Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported
financial results for the quarter ended March 31, 2012.
- Total revenue for the quarter ended
March 31, 2012 was $153.7 million, which included net product sales
of $150.6 million.
- Non-GAAP operating loss for the quarter
ended March 31, 2012 was $30.1 million, compared to $3.1 million
for the same period in 2011. The increase in non-GAAP operating
loss reflects investments to support the U.S. launch of BYDUREON™
(exenatide extended-release for injectable suspension).
- Cash, cash equivalents, short-term
investments and restricted cash totaled $315.3 million at the end
of the quarter.
"While still early, we have seen a positive uptake of BYDUREON
in the U.S. and Europe, and are pleased with the execution of our
U.S. commercial launch," said Daniel M. Bradbury, president and
chief executive officer of Amylin Pharmaceuticals. "We have also
made important progress against our other corporate priorities
during the quarter. The recently expanded use of BYETTA with
insulin glargine in the U.S. and Europe enables patients to achieve
better glycemic control, without weight gain or an increased risk
of hypoglycemia. In addition, we recently completed the Biologics
License Application submission to the FDA for the use of
metreleptin to treat diabetes and/or hypertriglyceridemia in
pediatric and adult patients with rare forms of lipodystrophy and
are excited to advance this drug for patients who currently have
such limited treatment options.”
Highlights of Amylin’s First Quarter and Recent
Activities
- Launched BYDUREON in the U.S., the
first and only once-weekly medication approved for the treatment of
type 2 diabetes.
- Received approval from the European
Commission for a new use of BYETTA® (exenatide twice-daily) as an
adjunctive therapy to basal insulin, with or without metformin
and/or Actos® (pioglitazone), for the treatment of type 2 diabetes
in adults who have not achieved adequate glycemic control with
these agents.
- Completed an underwritten public
offering of 13.5 million shares of common stock, resulting in net
proceeds to Amylin of $206.9 million.
- Completed the Biologics License
Application (BLA) submission to the U.S. Food and Drug
Administration (FDA) for the use of metreleptin to treat diabetes
and/or hypertriglyceridemia (high levels of triglycerides in the
bloodstream) in pediatric and adult patients with rare forms of
lipodystrophy, a life-threatening, ultra-orphan rare disease.
Financial ResultsNet product sales of $150.6 million for
the quarter ended March 31, 2012 include $120.6 million for BYETTA®
(exenatide) injection, $23.1 million for SYMLIN® (pramlintide
acetate) injection and $6.9 million for BYDUREON. This compares to
net product sales of $150.8 million, consisting of $128.0 million
for BYETTA and $22.8 million for SYMLIN for the same period in
2011. There were no BYDUREON revenues during the same period in
2011 because BYDUREON was not yet approved. Revenues under
collaborative agreements were $3.1 million for the quarter ended
March 31, 2012, compared to $1.9 million for the same period in
2011.
Since obtaining exclusive rights to develop and commercialize
exenatide in the U.S. in late 2011, the current year financial
results no longer reflect the cost-sharing reimbursement for
exenatide-related expenses. As a result, selling, general and
administrative expenses and research and development expenses for
the quarter ended March 31, 2012 increased over the quarter ended
March 31, 2011.
Selling, general and administrative expenses increased to $110.3
million for the quarter ended March 31, 2012 from $64.6 million for
the same period in 2011. The increase primarily reflects expenses
associated with the U.S. launch of BYDUREON, including the
expansion of the Company’s sales force, and the absence of
cost-sharing reimbursements for exenatide-related expenses.
Research and development expenses increased to $51.2 million for
the quarter ended March 31, 2012 from $41.9 million for the same
period in 2011, largely due to the absence of cost-sharing
reimbursements for exenatide-related expenses. The increase is
offset by a reduction of research and development expense caused by
the transfer of BYDUREON manufacturing costs from research and
development into cost of goods sold beginning in the quarter ended
March 31, 2012, the first period of U.S. commercialization of
BYDUREON.
Collaborative profit sharing, which represented Eli Lilly and
Company’s share of the gross margin for exenatide under the
now-terminated collaboration agreement, reduced to zero for the
quarter ended March 31, 2012, compared to $59.9 million for the
same period in 2011. The termination of the Lilly collaboration
resulted in the termination of gross margin sharing with Lilly in
the U.S. effective December 1, 2011.
Interest and other expense, net, primarily includes interest
expense on the Company’s debt, including the revenue sharing
obligation (RSO) payable to Lilly, and increased to $44.7 million
for the quarter ended March 31, 2012 from $8.2 million in the same
period of 2011.
Non-GAAP operating loss was $30.1 million for the quarter ended
March 31, 2012 compared to $3.1 million for the same period in
2011. Non-GAAP net loss was $34.0 million, or $0.23 per share, for
the quarter ended March 31, 2012, compared to $6.6 million, or
$0.05 per share, for the same period in 2011. GAAP net loss was
$99.0 million, or $0.66 per share, for the quarter ended March 31,
2012, compared to GAAP net loss of $37.3 million, or $0.26 per
share, for the same period in 2011.
Conference CallAmylin will webcast its Quarterly Update
Conference 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 2012 financial results. A
slide presentation accompanying the conference call is available
through the “Investors” section of Amylin’s corporate website at
www.amylin.com.
