Non-GAAP Operating Loss Improves by 64% to $41.6 Million in First
Nine Months of 2009 Compared to Same Period in 2008 SAN DIEGO,
Calif., Oct. 20 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) today reported financial results for the quarter
ended September 30, 2009. The Company reported total revenue of
$211.2 million for the third quarter, including net product sales
of $192.9 million. Non-GAAP operating income was $0.6 million for
the quarter ended September 30, 2009 compared to non-GAAP operating
loss of $32.7 million for the same period in 2008. Net loss for the
quarter ended September 30, 2009 was $26.7 million, or $0.19 per
share compared to $79.0 million, or $0.58 per share for the same
period in 2008. Net loss for the quarter ended September 30, 2008
included a loss on impairment of investments of $14.9 million, or
$0.11 per share. At September 30, 2009 the Company held cash, cash
equivalents and short-term investments of $619.7 million. "We
continue to make substantial progress toward our goal of becoming
operating cash flow positive on a sustainable basis by the end of
2010, and have generated positive cash flow in the third quarter,"
said Mark G. Foletta, senior vice president of finance and chief
financial officer at Amylin Pharmaceuticals. "Over the next few
quarters we will make incremental investments to successfully
launch exenatide once weekly, which will lead to variability in our
operating results, but we expect to achieve sustainable positive
operating cash flow by the end of next year." Quarter Ended
September 30, 2009 Net product sales of $192.9 million for the
quarter ended September 30, 2009 include $171.1 million for BYETTA®
(exenatide) injection and $21.8 million for SYMLIN® (pramlintide
acetate) injection. This compares to net product sales of $201.4
million consisting of $179.9 million for BYETTA and $21.5 million
for SYMLIN for the same period in 2008. Revenues under
collaborative agreements were $18.3 million for the quarter ended
September 30, 2009 compared to $17.0 million for the same period in
2008. The increase reflects higher cost-sharing payments from Lilly
for development expenses for BYETTA and exenatide once weekly.
Selling, general and administrative expenses decreased to $80.1
million for the quarter ended September 30, 2009, compared to $99.7
million for the same period in 2008. The decrease primarily
reflects lower sales force and business infrastructure expenses
driven by the Company's reduced cost structure. Research and
development expenses decreased to $52.6 million for the quarter
ended September 30, 2009, compared to $73.5 million for the same
period in 2008. The decrease primarily reflects decreased
development expenses for exenatide once weekly and the Company's
obesity development programs following recently completed clinical
trials and efficiencies driven by the Company's reduced cost
structure. Non-GAAP research and development expenses net of
cost-sharing payments decreased to $35.3 million for the quarter
ended September 30, 2009 compared to $57.5 million for the same
period in 2008. Collaborative profit sharing, which represents
Lilly's share of the gross margin for BYETTA, was $78.3 million for
the quarter ended September 30, 2009, compared to $80.6 million for
the same period in 2008. The Company's results for the quarter
ended September 30, 2008 included a loss on impairment of
investments of $14.9 million primarily related to recognized losses
on the Company's equity investments in privately held entities and
a corporate debt security in the Company's investment portfolio.
There was no comparable expense for the quarter ended September 30,
2009. Non-GAAP operating income was $0.6 million for the quarter
ended September 30, 2009 compared to a non-GAAP operating loss of
$32.7 million for the same period in 2008. GAAP operating loss was
$22.4 million for the quarter ended September 30, 2009 compared to
$58.7 million for the same period in 2008. Net loss for the quarter
ended September 30, 2009 was $26.7 million, or $0.19 per share,
compared to $79.0 million, or $0.58 per share, for the same period
in 2008. "The third quarter was one of strong operational and
financial results and positions us well for long-term growth," said
Daniel M. Bradbury, president and chief executive officer at Amylin
Pharmaceuticals. "We continue to execute on our growth strategy by
making progress against our long-term commercial plans, maximizing
the potential of our clinical programs and advancing our pipeline."
