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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
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x
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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, 2005 |
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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 No. 000-29089
Antigenics Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
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06-1562417 |
(State of Incorporation) |
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(I.R.S. Employer Identification Number) |
630 Fifth Avenue, Suite 2100, New York, New York,
10111
(Address of Principal Executive Offices)
(212) 994-8200
(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 is an accelerated
filer (as defined in Rule 12b-2 of the Exchange
Act). Yes þ No o
Number of shares outstanding of the registrants Common
Stock as of May 2, 2005: 45,564,652 shares.
Antigenics Inc.
Quarterly Period Ended March 31, 2005
Table of Contents
1
PART I FINANCIAL INFORMATION
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Item 1 |
Unaudited Consolidated Financial Statements |
ANTIGENICS INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
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March 31, | |
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December 31, | |
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2005 | |
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2004 | |
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ASSETS |
Cash and cash equivalents
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$ |
40,587,903 |
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$ |
15,979,714 |
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Short-term investments
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73,476,394 |
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70,941,163 |
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Accounts receivable
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104,561 |
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75,631 |
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Inventories
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159,818 |
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169,743 |
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Prepaid expenses
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2,686,892 |
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1,925,051 |
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Restricted cash
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2,895,114 |
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2,865,665 |
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Other current assets
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539,343 |
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647,299 |
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Total current assets
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120,450,025 |
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92,604,266 |
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Plant and equipment, net of accumulated amortization and
depreciation of $11,540,164 and $10,559,935 at March 31,
2005 and December 31, 2004, respectively
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25,133,797 |
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24,987,730 |
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Goodwill
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2,572,203 |
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2,572,203 |
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Core and developed technology, net of accumulated amortization
of $4,493,608 and $4,216,792 at March 31, 2005 and
December 31, 2004, respectively
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6,579,021 |
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6,855,837 |
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Restricted cash
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1,520,981 |
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2,256,018 |
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Debt issuance costs, net of accumulated amortization of $47,446
at March 31, 2005
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1,945,296 |
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Other long-term assets
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3,781,276 |
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3,781,893 |
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Total assets
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$ |
161,982,599 |
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$ |
133,057,947 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current portion, long-term debt
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$ |
5,463,879 |
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$ |
5,409,966 |
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Accounts payable
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1,020,900 |
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2,923,890 |
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Accrued liabilities
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11,096,727 |
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10,861,710 |
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Other current liabilities
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47,147 |
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8,525 |
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Total current liabilities
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17,628,653 |
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19,204,091 |
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Long-term debt, less current portion
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3,041,961 |
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4,512,035 |
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Convertible senior notes
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50,000,000 |
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Other long-term liabilities
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3,137,926 |
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2,898,487 |
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Commitments and contingencies
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Stockholders Equity
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Preferred stock, par value $0.01 per share;
25,000,000 shares authorized; series A convertible
preferred stock, par value $0.01 per share;
31,620 shares designated, issued and outstanding at
March 31, 2005 and December 31, 2004, respectively;
liquidation value of $31,817,625 at March 31, 2005
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316 |
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316 |
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Common stock, par value $0.01 per share;
100,000,000 shares authorized; 45,564,011 and
45,536,012 shares issued and outstanding at March 31,
2005 and December 31, 2004, respectively
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455,640 |
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455,360 |
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Additional paid-in-capital
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441,766,095 |
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442,021,962 |
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Deferred compensation
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(20,615 |
) |
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(27,134 |
) |
Accumulated other comprehensive loss
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(164,308 |
) |
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(147,377 |
) |
Accumulated deficit
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(353,863,069 |
) |
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(335,859,793 |
) |
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Total stockholders equity
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88,174,059 |
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106,443,334 |
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Total liabilities and stockholders equity
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$ |
161,982,599 |
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$ |
133,057,947 |
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See accompanying notes to unaudited consolidated financial
statements
2
ANTIGENICS INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months ended March 31, 2005 and 2004
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Three Months Ended | |
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March 31, | |
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2005 | |
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2004 | |
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(Unaudited) | |
Revenue
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$ |
120,363 |
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$ |
109,515 |
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Operating expenses:
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Research and development
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(11,303,812 |
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(10,945,542 |
) |
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General and administrative
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(6,800,091 |
) |
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(5,545,324 |
) |
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Operating loss
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(17,983,540 |
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(16,381,351 |
) |
Other income (expense):
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Interest expense
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(617,294 |
) |
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(152,150 |
) |
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Interest income
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597,558 |
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303,900 |
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Loss from continuing operations
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(18,003,276 |
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(16,229,601 |
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Loss from discontinued operations
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(925,646 |
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Net loss
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(18,003,276 |
) |
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(17,155,247 |
) |
Dividends on series A convertible preferred stock
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(197,625 |
) |
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(197,625 |
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Net loss attributable to common stockholders
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$ |
(18,200,901 |
) |
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$ |
(17,352,872 |
) |
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Per common share data, basic and diluted:
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Loss from continuing operations
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$ |
(0.40 |
) |
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$ |
(0.38 |
) |
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Loss from discontinued operations
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$ |
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$ |
(0.02 |
) |
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Net loss attributable to common stockholders
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$ |
(0.40 |
) |
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$ |
(0.41 |
) |
Weighted average number of common shares outstanding, basic and
diluted
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45,562,767 |
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42,778,105 |
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See accompanying notes to unaudited consolidated financial
statements.
3
ANTIGENICS INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the three months ended March 31, 2005 and 2004
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March 31, | |
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2005 | |
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2004 | |
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(Unaudited) | |
Cash flows from operating activities:
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Net loss
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$ |
(18,003,276 |
) |
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$ |
(17,155,247 |
) |
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Loss from discontinued operations
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(925,646 |
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Loss from continuing operations
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(18,003,276 |
) |
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(16,229,601 |
) |
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Adjustments to reconcile loss from continuing operations to net
cash used in continuing operations:
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Depreciation and amortization
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1,257,045 |
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1,382,225 |
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Non-cash stock compensation
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(253,596 |
) |
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186,283 |
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Loss on sale of fixed assets
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7,431 |
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Amortization of debt issuance costs
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47,446 |
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Changes in operating assets and liabilities:
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Accounts receivable
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(28,930 |
) |
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41,103 |
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Inventories
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9,925 |
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18,439 |
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Prepaid expenses
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(761,841 |
) |
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(470,412 |
) |
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Accounts payable
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(1,902,990 |
) |
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(2,164,038 |
) |
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Accrued liabilities and other current liabilities
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273,639 |
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(388,292 |
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Other operating assets and liabilities
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348,012 |
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(286,824 |
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Net cash used in continuing operations
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(19,014,566 |
) |
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(17,903,686 |
) |
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Net cash used in discontinued operations
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(295,300 |
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Net cash used in operating activities
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(19,014,566 |
) |
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(18,198,986 |
) |
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Cash flows from investing activities:
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Proceeds from maturities of available for sale securities
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54,248,197 |
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39,600,000 |
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Purchases of available for sale securities
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(56,800,359 |
) |
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(67,487,934 |
) |
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Purchases of plant and equipment
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(1,126,296 |
) |
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(985,695 |
) |
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Proceeds from divestiture of assets
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8,381,801 |
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Decrease in restricted cash
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|
705,588 |
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1,020,695 |
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Net cash used in investing activities
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(2,972,870 |
) |
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(19,471,133 |
) |
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Cash flows from financing activities:
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Net proceeds from sale of equity
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53,631,418 |
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Proceeds from exercise of stock options
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576,824 |
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Proceeds from employee stock purchases
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202,153 |
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Payments of series A convertible preferred stock dividend
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(197,625 |
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(224,140 |
) |
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Proceeds of long-term debt
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50,000,000 |
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Debt issuance costs
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(1,992,742 |
) |
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Payments of long-term debt
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(1,416,161 |
) |
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(1,782,603 |
) |
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Net cash provided by financing activities
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46,595,625 |
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52,201,499 |
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Net increase in cash and cash equivalents
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24,608,189 |
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14,531,380 |
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Cash and cash equivalents, beginning of period
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15,979,714 |
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24,416,311 |
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Cash and cash equivalents, end of period
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$ |
40,587,903 |
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$ |
38,947,691 |
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Supplemental cash flow information:
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Cash paid for interest
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$ |
95,190 |
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$ |
223,158 |
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See accompanying notes to unaudited consolidated financial
statements.
4
ANTIGENICS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2005
Note A Organization and Basis of
Presentation
We are a biotechnology company developing technology and
products to treat cancers, infectious diseases and autoimmune
disorders, primarily based on immunological approaches. Our most
advanced product candidate is Oncophage®, a personalized
therapeutic cancer vaccine being tested in several types of
cancer, including in Phase 3 clinical trials for the
treatment of renal cell carcinoma (the most common type of
kidney cancer) and for metastatic melanoma. Our product
candidate portfolio also includes (1) AG-858, a
personalized therapeutic cancer vaccine in a Phase 2
clinical trial for the treatment of chronic myelogenous
leukemia, (2) AG-702/AG-707, a therapeutic vaccine program
in Phase 1 clinical development for the treatment of
genital herpes, and
(3) Aroplatintm,
a liposomal chemotherapeutic currently completing pre-clinical
testing. Our related business activities include research and
development, regulatory and clinical affairs, clinical
manufacturing, business development, marketing, and
administrative functions that support these activities.
The accompanying unaudited consolidated financial statements
have been prepared in accordance with U.S. generally
accepted accounting principles for interim financial information
and with the instructions to Article 10 of
Regulation S-X and include the accounts of Antigenics Inc.
and our wholly owned subsidiaries. Accordingly, they do not
include all of the information and footnotes required by
U.S. generally accepted accounting principles for complete
annual consolidated financial statements. In the opinion of
management, all adjustments considered necessary for a fair
presentation have been included. All significant intercompany
transactions and accounts have been eliminated in consolidation.
Certain amounts previously reported have been reclassified in
order to conform to the current years presentation. This
includes a reclassification of auction rate notes and similar
instruments from cash and cash equivalents to short-term
investments as of March 31, 2004 in the amount of
$32,800,000. Operating results for the three-month period ended
March 31, 2005 are not necessarily indicative of the
results that may be expected for the year ending
December 31, 2005. For further information, refer to the
consolidated financial statements and footnotes thereto for the
year ended December 31, 2004 included in our annual report
on Form 10-K filed with the Securities and Exchange
Commission (SEC) on March 31, 2005.
The preparation of unaudited consolidated financial statements
in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and
disclosures of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues
and expenses during the reported period. Management bases its
estimates on historical experience and on various assumptions
that are believed to be reasonable under the circumstances.
Actual results could differ materially from those estimates.
We have incurred annual operating losses since inception and, as
a result, at March 31, 2005 have an accumulated deficit of
$353,863,000. Our operations have been funded principally by
sales of equity. We believe that our working capital resources
at March 31, 2005 are sufficient to satisfy our liquidity
requirements into 2006. Satisfying our long-term liquidity needs
will require the successful commercialization of Oncophage or
other product candidates and may require additional capital.
Our lead product candidates require clinical trials and
approvals from regulatory agencies as well as acceptance in the
marketplace. We are conducting clinical trials in various
cancers and in one infectious disease indication. Although we
believe our patents, patent rights and patent applications are
valid, the invalidation of our patents or failure of certain of
our pending patent applications to issue as patents could have a
material adverse effect upon our business. Part of our strategy
is to develop and commercialize some of our products by
continuing our existing collaborative arrangements with academic
and corporate collaborators and licensees and by entering into
new collaborations. Our success depends, in part, on the success
of these parties in performing research, preclinical and
clinical testing. We compete with specialized biotechnology
5
ANTIGENICS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
companies, major pharmaceutical companies, universities and
research institutions. Many of these competitors have
substantially greater resources than we do.
Note B Net Loss Per Share
Basic earnings or loss per common share (EPS) is
calculated by dividing the applicable earnings or loss by the
weighted average number of common shares outstanding. Diluted
EPS is calculated by dividing the applicable earnings or loss by
the weighted average common shares outstanding plus the dilutive
effect of outstanding stock options, stock warrants, shares of
series A convertible preferred stock, and convertible
senior notes. Because we have reported a loss from continuing
operations for all periods, diluted loss per common share is the
same as basic loss per common share as the effect of including
the dilutive effect of the outstanding stock options, stock
warrants, the convertible preferred stock, and the convertible
senior notes in the calculation would have reduced the loss from
continuing operations per common share. Therefore,
the 6,415,558 outstanding stock options, the
66,255 shares underlying outstanding stock warrants, the
2,000,000 shares into which outstanding shares of
series A convertible preferred stock are convertible, and
the 4,645,115 shares of common stock issuable upon
conversion of the $50,0000,000 convertible senior notes are not
included in the calculation.
Note C Inventories
Inventories are stated at the lower of cost or market using
standard costs that approximate the first-in, first-out method
and consist solely of finished goods at March 31, 2005 and
December 31, 2004.
Note D Stock-Based Compensation
We account for options granted to employees and directors in
accordance with Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees,
and related interpretations. As such, compensation expense is
recorded on fixed stock option grants only if the current fair
value of the underlying stock exceeds the exercise price of the
option at the date of grant and it is recognized on a
straight-line basis over the vesting period.
We account for stock options granted to non-employees on a
fair-value basis in accordance with Statement of Financial
Accounting Standards (SFAS) No. 123, Accounting for
Stock-Based Compensation and Emerging Issues Task Force
Issue No. 96-18, Accounting for Equity Instruments That
Are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services. As a result,
any non-cash charge to operations for non-employee options with
vesting or other performance criteria is affected each reporting
period by changes in the market price value of our common stock.
In December 2002, the Financial Accounting Standards Board
(FASB) issued SFAS No. 148, Accounting for
Stock-Based Compensation Transition and
Disclosure, an amendment of SFAS No. 123.
SFAS No. 148 amends SFAS No. 123 to provide
alternative methods of transition for a voluntary change to the
fair-value method of accounting for stock-based employee
compensation. In addition, SFAS No. 148 amends the
disclosure requirements of SFAS No. 123 to require
prominent disclosures in both annual and interim financial
statements, which interim disclosures are included below.
