Annual Reports

 
Quarterly Reports

  • 10-Q (Aug 5, 2016)
  • 10-Q (May 5, 2016)
  • 10-Q (Nov 5, 2015)
  • 10-Q (Aug 6, 2015)
  • 10-Q (May 7, 2015)
  • 10-Q (Nov 10, 2014)

 
8-K

 
Other

Sequenom 10-Q 2007
Form 10-Q
Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


FORM 10-Q

 


(Mark One)

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

For the quarterly period ending September 30, 2007

 

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

For the transition period from                      to                     

Commission File Number: 000-29101

 


SEQUENOM, INC.

(Exact name of registrant as specified in its charter)

 


 

DELAWARE   77-0365889

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

3595 John Hopkins Court San Diego, California   92121
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 202-9000

 


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.    x  Yes    ¨  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (check one):

Large accelerated filer  ¨                    Accelerated filer  ¨                    Non-accelerated filer  x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨    No  x

The number of shares of the Registrant’s Common Stock outstanding as of November 2, 2007 was 44,318,102.

 



Table of Contents

SEQUENOM, INC.

INDEX

 

          Page No.

PART I - FINANCIAL INFORMATION

  

Item 1.

  

Financial Statements

   3
  

Condensed Consolidated Balance Sheets – as of September 30, 2007 (unaudited) and December 31, 2006

   3
  

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2007 and 2006 (unaudited)

   4
  

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2007 and 2006 (unaudited)

   5
  

Notes to Unaudited Condensed Consolidated Financial Statements

   6

Item 2.

  

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

   13

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

   19

Item 4.

  

Controls and Procedures

   20

PART II – OTHER INFORMATION

  

Item 1.

  

Legal Proceedings

   20

Item 1A.

  

Risk Factors

   21

Item 6.

  

Exhibits

   34

 

2


Table of Contents

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

SEQUENOM, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share information)

 

    

September 30,

2007

   

December 31,

2006

 
     (Unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 4,340     $ 1,932  

Short-term investments

     24,737       22,996  

Restricted cash and investments

     1,389       1,402  

Accounts receivable, net

     8,239       4,834  

Inventories, net

     2,804       2,567  

Other current assets and prepaid expenses

     2,037       677  
                

Total current assets

     43,546       34,408  

Equipment and leasehold improvements, net

     5,821       4,528  

Intangible assets, net

     115       360  

Other assets

     632       585  
                

Total assets

   $ 50,114     $ 39,881  
                

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 5,114     $ 3,809  

Accrued expenses

     5,359       5,140  

Accrued acquisition and integration costs

     235       230  

Current portion asset-backed loan

     211       —    

Deferred revenue

     794       1,578  
                

Total current liabilities

     11,713       10,757  

Deferred revenue, less current portion

     328       149  

Long-term portion asset-backed loan

     462       —    

Other long-term liabilities

     4,538       2,804  

Long-term accrued acquisition and integration costs, less current portion

     543       721  

Stockholders’ equity:

    

Convertible preferred stock, par value $0.001; authorized shares—5,000,000, no shares issued or outstanding at September 30, 2007 and December 31, 2006, respectively

     —         —    

Common stock, par value $0.001; 185,000,000 shares authorized, 40,368,872 and 33,439,634 shares issued and outstanding at September 30, 2007 and December 31, 2006, respectively

     40       33  

Additional paid-in capital

     505,753       484,898  

Accumulated other comprehensive income

     943       656  

Accumulated deficit

     (474,206 )     (460,137 )
                

Total stockholders’ equity

     32,530       25,450  
                

Total liabilities and stockholders’ equity

   $ 50,114     $ 39,881  
                

See accompanying notes.

 

3


Table of Contents

SEQUENOM, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share information)

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2007     2006     2007     2006  
     (Unaudited)     (Unaudited)  

Revenues:

        

Consumables

   $ 4,033     $ 3,175     $ 11,951     $ 9,177  

Other product related

     4,926       2,956       15,321       10,456  

Services

     885       350       2,599       554  

Research and other

     —         29       18       422  
                                

Total revenues

     9,844       6,510       29,889       20,609  
                                

Costs and expenses:

        

Cost of product revenue

     3,388       2,744       10,486       8,427  

Cost of service revenue

     1,085       188       2,567       253  

Research and development

     2,758       3,009       9,889       7,900  

Selling and marketing

     4,585       2,672       11,941       7,776  

General and administrative

     3,858       2,688       10,133       8,328  

Amortization of acquired intangibles and other

     —         506       —         1,517  
                                

Total costs and expenses

     15,674       11,807       45,016       34,201  
                                

Loss from operations

     (5,830 )     (5,297 )     (15,127 )     (13,592 )