Third Quarter Highlights Highlights of Amylin's third quarter and
recent activities include: Corporate -- Improved non-GAAP operating
loss by 64% in the first nine months of 2009 compared to the same
period in 2008 -- Entered a Global Development and
Commercialization Agreement with Biocon Limited for a novel peptide
hybrid -- Announced Paulo F. Costa as Amylin's Chairman of the
Board Exenatide -- Received the Day 74 letter from the U.S. Food
and Drug Administration (FDA) and submitted the 120 day safety
update for exenatide once weekly -- Presented data from more than
20 studies, with partner Eli Lilly and Company, at the Annual
Meeting of the European Association for the Study of Diabetes
(EASD). Data presented were the latest research findings on BYETTA
and exenatide once weekly Nine Months Ended September 30, 2009
Total revenues for the nine months ended September 30, 2009 were
$614.3 million. This includes net product sales of $569.7 million,
including $503.9 million for BYETTA and $65.8 million for SYMLIN.
This compares to net product sales of $580.4 million, consisting of
$515.9 million for BYETTA and $64.5 million for SYMLIN for the same
period in 2008. Revenues under collaborative agreements were $44.6
million for the nine months ended September 30, 2009, compared to
$57.2 million for the same period in 2008. The decrease reflects
lower cost-sharing payments from Lilly for development expenses for
BYETTA and exenatide once weekly. Selling, general and
administrative expenses decreased to $259.7 million for the nine
months ended September 30, 2009, from $309.0 million for the same
period in 2008. The decrease primarily reflects lower sales force
and business infrastructure expenses driven by the Company's
reduced cost structure. Research and development expenses decreased
to $176.3 million for the nine months ended September 30, 2009,
from $226.1 million for the same period in 2008. The decrease
primarily reflects decreased development expenses for exenatide
once weekly and the Company's obesity programs following recently
completed clinical trials and efficiencies driven by the Company's
reduced cost structure. Research and development expenses for the
nine months ended September 30, 2008 included an $8.0 million
license payment for drug delivery technology. Non-GAAP research and
development expenses net of cost-sharing payments decreased to
$134.9 million for the quarter ended September 30, 2009 compared to
$172.1 million for the same period in 2008. Collaborative profit
sharing was $227.5 million for the nine months ended September 30,
2009, compared to $229.4 million for the same period in 2008.
Non-GAAP operating loss was $41.7 million for the nine months ended
September 30, 2009, a 64% improvement over the $117.0 million loss
for the same period in 2008. Net loss was $136.0 million, or $0.97
per share for the nine months ended September 30, 2009, compared to
$216.7 million, or $1.58 per share, for the same period in 2008.
Net loss for the nine months ended September 30, 2008 included a
loss on impairment of investments of $14.9 million, or $0.11 per
share. Conference Call Amylin will webcast its Quarterly Update
Conference Call today at 5:00 p.m. ET/2:00 p.m. PT. 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 quarterly financial results, and information
regarding assumptions for the remainder of 2009 operations. The
call will be webcast live through the "Investors" section of
Amylin's corporate Web site at http://www.amylin.com/. A slide
presentation accompanying the conference call will also be
available through the "Investors" section of Amylin's corporate Web
site. To access the webcast and slide presentation, please log on
to http://www.amylin.com/ approximately fifteen minutes prior to
the call to register, download and install any necessary audio
software. For those without access to the Internet, the live call
may be accessed by phone by calling (866) 730-5763 (U.S./Canada) or
(857) 350-1587 (international), conference access code 44746855. 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 access code 78094555. Note Regarding
Use of Non-GAAP Financial Measures Amylin reports non-GAAP
operating income (loss) excluding non-cash items and 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 sustainable 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 these non-GAAP
