-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, C+RMR9zT63ff2ihaI1cJHJrfFKFihsoohMth8hZTLRM4tb0kzdKnVKyU1N+01KIu +tD2o6tGnzTt7p3XrgsgYg== 0001193125-04-140659.txt : 20040813 0001193125-04-140659.hdr.sgml : 20040813 20040813172326 ACCESSION NUMBER: 0001193125-04-140659 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20040630 FILED AS OF DATE: 20040813 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VIROLOGIC INC CENTRAL INDEX KEY: 0001094961 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 943234479 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-30369 FILM NUMBER: 04975428 BUSINESS ADDRESS: STREET 1: 345 OYSTER POINT BLVD. CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650.635.1100 MAIL ADDRESS: STREET 1: 345 OYSTER POINT BLVD. CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 10-Q 1 d10q.htm FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2004 For The Quarterly Period Ended June 30, 2004
Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 10-Q

 


 

(MARK ONE)

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

 

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2004

 

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

 

FOR THE TRANSITION PERIOD FROM              TO              .

 

COMMISSION FILE NUMBER: 000-30369

 


 

VIROLOGIC, INC.

(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)

 


 

DELAWARE   94-3234479
(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION)
 

(IRS EMPLOYER

IDENTIFICATION NO.)

 

345 OYSTER POINT BLVD

SOUTH SAN FRANCISCO, CA 94080

(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)

 

TELEPHONE NUMBER (650) 635-1100

(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  x    No  ¨

 

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

 

As of August 12, 2004 there were 53,671,790 shares of the registrant’s common stock outstanding.

 



Table of Contents

VIROLOGIC, INC.

 

INDEX

 

     PAGE
NO.


PART I. FINANCIAL INFORMATION

    

Item 1. Financial Statements

    

             Condensed Balance Sheets as of June 30, 2004 and December 31, 2003

   3

             Condensed Statements of Operations for the three and six months ended June 30, 2004 and 2003

   4

             Condensed Statements of Cash Flows for the six months ended June 30, 2004 and 2003

   5

             Notes to Condensed Financial Statements

   6

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

   11

Item 3. Quantitative and Qualitative Disclosures About Market Risk

   31

Item 4. Controls and Procedures

   31

PART II. OTHER INFORMATION

    

Item 1. Legal Proceedings

   32

Item 2. Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities

   32

Item 3. Defaults Upon Senior Securities

   32

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

   32

Item 5. Other Information

   32

Item 6. Exhibits and Reports on Form 8-K

   32

Signatures

   33

 

2


Table of Contents

VIROLOGIC, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share data)

 

    

June 30,

2004


   

December 31,

2003


 
     (Unaudited)     (Note 1)  

ASSETS

                

Current assets:

                

Cash and cash equivalents

   $ 9,216     $ 8,893  

Short-term investments

     250       537  

Accounts receivable, net of allowance for doubtful accounts of $598 and $643 at June 30, 2004 and December 31, 2003, respectively

     5,858       6,165  

Prepaid expenses

     599       700  

Inventory

     1,014       1,378  

Restricted cash

     626       426  

Other current assets

     248       267  
    


 


Total current assets

     17,811       18,366  

Property and equipment, net

     7,409       8,445  

Restricted cash

     50       350  

Transaction costs related to pending merger

     1,686       —    

Other assets

     1,464       1,217  
    


 


Total assets

   $ 28,420     $ 28,378  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 2,912     $ 1,556  

Accrued compensation

     999       862  

Accrued liabilities

     2,818       2,108  

Deferred revenue

     715       268  

Current portion of capital lease obligations

     205       401  

Current portion of loans payable

     —         133  
    


 


Total current liabilities

     7,649       5,328  

Long-term portion of capital lease obligations

     43       87  

Other long-term liabilities

     379       382  

Redeemable convertible preferred stock, $0.001 par value, 274 shares authorized, designated by series, issued and outstanding at June 30, 2004 and December 31, 2003; aggregate liquidation preference of $2,856 at June 30, 2004

     1,994       1,994  

Commitments

                

Stockholders’ equity:

                

Preferred stock, $0.001 par value, 4,999,726 shares authorized, designated by series, none issued and outstanding at June 30, 2004 and December 31, 2003

     —         —    

Common stock, $0.001 par value, 100,000,000 shares authorized; 53,636,768 and 52,608,382 shares issued and outstanding at June 30, 2004 and December 31, 2003, respectively

     54       53  

Additional paid-in capital

     127,192       126,805  

Accumulated other comprehensive income

     —         1  

Accumulated deficit

     (108,891 )     (106,272 )
    


 


Total stockholders’ equity

     18,355       20,587  
    


 


Total liabilities and stockholders’ equity

   $ 28,420     $ 28,378  
    


 


 

See accompanying notes to Condensed Financial Statements.

 

3


Table of Contents

VIROLOGIC, INC.

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended
June 30,


    Six Months Ended
June 30,


 
     2004

    2003

    2004

    2003

 

Revenue:

                                

Product revenue

   $ 8,734     $ 7,786     $ 17,374     $ 14,337  

Contract revenue

     493       167       875       584  
    


 


 


 


Total revenue

     9,227       7,953       18,249       14,921  

Operating costs and expenses:

                                

Cost of product revenue

     4,475       4,268       8,891       8,087  

Research and development

     1,600       1,089       2,993       2,435  

Sales and marketing

     2,784       2,469       4,742       4,311  

General and administrative

     1,750       2,375       3,830       4,841  

Lease termination charge

     —         —         433       —    
    


 


 


 


Total costs and expenses

     10,609       10,201       20,889       19,674  
    


 


 


 


Operating loss

     (1,382 )     (2,248 )     (2,640 )     (4,753 )

Interest income

     19       26       40       63  

Interest expense

     (8 )     (36 )     (19 )     (88 )

Other income

     —         52       —         104  
    


 


 


 


Net loss

     (1,371 )     (2,206 )     (2,619 )     (4,674 )

Deemed dividend to preferred stockholders

     —         —         —         (2,155 )

Preferred stock dividend

     (77 )     (506 )     (145 )     (973 )
    


 


 


 


Loss applicable to common stockholders

   $ (1,448 )   $ (2,712 )   $ (2,764 )   $ (7,802 )
    


 


 


 


Basic and diluted loss per common share

   $ (0.03 )   $ (0.09 )   $ (0.05 )   $ (0.27 )
    


 


 


 


Weighted-average shares used in computing basic and diluted loss per common share

     53,494       29,643       53,376       29,001  
    


 


 


 


 

See accompanying notes to Condensed Financial Statements.

 

4


Table of Contents

VIROLOGIC, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

     Six Months Ended
June 30,


 
     2004

    2003

 

OPERATING ACTIVITIES

                

Net loss

   $ (2,619 )   $ (4,674 )

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

                

Depreciation and amortization

     1,375       1,708  

Loss on disposal of fixed assets related to lease termination

     108       —    

Stock-based compensation

     36       149  

Amortization of deferred gain on lease assignment

     —         (104 )

Changes in assets and liabilities

                

Accounts receivable

     307       534  

Prepaid expenses

     101       (168 )

Inventory

     364       212  

Other current assets

     19       17  

Accounts payable

     332       732  

Accrued compensation

     137       (19 )

Accrued liabilities

     418       (343 )

Deferred revenue

     447       (11 )

Long-term deferred rent

     (3 )     (20 )
    


 


Net cash provided by (used in) operating activities

     1,022       (1,987 )

INVESTING ACTIVITIES

                

Purchases of short-term investments

     (4 )     (4,569 )

Maturities and sales of short-term investments

     290       4,565  

Capital expenditures

     (447 )     (69 )

Restricted cash

     100       (349 )

Transaction costs related to pending merger

     (389 )     —    

Other assets

     (247 )     (184 )
    


 


Net cash used in investing activities

     (697 )     (606 )

FINANCING ACTIVITIES

                

Principal payments on loans payable

     (133 )     (416 )

Payments on capital lease obligations

     (240 )     (501 )

Net proceeds from issuance of common stock

     371       1,111  

Expenses relating to issuance of preferred stock

     —         (397 )
    


 


Net cash used in financing activities

     (2 )     (203 )
    


 


Net increase (decrease) in cash and cash equivalents

     323       (2,796 )

Cash and cash equivalents at beginning of period

     8,893       10,559  
    


 


Cash and cash equivalents at end of period

   $ 9,216     $ 7,763  
    


 


 

See accompanying notes to Condensed Financial Statements.

 

5


Table of Contents

VIROLOGIC, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

June 30, 2004

(Unaudited)

 

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting only of adjustments of a normal recurring nature) considered necessary for a fair presentation have been included. Operating results for the six-month period ended June 30, 2004 are not necessarily indicative of the results that may be expected for the year ending December 31, 2004 or any other future periods. The condensed balance sheet as of December 31, 2003 has been derived from the audited financial statements as of that date but does not include all of the information and footnotes required by US generally accepted accounting principles for complete financial statements. For further information, refer to the audited financial statements and notes thereto included in our Annual Report to Stockholders on Form 10-K for the year ended December 31, 2003.

 

Use of Estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles 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.

 

Revenue Recognition

 

Product revenue is recognized upon completion of tests made on samples provided by customers and the shipment of test results to those customers. Services are provided to certain patients covered by various third-party payor programs, such as Medicare and Medicaid. Billings for services under third-party payor programs are included in revenue net of allowances for differences between the amounts billed and estimated receipts under such programs. The Company estimates these allowances based on historical payment information and current sales data. If the government and other third-party payors significantly change their reimbursement policies, an adjustment to the allowance may be necessary. Revenue generated from the Company’s database of resistance test results is recognized when earned under the terms of the related agreements, generally upon shipment of the requested reports. Contract revenue consists of revenue generated from National Institutes of Health (“NIH”) grants and commercial assay development, and other non-product revenue. NIH grant revenue is recorded on a reimbursement basis as grant costs are incurred. The costs associated with contract revenue are included in research and development expenses. Deferred revenue relates to cash received in advance of meeting the revenue recognition criteria described above.

 

Accounts Receivable

 

The process for estimating the collectibility of receivables involves significant assumptions and judgments. Billings for services under third-party payor programs are recorded as revenue net of allowances for differences between amounts billed and the estimated receipts under such programs. Adjustments to the estimated receipts, based on final settlement with the third-party payors, are recorded upon settlement as an adjustment to net revenue. In addition, the Company reviews and estimates the collectibility of receivables based on the period of time such receivables have been outstanding. Historical collection and payor reimbursement experience is an integral part of the estimation process related to the allowance for doubtful accounts. Revisions to the allowance for doubtful accounts estimate are included in general and administrative expenses.

 

6


Table of Contents

Inventory

 

Inventory is stated at the lower of standard cost, which approximates actual cost on a first-in, first-out basis, or market. If inventory costs exceed expected market value due to obsolescence or lack of demand, reserves are recorded for the difference between the cost and the market value. These reserves are based on estimates. Inventory consists of the following:

 

    

June 30,

2004


  

December 31,

2003


     (In thousands)

Raw materials

   $ 652    $ 832

Work in process

     362      546
    

  

Total

   $ 1,014    $ 1,378
    

  

 

Stock-Based Compensation

 

The Company has elected to continue to follow Accounting Principles Board Opinion No. 25 “Accounting for Stock-Based Compensation” (“APB 25”) to account for employee stock options. Under APB 25, no compensation expense is recognized when the exercise price of the Company’s employee stock options equals the market price of the underlying stock on the date of grant. Deferred compensation, if recorded, is amortized using the graded vesting method. Statement of Financial Accounting Standards Board Statement No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”) as amended by Statement of Financial Accounting Standards Board Statement No. 148, “Accounting for Stock-Based Compensation — Transition and Disclosure — an amendment of FASB Statement No. 123” (“SFAS 148”) requires the disclosure of pro forma information regarding net loss and net loss per share as if the Company had accounted for its stock options under the fair value method.

 

The information regarding loss applicable to common stockholders and loss per share prepared in accordance with SFAS 123 has been determined as if the Company had accounted for its employee stock option and employee stock purchase plans using the fair value method prescribed by SFAS 123. The resulting pro forma effects on loss applicable to common stockholders and loss per share pursuant to SFAS 123 as amended by SFAS 148 are not likely to be representative of the effects in future years, due to the vesting provisions of employee stock options and the inclusion of additional grants in subsequent years.

 

At June 30, 2004, the Company had two stock-based employee compensation plans: the 2000 Equity Incentive Plan and the 2000 Employee Stock Purchase Plan. The Company estimates the fair value of these stock options and stock purchase rights at the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions for the three and six months ended June 30, 2004 and 2003: risk-free interest rate of 2.8% and 2.9% in 2004 and 2003, respectively; a weighted-average expected life of stock options from grant date of four years; a weighted-average expected stock purchase right of six months; volatility factor of the expected market price of the Company’s common stock of 100%; and a dividend yield of zero.

 

For purposes of disclosures pursuant to SFAS 123 as amended by SFAS 148, the estimated fair value of the stock options and stock purchase rights are amortized to expense over the vesting period. The Company’s pro forma information is as follows:

 

     Three Months Ended
June 30,


    Six Months Ended
June 30,


 
     2004

    2003

    2004

    2003

 
     (In thousands, except per share amounts)  

Loss applicable to common stockholders — as reported

   $ (1,448 )   $ (2,712 )   $ (2,764 )   $ (7,802 )

Add back:

                                

Amortization of deferred compensation

     —         48       —         125  

Deduct:

                                

Stock-based compensation expense for employee awards determined under SFAS 123

     (863 )     (384 )     (1,392 )     (888 )
    


 


 


 


Pro forma loss applicable to common stockholders

   $ (2,311 )   $ (3,048 )   $ (4,156 )   $ (8,565 )
    


 


 


 


Loss per common share:

                                

Loss applicable to common stockholders — as reported

   $ (0.03 )   $ (0.09 )   $ (0.05 )   $ (0.27 )
    


 


 


 


Loss applicable to common stockholders — pro forma

   $ (0.04 )   $ (0.10 )   $ (0.08 )   $ (0.30 )
    


 


 


 


 

The Company accounts for stock option grants to non-employees in accordance with the Emerging Issues Task Force Consensus No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” which requires the options subject to vesting to be periodically re-valued and expensed over their vesting periods, which approximates the period over which services are rendered or goods are received.

 

7


Table of Contents

2. COMPREHENSIVE INCOME (LOSS)

 

Comprehensive income (loss) is comprised of net loss and other comprehensive income (loss). Other comprehensive income includes certain changes in equity that are excluded from net income (loss). Specifically, unrealized gains and losses on our available-for-sale securities, which are reported separately in stockholders’ equity, are included in accumulated other comprehensive income. Comprehensive income (loss) and its components are as follows:

 

     Three Months Ended
June 30,


    Six Months Ended
June 30,


 
     2004

    2003

    2004

    2003

 
     (In thousands)  

Net loss

   $ (1,371 )   $ (2,206 )   $ (2,619 )   $ (4,674 )

Changes in unrealized gain on securities available-for-sale, net of tax

     (1 )     (1 )     (1 )     (1 )
    


 


 


 


Comprehensive loss

   $ (1,372 )   $ (2,207 )   $ (2,620 )   $ (4,675 )
    


 


 


 


 

3. LOSS PER SHARE

 

Basic loss per common share is calculated based on the weighted-average number of common shares outstanding during the periods presented. Diluted earnings per common share would give effect to the dilutive impact of potential common shares which consists of convertible preferred stock (using the as-if converted method), and stock options and warrants (using the treasury stock method). Potentially dilutive securities have been excluded from the diluted loss per common share computations in all periods presented as such securities have an anti-dilutive effect on loss per common share due to the Company’s net loss.

 

4. CAPITAL STOCK

 

Preferred Stock

 

Series A Redeemable Convertible Preferred Stock

 

In 2001, the Company issued and sold, in a private placement, an aggregate of 1,625 shares of the Company’s Series A Redeemable Convertible Preferred Stock (“Series A Preferred Stock”) and warrants to purchase an aggregate of 3.2 million shares of common stock, for an aggregate purchase price of $16.25 million.

 

Of the 1,625 shares issued in the financing, 274 shares remain outstanding as of June 30, 2004, and the remainder was converted into an aggregate of approximately 7.4 million shares of the Company’s common stock. As a result of the Company’s sale of Series C Preferred Stock in 2002, the conversion price of the Series A Preferred Stock and the exercise price of the warrants issued to the purchasers of the Series A Preferred Stock has each been reduced to $1.11. Accordingly, the 274 shares of Series A Preferred Stock outstanding are convertible into approximately 2.5 million shares of common stock, and the outstanding warrants are exercisable for approximately 4.0 million shares of common stock.

 

The Series A Preferred Stock bears dividends payable in common stock semi-annually. The dividends were initially at an annual rate of 6% but increased to an 8% annual rate on the fourth such payment, which was made in 2003, and will increase by 2 percentage points every six months up to a maximum annual rate of 14%. Subject to the limitations described below, the holders of Series A Preferred Stock may elect to convert their shares into the Company’s common stock at any time, just as they may choose to exercise their warrants at any time. Also, subject to the limitations described below, the Company may, at its option, convert the Series A Preferred Stock into common stock at any time if the Company’s stock price exceeds $5.10 for 20 consecutive trading days. The Company may also, at its option, convert the Series A Preferred Stock into common stock upon a sale of common stock in a firm commitment underwritten offering to the public if the public offering price exceeds $5.10, the aggregate gross proceeds exceed $40 million and the registration statements covering shares underlying the Series A Preferred Stock are effective.

 

8


Table of Contents

The holders are not subject to any limitations on the number of conversions of Series A Preferred Stock or subsequent sales of the corresponding common stock, that they can effect, other than a prohibition on any holder acquiring beneficial ownership of more than 4.99% of the outstanding shares of the Company’s common stock. This limitation also applies to the Company’s ability to convert Series A Preferred Stock.

