10-Q 1 d10q.htm FORM 10-Q Form 10-Q
Table of Contents

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

x   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2003

 

OR

 

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

 

Commission File Number: 0-21699

 


 

VIROPHARMA INCORPORATED

(Exact Name of Registrant as Specified in its Charter)

 

Delaware   94-2347624

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

405 Eagleview Boulevard

Exton, Pennsylvania 19341

(Address of Principal Executive Offices and Zip Code)

 

610-458-7300

(Registrant’s Telephone Number, Including Area Code)

 


 

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 requirement for the past 90 days:  Yes  x  No  ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act): Yes  ¨  No  x

 

Number of shares outstanding of the issuer’s Common Stock, par value $.002 per share, as of August 14, 2003: 25,969,134 shares.

 



Table of Contents

VIROPHARMA INCORPORATED

 

INDEX

 

PART I. FINANCIAL INFORMATION

 

     Page

     Item 1. Financial Statements:     
         

Consolidated Balance Sheets at December 31, 2002 and June 30, 2003

   3
         

Consolidated Statements of Operations for the three months ended June 30, 2002 and 2003, the six months ended June 30, 2002 and 2003 and the period from December 5, 1994 (Inception) to June 30, 2003

   4
         

Consolidated Statement of Stockholders’ Equity for the six months ended June 30, 2003

   5
         

Consolidated Statements of Cash Flows for the six months ended June 30, 2002 and 2003 and the period from December 5, 1994 (Inception) to June 30, 2003

   6
         

Notes to Consolidated Financial Statements

   8
     Important Information About Forward-Looking Statements    12
     Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations    13
     Item 3. Quantitative and Qualitative Disclosures About Market Risk    19
     Item 4. Controls and Procedures    19
PART II. OTHER INFORMATION     
     Item 1. Legal Proceedings    20
     Item 4. Submission of Matters to a Vote of Security Holders    20
     Item 6. Exhibits and Reports on Form 8-K    20
     Signatures    22

 

2


Table of Contents

PART I. FINANCIAL INFORMATION

 

ITEM 1.   FINANCIAL STATEMENTS

 

ViroPharma Incorporated

(A Development Stage Company)

Consolidated Balance Sheets

(unaudited)

December 31, 2002 and June 30, 2003

 

    

December 31,

2002


   

June 30,

2003


 
Assets                 

Current assets:

                

Cash and cash equivalents

   $ 15,987,056     $ 9,885,608  

Short-term investments

     142,294,488       128,123,374  

Notes receivable from officers – current

     88,743       88,743  

Due from partners

     —         1,439,000  

Other current assets

     3,447,928       2,620,648  
    


 


Total current assets

     161,818,215       142,157,373  

Equipment and leasehold improvements, net

     8,515,248       7,693,778  

Notes receivable from officers – noncurrent

     88,743       45,372  

Debt issue costs, net

     2,612,366       2,235,024  

Other assets

     496,185       94,458  
    


 


Total assets

   $ 173,530,757     $ 152,226,005  
    


 


Liabilities and Stockholders’ Equity                 

Current liabilities:

                

Loans payable - current

   $ 116,667     $ 58,379  

Accounts payable

     979,909       636,117  

Due to partners

     693,778       —    

Accrued expenses and other current liabilities

     6,739,353       5,687,485  

Deferred revenue – current

     516,667       563,636  
    


 


Total current liabilities

     9,046,374       6,945,617  

Loans payable – noncurrent

     8,334       —    

Convertible subordinated notes

     134,900,000       129,900,000  

Deferred revenue – noncurrent

     1,765,278       1,409,091  
    


 


Total liabilities

     145,719,986       138,254,708  
    


 


Commitments and Contingencies

                

Stockholders’ equity:

                

Preferred stock, par value $.001 per share. 5,000,000 shares authorized; Series A convertible participating preferred stock; no shares issued and outstanding

     —         —    

Series A junior participating preferred stock; 200,000 shares designated; no shares issued and outstanding

     —         —    

Common stock, par value $.002 per share. Authorized 100,000,000 shares; issued and outstanding 25,933,096 at December 31, 2002 and 25,969,134 at June 30, 2003

     51,866       51,938  

Additional paid-in capital

     248,782,497       248,820,775  

Deferred compensation

     (435,093 )     (344,909 )

Accumulated other comprehensive income (loss)

     (2,086,601 )     154,141  

Deficit accumulated during the development stage

     (218,501,898 )     (234,710,648 )
    


 


Total stockholders’ equity

     27,810,771       13,971,297  
    


 


Total liabilities and stockholders’ equity

   $ 173,530,757     $ 152,226,005  
    


 


 

See accompanying notes to consolidated financial statements.

 

 

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Table of Contents

ViroPharma Incorporated

(A Development Stage Company)

Consolidated Statements of Operations

(unaudited)

Three months ended June 30, 2002 and 2003, six months ended June 30, 2002 and 2003

and the period from December 5, 1994 (Inception) to June 30, 2003

 

    

Three months ended

June 30,


   

Six months ended

June 30,


   

Period from

December 5, 1994

(Inception)

June 30,


 
     2002

    2003

    2002

    2003

    2003

 

Revenues:

                                        

License fee and milestone revenue

   $ 538,462     $ 140,909     $ 1,076,923     $ 309,217     $ 15,027,272  

Grant revenue

     —         —         —         —         526,894  

Other revenue

     —         —         —         34,000       237,400  
    


 


 


 


 


Total revenues

     538,462       140,909       1,076,923       343,217       15,791,566  
    


 


 


 


 


Continuing operating expenses incurred in the development stage:

                                        

Research and development

     10,704,235       4,504,708       24,600,550       10,592,961       200,108,443  

Acquisition of technology rights

     —         —         —         —         16,500,000  

Marketing

     2,836,729       —         6,050,974       —         23,360,873  

General and administrative

     2,410,587       1,561,118       4,471,848       3,486,728       44,429,102  
    


 


 


 


 


Total operating expenses

     15,951,551       6,065,826       35,123,372       14,079,689       284,398,418  
    


 


 


 


 


Gain on repurchase of debt

     —         —         —         2,805,337       30,699,597  

Interest income

     1,446,472       792,671       3,562,237       1,098,720       34,089,869  

Interest expense

     2,909,559       2,102,278       5,820,274       4,248,914       37,233,825  
    


 


 


 


 


Loss from continuing operations

     (16,876,176 )     (7,234,524 )     (36,304,486 )     (14,081,329 )     (241,051,211 )

Discontinued operations:

                                        

Income (loss) from discontinued sales operations

     115,223       —         (1,933,182 )     —         6,340,563  
    


 


 


 


 


Net loss

   $ (16,760,953 )   $ (7,234,524 )   $ (38,237,668 )   $ (14,081,329 )   $ (234,710,648 )
    


 


 


 


 


Basic and diluted loss per share from continuing operations

   $ (0.74 )   $ (0.28 )   $ (1.60 )   $ (0.55 )        
    


 


 


 


       

Basic and diluted loss per share from discontinued sales operations

   $ 0.01     $ —       $ (0.09 )   $ —            
    


 


 


 


       

Basic and diluted net loss per share

   $ (0.74 )   $ (0.28 )   $ (1.69 )   $ (0.55 )        
    


 


 


 


       

Shares used in computing basic and diluted loss per share amounts

     22,702,277       25,886,314       22,688,907       25,806,961          
    


 


 


 


       

 

See accompanying notes to consolidated financial statements.

