Net product sales increased 48% over 2006 to $701 million SAN
DIEGO, Jan. 28 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) today reported financial results for the quarter
and year ended December 31, 2007. The Company reported total
revenue of $222.0 million for the quarter ended December 31, 2007,
which includes net product sales of $194.7 million. Net loss was
$76.9 million, or $0.57 per share for the quarter ended December
31, 2007. Net loss for the quarter ended December 31, 2007 includes
a full year non-cash expense of approximately $17 million
associated with the adoption of an employee stock ownership plan
(ESOP). The Company reported total revenue of $781.0 million for
the year ended December 31, 2007, which includes net product sales
of $701.5 million. Net loss for the year ended December 31, 2007
was $211.1 million, or $1.59 per share. At December 31, 2007 the
Company held cash, cash equivalents and short-term investments of
approximately $1.1 billion. "BYETTA and SYMLIN continued to
experience growth in physician adoption and prescriptions,
generating net product sales of over $700 million. In addition, we
announced positive clinical data from our key development programs,
including exenatide once weekly, BYETTA monotherapy, and our
pramlintide-metreleptin obesity program," said Daniel M. Bradbury,
President and Chief Executive Officer of Amylin Pharmaceuticals.
"For 2008, we remain confident in prospects for the continued
growth of BYETTA and SYMLIN and we have aggressive development
plans for the year. These plans balance investments across
opportunities in the near, mid and long-term and include the
completion of our Ohio manufacturing facility, a strong clinical
program to expand and enhance the profile of exenatide once weekly,
the advancement of our obesity program, and continued investments
in discovery research." Quarter ended December 31, 2007 Net product
sales of $194.7 million for the quarter include sales of $176.3
million for BYETTA(R) (exenatide) injection and $18.4 million for
SYMLIN(R) (pramlintide acetate) injection. This compares to net
product sales of $150.6 million, consisting of $137.0 million for
BYETTA and $13.6 million for SYMLIN for the same period in 2006.
Revenue under collaborative agreements was $27.3 million for the
quarter ended December 31, 2007, compared to $12.8 million for the
same period in 2006. The increase reflects higher cost-sharing
payments from Lilly and Company to equalize development expenses
for BYETTA and exenatide once weekly. The Company's results for
quarter ended December 31, 2007 includes $17 million in full year
non-cash expense associated with the adoption of an ESOP of which
$10 million is included in selling, general and administrative
expenses and $7 million is included in research and development
expenses. The adoption of the ESOP represents a change in the
composition of the Company's equity compensation. Selling, general
and administrative expenses increased to $122.4 million for the
quarter ended December 31, 2007, compared to $89.6 million for the
same period in 2006. The increase primarily reflects increased
promotional expenses for BYETTA and SYMLIN and increased business
infrastructure to support the Company's growth. Research and
development expenses increased to $83.9 million for the quarter
ended December 31, 2007, compared to $66.2 million for the same
period in 2006. The increase primarily reflects costs associated
with the development of exenatide once weekly, including
manufacturing scale-up. Collaborative profit sharing, which
represents Lilly's share of the gross margin for BYETTA, was $78.6
million for the quarter ended December 31, 2007, compared to $63.8
million for the same period in 2006. Net loss was $76.9 million, or
$0.57 per share, for the quarter ended December 31, 2007, compared
to a net loss of $58.4 million, or $0.45 per share, for the same
period in 2006. Fourth quarter highlights Highlights of Amylin's
fourth quarter include the following: -- Positive results from a
24-week study of monotherapy, or stand alone, BYETTA in drug na�ve
patients with type 2 diabetes. The Company plans for a regulatory
submission for a monotherapy indication to the U.S. Food and Drug
Administration, or FDA, in the first half of 2008. -- Positive
results from a 30-week comparator study of exenatide once weekly
injection and BYETTA taken twice daily in patients with type 2
diabetes. The Company anticipates a regulatory submission to the
FDA by the end of the first half of 2009. -- Positive results from
a 24-week proof-of-concept study with the combination treatment of
pramlintide, an analog of human amylin, and metreleptin, an analog
of human leptin in overweight or obese subjects, validating the
Company's novel integrated neurohormonal treatment of obesity
(INTO) strategy. The Company plans for additional clinical
development in 2008, including the initiation of a Phase 2B study.
