes and intend to continue to do so in the future. We also expect to rely upon third parties
to produce materials required for the commercial production of our product candidates if we succeed
in obtaining necessary regulatory approvals. If we are unable to arrange for third-party
manufacturing sources, or to do so on commercially reasonable terms, we may not be able to complete
development of our product candidates or market them.
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Reliance on third-party manufacturers entails risks to which we would not be subject if we
manufactured product candidates ourselves, including reliance on the third party for regulatory
compliance and quality assurance, the possibility of breach of the manufacturing agreement by the
third party because of factors beyond our control (including a failure to synthesize and
manufacture our product candidates in accordance with our product specifications) and the
possibility of termination or nonrenewal of the agreement by the third party, based on its own
business priorities, at a time that is costly or damaging to us. In addition, the FDA and other
regulatory authorities require that our product candidates be manufactured according to cGMP and
similar foreign standards. Any failure by our third-party manufacturers to comply with cGMP or
failure to scale up manufacturing processes, including any failure to deliver sufficient quantities
of product candidates in a timely manner, could lead to a delay in, or failure to obtain,
regulatory approval of any of our product candidates. In addition, such failure could be the basis
for action by the FDA to withdraw approvals for product candidates previously granted to us and for
other regulatory action, including recall or seizure, total or partial suspension of production or
injunction.
As part of our discussions to reactivate our US IND for A-623, we received a request from the
FDA for additional information regarding the characterization and qualification of the already
manufactured vials of A-623 and plans for any future manufactured vials of A-623 that we intend to
use in clinical studies. In response to this request, we provided the FDA additional analytical
data regarding all lots of previously manufactured A-623 to be utilized in the current PEARL-SC
clinical study. In addition, since new vials of A-623 will be manufactured at a new facility by our
partner Merck Biomanufacturing Network (recently acquired by Fujifilm ), we submitted a
comparability plan to the FDA on March 4, 2011 to establish appropriate comparability and
specifications requirements of newly manufactured vials of A-623 to be included in any future
clinical studies. We have had no comments to date. Should the FDA not agree with our comparability
protocol proposal or if we are unable to agree on the specifications for future A-623
manufacturing, further clinical development of A-623 beyond the PEARL-SC clinical study would be
substantially delayed and we would incur substantial additional expense.
We rely on our manufacturers to purchase from third-party suppliers the materials necessary to
produce our product candidates for our clinical studies. There are a small number of suppliers for
certain capital equipment and raw materials that we use to manufacture our drugs. Such suppliers
may not sell these raw materials to our manufacturers at the times we need them or on commercially
reasonable terms. We do not have any control over the process or timing of the acquisition of these
raw materials by our manufacturers. Moreover, we currently do not have any agreements for the
commercial production of these raw materials. Although we generally do not begin a clinical study
unless we believe we have a sufficient supply of a product candidate to complete the clinical
study, any significant delay in the supply of a product candidate or the raw material components
thereof for an ongoing clinical study due to the need to replace a third-party manufacturer could
considerably delay completion of our clinical studies, product testing and potential regulatory
approval of our product candidates. If our manufacturers or we are unable to purchase these raw
materials after regulatory approval has been obtained for our product candidates, the commercial
launch of our product candidates would be delayed or there would be a shortage in supply of such
product candidates, which would impair our ability to generate revenues from the sale of our
product candidates.
Because of the complex nature of our compounds, our manufacturers may not be able to
manufacture our compounds at a cost or in quantities or in a timely manner necessary to make
commercially successful products. If we successfully commercialize any of our drugs, we may be
required to establish large-scale commercial manufacturing capabilities. In addition, as our drug
development pipeline increases and matures, we will have a greater need for clinical study and
commercial manufacturing capacity. We have no experience manufacturing pharmaceutical products on a
commercial scale and some of these suppliers will need to increase their scale of production to
meet our projected needs for commercial manufacturing, the satisfaction of which on a timely basis
may not be met.
If we are unable to establish sales and marketing capabilities or enter into agreements with third
parties to market and sell our product candidates, we may be unable to generate any revenue.