 

 

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Table of Contents

ViroPharma Incorporated

(A Development Stage Company)

Consolidated Statement of Stockholders’ Equity

(unaudited)

Six months ended June 30, 2003

 

     Preferred stock

   Common stock

  

Additional
paid-in

capital


  

Deferred
compensation


    

Accumulated

other

comprehensive
income (loss)


    

Deficit

accumulated

during the

development

stage


    

Total
stockholders’

equity


 
     Number
of shares


   Amount

   Number
of shares


   Amount

              

Balance, December 31, 2002

   —      $ —      25,933,096    $ 51,866    $ 248,782,497    $ (435,093 )    $ (2,086,601 )    $ (218,501,898 )    $ 27,810,771  

Employee Stock Purchase Plan

   —        —      27,888      56      35,419      —          —          —          35,475  

Exercise of common stock options

   —        —      8,150      16      2,859      —          —          —          2,875  

Amortization of deferred compensation

   —        —      —        —        —        90,184        —          —          90,184  

Unrealized gain on available for sale securities

   —        —      —        —        —        —          113,321        —          113,321  

Adjustment to unrealized loss on available for sale securities

   —        —      —        —        —        —          2,127,421        (2,127,421 )      —    

Net loss

   —        —      —        —        —        —          —          (14,081,329 )      (14,081,329 )
    
  

  
  

  

  


  


  


  


Balance, June 30, 2003

   —      $ —      25,969,134    $ 51,938    $ 248,820,775    $ (344,909 )    $ 154,141      $ (234,710,648 )    $ 13,971,297  
    
  

  
  

  

  


  


  


  


 

See accompanying notes to consolidated financial statements.

 

 

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Table of Contents

ViroPharma Incorporated

(A Development Stage Company)

Consolidated Statements of Cash Flows

(unaudited)

Six months ended June 30, 2002 and 2003 and the

period from December 5, 1994 (Inception) to June 30, 2003

 

    

Six months ended

June 30,


   

Period from

December 5, 1994
(Inception)

to June 30,


 
      
     2002

    2003

    2003

 

Cash flows from operating activities:

                        

Net loss

   $ (38,237,668 )   $ (14,081,329 )   $ (234,710,648 )

Adjustments to reconcile net loss to net cash used in operating activities:

                        

Non-cash gain on sale of sales force

     —         —         (15,410,000 )

Non-cash gain on repurchase of convertible subordinated notes

     —         (2,875,000 )     (31,599,875 )

Write-off of deferred financing costs on repurchase of notes

     —         69,663       900,278  

Non-cash write-off of fixed assets

     —         —         1,517,172  

Non-cash acquisition of technology rights

     —         —         16,500,000  

Non-cash compensation expense

     213,227       90,184       1,750,737  

Non-cash warrant value

     —         —         153,751  

Non-cash consulting expense

     —         —         46,975  

Non-cash interest expense

     409,229       307,679       2,590,115  

Depreciation and amortization expense

     1,374,672       1,252,644       7,085,113  

Changes in assets and liabilities:

                        

Other current assets

     957,595       1,080,449       (2,367,478 )

Notes receivable from officers

     104,596       43,371       (134,115 )

Due (to) from partners

     542,192       (2,132,778 )     (1,439,000 )

Other assets

     (100,286 )     48,558       (94,458 )

Accounts payable

     2,508,412       (343,792 )     636,117  

Deferred revenue

     (1,076,923 )     (309,218 )     1,972,727  

Accrued expenses and other current liabilities

     8,943,993       (1,051,868 )     15,687,485  

Other liabilities

     (10,000,000 )     —         10,000,000  
    


 


 


Net cash used in operating activities

     (34,360,961 )     (17,901,437 )     (226,915,104 )
    


 


 


Cash flows from investing activities:

                        

Purchase of equipment and leasehold improvements

   $ (3,561,049 )   $ (431,174 )   $ (16,492,600 )

Proceeds from sale equipment

     —         —         196,537  

Purchases of short-term investments

     (102,397,613 )     (74,875,014 )     (1,099,228,185 )

Sales of short-term investments

     —         —         9,680,414  

Maturities of short-term investments

     144,570,031       89,259,449       961,325,368  
    


 


 


Net cash provided by (used in) investing activities

     38,611,369       13,953,261       (144,518,466 )
    


 


 


Cash flows from financing activities:

                        

Net proceeds from issuance of preferred stock

   $ —       $ —       $ 27,242,143  

Net proceeds from issuance of common stock

     37,951       38,350       198,854,366  

Preferred stock cash dividends

     —         —         (1,254,294 )

Proceeds from loans payable and milestone advance

     —         —         2,100,000  

Payment of loans payable

     (99,999 )     (66,622 )     (2,041,621 )

Repurchase of convertible subordinated notes

     —         (2,125,000 )     (18,500,125 )

Proceeds received on notes receivable

     —         —         1,625  

Gross proceeds from notes payable

     —         —         180,692,500  

Issuance costs on notes payable

     —         —         (5,725,416 )

Payment of notes payable

     —         —         (50,000 )
    


 


 


Net cash provided by (used in) financing activities

     (62,048 )     (2,153,272 )     381,319,178  
    


 


 


Net increase (decrease) in cash and cash equivalents

     4,188,360       (6,101,448 )     9,885,608  

Cash and cash equivalents at beginning of period

     9,826,879       15,987,056       —    
    


 


 


Cash and cash equivalents at end of period

   $ 14,015,239     $ 9,885,608     $ 9,885,608  
    


 


 


 

6


Table of Contents

Supplemental disclosure of non-cash transactions:

               

Conversion of Note Payable to Series A and Series B Preferred Stock

   —       —      642,500

Conversion of mandatorily redeemable convertible preferred stock to

               

common shares

   —       —      16,264,199

Notes issued for 828,750 common shares

   —       —      1,625

Deferred compensation

   —       —      2,222,158

Forfeiture of restricted stock

   —       —      126,511

Accretion of redemption value attributable to mandatorily redeemable

               

converted preferred stock

   —       —      1,616,445

Conversion of milestone advance to loan payable

   —       —      1,000,000

Unrealized gains (losses) on available for sale securities

   (1,114,606 )   113,321    154,141

Issuance of common stock to Aventis Pharmaceuticals Inc.

   —       —      4,590,000

Settlement of milestone advances to Aventis Pharmaceuticals Inc.

   —       —      20,000,000

Supplemental disclosure of cash flow information:

               

Cash paid for interest

   5,400,100     4,047,000    31,684,443

 

See accompanying notes to consolidated financial statements.

 

 

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Table of Contents

ViroPharma Incorporated

(A Development Stage Company)

Notes to Consolidated Financial Statements

 

(1)   Organization and Business Activities

 

ViroPharma Incorporated (a development stage company) commenced operations on December 5, 1994. ViroPharma Incorporated and its subsidiary (the “Company” or “ViroPharma”) is a development stage pharmaceutical company engaged in the discovery and development of new antiviral medicines.

 

The Company is devoting substantial effort towards conducting drug discovery and development, raising capital, conducting clinical trials, and pursuing regulatory approval for products under development. The only revenues from product sales that the Company has earned are detailing fees from discontinued sales operations during the first eight months of 2002 for detailing products owned by Aventis Pharmaceuticals Inc. (“Aventis”). Effective on August 31, 2002, the Company discontinued its sales force operations related to two products owned by Aventis Pharmaceuticals Inc. and all related sales administration activities. The Company has earned no significant revenue or product sales and has not achieved profitable operations or positive cash flow from continuing operations. The Company’s deficit accumulated during the development stage aggregated $234.7 million through June 30, 2003. There is no assurance that profitable operations can ever be achieved, and even if achieved, could be sustained on a continuing basis.