Interest income, net

     402       402       1,142       523  

Other (expense) income, net

     (63 )     22       (79 )     128  
                                

Loss before income taxes

     (5,491 )     (4,873 )     (14,064 )     (12,941 )

Income tax (expense) benefit

     (2 )     232       (6 )     695  
                                

Net loss

     (5,493 )     (4,641 )     (14,070 )     (12,246 )
                                

Net loss per common share, basic and diluted

   $ (0. 14 )   $ (0.14 )   $ (0. 38 )   $ (0. 56 )
                                

Weighted average shares outstanding, basic and diluted

     40,262       33,423       37,264       21,958  
                                

See accompanying notes.

 

4


Table of Contents

SEQUENOM, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

     Nine months ended
September 30,
 
     2007     2006  
     (Unaudited)  

Operating activities

    

Net loss

   $ (14,070 )   $ (12,246 )

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

    

Share-based compensation expense

     1,994       892  

Depreciation and amortization

     1,406       3,085  

Deferred rent

     1,734       1,778  

Deferred income tax benefit

     —         (697 )

Other non-cash items

     475       558  

Changes in operating assets and liabilities:

    

Accounts receivable, net

     (3,411 )     (974 )

Inventories, net

     (191 )     882  

Other current assets and prepaid expenses

     (1,361 )     (252 )

Accounts payable and accrued expenses

     879       (723 )

Deferred revenue

     (629 )     (256 )

Other liabilities

     385       (145 )
                

Net cash used in operating activities

     (12,789 )     (8,098 )

Investing activities

    

Purchases of equipment, leasehold improvements and intangibles

     (2,760 )     (536 )

Purchases of short-term investments

     (40,500 )     (32,156 )

Proceeds from sale and maturities of short-term investments

     38,759       10,122  

Net change in restricted cash

     18       1,141  
                

Net cash used in investing activities

     (4,483 )     (21,429 )

Financing activities

    

Proceeds from exercise of stock options and ESPP purchases

     329       26  

Borrowings from asset-backed loan

     692       —    

Repayments on asset-backed loan

     (19 )     —    

Payments on capital lease obligations

     —         (193 )

Payments of long-term debt

     —         (200 )

Proceeds from issuance of common stock and warrants, net of issuance costs

     18,539       29,865  
                

Net cash provided by financing activities

     19,541       29,498  
                

Net increase (decrease) in cash and cash equivalents

     2,269       (29 )

Effect of exchange rate changes on cash and cash equivalents

     139       28  

Cash and cash equivalents at beginning of period

     1,932       1,885  
                

Cash and cash equivalents at end of period

   $ 4,340     $ 1,884  
                

See accompanying notes.

 

5


Table of Contents

SEQUENOM, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(1) Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of Sequenom, Inc. have been prepared in accordance with U.S. generally accepted accounting principles with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments considered necessary for a fair presentation have been included. Interim results are not necessarily indicative of results for a full year. Certain reclassifications have been made to the prior period amounts in order to conform to the current presentation.

On May 31, 2006, in conjunction with our annual meeting of stockholders, our stockholders approved amendments to our certificate of incorporation to effect a reverse stock split of our common stock and to increase the number of authorized shares of common stock to 185,000,000. On June 1, 2006, we completed a 1-for-3 reverse stock split of our common stock. Accordingly, all share, warrant, option and per share information for all periods presented has been restated to account for the effect of the reverse stock split.

The condensed consolidated balance sheet at December 31, 2006 has been derived from the audited financial statements at that date, but does not include all of the information and disclosures required by generally accepted accounting principles for complete financial statements.

These financial statements should be read in conjunction with the audited financial statements and disclosures included in our Annual Report on Form 10-K for the year ended December 31, 2006, as filed with the Securities and Exchange Commission (SEC) on March 30, 2007.

Use of Estimates

The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses in the reporting period. We regularly evaluate estimates and assumptions related to inventory valuation and warranty liabilities, which affects cost of sales and gross margin; the allowance for doubtful accounts, which affects revenue recognition; the valuation of restructuring liabilities, which affects the amount and timing of restructuring charges; and the valuation of deferred income taxes, which affects income tax expense and benefit. We base our estimates and assumptions on historical experience and on various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. The actual results experienced by us may differ materially and adversely from management’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations will be affected.