We do not currently have an organization for the sales, marketing and distribution of
pharmaceutical products and the cost of establishing and maintaining such an organization may
exceed the cost-effectiveness of doing so. In order to market any products that may be approved by
the FDA, we must build our sales, marketing, managerial and other non-technical capabilities or
make arrangements with third parties to perform these services. If we are unable to establish
adequate sales, marketing and distribution capabilities, whether independently or with third
parties, we may not be able to generate product revenue and may not become profitable. We will be
competing with many companies that currently have extensive and well-funded marketing and sales
operations. Without an internal team or the support of a third party to perform marketing and sales
functions, we may be unable to compete successfully against these more established companies.
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Guidelines and recommendations published by various organizations may adversely affect the use of
any products for which we may receive regulatory approval.
Government agencies issue regulations and guidelines directly applicable to us and to our
product candidates. In addition, professional societies, practice management groups, private health
or science foundations and organizations involved in various diseases from time to time publish
guidelines or recommendations to the medical and patient communities. These various sorts of
recommendations may relate to such matters as product usage and use of related or competing
therapies. For example, organizations like the American Heart Association have made recommendations
about therapies in the cardiovascular therapeutics market. Changes to these recommendations or
other guidelines advocating alternative therapies could result in decreased use of any products for
which we may receive regulatory approval, which may adversely affect our results of operations.
Risks Related to Our Intellectual Property
If our or our licensors patent positions do not adequately protect our product candidates or any
future products, others could compete with us more directly, which would harm our business.
As of the date of this report, we hold a total of four pending U.S. non-provisional patent
applications, two pending U.S. provisional patent applications and two pending Patent Cooperation
Treaty, or PCT, patent applications. Another PCT application has entered the national phase in the
European Patent Office, the Eurasian Patent Organization and 17 other countries. We have also
entered into exclusive license agreements for certain composition of matter, method of use and
method of making patents and patent applications for certain of our development compounds. These
license agreements encompass (i) 13 U.S. patents, one pending U.S. non-provisional patent
application, five European, or EP, patents, one pending EP patent application, 20 non-EP foreign
patents and three pending non-EP foreign patent applications relating to varespladib and A-001;
(ii) more than 30 U.S. patents, one pending U.S. non-provisional patent application, five EP
patents, one pending EP patent application, 10 issued non-EP foreign patents and one pending non-EP
foreign patent applications relating to other sPLA2 inhibiting compounds including
A-003; and (iii) two U.S. patents, one pending U.S. non-provisional patent application, one EP
patent, two pending EP patent applications, eleven non-EP foreign patents and 13 non-EP foreign
patent applications relating to A-623. Our commercial success will depend in part on our and our
licensors ability to obtain additional patents and protect our existing patent positions,
particularly those patents for which we have secured exclusive rights, as well as our ability to
maintain adequate protection of other intellectual property for our technologies, product
candidates and any future products in the United States and other countries. If we or our licensors
do not adequately protect our intellectual property, competitors may be able to use our
technologies and erode or negate any competitive advantage we may have, which could materially harm
our business, negatively affect our position in the marketplace, limit our ability to commercialize
our product candidates and delay or render impossible our achievement of profitability. The laws of
some foreign countries do not protect our proprietary rights to the same extent as the laws of the
United States, and we may encounter significant problems in protecting our proprietary rights in
these countries.
The patent positions of biotechnology and pharmaceutical companies, including our patent
position, involve complex legal and factual questions, and, therefore, validity and enforceability
cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or
circumvented. We and our licensors will be able to protect our proprietary rights from unauthorized
use by third parties only to the extent that our proprietary technologies, product candidates and
any future products are covered by valid and enforceable patents or are effectively maintained as
trade secrets.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure
that:
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we or our licensors were the first to make the inventions covered by each of our pending
patent applications; |
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we or our licensors were the first to file patent applications for these inventions; |
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others will not independently develop similar or alternative technologies or duplicate
any of our technologies; |
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any of our or our licensors pending patent applications will result in issued patents; |
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any of our or our licensors patents will be valid or enforceable; |
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any patents issued to us or our licensors and collaborators will provide a basis for
commercially viable products, will provide us with any competitive advantages or will not be
challenged by third parties; |
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we will develop additional proprietary technologies or product candidates that are
patentable; or |
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the patents of others will not have an adverse effect on our business. |
We may be unable to adequately prevent disclosure of trade secrets and other proprietary
information.
