'We have made steady progress in the first quarter of 2008 across near-,
mid- and long-term opportunities, executing against the strategy detailed
earlier this year to build Amylin's diabetes portfolio and establish our
presence in the obesity field,' said
Bradbury continued, 'Importantly, we achieved a significant milestone
towards our efforts to submit the NDA for exenatide once weekly. We have
manufactured exenatide once weekly product at commercial scale in our facility
in
Financial results
Net product sales of
Revenues under collaborative agreements were
Selling, general and administrative expenses were
Research and development expenses increased to
Collaborative profit sharing, which represents Lilly's share of the gross
margin for BYETTA, was
Interest and other income, net decreased to
Net loss for the quarter ended
First Quarter 2008 Highlights
Highlights of Amylin's first quarter include:
BYETTA
-- Submitted a supplemental New Drug Application, or sNDA, to the Food and
Drug Administration, or FDA, to seek approval for expanded use of
BYETTA as monotherapy, or stand-alone therapy, in people with type 2
diabetes who are not achieving acceptable blood sugar control.
Approval for this expanded indication is expected in the second
half of 2008.
SYMLIN
-- Commercially launched the SymlinPen(TM) 120 and the SymlinPen(TM) 60
pen-injector devices for administering SYMLIN in the United States in
January 2008. These new pre-filled pen-injector devices feature
simple, fixed dosing to improve mealtime glucose control.
Exenatide once weekly
-- Initiated the first of three planned superiority clinical trials of
exenatide once weekly. The study compares exenatide once weekly to a
thiazolidinedione, or TZD, and a DPP-4 inhibitor in patients on
background metformin therapy. Results from this study are expected in
the first half of 2009.
-- Continued progress at the Company's exenatide once weekly manufacturing
facility in Ohio, including the manufacture of exenatide once weekly at
commercial scale. The Company plans to supply material from the
facility to support ongoing and planned clinical programs by the third
quarter of 2008
Conference Call
Amylin will webcast its Quarterly Update Conference Call today at
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.
Quarter ended March 31,
2008 2007
GAAP research and development expenses $77,206 $59,564
Cost-sharing payments (17,445) (8,903)
Non-GAAP net research and development expenses,
net of cost sharing payments $59,761 $50,661
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
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 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 March 31,
2008 2007
Revenues:
Net product sales $178,721 $162,003
Revenues under collaborative agreements 18,516 9,975
Total revenues 197,237 171,978
Costs and expenses:
Cost of goods sold 22,024 15,210
Selling, general and administrative 98,243 87,787
Research and development 77,206 59,564
Collaborative profit sharing 69,901 66,947
Total costs and expenses 267,374 229,508
Operating loss (70,137) (57,530)
Interest and other income, net 1,340 8,116
Net loss $(68,797) $(49,414)
Net loss per share - basic and diluted $(0.51) $(0.38)
Shares used in computing net loss per
share - basic and diluted 135,859 131,054
AMYLIN PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
March 31, December 31,
2008 2007
Assets
Cash, cash equivalents and short-term
investments $1,033,943 $1,130,415
Accounts receivable, net 65,512 73,579
Inventories, net 98,066 100,214
Other current assets 28,768 32,100
Property and equipment, net 476,990 390,301
Other assets 46,530 47,602
Total assets $1,749,809 $1,774,211
Liabilities and stockholders' equity
Current liabilities $260,136 $287,284
Other liabilities, net of current portion 36,775 34,109
Long-term debt 900,000 900,000
Stockholders' equity 552,898 552,818
Total liabilities and stockholders' equity $1,749,809 $1,774,211
SOURCE Amylin Pharmaceuticals, Inc.