 

The holders of Series A Preferred Stock have the right to require the Company to redeem all of the Series A Preferred Stock for cash equal to the greater of (i) 115% of their original purchase price plus 115% of any accrued and unpaid dividend or (ii) the aggregate fair market value of the shares of common stock into which such shares of Series A Preferred Stock are then convertible. Series A Preferred Stock is redeemable by the holders in any of the following situations:

 

  If the Company fails to remove a restrictive legend on any certificate representing any common stock that was issued to any holder of such series upon conversion of their preferred stock or exercise of their warrant and that may be sold pursuant to an effective registration statement or an exemption from the registration requirements of the federal securities laws

 

  If the Company fails to have sufficient shares of common stock reserved to satisfy conversions of the series

 

  If the Company fails to honor requests for conversion, or if the Company notifies any holder of such series of its intention not to honor future requests for conversion

 

  If the Company institutes voluntary bankruptcy or similar proceedings

 

  If the Company makes an assignment for the benefit of creditors, or applies for or consents to the appointment of a receiver or trustee for the Company or for a substantial part of the Company’s property or business, or such a receiver or trustee shall otherwise be appointed

 

  If the Company sells all or substantially all of its assets

 

  If the Company merges, consolidates or engages in any other business combination (with some exceptions), provided that such transaction is required to be reported pursuant to Item 1 of Form 8-K

 

  If the Company commits a material breach under, or otherwise materially violates the terms of, the transaction documents entered into in connection with the issuance of such series

 

  If the registration statements covering shares of common stock underlying the Series A Preferred Stock and related warrants cannot be used by the respective selling security holders for the resale of all the underlying shares of common stock for an aggregate of more than 30 days

 

  If the Company’s common stock is not tradable on the NYSE, the AMEX, the Nasdaq National Market or the Nasdaq SmallCap market for an aggregate of twenty trading days in any nine month period

 

  If 35% or more of the Company’s voting power is held by any one person, entity or group

 

  If the Company fails to pay any indebtedness in excess of $350,000 when due, or if there is any event of default under any agreement that is likely to have a material adverse effect on the Company

 

  Upon the institution of involuntary bankruptcy proceedings

 

Upon the occurrence of any of the redemption events described above, individual holders of the Series A Preferred Stock would have the option, while such event continues, to require the Company to purchase some or all of the then outstanding shares of Series A Preferred Stock held by such holder. If the Company receives any notice of redemption, the Company is required to immediately (no later than one business day following such receipt) deliver a written notice to all holders of the same series of preferred stock stating the date when the Company received the redemption notice and the amount of preferred stock covered by the notice. If holders of the Series A Preferred Stock were to exercise their rights to redeem a material number of their shares as a result of any of the events described above, such a redemption could have a material adverse effect on the Company.

 

9


Table of Contents

Subject to certain conditions, the Company may redeem the Series A Preferred Stock at any time. Due to the nature of the redemption features of the Series A Preferred Stock, such stock has been excluded from permanent equity in the Company’s financial statements.

 

The Company initially recorded the Series A Preferred Stock at its fair value on the date of issuance. In accordance with EITF Topic D-98: Classification and Measurement of Redeemable Securities (“EITF Topic D-98”), the Company has elected not to adjust the carrying value of the Series A Preferred Stock to the redemption value of such shares, since it is uncertain whether or when the redemption events described above will occur. Subsequent adjustments to increase the carrying value to the redemption value will be made when it becomes probable that such redemption will occur. As of June 30, 2004, the redemption value of the Series A Preferred Stock was $3.3 million.

 

Liquidation Preference

 

The holders of the Series A Preferred Stock are entitled to receive, upon liquidation of the Company, an amount equal to $10,000 per share of Series A Preferred Stock plus all accrued and unpaid premiums thereon. Any assets remaining for distribution following the payment of the preferences to the holders of the Series A Preferred Stock shall be distributed to the holders of the common stock. As of June 30, 2004, the liquidation preference of the Series A Preferred Stock was $2.9 million.

 

5. COMMITMENTS

 

At June 30, 2004, the Company leased one building which covers 41,000 square feet in South San Francisco, California. The lease expires in April 2010 and provides an option to extend the term for an additional ten years. In addition, at June 30, 2004, the Company subleased approximately 14,000 square feet in South San Francisco, California. This sublease expires on December 31, 2004.

 

In March 2004, the Company terminated a lease for its original laboratory and office space of approximately 25,000 square feet in South San Francisco, California. Under the terms of the lease termination agreement, the Company recorded a charge of $433,000 primarily related to the termination payment and the write-off of the net carrying value of the related leasehold improvements. This early termination enabled the Company to eliminate operating expenses related to this lease going forward and reduce its aggregate remaining obligation by approximately half.

 

In June 2002, the Company assigned a lease of excess laboratory and office space and transferred ownership through the sale of related leasehold improvements and equipment to a third party. The Company received net proceeds from the lease assignment of $3.8 million, resulting in a net gain of $0.3 million which was recognized as other income over the initial sublease term. In the event of default by the assignee, the Company would be contractually obligated for payments under the lease of: $0.6 million in 2004; $1.4 million in 2005; $1.5 million in 2006; $1.5 million in 2007; $1.5 million in 2008; and $3.9 million from 2009 to 2011.

 

At June 30, 2004, contractual obligations for the next five years and thereafter, excluding the lease assignment guarantee discussed above, are as follows:

 

     Payments Due By Period

    

Less Than

1 Year


   2-3 Years

   4-5 Years

   Thereafter

   Total

     (In thousands)

Operating leases

   $ 1,134    $ 1,964    $ 2,071    $ 1,064    $ 6,233

Capital leases

     205      28      15      —        248
    

  

  

  

  

Total

   $ 1,339    $ 1,992    $ 2,086    $ 1,064    $ 6,481
    

  

  

  

  

 

In addition, the Company is obligated to pay dividends to the Series A preferred stockholders. See “Capital Stock” note for further discussion.

 

6. PLAN OF MERGER AND REORGANIZATION WITH ACLARA BIOSCIENCES, INC.

 

On May 28, 2004, the Company entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with ACLARA BioSciences, Inc., a Delaware corporation (“ACLARA”). The completion of this merger transaction is subject to several conditions, including (i) approval by holders of a majority of the outstanding shares of common stock of ACLARA, (ii) approval of the issuance of the Company’s shares of common stock by a majority of the votes cast on such proposal

 

10


Table of Contents

at the stockholders meeting held to vote for such approval, and (iii) approval of an amendment to the Company’s Amended and Restated Certificate of Incorporation, to increase the number of shares of common stock authorized, by holders of a majority of the outstanding shares of common stock of the Company.

 

Under the terms of the Merger Agreement, each outstanding share of ACLARA common stock will be exchanged for 1.7 shares of ViroLogic common stock and 1.7 Contingent Value Rights (“CVR”). The CVR’s will be governed by a Contingent Value Rights Agreement to be executed by ViroLogic.

 

Costs associated with this merger transaction include fees for financial advisors, attorneys and accountants, filing fees and financial printing costs. The Company currently expects to incur approximately $4.6 million in costs, approximately $2.5 million of which are not contingent on the completion of the transaction. As of June 30, 2004, the Company incurred approximately $1.7 million of costs which has been recorded to other assets. Contingent upon completion of the merger, transaction costs would be included in the allocation of purchase price based on the fair value of assets acquired, including the fair value of in-process research and development and other intangibles, and the fair value of liabilities assumed as of the date that the acquisition is consummated.

 

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

 

The following discussion of the financial condition and results of operations should be read in conjunction with the financial statements and the notes thereto included in this Form 10-Q.

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding our PhenoSense and GeneSeq testing products, the growth of our pharmaceutical business, research and development expenditures, adequacy of our capital resources, and other financial matters. These statements, which sometimes include words such as “expect,” “goal,” “may,” “anticipate,” “should,” “continue,” or “will,” reflect our expectations and assumptions as of the date of this Quarterly Report based on currently available operating, financial and competitive information. Actual results could differ materially from those in the forward-looking statements as a result of a number of factors, including our ability to raise additional capital, the market acceptance of our resistance testing products, the effectiveness of our competitors’ existing products and new products, the ability to effectively manage growth and the risks associated with our dependence on patents and proprietary rights. These factors and others are more fully described in “Risk Factors Related to Our Business” and elsewhere in this Form 10-Q. We assume no obligation to update any forward-looking statements.

 

OVERVIEW

 

We are a biotechnology company developing, marketing and selling innovative products to guide and improve treatment of viral diseases. We incorporated in the state of Delaware on November 14, 1995 and commenced commercial operations in 1999. We developed a practical way of directly measuring the impact of genetic mutations on drug resistance and using this information to help guide therapy. We have proprietary technology, called PhenoSense, for testing drug resistance in viruses that cause serious viral diseases such as HIV/AIDS and hepatitis. Our products are used by physicians in selecting optimal treatments for their HIV patients and by industry, academia and government for clinical studies, drug screening and characterization, and basic research.

 

We currently have 23 experienced sales representatives promoting our resistance tests in the primary U.S. markets for drugs targeted at HIV/AIDS. We also distribute our products through national, regional and hospital laboratories. In May 2004, we signed an expanded referral testing agreement with Quest Diagnostics, the nation’s leading provider of diagnostic testing, information and services. Under the terms of the agreement, Quest Diagnostics will make ViroLogic its preferred provider of HIV phenotypic resistance testing. Quest Diagnostics has the largest national network of laboratories, with more than 30 full-service regional laboratories in major metropolitan areas and nearly 2,000 conveniently located patient service centers, where patients’ specimens are collected. This agreement will significantly expand the Company’s distribution capabilities for its suite of HIV drug resistance assays, specifically its combination test, PhenoSense GT and PhenoSense HIV. This new relationship provides increased access to the Company’s products for many more patients who are likely to benefit from this personalized approach to managing HIV disease.

 

In March 2004, the Company launched VLink, an online test reporting system for its comprehensive portfolio of HIV drug resistance assays, PhenoSense GT, PhenoSense HIV and GeneSeq HIV. The VLink system is designed to offer a fast and convenient way for healthcare professionals to access test results via a secure internet connection. The Company’s secure new online system facilitates data analysis, allowing examination of historical patient resistance data to help identify resistance patterns in patients over time as well as shorten the time period between sample submission and the reporting of results.

 

11


Table of Contents

In 2003 and 2004, the Company was awarded a total of five grants totaling more than $5 million over the next three years. These grants will help support the development of analytical and database tools to facilitate the identification and characterization of drug resistant strains of HIV, and assays that will aid in the pre-clinical and clinical evaluation of the next generation of anti-viral therapeutics.

 

With respect to reimbursement, over 75% of HIV/AIDS patients in the US are now estimated to have access to coverage for resistance testing. As of June 30, 2004, 48 state Medicaid programs, including California, Florida, New Jersey and New York, the states with the largest HIV/AIDS patient populations, had favorable coverage policies for drug resistance testing for HIV/AIDS. In addition, Medicare and nearly all private payors, including Aetna, the Blue Cross Blue Shield Association, Humana and United HealthCare, pay for resistance testing. The majority of our payors are currently reimbursing our products at varying levels from 70% to 100% of our list prices. We have an active reimbursement strategy, and educate both private and public payors concerning drug resistance testing in an effort to maximize reimbursement.

 

The diagnostic testing industry is subject to seasonal fluctuations in operating results and cash flows. Typically, testing volume declines during the summer months, year-end holiday periods and other major holidays, reducing net revenues and operating cash flows below annual averages. Testing volume is also subject to declines in winter months due to inclement weather, which varies in severity from year to year. The Company anticipates quarterly differences in the revenue growth rate relating to the timing of various clinical studies and seasonal effects observed in patient testing, which in keeping with the historical trend we expect to be most noticeable in the first quarter.

 

PLAN OF MERGER AND REORGANIZATION WITH ACLARA BIOSCIENCES, INC.

 

On May 28, 2004, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with ACLARA BioSciences, Inc., a Delaware corporation (“ACLARA”). The completion of this merger transaction is subject to several conditions, including (i) approval by holders of a majority of the outstanding shares of common stock of ACLARA, (ii) approval of the issuance of common stock by a majority of the votes cast on such proposal at the stockholders meeting held to vote for such approval, and (iii) approval of an amendment to our Amended and Restated Certificate of Incorporation, to increase the number of shares of common stock authorized, by holders of a majority of the outstanding shares of our common stock.

 

Under the terms of the Merger Agreement, each outstanding share of ACLARA common stock will be exchanged for 1.7 shares of our common stock and 1.7 Contingent Value Rights (“CVR”). The CVR’s will be governed by a Contingent Value Rights Agreement to be executed by us.

 

Costs associated with this merger transaction include fees for financial advisors, attorneys and accountants, filing fees and financial printing costs. We currently expect to incur approximately $4.6 million in costs, approximately $2.5 million of which are not contingent on the completion of the transaction. As of June 30, 2004, we incurred approximately $1.7 million of costs which has been recorded to other assets. Contingent upon completion of the merger, transaction costs would be included in the allocation of purchase price based on the fair value of assets acquired, the fair value of in-process research and development and other intangibles, and the fair value of liabilities assumed as of the date that the acquisition is consummated.

 

SUMMARY OF CRITICAL ACCOUNTING POLICIES

 

The preparation of our financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. Actual results could differ materially from those estimates. See Note 1 to the financial statements for further discussion. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financial statements:

 

Revenue Recognition

 

Product revenue is recognized upon completion of tests made on samples provided by customers and the shipment of test results to those customers. Services are provided to certain patients covered by various third-party payor programs, such as Medicare and Medicaid. Billings for services under third-party payor programs are included in revenue net of allowances for differences between the

 

12


Table of Contents

amounts billed and estimated receipts under such programs. We estimate these allowances based on historical payment information and current sales data. If the government and other third-party payors significantly change their reimbursement policies, an adjustment to the allowance may be necessary. Revenue generated from our database of resistance test results is recognized when earned under the terms of the related agreements, generally upon shipment of the requested reports. Contract revenue consists of revenue generated from National Institutes of Health (“NIH”) grants and commercial assay development, and other non-product revenue. NIH grant revenue is recorded on a reimbursement basis as grant costs are incurred. The costs associated with contract revenue are included in research and development expenses. Deferred revenue relates to cash received in advance of meeting the revenue recognition criteria described above.

 

Accounts Receivable

 

The process for estimating the collectibility of receivables involves significant assumptions and judgments. Billings for services under third-party payor programs are recorded as revenue net of allowances for differences between amounts billed and the estimated receipts under such programs. Adjustments to the estimated receipts, based on final settlement with the third-party payors, are recorded upon settlement as an adjustment to net revenue.

 

In addition, we review and estimate the collectibility of our receivables based on the period of time they have been outstanding. Historical collection and payor reimbursement experience is an integral part of the estimation process related to reserves for doubtful accounts. In addition, we assess the current state of our billing functions in order to identify any known collection or reimbursement issues in order to assess the impact, if any, on our reserve estimates, which involves judgment. We believe that the collectibility of our receivables is directly linked to the quality of our billing processes, most notably those related to obtaining the correct information in order to bill effectively for the services we provide. As such, we have implemented procedures to reduce the number of requisitions that we receive from healthcare providers with missing or incorrect billing information. Revisions in reserve for doubtful accounts estimates are recorded as an adjustment to bad debt expense within general and administrative expenses. We believe that our collection and reserves processes, along with our close monitoring of our billing processes, helps to reduce the risk associated with material revisions to reserve estimates resulting from adverse changes in collection and reimbursement experience and billing operations.

 

Deferred Tax Assets

 

We record a valuation allowance to reduce our deferred tax assets to the amount that we believe is more likely than not to be realized. Due to our lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance.

 

Deemed Dividends

 

We estimated a beneficial conversion feature for our convertible preferred stock in accordance with Emerging Issues Task Force Consensus No. 98-5, “Accounting for Convertible Securities with Beneficial Conversion Features” and No. 00-27, “Application of Issue No. 98-5 to Certain Convertible Instruments” based on the difference between the estimated conversion price and common stock fair market value at the date of issuance. We use the Black-Scholes option valuation model to estimate the conversion price at the date of issuance. This model considers a number of factors requiring judgment including the weighted-average expected life of stock options from grant date and the volatility factor of the expected market price of the Company’s common stock. We recorded the beneficial conversion feature as a deemed dividend on the Statement of Operations, resulting in an increase to the net loss applicable to common stockholders in the calculation of basic and diluted net loss per common share.

 

Stock-Based Compensation

 

We have elected to continue to follow Accounting Principles Board Opinion No. 25 “Accounting for Stock-Based Compensation” (“APB 25”) to account for employee stock options. Under APB 25, no compensation expense is recognized because the exercise price of our employee stock options equals the market price of the underlying stock on the date of grant. Deferred compensation, if recorded, is amortized using the graded vesting method. Statement of Financial Accounting Standards Board Statement No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”) as amended by Statement of Financial Accounting Standards Board Statement No. 148, “Accounting for Stock-Based Compensation — Transition and Disclosure — an amendment of FASB Statement No. 123” (“SFAS 148”) requires the disclosure of pro forma information regarding net loss and net loss per share as if we had accounted for stock options under the fair value method. See “Summary of Significant Accounting Policies” note to the financial statements for further discussion.

 

13


Table of Contents

We account for stock option grants to non-employees in accordance with the Emerging Issues Task Force Consensus No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” which requires the options subject to vesting to be periodically re-valued and expensed over their vesting periods. We estimate the fair value of these stock options and stock purchase rights at the date of grant using the Black-Scholes option valuation model, which considers a number of factors requiring judgment.

