AMLN Amylin Pharmaceuticals, Inc. (MM)

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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