Year ended December 31, 2007 Total revenue for the year ended
December 31, 2007 was $781.0 million. This includes net product
sales of $701.5 million, consisting of $636.0 million for BYETTA
and $65.5 million for SYMLIN. This compares to total revenue of
$510.9 million for the same period in 2006, including net product
sales of $474.0 million consisting of $430.2 million for BYETTA and
$43.8 million for SYMLIN. Revenues under collaborative agreements
were $79.5 million for the year ended December 31, 2007, compared
to $36.8 million for the same period in 2006. The increase reflects
higher cost-sharing payments to equalize development expenses for
BYETTA and exenatide once weekly and $15 million in milestones
associated primarily with the launch of BYETTA in the European
Union during the second quarter of 2007. Selling, general and
administrative expenses increased to $391.0 million for the year
ended December 31, 2007, compared to $282.0 million for the same
period in 2006. The increase reflects increased promotional
expenses for BYETTA and SYMLIN, costs associated with the Company's
expanded field force, and increased business infrastructure to
support the Company's growth. Research and development expenses
increased to $276.6 million for the year ended December 31, 2007
compared to $222.1 million for the same period in 2006. The
increase primarily reflects costs associated with the development
of exenatide once weekly. Collaborative profit sharing, which
represents Lilly's 50% share of BYETTA gross margin, was $290.9
million for the year ended December 31, 2007 compared to $194.2
million for the same period in 2006. Net loss for the year ended
December 31, 2007 was $211.1 million, or $1.59 per share, compared
to $218.9 million, or $1.78 per share for the same period in 2006.
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 website, 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 2007
financial results, and information regarding guidance for 2008
operations. For those without access to the Internet, the live call
may be accessed by phone by calling (800) 901-5231 (domestic) or
(617) 786-2961 (international), passcode 53471601. A replay of the
call will also be available by phone for 24 hours beginning
approximately one hour after the close of the call and can be
accessed at (888) 286-8010 (domestic) or (617) 801-6888
(international), passcode 32667415. 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 1,900 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. The
Company's 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 the
FDA may not approve the Company's sNDAs or product candidates;
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. AMYLIN PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except per share data) (unaudited)
Quarter ended Twelve months ended December 31, December 31, 2007
2006 2007 2006 Revenues: Net product sales $194,719 $150,581
$701,450 $474,038 Revenues under collaborative agreements 27,319
12,782 79,547 36,837 Total revenues 222,038 163,363 780,997 510,875
Costs and expenses: Cost of goods sold 22,135 11,136 65,457 50,073
Selling, general and administrative 122,356 89,562 390,982 281,950
Research and development 83,888 66,167 276,600 222,053
Collaborative profit sharing 78,606 63,809 290,934 194,191 Total
costs and expenses 306,985 230,674 1,023,973 748,267 Operating loss
(84,947) (67,311) (242,976) (237,392) Make-whole payment on debt
redemption - - - (7,875) Interest and other income, net 8,006 8,890
31,840 26,411 Net loss $(76,941) $(58,421) $(211,136) $(218,856)
Net loss per share - basic and diluted $(0.57) $(0.45) $(1.59)
$(1.78) Shares used in computing net loss per share - basic and
diluted 134,896 130,312 132,621 122,647 AMYLIN PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands)
(unaudited) December 31, 2007 2006 Assets Cash, cash equivalents
and short-term investments $1,130,415 $767,331 Accounts receivable,
net 73,579 58,089 Inventories, net 100,214 59,299 Other current
assets 32,100 22,098 Property and equipment, net 390,301 146,779
Other assets 47,602 6,790 Total assets $1,774,211 $1,060,386
Liabilities and stockholders' equity Current liabilities $287,284
$203,887 Other liabilities, net of current portion 34,109 21,208
Long-term debt 900,000 200,000 Stockholders' equity 552,818 635,291
Total liabilities and stockholders' equity $1,774,211 $1,060,386
DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: Mark G. Foletta,
Senior Vice President, Finance and Chief Financial Officer of
Amylin Pharmaceuticals, Inc., +1-858-552-2200 Web site:
http://www.amylin.com/
Copyright
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jul 2023 to Jul 2024