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UNITED
STATES FORM 10-Q (Mark One) |
| |X| | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2002OR |
| |_| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 |
Commission File Number: 0-19700AMYLIN
PHARMACEUTICALS, INC. |
|
Delaware (State or other jurisdiction of Incorporation or organization) |
33-0266089 (I.R.S. Employer Identification No.) |
|
9373 Towne Centre Drive, San Diego, California (Address of principal executive offices) |
92121 (Zip code) |
(858) 552-2200
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| Class
Common Stock, $.001 par value |
Outstanding at August 8, 2002
80,105,282 |
|
AMYLIN PHARMACEUTICALS, INC.
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| PAGE NO. | ||||||||
|---|---|---|---|---|---|---|---|---|
| COVER PAGE | 1 | |||||||
| TABLE OF CONTENTS | 2 | |||||||
| PART I. FINANCIAL INFORMATION | ||||||||
| ITEM 1. | Financial Statements | |||||||
| Condensed Consolidated Balance Sheets as of June 30, 2002 (unaudited) and | ||||||||
| December 31, 2001 | 3 | |||||||
| Condensed Consolidated Statements of Operations for the three months ended | ||||||||
| June 30, 2002 and 2001 (unaudited) | 4 | |||||||
| Condensed Consolidated Statements of Operations for the six months ended | ||||||||
| June 30, 2002 and 2001 (unaudited) | 5 | |||||||
| Condensed Consolidated Statements of Cash Flows for the six months ended | ||||||||
| June 30, 2002 and 2001 (unaudited) | 6 | |||||||
| Notes to Condensed Consolidated Financial Statements | 7 | |||||||
| ITEM 2. | Managements Discussion and Analysis of Financial Condition and | |||||||
| Results of Operations | 9 | |||||||
| ITEM 3. | Quantitative and Qualitative Disclosures about Market Risk | 13 | ||||||
| PART II. OTHER INFORMATION | ||||||||
| ITEM 4. | Submission of Matters to a Vote of Security Holders | 14 | ||||||
| ITEM 5. | Other Information | 14 | ||||||
| ITEM 6. | Exhibits and Reports on Form 8-K | 15 | ||||||
| SIGNATURE | 15 | |||||||
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2 Part I. Financial InformationItem 1. Financial StatementsAMYLIN PHARMACEUTICALS, INC.Condensed
Consolidated Balance Sheets
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| June 30, 2002 (Unaudited) |
December 31, 2001 (Note 1) |
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|---|---|---|---|---|---|---|---|---|
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 27,123 | $ | 22,395 | ||||
| Short-term investments | 68,931 | 24,179 | ||||||
| Inventories | 8,742 | 8,001 | ||||||
| Other current assets | 2,123 | 1,550 | ||||||
| Total current assets | 106,919 | 56,125 | ||||||
| Property and equipment, net | 3,790 | 3,628 | ||||||
| Patents and other assets, net | 3,834 | 3,774 | ||||||
| $ | 114,543 | $ | 63,527 | |||||
| Liabilities and Stockholders Equity (Deficit) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 13,537 | $ | 8,386 | ||||
| Current portion of notes payable and capital lease obligations | 550 | 551 | ||||||
| Total current liabilities | 14,087 | 8,937 | ||||||
| Note payable and capital lease obligations, net of current portion | 317 | 588 | ||||||
| Note payable to Johnson & Johnson | 59,905 | 56,985 | ||||||
| Other liabilities | 558 | 500 | ||||||
| Stockholders Equity (Deficit): | ||||||||
| Common stock, $.001 par value, 200,000 shares authorized, | ||||||||
| 80,007 and 67,554 issued and outstanding at June 30, 2002 | ||||||||
| and December 31, 2001, respectively | 80 | 68 | ||||||
| Additional paid-in capital | 496,824 | 404,114 | ||||||
| Accumulated deficit | (457,036 | ) | (407,744 | ) | ||||
| Deferred compensation | (332 | ) | (309 | ) | ||||
| Accumulated other comprehensive income | 140 | 388 | ||||||
| Total stockholders equity (deficit) | 39,676 | (3,483 | ) | |||||
| $ | 114,543 | $ | 63,527 | |||||
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See accompanying notes to condensed consolidated financial statements. 3 AMYLIN PHARMACEUTICALS, INC.Condensed
Consolidated Statements of Operations
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| Three months ended June 30, |
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|---|---|---|---|---|---|---|---|---|