 

The Company plans to continue to finance its operations with a combination of stock and debt issuances, as available, license payments, payments from strategic research and development arrangements when and if agreed upon milestones are achieved and, in the longer term, revenues from product sales or collaborations, if its planned products are commercialized. There are no assurances, however, that the Company will be successful in obtaining regulatory approval for any of its product candidates or in obtaining an adequate level of financing needed for the long-term development and commercialization of its product candidates.

 

Basis of Presentation

 

The financial information at June 30, 2003 and for the three and six months ended June 30, 2002 and 2003, is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which, in the opinion of management, are necessary to state fairly the financial information set forth therein in accordance with accounting principles generally accepted in the United States of America. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2002 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.

 

During the second quarter of 2003, the Company discovered that it had been accounting for the discounts and premiums associated with its short-term investments incorrectly. The amortization of these discounts and premiums should have been recorded ratably over the holding period for each investment to interest income. In prior financial statements, the Company has reported these amounts as a change in accumulated other comprehensive income (loss), a component of stockholders’ equity, in the consolidated balance sheet. Due to the lack of materiality, the cumulative net effect of the activity of approximately $2.1 million has been relieved from accumulated other comprehensive income (loss) and charged directly to deficit accumulated during the development stage in the consolidated balance sheet in 2003. The effects of this charge on loss from continuing operations for each of the years ended December 31, 2000, 2001 and 2002 and for the quarter ended March 31, 2003 and on the deficit accumulated during the development stage as of each period end is immaterial.

 

Reclassification

 

Certain prior year amounts have been reclassified to conform to the current year presentation.

 

(2)   Comprehensive Income (Loss)

 

In the Company’s annual consolidated financial statements, comprehensive income (loss) is presented as a separate financial statement. For interim consolidated financial statements, the Company is permitted to disclose the information in the footnotes to the consolidated financial statements. The disclosures are required for comparative purposes. The only comprehensive income (loss) item the Company has is unrealized gains and losses on available for sale securities. The following reconciles net loss to comprehensive loss for the three and six months ended June 30, 2002 and 2003:

 

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Table of Contents

ViroPharma Incorporated

(A Development Stage Company)

Notes to Consolidated Financial Statements

 

    

Three month period ended

June 30,


   

Six month period ended

June 30,


 
     2002

    2003

    2002

    2003

 

Net loss

   $ (16,760,953 )   $ (7,234,524 )   $ (38,237,668 )   $ (14,081,329 )

Other comprehensive income (loss):

                                

Unrealized gains (losses) on available for sale securities

     38,733       (219,931 )     (1,114,606 )     113,321  
    


 


 


 


Comprehensive loss

   $ (16,722,220 )   $ (7,454,455 )   $ (39,352,274 )   $ (13,968,008 )
    


 


 


 


 

(3)   Convertible Subordinated Note Repurchases

 

Through June 30, 2003, the Company had purchased $50.1 million of principal amount of its 6% convertible subordinated notes due in 2007. As a result of these purchases, the Company has reduced its annual interest expense by approximately $3.0 million. During the six months ended June 30, 2003, the Company recognized a $2.8 million gain, after the write-off of $0.1 million of deferred financing costs, related to the purchase of $5.0 million of principal amount of these notes. The gain is classified as other income. As of June 30, 2003, the Company may, in its discretion based on prior board of directors approval, spend up to $1.5 million to purchase additional convertible subordinated notes in the open market or in privately negotiated transactions from time to time as market conditions warrant.

 

(4)   Stock Compensation

 

The Company accounts for its stock option plans in accordance with the provisions of Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees” and related interpretations. As such, compensation cost is measured on the date of grant for fixed options as the excess of the current market price of the underlying stock over the exercise price. Such compensation amounts are amortized over the respective vesting periods of the option grant. Any charge to operations for variable options with performance criteria is affected each reporting period by changes in the fair value of the Company’s common stock. The Company adopted the disclosure provisions of SFAS No. 123, “Accounting for Stock-Based Compensation,” which permits entities to provide pro forma net income (loss) and pro forma earnings (loss) per share disclosures for employee stock option grants as if the fair-value based method defined in SFAS No. 123 had been applied.

 

In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation—Transition and Disclosure, an amendment of FASB Statement No. 123.” This Statement amended FASB Statement No. 123, “Accounting for Stock-Based Compensation,” to provide alternative methods of transition for a voluntary change to the fair value method of accounting for stock-based employee compensation. In addition, this Statement amended the disclosure requirements of Statement No. 123 to require prominent disclosures in both annual and interim financial statements.

 

Compensation expense for options granted to non-employees is determined in accordance with SFAS No. 123, and related interpretations, as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. Compensation expense for options granted to non-employees is remeasured each period as the underlying options vest.

 

The Company applies APB Opinion No. 25 in accounting for its stock options granted to employees and directors. Had the Company determined compensation cost for options granted to employees and directors based on the fair value at the grant date under SFAS No. 123, the Company’s net loss and net loss per share would have been increased to the pro forma amounts under SFAS No. 123 indicated below:

 

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Table of Contents

ViroPharma Incorporated

(A Development Stage Company)

Notes to Consolidated Financial Statements

 

    

For the three months

ended June 30,


   

For the six months

ended June 30,


 
     2002

    2003

    2002

    2003

 

Net loss:

                                

As reported

   $ (16,760,953 )   $ (7,234,524 )   $ (38,237,668 )   $ (14,081,329 )

Add: stock-based employee compensation expense included in net loss

     —         —         —         —    

Deduct: total stock-based employee compensation expense determined under the fair value-based method for all employee and director awards

     (2,966,245 )     (1,974,382 )     (5,992,441 )     (4,048,579 )
    


 


 


 


Pro forma under SFAS No. 123

   $ (19,727,198 )   $ (9,208,906 )   $ (44,230,109 )   $ (18,129,908 )
    


 


 


 


Net loss per share:

                                

Basic and diluted:

                                

As reported

   $ (0.74 )   $ (0.28 )   $ (1.69 )   $ (0.55 )

Pro forma under SFAS No. 123

     (0.87 )     (0.36 )     (1.95 )     (0.70 )

 

(5)   Restructuring

 

In August 2002, the Company adopted a restructuring plan to establish the foundation for its future growth.

 

Continuing Operations

 

As part of its restructuring plan, the Company terminated 33 employees within the development, commercial operations, and administration departments of the Company. In August 2002, the Company accrued $1.2 million in expenses associated with this portion of its restructuring plan, which primarily was comprised of employee severance costs associated with downsizing. This charge was included in the operating expenses of the Company in the third quarter of 2002. As of June 30, 2003, the Company has paid $1.1 million of termination benefits associated with the termination of 33 employees. During the six months ended June 30, 2003, the Company reduced its severance estimate by $0.05 million to reflect actual costs that it incurred, and other than the revision, there were no other changes to the accrued restructuring liability. As of June 30, 2003, $0.03 million of the restructuring accrual remained.

 

Discontinued Operations

 

On September 1, 2002, Aventis acquired the Company’s sales force, which totaled nearly 200 people, for $15.41 million, which was recorded as a gain in September 2002. There were no costs related to this transaction.

 

There was no activity related to the former sales force operations during 2003. During the quarter ended June 30, 2002, the income from operations of the sales force of the Company totaled $0.1 million. This income included detailing fee revenue of $6.8 million, and $6.7 million in sales force operational costs. During the six months ended June 30, 2002, the loss from operations of the sales force of the Company totaled $1.9 million. This loss included detailing fee revenue of $12.7 million, and $14.6 million in sales force operational costs.

