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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT UNDER SECTION 13 or 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

     
For Quarter Ended
June 30, 2003
  Commission File No.
0-26770

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

     
Delaware
(State or other jurisdiction of
incorporation or organization)
  22-2816046
(I.R.S. Employer
Identification No.)
     
8320 Guilford Road, Columbia, MD
(Address of principal executive offices)
  21046
(Zip code)

(301) 854-3900
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 requirements for the past 90 days.

     
Yes þ   No o

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act.)

     
Yes þ   No o

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

Common Shares Outstanding at August 8, 2003: 30,142,300

 


TABLE OF CONTENTS

Part I. Financial Information
Item 1. Financial Statements
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Item 4. Controls and Procedures
Part II. Other Information
Item 1 — Legal Proceedings
Item 2 — Changes in Securities
Item 3 — Defaults upon Senior Securities
Item 4 — Submission of Matters to a Vote of Security Holders
Item 5 — Other Information
Item 6 — Exhibits and Reports on Form 8-K
SIGNATURES
Exhibit 10.1
Exhibit 31.1
Exhibit 31.2
Exhibit 32.1
Exhibit 32.2


Table of Contents

NOVAVAX, INC.

Form 10-Q
For the Quarter Ended June 30, 2003
Table of Contents

                 
Part I. Financial Information   Page No.

 
Item 1  
Financial Statements
       
       
Consolidated Balance Sheets as of June 30, 2003 and December 31, 2002
    3  
       
Consolidated Statements of Operations for the three month and six month periods ended June 30, 2003 and 2002
    4  
       
Consolidated Statements of Cash Flows for the six months ended June 30, 2003 and 2002
    5  
       
Notes to Consolidated Financial Statements
    6  
Item 2  
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    10  
Item 3  
Quantitative and Qualitative Disclosure about Market Risk
    16  
Item 4  
Controls and Procedures
    16  
                 
Part II. Other Information        

       
Item 1  
Legal Proceedings
    *  
Item 2  
Changes in Securities
    *  
Item 3  
Defaults upon Senior Securities
    *  
Item 4  
Submission of Matters to a Vote of Security Holders
    17  
Item 5  
Other Information
    *  
Item 6  
Exhibits and Reports on Form 8-K
    18  
Signature
 
    19  


*   No information provided due to inapplicability of item.

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Table of Contents

Part I.     Financial Information

Item 1.     Financial Statements

NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)

                       
          June 30,   December 31,
          2003   2002
         
 
          (unaudited)        
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 9,625     $ 3,005  
 
Accounts receivable, net
    1,872       1,882  
 
Inventory
    801       633  
 
Prepaid expenses and other current assets
    539       722  
 
   
     
 
     
Total current assets
    12,837       6,242  
Property and equipment, net
    13,840       13,655  
Goodwill, net
    33,141       33,141  
Other intangible assets, net
    3,637       3,966  
Other long-term assets
    453       501  
 
   
     
 
     
Total assets
  $ 63,908     $ 57,505  
 
   
     
 
LIABILITIES and STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
 
Accounts payable
  $ 1,694     $ 2,534  
 
Accrued expenses
    2,021       2,844  
 
Deferred revenue — current
    250       275  
 
Current portion of long-term debt and capital lease obligations
    226       211  
 
   
     
 
     
Total current liabilities
    4,191       5,864  
Convertible notes
    40,000       40,000  
Deferred revenue — non-current
    2,250       2,375  
Long-term debt, capital lease obligations and other
    1,345       1,193  
Stockholders’ equity:
               
 
Preferred stock, $.01 par value, 2,000,000 shares authorized; no shares issued and outstanding
           
 
Common stock, $.01 par value, 50,000,000 shares authorized; 30,372,860 issued and 30,122,800 outstanding at June 30, 2003 and 25,222,110 issued and 24,664,358 outstanding at December 31, 2002
    303       252  
 
Additional paid-in capital
    120,389       102,361  
 
Notes receivable from directors
    (1,480 )     (1,480 )
 
Accumulated deficit
    (98,357 )     (87,527 )
 
Treasury stock, 250,060 and 557,752 shares, cost basis, at June 30, 2003 and December 31, 2002, respectively
    (4,733 )     (5,533 )
 
   
     
 
   
Total stockholders’ equity
    16,122       8,073  
 
   
     
 
   
Total liabilities and stockholders’ equity
  $ 63,908     $ 57,505  
 
   
     
 

     The accompanying notes are an integral part of the consolidated financial statements.

