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
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For the quarterly period ended March 31, 2010
OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from
to
Commission file number: 001-34637
Anthera Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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20-1852016
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(State or Other Jurisdiction of
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(I.R.S. Employer
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Incorporation or Organization)
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Identification No.)
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25801 Industrial Boulevard, Suite B
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Hayward, California
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94545
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(Address of Principal Executive Offices)
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(Zip Code)
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(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
No
o
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
o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
þ
(Do not check if a smaller reporting company)
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Smaller reporting company
o
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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 11, 2010, the number of outstanding shares of the registrants common stock, par
value $0.001 per share, was 22,305,570
.
ANTHERA PHARMACEUTICALS, INC.
FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2010
INDEX
2
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
ANTHERA PHARMACEUTICALS, INC
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(unaudited)
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March 31,
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December 31,
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2010
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2009
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ASSETS
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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56,661,609
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$
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3,803,384
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Prepaid expenses and other current assets
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359,252
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19,825
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Total current assets
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57,020,861
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3,823,209
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Property and equipmentnet
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15,470
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12,994
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Deferred financing cost
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1,922,183
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Other assets
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130,403
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TOTAL
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$
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57,036,331
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$
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5,888,789
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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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$
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3,329,651
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$
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3,145,706
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Accrued clinical study
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322,698
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565,034
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Accrued liabilities
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472,952
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767,663
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Accrued payroll and related costs
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179,156
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153,235
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Warrant and derivative liabilities
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406,130
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Convertible promissory notes
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13,129,877
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Total current liabilities
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4,304,457
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18,167,645
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Total liabilities
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4,304,457
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18,167,645
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Commitments and Contingencies (Note 7)
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Stockholders equity (deficit)
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Preferred stock, $0.001 par value, 5,000,000 and
11,948,557 shares authorized, 0 and 8,146,308 shares
issued and outstanding as of March 31, 2010 and
December 31, 2009, respectively; (aggregate
liquidation value of $0 and $52,597,692 as of March
31, 2010 and December 31, 2009, respectively)
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8,146
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Common stock, $0.001 par value, 95,000,000 and
18,443,341 shares authorized; 21,589,588 and
1,566,199 shares issued and outstanding as of March
31, 2010 and December 31, 2009, respectively
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21,589
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1,566
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Additional paid-in capital
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129,044,029
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52,941,384
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Deficit accumulated the during the development stage
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(76,333,744
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)
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(65,229,952
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)
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Total stockholders equity (deficit)
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52,731,874
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(12,278,856
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)
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TOTAL
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$
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57,036,331
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$
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5,888,789
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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
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from
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September 9,
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2004
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(Date of
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Inception)
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to
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Three Months Ended March 31,
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March 31,
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2010
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2009
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2010
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OPERATING EXPENSES:
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Research and development
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$
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5,241,814
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$
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2,914,766
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$
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56,565,795
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General and administrative
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1,224,110
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846,243
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11,141,677
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Total operating expenses
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6,465,924
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3,761,009
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67,707,472
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LOSS FROM OPERATIONS
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(6,465,924
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)
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(3,761,009
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)
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(67,707,472
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)
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OTHER EXPENSE:
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Interest and other income
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3,301
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13,046
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1,023,061
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Interest and other expense
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(4,641,169
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(37,397
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(5,340,789
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)
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Beneficial conversion features
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(4,308,544
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)
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Total other expense
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(4,637,868
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)
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(24,351
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(8,626,272
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)
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NET LOSS
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$
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(11,103,792
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)
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$
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(3,785,360
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$
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(76,333,744
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)
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Net loss per sharebasic and diluted
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$
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(0.83
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$
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(2.57
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)
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Weighted-average number of shares
used in per share calculationbasic
and diluted
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13,344,231
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1,470,722
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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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2010
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2009
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2010
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CASH FLOW FROM OPERATING ACTIVITIES:
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Net loss
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$
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(11,103,792
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)
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$
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(3,785,360
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)
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$
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(76,333,744
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)
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation
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3,270
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4,868
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75,598
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Amortization of discount on short-term investments
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(130,248
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)
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Realized loss on short-term investments
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(331
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)
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8,682
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Realized gain from disposal of property and equipment
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(214
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)
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Stock-based compensation expenseemployees
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48,412
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43,478
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525,291
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Stock-based compensation expenseconsultants
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4,204
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1,153
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162,149
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Issuance of common stock for consulting service
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41,366
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Issuance of common and preferred 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 common and preferred stock in lieu of interest payment
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173,194
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640,493
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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 debt issuance cost
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227,955
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307,599
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Mark to market adjustment on warrant and derivative liability
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3,796,491
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3,795,776
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Changes in assets and liabilities:
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Prepaid expenses and other assets
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(339,427
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)
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27,937
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(359,253
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)
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Accounts payable
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(103,890
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)
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|
576,912
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1,280,786
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Accrued clinical study
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(242,336
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)
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(157,641
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)
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322,698
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Accrued liabilities
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|
(34,662
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)
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62,639
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|
387,612
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Accrued payroll and related costs
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25,922
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29,469
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179,156
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License fee payable
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(500,000
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)
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Net cash used in operating activities
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(3,503,666
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)
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(3,696,876
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)
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(58,359,994
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)
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INVESTING ACTIVITIES:
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Property and equipment purchases
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(5,746
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)
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|
|
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(91,253
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)
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Proceeds from disposal of property and equipment
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|
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|
400
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Purchase of short-term investments
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|
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(14,800,564
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)
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Proceeds from sale of short-term investments
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14,922,132
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Net cash provided by (used in) investing activities
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(5,746
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)
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30,715
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FINANCING ACTIVITIES:
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Proceeds from issuance of convertible notes
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|
|
|
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26,560,000
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Payment of debt issuance cost
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(2,572
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)
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|
|
|
|
|
|
(99,889
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)
|
Net proceeds from issuance of preferred stock
|
|
|
|
|
|
|
|
|
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|
32,210,278
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Payment of financing cost for initial public offering
|
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(850,416
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)
|
|
|
|
|
|
|
(1,124,300
|
)
|
Proceeds from issuance of common stock
|
|
|
57,202,972
|
|
|
|
|
|
|
|
57,203,087
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Proceeds from exercise of stock options
|
|
|
17,653
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|
|
|
|
|
|
|
241,712
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
56,367,637
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|
|
|
|
|
|
|
114,990,888
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|
|
|
|
|
|
|
|
|
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|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
52,858,225
|
|
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(3,696,876
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)
|
|
|
56,661,609
|
|
CASH AND CASH EQUIVALENTSBeginning of period
|
|
|
3,803,384
|
|
|
|
7,895,113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTSEnd of period
|
|
$
|
56,661,609
|
|
|
$
|
4,198,237
|
|
|
$
|
56,661,609
|
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH DISCLOSURES OF CASH FLOWINFORMATION:
|
|
|
|
|
|
|
|
|
|
|
|
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Interest paid
|
|
$
|
|
|
|
$
|
|
|
|
$
|
15,229
|
|
|
|
|
|
|
|
|
|
|
|
Taxes paid
|
|
$
|
10,136
|
|
|
$
|
999
|
|
|
$
|
39,723
|
|
|
|
|
|
|
|
|
|
|
|
NONCASH INVESTMENT 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
|
|
|
|
|
|
|
|
|
|
|
|
Accrued and deferred debt issuance costs
|
|
$
|
97,552
|
|
|
$
|
|
|
|
$
|
207,711
|
|
|
|
|
|
|
|
|
|
|
|
Unamortized
debt discount charged to equity in conjunction with conversion of promissory notes into common stock
|
|
$
|
185,833
|
|
|
$
|
|
|
|
$
|
185,833
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of warrant and derivative liabilities to additional paid-in capital
|
|
$
|
406,130
|
|
|
$
|
|
|
|
$
|
406,130
|
|
|
|
|
|
|
|
|
|
|
|
IPO issuance
costs charged to equity
|
|
$
|
3,021,966
|
|
|
$
|
|
|
|
$
|
3,021,966
|
|
|
|
|
|
|
|
|
|
|
|
Accrued and deferred financing costs
|
|
$
|
884,952
|
|
|
$
|
|
|
|
$
|
1,897,666
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed financial statements.
5
ANTHERA PHARMACEUTICALS, INC.
(A Development Stage Company)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
1. ORGANIZATION AND DESCRIPTION OF BUSINESS
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, A-002 and A-001, are inhibitors of the family of human enzymes known as
secretory phospholipase A
2
, or sPLA
2
. The Companys other primary product
candidate, A-623, targets elevated levels of B-lymphocyte stimulator. 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, 2010, as defined by the Financial Accounting Standard Board
(FASB) Accounting Standard Codification (ASC) 915. 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; 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 deficit of $76.4 million. The Company expects to continue to incur substantial losses
over the next several years during its 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 and, in the longer term, revenue from product sales.
On February 26, 2010, the Companys Registration Statement on Form S-1 was declared effective
for its initial public offering (IPO), pursuant to which the Company sold 6,000,000 shares of its
common stock at a public offering price of $7.00 per share. The Company received gross proceeds of
approximately $42.0 million from this transaction, before underwriting discounts and commissions.
Concurrent with the closing of the IPO, the Company received an aggregate of $17.1 million from the
issuance of 2,598,780 shares of its common stock to certain of its investors pursuant to a common
stock purchase agreement.
