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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.

AFFYMAX, INC.

UNAUDITED CONDENSED BALANCE SHEETS

(in thousands)

   
September 30,

 

December 31,

2009

 

2008

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
 

AFFYMAX, INC.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

   
Three Months Ended

September 30,
Nine Months Ended

September 30,
  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

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