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SMALL BUSINESS
Affymax® Reports Third Quarter 2009 Financial Results
Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the third quarter ended September 30, 2009. The net loss for the third quarter of 2009 was $18.4 million compared to a net loss of $26.2 million for the third quarter of 2008.
Affymax recognized revenue for the quarter ended September 30, 2009 of $29.2 million compared to $21.6 million for the quarter ended September 30, 2008. The increase in revenue was the result of increased collaboration revenue from its partnership with Takeda Pharmaceutical Company Limited (Takeda), under their 2006 collaboration for development of Affymax’s compound, Hematide™.
Research and development expenses for the quarter ended September 30, 2009, were $37.2 million compared to $39.8 million for the quarter ended September 30, 2008. The decrease was primarily due to reduced purchases of comparator drugs used in the Company’s clinical trials.
General and administrative expenses for the quarter ended September 30, 2009 were $10.7 million compared to $8.3 million for the quarter ended September 30, 2008 primarily due to increased legal fees. The company’s cash, investments and receivables from Takeda totaled $121.2 million as of September 30, 2009.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. Affymax’s product candidate, Hematide™, is currently in Phase 3 clinical trials for the treatment of anemia associated with chronic renal failure. For additional information, please visit www.affymax.com.
This release contains forward-looking statements, including statements regarding financial condition, the success of the Company’s collaboration with Takeda, timing, design and results of the Company’s clinical trials and drug development program and the timing and likelihood of the commercialization of Hematide. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to the continued safety and efficacy of Hematide in clinical development, the potential for once per month dosing and room temperature stability, the cardiovascular event rate in our phase 3 clinical program, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in Affymax’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release.
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AFFYMAX, INC. UNAUDITED CONDENSED BALANCE SHEETS (in thousands) |
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| September 30, |
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December 31, |
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| 2009 |
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2008 |
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| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 67,336 | $ | 24,046 | ||||
| Short-term investments | 32,354 | 70,673 | ||||||
| Receivable from Takeda | 17,360 | 21,688 | ||||||
| Income tax receivable | 110 | 2,665 | ||||||
| Deferred tax assets | 1,351 | 1,351 | ||||||
| Prepaid expenses and other current assets | 8,894 | 6,658 | ||||||
| Total current assets | 127,405 | 127,081 | ||||||
| Property and equipment, net | 5,963 | 6,952 | ||||||
| Restricted cash | 1,135 | 1,135 | ||||||
| Long-term investments | 4,139 | 22,945 | ||||||
| Deferred tax assets, net of current | 5,889 | 5,889 | ||||||
| Other assets | 401 | 3,718 | ||||||
| Total assets | $ | 144,932 | $ | 167,720 | ||||
| Liabilities and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,464 | $ | 614 | ||||
| Accrued liabilities | 12,662 | 9,838 | ||||||
| Accrued clinical trial expenses | 37,696 | 27,806 | ||||||
| Income taxes payable | — | 163 | ||||||
| Deferred revenue | 67,446 | 54,930 | ||||||
| Total current liabilities | 120,268 | 93,351 | ||||||
| Deferred revenue, net of current | 16,986 | 54,915 | ||||||
| Long-term income tax liability | 9,419 | 9,400 | ||||||
| Other long-term liabilities | 991 | 1,070 | ||||||
| Total liabilities | 147,664 | 158,736 | ||||||
| Stockholders’ equity (deficit) | ||||||||
| Common stock | 19 | 15 | ||||||
| Additional paid-in capital | 357,748 | 306,824 | ||||||
| Accumulated deficit | (360,542 | ) | (298,328 | ) | ||||
| Accumulated other comprehensive gain | 43 | 473 | ||||||
| Total stockholders’ equity (deficit) | (2,732 | ) | 8,984 | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 144,932 | $ | 167,720 | ||||
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AFFYMAX, INC. UNAUDITED CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Collaboration revenue | $ | 29,157 | $ | 21,645 | $ | 81,924 | $ | 56,803 | ||||||||
| License and royalty revenue | 4 | 3 | 13 | 690 | ||||||||||||
| Total revenue | 29,161 | 21,648 | 81,937 | 57,493 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 37,237 | 39,780 | 118,462 | 96,093 | ||||||||||||
| General and administrative | 10,657 | 8,308 | 26,763 | 23,639 | ||||||||||||
| Total operating expenses | 47,894 | 48,088 | 145,225 | 119,732 | ||||||||||||
| Loss from operations | (18,733 | ) | (26,440 | ) | (63,288 | ) | (62,239 | ) | ||||||||
| Interest income | 164 | 821 | 826 | 3,913 | ||||||||||||
| Interest expense | — | (156 | ) | (1 | ) | (357 | ) | |||||||||
| Other income (expense), net | 163 | (436 | ) | 163 | (2,024 | ) | ||||||||||
| Net loss before benefit for income taxes | (18,406 | ) | (26,211 | ) | (62,300 | ) | (60,707 | ) | ||||||||
| Benefit for income taxes | (24 | ) | — | (86 | ) | — | ||||||||||
| Net loss | $ | (18,382 | ) | $ | (26,211 | ) | $ | (62,214 | ) | $ | (60,707 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.97 | ) | $ | (1.72 | ) | $ | (3.43 | ) | $ | (4.00 | ) | ||||
| Weighted-average number of shares used in computing basic and diluted net loss per share | 18,951 | 15,235 | 18,120 | 15,193 | ||||||||||||