UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON DC 20549

 


 

FORM 10-Q

 


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

 

For the quarterly period ended March 31,September 30, 2003

 

OR

 

x¨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: 0-29975

 


ACLARA BioSciences, Inc.

(Exact name of registrant as specified in its charter)

 


Delaware

 

94-3222727

(State of incorporation)

 

(IRS Employer Identification Number)

 

1288 Pear Avenue

Mountain View, California 94043

(Address of principal executive offices and zip code)

 

650-210-1200

(Registrant’s telephone number, including area code)


 

Indicate by check mark whether 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.    YESx    NO¨.

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

 

The number of shares outstanding of the registrant’s common stock as of April 30,November 8, 2003 was 35,463,049.35,810,932.

 



ACLARA BIOSCIENCES, INC.

 

TABLE OF CONTENTS

 

         

PAGE



Part I:

  

Financial Information

   
   

Item 1.

  

Financial Statements (Unaudited)

   
      

Condensed Balance Sheets as of March 31,September 30, 2003 and December 31, 2002

  

3

      

Condensed Statements of Operations for the Three and Nine Months Ended March 31,September 30, 2003 and 2002 and for the
Cumulative Period From May 5, 1995 (Inception) to March 31,September 30, 2003

  

4

      

Condensed Statements of Cash Flows for the ThreeNine Months Ended March 31,September 30, 2003 and 2002 and for the Cumulative Period from May 5, 1995 (Inception) to March 31,September 30, 2003

  

5

      

Notes to Condensed Financial Statements

  

6

   

Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

10

   

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

  

18

   

Item 4.

  

Controls and Procedures

  

18

Part II:

  

Other Information

   
   

Item 1.

  

Legal Proceedings

  

18

   

Item 2.

  

Changes in Securities and Use of Proceeds

  

18

   

Item 3.

  

Defaults upon Senior Securities

  

18

   

Item 4.

  

Submission of Matters to a Vote of Security Holders

  

19

   

Item 5.

  

Other Information

  

19

   

Item 6.

  

Exhibits and Reports on Form 8-K

  

19

Signatures

  

22

Certifications

23

PART I—I – FINANCIAL INFORMATION

 

ITEM 1. Financial Statements

 

ACLARA BIOSCIENCES, INC.

(A Development Stage Enterprise)

 

CONDENSED BALANCE SHEETS

(In Thousands, Except Share and Per Share Amounts)

(Unaudited)

 

  

March 31, 2003


   

December 31, 2002


   

September 30,

2003


  December 31,
2002


 

ASSETS

           

Current assets:

           

Cash and cash equivalents

  

$

76,368

 

  

$

38,006

 

  $34,088  $38,006 

Restricted cash

  

 

—  

 

  

 

34,125

 

   —     34,125 

Short-term marketable investments

  

 

7,756

 

  

 

12,842

 

   32,962   12,842 

Accounts receivable

  

 

172

 

  

 

469

 

   302   469 

Prepaid expenses and other current assets

  

 

309

 

  

 

422

 

   557   422 

Inventories

  

 

2,780

 

  

 

2,780

 

   2,767   2,780 
  


  


  


 


Total current assets

  

 

87,385

 

  

 

88,644

 

   70,676   88,644 

Long-term marketable investments

  

 

17,158

 

  

 

21,612

 

   26,105   21,612 

Property and equipment, net

  

 

6,833

 

  

 

7,098

 

   6,153   7,098 

Other assets, net

  

 

1,511

 

  

 

1,564

 

   1,404   1,564 
  


  


  


 


Total assets

  

$

112,887

 

  

$

118,918

 

  $104,338  $118,918 
  


  


  


 


LIABILITIES & STOCKHOLDERS’ EQUITY     

LIABILITIES & STOCKHOLDERS’ EQUITY

      

Current liabilities:

           

Accounts payable

  

$

896

 

  

$

689

 

  $623  $689 

Accrued payroll and related expenses

  

 

1,056

 

  

 

1,023

 

   1,099   1,023 

Accrued expenses and other current liabilities

  

 

1,667

 

  

 

1,357

 

   2,902   1,357 

Deferred revenue

  

 

75

 

  

 

104

 

   206   104 

Restructuring accrual

  

 

29

 

  

 

501

 

   —     501 

Current portion of loans payable

  

 

206

 

  

 

202

 

   196   202 
  


  


  


 


Total current liabilities

  

 

3,929

 

  

 

3,876

 

   5,026   3,876 

Loans payable, net of current portion

  

 

489

 

  

 

542

 

   399   542 

Deferred rent

  

 

433

 

  

 

414

 

   459   414 
  


  


  


 


Total liabilities

  

 

4,851

 

  

 

4,832

 

   5,884   4,832 
  


 


Contingencies (Note 3)

           

Stockholders’ equity:

           

Common stock, $0.001 par value:

           

Authorized 150,000,000 shares; Issued and outstanding: 35,463,049 shares at March 31, 2003 and 35,391,018 shares at December 31, 2002

  

 

36

 

  

 

36

 

Treasury stock at cost (900,000 shares at March 31, 2003 and December 31, 2002)

  

 

(1,350

)

  

 

(1,350

)

Authorized 150,000,000 shares; Issued and outstanding: 35,723,494 shares at September 30, 2003 and 35,391,018 shares at December 31, 2002

   36   36 

Treasury stock at cost (900,000 shares at September 30, 2003 and December 31, 2002)

   (1,350)  (1,350)

Additional paid-in capital

  

 

258,773

 

  

 

258,798

 

   259,110   258,798 

Deferred stock-based compensation

  

 

(415

)

  

 

(627

)

   (108)  (627)

Accumulated other comprehensive income

  

 

290

 

  

 

297

 

   126   297 

Deficit accumulated during development stage

  

 

(149,298

)

  

 

(143,068

)

   (159,360)  (143,068)
  


  


  


 


Total stockholders’ equity

  

 

108,036

 

  

 

114,086

 

   98,454   114,086 
  


  


  


 


Total liabilities and stockholders’ equity

  

$

112,887

 

  

$

118,918

 

  $104,338  $118,918 
  


  


  


 


 

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

ACLARA BIOSCIENCES, INC.

(A Development Stage Enterprise)

 

CONDENSED STATEMENTS OF OPERATIONS

(In Thousands, Except Share and Per Share Amounts)

(Unaudited)

 

  

Three Months Ended March 31,


   

Cumulative Period from May 5, 1995 (Inception) to March 31, 2003


   

Three Months Ended

September 30


  

Nine Months Ended

September 30


  

Cumulative

Period from

May 5, 1995

(Inception) to

September 30

2003


 
  

2003


   

2002


     2003

  2002

  2003

  2002

  

Revenues

  

$

179

 

  

$

590

 

  

$

18,067

 

  $276  $505  $860  $1,768  $18,748 
  


  


  


  


 


 


 


 


Costs and operating expenses:

                    

Research and development

  

 

4,350

 

  

 

6,392

 

  

 

91,170

 

   3,847   5,516   12,264   18,576   99,084 

Selling, general and administrative

  

 

2,499

 

  

 

2,833

 

  

 

50,283

 

   1,714   3,318   6,122   9,229   53,906 

Litigation settlement

  

 

—  

 

  

 

1,534

 

  

 

44,002

 

   —     396   —     3,740   44,002 

Restructuring

  

 

—  

 

  

 

—  

 

  

 

3,327

 

   —     3,327   —     3,327   3,327 
  


  


  


  


 


 


 


 


Total costs and operating expenses

  

 

6,849

 

  

 

10,759

 

  

 

188,782

 

   5,561   12,557   18,386   34,872   200,319 
  


  


  


  


 


 


 


 


Loss from operations

  

 

(6,670

)

  

 

(10,169

)

  

 

(170,715

)

   (5,285)  (12,052)  (17,526)  (33,104)  (181,571)

Interest income

  

 

455

 

  

 

1,093

 

  

 

23,167

 

   377   873   1,277   3,004   23,989 

Interest expense

  

 

(15

)

  

 

(12

)

  

 

(1,269

)

   (13)  (13)  (43)  (38)  (1,297)
  


  


  


  


 


 


 


 


Net loss

  

 

(6,230

)

  

 

(9,088

)

  

 

(148,817

)

   (4,921)  (11,192)  (16,292)  (30,138)  (158,879)
  


  


  


Dividends related to beneficial conversion feature of preferred stock

  

 

—  

 

  

 

—  

 

  

 

(5,000

)

   —     —     —     —     (5,000)

Accretion to redemption value and accrued dividends on mandatory redeemable convertible preferred stock

  

 

—  

 

  

 

—  

 

  

 

(6,292

)

   —     —     —     —     (6,292)
  


  


  


  


 


 


 


 


Net loss attributable to common stockholders

  

$

(6,230

)

  

$

(9,088

)

  

$

(160,109

)

  $(4,921) $(11,192) $(16,292) $(30,138) $(170,171)
  


  


  


  


 


 


 


 


Net loss per common share, basic and diluted

  $(0.14) $(0.31) $(0.46) $(0.84)  

Net loss per common share, basic and diluted

  

$

(0.18

)

  

$

(0.25

)

   

Weighted average shares used in net loss per common share calculation, basic and diluted

  

 

35,445

 

  

 

35,860

 

      35,681   36,148   35,564   36,020   

 

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

ACLARA BIOSCIENCES, INC.