 

RESULTS OF OPERATIONS

 

Three and Six Months Ended June 30, 2004 and 2003

 

     Three Months Ended
June 30,


   Six Months Ended
June 30,


     2004

   2003

   2004

   2003

     (In thousands)

Patient testing

   $ 6,451    $ 6,101    $ 12,225    $ 11,395

Pharmaceutical company testing

     2,283      1,685      5,149      2,942
    

  

  

  

Product revenue

     8,734      7,786      17,374      14,337

Contract revenue

     493      167      875      584
    

  

  

  

Total revenue

   $ 9,227    $ 7,953    $ 18,249    $ 14,921
    

  

  

  

 

Revenue. Revenue was $9.2 million and $18.2 million for the three and six months ended June 30, 2004, compared to $8.0 million and $14.9 million for the corresponding periods in 2003. The increase was primarily attributable to growth in the HIV resistance testing market and demand for our PhenoSense HIV, PhenoSense GT and GeneSeq HIV products for patient and pharmaceutical testing. Contract revenue consists of revenue from NIH research grants and commercial assay development, and other non-product revenue. In 2003, we were awarded four Small Business Innovation Research (“SBIR”) grants from the National Institute of Allergy and Infectious Diseases (“NIAID”), a division of the U.S. National Institutes of Health. In 2004, we were awarded one new SBIR grant from the NIAID, for a total of five grants totaling more than $5 million over the next three years. These grants will help support the development of analytical and database tools to facilitate the identification and characterization of drug resistant strains of HIV, and assays that will aid in the pre-clinical and clinical evaluation of the next generation of anti-viral therapeutics. We believe increased demand for existing and new products will be the primary factors contributing to an increased level of sales in 2004 as compared to 2003. We anticipate quarterly differences in the revenue growth rate due to timing of various clinical studies for pharmaceutical customers and the seasonal effects observed in patient testing, which have historically occurred in the first quarter.

 

Cost of product revenue. Cost of product revenue was $4.5 million and $8.9 million for the three and six months ended June 30, 2004, compared to $4.3 million and $8.1 million for the corresponding periods in 2003. The increase was primarily due to the higher volume of testing. Included in these costs are materials, supplies, labor and overhead related to product revenue. Gross margin on product revenue increased to 49% for the three and six months ended June 30, 2004 compared to 45% and 44% for the corresponding periods in 2003. The increase is primarily due to improved efficiencies in laboratory operations and economies of scale as well as increased contribution from pharmaceutical revenue, which contributed slightly, during the period. We anticipate that gross margin on our product revenue will continue to improve as revenue increases and further operational efficiencies and economies of scale are achieved.

 

Research and development. Research and development expense was $1.6 million and $3.0 million for the three and six months ended June 30, 2004, compared to $1.1 million and $2.4 million for the corresponding periods in 2003. Total research and development expenses included costs associated with contract revenue as follows:

 

     Three Months Ended
June 30,


   Six Months Ended
June 30,


     2004

   2003

   2004

   2003

     (In thousands)

NIH Grants:

                           

HIV assays

   $ 373      —      $ 647      —  

HIV Database

     47      —        86      —  

HCV assay

     73      —        142      —  

Commercial assay development and other projects

     —      $ 145      —      $ 335
    

  

  

  

Total

   $ 493    $ 145    $ 875    $ 335
    

  

  

  

 

14


Table of Contents

Because our resistance tests target viral diseases and our product lines overlap, most of our core research and development activities are advancing multiple potential product lines. Due to this substantial overlap, we do not track costs on a project by project basis, except for the costs reimbursed by the NIH as discussed above. We expect research and development spending in the future to trend with the level of NIH grants and/or other research and development cost reimbursement arrangements under contract.

 

Below is a summary of products and products in development. The information in the column labeled “Estimated Completion” contains forward-looking statements regarding completion of products in development and is dependent on securing NIH grants and/or other research and development funding as well as demand for the products. The actual timing of completion of those products could differ materially from the estimates provided in the table.

 

The following summarizes our products and products in development:

 

    

Estimated

Completion


PhenoSense HIV, a phenotypic HIV Resistance test

    

    Pharmaceutical and patient testing

   Completed

GeneSeq HIV, a genotypic HIV Resistance test

    

    Pharmaceutical and patient testing

   Completed

PhenoSense GT, a combination phenotype/genotype HIV Resistance test

    

    Pharmaceutical and patient testing

   Completed

Replication Capacity HIV, a measurement of viral fitness(1)

    

    Pharmaceutical and patient testing

   Completed

PhenoScreen, a high-throughput screening assay

    

    Pharmaceutical testing

   Completed

PhenoSense HIV Antibody Neutralization for Vaccine Development

    

    Pharmaceutical testing

   Completed

PhenoSense HIV Entry, for the assessment of entry inhibitor resistance (2)

    

    Pharmaceutical testing

   Completed

    Patient testing(6)

   2004

GeneSeq HIV Entry, for the assessment of entry inhibitor resistance (2)

    

    Pharmaceutical testing

   Completed

PhenoSense HIV Co-Receptor Tropism, an entry assay

    

    Pharmaceutical testing

   Completed

    Patient testing(4)

   2004

PhenoSense and GeneSeq HIV Integrase assays

    

    Pharmaceutical testing

   2004

    Patient testing(3)

   2006

GeneSeq HCV, a genotypic hepatitis C test

    

    Pharmaceutical testing

   Completed

    Patient testing(3)

   2005

PhenoSense HCV, a phenotypic hepatitis C test

    

    Pharmaceutical testing

   2005

    Patient testing(3)

   2006

GeneSeq HBV, a genotypic hepatitis B test

    

    Pharmaceutical testing

   Completed

    Patient testing

   (5)

PhenoSense HBV, a phenotypic hepatitis B test

    

    Pharmaceutical testing

   (5)

    Patient testing

   (5)

(1) Currently offered free of charge on phenotypic reports, in the future may be offered as a stand-alone product.
(2) This test may be incorporated into one of our existing products or possibly offered as a stand-alone product.
(3) This test is expected to be offered after more pharmaceutical drugs are available for patient use and based on demand for the product.
(4) This test was validated in May 2004 for use in clinical trials, and is expected to be subsequently offered to patients based on demand for the product.
(5) The timing of estimated completion is under evaluation and is dependent on securing NIH grants and/or other research and development funding as well as demand for the product.
(6) The phenotypic test for the FDA approved fusion inhibitor drug, Fuzeon, is expected to be validated in 2004 and available for patient use dependent on demand for the product.

 

15


Table of Contents

Sales and marketing. Sales and marketing expense was $2.8 million and $4.7 million for the three and six months ended June 30, 2004, compared to $2.5 million and $4.3 million for the corresponding periods in 2003. This increase was primarily attributable to the expansion of our sales force and increased marketing programs related to our existing products. We expect sales and marketing expenses in 2004 to increase from 2003 levels primarily due to increase in sales and marketing activities.

 

General and administrative. General and administrative expense was $1.8 million and $3.8 million for the three and six months ended June 30, 2004, compared to $2.4 million and $4.8 million for the corresponding periods in 2003. The decrease was primarily due to a decrease in fees for professional services and lower non-cash compensation expenses related to the granting of stock and stock options prior to our initial public offering. In addition, the decrease for the three months ended June 30, 2004 is due to lower facility costs resulting from our lease termination in March 2004 as described below. We expect general and administrative expenses in 2004 to decrease slightly from 2003 levels primarily due to lower facility costs and continued leveraging of existing infrastructure, partially offset by an increase in professional, accounting and other fees in order to comply with significant new government imposed procedures, reporting and audit requirements.

 

Lease termination charge. In March 2004, we terminated a lease for our original laboratory and office space of approximately 25,000 square feet in South San Francisco, California. Under the terms of the lease termination agreement, we recorded a charge of $433,000 primarily related to the termination payment and the write-off of the net carrying value of the related leasehold improvement. This early termination enabled us to eliminate operating expenses related to this lease going forward and reduce our aggregate remaining obligation by approximately half.

 

Interest income. Interest income was $19,000 and $40,000 for the three and six months ended June 30, 2004, compared to $26,000 and $63,000 for the corresponding periods in 2003. This decrease was primarily due to lower interest rates.

 

Interest expense. Interest expense was $8,000 and $19,000 for the three and six months ended June 30, 2004, compared to $36,000 and $88,000 for the corresponding periods in 2003. This decrease was primarily due to the payoff of several equipment loans which ended.

 

Other income. Other income of $52,000 and $104,000 for the three and six months ended June 30, 2003 represents residual income from our lease assignment in 2002.

 

Deemed dividend. On February 4, 2003, our stockholders approved the conversion of certain convertible secured promissory notes (“Notes”) issued to prior Series B preferred stockholders into Series C Preferred Stock and the issuance of warrants to purchase shares of our common stock in exchange for warrants originally issued in connection with Series B Preferred Stock. The warrant exchange resulted in a charge of $2.2 million which was recorded at the time of the exchange in the first quarter of 2003.

 

The beneficial conversion feature was calculated in accordance with Emerging Issues Task Force Consensus No. 98-5, “Accounting for Convertible Securities with Beneficial Conversion Features” and Emerging Issues Task Force Consensus No. 00-27 “Application of Issue No. 98-5 to Certain Convertible Instruments.” The beneficial conversion feature was reflected as deemed dividends in the Statement of Operations of $2.2 million in the first quarter of 2003, and was included in stockholders’ equity as offsetting charges and credits to additional paid-in capital.

 

Preferred stock dividend. We recorded a preferred stock dividend of $0.1 million for the three and six months ended June 30, 2004, compared to $0.5 million and $1.0 million for the corresponding periods in 2003. The Series A Preferred Stock issued in 2001 bears an initial 6% annual dividend rate, payable twice a year in shares of common stock, which increases to an 8% annual rate on the fourth such payment, and then increases by 2 percentage points every six months thereafter up to a maximum annual rate of 14%. The Series C Preferred Stock bore an initial 8% annual dividend rate, payable quarterly. In December 2003, we elected to convert all Series C Convertible Preferred Stock then outstanding into common stock.

 

LIQUIDITY AND CAPITAL RESOURCES

 

We expect our available cash and cash equivalents, short-term investments and short-term restricted cash of $10.1 million at June 30, 2004, funds provided by the sale of our products, contract revenue, and borrowing under equipment financing arrangements will enable us to maintain our current research and development, marketing, production and general administrative activities related to HIV drug resistance testing in the United States through at least December 31, 2005, assuming revenue reaches projected levels and cost containment measures continue to be effective. In addition, we plan to continue to evaluate various strategic opportunities, including among others, research and development collaborations, international alliances and marketing partnerships.

 

16


Table of Contents

We have funded our operations since inception primarily through public and private sales of common and preferred stock, equipment financing arrangements, product revenue and contract revenue. Assuming our product revenue, contract revenue, and cost containment measures continue in a positive trend, we do not foresee additional significant long term capital funding requirements. Although we expect our operating and capital resources will be sufficient to meet future requirements, we may have to raise additional funds to continue the development and commercialization of future technologies and our business operations in general. These funds may not be available on favorable terms, or at all. If adequate funds are not available on commercially reasonable terms, we may be required to curtail operations significantly or sell significant assets and may not be able to continue as a going concern. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe that we have sufficient funds for current or future operating plans.

 

Net cash provided by operating activities was $1.0 million for the six months ended June 30, 2004. Net cash used in operating activities was $2.0 million for the six months ended June 30, 2003. Cash flows from operating activities can vary significantly due to various factors including changes in accounts receivable, accrued liabilities and deferred revenue related to new arrangements with customers. The average collection period of our accounts receivable as measured in days sales outstanding (DSO) can vary and is dependent on various factors, including the type of revenue (i.e. patient testing, pharmaceutical company testing or contract revenue), the payment terms related to those revenues, and whether the related revenue was recorded at the beginning or ending of a period.

 

Net cash used in investing activities of $0.7 million for the six months ended June 30, 2004 resulted primarily from incurring transaction costs associated with our merger with ACLARA of $0.4 million, capital expenditures of $0.4 million and costs associated with acquiring other assets, partially offset by $0.3 million in proceeds from maturities and sales of short-term investments. Net cash used in investing activities of $0.6 million for the six months ended June 30, 2003 resulted from capital expenditures and costs associated with acquiring other assets.

 

Net cash used in financing activities of $2,000 and $203,000 for the six months ended June 30, 2004 and 2003, respectively, resulted primarily from payments on loans and capital lease obligations, partially offset by proceeds from common stock issuance of $0.4 million and $1.1 million for the six months ended June 30, 2004 and 2003, respectively.

 

At June 30, 2004, we leased one building which covers 41,000 square feet in South San Francisco, California. The lease expires in April 2010 and provides us with an option to extend the term for an additional ten years. In addition, at June 30, 2004, we subleased approximately 14,000 square feet in South San Francisco, California. This sublease expires on December 31, 2004.

 

In March 2004, we terminated a lease for our original laboratory and office space of approximately 25,000 square feet in South San Francisco, California. Under the terms of the lease termination agreement, we recorded a charge of $433,000 primarily related to the termination payment and the write-off of the net carrying value of the related leasehold improvements. This early termination enabled us to eliminate operating expenses related to this lease going forward and reduce our aggregate remaining obligation by approximately half.

 

In June 2002, we assigned a lease of excess laboratory and office space and transferred ownership through the sale of related leasehold improvements and equipment to a third party. We received net proceeds from the lease assignment of $3.8 million, resulting in a net gain of $0.3 million which is included in accrued liabilities and other long-term liabilities and is recognized as other income over the sublease term. In the event of default by the assignee, we would be contractually obligated for payments under the lease of: $0.6 million in 2004; $1.4 million in 2005; $1.5 million in 2006; $1.5 million in 2007; $1.5 million in 2008; and $3.9 million from 2009 to 2011.

 

At June 30, 2004, our contractual obligations for the next five years and thereafter, excluding the lease assignment guarantee discussed above, are as follows:

 

     Payments Due By Period

    
    

Less Than

1 Year


   2-3 Years

   4-5 Years

   Thereafter

   Total

     (In thousands)

Operating leases

   $ 1,134    $ 1,964    $ 2,071    $ 1,064    $ 6,233

Capital leases

     205      28      15      —        248
    

  

  

  

  

Total

   $ 1,339    $ 1,992    $ 2,086    $ 1,064    $ 6,481
    

  

  

  

  

 

17


Table of Contents

In addition, we are obligated to pay dividends to the Series A preferred stockholders. See “Capital Stock” note to the financial statements for further discussion.

 

The contractual obligations discussed above are fixed costs. If we are unable to generate sufficient cash from operations to meet these contractual obligations, we may have to raise additional funds. These funds may not be available on favorable terms or at all.

 

RISK FACTORS

 

You should carefully consider the following factors and other information in this Form 10-Q when considering our company and its stock.

 

We may incur future losses and may not achieve profitability as soon as expected, which may cause our stock price to fall.

 

We have experienced significant losses each year since our inception. We may incur additional losses, and expect that we would incur additional losses following the completion of the pending transaction with ACLARA. We experienced net losses applicable to common stockholders of approximately $2.8 million in the six month period ended June 30, 2004, $9.3 million for the year ended December 31, 2003 and $33.3 million for the year ended December 31, 2002. As of June 30, 2004, we had an accumulated deficit of approximately $108.9 million. We may continue to incur losses primarily as a result of spending related to:

 

  Expanding patient and pharmaceutical company sample processing capabilities

 

  Research and product development costs

 

  Sales and marketing activities

 

  Additional clinical laboratory and research space and other necessary facilities

 

  General and administrative costs

 

If our history of losses continues, our stock price may fall and you may lose part or all of your investment.

 

Our stockholders will experience substantial additional dilution if our shares of preferred stock or their related warrants are converted into or exercised for shares of common stock. As of June 30, 2004, our outstanding shares of preferred stock and related warrants were convertible into or exercisable for up to an aggregate of 14,811,578 shares of common stock, or approximately 28% of the number of shares of outstanding common stock.

 

As of June 30, 2004, we had 53,636,768 shares of common stock outstanding. However, as of June 30, 2004, we also had outstanding the following shares of preferred stock and related warrants:

 

  274 shares of Series A Redeemable Convertible Preferred Stock (“Series A Preferred Stock”), convertible into 2,468,468 shares of common stock (not including the conversion of accrued but unpaid premiums)

 

  warrants issued to the purchasers of our preferred stock in connection with our preferred stock financings to purchase 12,343,110 shares of common stock

 

We will not receive payment or other consideration for the issuance of shares of common stock upon conversion of the Series A Preferred Stock. Most of the warrants listed above have net exercise provisions, which, if elected as the method of exercise by the holder of the warrant, cause us to not receive cash consideration for the issuance of shares of common stock upon exercise. Together, the common shares reserved for issuance upon conversion of the Series A Preferred Stock and upon exercise of the warrants referenced above, represent approximately 14,811,578 shares of common stock, or 28% of the outstanding shares of our common stock at June 30, 2004, all of which are issuable for an approximate weighted-average effective price of $1.15 per share.

 

18


Table of Contents

The number of shares of common stock that we may be required to issue upon conversion of the Series A Preferred Stock, and exercise of the warrants granted to purchasers of our Series A Preferred Stock in connection with the issuance thereof, can increase substantially upon the occurrence of several events, including if:

 

  We issue shares of stock (with certain exceptions) for an effective price less than the conversion price of the Series A Preferred Stock or the related warrants (each $1.11 as of June 30, 2004)

 

  We fail to have sufficient shares of common stock reserved to satisfy conversions, exercises and other issuances

 

  We fail to honor requests for conversion, or notify any holder of Series A Preferred Stock of our intention not to honor requests for conversion

 

  We fail to issue shares upon exercise of the warrants

 

  We fail to redeem any shares of Series A Preferred Stock when required

 

We are also obligated to issue additional shares of common stock every six months to the holders of the Series A Preferred Stock as “premium payments.” As of June 30, 2004, these issuances equaled about 245 shares of common stock for every share of Series A Preferred Stock outstanding at the time the issuance is made. This number of shares will increase every six months, by about 40 shares of common stock for each share of Series A Preferred Stock, up to a maximum of about 285 shares of common stock for every share of Series A Preferred Stock. All of the previous share totals are based upon an assumed stock price of $2.45, which was the closing price of our stock on the Nasdaq National Market on June 30, 2004, but the actual number of shares will be based upon our stock price from time to time as of the payment dates. If the 274 shares of the Series A Preferred Stock outstanding as of June 30, 2004 remain outstanding for five years following such date, we will be required to issue as premium payments an additional 771,673 shares of common stock (again based on an assumed stock price of $2.45) to holders of the Series A Preferred Stock, which is 1.4% of the shares of common stock outstanding as of June 30, 2004. We do not receive payment or other consideration for these issuances.