2. BASIS OF PRESENTATION
The interim condensed financial statements have been prepared and presented by the
Company in accordance with accounting principles generally accepted in the United States (GAAP)
and the rules and regulations of the Securities and Exchange Commission (SEC), without audit, and
reflect all adjustments necessary to present fairly the Companys interim financial information.
The accounting principles and methods of computation adopted in these financial statements are the
same as those of the audited financial statements for the year ended December 31, 2009.
Certain information and footnote disclosures normally included in the Companys annual
financial statements prepared in accordance with GAAP have been condensed or omitted. The
accompanying unaudited financial statements should be read in conjunction with the audited
financial statements for the year ended December 31, 2009, included in the Companys Registration
Statement on Form S-1 (as amended). The financial results for any interim period are not
necessarily indicative of financial results for the full year.
3. RECENT ACCOUNTING PRONOUNCEMENTS
In June 2008, the FASB issued ASC 815-40,
Derivatives and Hedging
, that provides guidance on
how to determine if certain instruments (or embedded features) are considered indexed to a
companys own stock, including instruments similar to warrants to purchase the companys stock.
FASB ASC 815-40 requires companies to use a two-step approach to evaluate an instruments
contingent exercise provisions and settlement provisions in determining whether the instrument is
considered to be indexed to its own
6
stock and therefore exempt from the application of FASB ASC
815. FASB ASC 815-40 became effective January 1, 2009. Any outstanding instrument at the date of adoption requires a retrospective application of the
accounting through a cumulative effect adjustment to retained earnings upon adoption. The Companys
adoption of this guidance did not have a material impact on either its financial position or
results of operations.
In June 2009, the FASB issued ASC 105,
Generally Accepted Accounting Principles
, which
establishes the FASB Accounting Standards Codification as the sole source of authoritative GAAP.
The Company adopted the new standard for this interim reporting. The adoption of FASB ASC 105 did
not impact the Companys financial position or results of operations.
In January 2010, the FASB issued guidance that requires reporting entities to make new
disclosures about recurring or nonrecurring fair-value measurements including significant transfers
into and out of Level 1 and Level 2 fair value measurements and information on purchases, sales,
issuances and settlements on a gross basis in the reconciliation of Level 3 fair value
measurements. The guidance is effective for annual reporting periods beginning after December 15,
2009, except for Level 3 reconciliation disclosures that are effective for annual periods beginning
after December 15, 2010. We do not expect the adoption of this guidance to have a material impact
on our unaudited condensed financial statements.
4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of the Companys unaudited condensed financial statements in conformity with
GAAP requires management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at the date of the
unaudited condensed financial statements and the reported amounts of expenses during the reporting
period. Significant estimates include assumptions made in the accrual of clinical costs and
stock-based compensation. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid instruments purchased with an original maturity or
remaining maturities of three months or less at the date of purchase to be cash equivalents.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk
consist primarily of cash and cash equivalents. The Companys cash equivalents consist of cash,
certificates of deposits and treasury money market funds. The Company has not experienced any
losses in such accounts. The Company believes it is not exposed to significant credit risk related
to cash and cash equivalents.
Property and EquipmentNet
Property and equipment are stated at cost, less accumulated depreciation. Depreciation is
computed over the estimated useful lives of the respective assets, which range from three to five
years, using the straight-line method. Repairs and maintenance costs are expensed as incurred.
Deferred Financing Cost
Deferred financing costs included costs directly attributable to the Companys offering of its
equity securities. In accordance with FASB ASC 340-10,
Other Assets and Deferred Costs
, these costs
are deferred and capitalized as part of other assets. Costs attributable to the equity offerings
are charged against the proceeds of the offering once completed.
Long-Lived Assets
The Companys long-lived assets and other assets are reviewed for impairment in accordance
with the guidance of the FASB ASC 360-10,
Property, Plant, and Equipment
, whenever events or
changes in circumstances indicate that the carrying amount of the asset may not be recoverable.
Recoverability of an asset to be held and used is measured by a comparison of the carrying amount
of an asset to the future undiscounted cash flows expected to be generated by the asset. If such
asset is considered to be impaired, the impairment
7
to be recognized is measured by the amount by which the carrying amount of the asset exceeds
its fair value. Through March 31, 2010, the Company had not experienced impairment losses on its
long-lived assets.
Fair Value of Financial Instruments
The Company adopted the provisions of FASB ASC 820,
Fair Value Measurements and Disclosures
,
effective January 1, 2008. FASB ASC 820 defines fair value, establishes a framework for measuring
fair value under GAAP and enhances disclosures about fair value measurements.
Fair value is defined as the price that would be received to sell an asset or paid to transfer
a liability in an orderly transaction between market participants at the measurement date.
Valuation techniques used to measure fair value, as required by Topic 820 of the FASB ASC, must
maximize the use of observable inputs and minimize the use of unobservable inputs.
The standard describes a fair value hierarchy based on three levels of inputs, of which the
first two are considered observable and the last unobservable, that may be used to measure fair
value. The Companys assessment of the significance of a particular input to the fair value
measurements requires judgment, and may affect the valuation of the assets and liabilities being
measured and their placement within the fair value hierarchy. The three levels of input are:
Level 1
Quoted prices in active markets for identical assets or liabilities.
Level 2
Inputs other than Level 1 that are observable, either directly or indirectly, such
as quoted prices for similar assets or liabilities; quoted prices in markets that are not active;
or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level 3
Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
The adoption of this statement did not have a material impact on the Companys results of
operations and financial condition.
The following is a description of the Companys valuation methodologies for assets and
liabilities measured at fair value.
Where quoted prices are available in an active market, fair value is based upon quoted market
prices and are classified in Level 1 of the valuation hierarchy. If quoted market prices are not
available, fair value is based upon observable inputs such as quoted prices for similar assets or
liabilities, quoted prices in markets that are not active or other inputs that are observable or
can be corroborated by observable market data, the assets or liabilities are classified in Level 2
of the valuation hierarchy. When quoted prices and observable inputs are unavailable, fair values
are based on internally developed cash flow models and are classified in Level 3 of the valuation
hierarchy. The internally developed cash flow models primarily use, as inputs, estimates for
interest rates and discount rates including yields of comparable traded instruments adjusted for
illiquidity and other risk factors, amount of cash flows and expected holding periods of the
assets. These inputs reflect the Companys own assumptions about the assumptions market
participants would use in pricing the assets, including assumptions about risk developed based on
the best information available in the circumstances.
Other financial instruments, including accounts payable and accrued liabilities, are carried
at cost, which the Company believes approximates fair value because of the short-term maturity of
these instruments.
Stock-Based Compensation
Effective January 1, 2006, the Company adopted the provisions of FASB ASC 718,
Compensation
Stock Compensation
, using the modified prospective method. Compensation costs related to all equity
instruments granted after January 1, 2006 are recognized at the grant-date fair value of the
awards. Additionally, the Company is 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. The Company estimates the fair value of its
share-based payment awards on the date of grant using an option-pricing model.
Prior to January 1, 2006, the Company accounted for stock-based awards to employees and
directors using the intrinsic value method. Under the intrinsic value method, stock-based
compensation expense was recognized based on the intrinsic value method whereby any difference
between exercise price and fair value of the common stock on the date of grant was recognized as
stock-based compensation expense ratably over the vesting period. As all employee stock options
granted through December 31, 2005 were granted with an exercise price equal to the fair value of
the common stock at the date of grant, no expense was recognized through December 31, 2005.
8
The Company uses the Black-Scholes option-pricing model as the method for determining the
estimated fair value of stock options. The Black-Scholes model requires the use of highly
subjective and complex assumptions, which determine the fair value of share-based awards, including
the options expected term and the price volatility of the underlying stock.
Expected Term
The Companys expected term represents the period that the Companys stock-based
awards are expected to be outstanding and is determined using the simplified method.
Expected Volatility
Expected volatility is estimated using comparable public company
volatility for similar terms.
Expected Dividend
The Black-Scholes valuation model calls for a single expected dividend yield
as an input and the Company has never paid dividends and has no plans to pay dividends.
Risk-Free Interest Rate
The risk-free interest rate used in the Black-Scholes valuation method
is based on the U.S. Treasury zero-coupon issues in effect at the time of grant for periods
corresponding with the expected term of option.
Estimated Forfeitures
The estimated forfeiture rate is determined based on the Companys
historical forfeiture rates to date. The Company will monitor actual expenses and periodically
update the estimate.
Equity instruments issued to nonemployees are recorded at their fair value as determined in
accordance with FASB ASC 505-50,
Equity
, and are periodically revalued as the equity instruments
vest and are recognized as expense over the related service period.
Research and Development
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: research, clinical development and pharmaceutical development. Research
costs typically consist of preclinical and toxicology costs. Clinical development costs include
costs for Phase 1 and 2 clinical studies. Pharmaceutical development costs consist of expenses
incurred in connection with product formulation and chemical analysis.
