Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2009
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 001-32157
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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84-1318182 |
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.) |
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6725 Mesa Ridge Road, Suite 100, San Diego, CA
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92121 |
(Address of principal executive offices)
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(Zip Code) |
(858) 552-0866
(Registrants telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or shorter period that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
The number of shares outstanding of the registrants common stock, $0.001 par value, as of April
21, 2009 was 90,252,572.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
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March 31, |
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December 31, |
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2009 |
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2008 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,306,646 |
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$ |
9,849,904 |
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Interest and other receivables |
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304,594 |
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121,736 |
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Prepaid expenses |
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353,340 |
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477,902 |
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Total current assets |
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5,964,580 |
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10,449,542 |
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Property and equipment, net |
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166,527 |
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199,052 |
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Other assets |
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60,247 |
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60,664 |
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Total assets |
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$ |
6,191,354 |
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$ |
10,709,258 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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1,054,680 |
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1,721,376 |
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Accrued liabilities |
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1,342,945 |
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2,077,188 |
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Accrued compensation and payroll taxes |
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781,546 |
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915,459 |
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Total current liabilities |
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3,179,171 |
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4,714,023 |
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Stockholders equity: |
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Common stock, $0.001 par value; 200,000,000 shares
authorized; 90,252,572 shares issued and outstanding at
March 31, 2009 and December 31, 2008 |
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90,254 |
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90,254 |
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Additional paid-in capital |
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131,925,397 |
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131,751,439 |
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Deficit accumulated during the development stage |
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( 129,003,468 |
) |
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(125,846,458 |
) |
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Total stockholders equity |
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3,012,183 |
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5,995,235 |
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Total liabilities and stockholders equity |
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$ |
6,191,354 |
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$ |
10,709,258 |
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Note: |
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The balance sheet at December 31, 2008 has been derived from audited financial statements at
that date. It does not include, however, all of the information and notes required by accounting
principles generally accepted in the United States of America for complete financial statements. |
See accompanying notes to unaudited condensed consolidated financial statements.
3
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(Unaudited)
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Inception |
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(June 12, 1996) |
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through |
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Three months ended March 31, |
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March 31, |
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2009 |
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2008 |
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2009 |
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Revenues: |
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Net sales |
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$ |
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$ |
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$ |
174,830 |
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Grant revenue |
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129,733 |
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Licensing revenue |
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300,000 |
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1,300,000 |
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Total net revenues |
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300,000 |
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1,604,563 |
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Cost of goods sold |
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51,094 |
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Gross margin |
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300,000 |
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1,553,469 |
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Operating expenses: |
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Research and development |
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1,647,300 |
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3,820,307 |
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63,661,856 |
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Selling, general and administrative |
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1,779,240 |
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2,365,194 |
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44,748,442 |
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Depreciation and amortization |
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32,246 |
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46,779 |
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10,830,317 |
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In-process research and development |
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10,422,130 |
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Impairment loss write off of goodwill |
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5,702,130 |
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Equity in loss of investee |
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178,936 |
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Total operating expenses |
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3,458,786 |
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6,232,280 |
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135,543,811 |
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Loss from operations |
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(3,158,786 |
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(6,232,280 |
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(133,990,342 |
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Loss on fair value of warrants |
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(12,239,688 |
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Interest income |
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4,582,028 |
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Other income |
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1,776 |
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299,208 |
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114,154 |
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Interest expense |
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(179,090 |
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Loss before cumulative effect of change in accounting principle |
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(3,157,010 |
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(5,933,072 |
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(141,712,938 |
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Cumulative effect of change in accounting principle |
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(25,821 |
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Net loss |
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(3,157,010 |
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(5,933,072 |
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(141,738,759 |
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Preferred stock dividends |
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(621,240 |
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Net loss applicable to common stock |
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$ |
(3,157,010 |
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$ |
(5,933,072 |
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$ |
(142,359,999 |
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Net loss per common share basic and diluted |
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$ |
(0.03 |
) |
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$ |
(0.07 |
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Weighted average shares basic and diluted |
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90,252,572 |
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90,252,572 |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Inception |
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(June 12, 1996) |
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through |
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Three months ended March 31, |
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March 31, |
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2009 |
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2008 |
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2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(3,157,010 |
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$ |
(5,933,072 |
) |
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$ |
(141,738,759 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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32,246 |
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46,779 |
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10,380,317 |
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Loss (gain) on disposal of fixed assets |
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279 |
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188 |
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(3,319 |
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Fair value of warrant liability |
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12,239,688 |
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Expenses related to employee stock options |
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173,958 |
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638,416 |
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8,026,520 |
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Expense related to stock options issued to non-employees |
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5,680 |
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204,664 |
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Expenses paid by issuance of common stock |
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1,341,372 |
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Expenses paid by warrants |
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573,357 |
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Expenses paid by preferred stock |
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142,501 |
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Expenses related to stock warrants issued |
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612,000 |
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Accretion of discount |
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(131,929 |
) |
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(1,249,853 |
) |
Amortization of debt discount |
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450,000 |
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Gain /loss on disposals of property and equipment |
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Accretion of discount on investments in securities |
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(354,640 |
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Forgiveness of employee receivable |
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30,036 |
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Impairment loss write-off of goodwill |
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5,702,130 |
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Equity in loss of investee |
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178,936 |
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In-process research and development |
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10,422,130 |
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Write-off of license agreement |
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152,866 |
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Write-off of assets available-for-sale |
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108,000 |
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Cumulative effect of change in accounting principle |
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25,821 |
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Changes in assets and liabilities, net of effect of acquisitions: |
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Increase (decrease) in prepaid expenses and other assets |
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(57,879 |
) |
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17,648 |
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(965,550 |
) |
Increase (decrease) in accounts payable and accrued liabilities |
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(1,534,852 |
) |
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588,129 |
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3,355,878 |
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Decrease in other long-term liabilities |
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(5,352 |
) |
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Net cash used in operating activities |
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(4,543,258 |
) |
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(4,773,513 |
) |
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(90,365,905 |
) |
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Cash flows from investing activities: |
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Purchases of short-term investments |
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(6,437,340 |
) |
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(111,183,884 |
) |
Proceeds from sales and maturities of short-term investments |
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16,750,000 |
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112,788,378 |
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Purchases of property and equipment |
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(20,522 |
) |
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(1,030,354 |
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Proceeds from sale of property and equipment |
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33,906 |
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Purchase of certificate of deposit |
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(1,016,330 |
) |
Maturity of certificate of deposit |
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1,016,330 |
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Payment on obligation under license agreement |
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(106,250 |
) |
Cash acquired from acquisitions, net of cash paid |
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32,395 |
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Issuance of note receivable related party |
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(35,000 |
) |
Payments on note receivable |
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405,993 |
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Advance to investee |
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(90,475 |
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Cash transferred in rescission of acquisition |
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(19,475 |
) |
Cash received in rescission of acquisition |
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230,000 |
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Net cash provided by (used in) investing activities |
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10,292,138 |
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1,025,234 |
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Cash flows from financing activities: |
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Proceeds from sale of preferred stock |
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4,200,993 |
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Proceeds from sale of common stock |
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84,151,342 |
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Proceeds from exercise of stock options |
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712,367 |
|
Proceeds from sale or exercise of warrants |
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11,382,894 |
|
Repurchase of warrants |
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(55,279 |
) |
Payment of financing and offering costs |
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(6,483,809 |
) |
Payments of notes payable and long-term debt |
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|
|
|
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|
(605,909 |
) |
Proceeds from issuance of notes payable and detachable warrants |
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|
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|
1,344,718 |
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Net cash provided by financing activities |
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94,647,317 |
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Net increase (decrease) in cash and cash equivalents |
|
|
(4,543,258 |
) |
|
|
5,518,625 |
|
|
|
5,306,646 |
|
Cash and cash equivalents at beginning of period |
|
|
9,849,904 |
|
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|
14,780,739 |
|
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Cash and cash equivalents at end of period |
|
$ |
5,306,646 |
|
|
$ |
20,299,364 |
|
|
$ |
5,306,646 |
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|
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|
See accompanying notes to unaudited condensed consolidated financial statements.
