AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals Reports First Quarter Financial Results SAN DIEGO, April 28 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. today reported a net loss of $37.3 million, or $0.40 per share, for the first quarter ended March 31, 2004, compared to a net loss of $30.8 million, or $0.34 per share, for the same period in 2003. The Company's operating activities used approximately $49.4 million of cash in the first quarter of 2004, compared to $46.5 million in the same period in 2003. At March 31, 2004, the Company held cash, cash equivalents and short-term investments of approximately $221 million. In April 2004, the Company issued $200 million aggregate principal amount of 2.5% convertible senior notes in a private offering. "We finished the quarter on plan and achieved the first three of our corporate goals for 2004," said Ginger L. Graham, Amylin's President and Chief Executive Officer. "In addition, we recently completed a $200 million offering of convertible notes, strengthening our ability to launch our two late-stage diabetes product candidates following approvals by the FDA." The Company reported revenues under its collaborative agreements with Eli Lilly & Co. for exenatide of $6.7 million for the quarter ended March 31, 2004 compared to $11.9 million for the same period in 2003. Revenue in the current quarter consists primarily of cost-sharing amounts payable by Lilly for exenatide development expenses. Research and development expenses for the quarter ended March 31, 2004 were $27.5 million, compared to $28.1 million in the same period in 2003. The slight decrease reflects reduced development expenses for exenatide 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 March 31, 2004 were $16.1 million, compared to $10.5 million in the same period in 2003. The increase reflects increased pre-launch activities for exenatide and costs associated with an increased number of employees and associated infrastructure to support future product launches. The Company continues to expect to use between $160 and $170 million of cash 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 does not expect significant milestone payments from Lilly in 2004. SYMLIN(R) (pramlintide acetate) 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 specific requirements for SYMLIN approval. The Company also plans to maintain its commercialization capabilities and continue its progress with earlier stage development programs. Corporate milestones achieved by Amylin in the first quarter include initiation of the first Phase 2 study of AC137 (pramlintide) for obesity, the first Phase 1 study of AC162352 (PYY 3-36) for obesity, and a Phase 2 dose- proportionality study of exenatide LAR for type 2 diabetes. 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 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 in FDA requirements for SYMLIN and exenatide approval; risks and uncertainties that FDA approval, if any, may be delayed and/or limited; 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2003, under the heading "Risk Factors Related to Our Business". (financial information to follow) AMYLIN PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, December 31, 2004 2003 (unaudited) Assets Cash and cash equivalents $40,336 $76,615 Short-term investments 180,893 193,161 Inventories 13,549 12,574 Other current assets 11,825 6,198 Property and equipment, net 14,270 13,691 Other assets 8,482 8,806 Total assets $269,355 $311,045 Liabilities and stockholders' equity Accounts payable, accrued expenses and other current liabilities $34,468 $41,118 Current portion of deferred revenue 4,286 4,286 Other long-term liabilities, net of current portion 2,764 2,196 Deferred revenue, net of current portion 24,158 25,229 Convertible senior notes 175,000 175,000 Stockholders' equity 28,679 63,216 Total liabilities and stockholders' equity $269,355 $311,045 CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) Quarter Ended March 31, 2004 2003 Revenue under collaborative agreements $6,689 $11,885 Operating Expenses: Research and development $27,457 $28,122 Selling, general and administrative 16,088 10,515 Acquired in-process research and development -- 3,300 Total operating expenses 43,545 41,937 Operating Loss (36,856) (30,052) Interest expense, net (417) (758) Net loss $(37,273) $(30,810) Net loss per share - basic and diluted $(0.40) $(0.34) Shares used in computing net loss per share - basic and diluted 93,776 90,032 CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) Quarter Ended March 31, 2004 2003 Operating activities: Net loss $(37,273) $(30,810) Adjustments to reconcile net loss to cash used for operating activities: Non-cash expenses 1,428 2,277 Working capital changes (13,566) (17,982) Net cash used for operating activities $(49,411) $(46,515) Investing activities: Purchases, sales and maturities of short-term investments, net 12,303 (101,770) Purchases of equipment and increase in patents, net (1,682) (2,177) Net cash provided by (used for) investing activities 10,621 (103,947) Financing activities: Proceeds from issuance of common stock, net 2,514 165,712 Principal payments on notes payable and capital leases (3) (139) Net cash provided by financing activities 2,511 165,573 Increase (decrease) in cash and cash equivalents (36,279) 15,111 Cash and cash equivalents at beginning of period 76,615 69,415 Cash and cash equivalents at end of period $40,336 $84,526 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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