SAN DIEGO, April 19, 2010 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial
results for the quarter ended March 31,
2010. The Company reported total revenue of $174.1 million for the quarter ended March 31, 2010, which includes net product sales
of $172.3 million. Non-GAAP operating
loss was $3.8 million for the quarter
ended March 31, 2010, compared to
$19.9 million for the same period in
2009. GAAP net loss was $38.2
million, or $0.27 per share,
for the quarter ended March 31, 2010,
compared to $47.0 million, or
$0.34 per share, for the same period
in 2009. At March 31, 2010 the
Company held cash, cash equivalents and short-term investments of
$598.3 million.
"With the submission of our BYDUREON response this week, we are
preparing to make this revolutionary treatment option available
this year to the millions of patients living with type 2 diabetes,"
said Daniel M. Bradbury, president
and chief executive officer, Amylin Pharmaceuticals. "We remain
focused on driving revenue from our currently marketed products,
BYETTA and SYMLIN, and continue to exercise financial discipline so
that we remain on track to generate sustainable positive operating
cash flow by year end."
First Quarter Highlights
Highlights of Amylin's first quarter and recent activities
include:
BYDUREON
- Received a complete response letter regarding the BYDUREON™
(exenatide for extended-release injectable suspension) New Drug
Application (NDA) from the U.S. Food and Drug Administration (FDA),
and the response to the letter will be submitted to the FDA this
week
- Eli Lilly and Company submitted the marketing authorization
application to the European Medicines Agency for BYDUREON
- Enrolled first patient in DURATION-6 clinical study, a
head-to-head comparison of liraglutide, a GLP-1 analog, with
results anticipated in the first half of 2011
- DURATION-1 manuscript published in Diabetes Care
demonstrated that 52 weeks of treatment with BYDUREON produced
sustained glucose control and weight loss
Obesity Program
- Announced the combination treatment of pramlintide/metreleptin
will advance toward Phase 3 development
Financial Results
Net product sales of $172.3
million for the quarter ended March
31, 2010 include $149.8
million for BYETTA® (exenatide) injection and $22.5 million for SYMLIN® (pramlintide acetate)
injection. This compares to net product sales of $179.3 million, consisting of $157.7 million for BYETTA and $21.6 million for SYMLIN for the same period in
2009. Revenues under collaborative agreements were
$1.9 million for the quarter ended
March 31, 2010, compared to
$1.1 million for the same period in
2009 and consist of the amortization of up-front fees received
under the Company's collaboration agreements.
Selling, general and administrative expenses decreased to
$76.7 million for the quarter ended
March 31, 2010 from $87.6 million for the same period in 2009. The
decrease primarily reflects lower sales force spending and the
Company's reduced cost structure, partially offset by pre-launch
expenses associated with BYDUREON.
Research and development expenses decreased to $41.8 million for the quarter ended March 31, 2010 from $46.7
million for the same period in 2009. The decrease primarily
reflects lower development expenses for the Company's obesity
programs. This reduction reflects development expense cost-sharing
with Takeda Pharmaceutical Company Limited through the Company's
obesity collaboration agreement and lower clinical trial expenses
from trials that were completed in 2009.
Collaborative profit sharing, which represents Lilly's share of
the gross margin for BYETTA, was $67.9
million for the quarter ended March
31, 2010, compared to $73.0
million for the same period in 2009.
Non-GAAP operating loss was $3.8
million for the quarter ended March
31, 2010, compared to $19.9
million for the same period in 2009. GAAP net loss for the
quarter ended March 31, 2010 was
$38.2 million, or $0.27 per share, compared to $47.0 million, or $0.34 per share, for the same period in 2009.
Conference Call
Amylin will webcast its Quarterly Update Call today at
8:30 a.m. ET/5:30 a.m. PT. Daniel M.
Bradbury, Amylin's president and chief executive officer,
will lead the call. During the call, the Company plans to provide
further details underlying its first quarter financial results. A
slide presentation accompanying the conference call is available
through the "Investors" section of Amylin's corporate Web site at
www.amylin.com.
To access the webcast, please log on to the "Investors" section
of Amylin's corporate Web site at www.amylin.com approximately
fifteen minutes prior to the call to register, download and install
any necessary audio software. For those without access to the
Internet, the live call may be accessed by phone by calling (800)
884-5695 (U.S./Canada) or (617)
786-2960 (international), participant passcode# 11172097. A replay
of the call will also be available by phone beginning approximately
two hours after the close of the call and can be accessed at (888)
286-8010 (U.S./Canada) or (617)
801-6888 (international), passcode# 57594716.
Note Regarding Use of Non-GAAP Financial Measures
Amylin reports non-GAAP operating loss excluding non-cash items
and other items such as restructuring charges, which is a non-GAAP
financial measure. The Company believes that investors'
understanding of its progress towards its stated goal of generating
positive non-GAAP operating results by the end of 2010 is enhanced
by this disclosure. In addition, the Company refers to this
non-GAAP financial information with its analysis of the Company's
financial performance. This non-GAAP financial measure should be
considered in addition to, and not as a substitute for, or superior
to, financial measures calculated in accordance with GAAP.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide)
injection. Amylin's research and development activities leverage
the Company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in
San Diego, California. Further
information on Amylin Pharmaceuticals is available at
www.amylin.com.