The Company charges research and development costs, including clinical study costs, to expense
when incurred, consistent with the guidance of FASB ASC 730,
Research and Development
. Clinical
study costs are a significant component of research and development expenses. All of the Companys
clinical studies are performed by third-party CROs. The Company accrues costs for clinical studies
performed by CROs on a straight-line basis over the service periods specified in the contracts and
adjusts the estimates, if required, based upon the Companys ongoing review of the level of effort
and costs actually incurred by the CROs. The Company monitors levels of performance under each
significant contract, including the extent of patient enrollment and other activities through
communications with the CROs, and adjusts the estimates, if required, on a quarterly basis so that
clinical expenses reflect the actual effort expended by each CRO.
All material CRO contracts are terminable by the Company upon written notice and the Company
is generally only liable for actual effort expended by the CROs and certain noncancelable expenses
incurred at any point of termination.
Amounts paid in advance related to incomplete services will be refunded if a contract is
terminated. Some contracts include additional termination payments that become due and payable if
the Company terminates the contract. Such additional termination payments are only recorded if a
contract is terminated.
Income Taxes
The Company accounts for income taxes in accordance with FASB ASC 740,
Income Taxes
.
FASB ASC 740 prescribes the use of the liability method whereby deferred tax asset and liability
account balances are determined based on differences between the financial reporting and tax bases
of assets and liabilities and are measured using the enacted tax rates and laws that will be in
effect when the differences are expected to reverse. The Company provides a valuation allowance, if
necessary, to reduce deferred tax assets to their estimated realizable value.
FASB ASC 740-10 clarifies the accounting for income taxes, by prescribing a minimum
recognition threshold a tax position is required to meet before being recognized in the financial
statements. It also provides guidance on derecognition, measurement and classification of amounts
relating to uncertain tax positions, accounting for and disclosure of interest and penalties,
accounting in interim periods, disclosures and transition relating to the adoption of the new
accounting standard. FASB ASC 740-10 is effective for
9
fiscal years beginning after December 15, 2006. The Company adopted FASB ASC 740-10 as of
January 1, 2007, as required, and determined that the adoption of FASB ASC 740-10 did not have a
material impact on the Companys financial position and results of operations.
Segments
The Company operates in only one segment. Management uses cash flow as the primary
measure to manage its business and does not segment its business for internal reporting or
decision-making.
5. NET LOSS PER SHARE
The Company computes net loss per share in accordance with FASB ASC 260,
Earnings Per Share
,
under which basic net loss attributable to common stockholders per share is computed by dividing
income available to common stockholders (the numerator) by the weighted-average number of common
shares outstanding (the denominator) 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
(unaudited):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31
|
|
|
|
2010
|
|
|
2009
|
|
Net loss per share
|
|
|
|
|
|
|
|
|
Numerator
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(11,103,792
|
)
|
|
$
|
(3,785,360
|
)
|
Denominator
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding
|
|
|
13,357,149
|
|
|
|
1,616,534
|
|
Less: Weighted-average shares subject to repurchase
|
|
|
(12,918
|
)
|
|
|
(145,812
|
)
|
|
|
|
|
|
|
|
Denominator for basic and diluted net loss per share
|
|
|
13,344,231
|
|
|
|
1,470,722
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.83
|
)
|
|
$
|
(2.57
|
)
|
|
|
|
|
|
|
|
The following table shows weighted-average historical dilutive common share equivalents
outstanding, which are not included in the above historical calculation, as the effect of their
inclusion is anti-dilutive during each period (unaudited).
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31
|
|
|
|
2010
|
|
|
2009
|
|
Options to purchase common stock
|
|
|
1,102,614
|
|
|
|
523,749
|
|
Common stock subject to repurchase
|
|
|
12,918
|
|
|
|
145,812
|
|
Warrants to purchase common stock
|
|
|
493,268
|
|
|
|
194,474
|
|
Convertible preferred stock
|
|
|
|
|
|
|
8,146,308
|
|
|
|
|
|
|
|
|
Total
|
|
|
1,608,800
|
|
|
|
9,010,343
|
|
|
|
|
|
|
|
|
6. DEFERRED FINANCING COST
At December 31, 2009, the Company capitalized and deferred $1,922,183 of financing cost
attributable to the Companys IPO, which has been charged against the IPO proceeds upon the
completion of the Companys IPO on March 4, 2010.
7. 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 sPLA
2
inhibitors
for the treatment of inflammatory diseases. The agreement granted the Company commercialization
rights to Shionogi & Co., Ltd.s and Eli Lillys sPLA
2
inhibitors, including A-002 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
10
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 and in accordance with the guidance of the Research and
Development topic of the FASB ASC, the Company recorded the initiation and license fees in research
and development expenses during the year ended December 31, 2006. There was no outstanding
obligation pursuant to the license agreement in the years ended December 31, 2008 and 2009. The
Company is obligated to make additional milestone payments upon the achievement of certain
development, regulatory and commercial objectives, which includes a $1.5 million milestone payment
to each party upon the start of a Phase 3 clinical study. The Company amended the milestone payment
terms in 2009 with each of Eli Lilly and Shionogi & Co., Ltd. to no later than 12 months from the
enrollment of the first patient in a Phase 3 clinical study for A-002. In consideration for the
extension, the milestone payments increased to $1.75 million to each party.
On January 28, 2010 and February 24, 2010, the Company entered into separate agreements with
Eli Lilly and Shionogi & Co., Ltd. in which the parties agreed that the $1.75 million milestone
payment due to each of Eli Lilly and Shionogi & Co., Ltd. no later than 12 months from the
enrollment of the first patient in a Phase 3 clinical study for A-002 would be paid in the form of
shares of the Companys common stock issued at the price per share at which shares are sold to the
public in an IPO, minus any per-share underwriting discounts, commissions or fees. Concurrent with
the completion of the Companys IPO on March 4, 2010, the Company issued 265,957 shares of common
stock to each of Eli Lilly and Shionogi & Co., Ltd.
The Company is also obligated to make additional milestone payments of up to $5.0 million and
pay tiered royalties, which increase as a percentage from the mid-single digits to the low double
digits as net sales increase, of up to $92.5 million 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.
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 was required to pay a nonrefundable, upfront license fee of $6.0 million, payable in two
installments with the first installment due within 90 days from the effective date of the Amgen
Agreement and the second installment due on the earlier of (i) termination of the Amgen Agreement
by the Company or (ii) February 1, 2009. As there is no future alternative use for the technology,
the Company expensed the license fee in research and development expenses during the year ended
December 31, 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, that 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, 2010 and December 31, 2009.
8. CONVERTIBLE PROMISSORY NOTES AND EQUITY FINANCING
On July 17, 2009 and September 9, 2009, the Company sold (i) convertible promissory notes, or
the 2009 notes, that were secured by a first priority security interest in all of the Companys
assets, and (ii) warrants, or the 2009 warrants, to purchase shares of the Companys equity
securities to certain of its existing investors for an aggregate purchase price of $10.0 million.
These transactions are collectively referred to as the 2009 bridge financing. The 2009 notes
accrued interest at a rate of 8% per annum and had a maturity date of the earliest of (i) July 17,
2010, (ii) the date of the sale of all or substantially all of the Companys equity interests or
assets or (iii) an event of default pursuant to the terms of the 2009 notes. The 2009 notes and
accrued interest were converted into 1,985,575 shares of common stock upon the completion of the
Companys IPO on March 4, 2010 at $5.25 per share, which reflected a 25% discount to the offering
price of the Companys common stock.
11
On September 25, 2009, the Company executed a stock purchase agreement, which was amended to
add an additional purchaser on November 3, 2009, with certain existing investors for the sale of
shares of the Companys common stock equal to $20.5 million divided by the price per share at which
shares of the Companys common stock are sold to the public in an IPO, minus any per-share
underwriting discounts, commissions or fees. Pursuant to the terms of the stock purchase agreement,
the investors deposited $20.5 million into an escrow account for the purchase of the shares. On
December 11, 2009, the Company entered into a note purchase agreement and amended the
September 2009 stock purchase and escrow agreements. The agreements provided for the release of
$3.4 million of the $20.5 million, leaving a balance of $17.1 million in the escrow account. The
Company issued convertible promissory notes, or the escrow notes, for the released amount to the
investors. The escrow notes accrued interest at a rate of 8% per annum and had a maturity date of
the earlier of (i) July 17, 2010 or (ii) an event of default pursuant to the terms of the escrow
notes. The escrow notes and accrued interest were converted into 525,660 shares of common stock
upon the closing of the Companys IPO on March 4, 2010. Additionally, the Company issued 2,598,780
shares of common stock to the investors upon the release of the $17.1 million held in the escrow
account at the closing of the IPO.
9. STOCKHOLDERS EQUITY
Preferred Stock
In connection with the completion of the Companys IPO on March 4, 2010, all of the
Companys shares of preferred stock outstanding at the time of the offering were converted into
8,146,308 shares of common stock. As of March 31, 2010, no liquidation preference remained.
Liquidation preference as of December 31, 2009 was $52.6 million.
The Companys Fifth Amended and Restated Certificate of Incorporation designates
5,000,000 shares of the Companys capital stock as undesignated preferred stock.
Common Stock
The Company is authorized to issued 100,000,000 shares of capital stock, of which 95,000,000
shares are designated as common stock, par value $0.001 per share. Holders of common stock are
entitled to one vote per share on all matters to be voted upon by the stockholders of the Company.
Subject to the preferences that may be applicable to any outstanding shares of preferred stock, the
holders of common stock are entitled to receive ratably such dividends, if any, as may be declared
by the Board of Directors. No dividends have been declared to date.
