SAN DIEGO, July 26, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial
results for the quarter ended June 30,
2011.
- Total revenue was $158.1 million
for the quarter ended June 30, 2011,
which included net product sales of $154.8
million
- Non-GAAP operating loss was $1.7
million, compared to $7.4
million for the same period in 2010
- GAAP net loss was $31.4 million,
or $0.22 per share, compared to
$44.2 million, or $0.31 per share, for the same period in 2010
- The Company held cash, cash equivalents, short-term investments
and restricted cash of $443.9
million
"During this past quarter, we demonstrated significant progress
with the exenatide program. Specifically, the recent approval of
BYDUREON in Europe provides
patients with the first ever once weekly therapy for type 2
diabetes," said Daniel M. Bradbury,
president and chief executive officer of Amylin Pharmaceuticals.
"With clean results from the recently completed thorough QT study
for exenatide now in hand, we are set to submit our response to the
FDA and take a major step toward making this important therapy
available to patients in the U.S."
Highlights of Amylin's Second Quarter and Recent
Activities
BYETTA
- Announced results from a retrospective analysis of a healthcare
claims database at the American Diabetes Association's (ADA's)
annual meeting that demonstrated that use of BYETTA® (exenatide)
injection was associated with a 54% lower likelihood of heart
failure compared with other diabetes therapies
BYDUREON
- Reported results from a thorough QT (tQT) study that showed
exenatide, at and above therapeutic levels, did not prolong the
corrected QT interval in healthy individuals
- Announced that the European Commission granted marketing
authorization to BYDUREON™ (exenatide 2 mg powder and solvent for
prolonged release suspension for injection)
- Partner Eli Lilly and Company launched BYDUREON in the
United Kingdom in July, triggering
a $15 million milestone payment that
will be recognized in the third quarter
- Lilly filed for regulatory authorization of BYDUREON in
Japan
- Presented compelling efficacy and safety data at the ADA
meeting, including data that showed:
- Patients receiving BYDUREON™ (exenatide extended-release for
injectable suspension) experienced a significant reduction in A1C
and weight compared to baseline after three years
- Patients treated with BYDUREON experienced significantly
greater A1C reduction from baseline, sustained weight loss and a
lower risk of hypoglycemia than patients treated with Lantus®
(insulin glargine) after 84 weeks
Exenatide Once Monthly
- Announced additional results at the ADA's annual meeting from a
study of a once-monthly injectable suspension formulation of
exenatide which showed a clinical profile comparable to BYDUREON,
with substantial improvements in glycemic control, including
reductions in A1C and fasting plasma glucose
SYMLIN
- Presented a new analysis at the ADA annual meeting that showed
SYMLIN® (pramlintide acetate) injection helped reduce A1C, insulin
use and body weight in patients with type 1 diabetes who used
insulin pumps
- Entered into a research collaboration agreement with the
Juvenile Diabetes Research Foundation (JDRF) to provide financial
support for a series of clinical studies to investigate the
feasibility of mixing pramlintide with insulin to treat type 1
diabetes
Lipodystrophy Program
- Presented analysis at the American Association of Clinical
Endocrinologists (AACE) annual meeting that demonstrated
metreleptin led to long-term improvements in diabetes and lipid
control in patients with lipodystrophy. Improvements were
generally sustained for up to several years of treatment
- Presented results at the Endocrine Society (ENDO) annual
meeting that showed treatment with metreleptin improved diabetes
and lipid control in patients with partial lipodystrophy
Quarter Ended June 30,
2011
Net product sales of $154.8
million for the quarter ended June
30, 2011 include $129.0
million for BYETTA and $25.8
million for SYMLIN. This compares to net product sales of
$162.5 million, consisting of
$140.7 million for BYETTA and
$21.8 million for SYMLIN for the same
period in 2010. Revenues under collaborative agreements were
$3.3 million for the quarter ended
June 30, 2011, compared to
$1.9 million for the same period in
2010 and consist of the amortization of up-front fees received and
royalties earned under the Company's collaboration agreements.