Recent Accounting Pronouncements

In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 159, The Fair Value Option for Financial Assets and Financial Liabilities—Including an Amendment of FASB Statement No. 115 (SFAS No. 159), which provides companies with an option to report selected financial assets and liabilities at fair value. The objective of SFAS No. 159 is to reduce both the complexity in accounting for financial instruments and the volatility in earnings caused by measuring related assets and liabilities differently. SFAS No. 159 also establishes presentation and disclosure requirements designed to facilitate comparisons between companies that choose different measurement attributes for similar types of assets and liabilities. SFAS No. 159 is effective for fiscal years beginning after November 15, 2007, with earlier adoption permitted. We have not yet adopted, but are currently in the process of determining the impact of adopting the provisions of SFAS No. 159 on our results of operations.

In June 2007, the FASB ratified Emerging Issues Task Force Issue (“EITF”) No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities” (“EITF No. 07-3”). EITF No. 07-3 requires that nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities pursuant to executory contractual arrangements be deferred and recognized as an expense in the period that the related goods are delivered or services are performed. We will adopt EITF No. 07-3 as of January 1, 2008, and it is not expected to have a material impact on our results of operations or financial position.

 

6


Table of Contents

(2) Liquidity and Capital Resources

We have a history of recurring losses from operations and have an accumulated deficit of $474.2 million as of September 30, 2007. Our capital requirements to sustain operations, including research and development projects, have been and will continue to be significant. In April 2007, we closed a registered direct offering of our common stock and in October 2007 we closed a private placement of our common stock, both further described in Note 5 “Stockholders’ Equity.” As of September 30, 2007, we had available cash, cash equivalents and short-term investments totaling $29.1 million and working capital of $31.8 million.

(3) Comprehensive Loss

SFAS No. 130, Reporting Comprehensive Income (SFAS No. 130), requires reporting and displaying comprehensive income (loss) and its components, which, for the Company, includes net loss and unrealized gains and losses on investments and foreign currency translation gains and losses. In accordance with SFAS No. 130, the accumulated balance of other comprehensive income (loss) is disclosed as a separate component of stockholders’ equity. A summary of our comprehensive loss is as follows (in thousands):

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2007     2006     2007     2006  

Comprehensive loss:

        

Net loss

   $ (5,493 )   $ (4,641 )   $ (14,070 )   $ (12,246 )

Unrealized gains (losses) on available-for-sale securities

     8       —         —         (2 )

Foreign currency translation adjustments

     223       17       287       90  
                                

Comprehensive loss

   $ (5,262 )   $ (4,624 )   $ (13,783 )   $ (12,158 )
                                

(4) Net Loss Per Share

In accordance with SFAS No. 128, Earnings Per Share, basic net loss per share is computed by dividing the net loss for the period by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of common and common equivalent shares outstanding during the period. Common stock equivalents consisting of stock options, warrants and restricted stock were not included in the computation of diluted net loss per share as their effect was anti-dilutive for both periods presented.

(5) Stockholders’ Equity

In June 2006, we closed a private placement financing that provided us with approximately $30.0 million of net proceeds from the sale of 19,999,998 shares of common stock and seven year warrants to purchase up to an additional 11,999,999 shares of common stock, subject to certain adjustment provisions. In conjunction with the private placement financing and our annual meeting of stockholders, our stockholders approved amendments to our certificate of incorporation to effect a reverse stock split and increase the number of authorized shares of common stock to 185,000,000. On June 1, 2006, we completed a 1-for-3 reverse stock split of our common stock. Accordingly, all share, warrant, option and per share information for all periods presented has been restated to account for the effect of the reverse stock split.

On April 30, 2007, we closed a $20.0 million registered direct offering of our common stock to several new and existing investors. Under the terms of the transaction we issued and sold 6,666,666 shares at $3.00 per share, with net aggregate proceeds of approximately $18.3 million after deducting placement agents’ fees and transaction expenses.

In October 2007, we closed a private placement of our common stock for approximately $30.5 million to certain investors. Under the terms of the transaction we issued and sold 3,383,335 shares at $9.00 per share, with anticipated net aggregate proceeds of approximately $28.1 million after deducting placement agents’ fees and estimated transaction expenses.

