Product sales increased 20% over second quarter 2007 to $200 million
SAN DIEGO, July 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended
June 30, 2008. The Company reported total revenue of $222.0 million for the
second quarter, including net product sales of $200.3 million. Net loss for
the quarter ended June 30, 2008 was $64.8 million, or $0.47 per share. At
June 30, 2008, the Company held cash, cash equivalents and short-term
investments of approximately $891.0 million.
"In the second quarter we continued to make substantial progress
against our goals, with a focus on improving BYETTA and SYMLIN sales and
supporting the exenatide once weekly regulatory submission," said Daniel M.
Bradbury, President and Chief Executive Officer of Amylin Pharmaceuticals.
"SYMLIN sales continued to increase steadily and we implemented a number of
important changes in our sales and marketing approach for BYETTA to drive
growth in prescriptions with primary care physicians."
Bradbury continued, "We are encouraged by the scientific community's
strong interest in BYETTA and exenatide once weekly (investigational
therapy), as demonstrated by the many prominent discussions that centered
on both therapies at the American Diabetes Association's 2008 annual
meeting. It was apparent that not only is glucose control important in
managing diabetes; but how glucose control is achieved is being recognized
as an important consideration. A medicine such as BYETTA, which provides
powerful, durable glucose control with progressive weight loss and other
potential benefits, is uniquely poised to take advantage of the market's
growing appreciation for the benefits of our novel therapies."
Quarter ended June 30, 2008
Net product sales of $200.3 million for the quarter ended June 30, 2008
include $177.5 million for BYETTA(R) (exenatide) injection and $22.8
million for SYMLIN(R) (pramlintide acetate) injection. This compares to net
product sales of $167.3 million, consisting of $152.1 million for BYETTA
and $15.2 million for SYMLIN for the same period in 2007.
Revenues under collaborative agreements were $21.7 million for the
quarter ended June 30, 2008, compared to $29.6 million for the same period
in 2007. Collaborative revenues for the quarter ended June 30, 2008 consist
primarily of cost sharing payments from Eli Lilly and Company, or Lilly,
for development expenses associated with exenatide once weekly and BYETTA.
Collaborative revenues for the quarter ended June 30, 2007 included $15.0
million in milestones, earned upon Lilly's launch of BYETTA in the European
Union.
Selling, general and administrative expenses were $111.1 million for
the quarter ended June 30, 2008, compared to $93.1 million for the same
period in 2007. The increase reflects expenses associated with the recent
expansion of the Company's field force, increased promotional expenses for
BYETTA and SYMLIN, expenses associated with exenatide once weekly market
development and increases in business infrastructure to support the
Company's growth.
Research and development expenses were $75.4 million for the quarter
ended June 30, 2008, compared to $71.7 million for the same period in 2007.
The increase primarily reflects development expenses for exenatide once
weekly and growth in the Company's research capabilities. Research and
development expenses for the quarter ended June 30, 2007 included a
development milestone associated with leptin. Non-GAAP, research and
development expenses net of cost-sharing payments decreased to $54.8
million for the quarter ended June 30, 2008, compared to $58.2 million for
the same period in 2007.
Collaborative profit sharing, which represents Lilly's share of the
gross margin for BYETTA, was $79.0 million for the quarter ended June 30,
2008, compared to $70.4 million for the same period in 2007.
Net loss for the quarter ended June 30, 2008 was $64.8 million, or
$0.47 per share, compared to $45.0 million, or $0.34 per share, for the
same period in 2007.
Second quarter highlights
Highlights of Amylin's second quarter include:
BYETTA
-- Implemented the expanded and more closely aligned sales organization
with Lilly and initiated the BYETTA-CIALIS co-promotion at the end of the
quarter.
-- Introduced an expanded program to educate primary care physicians
that BYETTA is a unique solution offering the advantages of durable glucose
control and weight loss.
SYMLIN
-- Announced data showing that the use of mealtime SYMLIN with basal
insulin therapy for 24 weeks resulted in more patients with type 2 diabetes
achieving improved glucose control, without weight gain or hypoglycemia,
compared to the use of rapid-acting insulin (RAI) with basal insulin.
Exenatide once weekly
-- Held pre-NDA meeting with the FDA and gained clarity on its
regulatory path forward and remain confident that data from the DURATION-1
clinical study provides the necessary safety and efficacy data for an NDA
submission. The Company remains on track to submit an NDA for exenatide
once weekly to the FDA by the end of the first half of 2009 with
opportunity for acceleration of the filing.
-- Announced results from a 52-week open-label clinical study that
showed the durable efficacy of exenatide once weekly. Patients taking
exenatide once weekly experienced an average A1C decline of 2.0 percent
with 9.5 pound weight loss, and over the course of one year, sustained a
similar improvement in glucose control compared to those receiving
treatment for 30 weeks.
-- Manufactured and shipped exenatide once weekly at commercial scale
for use in ongoing and planned clinical programs during the third quarter
of 2008.
-- Initiated DURATION-3, the second of three planned superiority
clinical trials of exenatide once weekly, comparing exenatide once weekly
to insulin glargine in patients using oral diabetes medications. Results
from this study are expected in the first half of 2009.
Obesity
-- Initiated a Phase 2B clinical study evaluating various dosing
combinations of pramlintide, an analog of the natural hormone amylin, and
recombinant human leptin (r-metHuLeptin; metreleptin) for the treatment of
obesity. The objective of this dose-ranging study is to support dose
selection for Phase 3, and to guide the development of a delivery system
for this combination regimen.
Six months ended June 30, 2008
Total revenues for the six months ended June 30, 2008 were $419.3
million. This includes net product sales of $379.1 million, including
$336.0 million for BYETTA and $43.1 million for SYMLIN. This compares to
net product sales of $329.3 million, consisting of $298.6 million for
BYETTA and $30.7 million for SYMLIN for the same period in 2007.