(A Development Stage Enterprise)

 

CONDENSED STATEMENTS OF CASH FLOWS

(In Thousands)

(Unaudited)

(in thousands)

   

Three Months Ended March 31,


   

Cumulative Period from May 5, 1995 (Inception) to March 31,


 
   

2003


   

2002


   

2003


 

CASH FLOWS FROM OPERATING ACTIVITIES:

               

Net loss

  

$

(6,230

)

  

$

(9,088

)

  

$

(148,817

)

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

               

Depreciation and amortization

  

 

456

 

  

 

493

 

  

 

6,217

 

Amortization of discount on marketable investments

  

 

32

 

  

 

(192

)

  

 

(3,104

)

Amortization of note and long-term debt discount

  

 

—  

 

  

 

—  

 

  

 

597

 

Amortization of deferred stock based compensation

  

 

156

 

  

 

361

 

  

 

12,550

 

Loss on sale of fixed assets

  

 

—  

 

  

 

—  

 

  

 

45

 

Amortization of other assets

  

 

54

 

  

 

13

 

  

 

190

 

Preferred stock issued for interest expense

  

 

—  

 

  

 

—  

 

  

 

128

 

Non-cash restructuring charge

  

 

—  

 

  

 

—  

 

  

 

2,467

 

Interest income from notes receivable from stockholders

  

 

—  

 

  

 

(9

)

  

 

(86

)

Revaluation of litigation settlement

  

 

—  

 

  

 

1,534

 

  

 

10,350

 

Changes in assets and liabilities:

               

Accounts receivable

  

 

296

 

  

 

1,058

 

  

 

(172

)

Prepaid expenses and other current assets

  

 

114

 

  

 

251

 

  

 

(333

)

Inventories

  

 

1

 

  

 

—  

 

  

 

(2,765

)

Accounts payable

  

 

205

 

  

 

(301

)

  

 

897

 

Accrued payroll and related expenses

  

 

33

 

  

 

(123

)

  

 

1,055

 

Accrued expenses and other liabilities

  

 

311

 

  

 

864

 

  

 

1,666

 

Restructuring accrual

  

 

(472

)

  

 

—  

 

  

 

29

 

Litigation settlement

  

 

—  

 

  

 

—  

 

  

 

1,350

 

Deferred revenue

  

 

(30

)

  

 

(35

)

  

 

74

 

Deferred rent

  

 

18

 

  

 

28

 

  

 

431

 

   


  


  


Net cash used in operating activities

  

 

(5,056

)

  

 

(5,146

)

  

 

(117,231

)

   


  


  


CASH FLOWS FROM INVESTING ACTIVITIES:

               

Acquisition of property and equipment

  

 

(294

)

  

 

(898

)

  

 

(13,785

)

Sales of property and equipment

  

 

106

 

  

 

1

 

  

 

175

 

Change in restricted cash

  

 

34,125

 

  

 

—  

 

  

 

(125

)

Purchase of investments

  

 

(16,000

)

  

 

(44,921

)

  

 

(465,909

)

Sales and maturities of investments

  

 

25,500

 

  

 

36,817

 

  

 

444,388

 

Change in other assets

  

 

—  

 

  

 

—  

 

  

 

(1,597

)

   


  


  


Net cash (used in) provided by investing activities

  

 

43,437

 

  

 

(9,001

)

  

 

(36,853

)

   


  


  


CASH FLOWS FROM FINANCING ACTIVITIES:

               

Principal payments for leasehold obligations

  

 

(15

)

  

 

—  

 

  

 

(1,572

)

Principal payments under capital lease obligations

  

 

(37

)

  

 

—  

 

  

 

(102

)

Proceeds from issuance of notes payable to related parties

  

 

—  

 

  

 

—  

 

  

 

2,487

 

Proceeds from issuance of loans payable

  

 

—  

 

  

 

—  

 

  

 

4,365

 

Repayments of loans payable

  

 

—  

 

  

 

(14

)

  

 

(3,943

)

Proceeds from issuance of preferred stock, net of issuance costs

  

 

—  

 

  

 

—  

 

  

 

29,889

 

Principal payments for notes payable to related parties

  

 

—  

 

  

 

—  

 

  

 

(119

)

Repurchase of Series A preferred stock and one share of common stock

  

 

—  

 

  

 

—  

 

  

 

(2,713

)

Proceeds from initial public offering, net of issuance costs

  

 

—  

 

  

 

—  

 

  

 

201,003

 

Proceeds from notes receivable from stockholders

  

 

—  

 

  

 

7

 

  

 

709

 

Proceeds from issuance of common stock

  

 

32

 

  

 

52

 

  

 

1,797

 

Repurchase of common stock

  

 

—  

 

  

 

—  

 

  

 

(1,350

)

   


  


  


Net cash (used in) provided by financing activities

  

 

(20

)

  

 

45

 

  

 

230,451

 

Net increases (decreases) in cash and cash equivalents

  

 

38,361

 

  

 

(14,102

)

  

 

76,367

 

Cash and cash equivalents, beginning of period

  

 

38,006

 

  

 

30,970

 

  

 

—  

 

   


  


  


Cash and cash equivalents, end of period

  

$

76,367

 

  

$

16,868

 

  

$

76,367

 

   


  


  


   

Nine Months Ended

September 30


  

Cumulative

Period from

May 5, 1995

(Inception) to

September 30

2003


 
   2003

  2002

  

CASH FLOWS FROM OPERATING ACTIVITIES

             

Net loss

             

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

  $(16,292) $(30,138) $(158,879)

Depreciation and amortization

   1,432   1,413   7,193 

Amortization of discount on marketable investments

   (48)  (309)  (3,184)

Amortization of note and long-term debt discount

       —     597 

Amortization of deferred stock based compensation

   451   959   12,845 

Loss on sale of fixed assets

   25   2,488   70 

Amortization of other assets

   161   24   297 

Preferred stock issued for interest expense

       —     128 

Non-cash restructuring charge

       —     2,467 

Interest income from notes receivable from stockholders

       (25)  (86)

Revaluation of litigation settlement

       3,740   10,350 

Changes in assets and liabilities:

             

Accounts receivable

   166       (302)

Prepaid expenses and other current assets

   (134)  1,367   (557)

Inventories

   13   (39)  (2,767)

Accounts payable

   (66)  (252)  623 

Accrued payroll and related expenses

   76   156   1,099 

Accrued expenses and other liabilities

   1,547   1,307   2,902 

Restructuring accrual

   (501)  839   0 

Litigation settlement

       —     1,350 

Deferred revenue

   102   (265)  206 

Deferred rent

   45   74   459 
   


 


 


Net cash used in operating activities

   (13,023)  (18,661)  (125,189)
   


 


 


CASH FLOWS FROM INVESTING ACTIVITIES

             

Acquisition of property and equipment

   (597)      (14,222)

Sales of property and equipment

   73   (1,874)  142 

Change in restricted cash

   34,125   38   —   

Purchase of investments

   (74,881)  500   (524,790)

Sales and maturities of investments

   50,145   58,344   469,033 

Change in other assets

       —     (1,597)
   


 


 


Net cash provided by (used in) investing activities

   8,865   57,008   (71,434)
   


 


 


CASH FLOWS FROM FINANCING ACTIVITIES:

             

Principal payments for leasehold obligations

   (45)  —     (1,602)

Principal payments under capital lease obligations

   (95)  (24)  (160)

Proceeds from issuance of notes payable to related parties

       —     2,487 

Proceeds from issuance of loans payable

       (41)  4,365 

Repayments of loans payable

       —     (3,943)

Proceeds from issuance of preferred stock, net of issuance costs

       —     29,889 

Principal payments for notes payable to related parties

       —     (119)

Repurchase of Series A preferred stock and one share of common stock

       —     (2,713)

Proceeds from initial public offering, net of issuance costs

       —     201,003 

Proceeds from notes receivable from stockholders

       7   709 

Proceeds from issuance of common stock

   380   302   2,145 

Repurchase of common stock

       —     (1,350)
   


 


 


Net cash provided by financing activities

   240   244   230,711 

Net increases (decreases) in cash and cash equivalents

   (3,918)  38,591   34,088 

Cash and cash equivalents, beginning of period

   38,006   30,970   —   
   


 


 


Cash and cash equivalents, end of period

  $34,088  $69,561  $34,088 
   


 


 


 

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

ACLARA BIOSCIENCES, INC.

(A Development Stage Enterprise)

 

NOTES TO CONDENSED FINANCIAL STATEMENTS

(Unaudited)

 

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial statements and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments consisting of normal recurring adjustments necessary for a fair presentation of the interim financial information for ACLARA BioSciences, Inc. (“ACLARA”). Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for the presentation of complete financial statements. The preparation of interim financial statements in conformity with generally accepted accounting principals requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from these estimates.

 

This Form 10-Q should be read in conjunction with the financial statements and notes thereto included in ACLARA’s Form 10-K for the year ended December 31, 2002, as filed with the Securities and Exchange Commission. Furthermore, interim results of operations are not necessarily indicative of the results that may be expected for the entire year or for other interim periods.

 

Comprehensive Income

 

Comprehensive income generally represents all changes in stockholders’ equity (deficit) except those resulting from investments or contributions by stockholders. ACLARA’s unrealized gains on available-for-sale securities represent the only component of comprehensive income that is excluded from ACLARA’s net loss for the three and nine months ended March 31,September 30, 2003 and 2002 and for the cumulative period from May 5, 1995 (date of inception) to March 31,September 30, 2003. As this component of comprehensive income is not significant, individually or in the aggregate, no separate statements of comprehensive income have been presented.

 

Net Loss Per Share

 

Basic earnings per share is calculated based on the weighted-average number of common shares outstanding during the period. Diluted earnings per share would give effect to the dilutive effect of common stock equivalents consisting of stock options and warrants (calculated using the treasury stock method) and common stock subject to repurchase. Potentially dilutive securities have been excluded from the diluted earnings per share computations as they have an antidilutive effect due to ACLARA’s net loss.

 

A reconciliation of shares used in the calculations is as follows (in thousands, except per share data):

 

  

Three Months Ended March 31,


   Three Months Ending
September 30,


  Nine Months Ended
September 30,


 
  

2003


   

2002


   2003

  2002

  2003

  2002

 

Basic and diluted:

               

Net loss

  

$

(6,230

)

  

$

(9,088

)

  $(4,921) $(11,192) $(16,292) $(30,138)
  


  


  


 


 


 


Weighted average shares of common stock outstanding

  

 

35,445

 

  

 

35,934

 

   35,681   36,170   35,564   36,064 

Less: weighted average shares subject to repurchase

  

 

—  

 

  

 

(74

)

   —     (22)  —     (44)
  


  


  


 


 


 


Weighted-average shares of common stock used in basic and diluted net loss per share calculations

  

 

35,445

 

  

 

35,860

 

   35,681   36,148   35,564   36,020 
  


  


  


 


 


 


Net loss per common share—basic and diluted

  

$

(0.18

)

  

$

(0.25

)

Net loss per common share – basic and diluted

  $(0.14) $(0.31) $(0.46) $(0.84)
  


  


  


 


 


 


The following outstanding options and warrants (prior to the application of the treasury stock method), were excluded from the computation of diluted net loss per share as they had an anti-dilutiveantidilutive effect (in thousands):

 

  

Three Months Ended March 31,


  Three Months
Ended
September 30,


  Nine Months
Ended
September 30,


  

2003


  

2002


  2003

  2002

  2003

  2002

Options

  

4,171

  

2,984

  4,216  3,407  4,216  3,407

Warrants

  

276

  

276

  139  274  139  274

 

Accounting for Stock-Based Compensation

��

ACLARA accounts for stock-based employee compensation arrangements in accordance with the provisions of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB No. 25”) and its related interpretations and has elected to follow the disclosure-only provisions of Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS No. 123”). Under APB No. 25, compensation expense is based on the difference, if any, on the date of the stock option grant between the fair value of ACLARA’s stock and the exercise price of the stock option.