5
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. |
|
Basis of Presentation |
|
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|
ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (ADVENTRX, we or the Company),
prepared the unaudited interim condensed consolidated financial statements in accordance with
accounting principles generally accepted in the United States of America (U.S. GAAP) for
interim financial information and with the instructions of the Securities and Exchange Commission
(SEC). Accordingly, they do not include all of the information and disclosures required by U.S.
GAAP for annual audited financial statements and should be read in conjunction with our audited
consolidated financial statements and related notes for the year ended December 31, 2008 included
in our Annual Report on Form 10-K filed with the SEC on March 27, 2009 (2008 Annual Report).
The condensed consolidated balance sheet as of December 31, 2008 has been derived from the
audited consolidated financial statements included in the 2008 Annual Report. In the opinion of
management, these interim condensed consolidated financial statements include all adjustments
(consisting of normal recurring adjustments) necessary for a fair presentation of the financial
position, results of operations, and cash flows for the periods presented. The results of
operations for the interim periods shown in this report are not necessarily indicative of results
expected for the full year. |
|
|
|
Since our inception, we have an accumulated net loss of approximately $141.7 million and
recurring negative cash flows from operations. Currently, we are focused primarily on evaluating
strategic options, including the sale or exclusive license of one or more of our product
candidate programs, a strategic business merger and other similar transactions. We implemented
restructuring and cost-cutting measures in October 2008, January 2009 and March 2009 and
eliminated all but a select, small number of full-time employees and discontinued substantially
all of our development activities and fundamental business operations to provide additional time
to consummate a strategic transaction or otherwise obtain financing. |
|
|
|
The condensed consolidated financial statements include the accounts of the Company and its
wholly-owned subsidiaries, SD Pharmaceuticals, Inc. and ADVENTRX (Europe) Ltd. All intercompany
accounts and transactions have been eliminated in consolidation. |
|
2. |
|
Going Concern |
|
|
|
The accompanying unaudited interim condensed consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. Going concern contemplates the
realization of assets and the satisfaction of liabilities in the normal course of business over a
reasonable length of time. However, as a result of the Companys continued losses and current
cash and financing position, such realization of assets or satisfaction of liabilities, without
substantial adjustments, is uncertain. The future of the Company is dependent upon its ability to
obtain additional funding. |
|
|
|
In December 2008, the Company announced that it was evaluating various strategic options, including
the sale or exclusive license of one or more of the Companys product candidate programs, a
strategic business merger and other similar transactions, certain of which would result in a change
of control of the Company. However, progress with potential strategic transaction partners has not
been as rapid or on terms as attractive as the Company would have desired. The Company previously
has taken steps designed to provide additional time to consummate a strategic transaction or
otherwise obtain financing, including eliminating all but a select, small number of full-time
employees and discontinuing substantially all of its development activities and fundamental
business operations. As a result, its ability to further curtail expenses to provide further time
is limited, and the restructuring and cost-cutting measures it has taken may not provide it with
sufficient additional time to consummate a strategic transaction or otherwise obtain financing.
Further, in May 2009, the Company announced that the primary endpoint in its bioequivalence study
of ANX-514 was not met, that the resulting uncertainty around the cost and timeline to approval by
the U.S. Food and Drug Administration, or FDA, of ANX-514 may adversely impact the Companys
on-going strategic transaction discussions, and that, in light of its working capital, the Company
is evaluating both its strategic and non-strategic options. Accordingly, in May 2009, the Company
began to evaluate the process of winding-down its operations, including engaging a third-party firm
to assist it with its evaluation. There can be no assurances that we will continue to pursue our
strategic transaction alternatives or, if we do, that we will be able to consummate a strategic
transaction on a timely basis, or at all. The Company likely will not be
able to continue as a going concern, unless, as part of a strategic transaction or otherwise, it
raises adequate capital. Given this uncertainty, there is significant doubt as to the Companys
ability to continue as a going concern. |
|
|
|
The accompanying financial statements for the quarter ended March 31, 2009 do not include any
adjustments related to the recovery and classification of recorded assets, or the amounts and
classification of liabilities, that might be necessary in the event the Company cannot continue
as a going concern. |
6
3. |
|
Use of Estimates |
|
|
|
The preparation of financial statements in conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the amounts reported in the consolidated financial
statements and accompanying notes. Actual results could differ from those estimates. |
|
4. |
|
Fair Value Measurements |
|
|
|
Effective January 1, 2008, we adopted Statement of Financial Accounting Standards (FAS) No.
157, Fair Value Measurements (FAS 157). In February 2008, the Financial Accounting Standards
Board (FASB) issued FASB Staff Position (FSP) No. FAS 157-2, Effective Date of FASB
Statement No. 157, which provides a one year deferral of the effective date of FAS 157 for
non-financial assets and non-financial liabilities, except those that are recognized or disclosed
in the financial statements at fair value at least annually. As a result, we only partially
adopted FAS 157 as it relates to our financial assets and liabilities until we are required to
apply this pronouncement to our non-financial assets and liabilities beginning with fiscal year
2009. The adoption of FAS 157 did not have a material impact on our consolidated results of
operations or financial condition. |
|
|
|
In October 2008, the FASB issued FSP No. FAS 157-3 Determining the Fair Value of a Financial
Asset When the Market for That Asset Is Not Active (FSP FAS 157-3). FSP FAS 157-3 clarifies
the application of FAS No. 157, in a market that is not active and provides an example to
illustrate key considerations in determining the fair value of a financial asset when the market
for that financial asset is not active. FSP FAS 157-3 is effective upon issuance, including prior
periods for which financial statements have not been issued. The adoption of FSP FAS 157-3 had
no impact on our consolidated results of operations, financial position or cash flows. |
|
|
|
FAS 157 defines fair value, establishes a framework for measuring fair value under U.S. GAAP and
enhances disclosures about fair value measurements. Fair value is defined under FAS 157 as the
exchange price that would be received for an asset or paid to transfer a liability (an exit
price) in the principal or most advantageous market for the asset or liability in an orderly
transaction between market participants on the measurement date. Valuation techniques used to
measure fair value under FAS 157 must maximize the use of observable inputs and minimize the use
of unobservable inputs. FAS 157 describes a fair value hierarchy based on three levels of inputs,
of which the first two are considered observable and the last unobservable, that may be used to
measure fair value which are the following: |
|
|
|
|
|
|
|
|
|
|
|
Level 1
|
|
Quoted prices
in active markets for identical assets or liabilities. |
|
|
|
|
|
|
|
|
|
|
|
Level 2
|
|
Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or
liabilities; quoted prices in markets that are not active; or other
inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or
liabilities. |
|
|
|
|
|
|
|
|
|
|
|
Level 3
|
|
Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the assets
or liabilities. |
The following table represents our fair value hierarchy for our financial assets (which consisted
solely of cash equivalents) measured at fair value on a recurring basis as of March 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
Money Market funds |
|
$ |
5,306,646 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,306,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,306,646 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,306,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective January 1, 2008, we adopted FAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities (FAS 159). FAS 159 allows an entity the irrevocable option to elect
to measure specified financial assets and liabilities in their entirety at fair value on a
contract-by-contract basis. If an entity elects the fair value option for an eligible item,
changes in the items fair value must be reported as unrealized gains and losses in earnings at
each subsequent reporting date. In adopting FAS 159, we did not elect the fair value option for
any of our financial assets or financial liabilities.
