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SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES ACT OF 1934

For Quarter Ended June 30, 2004

Commission File Number: 000-50583

BioVeris Corporation

(Exact name of registrant as specified in its charter)
     
DELAWARE   80-0076765

 
(State or other jurisdiction
incorporation or organization)
  (IRS Employer
Identification No.)

16020 INDUSTRIAL DRIVE, GAITHERSBURG, MD 20877
(Address of principal executive offices) (Zip Code)

301-869-9800
(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 Act of 1934 during the preceding 12 months, (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

     
Yes     X       No           

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

     
Yes             No     X    

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

     
Class   Outstanding at July 30, 2004
Common Stock, $0.001 par value   26,728,070

 


 

BioVeris Corporation
Form 10-Q
For the Quarter Ended June 30, 2004

INDEX

             
        PAGE
PART I
  FINANCIAL INFORMATION        
Item 1:
  CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)        
 
  Condensed Consolidated Balance Sheets – June 30, 2004 and March 31, 2004     2  
 
  Condensed Consolidated Statements of Operations - For the three months ended June 30, 2004 and 2003     3  
 
  Condensed Consolidated Statements of Cash Flows - For the three months Ended June 30, 2004 and 2003     4  
 
  Notes to Condensed Consolidated Financial Statements     5  
Item 2:
  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS     20  
Item 3:
  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK     34  
Item 4:
  CONTROLS AND PROCEDURES     35  
PART II
  OTHER INFORMATION        
Item 1:
  LEGAL PROCEEDINGS     35  
Item 6:
  EXHIBITS AND REPORTS ON FORM 8-K     36  
SIGNATURES     37  

1


 

ITEM 1: CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

BioVeris Corporation
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)

                 
     
    June 30,    
    2004
Unaudited

  March 31,
2004
ASSETS
               
CURRENT ASSETS:
               
Cash and cash equivalents
  $ 62,237     $ 182,509  
Short term investments
    89,739        
Accounts receivable, net
    6,289       5,516  
Inventory
    8,319       8,207  
Other current assets
    5,722       4,332  
 
   
 
     
 
 
Total current assets
    172,306       200,564  
Equipment and leasehold improvements, net
    11,658       12,565  
OTHER NONCURRENT ASSETS:
               
Technology licenses
    18,778       19,266  
Other
    419       419  
 
   
 
     
 
 
TOTAL ASSETS
  $ 203,161     $ 232,814  
 
   
 
     
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
CURRENT LIABILITIES:
               
Accounts payable and accrued expenses
  $ 7,051     $ 7,187  
Accrued wages and benefits
    2,212       1,876  
Other liabilities
    2,920        
Distribution gain accrual
          20,000  
Deferred revenue
    2,349       2,273  
Note payable
          44  
 
   
 
     
 
 
Total current liabilities
    14,532       31,380  
 
   
 
     
 
 
NONCURRENT LIABILITIES
    69       54  
 
   
 
     
 
 
Total liabilities
    14,601       31,434  
 
   
 
     
 
 
COMMITMENTS
               
MINORITY INTEREST
    54       54  
SERIES B PREFERRED STOCK, 1,000 shares designated, issued and outstanding
    7,500       7,500  
STOCKHOLDERS’ EQUITY:
               
Preferred stock, par value $0.01 per share, 15,000,000 shares authorized, issuable in series:
               
Series A, 600,000 shares designated, none issued
           
Common stock, par value $0.001 per share, 100,000,000 shares authorized, 26,728,000 shares issued and outstanding
    27       27  
Additional paid-in capital
    203,464       203,464  
Accumulated deficit
    (22,516 )     (9,665 )
Accumulated other comprehensive income
    31        
 
   
 
     
 
 
Total stockholders’ equity
    181,006       193,826  
 
   
 
     
 
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  $ 203,161     $ 232,814  
 
   
 
     
 
 

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

2


 

BioVeris Corporation
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Unaudited

                 
    Three months ended
    June 30,   June 30,
    2004
  2003
REVENUES:
               
Product sales
  $ 7,839     $ 4,796  
Royalty income
    320       243  
Contract fees
    86       34  
 
   
 
     
 
 
Total
    8,245       5,073  
 
   
 
     
 
 
OPERATING COSTS AND EXPENSES:
               
Product costs
    4,604       2,433  
Research and development
    7,176       5,232  
Selling, general, and administrative
    9,710       4,776  
 
   
 
     
 
 
Total
    21,490       12,441  
 
   
 
     
 
 
LOSS FROM OPERATIONS
    (13,245 )     (7,368 )
OTHER, NET
    394       80  
EQUITY IN LOSS OF JOINT VENTURE
          (5,230 )
 
   
 
     
 
 
NET LOSS
  $ (12,851 )   $ (12,518 )
 
   
 
     
 
 
Net loss per common share (Basic and Diluted)
  $ (0.48 )   $ (0.47 )
 
   
 
     
 
 
COMMON SHARES OUTSTANDING (Basic and Diluted)
    26,728       26,728  
 
   
 
     
 
 

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

3


 

BioVeris Corporation
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Unaudited

                 
    Three months ended
    June 30,   June 30,
    2004
  2003
OPERATING ACTIVITIES:
               