We rely on trade secrets to protect our proprietary know-how and technological advances,
especially where we do not believe patent protection is appropriate or obtainable. However, trade
secrets are difficult to protect. We rely in part on confidentiality agreements with our employees,
consultants, outside scientific collaborators, sponsored researchers and other advisors to protect
our trade secrets and other proprietary information. These agreements may not effectively prevent
disclosure of confidential information and may not provide an adequate remedy in the event of
unauthorized disclosure of confidential information. In addition, others may independently discover
our trade secrets and proprietary information. Costly and time-consuming litigation could be
necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or
maintain trade secret protection could enable competitors to use our proprietary information to
develop products that compete with our products or cause additional, material adverse effects upon
our competitive business position.
We license patent rights from third-party owners. If we, or such owners, do not properly maintain
or enforce the patents underlying such licenses, our competitive position and business prospects
will be harmed.
We have obtained exclusive, worldwide licenses, except for Japan, of the composition of
matter, methods of making and methods of use for certain sPLA2 compounds from Eli Lilly
and Shionogi & Co., Ltd. In addition, we are party to a license agreement with Amgen that provides
exclusive and worldwide rights to develop and commercialize A-623, a novel BAFF inhibitor, as well
as non-exclusive rights to certain technology relating to peptibody compositions and formulations.
We may enter into additional licenses to third-party intellectual property in the future.
We depend in part on our licensors to protect the proprietary rights covering our in-licensed
sPLA2 compounds and A-623, respectively. Our licensors are responsible for maintaining
certain issued patents and prosecuting certain patent applications. We have limited, if any,
control over the amount or timing of resources that our licensors devote on our behalf or the
priority they place on maintaining these patent rights and prosecuting these patent applications to
our advantage. Our licensors may also be notified of alleged infringement and be sued for
infringement of third-party patents or other proprietary rights. We may have limited, if any,
control or involvement over the defense of these claims, and our licensors could be subject to
injunctions and temporary or permanent exclusionary orders in the United States or other countries.
Our licensors are not obligated to defend or assist in our defense against third-party claims of
infringement. We have limited, if any, control over the amount or timing of resources, if any, that
our licensors devote on our behalf or the priority they place on defense of such third-party claims
of infringement.
Our success will depend in part on the ability of us or our licensors to obtain, maintain and
enforce patent protection for their intellectual property, in particular, those patents to which we
have secured exclusive rights. We or our licensors may not successfully prosecute the patent
applications which we have licensed. Even if patents issue in respect of these patent applications,
we or our licensors may fail to maintain these patents, may determine not to pursue litigation
against other companies that are infringing these patents or may pursue such litigation less
aggressively than we would. Without protection for the intellectual property we license, other
companies might be able to offer substantially identical products for sale, which could adversely
affect our competitive business position and harm our business prospects.
If we do not obtain protection under the Hatch-Waxman Act and similar foreign legislation to
extend our licensed patent terms and to obtain market exclusivity for our product candidates, our
business will be materially harmed.