| 2002 |
2001 |
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| Operating expenses: | ||||||||
| Research and development | $ | 20,826 | $ | 12,360 | ||||
| General and administrative | 5,500 | 6,586 | ||||||
| 26,326 | 18,946 | |||||||
| Loss from operations | (26,326 | ) | (18,946 | ) | ||||
| Interest and other income | 600 | 1,047 | ||||||
| Interest and other expense | (1,468 | ) | (1,531 | ) | ||||
| Net loss | $ | (27,194 | ) | $ | (19,430 | ) | ||
| Net loss per share basic and diluted | $ | (0.34 | ) | $ | (0.30 | ) | ||
| Shares used in computing net loss per share basic and diluted | 79,981 | 64,792 | ||||||
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See accompanying notes to condensed consolidated financial statements. 4 AMYLIN PHARMACEUTICALS, INC.Condensed
Consolidated Statements of Operations
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| Six months ended June 30, |
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|---|---|---|---|---|---|---|---|---|
| 2002 |
2001 |
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| Operating expenses: | ||||||||
| Research and development | $ | 37,349 | $ | 23,260 | ||||
| General and administrative | 10,197 | 10,483 | ||||||
| 47,546 | 33,743 | |||||||
| Loss from operations | (47,546 | ) | (33,743 | ) | ||||
| Interest and other income | 1,203 | 2,507 | ||||||
| Interest and other expense | (2,949 | ) | (3,169 | ) | ||||
| Net loss | $ | (49,292 | ) | $ | (34,405 | ) | ||
| Net loss per share basic and diluted | $ | (0.64 | ) | $ | (0.54 | ) | ||
| Shares used in computing net loss per share basic and diluted | 77,128 | 64,160 | ||||||
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See accompanying notes to condensed consolidated financial statements. 5 AMYLIN PHARMACEUTICALS, INC.Condensed
Consolidated Statements of Cash Flows
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| Six months ended June 30, |
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|---|---|---|---|---|---|---|---|---|
| 2002 |
2001 |
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| Operating activities: | ||||||||
| Net loss | $ | (49,292 | ) | $ | (34,405 | ) | ||
| Adjustments to reconcile net loss to net | ||||||||
| cash used in operating activities: | ||||||||
| Depreciation and amortization | 895 | 557 | ||||||
| Inventory reserve | 400 | | ||||||
| Net book value of abandoned patents | 272 | | ||||||
| Amortization of deferred compensation | 39 | 141 | ||||||
| Stock based compensation | 103 | 417 | ||||||
| Issuance of warrants for services | | 411 | ||||||
| Amortization of debt discount | 599 | 599 | ||||||
| Accrued interest added to notes payable | 2,321 | 2,502 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Inventories | (1,141 | ) | (3,773 | ) | ||||
| Other current assets | (515 | ) | 308 | |||||
| Accounts payable and accrued liabilities | 5,151 | 2,062 | ||||||
| Other assets and liabilities, net | (85 | ) | 57 | |||||
| Net cash flows used for operating activities | (41,253 | ) | (31,124 | ) | ||||
| Investing activities: | ||||||||
| Purchases of short-term investments | (72,859 | ) | (162,392 | ) | ||||
| Sales and maturities of short-term investments | 27,859 | 198,326 | ||||||
| Purchase of fixed assets | (934 | ) | (907 | ) | ||||
| Increase in patents | (370 | ) | (450 | ) | ||||
| Net cash flows provided by (used for) investing activities | (46,304 | ) | 34,577 | |||||
| Financing activities: | ||||||||
| Principal payments on capital leases and notes payable | (272 | ) | (270 | ) | ||||
| Issuance of common stock, net | 92,557 | 34,533 | ||||||
| Net cash flows provided by financing activities | 92,285 | 34,263 | ||||||
| Change in cash and cash equivalents | 4,728 | 37,716 | ||||||
| Cash and cash equivalents at beginning of period | 22,395 | 6,265 | ||||||
| Cash and cash equivalents at end of period | $ | 27,123 | $ | 43,981 | ||||
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See accompanying notes to condensed consolidated financial statements. 6 AMYLIN PHARMACEUTICALS, INC.NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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| Six months ended June 30, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2002 |