Net loss
  $ (12,851 )   $ (12,518 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    2,011       852  
Loss on disposal of equipment
    34        
Equity in loss of joint venture
          5,230  
Expense related to stock options
          89  
Changes in assets and liabilities:
               
Increase(decrease) in accounts receivable
    (773 )     735  
Increase (decrease) in inventory
    (35 )     118  
(Increase) decrease in other current assets
    (1,390 )     457  
Increase (decrease) in accounts payable and accrued expenses
    156       (1,652 )
Increase in other liabilities
    2,920        
Increase (decrease) in deferred revenue
    91       (27 )
 
   
 
     
 
 
Net cash used in operating activities
    (9,837 )     (6,716 )
 
   
 
     
 
 
INVESTING ACTIVITIES:
               
Expenditures for equipment and leasehold improvements
    (727 )     (799 )
Purchase of short term investments
    (89,708 )      
Investments in joint venture
          (10,909 )
 
   
 
     
 
 
Net cash used in investing activities
    (90,435 )     (11,708 )
 
   
 
     
 
 
FINANCING ACTIVITIES:
               
Payment of distribution gain
    (20,000 )      
Cash contributed by Parent, net
          18,424  
 
   
 
     
 
 
Net cash (used in) provided by financing activities
    (20,000 )     18,424  
 
   
 
     
 
 
NET INCREASE IN CASH AND CASH EQUIVALENTS
    (120,272 )      
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR
    182,509        
 
   
 
     
 
 
CASH AND CASH EQUIVALENTS, END OF YEAR
  $ 62,237     $  
 
   
 
     
 
 

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

4


 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

1. ORGANIZATION AND BASIS OF PRESENTATION

On February 13, 2004, IGEN International, Inc. (IGEN or Parent) and Roche Holding Ltd (Roche) consummated a transaction pursuant to which Roche acquired IGEN and IGEN simultaneously distributed the common stock of BioVeris Corporation (the Company), to its stockholders (the merger). The transaction occurred in the following steps:

    IGEN restructured its operations so that the Company, a newly formed, wholly-owned subsidiary of IGEN at the time, assumed IGEN’s biodefense, life science and industrial product lines as well as IGEN’s opportunities in the clinical diagnostics and healthcare fields and the ownership of IGEN’s intellectual property, IGEN’s equity interest in Meso Scale Diagnostics, LLC. (MSD), cash and certain other rights and licenses currently held by IGEN; and
 
    A wholly-owned subsidiary of Roche merged with and into IGEN, as a result of which IGEN became a wholly-owned subsidiary of Roche and the Company became an independent, publicly-traded company. Simultaneously with the completion of the merger, certain ongoing commercial agreements between the Company and certain affiliates of Roche became effective.

The Company was organized as IGEN Integrated Healthcare, LLC, a Delaware limited liability company, on June 6, 2003, and converted into BioVeris Corporation, a newly formed Delaware corporation on September 22, 2003.

Prior to the completion of the merger and related transactions, the assets and businesses of the Company had historically been owned and operated by IGEN and IGEN held all cash in a centralized treasury, providing all of the necessary funding for the operations of the Company. The accompanying financial statements have been prepared and are presented as if the Company had been operating as a separate entity using IGEN’s historical cost basis in the assets and liabilities and including the historical operations of the businesses and assets transferred to the Company from IGEN as part of the restructuring.

During the quarter ended June 30, 2003, the Company was fully integrated with IGEN and these financial statements reflect the application of certain estimates and allocations. The Company’s consolidated statement of operations for the quarter ended June 30, 2003 include all revenues and costs that are directly attributable to the Company’s businesses. They have been prepared and are presented as if the Company had been operating as a separate entity using IGEN’s historical costs basis in the assets and liabilities and including the historical operations of the businesses and assets transferred to the Company from IGEN as part of the restructuring. In addition, certain expenses of IGEN have been allocated to the Company using various assumptions. These expenses include an allocated share of general and administrative salaries as well as certain other shared costs (primarily facility, human resources, legal, accounting and other administrative costs). General and administrative salaries have been allocated primarily based upon an estimate of actual time spent on the businesses of the Company. Facilities costs and centralized administrative services have been allocated based upon a percentage of total product sales as well as a percentage of total headcount. Allocated expenses of $4.8 million are included in selling, general and administrative expenses in the accompanying consolidated statements of operations for the three months ended June 30, 2003. These allocated expenses were derived from total IGEN selling, general and administrative expenses of $6.1 million.

5


 

Management believes these allocation methodologies and estimations are reasonable based upon the nature of the related expenses and management’s knowledge of the level of effort and space required to support the businesses of the Company. The financial information included herein for the three months ended June 30, 2003 may not be indicative of what results of operations and cash flows of the Company would have been had the Company been operating as a stand-alone entity. Results of operations and cash flows for the quarter ended June 30, 2004 are for the Company when it operated as an independent entity.

The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements have been condensed or omitted. In the opinion of the Company’s management, the financial statements reflect all adjustments necessary to present fairly the results of operations and cash flows for the three month periods ended June 30, 2004 and 2003, and the Company’s financial position at June 30, 2004.