6
ANTIGENICS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table illustrates the effect on net loss
attributable to common stockholders and net loss attributable to
common stockholders per common share, basic and diluted, had
compensation cost for options granted to employees and directors
and sold through our employee stock purchase plan been
determined consistent with the fair value method of
SFAS No. 123:
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|
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|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net loss attributable to common stockholders, as reported
|
|
$ |
(18,201,000 |
) |
|
$ |
(17,353,000 |
) |
Add: stock-based employee and director compensation recognized
under APB Opinion No. 25
|
|
|
32,000 |
|
|
|
35,000 |
|
Deduct: total stock-based employee and director compensation
expense determined under fair-value based method for all awards
|
|
|
(1,822,000 |
) |
|
|
(1,329,000 |
) |
|
|
|
|
|
|
|
Pro forma net loss attributable to common stockholders
|
|
$ |
(19,991,000 |
) |
|
$ |
(18,647,000 |
) |
|
|
|
|
|
|
|
Net loss attributable to common stockholders per common share,
basic and diluted:
|
|
|
|
|
|
|
|
|
As reported
|
|
$ |
(0.40 |
) |
|
$ |
(0.41 |
) |
Pro forma
|
|
$ |
(0.44 |
) |
|
$ |
(0.44 |
) |
The effects of applying SFAS No. 123, for either
recognizing or disclosing compensation costs under such
pronouncement, may not be representative of the effects on
reported net income or loss for future years. The fair value of
each option and employee stock purchase right granted is
estimated on the date of grant using an option-pricing model
with the following weighted average assumptions:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Estimated volatility employee and director options
|
|
|
49 |
% |
|
|
47 |
% |
Estimated volatility employee stock purchase rights
|
|
|
36 |
% |
|
|
n/a |
|
Expected life in years employee and director options
|
|
|
6 |
|
|
|
6 |
|
Expected life in years employee stock purchase rights
|
|
|
1 |
|
|
|
n/a |
|
Risk-free interest rate employee and director options
|
|
|
4.39 |
% |
|
|
2.80 |
% |
Risk-free interest rate employee stock purchase
rignts
|
|
|
2.14 |
% |
|
|
n/a |
|
Dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
The expected life used to estimate the fair value of
non-employee options is equal to the contractual life of the
option granted.
In December 2004, the FASB issued SFAS No. 123R,
Share-Based Payment (SFAS No. 123R) which
replaces SFAS No. 123, Accounting for Stock-Based
Compensation and supersedes APB Opinion No. 25,
Accounting for Stock Issued to Employees.
SFAS No. 123R is focused primarily on the
accounting for transactions in which a company obtains employee
services in exchange for stock options or share-based payments.
Currently, we account for stock option grants to our employees
in accordance with APB Opinion No. 25 and disclose the pro
forma effect of compensation expense for these stock options as
if the fair value method under SFAS No. 123 had been
used. SFAS No. 123R requires that companies recognize
compensation expense associated with these grants of stock
options in the their results of operations. We are required to
adopt SFAS No. 123R in the first quarter of fiscal
2006, beginning January 1, 2006. The pro forma disclosures
previously permitted under SFAS No. 123 will no longer
be an alternative to financial statement recognition.
SFAS No. 123R requires that compensation expense be
recorded for all unvested stock options and restricted stock at
the beginning of the first quarter of adoption of
SFAS No. 123R and for
7
ANTIGENICS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
all stock options granted thereafter. Compensation expense will
be measured based on the fair value of the instrument on the
grant date and will be recognized over the vesting period. SFAS
No. 123R also requires that companies recognize
compensation expense associated with purchases of shares of
common stock by employees at a discount to market value under
employee stock purchase plans that meet certain criteria. We are
currently evaluating the full impact of adoption of this
statement. We anticipate that implementation of
SFAS No. 123R will result in material non-cash charges
to our consolidated results of operations.
Note E Comprehensive Loss
The following table provides the calculation of other
comprehensive loss for the three months ended March 31,
2005 and 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Net loss attributable to common stockholders
|
|
$ |
(18,201,000 |
) |
|
$ |
(17,353,000 |
) |
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
|
Unrealized loss on available for sale securities, net
|
|
|
(17,000 |
) |
|
|
(161,000 |
) |
|
|
|
|
|
|
|
|
|
Other comprehensive loss
|
|
$ |
(18,218,000 |
) |
|
$ |
(17,514,000 |
) |
|
|
|
|
|
|
|
Note F Commitments and Contingencies
On May 18, 2000, we committed $3,000,000 to become a
limited partner in a limited partnership called Applied Genomic
Technology Capital Fund (AGTC), which invests principally in
companies that apply genomic technologies and information in
their offerings of products and services or that are engaged in
research and development involving genomic technologies. Capital
contributions to the limited partnership are made as authorized
by the general partner. Through March 31, 2005, we have
invested $2,250,000. No capital contributions were made by us to
AGTC during the quarter ended March 31, 2005. This
investment is accounted for under the cost method as our
ownership is approximately 2%. In order to assess whether or not
there has been an other than temporary decline in the value of
this investment, we analyze several factors including:
(1) the carrying value of the limited partnerships
investments in its portfolio companies, (2) how recently
investments in the portfolio companies have been made,
(3) the post-financing valuations of those investments,
(4) the level of un-invested capital held by the limited
partnership and (5) the overall trend in venture capital
valuations. Based on these analyses, at March 31, 2005, we
concluded that an other than temporary decline had not occurred
and therefore, have not reduced the carrying value of the asset.
Our investment balance aggregated $1,844,000 at March 31,
2005 and December 31, 2004 and is included in other
long-term assets. The general partner of AGTC is AGTC Partners,
L.P. Noubar Afeyan, Ph.D., who is one of our directors, is
the Chairman and Senior Managing Director and CEO of Flagship
Ventures, a partnership of funds including AGTC and, until its
dissolution during 2004, NewcoGen Group Inc. Garo H.
Armen, Ph.D., our chairman and chief executive officer, was
a director of NewcoGen Group Inc. until its dissolution during
2004.
Antigenics, our Chairman and Chief Executive Officer Garo Armen,
and two investment banking firms that served as underwriters in
our initial public offering have been named as defendants in a
civil class action lawsuit filed on November 5, 2001 in the
Federal District Court for the Southern District of New York on
behalf of a class of purchasers of our stock between
February 3, 2000 and December 6, 2000. Similar
complaints were filed against about 300 other issuers, their
underwriters, and in many instances their directors and
officers. These cases have been coordinated under the caption
In re Initial Public Offering Securities Litigation, Civ.
No. 21 MC 92 (SAS), by order dated August 9, 2001. The
suit against Antigenics and
8
ANTIGENICS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Dr. Armen alleges that the brokerage arms of the investment
banking firms charged secret excessive commissions to certain of
their customers in return for allocations of our stock in the
offering. The suit also alleges that shares of our stock were
allocated to certain of the investment banking firms
customers based upon agreements by such customers to purchase
additional shares of our stock in the secondary market. The
complaint alleges that Antigenics is liable under
Section 11 of the Securities Act of 1933, as amended (the
Securities Act), and Dr. Armen is liable under
Sections 11 and 15 of the Securities Act because our
registration statement did not disclose these alleged practices.
On April 19, 2002, the plaintiffs in this action filed an
amended class action complaint, which contains new allegations.
Again, similar amended complaints were filed with respect to the
other 300 companies. In addition to the claims in the
earlier complaint, the amended complaint alleges that Antigenics
and Dr. Armen violated Sections 10(b) and 20 of the
Securities Exchange Act and SEC Rule 10b-5 by making false
and misleading statements and/or omissions in order to inflate
our stock price and conceal the investment banking firms
alleged secret arrangements. The claims against Dr. Armen,
in his individual capacity, have been dismissed without
prejudice. On July 15, 2002, Antigenics and Dr. Armen
joined the Issuer Defendants Motion to Dismiss the
Consolidated Amended Complaints. By order of the Court, this
motion set forth all common issues, i.e., all
grounds for dismissal common to all or a significant number of
Issuer Defendants. The hearing on the Issuer Defendants
Motion to Dismiss and the other Defendants motions to
Dismiss was held on November 1, 2002. On February 19,
2003, the Court issued its opinion and order on the Issuer
Defendants Motion to Dismiss. The Court granted Antigenics
motion to dismiss the Rule 10(b)-5 and Section 20
claims with leave to amend and denied our motion to dismiss the
Section 11 and Section 15 claims. On June 14,
2004, papers formalizing a proposed settlement among the
plaintiffs, Issuer Defendants, and issuers were presented to the
Federal District Court for the Southern District of New York. In
an Opinion and Order dated February 15, 2005, the Court
granted preliminary approval of the settlement, conditioned upon
certain modifications. There is no guarantee that the settlement
will become effective as it is subject to a number of
conditions, including Court approval. If the settlement becomes
effective, Antigenics anticipates that it will not incur
significant out-of-pocket costs, after considering insurance.
Accordingly, an accrual has not been recorded at March 31,
2005.
We currently are a party to other legal proceedings as well.
While we currently believe that the ultimate outcome of any of
these proceedings will not have a material adverse effect on our
financial position, results of operations or liquidity,
litigation is subject to inherent uncertainty. Furthermore,
litigation consumes both cash and management attention.
Note G Discontinued Operations
On March 17, 2004, we sold our manufacturing rights for
feline leukemia virus (FeLV) vaccine to French veterinary
pharmaceutical manufacturer Virbac S.A. (Virbac).
Pursuant to this arrangement, in exchange for the transfer of
our manufacturing rights and related equipment for FeLV, we
received $14,552,000 in cash. In addition, we entered into a
sublease agreement with PP Manufacturing, a subsidiary of
Virbac, for a portion of the manufacturing facility in
Framingham, MA.
In April 2004, upon the satisfaction of a contingency of the
sale, in accordance with SFAS No. 144, Accounting
for the Impairment or Disposal of Long-Lived Assets, we
recorded a gain on the divestiture of these assets of
approximately $14,132,000 before taxes. The carrying value of
the assets sold and liabilities assumed were approximately
$409,000 and $15,000, respectively. In addition, we have
classified the results
9
ANTIGENICS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
of operations of the FeLV activity as discontinued operations in
the accompanying consolidated financial statements, for all
periods presented. The loss from discontinued operations consist
of the following:
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
March 31, | |
|
|
| |
|
|
2005 |
|
2004 | |
|
|
|
|
| |
Revenue
|
|
$ |
|
|
|
$ |
338,000 |
|
Expenses
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
|
|
(594,000 |
) |
|
Research and Development
|
|
|
|
|
|
|
(193,000 |
) |
|
General and Administrative
|
|
|
|
|
|
|
(477,000 |
) |
|
|
|
|
|
|
|
Net loss from discontinued operations
|
|
$ |
|
|
|
$ |
(926,000 |
) |
|
|
|
|
|
|
|
Virbac held exclusive perpetual worldwide marketing rights to
the FeLV vaccine since 1983. The supply agreement was up for
renewal in July 2002, at which point we began to supply product
to Virbac through month-to-month supply agreements until the
sale of our FeLV manufacturing rights to them in March 2004.
Subsequent to the completion of the sale there are no further
product sales of the FeLV vaccine.
Note H Convertible Senior Notes
On January 25, 2005, we issued $50,000,000 of convertible
senior notes in a private placement. Proceeds from the sale of
the notes were approximately $48,000,000 net of issuance costs.
Issuance costs are included in other long-term assets on our
consolidated balance sheet and are being amortized over seven
years, the expected life of the notes based on the earliest date
on which the holders can require redemption. The notes, which
mature in 2025, bear interest semi-annually on February 1 and
August 1 each year, at a rate of 5.25% per annum and
are initially convertible into common stock at any time at a
conversion price (subject to adjustment) of approximately
$10.76 per share. Notes surrendered for conversion in
connection with certain fundamental changes, as defined, that
occur before February 1, 2012 may in certain circumstances
be entitled to an increase in the conversion rate per $1,000
principal amount of notes. From February 1, 2012, we may
redeem the notes for cash, at a redemption price equal to 100%
of the principal amount of the notes, plus any accrued and
unpaid interest. On each of February 1, 2012,
February 1, 2015 and February 1, 2020, holders may
require us to purchase their notes for cash equal to 100% of the
principal amount of the notes, plus any accrued and unpaid
interest. Holders may require us to repurchase their notes upon
a fundamental change, as defined, at a repurchase price, in
cash, equal to 100% of the principal amount of the notes to be
repurchased, plus any accrued and unpaid interest. The notes are
senior unsecured obligations of Antigenics and rank equally with
all of our existing and future senior unsecured indebtedness.
The notes are effectively subordinated to all of our existing
and future secured indebtedness and all existing and future
liabilities of our subsidiaries. The notes do not contain any
financial covenants and do not limit our ability to incur
additional indebtedness, including senior or secured
indebtedness, issue securities, pay dividends or repurchase our
securities. The notes and underlying shares of common stock have
not been registered under the Securities Act and may not be
offered or sold within the United States or to, or for, the
account or benefit of, U.S. persons except pursuant to an
exemption from or in a transaction not subject to, the
registration requirement of the Securities Act. We are required
within 120 days of January 25, 2005 to file a shelf
registration statement with the SEC for resale of the notes and
the shares of common stock issuable upon conversion of the notes
by the holders thereof. If a shelf registration statement is not
filed with the SEC by such
120th
day, the shelf registration statement does not become effective
under the Securities Act within 180 days of
January 25, 2005, or we fail to name as security holder in
the shelf registration statement any holder that is entitled to
be so named as a security holder in accordance with the terms of
the registration rights agreement relating to the notes, then we
will pay additional interest to each holder of registrable
securities who is affected. The fair value of these notes is
estimated to be approximately $33,000,000 at March 31, 2005
based on trader quotes.
10
|
|
Item 2 |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
Overview
We are currently researching and/or developing products to treat
cancers, infectious diseases and autoimmune disorders. Since our
inception in March 1994, our activities have primarily been
associated with the development of our heat shock protein
technology and our most advanced product candidate, our
Oncophage personalized therapeutic cancer vaccine. Our business
activities have included product research and development,
intellectual property prosecution, manufacturing therapeutic
vaccines for clinical trials, regulatory and clinical affairs,
corporate finance and development activities, marketing and
integration of our acquisitions.
We have incurred significant losses since our inception. As of
March 31, 2005, we had an accumulated deficit of
$353,863,000. We continue to finance the majority of our
operations through the sale of equity. On January 25, 2005,
we raised net proceeds of approximately $48,000,000 through the
issuance of 5.25% Convertible Senior Notes due 2025 (see
Note H to our unaudited consolidated financial statements).
We expect, as we have in the past, to attempt to raise
additional funds in advance of depleting our current funds.
Satisfying long-term liquidity needs will require the successful
commercialization of Oncophage or other products and may require
substantial additional capital. We expect that we will be able
to fund our growing operations and capital expenditures into
2006 with our current working capital.
Forward-Looking Statements
This report contains forward-looking statements. Generally,
these statements can be identified by the use of terms like
believe, expect, anticipate,
plan, may, will,
could, estimate, potential,
opportunity, future, project
and similar terms. Forward-looking statements include statements
about our timelines for completing clinical trials, timelines
for releasing data from clinical trials, timelines for
initiating new clinical trials, expectations regarding clinical
trials and regulatory processes, expectations regarding test
results, future product research and development activities, the
expected effectiveness of therapeutic drugs and vaccines in
treating diseases, applicability of our heat shock protein
technology to multiple cancers and infectious diseases,
competitive position, plans for regulatory filings, the
sufficiency of our clinical trials in renal cell carcinoma to
support a biologics license application for product approval;
possible receipt of future regulatory approvals, expected cash
needs, plans for sales and marketing, implementation of
corporate strategy and future financial performance. These
forward-looking statements involve a number of risks and
uncertainties that could cause actual results to differ
materially from those suggested by the forward-looking
statements. These risks and uncertainties include, among others,
that clinical trials may not demonstrate that our products are
both safe and more effective than current standards of care;
that we may be unable to obtain the regulatory approvals
necessary to conduct additional clinical trials; that we may not
be able to enroll sufficient numbers of patients in our clinical
trials; that we may be unable to obtain the regulatory approvals
necessary to commercialize our products because the United
States Food and Drug Administration (FDA) or other
regulatory agencies are not satisfied with our trial protocols
or the results of our trials; that we may fail to adequately
protect our intellectual property or that we are determined to
infringe on the intellectual property of others; changes in
financial markets and geopolitical developments; and the
solvency of counter-parties under subleases and general real
estate risks. Forward-looking statements, therefore, should be
considered in light of all of the information included or
referred to in this report, including the information set forth
under the heading Factors That May Impact Future
Results. You are cautioned not to place significant
reliance on these forward-looking statements, which speak only
as of the date of this report. We undertake no obligation to
update these statements.
