Product sales increased 14% over third quarter 2007 to $201 million
SAN DIEGO, Oct. 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended
September 30, 2008. The Company reported total revenue of $218.4 million
for the third quarter, including net product sales of $201.4 million, a 14%
increase over the same period in 2007. Net loss for the quarter ended
September 30, 2008 was $77.7 million, or $0.57 per share. Net loss per
share, excluding an impairment loss on investments of $14.9 million, or
$0.11 per share, was $0.46 per share.
"This quarter we reported strong product sales in the face of an
increasingly challenging environment. Additionally we completed an
exenatide once weekly product supply agreement with Lilly that strengthens
our balance sheet and provides financial flexibility for the future," said
Daniel M. Bradbury, president and chief executive officer of Amylin
Pharmaceuticals. "We continue to manage the company towards sustainable,
profitable growth by driving BYETTA and SYMLIN revenue, managing our
expenses, and bringing exenatide once weekly to market."
Quarter ended September 30, 2008
Net product sales of $201.4 million for the third quarter include
$179.9 million for BYETTA(R) (exenatide) injection and $21.5 million for
SYMLIN(R) (pramlintide acetate) injection. This represents a 14% increase
over net product sales of $177.4 million for the same period in 2007.
Revenues under collaborative agreements were $17.0 million for the
quarter ended September 30, 2008, compared to $12.6 million for the same
period in 2007. The increase reflects higher cost-sharing payments from
Lilly for development expenses for BYETTA and exenatide once weekly.
Selling, general and administrative expenses increased to $99.7 million
for the quarter ended September 30, 2008, compared to $87.7 million for the
same period in 2007. The increase reflects costs associated with the
Company's expanded field force, investments in market development
activities for exenatide once weekly and continued investment in
promotional activities for BYETTA and SYMLIN.
Research and development expenses increased to $73.5 million for the
quarter ended September 30, 2008, compared to $61.5 million for the same
period in 2007. The increase primarily reflects increased development
expenses for exenatide once weekly and increased expenses for the Company's
obesity development programs. Non-GAAP, research and development expenses
net of cost sharing payments increased to $57.5 million for the quarter
ended September 30, 2008 compared to $49.9 million for the same period in
2007.
Collaborative profit sharing, which represents Lilly's share of the
gross margin for BYETTA, was $80.6 million for the quarter ended September
30, 2008, compared to $75.0 million for the same period in 2007.
Loss on impairment of investments was $14.9 million for the quarter
ended September 30, 2008. This primarily represents recognized impairment
losses on the Company's equity investments in privately held entities of
$9.0 million and an impairment loss of $5.9 million associated with a
corporate debt security in the Company's investment portfolio. The net book
value of the Company's remaining equity investments in privately held
entities was less than $5.0 million at September 30, 2008. There was no
comparable expense for the quarter ended September 30, 2007.
Net loss for the quarter ended September 30, 2007 was $77.7 million, or
$0.57 per share, compared to $39.8 million, or $0.30 per share, for the
same period in 2007.
Third quarter highlights
Highlights of Amylin's third quarter and recent activities include:
BYETTA
-- Initiated co-promotion of BYETTA with third party Lilly primary care
sales force, increasing the sales force promoting BYETTA by 40%.
Exenatide Once Weekly
-- Executed an exenatide once weekly supply agreement with Lilly, under
which Lilly will make an initial payment of $125 million to Amylin in
the fourth quarter of 2008. In addition, Lilly extended a $165 million
line of credit to Amylin. These agreements underscore Amylin's and
Lilly's commitment to the successful commercialization of exenatide
once weekly, strengthen Amylin's balance sheet and provide
additional financial flexibility.
-- Announced publication of DURATION-1 results in The Lancet. The study
showed that continuous steady state levels of exenatide, on board 24
hours a day, seven days a week, provided durable glycemic control and
sustained weight loss.
-- Completed enrollment of DURATION-2, which compares exenatide once weekly
against a thiazolidinedione and a DDP-4 inhibitor on a background of
metformin therapy.
Obesity Program
-- Completed enrollment of a phase 2B study to evaluate different dosing
combinations of pramlintide and metreleptin. 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.
