Net Product Sales Increased 9% Over 2007 to $765.3 Million;
Positive Operating Cash Flow Targeted By End of 2010 SAN DIEGO,
Calif., Jan. 27 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) today reported financial results for the quarter
and year ended December 31, 2008. The Company reported total
revenue of $202.5 million for the quarter ended December 31, 2008,
which includes net product sales of $184.9 million. Net loss,
excluding a charge of $54.9 million associated with the Company's
strategic restructuring and workforce reduction in the fourth
quarter, was $49.1 million, or $0.36 per share. Non-GAAP operating
loss, excluding non-cash items and the restructuring charge, was
$20.2 million for the quarter ended December 31, 2008, compared to
$47.0 million for the same period in 2007. GAAP net loss including
the restructuring charge was $104.1 million, or $0.76 per share for
the quarter ended December 31, 2008. For the year ended December
31, 2008, the Company reported total revenue of $840.1 million,
which includes net product sales of $765.3 million, a 9% increase
over 2007. Net loss, excluding the restructuring charge of $54.9
million, was $260.5 million, or $1.90 per share. For the year ended
December 31, 2008 non-GAAP operating loss, excluding non-cash items
and the restructuring charge, was $137.2 million compared to $147.2
million for the same period in 2007. GAAP net loss for the year
ended December 31, 2008 was $315.4 million, or $2.30 per share. At
December 31, 2008 the Company held cash, cash equivalents and
short-term investments of $816.8 million. "In 2008, we continued to
deliver year over year revenue growth in a challenging market
environment," said Daniel M. Bradbury, president and chief
executive officer, Amylin Pharmaceuticals. "In 2009, we will create
value for patients and our shareholders by capitalizing on key
market drivers, such as the American Diabetes Association's
inclusion of BYETTA as the only new addition to their treatment
guidelines. Our focus remains on increasing BYETTA revenue,
submitting the New Drug Application (NDA) for exenatide once
weekly, significantly improving operating results and progressing
toward positive operating cash flow by the end of 2010." Quarter
ended December 31, 2008 Net product sales of $184.9 million for the
quarter include sales of $162.7 million for BYETTA(R) (exenatide)
injection and $22.2 million for SYMLIN(R) (pramlintide acetate)
injection. This compares to net product sales of $194.7 million,
consisting of $176.3 million for BYETTA and $18.4 million for
SYMLIN for the same period in 2007. Revenue under collaborative
agreements was $17.6 million for the quarter ended December 31,
2008, compared to $27.3 million for the same period in 2007. The
decrease reflects lower cost-sharing payments from Eli Lilly and
Company for BYETTA and exenatide once weekly development expenses.
Selling, general and administrative expenses decreased to $86.1
million for the quarter ended December 31, 2008 from $122.4 million
for the same period in 2007. The decrease primarily reflects lower
promotional spending for BYETTA and the Company's reduced cost
structure following its restructuring. Research and development
expenses decreased to $67.0 million for the quarter ended December
31, 2008 from $83.9 million for the same period in 2007. The
decrease primarily reflects lower development expenses for
exenatide once weekly and the Company's reduced cost structure
following its restructuring. Collaborative profit sharing, which
represents Lilly's share of the gross margin for BYETTA, was $73.2
million for the quarter ended December 31, 2008, compared to $78.6
million for the same period in 2007. The Company's results for the
quarter ended December 31, 2008 include a charge of $54.9 million
associated with the Company's restructuring. This charge consists
primarily of one-time expenses related to facility leases,
including impairments of related tenant improvements and employee
termination benefits. Net loss excluding this charge was $49.1
million, or $0.36 per share. Non-GAAP operating loss, excluding
non-cash items and the restructuring charge, was $20.2 million for
the quarter ended December 31, 2008 compared to $47.0 million for
the same period in 2007. Including the restructuring charge, GAAP
net loss was $104.1 million, or $0.76 per share, for the quarter
ended December 31, 2008, compared to $76.9 million, or $0.57 per
share, for the same period in 2007. Fourth quarter highlights
Highlights of Amylin's fourth quarter and recent activities
include: BYETTA -- Communicated the addition of BYETTA to the
American Diabetes Association's treatment guidelines for the
medical management of type 2 diabetes. Exenatide Once Weekly --
Announced that the ongoing extension of the DURATION-1 study is
appropriate to use as the basis for demonstrating comparability
between intermediate-scale clinical trial material made in
Alkermes' manufacturing facility, and commercial-scale drug product
made at Amylin's manufacturing facility based on feedback from the
U.S. Food and Drug Administration (FDA). -- Reaffirmed plans for
exenatide once weekly NDA submission to the FDA by the end of the
first half of 2009. -- Completed enrollment of DURATION-3, the
third in a planned program of superiority clinical studies 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 third quarter of 2009. -- Initiated
DURATION-4 clinical study, comparing exenatide once weekly as a
monotherapy treatment to either metformin, a thiazolidinedione
(TZD) or a dipeptidyl peptidase-4 (DPP-4) inhibitor. Results from
this study are expected in 2010. Corporate -- Implemented a
strategic restructuring that reduced the Company's San Diego
workforce by approximately 25 percent, and announced plans to have
a positive operating cash flow (defined as positive non-GAAP
operating results) by the end of 2010. Obesity Program -- Presented
novel data on Amylin's promising obesity pipeline at The Obesity
Society's Scientific Conference that supported the therapeutic
potential of the integrated neurohormonal approach to obesity
pharmacotherapy. Year ended December 31, 2008 Total revenue for the
year ended December 31, 2008 was $840.1 million. This includes net
product sales of $765.3 million, consisting of $678.5 million for
BYETTA and $86.8 million for SYMLIN. This compares to total revenue
of $781.0 million for the same period in 2007, including net
product sales of $701.5 million consisting of $636.0 million for
BYETTA and $65.5 million for SYMLIN. Revenues under collaborative
agreements were $74.8 million for the year ended December 31, 2008,
compared to $79.5 million for the same period in 2007. Revenues
under collaborative agreements consist primarily of cost-sharing
payments from Lilly for BYETTA and exenatide once weekly
development expenses. Collaborative revenues for the year ended
December 31, 2007 included $15.0 million in milestones earned
primarily upon Lilly's launch of BYETTA in the European Union.