Historical Results of Operations
|
|
|
Three Months Ended March 31, 2005 Compared To The
Three Months Ended March 31, 2004 |
Revenue: We generated $120,000 and $110,000 of research
and development revenue during the three months ended
March 31, 2005 and 2004, respectively. Revenues from
research and development activities
11
include revenues earned on shipments of QS-21 to our QS-21
licensees, grant revenue and license fees earned.
Research and Development: Research and development
expenses include the costs associated with our internal research
and development activities, including salaries and benefits,
occupancy costs, clinical manufacturing costs, related
administrative costs, and research and development conducted for
us by outside advisors, such as sponsored university-based
research partners, including the University of Connecticut where
we sponsor research, and clinical research organizations as well
as expenses related to grant revenue. Research and development
expense increased 3% to $11,304,000 for the three months ended
March 31, 2005 from $10,946,000 for the three months ended
March 31, 2004. The increase was primarily due to an
increase in payroll related expenses due to the hiring of
personnel to assist with our research and development
activities. Payroll related expenses increased $1,263,000 in
comparison to the first quarter of 2004. This increase was
partially offset by reduced clinical trial activity due to the
completion of enrollment in part I of our Phase 3
clinical trial in renal cell carcinoma trial and our
Phase 3 clinical trial in metastatic melanoma during the
third quarter of 2004. Comparing the quarter ended
March 31, 2005 to the quarter ended March 31, 2004,
trial related expenses have decreased $888,000.
General and Administrative: General and administrative
expenses consist primarily of personnel costs, office expenses
and professional fees. General and administrative expenses
increased 23% to $6,800,000 for the three months ended
March 31, 2005 from $5,545,000 for the three months ended
March 31, 2004. This increase is primarily attributable to
a $670,000 increase in professional fees relating mostly to
increased legal fees and additional consulting services driven
by our preparations for commercialization of Oncophage in
addition to increased accounting fees related to compliance with
the Sarbanes-Oxley Act of 2002. Additionally, all other expenses
increased $585,000 due primarily to the increased activities
related to preparations for the potential commercialization of
Oncophage.
Interest Expense: Interest expense increased 306% to
$617,000 for the three months ended March 31, 2005 from
$152,000 for the three months ended March 31, 2004. This
increase relates primarily to interest on our
5.25% convertible senior notes due 2025 that were issued on
January 25, 2005.
Interest Income: Interest income increased 97% to
$598,000 for the three months ended March 31, 2005 from
$304,000 for the same period in 2004. This increase is primarily
attributable to a rise in interest rates earned on our cash,
cash equivalents and short-term investments. Our average
interest rate increased from 1.14% for the three months ended
March 31, 2004 to 2.02% for the three months ended
March 31, 2005.
Discontinued Operations: Due to the sale of our
manufacturing rights for feline leukemia virus (FeLV) vaccine
and related assets to Virbac in 2004, we have reported the
results of those operations as discontinued in accordance with
SFAS No. 144 Accounting for the Impairment or
Disposal of Long-Lived Assets.
12
Research and Development Programs
Prior to 2002, we did not track costs on a per project basis,
and therefore have estimated the allocation of our total
research and development costs to each of our three largest
research and development programs. These research and
development programs contain our four lead product candidates,
Oncophage®, AG-858,
Aroplatintm,
and AG-702/707, as indicated in the following table.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months | |
|
|
|
|
|
|
|
|
Ended | |
|
Year Ended December 31, | |
|
|
|
|
|
|
March 31, | |
|
| |
|
Prior to | |
Research and Development Program |
|
Lead Product | |
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Heat Shock Proteins for Cancer
|
|
Oncophage & AG-858 |
|
$ |
9,358,000 |
|
|
$ |
35,462,000 |
|
|
$ |
40,052,000 |
|
|
$ |
31,046,000 |
|
|
$ |
23,277,000 |
|
|
$ |
36,798,000 |
|
Heat Shock Proteins for Infectious Diseases
|
|
|
AG-702/707 |
|
|
|
765,000 |
|
|
|
2,682,000 |
|
|
|
2,376,000 |
|
|
|
1,248,000 |
|
|
|
735,000 |
|
|
|
2,085,000 |
|
Liposomal Cancer Treatments*
|
|
|
Aroplatin |
|
|
|
424,000 |
|
|
|
1,112,000 |
|
|
|
1,263,000 |
|
|
|
2,061,000 |
|
|
|
1,442,000 |
|
|
|
|
|
Other Research and Development Programs
|
|
|
|
|
|
|
757,000 |
|
|
|
2,462,000 |
|
|
|
2,573,000 |
|
|
|
3,123,000 |
|
|
|
5,805,000 |
|
|
|
2,578,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Research and Development Expenses
|
|
|
|
|
|
$ |
11,304,000 |
|
|
$ |
41,718,000 |
|
|
$ |
46,264,000 |
|
|
$ |
37,478,000 |
|
|
$ |
31,259,000 |
|
|
$ |
41,461,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
Prior to 2001 costs were incurred by Aronex Pharmaceuticals, a
company we acquired in July 2001. |
We have allocated direct and indirect costs to each program
based on certain assumptions and our review of the status of
each program, payroll-related expenses and other overhead costs
based on estimated usage by each program. Each of our lead
product candidates is in various stages of development as
described below. Significant additional expenditures will be
required if we complete our clinical trials, start new trials,
apply for regulatory approvals, continue development of our
technologies, expand our operations and bring our product
candidates to market. The eventual total cost of each clinical
trial is dependent on a number of uncertainties such as trial
design, the length of the trial, the number of clinical sites
and the number of patients. The process of obtaining and
maintaining regulatory approvals for new therapeutic products is
lengthy, expensive and uncertain. Because the successful
development of our most advanced product candidate, Oncophage,
is uncertain, and because AG-858, AG-702/707, and Aroplatin are
in early-stage clinical development, we are unable to reliably
estimate the cost of completing our research and development
programs, the timing of bringing such programs to market and,
therefore, when material cash inflows are likely to commence.
We started enrolling patients in our first clinical trial
studying Oncophage in November 1997. To date, over
700 patients have been treated with the Oncophage vaccine
in our various clinical trials. We have ongoing Phase 1 and
Phase 2 trials in several types of cancer, and we have
completed enrollment in part I of a Phase 3 trial for renal
cell carcinoma and a Phase 3 trial for metastatic melanoma.
Because Oncophage is a novel therapeutic cancer vaccine that is
personalized for each patient, it may experience a longer
regulatory review process and higher development costs, either
of which could delay or prevent our commercialization efforts.
For additional information regarding regulatory risks and
uncertainties, please read the risks identified under
Factors That May Impact Future Results.
On September 3, 2003, the FDA placed our Phase 3
Oncophage clinical trials on partial clinical hold because of
inadequate data to support specifications for our product
purity, identity, potency and pH. With FDA consent, we continued
to treat and monitor patients who were already enrolled in the
trials as of that date. On October 22, 2003 we provided
information in response to the FDA comments received, and on
November 23, 2003, the agency lifted the partial clinical
hold.
On December 22, 2003, we announced the result of the
planned interim analysis of the data from our Phase 3 trial
of Oncophage in renal cell carcinoma. Based on its review of the
safety data, efficacy data, and other information regarding the
trial, the independent Data Monitoring Committee (DMC) for
the trial, a
13
panel of cancer specialists who are reviewing the safety and
conduct of the trial at regular intervals but are not otherwise
involved in the study, recommended that the trial proceed as
planned and did not require that we change the number of
patients we planned to enroll in this trial for a successful
analysis of part I of the Phase 3 trial. At the interim
analysis, the DMC also declared the design and conduct of the
trial sound and raised no apparent safety concerns.
In July 2004, we held a meeting with the medical review team of
the FDA for Oncophage in renal cell carcinoma. The medical
review team is specifically focused on the review of patient
safety, product efficacy, clinical protocols and clinical
development plan-related issues. The purpose of the meeting was
to address issues surrounding the clinical development plan for
product registration of Oncophage in renal cell carcinoma. The
FDA expressed agreement with our overall proposed registration
plan. This plan includes our ability to use part I of the
Phase 3 trial as part of our product registration strategy
as well as starting a second part of the trial in a similar
patient population. We commenced study initiation activities for
part II of this Phase 3 trial in renal cell carcinoma
in February 2005. The FDA has indicated that, by itself, part I
of our Phase 3 clinical trial in renal cell carcinoma is
not sufficient to support a biologics license application, also
known as a BLA, as they consider part II of the trial as
potentially providing the definitive evidence of safety and
efficacy; however, we expect that part I will be accepted as
part of the BLA filing. We intend to complete part I,
perform final analysis and review the data closely. Should the
results from the first part of the trial be clearly positive in
terms of clinical outcomes, we plan to submit data to the FDA
and request that the agency reconsider its position regarding
the use of the data from part I of the trial alone to support a
BLA filing, while part II of the study is continuing. There
is no assurance that we will be successful in demonstrating that
our product is sufficiently characterized or that the FDA would
accept such a strategy.
During the quarter ended September 30, 2004, part I of our
phase 3 renal cell carcinoma trial was closed to
enrollment. The final analysis for part I will be triggered once
a pre-specified number of events occur. An event is defined as a
recurrence of a patients renal cell carcinoma or a death
of a patient. Events are reviewed and confirmed, on a blinded
basis, by an independent Clinical Events Committee comprised of
expert radiologists and an expert oncologist. Based on the
overall trend of events in this trial to date, we believe that
the earliest the final analysis for this trial could be
triggered is during the third quarter of 2005. If the efficacy
data demonstrates a statistically significant improvement in the
primary endpoint for patients treated with Oncophage, and if the
FDA accepts the data from this trial as being pivotal and
sufficient to support product registration, we would expect to
file a BLA within six months after completing the final analysis.
During the quarter ended September 30, 2004 we also
completed enrollment of our ongoing Phase 3 trial in
metastatic melanoma. We had a meeting with the DMC during the
first quarter of 2004 to review the safety and conduct of our
Phase 3 metastatic melanoma trial of Oncophage. This
meeting was not an interim analysis of the efficacy data from
this trial. Our overall manufacturing success rate for this
trial is approximately 70%. We believe this study will not
qualify as registrational. We believe that final analysis for
this trial will also be triggered during the second half of 2005.
We initiated a Phase 2 trial of Oncophage in lung cancer
during 2004. We intend to initiate a Phase 1/2 trial in
breast cancer during the second half of 2005, as well as
Phase 1/2 trials of Oncophage in combination with other
molecules for advanced disease in multiple tumor types.
In December 2002, interim data were reported from a pilot
Phase 1 clinical trial conducted at the University of
Connecticut School of Medicine using HSPPC-70, a purified HSP70
and its associated antigens, for the treatment of chronic
myelogenous leukemia, or CML. In April 2003, we initiated a
Phase 2 trial in CML combining AG-858, our HSP70 based
product candidate, with Gleevec® (imatinib mesylate,
Novartis) in patients with CML refractory to Gleevec. In May
2004, we voluntarily placed enrollment of this study on hold to
modify the cell collection procedure. The study resumed on
July 24, 2004. The trial will evaluate the safety and
cytogenetic response (changes in the amount of tumor cells in
the patients blood) of this combination treatment in
approximately 40 patients with chronic phase CML who are
currently receiving Gleevec treatment but are cytogenetically
positive. We plan to study longer duration of treatment and
14
therefore may add additional patients. We expect to complete
enrollment in this trial during the second half of 2005 and
expect to see data from this trial approximately
12-15 months after completion of treatment.
We initiated a proof-of principle Phase 1 trial for AG-702
in the fourth quarter of 2001. Subject to the results of ongoing
toxicology studies and other pre-clinical activities, we plan to
file an investigational new drug application (IND) during
the first half of 2005 for AG-707, and we plan to initiate a
Phase 1 clinical trial of AG-707 shortly thereafter. We
have experienced delays in the animal experiments performed to
support the basis of clinical development and IND filing. We
continue to work towards achieving an effective formulation from
our animal studies and expect to complete these studies in the
first half of 2005. We do not anticipate further developing
AG-702 given that AG-707 should be beneficial to a larger number
of patients with genital herpes.
We initiated a Phase 2 trial for advanced colorectal cancer
unresponsive to medical treatment (refractory) in 2002.
This single-arm, open-label trial, conducted at the Arizona
Cancer Center, was designed to evaluate the effect of Aroplatin
alone in patients whose disease is not responsive to standard
first-line cancer treatments (5-fluorouracil/leucovorin or
capecitabine and irinotecan). In September 2003, the
investigators presented findings from this trial at ECCO. One
out of the 15 evaluable patients demonstrated a partial clinical
response and two experienced disease stabilization. Because this
was a single-arm study without a comparator arm, statistical
significance is not calculable. In addition, researchers
observed that Aroplatin appeared well tolerated in this
pretreated patient population. This trial is closed to
enrollment.
In January 2003, we also initiated at the John Wayne Cancer
Center, in Santa Monica, California, a Phase 1/2 trial of
Aroplatin for a variety of advanced solid tumors amenable to
platinum therapy. This study is closed to enrollment.
We have developed a new formulation of Aroplatin and a bridging
Good Laboratory Practices toxicology study comparing the old and
new formulations of Aroplatin was initiated in early January
2005 and completed during the second quarter of 2005. The
results from this study and studies describing characterization
of the new formulation will form the basis of an IND amendment
that we expect to file with the FDA during the second quarter of
2005.
Liquidity and Capital Resources
We have incurred annual operating losses since inception, and,
as of March 31, 2005, we had an accumulated deficit of
$353,863,000. We expect to incur increasing and significant
losses over the next several years as we continue our clinical
trials, apply for regulatory approvals, continue development of
our technologies, and expand our operations. Phase 3 trials
are particularly expensive to conduct, and we initiated
part II of our Phase 3 clinical trial in renal cell
carcinoma during February 2005. Since our inception, we have
financed our operations primarily through the sale of equity,
issuance of convertible notes, interest income earned on cash,
cash equivalents, and short-term investment balances and debt
provided through secured lines of credit. From our inception
through March 31, 2005, we have raised aggregate net
proceeds of $399,099,000 through the sale of equity, the
exercise of stock options and warrants, proceeds from our
employee stock purchase plan, and the issuance of convertible
notes, and borrowed $20,523,000 under two credit facilities. At
March 31, 2005, we had debt outstanding of approximately
$58,506,000.