Reverse Stock Split
On November 8, 2009, the Companys board of directors approved a 1 -for- 1.712 reverse split
of the Companys common stock that was effected on February 22, 2010. The financial statements give
retroactive effect to the reverse split.
Warrants
In August 2008, in connection with the issuance of Series B-2 convertible preferred stock, the
Company issued 240,516 warrants for the purchase of common stock at $1.34 per share to two new
investors. The warrants expired upon the earliest of (i) seven years from the issuance date,
(ii) the closing date of the Companys IPO or (iii) upon consummation by the Company of any
consolidation or merger. The Company valued the warrants using the Black-Scholes valuation model
with the following assumptions: expected volatility of 72%, risk-free interest rate of 3.46% and
expected term of seven years. The fair value of the warrants was calculated to be $224,478 and
recorded as issuance cost and an increase to additional paid-in capital. As of December 31, 2009,
240,516, warrants remain outstanding. Each of the warrants contained a net issuance feature, which
allowed the warrant holder to pay the exercise price of the warrant by forfeiting a portion of the
exercised warrant shares with a value equal to the aggregate exercise. The warrants were net
exercised upon the closing of the Companys IPO on March 4, 2010.
In connection with the issuance of the 2009 notes discussed in Note 8, the Company issued
warrants to each note holder to purchase shares of its equity securities. Each 2009 warrant is
exercisable for the security into which each 2009 note is converted, at the price at which that
security is sold to other investors. Depending on when the 2009 notes are converted, each 2009
warrant may be exercisable for a number of shares equal to the quotient obtained by dividing (x)
(i) 25% of the principal amount of the accompanying 2009 notes, in the event the conversion occurs
prior to April 1, 2010, or (ii) 50% of the principal amount of the accompanying 2009 notes, in the
event the conversion occurs on or after April 1, 2010, by (y) the purchase price of the securities
into which the note is ultimately converted. The Company accounted for the 2009 warrants in
accordance with FASB ASC 480, which requires that a financial instrument, other than outstanding
shares, that, at inception, is indexed to an obligation to repurchase the issuers equity shares,
12
regardless of the timing of the redemption feature, and may require the issuer to settle the
obligation by transferring assets, be classified as liability through the completion of the
Companys IPO. The Company measured the fair value of the 2009 warrants using the Black-Scholes
valuation model on issuance date and adjusted the fair value at the end of each reporting period
based on the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2009
|
|
Expected Volatility
|
|
|
94
|
%
|
|
|
78
|
%
|
|
|
78
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
2.28
|
%
|
|
|
2.34
|
%
|
|
|
2.38
|
%
|
Expected Term (years)
|
|
|
4.50
|
|
|
|
5.00
|
|
|
|
5.00
|
|
The Company then applied probability factors to the different possible conversion scenarios
and calculated the initial fair value of the 2009 warrants to be $320,000, which amount was
recorded as a discount to the 2009 notes. The discount is amortized as interest expense over the
terms of the 2009 notes. The Company re-measured the fair value of the 2009 warrants on December
31, 2009 and recorded the change in fair value in non-operating income. Upon conversion of the
2009 notes into shares of common stock at the completion of the Companys IPO, the fair value of
the 2009 warrants was re-measured again by the Company and the aggregate fair value of $1.5 million
was recorded in non-operating expense during the three months ended March 31, 2010. Concurrent
with the conversion of the 2009 notes, the Company calculated the number of warrant shares to be
357,136 based on 25% of the principal amount of the accompanying 2009 notes and the IPO price of
the Companys common stock of $7.00 per share. The warrant liability and unamortized discount were
reclassified to additional paid-in-capital as a result of the conversion of the 2009 notes.
In connection with the issuance of the escrow notes, which are exchangeable for exchange
notes, each exchange note that is issued would be accompanied by a warrant, which is exercisable
for the security into which the accompanying exchange note, if any, is converted, at the price at
which that security is sold to other investors. Depending on when the exchange notes are converted,
each warrant may be exercisable for a number of shares equal to the quotient obtained by dividing
(x) (i) 25% of the principal amount of the accompanying exchange notes, in the event the conversion
occurs prior to April 1, 2010, or (ii) 50% of the principal amount of the accompanying exchange
notes, in the event the conversion occurs on or after April 1, 2010, by (y) the purchase price of
the securities into which the exchange note is ultimately converted. The Company accounts for the
potential issuance of the warrants in accordance with FASB ASC 480, which requires that a financial
instrument, other than outstanding shares, that, at inception, is indexed to an obligation to
repurchase the issuers equity shares, regardless of the timing of the redemption feature, and may
require the issuer to settle the obligation by transferring assets, be classified as liability
through the completion of the Companys IPO. The Company measured the fair value of its derivative
using the Black-Scholes valuation model with the following assumptions: expected volatility of 78%,
risk-free interest rate of 2.34% and expected term of five years. The Company then applied
probability factors to the different possible exchange and conversion scenarios and calculated the
fair value of the warrants to be $86,845, which amount was recorded as a discount to the escrow
notes. The discount is amortized as interest expense over the terms of the escrow notes. The escrow
notes were converted into shares of the Companys common stock upon the closing of its IPO. As a
result of the conversion taking place prior to the exchange of the escrow notes into exchange
notes, the Companys obligation to issue the warrants was eliminated. Consequently, the Company
reclassified the unamortized discount into additional paid-in capital and reduced the fair value of
the warrant liability to zero.
Embedded Derivative
The 2009 notes and the escrow notes discussed in Note 8 contained a contingent automatic
redemption feature and a contingent put option that meet the definition of an embedded derivative
as defined in the Derivatives and Hedging topic of FASB ASC 815 because these notes contain
features with implicit or explicit terms that affect some or all of the cash flows or the value of
other exchanges required by a contract in a manner similar to a derivative instrument. As a
result, the Company evaluated these embedded derivative features under the guidance of FASB ASC 815
and determined that the embedded derivative features should be separated from the 2009 notes and
escrow notes and recognized as derivative instruments. Pursuant to the guidance of FASB ASC 815,
if a hybrid instrument contains more than one embedded derivative feature that would individually
warrant separate accounting as a derivative instrument, those embedded derivative features shall be
bundled together as a single, compound embedded derivative that shall then be bifurcated and
accounted for separately from the host contract unless a fair value election is made. Since the
Company may not make a fair value election, the contingent automatic redemption and the contingent
put option should be bundled together as a single, compound embedded derivative and separated from
the 2009 notes and escrow notes. The Company recognized the bundled embedded derivative as a
derivative liability with initial and subsequent measurements at fair value and changes in fair
value recorded in earnings. Upon conversion of the 2009 notes and escrow notes into shares of
common stock at the completion of the Companys
13
IPO, the Company re-measured the fair value of the embedded derivative and recorded a charge of
$2.5 million in non-operating expense during the three months ended March 31, 2010.
10. STOCK OPTIONS
Option Plan
On February 1, 2010, the Companys board of directors adopted the 2010 Stock Option and
Incentive Plan (the 2010 Plan) effective upon consummation of the IPO, which was also approved by
the Companys stockholders. The Company initially reserved 233,644 shares of common stock for
issuance under the 2010 Plan, plus additional shares returned under the Companys 2005 Equity
Incentive Plan (the 2005 Plan) as a result of the cancellation of options or the repurchase of
shares issued pursuant to the 2005 Plan. As of March 31, 2010, an additional 6,267 shares have been
reserved under the 2010 Plan as a result of the cancellation of options or repurchase of shares
under the 2005 Plan. In addition, the 2010 Plan provides for annual increases in the number of
shares available for issuance thereunder on the first day of each fiscal year, beginning with the
2011 fiscal year, equal to four percent (4%) of the outstanding shares of the Companys common
stock on the last day of the immediately preceding fiscal year. The maximum aggregate number of
shares of stock that may be issued in the form of incentive stock options shall not exceed the
lesser of (i) the number of shares reserved and available for issuance under the Plan or (ii)
1,460,280 shares of stock, subject in all cases to adjustment including reorganization,
recapitalization, reclassification, stock dividend, stock split, reverse stock split or other
similar change in the Companys capital stock. The 2010 Plan permits the granting of incentive and
non-statutory stock options, restricted and unrestricted stock awards, restricted stock units,
stock appreciation rights, performance share awards, cash-based awards and dividend equivalent
rights to eligible employees, directors and consultants. The option exercise price of an option
granted under the 2010 Plan may not be less than 100% of the fair market value of a share of the
Companys Common Stock on the date the stock option is granted. Options granted under
the 2010 Equity Plan have a maximum term of 10 years and generally vest over four years. In
addition, in the case of certain large stockholders, the minimum exercise price of incentive
options must equal 110% of fair market value on the date of grant and the maximum term is limited
to five years.
The 2010 Plan does not allow the option holders to exercise their options prior to vesting.
The 2005 Plan allows the option holders to exercise their options prior to vesting. Unvested shares
are subject to repurchase by the Company at the option of the Company. Unvested shares subject to
repurchase have been excluded from the number of shares outstanding. Option activity in the table
below includes options exercised prior to vesting. At March 31, 2010 and 2009, 43,151 and
69,424 shares were subject to repurchase with a corresponding liability of $22,858 and $31,131,
respectively.