 

The Company has adopted SFAS No. 148, “Accounting for Stock-Based Compensation, Transition and Disclosure.” Had compensation cost for stock-based employee compensation arrangements been determined based on the fair value at the date of the awards consistent with the provisions of SFAS No. 123, the impact on ACLARA’s net loss would be as follows (in thousands, except per share data):

 

  

Three Months Ended March 31,


   Three Months Ended
September 30,


  Nine Months Ended
September 30,


 
  

2003


   

2002


   2003

  2002

  2003

  2002

 

Net loss attributable to common stockholders:

               

As reported

  

$

(6,230

)

  

$

(9,088

)

  $(4,921) $(11,192) $(16,292) $(30,138)

Add: Stock-based compensation expense included in reported net loss

  

 

156

 

  

 

361

 

   146   254   451   959 

Deduct: Total stock-based compensation expense determined under fair value based method for all awards

  

 

(514

)

  

 

(814

)

   (762)  (599)  (1,941)  (2,142)
  


  


  


 


 


 


Pro forma net loss

  

$

(6,588

)

  

$

(9,541

)

  $(5,537) $(11,537) $(17,782) $(31,321)
  


  


  


 


 


 


Net loss per share:

               

Basic—as reported

  

$

(0.18

)

  

$

(0.25

)

  $(0.14) $(0.31) $(0.46) $(0.84)

Basic—pro forma

  

$

(0.19

)

  

$

(0.27

)

Diluted—as reported

  

$

(0.18

)

  

$

(0.25

)

  $(0.14) $(0.31) $(0.46) $(0.84)

Diluted—pro forma

  

$

(0.19

)

  

$

(0.27

)

 

ACLARA accounts for equity instruments issued to non-employees based on fair value in accordance with the provisions of SFAS No. 123 and Emerging Issues Task Force Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.”

 

Recent Accounting Developments

 

In January 2003,May 2002, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 46 (“FIN 46”), “Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51.” FIN 46 requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective immediately for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46 must be applied for the first interim or annual period beginning after June 15, 2003. The Company believes that the adoption of this standard will have no material impact on its financial statements.

In November 2002, the FASB issued Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others.” Interpretation No. 45 requires a Company, at the time it issues a guarantee, to recognize an initial liability for the fair value of obligations assumed under the guarantee and elaborates on existing disclosure requirements. The disclosure requirements of FIN 45 are effective for financial statements of interim or annual periods ending after December 15, 2002. Agreements that we have determined to be within the scope of FIN 45 include indemnification arrangements with officers and directors and indemnification arrangements with customers with respect to

intellectual property. To date, we have not incurred material costs, if any, in relation to any of the above guarantees and, accordingly, adoption of this standard did not have a material impact on our financial position, results or operations or cash flows.

In November 2002, the Emerging Issues Task Force (EITF) issued Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. EITF issue No. 00-21 addresses determination of whether an arrangement involving more than one deliverable contains more than one unit of accounting and how arrangement consideration should be measured and allocated to the separate units of accounting. EITF Issue No. 00-21 will be effective for revenue arrangements entered into in fiscal periods beginning after June 15, 2003 or the Company may elect to report the change in accounting as a cumulative-effect adjustment. The Company believes that the adoption of this standard will have no material impact on its financial statements.

In May 2002, the FASB issued SFAS No. 145, “Rescission of SFAS Nos. 4, 44, 64, Amendment of SFAS 13, and Technical Corrections as of April 2002.” SFAS No. 145 rescinds SFAS No. 4, “Reporting Gains and Losses from Extinguishment of Debt,” which required that gains and losses from extinguishment of debt that were included in the determination of net income be aggregated and, if material, classified as an extraordinary item, net of the related income tax effect. Under SFAS No. 145, gains or losses from extinguishment of debt should be classified as extraordinary items only if they meet the criteria in Accounting Principal’s Board Opinion No. 30 (“APB 30”), “Reporting the Results of Operations—Operations - Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions”. Applying the criteria in APB 30 will distinguish transactions that are part of an entity’s recurring operations from those that are unusual or infrequent or that meet the criteria for classification as an extraordinary item. The Company adopted SFAS No. 145 on January 1, 2003. The losses of $1.1 million on early extinguishment of debt obligations that were classified as extraordinary items in prior periods presented that did not meet the criteria of APB 30 for classification as extraordinary items were reclassified to lossgeneral and administrative from operations.

2. RESTRICTED CASH

 

Current restrictedRestricted cash at December 31, 2002 comprised $34.1 million held in escrow as part of its settlement of litigation with Caliper Technologies Corporation (“Caliper”). Pursuant to the Caliper settlement agreement, ACLARA provided a letter of credit to Caliper in the amount of $32.5 million as a guarantee of ACLARA’s performance. The banking institution that had issued the letter of credit required ACLARA to maintain a balance of 105% of the letter of credit amount in a segregated account. This amount of $34.1 million was invested in short-term US government agency debt and money market funds. On February 15, 2003 the letter of credit was terminated and the restricted cash was released.

 

3. LITIGATION SETTLEMENT AND CONTINGENCIES

 

As part of the litigation settlement with Caliper, 900,000 shares of ACLARA common stock were issued in March 2001 with a guaranteed liquidation price of $36.11 per share if Caliper sold the shares after August 21, 2002 but before February 21, 2003. ACLARA initially valued the put obligation associated with these shares at $20.8 million. Based on the change in ACLARA’s stock price and in accordance with EITF No. 96-13 “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock” (“EITF No. 96-13”) and its related interpretations, and Statement of Financial Accounting Standards No. 133, “Accounting for Derivatives Instruments and Hedging Activities” (“SFAS 133”), the put obligation was subsequently revalued at the end of each reporting period prior to its settlement in October 2002. The revaluation of the put obligation used a Black-Scholes pricing model with changes in valuation being recorded in the Statements of Operations. At December 31, 2001, March 31, 2002, June 30, 2002 and September 30, 2002, the put obligation had a value of $27.2 million, $28.7 million, $30.5 million, and $30.9 respectively. As a result of these revaluations and the eventual settlement, in October 2002, revaluation expenses of $4.0 million and $6.4 million were recorded in the years ended December 31, 2002 and 2001, respectively, and revaluation expense of $1.5$3.7 million and $5.2 million, respectively was recorded in the accompanying Statement of Operations for the three and nine months ended March 31,September 30, 2002. In October 2002, we paid Caliper $32.5 million related to this settlement. Of this amount approximately $1.4 million was for the repurchase at the then-current market price of the 900,000 shares previously issued to Caliper in the original settlement agreement. Accordingly, no revaluation adjustments are applicable in periods after December 31, 2002.

 

In August 2000, ACLARA entered into a settlement and release with Rodenstock North America (“Rodenstock”) (formerly 2C Optics) relating to a dispute arising out of ACLARA’s repurchase of its Series A Preferred Stock from Rodenstock in 1999. The settlement agreement was approved by the board of directors of Rodenstock and a majority of Rodenstock’s outstanding shares entitled to vote on the matter. On April 27, 2001, S&A Biotech Investments, LLC (“S&A”), a stockholder of Rodenstock, filed a shareholder derivative suit in the Superior Court of California for the County of Santa Clara, naming the directors of Rodenstock as individual defendants, Rodenstock as a nominal defendant, and ACLARA as a defendant. S&A alleges breach of fiduciary duties by Rodenstock and the individual defendants, including Thomas Baruch, who was the chairman of the boards of ACLARA and Rodenstock, in connection with the August 2000 settlement between ACLARA and Rodenstock. S&A also asserts a claim against ACLARA for allegedly aiding and abetting the purported breach of fiduciary duty by Rodenstock and

Rodenstock’s directors. Among other remedies, S&A seeks rescission of the settlement agreement and the above-referenced stock repurchase. ACLARA filed its demurrer, and Rodenstock and Mr. Baruch filed their demurrers and notices of summary judgment, which were heard in April 2002. The Court denied all demurrers, but granted Rodenstock and Mr. Baruch’s notice for summary judgment. Plaintiff has dismissed without prejudice its claim against ACLARA, while it considers appealingappealed the judgment for the other defendants. In September 2003 plaintiff’s appeal was rejected. We believe that the time period within which the plaintiff had to appeal this latter decision of the appeals court has expired, and that no further appeal is therefore possible. Accordingly ACLARA does not believe that it will have any liability from this litigation.

 

ACLARA and certain of its current or former officers and directors (the “ACLARA defendants”) are named as defendants in a securities class action lawsuit filed in the United States District Court for the Southern District of New York. This action, which was filed on November 13, 2001 and is now captionedACLARA Biosciences, Inc. Initial Public Offering Securities Litigation, also names several of the underwriters involved in ACLARA’s initial public offering (“IPO”) as defendants. This class action is brought on behalf of a purported class of purchasers of ACLARA common stock from the time of ACLARA’s IPO (March 20, 2000) through December 6, 2000. The central allegation in this action is that the underwriters in the ACLARA IPO solicited and received undisclosed commissions from, and entered into undisclosed arrangements with, certain investors who purchased ACLARA stock in the IPO and the after-market. The complaint also alleges that the ACLARA defendants violated the federal securities laws by failing to disclose in the IPO prospectus that the underwriters had engaged in these allegedly undisclosed arrangements. (MoreMore than 300 issuers who went public between 1998 and 2000 have been named in similar lawsuits.) In July 2002, an omnibus motion to dismiss all complaints against issuers and individual defendants affiliated with issuers (including

(including ACLARA defendants) was filed by the entire group of issuer defendants in these similar actions. On February 19, 2003, the Court in this action issued its decision on Defendant’s omnibus motion to dismiss. This decision dismissed the Section 10(b) claim as to ACLARA but denied the motion to dismiss Section 11 claim as to ACLARA and virtually all of the other defendants. On June 26, 2003, the plaintiffs in the consolidated class action lawsuits announced a proposed settlement with us and the other issuer defendants. The proposed settlement, which has been approved by our board of directors, provides that the insurers of all settling issuers will guarantee that the plaintiffs recover $1 billion from non-settling defendants, including the investment banks who acted as underwriters in those offerings. In the event that the plaintiffs do not recover $1 billion, the insurers for the settling issuers will make up the difference. Under the proposed settlement, the maximum amount that could be charged to our insurance policy in the event that the plaintiffs recovered nothing from the investment banks would be approximately $3.9 million. We believe that we have sufficient insurance coverage to cover the maximum amount that we may be responsible for under the proposed settlement. It is possible that the parties may not reach agreement on the final settlement documents or that the Federal District Court may not approve the settlement in whole or part. If a final settlement is not reached or is not approved by the court, ACLARA believes it has meritorious defenses and intends, in that event, to vigorously defend itself against thisthe suit. As a result of this belief, no liability for this suit has been recorded in the accompanying financial statements. However, we could be forced to incur significant expenses in the litigation, and in the event there is an adverse outcome, our business could be harmed.