 

Aventis Termination Agreement

 

Under the agreement ending their collaboration to co-develop and co-promote Picovir®, Aventis returned Picovir® to the Company, and both parties received mutual releases of all obligations without incurring termination fees. Aventis compensated the Company for Aventis’ share of development and commercial expenses through July 2002 and the Company’s detailing fees through August 2002, and the Company has returned to Aventis advance milestone payments of $20.0 million. Aventis also purchased 3 million shares of the Company’s common stock with a fair market value of $4.59 million. In accordance with the terms of the aforementioned agreements, the Company and Aventis offset all amounts due to each other with respect to the settlement, purchase of stock and sale of the sales force.

 

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ViroPharma Incorporated

(A Development Stage Company)

Notes to Consolidated Financial Statements

 

As a result of the termination of the Aventis agreement during August of 2002, the Company accelerated the recognition of the remaining $4.0 million of deferred revenue related to the $5.0 million up-front payment received in September 2001.

 

In September 2001, the Company entered into a collaboration to co-develop and co-promote Picovir® in the United States with Aventis. As part of the agreement, the Company received an initial payment of $25.0 million from Aventis. $5.0 million of the initial payment received was reflected in Deferred revenue, and was recognized as revenue on a straight-line basis through July 31, 2002 based on the then estimated performance period ending December 31, 2005. At June 30, 2002, $20.0 million of the initial payment was reflected in Accrued expenses. From September 2001 to July 31, 2002, the Company and Aventis shared the cost of preparing for the commercial launch of Picovir® and the marketing and commercialization efforts: 55 percent by Aventis and 45 percent by ViroPharma. Additionally, the agreement called for Aventis to fund 50 percent of the Company’s research and development efforts for the use of Picovir® in the treatment of adult and pediatric viral respiratory infection (VRI). At June 30, 2003, the Company was not due any payment under these cost sharing provisions. For the quarter ended June 30, 2002, approximately $1.2 million and $1.1 million were reflected as reductions of Picovir® research and development and marketing costs, respectively. For the six months ended June 30, 2002, approximately $4.3 million and $1.4 million were reflected as reductions of Picovir® research and development and marketing costs, respectively.

 

(6)   Litigation

 

In March and May 2002, the Company and certain of its directors were named as defendants in purported class actions filed in the United States District Court for the Eastern District of Pennsylvania. In July 2002, these actions were consolidated into a single complaint which also named certain of our officers as defendants. The plaintiffs in these actions have alleged that certain statements by the Company about Picovir® were misleading. A judgment against the Company could materially exceed the coverage which may be available under the Company’s directors’ and officers’ liability insurance. The Company filed a motion to dismiss this action in August 2002. In April 2003, the court granted in part and denied in part the Company’s motion to dismiss the consolidated complaint. The Company is vigorously defending itself against this action and believes it has meritorious defenses against these claims. While it is not feasible to predict the outcome of this claim at this time, the ultimate resolution of this action could require substantial payment by the Company which could have a material adverse effect on its financial position and liquidity, and the resolution of this matter during a specific period could have a material adverse effect on the quarterly or annual operating results for that period. To date no liability related to this matter has been reflected in the Company’s consolidated balance sheet.

 

(7)   Stockholders’ Meeting Action

 

In May 2003, the stockholders of the Company approved an amendment to the Company’s Stock Option and Restricted Share Plan (the “plan”) to increase the number of shares eligible for grant under the plan by 300,000 shares.

 

(8)   Subsequent Events

 

In August 2003, ViroPharma announced the acquisition of worldwide rights (excluding Japan) from GlaxoSmithKline to an antiviral compound (maribavir, or 1263W94) that is an inhibitor of cytomegalovirus (CMV). ViroPharma plans to advance maribavir initially for the prevention and treatment of CMV infection in transplant patients.

 

Under the terms of the agreement, ViroPharma has exclusive worldwide rights (excluding Japan) to develop and commercialize maribavir (1263W94), for the prevention and treatment of cytomegalovirus infections related to transplant (including solid organ and hematopoietic stem cell transplantation), congenital transmission, and in patients with HIV infection. ViroPharma will focus initially on patients who have received a hematopoietic stem cell (bone marrow) or solid organ transplant, and are at risk for or have been infected with CMV. ViroPharma paid GlaxoSmithKline a $3.5 million up-front licensing fee and will pay additional milestones based upon the defined clinical development and regulatory events. The Company also will pay royalties to GlaxoSmithKline and its licensor on product sales in the United States and the rest of the world (excluding Japan). The $3.5 million up-front licensing fee will be recorded as an expense in the third quarter of 2003 as the underlying technology has not reached technological feasibility and has no alternative uses.

 

 

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IMPORTANT INFORMATION ABOUT FORWARD-LOOKING STATEMENTS

 

Our disclosure and analysis in this report contains some forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. These forward-looking statements include the statements in this report on Form 10-Q about:

 

    our plan to advance an additional HCV compound into human clinical trials in early 2004;
    our plan to initiate phase 1 / 2 clinical trials with our cytomegalovirus (CMV) product candidate in transplant patients in the fourth quarter of 2003 or the first quarter of 2004;
    our plan to evaluate an intranasal approach for using Picovir® to treat the common cold, including our consideration of conducting studies to evaluate the tolerability and antiviral activity of our intranasal formulation of Picovir®;
    our plan not to fund additional significant clinical development of Picovir® for the treatment of the common cold without a new partner;
    the possibility that we may purchase a portion of our convertible subordinated notes;
    our expectation that our most significant sources of our near-term operating expenses will be discovery and development activities with our CMV program, our hepatitis C program, the exploration of alternatives regarding the future development of Picovir® for the treatment of serious or life-threatening diseases caused by enteroviruses, and business development activities seeking new opportunities to expand our pipeline;
    our expectation that our monthly expenses and operating losses in 2003 should be lower than we experienced during the first eight months of 2002; and
    our expectation that our available cash, cash equivalents and short term investments at June 30, 2003 will be sufficient to fund our planned business operations and debt service requirements through 2005.

 

Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. There can be no assurance that:

 

    we will, or will be able to, achieve the development milestones for our CMV and HCV programs during the timeframe described in this quarterly report on Form 10-Q, or at all;
    we will, or we will be able to, purchase additional convertible subordinated debts at prices favorable to us or at all;
    we will develop, or will be successful in developing, Picovir® to treat any serious or life threatening enteroviral infection;
    we will conduct a study to evaluate the tolerability and antiviral activity of an intranasal formulation of Picovir®, or that we will be successful in developing a viable intranasal formulation of Picovir®, for the treatment of the common cold;
    we will be successful in engaging a partner for the development and commercialization of an intranasal formulation of Picovir®;
    our research and development plan will not change from our current focus on CMV, HCV, biodefense and emerging diseases, and serious or life-threatening diseases caused by enteroviruses; or
    our available cash, cash equivalents and short term investments at June 30, 2003 will be sufficient to fund our planned business operations and debt service requirements through 2005.

 

Our actual expenses over the period described in this quarterly report on Form 10-Q may vary depending on a variety of factors, including: the actual cost of conducting clinical trials; the outcome of clinical trials in our CMV and HCV programs, and our resulting right to receive or obligation to pay milestone payments under our agreements relating to those programs; our ability to develop Picovir® for serious or life-threatening diseases caused by enteroviruses and the cost of that development program; our ability to continue with, or attract a development and commercialization partner for, an intranasal formulation of Picovir®; the cost of conducting studies to evaluate the tolerability and antiviral activity of an intranasal formulation of Picovir®, if we decide to conduct such studies; the actual face amount of our convertible subordinated notes that we are able or willing to acquire, if any; the resulting reduction in interest expense associated with the purchase of such convertible subordinated notes, if any; costs associated with litigation; and the cost of exploring and investing in other strategic opportunities. Conducting clinical trials for investigational pharmaceutical products are subject to risks and uncertainties. There can be no assurance that planned clinical trials can be initiated, or that planned or ongoing clinical trials can be successfully concluded or concluded in accordance with our anticipated schedule. In addition, in the future, we may not be able to maintain our listing on the Nasdaq Stock Market.