The results of operations for the interim periods are not necessarily indicative of the results for any future interim period or for the entire year. These financial statements should be read together with the audited financial statements and notes for the year ended March 31, 2004 contained in the Company’s Annual Report on Form 10-K for the year ended March 31, 2004 filed with the Securities and Exchange Commission (SEC).

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Consolidation Accounting — The consolidated financial statements include the accounts of the Company and its subsidiaries. In addition, the Company adopted FIN 46 as of March 31, 2004 and has determined that MSD (a joint venture formed in 1995 by IGEN and Meso Scale Technologies, LLC., or MST, which is a company established and wholly-owned by Mr. Jacob Wohlstadter, a son of the Company’s chief executive officer), qualifies as a variable interest entity and the Company is the primary beneficiary. Accordingly, beginning March 31, 2004, the Company has consolidated the financial results of MSD.

All significant intercompany transactions and balances have been eliminated.

Under the transition guidance of FIN 46, because MSD was created before February 1, 2003, the Company has measured the assets, liabilities and noncontrolling interests of MSD as of March 31, 2004 for purposes of the initial consolidation. The amounts of the assets, liabilities and noncontrolling interests are reflective of their respective carrying amounts had FIN 46 been effective when the Company first met the conditions to be the primary beneficiary of MSD upon MSD’s inception in 1995. The Company has historically recorded approximately 100% of MSD’s losses.

6


 

The balance sheet reclassified amounts formerly recorded on a “net” basis as investment in joint venture to be reflected on a “gross” basis primarily as cash, accounts receivable, inventory, fixed assets, accounts payable and accrued expenses. The statement of operations reclassified amounts formerly recorded on a “net” basis as equity in loss of joint venture to be reflected on a “gross” basis primarily as revenue, product costs, research and development expenses and selling, general and administrative expenses.

Estimates — The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

Cash and Cash Equivalents — Cash and cash equivalents include cash in banks, money market funds, securities of the U.S. Treasury, and certificates of deposit with original maturities of three months or less. The Company has invested its excess cash generally in securities of the U.S. Treasury, money market funds, certificates of deposit and corporate bonds. The Company invests its excess cash in accordance with a policy approved by the Company’s Board of Directors. This policy is designed to provide both liquidity and safety of principal. The policy limits investments to certain types of instruments issued by institutions with strong investment grade credit ratings and places restrictions on the Company’s investment by terms and concentrations by type and issuer.

The Company’s consolidated balance sheet at June 30, 2004 had cash, cash equivalents and short-term investments of $152.0 million. Of this amount, $32.1 million represented the cash, cash equivalents and short-term investments of MSD. The Company has no rights or access to these funds or any other capital resources of MSD. The amount of cash, cash equivalents and short-term investments to which the Company and its wholly-owned subsidiaries have unrestricted use is $119.9 million at June 30, 2004.

Short-Term Investments — Short-term investments consist primarily of corporate, federal and municipal debt-securities that are classified as “available for sale”. These “available for sale” securities, which are all due within one year, are accounted for at their fair market value and unrealized gains and losses on these securities, if any, are included in accumulated other comprehensive gain or loss in stockholders’ equity. As of June 30, 2004, the Company had unrealized gains on “available for sale” securities of approximately $31,000. The Company uses the specific identification method in computing realized gains and losses on the sale of investments, which are included in results of operation as generated. For the quarter ended June 30, 2004, the Company did not have any realized gains or losses.

The following is a summary of the Company’s available-for-sale marketable securities as of June 30, 2004:

                                 
            Gross Unrealized   Gross Unrealized   Estimated Fair
(In thousands)
  Amortized Cost
  Gains
  Losses
  Value
U.S. government agencies
  $ 20,203     $ 26     $ 9     $ 20,220  
Municipal Bonds
    44,850                   44,850  
U.S. corporate debt
    24,655       23       9       24,669  
 
   
 
     
 
     
 
     
 
 
 
  $ 89,708     $ 49     $ 18     $ 89,739  
 
   
 
     
 
     
 
     
 
 

Concentration of Credit Risk — The Company has not experienced any losses on its investments due to credit risk. During the quarters ended June 30, 2004 and 2003, agencies of the U.S. government accounted for 25% and 21% of total revenue, respectively, and 23% and 26% of total accounts receivable as of June 30 and March 31, 2004, respectively. Additionally, one customer accounted for 11% of revenues for the quarter ended June 30, 2004 and 21% of accounts receivable as of June 30, 2004.

Allowance for Doubtful Accounts — The Company maintains reserves on customer accounts where estimated losses may result from the inability of its customers to make required payments. These reserves are determined based on a number of factors, including the current financial condition of specific customers, the age of accounts receivable balances and historical loss rates.