 

4. RESTRUCTURING

 

During the third quarter of 2002 ACLARA initiated a restructuring plan to streamline its operations, reduce costs associated with the microfluidics aspect of our business and increase our focus on oureTag assay chemistry. Accordingly, we recognized a restructuring charge of $3.3 million during the third quarter of 2002, including $0.8 million of severance and related costs related to the reduction of our employment level by over 50 employees. This reduction was phased in over the second half of 2002 and primarily affected the microfluidics area of our business, where essentially all of our active programs were eliminated. Termination benefits related to severance packages, out-placement services and other associated costs are included in restructuring expense on the statement of operations and restructuring accrual on thethere was no remaining balance sheet at March 31,September 30, 2003. We also wrote off approximately $2.5 million of fixed assets that are not expected to be used prospectively.

 

The following table sets forth an analysis of the components of the restructuring charges (in thousands):

 

  

Severance and Benefits


   

Fixed Assets


   

Other Charges


   

Total


   Severance
and Benefits


  Fixed
Assets


  Other
Charges


  Total

 

Restructuring provision:

                     

Severance and benefits

  

$

753

 

  

$

—  

 

  

$

—  

 

  

$

753

 

  $753  $—    $—    $753 

Property and equipment write off

  

 

—  

 

  

 

2,467

 

  

 

—  

 

  

 

2,467

 

   —     2,467   —     2,467 

Other charges

  

 

—  

 

  

 

—  

 

  

 

107

 

  

 

107

 

   —     —     107   107 
  


  


  


  


  


 


 


 


Total

  

$

753

 

  

$

2,467

 

  

$

107

 

  

$

3,327

 

  $753  $$2,467  $107  $3,327 

Non-cash charges

  

 

—  

 

  

 

(2,467

)

  

 

—  

 

  

 

(2,467

)

   —     (2,467)  —     (2,467)

Cash paid

  

 

(280

)

  

 

—  

 

  

 

(79

)

  

 

(359

)

   (280)  —     (79)  (359)
  


  


  


  


  


 


 


 


Reserve balance at December 31, 2003

  

$

473

 

  

$

—  

 

  

$

28

 

  

$

501

 

Reserve balance at December 31, 2002

  $473  $—    $28  $501 

Cash paid

  

 

(453

)

  

 

—  

 

  

 

(19

)

  

 

(472

)

   (473)  —     (28)  (501)
  


  


  


  


  


 


 


 


Reserve balance at March 31, 2003

  

$

20

 

  

$

—  

 

  

$

9

 

  

$

29

 

Reserve balance at September 30, 2003

  $—    $—    $—    $—   
  


  


  


  


  


 


 


 


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 our condensed financial statements and the notes to those for the quarters ended March 31, 2003 and 2002accompanying footnotes included elsewhere in this Form 10-Q, and in conjunction with the Form 10-K for the year ended December 31, 2002. Statements in this Management’s Discussion and Analysis of Financial Condition and Results of Operations that express that ACLARA “believes”, “anticipates”, “expects” or “plans to” as well as other statements that are not historical fact, are forward-looking statements within the meaning of the Private Securities Litigation Act of 1995. Actual events or results may differ materially as a result of the risks and uncertainties described herein and elsewhere, including, but not limited to, those factors discussed in “Factors Affecting Operating Results” set forth below.

 

OVERVIEW

 

We were formed by a spin-off transaction from Soane Technologies, Inc. which was incorporated in 1991 and subsequently changed its name to 2C Optics, Inc. We were incorporated in Delaware in 1995 under the name Soane BioSciences, Inc. and changed our name in 1998 to ACLARA BioSciences, Inc. ACLARA is a leading developer of assay systems for life science research. Since our inception, we have engaged primarily in research and development activities related to the application of our proprietary microfluidics and assay technologies to genomic and proteomic applications in the field of drug discovery and development.

 

We have invested substantial amounts in establishing oureTag assay technology for life science research. From our inception to March 31,September 30, 2003, we have incurred $91.2$99.1 million in research and development expenses. Total costs and operating expenses were $6.8$18.4 million and $10.8$34.9 million for the threenine months ended March 31,September 30, 2003 and 2002, respectively. Over 70% of our 9564 employees at March 31,September 30, 2003 were engaged in research and development activities.

 

We have incurred significant losses since our inception. As of March 31,September 30, 2003, our accumulated deficit was $149.3$159.4 million and total stockholders’ equity was $108.0$98.5 million. We expect to incur additional operating losses over at least the next two years as we continue to invest heavily in research and development activities, build our sales and marketing organization and commercialize oureTag products.

 

Essentially all our revenues through 2002 were generated from commercial research collaborations and from government grants related to discontinued microfluidics programs that are not active in 2003. Our sources of potential revenue in 2003 and for the next several years are likely to be primarily from commercialization of oureTag assay system. InCommencing in late 2002, we introduced commercial access programs under which customers can gain access tomade oureTag Assay System.System commercially available to potential customers.

 

In July 2002, we took steps to increase our focus on oureTag assay opportunities and to reduce costs, particularly those costs associated with the microfluidics aspect of our business. Related to these actions, we took a charge in the third quarter of 2002 of $3.3 million. Additional cost reduction steps were taken in April 2003. All of our resources are currently directed at developing theeTag Assay System and expanding its applications.

 

RESULTS OF OPERATIONS

 

PERIODS ENDED MARCH 31,SEPTEMBER 30, 2003 AND 2002

 

Revenues. Revenues for the three and nine months ending March 31,September 30, 2003 were $179,000$276,000 and $860,000, respectively, and were derived primarily from collaborations related to oureTag access programs.Assay System. Revenues for the three and nine months ended March 31,September 30, 2002 were $590,000$505,000 and $1.8 million, respectively, and were derived primarily from commercial collaboration agreements and government grants related to microfluidics-related programs that are no longer active. While revenue from these sources havehas been significant in prior years, they are not expected to be significant in 2003 when the primary source of revenue is expected to be theeTag Assay System.and subsequent years. The timing and amount of government grant awards and completion of milestones under these grants and in our commercial collaborations has caused quarterly variations in these revenues. Our sources of potential revenue in 2003 and for the next several years are likely to be primarily from commercialization of oureTag Assay System. InCommencing in late 2002, we introduced commercial access programs under which customers can gain access tomade oureTagAssay System. Under theSystem commercially available to potential customers. ACLARA’seTag Expert Access Program, customers can gainAssay System is being commercialized for use both in drug discovery research and to support preclinical and clinical development of specific targeted therapies. In these application areas, pharmaceutical researchers are able to access toeTag assays for gene expression profiling, protein expression analysis, and cell-surface antigen assays. Under this program, customers can buyeTag reagent kits,products, software, custom assay services, and consulting support. Under the Discovery Partners Program, customers can gain access to applications that may allow them to discoverservices. For multiplexed gene expression, ACLARA useseTag Multiplex Invader® Assays, which incorporate Invader technology and adopt novel drug targets, lead compounds, proteinCleavase® enzyme and antibody therapeutics and diagnostics.are licensed for use from Third Wave Technologies, Inc.

Research & Development. Research and development expenses for the three months ended March 31,September 30, 2003 and 2002 were $4.4$3.8 million and $6.4$5.5 million, respectively. Research and development expenses for the nine months ended September 30, 2003 and 2002 were $12.3 million and $18.6 million, respectively. The decrease in spending from 2002 to 2003 was primarily due to a decrease of $1.4decreased personnel related expenses, which were lower by $1.5 million in personnel-related expenses. This reduction wasand $4.5 million, and project costs and materials, which were lower by $257,000 and $715,000, for the three and nine months ended September 30, 2003, respectively. These reductions were due to the restructuring plan implemented in July 2002, in which essentially all microfluidics-relatedmicro-fluidics-related programs were eliminated and the related staffing level correspondingly reduced over the second half of 2002. We expect to continue to devote substantial resources toIncluded in research and development.development expenses for the second quarter of 2003 was severance costs of $318,000 related to an additional staff reduction implemented in April 2003. At September 30, 2002, we had 79 employees engaged in research and development activities, whereas by September 30, 2003, this had been reduced to 47 employees. Essentially all of our research and development expenditures are now focused on developing theeTag Assay System and on expanding the applications for which it can be used.

 

Selling, General and Administrative. Selling, general and administrative expenses for the three months ended March 31,September 30, 2003 and 2002 were $2.5$1.7 million and $2.8$3.3 million, respectively. Selling, general and administrative expenses for the nine months ended September 30, 2003 and 2002 were $6.1 million and $9.2 million, respectively. The decrease in spending from 2002 to 2003 was primarily due primarily to reduceddecreased legal expenses, which were lower by $809,000 and $2.4 million and personnel related expenses, which were lower by $575,000 and $587,000, for the three and nine months ended September 30, 2003 and 2002, respectively. Included in selling, general and administrative expenses for the second quarter of 2003 was severance costs of $121,000 related to litigation that has been settled or is no longer active.an additional staff reduction implemented in April 2003. We expect that our selling, general and administrative expenses will continue to be substantial as we increase our sales, marketing and business development activities related to the commercialization of our products, and as a result of the administrative and support infrastructure required to support our operations.

 

Litigation Settlements. As part of the litigation settlement with Caliper, 900,000 shares of ACLARA common stock were issued in March 2001 with a guaranteed liquidation price of $36.11 per share if Caliper sold the shares after August 21, 2002 but before February 21, 2003. ACLARA initially valued the put obligation associated with these shares using a Black-Scholes pricing model. The put obligation was subsequently revalued with changes in valuation being recorded in the statement of operations. As a result of these revaluations, revaluation expense of $1.5$396,000 and $3.7 million was recorded in the accompanying Statements of Operations for the three and nine months ended March 31,September 30, 2002, but asrespectively. As a result of the final settlement payment to Caliper and the repurchase of the stock from Caliper in October 2002, revaluation adjustments are no longer necessary and no expense has been recorded in 2003. (See Note 3 in the accompanying Notes to Condensed Financial Statements.)

 

Restructuring. During the third quarter of 2002 ACLARA initiated a restructuring plan to streamline our operations, reduce costs associated with the micro fluidicsmicrofluidics aspect of our business and increase our focus on oureTag assay technology. Accordingly, we recognized a restructuring charge of $3.3 million during the third quarter, including $0.8 million of severance and related costs related to the reduction of our employment level by over 50 employees. This reduction was phased in over the second half of 2002 and primarily affected the microfluidics area of our business, where essentially all of our active programs were eliminated. Termination benefits related to severance packages, out-placement services and other associated costs are included in restructuring expense on the statement of operations and restructuring accrual on the balance sheet at December 31, 2002. We also wrote off approximately $2.5 million of fixed assets that are not expected to be used prospectively.