 

These and other risks and uncertainties that could affect our actual results are discussed in greater detail in this report and in our other filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, events, levels of activity, performance,

 

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or achievements. We do not assume responsibility for the accuracy and completeness of the forward-looking statements other than as required by applicable law.

 

We do not undertake any duty to update after the date of this report any of the forward-looking statements in this report to conform them to actual results.

 

You should read this report on Form 10-Q in combination with the Management’s Discussion and Analysis of Financial Condition and Results of Operations, the description of our business and the discussion of our risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2002.

 

ITEM 2.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

We have not been profitable since inception and have incurred a cumulative net loss of $234.7 million through June 30, 2003. Losses have resulted principally from costs incurred in research and development activities, general and administrative expenses and sales and marketing expenses. We expect to incur additional operating losses over the next several years.

 

Since inception, we have devoted substantially all of our resources to our research, sales and marketing and product development programs. In the first eight months of 2002, we earned detailing fees of approximately $17.2 million for promoting Nasacort® AQ and Allegra®, two products owned by Aventis Pharmaceuticals Inc. (Aventis). We stopped promoting Nasacort® AQ and Allegra® at the end of August 2002. As a result of the sale of our sales force, we will earn no future revenue from detailing Aventis or other products and we have accounted for all Nasacort® AQ and Allegra® promotion related activities as discontinued sales operations. We have generated no revenues from sales of our own products and have been dependent upon funding primarily from equity and debt financing.

 

In August 2003, we announced the acquisition of worldwide rights (excluding Japan) from GlaxoSmithKline to an antiviral compound (maribavir, or 1263W94) that is an inhibitor of cytomegalovirus (CMV). Maribavir (1263W94) is a benzimidazole compound that was originally intended as a treatment for CMV retinitis, and phase 1 data demonstrated antiviral effect and a favorable safety profile in HIV-infected patients with CMV infection. We plan to advance maribavir initially for the prevention and treatment of CMV infection in transplant patients.

 

Under the terms of the agreement, we have exclusive worldwide rights (excluding Japan) to develop and commercialize maribavir (1263W94), for the prevention and treatment of cytomegalovirus infections related to transplant (including solid organ and hematopoietic stem cell transplantation), congenital transmission, and in patients with HIV infection. We plan to focus initially on patients who have received a hematopoietic stem cell (bone marrow) or solid organ transplant, and are at risk for or have been infected with CMV. We paid GlaxoSmithKline a $3.5 million up-front licensing fee and will pay additional milestones based upon the successful outcome of certain clinical development and regulatory events. We also will pay royalties to GlaxoSmithKline and its licensor on product sales in the United States and the rest of the world (excluding Japan). We expect to initiate phase 1 / 2 clinical trials in transplant patients in the fourth quarter of 2003 or the first quarter of 2004. The $3.5 million up-front licensing fee will be recorded as an expense in the third quarter of 2003 as the underlying technology has not reached technological feasibility and has no alternative uses.

 

In July 2003, ViroPharma and Wyeth announced the results of a phase 1 clinical study with our lead hepatitis C (HCV) product candidate, HCV-371. The data from this study did not support advancing HCV-371 into additional studies in HCV-infected patients. ViroPharma and Wyeth are advancing several distinct compound classes shown to inhibit viral replication activities in preclinical studies, and expect an additional compound to enter human trials in early 2004.

 

We are continuing to explore ways to maximize the value of Picovir® by evaluating an intranasal approach to treating the common cold and the potential use of oral Picovir® for the treatment of serious or life-threatening diseases caused by enteroviruses. ViroPharma is in discussions with potential partners for the intranasal program. While we do not intend to fund significant clinical development of Picovir® for the treatment of the common cold without a partner, we may conduct studies intended to evaluate the tolerability and antiviral activity of an intranasal formulation of Picovir®.

 

In January 2003, we announced that we discontinued the development of our phase 1 and pre-clinical RSV compounds. This decision was based on the combination of the cost of advancing the program and the timeframe to commercialization. We are actively seeking to out license our RSV assets.

 

Our ability to achieve profitability is dependent on developing and obtaining regulatory approvals for our product candidates, successfully commercializing such product candidates (which may include entering into collaborative agreements for product development and commercialization), and securing contract manufacturing services and distribution and logistics services. We will need to raise substantial additional funds to continue our business activities and fund our debt service obligations beyond 2005.

 

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In March and May 2002, we and certain of our directors were named as defendants in purported class actions filed in the United States District Court for the Eastern District of Pennsylvania. In July 2002, these actions were consolidated into a single complaint which also named certain of our officers as defendants. The plaintiffs in these actions have alleged that certain statements by us about Picovir® were misleading. A judgment against us could materially exceed the coverage which may be available under our directors’ and officers’ liability insurance. We filed a motion to dismiss this action in August 2002. In April 2003, the court granted in part and denied in part our motion to dismiss the consolidated complaint. We are vigorously defending ourselves against this action and believe we have meritorious defenses against these claims. While it is not feasible to predict the outcome of this claim at this time, the ultimate resolution of this action could require substantial payment by us which could have a material adverse effect on our financial position and the resolution of this matter during a specific period could have a material adverse effect on the quarterly or annual operating results for that period. To date no liability related to this matter has been reflected in our consolidated balance sheet.

 

Critical Accounting Policies

 

Our consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America. Preparing consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. These estimates and assumptions are affected by the application of our accounting policies. Critical policies and practices are both most important to the portrayal of a company’s financial condition and results of operations, and require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effects of matters that are inherently uncertain. Due to the nature of our business and our stage of development, we do not currently face the many complex or subjective judgments that face companies that are further along in their life cycle that may be necessary in applying accounting policies. Our decision to apply APB Opinion No. 25 to account for our stock option plans rather than SFAS No. 123 is one area where our practice could be construed to be critical. Had we applied SFAS No. 123 our net loss allocable to common shareholders for the quarters ended June 30, 2002 and 2003 would have been increased by approximately $3.0 million, and $2.0 million, respectively. Had we applied SFAS No. 123 our net loss allocable to common shareholders for the six month periods ended June 30, 2002 and 2003 would have been increased by approximately $6.0 million, and $4.0 million, respectively.

 

Liquidity and Capital Resources

 

We commenced operations in December 1994. We are a development stage company and, other than detailing fees from discontinued sales operations earned in the first eight months of 2002 for promoting products owned by Aventis, we have not generated revenues from product sales. The cash flows used in operations historically have been applied to research and development activities, supporting Picovir® marketing, general and administrative expenses, and servicing our debt. We expect that the most significant sources of our near-term operating expenses will be development activities with our CMV program, discovery and development activities with our hepatitis C program, discovery and preclinical development activities in our biodefense and emerging disease program, the exploration of alternatives regarding the future development of Picovir® for the treatment of serious or life-threatening diseases caused by enteroviruses, and business development activities seeking new opportunities to expand our pipeline. While we do not intend to fund any significant clinical development of Picovir® for the treatment of the common cold without a partner, we may conduct studies intended to evaluate the tolerability and antiviral activity of an intranasal formulation of Picovir®. In January 2003, we announced that we discontinued our respiratory syncytial virus (RSV) program based on the combination of the cost of advancing the program and the timeframe to commercialization. We are actively seeking to out license our RSV assets. In the fourth quarter of 2002, we applied for government funding to help defray the costs of advancing our biodefense program. We cannot be assured that we will receive any government funding.

