Exhibit 99.1
Corporate Contact:
Sylvia Wheeler
Executive Director, Corporate Communications
Affymax, Inc.
650-812-8861
AFFYMAX® REPORTS YEAR END 2009 FINANCIAL RESULTS
PALO ALTO, Calif., March 4, 2010 — Affymax, Inc. (Nasdaq: AFFY) today reported financial results for the year ended December 31, 2009. The net loss for the year 2009 was $76.5 million compared to a net loss of $86.5 million for the year ended December 31, 2008.
Affymax recognized revenue for the year ended December 31, 2009 of $114.9 million compared to $82.9 million for the year ended December 31, 2008. The increase in revenue was the result of higher collaboration revenue from its partnership with Takeda Pharmaceutical Company Limited (Takeda), under their 2006 collaboration for development of Affymax’s lead compound, Hematide™.
Research and development expenses for the year ended December 31, 2009 were $157.1 million compared to $137.5 million for the year ended December 31, 2008. The increase was primarily due to expenses associated from a full year of Phase 3 clinical development of Hematide™ (peginesatide) in chronic renal failure.
General and administrative expenses for the year ended December 31, 2009 were $36.7 million compared to $34.1 million for the year ended December 31, 2008 primarily due to higher legal fees.
The company’s year end cash, investments and receivable from Takeda was $187.1 million, which includes proceeds from the company’s $80.6 million sale of common stock in a follow-on offering completed in November 2009.
Guidance
In 2010, the company plans to announce pivotal Phase 3 clinical trial results and to submit a New Drug Application (NDA) for Hematide. With respect to total operating expenses prior to Takeda reimbursement, Affymax expects a significant reduction in Phase 3 clinical trial costs, the majority of which is offset by expenses associated with NDA preparation activities, increase of API manufacturing and expansion of our commercial capabilities. While Affymax expects lower total operating expenses for 2010 relative to 2009, the company expects 2010 operating expenses, net of Takeda reimbursement, to be relatively flat compared to 2009, in a range of approximately $100 — 110 million (excluding stock-based compensation), due primarily to a lower reimbursement rate for eligible commercial-related expenses and the timing of payments following shipment of API under our 2006 collaboration with Takeda.
Affymax expects to have cash, investments and receivable from Takeda of approximately $75 - 85 million at December 31, 2010. This estimate includes the expected receipt of a $30 million milestone payment from Takeda in conjunction with database lock in the Phase 3 program and $5 million milestone payment from Takeda in conjunction with the initiation of the Phase 3 trial of Hematide in Japan. The 2010 estimate also anticipates the payment of almost all of $39.5 million in accrued clinical trial costs at December 31, 2009 as well as the repayment of a $9.2 million loan from UBS for auction rate securities that is expected to be due upon sale of auction rate securities back to UBS in mid-2010.
We expect cash resources, on-going Takeda reimbursement and receipt of the $20 million milestone payment from Takeda upon acceptance of the NDA by the Food and Drug Administration to fund our operations until late 2011. Under the terms of our 2006 collaboration with Takeda, we are eligible to receive a $95 million milestone upon approval of the NDA by the FDA.
In calendar 2010, the company anticipates accomplishing the following milestones:
· Announcement of safety and efficacy results from four Phase 3 clinical trials of Hematide
· Data presentation on Hematide at several medical/scientific conferences
· Submission of a New Drug Application for Hematide
The company intends to begin a quiet period at some point during the second quarter in connection with the analysis of data from the first of the Phase 3 clinical trials, and this period will continue until the announcement of top-line results.
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), 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 projections and condition, the milestones expected to be accomplished in the next 12 months, the continuation and success of the Company’s collaboration with Takeda, including the ability to achieve and timing of any projected milestone payments, the 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 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 Annual Report on Form 10-K 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.