Early Exercise of Employee Options
Stock options granted under the Companys 2005 Plan provide employee option holders the right
to elect to exercise unvested options in exchange for restricted common stock. Unvested shares,
which amounted to 43,151 and 69,424 at March 31, 3010 and December 31, 2009, respectively, were
subject to a repurchase right held by the Company at the original issuance price in the event the
optionees employment is terminated either voluntarily or involuntarily. For exercises of employee
options, this right lapses 25% on the first anniversary of the vesting start date and in 36 equal
monthly amounts thereafter. These repurchase terms are considered to be a forfeiture provision and
do not result in variable accounting. The shares purchased by the employees pursuant to the early
exercise of stock options are not deemed to be outstanding until those shares vest. In addition,
cash received from employees for exercise of unvested options is treated as a refundable deposit
shown as a liability in the Companys financial statements. For the three months ended March 31,
2010, and the year ended December 31, 2009, cash received for early exercise of options totaled to
$0 and $6,615, respectively. As the shares vest, the shares and liability are released into common
stock and additional paid-in capital.
14
The activity of unvested shares for the period ended March 31, 2010 as a result of early
exercise of options granted to employees is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
Average
|
|
Unvested Shares
|
|
Shares
|
|
|
Grant Price
|
|
|
|
(unaudited)
|
|
Balance as of December 31, 2007
|
|
|
289,824
|
|
|
$
|
0.24
|
|
Early exercise of options
|
|
|
59,191
|
|
|
$
|
0.62
|
|
Vested
|
|
|
(168,386
|
)
|
|
$
|
0.22
|
|
Repurchases
|
|
|
(18,983
|
)
|
|
$
|
0.26
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2008
|
|
|
161,646
|
|
|
$
|
0.34
|
|
Early exercise of options
|
|
|
4,381
|
|
|
$
|
1.51
|
|
Vested
|
|
|
(96,603
|
)
|
|
$
|
0.35
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2009
|
|
|
69,424
|
|
|
$
|
0.45
|
|
Early exercise of options
|
|
|
|
|
|
|
|
|
Vested
|
|
|
(20,006
|
)
|
|
$
|
0.33
|
|
Repurchases
|
|
|
(6,267
|
)
|
|
$
|
0.26
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2010
|
|
|
43,151
|
|
|
$
|
0.53
|
|
|
|
|
|
|
|
|
|
15
The following table summarizes stock option activity for the Company:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Average
|
|
|
|
Shares
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
|
Available for
|
|
|
Number of
|
|
|
Exercise
|
|
|
Contractual
|
|
|
|
Grant
|
|
|
Options
|
|
|
Price
|
|
|
Life in Years
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Balance at September 9, 2004 (Date of Inception)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares authorized
|
|
|
248,247
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(187,202
|
)
|
|
|
187,202
|
|
|
$
|
0.14
|
|
|
|
|
|
Options exercised
|
|
|
|
|
|
|
(33,292
|
)
|
|
$
|
0.14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
61,045
|
|
|
|
153,910
|
|
|
$
|
0.14
|
|
|
|
8.42
|
|
Shares authorized
|
|
|
1,285,047
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(65,998
|
)
|
|
|
65,998
|
|
|
$
|
0.14
|
|
|
|
|
|
Options exercised
|
|
|
|
|
|
|
(125,581
|
)
|
|
$
|
0.14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
1,280,094
|
|
|
|
94,327
|
|
|
$
|
0.14
|
|
|
|
6.89
|
|
Shares authorized
|
|
|
292,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(1,339,655
|
)
|
|
|
1,339,655
|
|
|
$
|
0.26
|
|
|
|
|
|
Options exercised
|
|
|
|
|
|
|
(493,605
|
)
|
|
$
|
0.25
|
|
|
|
|
|
Options cancelled
|
|
|
92,642
|
|
|
|
(92,642
|
)
|
|
$
|
0.24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
325,137
|
|
|
|
847,735
|
|
|
$
|
0.26
|
|
|
|
8.08
|
|
Shares authorized
|
|
|
350,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(327,973
|
)
|
|
|
327,973
|
|
|
$
|
1.34
|
|
|
|
|
|
Options exercised
|
|
|
|
|
|
|
(179,886
|
)
|
|
$
|
0.38
|
|
|
|
|
|
Options cancelled
|
|
|
38,697
|
|
|
|
(38,697
|
)
|
|
$
|
0.42
|
|
|
|
|
|
Repurchase
|
|
|
18,983
|
|
|
|
|
|
|
$
|
0.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
405,311
|
|
|
|
957,125
|
|
|
$
|
0.60
|
|
|
|
8.28
|
|
Options granted
|
|
|
(405,358
|
)
|
|
|
405,358
|
|
|
$
|
1.69
|
|
|
|
|
|
Options exercised
|
|
|
|
|
|
|
(19,089
|
)
|
|
$
|
0.80
|
|
|
|
|
|
Options cancelled
|
|
|
19,618
|
|
|
|
(19,618
|
)
|
|
$
|
0.92
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2009
|
|
|
19,571
|
|
|
|
1,323,776
|
|
|
$
|
0.92
|
|
|
|
7.94
|
|
Shares authorized under the 2010 Plan
|
|
|
233,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
(25,000
|
)
|
|
|
25,000
|
|
|
$
|
6.99
|
|
|
|
|
|
Options exercised
|
|
|
|
|
|
|
(20,672
|
)
|
|
$
|
0.85
|
|
|
|
|
|
Options cancelled
|
|
|
9,832
|
|
|
|
(9,832
|
)
|
|
$
|
1.50
|
|
|
|
|
|
Repurchase
|
|
|
6,267
|
|
|
|
|
|
|
$
|
0.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2010
|
|
|
244,314
|
|
|
|
1,318,272
|
|
|
$
|
1.03
|
|
|
|
7.74
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending Vested as of March 31, 2010
|
|
|
|
|
|
|
1,001,276
|
|
|
$
|
0.80
|
|
|
|
7.50
|
|
Ending Vested and Expected to Vest as of March 31, 2010
|
|
|
|
|
|
|
1,318,272
|
|
|
$
|
1.03
|
|
|
|
7.74
|
|
Stock-Based Compensation Expense
Total employee stock-based compensation expense recognized under FASB ASC 718 was as follows
(unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
|
|
(Date of
|
|
|
|
|
|
|
|
|
|
|
|
Inception)
|
|
|
|
Three Months Ended March 31,
|
|
|
to March 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
Research and development
|
|
$
|
16,027
|
|
|
$
|
14,472
|
|
|
$
|
210,029
|
|
General and administrative
|
|
|
32,385
|
|
|
|
29,006
|
|
|
|
315,262
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation
|
|
$
|
48,412
|
|
|
$
|
43,478
|
|
|
$
|
525,291
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2010 and December 31, 2009, total compensation cost related to unvested stock
options not yet recognized was $535,015 and $456,288, which is expected to be allocated to expenses
over a weighted-average period of 2.16 and 2.25 years, respectively.
16
The assumptions used in the Black-Scholes option-pricing model for the three months ended
March 31, 2010 and 2009, and for the period from September 9, 2004 (Date of Inception) to March 31,
2010, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
Three Months Ended March 31,
|
|
|
Inception) to
|
|
|
|
2010
|
|
|
2009
|
|
|
March 31, 2010
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Expected Volatility
|
|
|
89
|
%
|
|
|
74
|
%
|
|
|
80
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
3.02
|
%
|
|
|
2.09
|
%
|
|
|
3.95
|
%
|
Expected Term (years)
|
|
|
6.25
|
|
|
|
6.25
|
|
|
|
6.25
|
|
The weighted-average grant date fair values of stock options granted during the three months
ended March 31, 2010 and 2009, and for the period from September 9, 2004 (Date of Inception) to
March 31, 2010 were $5.30, $1.01 and $0.50 per share, respectively.
Nonemployee Stock-Based Compensation
The Company accounts for stock options granted to nonemployees as required by the Equity Topic
of the FASB ASC. In connection with stock options granted to consultants, the Company recorded
$4,204, $1,153 and $162,149 for nonemployee stock-based compensation during the three months ended
March 31, 2010, 2009, and for the period from September 9, 2004 (Date of Inception) to March 31,
2010, respectively. These amounts were based upon the fair value of the vested portion of the
grants.
The assumptions used in the Black-Scholes option-pricing model for the years ended March 31,
2010 and 2009, and for the period from September 9, 2004 (Date of Inception) to March 31, 2010, are
as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
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|
|
|
|
|
|
September 9,
|
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|
|
|
|
|
|
|
|
2004 (Date of
|
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|
Three Months Ended March 31,
|
|
|
Inception) to
|
|
|
2010
|
|
2009
|
|
|
March 31, 2010
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Expected Volatility
|
|
|
98
|
%
|
|
|
98
|
%
|
|
|
98
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
3.29
|
%
|
|
|
2.85
|
%
|
|
|
3.68
|
%
|
Expected Term (years)
|
|
|
8.11
|
|
|
|
8.56
|
|
|
|
9.67
|
|
Amounts expensed during the remaining vesting period will be determined based on the fair
value at the time of vesting.