We expect that we will be able to fund our capital expenditures
and growing operations into 2006 with our current working
capital. In order to fund our needs subsequently, we may need to
raise additional money and may attempt to do so by:
(1) out-licensing technologies or products to one or more
corporate partners, (2) renegotiating license agreements
with current corporate partners, (3) completing an outright
sale of assets, (4) securing additional debt financing
and/or (5) completing equity securities offerings. Our
ability to successfully enter into any such arrangements is
uncertain and if funds are not available, or not available on
15
terms acceptable to us, we may be required to revise our planned
clinical trials, other development activities, capital
expenditures and/or the scale of our operations. We expect to
attempt to raise additional funds in advance of depleting our
current funds; however, we may not be able to raise funds or
raise amounts sufficient to meet the long-term needs of the
business. Satisfying long-term liquidity needs will require the
successful commercialization of Oncophage or other product
candidates and, at this time, we cannot reliably estimate if or
when that will occur, and the process may require substantial
additional capital as discussed above. Please see the
Forward-Looking Statements section and the factors
highlighted in the Factors That May Impact Future
Results section.
Our future cash requirements include, but are not limited to,
supporting our clinical trial efforts and continuing our other
research and development programs. Since inception we have
entered into various agreements with institutions and clinical
research organizations to conduct and monitor our current
clinical studies. Under these agreements, subject to the
enrollment of patients and performance by the applicable
institution of certain services, we have estimated our payments
to be $56,090,000 over the term of the studies. Through
March 31, 2005, approximately $33,081,000 has been expensed
as research and development expenses in the accompanying
consolidated statements of operations and $29,285,000 has been
paid related to these clinical studies. The timing of our
expense recognition and future payments related to these
agreements are subject to the enrollment of patients and
performance by the applicable institution of certain services.
In addition, we have entered into sponsored research agreements
related to our product candidates that require payments of
approximately $9,217,000, of which $3,901,000 has been paid
through March 31, 2005. Part of our strategy is to develop
and commercialize some of our product candidates by continuing
our existing collaborative arrangements with academic and
corporate partners and licensees, and by entering into new
collaborations. As a result of our collaborative agreements, we
will not completely control the efforts to attempt to bring
those product candidates to market. We have various agreements,
for example, with corporate partners that allow the use of our
QS-21 adjuvant in numerous vaccines. These agreements grant
exclusive worldwide rights in some fields of use, and
co-exclusive or non-exclusive rights in others. The agreements
call for royalties to be paid to us by the partner on its future
sales of licensed vaccines that include QS-21, which may or may
not be achieved. The actual amounts we pay out related to these
agreements, if any, will depend on a range of factors outside of
our control, including the success of our pre-clinical and
clinical development efforts with respect to product candidates
being developed which incorporate the patents, the content and
timing of decisions made by the United States Patent and
Trademark Office (USPTO), the FDA and other regulatory
authorities, the existence and scope of third party intellectual
property, the reimbursement and competitive landscape around
such products, and other factors affecting operating results. As
we expand our clinical studies we plan to enter into additional
agreements. We anticipate significant additional expenditures
will be required to complete our clinical trials, apply for
regulatory approvals, continue development of our technologies
and expand our operations and bring our product candidates to
market.
Our cash, cash equivalents and short-term investments at
March 31, 2005 were $114,064,000, an increase of
$27,143,000 from December 31, 2004. During the three months
ended March 31, 2005, we used cash primarily to finance our
operations, including our Oncophage clinical trials. Net cash
used in operating activities for the three months ended
March 31, 2005 and 2004 was $19,015,000 and $18,199,000,
respectively. The increase resulted primarily from the increase
in the activity to support our Oncophage clinical trials and
on-going development activities. As we develop our technologies
and further our clinical trial programs we expect to increase
our spending. Our future ability to generate cash from
operations will depend on achieving regulatory approval of our
products, market acceptance of such products, achieving
benchmarks as defined in existing collaborative agreements, and
our ability to enter into new collaborations. Please see the
Forward-Looking Statements section and the risks
highlighted in the Factors That May Impact Future
Results section.
Net cash used in investing activities for the three months ended
March 31, 2005 was $2,973,000 as compared to net cash used
in investing activities of $19,471,000 for the three months
ended March 31, 2004. During the three months ended
March 31, 2005 we had net purchases of $2,552,000 in
short-term investments. Additionally, our investment in the
purchase of equipment, furniture and fixtures increased
16
$141,000 to $1,126,000 for the three months ended March 31,
2005 from $986,000 for the three months ended March 31,
2004. We anticipate capital expenditures of up to $2,000,000
during the remainder of 2005. We also received $706,000 during
the quarter ended March 31, 2005 from the release of
restrictions on our restricted cash balance.
Net cash provided by financing activities was $46,596,000 for
the three months ended March 31, 2005 as compared to
$52,201,000 for the three months ended March 31, 2004.
Since inception, our primary source of financing has been from
equity sales. During the three months ended March 31, 2005
and 2004, sales of equity, exercises of stock options and
proceeds from our employee stock purchase plan totaled
approximately $202,000 and $54,208,000, respectively. During the
quarter ended March 31, 2005 we received net proceeds of
approximately $48,000,000 from the issuance of our convertible
senior notes. In July 2003 we entered into a $17,100,000 debt
facility to finance the first phase of build-out of our
Lexington facility. Through March 31, 2005, we have
borrowed $17,042,000 under this facility. Specific assets,
including leasehold improvements, which they finance, and a cash
security deposit (restricted cash) of $4,416,000 secure the
loans drawn on the credit facility. At March 31, 2005, we
had an $8,360,000 debt balance under this credit facility.
Effective July 19, 2002, we sublet part of our Framingham
manufacturing, research and development, and office space to GTC
Biotherapeutics, Inc. (GTC) and we have leased related leasehold
improvements and equipment under agreements which expire on
December 31, 2006. GTC has an option to extend this lease
until September 2010. Under the terms of our original lease, we
are obligated to pay our landlord approximately 7% of our rental
income. Effective March 17, 2004, we sublet an additional
part of our Framingham manufacturing, research and development,
and office space to PP Manufacturing whose lease expires on
September 30, 2010. As a result of the PP Manufacturing
lease agreement, we amended our agreement with GTC effective
March 16, 2004, adjusting the leaseable square footage. In
addition, we sublet part of our Texas facility to a few small
private companies under agreements that expire in 2008. We are
contractually entitled to receive rental income of $1,292,000 in
2005; $1,375,000 in 2006; $753,000 in 2007; $535,000 in 2008,
$515,000 in 2009 and $386,000 thereafter; the collection of this
income, however, is subject to uncertainty.
We are currently involved in certain legal proceedings as
detailed in Note F to our unaudited consolidated financial
statements above. We do not believe these proceedings will have
a material adverse effect on our consolidated financial
position, results of operations or liquidity. Litigation
however, is subject to inherent uncertainty.
Related Parties
As of March 31, 2005 and December 31, 2004, we had
invested $2,250,000 in a limited partnership, AGTC. Our total
capital commitment to AGTC is $3,000,000. One of our directors,
Noubar Afeyan, Ph.D., is the Chairman and Senior Managing
Director and CEO of a partnership of funds that includes the
general partner of AGTC and, until its dissolution during 2004,
NewcoGen Group Inc. For details refer to Note F to our
unaudited consolidated financial statements. Garo H.
Armen, Ph.D., our chairman and chief executive officer, was
a director of NewcoGen Group Inc. until its dissolution during
2004.
As detailed in Note 11 to our consolidated financial
statements included in Form 10-K for the year ended
December 31, 2004 filed with the SEC, our predecessor
company, Founder Holdings, Inc., which, indirectly, remains a
significant stockholder, approved a stock option plan pursuant
to which our officers, directors, employees and consultants may
be granted options in the predecessor company. In accordance
with U.S. generally accepted accounting principles, options
granted under this plan are accounted for as compensation
expense by us and treated as a contribution to
stockholders equity.
We currently have a QS-21 license and supply agreement with
Neuralab Limited, a wholly owned subsidiary of Elan Corporation,
plc, for use of QS-21 with an antigen in the field of
Alzheimers disease. Garo H. Armen, Ph.D., our
Chairman and Chief Executive Officer, is a director of Elan. For
the three months ended March 31, 2005 and 2004, no revenues
were earned under these agreements and at March 31, 2005
and December 31, 2004, we had no amounts due to us under
these agreements.
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In March 1995, we entered into a consulting agreement with
Dr. Pramod Srivastava, our scientific founder and one of
our directors. This agreement was to expire in March 2005 but
was extended for an additional one-year period until March 2006.
This agreement will automatically renew for additional one-year
periods unless either party decides not to extend the agreement.
We paid Dr. Srivastava cash bonuses of $135,000, and
granted him options to purchase 120,000 shares of our
common stock in three months ended March 31, 2005 and 2004
for services performed in each 2004 and 2003.
In February 1998, we entered into a research agreement with the
University of Connecticut Health Center (UConn) to fund research
in Dr. Pramod Srivastavas laboratory at UConn.
Dr. Srivastava is a member of the faculty of the University
of Connecticut School of Medicine and one of our directors. The
research agreement was amended on December 30, 2003, to
extend the term to December 31, 2008 and calls for payments
to UConn totaling a minimum of $6,750,000, payable quarterly at
the rate of $337,500 (contingent on the continuing employment of
Dr. Srivastava by UConn). In return, we have an option to
obtain an exclusive license to new inventions (as defined in the
research agreement) subject to our payment to UConn of royalties
at varying rates upon commercialization of a product utilizing
technology discovered under the research agreement. In February
2005, we entered into a letter amendment agreement to pay UConn
an additional one-time payment of $135,000 for additional costs
associated with activities to be performed under the agreement
in 2005.
In September 2004, we entered into a $60,000 one-year service
agreement with Techsoft, Inc. d.b.a Medical Systems and NG
Techsoft Pvt. Ltd for data management services. Navin Gupta is
the President and CEO of Techsoft, Inc. d.b.a Medical Systems,
Director and Chairman of the Board of NG Techsoft Pvt Ltd and is
the spouse of Renu Gupta, our Senior Vice President of
Development. On March 21, 2005 we amended this service
agreement to eliminate the $60,000 limit of expenses and to
provide for additional expenses of approximately $3,000 per
month. As of March 31, 2005, approximately $11,500 due
under this agreement is included in accrued expenses. For the
three months ended March 31, 2005 we expensed approximately
$34,000 under this agreement.
On October 22, 2004, we executed a letter of intent with
Symphony Capital LLC for a potential transaction to provide
funding for certain of our research programs. Mr. Mark
Kessel, one of our directors, is a managing director of Symphony
Capital LLC. During February 2005 this potential transaction was
terminated. During 2004, we made payments to Symphony Capital
LLC of $125,000 for development planning activities. At
December 31, 2004, we had accrued $159,000 due to Symphony
Capital LLC. At March 31, 2005, we had no amounts due to
Symphony Capital LLC. During the three months ended
March 31, 2005, $37,000, was incurred related to activities
up to termination.
Factors That May Impact Future Results
Our future operating results could differ materially from the
results described above due to the risks and uncertainties
described below.
Risks Related to our Business
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If we incur operating losses for longer than we expect, we
may be unable to continue our operations. |
From our inception through March 31, 2005, we have
generated net losses totaling approximately $354 million.
Our net losses for the three months ended March 31, 2005,
and for the years ended December 31, 2004, 2003, and 2002,
were approximately $18.0 million, $56.2 million,
$65.9 million, and $55.9 million, respectively. We
expect to incur significant losses over the next several years
as we continue our clinical trials, apply for regulatory
approvals, continue development of our technologies, and expand
our operations. Phase 3 clinical trials are particularly
expensive to conduct, and in February 2005 we initiated
part II of our Phase 3 clinical trial in renal cell
carcinoma. Furthermore, our ability to generate cash from
operations is dependent on if and when we will be able to
commercialize our product candidates. We expect that the
earliest we may be able to commercialize Oncophage would be in
2006. If we incur operating losses for longer than we expect, we
may be unable to continue our operations.
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If we fail to obtain the capital necessary to fund our
operations, we will be unable to advance our development
programs and complete our clinical trials. |
On March 31, 2005, we had approximately $114.1 million
in cash, cash equivalents and short-term investments. With our
current working capital we expect that we could fund our
development programs, clinical trials, and other operating
expenses into 2006. We plan to raise additional funds prior to
that time. For the three months ended March 31, 2005, the
sum of our average monthly cash used in operating activities
plus our average monthly capital expenditures was approximately
$6.7 million. Total capital expenditures for the three
months ended March 31, 2005 were $1.1 million and we
anticipate capital expenditures of up to $2.0 million
during the remainder of 2005. Since our inception, we have
financed our operations primarily through the sale of equity. In
order to finance our future operations, we will be required to
raise additional funds in the capital markets, through
arrangements with corporate partners, or from other sources.
Additional financing, however, may not be available on favorable
terms or at all. If we are unable to raise additional funds when
we need them, we will be required to delay, reduce, or eliminate
some or all of our development programs and some or all of our
clinical trials, including the development programs and clinical
trials supporting our most advanced product candidate,
Oncophage. We also may be forced to license technologies to
others under agreements that allocate to third parties
substantial portions of the potential value of these
technologies.
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We have significant long-term debt and we may not be able
to make interest or principal payments when due. |
As of March 31, 2005, our total long-term debt, excluding
the current portion, was approximately $53 million. Our
5.25% convertible senior notes due 2025 do not restrict our
ability or the ability of our subsidiaries to incur additional
indebtedness, including debt that ranks senior to the notes.
Current and any future secured indebtedness will be senior to
the notes. On each of February 1, 2012, February 1,
2015 and February 1, 2020, holders may require us to
purchase their notes for cash equal to 100% of the principal
amount of the notes, plus any accrued and unpaid interest.
Holders may require us to repurchase their notes upon a
fundamental change, as defined, at a repurchase price, in cash,
equal to 100% of the principal amount of the notes to be
repurchased, plus any accrued and unpaid interest. Our ability
to satisfy our obligations will depend upon our future
performance, which is subject to many factors, including the
factors identified in the Factors That May Impact Future
Results section, and other factors beyond our control. To
date, we have had negative cash flow from operations. For the
three months ended March 31, 2005, and for the year ended
December 31, 2004, net cash used in operating activities
was approximately $19 million and $60 million,
respectively. Assuming no additional interest-bearing debt is
incurred and no convertible senior notes are converted,
redeemed, or repurchased or exchanged, until 2025, our debt
service requirement (payments of principal and interest) is
$6.5 million during 2005, $7.2 during 2006,
$2.7 million during 2007 and $2.6 million annually
during 2008 and thereafter until the convertible senior notes
are no longer outstanding. Unless we are able to generate
sufficient operating cash flow to service our outstanding debt,
we will be required to raise additional funds or default on our
obligations, including our obligations under the notes.