 

Interest Income (Expense) Net. Interest income (expense) net represents income earned on our cash and cash equivalents, short-term investments, long-term investments and restricted cash, and interest paid on bridge loans, capital leases and equipment loans. Net interest income was $0.5 million$364,000 and $1.1$1.2 million for the three and nine months ended March 31,September 30, 2003 respectively. Net interest income was $860,000 and $3.0 million for the three and nine months ended September 30, 2002 respectively. The decrease in net interest income from 2002 to 2003 was primarily due to lower average balances in cash, cash equivalents, short-term and long-term investments and lower market interest rates.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Since inception, we have financed our operations primarily through our initial public offering in March 2000 that raised net proceeds of $201.0 million, private placements of preferred stock totaling $32.3 million, loans from the landlord of our Mountain View facility and equipment financing lines of credit totaling $4.4 million, capital leases totaling $1.8 million, and research and development funding from collaborators and government grants. As of March 31,September 30, 2003, we had total unrestricted cash resources of $101.3$93.2 million, comprising $76.4 million$34.1million in cash and cash equivalents, $7.8$33.0 million in short-term marketable investments and $17.2$26.1 million in long-term marketable investments.

A loan agreement with the landlord of the Mountain View facility allowed us to borrow $663,000 for leasehold improvements at an annual interest rate of 8.5%. The principal balance of this loan at March 31,September 30, 2003 was $493,000.$463,000. The note matures on July 1, 2009.

 

In March 1999, ACLARA entered into a ten year operating lease agreement for our Mountain View facility. The future annual minimum loan payments including accrued interest and lease payments under the loan and lease agreements at March 31,September 30, 2003 are as follows (in thousands):

 

Years Ending December 31,


    

Capital Lease Commitments


   

Loan Payments


     

Operating Lease Commitments


  

Capital

Lease
Commitments


  Loan
Payments


  Operating
Lease
Commitments


2003

    

$

117

 

  

$

76

 

    

$

862

  $39  $25  $297

2004

    

 

98

 

  

 

101

 

    

 

1,208

   98   101   1,208

2005

    

 

—  

 

  

 

101

 

    

 

1,250

   —     101   1,250

2006

    

 

—  

 

  

 

101

 

    

 

1,294

   —     101   1,294

2007

    

 

—  

 

  

 

101

 

    

 

1,339

   —     101   1,339

2008 and thereafter

    

 

—  

 

  

 

126

 

    

 

2,091

   —     201   2,091
    


  


    

  


 


 

Total minimum loan and lease payments

    

 

215

 

  

 

606

 

    

$

8,044

   137   630  $7,479
            

      

Amount representing interest

    

 

(12

)

  

 

(113

)

        (5)  (167)  
    


  


       


 


  

Present value of minimum lease payments

    

$

203

 

  

$

493

 

       $132  $463   
    


  


       


 


  

 

Operating activities used cash of $5.1$13.0 million and $18.7 million for each of the threenine months ended March 31,September 30, 2003 and 2002, respectively. Uses of cash in operating activities primarily resulted from operating losses adjusted for non-cash expenses and changes in working capital and other liabilities.

 

Cash provided by investing activities was $43.4$8.9 million for the threenine months ended March 31,September 30, 2003, including the release of restricted cash from the Caliper settlement of $34.1 million and net maturities of investments of $9.5$24.7 million, compared to cash used inprovided by investing activities of $9.0$57.0 million for the threenine months ended MarchSeptember 30, 2002. As part of our litigation settlement with Caliper, we provided a letter of credit to Caliper in the amount of $32.5 million as a guarantee of our performance under the settlement agreement. The banking institution that issued the letter of credit required us to maintain a balance of 105% of the letter of credit amount in a segregated account. This amount of $34.1 million is recorded as restricted cash in our financial statements at December 31, 2002. In October 2002, we paid Caliper $32.5 million related to this settlement. Of this amount approximately $1.4 million was for the repurchase at the then-current market price of the 900,000 shares previously issued to Caliper in the original settlement agreement. On February 15, 2003 the letter of credit was terminated and the restricted cash was released. Cash provided by financing activities remained essentially unchanged for the threenine months ended March 31,September 30, 2003 and 2002. Financing activity primarily reflects cash proceeds received through the employee exercise of stock options and employee participation in the employee stock purchase programprogram.

 

We believe that our current cash and cash equivalents, short-term and long-term marketable investment balances and funding received from collaborators and government grants will be sufficient to satisfy our anticipated cash needs for working capital and capital expenditures for at least the next 24 months. After that time, we cannot be certain that additional funding, if required, will be available on acceptable terms, or at all. We expect that our costs will continue to exceed our revenues on an annual basis for at least the next two years. From time to time, we may consider possible strategic transactions, including the potential acquisitions of products, technologies and companies, with the goal of further developing our business and maximizing stockholder value. Such transactions, if any, could materially affect our future liquidity and capital resources. We may raise additional funds through public or private financing, collaborative relationships or other arrangements. Further, any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. Our failure to raise capital when needed may harm our business and operating results.

As part of our litigation settlement with Caliper, we have provided a letter of credit to Caliper in the amount of $32.5 million as a guarantee of our performance under the settlement agreement. The banking institution that issued the letter of credit required us to maintain a balance of 105% of the letter of credit amount in a segregated account. This amount of $34.1 million is recorded as restricted cash in our financial statements at December 31, 2002. In October 2002, we paid Caliper $32.5 million related to this settlement. Of this amount approximately $1.3 million was for the repurchase at the then-current market price of the 900,000 shares previously issued to Caliper in the original settlement agreement. On February 15, 2003 the letter of credit was terminated and the restricted cash was released.

CRITICAL ACCOUNTING POLICIES

 

There have been no material changes to our critical accounting policies and estimates from those disclosed in our report on Form 10-K for our fiscal year ended December 31, 2002.

 

RECENT ACCOUNTING DEVELOPMENTS

 

In January 2003,May 2002, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 46 (“FIN 46”), “Consolidation of Variable Interest Entities, an Interpretation of ARB No. 51.” FIN 46 requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective immediately for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46 must be applied for the first interim or annual period beginning after June 15, 2003. The Company believes that the adoption of this standard will have no material impact on its financial statements.

In November 2002, the FASB issued Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others.” Interpretation No. 45 requires a Company, at the time it issues a guarantee, to recognize an initial liability for the fair value of obligations assumed under the guarantee and elaborates on existing disclosure requirements. The disclosure requirements of FIN 45 are effective for financial statements of interim or annual periods ending after December 15, 2002. Agreements that we have determined to be within the scope of FIN 45 include indemnification arrangements with officers and directors and indemnification arrangements with customers with respect to intellectual property. To date, we have not incurred material costs, if any, in relation to any of the above guarantees and, accordingly, adoption of this standard did not have a material impact on our financial position, results or operations or cash flows.

In November 2002, the Emerging Issues Task Force (EITF) issued Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. EITF issue No. 00-21 addresses determination of whether an arrangement involving more than one deliverable contains more than one unit of accounting and how arrangement consideration should be measured and allocated to the separate units of accounting. EITF Issue No. 00-21 will be effective for revenue arrangements entered into in fiscal periods beginning after June 15, 2003 or the Company may elect to report the change in accounting as a cumulative-effect adjustment. The Company believes that the adoption of this standard will have no material impact on its financial statements.

In May 2002, the FASB issued SFAS No. 145, “Rescission of SFAS Nos. 4, 44, 64, Amendment of SFAS 13, and Technical Corrections as of April 2002.” SFAS No. 145 rescinds SFAS No. 4, “Reporting Gains and Losses from Extinguishment of Debt,” which required that gains and losses from extinguishment of debt that were included in the determination of net income be aggregated and, if material, classified as an extraordinary item, net of the related income tax effect. Under SFAS No. 145, gains or losses from extinguishment of debt should be classified as extraordinary items only if they meet the criteria in Accounting Principal’s Board Opinion No. 30 (“APB 30”), “Reporting the Results of Operations—Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions”. Applying the criteria in APB 30 will distinguish transactions that are part of an entity’s recurring operations from those that are unusual or infrequent or that meet the criteria for classification as an extraordinary item. The Company adopted SFAS No. 145 on January 1, 2003. The losses of $1.1 million on early extinguishment of debt obligations that were classified as extraordinary items in prior periods presented that did not meet the criteria of APB 30 for classification as extraordinary items were reclassified to lossgeneral and administrative from operations.

 

FACTORS AFFECTING OPERATING RESULTS

 

The following risk factors outline certain risks and uncertainties concerning future results and should be read in conjunction with the other information contained in this Report on Form 10-Q and with the Company’s Annual Report on Form 10-K for the year ended December 31, 2002. Any of these risk factors could materially and adversely affect our business, results of operations, financial condition and future growth prospects. Additional risks and uncertainties that we do not currently know about or that we currently deem immaterial may also impair our business, financial condition, results of operations and future growth prospects.

 

WE HAVE A HISTORY OF OPERATING LOSSES AND AN ACCUMULATED DEFICIT, AND WE MAY NOT ACHIEVE OR MAINTAIN PROFITABILITY IN THE FUTURE.

 

Since we were founded in May 1995, we have engaged primarily in research and development efforts. We have incurred operating losses every year since inception, and we may never achieve profitability. Net losses for the years ended December 31, 2002, 2001 and 2000 were $37.2 million, $29.0 million and $59.2 million, respectively. Net losses for the three and nine months ended March 31,September 30, 2003 were $4.9 million and $16.3 million respectively. Net losses for the three and nine months ended September 30, 2002 were $6.2$11.2 million and $9.1$30.1 million respectively. As of March 31,September 30, 2003, we had an accumulated deficit of $149.3$159.4 million. Our losses have resulted principally from costs incurred in connection with our research and development activities, from litigation settlement charges and from selling, general and administration costs associated with our operations.

 

To date, we have not generated any significant revenue from the sale of products. Our ability to generate revenues from product sales or to achieve profitability is dependent on our ability, alone or with collaborative partners, to successfully design, develop, manufacture and commercialize our proprietary assay chemistry systems in a timely manner and on adoption of our

technological approach by customers. Our revenue through 2002 has been generated principally from collaborative research and development agreements, government grants and commercial collaborations related to our former microfluidics activities. None of these revenue sources are expected to be significant in 2003 and subsequent years, when oureTag Assay System is anticipated to be the primary source of revenue. We expect that our costs will continue to exceed our revenues on an annual basis for at least the next two years. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

 

OUR OPERATING RESULTS MAY FLUCTUATE SIGNIFICANTLY.