 

All of the foregoing issuances of common stock would be substantially dilutive to the outstanding shares of common stock, especially where, as described above, the shares of common stock are issued without additional consideration. We cannot predict whether or how many additional shares of our common stock will become issuable due to these provisions.

 

Any dilution or potential dilution may cause our stockholders to sell their shares, which would contribute to a downward movement in the stock price of our common stock. Any downward pressure on the trading price of our common stock could encourage investors to engage in short sales, which could further contribute to a downward trend in the price of our common stock.

 

The issuance of shares of our common stock to ACLARA stockholders in the pending merger transaction will substantially reduce the percentage interests of our current stockholders.

 

If the transaction is completed, approximately 62 million shares of our common stock will be issued to ACLARA stockholders, and former ACLARA stockholders will own, in the aggregate, approximately 48% of the combined company, assuming the conversion of our outstanding preferred stock, and the exercise of all our outstanding warrants and our and ACLARA’s stock options. The issuance of approximately 62 million shares of our common stock to ACLARA stockholders will cause a significant reduction in the relative percentage interests of our current stockholders in earnings, voting, liquidation value and book and market value. The issuance of additional shares of our common stock in future transactions would also reduce the percentage interests of stockholders in the combined company.

 

We may not realize the benefits we expect from the pending merger with ACLARA.

 

The integration of ViroLogic and ACLARA will be complex, time consuming and expensive, and may disrupt our business. After the merger, ViroLogic will need to overcome significant challenges in order to realize any benefits or synergies from the proposed merger. These challenges include the timely, efficient and successful execution of a number of post-transaction integration activities, including:

 

  integrating the operations and technologies of the two companies;

 

  successfully completing the development of ACLARA’s eTag technology and developing commercial products based on that technology;

 

  retaining and assimilating the key personnel of each company;

 

19


Table of Contents
  retaining existing customers of both companies and attracting additional customers;

 

  utilizing ViroLogic’s existing sales channels to sell new products into new markets;

 

  retaining strategic partners of each company and attracting new strategic partners; and

 

  implementing and maintaining uniform standards, controls, processes, procedures, policies and information systems.

 

The process of integrating operations and technology could cause an interruption of, or loss of momentum in, the activities of one or more of the combined company’s businesses and the loss of key personnel. The diversion of management’s attention and any delays or difficulties encountered in connection with the merger and the integration of the two companies’ operations and technology could have an adverse effect on the business, results of operations or financial condition of the combined company. Furthermore, the execution of these post-transaction integration activities will involve considerable risks and may not be successful. These risks include:

 

  the potential strain on the combined company’s financial and managerial controls and reporting systems and procedures;

 

  unanticipated expenses and potential delays related to integration of the operations, technology and other resources of the two companies;

 

  the impairment of relationships with employees, suppliers and customers as a result of any integration of new management personnel;

 

  greater than anticipated costs and expenses related to restructuring, including employee severance and costs related to vacating leased facilities; and

 

  potential unknown liabilities associated with the transaction and the combined operations.

 

We may not succeed in addressing these risks or any other problems encountered in connection with the transaction. The inability to successfully integrate the operations, technology and personnel of ViroLogic and ACLARA, or any significant delay in achieving integration, could have a material adverse effect on the combined company after the transaction and, as a result, on the market price of ViroLogic common stock.

 

We may be obligated to redeem our Series A Preferred Stock.

 

Holders of our Series A Preferred Stock have the right, under certain circumstances, to require us to redeem for cash all of the preferred stock that they own. The redemption price for the Series A Preferred Stock is the greater of (i) 115% of the original purchase price plus 115% of any accrued premium payment thereon and (ii) the aggregate fair market value of the shares of common stock into which such shares of Series A Preferred Stock are then convertible. As of June 30, 2004, there were 274 shares of Series A Preferred Stock outstanding, with an aggregate redemption price equal to approximately $3.3 million.

 

Shares of Series A Preferred Stock are redeemable by the holders of the respective series in any of the following situations:

 

  If we fail to remove a restrictive legend on any certificate representing any common stock that was issued to any holder of such series upon conversion of their preferred stock or exercise of their warrants and that may be sold pursuant to an effective registration statement or an exemption from the registration requirements of the federal securities laws

 

  If we fail to have sufficient shares of common stock reserved to satisfy conversions of the series

 

  If we fail to honor requests for conversion, or if we notify any holder of such series of our intention not to honor future requests for conversion

 

  If we institute voluntary bankruptcy or similar proceedings

 

  If we make an assignment for the benefit of creditors, or apply for or consent to the appointment of a receiver or trustee for us or for a substantial part of our property or business, or such a receiver or trustee shall otherwise be appointed

 

20


Table of Contents
  If we sell all or substantially all of our assets

 

  If we merge, consolidate or engage in any other business combination (with some exceptions), provided that such transaction is required to be reported pursuant to Item 1 of Form 8-K

 

  If we commit a material breach under, or otherwise materially violate the terms of, the transaction documents entered into in connection with the issuance of such series

 

  If the registration statements covering shares of common stock underlying the Series A Preferred Stock and related warrants cannot be used by the respective selling security holders for the resale of all the underlying shares of common stock for an aggregate of more than 30 days

 

  If our common stock is not tradable on the NYSE, the AMEX, the Nasdaq National Market or the Nasdaq SmallCap market for an aggregate of twenty trading days in any nine month period

 

  If 35% or more of our voting power is held by any one person, entity or group

 

  If we fail to pay any indebtedness in excess of $350,000 when due, or if there is any event of default under any agreement that is likely to have a material adverse effect on us

 

  Upon the institution of involuntary bankruptcy proceedings

 

Upon the occurrence of any of the events described above, individual holders of the Series A Preferred Stock would have the option, while such event continues, to require us to purchase some or all of the then outstanding shares of Series A Preferred Stock held by such holder. If we receive any notice of redemption, we are required to immediately (no later than one business day following such receipt) deliver a written notice to all holders of the same series of preferred stock stating the date when we received the redemption notice and the amount of preferred stock covered by the notice. Redemption of the Series A Preferred Stock in any event described above would require us to expend a significant amount of cash that could exceed our total available cash and cash equivalents and could negatively impact our ability to operate our business or raise additional capital. See the notes to the financial statements for further details.

 

In the event that we need to raise additional capital, our stockholders could experience substantial additional dilution. If such financing is not available on commercially reasonable terms, we may have to significantly curtail our operations or sell significant assets and may be unable to continue as a going concern.

 

As of June 30, 2004, we had available cash and cash equivalents, short-term investments and short-term restricted cash of $10.1 million. We anticipate that our existing capital resources together with funds from the sale of our products, contract revenue and borrowing under equipment financing arrangements will enable us to maintain our current research and development, marketing, production and general administrative activities related to HIV drug resistance testing in the United States through at least December 31, 2005. However, we may need additional funding sooner than that. To the extent operating and capital resources are insufficient to meet our obligations, including lease payments and future requirements, we will have to raise additional funds to continue the development, commercialization and expansion of our technologies. Our inability to raise capital would seriously harm our business and product development efforts. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. However, we cannot guarantee that additional financing, in any form, will be available at all, or on terms acceptable to us. If we sell equity or convertible debt securities to raise additional funds, our existing stockholders may incur substantial dilution and any shares so issued will likely have rights, preferences and privileges superior to the rights, preferences and privileges of our outstanding common and preferred stock. In the event financing is not available in the time frame required, we will be forced to reduce our operating expenses, curtail sales and marketing activities, reschedule research and development projects or delay, scale back or eliminate some or all of our activities. Further, we might be required to sell certain of our assets or obtain funds through arrangements with third parties that require us to relinquish rights to certain of our technologies or products that we would seek to develop or commercialize ourselves. These actions, while necessary for the continuance of operations during a time of cash constraints and a shortage of working capital, could make it difficult or impossible to implement our long-term business plans or could affect our ability to continue as a going concern.

 

21


Table of Contents

Our testing products may not achieve market acceptance, which could limit our future revenue.

 

Our ability to establish phenotypic resistance testing as the standard of care to guide and improve the treatment of viral diseases will depend on physicians’ and clinicians’ acceptance and use of phenotypic resistance testing. Phenotypic resistance testing is still relatively new. We cannot predict the extent to which physicians and clinicians will accept and use phenotypic resistance testing. They may prefer competing technologies and products. The commercial success of phenotypic resistance testing will require demonstrations of its advantages and potential economic value in relation to the current standard of care, as well as to competing products. We have introduced two products using our proprietary PhenoSense technology, PhenoSense HIV and PhenoSense GT, which we began actively marketing in November 1999 and November 2001, respectively. We are still in the early stages of development of new products applying our PhenoSense technology to other viral diseases. If PhenoSense HIV or PhenoSense GT is not accepted in the marketplace, our ability to sell other PhenoSense products would be undermined. Market acceptance will depend on:

 

  Our marketing efforts and continued ability to demonstrate the utility of PhenoSense in guiding anti-viral drug therapy, for example, through the results of retrospective and prospective clinical studies.

 

  Our ability to demonstrate the advantages and potential economic value of our PhenoSense testing products over current treatment methods and other resistance tests.

 

  General and industry-specific economic conditions, which may affect our pharmaceutical customers’ research and development and clinical trial expenditures and the use of our PhenoSense products. For example, in July 2004, we announced that a pharmaceutical customer had postponed the start of a significant, late-stage clinical trial, which impacted our expectations regarding the fiscal period in which the associated testing revenue would be recognized, and that we had experienced slower than expected growth in patient testing in the first half of 2004.

 

  Changes in the cost, quality and availability of equipment, reagents and components required to manufacture or use our PhenoSense products System and other future testing product candidates.

 

  The development by the pharmaceutical industry of targeted medicines for specific patient populations, the success of these targeted medicines in clinical trials and the adoption of our technological approach in these development activities.

 

If the market does not accept phenotypic resistance testing, or our PhenoSense products in particular, our ability to generate revenue will be limited.

 

Our revenues will be diminished if changes are made to the way that our products are reimbursed, or if government or third-party payors limit the amounts that they will reimburse for our current products, or do not authorize reimbursement for our planned products.

 

Government and third-party payors, including Medicare and Medicaid require that we identify the services we perform using industry standard codes known as the Current Procedural Terminology (“CPT”) codes, which are developed by the American Medical Association (“AMA”). Most payors maintain a list of standard reimbursement rates for each such code, and our ability to be reimbursed for our services is therefore effectively limited by our ability to describe the services accurately using the CPT codes. From time to time, the AMA changes its instructions about how our services should be coded using the CPT codes. If these changes leave us unable to accurately describe our services or are not coordinated with payors such that corresponding changes are made to the payors’ reimbursement schedules, we may have to renegotiate our pricing and reimbursement rates, the changes may interrupt our ability to be reimbursed, and/or the overall reimbursement rates for our services may decrease dramatically. In addition, we may spend significant time and resources to minimize the impact of these changes on reimbursement.

 

Government and third-party payors are attempting to contain or reduce the costs of healthcare and are challenging the prices charged for medical products and services. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of healthcare products. This could in the future limit the price that we can charge for our products. This could also hurt our ability to generate revenues. Significant uncertainty exists as to the reimbursement status of new medical products like the products we are currently developing, particularly if these products fail to show demonstrable value in clinical studies. Currently, nearly all public and a majority of private payors have approved the reimbursement of our existing products. However, the majority of our payors are currently reimbursing our products at varying levels from 70% to 100% of our list prices. If government and other third-party payors do not continue to provide adequate coverage and reimbursement for our testing products or do not authorize reimbursement for our planned products, our revenues will be reduced.

 

22


Table of Contents

Billing complexities associated with health care payors may result in increased bad debt expense, which could impair our cash flow and limit our ability to reach profitability.

 

Billing for laboratory services is complex. Laboratories must bill various payors, such as Medicare, Medicaid, insurance companies, doctors, employer groups and patients, all of whom have different requirements. Billing difficulties often result in a delay in collecting, or ultimately an inability to collect, the related receivable. This impairs cash flow and ultimately reduces profitability if we are required to record bad debt expense for these receivables. ViroLogic recorded bad debt expense of $0.1 million for the six month period ended June 30, 2004 and $0.1 million, $0.6 million and $0.6 million for the years ended 2003, 2002 and 2001, respectively. Most of the bad debt expense is the result of noncredit related issues, primarily missing or incorrect billing information on requisitions. We perform the requested tests and report test results regardless of incorrect or missing billing information. We subsequently attempt to obtain any missing information and rectify incorrect billing information received from the healthcare provider. Missing or incorrect information on requisitions slows the billing process, creates backlogs of unbilled requisitions and generally increases the aging of accounts receivable. Among many other factors complicating billing are:

 

  Pricing differences between our fee schedules and those of the payors

 

  Changes in or questions about how products are to be identified in the requisitions

 

  Disputes between payors as to which party is responsible for payment

 

  Disparity in coverage among various payors

 

  Difficulties of adherence to specific compliance requirements and procedures mandated by various payors

 

Ultimately, if all issues are not resolved in a timely manner, the related receivables are charged to the allowance for doubtful accounts.

 

We may encounter problems or delays in processing tests, or in expanding our automated testing systems, which could impair our ability to grow our business, generate revenue and achieve and sustain profitability.

 

In order to meet future projected demand for our products and fully utilize our current clinical laboratory facilities, we estimate that we will have to continue to expand the volume of patient samples that we are able to process. We are also continuing to develop our quality-control procedures and to establish more consistency with respect to test turnaround so that results are delivered in a timely manner. Thus, we need to continue to develop and implement additional automated systems to perform our tests. We have installed several information systems over the past few years, including enterprise resource and laboratory information systems, to support the automated tests, analyze the data generated by our tests and report the results. If these systems do not work effectively as we scale up our processing of patient samples, we may experience processing or quality-control problems and we may experience delays or failures in our operations. These problems, delays or failures could adversely impact the promptness and accuracy of our transaction processing, which could impair our ability to grow our business, generate revenue and achieve and sustain profitability. We have experienced periods during which processing of our test results was delayed. In the fourth quarter of 2003, we completed an automation project, the implementation of which resulted in a temporary backlog of approximately $0.5 million at December 31, 2003. These backlogged samples were completed and corresponding revenue recorded in the first quarter of 2004. While to date we have not experienced any adverse impact on our business as a result of these delays, and are taking steps to minimize the likelihood of any recurrence of the delays, future delays and backlog may nevertheless occur, resulting in the loss of customers and/or revenue.

 

We face intense competition, and if our competitors’ existing products or new products are more effective than our products, the commercial opportunity for our products will be reduced or eliminated.

 

The commercial opportunity for our products will be reduced or eliminated if our competitors develop and market new testing products that are superior to, or are less expensive than, our phenotypic and/or genotypic resistance testing products we develop using our proprietary technology. The biotechnology industry evolves at a rapid pace and is highly competitive. Our major competitors include manufacturers and distributors of phenotypic drug resistance technology, such as Tibotec-Virco (division of Johnson & Johnson) and Specialty Laboratory. We also compete with makers of genotypic tests such as Applied Biosystems Group, Visible Genetics Inc. (division of Bayer Diagnostics) and laboratories performing genotypic testing as well as other genotypic testing referred to as virtual phenotyping. Each of these competitors is attempting to establish its test as the standard of care. Tibotec-Virco’s phenotypic and genotypic tests have been commercially available for a longer time than has PhenoSense HIV or GeneSeq HIV. Genotypic tests are cheaper and generally faster than phenotypic resistance tests. Our competitors may successfully develop and

 

23


Table of Contents

market other testing products that are either superior to those that we may develop or that are marketed prior to marketing of our testing products. One or more of our competitors may render our technology obsolete or uneconomical by advances in existing technological approaches or the development of different approaches. Some of our competitors have substantially greater financial resources and research and development staffs than we do. In addition, some of our competitors have significantly greater experience in developing products, and in obtaining the necessary regulatory approvals of products and processing and marketing products.

 

We derive a significant portion of our revenues from a small number of customers and our revenues may decline significantly if any major customer cancels or delays a purchase of our products.

 

Our revenues to date and for the foreseeable future consist largely of sales of our PhenoSense products. In 2003, we had no customers that represented more than 10% of our total revenue. However, in 2002, one customer, Quest Diagnostics Incorporated, represented 10% of our total revenue. In the quarter ended June 30, 2004 Quest Diagnostics represented approximately 10% of our revenue and it is likely that we will have significant customer concentration in the future. Our customers are not typically required to purchase tests from us under long-term contracts, and may stop ordering tests from us at any time. The loss of any major customer, a slowdown in the pace of increasing physician and physician group sales as a percentage of sales, or the delay of significant orders from any significant customer, even if only temporary, could have a significant negative impact on our revenues and our ability to fund operations from revenues, generate cash from operations or achieve profitability.

 

Various testing materials that we use are purchased from single qualified suppliers, which could result in our inability to secure sufficient materials to conduct our business.

 

We purchase some of the testing materials used in our laboratory operations from single qualified suppliers. Although these materials could be purchased from other suppliers, we would need to qualify the suppliers prior to using their materials in our commercial operations. Although we believe we have ample inventory stock to allow validation of another source, in the event of a material interruption of these supplies, the quantity of our stock may not be adequate. Any extended interruption, delay or decreased availability of the supply of these materials could prevent us from running our business as contemplated and result in failure to meet our customers’ demands. If significant customer relationships were harmed by our failure to meet customer demands, our revenues may decrease. We might also face significant additional expenses if we are forced to find alternate sources of supplies, or change materials we use. Such expenses could make it more difficult for us to attain profitability, offer our tests at competitive prices and continue our business as currently conducted or at all.

 

We are dependent on licenses for technology we use in our resistance testing, and our business would suffer if these licenses were terminated.

 

We license technology that we use in our PhenoSense and GeneSeq tests from Roche. We hold a non-exclusive license for the life of the patent term of the last licensed Roche patent. Currently, the last Roche patent expires in 2005. However, if additional patents are identified that would be necessary or useful for our operations, such patents could be added to the license at our option, which may extend the term of the license. We believe that many of our competitors, including Tibotec-Virco (division of Johnson & Johnson) and other resistance testing companies, also license this technology on non-exclusive terms. Roche has the right to terminate this license if we fail to pay royalties, make a semi-annual royalty report or participate in proficiency testing. We believe we are in compliance with these requirements. The license allows us to use technology covered by the licensed Roche patents within a broad field that includes all of our currently planned products. If we were to expand our product line beyond the licensed field, however, we would need to negotiate an expansion of the license. In addition, we also license technology from other third parties. If these licenses were to be terminated, we would likely have to change a portion of our testing methodology, which would halt our testing, at least temporarily, and cause us to incur substantial additional expenses.