Revenues under collaborative agreements were $40.2 million for the six
months ended June 30, 2008, compared to $39.6 million for the same period
in 2007. Collaborative revenues for the six months ended June 30, 2008
consist primarily of cost sharing payments from Lilly for development
expenses associated with exenatide once weekly and BYETTA. Collaborative
revenues for the six months ended June 30, 2007 included $15.0 million in
milestones, earned upon Lilly's launch of BYETTA in the European Union.
Selling, general and administrative expenses were $209.3 million for
the six months ended June 30, 2008, compared to $180.9 million for the same
period in 2007. The increase primarily reflects increased promotional
expenses for BYETTA and SYMLIN, expenses associated with exenatide once
weekly market development, including field force expansion, and increases
in business infrastructure to support the Company's growth.
Research and development expenses were $152.6 million for the six
months ended June 30, 2008, compared to $131.3 million for the same period
in 2007. The increase reflects increased development expenses for exenatide
once weekly. Non-GAAP, research and development expenses net of
cost-sharing payments increased to $114.6 million for the six months ended
June 30, 2008, compared to $108.8 million for the same period in 2007.
Collaborative profit sharing was $148.9 million for the six months
ended June 30, 2008, compared to $137.3 million for the same period in
2007.
Net loss was $133.6 million, or $0.98 per share for the six months
ended June 30, 2008, compared to $94.4 million, or $0.72 per share, for the
same period in 2007.
Conference Call
Amylin will Webcast its Quarterly Update Conference Call today at 5:00
p.m. ET/2:00 p.m. PT. The call will be Webcast live through Amylin's
corporate Web site, http://www.amylin.com, and a recording will be made
available following the close of the call.
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, and information
regarding assumptions for the remainder of 2008 operations. For those
without access to the Internet, the live call may be accessed by phone by
calling (866) 244-4530 (U.S./Canada) or (703) 639-1173 (international),
Conference ID# 1262019. 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) 266-2081 (U.S./Canada) or (703) 925-2533
(international), Conference ID# 1262019.
Note Regarding Use of Non-GAAP Financial Measures
Amylin reports non-GAAP, research and development expenses net of
cost-sharing payments, which is a non-GAAP financial measure. The Company
believes that investors' understanding of Amylin's net investment in
research and development activities 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 information should be considered in addition to, and not as a
substitute for, or superior to, financial measures calculated in accordance
with GAAP. A reconciliation of reported GAAP research and development
expenses to non-GAAP research and development expenses, net of cost-sharing
payments, is provided in the table that follows (in thousands, unaudited):
Quarter ended June 30, Six months ended June 30,
2008 2007 2008 2007
GAAP research and
development expenses $ 75,401 $ 71,691 $ 152,607 $ 131,255
Cost-sharing payments (20,612) (13,545) (38,057) (22,448)
Non-GAAP net research
and development
expenses, net of cost-
sharing payments $ 54,789 $ 58,146 $ 114,550 $ 108,807
About Amylin
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate)
injection and BYETTA(R) (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 with over 2,000 employees
nationwide. Further information on Amylin Pharmaceuticals is available at
http://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 may be affected by
competition, unexpected new data, 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 or may not replicate previous
results; risks that our preclinical studies may not be predictive; risks
that our NDAs for product candidates or sNDAs for label expansion requests,
such as exenatide once weekly NDA or the BYETTA monotherapy sNDA, may not
be submitted timely or receive FDA approval; risks that we may not be able
to complete our manufacturing facility on a timely basis; 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 or SYMLIN. 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,
2008 2007 2008 2007
Revenues:
Net product sales $ 200,335 $ 167,337 $ 379,056 $ 329,340
Revenues under
collaborative
agreements 21,684 29,616 40,200 39,591
Total revenues 222,019 196,953 419,256 368,931
Costs and expenses:
Cost of goods sold 24,682 14,362 46,706 29,572
Selling, general and
administrative 111,088 93,121 209,331 180,908
Research and
development
75,401 71,691 152,607 131,255
Collaborative
profit sharing 78,950 70,355 148,851 137,302
Total costs and
expenses 290,121 249,529 557,495 479,037
Operating loss (68,102) (52,576) (138,239) (110,106)
Interest income, net 3,286 7,553 4,626 15,669
Net loss $ (64,816) $ (45,023) $ (133,613) $ (94,437)
Net loss per
share - basic and
diluted $ (0.47) $ (0.34) $ (0.98) $ (0.72)
Shares used in
computing net loss
per share - basic
and diluted 137,142 131,774 136,500 131,416
AMYLIN PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
June 30, December 31,
2008 2007
Assets
Cash, cash equivalents and
short-term investments $ 890,864 $ 1,130,415
Accounts receivable, net 65,638 73,579
Inventories, net 100,166 100,214
Other current assets 33,480 32,100
Property, plant and equipment, net 548,290 390,301
Other assets 44,830 47,602
Total assets $ 1,683,268 $ 1,774,211
Liabilities and stockholders' equity
Current liabilities $ 260,207 $ 287,284
Other liabilities, net
of current portion 33,213 34,109
Long-term debt, net
of current portion 884,375 900,000
Stockholders' equity 505,473 552,818
Total liabilities and
stockholders' equity $ 1,683,268 $ 1,774,211
SOURCE Amylin Pharmaceuticals Inc.
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Related links:
http://www.amylin.com/
CONTACT:
Financial, Michael York, Senior Director,
Investor Relations, +1-858-552-2200 ext. 8602, or Media, Anne
Erickson, Director, Public Relations, +1-858-552-2200 ext. 4443,
both of Amylin Pharmaceuticals, Inc.
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