 

Our operating results have fluctuated in the past and are likely to do so in the future. These fluctuations could cause our stock price to decline. Some of the factors that could cause our operating results to fluctuate include:

 

the willingness of our customers to enter into our access programs and the adoption of our technologies by customers;

 

the timing of the release, and the competitiveness of our products;

 

expiration or termination of contracts with collaborators or government research grants, which may not be renewed or replaced;

final outcome of litigation to which we are currently a party or threatened claims against us;

 

disagreements regarding intellectual property rights; and

 

general and industry-specific economic conditions, which may affect our customers’ research and development expenditures and use of our products.

 

If revenue declines in a quarter, whether due to a delay in recognizing expected revenue or otherwise, our earnings will decline because many of our expenses are relatively fixed in the short-term. In particular, research and development and selling, general and administrative expenses are not affected directly by variations in revenue.

 

Due to fluctuations in our revenue and operating expenses, we believe that period-to-period comparisons to results of historical operations are not a good indication of our future performance. It is possible that in some future quarter or quarters, our operating results will be below the expectations of securities analysts or investors, or will be below the level of prior periods. In these cases, our stock price could fluctuate significantly or decline.

 

NONE OF OUR PRODUCTS HAS YET BEEN SUCCESSFULLY COMMERCIALIZED.

 

We are in the process of commercially launching oureTag Assay System, through our Expert Access Program and Discovery Partners Program.System. However, we have limited experience with developing, manufacturing, distributing or selling commercial products. We may not be able to perfect the design of our products due to the complexity of the technologies on which they are based and/or the demands of the scientific processes that they address. Additionally, we may not be able to adequately provide the desired level of services required under our access programs.commercial collaborations. For instance, we have limited experience establishing the high degrees of accuracy, reliability and ease of use required for commercial introduction of our products and services. Even though we have designed products that function in a prototype system or on a limited volume basis, we cannot assure you that we will be able to adapt the design or develop our organization to allow for large-scale manufacturing. Although we have projected launch periods for certain of our products, we cannot assure you that we will complete development of the products by those launch dates, or at all. If we are unable to design commercially viable assay products, or other products or systems, either independently or with our collaborative partners, we may be unable to remain in business.

 

COMMERCIALIZATION OF OUR PRODUCTS DEPENDS ON MARKET ACCEPTANCE OF OUR ASSAY TECHNOLOGY. IF IT DOES NOT ACHIEVE ACCEPTANCE, OUR ABILITY TO GENERATE SALES WOULD BE LIMITED AND OUR LOSSES WOULD INCREASE.

 

Demand for our products is substantially dependent upon widespread market acceptance of our assay system for applications in drug discovery and for applications in genomics, proteomics and pharmaceutical drug screening.development. Our assay system represents a new technological approach, and our ability to sell this assay system will depend on the willingness of customers to adopt such new technological approaches. We cannot assure you that our assay system will achieve substantial acceptance in our target markets. Market acceptance will depend on many factors, including:

 

our ability to demonstrate to potential customers the benefits and cost effectiveness of our assay system, relative to competing technologies and products;

 

the extent and success of our efforts to market, sell and distribute the assay chemistry products; and

 

adoption of the systems biology approach to drug discovery and development.

 

Further, failure of our initial assay products to be favorably received by the market could undermine our ability to successfully introduce subsequent assay products. If our assay products do not gain market acceptance, our losses would increase and we may be unable to remain in business.

 

OUR DIRECT AND THIRD PARTY SALES AND MARKETING CHANNELS NEED TO BE DEVELOPED. IF WE ARE UNABLE TO DO SO SUCCESSFULLY, WE MAY BE UNABLE TO GENERATE SIGNIFICANT REVENUES.

 

We do not have fully developed sales and distribution channels for our products. In 2002, we restructured our relationship with Third Wave Technologies, Inc. and have assumed direct responsibility for the commercialization ofeTag assay system for the gene expression market that incorporate Third Wave’s technology. In addition, for applications in proteomics, we will continue to be dependent on our own business development organization, which has yet to be fully developed. We may not be able to successfully recruit executive management and sales and marketing personnel to market and sell our products.

 

Our ability to generate revenues will be dependent on the development of the appropriate partnerships, on the resources devoted by our partners to commercialization activities and on the success of those activities. Our ability to generate revenue will also be dependent on our success in recruiting management and business development personnel and in building a sales and marketing organization. We cannot assure you that we will be able to successfully build and manage effective sales and distribution channels, or that our partners will devote sufficient resources to our commercialization efforts to be effective.

 

IF WE ARE UNABLE TO EFFECTIVELY PROTECT OUR INTELLECTUAL PROPERTY, WE WOULD BE UNABLE TO PREVENT THIRD PARTIES FROM USING OUR TECHNOLOGY, WHICH COULD IMPAIR OUR ABILITY TO COMPETE IN THE MARKET. THE COST OF ENFORCING OUR PROPRIETARY RIGHTS MAY BE EXPENSIVE AND RESULT IN INCREASED LOSSES. WE MAY BE FOUND TO INFRINGE THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS.

 

Our success will depend in part on our ability to obtain and maintain meaningful patent protection for our products, both in the United States and in other countries, and our inability to do so could harm our competitive position. We rely on our portfolio of over 240approximately 250 issued and pending patent applications in the United States and in other countries to protect a large part of our intellectual property and our competitive position. We cannot assure you that any of the currently pending or future patent applications will be issued as patents, or that any patents issued to us will not be challenged, invalidated, held unenforceable or circumvented. Further, we cannot assure you that our intellectual property rights will be sufficiently broad to prevent third parties from producing competing products similar in design to our products.

 

In addition to patent protection, we also rely on protection of trade secrets, know-how and confidential and proprietary information. We generally enter into confidentiality agreements with our employees, consultants and our collaborative partners upon commencement of a relationship with us. 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 our 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.

 

Our commercial success also depends in part on avoiding the infringement of other parties’ patents or proprietary rights and the breach of any licenses that may relate to our technologies and products. We are aware of various third-party patents that may relate to our technology. We believe that we do not infringe these patents but cannot assure you that we will not be found in the future to infringe these or other patents or proprietary rights of third parties, either with products we are currently developing or with new products that we may seek to develop in the future. If third parties assert infringement claims against us, we may be forced to enter into license arrangements with them. We cannot assure you that we could enter into the required licenses on commercially reasonably terms, if at all. The failure to obtain necessary licenses or to implement alternative approaches may prevent us from commercializing products under development and would impair our ability to be commercially competitive. We may also become subject to interference proceedings conducted in the U.S. Patent and Trademark Office to determine the priority of inventions.

 

The defense and prosecution, if necessary, of intellectual property suits, U.S. Patent and Trademark Office interference proceedings and related legal and administrative proceedings will result in substantial expense to us, and significant diversion of effort by our technical and management personnel. An adverse determination in litigation or interference proceedings to which we may become a party could subject us to significant liabilities to third parties, could put our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

 

Further, 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 stock.

 

WE HAVE LIMITED MANUFACTURING EXPERIENCE AND WILL BE SUBJECT TO THE RISK OF DEVELOPING AND MAINTAINING RELATIONSHIPS WITH THIRD PARTY MANUFACTURERS AND SUPPLIERS AND THE RISK OF IMPAIRMENT IN VALUE OF INVENTORY.

 

We have no experience manufacturing our products in the high volumes that will be necessary for us to achieve significant commercial sales. To date, we have limited our manufacturing activities to low volume manufacturing ofeTag assay products for testing purposes and for validation use by our collaborative partners and potential customers. The nature of our assay products necessitates access to specialized chemicals, reagents and raw materials, such as antibodies used in conjunction with oureTag components. There are only a limited number of vendors who supply these materials and for some of these materials the suppliers are the sole source of supply. We cannot be certain that we will be able to successfully secure supply of all needed

materials, nor can we be certain that these vendors will supply these materials consistently or in the quantities necessary for high volume production. We will need to enter into contractual relationships with these or other manufacturers to facilitate commercial scale production of eTag assay products, and we cannot assure you that we will be able to do so on a timely basis, for sufficient quantities of products or on commercially reasonable terms. We will need to secure supply of antibodies for use in our protein applications and there can be no assurance that we will be able to do so on commercially reasonable terms. We will be dependent on Third Wave for supply of Cleavase enzyme that is a critical component of products that we will commercialize for gene expression applications, and this enzyme is proprietary to Third Wave. Failure of Third Wave to supply enzyme could seriously impair our business. Pursuant to the Supply Agreement with Third Wave, we purchased an initial quantity of Cleavase enzyme from Third Wave. This initial quantity of enzyme represents more than one year’s supply. Accordingly, we cannot assure you that we can establish or maintain reliable, high-volume manufacturing at commercially reasonable costs. In addition, the loss of any of these suppliers may result in a delay or interruption of our supply of assay chemistries.products. Any significant delay or interruption would have a material adverse effect on our ability to supply adequate quantities of our products and would result in lost revenues. In addition, we have limited experience in developing and providing the software tools necessary to perform analyses of data derived from oureTag assays.

 

WE DEPEND ON OUR KEY PERSONNEL, THE LOSS OF WHOM WOULD IMPAIR OUR ABILITY TO COMPETE.

 

Our performance is substantially dependent on the performance of our senior management and key scientific and technical personnel. The loss of the services of any member of our senior management, scientific or technical staff may significantly delay or prevent the achievement of product development and other business objectives and could have a material adverse effect on our business, operating results and financial condition. Our future success will also depend on our ability to identify, recruit and retain additional qualified scientific, technical and managerial personnel. There is currently a shortage of skilled executives and intense competition for such personnel in the areas of our activities, and we cannot assure you that we will be able to continue to attract and retain personnel with the advanced qualifications necessary for the development of our business. The inability to attract and retain the necessary scientific, technical and managerial personnel could have a material adverse effect on our research and development activities, sales revenue, operating costs and future growth prospects.

 

WE EXPECT INTENSE COMPETITION IN OUR TARGET MARKETS.

 

We compete with companies that design, manufacture and market analytical instruments and reagents for genomics, proteomics and pharmaceutical drug screening using alternate technologies for applications such as gene expression analysis and protein function analysis and other products and systems. In addition, a number of companies are developing new technologies for miniaturizing various laboratory procedures for genomics, proteomics and drug screening markets targeted by us, using such methods as beads, hybridization chips and high-density microwell plates.