 

The intellectual property protection for our technology and trade secrets may not be adequate, allowing third parties to use our technology or similar technologies, and thus reducing our ability to compete in the market.

 

The strength of our intellectual property protection is uncertain. In particular, we cannot be sure that:

 

  We were the first to invent the technologies covered by our patent or pending patent applications

 

  We were the first to file patent applications for these inventions

 

  Others will not independently develop similar or alternative technologies or duplicate any of our technologies

 

24


Table of Contents
  Any of our pending patent applications will result in issued patents

 

  Any patents issued to us will provide a basis for commercially viable products or will provide us with any competitive advantages or will not be challenged by third parties

 

We currently have 19 issued patents and 113 pending applications for additional patents, including international counterparts to our U.S. patents and foreign applications and counterparts. We have licensed seven patents under the Roche license discussed above. These patents cover a broad range of technology applicable across our entire current and planned product line. Other companies may have patents or patent applications relating to products or processes similar to, competitive with or otherwise related to our products. Patent law relating to the scope of claims in the technology fields in which we operate, including biotechnology and information technology, is still evolving and, consequently, patent positions in our industry are generally uncertain. We cannot assure you that we will prevail in any lawsuits regarding the enforcement of patent rights or that, if successful, we will be awarded commercially valuable remedies. In addition, it is possible that we will not have the required resources to pursue offensive litigation or to otherwise protect our patent rights. In addition to patent protection, we rely on protection of trade secrets, know-how and confidential and proprietary information. We generally enter into confidentiality agreements with our employees, consultants and collaborative partners upon commencement of a relationship with them. However, we cannot assure you that these agreements will provide meaningful protection against the unauthorized use or disclosure of our trade secrets or other confidential information or that adequate remedies would exist if unauthorized use or disclosure were to occur. The exposure of our trade secrets and other proprietary information would impair its competitive advantages and could have a material adverse effect on our operating results, financial condition and future growth prospects. Further, we cannot assure you that others have not or will not independently develop substantially equivalent know-how and technology.

 

In addition, there is a risk that some of our confidential information could be compromised during the discovery process of any litigation. During the course of any lawsuit, there may be public announcements of the results of hearings, motions and other interim proceedings or developments in the litigation. If securities analysts or investors perceive these results to be negative, it could have a substantial negative effect on the trading price of our common stock.

 

Our products could infringe on the intellectual property rights of others, which may cause us to engage in costly litigation and, if we are not successful defending any such litigation or we cannot obtain necessary licenses, could cause us to pay substantial damages and prohibit us from selling our products.

 

Our commercial success depends upon our ability to develop, manufacture, market and sell our products and use our proprietary technologies without infringing the proprietary rights of others. Companies in our industry typically receive a higher than average number of claims and threatened claims of infringement of intellectual property rights, and numerous U.S. and foreign issued patents and pending patent applications owned by others exist in HIV, HCV, HBV and the other fields in which we are selling and/or developing products. We may be exposed to future litigation by third parties based on claims that our products, technologies or activities infringe the intellectual property rights of others. Because patent applications can take many years to issue, there may be currently pending applications, unknown to us, which may later result in issued patents that our products or technologies may infringe. There also may be existing patents, of which we are not aware, that our products or technologies may inadvertently infringe. Further, there may be issued patents and pending patent applications in fields relevant to our business, of which we may become aware from time to time, that we believe we do not infringe or that we believe are invalid or relate to immaterial portions of our overall business. We cannot assure you that third parties holding any of these patents or patent applications will not assert infringement claims against us for damages or seeking to enjoin our activities. We also cannot assure you that, in the event of litigation, we will be able to successfully assert any belief we may have as to non-infringement, invalidity or immateriality, or that any infringement claims will be resolved in our favor. Third parties have from time to time threatened to assert infringement or other intellectual property claims against us based on their patents or other intellectual property rights or inform us that they believe we required one or more licenses in order to perform certain of our tests. For instance, we have recently been informed by Bayer Diagnostics, or Bayer, that it believes we require one or more licenses to patents controlled by Bayer in order to conduct certain of our current and planned operations and activities. We, in turn, believe that Bayer may require one or more licenses to patents controlled by us. Although we believe that we do not need a license from Bayer, we are in discussions with Bayer concerning the possibility of entering into a cross-licensing arrangement, and believe that if necessary, licenses from Bayer would be available to us on commercial terms. However, in the future we may have to pay substantial damages, possibly including treble damages, for infringement if it is ultimately determined that our products infringe a third party’s patents. Further, we may be prohibited from selling our products before we obtain a license, which, if available at all, may require us to pay substantial royalties. Even if infringement claims against us are without merit, defending a lawsuit will take significant time, and may be expensive and divert management attention from other business concerns.

 

25


Table of Contents

If we do not successfully introduce new products using our technology, we may not sustain long-term revenue growth.

 

We may not be able to develop and market new resistance testing products for HIV and other serious diseases, including hepatitis. Demand for these products will depend in part on the development by others of additional anti-viral drugs to fight these diseases. Physicians will likely use our resistance tests to determine which drug is best for a particular patient only if there are multiple drug treatment options. Several anti-viral drugs currently are in development but we cannot assure you that they will be approved for marketing, or if these drugs are approved that there will be a need for our resistance tests. If we are unable to develop and market resistance test products for other viral diseases, or if an insufficient number of anti-viral drugs are approved for marketing, we may not sustain long-term revenue growth.

 

Our business operations and the operation of our clinical laboratory facility are subject to stringent regulations and if we are unable to comply with them, we may be prohibited from accepting patient samples or may incur additional expense to attain and maintain compliance, which would have an adverse impact on ViroLogic’s revenue and profitability.

 

The operation of our clinical laboratory facility is subject to a stringent level of regulation under the Clinical Laboratory Improvement Amendments of 1988. Laboratories must meet various requirements, including requirements relating to quality assurance, quality control and personnel standards. Our laboratory is also subject to regulation by the state of California and various other states. We have received accreditation by the College of American Pathologists and therefore are subject to their requirements and evaluation. Our failure to comply with applicable requirements could result in various penalties, including loss of certification or accreditation, and we may be prevented from conducting our business as we do now or as we may wish to in the future.

 

The FDA may impose medical device regulatory requirements on our tests, including possibly premarket approval requirements, which could be expensive and time-consuming and could prevent us from marketing these tests.

 

In the past, the FDA has not required that genotypic or phenotypic testing conducted at a clinical laboratory be subject to premarketing clearance or approval, although the FDA has stated that it believes its jurisdiction extends to tests generated in a clinical laboratory. We received a letter from the FDA in September 2001 that asserted such jurisdiction over in-house tests like ours, but which also stated the FDA is not currently requiring premarket approval for HIV monitoring tests such as ours provided that the promotional claims for such tests are limited to its analytical capabilities and do not mention the benefit of making treatment decisions on the basis of test results. The FDA letter also asserted that our GeneSeq test had been misbranded due to the use of purchased analyte specific reagents (ASRs), if test reports do not include a statement disclosing that the test has not been cleared or approved by the FDA. We now utilize in-house prepared ASRs in our products. The FDA has indicated in discussions that the focus of the letter was our genotypic tests and not our phenotypic tests, but there is no certainty its focus will remain narrow.

 

We have had several discussions with the FDA related to its positions set forth in the letter. We do not at this point believe the FDA will require us to take steps that materially affect our business or financial performance, but we cannot guarantee this will remain the case.

 

We cannot be sure that the FDA will accept the steps we take, or that the FDA will not require us to alter our promotional claims or undertake the expensive and time-consuming process of seeking premarket approval with clinical data demonstrating the sensitivity and specificity of our tests. If premarket approval is required, we cannot be sure that we will be able to obtain it in a timely fashion or at all; and in such event the FDA would have authority to require us to cease marketing tests until such approval is granted.

 

In general, we cannot predict the extent of future FDA regulation of our business. We might be subject in the future to greater regulation, or different regulations, that could have a material effect on our finances and operations. If we fail to comply with existing or additional FDA regulations, it could cause us to incur civil or criminal fines and penalties, increase our expenses, prevent us from increasing revenues, or hinder our ability to conduct our business.

 

If we do not comply with laws and regulations governing the confidentiality of medical information, we may lose the state licensure we need to operate our business, and may be subject to civil, criminal or other penalties. Compliance with such laws and regulations could be expensive.

 

The Department of Human Health and Services, or HHS, has issued final regulations under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), designed to improve the efficiency and effectiveness of the health care system by facilitating the electronic exchange of information in certain financial and administrative transactions, while protecting the privacy and security of the information exchanged. Three principal regulations have been issued:

 

  privacy regulations;

 

26


Table of Contents
  security regulations; and

 

  standards for electronic transactions, or transaction standards.

 

We have implemented the HIPAA privacy regulations. In addition, we implemented measures we believe will reasonably and appropriately meet the specifications of the security regulations and the transaction standards.

 

These standards are complex, and subject to differences in interpretation. We cannot guarantee that our compliance measures will meet the specifications for any of these regulations. In addition, certain types of information, including demographic information not usually provided to us by physicians, could be required by certain payors. As a result of inconsistent application of requirements by payors, or our inability to obtain billing information, we could face increased costs and complexity, a temporary disruption in receipts and ongoing reductions in reimbursements and net revenues. At this time, we cannot estimate the potential impact of payors implementing (or failing to implement) the HIPAA transaction standards on our cash flows and results of operations.

 

In addition to the HIPAA provisions described above, there are a number of state laws regarding the confidentiality of medical information, some of which apply to clinical laboratories. These laws vary widely, and new laws in this area are pending, but they most commonly restrict the use and disclosure of medical information without patient consent. Penalties for violation of these laws include sanctions against a laboratory’s state licensure, as well as civil and/or criminal penalties. Compliance with such rules could require us to spend substantial sums, which could negatively impact our profitability.

 

We may be unable to build brand loyalty because our trademarks and trade names may not be protected.

 

Our registered or unregistered trademarks or trade names such as the name PhenoSense, PhenoSense GT, PhenoScreen and GeneSeq may be challenged, canceled, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build brand loyalty. Brand recognition is critical to our short-term and long-term marketing strategies especially as we commercialize future enhancements to our products.

 

Clinicians or patients using our products or services may sue us and our insurance may not sufficiently cover all claims brought against us, which will increase our expenses.

 

Clinicians, patients and others may at times seek damages from us if drugs are incorrectly prescribed for a patient based on testing errors or similar claims. Although we have obtained product liability insurance coverage, of up to $6 million, and expect to continue to maintain product liability insurance coverage, we cannot guarantee that liability insurance will continue to be available to us on acceptable terms or that our coverage will be sufficient to protect us against all claims that may be brought against us. We may incur significant legal defense expenses in connection with a liability claim, even one without merit or for which we have coverage.

 

We may have difficulty managing our growth and attracting and retaining skilled personnel, which could hinder our commercial efforts and impair our ability to compete.

 

If our management is unable to manage our growth effectively, it is possible that our systems and our facilities may become inadequate. Our success also depends on our continued ability to attract and retain highly qualified management and scientific personnel. If we cannot successfully attract and retain qualified personnel, our research and development efforts could be hindered and our ability to run our business effectively and compete with others in our industry will be harmed. With the exception of William Young, our CEO, we do not have employment agreements with any of our employees, and we do not maintain “key man” insurance for any employee. We consider William Young and Christos J. Petropoulos, Ph.D., Vice President, Research and Development, to be key to the management of our business and operations. If any of our key employees were to leave, we may incur significant costs searching for a replacement. Any of our key personnel could terminate their employment at any time and without notice. In addition, we have entered into severance agreements with our officers that would, in some instances, require us to pay severance to such officers upon the termination of their employment. We are not aware that any key employee has plans to retire or leave in the near future.

 

27


Table of Contents

Decreased effectiveness of equity compensation could adversely affect our ability to attract and retain employees, and proposed changes in accounting for equity compensation could adversely affect earnings.

 

We have historically used stock options and other forms of equity-related incentives as a key component of our employee compensation packages. We believe that stock options and other long-term equity incentives directly motivate our employees to maximize long-term stockholder value and, through the use of long-term vesting, encourage employees to remain with us. The Financial Accounting Standards Board and other agencies have proposed, and are currently considering, changes to accounting principles generally accepted in the U.S. that would require us to record a charge to earnings for employee stock option grants and other equity incentives. Moreover, applicable stock exchange listing standards related to obtaining stockholder approval of equity compensation plans could make it more difficult or expensive for us to grant options to employees in the future, which may result in changes in our equity compensation strategy. These and other developments in the provision of equity compensation to employees could make it more difficult to attract, retain and motivate employees, and such a change in accounting rules may adversely impact our future financial condition and operating results.

 

We may be subject to litigation, which would be time consuming and divert our resources and the attention of our management.

 

In November 2002, we implemented a business restructuring plan. With the exception of one, all of the employees terminated in connection with the business restructuring signed a release of claims. We have received correspondence from the former employee that did not sign a release threatening to bring claims against us that stem from that termination. We do not have employee practices liability insurance to cover any potential claims by employees terminated in the reduction of force. Even if we are eventually successful in our defense of this or any other similar claims, the time and money spent may prevent us from operating our business effectively or profitably or may distract our management.

 

Our operating results may fluctuate from quarter to quarter, making it likely that, in some future quarter or quarters, we will fail to meet estimates of operating results or financial performance, causing our stock price to fall.

 

If revenue declines in a quarter, our losses will likely increase or our earnings will likely decline because many of our expenses are relatively fixed. Though our revenues may fluctuate significantly as we continue to build the market for our products, expenses such as research and development, sales and marketing and general and administrative are not affected directly by variations in revenue. In addition, our cost of product revenue could also fluctuate significantly due to variations in the demand for our product and the relatively fixed costs to produce it. We are contractually obligated for rental payments under a building lease assignment through 2011 in the event of default by the assignee. We cannot accurately predict how volatile our future operating results will be because our past and present operating results, which reflect moderate sales activity, are not indicative of what we might expect in the future. As a result it is very difficult for us to forecast our revenues accurately and it is likely that in some future quarter or quarters, our operating results will be below the expectations of securities analysts or investors. In this event, the market price of our common stock may fall abruptly and significantly. Because our revenue and operating results are difficult to predict, period-to-period comparisons of our results of operations may not be a good indication of our future performance.

 

If a natural disaster strikes our clinical laboratory facility and we are unable to receive and or process our customers’ samples for a substantial amount of time, we would lose revenue.

 

We rely on a single clinical laboratory facility to process patient samples for our tests, which are received via delivery service or mail, and have no alternative facilities. We will also use this facility for conducting other tests we develop, and even if we move into different or additional facilities they will likely be in close proximity to our current clinical laboratory. Our clinical laboratory and some pieces of processing equipment are difficult to replace and could require substantial replacement lead-time. Our processing facility may be affected by natural disasters such as earthquakes and floods. Earthquakes are of particular significance since our clinical laboratory is located in South San Francisco, California, an earthquake-prone area. Our laboratory and equipment are insured up to $18 million against loss or damage in the event of a fire but not in the event of a flood or an earthquake. We also have business interruption insurance that provides coverage up to $20 million for business losses related to fire. Our insurance coverage may not be adequate to cover total losses incurred in a fire. However, even if covered by insurance, in the event our existing clinical laboratory facility or equipment is affected by natural disasters, we would be unable to process patient samples and meet customer demands or sales projections. If our patient sample processing operations were curtailed or ceased, we would not be able to perform our tests, which would reduce our revenues, and may cause us to lose the trust of our customers or market share.

 

28


Table of Contents

We use hazardous chemicals and biological materials in its business, and any claims relating to any alleged improper handling, storage, use or disposal of these materials could adversely harm its business.

 

Our research and development and manufacturing processes involve the use of hazardous materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We will not be able to eliminate the risk of accidental contamination or discharge and any resultant injury from these materials. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of these materials. We do not maintain insurance coverage for damage caused by accidental release of hazardous chemicals, or exposure of individuals to hazardous chemicals off of our premises. We could be subject to damages in the event of an improper or unauthorized release of, or exposure of individuals to, hazardous materials. In addition, claimants may sue us for injury or contamination that results from its use, or the use by third parties, of these materials, and our liability under a claim of this nature may exceed our total assets. Compliance with environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development or production efforts.

 

Concentration of ownership among some of our stockholders may prevent other stockholders from influencing significant corporate decisions.

 

At June 30, 2004, approximately 38% of our common stock was beneficially held by a small number of stockholders including our directors, entities affiliated with our directors and former directors, our executive officers and all those known by us to be beneficial owners of more than five percent of our common stock. The most significant of these stockholders in terms of ownership are BB Biotech AG, Zesiger Capital Group LLC, Perry Corporation and William Young. In addition, our Series A Preferred Stock is held by a small number of stockholders, some of who also own shares of our common stock and could acquire significant additional shares of common stock by converting shares of preferred stock. Consequently, a small number of our stockholders may be able to substantially influence our management and affairs. If acting together, they would be able to influence most matters requiring the approval by our stockholders, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets and any other significant corporate transaction. The concentration of ownership may also delay or prevent a change in our control at a premium price if these stockholders oppose it. There are also certain approval rights of the Series A Preferred Stock, and the few holders of those shares could prevent certain important corporate actions by not approving those actions.

 

Whether or not the merger transaction with ACLARA is completed, we will incur substantial costs

 

We will incur substantial costs related to the merger transaction with ACLARA whether or not the transaction is completed. These costs include fees for financial advisors, attorneys and accountants, filing fees and financial printing costs. We currently expect to incur approximately $4.6 million in costs, approximately $2.5 million of which are not contingent on the completion of the transaction. In addition, if either party terminates the merger agreement, it may be obligated to pay a termination fee and expenses to the other party, totaling $6.5 million, under certain circumstances.