11. RELATED PARTY TRANSACTIONS
For the three months ended March 31, 2010 and 2009, and for the period from September 9, 2004
(Date of Inception) to March 31, 2010, the Company paid $0, $38,274 and $131,574, respectively, for
clinical management services rendered by an outside organization where one of the founders is
employed.
12. SUBSEQUENT EVENT
On April 6, 2010, pursuant to the terms and conditions of the underwriting agreement, the
underwriters of the IPO exercised their over-allotment option and purchased 604,492 shares of
common stock at the public offering price of $7.00 per share, less any underwriting discount,
commissions and fees, resulting in gross proceeds of approximately $4.0 million.
17
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ITEM 2.
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|
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, a 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
Anthera Pharmaceuticals, Inc. (the Company, we, our, or us) is 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
ready clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. Two of our
product candidates, A-002 and A-001, are designed to inhibit a novel enzyme target known as
secretory phospholipase A
2,
or sPLA
2.
Elevated levels of sPLA
2
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 ready product
candidate, A-623, targets elevated levels of B-lymphocyte stimulator, which has been associated
with a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus
(lupus), lupus nephritis, rheumatoid arthritis, multiple sclerosis, Sjögrens Syndrome, Graves
Disease and others.
We have generated significant losses since inception. As of March 31, 2010, we had an
accumulated deficit of approximately $76.3 million. We recognized net losses of $11.1 million and
$3.8 million for the three months ended March 31, 2010 and 2009, respectively. These losses have
resulted primarily from expense incurred in connection with research and development activities,
consisting primarily of clinical trials, preclinical studies and manufacturing services associated
with our current production candidates. We expect our net losses to increase as we continue to
advance our clinical trials, expand our research and development efforts, and add personnel for our
anticipated growth.
On February 26, 2010, our Registration Statement on Form S-1 was declared effective by
the SEC for our IPO, pursuant to which we sold 6,000,000 shares of our common stock at a public
offering price of $7.00 per share. We received gross proceeds of approximately $42 million from
this transaction, before underwriting discounts and commissions. Concurrent with the closing of
the IPO, we received an aggregate of $17.1 million from the issuance of 2,598,780 shares of our
common stock to certain of our investors pursuant to a common stock purchase agreement. On April
6, 2010, pursuant to the terms and conditions of the underwriting agreement, the underwriters of
our IPO exercised their over-allotment option and purchased 604,492 shares of common stock at our
public offering price of $7.00 per share, less the underwriting discount and commissions, resulting
in gross proceeds of approximately $4.2 million.
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
18
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 anticipated Phase 3 clinical study named
VISTA-16 for A-002, 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, consulting fees and travel.
The following table shows our total research and development expenses for the three months
ended March 31, 2010 and 2009, and for the period from September 9, 2004 (Date of Inception)
through March 31, 2010 (unaudited):
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
For the Period
|
|
|
|
|
|
|
|
|
|
|
|
September 9,
|
|
|
|
|
|
|
|
|
|
|
|
2004 (Date of
|
|
|
|
|
|
|
|
|
|
|
|
Inception)
|
|
|
|
Three Months Ended March 31,
|
|
|
to March 31,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Allocated costs:
|
|
|
|
|
|
|
|
|
|
|
|
|
A-001
|
|
$
|
91,729
|
|
|
$
|
82,109
|
|
|
$
|
6,611,775
|
|
A-002
|
|
|
4,252,849
|
(1)
|
|
|
2,187,250
|
|
|
|
32,113,493
|
|
A-623
|
|
|
304,950
|
|
|
|
5,573
|
|
|
|
6,448,367
|
(2)
|
Unallocated costs
|
|
|
592,286
|
|
|
|
639,834
|
|
|
|
11,392,160
|
|
|
|
|
|
|
|
|
|
|
|
Total development
|
|
$
|
5,241,814
|
|
|
$
|
2,914,766
|
|
|
$
|
56,565,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Includes milestone payments of $3.5 million pursuant to amendments to the license agreements
with each of Eli Lilly and Shionogi & Co. Ltd.
|
|
(2)
|
|
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 anticipate enrolling the first
patient in the VISTA-16 study of A-002
in the second quarter of 2010.
We also anticipate enrolling patients in a Phase 2 clinical study of
A-623 for lupus in the second half of 2010.
We intend to fund our clinical studies with proceeds we raised from existing investors and our IPO.
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.
|
19
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.
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 anticipate
incurring a significant increase in general and administrative expenses as we operate as a public
company. These increases will likely include increased costs for insurance, costs related to the
hiring of additional personnel and payment to outside consultants, lawyers and accountants. We also
expect to incur significant costs to comply 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 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 Note 2 to our financial
statements included at the end of this prospectus, 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
As part of the process of preparing our financial statements, we are required to estimate our
accrued expenses. 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 monthly in arrears for services performed. 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. 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;
|
20
|
|
|
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
Effective January 1, 2006, we adopted the provisions of FASB ASC 718,
Compensation Stock
Compensation
, using the modified prospective method. Compensation costs related to all equity
instruments granted after January 1, 2006 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 estimate the fair value of our share-based payment
awards on the date of grant using an option-pricing model. We recognized employee stock-based
compensation expense of $74,861 in 2007, $143,406 in 2008, and $253,964 in 2009, respectively. As
of March 31, 2010, we had $535,015 in total unrecognized compensation cost related to non-vested
employee stock-based compensation arrangements, which we expect to recognize over a
weighted-average period of approximately 2.16 years. The intrinsic value of all outstanding vested
and non-vested stock-based compensation arrangements, based on the closing price of $6.99 per
share, is $7.9 million, based on 1,318,272 shares of our common stock issuable upon exercise of
stock-based compensation arrangements outstanding at March 31, 2010 at a weighted-average exercise
price of $1.03 per share.
We calculate the fair value of stock-based compensation awards using the Black-Scholes
option-pricing model. For the three months ended March 31, 2010 and 2009, the weighted-average
assumptions used in the Black-Scholes model were 6.25 years for the expected terms, 89% and 74% for
the expected volatility, 3.02% and 2.09% for the risk free rate and 0.0% for dividend yield,
respectively. Expense amounts for future awards for any particular quarterly or annual period could
be affected by changes in our assumptions. The weighted-average expected option terms for 2010 and
2009 reflect the application of the simplified method set out in FASB ASC 718-10. The simplified
method defines the life as the average of the contractual term of the stock-based compensation
award and the weighted-average vesting period for all tranches. Estimated volatility for fiscal
2010 and 2009 also reflects the application of interpretive guidance provided in FASB ASC 718-10
and, accordingly, incorporates historical volatility of similar public entities.
Results of Operations
Comparison of the Three Months Ended March 31, 2010 and 2009
Research and Development Expenses.
Research and development expenses were $5.2 million for
the three months ended March 31, 2010, compared with $2.9 million for the three months ended
March 31, 2009. The $2.3 million increase in our research and development expenses was primarily
attributable to the recognition of a $3.5 million non-cash charge related to milestone payments
recorded in connection with the initiation of our Phase 3 clinical study of A-002 VISTA-16
(
V
ascular
I
nflammation
S
uppression to
T
reat
A
cute Coronary Syndrome 16 Weeks), which were paid
through the issuance of 531,914 shares of common stock; offset by a decrease of $1 million in
clinical trial expense due to the completion of Antheras Phase
2b clinical study of A-002 FRANCIS (Fewer Recurrent Acute Coronary
Events with Near-term Cardiovascular Inflammation Suppression) in
acute coronary syndrome patients with high levels of inflammation and
dislipidemia.
General and Administrative Expenses.
General and administrative expenses were $1.2 million
for the three months ended March 31, 2010, compared with $0.8 million for the three months ended
March 31, 2009. The $0.4 million increase was primarily
attributable to professional services incurred in connection with our financial audit and
other costs associated with operating as a public company.
21
Interest and Other Income.
Interest and other income was $3,301 for the three months ended
March 31, 2010, compared with $13,046 for the three months ended March 31, 2009.
The decrease in
interest and other income was due to lower average cash balances.
Interest and Other Expense.
Interest and other expense was $4.7 million for the three months
ended March 31, 2010, compared with $37,397 for the three months ended March 31, 2009. Interest
and other expense recorded during the three months ended
March 31, 2010 included a $4.5 million non-cash charge
recorded as part of interest and other expense related to
the amortization of discounts on the Companys convertible
promissory notes and the mark-to-market adjustment relating to
warrants and embedded derivative connected to the Companys
convertible promissory notes.
Interest and other expense recorded
during the comparable period in 2009 consisted of interest accrued on past due license fee
obligations.
Liquidity and Capital Resources
To date, we have funded our operations primarily through private placements of preferred
stock, convertible debt and public financing. As of March 31, 2010, we had received net proceeds of
approximately $88.3 million from the sale of equity securities, and net proceeds of approximately
$26.4 million from the issuance of the 2009 Notes. As of March 31, 2010, we had cash and cash
equivalents of approximately $56.7 million.
Cash Flows
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
adjustments for non-cash charges such as stock-based compensation of approximately $52,616,
amortization of note discount and debt issuance cost of approximately $0.8 million, issuance of
$3.5 million worth of common stock in lieu of cash milestone payments due to Eli Lilly and Shionogi
& Co., Ltd., the conversion of $0.3 million of accrued interest into shares of common stock upon
conversion of the 2009 Notes, mark to market adjustments relating to warrant and derivative
liability of $3.8 million, and a decrease in operating assets and liabilities of approximately 0.9
million.