Nine months ended September 30, 2008
Total revenues for the nine months ended September 30, 2008 were $637.6
million. This includes net product sales of $580.4 million, including
$515.9 million for BYETTA and $64.5 million for SYMLIN. This compares to
net product sales of $506.7 million, consisting of $459.7 million for
BYETTA and $47.0 million for SYMLIN for the same period in 2007.
Revenues under collaborative agreements were $57.2 million for the nine
months ended September 30, 2008, compared to $52.2 million for the same
period in 2007. The increase reflects higher cost-sharing payments from
Lilly for development expenses for BYETTA and exenatide once weekly.
Collaborative revenues for the nine months ended September 30, 2007
included $15.0 million in milestones earned upon Lilly's launch of BYETTA
in the European Union.
Selling, general and administrative expenses increased to $309.0
million for the nine months ended September 30, 2008, from $268.6 million
for the same period in 2007. The increase reflects costs associated with
the Company's expanded field force, increased promotional activities for
BYETTA and SYMLIN, investments in market development activities for
exenatide once weekly and increases in business infrastructure.
Research and development expenses increased to $226.1 million for the
nine months ended September 30, 2008, from $192.7 million for the same
period in 2007. The increase primarily reflects increased development
expenses for exenatide once weekly and continued investment in the
Company's obesity programs. Non-GAAP, research and development expenses net
of cost sharing payments increased to $172.1 million for the quarter ended
September 30, 2008 compared to $158.7 million for the same period in 2007.
Collaborative profit sharing was $229.4 million for the nine months
ended September 30, 2008, compared to $212.3 million for the same period in
2007.
Net loss was $211.3 million, or $1.54 per share for the nine months
ended September 30, 2008, compared to $134.2 million, or $1.02 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 third 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 (888) 536-6007 (U.S./Canada) or (706) 758-4632 (international),
Conference ID# 68128288. 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) 642-1687 (U.S./Canada) or (706) 645-9291
(international), Conference ID# 6812822.
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 Nine months ended
September 30, September 30,
2008 2007 2008 2007
GAAP research
and development
expenses $73,466 $61,457 $226,073 $192,712
Cost-sharing
payments (15,927) (11,566) (53,983) (34,013)
Non-GAAP
research and
development
expenses,
net of cost
sharing payments $57,539 $49,891 $172,090 $158,699
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 Nine months ended
September 30, September 30,
2008 2007 2008 2007
Revenues:
Net product sales $201,364 $177,391 $580,420 $506,731
Revenues under
collaborative
agreements 16,998 12,637 57,198 52,228
Total revenues 218,362 190,028 637,618 558,959
Costs and expenses:
Cost of goods sold 23,395 13,750 70,101 43,322
Selling, general and
administrative 99,676 87,718 309,007 268,626
Research and development 73,466 61,457 226,073 192,712
Collaborative profit
sharing 80,567 75,026 229,418 212,328
Total costs and expenses 277,104 237,951 834,599 716,988
Operating loss (58,742) (47,923) (196,981) (158,029)
Interest (expense)
income, net (4,036) 8,165 590 23,834
Loss on impairment of
equity method and
available for sale
investments (14,943) - (14,943) -
Net loss $(77,721) $(39,758) $(211,334) $(134,195)
Net loss per share -
basic and diluted $(0.57) $(0.30) $(1.54) $(1.02)
Shares used in computing
net loss per share -
basic and diluted 137,389 132,805 136,799 131,884
AMYLIN PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, December 31,
2008 2007
Assets
Cash, cash equivalents and
Short-term investments $805,451 $1,130,415
Accounts receivable, net 64,130 73,579
Inventories, net 98,508 100,214
Other current assets 28,422 32,100
Property, plant and equipment, net 600,204 390,301
Other assets 35,883 47,602
Total assets $1,632,598 $1,774,211
Liabilities and stockholders' equity
Current liabilities $278,909 $287,284
Other liabilities, net of
current portion 32,661 34,109
Long-term debt, net of current
portion 876,563 900,000
Stockholders' equity 444,465 552,818
Total liabilities and
stockholders' equity $1,632,598 $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, +1-858-458-8602, michael.york@amylin.com, or
Media, Alice Izzo, Executive Director, Corporate Affairs,
+1-858-642-7272, alice.izzo@amylin.com, both of Amylin
Pharmaceuticals, Inc.
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