2001 |
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| Net loss | $ | (49,292 | ) | $ | (34,405 | ) | ||||||||
| Other comprehensive income (loss): | ||||||||||||||
| Unrealized gain (loss) on investments: | (248 | ) | 33 | |||||||||||
| Comprehensive loss | $ | (49,540 | ) | $ | (34,372 | ) | ||||||||
5. Class Action LawsuitOn August 9, 2001, plaintiff Eric W. Peters, on behalf of himself and purportedly on behalf of a class of Company stockholders, filed a complaint in the United States District Court for the Southern District of California against the Company and its chief executive officer. Additional similar lawsuits were filed against the Company and certain officers and directors in the same court. The complaint alleges securities fraud in connection with various statements and alleged omissions to the public and to the securities markets related to the development of SYMLIN. All of the existing lawsuits were consolidated into a single action and a consolidated complaint was filed in February 2002. The Company believes that the lawsuit is without merit and intends to defend itself vigorously against the claims, although there are no assurances that the Company will be successful in defending such claims. The lawsuit is at an early stage and the extent or range of possible damages, if any, cannot yet be reasonably estimated. 6. Stockholders EquityOn February 19, 2002, the Company completed a public offering of 12.075 million shares of its common stock at a price of $8.00 per share. This transaction generated net proceeds of approximately $90.7 million for the Company. The Company intends to use the net proceeds for research and development and general corporate purposes. In June 2002, the Company adopted a Preferred Share Purchase Rights Plan (the Plan). The Plan provides for a dividend distribution of one preferred stock purchase right (a Right) for each outstanding share of the Companys common stock, par value $0.001 per share (the Common Shares), held of record at the close of business on June 28, 2002. The Rights are not currently exercisable. Under certain conditions involving an acquisition or proposed acquisition by any person or group of 15% or more of the Companys common stock the Rights permit the holders (other than the 15% holder) to purchase one one-hundredth of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share (the Preferred Shares), at a price of $100 per one-one hundredth of a Preferred Share, subject to adjustment. Each one one-hundredth of a share of Preferred Shares has designations and powers, preferences and rights, and the qualifications, limitations and restrictions which make its value approximately equal to the value of a Common Share. Under certain conditions, the Rights may be redeemed by the Companys Board of Directors in whole, but not in part, at a price of $0.001 per Right. 8 Item 2. Managements Discussion and Analysis of Financial Condition and Results of OperationsExcept for the historical information contained herein, the discussion in this report contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in this report due to a number of risks and uncertainties including, among other things, risks and uncertainties in the United States Food and Drug Administrations, or FDAs, review of New Drug Applications, generally, risks and uncertainties regarding the additional ongoing clinical testing of SYMLIN, risks and uncertainties that approvals of SYMLIN, if obtained, may be delayed and/or limited to specific indications, uncertainties in the review of our European Marketing Authorization Applications for SYMLIN, our ability to commercialize SYMLIN, if approved, our ability to enter into sales distribution, marketing and/or corporate partnering agreements with respect to SYMLIN and AC2993 (synthetic exendin-4), the results of our preclinical and clinical studies of our drug candidates, including AC2993, AC2993 LAR, and AC3056, and potential liability and indemnification obligations arising out of ongoing litigation. Additional factors that could cause or contribute to such differences include, without limitation, those discussed in the section entitled Liquidity and |