Inventory — Inventory is recorded at the lower of cost or market using the first-in, first-out method and consists of the following:

7


 

                 
    June 30,   March 31,
    2004
  2004
    (in thousands)
BioVeris and Wholly-Owned Subsidiaries:
               
Finished Goods
  $ 1,972     $ 1,740  
Work in process
    624       619  
Raw materials
    2,265       2,654  
 
   
 
     
 
 
Total
    4,861       5,013  
 
   
 
     
 
 
MSD:
               
Finished Goods
    1,595       757  
Work in process
    608       366  
Raw materials
    1,255       2,071  
 
   
 
     
 
 
Total
    3,458       3,194  
 
   
 
     
 
 
 
  $ 8,319     $ 8,207  
 
   
 
     
 
 

Equipment and Leasehold Improvements — Equipment and leasehold improvements are carried at cost, less accumulated depreciation and amortization. Depreciation on equipment, which includes lab instruments and furniture, is computed over the estimated useful lives of the assets, generally three to five years, using straight-line. Leasehold improvements are amortized on a straight-line basis over the life of the lease. Equipment and leasehold improvements consist of the following:

                 
    June 30,   March 31,
    2004
  2004
    (in thousands)
BioVeris and Wholly-Owned Subsidiaries:
               
Lab instruments and equipment
  $ 5,960     $ 6,413  
Office furniture and equipment
    5,561       5,511  
Leasehold improvements
    4,010       3,980  
 
   
 
     
 
 
 
    15,531       15,904  
Accumulated depreciation and amortization
    (10,779 )     (10,432 )
 
   
 
     
 
 
Total
    4,752       5,472  
 
   
 
     
 
 
MSD:
               
Lab instruments and equipment
    8,204       7,555  
Office furniture and equipment
    3,185       3,166  
Leasehold improvements
    1,294       1,327  
 
   
 
     
 
 
 
    12,683       12,048  
Accumulated depreciation and amortization
    (5,575 )     (4,686 )
 
   
 
     
 
 
Total
    7,108       7,362  
Consolidating eliminations
    (202 )     (269 )
 
   
 
     
 
 
Total
  $ 11,658     $ 12,565  
 
   
 
     
 
 

Technology Licenses — Simultaneous with the execution of the merger, the Company entered into worldwide, non-exclusive PCR license agreements with certain affiliates of Roche. One agreement grants the Company rights to make, import, use and sell certain PCR products within specified fields, while the other agreement grants the Company rights to perform certain PCR services within specified fields.

8


 

The Company paid Roche a license fee of $50 million in fiscal 2004 and will also pay royalties on sales of the licensed products in the licensed fields and on any instrument, accessory, device or system sold for use with the licensed products in the licensed fields at royalty rates ranging from 3% to 20% of net sales, depending on the field, the year, the country of sale and the patents covering such products. It will also pay royalties of $16 or $25 for every PCR plasma test it performs or has a laboratory perform and royalties ranging from 5% to 20% of net service revenue that the Company receives for diagnostic testing procedures that it performs using PCR technology. The Company has performed a valuation of the PCR technology licenses and has recorded their value of $19.5 million and reflected a $30.5 million adjustment reducing the amount recorded for consideration paid by Roche with respect to the merger and related transactions. These licenses are being amortized over an estimated useful life of ten years which is based upon a consideration of the range of patent lives and the weighted average remaining life of the most important underlying patents, as well as a consideration of technological obsolescence and product life cycles. Amortization expense was $488,000 for the quarter ended June 30, 2004 and accumulated amortization was $731,000 at June 30, 2004. Amortization expense is expected to approximate $2.0 million for each year through March 31, 2009.

Evaluation of Long-lived Assets — The Company evaluates the potential impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable. In evaluating the recoverability of an asset, management’s policy is to compare the carrying amount of an asset with the projected undiscounted future cash flow. Management believes no impairment of these assets exists as of June 30, 2004.

Warranty Reserve — The Company warrants its products against defects in material and workmanship for one year after sale and records estimated future warranty costs at the time revenue is recognized. A reserve for future warranty claims is recorded based upon management’s review of historical claims, supplemented by expectations of future costs. At June 30, 2004 and March 31, 2004, our warranty reserve was $450,000. The Company also offers extended warranty arrangements to customers, for which related costs are recorded as incurred.

Other Current Assets — Other current assets include certain assets of MSD aggregating $2.7 million that represent automobiles and deposits on real property. On June 17, 2004, MSD received $2.9 million from Mr. Jacob Wohlstadter, as consideration for the proposed sale by MSD of real property and automobiles, pending approval by the MSD Board of Managers, which is recorded as an other liability. Jacob Wohlstadter, also assumed MSD’s purchase obligations with respect to a prospective real property purchase in the approximate amount of $4.1 million. In August 2004, MSD transferred the real property and automobiles and MSD’s limited liability company interests to Jacob Wohlstadter.

Fair Value of Financial Instruments — The carrying amounts of the Company’s financial instruments, which include cash equivalents, accounts receivable, accounts payable and accrued expenses, approximate their fair value due to their short maturities.

Comprehensive Income (Loss) — Comprehensive income (loss) is comprised of net income (loss) and other items of comprehensive income (loss). Other comprehensive income for the quarter ended June 30, 2004 includes unrealized gains on “available for sale” securities that are excluded from net loss. There were no significant elements of comprehensive income (loss) for the quarter ended June 30, 2003.

Revenue Recognition — The Company derives revenue principally from three sources: product sales, royalty income and contract fees.