Net cash used by investing activities was $5,746 and consisted of computer equipment purchased
during the quarter.
Net cash provided by financing activities was approximately $56.3 million and consisted of
proceeds of $57.2 million received from the issuance of common stock at our IPO and the release of
funds held in an escrow account concurrent with the closing of our IPO, offset by approximately
$0.9 million of issuance cost paid during the quarter.
Three Months Ended March 31, 2009
For the three months ended March 31, 2009, we incurred a net loss of approximately
$3.8 million.
Net cash used in operating activities was approximately $3.7 million. The net loss is higher
than cash used in operating activities by $0.1 million. The primary drivers for the difference are
adjustments for non-cash charges such as stock-based compensation of $44,631, an increase in
current operating assets and liabilities of $0.5 million, offset by a decrease in license fee
payable of $0.5 million due to payment made during the quarter.
There were no investing and financing activities during the quarter ended March 31, 2009.
Contractual Obligations and Commitments
The following table summarizes our long-term contractual obligations and commitments as of
March 31, 2010:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
Less than
|
|
|
|
|
|
|
|
|
|
|
After
|
|
|
|
Total
|
|
|
1 Year
|
|
|
1-3 Years
|
|
|
4-5 Years
|
|
|
5 Years
|
|
Operating lease obligations (1)
|
|
$
|
63,324
|
|
|
$
|
56,304
|
|
|
$
|
7,020
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
(1)
|
|
Operating lease obligations reflect our obligation to make payments in
connection with a sublease that commenced in October 2008 and will
expire on September 30, 2010 for approximately 7,800 square feet of
office space and office equipment leases that commenced in October
2007 and will expire in June 2013.
|
22
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 sPLA
2
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 are 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:
|
|
|
initiate the Phase 3 VISTA-16 study for A-002;
|
|
|
|
|
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;
|
|
|
|
|
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 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.
23
We expect the proceeds from our IPO, recent private placement and exercise of the
over-allotment option by the underwriters of our IPO, together with our existing resources, 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 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 convertible debt
securities 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 DISCLOSURE ABOUT MARKET RISK
As of March 31, 2010, our investment portfolio consists of U.S. Treasury bills and money
market funds. The primary objectives of our investment are to preserve capital and maintain
liquidity. Our primary exposure to market risk is interest income sensitivity, which is affected
by changes in the general level of U.S. interest rates. However, since all of our investments are
in U.S. Treasury bills and money market funds, we do not believe we are subject to any material
market risk exposure. We do not have any foreign currency or any other material derivative
financial instruments.
ITEM 4T. 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, 2010. 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, 2010, our chief executive officer and chief
financial officer concluded that, as of such date, our disclosure controls and procedures were
effective at the reasonable assurance level.
24
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during the quarter ended March
31, 2010 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
Investing in our common stock involves a high degree of risk. You should carefully consider
the risks described below and the other information in this Quarterly Report on
Form 10-Q
. If any
of such risks actually occur, our business, operating results or financial condition could be
adversely affected. In those cases, the trading 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 five years of operating history. We have focused
primarily on developing our three product candidates, varespladib methyl (A-002), A-623 and
varespladib sodium (A-001). We have financed our operations exclusively through private placements
of preferred stock and convertible debt and we have incurred losses in each year since our
inception in September 2004. Our net losses were approximately $15,000 in 2004, $540,000 in 2005,
$8.7 million in 2006, $25.7 million in 2007, $18.1 million in 2008, $12.2 million in 2009 and $11.2
million for the three months ended March 31, 2010. As of March 31, 2010, we had an accumulated
deficit of approximately $76.3 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. These 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 planned pivotal Phase 3 clinical study named VISTA-16 for A-002 and
our planned Phase 2b clinical study for A-623. In addition, we will incur additional costs of
operating as a 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:
25
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obtain favorable results for and advance the development of our lead product candidate,
A-002, for the treatment of acute coronary syndrome, including successfully launching and
completing the VISTA-16 study;
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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 a Phase 2b clinical study in patients with systemic lupus erythematosus
(lupus);
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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;
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successfully execute our planned preclinical studies in animals and clinical studies in
human beings for our other product candidates;
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obtain regulatory approval for A-002, A-623, A-001 and our other product candidates;
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if regulatory approvals are obtained, begin the commercial manufacturing of our product
candidates with our third-party manufacturers;
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launch commercial sales and effectively market our product candidates, either
independently or in strategic collaborations with third parties; and
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achieve broad market acceptance of our product candidates in the medical community and
with third-party payors.
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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: A-002, 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.
Because we will need substantial additional capital in the future to fund our operations, our
independent registered public accounting firm included a paragraph regarding concerns about our
ability to continue as a going concern in their report on our financial statements. 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 planned VISTA-16 study for A-002 and our planned Phase 2b
clinical study 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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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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26
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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.
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As of the date of this report, we anticipate that the net proceeds from our IPO, recent
private placement and exercise of the over-allotment option by the underwriters of our IPO, and
interest earned thereon, together with our existing cash and cash equivalents, 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.
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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
A
2
, or sPLA
2
, 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 sPLA
2
inhibitors, including A-002 and A-001, and our
achievement of certain significant corporate, clinical and financial events. For A-002, 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.(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 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 sPLA
2
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 or seek funds to meet these
obligations at terms unfavorable to us.
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, A-002, 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
27
We depend substantially on the success of our three primary product candidates, A-002, 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 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 A-002, 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 A-002. We anticipate enrolling the first patient in the VISTA-16 study for A-002 in
the second quarter of 2010.
Our next product candidate is A-623, which has completed Phase 1 clinical studies and for
which we expect to commence a Phase 2b clinical study in the second half of 2010 after we
reactivate the IND that was transferred from Amgen. We have submitted a protocol amendment and
additional information necessary to support our proposed Phase 2 clinical study to the FDA and have
received an IND advice letter from the FDA in the first quarter of 2010. As of March 31, 2010, we
remain on track for beginning enrollment of patients for the clinical study in the second half of
2010.
Our third product candidate is A-001. 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.
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We are not permitted to market our A-002 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.
28
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 (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.
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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, the
Data Safety Monitoring Board (DSMB) may recommend that we stop our planned VISTA-16 study for
A-002 if certain biomarkers of inflammation and lipid profiles fail to meet pre-specified
reductions in the first 1,000 or more patients. 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.
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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 planned VISTA-16
study for A-002 if the overall major adverse cardiovascular event (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.
29
The results of biomarker assays in earlier clinical studies in A-002 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, sPLA
2
and interleukin-6, or IL-6, during treatment
with A-002 does not ensure that later clinical studies, such as our planned 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 A-002.
Because the results of preclinical testing or earlier clinical studies are not necessarily
predictive of future results, A-002, 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 A-002, 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.
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 sPLA
2
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 A-002, 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
A-002, 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.
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The market for inflammatory disease therapeutics is especially large and competitive. All of
the sPLA
2
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 A
2
,
or Lp-PLA
2
, inhibitor currently being evaluated in Phase 3 clinical studies. Although
there are no sPLA
2
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. Further, we are aware of companies
with other products in development that are being tested for potential treatment of lupus,
including Human Genome Sciences, Inc. and GlaxoSmithKline plc, who have a BLyS antagonist
monoclonal antibody product candidate, Benlysta, which recently reported favorable results from a
Phase 3 clinical study in lupus; ZymoGenetics, Inc. and Merck Serono S.A., whose dual BLyS/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.
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.
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.
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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.
31
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.
We cannot commercialize any of our product candidates until the appropriate regulatory
authorities have reviewed and approved the applications for the 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.
We have reached agreement with the FDA on an SPA for our planned VISTA-16 study of A-002 for the
potential treatment of acute coronary syndrome, which 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. We have reached agreement with the FDA on an SPA for our planned VISTA-16 clinical
study of A-002 for the potential short-term (16-week) treatment of acute coronary syndrome.
However, 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 A-002 product candidate for
the short-term (16-week) treatment of acute coronary syndrome. Regardless of our SPA agreement, we
cannot guarantee any particular outcome from regulatory review of our planned 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 A-002, if any, may include restrictions on use. Further, the FDA has
indicated that long-term safety data on A-002 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.
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32
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 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 FDA Amendments Act of 2007, 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.
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 A-002 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 A-002, 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.
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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.
33
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. James E. Pennington, our Executive Vice President and Chief Medical Officer, Dr. Colin Hislop,
our Senior Vice President of Cardiovascular Products 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.
Legislative 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.
Specifically, in both the United States and some foreign jurisdictions, there have been a
number of legislative and regulatory changes and proposals to change the health care system in ways
that could affect our ability to sell our products profitably.
Congress has considered and is considering a
number of proposals that are intended to reduce or limit the growth of health care costs and which
could significantly transform the market for pharmaceuticals and biological products. 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. 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 provided authority for
limiting 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 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.
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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.
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Our product liability insurance coverage, with a $5.0 million annual aggregate coverage limit,
for our clinical studies may not be sufficient to reimburse us for any 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 which 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
35
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.
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.
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, 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.