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Table of Contents

NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share data)
(unaudited)

                                     
        Three months ended   Six months ended
        June 30,   June 30,
       
 
        2003   2002   2003   2002
       
 
 
 
                (restated)           (restated)
               
         
Revenues:
                               
 
Product sales
  $ 1,959     $ 4,218     $ 2,862     $ 8,994  
 
Contract research and development
    253       109       457       233  
 
Milestone and licensing fees
    63       137       150       950  
 
   
     
     
     
 
   
Total revenues
    2,275       4,464       3,469       10,177  
Operating costs and expenses:
                               
 
Cost of sales
    388       1,008       622       2,065  
 
Research and development
    2,792       3,205       5,157       6,147  
 
Selling and marketing
    1,917       3,549       4,073       7,925  
 
General and administrative
    1,810       2,217       3,650       5,030  
 
   
     
     
     
 
   
Total operating costs and expenses
    6,907       9,979       13,502       21,167  
 
   
     
     
     
 
Loss from operations
    (4,632 )     (5,515 )     (10,033 )     (10,990 )
Interest expense, net
    (396 )     (263 )     (797 )     (510 )
 
   
     
     
     
 
Net loss
  $ (5,028 )   $ (5,778 )   $ (10,830 )   $ (11,500 )
 
   
     
     
     
 
Basic and diluted loss per share
  $ (.17 )   $ (.24 )   $ (.38 )   $ (.48 )
 
   
     
     
     
 
Basic and diluted weighted average number of common shares outstanding
    29,988,875       24,563,612       28,489,651       24,209,198  
 
   
     
     
     
 

     The accompanying notes are an integral part of the consolidated financial statements.

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NOVAVAX, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
(unaudited)

                     
        Six months ended
        June 30,
       
        2003   2002
       
 
                (restated)
Operating Activities:
               
 
Net loss
  $ (10,830 )   $ (11,500 )
Reconciliation of net loss to net cash used by operating activities:
               
   
Amortization
    329       329  
   
Depreciation
    234       247  
   
Provision for bad debt
    143       60  
   
Deferred rent expense
    48       48  
Changes in operating assets and liabilities:
               
   
Accounts receivable
    (133 )     1,207  
   
Inventory
    (168 )     (118 )
   
Prepaid expenses and other assets
    183       (1,321 )
   
Accounts payable and accrued expenses
    (863 )     1,144  
   
Deferred revenue
    (150 )     (950 )
 
   
     
 
Net cash used by operating activities
    (11,207 )     (10,854 )
 
   
     
 
Investing Activities:
               
Capital expenditures
    (419 )     (6,365 )
 
   
     
 
Net cash used by investing activities
    (419 )     (6,365 )
 
   
     
 
Financing Activities:
               
Proceeds from the issuance of convertible notes
          10,000  
Net proceeds from equipment loans
    217        
Deferred financing costs
    48        
Payments of capital lease obligations
    (98 )      
Proceeds from private placements of common stock
    16,625        
Proceeds from the exercise of stock options and warrants
    1,454       3,101  
 
   
     
 
Net cash provided by financing activities
    18,246       13,101  
 
   
     
 
Net change in cash and cash equivalents
    6,620       (4,118 )
Cash and cash equivalents at beginning of period
    3,005       20,045  
 
   
     
 
Cash and cash equivalents at end of period
  $ 9,625     $ 15,927  
 
   
     
 

     The accompanying notes are an integral part of the consolidated financial statements.