9


 

Product sales revenue is recognized when persuasive evidence of an arrangement exists, the price to the buyer is fixed and determinable, collectibility is reasonably assured and the product is shipped to the customer thereby transferring title and risk of loss. For instrument sales, the instrument and the related installation are considered to be separate elements under EITF 00-21 “Accounting for revenue arrangements with multiple deliverables” . Revenue is recognized for the instrument upon shipment and is recognized for the installation when complete based upon the residual value method. For instrument and reagent sales, there is no option of return and refund, only the option to repair or replace the product. Other than the installation required for the instruments, there are no contingencies, allowances or other post-sale obligations. For instrument leases, the instrument rental and related minimum reagent purchases are considered to be separate elements under EITF 00-21 and, accordingly, the sales price is allocated to the two elements based upon their relative fair values. Instrument rental revenue is recognized ratably over the life of the lease agreements and the related reagent revenue is recognized upon shipment. Revenue associated with extended warranty arrangements is recognized over the term of the extended warranty contract.

Royalty income is recorded when earned, based on information provided by licensees. Revenue from services performed under contracts is recognized when obligations under the contract have been satisfied. The satisfaction of obligations may occur over the term of the underlying customer contract, if the contract is based on the achievement of certain “milestones,” or may occur at the end of the underlying customer contract, if based only upon delivery of the final work product.

Research and Development — Research and development costs are expensed as incurred.

Foreign Currency — Gains and losses from foreign currency transactions such as those resulting from the settlement of foreign receivables or payables, are included in the results of operations as incurred. These amounts were not material during the quarters ended June 30, 2004 and 2003.

Income Taxes — Deferred income tax assets and liabilities are computed annually for differences between the financial statement and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized. The Company has not recorded an income tax benefit associated with the losses for the quarters ended June 30, 2004 and 2003 and has recorded a full valuation allowance on its net deferred tax assets as the Company has determined that it is more likely than not that the deferred tax assets will not be realized.

Stock-based Compensation — The Company has elected to follow the recognition and measurement principles of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations in accounting for employee stock options and, accordingly, will not recognize compensation cost for options granted under its 2003 Stock Incentive Plan whose exercise price equaled the market value of a share of the underlying common stock on the date of grant.

The following table illustrates the effect on net loss and net loss per share as if the Company had applied the fair value recognition provisions of SFAS No. 123, “Accounting for Stock-Based Compensation” as amended by SFAS 148, “Accounting for Stock-Based Compensation — Transition and Disclosure — An Amendment of SFAS 123” to stock-based employee compensation (in thousands, except per share amounts):

10


 

                 
    Quarter Ended
    June 30,
    2004
  2003
Net loss, as reported
  $ (12,851 )   $ (12,518 )
Deduct: Total stock-based employee compensation expense determined under fair value method
    (145 )     (455 )
 
   
 
     
 
 
Pro-forma net loss
  $ (12,996 )   $ (12,973 )
 
   
 
     
 
 
Loss per share:
               
Basic and diluted loss per common share – as reported
  $ (0.48 )   $ (0.47 )
Basic and diluted loss per common share – pro forma
  $ (0.49 )   $ (0.49 )

All per share information for the Company is based on the number of shares of common stock of the Company outstanding upon completion of the merger and related transactions. The pro forma net loss and pro forma net loss per share disclosed above is not representative of the effects on net loss and net loss per share on a pro forma basis in future periods, as future periods may include grants by the Company of options for the Company’s common stock. In addition, information for the quarter ended June 30, 2003 represents options for IGEN common stock which were canceled upon completion of the merger.

The fair value of BioVeris options for the quarter ended June 30, 2004 was estimated at the date of grant using a Black-Scholes option pricing model with the following assumptions:

         
Expected dividend yield
    0.00 %
Expected stock price volatility
    64.06 %
Risk-free interest rate
    3.89 %
Expected option term (in years)
    3  

Based on this calculation, the weighted average fair value of BioVeris options granted during the quarter ended June 30, 2004 was $7.19. The Company did not have a stock option plan prior to September 2003.

The fair value of IGEN options for the quarter ended June 30, 2003 was estimated at the date of grant using a Black-Scholes option pricing model with the following assumptions:

         
Expected dividend yield
    0.00 %
Expected stock price volatility
    65.00 %
Risk-free interest rate
    2.30 %
Expected option term (in years)
    5  

Based on this calculation, the weighted average fair value of IGEN options granted during the quarter ended June 30, 2003 was $21.09.

Loss Per Share - The Company uses SFAS No. 128 “Earnings per Share” for the calculation of basic and diluted earnings (loss) per share. For the quarters ended June 30, 2004 and 2003, the Company incurred a net loss; therefore, net loss per common share does not reflect the potential dilution that could occur to common shares related to outstanding stock options. For the quarter ended June 30, 2003, the unaudited pro-forma net loss per share is based on the number of common shares outstanding upon completion of the merger and related transactions. As the Company incurred a loss for the quarter ended June 30, 2004, it did not assume exercise of 20,300 options because to do so would have been anti-dilutive.

New Accounting Standards – For a discussion of FASB Interpretation No. 46, see Note 2-“Summary of Significant Accounting Policies-Consolidation Accounting.”

3. MESO SCALE DIAGNOSTICS JOINT VENTURE

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MSD is a joint venture formed by MST and IGEN in 1995. As part of the merger and related restructuring, IGEN transferred its equity interest in MSD to the Company and assigned the MSD agreements to the Company. MSD was formed for the development, manufacture, marketing and sale of products utilizing a combination of MST’s multi-array technology together with IGEN’s technology.