 

Failure to complete the merger transaction with ACLARA could negatively affect our stock prices and future business and operations.

 

If the merger transaction with ACLARA is not completed for any reason, the price of our common stock may decline to the extent that the current market prices of our common stock reflects a positive market assumption that the transaction will be completed. In addition, if the merger agreement is terminated, we may be unable to find a third party willing to engage in a similar transaction on terms as favorable as those set forth in the merger agreement, or at all. This could limit our ability to pursue its strategic goals and make it difficult to retain and attract key employees in an atmosphere of increased uncertainty.

 

Our stock price may be volatile, and our stock could decline in value.

 

The market prices for securities of biotechnology companies in general have been highly volatile and may continue to be highly volatile in the future. Our stock price has fluctuated widely during the last two years from a low of $0.72 per share in September 2002 to a high of $4.40 per share in January 2004. The following factors, in addition to other risk factors described in this section, may have a significant negative impact on the market price of our common stock:

 

  Period-to-period fluctuations in financial results

 

  Financing activities

 

  Litigation

 

  Delays in product introduction, launches or enhancements

 

29


Table of Contents
  Announcements of technological innovations or new commercial products by our competitors

 

  Results from clinical studies

 

  Developments concerning proprietary rights, including patents

 

  Publicity regarding actual or potential medical results relating to products under development by our competitors or our own products or products under development

 

  Regulatory developments in the United States and foreign countries

 

  Changes in payor reimbursement policies

 

  Economic and other external factors or other disaster or crisis

 

A low or volatile stock price may negatively impact our ability to raise capital and to attract and maintain key employees.

 

We may be required to obtain the consent of the holders of our preferred stock before taking corporate actions, which could harm our business.

 

Our charter documents require us to obtain the consent of the holders of the Series A Preferred Stock before we may issue securities that have senior or equal rights to the respective series, incur unsecured indebtedness for borrowed money, or take other actions with respect to the respective series or other securities. We are also required to obtain the consent of the holders of the Series A Preferred Stock before we amend or modify our certificate of incorporation or bylaws to change any of the rights of such series. To obtain these consents, we would need to get consent from holders of a majority of the outstanding shares of the Series A Preferred Stock.

 

These obligations, and our complicated capitalization structure in general, might frustrate attempts to remove our board or management by making it difficult to find suitable replacements willing to spend substantial amounts of time and efforts on company matters. Moreover, these obligations may deter a potential acquirer from completing a transaction with us. They may also prevent us from taking corporate actions that would be beneficial to our stockholders and us, such as raising capital. Even if we are not prevented from taking such actions, they might be more expensive to us. This was the case when we issued our Series B Preferred Stock in March 2002, because we had to grant additional warrants to holders of Series A Preferred Stock as consideration in order to secure their consent and waiver concerning the financing and the resulting impact on the Series A Preferred Stock. This was also the case when we issued our Series C Convertible Preferred Stock in November 2002, because we had to agree to exchange the shares of Series B Preferred Stock for notes that were convertible into our Series C Convertible Preferred Stock, and to exchange the warrants associated with shares of Series B Preferred Stock for new warrants as consideration to secure the consent and waiver of the Series B Preferred Stock holders concerning the financing and the resulting impact on their respective preferred stock.

 

If our stockholders sell substantial amounts of our common stock, the market price of our common stock may fall.

 

If our stockholders sell substantial amounts of our common stock, including shares issued upon the exercise of outstanding options and warrants and upon the conversion of the Series A Preferred Stock, the market price of our common stock may fall. These sales also might make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate. Sales of a substantial number of shares could occur at any time. This may decrease the price of our common stock and may impair our ability to raise capital in the future.

 

Provisions of our charter documents and Delaware law may make it difficult for our stockholders to replace our management and may inhibit a takeover, either of which could limit the price investors might be willing to pay in the future for our common stock.

 

Provisions in our certificate of incorporation and bylaws may make it difficult for our stockholders to replace or remove our current management, and may delay or prevent an acquisition or merger in which we are not the surviving company. In particular:

 

  Our Board of Directors is classified into three classes, with only one of the three classes elected each year, so that it would take at least two years to replace a majority of our directors

 

  Our bylaws contain advance notice provisions that limit the business that may be brought at an annual meeting and place procedural restrictions on the ability to nominate directors

 

  Our stockholders are not permitted to call special meetings or act by written consent

 

30


Table of Contents

The holders of Series A Preferred Stock also have voting rights relating to many types of transactions, such as the creation or issuance of senior or pari passu equity or debt securities and the payment of dividends or distributions, and are subject to redemption at the option of the holder upon certain mergers, consolidations or other business combinations. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law. These provisions could discourage changes of our management and acquisitions or other changes in our control and otherwise limit the price that investors might be willing to pay in the future for our common stock.

 

We could adopt a stockholder rights plan, commonly referred to as a “poison pill,” at any time without seeking the approval of our stockholders. Stockholder rights plans can act through a variety of mechanisms, but typically would allow our board of directors to declare a dividend distribution of preferred share purchase rights on outstanding shares of our common stock. Each such share purchase right would entitle our stockholders to buy a newly created series of preferred stock in the event that the purchase rights become exercisable. The rights would typically become exercisable if a person or group acquires over a predetermined portion of our common stock or announces a tender offer for more than a predetermined portion of our common stock. Under such a stockholder rights plan, if we were acquired in a merger or other business combination transaction which had not been approved by its board of directors, each right would entitle its holder to purchase, at the right’s then-current exercise price, a number of the acquiring company’s common shares at a price that is preferential to the holder of the right. If adopted by our board of directors, a stockholder rights plan may have the effect of making it more difficult for a third party to acquire, or discourage a third party from attempting to acquire, control of us.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our investments without significantly increasing risk. Some of the securities that we invest in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the then-prevailing rate and the prevailing interest rate later rises, the principal amount of our investment will probably decline. To minimize this risk in the future, we intend to maintain our portfolio of cash equivalents and short-term investments in a variety of securities, including commercial paper, money market funds, government and non-government debt securities. Due to the relatively short-term nature of our investments, we believe we have no material exposure to interest rate risk arising from our investments. Therefore we have not included quantitative tabular disclosure in this Form 10-Q.

 

We do not enter into financial investments for speculation or trading purposes and are not a party to financial or commodity derivatives.

 

We have operated primarily in the United States and all sales to date have been made in U.S. Dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations.

 

Item 4. Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our filings under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Our Chief Executive Officer and Chief Financial Officer, with the assistance of other members of our management, have evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as of the end of the period covered by this report, and have concluded based on that evaluation that those disclosure controls and procedures are effective. There has been no change in our internal control over financial reporting during the fiscal quarter ended June 30, 2004 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

31


Table of Contents

PART II

 

Item 1. Legal Proceedings

 

None.

 

Item 2. Changes In Securities, Use of Proceeds and Issuer Purchases of Equity Securities

 

  (a) None.

 

  (b) None.

 

  (c) None.

 

  (d) None.

 

  (e) None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

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

 

None.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits and Reports on Form 8-K

 

(a) Exhibits

 

Exhibit

Number


 

Caption


2.1(1)   Agreement and Plan of Merger and Reorganization, dated as of May 28, 2004, by and among ViroLogic, Inc., Apollo Acquisition Sub, Inc., Apollo Merger Subsidiary, LLC and ACLARA BioSciences, Inc.
10.1 *   Referral Testing Agreement Between Virologic, Inc. and Quest Diagnostics Incorporated, dated April 1, 2004
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(A) or Rule 15d-14(A) promulgated under the Securities Exchange Act of 1934.
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(A) or Rule 15d-14(A) promulgated under the Securities Exchange Act of 1934.
32.1   Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) or Rule 15d-14(B) promulgated under the Securities Exchange Act of 1934.
99.1(2)   Form of Contingent Value Rights Agreement between ViroLogic, Inc. and U.S. Bank National Association, as trustee.
99.2(3)   Registration Rights Agreement dated May 28, 2004 between ViroLogic, Inc. and Tang Capital Partners, L.P.

* Confidential treatment requested.

 

32


Table of Contents
(1) Incorporated by reference to the similarly described exhibit in ViroLogic, Inc.’s Current Report on Form 8-K filed on June 1, 2004 (File No. 000-30369).
(2) Incorporated by reference to the similarly described exhibit in ACLARA BioSciences, Inc.’s Current Report on Form 8-K filed on June 1, 2004 (File No. 000-29975).
(3) Incorporated by reference to the similarly described exhibit in ViroLogic, Inc.’s registration statement on Form S-4 filed on June 30, 2004 (File No. 333-116981).

 

(b) Reports on Form 8-K

 

On May 3, 2004, we filed a report on Form 8-K to furnish our earnings release for the first quarter ended March 31, 2004.

 

On June 1, 2004, we filed a report on Form 8-K to report that we entered into an Agreement and Plan of Merger and Reorganization with Apollo Acquisition Sub, Inc., a Delaware corporation and wholly-owned subsidiary of ViroLogic, Apollo Merger Subsidiary, LLC, a Delaware limited liability company and wholly-owned subsidiary of ViroLogic and ACLARA BioSciences, Inc., a Delaware corporation.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1934, as amended, the registrant has duly caused this Quarterly Report on Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of South San Francisco, County of San Mateo, State of California, on August 13, 2004.

 

    ViroLogic, Inc.

By:

 

/s/ William D. Young


    William D. Young
    Chief Executive Officer
    (On Behalf of the Registrant)
   

/s/ Karen J. Wilson


    Karen J. Wilson
    Vice President and Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

33


Table of Contents

EXHIBITS INDEX

 

Exhibit

Number


 

Caption


2.1(1)   Agreement and Plan of Merger and Reorganization, dated as of May 28, 2004, by and among ViroLogic, Inc., Apollo Acquisition Sub, Inc., Apollo Merger Subsidiary, LLC and ACLARA BioSciences, Inc.
10.1 *   Referral Testing Agreement Between Virologic, Inc. and Quest Diagnostics Incorporated, dated April 1, 2004
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(A) or Rule 15d-14(A) promulgated under the Securities Exchange Act of 1934.
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(A) or Rule 15d-14(A) promulgated under the Securities Exchange Act of 1934.
32.1   Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(B) or Rule 15d-14(B) promulgated under the Securities Exchange Act of 1934.
99.1(2)   Form of Contingent Value Rights Agreement between ViroLogic, Inc. and U.S. Bank National Association, as trustee.
99.2(3)   Registration Rights Agreement dated May 28, 2004 between ViroLogic, Inc. and Tang Capital Partners, L.P.

* Confidential treatment requested.
(1) Incorporated by reference to the similarly described exhibit in ViroLogic, Inc.’s Current Report on Form 8-K filed on June 1, 2004 (File No. 000-30369).
(2) Incorporated by reference to the similarly described exhibit in ACLARA BioSciences, Inc.’s Current Report on Form 8-K filed on June 1, 2004 (File No. 000-29975).
(3) Incorporated by reference to the similarly described exhibit in ViroLogic, Inc.’s registration statement on Form S-4 filed on June 30, 2004 (File No. 333-116981).

 

34

EX-10.1 2 dex101.htm REFERRAL TESTING AGREEMENT Referral Testing Agreement

Exhibit 10.1

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Referral Testing Agreement

Between

Virologic, Inc. and

Quest Diagnostics Incorporated

 

THIS AGREEMENT is entered into effective as of April 1, 2004 (the “Effective Date”), between Virologic, Inc. (Virologic), with offices located at 345 Oyster Point Blvd., South San Francisco, CA 94080 (“Contractor”) and Quest Diagnostics Incorporated, a Delaware corporation with offices located at 1 Malcolm Avenue, Teterboro, New Jersey 07608 (“Quest Diagnostics”).

 

Quest Diagnostics is the owner and/or operator of certain clinical laboratories located in various states throughout the United States.

 

Contractor operates a referral testing laboratory that is duly licensed to perform clinical laboratory testing.

 

Quest Diagnostics wishes to engage Contractor as its preferred provider for HIV phenotypic resistance testing to perform laboratory testing services upon the terms and conditions set forth in this Agreement and Contractor wishes to provide to Quest Diagnostics those services upon those terms and conditions.

 

In consideration of the mutual covenants hereinafter set forth, the parties, intending to be legally bound, agree as follows:

 

1. Term

 

The term of this Agreement shall commence on the Effective Date and shall continue for a period of (1) year, subject to the early termination provisions of Section 13 of this Agreement and to the following renewal option: Quest Diagnostics shall have two one-year options to extend the Agreement on the condition that the annual minimum volume term of [*], as set forth on Exhibit A hereto, is met in the preceding year of this Agreement and upon written notice thereof to Contractor.

 

2. Services; Contractor Certification and Standard of Work

 

  (a) Services: Upon the request of Quest Diagnostics, Contractor shall provide Quest Diagnostics with laboratory testing services. Contractor represents and warrants to Quest Diagnostics that it will perform all testing services under this Agreement in a professional, accurate, and timely manner.

 

Turn Around Time/Non Reportable Rate: Contractor shall use its best efforts to ensure that its turn around time for delivering laboratory test results to Quest Diagnostics shall not exceed twenty-four (24) hours from the time of specimen receipt at Contractor’s location to the time that a detailed lab report is received by the requesting lab site (unless a longer turn around time is specified on Exhibit B with respect to particular tests, in which event Contractor shall use its best efforts to meet the turn around times set forth on Exhibit B for those tests). Contractor represents and warrants that it has not and will not offer another distributor a shorter or enhanced Turn Around Time or otherwise differentiate to the disadvantage of Quest in sample Turn Around Time and will make best efforts to meet the Turn Around Time for Results set forth on Exhibit B. If there is a delay in reported results or additional testing is required to confirm or clarify the result of a specific test, and cannot be performed within the applicable turn around time, Contractor shall notify the Quest Diagnostics’ laboratory that referred the test to Contractor of the time when results will be available to Quest Diagnostics. Repeat testing, when necessary or requested, will be performed at no charge. Quest Diagnostics and Contractor will work together to reduce non-reportable results through mutual efforts to educate physicians and phlebotomists on appropriate specimen collection and handling requirements as set forth on Exhibit D hereto.


  (b) Changes: Contractor shall provide Quest Diagnostics with at least sixty (60) days’ prior written notice before making any change to test methods for tests performed under this Agreement (except for changes necessitated by causes beyond the control of Contractor or for changes necessary to maintain or improve quality levels, which changes shall be communicated to the parties referenced below immediately upon Contractor’s knowledge of such changes). Contractor shall provide such notice to Quest Diagnostics via electronic mail with hard copy follow-up to the parties identified below or as directed by the applicable Quest Diagnostics’ Sourcing Manager. The requirement to provide such notice is a material term, any breach of which shall be deemed a material breach of this Agreement. If it is Contractor’s practice to perform data base changes/updates on a regular schedule, the implementation timeline shall be communicated to Quest Diagnostics at least ninety (90) days in advance of implementation.

 

Unless otherwise designated by Quest Diagnostics from time to time, parties to be notified under this Section 2(c) are as follows:

 

1. Database Management:

 

(a) Corporate - DB.Requests@questdiagnostics.com

 

(b) Nichols Institute/SJC: sjctsohd@questdiagnsotics.com; and

 

(c) Nichols Institute/Chantilly:mary.a.goodspeed@questdiagnostics.com

 

2. Sourcing Manager – tramposj@questdiagnostics.com

 

3. National Director of Test Referral Networking - humesm@questdiagnostics.com

 

  (d) Certifications: All testing performed by Contractor shall be in accordance with applicable state and federal testing requirements for clinical reference laboratories. Contractor shall maintain, and hereby certifies its and its employees are in possession of, all necessary licenses, permits, accreditation and certifications, including approvals for specialties or subspecialties (all such licenses, permits, accreditation and certifications, including approvals for specialties or subspecialties being collectively referred to hereafter as “Required Approvals”) required under applicable law, rule or regulation for Contractor and its clinical laboratories to perform the tests referred to Contractor by Quest Diagnostics, including, without limitation, Required Approvals under the Clinical Laboratory Improvement Amendments (“CLIA”) of 1988, and any applicable state laws and regulations, including the States identified on Exhibit B. Contractor shall maintain all Required Approvals for the duration of the term of this Agreement and any renewals. Before commencing laboratory testing under this Agreement, and within thirty (30) days after the renewal date for any Required Approval, Contractor shall provide to Quest Diagnostics at its address provided above, Attn: Virginia Sturmfels, Manager, Medical Compliance, or such other address that Quest Diagnostics may direct in accordance with the notice requirements of Section 14(b) of this Agreement, copies of all Required Approvals or any renewals thereof, under CLIA, from the States identified on Exhibit C and from Contractor’s applicable accreditation agency or agencies. If for any reason Contractor loses or is denied any Required Approval to perform one or more tests pursuant to this Agreement, Contractor shall immediately notify Quest Diagnostics at the address provided above and Quest Diagnostics shall discontinue referral of any such test or tests, in the state, or states, affected until such time as Contractor can demonstrate it has the Required Approval. Recurrent loss of Required Approvals shall constitute a breach of this Agreement authorizing Quest Diagnostics to terminate the Agreement under Section 13. Contractor shall provide Quest Diagnostics at the address provided above with a copy of any new Required Approval that it obtains during the term of this Agreement and any renewals within thirty (30) days of receipt thereof.

 

(e) Reports: Contractor shall furnish utilization reports monthly to Quest Diagnostics’ Sourcing Manager and other personnel designated by it from time to time. At a minimum, Contractor shall include in each utilization report test names, Contractor’s test codes, and the volume and dollar amount of each test.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

2


Utilization reports shall present this information separately for each Quest Diagnostics’ Business Unit. This report shall be submitted by Contractor electronically to email addresses designated by Quest Diagnostics from time to time.

 

3. Pricing

 

Pricing Generally: Pricing for laboratory testing services provided by Contractor to Quest Diagnostics shall be in accordance with the Pricing Schedule attached as Exhibit Quest A.