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 16 other countries. We have also entered into 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, 17 non-EP foreign patents and five pending non-EP foreign patent
applications relating to A-002 and A-001; (ii) more than 30 U.S. patents, one pending
U.S. non-provisional patent application, six EP patents, one pending EP patent application, twelve
issued non-EP foreign patents and two pending non-EP foreign patent applications relating to new
sPLA
2
compounds including A-003; and (iii) one U.S. patent, one pending
U.S. non-provisional patent application, one EP patent, one pending EP patent application, eight
non-EP foreign patents and 16 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.
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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 sPLA
2
compounds from Eli Lilly
and Shionogi & Co., Ltd. In addition, we are party to a license agreement with Amgen for the
exclusive and worldwide rights to develop and commercialize A-623, a novel BLyS inhibitor. 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
sPLA
2
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 terms for drug
compounds for a period of up to five years to compensate for time spent in development. 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 A-002s 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
A-002s European new chemical entity patents until 2020 and to A-623s European new chemical entity
patents until 2027. In addition, since A-002 has not been previously approved in the United States,
A-002 could be eligible for up to five years of New Chemical Entity, or
38
NCE, exclusivity from the FDA. NCE exclusivity would prevent the FDA from accepting any
generic competition following NDA approval independent of the patent status of A-002. Similarly, a
recent directive in the European Union provides that companies who receive regulatory approval for
a new compound will have a 10-year period of market exclusivity for that compound (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.
39
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 infringed 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 is likely to be volatile and 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 A-002, 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 sPLA
2
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.
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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.
Management has discretion in allocating the net proceeds from our initial public offering and may
do so in ways that you and other stockholders may not approve.
We expect to use the net proceeds from our public offering to fund further clinical
development of our current product candidates and for general corporate purposes, such as general
and administrative expenses, capital expenditures, working capital, prosecution and maintenance of
our intellectual property and the potential investment in technologies or products that complement
our business.
40
Because of the number and variability of factors that will determine our use of the proceeds
from our offering, their ultimate use may vary substantially from their currently intended use. As
such, our management has broad discretion in the application of the net proceeds from our public
offering and could spend the proceeds in ways that do not necessarily improve our operating results
or enhance the value of our common stock.
Because a small number of our existing stockholders own a majority of our voting stock, your
ability to influence corporate matters will be limited.
As of March 31, 2010, our executive officers, directors and greater than 5% stockholders, in
the aggregate, own approximately 70.3% of our outstanding common stock. As a result, such persons,
acting together, will have the ability to control our management and affairs and substantially 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 shares by existing shareholders could cause our stock price to decline.
Approximately 15,587,023 shares of our common stock will become available for sale by our
shareholders upon the expiration of lock-up agreements in September 2010. If these shareholders
sell, or indicate an intention to sell, substantial amounts of our common stock in the public
market after the lock-up period lapses, the trading price of our common stock could decline. In
addition, 1,919,722 shares of common stock that are either subject to outstanding warrants or
subject to outstanding options or reserved for future issuance under our employee benefit plans
will become eligible for sale in the public market to the extent permitted by the provisions of
various vesting agreements, the lock-up agreements and Rules 144 and 701 under the Securities Act,
as applicable. If these additional shares are sold, or if it is perceived that they will be sold,
in the public market, the trading price of our common stock could decline.
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 will 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.
We
will continue to incur significant increased costs as a result of operating as a public company, and our
management will be required to divert attention from product development to devote substantial time
to compliance initiatives.
As a public company, we will incur significant legal, accounting and other expenses that we
did not incur as a private company. In addition, 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, have imposed various requirements on public companies, increasing our legal and financial
compliance costs and making some activities more time-consuming and costly. For example, we expect
these rules and regulations to make it more difficult and more expensive for us to obtain director
and officer liability insurance, and we may be required to accept reduced policy limits and
coverage or incur substantially higher costs to obtain the same or similar coverage. As a result,
it may be more difficult for us to attract and retain qualified people to serve on our board of
directors, our board committees or as executive officers.
The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal
controls for financial reporting and disclosure. In particular, commencing in fiscal year 2011, we
must perform system and process evaluation and testing of our internal controls over financial
reporting to allow management and our independent registered public accounting firm to report on
the effectiveness of our internal controls over financial reporting, as required by Section 404 of
the Sarbanes-Oxley Act. We expect to incur significant expenses and devote substantial management
effort toward ensuring compliance with Section 404. We do not have an internal audit function, and
we may need to hire additional accounting and financial staff with appropriate public company
experience and technical accounting knowledge. Moreover, if we are not able to comply with the
requirements of Section 404 in a timely manner, or if we or our independent registered public
accounting firm identifies deficiencies in our internal controls that are deemed to be material
weaknesses, the market price of our stock could decline and we could be subject to sanctions or
investigations by The NASDAQ Global Market, the SEC or other regulatory authorities, which would entail expenditure
of additional financial and management resources.
41
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.
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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. In addition,
the number of shares of common stock that we issued in connection with our IPO may be sufficient,
taking into account prior or future shifts in our ownership over a three-year period, to 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.
42
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
On March 4, 2010, concurrent with the closing of our initial public offering, we issued the
following shares of common stock to certain of our existing investors:
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(i)
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1,985,575 shares of common stock upon the conversion of convertible promissory notes
issued in July and September 2009 and associated accrued interest, at a price of $5.25, or
75% of our initial public offering price of $7.00 per share;
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(ii)
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2,598,780 shares of common stock to certain of our investors pursuant to a common stock
purchase agreement, at a price of $7.00 per share, minus any per-share underwriting
discounts, commissions or fees;
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(iii)
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525,660 shares of common stock upon the conversion of convertible promissory notes
issued in December 2009 and associated accrued interest, at a price equal to our initial
public offering price of $7.00 per share, minus any per-share underwriting discounts,
commissions or fees;
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(iv)
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265,957 shares of common stock to Eli Lilly and Company, one of our licensors, in
satisfaction of a $1.75 million milestone payment, at a price equal to our initial public
offering price of $7.00 per share, minus any per-share underwriting discounts, commissions
or fees; and
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(v)
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265,957 shares of common stock to Shionogi & Co., Ltd., one of our licensors, in
satisfaction of a $1.75 million milestone payment, at a price equal to our initial public
offering price of $7.00 per share, minus any per-share underwriting discounts, commissions
or fees.
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No underwriters were used in the foregoing transactions. Unless otherwise stated, the sales of
securities described above were offered to accredited investors and were deemed to be exempt from
registration pursuant to Section 4(2) of the Securities Act as transactions by an issuer not
involving a public offering. All of the foregoing securities are deemed restricted securities for
the purposes of the Securities Act.
Use of Proceeds
On February 26, 2010, the Securities and Exchange Commission declared effective the
registration statement on Form S-1 (File No. 333-161930) for the initial public offering of our
common stock. Pursuant to the registration statement, we registered the offer and sale of
6,000,000 shares of our common stock at $7.00 per share as well as an additional 900,000 shares at
the same price pursuant to the underwriters over-allotment option. On March 4, 2010, we sold
6,000,000 shares of our common stock and on April 6, 2010, we sold 604,492 shares of our common
stock pursuant to the underwriters over-allotment option, for an aggregate offering price of
approximately $46.2 million. The offering has terminated. The managing underwriters of the offering
were Deutsche Bank Securities, Piper Jaffray, Cowan and Company, and Merriman Curhan Ford. After
deducting underwriting discounts, commissions and offering expenses paid or payable by us of
approximately $3.0 million, the net proceeds from the offering
were approximately $41.1 million.
No offering expenses were paid or are payable directly or indirectly, to our directors or officers,
to persons owning 10% or more of any class of our equity securities or to any of our affiliates.
The net proceeds from the offering have been invested in highly-liquid money market funds and
U.S. Treasury bills. There has been no material change in the expected use of the net proceeds
from our initial public offering as described in the final prospectus filed with the Securities and
Exchange Commission pursuant to Rule 424(b).
Purchase of Equity Securities by the Issuer and Affiliated Purchasers
From January 1, 2010 to March 31, 2010, we repurchased the following shares of our common
stock:
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Total Number of Shares
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Maximum Number of
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Total Number of
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Purchased as Part of
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Shares that May Yet
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Shares Number
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Average Price
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Publicly Announced Plans
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Be Purchased Under
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Period
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Purchased
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Paid Per Share
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or Programs
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the Plans or Programs
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1/1/2010 1/31/2010
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0
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0
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N/A
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N/A
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2/1/2010 2/28/2010
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0
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0
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N/A
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N/A
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3/1/2010 3/31/2010
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6,267 (1)
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$0.26
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N/A
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N/A
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Total
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6,267
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N/A
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N/A
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N/A
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(1)
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Represents unvested shares of common stock that we repurchased from former employees at their
original issuance price pursuant to restricted stock purchase agreements.
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4.
(REMOVED AND RESERVED)
ITEM 5. OTHER INFORMATION
None.
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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Forms of Restricted Stock Unit Agreements under the 2010 Stock Option and Incentive Plan.
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31.1
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Certification of President and Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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31.2
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Certification of Chief Financial Officer and Vice President of Administration pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002.
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32.1
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Certification of President and Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
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32.2
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Certification of Chief Financial Officer and Vice President of
Administration pursuant to 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 14, 2010
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By:
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/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 14, 2010
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By:
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/s/ Christopher P. Lowe
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Christopher P. Lowe
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Chief Financial Officer and Vice
President of Administration
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