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Table of Contents

NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

1. Basis of Presentation

     Novavax, Inc., a Delaware corporation (“Novavax” or “the Company”), was incorporated in 1987, and is a specialty pharmaceutical company engaged in the research, development and commercialization of proprietary products focused on women’s health and infectious diseases. The Company sells, markets, and distributes a line of prescription pharmaceuticals The Company’s principal technology platform involves the use of patented oil and water emulsions that we believe can be used as vehicles for the topical delivery of a wide variety of drugs and other therapeutic products, including hormones. Other drug delivery technologies, such as our Novasome® and Sterisome® technologies, are being utilized to develop other products. Novasomes are used as adjuvants to enhance vaccine effectiveness. Sterisomes are being used for, among other things, subcutaneous injections that can deliver long-lasting drug effects. In addition, Novavax conducts research and development on preventative and therapeutic vaccines and proteins for a variety of infectious diseases and immunotherapies.

     The consolidated financial statements of Novavax for the six months ended June 30, 2003 and 2002 are unaudited. These financial statements reflect all adjustments that, in the opinion of management, are necessary for a fair presentation of the results for the interim periods presented. All such adjustments are of a normal recurring nature. These interim results are not necessarily indicative of the results to be expected for the year ending December 31, 2003.

     Certain information in footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles has been condensed or omitted pursuant to SEC rules and regulations, although the Company believes the disclosures herein are adequate to make the information presented not misleading. It is suggested that these consolidated financial statements be read in conjunction with the consolidated financial statements and the notes thereto in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002.

2. Summary of Significant Accounting Policies

Basis of Presentation
     The accompanying consolidated financial statements include the accounts of the corporation and its wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates
     The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Inventories
     Inventories consist of raw materials and finished goods as follows, and are priced at the lower of cost or market, using the first-in-first-out method.

                 
    As of:
   
    June 30, 2003   December 31, 2002
   
 
    (amounts in thousands)
Raw materials
  $ 431     $ 479  
Finished goods
    370       154  
 
   
     
 
 
  $ 801     $ 633  
 
   
     
 

Revenue Recognition
     The Company recognizes revenue in accordance with the provisions of Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements, whereby revenue is not recognized until it is realized or realizable and earned. Revenue is recognized when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the seller’s price to the buyer is fixed or determinable and collectibility is reasonably assured. Revenues from product sales are recognized upon shipment, net of allowances for returns, rebates and chargebacks. The Company is obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. A large part of our product sales are to distributors who resell the products to their customers. We provide rebates to members of certain buying groups who purchase from our distributors, to distributors that sell to their customers at prices determined under a contract between the customer and us, or to state agencies that administer various programs such as the federal Medicaid and Medicare programs. Rebate amounts are usually based upon the volume of purchases or by reference to a specific price for a product. We estimate the amount of the rebate that will be paid, and record the liability as a reduction of revenue when we record our sale of the products. Settlement of the rebate generally occurs from 3 to 12 months after sale. We regularly analyze historical rebate trends and make adjustments to recorded reserves for changes in trends and terms of rebate programs.

     Up-front payments and licensing fees are deferred and recognized as earned over the life of the related agreement. Milestone payments are recognized as revenue upon achievement of contract-specified events and when there are no remaining performance obligations.

     Revenues earned under research contracts are generally recognized as milestones are achieved or ratably over the term of the agreement. When the current estimates of total contract revenue and contract cost indicate a loss, a provision for the entire loss on the contract is made. Revenues from contracts with acceptance terms are recognized when the customer has received and approved the services. During the fourth quarter of 2002, we reassessed the remaining costs, progress and milestones outstanding on four contracts. Based on this assessment, we determined that estimated costs to complete the contracts had been underestimated throughout the year. We reevaluated the estimated costs to complete on all contracts. The effect of this reevaluation was a reduction to revenue for the three-month period ended June 30, 2002 from $4.7 million to $4.5 million and for the six-month period ended June 30, 2002 from $10.8 million to $10.2 million. Additionally, the net loss and net loss per share increased from $5.4 million to $5.8 million and from $0.22 to $0.24 for the three-month period ended June 30, 2002, and from $10.8 million to $11.5 million and from $0.44 to $0.48 for the six-month period ended June 30, 2002.