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Because the FDA has indicated to us that part I of our
current Phase 3 trial in renal cell carcinoma, by itself,
will not be sufficient to support a biologics license
application for product approval, unless the FDA changes its
position, we would not expect to generate product revenue from
sales of Oncophage for at least several years, if ever. |
On September 3, 2003, the FDA placed our Phase 3
Oncophage clinical trials in renal cell carcinoma and in
melanoma on partial clinical hold. The FDAs written
correspondence instituting the partial clinical hold indicated
that Oncophage was not sufficiently characterized. Product
characterization represents our products specifications
for purity, identity, potency and pH. On October 22, 2003,
we submitted to the FDA additional specifications for purity,
identity, potency and pH, which represent product
characterization data, and on November 23, 2003, the FDA
lifted the partial clinical hold. Even though the FDA lifted the
partial clinical hold, the FDA has informed us that, for
purposes of part I of our Phase 3 trial in renal cell
carcinoma (study C-100-12) and our Phase 3 trial in
melanoma (study C-100-21), Oncophage has been insufficiently
19
characterized and that the results obtained with an
insufficiently characterized product could not be used to
provide efficacy data in support of a biologics license
application, or BLA. The FDA deemed the Oncophage provided to
patients before December 2003 as insufficiently characterized
because it had not undergone the full battery of tests required
for drugs used in pivotal trials. Some of these tests, such as
potency assays, were not fully developed until after September
2003. The imposition of the partial clinical hold prevented us
from enrolling new patients in our Phase 3 clinical trials
between September 3, 2003 and November 21, 2003. We
believe that we addressed the comments the FDA raised in
connection with the partial clinical hold. After the clinical
hold was lifted, the FDA asked us to implement the use of the
qualified potency assays to release vaccine lots for all trials
of Oncophage, including our Phase 3 trials. After the
clinical hold was lifted, we submitted, during 2004, our
validation package to the FDA for the qualified potency assays
and in May 2005 successfully concluded discussions with the
FDA. Validation of the assays refers, in general terms, to
establishing the robustness and reproducibility of the assays on
an ongoing basis and under various different conditions to
demonstrate that the qualified potency assays, accepted by the
FDA for continuation of the clinical trial, work consistently.
We believe we have addressed all product characterization issues
raised by the FDA to date other than retrospective potency
testing of Oncophage product administered to patients before
December 2003.
The FDA has indicated that, by itself, part I of our ongoing
Phase 3 clinical trial in renal cell carcinoma is not
sufficient to support a BLA filing. We have expanded our
clinical development plan by initiating a part II to this
Phase 3 trial in a similar patient population. The FDA has
agreed with this registration plan, which comprises two
components part I and part II. The FDA has
indicated that part I alone will not be sufficient for approval,
as they consider part II of the trial as potentially
providing the definitive evidence of safety and efficacy;
however, we expect that part I will be accepted as part of the
BLA filing. While the FDA has expressly excluded the possibility
that part I of our renal cell carcinoma trial alone can support
a BLA filing, we intend to complete part I, which is a
large, controlled study, perform final analysis, and review the
data closely. Should the results from the first part of the
trial be clearly positive in terms of clinical outcomes, we plan
to submit the data to the FDA and request that the agency
reconsider its position regarding the use of the data from part
I of the trial alone to support a BLA filing, while part II
of the study is continuing. We expect to support that position
with data that may demonstrate that Oncophage used in part I of
the study should be considered sufficiently characterized. We
would expect to derive that data from additional tests we plan
to perform on frozen stored portions of product administered to
patients prior to December 2003. We have commenced these
additional tests and plan to have them completed in time for any
BLA filing. We believe that the FDA is unlikely to reverse its
position unless part I of the trial demonstrates significant
benefit to patients. We believe that demonstration of efficacy
might be persuasive because (1) part I of our Phase 3
renal cell carcinoma trial is designed to show that patients
being treated with Oncophage have a statistically significant
benefit in terms of recurrence-free survival over patients in
the observation arm, (2) Oncophage appears to have a
favorable safety profile, particularly when compared with the
toxicity associated with many cancer drugs, (3) part I of
the trial represents the largest single randomized trial to date
in this patient population and was designed to show
statistically significant results, and (4) the patients
with the stage of renal cell carcinoma addressed in this trial
have no approved post-surgical treatment options. Other
companies have submitted BLAs, and obtained approvals, based on
data from non-definitive Phase 2 and Phase 3 studies
while they complete confirmatory studies. We are not aware of a
situation in which the FDA has reconsidered its position that a
clinical trial could not be considered pivotal, and therefore
would not support licensure, because of its determination that
the product candidate was insufficiently characterized. However,
as noted previously, we plan to perform additional tests of
frozen stored Oncophage product samples produced prior to
December 2003 and attempt to demonstrate that our product
candidate should be considered sufficiently characterized. There
is no assurance that we will be successful in demonstrating that
our product candidate is sufficiently characterized or that the
FDA would accept such a strategy.
Even if we are able to demonstrate that the Oncophage used in
part I of the trial should be considered sufficiently
characterized and part I of the trial demonstrates significant
benefit to patients, the FDA may continue to adhere to its
current position that the data from this part of the trial
cannot, by itself, support a BLA filing. In addition, the
results of our two potency tests may not indicate that the
Oncophage used in part I of the trial is sufficiently
characterized. Furthermore, part I may not meet its statistical
endpoint, or the
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FDA could determine that making Oncophage available based on the
part I results is not in the best interests of patients. We
estimate that completing part II of the study will take at
least three years and cost between $20 million and
$40 million. Furthermore, we intend to continue with
part II of the renal cell carcinoma study unless and until
the FDA indicates that is not necessary.
We may not be able to secure additional financing to complete
part II of the renal cell carcinoma trial even if the
results from part I of the trial are positive. If we cannot
raise funding because we are unable to convince the FDA that the
data from part I should be deemed sufficient, by itself, to
support a BLA filing, we may become insolvent.
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Because we expect to conduct additional Phase 3
clinical trials of Oncophage in the treatment of melanoma prior
to submitting a BLA for this indication, we will not
commercialize Oncophage in this indication for several years, if
ever. |
We have concluded enrollment in our Phase 3 trial of
Oncophage in patients with metastatic melanoma (C-100-21). We
believe that, due to a relatively high failure rate in vaccine
manufacturing, this study will not, by itself, support a BLA
filing. Even if we had not experienced the high manufacturing
failure rate, the FDA has indicated that this study, like part I
of our Phase 3 renal cell carcinoma study, could not, by
itself, support a BLA filing because the FDA views the Oncophage
administered to patients in this study prior to December 2003 as
insufficiently characterized. We have not yet had any specific
discussions with the FDA regarding our clinical development plan
for melanoma. Accordingly, we do not know the types of studies
that the FDA will require to support a BLA filing. We did not
discuss our regulatory strategy for melanoma during our meeting
in July 2004 with the FDA to discuss Oncophage for renal cell
carcinoma. Even if the FDA were to indicate agreement with our
clinical development plan, that plan may fail to support a BLA
filing for many reasons, including failure of the trials to
demonstrate that Oncophage is safe and effective in this
indication, failure to conduct the studies in compliance with
the clinical trial protocols, or a change in the FDAs
views.
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Our commercial launch of Oncophage may be delayed or
prevented, which would diminish our business prospects. |
In December 2003, we announced that the Data Monitoring
Committee, or DMC, had convened as scheduled for the interim
analysis of our ongoing Phase 3 clinical trial of Oncophage
in the treatment of renal cell carcinoma, C-100-12. The DMC is a
panel of cancer specialists who review the safety and conduct of
the trial at regular intervals but are not otherwise involved in
the study. The DMC has no direct relationship with the FDA but
can make recommendations regarding the further conduct of the
trial, which recommendations are reported to the FDA. The use of
the DMC is intended to enhance patient safety and trial conduct.
The DMC recommended that the trial proceed as planned and did
not require that we change the number of patients required to
meet the trials objectives. Part I of our
Phase 3 renal cell carcinoma trial is designed with the
intent to show that patients in the Oncophage arm demonstrate a
statistically significant benefit in recurrence-free survival
over the patients in the observation arm. We interpreted the
recommendation by the DMC that we would not need to add patients
in order to potentially achieve a statistically significant
benefit as an encouraging development, indicating that the trial
could demonstrate efficacy goals without increasing the number
of patients in the trial. The DMCs recommendations do not
assure either that the trial will demonstrate statistically
significant results or that the trial will prove adequate to
support approval of Oncophage for commercialization in the
treatment of patients with renal cell carcinoma. The assessment
of the interim analysis by the DMC is preliminary. The final
data from the trial may not demonstrate efficacy and safety.
Furthermore, data from clinical trials are subject to varying
interpretations.
Inconclusive or negative final data from part I of our
Phase 3 renal cell carcinoma trial would have a significant
negative impact on our prospects. If the results in any of our
clinical trials are not positive, we may abandon development of
Oncophage for the applicable indication.
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The regulatory approval process is uncertain,
time-consuming and expensive. |
The process of obtaining and maintaining regulatory approvals
for new therapeutic products is lengthy, expensive and
uncertain. It also can vary substantially, based on the type,
complexity and novelty of the product. Our most advanced product
candidate, Oncophage, is a novel therapeutic cancer vaccine that
is
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personalized for each patient. To date, the FDA has not approved
any therapeutic cancer vaccines for commercial sale, and foreign
regulatory agencies have approved only a limited number. Both
the FDA and foreign regulatory agencies, particularly the
European Medicines Agency responsible for product approvals in
Europe, have relatively little experience in reviewing
personalized oncology therapies, and the partial clinical hold
that the FDA had placed, and subsequently lifted, on our current
Phase 3 Oncophage clinical trials primarily related to
product characterization issues partially associated with the
personalized nature of Oncophage. Oncophage may experience a
long regulatory review process and high development costs,
either of which could delay or prevent our commercialization
efforts. We also initiated communications with other health
regulatory authorities in other jurisdictions to discuss
requirements for the approval of Oncophage in renal cell
carcinoma. As of March 31, 2005, we have spent
approximately 10 years and $176 million on our
research and development program in heat shock proteins for
cancer.
To obtain regulatory approvals, we must, among other
requirements, complete carefully controlled and well-designed
clinical trials demonstrating that a particular product
candidate is safe and effective for the applicable disease.
Several biotechnology companies have failed to obtain regulatory
approvals because regulatory agencies were not satisfied with
the structure or conduct of clinical trials or the ability to
interpret the data from the trials; similar problems could delay
or prevent us from obtaining approvals. We initiated
part II of our Phase 3 trial for Oncophage in renal
cell carcinoma in early 2005. Even after reviewing our protocols
for these trials, the FDA and other regulatory agencies may not
consider the trials to be adequate for registration and may
disagree with our overall strategy to seek approval for
Oncophage in renal cell carcinoma. In this event, the potential
commercial launch of Oncophage would be at risk, which would
likely have a materially negative impact on our ability to
generate revenue and our ability to secure additional funding.
The timing and success of a clinical trial is dependent on
enrolling sufficient patients in a timely manner, avoiding
serious or significant adverse patient reactions and
demonstrating efficacy of the product candidate in order to
support a favorable risk versus benefit profile. Because we rely
on third-party clinical investigators and contract research
organizations to conduct our clinical trials, we may encounter
delays outside our control, particularly if our relationships
with any third-party clinical investigators or contract research
organizations are adversarial. The timing and success of our
Phase 3 trials, in particular, are also dependent on the
FDA and other regulatory agencies accepting each trials
protocol, statistical analysis plan, product characterization
tests, and clinical data. If we are unable to satisfy the FDA
and other regulatory agencies with such matters, including the
specific matters noted above, and/or our Phase 3 trials
yield inconclusive or negative results, we will be required to
modify or expand the scope of our Phase 3 studies or
conduct additional Phase 3 studies to support BLA filings,
including additional studies beyond the new part II
Phase 3 trial in renal cell carcinoma and additional
Phase 3 trials in melanoma. In addition, the FDA may
request additional information or data that is not readily
available. Delays in our ability to respond to such an FDA
request would delay, and failure to adequately address all FDA
concerns would prevent, our commercialization efforts.
In addition, we, or the FDA, might further delay or halt our
clinical trials for various reasons, including but not limited
to:
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we may fail to comply with extensive FDA regulations; |
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a product candidate may not appear to be more effective than
current therapies; |
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a product candidate may have unforeseen or significant adverse
side effects or other safety issues; |
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the time required to determine whether a product candidate is
effective may be longer than expected; |
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we may be unable to adequately follow or evaluate patients after
treatment with a product candidate; |
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patients may die during a clinical trial because their disease
is too advanced or because they experience medical problems that
may not be related to the product candidate; |
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sufficient numbers of patients may not enroll in our clinical
trials; or |
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we may be unable to produce sufficient quantities of a product
candidate to complete the trial. |
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Furthermore, regulatory authorities, including the FDA, may have
varying interpretations of our pre-clinical and clinical trial
data, which could delay, limit, or prevent regulatory approval
or clearance. Any delays or difficulties in obtaining regulatory
approvals or clearances for our product candidates may:
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adversely affect the marketing of any products we or our
collaborators develop; |
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impose significant additional costs on us or our collaborators; |
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diminish any competitive advantages that we or our collaborators
may attain; and |
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limit our ability to receive royalties and generate revenue and
profits. |
If we do not receive regulatory approval for our product
candidates in a timely manner, we will not be able to
commercialize them in the timeframe anticipated, and, therefore,
our business will suffer.
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We must receive separate regulatory approvals for each of
our product candidates for each type of disease indication
before we can market and sell them in the United States or
internationally. |
We and our collaborators cannot sell any drug or vaccine until
we receive regulatory approval from governmental authorities in
the United States, and from similar agencies in other
jurisdictions. Oncophage and any other drug candidate could take
a significantly longer time to gain regulatory approval than we
expect or may never gain approval or may gain approval for only
limited indications.
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Even if we do receive regulatory approval for our product
candidates, the FDA or international regulatory authorities will
impose limitations on the indicated uses for which our products
may be marketed or subsequently withdraw approval, or take other
actions against us or our products adverse to our
business. |
The FDA and international regulatory authorities generally
approve products for particular indications. If an approval is
for a limited indication, this limitation reduces the size of
the potential market for that product. Product approvals, once
granted, may be withdrawn if problems occur after initial
marketing. Failure to comply with applicable FDA and other
regulatory requirements can result in, among other things,
warning letters, fines, injunctions, civil penalties, recall or
seizure of products, total or partial suspension of production,
refusal of the government to renew marketing applications and
criminal prosecution.
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Delays enrolling patients and/or the timing of clinical
events in our studies will slow or prevent completion of
clinical trials. |
We have encountered in the past, and may encounter in the
future, delays in initiating trial sites and in enrolling
patients into our clinical trials. Future enrollment delays will
postpone the dates by which we expect to complete the impacted
trials and the potential receipt of regulatory approvals. If we
fail to enroll sufficient numbers of patients in clinical
trials, the trials may fail to demonstrate the efficacy of a
product candidate at a statistically significant level. While
such trials may help support our efforts to obtain marketing
approval, they generally would not, by themselves, be sufficient
for obtaining approval. In our cancer trials, enrollment
difficulties may arise due to many factors, including the novel
nature of Oncophage, the identification of patients
meeting the specific criteria for inclusion in our trials, the
speed by which participating clinical trial sites review our
protocol and allow enrollment and any delay in contract
negotiations between us and the participating clinical trial
sites. In addition, we may encounter problems in our clinical
trials due to the advanced disease state of the target patient
population. Even if our patient enrollment is adequate, patients
may die during a clinical trial if their disease is too advanced
or because they experience problems that may be unrelated to the
product candidate. A high dropout rate in a trial may undermine
the ability to gain statistically significant data from the
study.