Selling, general and administrative expenses decreased to
$65.2 million for the quarter ended
June 30, 2011 from $71.0 million for the same period in 2010. The
decrease primarily reflects lower sales force spending, lower
expenses associated with BYDUREON pre-launch activities and a
reduced cost structure associated with the Company's efforts to
drive efficiencies in the business.
Research and development expenses decreased to $45.1 million for the quarter ended June 30, 2011 from $49.2
million for the same period in 2010. The decrease reflects
reduced spending related to efforts to manage our expenses,
partially offset by increased spending on our BYDUREON
cardiovascular outcomes study (EXSCEL) and lipodystrophy
development program.
Collaborative profit sharing, which represents Lilly's share of
the gross margin for BYETTA, was $60.7
million for the quarter ended June
30, 2011, compared to $64.9
million for the same period in 2010.
Non-GAAP operating loss was $1.7
million for the quarter ended June
30, 2011, a 77% improvement compared to $7.4 million for the same period in 2010. Net
loss excluding restructuring charges was $31.3 million, or $0.21 per share, for the quarter ended
June 30, 2011, an improvement of 23%
compared to $40.8 million, or
$0.28 per share, for the same period
in 2010. GAAP net loss was $31.4
million, or $0.22 per share,
for the quarter ended June 30, 2011,
compared to $44.2 million, or
$0.31 per share, for the same period
in 2010.
Six Months Ended June 30,
2011
Total revenues for the six months ended June 30, 2011 were $310.8
million. This includes net product sales of $305.6 million, including $257.0 million for BYETTA and $48.6 million for SYMLIN. This compares to net
product sales of $334.8 million,
consisting of $290.5 million for
BYETTA and $44.3 million for SYMLIN
for the same period in 2010.
Revenues under collaborative agreements were $5.2 million for the six months ended
June 30, 2011, compared to
$3.8 million for the same period in
2010 and consist of the amortization of up-front fees received and
royalties earned under the Company's collaboration agreements.
Selling, general and administrative expenses decreased to
$129.8 million for the six months
ended June 30, 2011 from $144.3 million for the same period in 2010. The
10% decrease primarily reflects lower sales force spending,
decreased expenses associated with BYDUREON pre-launch activities,
and reduced business infrastructure spending resulting from
continued efforts to drive efficiencies in the business.
Research and development expenses decreased to $87.0 million for the six months ended
June 30, 2011 from $94.4 million for the same period in 2010. The
8.0% decrease reflects reduced spending related to our efforts to
manage our expenses, partially offset by increased spending on our
BYDUREON cardiovascular outcomes study (EXSCEL) and lipodystrophy
development program.
Collaborative profit sharing was $120.5
million for the six months ended June
30, 2011, compared to $132.8
million for the same period in 2010.
Non-GAAP operating loss was $5.0
million for the six months ended June
30, 2011, a 55% improvement compared to $11.2 million for the same period in 2010. Net
loss excluding restructuring charges was $65.7 million, or $0.45 per share, for the six months ended
June 30, 2011, a 17% improvement
compared to $79.0 million, or
$0.55 per share, for the six months
ended June 30, 2010. GAAP net loss
for the six months ended June 30,
2011 was $68.7 million, or
$0.47 per share, compared to
$82.4 million, or $0.58 per share for the same period in 2010.
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 second quarter 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 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) 857-5738 (U.S./Canada) or (415) 228-4970 (international),
participant passcode number 75593. 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) 513-1173
(U.S./Canada) or (402) 344-6829
(international).
