Back to GetFilings.com





UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


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, 2002

OR


|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934

Commission File Number: 0-19700

AMYLIN PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)


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
(Registrant’s telephone number, including area code)

Not Applicable
(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes |X|   No |_|

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.


Class
Common Stock, $.001 par value
Outstanding at August 8, 2002
80,105,282



 


AMYLIN PHARMACEUTICALS, INC.
TABLE OF CONTENTS

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.     Management’s 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  

2


Part I. Financial Information

Item 1. Financial Statements

AMYLIN PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets
(in thousands)

  June 30,
2002

(Unaudited)
  December 31,
2001

(Note 1)
 
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  
 
 
 

See accompanying notes to condensed consolidated financial statements.

3


AMYLIN PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)

  Three months ended
June 30,

 
  2002
  2001
 
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  
 
 
 

See accompanying notes to condensed consolidated financial statements.

4


AMYLIN PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)

  Six months ended
June 30,

 
  2002
  2001
 
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  
 
 
 

See accompanying notes to condensed consolidated financial statements.

5


AMYLIN PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)

  Six months ended
June 30,

 
  2002
  2001
 
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  
 
 
 

See accompanying notes to condensed consolidated financial statements.

6


AMYLIN PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2002
(Unaudited)

1. Summary of Significant Accounting Policies

     Basis of Presentation

     The information contained herein has been prepared in accordance with instructions for Form 10-Q and Article 10 of Regulation S-X. The information as of June 30, 2002, and for the three and six month periods ended June 30, 2002, and June 30, 2001, are unaudited. In the opinion of management, the information reflects all adjustments necessary to make the results of operations for the interim periods a fair statement of such operations. All such adjustments are of a normal recurring nature. Interim results are not necessarily indicative of results for a full year. The balance sheet at December 31, 2001, has been derived from the audited financial statements at that date but does not include all information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. For more complete financial information, these financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2001.

     Per Share Data

     Basic and diluted net loss applicable to common stock per share is computed using the weighted average number of common shares outstanding during the periods. Common stock equivalents from stock options and warrants of 3,153,000 and 3,539,000 for the three and six months ended June 30, 2002, respectively, and common stock equivalents of 3,012,000 and 3,516,000 for the three and six months ended June 30, 2001, respectively, are excluded from the calculation of diluted loss per share because the effect is antidilutive.

     Consolidation

     The consolidated financial statements include the accounts of Amylin and its wholly owned subsidiary, Amylin Europe Limited. All significant intercompany transactions and balances have been eliminated.

2. Investments

     The Company has classified its debt securities as available-for-sale, and accordingly, carries its short-term investments at fair value, and unrealized holding gains or losses on these securities are carried as a separate component of stockholders’ equity. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest and other income or expense as applicable. Realized gains and losses and declines in value judged to be “other-than-temporary” (of which there have been none to date) on available-for-sale securities are also included in interest and other expense as applicable. The cost of securities sold is based on the specific identification method.

3. Inventories

     Inventories are stated at the lower of cost (FIFO) or market and consist primarily of SYMLIN™ (pramlintide acetate) bulk drug material, which will be used in the manufacture of finished SYMLIN drug product in vials for syringe administration and cartridges for pen administration, pending regulatory approvals. At June 30, 2002, total inventories were approximately $8.7 million, of which approximately $1.4 million, net of a valuation allowance of $0.4 million, was in finished form.

7


4. Comprehensive Income

     Statement of Financial Accounting Standards No. 130, Reporting Comprehensive Income (“SFAS 130”), requires reporting and displaying comprehensive income (loss) and its components which, for the Company, includes net loss and unrealized gains and losses on investments. In accordance with SFAS 130, the accumulated balance of other comprehensive income is disclosed as a separate component of stockholders’ equity. For the six months ended June 30, 2002 and 2001, the comprehensive loss consisted of:


  Six months ended June 30,  
  2002
  2001
 
      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 Lawsuit

     On 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’ Equity

     On 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 Company’s 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 Company’s 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 Company’s Board of Directors in whole, but not in part, at a price of $0.001 per Right.

8


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

     Except 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 Administration’s, or FDA’s, 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