Amylin Pharmaceuticals Reports Second Quarter Financial Results
Exenatide New Drug Application Submitted to FDA as Planned SAN
DIEGO, Aug. 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) today reported a net loss of $39.4 million, or
$0.42 per share, for the three months ended June 30, 2004, compared
to a net loss of $37.2 million, or $0.40 per share, for the same
period in 2003. For the six months ended June 30, 2004, the company
reported a net loss of $76.7 million, or $0.82 per share, compared
to a net loss of $68.0 million, or $0.74 per share, for the same
period in 2003. The Company's operating activities used
approximately $88.1 million of cash in the first half of 2004,
compared to $85.3 million for the same period in 2003. At June 30,
2004, the Company held cash, cash equivalents and short-term
investments of approximately $370 million. "We continue to execute
according to plan. The June submission of the exenatide New Drug
Application to the FDA marked a major milestone for Amylin and for
the exenatide development program," said Ginger L. Graham, Amylin's
President and Chief Executive Officer. "We also strengthened our
financial position with the completion of the $200 million
convertible debt offering in April 2004." The Company reported
revenues under its collaborative agreements of $7.6 million for the
three months ended June 30, 2004, compared to $17.4 million for the
same period in 2003. For the six months ended June 30, 2004,
revenue under collaborative agreements were $14.2, compared to
$29.3 million for the same period in 2003. Revenue in the current
periods consists primarily of equalization payments for exenatide
development expenses earned pursuant to the Company's collaboration
with Eli Lilly & Company. Research and development expenses
were $29.9 million for the three months ended June 30, 2004,
compared to $40.4 million for the same period in 2003. For the six
months ended June 30, 2004, research and development expenses were
$57.4 million compared to $68.5 million for the same period in
2003. The decrease in the current periods primarily reflects
reduced development expenses for exenatide following the completion
of the pivotal Phase 3 trials in late 2003, partially offset by
increased costs associated with the advancement of Amylin's earlier
stage development programs. Selling, general and administrative
expenses for the quarter ended June 30, 2004, were $15.7 million
compared to $13.4 million for the same period in 2003. For the six
months ended June 30, 2004, selling, general and administrative
expenses were $31.8 million compared to $23.9 million for the same
periods in 2003. The increase in the current periods reflects
increased pre-launch activities for exenatide and costs associated
with an increased number of employees and associated infrastructure
to support potential future product launches. The Company plans to
use between $160 and $170 million for its operating activities
during 2004. This assumes net cost-sharing payments to Amylin from
Lilly to equalize exenatide U.S. development and pre-launch costs.
The Company recently announced that it will receive a $5 million
development milestone from Lilly in connection with the results of
a clinical trial comparing exenatide to insulin glargine. The
Company does not expect any further milestone payments from Lilly
in 2004. 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 in this
press release due to a number of factors, including risks and
uncertainties that the Company may require more cash for operating
activities than anticipated; risks and uncertainties in FDA
requirements for exenatide and/or SYMLIN approval; risks and
uncertainties that FDA approval, if any, may be delayed and/or
limited; risks and uncertainties inherent in our collaboration with
and dependence upon Lilly; risks that the anticipated payments from
Lilly will not be earned; risks and uncertainties in the FDA's
review of New Drug Applications (NDAs) generally; risks and
uncertainties regarding the drug discovery and development process;
risks and uncertainties regarding the Company's ongoing clinical
studies, including the timing of results; the Company's ability to
commercialize its product candidates; and the Company's ability to
protect its intellectual property. These and other risks and
uncertainties are described more fully in the Company's most
recently filed SEC documents, including its recently filed
Registration Statement on Form S-3, under the heading "Risks
Related to Our Business". AMYLIN PHARMACEUTICALS, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands) June 30, December 31,
2004 2003 (unaudited) Assets Cash and cash equivalents $83,310
$76,615 Short-term investments 287,040 193,161 Inventories 14,278
12,574 Other current assets 10,814 6,198 Property and equipment,
net 18,981 13,691 Other assets 14,343 8,806 Total assets $428,766
$311,045 Liabilities and stockholders' equity (deficit) Accounts
payable, accrued expenses and other current liabilities $34,098
$41,118 Current portion of deferred revenue 4,482 4,286 Other
long-term liabilities, net of current portion 2,769 2,196 Deferred
revenue, net of current portion 23,086 25,229 Convertible senior
notes 375,000 175,000 Stockholders' equity (deficit) (10,669)
63,216 Total liabilities and stockholders' equity (deficit)
$428,766 $311,045 CONSOLIDATED STATEMENTS OF OPERATIONS (in
thousands, except per share data) Three Months Ended Six Months
ended June 30, June 30, 2004 2003 2004 2003 Revenue under
collaborative agreements $7,559 $17,384 $14,248 $29,269 Operating
expenses: Research and development 29,932 40,388 57,389 68,511
Selling, general and administrative 15,691 13,417 31,779 23,931
Acquired in-process research and development -- -- -- 3,300 Total
operating expenses 45,623 53,805 89,168 95,742 Operating loss
(38,064) (36,421) (74,920) (66,473) Interest expense, net (1,363)
(736) (1,780) (1,494) Net loss $(39,427) $(37,157) $(76,700)
$(67,967) Net loss per share - basic and diluted $(0.42) $(0.40)
$(0.82) $(0.74) Shares used in computing net loss per share - basic
and diluted 93,889 92,825 93,864 91,612 CONSOLIDATED STATEMENTS OF
CASH FLOWS (in thousands) Six Months Ended June 30, 2004 2003
Operating activities: Net loss $(76,700) $(67,967) Adjustments to
reconcile net loss to cash used for operating activities: Non-cash
expenses 3,192 4,758 Working capital changes (14,625) (22,123) Net
cash used for operating activities $(88,133) $(85,332) Investing
activities: Purchases, sales and maturities of short-term
investments, net (94,699) (139,098) Purchases of equipment and
increase in patents, net (7,607) (5,876) Net cash provided by (used
for) investing activities (102,306) (144,974) Financing activities:
Proceeds from issuance of common stock, net 3,498 168,676 Proceeds
from issuance of convertible senior notes 193,642 145,575 Principal
payments on notes payable and capital leases (6) (276) Net cash
provided by financing activities 197,134 313,975 Increase
(decrease) in cash and cash equivalents 6,695 83,669 Cash and cash
equivalents at beginning of period 76,615 69,415 Cash and cash
equivalents at end of period $83,310 $153,084 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/
Copyright
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Jul 2023 to Jul 2024