Reaffirms Guidance for 2011
PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the second quarter ended June 30, 2011. The net loss for the second quarter of 2011 was $12.5 million compared to net income of $17.3 million for the second quarter of 2010. The net income in second quarter 2010 was due to $30 million in milestone payments paid to Affymax by Takeda in connection with database lock for the Phase 3 trials under their 2006 collaboration for development of peginesatide (formerly known as Hematide™).
Affymax recognized revenue for the quarter ended June 30, 2011 of $14.2 million compared to $54.3 million for the quarter ended June 30, 2010. In addition to the unusually high revenue in 2010 due to the milestone payment mentioned above, the decrease in revenue in 2011 was due to decreased reimbursement from Takeda resulting from reduced development expenses.
Research and development expenses for the quarter ended June 30, 2011, were $18.6 million compared to $28.9 million for the quarter ended June 30, 2010. The decrease was primarily due to the completion of the treatment and follow up of Phase 3 clinical trials for peginesatide in 2010.
General and administrative expenses for the quarter ended June 30, 2011 were $8.1 million compared to $8.2 million for the quarter ended June 30, 2010. The decrease was primarily due to reductions in consulting services.
The company had cash and investments of $124.4 million as of June 30, 2011, a decrease of $28.7 million from March 31, 2011. In addition to supporting normal course operations, the cash utilization in the second quarter 2011 included payment of $5.3 million to Takeda relating to clinical trial accrual adjustments recorded in the fourth quarter of 2010. The $10 million milestone payment due from Takeda as a result of the FDA acceptance of the NDA submission in July is expected to be received in the third quarter.
Affymax reaffirms its previously issued financial guidance of total expected 2011 payments from Takeda of $20 million to $25 million and total 2011 operating expenses of $105 million to $110 million, excluding stock-based compensation.
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, peginesatide, is currently under FDA review for the treatment of anemia in dialysis patients with chronic kidney disease. For additional information, please visit www.affymax.com.
This release contains forward-looking statements, including statements regarding financial projections and condition, milestones expected to be accomplished, continuation and success of the Company’s collaboration with Takeda, timing, design and progress of the Company’s peginesatide development program and the timing and potential regulatory approval and commercialization of peginesatide. 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 approvability and completeness of the New Drug Application (NDA), risks related to regulatory requirements and approvals, in particular the FDA’s interpretation and review of the data in the NDA including issues related to the subgroup analyses in non-dialysis, data quality and integrity particularly in non-inferiority designed trials, risks related to the continued safety and efficacy of peginesatide in clinical development, the potential for once per month dosing and room temperature stability, 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 potential for costs, disruptions and consequences of litigation, 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.
|June 30,||December 31,|
|Cash and cash equivalents||$||73,591||$||63,499|
|Receivable from Takeda||4,234||—|
|Deferred tax assets||438||438|
|Prepaid expenses and other current assets||2,013||2,023|
|Total current assets||119,993||99,542|
|Property and equipment, net||3,253||3,982|
|Deferred tax assets, net of current||6,802||6,802|
|Liabilities and Stockholders’ Equity|
|Accrued clinical trial expenses||8,529||11,247|
|Payable to Takeda||—||5,958|
|Total current liabilities||19,401||47,617|
|Long-term income tax liability||10,341||10,249|
|Other long-term liabilities||1,088||974|
|Additional paid-in capital||521,503||461,425|
|Accumulated other comprehensive income||70||31|
|Total stockholders’ equity||110,564||72,547|
|Total liabilities and stockholders’ equity||$||141,394||$||131,387|
STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|Three Months Ended
|Six Months Ended
|License and royalty revenue||5||5||9||9|
|Research and development||18,594||28,909||36,743||62,002|
|General and administrative||8,088||8,172||16,254||17,591|
|Total operating expenses||26,682||37,081||52,997||79,593|
|Income (loss) from operations||(12,531||)||17,265||(22,163||)||9,403|
|Other income (expense), net||2||(1||)||36||(68||)|
|Net income (loss) before provision for income taxes||(12,519||)||17,312||(22,109||)||9,446|
|Provision for income taxes||—||—||1||—|
|Net income (loss)||$||(12,519||)||$||17,312||$||(22,110||)||$||9,446|
|Net income (loss) per share:|
Weighted-average number of shares used in
Weighted-average number of shares used in
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical General Health