Affymax, Inc. (NASDAQ: AFFY) today reported financial results for the
third quarter ended September 30, 2012. The net loss for the third
quarter of 2012 was $24.6 million (or ($0.68) per share) compared to a
net loss of $9.8 million (or ($0.28) per share) for the third quarter of
2011.
Affymax recognized total revenue for the quarter ended September 30,
2012, of $13.6 million compared to $13.2 million for the quarter ended
September 30, 2011. Revenue for the quarter ended September 30, 2012
primarily consisted of a $10.4 million profit equalization payment
earned from its partner, Takeda Pharmaceutical Company Limited (Takeda)
related to OMONTYS® (peginesatide) Injection product sales
during the period. OMONTYS net product sales, as provided by Takeda,
were $15.0 million for the quarter. In addition, Affymax earned a $2.25
million milestone payment from Takeda during the quarter as a result of
the commercial progress achieved with OMONTYS during its product launch.
Revenue for the quarter ended September 30, 2011 consisted of a $10
million regulatory milestone payment from Takeda and pre-approval
research and development and commercialization expenses reimbursable by
Takeda.
Research and development expenses for the quarter ended September 30,
2012, were $11.4 million compared to $14.9 million for the quarter ended
September 30, 2011. The decrease was primarily due to reduced consultant
and personnel-related costs as a result of the completion of both the
filing of the OMONTYS New Drug Application with the U.S. Food and Drug
Administration (FDA) in May 2011 and the preparation for an FDA advisory
committee meeting which occurred in December 2011. These decreases were
partially offset by clinical trial activity for the company’s Phase 3b
trial during the current quarter.
Selling, general and administrative expenses for the quarter ended
September 30, 2012, were $26.2 million compared to $8.2 million for the
quarter ended September 30, 2011. The increase was primarily due to
increases in commercial and medical affairs costs, including
personnel-related costs associated with the establishment of its
commercial and medical affairs field organizations, as the company
continues to execute on the launch and commercialization of OMONTYS.
The company had cash and investments of $100.0 million as of September
30, 2012.
Updated Financial Guidance
Affymax is updating its financial guidance for 2012. With respect to
collaboration revenue, Affymax has earned milestone payments of $60.3
million and is not expecting additional milestone payments in 2012,
consistent with its previously issued guidance. Affymax is not providing
profit equalization payment or OMONTYS net product sales guidance for
2012.
With respect to operating expenses, Affymax now expects to incur $130
million to $135 million in total operating expenses for 2012, excluding
stock based compensation. This reduction from the previously issued
operating expense guidance of $135 million to $145 million for 2012 is
primarily driven by lower than expected increases in selling, general
and administrative expenses as a result of cost savings.
“We continue to be pleased with our commercial progress since the launch
of OMONTYS in the second quarter of this year,” said John Orwin, chief
executive officer of Affymax. “A number of dialysis providers are
evaluating the conversion process and experience with OMONTYS, including
a key large dialysis organization and four medium dialysis
organizations, while some of the smaller dialysis providers have
completely converted centers to the once-monthly drug.”
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, November 8, 2012, at 4:30 p.m. Eastern Time (1:30 p.m.
Pacific Time).
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 Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company based in Palo Alto,
California. Affymax's mission is to discover, develop and deliver
innovative therapies that improve the lives of patients with kidney
disease and other serious and often life-threatening illnesses.
The company's first marketed product, OMONTYS® (peginesatide)
Injection, was approved by the U.S. Food and Drug Administration (FDA)
in March 2012. For additional information, please visit www.affymax.com.
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 FDA or other regulatory authorities,
including post-marketing studies, trials and Risk Evaluation and
Mitigation Strategy, potential for disruptions to supply, 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.
AFFYMAX, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share data)
September 30, 2012
December 31, 2011
(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: $0.001 par value, 100,000,000 shares authorized,
36,663,946 and 35,733,181 shares issued and outstanding at September
30, 2012 and December 31, 2011, respectively
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
AFFYMAX, INC.
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except per share data)
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
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
)
AFFYMAX, INC.
COLLABORATION REVENUE
(in thousands)
Three Months Ended
Nine Months Ended
September 30,
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
)
—
Affymax share of collaboration profit (loss)
(4,199
)
—
(13,956
)
—
Net reimbursement of Affymax costs & expenses
14,576
—
27,004
—
Profit equalization payment earned by Affymax (2)
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
Affymax and Takeda including amounts provided to us by Takeda.
(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 March 27, 2012.
(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 May 2011 with the
submission of the NDA for OMONTYS to the FDA.
(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 May 2011 and prior to the
launch of OMONTYS on March 27, 2012, after which such costs are
incorporated into the profit equalization payment and (ii) the
reimbursement of those development expenses that fall under the
70/30 expense split in our collaboration agreement with Takeda
subsequent to the submission of the NDA for OMONTYS in May 2011.
Contacts:
Affymax, Inc. Sylvia Wheeler, 650-812-8861 Vice President,
Corporate Communications