7
5. |
|
Share-Based Payments |
|
|
|
Estimated share-based compensation expense related to equity awards granted to employees for the
three months ended March 31, 2009 and 2008 was as follows: |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2009 |
|
|
2008 |
|
Selling, general and administrative expense |
|
$ |
199,334 |
|
|
$ |
332,720 |
|
Research and development expense |
|
|
(25,376 |
) |
|
|
305,696 |
|
|
|
|
|
|
|
|
Share-based compensation expense before taxes |
|
|
173,958 |
|
|
|
638,416 |
|
Related income tax benefits |
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
$ |
173,958 |
|
|
$ |
638,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net share-based compensation expense per common share basic and diluted |
|
$ |
0.002 |
|
|
$ |
0.001 |
|
|
|
|
|
|
|
|
|
|
In January 2009, we granted under our 2008 Omnibus Incentive Plan restricted stock units to seven
employees that represented the right to receive in the aggregate 3,700,000 shares of our common
stock. These units will vest immediately prior to a strategic transaction (as defined in the
documentation evidencing the grant of the units). We will record share-based compensation
expense in connection with these restricted stock units, if at all, only if a strategic
transaction is consummated. |
|
|
|
Since we have a net operating loss carryforward as of March 31, 2009, no excess tax benefits for
the tax deductions related to share-based awards were recognized in the condensed consolidated
statement of operations. There were no employee stock options exercised in the three months ended
March 31, 2009 and 2008. |
|
|
|
At March 31, 2009, total employee stock compensation expense
included forfeitures for terminated employees resulting in a credit to research and development stock
compensation expense for the three month period ended March 31, 2009. |
|
|
|
At March 31, 2009, total unrecognized estimated compensation cost related to non-vested employee
and non-employee director share-based awards granted prior to that date was $1.7 million, which
is expected to be recognized over a weighted-average period of 3.0 years. During the three months
ended March 31, 2009 and 2008, we granted 0 and 1,802,500 stock options, respectively, to our
employees and non-employee directors with an estimated weighted-average grant-date fair value of
$0 and $0.51. |
|
|
|
Estimated share-based compensation expense related to equity awards granted to non-employee
consultants was $0 and $6,000 for the three months ended March 31, 2009 and 2008, respectively. |
|
6. |
|
Net Loss Per Common Share |
|
|
|
We calculate basic and diluted net loss per common share in accordance with the FAS No. 128,
Earnings Per Share. Basic net loss per common share was calculated by dividing the net loss for
the period by the weighted-average number of common shares outstanding during the period, without
consideration for common stock equivalents. Options, warrants and restricted stock units are
considered to be common stock equivalents and are only included in the calculation of diluted
earnings per common share when their effect is dilutive. Because of the net loss, all of the
options, warrants and restricted stock units were excluded from the calculation. |
|
|
|
We have excluded the following options, warrants and restricted stock units from the calculation
of diluted net loss per common share for the three months ended March 31, 2009 and 2008 because
they are anti-dilutive, due to the net loss: |
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Warrants |
|
|
13,373,549 |
|
|
|
13,373,549 |
|
Options |
|
|
3,509,897 |
|
|
|
5,589,483 |
|
Restricted Stock Units |
|
|
3,700,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,583,446 |
|
|
|
18,963,032 |
|
|
|
|
|
|
|
|
8
7. |
|
Comprehensive Loss |
|
|
|
Comprehensive loss is defined as the change in equity of a business enterprise during a
period from transactions and other events and circumstances from non-owner sources, including
foreign currency translation adjustments and unrealized gains and losses on short-term
investments. Our components of comprehensive loss consist of net loss and unrealized gains or
losses on short-term investments in securities. For the three months ended March 31, 2009 and
2008, comprehensive loss was $3.2 million and $5.9 million, respectively. For the three months
ended March 31, 2008 and 2007 and the period from inception (June 12, 1996) through March 31,
2009, comprehensive loss was $5.9 million, $5.1 million and $141.7 million, respectively. |
|
8. |
|
Recent Accounting Pronouncements |
|
|
|
In April 2009, the FASB issued three new FASB Staff Positions (FSP) relating to fair value
accounting; FSP FAS 157-4, Determining Fair Value When the Volume and Level of Activity of the
Asset or Liability Have Significantly Decreased and Identifying Transactions That Are Not
Orderly, FSP FAS 115-2 and FSP FAS 124-2, Recognition and Presentation of Other-Than-Temporary
Impairments and FSP FAS 107-1/APB 28-1, Interim Disclosures about Fair Value of Financial
Instruments. These FSPs impact certain aspects of fair value measurements, impairments of
securities and related disclosures. The provisions of these FSPs are effective for interim and
annual periods ending after June 15, 2009. The Company does not expect the impact of adopting
these FSPs to have a material effect on its consolidated results of operations or financial
position. |
|
|
|
In April 2009, the FASB issued FSP FAS 141(R) -1, Accounting for Assets Acquired and Liabilities
Assumed in a Business Combination That Arises from Contingencies. The FSP amends and clarifies
FASB Statement No. 141 (revised 2007), Business Combinations to address application issues on
initial recognition and measurement, subsequent measurement and accounting, and disclosure of
assets and liabilities arising from contingencies in a business combination. This FSP is
effective for assets or liabilities arising from contingencies in business combinations for which
the acquisition date is on or after the beginning of the first annual reporting beginning on or
after December 15, 2008. |
|
9. |
|
Licensing Revenue |
|
|
|
In March 2009, we announced that we and our wholly-owned subsidiary, SD Pharmaceuticals, Inc.,
had entered into a license agreement with respect to our product candidate ANX-514 (docetaxel
emulsion) (the License Agreement) with Shin Poong Pharmaceutical Co., Ltd., a company organized
under the laws of the Republic of Korea (Shin Poong), pursuant to which we granted to Shin
Poong an exclusive license, including the right to sublicense, to research, develop, make, have
made, use, offer for sale, sell and import licensed products, in each case solely for the
treatment of cancer by intravenous administration of formulations of docetaxel as emulsified
products and solely in South Korea. Under the terms of the License Agreement, we will receive an
upfront licensing fee of $0.3 million, a regulatory milestone payment of either $0.2 million or
$0.4 million (depending on whether Shin Poong is required by the Korea Food and Drug
Administration to conduct a bioequivalence or clinical study in human subjects prior to receipt
of regulatory approval) upon receipt of regulatory approval for marketing a licensed product in
South Korea, one-time commercial milestone payments tied to annual net sales of licensed products
in an aggregate amount of up to $1.5 million and royalty payments on net sales of licensed
products. Shin Poong is responsible for all development and commercial activities related to
ANX-514 in South Korea. If Shin Poong is required by the Korea Food and Drug Administration to
conduct a bioequivalence or clinical trial in human subjects prior to receipt of regulatory
approval and we elect not to supply product to conduct such trial, which supply obligation is
subject to limitations, we will pay Shin Poong $0.1 million. |
|
|
|
We received the $0.3 million upfront licensing fee in April 2009. We recognized $0.3 million in
licensing revenue in the three-month period ended March 31, 2009 because we met the criteria
under our revenue recognition policy in that period. |
9
10. |
|
Supplementary Cash Flow Information |
|
|
|
Noncash investing and financing transactions not presented on the condensed consolidated
