Amylin Pharmaceuticals Reports 2003 Financial Results SAN DIEGO,
Feb. 24 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
today reported a net loss of $122.8 million, or $1.33 per share,
for the fiscal year ended December 31, 2003, compared to a net loss
of $109.8 million, or $1.39 per share, for the year ended December
31, 2002. For the fourth quarter ended December 31, 2003, the
Company reported a net loss of $17.3 million, or $0.19 per share,
compared to a net loss of $29.2 million, or $0.36 per share, for
the same period in 2002. The fourth quarter of 2003 included the
recognition to revenue of the majority of a $35 million milestone
payment received from Eli Lilly & Company in December 2003
pursuant to the collaboration on exenatide, the Company's drug
candidate targeted for type 2 diabetes. The milestone payment was
received following the successful completion of three pivotal phase
3 trials. The Company used approximately $143 million of cash for
its operating activities in 2003, and held cash, cash equivalents
and short-term investments of approximately $270 million at
December 31, 2003. "Significant progress was made in 2003,
including the successful completion of the exenatide Phase 3
development program, which providesthe base for the New Drug
Application planned for submission in mid-2004," said Ginger L.
Graham, President and Chief Executive Officer of Amylin
Pharmaceuticals, Inc. "In addition, we enhanced our financial
position, improved our business capabilities, and expanded our
pipeline." The Company reported revenues under its collaborative
agreement with Lilly for exenatide of $85.7 million in 2003,
compared to $13.4 million in 2002. For the fourth quarter of 2003,
revenues from the collaborative agreement were $41.0 million,
compared to $11.9 million in 2002. The increase reflects primarily
the continued amortization of up-front payments made by Lilly,
recognition of $30 million of the $35 million milestone payment,
and amounts from Lilly to equalize development costs. The Company
also recorded amounts earned related to the co-promotion of
Humatrope(R). Research and development expenses for 2003 increased
to $149.4 million, compared to $94.5 million in 2002. For the
fourth quarter of 2003, research and development expenses increased
to $40.0 million, compared to $31.3 million in 2002. The increase
reflects primarily costs for the completion of the exenatide Phase
3 clinical trials, the open-label extensions of these trials,
manufacturing scale-up, the ongoing open-label clinical trials for
SYMLIN(R) (pramlintide acetate), and costs for earlier stage
programs. Amylin also recorded an expense of $3.3 million for
acquired in-process research and development related to the
acquisition of a Phase 2 development program utilizing AC2592
(GLP-1) for the treatment of severe congestive heart failure.
Selling, general and administrative expenses for 2003 increased to
$56.8 million, compared to $25.3 million in 2002. For the fourth
quarter of 2003, selling, general and administrative expenses
increased to $17.9 million compared to $9.0 million for the same
period in 2002. The increase reflects costs associated with an
increased number of employees, including a 50-person sales force
established early in 2003, medical education and pre-launch
activities for SYMLIN, and expansion of the organization to support
future product launches. Net interest and other income improved
$4.4 million for the year ended December 31, 2003. This improvement
reflects primarily the recognition of a one-time gain of $3.6
million in connection with the repayment of the Company's
indebtedness to Johnson & Johnson at a discount. The Company
currently expects to use between $160 million and $170 million for
its operating activities in 2004. This assumes net cost-sharing
payments from Lilly to equalize exenatide U.S. development and
pre-launch costs. The Company does not expect significant milestone
payments from Lilly in 2004. SYMLIN activities planned for 2004
will be focused primarily on support for ongoing open-label
clinical studies, and continued interactions with the FDA to
clarify the requirements for SYMLIN approval. This also assumes the
maintenance of our commercial capabilities and continued progress
with earlier stage development programs. This press release
contains forward-looking statements about Amylin, which involve
risks and uncertainties. The Company's actual results could differ
materially from those forward-looking statements discussed in this
press release, due to a number of risks and uncertainties,
including risks and uncertainties that cash used from operations in
2004 may be higher than expected, risks and uncertainties that the
anticipated payments from Lilly will not be earned, risks and
uncertainties in the FDA's review of NDAs generally, risks and
uncertainties in FDA regulatory requirements for SYMLIN approval,
risks and uncertainties that approval, if any, may be withheld,
delayed and/or limited by indications, risks and uncertainties
regarding the drug discovery and development process, and risks and
uncertainties regarding the Company's ongoing clinical studies of
its drug candidates, including SYMLIN and exenatide. Additional
risks and uncertainties are described more fully in the Company's
most recently filed SEC documents, such as its Annual Report on
Form 10-K for the fiscal year ended December 31, 2002 under the
heading "Risk Factors," its Quarterly Reports on Form 10-Q, and its
recently filed registration statement on form S-3. AMYLIN
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands) December 31, 2003 2002 Assets Current assets: Cash, cash
equivalents and short-term investments $269,776 $147,358
Inventories 12,574 9,820 Other current assets 6,198 3,203 Property
and equipment, net 13,691 4,469 Other assets 8,806 3,695 Total
assets $311,045 $168,545 Liabilities and stockholders' equity
Accounts payable, accrued expenses and other current liabilities
$41,118 $25,923 Current portion of deferred revenue 4,286 42,090
Long-term debt and other liabilities 2,196 63,719 Deferred revenue,
net of current portion 25,229 24,515 Convertible senior notes
175,000 -- Stockholders' equity 63,216 12,298 Total liabilities and
stockholders' equity $311,045 $168,545 CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except per share data) Three Months Ended
Years Ended December 31, December 31, 2003 2002 2003 2002 Revenues
under collaborative agreement $41,022 $11,857 $85,652 $13,395
Operating Expenses: Research and development 40,045 31,289 149,431
94,456 General and administrative 17,920 8,971 56,761 25,334
Acquired in-process research and development -- -- 3,300 -- Total
operating expenses 57,965 40,260 209,492 119,790 Operating Loss
(16,943) (28,403) (123,840) (106,395) Interest income (expense),
net (395) (793) 1,032 (3,392) Net loss $(17,338) $(29,196)
$(122,808) $(109,787) Net loss per share - basic and diluted
$(0.19) $(0.36) $(1.33) $(1.39) Shares used in computing net loss
per share - basic and diluted 93,482 80,288 92,396 79,106
CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands, except per
share data) Years Ended December 31, 2003 2002 Cash used in
operating activities $(143,405) $(20,394) Investing activities:
Purchases, sales and maturities of short-term investments, net
(115,427) (53,936) Purchases of equipment and increase in patents,
net (12,860) (3,236) Cash used in investing activities (128,287)
(57,172) Financing activities: Proceeds from issuance of common
stock, net 172,446125,133 Proceeds from issuance of convertible
debt, net 169,696 -- Principal payments on notes payable and
capital leases (63,250) (547) Cash provided byfinancing activities
278,892 124,586 Increase in cash and cash equivalents 7,200 47,020
Cash and cash equivalents at beginning of year 69,415 22,395 Cash
and cash equivalents at end of year $76,615 $69,415 DATASOURCE:
Amylin Pharmaceuticals, Inc. CONTACT: Mark G. Foletta, Vice
President Finance and Chief Financial Officer of Amylin
Pharmaceuticals, Inc., +1-858-552-2200 Web site:
http://www.amylin.com/
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