Exhibit 99.1
| CONTACT: |
| Mark G. Foletta |
| Vice President Finance and |
| Chief Financial Officer |
| (858) 552-2200 |
| www.amylin.com |
FOR IMMEDIATE RELEASE
AMYLIN PHARMACEUTICALS REPORTS SECOND QUARTER FINANCIAL RESULTS
Exenatide New Drug Application Submitted to FDA as Planned
San Diego, CA – August 5, 2004 – 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”.
(financial information to follow)
AMYLIN PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| | June 30,
2004 | | December 31,
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
June 30, | | Six Months ended
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 | |
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