AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals Reports Third Quarter Financial Results Two Diabetes Drug Candidates Under FDA Review SAN DIEGO, Nov. 2 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) today reported financial results for the third quarter ended September 30, 2004. The Company reported a net loss of $34.1 million, or $0.36 per share, for the three months ended September 30, 2004, compared to a net loss of $37.5 million, or $0.40 per share for the same period in 2003. For the nine months ended September 30, 2004, the Company reported a net loss of $110.8 million, or $1.18 per share, compared to a net loss of $105.5 million, or $1.15 per share for the same period in 2003. The Company used $121.3 million of cash for its operating activities in the nine months ended September 30, 2004, compared to $128.1 million of cash used for operating activities for the same period in 2003. The Company held cash, cash equivalents and short-term investments of approximately $337 million at September 30, 2004. The Company reported revenues under its collaborative agreements of $13.4 million in the three months ended September 30, 2004, compared to $15.4 million for the same period in 2003. For the nine months ended September 30, 2004 the Company reported revenues under its collaborative agreements of $27.7 million, compared to $44.6 million for the same period in 2003. Revenue in the current periods consists primarily of equalization payments for exenatide development earned pursuant to the Company's collaboration agreement with Eli Lilly & Company ("Lilly"). In the third quarter of 2004, the Company also recognized as revenue a $5 million milestone payment received from Lilly in connection with the results of a clinical study comparing exenatide and insulin glargine. Research and development expenses decreased to $30.8 million in the third quarter of 2004, compared to $40.9 million for the third quarter of 2003. For the nine months ended September 30, 2004, research and development expenses decreased to $88.2 million, compared to $109.4 million for the same period in 2003. The decrease in the current periods reflects primarily reduced expenses for exenatide following the completion of the pivotal Phase 3 trials in late 2003, partially offset by increased investments in the Company's earlier stage development programs. Selling, general and administrative expenses were $15.0 million in the third quarter of 2004, compared to $14.9 million for the same period in 2003. For the nine months ended September 30, 2003, selling, general and administrative expenses increased to $46.8 million, compared to $38.8 million in 2003. The increase in the nine months ended September 30, 2004, as compared to the same period in 2003, reflects increased pre-launch costs and increased business infrastructure costs to support potential future product launches. Interest and other, net, decreased approximately $4.6 million and $4.8 million for the three and nine months ended September 30, 2004, respectively. This decrease reflects the recognition of a one-time gain of approximately $3.6 million in the third quarter of 2003, in connection with an early repayment of debt, and increased interest expense in 2004 associated with the Company's $200 million convertible debt offering in April 2004. The Company continues to expect to use between $160 and $170 million for its operating activities during 2004. This assumes ongoing net cost-sharing payments to Amylin from Lilly to equalize exenatide U.S. development and pre-launch costs. 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 (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 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". (financial information to follow) AMYLIN PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, December 31, 2004 2003 (unaudited) Assets Cash and cash equivalents $ 101,906 $ 76,615 Short-term investments 234,959 193,161 Receivables from collaborative partners 9,216 791 Inventories 13,124 11,841 Other current assets 8,780 6,140 Property and equipment 20,157 13,691 Other assets 13,588 8,806 Total Assets $ 401,730 $ 311,045 Liabilities and Stockholders' Equity (Deficit) Accounts payable, accrued expenses and other current liabilities 39,065 41,118 Current portion of deferred revenue 4,286 4,286 Other liabilities, net of current portion 3,848 2,196 Deferred revenue, net of current portion 22,015 25,229 Convertible senior notes 375,000 175,000 Stockholders' equity (deficit) (42,484) 63,216 Total liabilities and stockholders' equity (deficit) $ 401,730 $ 311,045 CONSOLIDATED STATEMENT OF OPERATIONS DATA (Unaudited) (in thousands, except per share data) Three months ended Nine months ended September 30, September 30, 2004 2003 2004 2003 Revenues under collaborative agreements $ 13,423 $ 15,361 $ 27,671 $ 44,630 Operating expenses: Research and development 30,834 40,876 88,223 109,386 Selling, general and administrative 15,006 14,909 46,785 38,841 Acquired in-process research and development -- -- -- 3,300 Total operating expenses 45,840 55,785 135,008 151,527 Operating loss (32,417) (40,424) (107,337) (106,897) Interest and other, net (1,639) 2,920 (3,419) 1,427 Net loss $ (34,056) $ (37,504) $ (110,756) $ (105,470) Net loss per share -- basic and diluted $ (0.36) $ (0.40) $ (1.18) $ (1.15) Shares used in calculation of net loss per share -- basic and diluted 94,157 93,199 93,962 92,030 CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (in thousands) Nine months ended September 30, 2004 2003 Operating activities: Net loss $(110,756) $ (105,470) Adjustments to reconcile net loss to cash used for operating activities: Non-cash expenses 5,418 2,862 Working capital changes (15,983) (25,477) Cash used for operating activities (121,321) (128,085) Investing activities: Purchases, sales and maturities of short-term investments, net (42,276) (154,380) Purchases of equipment and increase in patents, net (10,214) (8,534) Cash used for investing activities (52,490) (162,914) Financing activities: Proceeds from issuance of common stock 5,499 171,936 Proceeds from issuance of convertible senior notes 193,613 169,696 Principle payments on notes payable and capital leases (10) (63,113) Cash provided by financing activities 199,102 278,519 Increase (decrease) in cash and cash equivalents 25,291 (12,480) Cash and cash equivalents at beginning of period 76,615 69,415 Cash and cash equivalents at end of period $ 101,906 $ 56,935 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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