The United States Drug Price Competition and Patent Term Restoration Act of 1984, more
commonly known as the Hatch-Waxman Act, provides for an extension of patent term for drug
compounds for a period of up to five years to compensate for time spent in the regulatory approval
process. Assuming we gain a five-year patent term extension for each of our current product
candidates in clinical development, and that we continue to have rights under our license
agreements with respect to these product candidates, we would have exclusive rights to
varespladibs U.S. new chemical entity patent (the primary patent covering the compound as a new
composition of matter) until 2019 and to A-623s U.S. new chemical entity patent until 2027. In
Europe, similar legislative enactments allow patent terms in the European Union to be extended for
up to five years through the grant of a Supplementary Protection Certificate. Assuming we gain such
a five-year extension for each of our current product candidates in clinical development, and that
we continue to have rights under our license agreements with respect to these product candidates,
we would have exclusive rights to varespladibs European new chemical entity patents until 2020 and
to A-623s European new chemical
entity patents until 2027. In addition, since varespladib has not been previously approved in
the United States, varespladib could be eligible for up to five years of New Chemical Entity, or
NCE, exclusivity from the FDA. NCE exclusivity would prevent the FDA
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from approving any generic competitor following NDA approval independent of the patent status of
varespladib. Further, since A-623 has not been previously approved, A-623 could be eligible for 12
years of data exclusivity from the FDA. During the data exclusivity period, competitors are barred
from relying on the innovator biologics safety and efficacy data to gain approval. Similarly, the
European Union provides that companies who receive regulatory approval for a new small molecule
compound or biologic will have a 10-year period of data exclusivity for that compound or biologic
(with the possibility of a further one-year extension) in most EU countries, beginning on the date
of such European regulatory approval, regardless of when the European new chemical entity patent
covering such compound expires. A generic version of the approved drug may not be marketed or sold
during such market exclusivity period. However, there is no assurance that we will receive the
extensions of our patents or other exclusive rights available under the Hatch-Waxman Act or similar
foreign legislation. If we fail to receive such Hatch-Waxman extensions or marketing exclusivity
rights or if we receive extensions that are materially shorter than expected, our ability to
prevent competitors from manufacturing, marketing and selling generic versions of our products will
be materially harmed.
Our current patent positions and license portfolio may not include all patent rights needed for
the full development and commercialization of our product candidates. We cannot be sure that
patent rights we may need in the future will be available for license to us on commercially
reasonable terms, or at all.
We typically develop our product candidates using compounds for which we have in-licensed and
original composition of matter patents and patents that claim the activities and methods for such
compounds production and use to the extent known at that time. As we learn more about the
mechanisms of action and new methods of manufacture and use of these product candidates, we may
file additional patent applications for these new inventions or we may need to ask our licensors to
file them. We may also need to license additional patent rights or other rights on compounds,
treatment methods or manufacturing processes because we learn that we need such rights during the
continuing development of our product candidates.
Although our in-licensed and original patents may prevent others from making, using or selling
similar products, they do not ensure that we will not infringe the patent rights of third parties.
We may not be aware of all patents or patent applications that may impact our ability to make, use
or sell any of our product candidates or proposed product candidates. For example, because we
sometimes identify the mechanism of action or molecular target of a given product candidate after
identifying its composition of matter and therapeutic use, we may not be aware until the mechanism
or target is further elucidated that a third party has an issued or pending patent claiming
biological activities or targets that may cover our product candidate. U.S. patent applications
filed after November 29, 2000 are confidential in the U.S. Patent and Trademark Office for the
first 18 months after such applications earliest priority date, and patent offices in non-U.S.
countries often publish patent applications for the first time six months or more after filing.
Furthermore, we may not be aware of published or granted conflicting patent rights. Any conflicts
resulting from patent applications and patents of others could significantly reduce the coverage of
our patents and limit our ability to obtain meaningful patent protection. If others obtain patents
with conflicting claims, we may need to obtain licenses to these patents or to develop or obtain
alternative technology.
We may not be able to obtain any licenses or other rights to patents, technology or know-how
from third parties necessary to conduct our business as described in this report and such licenses,
if available at all, may not be available on commercially reasonable terms. Any failure to obtain
such licenses could delay or prevent us from developing or commercializing our drug candidates or
proposed product candidates, which would harm our business. Litigation or patent interference
proceedings may be necessarily brought against third parties, as discussed below, to enforce any of
our patents or other proprietary rights or to determine the scope and validity or enforceability of
the proprietary rights of such third parties.
Litigation regarding patents, patent applications and other proprietary rights may be expensive
and time consuming. If we are involved in such litigation, it could cause delays in bringing
product candidates to market and harm our ability to operate.
Our commercial success will depend in part on our ability to manufacture, use, sell and offer
to sell our product candidates and proposed product candidates without infringing patents or other
proprietary rights of third parties. Although we are not currently aware of any litigation or other
proceedings or third-party claims of intellectual property infringement related to our product
candidates, the pharmaceutical industry is characterized by extensive litigation regarding patents
and other intellectual property rights. Other parties may obtain patents in the future and allege
that the use of our technologies infringes these patent claims or that we are employing their
proprietary technology without authorization. Likewise, third parties may challenge or infringe
upon our or our licensors existing or future patents.