 

We anticipate that we will face increased competition in the future as companies enter the market with new technologies. Rapidly changing technology, evolving industry standards, changes in customer needs, emerging competition and new product introduction, characterize the markets for our 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. Many of these competitors have greater financial and personnel resources and more experience in research and development than we have. We also cannot assure you that we will be able to compete effectively with the competitor’scompetitors’ greater market presence. Furthermore, we cannot assure you that the pharmaceutical and biotechnology companies which are our potential customers or our strategic partners will not develop competing products.

 

WE MAY BE SUBJECT TO PRODUCT LIABILITY CLAIMS AND MAY NOT BE ABLE TO OBTAIN ADEQUATE INSURANCE, WHICH WOULD INCREASE OUR LOSSES IF SUCH CLAIMS OCCURRED.

 

As we begin commercialization of our products, we will face exposure to product liability claims. Any product liability claims arising in the future, regardless of their merit or eventual outcome, could increase our losses. We cannot assure you that we will continue to be able to maintain our current coverage or obtain new insurance on acceptable terms with adequate coverage,

or at reasonable costs. In addition, potential product liability claims may exceed the amount of our insurance or may be excluded from coverage under the terms of the policy.

 

WE MAY BE UNABLE TO RAISE ADDITIONAL CAPITAL WHEN NEEDED OR GENERATE THE CAPITAL NECESSARY TO EXPAND OUR OPERATIONS AND INVEST IN NEW PRODUCTS, WHICH COULD HURT OUR ABILITY TO COMPETE OR ACHIEVE PROFITABILITY.

 

It might be necessary for us to raise additional capital over the next few years to continue our research and development efforts and to commercialize our products. We believe that the proceeds from our initial public offering and projected revenue from collaborations should be sufficient to fund our anticipated levels of operations through at least the next 24 months. However, we cannot assure you that our business or operations will not change in a manner that would consume available resources more

rapidly than anticipated. We also cannot assure you that existing or potential future collaborations or sales revenue will be adequate to fund our operations. We may need additional funds sooner than planned to meet operational needs, capital requirements for product development and commercialization and payment of monetary damages in any on-going or future litigation. From time to time, we may consider possible strategic transactions, including the potential acquisitions of products, technologies and companies, with the goal of further developing our business and maximizing stockholder value. Such transactions, if any, could materially affect our capital resources. We cannot assure you that additional funds will be available when needed, or on terms acceptable to us, or that sufficient revenue will be generated from sales. If adequate funds are not available, we may have to reduce substantially or eliminate expenditures for the development and production of certain of our proposed products or obtain funds through arrangements with collaboration partners that require us to relinquish rights to certain of our technologies or products. Either of these alternatives could have a material adverse effect on our business, operating results, financial condition and future growth prospects.

 

CONCENTRATION OF OWNERSHIP AMONG OUR EXISTING EXECUTIVE OFFICERS, DIRECTORS AND PRINCIPAL STOCKHOLDERS MAY PREVENT NEW INVESTORS FROM INFLUENCING SIGNIFICANT CORPORATE DECISIONS.

 

Our executive officers, directors and their affiliates presently beneficially own or control a significant percentage of the outstanding shares of common stock. Accordingly, our current executive officers, directors and their affiliates, if acting together, would have the ability to influence the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets and any other significant corporate transactions. The concentration of ownership could also delay or prevent a change of control of our company at a premium price if these stockholders oppose it.

 

THE MARKET PRICE OF OUR COMMON STOCK IS HIGHLY VOLATILE.

 

There has only been a public market for our common stock since March 21, 2000, and since then our common stock has traded in a range between $1.30 and $60.00 per share.

 

The trading price of our common stock may continue to be highly volatile and could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including: quarterly fluctuations in results of operations; our ability to successfully commercialize our products; technological innovations or new commercial products by us or our competitors; developments concerning government regulations or proprietary rights which could affect the potential growth of our customers; the execution of new collaborative agreements and material changes in the relationships with business partners; market reaction to trends in revenues and expenses, especially research and development; changes in earnings estimates by analysts; sales of common stock by existing stockholders; and economic and political conditions.

 

The market price for our common stock may also be affected by our ability to meet analysts’ expectations. Any failure to meet such expectations, even slightly, could have an adverse effect on the market price of our common stock. In addition, the stock market, and the NASDAQ National Market and the market for technology companies in particular, is subject to extreme price and volume fluctuations. This volatility has had a significant effect on the market prices of securities issued by many companies for reasons unrelated to the operating performance of these companies. In the past, companies that have experienced volatility in the market price of their securities have been the subjects of securities class action litigation, and as noted elsewhere in this Form 10-Q, we have been sued in a securities class action lawsuit. Although we believe that the class action lawsuit and the other lawsuits described elsewhere in this Form 10-Q are without merit, an adverse determination in any of the lawsuits could have a very significant effect on our business and results of operations, and could materially affect the price of our stock. Moreover, regardless of the ultimate result, it is likely that the lawsuits will divert management’s attention and resources from other matters, which could also adversely affect our business and the price of our stock.

 

ANTI-TAKEOVER PROVISIONS IN OUR CHARTER DOCUMENTS AND DELAWARE LAW LIMIT THE ABILITY OF ANOTHER PARTY TO ACQUIRE US, WHICH COULD CAUSE OUR STOCK PRICE TO DECLINE.

 

Certain provisions of our certificate of incorporation and our bylaws could delay or prevent a third party from acquiring us, even if doing so might be beneficial to our stockholders. For example, we have a classified board of directors whose members serve staggered three-year terms and are removable only for cause. In addition, on March 16, 2001, ACLARA adopted a stockholder rights plan (the “Rights Plan”). Pursuant to the Rights Plan, ACLARA’s Board of Directors declared a dividend

distribution of one Preferred Share Purchase Right (a “Right”) on each outstanding share of ACLARA’s common stock. Each Right will entitle stockholders to buy one-one hundredth of a share of newly created Series A Junior Participating Preferred Stock at an exercise price of $40.50 in the event that the Rights become exercisable. Subject to limited exceptions, the Rights will be exercisable if a person or group acquires 15% or more of the Company’s common stock or announces a tender offer for 15% or more of the common stock. If ACLARA is acquired in a merger or other business combination transaction which has not been approved by the Board of Directors, each Right will entitle its holder to purchase, at the Right’s then-current exercise price, a number of the acquiring company’s common shares having a market value at the time of twice the Right’s exercise price. These

provisions 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 ACLARA. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit large stockholders from consummating a merger or combination with us. These factors could also limit the price that investors might be willing to pay for our common stock in the future.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our exposure to interest rate risk relates primarily to our investment portfolio. Fixed rate securities may have their fair market value adversely impacted due to fluctuations in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future investment income may fall short of expectations due to changes in interest rates or we may suffer losses in principle if forced to sell securities that have declined in market value due to changes in interest rates. The primary objective of our investment activities is to preserve principal while at the same time maximize yields without significantly increasing risk. To achieve this objective, we invest in debt instruments of the U.S. Government and its agencies and high-quality corporate issuers, and, by policy, restrict our exposure to any single corporate issuer by imposing concentration limits. To minimize the exposure due to adverse shifts in interest rates, we maintain investments at an average maturity of generally less than two years. Assuming a hypothetical increase in interest rates of one percentage point, the fair value of our total investments as of March 31,September 30, 2003 would have potentially declined by approximately $394,000.$674,000.

 

We do not utilize derivative financial instruments, derivative commodity instruments or other market-risk sensitive instruments, positions or transactions in any material fashion.

 

ITEM 4. CONTROLS AND PROCEDURES

 

We maintain disclosure controls and procedures (as defined in Securities Exchange Act 1934 Rules 13a-14(c) and 15d-14(c)) that are designed to ensure that information required to be disclosed in our Exchange Act reports 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 our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizedrecognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily wasis required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Within 90 days of the filing date of this quarterly report,As required by SEC Rule 13a – 15(b), we carried out an evaluation, under the supervision and with the participation of the Company’s management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.procedures as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective. effective at the reasonable assurance level.

There havehas been no significant changeschange in our internal controls over financial reporting during our most recent fiscal quarter that has materially affected, or in other factors that could significantlyis reasonably likely to materially affect, theour internal controls subsequent to the date we completed our evaluation.over financial reporting.

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

Information with respect to this item is incorporated into this Part II, Item 1 by reference to Note 3, “Litigation Settlement and Contingencies” contained in Part 1, Item 1 above.

 

ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS

 

Not applicable.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

Not Applicable.

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

Not applicable.Applicable.

 

ITEM 5. OTHER INFORMATION

 

Not Applicable.

 

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K

 

(a) Exhibits. The exhibits listed below are incorporated by reference as part of this report

 

Exhibit
Number



 

Description


3.1

 

Amended and Restated Certificate of Incorporation of ACLARA BioSciences, Inc. (Incorporated by reference to Exhibit 3.1 to our Registration Statement on Form S-1 filed with the Securities and Exchange Commission, File No. 222-95107 (our “Form S-1”).)

3.2

 

Certificate of Amendment to Amended and Restated Certificate of Incorporation of ACLARA BioSciences, Inc. (Incorporated by reference to Exhibit 3.6 to our Form S-1.)

3.3

 

Amended and Restated Bylaws of ACLARA BioSciences, Inc. (Incorporated by reference to Exhibit 3.4 to our
Form S-1.)

10.1*

 

Form of Indemnification Agreement between ACLARA and each of our directors and officers (Incorporated by reference to Exhibit 10.1 to our Form S-1.)

10.2*

 

1995 Stock Option Plan (Incorporated by reference to Exhibit 10.2 to our Form S-1.)

10.3*

 

Amended and Restated ACLARA BioSciences, Inc. 1997 Stock Plan (Incorporated by reference to Exhibit 10.3 to our Form S-1.)

10.4

 

Amended and Restated Investors’ Rights Agreement, dated as of December 30, 1999 (Incorporated by reference to Exhibit 10.4 to our Form S-1.)

10.5

 

Lease Agreement between ACLARA BioSciences, Inc. and The Pear venue Group, dated March 1, 1999 (Incorporated by reference to Exhibit 10.8 to our Form S-1.)

10.6

 

Master Equipment Lease between Phoenix Leasing and Soane BioSciences, Inc., dated as of November 15, 1995 (Incorporated by reference to Exhibit 10.9 to our Form S-1.)

10.7+

 

Agreement for an Exclusive Alliance to Develop, Manufacture and Market a Chip-Based Screening System for Cell Analysis between Cellomics, Inc. and ACLARA BioSciences, Inc., dated as of October 26, 1999 (Incorporated by reference to Exhibit 10.10 to our Form S-1.)

10.8+

 

Collaboration Agreement between ACLARA BioSciences, Inc., and The Perkin-Elmer Corporation, dated as of March 19, 1999 (Incorporated by reference to Exhibit 10.11 to our Form S-1.)

