Amylin Pharmaceuticals Reports Third Quarter Financial Results SAN
DIEGO, Nov. 4 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. today reported financial results for the third quarter ended
September 30, 2003. The Company reported a net loss of $37.5
million, or $0.40 per share, and $105.5 million, or $1.15 per
share, for the three and nine months ended September 30, 2003.
These results compare with reported losses of $31.3 million, or
$0.39 per share, and $80.6 million, or $1.03 per share, for the
comparable periods in 2002. The Company held cash, cash equivalents
and short-term investments of approximately $289 million at
September 30, 2003. The Company reported revenues under its
collaborative agreement with Eli Lilly & Company ("Lilly") of
$15.4 million and $44.6 million in the three and nine months ended
September 30, 2002. This compares to reported revenues of $1.5
million for both the three and nine months ended September 30,
2002. Research and development expenses increased to $40.9 million
in the third quarter of 2003, compared to $25.8 million for the
third quarter of 2002. For the nine months ended September 30,
2003, research and development expenses increased to $109.4
million, compared to $63.2 million in 2002. The increase reflects
costs associated with the Phase 3 clinical trials for exenatide,
the open label extensions of these trials and the manufacturing
scale-up for exenatide. Selling, general and administrative
expenses increased to $14.9 million in the third quarter of 2003,
compared to $6.2 million for the third quarter of 2002. For the
nine months ended September 30, 2003, selling, general and
administrative expenses increased to $38.8 million, compared to
$16.4 million in 2002. The increase reflects costs associated with
an increased number of employees, increased medical education and
other pre-launch activities for SYMLIN(R) and increased facilities
and other infrastructure costs. Interest and other, net, improved
approximately $3.8 million and $4.0 million for the three and nine
months ended September 30, 2003, respectively. This improvement
reflects primarily the recognition of a one- time gain of
approximately $3.6 million in connection with the repayment of all
of the Company's outstanding indebtedness to Johnson & Johnson
in July 2003 at a 7% discount from face value on the date of
payment. The Company expects to use approximately $140-$150 million
for its operating activities in fiscal year 2003 and finish the
year with greater than $260 million in cash, cash equivalents and
short-term investments. This assumes payments from Lilly,
consisting of milestones and cost-sharing reimbursements, which are
contingent upon the continued success of the exenatide Phase 3
development program. The collaboration agreement with Lilly
provides for equal sharing of exenatide development expenses and
operating profits in the U.S. At signing, Lilly made $80 million of
up-front payments, and Amylin agreed to incur the first $100
million of development costs. Accordingly, Amylin has recorded 100%
of the U.S. development expenses for exenatide to date, whether
incurred by Amylin or Lilly, and has recorded as revenue 50% of
these development costs through an amortization of a portion of
Lilly's up-front payments. Toward the end of the third quarter of
2003, the Company reached the $100 million level of cumulative
exenatide development expenses. Going forward, Amylin will continue
to lead the development of exenatide and will record, as research
and development expenses, the costs incurred directly by the
Company. It is planned that Lilly will also directly incur
exenatide expenses and will make cash payments to Amylin to
equalize development costs. Amylin will record these payments as
collaborative revenue. Remaining goals for 2003 include reporting
data from the final two pivotal Phase 3 trials for exenatide, an
IND submission for AC162352 (PYY 3-36) and possible regulatory
approval for SYMLIN(R) in the United States. Amylin Pharmaceuticals
is a biopharmaceutical company dedicated to developing innovative
medicines to improve the lives of people with metabolic diseases.
The Company's two late-stage, first-in-class diabetes product
candidates -- SYMLIN(R) (pramlintide acetate) and exenatide
(synthetic exendin-4) -- are being developed to address the global
epidemic of diabetes. Amylin has a strategic alliance with Eli
Lilly & Company for the co- development and global
commercialization of exenatide, and an extended release
formulation, exenatide LAR. Building on its experience in the
diabetes field, the Company is developing candidates for
cardiovascular disease and obesity by utilizing its research
experience with the metabolic properties common to all three
conditions. Further information on Amylin and its pipeline in
metabolism is available at http://www.amylin.com/ . 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 operating expenses and cash
used for operations for 2003 may be higher than expected,
uncertainties that the planned milestone and/or cost-sharing
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(R) approval, risks and
uncertainties that approval by those authorities, if any, may be
withheld, delayed and/or limited by indications, risks and
uncertainties regarding the drug discovery and development process,
and uncertainties regarding the Company's ongoing clinical studies
of its drug candidates, including SYMLIN(R), exenatide and
exenatide LAR and anticipated completion times for these studies.
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 recently filed registration
statement on Form S-3, and its quarterly reports on Form 10-Q.
(financial information to follow) Amylin Pharmaceuticals, Inc.
Consolidated Statement of Operations Data (Unaudited) (in
thousands, except per share data) Three Months Ended Nine Months
Ended September 30, September 30, 2003 2002 2003 2002 Revenues
under collaborative agreement $15,361 $1,538 $44,630 $1,538
Operating expenses: Research and development 40,876 25,818 109,386
63,167 Selling, general and administrative 14,909 6,166 38,841
16,363 Acquired in-process research and development -- -- 3,300 --
Total expenses 55,785 31,984 151,527 79,530 Operating loss (40,424)
(30,446) (106,897) (77,992) Interest and other, net 2,920 (853)
1,427 (2,599) Net loss (37,504) (31,299) (105,470) (80,591) Net
loss per share - basic and diluted $(0.40) $(0.39) $(1.15) $(1.03)
Shares used in calculation of net loss per share - basic and
diluted 93,199 80,141 92,030 78,156 Amylin Pharmaceuticals, Inc.
Consolidated Balance Sheets Data (in thousands) September 30,
December 31, 2003 2002 Assets (Unaudited) Cash, cash equivalents
and short-term investments $289,239 $147,358 Inventories 13,337
9,820 Other current assets 7,734 3,203 Property and equipment
10,484 4,469 Other assets 8,255 3,695 Total assets $329,049
$168,545 Liabilities and Stockholders' Equity Accounts payable,
accrued expenses and other current liabilities $47,468 $25,923
Current portion of deferred collaboration revenue 4,286 42,090
Long-term debt and other liabilities 176,871 63,719 Long-term
deferred collaboration revenue 21,300 24,515 Stockholders' equity
79,124 12,298 Total liabilities and stockholders' equity $329,049
$168,545 DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: Mark G.
Foletta, Vice President of Finance and Chief Financial Officer of
Amylin Pharmaceuticals, Inc., +1-858-552-2200 Web site:
http://www.amylin.com/
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