 

Through June 30, 2003, we have used approximately $226.9 million of cash in operating activities. We invest our cash in short-term investments. Through June 30, 2003, we have used approximately $144.5 million in investing activities, including $128.2 million in short-term investments and $16.3 million in equipment purchases and new construction. Through June 30, 2003, we have financed our operations primarily through private and public offerings of common stock, a convertible subordinated notes offering, private placements of redeemable preferred stock, two bank loans and equipment lease lines totaling approximately $381.3 million, net of approximately $18.5 million used to repurchase $50.1 million in principal amount of our 6% convertible subordinated notes due 2007.

 

During the six months ended June 30, 2003 we used approximately $17.9 million of cash in operating activities. We invest our cash in short-term investments. For the six months ended June 30, 2003, cash provided by investing activities was approximately $14.0 million, including $14.4 million from short-term investments, net of $0.4 million in equipment purchases. For the six months ended June 30, 2003, we have used approximately $2.2 million of cash in financing activities, which primarily relates to $2.1 million in cash used to repurchase $5.0 million in principal amount of our 6% convertible subordinated notes due 2007. At June 30, 2003, we had cash and cash equivalents and short-term investments aggregating approximately $138.0 million. Also, at June 30, 2003 the annualized weighted average nominal interest rate on our short-term investments was approximately 1.2%.

 

 

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Future contractual obligations and commercial commitments at June 30, 2003 are as follows:

 

 

    

Payments due by period

(in millions)


Contractual Obligations


   Total

   Less than
1 year


   2-3 years

   4-5 years

   More than
5 years


Long-Term Debt

   $ 129.9    $ 0.0    $ 0.0    $ 129.9    $ 0.0

Capital Lease Obligations

     0.0      0.0      0.0      0.0      0.0

Operating Leases

     16.7      1.8      3.6      3.5      7.8

Purchase Obligations

     0.0      0.0      0.0      0.0      0.0

Other Long-Term Liabilities Reflected on the Registrant’s Balance Sheet under GAAP

     0.0      0.0      0.0      0.0      0.0
    

  

  

  

  

Total

   $ 146.6    $ 1.8    $ 3.6    $ 133.4    $ 7.8
    

  

  

  

  

 

We lease our corporate and research and development facilities under an operating lease expiring in 2008. We also have the right, under certain circumstances, to purchase the facility. We also lease approximately 30,000 square feet of additional office space, which has resulted in an annual increase in rent expense of approximately $0.6 million starting in September 2002. The term of the lease is fifteen years. We are currently exploring several potential opportunities, including subleasing, related to its use. We cannot be certain that we will find a use for the facility or that we will be able to sublease the facility on favorable terms or at all.

 

In August 2002, we and Aventis mutually agreed to end our collaboration to co-develop and co-promote Picovir®. Under the agreement, Aventis returned Picovir® to us, and both parties received mutual releases of all obligations without incurring termination fees. Aventis has compensated us for their share of development and commercial expenses through July 2002 and our detailing fees through August 2002, and we returned to Aventis advance milestone payments of $20.0 million. Aventis also purchased 3 million shares of our common stock with a fair market value of $4.59 million. In a separate agreement, Aventis acquired our sales force for a payment to us of approximately $15.41 million. The sales force promoted products from the Aventis respiratory portfolio, Nasacort® AQ and the Allegra® family, through August 31, 2002. In accordance with the terms of the aforementioned agreements, we and Aventis offset all amounts due to each other with respect to the settlement, purchase of stock and sale of the sales force.

 

As a result of our restructuring in August 2002, particularly the termination of our co-promotion and co-development agreement with Aventis and our decision not to fund any additional significant clinical development of Picovir® for the treatment of the common cold without a new partner, we expect our monthly expenses and operating losses in 2003 to be lower than we experienced during the first eight months of 2002. Our expected decreases in expenses and operating losses would be due to lower development, marketing, sales and general and administrative expenses.

 

In June 2003, we amended our collaboration agreement with Wyeth to, among other things, focus the parties’ screening activity on one target, to allocate more of the collaboration’s pre-development efforts to ViroPharma (subject to our cost sharing arrangement with Wyeth for this work), and to clarify certain of the reconciliation and reimbursement provisions of the collaboration agreement. In addition, under the amended agreement both companies are permitted to work outside the collaboration on screening against targets other than the target being addressed by each company under the collaboration. We will continue to fund the development of additional compounds under our collaboration agreement with Wyeth. Wyeth pays a substantial portion of the collaboration’s HCV research and development expenses.

 

Our ability to achieve profitability is dependent on developing and obtaining regulatory approvals for our product candidates, successfully commercializing such product candidates (which may include entering into collaborative agreements for product development and commercialization), and securing contract manufacturing, distribution and logistics, sales and marketing services.

 

In order to improve our capital structure and reduce annual interest expense, we have purchased an aggregate of $50.1 million in principal amount of our convertible subordinated notes for approximately $18.5 million through June 30, 2003. We have remaining convertible subordinated notes payable in the principal amount of $129.9 million as of June 30, 2003. These notes bear interest at 6% per annum and become due in March 2007. As a result of our repurchase of $50.1 million in principal amount of our outstanding 6% convertible subordinated notes our annual interest expense will be reduced by approximately $3.0 million. As of June 30, 2003, the Company may, in its discretion based on prior board of directors approval, spend up to $1.5 million to purchase additional convertible subordinated notes in the open market or in privately negotiated transactions from time to time as market conditions warrant. In May 2003, our board of directors instructed us to continue to assess and pursue alternatives to reduce the outstanding principal amount of our convertible subordinated notes.

 

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There can be no assurance that we will be able to purchase any additional notes at prices favorable to us, or at all.

 

We expect that our available cash, cash equivalents and short term investments at June 30, 2003 will be sufficient to fund our planned business operations and debt service requirements through 2005. We expect that we will need to raise substantial additional funds to continue our business activities and fund our debt service and other obligations beyond 2005. To obtain this financing, we intend to access the public or private equity or debt markets or enter into additional arrangements with corporate collaborators to whom we may issue shares of our stock. We have an effective Form S-3 universal shelf registration statement filed with the Securities and Exchange Commission for the potential additional issuance of up to approximately $212.0 million of our securities. The registration statement provides us with the flexibility to determine the type of security we choose to sell, including common stock, preferred stock, warrants and debt securities, as well as the ability to time such sales when market conditions are favorable. In order for us to issue securities registered on this registration statement we must either have an aggregate market value of the voting and non-voting common equity excluding shares held by our affiliates of $75 million or more, or we must file a post effective amendment to the registration statement on Form S-2 or S-1.

 

If we raise additional capital by issuing equity securities, the terms and prices for these financings may be much more favorable to the new investors than the terms obtained by our existing stockholders. These financings also may significantly dilute the ownership of existing stockholders.

 

Additional financing, however, may not be available on acceptable terms from any source as a result of, among other factors, our inability to achieve regulatory approval of any of our product candidates, our inability to generate revenue through our existing collaborative agreements, the existence of pending litigation involving allegations of securities fraud, and our inability to file, prosecute, defend and enforce any patent claim and or other intellectual property rights. If sufficient additional financing is not available, we may need to delay, reduce or eliminate current research and development programs, or reduce or eliminate other aspects of our business.

 

Additionally, Wyeth is required to purchase our common stock at the time of completion of certain product development events pursuant to the terms of our collaboration agreement. However, in the event we are not able to successfully achieve the product development or regulatory approval events, this additional financing would not be available to us.

 

Results of Operations

 

Quarters ended June 30, 2003 and 2002

 

For the quarter ended June 30, 2003, we reported a net loss of $7.2 million compared to a net loss of $16.8 million for the same period in 2002. Net loss per share for the quarter ended June 30, 2003 was $0.28 per share, basic and diluted, compared to $0.74 per share, basic and diluted, for the same period in 2002.