Proceedings involving our patents or patent applications or those of others could result in
adverse decisions regarding the patentability of our inventions relating to our product candidates
or the enforceability, validity or scope of protection offered by our patents relating to our
product candidates.
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Even if we are successful in these proceedings, we may incur substantial costs and divert
management time and attention in pursuing these proceedings. If we are unable to avoid infringing
the patent rights of others, we may be required to seek a license, defend an infringement action or
challenge the validity of the patents in court. Patent litigation is costly and time-consuming. We
may not have sufficient resources to bring these actions to a successful conclusion. In addition,
if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an
infringement action successfully or have our patents declared invalid, we may incur substantial
monetary damages; encounter significant delays in bringing our product candidates to market; or be
precluded from participating in the manufacture, use or sale of our product candidates or methods
of treatment requiring licenses.
Risks Related to the Securities Markets and Investment in Our Common Stock
Market volatility may affect our stock price and the value of your investment.
The market price for our common stock has been, and is likely to continue to be, volatile. In
addition, the market price of our common stock may fluctuate significantly in response to a number
of factors, most of which we cannot predict or control, including:
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plans for, progress in and results from clinical studies for varespladib, A-623, A-001
and our other product candidates; |
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announcements of new products, services or technologies, commercial relationships,
acquisitions or other events by us or our competitors; |
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developments concerning proprietary rights, including those pertaining to patents held by
Eli Lilly and Shionogi & Co., Ltd. concerning our sPLA2 inhibitors and Amgen
concerning A-623; |
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failure of any of our product candidates, if approved, to achieve commercial success; |
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fluctuations in stock market prices and trading volumes of securities of similar
companies; |
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general market conditions and overall fluctuations in U.S. equity markets; |
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variations in our operating results, or the operating results of our competitors; |
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changes in our financial guidance or securities analysts estimates of our financial
performance; |
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changes in accounting principles; |
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sales of large blocks of our common stock, including sales by our executive officers,
directors and significant stockholders; |
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additions or departures of any of our key personnel; |
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announcements related to litigation; |
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changing legal or regulatory developments in the United States and other countries; and |
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discussion of us or our stock price by the financial press and in online investor
communities. |
Although our common stock is listed for trading on the NASDAQ Global Market, our securities
have been relatively thinly traded. Investor trading patterns could serve to exacerbate the
volatility of the price of the stock. Accordingly, it may be difficult to sell shares of common
stock quickly without significantly depressing the value of the stock. Unless we are successful in
developing continued investor interest in our stock, sales of our stock could result in major
fluctuations in the price of the stock. In addition, the stock market in general, and The NASDAQ
Global Market in particular, have experienced substantial price and volume volatility that is often
seemingly unrelated to the operating performance of particular companies. These broad market
fluctuations may cause the trading price of our common stock to decline. In the past, securities
class action litigation has often been brought against a company after a period of volatility in
the market price of its common stock. We may become involved in this type of litigation in the
future. Any securities litigation claims brought against us could result in substantial expenses
and the diversion of our managements attention from our business.
Because a small number of our existing stockholders own a majority of our voting stock, your
ability to influence corporate matters will be limited.
Our executive officers, directors and greater than 5% stockholders, in the aggregate, own
approximately 75% of our outstanding common stock. As a result, such persons, acting together, will
have the ability to control our management and affairs and substantially
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all matters submitted to our stockholders for approval, including the election and removal of
directors and approval of any significant transaction. These persons will also have the ability to
control our management and business affairs. This concentration of ownership may have the effect of
delaying, deferring or preventing a change in control, impeding a merger, consolidation, takeover
or other business combination involving us, or discouraging a potential acquirer from making a
tender offer or otherwise attempting to obtain control of our business, even if such a transaction
would benefit other stockholders.
Future sales of our common stock may cause our stock price to decline.