statements of cash flows for the three months ended March 31, 2009 and 2008 and for the period
from inception (June 12, 1996) through March 31, 2009 are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inception |
|
|
|
|
|
|
|
|
|
|
|
(June 12, 1996) |
|
|
|
|
|
|
|
|
|
|
|
through |
|
|
|
Three months ended March 31, |
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
|
|
|
$ |
179,090 |
|
Income taxes paid |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants, common stock and preferred stock for: |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of notes payable and accrued interest |
|
$ |
|
|
|
$ |
|
|
|
|
1,213,988 |
|
Prepaid services to consultants |
|
|
|
|
|
|
|
|
|
|
1,482,781 |
|
Conversion of preferred stock |
|
|
|
|
|
|
|
|
|
|
2,705 |
|
Acquisitions |
|
|
|
|
|
|
|
|
|
|
24,781,555 |
|
Payment of dividends |
|
|
|
|
|
|
|
|
|
|
213,000 |
|
Financial advisor services in connection with private placement |
|
|
|
|
|
|
|
|
|
|
1,137,456 |
|
Acquisition of treasury stock in settlement of a claim |
|
|
|
|
|
|
|
|
|
|
34,747 |
|
Cancellation of treasury stock |
|
|
|
|
|
|
|
|
|
|
(34,737 |
) |
Assumptions of liabilities in acquisitions |
|
|
|
|
|
|
|
|
|
|
1,235,907 |
|
Acquisition of license agreement for long-term debt |
|
|
|
|
|
|
|
|
|
|
161,180 |
|
Cashless exercise of warrants |
|
|
|
|
|
|
|
|
|
|
4,312 |
|
Dividends accrued |
|
|
|
|
|
|
|
|
|
|
621,040 |
|
Trade asset converted to available-for-sale asset |
|
|
|
|
|
|
|
|
|
|
108,000 |
|
Dividends extinguished |
|
|
|
|
|
|
|
|
|
|
408,240 |
|
Trade payable converted to note payable |
|
|
|
|
|
|
|
|
|
|
83,948 |
|
Issuance of warrants for return of common stock |
|
|
|
|
|
|
|
|
|
|
50,852 |
|
Detachable warrants issued with notes payable |
|
|
|
|
|
|
|
|
|
|
450,000 |
|
Purchases of equipment, which are included in accounts payable |
|
|
|
|
|
|
12,382 |
|
|
|
3,825 |
|
Unrealized (gain) loss on short-term investments |
|
|
|
|
|
|
(6,101 |
) |
|
|
|
|
11. |
|
Severance Related Expenses |
|
|
|
In January 2009, as part of a restructuring to reduce operating costs, we completed a work force
reduction of six employees. As a result of the work force reduction, in accordance with SFAS No.
146, Accounting for Costs Associated with Exit or Disposal Activities, we recorded
severance-related charges of $174,000, of which $86,000 was recorded in research and development
and the remainder in selling, general, and administrative expenses. Severance-related charges
of $144,000 were recorded in the first quarter of 2009 and the remainder will be recorded in the
second quarter of 2009. |
|
|
|
On April 3, 2009, we effected the reduction in our full-time workforce to small, select number of
full-time employees that we announced on March 20, 2009. In addition, we have discontinued
substantially all of our development activities and fundamental business operations. Our
remaining employees will focus their efforts primarily on continuing to evaluate and execute
strategic options. As a result of this reduction in force, we recorded severance-related charges
of $163,000, of which $114,000 was recorded in the first quarter of 2009 and $49,000 is expected
to be recorded in the second quarter of 2009. The severance-related charges that we expect to
incur in the second quarter of 2009 are subject to a number of assumptions, and actual results
may differ. We may also incur other charges not currently contemplated due to events that may
occur as a result of, or associated with, this and other reductions in our workforce. |
|
12. |
|
Subsequent Event |
|
|
|
In May 2009, we announced that we did not meet the primary endpoint in our bioequivalence study
of ANX-514, that the resulting uncertainty around the cost and timeline to FDA approval of
ANX-514 may adversely impact our on-going strategic transaction discussions, and that, in light
of our working capital, we are evaluating both our strategic and
non-strategic options. Accordingly, in May 2009, the Company began to evaluate the process of winding-down its operations,
including engaging a third-party firm to assist it with its evaluation. |
10
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should
be read in conjunction with the condensed consolidated financial statements and related notes
appearing elsewhere in this report. In addition to historical information, this discussion and
analysis contains forward-looking statements that involve risks, uncertainties, and assumptions.
Our actual results may differ materially from those anticipated in these forward-looking
statements.
Overview
We are a development-stage biopharmaceutical company whose fundamental business is focused on
in-licensing, developing and commercializing proprietary product candidates for the treatment of
cancer. We seek to improve the performance and commercial potential of existing treatments by
addressing limitations associated principally with their safety and use. We have devoted
substantially all of our resources to R&D or to acquisition of our product candidates. We have not
yet marketed or sold any products or generated any significant revenue.
We have an immediate need to raise additional capital to support our operations. We have
incurred annual net losses since inception. We had a net loss of $3.2 million in the first quarter
of 2009, which included charges associated with our October 2008 and January and March 2009
reductions in force, and cash and cash equivalents of approximately $5.3 million and working
capital of $2.8 million at March 31, 2009. These factors raise substantial doubt about our ability
to continue as a going concern. Our interim condensed consolidated financial statements for the
period ended and at March 31, 2009 have been prepared assuming we will continue as a going concern.
This basis of accounting contemplates the recovery of our assets and the satisfaction of
liabilities in the normal course of business and does not include any adjustments to reflect the
possible future effects on the recoverability and classification of assets or the amounts and
classification of liabilities that might be necessary should we be unable to continue as a going
concern.
In December 2008, we announced that we were evaluating strategic options, including the sale or
exclusive license of one or more of our product candidate programs, a strategic business merger and
other similar transactions. However, progress with potential strategic transaction partners has not
been as rapid or on terms as attractive as we would have desired. We previously have taken steps
designed to provide additional time to consummate a strategic transaction or otherwise obtain
financing, including eliminating all but a small, select number of full-time employees and
discontinuing substantially all of our development activities and fundamental business operations.
As a result, our ability to further curtail expenses to provide further time is limited, and the
restructuring and cost-cutting measures we have taken may not provide us with sufficient additional
time to consummate a strategic transaction or otherwise obtain financing. Further, in May 2009, we
announced that we did not meet the primary endpoint in our bioequivalence study of ANX-514, that
the resulting uncertainty around the cost and timeline to approval by the FDA of ANX-514 may
adversely impact our on-going strategic transaction discussions, and that, in light of our working
capital, we are evaluating both our strategic and non-strategic options. Accordingly, in May 2009,
the Company began to evaluate the process of winding-down its operations, including engaging a
third-party firm to assist it with its evaluation. There can be no assurances that we will
continue to pursue our strategic transaction alternatives or, if we do, that we will be able to
consummate a strategic transaction on a timely basis, or at all. If we are unable to consummate a
strategic transaction or otherwise obtain financing on a timeline that we believe is acceptable, we will
begin the process of divesting our assets on best-available terms, entirely winding-down our
operations and distributing any remaining cash to our stockholders. However, based on our current
working capital and the estimated costs associated with seeking approval for and implementing a
liquidation plan, we expect our remaining cash, if any, to be insignificant.