(6) Share-Based Compensation

We maintain several share-based compensation plans for the grant of incentive stock options and non-qualified stock options to employees, consultants and non-employee directors. In accordance with the provisions of SFAS No. 123, Share-Based Payment (SFAS No. 123(R)) the estimated fair value of share-based payments is measured at the grant date and is recognized as stock-based compensation expense over the employee’s requisite service period. We adopted the provisions of SFAS No. 123(R) on January 1, 2006 using the modified prospective method, which provided for certain changes to the method for valuing stock-based compensation.

 

7


Table of Contents

For the three months ended September 30, 2007 and 2006, we recorded $1,025,000 and $364,000 of compensation expense related to our share-based compensation awards, respectively. The compensation expense related to our share-based compensation arrangements is recorded as components of research and development expense ($175,000 and $74,000), selling and marketing expense ($202,000 and $45,000) and general and administrative expense ($648,000 and $245,000) for the three months ended September 30, 2007 and 2006, respectively.

For the nine months ended September 30, 2007 and 2006, we recorded $1,995,000 and $886,000 of compensation expense related to our share-based compensation awards, respectively. The compensation expense related to our share-based compensation arrangements is recorded as components of research and development expense ($315,000 and $193,000), selling and marketing expense ($380,000 and $116,000) and general and administrative expense ($1,300,000 and $577,000) for the nine months ended September 30, 2007 and 2006, respectively.

We have not recognized, and do not expect to recognize in the near future, any tax benefit related to stock-based compensation cost as a result of the full valuation allowance of our net deferred tax assets and our net operating loss carryforwards.

We account for options granted to non-employees in accordance with EITF No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, and SFAS No. 123(R). The fair value of these options at the measurement dates was estimated using the Black-Scholes pricing model. Total stock-based compensation for options granted to non-employees for the three months ended September 30, 2007 and 2006, was $36,000 and $0, respectively, and is included in research and development and sales and marketing expenses, totaling $27,000 and $9,000, respectively, in the statements of operations. For the nine months ended September 30, 2007 and 2006, total stock-based compensation for options granted to non-employees was $79,000 and $0, respectively, and is included in general and administrative, research and development and selling and marketing expenses, totaling $39,000, $29,000 and $11,000, respectively, in the statements of operations.

Share-Based Compensation Plans

Stock Compensation Plans

On May 31, 2006, stockholders approved our 2006 equity incentive plan (the 2006 Plan), as the successor to our 1999 stock option plan (the 1999 Plan). In connection with the adoption of the 2006 Plan, we terminated the automatic annual increase feature under the 1999 Plan and resolved to cease to grant additional stock awards under the 1999 Plan following the effectiveness of the 2006 Plan. As of September 30, 2007, the aggregate number of shares of common stock that may be issued under the 2006 Plan was 7,099,034 shares, plus the number of shares subject to any stock awards under the 1999 Plan that terminate or are forfeited or repurchased and would otherwise have been returned to the share reserve under the 1999 Plan.

Restricted Stock

On January 28, 2007, we granted restricted stock awards to certain executive officers and employees. At September 30, 2007, 58,397 shares with a weighted average grant date fair value of $4.60 per share remained outstanding. The awards fully vest one year from the grant date.

Employee Stock Purchase Plan

In 1999 we adopted the 1999 Employee Stock Purchase Plan (the 1999 ESPP). As of September 30, 2007, we had reserved 626,123 shares of common stock for issuance under the 1999 ESPP. Beginning in 2001, the amount of authorized shares available under the 1999 ESPP automatically increases each January 1st by an amount equal to 1% of the outstanding common stock on the last trading day of the prior year, subject to an annual increase limitation of 166,666 shares. The 1999 ESPP allows for a series of concurrent offering periods, each with a maximum duration of 24 months. Shares are purchased semi-annually at 85% of the lower of the closing stock price at the beginning or end of the period.

In October 2006 the Board of Directors approved a change to all offerings under the 1999 ESPP that commence on or after February 1, 2007. New offerings will be for a duration of six months and will consist of one purchase interval, but will not impose either an individual or all-participant limitation on the number of shares purchasable on a purchase date, although the 1999 ESPP limits stock purchases to $25,000 per individual per calendar year. Participants had the option of: continuing under the current plan offering period until its expiration, or, withdrawing from the current offering prior to its expiration and enrolling in the new offering commencing February 1, 2007. Those employees not electing to enroll in the new offering period will continue under the then current offering until the 24 month offering period expires. As of September 30, 2007, employees have contributed approximately $88,000 to the current offering period of the 1999 ESPP, since the beginning of the offering period that commenced August 2007. For the three and nine months ended September 30, 2007, we have recognized $4,000 and $8,000, respectively, as share-based compensation expense related to the 1999 ESPP.