As of March 31, 2011, there were 32,926,100 shares of our common stock outstanding. In
addition, as of March 31, 2011, we had outstanding options to purchase shares of our common stock
and restricted stock units of 2,512,931 that, if exercised or released, will result in these
additional shares becoming available for sale. A large portion of these shares and outstanding
equity awards are held by a small number of persons and investment funds. Sales by these
stockholders or option holders of a substantial number of shares could significantly reduce the
market price of our common stock. Moreover, certain holders of shares of common stock will have
rights, subject to some conditions, to require us to file registration statements covering the
shares they currently hold, or to include these shares in registration statements that we may file
for ourselves or other stockholders.
We have registered all common stock that we may issue under our Amended and Restated 2010
Stock Option and Incentive Plan (the 2010 Plan) and our Employee Stock Purchase Plan (the
ESPP). As of March 31, 2011, an aggregate of 1,778,261 shares of our common stock has been
reserved for future issuance under the 2010 Plan, plus any shares reserved and unissued under our
2005 Equity Incentive Plan, and an aggregate of 350,000 shares has been reserved for future
issuance under our ESPP. These shares can be freely sold in the public market upon issuance. If a
large number of these shares are sold in the public market, the sales could reduce the trading
price of our common stock.
In addition, we have filed a universal shelf registration statement with the SEC on Form S-3
(File No. 333-172637) on March 7, 2011, which was declared effective on March 11, 2011, for the
proposed offering from time to time of up to $75.0 million of our securities, including common
stock, preferred stock, debt securities and/or warrants. We may issue securities in the future
pursuant to the shelf registration statement based on market conditions or other circumstances.
We may need to raise additional capital to fund our operations, which may cause dilution to our
existing stockholders, restrict our operations or require us to relinquish rights.
We may seek additional capital through a combination of private and public equity offerings,
debt financings and collaboration, strategic and licensing arrangements. To the extent that we
raise additional capital through the sale of equity or convertible debt securities, your ownership
interest may be diluted, and the terms may include liquidation or other preferences that adversely
affect your rights as a stockholder. Debt financing, if available, may involve agreements that
include covenants limiting or restricting our ability to take specific actions such as incurring
debt, making capital expenditures or declaring dividends. If we raise additional funds through
collaboration, strategic alliance and licensing arrangements with third parties, we may have to
relinquish valuable rights to our technologies or product candidates or grant licenses on terms
that are not favorable to us.
Operating as a public company increases our expenses and administrative burden.
As a public company, we incur significant legal, accounting and other expenses that we did not
incur as a private company. In addition, our administrative staff will be required to perform
additional tasks. For example, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well
as rules subsequently implemented by the SEC and The NASDAQ Global Market, impose various
requirements on public companies, including establishment and maintenance of effective disclosure
and financial controls and changes in corporate governance practices. We must also bear all of the
internal and external costs of preparing and distributing periodic public reports in compliance
with our obligations under the securities laws.
In particular, the Sarbanes-Oxley Act requires, among other things, that we maintain effective
internal control over financial reporting and disclosure controls and procedures. Commencing in
2011, we must perform system and process evaluation and testing of our internal control over
financial reporting to allow management and our independent registered public accounting firm to
report on the effectiveness of our internal control over financial reporting, as required by
Section 404 of the Sarbanes-Oxley Act. Our compliance with Section 404 will require that we incur
substantial accounting expense and expend significant management time on compliance-related issues.
Moreover, if we are not able to comply with the requirements of Section 404 in a timely manner, our
stock price could decline, and we could face sanctions, delisting or investigations by The NASDAQ
Global Market, or other material adverse effects on our business, reputation, results of
operations, financial condition or liquidity.
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We do not intend to pay dividends on our common stock so any returns will be limited to the value
of our stock.
We have never declared or paid any cash dividend on our common stock. We currently anticipate
that we will retain future earnings for the development, operation and expansion of our business
and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return
to stockholders will therefore be limited to the value of their stock.
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition
of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our
stockholders to replace or remove our current management.
