Net product sales increased 28% over third quarter 2006 to $177 million
SAN DIEGO, Oct. 17 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended
September 30, 2007. The Company reported total revenue of $190.0 million
for the third quarter, including net product sales of $177.4 million. Net
loss for the quarter ended September 30, 2007 was $39.8 million, or $0.30
per share. At September 30, 2007, the Company held cash, cash equivalents
and short-term investments of approximately $1.1 billion.
"BYETTA and SYMLIN, our first-in-class diabetes medicines, have been on
the market for nearly 30 months and continued to show growth in physician
adoption, prescriptions and reported revenue in the third quarter," said
Daniel M. Bradbury, President and Chief Executive Officer of Amylin
Pharmaceuticals. "Additionally we continued to advance our pipeline drug
candidates and remain on track to report key clinical data later this
quarter from our once-weekly exenatide long-acting release program and our
integrated neurohormone obesity program."
Quarter ended September 30, 2007
Net product sales of $177.4 million for the third quarter include
$161.1 million for BYETTA(R) (exenatide) injection and $16.3 million for
SYMLIN(R) (pramlintide acetate) injection. This compares to net product
sales of $138.8 million, consisting of $126.4 million for BYETTA and $12.4
million for SYMLIN for the same period in 2006.
Revenues under collaborative agreements were $12.6 million for the
quarter ended September 30, 2007, compared to $8.2 million for the same
period in 2006. The increase reflects higher cost-sharing payments from
Lilly to equalize development expenses for BYETTA and exenatide long-acting
release (LAR).
Selling, general and administrative expenses increased to $87.7 million
for the quarter ended September 30, 2007, compared to $69.0 million for the
same period in 2006. The increase reflects higher promotional expenses for
BYETTA and SYMLIN, increased expenses associated with the Company's
expanded field force, and increased business infrastructure to support the
Company's growth.
Research and development expenses increased to $61.5 million for the
quarter ended September 30, 2007, compared to $53.7 million for the same
period in 2006. The increase primarily reflects increased development
expenses for exenatide LAR and ongoing costs associated with the
advancement of the Company's obesity development programs.
Collaborative profit sharing, which represents Lilly's share of the
gross margin for BYETTA, was $75.0 million for the quarter ended September
30, 2007, compared to $57.0 million for the same period in 2006.
Net loss for the quarter ended September 30, 2007 was $39.8 million, or
$0.30 per share, compared to $46.1 million, or $0.36 per share, for the
same period in 2006. Net loss for the quarter ended September 30, 2006
included a $7.9 million non-operating charge related to a make-whole
payment associated with the early redemption of convertible senior debt in
August 2006.
Third quarter highlights
Highlights of Amylin's third quarter include:
-- Received U.S. Food and Drug Administration (FDA) approval of the
SymlinPen(TM) 120 and the SymlinPen(TM) 60 pen-injector devices for
administering SYMLIN(R) (pramlintide acetate) injection. These new
pre-filled pen-injector devices feature simple, fixed dosing to improve
mealtime glucose control.
-- Announced study results showing that with similar glycemic improvement,
one year of exenatide treatment improved indices of beta cell function
compared to insulin glargine, with reduced risk of hypoglycemia, and
weight loss instead of weight gain.
Nine months ended September 30, 2007
Total revenues for the nine months ended September 30, 2007 were $559.0
million. This includes net product sales of $506.7 million, including
$459.7 million for BYETTA and $47.0 million for SYMLIN. This compares to
net product sales of $323.5 million, consisting of $293.2 million for
BYETTA and $30.3 million for SYMLIN for the same period in 2006.
Revenues under collaborative agreements were $52.2 million for the nine
months ended September 30, 2007, compared to $24.1 million for the same
period in 2006. The increase reflects $15 million in milestones associated
primarily with the launch of BYETTA in the European Union during the second
quarter of 2007 and higher cost-sharing payments to equalize development
expenses for BYETTA and exenatide LAR.
Selling, general and administrative expenses increased to $268.6
million for the nine months ended September 30, 2007, from $192.4 million
for the same period in 2006. The increase reflects higher promotional
expenses for BYETTA and SYMLIN, costs associated with the Company's
expanded sales force and increased business infrastructure to support the
Company's growth.
Research and development expenses increased to $192.7 million for the
nine months ended September 30, 2007, from $155.9 million for the same
period in 2006. The increase primarily reflects costs associated with the
development of exenatide LAR and costs associated with the Company's
obesity programs.
Collaborative profit sharing was $212.3 million for the nine months
ended September 30, 2007, compared to $130.4 million for the same period in
2006.
Net loss was $134.2 million, or $1.02 per share for the nine months
ended September 30, 2007, compared to $160.4 million, or $1.33 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 third quarter financial results, and information
regarding assumptions for the remainder of 2007 operations. For those
without access to the Internet, the live call may be accessed by phone by
calling (866) 700-6979 (domestic) or (617) 213-8836 (international),
passcode 48312438. 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 10940869.
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
located in San Diego, California with over 1,800 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 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.
(Financial information to follow)
AMYLIN PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Quarter ended Nine months ended
September 30, September 30,
2007 2006 2007 2006
Revenues:
Net product sales $177,391 $138,798 $506,731 $323,457
Revenues under collaborative
agreements 12,637 8,219 52,228 24,055
Total revenues 190,028 147,017 558,959 347,512
Costs and expenses:
Cost of goods sold 13,750 14,508 43,322 38,937
Selling, general and
administrative 87,718 69,037 268,626 192,388
Research and development 61,457 53,703 192,712 155,886
Collaborative profit sharing 75,026 57,026 212,328 130,382
Total costs and expenses 237,951 194,274 716,988 517,593
Operating loss (47,923) (47,257) (158,029) (170,081)
Make-whole payment on debt
redemption - (7,875) - (7,875)
Interest income, net 8,165 8,992 23,834 17,521
Net loss $(39,758) $(46,140) $(134,195) $(160,435)
Net loss per share - basic and
diluted $(0.30) $(0.36) $(1.02) $(1.33)
Shares used in computing net
loss per share - basic and
diluted 132,805 126,582 131,884 120,423
AMYLIN PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, December 31,
2007 2006
Assets
Cash, cash equivalents and short-term
investments $1,082,478 $767,331
Accounts receivable, net 63,155 58,089
Inventories, net 103,480 59,299
Other current assets 32,223 22,098
Property and equipment, net 335,563 146,779
Other assets 33,816 6,790
Total assets $1,650,715 $1,060,386
Liabilities and stockholders' equity
Current liabilities $229,999 $203,887
Other liabilities, net of current portion 33,293 21,208
Convertible senior notes 775,000 200,000
Stockholders' equity 612,423 635,291
Total liabilities and stockholders' equity $1,650,715 $1,060,386
SOURCE Amylin Pharmaceuticals, Inc.
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Related links:
http://www.amylin.com
CONTACT:
Mark Foletta, Senior Vice President, Finance
and Chief Financial Officer of Amylin Pharmaceuticals, Inc.,
+1-858-552-2200
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