 

  (a) Most Favored Nations: Quest Diagnostics shall receive most favored nation pricing PhenoSense GT testing services provided by Contractor under this Agreement as follows: If at any time during the term of this Agreement, Contractor provides pricing (including the effect of any discounts, credits or other allowances) that is lower than the pricing provided to Quest Diagnostics for PhenoSense GT performed by Contractor under this Agreement to any commercial laboratory customer of Contractor that is a commercial local or regional laboratory, that purchases similar or lesser volumes of those tests, Contractor shall immediately (i) decrease Quest Diagnostics’ pricing so that pricing afforded to Quest Diagnostics is equal to or lower than the prices afforded to that commercial local or regional laboratory customer, and (ii) notify Quest Diagnostics of the price decrease. Throughout the term of this Agreement, Quest Diagnostics shall have the right, at its expense and subject to confidentiality undertakings reasonably satisfactory to Contractor, to cause a major independent auditing firm, not doing business with either Quest Diagnostics or Contractor, to audit Contractor’s prices to its customers to ensure compliance with this Section. If any discrepancies are found, Quest Diagnostics shall receive, at its option, a refund or credit for all monies paid in excess of the amount that would have been payable had Contractor afforded Quest Diagnostics pricing consistent with this most favored nations pricing provision beginning from the date the other customer was afforded lower pricing and continuing for so long as Quest Diagnostics paid the excess amounts. However, Quest Diagnostics agrees that in the event that any of its individual business units do not make available all of the ViroLogic products listed on Exhibit A in accordance with this agreement, these obligations with respect to Most Favored Nations pricing for PhenoSense GT shall be null and void.

 

4. Invoicing

 

Contractor shall invoice Quest Diagnostics on a monthly basis for all testing performed at the request of Quest Diagnostics. Invoices shall be provided to such physical or email addresses as Quest Diagnostics may designate from time to time. Accrued, undisputed fees shall be paid to Contractor within thirty (30) days of Quest Diagnostics’ receipt of invoices. All invoices shall be in sufficient detail, as reasonably requested by Quest Diagnostics, to identify the tests completed and the price per test. Failure of Contractor to submit invoices in the time required or to provide sufficient documentation as requested shall be a basis to deny a claim for payment. Contractor will not be entitled to receive payment for services that produce invalid test results, except where the cause of such invalid result is Quest Diagnostics referring of an untestable specimen to Contractor (e.g., the specimen was too old). If services are rendered on behalf of a Medicaid patient residing in a state in which applicable Medicaid regulations require that laboratory services rendered to a Medicaid recipient be billed only by the laboratory performing the testing services, Contractor shall, if requested by Quest Diagnostics, bill such services to Medicaid, and accept payment from Medicaid as full payment for those services.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

3


5. Preferred Provider Relationship

 

  a) Customer Support: Contractor will provide Payor Relations support with all payor types to establish medical policy for HIV RT and increase reimbursement rates where needed. Contractor will educate HIV providers regarding the availability of its products through Quest Diagnostics.

 

  b) Exclusivity and Product Offering: Within 10 business days upon execution of this Agreement Quest Diagnostic’s will make unique test codes available throughout it’s network of laboratories for Contractors products listed on Exhibit A hereto and will use best efforts to ensure that those product test codes are the same across all Quest business units. Contractor agrees to make Quest Diagnostics its exclusive nationwide distributor for the term of this agreement, (nationwide distributor is defined for purposes of this agreement as a laboratory offering full scope of testing services including routine diagnostics and esoteric testing, anatomic pathology, drug testing, clinical trials throughout the majority of the United States) for its PhenoSense GT assay nothing herein is intended to prohibit Contractor from distributing its products directly or through local or regional laboratories. Quest Diagnostics agrees that in the event that any of its individual business units do not make available all ViroLogic products listed on Exhibit A in accordance with this agreement, ViroLogic may, in its sole discretion, terminate this nationwide exclusivity of the PSGT offering at any time during this Agreement.

 

6. Non-solicitation of Clients Trade Secrets:

 

  (a) Trade Secrets: Contractor understands and acknowledges that should Quest Diagnostics provide any client-identifiable information to Contractor, such information shall be considered a confidential trade secret of Quest Diagnostics that shall be treated and protected with the same care that Contractor would treat similar information of its own, but with no less than a reasonable degree of care.

 

  (b) Non-Solicitation: Contractor agrees that during the term of this Agreement, or any renewals thereof, and for a period of one year thereafter, it will not knowingly utilize information acquired from the business relationship with Quest Diagnostics to directly solicit business from Quest Diagnostics’ clients.

 

7. Tests Added During the Contract Period

 

From time to time, Quest Diagnostics may request Contractor to provide additional tests not currently performed by Contractor and/or to consolidate additional tests with Contractor that Quest Diagnostics currently sends to other reference laboratories. Upon mutual written agreement between Contractor and Quest Diagnostics, Contractor shall set up the test(s) requested within its laboratory, within six (6) to ten (10) weeks of Quest Diagnostics’ request, and shall obtain all necessary legal and regulatory approvals required to perform such test(s) and to sell such testing services to Quest Diagnostics. If more than six (6) to ten (10) weeks are required to set up such test(s), Contractor shall notify Quest Diagnostics of the necessary set up time when Quest Diagnostics requests such test(s) and Quest Diagnostics and Contractor shall negotiate in good faith regarding the appropriate pricing for such tests.

 

8. Business Reviews

 

Contractor agrees that Quest Diagnostics shall have the right to perform quality assurance audits. All audits will be used by Quest Diagnostics solely to evaluate Contractor’s performance of the services under this Agreement. Such audits may include onsite inspections to evaluate

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

4


Contractor’s processes against a Quest Diagnostics’ checklist used for reference laboratory providers to monitor compliance with regulatory standards and all Quest Diagnostics’ quality assurance requirements. Quest Diagnostics reserves the right to hold formal performance reviews every six months. These reviews shall include, but not be limited to, contract performance, customer satisfaction, issues/opportunities, new test requirements, technology/overview and general operational issues.

 

9. Promotional Material

 

Neither party shall use the name, symbol, logo or any trademark or service mark of the other party in any promotional or advertising material, nor for any other purpose unless advance written consent has been received from the other party. Except that, for the purposes of educating physicians, Contractor may issue client letters, marketing information and other promotional materials that reference Quest Diagnostics and the Agreement. Contractor will seek Quest Diagnostics review and approval of all such materials which approval shall not be unreasonably withheld. The terms of this Agreement may require SEC disclosure on behalf of Contractor and in such event Contractor will comply with such disclosure requirements, however, Contractor agrees to provide a draft of any such 8K or press release to Quest Diagnostics for comments.

 

10. Proprietary Information

 

  (a) Confidential Information: Contractor and Quest Diagnostics acknowledge that they may gain access to the other’s confidential business information in the course of performing their obligations under this Agreement. Except as required by law or legal process, Contractor and Quest Diagnostics each agrees that it will not use (except as required by those employees, officers, directors, or consultants, acting pursuant to this Agreement or as required by law or legal process) or disclose to third parties the following information: client lists, information related to proprietary research techniques and technology, types of supplies, pricing for supplies, patient information (including but not limited to, social security numbers, addresses, insurance information, results, and diagnosis information), and any information that the disclosing party marks with the word “confidential” at the time of disclosure (together “Confidential Information”). Contractor and Quest Diagnostics each agrees to treat such Confidential Information it receives from the other with the same degree of care that it treats its own proprietary information, but with no less than a reasonable degree of care.

 

  (b) Exceptions to Confidential Information: Notwithstanding subsection (a) above, information shall not be deemed Confidential Information if it (i) is or becomes generally known to the public through no unlawful act of the recipient; (ii) was known to the recipient at the time of disclosure; (iii) is disclosed with the prior written approval of the disclosing party; (iv) was independently developed by the recipient without any use of the disclosing party’s Confidential Information; (v) becomes known to the recipient from a source other than the disclosing party without breach of this Agreement and otherwise not in violation of the disclosing party’s rights; or (vi) is required to be disclosed in accordance with law or court order.

 

  (c) Return of Confidential Information: Each party shall promptly return all Confidential Information of the other party it holds in written form and all copies of it upon the other party’s written demand, except for Confidential Information that may be incorporated in any information that the recipient is required to maintain by law to verify the work that it performed, which may be retained by the recipient subject to the restrictions contained in this Section 9.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

5


11. Indemnification, Insurance and Notice

 

  (a) Indemnification: Contractor agrees to indemnify, defend and hold Quest Diagnostics, including its subsidiaries and affiliates and their employees, agents, servants and representatives, harmless from any claim, liability, loss, suit, damage, cost or expense, including reasonable attorneys’ fees and expenses (collectively “Claims”), including wrongful death, to the extent arising out of or attributable to the negligence, breach of this Agreement or willful misconduct of Contractor, its employees, subcontractors, directors and officers related to this Agreement, including, but not limited to, any third party billing Claims brought against Quest Diagnostics arising out of Contractor’s failure to inform Quest Diagnostics of a test methodology change, and any Claims brought against Quest Diagnostics based upon, arising out of or attributable to Quest Diagnostics’ hiring or supervision of Contractor.

 

  (b) Indemnification Procedure: Quest Diagnostics shall notify Contractor of any Claim for which indemnification is sought. Contractor shall have the right to control the investigation, trial and defense of any lawsuit or action (including all negotiations to effect settlement) and any appeal arising there from and to employ or engage attorneys of its own choice. Quest Diagnostics may, at its own cost, participate in such investigation, trial and defense of such lawsuit or action and may take an appeal from any resulting adverse judgment. Quest Diagnostics shall cooperate with Contractor, at Contractor’s expense, at all times during the pendency of the Claim or lawsuit, including, without limitation, providing it with all available information concerning the Claim. Contractor shall not enter into any settlement agreement, consent judgment or admission of liability on behalf of Quest Diagnostics without its prior written consent, which consent shall not be unreasonably withheld.

 

  (c) Insurance: Contractor agrees to maintain professional liability and commercial general liability insurance to cover its services provided hereunder in the minimum amounts of Three Million Dollars ($3,000,000) per claim and Five Million Dollars ($5,000,000) annual aggregate. Contractor agrees to furnish Quest Diagnostics with a current and valid certificate of insurance from Contractor’s insurance carrier verifying the nature and amounts of coverage (or if Contractor self insures, documented proof of the existence of a self-insurance program meeting the requirements hereof), and Contractor agrees to keep and maintain such insurance (or self-insurance) coverage in full force and effect during the term of this Agreement. If such insurance is of the “claims made” type, Contractor agrees that the insurance shall be continued for a period of at least four (4) years after the termination of this Agreement, or Contractor shall purchase extended reporting period insurance (also known as “tail coverage”) to extend the insurance for a minimum of four (4) years after the termination of this Agreement.

 

12. Regulatory Compliance

 

  (a) Compliance with Law/Material Breach: Each party represents and warrants that in the performance of its obligations under this Agreement, it will comply with all applicable laws, rules or regulations (“Applicable Laws”), including, but not limited to, the federal Physician Self-Referral Law, 42 U.S.C. 1395nn (“Stark Law”), and the regulations promulgated thereunder, similar state physician self-referral laws and regulations, the federal Medicare/Medicaid Anti-kickback Law (42 USC 13202-7b) and regulations promulgated thereunder and similar state Anti-kickback laws and regulations, the Health Insurance Portability and Accountability Act (“HIPAA”) regulations. Failure by either party to comply with any Applicable Law as required hereby shall be considered a material breach of this Agreement. In the event of a determination that this Agreement is not in compliance with any Applicable Law, then the parties shall negotiate in good faith to bring this Agreement into compliance. All amendments to this Agreement to bring this Agreement into

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

6


compliance must be mutually agreed to by both parties in writing. If such agreement cannot be reached, either party may terminate this Agreement by written notice to the other party.

 

  (b) HIPAA Compliance: Each party represents and warrants that with respect to all protected health information (as that term is defined in the Privacy Regulations), it is a covered entity (and not a business associate of the other party) under the Privacy Regulations and that it shall protect the privacy, integrity, security, confidentiality and availability of the protected health information disclosed to, used by, or exchanged by the parties by implementing and maintaining privacy and security policies, procedures, and practices, and administrative, physical and technological safeguards and security mechanisms that reasonably and adequately protect the confidentiality, integrity and availability of the protected health information created, received, maintained or transmitted under this Agreement, all as required by, and set forth more specifically in, the Privacy Regulations and the Security Regulations, as each may be amended from time to time. In the event HIPPA or the Privacy Regulations or Security Regulations require any addition to or modification of this Agreement, the parties shall use commercially reasonable efforts to agree upon such additions or modifications in a timely manner. If such agreement cannot be reached in a timely manner, either party may terminate this Agreement by written notice to the other party.

 

  (c) Federal Program Access to Records: If payment for any laboratory services performed hereunder is made by a Federal Program, to assure compliance with 42 USC 1395X(v)(I), until the expiration of four (4) years after the furnishing of laboratory services pursuant to this Agreement, Contractor shall, upon written request, make available to the Secretary of the Department of Health and Human Services (HHS), the Comptroller General, or any of their duly authorized representatives, this Agreement, and any books, documents and records that are necessary to certify the nature and extent of the costs incurred by a health care provider that were performed under this Agreement. This provision shall apply if the amount paid under this Agreement is $10,000 or more over a twelve (12) month period.

 

The availability of Contractor’s books, documents and records shall at all times be subject to such criteria and procedures for seeking or obtaining access as may be promulgated by the Secretary of HHS in regulations, and other applicable laws. Contractor’s disclosure under this provision will not be construed as a waiver of any legal rights to which Quest Diagnostics or Contractor may be entitled under statute or regulation.

 

  (d) Excluded Provider: Each party represents and warrants that it is not an Excluded Provider. For purposes of this Section, the term “Excluded Provider” means a person or entity that either (1) has been convicted of a crime related to health care, or (ii) is currently listed by a federal agency as debarred, excluded or otherwise ineligible for participation in federally funded programs (including without limitation federally-funded health care programs such as Medicare and Medicaid). Either party shall notify the other within 5 days after the party receives notice that it is an Excluded Provider. The party receiving such notice shall have the right to terminate this Agreement at any time after learning that the notifying party is an Excluded Provider. For purposes of this Section, “Quest Diagnostics” and “Contractor” shall include, as applicable, the (1) person entering into this Agreement any partners, associates, or agents of that person (including without limitation subcontractors or employees providing Testing), or (2) the entity entering into this Agreement and any such entity’s parent, principals, shareholders, directors, and officers of such entity (including, without limitation, subcontractors or employees providing Testing).

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

7


  (e) EEO, Small Business, Affirmative Action: To the extent Contractor’s services will be used by Quest Diagnostics in the performance of a federal government contract, Contractor hereby certifies that all services provided in the United States are provided in compliance with all applicable requirements, orders and regulations of the United States Federal Government pertaining to nondiscrimination, equal employment opportunity and affirmative action, including, without limitation, the following, as the same may be amended from time to time: (1) Executive Order 11246, as amended by Executive Order 11375, including 41 CFR Part 60.1 et seq. and 48 CFR 52.222-26, Equal Opportunity; (2) the Rehabilitation Act of 1973 (29 USC 793), as amended, including 41 CFR Part 60-741 et seq. and 48 CFR 52.222-36, Affirmative Action for Workers With Disabilities; (3) the Vietnam Era Veterans Readjustment Assistance Act of 1974 (38 USC 4212), including 41 CFR Part 60-250 et seq. and 48 CFR 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans; (4) the certification requirements for nonsegregated facilities as ordered by the Secretary of Labor (32 F.R. 7439) and as required by 41 CFR Part 60-1 et seq.; (5) Executive Order 11141 (proscribing age discrimination); (6) the Service Contract Act of 1965, as amended (41 USC 351 et seq.) including 48 CFR 52.222-41; (7) 48 CFR 52.237-7, Indemnification and Medical Liability Insurance; and (8) all regulations, rules, orders and applicable contract clauses promulgated under (1) through (7) above and/or required by federal, state or local law, rule or regulation to be included in this Agreement. Contractor agrees that until four years after payment under this Agreement Contractor will afford the Secretary of Health and Human Services, Comptroller General of the United States or any of their duly authorized representatives, access to, and the right to examine, any pertinent books, documents, papers and records of the successful bidder or offer or involving transactions relating to this Agreement.

 

13. Legislative / Regulatory Modification

 

In the event any Medicare and/or Medicaid laws, rules, regulations or payment policies; or any rules or policies of any third-party payer; or any other federal, state or local law, rule, regulation or policy; or any interpretation thereof at any time during the term of this Agreement is modified, implemented, threatened to be implemented, or determined to prohibit or in any way materially change the method or amount of reimbursement or payment (1) for services under this Agreement, or (2) for services to patients of a party necessitated as a result of this Agreement, or by virtue of the existence of this Agreement has or will materially affect the ability of Quest Diagnostics to engage in any commercial activity on terms at least as favorable to Quest Diagnostics as those reasonably attributable as of the date hereof (all of the foregoing being hereinafter collectively referred to as “Changes,” and individually, a “Change”), then the parties to this Agreement shall negotiate in good faith to amend this Agreement to provide for payment of compensation hereunder, while at the same time preserving the economic expectations of the parties to the greatest extent possible in a manner consistent with any such Change(s). All amendments to this Agreement necessitated by such Change(s) must be mutually agreed to by both parties in writing. If such agreement cannot be reached, either party may terminate this Agreement by written notice to the other party.

 

14. Termination

 

This Agreement may be terminated as follows:

 

(a) Upon the filing of a petition in bankruptcy by either party or the making by either party of an assignment for the benefit of creditors, or if any involuntary petition in bankruptcy or petition for an arrangement pursuant to the Bankruptcy Act is filed against either party and is not dismissed within thirty (30) days; or if a receiver is appointed for the business of either party, or any part thereof, the other party may immediately terminate this Agreement;

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

8


(b) If action is taken against Contractor to revoke, suspend, or terminate its applicable federal or state license(s) to operate a clinical laboratory, or to revoke, suspend or terminate participation in Medicaid, Medicare or other federally funded programs; and such action is not resolved within thirty (30) days of initiation thereof, Quest Diagnostics may immediately terminate this Agreement;

 

(c) Either party may terminate this Agreement immediately on written notice if the other party has committed a material breach of this Agreement and has not cured such breach within thirty (30) days after written notice thereof by the non-breaching party; and

 

(d) In accordance with Sections 2(d), 12(a), 12(b) and 13.