Our part I and part II trials in renal cell carcinoma are
event driven trials. Therefore, final analysis of the trials
will be triggered once a specified number of events occur. An
event is defined as a recurrence of a patients renal cell
carcinoma or death of a patient. We currently anticipate that
the earliest the final event to trigger final analysis of our
C-100-12 part I renal cell carcinoma trial will occur is during
the third quarter of
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2005. We continue to adjust this estimate of the timing based on
our monitoring of the number of events. While this time estimate
is based on our current expectations, we do not control the
timing of occurrence of events in the trial and there can be no
assurance that the total number of required events will occur
when predicted.
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If new data from our research and development activities
continues to modify our strategy, then we expect to continually
adjust our projections of timelines and costs of programs; this
uncertainty may depress the market price of our stock and
increase our expenses. |
Because we are focused on novel technologies, our research and
development activities, including our clinical trials, involve
the ongoing discovery of new facts and the generation of new
data, based on which, we determine next steps for a relevant
program. These developments are sometimes a daily occurrence and
constitute the basis on which our business is conducted. We need
to make determinations on an ongoing basis as to which of these
facts or data will influence timelines and costs of programs. We
may not always be able to make such judgments accurately, which
may increase the costs we incur attempting to commercialize our
product candidates. These issues are pronounced in our efforts
to commercialize Oncophage, which represents an unprecedented
approach to the treatment of cancer.
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Failure to enter into significant collaboration agreements
may hinder our efforts to commercialize Oncophage and will
increase our need to rely on equity sales to fund our
operations. |
We are engaged in efforts to partner Oncophage, our most
advanced product candidate, with a pharmaceutical or larger
biotech company to assist us with global commercialization.
While we have been pursuing these business development efforts
for several years, we have not negotiated a definitive agreement
relating to the potential commercialization of Oncophage. Many
larger companies may be unwilling to commit to a substantial
agreement prior to receipt of additional clinical data or, in
the absence of such data, may demand economic terms that are
unfavorable to us. Even if Oncophage generates favorable
clinical data, we may not be able to negotiate a transaction
that provides us with favorable economic terms. While some other
biotechnology companies have negotiated large collaborations, we
may not be able to negotiate any agreements with terms that
replicate the terms negotiated by those other companies. We may
not, for example, obtain significant upfront payments or
substantial royalty rates. Some larger companies are skeptical
of the commercial potential and profitability of a personalized
product candidate like Oncophage. If we fail to enter into such
collaboration agreements, our efforts to commercialize Oncophage
may be undermined. In addition, if we do not raise funds through
collaboration agreements, we will need to rely on sales of
additional securities to fund our operations. Sales of
additional equity may substantially dilute the ownership of
existing stockholders.
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We may not receive significant payments from
collaborators, including due to unsuccessful results in existing
collaborations or failure to enter into future
collaborations. |
Part of our strategy is to develop and commercialize some of our
product candidates by continuing our existing arrangements with
academic and corporate collaborators and licensees and by
entering into new collaborations. Our success depends on our
ability to negotiate such agreements and on the success of the
other parties in performing research, preclinical and clinical
testing. Our collaborations involving QS-21, for example, depend
on our licensees successfully completing clinical trials and
obtaining regulatory approvals. These activities frequently fail
to produce marketable products. For example, in March 2002, Elan
Corporation and Wyeth Ayerst Laboratories announced a decision
to cease dosing patients in their Phase 2A clinical trial
of their AN-1792 Alzheimers vaccine containing our QS-21
adjuvant after several patients experienced clinical signs
consistent with inflammation in the central nervous system.
Several of our agreements also require us to transfer important
rights to our collaborators and licensees. As a result of
collaborative agreements, we will not completely control the
nature, timing or cost of bringing these product candidates to
market. These collaborators and licensees could choose not to
devote resources to these arrangements or, under certain
circumstances, may terminate these arrangements early. They may
cease pursuing the programs or elect to collaborate with
different companies. In addition, these collaborators and
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licensees, outside of their arrangements with us, may develop
technologies or products that are competitive with those that we
are developing. From time to time we may also become involved in
disputes with our collaborators. As a result of these factors,
our strategic collaborations may not yield revenues. In
addition, we may be unable to enter into new collaborations or
enter into new collaborations on favorable terms. Failure to
generate significant revenue from collaborations would increase
our need to fund our operations through sales of equity.
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If we are unable to purify heat shock proteins from some
cancer types, we may have difficulty successfully completing our
clinical trials and, even if we do successfully complete our
clinical trials, the size of our potential market would
decrease. |
Our ability to successfully develop and commercialize Oncophage
or AG-858 for a particular cancer type depends on our ability to
purify heat shock proteins from that type of cancer. If we
experience difficulties in purifying heat shock proteins for a
sufficiently large number of patients in our clinical trials,
including our Phase 3 clinical trials, it may lower the
probability of a successful analysis of the data from these
trials and ultimately the ability to obtain FDA approval. Our
overall manufacturing success rate to date for our Phase 3
trial, C-100-12, in renal cell carcinoma is 92%; for our
Phase 3 trial in metastatic melanoma, C-100-21, it is 70%.
Our inability to manufacture adequate amounts of Oncophage for
approximately 30% of the patients randomized to date in the
Oncophage treatment arm of the metastatic melanoma trial
undermines the potential for the trial, as currently designed,
to meet its pre-specified clinical endpoints. To address this
lower success rate for melanoma we instituted an inhibitor
process to avoid the breakdown of proteins. Subsequent to the
implementation of this change we successfully produced Oncophage
for 19 of 25 patients, a success rate of approximately 76%,
whereas previously we had produced Oncophage for 123 of
179 patients. The small sample size used subsequent to our
process change may make the reported improvement in our
manufacturing success unreliable as a predictor of future
success.
Based on our completed earlier clinical trials and our ongoing
clinical trials conducted in renal cell carcinoma (including our
C-100-12 trial), we have been able to manufacture Oncophage from
93% of the tumors delivered to our manufacturing facility; for
melanoma (including our C-100-21 trial), 78%; for colorectal
cancer, 98%; for gastric cancer, 81%; for lymphoma, 89%; and for
pancreatic cancer, 46%. The relatively low rate for pancreatic
cancer is due to the abundance of proteases in pancreatic
tissue. Proteases are enzymes that break down proteins. These
proteases may degrade the heat shock proteins during the
purification process. We have made process development advances
that have improved the manufacture of Oncophage from pancreatic
tissue. In an expanded Phase 1 pancreatic cancer study,
Oncophage was manufactured from five of five tumor samples
(100%), bringing the aggregate success rate for this cancer
type, which was previously 30%, to 46%. We have successfully
manufactured AG-858 from approximately 81% of the patient
samples received.
We may encounter problems with other types of cancers as we
expand our research. If we cannot overcome these problems, the
number of cancer types that our heat shock protein product
candidates could treat would be limited. In addition, if we
commercialize our heat shock protein product candidates, we may
face claims from patients for whom we are unable to produce a
vaccine.
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If we fail to sustain and further build our intellectual
property rights, competitors will be able to take advantage of
our research and development efforts to develop competing
products. |
If we are not able to protect our proprietary technology, trade
secrets, and know-how, our competitors may use our inventions to
develop competing products. We currently have exclusive rights
to at least 80 issued US patents and 112 foreign patents. We
also have rights to at least 70 pending US patent applications
and 199 pending foreign patent applications. However, our
patents may not protect us against our competitors. The
standards which the United States Patent and Trademark Office
uses to grant patents, and the standards which courts use to
interpret patents, are not always applied predictably or
uniformly and can change, particularly as new technologies
develop. Consequently, the level of protection, if any, that
will be provided by our patents if we attempt to enforce them,
and they are challenged, is uncertain. In addition, the
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type and extent of patent claims that will be issued to us in
the future is uncertain. Any patents that are issued may not
contain claims that permit us to stop competitors from using
similar technology.
In addition to our patented technology, we also rely on
unpatented technology, trade secrets and confidential
information. We may not be able to effectively protect our
rights to this technology or information. Other parties may
independently develop substantially equivalent information and
techniques or otherwise gain access to or disclose our
technology. We generally require each of our employees,
consultants, collaborators and certain contractors to execute a
confidentiality agreement at the commencement of an employment,
consulting, collaborative or contractual relationship with us.
However, these agreements may not provide effective protection
of our technology or information or, in the event of
unauthorized use or disclosure, they may not provide adequate
remedies.
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We may incur substantial costs as a result of litigation
or other proceedings relating to patent and other intellectual
property rights, and we may be unable to protect our rights to,
or use, our technology. |
If we choose to go to court to stop someone else from using the
inventions claimed in our patents, that individual or company
has the right to ask a court to rule that our patents are
invalid and should not be enforced against that third party.
These lawsuits are expensive and would consume time and other
resources even if we were successful in stopping the
infringement of our patents. In addition, there is a risk that
the court will decide that our patents are not valid and that we
do not have the right to stop the other party from using the
inventions. There is also the risk that, even if the validity of
our patents is upheld, the court will refuse to stop the other
party on the grounds that such other partys activities do
not infringe our patents.
Furthermore, a third party may claim that we are using
inventions covered by such third partys patents or other
intellectual property rights and may go to court to stop us from
engaging in our normal operations and activities. These lawsuits
are expensive and would consume time and other resources. There
is a risk that a court would decide that we are infringing the
third partys patents and would order us to stop the
activities covered by the patents. In addition, there is a risk
that a court will order us to pay the other party substantial
damages for having violated the other partys patents. The
biotechnology industry has produced a proliferation of patents,
and it is not always clear to industry participants, including
us, which patents cover various types of products. The coverage
of patents is subject to interpretation by the courts, and the
interpretation is not always uniform. We know of patents issued
to third parties relating to heat shock proteins and alleviation
of symptoms of cancer, respectively. We have reviewed these
patents, and we believe, as to each claim in those patents, that
we either do not infringe the claim of the patents or that the
claim is invalid. Moreover, patent holders sometimes send
communications to a number of companies in related fields,
suggesting possible infringement, and we, like a number of
biotechnology companies, have received this type of
communication, including with respect to the third-party patents
mentioned above, as well as a communication alleging
infringement of a patent relating to certain gel-fiberglass
structures. If we are sued for patent infringement, we would
need to demonstrate that our products either do not infringe the
patent claims of the relevant patent and/or that the patent
claims are invalid, which we may not be able to do. Proving
invalidity, in particular, is difficult since it requires a
showing of clear and convincing evidence to overcome the
presumption of validity enjoyed by issued patents. Additionally,
two of the patent applications licensed to us contain claims
that are substantially the same as claims in a third-party
patent relating to heat shock proteins. We will ask the United
States Patent and Trademark Office to declare an interference
with this third-party patent, U.S. Patent No. 6,713,608
which we believe is owned by the Science & Technology
Corporation @UNM (University of New Mexico). We believe that the
invention of U.S. Patent No. 6,713,608 is the same as that
of earlier-filed U.S. Patents No. 5,747,332, 6,066,716, and
6,433,141, which we believe are owned by the University of New
Mexico, and which were involved in a previous interference
proceeding with one of those two applications. During that
interference proceeding, we were awarded priority based upon our
earlier effective filing date. Accordingly, we believe that the
United States Patent and Trademark Office would declare an
interference between our pending patent applications and this
latest third-party patent and that the claims of U.S. Patent
No. 6,713,608 would be deemed invalid. Although we believe
that we should prevail against this third-party patent in an
interference proceeding, there is no guarantee that that will be
the outcome.
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Some of our competitors may be able to sustain the costs of
complex patent litigation more effectively than we can because
they have substantially greater resources. In addition, any
uncertainties resulting from the initiation and continuation of
any litigation could have a material adverse effect on our
ability to enter into collaborations with other entities.
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If we fail to maintain positive relationships with
particular individuals, we may be unable to successfully develop
our product candidates, conduct clinical trials and obtain
financing. |
Pramod K. Srivastava, Ph.D., a member of our board of
directors, the chairman of our scientific and medical advisory
board, and a consultant to us, and Garo H. Armen, Ph.D.,
the chairman of our board of directors and our chief executive
officer, who together founded Antigenics in 1994, have been, and
continue to be, integral to building the company and developing
our technology. If either of these individuals decreases his
contributions to the company, our business could be adversely
impacted. Dr. Srivastava is not an employee of Antigenics
and has other professional commitments. We sponsor research in
Dr. Srivastavas laboratory at the University of
Connecticut Health Center in exchange for the right to license
discoveries made in that laboratory with our funding.
Dr. Srivastava is a member of the faculty of the University
of Connecticut School of Medicine. The regulations and policies
of the University of Connecticut Health Center govern the
relationship between a faculty member and a commercial
enterprise. These regulations and policies prohibit
Dr. Srivastava from becoming our employee. Furthermore, the
University of Connecticut may modify these regulations and
policies in the future to further limit
Dr. Srivastavas relationship with us.
Dr. Srivastava has a consulting agreement with Antigenics,
which includes financial incentives for him to remain associated
with us, but these may not prove sufficient to prevent him from
severing his relationship with Antigenics, even during the time
covered by the consulting agreement. In addition, this agreement
does not restrict Dr. Srivastavas ability to compete
against us after his association with Antigenics is terminated.
This agreement was to expire in March 2005 but was extended for
an additional one-year period until March 2006. This agreement
will automatically renew for additional one-year periods unless
either party decides not to extend the agreement. If
Dr. Srivastava were to terminate his affiliation with us or
devote less effort to advancing our technologies, we may not
have access to future discoveries that could advance our
technologies.
We do not have an employment agreement with Dr. Armen. In
addition, we do not carry key employee insurance policies for
Dr. Armen or any other employee.
We also rely greatly on employing and retaining other highly
trained and experienced senior management and scientific
personnel. Since our manufacturing process is unique, our
manufacturing and quality control personnel are very important.
The competition for these and other qualified personnel in the
biotechnology field is intense. If we are not able to attract
and retain qualified scientific, technical and managerial
personnel, we probably will be unable to achieve our business
objectives.
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We face litigation that could result in substantial
damages and may divert managements time and attention from
our business. |
Antigenics, our chairman and chief executive officer, Garo H.
Armen, Ph.D., and two brokerage firms that served as
underwriters in our initial public offering have been named as
defendants in a federal civil class action lawsuit. The suit
alleges that the brokerage arms of the investment banking firms
charged secret excessive commissions to certain of their
customers in return for allocations of our stock offering. The
suit also alleges that shares of our stock were allocated to
certain of the investment banking firms customers based
upon agreements by such customers to purchase additional shares
of our stock in the secondary market. To date, the plaintiffs
have not asserted a specific amount of damages. We have
submitted settlement papers with the Federal District Court for
the Southern District of New York and in an Opinion and Order,
the court granted preliminary approval of the settlement,
conditioned upon certain modifications. There is no guarantee
that the settlement will become effective as it is subject to a
number of conditions, including Court approval; a failure to
finalize a settlement could require us to pay substantial
damages. Regardless of the outcome, participation in a lawsuit
may cause a diversion of our managements time and
attention from our business.
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In addition, we are involved in other litigation, and may become
involved in additional litigation. Any such litigation could be
expensive in terms of out-of-pocket costs and management time,
and the outcome of any such litigation will be uncertain.