MST is a company established and wholly-owned by Mr. Jacob Wohlstadter. In August 2001, there were amendments to the MSD joint venture agreement, the MSD limited liability company agreement and certain license and other agreements with MSD and MST to continue the MSD joint venture and various related agreements (the MSD agreements). An independent committee of IGEN’s board of directors, with the advice of independent advisors and counsel, negotiated and approved the MSD agreements. As part of the merger agreement and related transaction agreements, the Company, IGEN and MSD agreed that the MSD joint venture agreement would expire upon completion of the merger and related transactions.

MSD manufactures, markets and sells instrument systems, including the Sector HTS and the Sector PR, which combine MST’s multi-array technology and the Company’s ECL technology. The Sector HTS is an ultra high throughput drug discovery system engineered for applications such as high throughput screening and large-scale proteomics. The Sector PR is a smaller system designed for benchtop applications such as assay development, research in therapeutic areas, cellular biology and medium throughput screening. MSD also manufactures and markets a line of its own reagents, assays and plates that are used on these systems. MSD commenced product sales in October 2002.

Under the MSD agreements, IGEN’s funding commitment was based on an annual budget of MSD approved by the Joint Venture Oversight Committee (JVOC), a committee of the IGEN board of directors consisting of independent directors. The JVOC approved funding for MSD for the period from January 1, 2003 to November 30, 2003 in an amount of $20.6 million, subject to a permitted variance of 15%, of which approximately $19.1 million was spent by MSD and funded by the Company. The funding commitment was satisfied in part through in-kind contributions of scientific and administrative personnel and shared facilities. MSD asserted that the Company was obligated to pay MSD up to an additional $4.6 million, which is the difference between the amount spent by MSD and the budgeted amount plus the permitted variance. As part of an August 2004 settlement agreement between the parties, the Company agreed to pay MSD the net amount of $3.0 million which represents full and complete satisfaction of amounts due to MSD pursuant to the MSD agreements, including this dispute regarding unsatisfied committed funding obligations, certain intellectual property matters, and the previously outstanding dispute regarding the payment of certain legal fees and expenses incurred by MSD in connection with its participation and involvement in the merger and related transactions. The Company’s $3.0 million payment will be net of a $2.0 million non-refundable pre-payment by MSD to the Company for future amounts payable by MSD to the Company pursuant to the buyout of the Company's interest in MSD. The Company made no contributions to MSD in the quarter ended June 30, 2004. For the quarter ended June 30, 2003, the total contributions made to MSD was $10.9 million.

After the restructuring, and subject to MSD’s and MST’s right to buy the Company’s interests in MSD, the Company replaced IGEN as a member of MSD and holds a 31% voting equity interest in MSD and is entitled to a preferred return on approximately $114 million of the funds previously invested by IGEN in MSD through the date of the merger and on the additional funds invested by the Company thereafter. This preferred return would be payable out of a portion of both future profits and certain third-party financings of MSD, generally before any payments are made to other equity holders.

The Company and MST are the sole members of MSD, and each held one seat on MSD’s two-member board of managers. Dr. Richard Massey, the Company’s president and chief operating officer, was the Company’s representative on the MSD board of managers and also served as the treasurer and secretary of MSD. The other member of the MSD board of managers is Mr. Jacob Wohlstadter, who is the sole owner of MST and serves as president and chief executive officer of MSD. As part of an August 2004 settlement agreement between the parties, the Company’s representative on the MSD board of managers has resigned and the Company has executed an amendment to the MSD agreements for the purpose of changing the composition of the MSD board of managers to one person designated by MST.

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Under the terms of one of the MSD agreements, IGEN granted to MSD a worldwide, perpetual, exclusive license (with certain exceptions) to IGEN’s technology, including ECL technology, for use in MSD’s research program, defined in the MSD agreements. If the Company ceases to be a member of MSD, it will become entitled to receive royalty payments from MSD on all products developed and sold by MSD using the Company’s patents.

MST holds a worldwide, perpetual, non-exclusive sublicense from MSD for certain non-diagnostic applications of the Company’s technology. The Company is entitled to receive royalty payments from MST on any products developed and sold by MST using the patents the Company received as part of the restructuring.

Upon completion of the merger and related transactions, the MSD joint venture agreement expired. As a result, MSD and MST have the option to purchase the Company’s interest in MSD and as part of an August 2004 settlement agreement between the parties, they agreed to do so. As of June 30, 2004 and March 31, 2004, the Company has recorded a $1.2 million liability representing the value of MSD’s option to purchase the Company’s interests in MSD.

The purchase price will be equal to fair market value (determined in accordance with the MSD agreements), which includes third-party appraisal if the parties are unable to agree on fair market value) minus a 7.5% discount factor. The parties have commenced the valuation process and the initial appraisers’ reports are due on August 30, 2004. If those reports do not reflect fair market value calculations within 10% of each other, then a third appraiser will be appointed to provide a report on or about October 15, 2004. The average of the two closest appraisals will be the purchase price. MSD or MST will be required to pay the Company the outstanding purchase price plus simple (cumulated, not compounded) interest at the fixed annual rate of 0.5% over the prime rate in effect on the purchase date. The purchase price is payable over time in installments equal to the sum of 5% of MSD net sales, as determined in accordance with the MSD agreements, and 20% of the net proceeds realized by MSD from the sale of its debt or equity securities in any third-party financing after the date of the sale of the Company’s interest in MSD. There is no assurance the purchase price will be paid in full. The Company expects that MSD will require substantial additional funding for its ongoing operations. If MSD is not able to obtain this funding, it may not be able to pay the purchase price in full and we could lose our ability to realize the value of most or all of our $41.2 million investment in MSD.