 

15. Miscellaneous

 

(a) Assignment: Without the prior written consent of the other party hereto, which consent shall not be unreasonably withheld, neither party may assign any of its rights or obligations hereunder. Notwithstanding anything to the contrary herein contained, either party may assign its rights or obligations hereunder in the entirety to its parent or any subsidiary or successor corporation without prior written consent; provided, however, that nothing contained herein shall release the assigning party from its obligations hereunder. Subject to the foregoing, this Agreement inures to the benefit of, and is binding upon, the successors and assigns of the parties hereto.

 

(b) Notice: Except as otherwise expressly provided in this Agreement, all notices hereunder shall be in writing, personally delivered, sent by certified mail, return receipt requested, or by confirmed facsimile, addressed to the other party as follows:

 

If to Contractor:

  Kathy Hibbs, Esq
    Vice President and General Counsel
    ViroLogic, Inc.
   

Phone: (650)624-4243

   

Facsimile: (650) 635-1111

If to Quest Diagnostics:

  Jerry Tramposh, Ph.D.
    Materials and Services Management
    Quest Diagnostics, Nichols Institute
    San Juan Capistrano, CA
    Phone: (800) 642-4657 ext. 4005
    Facsimile: (949) 728-4998

 

Either party may change its address to which notices shall be sent by a notice that conforms to the requirements of this subsection.

 

(c) Entire Agreement: This Agreement, including Exhibits A, B, and C, contains the entire understanding between Quest Diagnostics and Contractor and supersedes any and all prior agreements, understandings, and arrangements between them relating to the subject matter hereof. No amendment, change modification or alteration of the terms and conditions hereof shall be binding unless in writing and signed by the parties to be bound.

 

(d) Choice of Law: This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Pennsylvania, without regard to its conflict of law principles.

 

(e) Waiver: The failure of either party to this Agreement to exercise or enforce any right conferred upon it hereunder shall not be deemed to be a waiver of any such right nor operate to bar the exercise or performance thereof at any time or times thereafter, nor shall a waiver of any right hereunder at any given time be deemed a waiver thereof for any other time.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9


(f) Severability: It is the intention of the parties that the provisions of this Agreement shall be enforceable to the fullest extent permissible under applicable laws, and that the invalidity or unenforceability of any provisions under such laws will not render unenforceable, or impair, the remainder of the Agreement. If any provisions hereof are deemed invalid or unenforceable, either in whole or in part, this Agreement will be deemed amended to modify, or delete, as necessary, the offending provisions and to alter the bounds thereof in order to render it valid and enforceable.

 

(g) Non-Exclusive Arrangement: Contractor acknowledges that this is a non-exclusive arrangement and that this Agreement places no restrictions on Quest Diagnostics’ ability to refer laboratory testing to other laboratories and that Quest Diagnostics does not guarantee any minimum volume of specimens to be referred to Contractor for testing under this Agreement.

 

(h) Parties Bound: For purposes of this Agreement, “Quest Diagnostics” shall include all direct and indirect subsidiaries, business units or affiliates of Quest Diagnostics engaged in the laboratory services business in the continental United States in which Quest Diagnostics owns a majority of the equity interest. Any subsidiary or affiliate of Quest Diagnostics that is not a party to this Agreement shall have the option severally to join in the terms hereof by providing at least thirty (30) days written notice to Contractor. Quest Diagnostics may, at its option, obtain services pursuant to the terms hereof on behalf of laboratories for which it provides management services only.

 

(i) Relationship of the Parties: Nothing contained in this Agreement shall be construed as creating a joint venture, partnership, or employment relationship between the parties. Neither party is an agent of the other, and neither party has any authority whatsoever to bind the other party, by contract or otherwise.

 

(j) Force Majeure: Either party shall be excused from non-performance or delay in performance to the extent that such non-performance or delay in performance arises out of causes beyond the control and without the fault or negligence of the non-performing party. Such cases include, but are not limited to, acts of God, the public enemy or terrorism, acts of any government in either its sovereign or contractual capacity, fires, floods, epidemics, strikes or freight embargo. Each party shall promptly notify the other of any such circumstances and its probable duration as a result of which such party claims its inability to perform this Agreement.

 

(k) Section Headings: Section headings contained in this Agreement are for reference purposes only and shall not affect, in any way, the meaning and interpretation of this Agreement.

 

(l) Execution in Counterparts: This Agreement may be executed simultaneously in one or more counterparts, each of which shall be deemed an original, but all of which shall constitute the same instrument.

 

(m) Survival: The provisions of this Agreement which by their nature are intended to survive termination of this Agreement shall so survive, including the provisions of Sections 4, 8, 9, 10, 11 and 15.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

10


16. Medicare+Choice Regulations

 

(This Section applies only when patients served under this Agreement include Medicare+Choice Beneficiaries under contracted Medicare+Choice Benefit programs.)

 

(a) Compliance with Medicare+Choice. The terms and conditions herein are included to meet federal statutory and regulatory requirements of the federal Medicare+Choice Program under Part C of Title XVIII of the Social Security Act (“Medicare+Choice Program”). Notwithstanding Section 11, Contractor understands that the specific terms as set forth herein are subject to amendment in accordance with federal statutory and regulatory changes to the Medicare+Choice Program.

 

(b) Definitions: For the purposes of this Agreement, the following terms shall have the meanings set forth:

 

(1) “CMS” means the U.S. Centers for Medicare and Medicaid Services (formerly known as the Health Care Financing Administration).

 

(2) “Health Plans” shall mean those plans, which have entered into a Medicare+Choice Contract with CMS.

 

(3) “Medicare+Choice Contracts” means the agreements entered into between CMS and Health Plans pursuant to which Health Plans provide health care coverage to Medicare Covered Persons.

 

(4) “Medicare+Choice Regulations” means those regulations promulgated by CMS at 42 C.F.R. § 422.100 et. seq., as amended.

 

(5) “Medicare Covered Beneficiaries” means an individual who is entitled to receive benefits pursuant to Title XVIII of the Social Security Act and is enrolled in Health Plan pursuant to the Medicare Contract. The term “Covered Persons,” “Members” or “Enrollees” in the Agreement shall refer to Medicare Covered Persons unless the context clearly indicates otherwise.

 

(c) Compliance Requirements: Notwithstanding any other provisions in this Agreement, the following terms and conditions apply to laboratory services rendered under this Agreement.

 

(1) Quest Diagnostics delegates to Contractor its responsibility under its Medicare+Choice Contracts with Health Plans to provide the services set forth in the Agreement to Medicare Covered Persons. Quest Diagnostics or Healthplan may revoke this delegation, and thereby terminate the Agreement if Quest Diagnostics or Health Plan reasonably determines that Contractor has not performed satisfactorily. Such revocation shall be consistent with the termination provisions of the Agreement. Performance of Contractor shall be monitored by Quest Diagnostics and Health Plan on an ongoing basis. Contractor acknowledges that Health Plan shall oversee and is accountable to CMS for the functions and responsibilities described in the Medicare+Choice Program regulatory standards.

 

(2) Contractor agrees to comply, and to require any of its permitted subcontractors to comply, with all Medicare laws, the Medicare + Regulations and CMS instructions submitted. Further, Contractor agrees that any services provided by the Contractor or its subcontractors to Medicare Covered Persons, to the extent required by applicable laws and regulations, will be consistent with and will comply with Health Plan’s Medicare+Choice contractual obligations.

 

(3) Contractor agrees to maintain records, documents and any other information relating to Covered Persons and this Agreement for six (6) years or such longer period as required by law. Contractor acknowledges that Health and Human Services, the Comptroller General, or their designees have the right to audit, evaluate, or inspect any books, contracts, medical records, patient care documentation, and other records of Contractor, or its subcontractors or transferees involving transactions related to Quest Diagnostics’ Medicare+Choice contracts with Health Plans through 6 years from the final date of the contract period or from the date of

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

11


the completion of any audit, or for such longer period provided for in 42 CFR 422.502(e)(4) or other applicable law, whichever is later. Contractor agrees to make available its premises, physical facilities and equipment, records elating to its Medicare members and any additional relevant information.

 

(4) Contractor agrees to maintain records and other information with respect to Medicare Covered Persons in an accurate and timely manner; to ensure timely access by Medicare Covered Persons to the records and information that pertain to them; and to safeguard the privacy of any information that identifies a particular Medicare Covered Person in accordance with applicable laws and regulations and Medicare+Choice requirements. Contractor agrees to abide by all federal and state laws applicable to Contractor regarding confidentiality and disclosure for mental health records, medical records, other health information, and patient information.

 

(5) Contractor agrees to provide services in a manner consistent with professionally recognized standards of health care. Contractor agrees to provide services in a culturally competent manner to all enrollees. Contractor shall be paid for the services provided under this Agreement in the manner and at the rates contemplated by the Agreement. Contractor may obtain additional information by requesting same from Quest Diagnostics. The period for payment of fees by Quest Diagnostics is set forth in the Agreement.

 

(6) Contractor agrees to comply and cooperate with an independent quality review and improvement activities pertaining to the provision of services for Medicare Covered Persons. Contractor agrees to comply with Quest Diagnostics’ and/or Health Plan’s medical policies, quality assurance and performance improvement programs, and medical management programs. Contractor agrees to comply with all applicable Health Plan credentialing requirements. Contractor also agrees that the credentialing process will be reviewed by Health Plan and/or Quest Diagnostics and Health Plan and/or Quest Diagnostics will audit the process on an ongoing basis.

 

(7) Contractor agrees that in no event, including but not limited to nonpayment by Quest Diagnostics or Health Plan, insolvency of Quest Diagnostics or Health Plan or breach of the Agreement, shall the Contractor bill, charge, collect a deposit from, seek compensation, remuneration or reimbursement from, or have any recourse against a Medicare Beneficiary or persons or person acting on behalf of Medicare Beneficiary for services provided pursuant to the Agreement. Contractor agrees that in the event of Quest Diagnostics’ or Health Plan’s insolvency or other cessation of operations, services to Medicare Covered Persons will continue through the period CMS premiums have been paid to Health Plan. Contractor further agrees that (i) the Hold Harmless and Continuation of Benefits provisions shall survive the termination of the Agreement regardless of the cause giving rise to the termination and shall be construed to be for the benefit of the Medicare Covered Person, and that (ii) these provisions supersede any oral or written contrary agreement now existing or hereafter entered into between Contractor and a Medicare Covered Person or persons acting on their behalf that relates to liability for payment for, or continuation of, services provided under the terms and conditions of these clauses.

 

(8) Contractor acknowledges that the Agreement shall be terminated if Contractor, or a person with an ownership or control interest in Contractor, is excluded from participation in Medicare under Section 1128 or 1128A of the Social Security Act or from participation in any other federal health care program. Neither Contractor nor Quest Diagnostics may employ or subcontract with an individual, or with an entity that employs or contracts with an individual, who is excluded from participation in Medicare under Section 1128 or 1128A of the Social Security Act or from participation in a federal health care program.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

12


(9) Contractor acknowledges that payments Contractor receives from Quest Diagnostics to provide Covered Services to Medicare Covered Persons are, in whole or part, from federal funds. Contractor and any of its subcontractors are subject to certain laws that are applicable to individuals and entities receiving federal funds, including but not limited to, Title VI of the Civil Rights Act of 1964 as implemented by 45 CFR Part 84; The Age Discrimination Act of 1975 as implemented by 45 CFR Part 91; the Rehabilitation Act of 1973; and the Americans With Disabilities Act. Contractor shall not deny, limit or condition the furnishing of health care Covered Services to Medicare + Choice Beneficiaries on the basis of any factor that is related to health status or source of payment.

 

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement effective as of the Effective Date.

 

CONTRACTOR   QUEST DIAGNOSTICS INCORPORATED
By:  

/s/ William D. Young


  By:  

/s/ David M. Zewe


    (Signature)       (Signature)
   

William D. Young


     

David M. Zewe


    (Print Name)       (Print Name)
   

Chairman and CEO


     

Senior VP Operations


    (Title)       (Title)
   

April 29, 2004


     

April 29, 2004


    (Date)       (Date)

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13


EXHIBIT A

 

Volume based pricing per 12 month period

 

Number of PS/PSGT Billable Units

  [ * ]

PS/PSGT Pricing

  [ * ]

 

Other Pricing Features

 

  The parties agree that upon date of issuance of an updated policy guideline from AMA or other favorable coverage decision or action by a payor or group of payors which results in an increase in the reimbursement rates for Quest Diagnostics for the testing services listed on Exhibit A hereto they will negotiate in good faith to agree to pricing increase to the prices set forth herein be mutually agreed to. Quest Diagnostics will provide a quarterly report of its reimbursement rates for Contractor’s testing services throughout the term of this Agreement and any extension period. Quest Diagnostics will provide a quarterly report of its reimbursement rates for Contractor’s testing services throughout the term of this Agreement and any extension period.

 

  Volume pricing in any extension period shall be calculated as follows and shall begin at the lower price level of either: i) the volume discount level of the prior period’s volume for the total of the 12 month period or ii) a projected annualized volume rate based upon the last three months of the twelve month period immediately preceding the extension. For Example, if in the first twelve month term the total billable samples is [ * ] which would mean a price level of [ * ], however in months 10, 11 and 12, the monthly volumes were [ * ] respectively, the projected annualized volume for the extension year would be [ * ] therefore a price level of [ * ] would apply as it is a lower price. During the term of any extension period, the volume discount shall be adjusted on a quarterly basis to the price level of the projected annualized volume rate based upon the actual volume of the prior three months.

 

  Virologic agrees to provide Quest Diagnostics with 60 days advanced notice of any price tier changes.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

14


EXHIBIT B

 

Turn around time for PhenoSense and PhenoSense GT is fourteen days, from receipt at Contractor’s

laboratory to shipment of test results to Quest Diagnostics.

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

15


EXHIBIT C

 

STATES WHERE LICENSE, PERMIT OR CERTIFICATION NECESSARY

 

In addition to the certification set forth in Section 2(d), Contractor specifically represents that it currently maintains Required Approvals in the states identified in (1) below, and should Contractor perform tests referred to in (2) or (3) below, in the states referred to in (2) or (3) below for those tests.

 

(1) The state in which Contractor is domiciled, together with the States of Pennsylvania, Maryland, Florida, Rhode Island and New York.

 

(2) If Contractor performs HIV testing under this Agreement: North Carolina, Mississippi and West Virginia.

 

(3) If Contractor performs lead testing under this Agreement: Ohio

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

16


EXHIBIT D

 

Sample Collection and Handling Requirements for:

 

PhenoSense GTand PhenoSense HIV

 

This document describes the requirements for collection, handling, and shipment of blood

samples prior to testing in the PhenoSense HIV and PhenoSense GT assays. HIV RNA is

especially vulnerable to degradation, therefore proper collection and handling of blood specimens

is essential for successful performance of the assays. Samples with lower viral loads are more

susceptible to degradation than samples with higher viral loads.

 

Specimen Volume and Identification Requirements:

 

3.0 mL of plasma must be sent for optimal performance of the assays. Either sterile PPT (pearl top) or tubes containing EDTA (lavender top) may be used for sample collection.

 

Proper identification of specimens is extremely important. Confirm patient identification and print the patient’s first and last name or unique identifier as they appear on the test request form on the tubes in the patient’s presence. The patient’s name or unique identifier on the specimen must be identical to the patient’s name on the test request form.

 

Please indicate on the test request form the patient’s most recent viral load with viral load collection date. For best results, viral loads should be confirmed within the two weeks prior to submission for testing at ViroLogic. NOTE: PhenoSense GT, PhenoSense HIV assays are intended for use only for patients with viral loads greater than or equal to 500 copies/mL.

 

Sample Collection and Processing:

 

Draw whole blood into either two 5.0 mL PPT (pearl top) or tubes containing EDTA anticoagulant (lavender top).

 

Immediately centrifuge blood (within 2 hours of collection) at 1000-1200 x g at room temperature (18 – 25o C) for 10-15 minutes.

 

Do not allow samples to remain in centrifuge after centrifugation.

 

For EDTA samples: after centrifugation, immediately remove plasma from cells and transfer to a screw cap top tube.

 

Immediately after centrifugation, freeze plasma sample at or below - 20o C in a standard laboratory freezer. Sample should be frozen when courier arrives to pick it up.

 

DO NOT THAW SAMPLE AFTER FREEZING!

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

17

EX-31.1 3 dex311.htm SECTION 302 CEO CERTIFICATION Section 302 CEO Certification

EXHIBIT 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO RULE 13A-14(A) OR RULE 15D-14(A)

PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

I, William D. Young, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of ViroLogic, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) [Paragraph reserved pursuant to SEC Release 33-8238];

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 13, 2004.

/s/ William D. Young


William D. Young

Chief Executive Officer

EX-31.2 4 dex312.htm SECTION 302 CFO CERTIFICATION Section 302 CFO Certification

EXHIBIT 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO RULE 13A-14(A) OR RULE 15D-14(A)

PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

I, Karen J. Wilson, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of ViroLogic, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) [Paragraph reserved pursuant to SEC Release 33-8238];

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 13, 2004.

/s/ Karen J. Wilson


Karen J. Wilson

Chief Financial Officer

EX-32.1 5 dex321.htm SECTION 906 CEO & CFO CERTIFICATIONS Section 906 CEO & CFO Certifications

EXHIBIT 32.1

 

CERTIFICATION OF

CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350 AND

RULE 13A-14(B) OR RULE 15D-14(B)

PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934.

 

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. Section 1350), William D. Young, the Chief Executive Officer of ViroLogic, Inc. (the “Company”), and Karen J. Wilson, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:

 

1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2004, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of, and for, the periods presented in the Report.

 

Dated: August 13, 2004.        

/s/ William D. Young


     

/s/ Karen J. Wilson


William D. Young

     

Karen J. Wilson

Chief Executive Officer

     

Chief Financial Officer

-----END PRIVACY-ENHANCED MESSAGE-----