Our business was incorporated in Delaware in December 1995. In October 2000, we merged our
wholly-owned subsidiary, Biokeys Acquisition Corp., with and into Biokeys, Inc. and changed our
name to Biokeys Pharmaceuticals, Inc. In May 2003, we merged Biokeys, Inc., our wholly-owned
subsidiary, with and into us and changed our name to ADVENTRX Pharmaceuticals, Inc. In July 2004,
we formed a wholly-owned subsidiary, ADVENTRX (Europe) Ltd., in the United Kingdom primarily to
facilitate conducting clinical trials in the European Union and to obtain favorable pricing for
discussions with the European Medicines Agency. In April 2006, we acquired SD Pharmaceuticals, Inc.
as a wholly-owned subsidiary. Our executive offices are located at 6725 Mesa Ridge Road, Suite 100,
San Diego, California 92121, and our telephone number is (858) 552-0866. Our corporate website is
located at www.adventrx.com.
Our trademark CoFactor® is registered in the United States Patent and Trademark
Office (in the Supplemental Register) under Registration No. 2,946,934, for use in connection with
chemotherapy modulators derived from folic acid. We are developing commercial names for our other
product candidates. All other trademarks, service marks or trade names appearing in this report,
including but not limited to Navelbine® and Taxotere®, are the property of
their respective owners. Use or display by us of other
parties trademarks, service marks, trade names, trade dress or products is not intended to
and does not imply a relationship with, or endorsements or sponsorship of, us by the trademark,
service mark, trade name, trade dress or product owners.
11
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon
consolidated financial statements that we have prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these consolidated financial
statements requires management to make a number of assumptions and estimates that affect the
reported amounts of assets, liabilities, revenues and expenses in our consolidated financial
statements and accompanying notes. On an on-going basis, we evaluate these estimates and
assumptions, including those related to recognition of expenses in service contracts, license
agreements, share-based compensation and registration payment arrangements. Management bases its
estimates on historical information and assumptions believed to be reasonable under the
circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities not readily apparent from other sources. Actual results may differ from
these estimates under different assumptions or conditions.
Revenue Recognition. We recognize revenue in accordance with the SECs Staff Accounting
Bulletin Topic 13, Revenue Recognition, or Topic 13, and Emerging Issues Task Force Issue, or
EITF, No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21. Revenue is
recognized when all of the following criteria are met: (1) persuasive evidence of an arrangement
exists; (2) delivery has occurred or services have been rendered; (3) the sellers price to the
buyer is fixed and determinable; and (4) collectibility is reasonably assured.
Revenue from licensing agreements is recognized based on the performance requirements of the
agreement. Revenue is deferred for fees received before earned. Nonrefundable upfront fees that are
not contingent on any future performance by us are recognized as revenue when revenue recognition
criteria under Topic 13 and EITF 00-21 are met and the license term commences. Nonrefundable
upfront fees, where we have ongoing involvement or performance obligations, are recorded as
deferred revenue and recognized as revenue over the life of the contract, the period of the
performance obligation or the development period, whichever is appropriate in light of the
circumstances.
Payments related to substantive, performance-based milestones in an agreement are recognized
as revenue upon the achievement of the milestones as specified in the underlying agreement when
they represent the culmination of the earnings process. Royalty revenue from licensed products will
be recognized when earned in accordance with the terms of the applicable license agreements.
R&D Expenses. R&D expenses consist of expenses incurred in performing R&D activities,
including salaries and benefits, facilities and other overhead expenses, bioequivalence and
clinical trials, research-related manufacturing services, contract services and other outside
expenses. R&D expenses are charged to operations as they are incurred. Advance payments, including
nonrefundable amounts, for goods or services that will be used or rendered for future R&D
activities are deferred and capitalized. Such amounts will be recognized as an expense as the
related goods are delivered or the related services are performed. If the goods will not be
delivered, or services will not be rendered, then the capitalized advance payment is charged to
expense.
Milestone payments that we make in connection with in-licensed technology or product
candidates are expensed as incurred when there is uncertainty in receiving future economic benefits
from the licensed technology or product candidates. We consider the future economic benefits from
the licensed technology or product candidates to be uncertain until such licensed technology or
product candidates are approved for marketing by the FDA or when other significant risk factors are
abated. For accounting purposes, management has viewed future economic benefits for all of our
licensed technology or product candidates to be uncertain.
Payments in connection with our bioequivalence and clinical trials are often made under
contracts with multiple contract research organizations that conduct and manage these trials on our
behalf. The financial terms of these agreements are subject to negotiation and vary from contract
to contract and may result in uneven payment flows. Generally, these agreements set forth the scope
of work to be performed at a fixed fee or unit price or on a time-and-material basis. Payments
under these contracts depend on factors such as the successful enrollment or treatment of patients
or the completion of other milestones. Expenses related to bioequivalence and clinical trials are
accrued based on our estimates and/or representations from service providers regarding work
performed, including actual level of patient enrollment, completion of patient studies, and trials
progress. Other incidental costs related to patient enrollment or treatment are accrued when
reasonably certain. If the contracted amounts are modified (for instance, as a result of changes in
the bioequivalence or clinical trial protocol or scope of work to be performed), we modify our
accruals accordingly on a prospective basis. Revisions in scope of contract are charged to expense
in the period in which the facts that give rise to the revision become reasonably certain. Because
of the uncertainty of possible future changes to the scope of work in bioequivalence and clinical
trials contracts, we are unable to quantify an estimate of the reasonably likely effect of any such
changes on our consolidated results of operations or
financial position. Historically, we have had no material changes in our bioequivalence and
clinical trial expense accruals that would have had a material impact on our consolidated results
of operations or financial position.
12
Purchased In-Process Research and Development. In accordance with SFAS No. 141, Business
Combinations, we accounted for the costs associated with any purchased in-process research and
development, or IPR&D, to the statement of operations upon acquisition through December 31, 2008.
These amounts represent an estimate of the fair value of purchased IPR&D for projects that, as of
the acquisition date, had not yet reached technological feasibility, had no alternative future use,
and had uncertainty in generating future economic benefits. We determine the future economic
benefits from the purchased IPR&D to be uncertain until such technology is incorporated into
products approved for marketing by the FDA or when other significant risk factors are abated.
We adopted SFAS No. 141(R)-1, Business Combinations, effective for fiscal years beginning on
or after December 15, 2008. The adoption of SFAS 141(R) did not have a material effect on our
consolidated results of operations and financial condition.
Stock-based Compensation Expenses. Effective January 1, 2006, we accounted for stock-based
compensation awards granted to employees, including members of our board of directors, in
accordance with the revised SFAS No. 123, Share-Based Payment, or SFAS 123R, including the
provisions of Staff Accounting Bulletins No. 107 and No. 110. Share-based compensation cost is
measured at the grant date, based on the estimated fair value of the award, and is recognized as
expense over the employees requisite service period. As of March 31, 2009, we had no awards with
market or performance conditions other than the restricted stock units that we granted in January
2009, which will vest, if at all, immediately prior to a strategic transaction (as defined in the
documentation evidencing the grant of the units). As stock-based compensation expense is based on
awards ultimately expected to vest, it has been reduced for estimated forfeitures. SFAS 123R
requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on
historical experience. Although estimates of stock-based compensation expenses are significant to
our consolidated financial statements, they are not related to the payment of any cash by us. Prior
to January 1, 2006, we accounted for stock-based compensation under the recognition and measurement
principles of SFAS 123, Accounting for Stock-Based Compensation.
We estimate the fair value of stock option awards on the date of grant using the Black-Scholes
option-pricing model, or Black-Scholes model. The determination of the fair value of stock-based
payment awards on the date of grant using an option-pricing model is affected by our stock price as
well as assumptions regarding a number of complex and subjective variables. These variables
include, but are not limited to, our expected stock price volatility over the term of the awards,
actual and projected employee stock option exercise behaviors, a risk-free interest rate and
expected dividends. We may elect to use different assumptions under the Black-Scholes model in the
future, which could materially affect our net income or loss and net income or loss per share.