To access the webcast, please log on to http://www.amylin.com
approximately 15 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
(888) 989-4344 (U.S./Canada) or (312) 470-7140 (international),
participant passcode number 7994841. 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 (800) 756-0205
(U.S./Canada) or (203) 369-3002 (international).
Note Regarding Use of Non-GAAP Financial MeasuresAmylin
reports non-GAAP operating income or loss adjusted for non-cash
items and other items such as restructuring charges, and the 15%
payment on exenatide global sales, which is a non-GAAP financial
measure. The Company believes that investors’ understanding of its
progress towards its stated goal of generating sustainable positive
non-GAAP operating results 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.
Additionally, Amylin reports non-GAAP net loss adjusted for
non-cash items and other items such as restructuring charges, and
the 15% payment on exenatide global sales, which is also a non-GAAP
financial measure. These non-GAAP financial measures should be
considered in addition to, and not as a substitute for, or superior
to, financial measures calculated in accordance with GAAP.
About Amylin PharmaceuticalsAmylin Pharmaceuticals is a
biopharmaceutical company dedicated to improving lives of patients
through the discovery, development and commercialization of
innovative medicines. Amylin is committed to delivering novel
therapies that transform the way diabetes and other metabolic
disorders are treated. Amylin is headquartered in San Diego,
Calif., and has a commercial manufacturing facility in Ohio. More
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, SYMLIN or
BYDUREON, and the revenues or royalties 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 or BLAs for our
product candidates, including the BLA mentioned in this press
release, or sNDAs for label expansion requests, may not be
submitted timely or receive FDA approval; risks that the launch of
BYDUREON will not produce the results we expect; risks that we will
not be successful in our efforts to secure an exenatide development
and commercial partner outside the U.S.; risks that our expense
reductions will not be as large as 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, SYMLIN or BYDUREON. 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.
AMYLIN PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except per share data)
(unaudited) Quarter ended March 31,
2012 2011 Revenues:
Net product sales $ 150,586 $ 150,839 Revenues under
collaborative agreements 3,100 1,875
Total revenues 153,686 152,714 Costs and expenses: Cost of
goods sold 34,557 12,544 Selling, general and administrative
110,348 64,625 Research and development 51,236 41,915 Collaborative
profit sharing - 59,851 Restructuring 151 2,858 Loss on fair value
adjustments 3,947 - Amortization of acquired intangible assets
7,780 - Total costs and expenses
208,019 181,793 Operating loss (54,333 ) (29,079 )
Interest and other expense, net (44,707 ) (8,245 )
Net loss $ (99,040 ) $ (37,324 ) Net loss per share -
basic and diluted $ (0.66 ) $ (0.26 ) Shares used in
computing net loss per share - basic and diluted 150,365
144,787
A reconciliation of reported GAAP operating loss to non-GAAP
operating loss, excluding non-cash items, and GAAP net loss to
non-GAAP net loss excluding non-cash items is provided in the
tables that follow (in thousands, unaudited):
Quarter ended March 31, 2012
2011 GAAP operating loss $ (54,333 )
$ (29,079 ) Revenue sharing obligation note payments
on net exenatide sales (19,127 ) - Stock-based compensation 9,158
7,917 Other non-cash compensation 7,698 4,238 Depreciation and
amortization 24,242 12,888 Amortization of deferred revenue (1,875
) (1,875 ) Restructuring 151 2,858 Loss on fair value adjustments
3,947 - Non-GAAP operating loss
$ (30,139 ) $ (3,053 )
Quarter ended March 31,
2012 2011 GAAP net loss $
(99,040 ) $ (37,324 ) Revenue sharing obligation note
payments on net exenatide sales (19,127 ) - Stock-based
compensation 9,158 7,917 Other non-cash compensation 7,698 4,238
Depreciation and amortization 24,242 12,888 Amortization of
deferred revenue (1,875 ) (1,875 ) Restructuring 151 2,858 Non-cash
interest expense 35,606 4,717 Loss on fair value adjustments
9,197 ‒ Non-GAAP net loss $ (33,990 ) $ (6,581
) Non-GAAP net loss per share - basic and diluted $ (0.23 )
$ (0.05 ) Shares used in computing non-GAAP
net loss per share - basic and diluted
150,365 144,787
AMYLIN
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (in thousands) March
31, December 31, 2012 2011
Assets Cash, cash equivalents and short-term
investments $ 304,626 $ 204,065 Restricted cash 10,673 10,519
Accounts receivable, net 52,832 45,489 Inventories, net 135,507
111,959 Other current assets 57,611 49,158 Property and equipment,
net 829,707 831,162 Intangible and other assets related to economic
rights reacquired or to be reacquired 593,758 601,539 Other assets
22,557 16,308 Total assets $ 2,007,271 $
1,870,199
Liabilities and stockholders’ equity
Current liabilities 290,206 296,017 Other liabilities, net of
current portion 102,806 137,520 Revenue sharing obligation, net of
current portion 947,092 924,306 Long-term debt 658,876 651,101
Stockholders’ equity (deficit) 8,291 (138,745 ) Total
liabilities and stockholders’ equity (deficit) $ 2,007,271 $
1,870,199
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