As part of an August 2004 settlement agreement between the parties, the Company received a $2.0 million non-refundable pre-payment from MSD for future amounts payable by MSD to the Company pursuant to the buy-out of its interest in MSD. The amount of the pre-payment credit outstanding from time to time shall bear simple interest (cumulated, not compounded) at the fixed annual rate of 0.5% over the prime rate in effect on the date that MSD or MST, as the case may be, purchases the Company’s interests in MSD. The amount of the outstanding credit balance of the prepayment credit, including accrued interest, shall be reduced for amounts due and payable to the Company pursuant to the buy-out of its interest in MSD and no further cash payments will be payable by MSD to the Company until the $2.0 million prepayment credit, including accrued interest, is utilized. In the event future net sales or third-party financings in excess of the prepayment credit and accrued interest do not materialize, the Company will not receive any additional payments from MSD or MST, as the case may be, for the purchase of the Company’s interest in MSD. As security for the payment obligation, the Company will hold a security interest in the interests in MSD that are being purchased. MST or MSD, as the case may be, may repay all or any part of the outstanding purchase price plus accrued interest at any time and from time to time without penalty. The holder of the Company’s Series B preferred stock will be entitled to a pro-rata share, representing the proportionate amount of the Company’s class C interest in MSD that was funded by the sale of the Series B stock, of the portion of the $2.0 million that is allocable to our Class C interests.

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Upon expiration of the MSD joint venture agreement, many of the licenses and other arrangements with MSD and MST assigned to the Company continue indefinitely in accordance with their terms and the Company may not use the improvements granted to it by MSD if doing so would compete with MSD in the diagnostic field or use research technologies defined in the MSD agreements.

Following the expiration of the MSD joint venture agreement, MSD is entitled to continue to lease certain facilities and related equipment from the Company (including laboratory facilities located in the Company’s corporate headquarters) pursuant to the terms of the existing sublease agreements with MSD. The term of each sublease will expire one day prior to the expiration of the prime lease for that facility. Each sublease agreement provides that, subject to certain exceptions, the Company must exercise all available extension rights under the prime lease. Each of MSD and the Company may unilaterally terminate any or all of the subleases by providing at least 18 months prior written notice of termination and on February 29, 2004, the Company elected to terminate all of the subleases effective the earlier of September 1, 2005, or the date on which the applicable prime lease terminates. As part of an August 2004 settlement agreement between the parties, MSD’s rental and expense payment obligations under the sublease agreements, for the period from March 1, 2004 through August 31, 2005, for approximately $2.2 million will be added into the price payable to the Company for the purchase of its interest in MSD, in lieu of current payments. MSD may elect, notwithstanding any termination of the sublease, to remain in the subleased facility after the 18 month period expires for any period of time selected by MSD, but not longer than one day prior to the expiration of the prime lease (including any extensions of the prime lease). In that event, MSD will be required to pay rent in cash for any additional rental period MSD may elect.

MSD has an employment agreement with Mr. Jacob Wohlstadter, its president and chief executive officer, the current term of which runs through November 30, 2005. The term of the employment agreement will automatically renew for a 12-month period on November 30 of each year unless either MSD or Mr. Jacob Wohlstadter gives notice of termination no later than 180 days prior to that renewal date. That employment agreement provides for a salary at the annual rate of $250,000 through November 30, 2004, and 2005. Thereafter, the salary is to be increased as agreed to by MSD and Mr. Jacob Wohlstadter. In addition, Mr. Jacob Wohlstadter is also eligible to receive an annual cash bonus in an amount not to exceed 20% of his annual salary upon the achievement of agreed-upon performance factors. Mr. Jacob Wohlstadter is also entitled to receive pension, welfare and fringe benefits comparable to those received by senior executives of the Company and other insurance benefits. If MSD terminates the employment agreement without cause, or Mr. Jacob Wohlstadter terminates the employment agreement for good reason (which includes a “change in control” of the Company, as defined), Mr. Jacob Wohlstadter will be entitled to receive, in addition to salary and pro rata bonus and adjustments earned through the 60th day following the notice of termination, an amount equal to from 3 to 12 times (depending on the reason for the termination) the monthly pro rata salary, bonus and adjustments in effect at the time of the termination. Under the employment agreement Mr. Jacob Wohlstadter is also entitled to receive a gross-up for any “parachute” excise tax that may be imposed on payments made or benefits provided pursuant to the agreement. The Company is obligated to maintain in effect directors and officer’s liability insurance coverage for Mr. Jacob Wohlstadter and to pay Mr. Jacob Wohlstadter the applicable salary, pro rata bonus and adjustments in effect at the time of termination as described above and a gross-up for any “parachute” excise tax that may be imposed.