Provisions in our amended and restated certificate of incorporation and amended and restated
bylaws may delay or prevent an acquisition of us or a change in our management. These provisions
include:
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a classified and staggered board of directors whose members can only be dismissed for
cause; |
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the prohibition on actions by written consent of our stockholders; |
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the limitation on who may call a special meeting of stockholders; |
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the establishment of advance notice requirements for nominations for election to our
board of directors or for proposing matters that can be acted upon at stockholder meetings; |
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the ability of our board of directors to issue preferred stock without stockholder
approval, which would increase the number of outstanding shares and could thwart a takeover
attempt; and |
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the requirement of at least 75% of the outstanding common stock to amend any of the
foregoing provisions. |
In addition, because we are incorporated in Delaware, we are governed by the provisions of
Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders
owning in excess of 15% of our outstanding voting stock to merge or combine with us. Although we
believe these provisions collectively provide for an opportunity to obtain greater value for
stockholders by requiring potential acquirors to negotiate with our board of directors, they would
apply even if an offer rejected by our board were considered beneficial by some stockholders. In
addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or
remove our current management by making it more difficult for stockholders to replace members of
our board of directors, which is responsible for appointing the members of our management.
Our ability to use our net operating loss carryforwards may be subject to limitation and may
result in increased future tax liability to us.
Generally, a change of more than 50% in the ownership of a corporations stock, by value, over
a three-year period constitutes an ownership change for U.S. federal income tax purposes. An
ownership change may limit a companys ability to use its net operating loss carryforwards
attributable to the period prior to such change. We have not performed a detailed analysis to
determine whether an ownership change under Section 382 of the Internal Revenue Code has occurred
after each of our previous private placements of preferred stock and convertible debt, or our
previous issuances of common stock, which if sufficient, taking into account prior or future shifts
in our ownership over a three-year period, could cause us to undergo an ownership change. As a
result, if we earn net taxable income, our ability to use our pre-change net operating loss
carryforwards to offset U.S. federal taxable income may become subject to limitations, which could
potentially result in increased future tax liability to us.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Previously reported in a Current Report on Form 8-K.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. (REMOVED AND RESERVED)
ITEM 5. OTHER INFORMATION
None.
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ITEM 6. EXHIBITS
The following exhibits are filed as part of this report:
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3.1
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Fifth Amended and Restated Certificate of Incorporation (filed as Exhibit 3.6 to
the registrants Registration Statement on Form S-1/A (File No. 333-161930) filed
with the SEC on February 3, 2010, and incorporated herein by reference). |
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3.2
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Amended and Restated Bylaws (filed as Exhibit 3.7 to the registrants
Registration Statement on Form S-1/A (File No. 333-161930) filed with the SEC on
February 3, 2010, and incorporated herein by reference). |
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10.1
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Second Addendum to Sublease by and between the Company and Millipore Corporation,
as a successor in interest to Guava Technologies, dated as of January 12, 2011
(filed as Exhibit 10.41 to the registrants Annual Report on Form 10-K filed with
the SEC on March 7, 2011, and incorporated herein by reference). |
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10.2
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Loan and Security Agreement dated
March 25, 2011, by and between the Company, Hercules Technology
II, L.P. and Hercules Technology Growth Capital, Inc.,
(filed as Exhibit 10.1 to the registrants Current Report on Form 8-K filed with
the SEC on March 29, 2011, and incorporated herein by reference). |
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10.3
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Form of Warrant Agreement dated March 25, 2011 (filed as Exhibit 10.2 to
registrants Current Report on Form 8-K filed with the SEC on March 29, 2011, and
incorporated herein by reference). |
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10.4
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Lease by and between the Company and MEPT Mount Eden LLC, dated as of May 4, 2011. |
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31.1
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Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule
15d-14(a) of the Securities Exchange Act of 1934, as amended. |
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31.2
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Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule
15d-14(a) of the Securities Exchange Act of 1934, as amended. |
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32.1
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Certification of Principal Executive Officer pursuant to Rule 13a-14(b) of the
Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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32.2
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Certification of Principal Financial Officer pursuant to Rule 13a-14(b) of the
Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as
adopted pursuant Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ANTHERA PHARMACEUTICALS, INC.
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May 13, 2011 |
By: |
/s/ Paul F. Truex
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Paul F. Truex |
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President and Chief Executive Officer |
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May 13, 2011 |
By: |
/s/ Christopher P. Lowe
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Christopher P. Lowe |
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Chief Financial Officer |
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