We account for stock-based compensation awards granted to non-employees in accordance with
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, or EITF 96-18. Under EITF 96-18, we
determine the fair value of the stock-based compensation awards granted as either the fair value of
the consideration received or the fair value of the equity instruments issued, whichever is more
reliably measurable. If the fair value of the equity instruments issued is used, it is measured
using the stock price and other measurement assumptions as of the earlier of either of (1) the date
at which a commitment for performance by the counterparty to earn the equity instruments is reached
or (2) the date at which the counterpartys performance is complete.
Income Taxes. In June 2006, FASB issued Financial Interpretation No., or FIN, 48, Accounting
for Uncertainty in Income Taxes-an Interpretation of FASB Statement 109, which clarifies the
accounting for uncertainty in tax positions. FIN 48 provides that the tax effects from an uncertain
tax position can be recognized in our consolidated financial statements only if the position is
more likely than not of being sustained upon an examination by tax authorities. An uncertain income
tax position will not be recognized if it has less than a 50% likelihood of being sustained.
Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. The provisions of FIN 48 were effective
for us as of January 1, 2007, with the cumulative effect of the change in accounting principle
recorded as an adjustment to opening retained earnings in the year of adoption. We adopted FIN 48
on January 1, 2007, which did not have a material impact on our consolidated results of operations
or financial position.
Costs Associated with Exit or Disposal Activities. In accordance with SFAS No. 146,
Accounting for Costs Associated with Exit or Disposal Activities, as part of a restructuring to
reduce operating costs, in January 2009, we completed a work force reduction of six employees. As
a result of the reduction in force, we recorded severance-related charges of $174,000, of which
$86,000 was recorded in research and development and the remainder in selling, general, and
administrative expenses. Severance-related charges of $144,000 were recorded in the first quarter
of 2009 and the remainder will be recorded in the second quarter of 2009.
13
In accordance with SFAS No. 146, Accounting for Costs Associated with Exit or Disposal
Activities, as part of a restructuring to reduce operating costs, in March 2009, we announced that
we would reduce to a small, select number of full-time employees. The severance costs and employer
taxes associated with the reduction in force of nine employees was $163,000. Severance-related
charges of $114,000 were recorded in the first quarter of 2009 and the remainder will be recorded
in the second quarter of 2009. We may also incur other charges not currently contemplated due to
events that may occur as a result of, or associated with, the restructuring.
The foregoing is not intended to be a comprehensive list of all of our accounting policies. In
most cases, the accounting treatment of a particular transaction is specifically dictated by
accounting principles generally accepted in the United States of America.
Results of Operations
A general understanding of the drug development process is critical to understanding our
results of operations. Drug development in the U.S. and most countries throughout the world is a
process that includes several steps defined by the FDA and similar regulatory authorities in
foreign countries. The FDA approval processes relating to new drugs differ, depending on the nature
of the particular drug for which approval is sought. With respect to any drug product with active
ingredients not previously approved by the FDA, a prospective drug manufacturer is required to
submit a new drug application, or NDA, which includes complete reports of pre-clinical, clinical
and laboratory studies and extensive manufacturing information to prove such products safety and
effectiveness. The NDA process generally requires, before the submission of the NDA, filing of an
investigational new drug application, or IND, pursuant to which permission is sought to begin
clinical testing of the new drug product. An NDA based on published safety and effectiveness
studies conducted by others, or previous findings of safety and effectiveness by the FDA, may be
submitted under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FDCA. Development
of new formulations of pharmaceutical products under Section 505(b)(2) of the FDCA may have shorter
timelines than those associated with developing new chemical entities.
Generally, with respect to any drug product with active ingredients not previously approved by
the FDA, an NDA must be supported by data from at least phase 1, phase 2 and phase 3 clinical
trials. Phase 1 clinical trials can be expected to last from 6 to 18 months, phase 2 clinical
trials can be expected to last from 12 to 24 months and phase 3 clinical trials can be expected to
last from 18 to 36 months. However, clinical development timelines vary widely, as do the total
costs of clinical trials and the likelihood of success. We anticipate that we will make
determinations as to which R&D programs to pursue and how much funding to direct to each program on
an ongoing basis in response to the scientific and clinical success of each product candidate, our
ongoing assessment of its market potential and our available resources. In March 2009, we announced
that we would discontinue substantially all of our development activities and fundamental business
operations to provide additional time to consummate a strategic transaction or otherwise obtain
financing.
If we are successful in consummating a strategic transaction, future expenditures on R&D
programs are subject to many uncertainties, including whether our product candidates will be
further developed with a partner or independently. At this time, due to such uncertainties and the
risks inherent in drug development and the associated regulatory process, we cannot estimate with
reasonable certainty the duration of or costs to complete our R&D programs or whether or when or to
what extent revenues will be generated from the commercialization and sale of any of our product
candidates. The duration and costs of our R&D programs, in particular those associated with
bioequivalence trials and research-related manufacturing, can vary significantly among programs as
a result of a variety of factors, including:
|
|
|
the number and location of sites included in trials and the rate of site approval for
the trial; |
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|
|
the rates of patient recruitment and enrollment; |
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|
the ratio of randomized to evaluable patients; |
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the availability and cost of reference product in the jurisdiction of each site; |
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|
the time and cost of process development activities related to our product
candidates; |
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|
the costs of manufacturing our product candidates; and |
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|
|
the costs, requirements, timing of and the ability to secure regulatory approvals. |
14
The difficult process of seeking regulatory approvals for our product candidates, in particular
those containing new chemical entities, and compliance with applicable regulations, requires the
expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining,
regulatory approvals could cause our R&D expenditures to increase and, in turn, have a material and
unfavorable effect on our results of operations. We cannot be certain when, if ever, we will
generate revenues from sales of any of our products.
While substantially all of our R&D expenses are transacted in U.S. dollars, certain of our expenses
are required to be paid in foreign currencies and expose us to transaction gains and losses that
could result from changes in foreign currency exchange rates. We include realized gains and losses
from foreign currency transactions in operations as incurred.
Comparison of Three Months Ended March 31, 2009 and 2008
Revenue. Revenue recognized for the three months ended March 31, 2009 represents a $0.3 million
nonrefundable license fee under our license agreement with Shin Poong Pharmaceutical Co., Ltd.
Consistent with our revenue recognition policy, we recognized the license fee as revenue in the
three-month period ended March 31, 2009 because, in that period, persuasive evidence of an
arrangement existed, services had been rendered, the amount of the payment was fixed and
determinable and collectability was reasonably assured. No revenue was recognized for the three
months ended March 31, 2008.
