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Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
The company had cash and investments of
Updated Financial Guidance
With respect to operating expenses,
"We continue to be pleased with our commercial progress since the launch
of OMONTYS in the second quarter of this year," said
Conference Call with Management Today
Management will host a teleconference and webcast to provide a general
business overview, as well as to discuss third quarter 2012 financial
results today,
Interested parties can listen to the live teleconference by dialing (866) 393-1565 from the U.S. or +1 (973) 409-9608 for international callers. Individuals may access the live audio webcast by visiting: http://www.investors.affymax.com/events.cfm. A replay of the webcast will be available on the Company's website for 30 days following the live event.
About
The company's first marketed product, OMONTYS® (peginesatide)
Injection, was approved by the
This release contains forward-looking statements, including
statements regarding financial projections and condition, the
continuation and success of the Company's collaboration with Takeda and
the commercialization of OMONTYS. 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
factors affecting the commercial potential of OMONTYS, the continued
safety and efficacy of OMONTYS, industry and competitive environment,
regulatory requirements by the
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| CONDENSED BALANCE SHEETS | ||||||||
| (in thousands, except share data) | ||||||||
|
September 30, 2012 |
December 31, |
|||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 89,169 | $ | 54,339 | ||||
| Short-term investments | 9,684 | 44,165 | ||||||
| Receivable from Takeda | 9,710 | 6,937 | ||||||
| Inventory | 2,040 | — | ||||||
| Deferred tax assets | 351 | 351 | ||||||
| Prepaid expenses and other current assets | 7,267 | 1,828 | ||||||
| Total current assets | 118,221 | 107,620 | ||||||
| Property and equipment, net | 3,024 | 3,013 | ||||||
| Restricted cash | 1,135 | 1,135 | ||||||
| Deferred tax assets, net of current | 6,888 | 6,888 | ||||||
| Other assets | 3,481 | 339 | ||||||
| Total assets | $ | 132,749 | $ | 118,995 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 3,766 | $ | 941 | ||||
| Accrued liabilities | 17,749 | 13,733 | ||||||
| Accrued clinical trial expenses | 2,500 | 3,365 | ||||||
| Deposit from Takeda | 559 | 1,998 | ||||||
| Notes payable, current | 2,766 | — | ||||||
| Total current liabilities | 27,340 | 20,037 | ||||||
| Long-term income tax liability | 10,513 | 10,411 | ||||||
| Advance from Takeda | 9,310 | 6,121 | ||||||
| Deferred revenue | 12,386 | 5,174 | ||||||
| Notes payable, net of current | 7,234 | — | ||||||
| Other long-term liabilities | 810 | 1,255 | ||||||
| Total liabilities | 67,593 | 42,998 | ||||||
| Commitments and contingencies | — | — | ||||||
| Stockholders' equity | ||||||||
|
Common stock: |
37 | 36 | ||||||
| Additional paid-in capital | 540,560 | 526,244 | ||||||
| Accumulated deficit | (475,442 | ) | (450,301 | ) | ||||
| Accumulated other comprehensive income | 1 | 18 | ||||||
| Total stockholders' equity | 65,156 | 75,997 | ||||||
| Total liabilities and stockholders' equity | $ | 132,749 | $ | 118,995 | ||||
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| CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
|
|
September 30, | |||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue | $ | 13,603 | $ | 13,204 | $ | 79,562 | $ | 44,029 | ||||||||
| License and royalty revenue | 4 | 5 | 9 | 14 | ||||||||||||
| Total revenue | 13,607 | 13,209 | 79,571 | 44,043 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 11,416 | 14,863 | 40,486 | 51,606 | ||||||||||||
| Selling, general and administrative | 26,181 | 8,172 | 62,936 | 24,426 | ||||||||||||
| Total operating expenses | 37,597 | 23,035 | 103,422 | 76,032 | ||||||||||||
| Loss from operations | (23,990 | ) | (9,826 | ) | (23,851 | ) | (31,989 | ) | ||||||||
| Interest income | 23 | 45 | 56 | 136 | ||||||||||||
| Interest expense | (668 | ) | (38 | ) | (1,316 | ) | (111 | ) | ||||||||
| Other income (expense), net | (3 | ) | 3 | (29 | ) | 39 | ||||||||||
| Net loss before provision for income taxes | (24,638 | ) | (9,816 | ) | (25,140 | ) | (31,925 | ) | ||||||||
| Provision for income taxes | — | — | (1 | ) | (1 | ) | ||||||||||
| Net loss | $ | (24,638 | ) | $ | (9,816 | ) | $ | (25,141 | ) | $ | (31,926 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | (0.68 | ) | $ | (0.28 | ) | $ | (0.70 | ) | $ | (0.98 | ) | ||||
| Weighted-average number of shares used in computing basic and diluted net loss per share | 36,350 | 35,578 | 36,067 | 32,474 | ||||||||||||
| Total comprehensive loss | $ | (24,641 | ) | $ | (9,844 | ) | $ | (25,158 | ) | $ | (31,915 | ) | ||||
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| COLLABORATION REVENUE | |||||||||||||||
| (in thousands) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
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|
September 30, | ||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||
| OMONTYS net product sales (as provided by Takeda) | $ | 15,008 | $ | — | $ | 15,008 | $ | — | |||||||
| Total Collaboration costs & expenses (1) | 23,406 | — | 42,920 | — | |||||||||||
| OMONTYS collaboration profit (loss) | (8,398 | ) | — | (27,912 | ) | — | |||||||||
|
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(4,199 | ) | — | (13,956 | ) | — | |||||||||
|
Net reimbursement of |
14,576 | — | 27,004 | — | |||||||||||
|
Profit equalization payment earned by |
10,377 | — | 13,048 | — | |||||||||||
| Milestone payments | 2,250 | 10,000 | 60,250 | 10,000 | |||||||||||
| Revenue previously deferred related to API | 441 | — | 441 | — | |||||||||||
| Revenue recognized under CAPM (3) | — | — | — | 26,606 | |||||||||||
| Net expense reimbursement after CAPM (4) | 535 | 3,204 | 5,823 | 7,423 | |||||||||||
| Total collaboration revenue | $ | 13,603 | $ | 13,204 | $ | 79,562 | $ | 44,029 | |||||||
| (1) |
Total Collaboration costs and expenses include costs incurred by
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| (2) |
Profit equalization payment earned is comprised of Affymax's share
of collaboration profit or loss as well as net reimbursement for
commercialization costs and certain post-marketing development costs
incurred subsequent to the launch of OMONTYS on |
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| (3) |
Revenue recognized under CAPM (Contingency Adjusted Performance
Model) includes amounts received related to upfront payments,
development milestones, purchase of active pharmaceutical
ingredient, or API, and reimbursement of development expenses. Under
CAPM, revenue for these amounts was recognized ratably over the
expected development period, which ended in |
|||
| (4) |
Net expense reimbursement after CAPM is comprised of two components:
(i) net reimbursement of commercialization expenses and certain
post-marketing development costs incurred subsequent to the
submission of the NDA for OMONTYS in |
Vice President,
Corporate Communications
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