 

Our loss from continuing operations for the quarter ended June 30, 2003 decreased to approximately $7.2 million from a loss of approximately $16.9 million for the same period in 2002. Loss per share from continuing operations for the quarter ended June 30, 2003 was $0.28 per share, basic and diluted, compared to a loss per share from continuing operations of $0.74 per share, basic and diluted, in the same period in 2002.

 

Revenues were approximately $0.1 million for the quarter ended June 30, 2003, compared to approximately $0.5 million during the same period in 2002. During the quarter ended June 30, 2003, we recognized license fee and milestone revenue of approximately $0.1 million from advance payments received under our collaboration with Wyeth, compared to recognizing license fee and milestone revenue of approximately $0.5 million from advance payments received under our collaboration agreements with Wyeth and Aventis (which was terminated in 2002) during the same period in 2002. The revenue recognized from our collaboration with Wyeth was lower in the second quarter of 2003 because the performance period over which we recognized the Wyeth deferred revenue was increased to reflect the extension of the screening phase of the agreement in June 2002.

 

Research and development expenses decreased approximately $6.2 million to $4.5 million in the second quarter of 2003 from $10.7 million in the second quarter of 2002. In the quarter ended June 30, 2003, we experienced a $3.1 million reduction in development and manufacturing expenses related to Picovir®, a $0.8 million reduction in development expenses related to our RSV program that we discontinued in January 2003, a $0.3 million reduction in research and development compensation expenses, a $1.7 million reduction in costs related to our collaboration with Wyeth, and a $0.7 million reduction in costs previously incurred that will be borne by Wyeth as a result of our June 2003 amendment, in each case when compared to the same expenses incurred during the quarter ended June 30, 2002. This reduction in expenses during the second quarter of 2003 costs was slightly offset by an increase of $0.2 million in discovery expenses and a $0.2 million increase in facilities costs. During the quarter ended June 30, 2003 we were engaged in phase 1 clinical trials and discovery research in our hepatitis C program, activities related to exploring the feasibility of pursing the development of Picovir® (pleconaril) for the treatment of serious and life-threatening diseases caused by enterovirus infections, preclinical activities related to developing an intranasal formulation of Picovir® for the treatment of the common cold and discovery research. In comparison, during the second quarter of 2002 our primary research and development focus related to Picovir® for the treatment of the common cold in adults, manufacturing validation batches of Picovir® and conducting clinical trials in other common cold indications and in respiratory syncytial virus disease and discovery research.

 

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During the quarter ended June 30, 2003, we had no marketing expenses. During the same period in 2002, we incurred $2.8 million in marketing expenses related to Picovir® as a result of our joint marketing efforts with Aventis Pharmaceuticals Inc.

 

General and administrative expenses for the quarter ended June 30, 2003 of approximately $1.6 million decreased $0.8 million from $2.4 million in the same period in 2002. This decrease was primarily due to a $0.3 million reduction in personnel related costs, a $0.2 million reduction in legal costs, and a $0.3 reduction in other costs.

 

Interest income for the quarter ended June 30, 2003 of $0.8 million decreased by $0.6 million when compared to interest income of $1.4 million during the same period in the prior year. This decrease in interest income is due from lower invested balances and lower interest yields. Interest expense for the quarter ended June 30, 2003 decreased $0.8 million to $2.1 million. This decrease in interest expense is due to the repurchase of $50.1 million in principal amount of our outstanding 6% convertible subordinated notes due 2007 in the second half of 2002 and first quarter of 2003.

 

During the third quarter of 2002, we terminated our co-promotion and co-development agreement with Aventis Pharmaceuticals Inc., discontinued our sales force operations and sold our sales force to Aventis. We had no income or loss from discontinued sales operations for the quarter ended June 30, 2003 compared to income of approximately $0.1 million for the same period in 2002. Costs associated with the discontinued sales operations for the same period in 2002 related primarily to the detailing of two of Aventis’s products. The loss from discontinued sales operations for the quarter ended June 30, 2002 is net of $6.8 million in detailing fees received by us for detailing activities during that period.

 

Six months ended June 30, 2003 and 2002

 

For the six months ended June 30, 2003, we reported a net loss of $14.1 million compared to a net loss of $38.2 million for the same period in 2002. Net loss per share for the six month ended June 30, 2003 was $0.55 per share, basic and diluted, compared to $1.69 per share, basic and diluted for the same period in 2002.

 

Our loss from continuing operations for the six months ended June 30, 2003 decreased to approximately $14.1 million from a loss of approximately $36.3 million for the same period in 2002. During the six months ended June 30, 2003, we purchased $5.0 million of face value of our outstanding 6% convertible subordinated notes due 2007 for $2.1 million, resulting in a gain of approximately $2.8 million after the write-off of $0.1 million in related deferred financing costs. Loss per share from continuing operations for the quarter ended June 30, 2003 was $0.55 per share, basic and diluted, compared to a loss per share from continuing operations of $1.60 per share, basic and diluted, in the same period in 2002.

 

Revenues were approximately $0.3 million for the six months ended June 30, 2003, compared to approximately $1.1 million during the same period in 2002. During the six months ended June 30, 2003, we recognized license fee and milestone revenue of approximately $0.3 million from advance payments received under our collaboration with Wyeth, compared to recognizing license fee and milestone revenue of approximately $1.1 million from advance payments received under our collaboration agreements with Wyeth and Aventis (which was terminated in 2002) during the same period in 2002. The revenue recognized from our collaboration with Wyeth was lower in the first six months of 2003 because the performance period over which we recognized the Wyeth deferred revenue was increased to reflect the extension of the screening phase of the agreement in June 2002.

 

Research and development expenses decreased approximately $14.0 million to $10.6 million in the six month period ended June 30, 2003 from $24.6 million in the same period in 2002. In the first six months of 2003, we experienced a $7.3 million reduction in development and manufacturing expenses related to Picovir®, a $1.4 million reduction in our research and development expenses related to our collaboration with Wyeth, a $0.7 million reduction in costs previously incurred that will be borne by Wyeth as a result of our June 2003 amendment, a $3.2 million reduction in development expenses related to our RSV program that we discontinued in January 2003 and a $1.3 million reduction in research and development compensation expenses, in each case when compared to the same expenses incurred during the first six months of 2002. During the six months ended June 30, 2003 we were engaged in phase 1 clinical trials and discovery research in our hepatitis C program, a variety of clinical and regulatory activities related to exploring the feasibility of pursuing the development of Picovir® (pleconaril) for the treatment of serious and life-threatening diseases caused by enterovirus

 

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infections, preclinical activities related to developing an intranasal formulation of Picovir® for the treatment of the common cold and discovery research. In comparison, during the first six months of 2002 our primary research and development focus related to Picovir® for the treatment of the common cold in adults, including preparing for an FDA Advisory Committee meeting for Picovir®, manufacturing validation batches of Picovir® and conducting clinical trials in other common cold indications and in respiratory syncytial virus disease and discovery research.

 

During the six month period ended June 30, 2003, we had no marketing expenses. During the same period in 2002, we incurred $6.1 million in marketing expenses related to Picovir® as a result of our joint marketing efforts with Aventis Pharmaceuticals Inc.

 

General and administrative expenses for the six months ended June 30, 2003 of approximately $3.5 million decreased $1.0 million from $4.5 million in the same period in 2002. This decrease was primarily due to a $0.4 million reduction in personnel related costs, $0.3 million reduction in legal costs, $0.1 million reduction in facility costs and $0.5 million reduction in other costs. During the first six months of 2003, we spent $0.3 million on business development activities for which comparable activities were not performed during the same period in 2002.