Selling, general and administrative expenses increased to $395.1
million for the year ended December 31, 2008 from $391.0 million
for the same period in 2007. Selling general and administrative
expenses consist of continued investments in promotional spending
for BYETTA and SYMLIN and business infrastructure to support the
Company's operations. Research and development expenses increased
to $293.1 million for the year ended December 31, 2008 from $276.6
million for the same period in 2007. The increase primarily
reflects continued investments in exenatide once weekly and the
Company's obesity development programs. Collaborative profit
sharing, which represents Lilly's 50% share of BYETTA gross margin,
was $302.6 million for the year ended December 31, 2008 compared to
$290.9 million for the same period in 2007. Non-GAAP operating
loss, excluding non-cash items and the restructuring charge, was
$137.2 million for the year ended December 31, 2008 compared to
$147.2 million for the same period in 2007. Net loss excluding the
restructuring charge was $260.5 million, or $1.90 per share. GAAP
net loss for the year ended December 31, 2008 was $315.4 million,
or $2.30 per share, compared to $211.1 million, or $1.59 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 fourth quarter and 2008 financial results, and
information regarding guidance for 2009 operations. For those
without access to the Internet, the live call may be accessed by
phone by calling (888) 713-4209 (U.S./Canada) or (617) 213-4863
(international), Conference ID# 59487694. 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), Conference ID#
22593977. Note Regarding Use of Non-GAAP Financial Measures Amylin
reports non-GAAP operating loss excluding non-cash items and other
one-time items, 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. Amylin also 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. 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
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. 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 the exenatide once weekly NDA mentioned in this press
release, may not be submitted timely or receive FDA approval; risks
that our expense reductions will not be as large as we expect;
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
December 31, Year ended December 31, 2008 2007 2008 2007 Revenues:
Net product sales $184,922 $194,719 $765,342 $701,450 Revenues
under collaborative agreements 17,569 27,319 74,767 79,547 Total
revenues 202,491 222,038 840,109 780,997 Costs and expenses: Cost
of goods sold 21,495 22,135 91,596 65,457 Selling, general and
administrative 86,105 122,356 395,112 390,982 Research and
development 67,022 83,888 293,095 276,600 Collaborative profit
sharing 73,182 78,606 302,600 290,934 Restructuring 54,926 - 54,926
- Total costs and expenses 302,730 306,985 1,137,329 1,023,973
Operating loss (100,239) (84,947) (297,220) (242,976) Interest
(expense) income, net (3,832) 8,006 (3,242) 31,840 Loss on
impairment of equity method and available for sale investments - -
(14,943) - Net loss $(104,071) $(76,941) $(315,405) $(211,136) Net
loss per share - basic and diluted $(0.76) $(0.57) $(2.30) $(1.59)
Shares used in computing net loss per share - basic and diluted
137,623 134,896 137,006 132,621 A reconciliation of reported GAAP
net loss to non-GAAP operating loss excluding non-cash items, and
other one-time items is provided in the table that follows (in
thousands, unaudited): Quarter ended December 31, Year ended
December 31, 2008 2007 2008 2007 GAAP operating loss $(100,239)
$(84,947) $(297,220) $(242,976) Stock-based compensation 12,104
14,837 55,115 59,064 Other non-cash compensation 5,833 18,425
24,680 21,693 Depreciation and amortization 7,161 4,700 25,280
15,049 Restructuring 54,926 - 54,926 - Non-GAAP operating loss
$(20,215) $(46,985) $(137,219) $(147,170) 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 Year ended December 31, December 31, 2008 2007 2008
2007 GAAP research and development expenses $67,022 $83,888
$293,095 $276,600 Cost-sharing payments (16,498) (26,248) (70,481)
(60,261) Non-GAAP research and development expenses, net of cost
sharing payments $50,524 $57,640 $222,614 $216,339 AMYLIN
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands) (unaudited) December 31, December 31, 2008 2007 Assets
Cash, cash equivalents and short-term investments $816,838
$1,130,415 Accounts receivable, net 62,369 73,579 Inventories, net
115,823 100,214 Other current assets 41,038 32,100 Property, plant
and equipment, net 636,922 390,301 Other assets 39,639 47,602 Total
assets $1,712,629 $1,774,211 Liabilities and stockholders' equity
Current liabilities $313,778 $287,284 Other liabilities, net of
current portion 179,227 34,109 Long-term debt, net of current
portion 868,750 900,000 Stockholders' equity 350,874 552,818 Total
liabilities and stockholders' equity $1,712,629 $1,774,211
DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: media, Alice
Izzo, +1-858-642-7272, , or investors, Michael York,
+1-858-458-8602, , both of Amylin Pharmaceuticals, Inc. Web Site:
http://www.amylin.com/
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