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If we fail to obtain adequate levels of reimbursement for
our product candidates from third-party payers, the commercial
potential of our product candidates will be significantly
limited. |
Our profitability will depend on the extent to which government
authorities, private health insurance providers and other
organizations provide reimbursement for the cost of our product
candidates. Many patients will not be capable of paying for our
product candidates by themselves. A primary trend in the United
States health care industry is toward cost containment. Large
private payers, managed care organizations, group purchasing
organizations, and similar organizations are exerting increasing
influence on decisions regarding the use of particular
treatments. Furthermore, many third-party payers limit
reimbursement for newly approved health care products. Cost
containment measures may prevent us from becoming profitable.
It is not clear that public and private insurance programs will
determine that Oncophage or our other product candidates come
within a category of items and services covered by their
insurance plans. For example, although the federal Medicare
program covers drugs and biological products, the program takes
the position that the FDAs treatment of a product as a
drug or biologic does not require the Medicare program to treat
the product in the same manner. Accordingly, it is possible that
the Medicare program will not cover Oncophage or our other
product candidates if they are approved for commercialization.
It is also possible that there will be substantial delays in
obtaining coverage of Oncophage or our other product candidates
and that, if coverage is obtained, there may be significant
restrictions on the circumstances in which there would be
reimbursement. Where insurance coverage is available, there may
be limits on the payment amount. Congress and the Medicare
program periodically propose significant reductions in the
Medicare reimbursement amounts for drugs and biologics. Such
reductions could have a material adverse effect on sales of any
of our product candidates that receive marketing approval. In
December 2003, the President of the United States signed the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003. The future impact of this legislation on our product
candidates is uncertain. Effective January 1, 2004,
Medicare payments for many drugs administered in
physicians offices were reduced significantly. This
provision impacts many drugs used in cancer treatment by
oncologists and urologists. The payment methodology changes in
future years, and it is unclear how the payment methodology will
impact reimbursement for Oncophage, if it receives regulatory
approval, and incentives for physicians to recommend Oncophage
relative to alternative therapies.
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Product liability and other claims against us may reduce
demand for our products or result in substantial damages. |
We face an inherent risk of product liability exposure related
to testing our product candidates in human clinical trials and
will face even greater risks if we sell our product candidates
commercially. An individual may bring a product liability claim
against us if one of our product candidates causes, or merely
appears to have caused, an injury. Product liability claims may
result in:
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decreased demand for our product candidates; |
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injury to our reputation; |
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withdrawal of clinical trial volunteers; |
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costs of related litigation; and |
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substantial monetary awards to plaintiffs. |
We manufacture Oncophage and AG-858 from a patients cancer
cells, and a medical professional must inject Oncophage or
AG-858 into that same patient. A patient may sue us if we, a
hospital, or a delivery company fails to deliver the removed
cancer tissue or that patients Oncophage or AG-858. We
anticipate that the logistics of shipping will become more
complex if the number of patients we treat increases, and it is
possible that all shipments will not be made without incident.
In addition, administration of Oncophage or
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AG-858 at a hospital poses risk of delivery to the wrong
patient. Currently, we do not have insurance that covers loss of
or damage to Oncophage or AG-858, and we do not know whether
insurance will be available to us at a reasonable price or at
all. We have limited product liability coverage for clinical
research use of product candidates. Our product liability policy
provides $10 million aggregate coverage and
$10 million per occurrence. This limited insurance coverage
may be insufficient to fully cover us for future claims.
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We may incur significant costs complying with
environmental laws and regulations. |
We use hazardous, infectious, and radioactive materials in our
operations, which have the potential of being harmful to human
health and safety or the environment. We store these hazardous
(flammable, corrosive, toxic), infectious, and radioactive
materials, and various wastes resulting from their use, at our
facilities pending use and ultimate disposal. We are subject to
a variety of federal, state and local laws and regulations
governing use, generation, storage, handling, and disposal of
these materials. We may incur significant costs complying with
both current and future environmental health and safety laws and
regulations. In particular, we are subject to regulation by the
Occupational Safety and Health Administration, the Environmental
Protection Agency, the Drug Enforcement Agency, the Department
of Transportation, the Centers for Disease Control and
Prevention, the National Institutes of Health, the International
Air Transportation Association, and various state and local
agencies. At any time, one or more of the aforementioned
agencies could adopt regulations that may affect our operations.
We are also subject to regulation under the Toxic Substances
Control Act and the Resource Conservation Development programs.
Although we believe that our current procedures and programs for
handling, storage, and disposal of these materials comply with
federal, state, and local laws and regulations, we cannot
eliminate the risk of accidents involving contamination from
these materials. Although we have limited pollution liability
coverage ($2 million) and a workers compensation
liability policy, in the event of an accident or accidental
release, we could be held liable for resulting damages, which
could be substantially in excess of any available insurance
coverage and could substantially disrupt our business.
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Our competitors in the biotechnology and pharmaceutical
industries may have superior products, manufacturing capability
or marketing expertise. |
Our business may fail because we face intense competition from
major pharmaceutical companies and specialized biotechnology
companies engaged in the development of product candidates and
other therapeutic products, including heat shock proteins
directed at cancer, infectious diseases, and autoimmune
disorders. Several of these companies have products that utilize
similar technologies and/or personalized medicine techniques,
such as CancerVaxs Canvaxin, currently in a Phase 3
trial for melanoma and a Phase 2 trial in colon cancer,
Dendreons Provenge, with Fast Track designation and
currently in a Phase 3 trial for prostate cancer, and
Mylovenge in a Phase 2 trial for multiple myeloma,
Stressgens HspE7 currently in a Phase 2 trial in
HPV-internal genital warts, AVAXs M-Vax in melanoma, L-Vax
currently in Phase 2 trials for acute myelogenous leukemia
(AML) and O-Vax, currently in a Phase 2 for ovarian
cancer, Intracels OncoVax, currently approved for
administration in the Netherlands, Switzerland and Israel and in
a Phase 3 trial in the U.S. for colon cancer, and Cell
Genesys GVAX vaccines currently in trials for prostate
(Phase 3), AML (Phase 2), pancreas (Phase 2),
lung cancer (Phase 2), and myeloma (Phase 1/2).
Patents have been issued in both the U.S. and Europe related to
Stressgens heat shock protein technology. In particular,
U.S. patents 6,797,491, 6,657,055, 6,524,825, 6,495,347,
6,338,952 and 6,335,183; and European patents EP700445 and
EP1002110 are issued. Additionally, many of our competitors,
including large pharmaceutical companies, have greater financial
and human resources and more experience than we do. Our
competitors may:
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commercialize their product candidates sooner than we
commercialize our own; |
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develop safer or more effective therapeutic drugs or preventive
vaccines and other therapeutic products; |
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implement more effective approaches to sales and marketing; |
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establish superior intellectual property positions; or |
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discover technologies that may result in medical insights or
breakthroughs that render our drugs or vaccines obsolete,
possibly before they generate any revenue. |
More specifically, if we receive regulatory approvals, some of
our product candidates will compete with well-established,
FDA-approved therapies such as interleukin-2 and
interferon-alpha for renal cell carcinoma and melanoma, which
have generated substantial sales over a number of years. We
anticipate that we will face increased competition in the future
as new companies enter markets we seek to address and scientific
developments surrounding immunotherapy and other cancer
therapies continue to accelerate.
Risks Related to our Common Stock
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Our officers and directors may be able to block proposals
for a change in control. |
Antigenics Holdings L.L.C. is a holding company that owns shares
of our common stock, and, as of March 31, 2005, Antigenics
Holdings L.L.C. controlled approximately 25% of our outstanding
common stock. Due to this concentration of ownership, Antigenics
Holdings L.L.C. may be able to prevail on all matters requiring
a stockholder vote, including:
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the election of directors; |
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the amendment of our organizational documents; or |
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the approval of a merger, sale of assets, or other major
corporate transaction. |
Certain of our directors and officers, including our chief
executive officer, directly and indirectly own approximately 74%
of Antigenics Holdings L.L.C. and, if they elect to act
together, can control Antigenics Holdings L.L.C. In addition,
several of our directors and officers directly and indirectly
own approximately 4% of our outstanding common stock.
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A single, otherwise unaffiliated, stockholder holds a
substantial percentage of our outstanding capital stock. |
According to publicly filed documents, Mr. Brad M. Kelley
beneficially owns 5,546,240 shares of our outstanding
common stock and 31,620 shares of our series A
convertible preferred stock. The shares of preferred stock are
currently convertible at any time into 2,000,000 shares of
common stock at an initial conversion price of $15.81, are
non-voting, and carry a 2.5% annual dividend yield. If
Mr. Kelley had converted all of the shares of preferred
stock on March 31, 2005, he would have held approximately
16% of our outstanding common stock. We currently have a right
of first refusal agreement with Mr. Kelley that provides us
with limited rights to purchase certain of
Mr. Kelleys shares if he proposes to sell them to a
third party.
Mr. Kelleys substantial ownership position provides
him with the ability to substantially influence the outcome of
matters submitted to our stockholders for approval. Furthermore,
collectively, Mr. Kelley and Antigenics Holdings L.L.C.
control approximately 37% of our outstanding common stock,
providing substantial ability, if they vote in the same manner,
to determine the outcome of matters submitted to a stockholder
vote. If Mr. Kelley were to convert all of his preferred
stock into common stock, the combined percentage would increase
to 39%. Additional purchases of our common stock by
Mr. Kelley also would increase both his own percentage of
outstanding voting rights and the percentage combined with
Antigenics Holdings L.L.C. (Mr. Kelleys shares of
preferred stock do not carry voting rights; the common stock
issuable upon conversion, however, carries the same voting
rights as other shares of common stock.)
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Provisions in our organizational documents could prevent
or frustrate attempts by stockholders to replace our current
management. |
Our certificate of incorporation and bylaws contain provisions
that could make it more difficult for a third party to acquire
us without consent of our board of directors. Our certificate of
incorporation provides for a staggered board and removal of
directors only for cause. Accordingly, stockholders may elect
only a minority of our board at any annual meeting, which may
have the effect of delaying or preventing changes in management.
In addition, under our certificate of incorporation, our board
of directors may issue shares of
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preferred stock and determine the terms of those shares of stock
without any further action by our stockholders. Our issuance of
preferred stock could make it more difficult for a third party
to acquire a majority of our outstanding voting stock and
thereby effect a change in the composition of our board of
directors. Our certificate of incorporation also provides that
our stockholders may not take action by written consent. Our
bylaws require advance notice of stockholder proposals and
director nominations, and permit only our president or a
majority of the board of directors to call a special stockholder
meeting. These provisions may have the effect of preventing or
hindering attempts by our stockholders to replace our current
management. In addition, Delaware law prohibits a corporation
from engaging in a business combination with any holder of 15%
or more of its capital stock until the holder has held the stock
for three years unless, among other possibilities, the board of
directors approves the transaction. Our board of directors may
use this provision to prevent changes in our management. Also,
under applicable Delaware law, our board of directors may adopt
additional anti-takeover measures in the future.
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Our stock has low trading volume and its public trading
price has been volatile. |
Between our initial public offering on February 4, 2000 and
May 2, 2005, and for the twelve months ended May 2,
2005, the closing price of our common stock has fluctuated
between $4.72 and $52.63 per share, and $4.72 and
$11.04 per share, respectively, with an average daily
trading volume for the three months ended March 31, 2005 of
approximately 504,000 shares. The market has experienced
significant price and volume fluctuations that are often
unrelated to the operating performance of individual companies.
In addition to general market volatility, many factors may have
a significant adverse effect on the market price of our stock,
including:
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continuing operating losses, which we expect over the next
several years as we continue our clinical trials; |
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announcements of decisions made by public officials; |
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results of our preclinical and clinical trials; |
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announcements of technological innovations or new commercial
products by our competitors; |
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developments concerning proprietary rights, including patent and
litigation matters; |
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publicity regarding actual or potential results with respect to
products under development by us or by our competitors; |
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regulatory developments; and |
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quarterly fluctuations in our financial results. |
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The sale of a significant number of shares could cause the
market price of our stock to decline. |
The sale by us or the resale by stockholders of a significant
number of shares of our common stock could cause the market
price of our common stock to decline. As of March 31, 2005,
we had approximately 45,564,000 shares of common stock
outstanding. All of these shares are eligible for sale on the
NASDAQ National Market, although certain of the shares are
subject to sales volume and other limitations.
We have filed registration statements to permit the sale of
10,436,831 shares of common stock under our equity
incentive plan, and certain equity plans that we assumed in the
acquisitions of Aquila Biopharmaceuticals, Inc. and Aronex
Pharmaceuticals, Inc. We have also filed a registration
statement to permit the sale of 300,000 shares of common
stock under our employee stock purchase plan. We have also filed
a registration statement to permit the sale of
100,000 shares of common stock under our directors
deferred compensation plan. As of March 31, 2005, options
to purchase approximately 6,416,000 shares of our common
stock upon exercise of options with a weighted average exercise
price per share of $9.21 were outstanding. Many of these options
are subject to vesting that generally occurs over a period of up
to five years following the date of grant. As of March 31,
2005, warrants to purchase approximately 66,000 shares of
our common stock with a weighted average exercise price per
share of $51.07 were outstanding. On August 12, 2004, we
filed a
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registration statement relating to the resale of
350,000 shares of our common stock that we issued in a
private placement on July 30, 2004 in connection with our
acquisition of assets from Mojave Therapeutics, Inc. That
registration statement has become effective, and those shares
may be offered and sold from time to time by the selling
security holders listed in the related prospectus. The market
price of our common stock may decrease based on the expectation
of such sales. Similarly, on August 12, 2004, we filed a
registration statement with respect to an aggregate of
$100 million of our common stock, preferred stock, and
debt. That registration statement has become effective, and we
may offer and sell any of those securities from time to time.
The market price of our common stock may decrease based on
investor expectations that we will issue a substantial number of
shares of common stock or securities convertible into common
stock at low prices.
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Because we are a relatively small company and are cash
flow negative, we have been disproportionately negatively
impacted by the Sarbanes-Oxley Act of 2002 and related
regulations, which have increased our costs and required
additional management resources. |
The Sarbanes-Oxley Act of 2002, which became law in July 2002,
has required changes in some of our corporate governance,
securities disclosure and compliance practices. In response to
the requirements of that Act, the SEC and the NASDAQ have
promulgated new rules and listing standards covering a variety
of subjects. Compliance with these new rules and listing
standards has significantly increased our legal and financial
and accounting costs, which we expect to continue to increase as
we continue to develop our product candidates and seek to
commercialize these product candidates. In addition, the
requirements have taxed a significant amount of
managements and the board of directors time and
resources. Likewise, these developments have made it more
difficult for us to attract and retain qualified members of our
board of directors, particularly independent directors, or
qualified executive officers. Because we are a relatively small
company and are cash flow negative, we expect to be
disproportionately negatively impacted by these changes in
securities laws and regulations, which have increased our costs
and required additional management resources.
Our internal control over financial reporting (as defined in
Rules 13a-15 of the Exchange Act of 1934, as amended) is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of our
financial statements for external purposes in accordance with
U.S. generally accepted accounting principles. Because of
its inherent limitations, internal control over financial
reporting may not prevent or detect all deficiencies or
weaknesses in our financial reporting. While our management has
concluded in its report included in our annual report on
Form 10-K for the year ended December 31, 2004 that
there were no material weaknesses in our internal control over
financial reporting as of December 31, 2004, our procedures
are subject to the risk that our controls may become inadequate
because of changes in conditions or as a result of a
deterioration in compliance with such procedures. No assurance
is given that our procedures and processes for detecting
weaknesses in our internal control over financial reporting will
be effective.
