PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the second quarter ended June 30, 2010. Net income for the second quarter of 2010 was $17.3 million compared to a net loss of $22.1 million for the second quarter of 2009. The company received milestone payments of $30.0 million from Takeda Pharmaceutical Company Limited for database lock of the Hematide™/peginesatide Phase 3 clinical trials. Due to the recognition of revenue from these milestone payments, Affymax was profitable in the quarter ended June 30, 2010. The company continues to expect to incur substantial losses for the foreseeable future.
Affymax recognized revenue for the quarter ended June 30, 2010 of $54.3 million compared to $26.9 million for the quarter ended June 30, 2009. The increase in revenue was the result of its collaboration with Takeda, including the milestone payments.
Research and development expenses for the quarter ended June 30, 2010 were $28.9 million compared to $40.8 million for the quarter ended June 30, 2009. The decrease was primarily due to the completion of the treatment and follow up of the company’s Phase 3 clinical trials at the start of 2010.
General and administrative expenses for the quarter ended June 30, 2010 were $8.2 million compared to $8.7 million for the quarter ended June 30, 2009. The decrease was primarily due to lower legal fees.
The company’s cash, investments and receivables from Takeda totaled $167.2 million as of June 30, 2010, including $30.0 million in milestone payments.
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™/peginesatide, recently completed 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 continuation and success of the Company’s collaboration with Takeda, timing, design and results of the Company’s clinical trials and drug development program and registration strategy 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 timing of and regulatory requirements for approvals, including the FDA’s interpretation of the data from the Phase 3 studies, in particular with respect to the secondary analyses in the non-dialysis patients, the continued safety and efficacy of Hematide in clinical development, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, the factors affecting the commercial potential of Hematide, industry and competitive environment, intellectual property rights and disputes, financing requirements and ability to access capital, 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) |
||||||||
| June 30, | December 31, | |||||||
| 2010 | 2009 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 64,178 | $ | 125,296 | ||||
| Short-term investments | 77,651 | 35,292 | ||||||
| Receivable from Takeda | 10,275 | 18,561 | ||||||
| Income taxes receivable | 125 | 1,443 | ||||||
| Deferred tax assets | 1,443 | 1,443 | ||||||
| Prepaid expenses and other current assets | 8,465 | 8,704 | ||||||
| Total current assets | 162,137 | 190,739 | ||||||
| Property and equipment, net | 4,682 | 5,469 | ||||||
| Restricted cash | 1,135 | 1,135 | ||||||
| Long-term investments | 15,132 | 7,978 | ||||||
| Deferred tax assets, net of current | 5,797 | 5,797 | ||||||
| Other assets | 253 | 392 | ||||||
| Total assets | $ | 189,136 | $ | 211,510 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,467 | $ | 464 | ||||
| Accrued liabilities | 11,528 | 12,594 | ||||||
| Accrued clinical trial expenses | 30,690 | 39,499 | ||||||
| Deferred revenue | 44,054 | 71,972 | ||||||
| UBS loan | 5,378 | 9,192 | ||||||
| Total current liabilities | 94,117 | 133,721 | ||||||
| Long-term income tax liability | 9,425 | 9,425 | ||||||
| Other long-term liabilities | 1,454 | 1,459 | ||||||
| Total liabilities | 104,996 | 144,605 | ||||||
| Stockholders’ equity | ||||||||
| Common stock | 24 | 24 | ||||||
| Additional paid-in capital | 449,483 | 441,795 | ||||||
| Accumulated deficit |
(365,413 |
) |
(374,859 |
) |
||||
| Accumulated other comprehensive income (loss) | 46 |
(55 |
) |
|||||
| Total stockholders’ equity | 84,140 | 66,905 | ||||||
| Total liabilities and stockholders’ equity | $ | 189,136 | $ | 211,510 | ||||
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AFFYMAX, INC. UNAUDITED CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share data) |
||||||||||||||||
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| Collaboration revenue | $ | 54,341 | $ | 26,918 | $ | 88,987 | $ | 52,767 | ||||||||
| License and royalty revenue | 5 | 5 | 9 | 9 | ||||||||||||
| Total revenue | 54,346 | 26,923 | 88,996 | 52,776 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 28,909 | 40,778 | 62,002 | 81,225 | ||||||||||||
| General and administrative | 8,172 | 8,689 | 17,591 | 16,106 | ||||||||||||
| Total operating expenses | 37,081 | 49,467 | 79,593 | 97,331 | ||||||||||||
| Income (loss) from operations | 17,265 |
(22,544 |
) |
9,403 |
(44,555 |
) |
||||||||||
| Interest income | 83 | 261 | 180 | 662 | ||||||||||||
| Interest expense |
(35 |
) |
(1 |
) |
(69 |
) |
(1 |
) |
||||||||
| Other income (expense), net |
(1 |
) |
161 |
(68 |
) |
— | ||||||||||
| Net income (loss) before benefit for income taxes | 17,312 |
(22,123 |
) |
9,446 |
(43,894 |
) |
||||||||||
| Benefit for income taxes | — |
(31 |
) |
— |
(62 |
) |
||||||||||
| Net income (loss) | $ | 17,312 |
$ |
(22,092 |
) |
$ | 9,446 |
$ |
(43,832 |
) |
||||||
| Net income (loss) per share: | ||||||||||||||||
| Basic | $ | 0.71 |
$ |
(1.17 |
) |
$ | 0.39 |
$ |
(2.48 |
) |
||||||
|
Weighted-average number of shares used in |
24,219 | 18,894 | 24,076 | 17,698 | ||||||||||||
| Diluted | $ | 0.70 |
$ |
(1.17 |
) |
$ | 0.38 |
$ |
(2.48 |
) |
||||||
|
Weighted-average number of shares used in |
24,736 | 18,894 | 24,676 | 17,698 | ||||||||||||
CONTACT:
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications
or
WCG
Carolyn Wang, 415-946-1065
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical General Health
MEDIA:
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