 

Interest income for the six months ended June 30, 2003 of $1.1 million decreased by $2.5 million when compared to interest income of $3.6 million during the same period in the prior year. This decrease in interest income is due from lower invested balances and lower interest yields. Interest expense for the six months ended June 30, 2003 decreased $1.6 million to $4.2 million. This decrease in interest expense is due to the repurchase of $50.1 million in principal amount of our outstanding 6% convertible subordinated notes due 2007 in the second half of 2002 and first quarter of 2003.

 

During the third quarter of 2002, we terminated our co-promotion and co-development agreement with Aventis Pharmaceuticals Inc., discontinued our sales force operations and sold our sales force to Aventis. We had no income or loss from discontinued sales operations for the six months ended June 30, 2003 compared to a loss of approximately $1.9 million for the same period in 2002. Costs associated with the discontinued sales operations for the same period in 2002 related primarily to sales force start-up activities and the detailing of two of Aventis’s products. The loss from discontinued sales operations for the six months ended June 30, 2002 is net of $12.7 million in detailing fees received by us for detailing activities during that period. Basic and diluted loss per share from discontinued sales operations for the six months ended June 30, 2002 was $0.09 per share.

 

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ITEM 3.   Quantitative and Qualitative Disclosures About Market Risk

 

Our holdings of financial instruments are comprised of a mix of U.S. corporate debt, government securities and commercial paper. All such instruments are classified as securities available for sale. Our debt security portfolio represents funds held temporarily pending use in our business and operations. We manage these funds accordingly. Our primary investment objective is the preservation of principal, while at the same time maximizing the generation of investment income. We seek reasonable assuredness of the safety of principal and market liquidity by investing in cash equivalents (such as Treasury bills and money market funds) and fixed income securities (such as U.S. government and agency securities, municipal securities, taxable municipals, and corporate notes) while at the same time seeking to achieve a favorable rate of return. Our market risk exposure consists principally of exposure to changes in interest rates. Our holdings are also exposed to the risks of changes in the credit quality of issuers. Historically, we have typically invested in financial instruments with maturities less than one year. The carrying amount and the annualized weighted average nominal interest rate of our investment portfolio at June 30, 2003 was approximately $128.1 million and approximately 1.2%, respectively.

 

At June 30, 2003, we had outstanding $129.9 million of 6% convertible subordinated notes due 2007. The notes are convertible into shares of our common stock at a price of $109 per share, subject to certain adjustments. The notes bear interest at a rate of 6% per annum, payable semi-annually in arrears, and can be redeemed by us, at certain premiums over the principal amount, at any time on or after March 6, 2003. At June 30, 2003, the market value of our convertible subordinated notes was approximately $65.0 million, based on quoted market prices. The fair value of our convertible subordinated notes is dependant upon, among other factors, the fair value of our common stock and prevailing market interest rates.

 

ITEM 4.   Controls and Procedures

 

(a) An evaluation was performed under the supervision and with the participation of the Company’s management, including its Chief Executive Officer, or CEO, and Chief Financial Officer, or CFO, of the effectiveness of the Company’s disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) as of June 30, 2003. Based on that evaluation, the Company’s management, including the CEO and CFO, concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act, is recorded, processed, summarized and reported as specified in Securities and Exchange Commission rules and forms.

 

(b) There were no significant changes in the Company’s internal control over financial reporting that occurred during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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PART II – OTHER INFORMATION

 

ITEM 1.   Legal Proceedings

 

In March and May 2002, we and certain of our directors were named as defendants in purported class actions filed in the United States District Court for the Eastern District of Pennsylvania. In July 2002, these actions were consolidated into a single complaint which also named certain of our officers as defendants. The plaintiffs in these actions have alleged that certain statements by us about Picovir® were misleading. A judgment against us could materially exceed the coverage which may be available under our directors’ and officers’ liability insurance. We filed a motion to dismiss this action in August 2002. In April 2003, the court granted in part and denied in part our motion to dismiss the consolidated complaint. We are vigorously defending ourselves against this action and believe we have meritorious defenses against these claims.

 

ITEM 4.   Submission of Matters to a Vote of Security Holders

 

On May 6, 2003 the Company held its annual stockholders meeting. In connection with the stockholders meeting, the Company solicited proxies (1) for the election of Mr. Paul A. Brooke, Mr. Robert J. Glaser and Mr. David J. Williams as our class I directors, and (2) to approve an amendment to the our Employee Stock Purchase Plan to increase the number of shares of common stock available for issuance under that plan by 300,000 shares. The record date for determining the stockholders entitled to receive notice of, and vote at, the meeting was March 21, 2003. We had 25,931,050 shares of our common stock outstanding on the record date for the meeting, of which, a total of 22,686,736 shares were represented at the stockholders meeting by proxy. Such shares were voted at the stockholders meeting as follows:

 

     Number of Votes

     FOR

   AGAINST

   WITHHELD

   ABSTAIN

Election to the Board:

                   

Mr. Paul A. Brooke

   22,337,247         349,489     

Mr. Robert J. Glaser

   22,397,779         288,957     

Mr. David J. Williams

   20,496,092         2,190,644     

Approval of Amendment to Employee Stock Purchase Plan

   22,210,159    374,307         102,270

 

Mr. Michel de Rosen, Mr. Howard Pien, Dr. Frank Baldino, Jr. and Dr. Claude Nash constitute class II and III directors whose terms continued after the annual meeting. Mr. Pien subsequently resigned from our Board in late May 2003.

 

ITEM 6.   Exhibits and Reports on Form 8-K

 

  (a)   List of Exhibits:

 

10.33*

   First Amended and Restated Collaboration and License Agreement dated June 26, 2003 between ViroPharma Incorporated and Wyeth.

10.34*

   Amendment to Stock Purchase Agreement dated June 26, 2003 between ViroPharma Incorporated and Wyeth.

31.1

   Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

   Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1

   Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

  *   Portions of this exhibit were omitted and filed separately with the Secretary of the Commission pursuant to an application for confidential treatment filed with the Commission pursuant to Rule 406 under the Securities Act of 1933, as amended.

 

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  (b)   Reports on Form 8-K:

 

We filed the following Current Reports on Form 8-K during the quarter ended June 30, 2003:

 

  (i)   We filed a Current Report on Form 8-K dated May 8, 2003 to report, pursuant to Item 5, a set of “Frequently Asked Questions” describing information that experience has demonstrated to be often requested by analysts and investors, and the answers to these questions.

 

  (ii)   We filed a Current Report on Form 8-K dated May 8, 2003 to report, pursuant to Item 5, our financial results for the first quarter ended March 31, 2003.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

       

VIROPHARMA INCORPORATED

Date: August 14, 2003       By:  

                        /S/    MICHEL DE ROSEN


               

Michel de Rosen

President, Chief Executive Officer

and Chairman of the Board of Directors

(Principal Executive Officer)

        By:  

                        /S/    VINCENT J. MILANO


               

Vincent J. Milano

Vice President, Chief Financial Officer and Treasurer

(Principal Financial and Accounting Officer)

 

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Exhibit Index

 

Exhibit

 

Description


10.33*   First Amended and Restated Collaboration and License Agreement dated June 26, 2003 between ViroPharma Incorporated and Wyeth.
10.34*   Amendment to Stock Purchase Agreement dated June 26, 2003 between ViroPharma Incorporated and Wyeth.
31.1       Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2       Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1       Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

*   Portions of this exhibit were omitted and filed separately with the Secretary of the Commission pursuant to an application for confidential treatment filed with the Commission pursuant to Rule 406 under the Securities Act of 1933, as amended.

 

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