financial measures 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 dedicated to
improving lives of patients through the discovery, development and
commercialization of innovative medicines. Amylin has developed and
gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (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, safety and 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, may not replicate
previous results or achieve desired end-points; risks that our
preclinical studies may not be predictive; risks that our NDAs for
product candidates, such as the exenatide once weekly NDA, or sNDAs
for label expansion requests may not be submitted timely or receive
FDA approval; risks that our expense reductions will not be as
large as we expect; risks that the restructured operations for
exenatide or our sales force will not produce the results we
expect; 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, 2009 2008 2009 2008
---- ---- ---- ---- Revenues: Net product sales $192,887 $201,364
$569,716 $580,420 Revenues under collaborative agreements 18,348
16,998 44,565 57,198 ------ ------ ------ ------ Total revenues
211,235 218,362 614,281 637,618 Costs and expenses: Cost of goods
sold 22,624 23,395 65,549 70,101 Selling, general and
administrative 80,088 99,676 259,696 309,007 Research and
development 52,660 73,466 176,280 226,073 Collaborative profit
sharing 78,265 80,567 227,481 229,418 Restructuring - - 11,376 -
------ ------- ------ ------- Total costs and expenses 233,637
277,104 740,382 834,599 Operating loss (22,402) (58,742) (126,101)
(196,981) Interest and other income, net (4,257) (5,338) (8,507)
(4,789) Loss on impairment of investments - (14,943) (1,377)
(14,943) ------ ------ ----- ------ Net loss $(26,659) $(79,023)
$(135,985) $(216,713) ======== ======== ========= ========= Net
loss per share - basic and diluted $(0.19) $(0.58) $(0.97) $(1.58)
====== ====== ====== ====== Shares used in computing net loss per
share - basic and diluted 141,308 137,389 140,350 136,799 A
reconciliation of reported GAAP operating loss to non-GAAP
operating income (loss) excluding non-cash items and one-time items
is provided in the table that follows (in thousands, unaudited):
Quarter ended Nine months ended September 30, September 30, 2009
2008 2009 2008 ---- ---- ---- ---- GAAP operating loss $(22,402)
$(58,742) $(126,101) $(196,981) Stock-based compensation 10,900
14,009 33,947 43,011 Other non-cash compensation 4,392 5,531 15,719
18,847 Depreciation and amortization 8,733 7,594 26,587 21,333
Amortization of deferred revenue (1,033) (1,071) (3,176) (3,214)
Restructuring - - 11,376 - ----- ------ ------ ------ Non-GAAP
operating income (loss) $590 $(32,679) $(41,648) $(117,004) ====
======== ======== ========= 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, 2009 2008 2009 2008
---- ---- ---- ---- GAAP research and development expenses $52,660
$73,466 $176,280 $226,073 Cost-sharing payments (17,314) (15,927)
(41,388) (53,983) ------ ------ ------ ------ Non-GAAP research and
development expenses, net of cost-sharing payments $35,346 $57,539
$134,892 $172,090 ======= ======= ======== ======== AMYLIN
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands) (unaudited) September 30, December 31, 2009 2008 ----
---- Assets Cash, cash equivalents and short-term investments
$619,696 $816,838 Accounts receivable, net 77,049 62,369
Inventories, net 103,831 115,823 Other current assets 71,283 41,038
Property and equipment, net 751,609 655,444 Other assets 39,230
35,541 ------ ------ Total assets $1,662,698 $1,727,053 ==========
========== Liabilities and stockholders' equity Current liabilities
277,169 313,778 Other liabilities, net of current portion 214,706
179,227 Long-term debt 708,192 714,771 Stockholders' equity 462,631
519,277 ------- ------- Total liabilities and stockholders' equity
$1,662,698 $1,727,053 ========== ========== DATASOURCE: Amylin
Pharmaceuticals, Inc. CONTACT: Financial, Michael York, Senior
Director, Investor Relations, +1-858-458-8602, , or Media, Alice
Izzo, Executive Director, Corporate Affairs, +1-858-642-7272, ,
both of Amylin Pharmaceuticals, Inc. Web Site:
http://www.amylin.com/
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