MSD and Mr. Jacob Wohlstadter have each agreed that the merger and related transactions did not constitute a change in control for purposes of the MSD agreements and the employment agreement. The Company will also indemnify Mr. Jacob Wohlstadter against certain liabilities, including certain liability from the MSD joint venture relating to the period of IGEN’s or the Company’s involvement with MSD.

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In addition, the Company will be obligated to the extent provided in the MSD agreements to indemnify each board member or officer of MSD with respect to any action taken by such person prior to the termination of the MSD joint venture agreement by reason of the fact that such person is or was a board member or an officer of MSD. In connection with the audit of MSD, the Company will indemnify MSD, MST and Jacob Wohlstadter and their respective directors, officers, employees and agents for any losses, costs, fees and expenses arising out of or related in any way to past, current or future audits of MSD, the preparation of MSD financial statements requested by the Company, and with respect to regulatory or legal proceedings and investigations resulting from or related to the fact that the Company is a public company. With respect to such indemnification obligations, there are no pending or known matters covered by these indemnification provisions that would have a material effect on the Company’s financial position or results of operations.

Since inception of the MSD joint venture through March 31, 2004, the equity method has been utilized to account for this investment. Prior to July 1, 2001, given MSD’s status as a development stage enterprise without having established technological feasibility of its intended product offering, the Company considered its investments in MSD to be other than temporarily impaired. As such, any residual investment book value, after recognizing the Company’s share of MSD losses in accordance with the equity method, was written off upon contribution. All expenses related to the MSD investment prior to July 1, 2001 were recorded as research and development expenses based upon the significance and character of the MSD losses as substantially all contributions supported research and development initiatives.

Beginning on July 1, 2001, taking into account the progress made by MSD in the development of its products, the Company determined that no additional impairments were required to its prospective contributions and thus ceased writing-off the amount of its contributions to MSD that were in excess of MSD’s losses. At that time, MSD was transitioning from a development stage entity to a commercial enterprise and milestones establishing the continued viability of MSD were first achieved in the quarter ended September 30, 2001. For example, prototypes had been assembled demonstrating product feasibility, and MSD was anticipating initial product launch in approximately one year. As a result of this transition, MSD’s expenses were no longer primarily research and development. Accordingly, since July 1, 2001, the Company has recorded only its proportionate share of MSD losses, representing approximately 100% of MSD’s losses, for each respective period as equity in loss of joint venture consistent with accounting for equity method investments.

MSD-related losses included in equity in loss of joint venture were $5.2 million for the quarter ended June 30, 2003. Beginning March 31, 2004, the Company has consolidated the financial results of MSD. During the quarters ended June 30, 2004 and June 30, 2003, operating costs allocated to MSD by the Company in connection with shared personnel and facilities totaled $526,000 and $2.0 million, respectively. Since July 1, 2001 and through March 31, 2004, these allocated operating costs reduced certain operating costs and expenses and increased Equity in Loss of Joint Venture in the accompanying consolidated statements of operations. At June 30, 2004 and March 31, 2004, the Company’s investment in joint venture has been eliminated as part of the consolidation of MSD’s balance sheet. See Note 2 for a discussion of consolidation accounting for MSD.

4. LITIGATION

In June 2004, the Audit Committee of the Company’s Board of Directors commenced an investigation of MSD that was prompted by the discovery of a series of transactions undertaken by MSD involving the actual or proposed purchase by MSD of residential real property and luxury automobiles having an aggregate cost of approximately $7 million. The transactions were entered into by MSD upon Jacob Wohlstadter’s sole approval and without the Company’s knowledge.

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On June 15, 2004, the Company filed an action in the Court of Chancery of the State of Delaware, which we refer to in this Form 10-K as the court, against Jacob Wohlstadter, MSD and MST, seeking Court confirmation that we remained entitled to designate one of the two members of the MSD Board of Managers, and asking the Court to enter an order, pending the outcome of the litigation, prohibiting MSD from taking any actions outside the ordinary course of MSD’s business without providing prior notice to us. On June 17, 2004, the Court ordered that, pending the court’s final determination of the lawsuit, the Company’s representative on the MSD Board of Managers shall remain on the MSD Board of Managers and that MSD would not engage in any transaction outside the ordinary course of business which has a value in excess of $10,000 without the approval of both members of the MSD Board of Managers. Also on June 15, 2004, the Company submitted a formal demand to MSD requesting the right to examine certain books and records of MSD to aid the Audit Committee in its investigation and to permit us to value the Company’s interest in MSD. Beginning late June, MSD permitted the Company’s to examine the requested books and records.

On June 17, 2004, MSD received $2.9 million from Jacob Wohstadter as consideration for the proposed sale by MSD to Jacob Wohlstadter of real property and automobiles, pending approval by the Board of Managers. Jacob Wohlstadter also assumed MSD’s purchase obligations with respect to a prospective real property purchase in the approximate amount of $4.1 million.

Also on June 17, 2004, the Company was informed by the staff of the Securities and Exchange Commission that it had commenced an informal inquiry as to certain issues relating to MSD.

On July 6, 2004, the Company entered into an agreement with MSD, MST and Jacob Wohlstadter pursuant to which it was agreed that the first lawsuit would be stayed, that the parties would not file new litigation against each other, and that the valuation process in connection with MST’s and MSD’s right to purchase our interest in MSD would be stayed. This stay agreement was intended to permit the parties to