BALANCE SHEETS
(in thousands)
| | December 31, | | December 31, | |
| | 2009 | | 2008 | |
Assets | | | | | |
Current assets | | | | | |
Cash and cash equivalents | | $ | 125,296 | | $ | 24,046 | |
Restricted cash | | 11 | | 11 | |
Short-term investments | | 35,292 | | 70,673 | |
Receivable from Takeda | | 18,561 | | 21,688 | |
Income taxes receivable | | 1,443 | | 2,665 | |
Deferred tax assets | | 1,443 | | 1,351 | |
Prepaid expenses and other current assets | | 8,693 | | 6,647 | |
Total current assets | | 190,739 | | 127,081 | |
Property and equipment, net | | 5,469 | | 6,952 | |
Restricted cash | | 1,135 | | 1,135 | |
Long-term investments | | 7,978 | | 22,945 | |
Deferred tax assets, net of current | | 5,797 | | 5,889 | |
Other assets | | 392 | | 3,718 | |
Total assets | | $ | 211,510 | | $ | 167,720 | |
| | | | | |
Liabilities and Stockholders’ Equity | | | | | |
Current liabilities | | | | | |
Accounts payable | | $ | 464 | | $ | 614 | |
Accrued liabilities | | 12,594 | | 9,831 | |
Accrued clinical trial expenses | | 39,499 | | 27,806 | |
Income taxes payable | | — | | 163 | |
Deferred revenue | | 71,972 | | 54,930 | |
UBS loan | | 9,192 | | — | |
Capitalized lease obligations, current | | — | | 7 | |
Total current liabilities | | 133,721 | | 93,351 | |
Deferred revenue, net of current | | — | | 54,915 | |
Long-term income tax liability | | 9,425 | | 9,400 | |
Other long-term liabilities | | 1,459 | | 1,070 | |
Total liabilities | | 144,605 | | 158,736 | |
| | | | | |
Stockholders’ equity | | | | | |
Common stock | | 24 | | 15 | |
Additional paid-in capital | | 441,795 | | 306,828 | |
Deferred stock-based compensation | | — | | (4 | ) |
Accumulated deficit | | (374,859 | ) | (298,328 | ) |
Accumulated other comprehensive income (loss) | | (55 | ) | 473 | |
Total stockholders’ equity | | 66,905 | | 8,984 | |
Total liabilities and stockholders’ equity | | $ | 211,510 | | $ | 167,720 | |
AFFYMAX, INC.
STATEMENTS OF OPERATIONS
(in thousands, except per share data)
| | Year Ended December 31, | |
| | 2009 | | 2008 | | 2007 | |
Collaboration revenue | | $ | 114,883 | | $ | 82,162 | | $ | 44,303 | |
License and royalty revenue | | 16 | | 689 | | 33 | |
Total revenue | | 114,899 | | 82,851 | | 44,336 | |
Operating expenses | | | | | | | |
Research and development | | 157,125 | | 137,492 | | 69,398 | |
General and administrative | | 36,716 | | 34,090 | | 24,075 | |
Total operating expenses | | 193,841 | | 171,582 | | 93,473 | |
Loss from operations | | (78,942 | ) | (88,731 | ) | (49,137 | ) |
Interest income | | 934 | | 4,545 | | 11,393 | |
Interest expense | | (105 | ) | (609 | ) | (14 | ) |
Other income (expense), net | | 171 | | (1,433 | ) | 46 | |
Net loss before provision (benefit) for income taxes | | (77,942 | ) | (86,228 | ) | (37,712 | ) |
Provision (benefit) for income taxes | | (1,411 | ) | 282 | | 5,357 | |
Net loss | | $ | (76,531 | ) | $ | (86,510 | ) | $ | (43,069 | ) |
Net loss per common share: | | | | | | | |
Basic and diluted | | $ | (4.06 | ) | $ | (5.68 | ) | $ | (2.88 | ) |
Weighted-average number of common shares used in computing basic and diluted net loss per common share | | 18,865 | | 15,220 | | 14,941 | |
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