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- Provides Financial Guidance for 2012 -
Research and development expenses for the year ended
Selling, general and administrative expenses for the year ended
"2011 was a banner year for
2012 Financial Guidance
With respect to revenue in 2012,
With respect to operating expenses
This increase in operating expenses relative to 2011 is primarily a
result of significantly increased investment in the
Conference Call
Affymax's management will host a teleconference and webcast to discuss
the company's financial results and provide a general business update
today at
About
This release contains forward-looking statements, including
statements regarding financial projections and conditions, milestones
expected to be accomplished, continuation and success of Affymax's
collaboration with Takeda, timing, design and progress of Affymax's
peginesatide development program, the timing and potential regulatory
approval and commercialization of peginesatide, the level of expenses in
commercialization efforts and the ability to fund operations in the
future from existing cash balances and collaboration payments from
Takeda. Affymax'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 U.S. Food and
Drug Administration's (FDA) 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, potential delays or additional studies that may be required by
the
|
BALANCE SHEETS (in thousands, except share and per share data) |
||||||||
|
|
||||||||
| 2011 | 2010 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents |
$ |
54,339 |
$ |
63,499 |
||||
| Restricted cash | — | 11 | ||||||
| Short-term investments | 44,165 | 33,582 | ||||||
| Receivable from Takeda | 6,937 | — | ||||||
| Deferred tax assets | 351 | 438 | ||||||
| Prepaid expenses and other current assets | 1,828 | 2,012 | ||||||
| Total current assets | 107,620 | 99,542 | ||||||
| Property and equipment, net | 3,013 | 3,982 | ||||||
| Restricted cash | 1,135 | 1,135 | ||||||
| Long-term investments | — |
19,876 |
||||||
| Deferred tax assets, net of current | 6,888 | 6,802 | ||||||
| Other assets | 339 | 50 | ||||||
| Total assets |
$ |
118,995 |
$ |
131,387 |
||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable |
$ |
941 |
$ |
321 |
||||
| Accrued liabilities | 13,462 | 11,594 | ||||||
| Accrued clinical trial expenses | 3,365 | 11,247 | ||||||
| Payable to Takeda | — | 5,958 | ||||||
| Deferred revenue | — | 18,497 | ||||||
| Deposit from Takeda | 1,998 | — | ||||||
| Total current liabilities | 19,766 | 47,617 | ||||||
| Long-term income tax liability | 10,411 | 10,249 | ||||||
| Advance from Takeda | 6,121 | — | ||||||
| Deferred revenue, net of current | 5,174 | — | ||||||
| Other long-term liabilities | 1,526 | 974 | ||||||
| Total liabilities | 42,998 | 58,840 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders' equity | ||||||||
|
Common stock: |
36 | 25 | ||||||
| Additional paid-in capital | 526,244 | 461,425 | ||||||
| Accumulated deficit |
(450,301 |
) |
(388,934 |
) |
||||
| Accumulated other comprehensive income | 18 | 31 | ||||||
| Total stockholders' equity | 75,997 | 72,547 | ||||||
| Total liabilities and stockholders' equity |
$ |
118,995 |
$ |
131,387 |
||||
|
(in thousands, except per share data) |
||||||||||||
|
Year Ended |
||||||||||||
| 2011 | 2010 | 2009 | ||||||||||
| Revenue: | ||||||||||||
| Collaboration revenue |
$ |
47,703 |
$ |
112,503 |
$ |
114,883 |
||||||
| License and royalty revenue | 17 | 18 | 16 | |||||||||
| Total revenue | 47,720 | 112,521 | 114,899 | |||||||||
| Operating expenses: | ||||||||||||
| Research and development | 76,308 | 93,638 | 157,125 | |||||||||
| Selling, general and administrative | 32,818 | 33,331 | 36,716 | |||||||||
| Total operating expenses | 109,126 | 126,969 | 193,841 | |||||||||
| Loss from operations |
(61,406 |
) |
(14,448 |
) |
(78,942 |
) |
||||||
| Interest income | 169 | 275 | 934 | |||||||||
| Interest expense |
(144 |
) |
(140 |
) |
(105 |
) |
||||||
| Other income (expense), net | 15 | 239 | 171 | |||||||||
| Net loss before provision (benefit) for income taxes |
(61,366 |
) |
(14,074 |
) |
(77,942 |
) |
||||||
| Provision (benefit) for income taxes | 1 | 1 |
(1,411 |
) |
||||||||
| Net loss |
$ |
(61,367 |
) |
$ |
(14,075 |
) |
$ |
(76,531 |
) |
|||
| Net loss per common share: | ||||||||||||
| Basic and diluted |
$ |
(1.84 |
) |
$ |
(0.57 |
) |
$ |
(4.06 |
) |
|||
| Weighted-average number of common shares used in computing basic and diluted net loss per common share | 33,288 | 24,488 | 18,865 | |||||||||
|
Collaboration Revenue (in thousands) |
||||||||||||
|
Year ended |
||||||||||||
|
2011 |
2010 |
2009 | ||||||||||
| Revenue recognized under CAPM (1) |
$ |
26,606 |
$ |
112,503 |
$ | 114,883 | ||||||
| Expense reimbursement after CAPM |
11,097 |
— |
— | |||||||||
| Milestones |
10,000 |
— |
— | |||||||||
| Total collaboration revenue |
$ |
47,703 |
$ |
112,503 |
$ | 114,883 | ||||||
|
(1) Collaboration revenue recognized for each of the three years
ended |
||||||||||||
Vice President,
Corporate Communications
Source:
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