Critical Accounting Policies and Estimates
The SEC defines critical accounting policies as
those that require application of managements most
difficult, subjective, or complex judgments, often as a result
of the need to make estimates about the effect of matters that
are inherently uncertain and may change in subsequent periods.
The preparation of consolidated financial statements in
conformity with U.S. generally accepted accounting
principles requires us to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosures of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues
and expenses during the reporting period. We base those
estimates on historical experience and on various assumptions
that are believed to be reasonable under the circumstances.
Actual results could differ from those estimates.
The following listing is not intended to be a comprehensive list
of all of our accounting policies. Our significant accounting
policies are described in Note 2 to our consolidated
financial statements included in our Form 10-K for the year
ended March 31, 2005 filed with the SEC. In many cases, the
accounting treatment
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of a particular transaction is dictated by U.S. generally
accepted accounting principles, with no need for our judgment in
their application. There are also areas in which our judgment in
selecting an available alternative would not produce a
materially different result. We have identified the following as
our critical accounting policies:
Research and development expenses include the costs associated
with our internal research and development activities, including
salaries and benefits, occupancy costs, clinical manufacturing
costs, related administrative costs, and research and
development conducted for us by outside advisors, such as
sponsored university-based research partners, and clinical study
partners. We account for our clinical study costs by estimating
the total cost to treat a patient in each clinical trial and
recognizing this cost as we estimate when the patient receives
treatment, beginning when the patient enrolls in the trial. This
estimated cost includes payments to the trial site and
patient-related costs, including laboratory costs, related to
the conduct of the trial. Cost per patient varies based on the
type of clinical trial, the site of the clinical trial and the
length of the treatment period for each patient. As we become
aware of the actual costs, we adjust our accrual; such changes
in estimate may be a material change in our clinical study
accrual, which could also materially affect our results of
operations. Research and development costs are expensed as
incurred and were $11,304,000, $41,718,000, $46,264,000, and
$37,478,000 for the three months ended March 31, 2005, and
the years ended December 31, 2004, 2003, and 2002,
respectively.
We classify investments in marketable securities at the time of
purchase. At March 31, 2005, all marketable securities were
classified as available-for-sale and as such, changes in the
fair value of the available-for-sale securities are reported as
a separate component of accumulated other comprehensive income
(loss) until realized. If we were to classify future investments
as trading securities rather than available-for-sale, our
financial results would be subject to greater volatility. If
declines in the fair value of available-for-sale securities are
determined to be other than temporary, accumulated other
comprehensive income is reduced and the impairment is charged to
operations.
Investments of less than 20% of the voting control of companies
or other entities over whose operating and financial policies we
do not have the power to exercise significant influence, are
accounted for by the cost method. Pursuant to this method, we
currently account for our investment in AGTC under the cost
method and, as of March 31, 2005, we have included it in
other long-term assets on the consolidated balance sheet, as
more fully disclosed in Note F to our consolidated
financial statements included in this report. The general
partner of AGTC determines the timing of our additional
contributions. Our investment represents an approximate
ownership of 2%. We continue to assess the realizability of this
investment. In order to assess whether or not there has been an
other than temporary decline in the value of this investment, we
analyze several factors including: (1) the carrying value
of the limited partnerships investments in its portfolio
companies, (2) how recently the investments in the
portfolio companies had been made, (3) the post-financing
valuations of those investments, (4) the level of
un-invested capital held by the limited partnership, and
(5) the overall trend in venture capital valuations. Based
on this analysis, during the three months ended March 31,
2005, we concluded that an other than temporary decline had not
occurred and therefore no adjustment to the investment balance
was made. Our investment balance aggregated $1,844,000 at
March 31, 2005.
Revenue from product sales is recognized at the time of product
shipment. Revenue for services under research and development
grants and contracts are recognized as the services are
performed, milestones are achieved, or clinical trial materials
are provided.
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We account for options granted to employees and directors in
accordance with Accounting Principles Board (APB)
Opinion No. 25, Accounting for Stock Issued to
Employees, and related interpretations. As such,
compensation expense is recorded on fixed stock option grants
only if the current fair value of the underlying stock exceeds
the exercise price of the option at the date of grant and it is
recognized on a straight-line basis over the vesting period. We
account for stock options granted to non-employees on a
fair-value basis in accordance with Statement of Financial
Accounting Standards (SFAS) No. 123,
Accounting for Stock-Based Compensation and Emerging
Issues Task Force Issue (EITF) No. 96-18,
Accounting for Equity Instruments That Are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. As a result, the non-cash charge to
operations for non-employee options with vesting or other
performance criteria is affected each reporting period by
changes in the fair value of our common stock. As required, we
also provide pro forma net loss attributable to common
stockholders and pro forma net loss attributable to common
stockholders per common share disclosures for employee and
director stock option grants as if the fair-value-based method
defined in SFAS No. 123 had been applied (see
Note D to our unaudited consolidated financial statements).
Recently Issued Accounting Standards
In December 2004, the Financial Accounting Standards Board
issued Standards SFAS No. 123R, Share-Based Payment
(SFAS No. 123R) which replaces
SFAS No. 123, Accounting for Stock-Based
Compensation and supersedes APB Opinion No. 25,
Accounting for Stock Issued to Employees.
SFAS No. 123R is focused primarily on the
accounting for transactions in which a company obtains employee
services in exchange for stock options or share-based payments.
Currently, we account for stock options grants to our employees
in accordance with APB Opinion No. 25 and disclose the pro
forma effect of compensation expense for these stock options as
if the fair value method under SFAS No. 123 had been used.
SFAS No. 123R requires that companies recognize
compensation expense associated with these grants of stock
options in their results of operations. We are required to adopt
SFAS No. 123R in the first quarter of fiscal 2006,
beginning January 1, 2006. The pro forma disclosures
previously permitted under SFAS No. 123 will no longer
be an alternative to financial statement recognition.
SFAS No. 123R requires that compensation expense be
recorded for all unvested stock options and restricted stock at
the beginning of the first quarter of adoption of
SFAS No. 123R and for all stock options granted
thereafter. Compensation expense will be measured based on the
fair value of the instrument on the grant date and will be
recognized over the vesting period. SFAS No. 123R also
requires that companies recognize compensation expense
associated with purchases of shares of common stock by employees
at a discount to market value under employee stock purchase
plans that meet certain criteria. We are currently evaluating
the full impact of adoption of this statement. We anticipate
that implementation of SFAS No. 123R will result in
material non-cash charges to our consolidated results of
operations.
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Item 3 |
Quantitative and Qualitative Disclosures About Market
Risk |
In the normal course of business, we are exposed to fluctuations
in interest rates as we seek debt financing to make capital
expenditures and invest excess cash and also foreign currency
exchange rate fluctuation risk related to our transactions
denominated in foreign currencies. We do not employ specific
strategies, such as the use of derivative instruments or
hedging, to manage these exposures. Our currency exposures vary,
but are primarily concentrated in the Euro. Since the fiscal
year ended December 31, 2004, there has been no material
change with respect to our interest rate and foreign currency
exposures or our approach toward those exposures. Further, we do
not expect our market risk exposures to change in the near term.
We had cash equivalents and short-term investments at
March 31, 2005 of approximately $114.1 million, which
are exposed to the impact of interest rate changes and our
interest income fluctuates as interest rates change. Due to the
short-term nature of our investments in money market funds,
corporate debt securities, taxable auction preferreds, and
government-backed securities, our carrying value approximates
the fair value of these investments at March 31, 2005,
however, we are subject to investment risk.
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We invest our cash, cash equivalents and short-term investments
in accordance with our Investment Policy. The primary objectives
of our Investment Policy are to preserve principal, maintain
proper liquidity to meet operating needs and maximize yields.
Although our investments are subject to credit risk, our
Investment Policy specifies credit quality standards for our
investments and limits the amount of credit exposure from any
single issue, issuer or type of investment. Our investments are
also subject to interest rate risk and will decrease in value if
market interest rates increase. However, due to the conservative
nature of our investments and relatively short duration,
interest rate risk is mitigated. We do not own derivative
financial instruments in our investment portfolio. Accordingly,
we do not believe that there is any material market risk
exposure with respect to derivative or other financial
instruments that would require disclosure under this item.
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Item 4 |
Controls and Procedures |
Under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief
Financial Officer, we conducted an evaluation of the
effectiveness of our disclosure controls and procedures as such
term is defined in Rules 13a-15(e) promulgated under the
Securities Exchange Act of 1934, as amended (the Exchange Act).
Based on this evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that our disclosure controls and
procedures were functioning effectively as of March 31,
2005 to provide reasonable assurance that the Company can meet
its disclosure obligations.
During the first quarter of 2005, there was no change in our
internal control over financial reporting (as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that
has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
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PART II OTHER INFORMATION
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Item 1 |
Legal Proceedings |
Antigenics, our Chairman and Chief Executive Officer Garo Armen,
and two investment banking firms that served as underwriters in
our initial public offering have been named as defendants in a
civil class action lawsuit filed on November 5, 2001 in the
Federal District Court for the Southern District of New York on
behalf of a class of purchasers of our stock between
February 3, 2000 and December 6, 2000. Similar
complaints were filed against about 300 other issuers, their
underwriters, and in many instances directors and officers.
These cases have been coordinated under the caption In re
Initial Public Offering Securities Litigation, Civ.
No. 21 MC 92 (SAS), by order dated August 9, 2001. The
suit against Antigenics and Dr. Armen alleges that the
brokerage arms of the investment banking firms charged secret
excessive commissions to certain of their customers in return
for allocations of our stock in the offering. The suit also
alleges that shares of our stock were allocated to certain of
the investment banking firms customers based upon
agreements by such customers to purchase additional shares of
our stock in the secondary market. The complaint alleges that
Antigenics is liable under Section 11 of the Securities Act
of 1933, as amended, and Dr. Armen is liable under
Sections 11 and 15 of the Securities Act because our
registration statement did not disclose these alleged practices.
On April 19, 2002, the plaintiffs in this action filed an
amended class action complaint, which contains new allegations.
Similar amended complaints were filed with respect to about
300 companies. In addition to the claims in the earlier
complaint, the amended complaint alleged that Antigenics and
Dr. Armen violated Sections 10(b) and 20 of the
Securities Exchange Act and SEC Rule 10b-5 by making false
and misleading statements and/or omissions in order to inflate
our stock price and conceal the investment banking firms
alleged secret arrangements. The claims against Dr. Armen,
in his individual capacity, have been dismissed without
prejudice. On July 15, 2002, Antigenics and Dr. Armen
joined the Issuer Defendants Motion to Dismiss the
Consolidated Amended Complaints. By order of the Court, this
motion set forth all common issues, i.e., all
grounds for dismissal common to all or a significant number of
Issuer Defendants. The hearing on the Issuer Defendants
Motion to Dismiss and the other Defendants motions to
Dismiss was held on November 1, 2002. On February 19,
2003, the Court issued its opinion and order on the Issuer
Defendants Motion to Dismiss. The Court granted
Antigenics motion to dismiss the Rule 10b-5 and
Section 20 claims with leave to amend and denied our motion
to dismiss the Section 11 and Section 15 claims. On
June 14, 2004, papers formalizing a proposed settlement
among the plaintiffs, Issuer Defendants, and issuers were
presented to the Federal District Court for the Southern
District of New York. In an Opinion and Order dated
February 15, 2005, the Court granted preliminary approval
of the settlement, conditioned upon certain modifications. There
is no guarantee that the settlement will become effective as it
is subject to a number of conditions, including Court approval.
If the settlement becomes effective, Antigenics anticipates that
it will not incur significant out-of-pocket costs, after
considering insurance coverage. Accordingly, an accrual has not
been recorded at March 31, 2005.
We currently are a party to other legal proceedings as well.
While our management currently believes that the ultimate
outcome of any of these proceedings will not have a material
adverse effect on our consolidated financial position, results
of operations, or liquidity, litigation is subject to inherent
uncertainty. Litigation also consumes both cash and management
attention.
(a) Exhibits
|
|
|
*Exhibit 3.1
|
|
Amended and Restated Certificate of Incorporation of Antigenics
Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K
dated June 10, 2002 (File No. 000-29089). |
|
*Exhibit 3.2
|
|
Amended and Restated By-Laws of Antigenics Inc. Filed as
Exhibit 3.2 to our Current Report on Form 8-K dated
June 10, 2002. (File No. 000-29089). |
|
Exhibit 10.1
|
|
Employment Agreement dated July 26, 2004 between Antigenics
Inc. and Roman Chicz |
36
|
|
|
|
Exhibit 31.1
|
|
Certification Pursuant to Rules 13a-14(a) and 15d-14(a)
under the Securities Exchange Act of 1394, as amended |
|
Exhibit 31.2
|
|
Certification Pursuant to Rules 13a-14(a) and 15d-14(a)
under the Securities Exchange Act of 1394, as amended |
|
Exhibit 32.1(1)
|
|
Certification pursuant to 18 U.S.C. Section 1350 as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
* |
Indicates exhibit previously filed with the Securities and
Exchange Commission and incorporated herein by reference. |
|
|
(1) |
This certification accompanies the Quarterly Report on
Form 10-Q and is not filed as part of it. |
37
ANTIGENICS INC.
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.
|
|
|
Antigenics Inc.
|
|
|
/s/ Garo H. Armen
|
|
|
|
Garo H. Armen Ph.D. |
|
Chairman and Chief Executive Officer |
|
|
|
/s/ Peter Thornton
|
|
|
|
Peter Thornton |
|
Chief Financial Officer |
Date: May 10, 2005
38
EXHIBIT INDEX
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
*Exhibit 3.1 |
|
|
Amended and Restated Certificate of Incorporation of Antigenics
Inc. Filed as Exhibit 3.1 to our Current Report on Form 8-K
dated June 10, 2002 (File No. 000-29089). |
|
|
*Exhibit 3.2 |
|
|
Amended and Restated By-Laws of Antigenics Inc. Filed as
Exhibit 3.2 to our Current Report on Form 8-K dated
June 10, 2002. (File No. 000-29089). |
|
|
Exhibit 10.1 |
|
|
Employment Agreement dated July 26, 2004 between Antigenics
Inc. and Roman Chicz |
|
|
Exhibit 31.1 |
|
|
Certification Pursuant to Rules 13a-14(a) and 15d-14(a)
under the Securities Exchange Act of 1394, as amended |
|
|
Exhibit 31.2 |
|
|
Certification Pursuant to Rules 13a-14(a) and 15d-14(a)
under the Securities Exchange Act of 1394, as amended |
|
|
Exhibit 32.1(1) |
|
|
Certification pursuant to 18 U.S.C. Section 1350 as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002 |
|
|
|
|
* |
Indicates exhibit previously filed with the Securities and
Exchange Commission and incorporated herein by reference. |
|
|
(1) |
This certification accompanies the Quarterly Report on
Form 10-Q and is not filed as part of it. |