R&D Expenses. We maintain and evaluate our R&D expenses by the type of cost incurred rather than by
project. We maintain and evaluate R&D expenses by type primarily because of the uncertainties
described above, as well as because we out-source a substantial portion of our work and our R&D
personnel work across multiple programs rather than dedicating their time to one particular
program. We began maintaining such expenses by type on January 1, 2005. The following table
summarizes our consolidated R&D expenses by type for the three months ended March 31, 2009 compared
to the same period in 2008:
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|
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|
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|
|
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|
|
|
|
|
|
|
|
January 1, 2005 |
|
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|
Three months ended March 31, |
|
|
through |
|
|
|
2009 |
|
|
2008 |
|
|
$ Variance |
|
|
% Variance |
|
|
March 31, 2009 |
|
External clinical study fees
and expenses |
|
$ |
578,992 |
|
|
$ |
1,021,920 |
|
|
$ |
(442,928 |
) |
|
|
(43 |
%) |
|
$ |
23,778,472 |
|
External non-clinical study
fees and expenses (1) |
|
|
470,248 |
|
|
|
1,418,985 |
|
|
|
(948,737 |
) |
|
|
(67 |
%) |
|
|
19,415,722 |
|
Personnel costs |
|
|
623,436 |
|
|
|
1,073,706 |
|
|
|
(450,270 |
) |
|
|
(42 |
%) |
|
|
10,134,624 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
(25,376 |
) |
|
|
305,696 |
|
|
|
(331,072 |
) |
|
|
(108 |
%) |
|
|
2,858,784 |
|
|
|
|
|
|
|
|
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,647,300 |
|
|
$ |
3,820,307 |
|
|
$ |
(2,173,007 |
) |
|
|
(57 |
%) |
|
$ |
56,187,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
External non-clinical study fees and expenses include preclinical,
research-related manufacturing, quality assurance and regulatory expenses. |
R&D expenses decreased by $2.2 million, or 57%, to $1.6 million for the three months ended March
31, 2009, compared to $3.8 million for the comparable period in 2008. The decrease in R&D expenses
was primarily due to a $0.6 million decrease in external clinical trial expenses related to
CoFactor, a $1.0 million decrease
in non-clinical expenses related to ANX-514 and ANX-530, a $0.5 million decrease in personnel costs related to
the reductions in staff and a $0.3 million decrease in
share-based compensation expense, offset by a $0.2 million
increase in clinical trial expenses related to ANX-514. We expect
R&D expenses to continue to decline given our recent reductions in full-time employees and that we
have discontinued substantially all of our development activities and fundamental business
operations until we complete a strategic transaction or otherwise obtain financing.
Selling, General and Administrative Expenses. SG&A expenses decreased by $0.6 million, or 25%, to
$1.8 million for the three months ended March 31, 2009, compared to $2.4 million for the comparable
period in 2008. The decrease was primarily due to a $0.3 million
decrease in personnel costs
related to reductions in staff, a $0.2 million decrease in legal
and professional services and a $0.1 million decrease in business insurance. We expect SG&A expenses to continue to decline given our
recent reductions in full-time employees and that we have discontinued substantially all of our
development activities and fundamental business operations until we complete a strategic
transaction or otherwise obtain financing.
Interest and Other Income. Interest and other income decreased by $0.3 million, or 99%, to $1,776
for the three months ended March 31, 2009, compared to $0.3 million for the comparable period in
2008. The decrease was primarily attributable to lower interest
income based on lower cash balances. We expect that interest income will continue to decline as
forecasted interest rates decline along with lower cash balances.
15
Net Loss. Net loss was $3.2 million, or $0.03 per share, for the three months ended March 31,
2009, compared to a net loss of $5.9 million, or $0.07 per share, for the comparable period in
2008. Included in the net loss for the three months ended March 31, 2009 were charges associated
with our October 2008 and January and March 2009 reductions in force.
Liquidity and Capital Resources
We have a history of recurring losses from operations and we have funded our operations
primarily through sales of our equity securities. We had a net loss of $3.2 million in the first
quarter of 2009, which included charges associated with our October 2008 and January and March 2009
reductions in force, and cash and cash equivalents of approximately $5.3 million and working
capital of $2.8 million at March 31, 2009. We have an immediate need to raise additional capital to
support our operations, though in the current financial and economic environment it is uncertain
that we can obtain funding through our traditional sources of capital. These factors raise
substantial doubt about our ability to continue as a going concern.
We are evaluating strategic options, including the sale or exclusive license of one or more of our
product candidate programs, a strategic business merger and other similar transactions, as well as
non-strategic options, including financing transactions and orderly winding-down our operations.
Certain strategic options may improve our liquidity and provide us with working capital to fund
continuing business operations or may result in the divestiture of future development and
commercialization activities and related expenses. However, there can be no assurances that we will
continue to pursue our strategic alternatives or, if we do, that we will be successful in
consummating a strategic transaction on a timely basis, or at all. We likely will not be able to
continue as a going concern, unless, as part of a strategic transaction or otherwise, we raise
adequate capital. We have eliminated all but a select, small number of full-time employees and
discontinued substantially all of our development activities and fundamental business operations
and our ability to further curtail expenses to provide additional time to consummate a strategic
transaction or otherwise obtain financing is limited.
Operating Activities. Net cash used in operating activities was $4.5 million for the three
months ended March 31, 2009, compared to $4.8 million for the comparable period in 2008. The
decrease in net cash used in operating activities was primarily due to reductions in development
activities and fundamental business operations, offset by a $0.3 million increase in licensing
revenue. Included in net cash used in operating activities for the three months ended March 31,
2009 were charges associated with our October 2008 and January and March 2009 reductions in force.
Accordingly, the decreased expenses we otherwise would have realized in the first quarter of 2009
were offset by charges associated with our October 2008 and January and March 2009 reductions in
force.
Investing Activities. Net cash provided by investing activities was $0 for the three months
ended March 31, 2009, compared to net cash used in investing activities of $10.3 million for the
comparable period in 2008.
Financing Activities. There were no financing activities in the three months ended March 31,
2009 and 2008.
Accrued Compensation and Payroll Taxes. Accrued compensation and payroll taxes were $0.8
million at March 31, 2009, compared to $0.9 million at December 31, 2008, a decrease of $0.1
million, or 15%. The decrease was primarily due to the paying-down of severance-related expenses
associated with our October 2008 reduction in staff, offset by severance-related expenses
associated with our January and March 2009 reductions in staff.
Management Outlook
We have an immediate need to raise additional capital to support our operations. Our ability
to raise capital has been materially and adversely affected by current credit conditions and the
downturn in the financial markets and overall economy. In addition, our ability to timely raise
capital on commercially reasonable terms may be limited by requirements, rules and regulations of
the Securities and Exchange Commission and the NYSE Amex (formerly, the American Stock Exchange).
In December 2008, we announced that we were evaluating strategic options, including the sale or
exclusive license of one or more of our product candidate programs, a strategic business merger and
other similar transactions. However, progress with potential strategic transaction partners has not
been as rapid or on terms as attractive as we would have desired. We previously have taken steps
designed to provide additional time to consummate a strategic transaction or otherwise obtain
financing, including eliminating all but a small, select number of full-time employees and
discontinuing substantially all of our development activities and fundamental business operations.
As a result, our ability to further curtail expenses to provide further time is limited, and the
restructuring and cost-cutting measures we have taken may not provide us with sufficient additional
time to consummate a strategic transaction or otherwise obtain financing. Further, in May 2009, we
announced that we did not meet the primary endpoint in our bioequivalence study of ANX-514, that
the resulting uncertainty around the cost and timeline to approval by the FDA of ANX-514 may
adversely impact our on-going strategic transaction discussions, and that, in light of our working
capital, we are evaluating both our strategic and non-strategic options. Accordingly, in May 2009,
the Company began to evaluate the process of winding-down its operations, including engaging a
third-party firm to assist it with its evaluation. There can be no assurances that we will
continue to pursue our strategic transaction alternatives or, if we do, that we will be able to
consummate a strategic transaction on a timely basis, or at all. If we are unable to consummate a
strategic transaction or otherwise obtain financing on a timeline that we believe is acceptable, we
will begin the process of divesting our assets on best-available terms, entirely winding-down our
operations and distributing any remaining cash to our stockholders. However, based on our current
working capital and the estimated costs associated with seeking approval for and implementing a
liquidation plan, we expect our remaining cash, if any, to be insignificant.