This press release contains forward-looking statements about
Amylin, which involve risks and uncertainties. Our actual results
could differ materially from those discussed herein due to a number
of risks and uncertainties, including risks that BYETTA or SYMLIN,
and the revenues generated from these products, may be affected by
competition, unexpected new data, safety and technical issues, or
manufacturing and supply issues; risks that our financial results
may fluctuate significantly from period to period and may not meet
market expectations; risks that any financial guidance we provide
may not be accurate; risks that our clinical trials will not be
completed when planned, may not replicate previous results, may not
be predictive of real world use or may not achieve desired
end-points; risks that our preclinical studies may not be
predictive; risks that our NDAs for product candidates, such as the
BYDUREON NDA, or sNDAs for label expansion requests may not be
submitted timely or receive FDA approval; risks that BYDUREON, if
approved, will not be launched in a timely manner; risks that our
response to the FDA's BYDUREON complete response letter may not be
submitted in a timely manner and/or the information we provide in
our response may not satisfy the FDA; risks that the FDA may
request additional information prior to approving BYDUREON; risks
that the BYDUREON marketing authorization application mentioned in
this press release will not be approved; risks that our expense
reductions will not be as large as we expect; risks that the
restructured operations of our sales force will not produce the
results we expect; and other risks inherent in the drug development
and commercialization process. Commercial and government
reimbursement and pricing decisions and the pace of market
acceptance may also affect the potential for BYETTA, BYDUREON or
SYMLIN. These and additional risks and uncertainties are described
more fully in the Company's recently filed Form 10-K.
Amylin disclaims any obligation to update these
forward-looking statements.
(Financial information to follow)
AMYLIN PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
|
Quarter
ended March 31,
|
|
|
2010
|
|
2009
|
|
Revenues:
|
|
|
|
|
Net product sales
|
$
172,261
|
|
$
179,332
|
|
Revenues under collaborative agreements
|
1,875
|
|
1,071
|
|
Total
revenues
|
174,136
|
|
180,403
|
|
|
|
|
|
|
Costs
and expenses:
|
|
|
|
|
Cost of goods sold
|
20,502
|
|
18,632
|
|
Selling, general and administrative
|
76,747
|
|
87,556
|
|
Research and development
|
41,827
|
|
46,748
|
|
Collaborative profit sharing
|
67,900
|
|
73,017
|
|
Total
costs and expenses
|
206,976
|
|
225,953
|
|
|
|
|
|
|
Operating
loss
|
(32,840)
|
|
(45,550)
|
|
|
|
|
|
|
Interest
and other income, net
|
(5,363)
|
|
(1,404)
|
|
|
|
|
|
|
Net
loss
|
$
(38,203)
|
|
$
(46,954)
|
|
|
|
|
|
|
Net loss
per share - basic and diluted
|
$
(0.27)
|
|
$
(0.34)
|
|
|
|
|
|
|
Shares
used in computing net loss per share - basic and diluted
|
142,702
|
|
138,804
|
|
|
|
|
|
|
|
A reconciliation of reported GAAP net loss to non-GAAP operating
loss excluding non-cash items is provided in the table that follows
(in thousands, unaudited):
|
|
|
Quarter
ended March 31,
|
|
|
2010
|
|
2009
|
|
GAAP
operating loss
|
$
(32,840)
|
|
$
(45,550)
|
|
|
|
|
|
|
Stock-based
compensation
|
9,703
|
|
10,954
|
|
Other
non-cash compensation
|
7,088
|
|
7,086
|
|
Depreciation
and amortization
|
14,153
|
|
8,722
|
|
Amortization
of deferred revenue
|
(1,875)
|
|
(1,071)
|
|
|
|
|
|
|
Non-GAAP
operating loss
|
$
(3,771)
|
|
$
(19,859)
|
|
|
|
|
|
|
|
AMYLIN PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
March
31,
|
December
31,
|
|
|
2010
|
2009
|
|
Assets
|
|
|
|
Cash,
cash equivalents and short-term investments
|
$
598,251
|
$
667,769
|
|
Accounts
receivable, net
|
56,011
|
60,732
|
|
Inventories,
net
|
93,518
|
99,700
|
|
Other
current assets
|
95,523
|
78,481
|
|
Property
and equipment, net
|
792,498
|
780,058
|
|
Other
assets
|
39,973
|
39,679
|
|
Total assets
|
$
1,675,774
|
$
1,726,419
|
|
|
|
|
|
Liabilities
and stockholders' equity
|
|
|
|
Current
liabilities
|
$
300,797
|
$
365,369
|
|
Other
liabilities, net of current portion
|
303,543
|
294,754
|
|
Long-term
debt
|
649,783
|
643,762
|
|
Stockholders'
equity
|
421,651
|
422,534
|
|
Total liabilities and stockholders'
equity
|
$
1,675,774
|
$
1,726,419
|
|
|
|
|
|
|
SOURCE Amylin Pharmaceuticals, Inc.