10.9+

 

Side Agreement between ACLARA BioSciences, Inc. and The Perkin-Elmer Corporation, dated as of March 19, 1999 (Incorporated by reference to Exhibit 10.12 to our Form S-1.)

10.10+

 

Custom Instrument Development and Commercialization Agreement between The R.W. Johnson Pharmaceutical Research Initiative, The Perkin-Elmer Corporation and CLARA BioSciences, Inc., signed in March 1999 (Incorporated by reference to Exhibit 10.13 to our Form S-1.)

10.11+

 

Collaboration Agreement between Soane BioSciences, Inc. and The Perkin-Elmer Corporation, dated as of April 25, 1998 (Incorporated by reference to Exhibit 10.14 to our Form S-1.)

10.12

 

Master Loan and Security Agreement by and between ACLARA BioSciences, Inc. and Transamerica Business Credit Corporation, dated as of May 27, 1999 (Incorporated by reference to Exhibit 10.15 to our Form S-1.)

10.13

 

ACLARA BioSciences, Inc. Employee Stock Purchase Plan (Incorporated by reference to Exhibit 10.16 to our
Form S-1.)

10.14

 

Agreement between Packard BioSciences Company and ACLARA BioSciences, dated as of February 21, 2000 (Incorporated by reference to Exhibit 10.17 to our Form S-1.)

10.15

 

Consulting Agreement with Dr. Eric Lander dated as of January 15, 2000 (Incorporated by reference to Exhibit 10.18 to our Form S-1.)

10.16

 

Consulting Agreement with Mr. Andre Marion dated as of January 19, 2000 (Incorporated by reference to Exhibit 10.19 to our Form S-1.)

10.17+

 

Settlement Agreement and Mutual General Release between Caliper Technologies Corp. and CLARA BioSciences, Inc., dated as of March 12, 2001 (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q filed on May 15, 2001.)

10.18+

 

Cross-License Agreement between Caliper Technologies Corp. and ACLARA BioSciences, Inc., dated as of March 12, 2001 (Incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q filed on November 14, 2001.)

10.19

 

Common Stock Issuance Agreement between ACLARA BioSciences, Inc. and Caliper Technologies Corp., dated as of March 12, 2001 (Incorporated by reference to Exhibit 10.3 to our Quarterly Report on Form 10-Q filed on May 15, 2001.)

10.20+

 

Amended and Partially Restated Collaboration Agreement between ACLARA BioSciences, Inc. and PE Corporation (NY), executed as of March 22, 2002. (Incorporated by reference to Exhibit 10.24 to our Annual Report on
Form 10-K filed on April 1, 2002.)

10.21

 

Second Side Agreement Between ACLARA BioSciences, Inc. and PE Corporation (NY), effective as of September 30, 2000. (Incorporated by reference to Exhibit 10.25 to our Annual Report on Form 10-K filed on April 1, 2002.)

10.22+

 

Supply and Distributorship Agreement between ACLARA BioSciences, Inc. and Roche Diagnostics Corporation, dated as of October 26, 2001. (Incorporated by reference to Exhibit 10.26 to our Annual Report on Form 10-K filed on April 1, 2002.)

10.23

 

First Amendment to the Custom Instrument Development and Commercialization Agreement between The R.W. Johnson Pharmaceutical Research Institute and ACLARA BioSciences, Inc., executed as of October 1, 2001. (Incorporated by reference to Exhibit 10.27 to our Annual Report on Form 10-K filed on April 1, 2002.)

10.24+

 

Second Amendment to the Custom Instrument Development and Commercialization Agreement between The R.W. Johnson Pharmaceutical Research Institute and ACLARA BioSciences, Inc., dated as of October 26, 2001. (Incorporated by reference to Exhibit 10.28 to our Annual Report on Form 10-K filed on April 1, 2002.)

10.25+

 

Development and Commercialization Agreement between Third Wave Technologies, Inc. and ACLARA BioSciences, Inc., dated as of October 24, 2001. (Incorporated by reference to Exhibit 10.29 to our Annual Report on Form 10-K filed on April 1, 2002.)

10.26+

 

Agreement between Third Wave Technologies, Inc. and ACLARA BioSciences, Inc. dated as of October 24, 2001. (Incorporated by reference to Exhibit 10.30to our Annual Report on Form 10-K filed on April 1, 2002.)

10.27

 

Amendment to the ACLARA BioSciences, Inc. Employee Stock Purchase Plan, effective April 23, 2002.

23,2002. (Incorporated by reference to Exhibit 10.31 to our Quarterly Report on Form 10-Q filed on August 14, 2002.)

10.28+

 

License Agreement between Third Wave Technologies, Inc. and ACLARA BioSciences, Inc. dated October 15, 2002. (Incorporated byy reference to Exhibit 10.32 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.29+

 

Supply Agreement between Third Wave Technologies, Inc. and ACLARA BioSciences, Inc. dated October 15, 2002. (Incorporated by reference to Exhibit 10.33 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.30+

 

InvaderCreator Access Agreement between Third Wave Technologies, Inc. and ACLARA BioSciences, Inc. dated October 15, 2002. (Incorporated by reference to Exhibit 10.34 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.31+

 

Transition Manufacturing Plan Letter Agreement between Third Wave Technologies, Inc. and ACLARA BioSciences, Inc. dated October 15, 2002. (Incorporated by reference to Exhibit 10.35 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.32

 

InvaderCreator Access Letter Agreement between Third Wave Technologies, Inc and ACLARA BioSciences, Inc. dated October 15, 2002. (Incorporated by reference to Exhibit 10.36 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.33

 

Termination Agreement between Roche Diagnostics Corporation and ACLARA BioSciences, Inc. dated October 10, 2002. (Incorporated by reference to Exhibit 10.37 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.34*

 

General Release and Separation Agreement between Joseph M. Limber and ACLARA BioSciences, Inc. dated October 10, 2002. (Incorporated by reference to Exhibit 10.38 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.35*

 

Change in Control Agreement between Joseph M. Limber and ACLARA BioSciences, Inc. dated October 10, 2002. (Incorporated by reference to Exhibit 10.39 to our Quarterly Report on Form 10-Q filed on November 14, 2002.)

10.36*

 

Form of Change of Control Agreement between ACLARA BioSciences, Inc. and each of our executive officers except the chief executive officer. (Incorporated by reference to Exhibit 10.36 to our Annual Report on Form 10-K filed on March 31, 2003.)

10.37*

 

Letter Agreement between Edward M. Hurwitz and ACLARA BioSciences, Inc. dated October 29, 2002. (Incorporated by reference to Exhibit 10.37 to our Annual Report on Form 10-K filed on March 31, 2003.)

10.38*

 

Letter Agreement between Edward M. Hurwitz and ACLARA BioSciences, Inc. dated November 27, 2002. (Incorporated by reference to Exhibit 10.38 to our Annual Report on Form 10-K filed on March 31, 2003.)

10.39*

 

Employment Letter Agreement between Thomas G. Klopack and ACLARA BioSciences, Inc. dated March 18, 2003. (Incorporated by reference to Exhibit 10.39 to our Annual Report on Form 10-K filed on March 31, 2003.)

10.40*

 

Severance Agreement between Thomas G. Klopack and ACLARA BioSciences, Inc. dated March 18, 2003. (Supersedes agreement previously filed as Exhibit 10.40 to our Annual Report on Form 10-K filed on March 31, 2003.)

10.41*

Employment Letter Agreement between Michael J. Dunn and ACLARA BioSciences, Inc. dated April 11, 2003. (Incorporated by reference to Exhibit 10.41 to our Quarterly Report on Form 10Q filed on August 14, 2003.)

10.42*

Severance Agreement between Michael J. Dunn and ACLARA BioSciences, Inc. dated April 11, 2003. (Incorporated by reference to Exhibit 10.42 to our Quarterly Report on Form 10Q filed on August 14, 2003.)

10.43*

Form of Change of Control Agreement between ACLARA BioSciences, Inc. and each of our non-employee directors. (Incorporated by reference to Exhibit 10.43 to our Quarterly Report on Form 10Q filed on August 14, 2003.)

10.44++

Research Agreement between ACLARA BioSciences, Inc. and Genentech, Inc. dated July 17, 2002. (Incorporated by reference to Exhibit 10.44 to our Quarterly Report on Form 10Q filed on August 14, 2003.)

10.45++

Amendment No. 1 to Research Agreement between ACLARA BioSciences, Inc. and Genentech, Inc. dated April 17, 2003. (Incorporated by reference to Exhibit 10.45 to our Quarterly Report on Form 10Q filed on August 14, 2003.)

31.1

Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1

Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2

Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


+Confidential treatment has been granted as to portions of this exhibit.
*++Confidential treatment has been requested as to portions of this exhibit.
*Management contract or compensatory plan or arrangementarrangement.

(b) Current Reports on Form 8-K.

 

On February 27,July 30, 2003, the Company filedfurnished a current report on Form 8-K with respect to a press release announcing the Company’s management transition plan.

On April 30, 2003, the Company filed a current report on Form 8-Kunder “Item 12. Results of Operations and Financial Condition” with respect to a press release announcing its results of operationsoperation for the quarter ended March 31,June 30, 2003.

 

November 5, 2003, the Company furnished a current report on Form 8-K under “Item 12. Results of Operations and Financial Condition” with respect to a press release announcing its results of operation for the quarter ended September 30, 2003.

SIGNATURES

 

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

 

/s/ ALFRED G. MERRIWEATHER


Alfred G. Merriweather


  

Vice President, Finance and Chief Financial Officer (duly authorized officer and principal financial officer)

 

May 15,November 14, 2003

CERTIFICATIONS

I, Thomas G. Klopack, certify that:

1. I have reviewed this quarterly report on Form 10-Q of ACLARA BioSciences, Inc:

2. Based on my knowledge, this quarterly 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 quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;

4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

(a) Designed such disclosure controls and procedures 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 periods in which this quarterly report is being prepared;

(b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

(c) Presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

(a) All significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

6. The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

Date: May 15, 2003

By:

/s/    THOMASAlfred G. KLOPACK        


Merriweather
   

Thomas G. Klopack

Chief Executive Officer

 

I, Alfred G. Merriweather, certify that:

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

2. Based on my knowledge, this quarterly 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 quarterly report;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;

4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

(a) Designed such disclosure controls and procedures 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 periods in which this quarterly report is being prepared;

(b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

(c) Presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

(a) All significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls: and

6. The registrant’s other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

Date: May 15, 2003

By:

/s/    ALFRED G. MERRIWEATHER        


Alfred G. Merriweather

Chief Financial Officer

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