16
We are unable to predict when, if ever, we will consummate a strategic transaction or the
form, structure or terms of any potential strategic transaction, including whether we will continue
as a going concern, or whether we will entirely wind-down our operations. As a result, the duration
that our existing cash and cash equivalents will sustain our current operations is uncertain.
Recent Accounting Pronouncements
See Note 8, Recent Accounting Pronouncements, of the Notes to the Condensed Consolidated
Financial Statements (unaudited) in this report for a discussion of recent accounting announcements
and their effect, if any, on us.
Forward Looking Statements
This Quarterly Report on Form 10-Q, particularly in Item 2 Managements Discussion and
Analysis of Financial Condition and Results of Operations, includes forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. All statements, other than statements of historical
fact, are statements that could be deemed forward-looking statements, including, but not limited
to, statements regarding business strategy, expectations and plans, our objectives for future
operations, including product development, and our future financial position. When used in this
report, the words believe, may, could, will, estimate, continue, anticipate,
intend, expect, indicate and similar expressions are intended to identify forward-looking
statements.
We have based these forward-looking statements on our current expectations and projections
about future events and trends that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business operations and objectives, and
financial needs, including our ability to consummate a strategic transaction or otherwise satisfy
our immediate need for additional capital. These forward-looking statements are subject to risks
and uncertainties that could cause our actual results to differ materially from those reflected in
these forward-looking statements. Factors that could cause or contribute to such differences
include, but are not limited to: the risk that we will liquidate our
assets, entirely wind-down our operations and dissolve; the risk that, based on our current working capital,
and the estimated costs associated with seeking approval for and implementing a plan of
liquidation, our remaining capital available for distribution to our stockholders, if any, will be
insignificant; the risk that we will be unable to consummate a strategic or partnering transaction
or otherwise raise sufficient capital on a timely basis, or at all, to continue as a going concern,
including as a result of negative perceptions of the data from our bioequivalence study of ANX-514;
the risk that our recent cost-containment measures, including the discontinuation of substantially
all of our development activities and fundamental business operations and reduction in force to a
small, select number of full-time employees, will negatively impact our ability to consummate a
strategic transaction; the potential for regulatory authorities to require additional preclinical
work and/or clinical activities to support regulatory filings, including prior to the submission or
the approval of a New Drug Application for ANX-530 and ANX-514, and the impact of increased
uncertainty regarding the need for such activities on strategic, partnering and capital-raising
transactions; the risk that the departure of our former Chief Executive Officer and President, our
former Executive Vice President and Chief Financial Officer and/or our reduced workforce and
leadership by officers who do not have substantial previous experience in executive leadership
roles will negatively impact our ability to attract a strategic or other partner, raise capital or
maintain effective disclosure controls and procedures or internal control over financial reporting;
the risk the FDA will determine that ANX-530 and Navelbine and/or ANX-514 and Taxotere are not
bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based on a
patient population other than the population on which we based our analysis or determining that
increased docetaxel blood-levels during and immediately following infusion are clinically relevant;
the risk of investigator bias in reporting adverse events as a result of the open-label nature of
the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events
associated with Navelbine and/or that decreased the reporting of adverse events associated with
ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing
ANX-530 and ANX-514, including validating commercial manufacturers and suppliers and the potential
for automatic injunctions regarding FDA approval of ANX-514; the risk that the performance of third
parties on whom we rely to conduct our studies or evaluate the data, including clinical
investigators, expert data monitoring
17
committees, contract laboratories and contract research
organizations, may be substandard, or they may fail to perform as expected; the risk that our common stock will be delisted by the NYSE Amex
(formerly, the American Stock Exchange), including as a result of failing to maintain sufficient
stockholders equity or a sufficient stock price; the risk that we are unable to file timely
required reports with the Securities and Exchange Commission; the risk that we will trigger a
maintenance failure under that certain Rights Agreement, dated July 27, 2005, as amended, and be
required to pay liquidated damages, including as a result of losing our eligibility to use Form S-3
if our common stock is delisted from the NYSE Amex or we are not timely in our filings with the
Securities and Exchange Commission; and other risks and uncertainties discussed in other reports
and documents we file with the Securities and Exchange Commission. Except as required by law, we do
not intend to update these forward-looking statements publicly or to update the reasons actual
results could differ materially from those anticipated in these forward-looking statements, even if
new information becomes available in the future.
In light of these risks and uncertainties and our assumptions, the forward-looking events and
circumstances discussed in this report and in the documents incorporated in this report may not
occur and actual results could differ materially and adversely from those anticipated or implied in
such forward-looking statements. Accordingly, you are cautioned not to place undue reliance on such
forward-looking statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required.
Item 4T. Controls and Procedures
Evaluation of disclosure controls and procedures
As of the end of the period covered by this report, we conducted an evaluation, under the
supervision and with the participation of our principal executive officer and principal financial
officer, of the effectiveness of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act).
Based on this evaluation, our principal executive officer and principal financial officer concluded
that our disclosure controls and procedures were effective as of March 31, 2009.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with
the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during
the period covered by this report that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting. However, as a result of recent reductions in our workforce and other departures, we have
experienced substantial turn-over in our personnel responsible for performing activities related to
our internal control over financing reporting. We have used third-party contractors to ensure our
internal control over financial reporting remains effective during this turn-over. We intend to
continue to use these contractors as long as our working capital permits.
18
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
In the normal course of business, we may become subject to lawsuits and other claims and
proceedings. Such matters are subject to uncertainty and outcomes are often not predictable with
assurance.
Item 1A. Risk Factors
Not required.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
An Exhibit Index has been attached as part of this report and is incorporated herein by reference.
19
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ADVENTRX Pharmaceuticals, Inc.
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Date: May 15, 2009 |
By: |
/s/ Brian M. Culley
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Brian M. Culley |
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Chief Business Officer and Senior Vice President
(Duly Authorized Officer) |
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By: |
/s/ Mark N.K. Bagnall
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Mark N.K. Bagnall |
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Director
(Principal Financial and Principal Accounting Officer) |
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20
Exhibit Index
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Exhibit |
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Description |
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10.1 |
# |
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Confidential Separation Agreement and General Release of All Claims, effective January 8, 2009, between
the registrant and Mark N.K. Bagnall |
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10.2 |
#(1) |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Brian M. Culley |
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10.3 |
# |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Patrick L. Keran |
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10.4 |
# |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Mark E. Erwin |
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10.5 |
# |
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Retention and Incentive Agreement, dated January 28, 2009, between the registrant and Michele L. Yelmene |
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10.6 |
#(1) |
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Form of Notice of Grant of Restricted Stock Units under the 2008 Omnibus Incentive Plan (for grants to
employees in January 2009) |
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10.7 |
#(1) |
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Form of Restricted Stock Units Agreement under the 2008 Omnibus Incentive Plan |
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10.8 |
* |
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License Agreement, dated March 25, 2009, between the registrant, SD Pharmaceuticals, Inc. and Shin
Poong Pharmaceutical Co., Ltd. |
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31.1 |
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Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) |
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31.2 |
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Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) |
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32.1 |
± |
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Certification of principal executive officer and principal financial officer pursuant to 18 U.S.C.
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Indicates that confidential treatment has been requested or granted to certain
portions, which portions have been omitted and filed separately with the SEC |
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# |
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Indicates management contract or compensatory plan |
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± |
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These certifications are being furnished solely to accompany this report pursuant to 18
U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange
Act of 1934 and are not to be incorporated by reference into any filing of the registrant,
whether made before or after the date hereof, regardless of any general incorporation
language in such filing. |
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(1) |
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Filed with the registrants Current Report on Form 8-K on February 2, 2009 (SEC file
number 001-32157- 09561715) |
21