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
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. 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, and has a
commercial manufacturing facility in Ohio. 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, 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 the CMC section
of the metreleptin BLA may not be submitted in a timely fashion or
that the BLA will not receive regulatory approval; risks that our
preclinical studies or the data analyses mentioned in this press
release 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 will not be approved in Japan; 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 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-Q. 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 June 30,
|
|
Six months
ended June 30,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product
sales
|
$ 154,789
|
|
$ 162,511
|
|
$ 305,628
|
|
$ 334,772
|
|
Revenues under
collaborative agreements
|
3,276
|
|
1,875
|
|
5,151
|
|
3,750
|
|
Total revenues
|
158,065
|
|
164,386
|
|
310,779
|
|
338,522
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
11,843
|
|
14,462
|
|
24,387
|
|
34,964
|
|
Selling, general and
administrative
|
65,217
|
|
70,999
|
|
129,842
|
|
144,312
|
|
Research and
development
|
45,069
|
|
49,158
|
|
86,984
|
|
94,419
|
|
Collaborative profit
sharing
|
60,652
|
|
64,907
|
|
120,503
|
|
132,807
|
|
Restructuring
|
126
|
|
3,424
|
|
2,984
|
|
3,424
|
|
Total costs and
expenses
|
182,907
|
|
202,950
|
|
364,700
|
|
409,926
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
(24,842)
|
|
(38,564)
|
|
(53,921)
|
|
(71,404)
|
|
|
|
|
|
|
|
|
|
|
Interest and other income,
net
|
(6,566)
|
|
(5,632)
|
|
(14,811)
|
|
(10,995)
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$ (31,408)
|
|
$ (44,196)
|
|
$ (68,732)
|
|
$ (82,399)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and
diluted
|
$ (0.22)
|
|
$ (0.31)
|
|
$ (0.47)
|
|
$ (0.58)
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net
loss per share - basic and diluted
|
145,849
|
|
143,585
|
|
145,321
|
|
143,146
|
|
|
|
|
|
|
|
|
|
|
|
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 June 30,
|
|
Six months
ended June 30,
|
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
|
GAAP operating loss
|
$ (24,842)
|
|
$ (38,564)
|
|
$ (53,921)
|
|
$ (71,404)
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
7,952
|
|
10,502
|
|
15,868
|
|
20,204
|
|
Other non-cash
compensation
|
4,343
|
|
4,522
|
|
8,582
|
|
11,610
|
|
Depreciation and
amortization
|
12,553
|
|
14,578
|
|
25,265
|
|
28,731
|
|
Amortization of deferred
revenue
|
(1,875)
|
|
(1,875)
|
|
(3,750)
|
|
(3,750)
|
|
Restructuring
|
126
|
|
3,424
|
|
2,984
|
|
3,424
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP operating
loss
|
$ (1,743)
|
|
$
(7,413)
|
|
$ (4,972)
|
|
$ (11,185)
|
|
|
|
|
|
|
|
|
|
|
|
AMYLIN
PHARMACEUTICALS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
|
|
|
|
|
June
30,
|
December
31,
|
|
|
2011
|
2010
|
|
Assets
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$ 428,905
|
$ 442,663
|
|
Restricted
cash
|
15,000
|
15,000
|
|
Accounts receivable,
net
|
47,779
|
54,645
|
|
Inventories,
net
|
103,171
|
118,629
|
|
Other current
assets
|
35,484
|
45,458
|
|
Property and
equipment, net
|
817,644
|
811,745
|
|
Other
assets
|
35,473
|
43,289
|
|
Total
assets
|
$ 1,483,456
|
$ 1,531,429
|
|
|
|
|
|
Liabilities
and stockholders' equity
|
|
|
|
Current
liabilities
|
$ 200,288
|
$ 401,595
|
|
Other liabilities,
net of current portion
|
319,405
|
317,654
|
|
Long-term
debt
|
647,052
|
468,697
|
|
Stockholders'
equity
|
316,711
|
343,483
|
|
Total
liabilities and stockholders' equity
|
$ 1,483,456
|
$ 1,531,429
|
|
|
|
|
|
|
SOURCE Amylin Pharmaceuticals, Inc.