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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Net Loss per Share
     Basic loss per share is computed by dividing the net loss available to common stockholders (the numerator) by the weighted average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. The computation of diluted loss per share is similar to the computation of basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares from the exercise of common stock options, warrants or convertible debt had been issued. Potentially dilutive common shares are not included in the computation of dilutive earnings per share if they are antidilutive. Net loss per share as reported was not adjusted for potential common shares, as they are antidilutive.

Goodwill and Intangible Assets
     Goodwill principally results from business acquisitions. Assets acquired and liabilities assumed are recorded at their fair values; the excess of the purchase price over the identifiable net assets acquired is recorded as goodwill. Other intangible assets are a result of product acquisitions, non-compete arrangements, and internally discovered patents. In accordance with SFAS No. 142, Goodwill and Other Intangible Assets, goodwill and intangible assets deemed to have indefinite lives are not amortized but are subject to impairment tests annually, or more frequently, should indicators of impairment arise. The Company utilizes a discounted cash flow analysis that includes profitability information, estimated future operating results, trends and other information in assessing whether the value of indefinite-lived intangible assets can be recovered. Under SFAS No. 142, goodwill impairment is deemed to exist if the carrying value of a reporting unit exceeds its estimated fair value. Other intangible assets are amortized on a straight-line basis over their estimated useful lives, ranging from 5 to 15 years. Amortization expense was $163,000 and $329,000, respectively, for both the three months ending June 30, 2003 and 2002, and the six months ending June 20, 2003 and 2002.

     As of June 30, 2003 and December 31, 2002, goodwill and other intangible assets consisted of the following:

                                                   
      June 30, 2003   December 31, 2002
     
 
              Accumulated                   Accumulated        
      Gross   Amortization   Net   Gross   Amortization   Net
     
 
 
 
 
 
Goodwill-Fielding acquisition
  $ 35,590     $ (2,449 )   $ 33,141     $ 35,590     $ (2,449 )   $ 33,141  
 
   
     
     
     
     
     
 
Other intangible assets, net
                                               
Non-compete-Biomedical Services acquisition
  $ 148     $ (116 )   $ 32     $ 148     $ (101 )   $ 47  
AVC-Product acquisition
    3,332       (1,190 )     2,142       3,332       (952 )     2,380  
Patents
    2,525       (1,062 )     1,463       2,525       (986 )     1,539  
 
   
     
     
     
     
     
 
 
Total other intangible assets, net
  $ 6,005     $ (2,368 )   $ 3,637     $ 6,005     $ (2,039 )   $ 3,966  
 
   
     
     
     
     
     
 

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NOVAVAX, INC. AND SUBSIDIARIES
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

Stock Based Compensation
     In accordance with SFAS No. 148, Accounting for Stock-Based Compensation—Transition and Disclosure, the effect on net loss and net loss per share if the Company had applied the fair value recognition provisions of SFAS No. 123, Accounting for Stock-Based Compensation, to stock-based employee compensation is as follows:

                                   
      Three Months Ended June 30,   Six Months Ended June 30,
     
 
      2003   2002   2003   2002
     
 
 
 
      (Amounts in thousands, except per share data)
Net loss, as reported
  $ (5,028 )   $ (5,778 )   $ (10,830 )   $ (11,500 )
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards
    (851 )     (848 )     (1,363 )     (1,771 )
 
   
     
     
     
 
Pro forma net loss
  $ (5,879 )   $ (6,626 )   $ (12,193 )   $ (13,271 )
 
   
     
     
     
 
Net loss per share:
                            <