 

8


Table of Contents

Warrants

In connection with the acquisition of Axiom Biotechnologies in 2002, we assumed an outstanding warrant to purchase 7,333 Axiom ordinary shares at an exercise price of $10.50, which was adjusted to become a warrant to purchase 1,535 shares of our common stock at an exercise price of $50.19 per share. As of September 30, 2007, this warrant has not been exercised and expires in December 2011.

In connection with the Series C Preferred Stock issued in May 1997, we issued warrants to purchase an aggregate of 106,508 shares of our Series C Preferred Stock at an exercise price of $3.15 per share. These warrants became exercisable for 35,503 shares of our common stock at an exercise price of $9.45 per share upon our initial public offering. In May 2007, 11,694 of these remaining warrants expired unexercised.

In connection with an amendment to our lease for our corporate headquarters in San Diego, California in September 2005, we issued to the landlord a warrant to purchase 50,000 shares of our common stock with an exercise price of $2.64 per share. The warrant expires in October 2015. As of September 30, 2007, the warrant remains outstanding and exercisable.

In connection with the private placement financing completed in June 2006, we issued to the investors warrants to purchase an aggregate of 11,999,999 shares of our common stock at an exercise price of $2.10 per share. These warrants expire in September 2013. As of September 30, 2007, all of these warrants remain outstanding and exercisable.

Additionally in connection with the June 2006 private placement financing, we issued to our placement agent a warrant to purchase 866,666 shares of our common stock at an exercise price of $2.52 per share that expires in June 2011. In 2007, the placement agent transferred portions of the warrant to certain of its employees. As of September 30, 2007, the placement agent and its transferees had exercised warrants in both cash and cashless exercises to purchase 129,546 shares of our common stock. As of September 30, 2007, warrants to purchase an aggregate of 706,666 shares remained outstanding and exercisable.

Subsequent to September 30, 2007, the placement agent and its transferees exercised in both cash and cashless exercises warrants to purchase an additional 460,474 shares of our common stock and as of October 31, 2007, warrants to purchase 204,866 shares remain outstanding and exercisable.

Stock Options

The estimated fair value of each stock option award granted was determined on the date of grant using the Black-Scholes option valuation model with the following weighted-average assumptions for stock option grants:

 

     September 30,  
     2007     2006  

Risk free interest rates

   4.7 %   4.6% - 5.0 %

Volatility

   83 %   101 %

Dividend yield

   0 %   0 %

Expected option term (years)

   6.4     6.7  

The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of our employee stock options. The expected volatility is based on the historical volatility of our stock. We have not paid any dividends on common stock since our inception and do not anticipate paying dividends on our common stock in the foreseeable future. The computation of the expected option term is based on a weighted-average calculation combining the average life of stock options that have already been exercised or cancelled with the estimated life of all unexercised stock options.

SFAS No. 123(R) requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Pre-vesting forfeitures were estimated to be 12.5% based on historical experience. Our determination of fair value is affected by our stock price as well as a number of assumptions that require judgment. The weighted-average fair value of each stock option granted to employees during the nine months ended September 30, 2007 and 2006, estimated as of the grant date using the Black-Scholes option valuation model was $3.53 and $1.60, respectively, per share of our common stock subject to the stock option.

 

9


Table of Contents

A summary of the status of our stock option plans as of September 30, 2007 and of changes in stock options outstanding under the plans during the nine months ended September 30, 2007 is as follows:

 

Outstanding

   Shares Subject
to Options
    Weighted
Average Exercise
Price per Share
   Weighted
Average
Remaining
Contractual
Term (in years)
   Aggregate
Intrinsic Value

Outstanding at December 31, 2006

   3,285,783     $ 6.45      

Granted

   1,938,013       4.70      

Canceled

   (181,584 )     4.64      

Exercised

   (96,894 )     2.35      
                  

Outstanding at September 30, 2007

   4,945,318     $ 5.91    8.3    $ 17,117,246
                        

Options vested and exercisable at September 30, 2007

   1,593,373     $ 10.89    6.6    $ 4,880,597
                        

As of September 30, 2007, there was $6.3 million of unamortized compensation expense related to unvested stock option awards, which is expected to be recognized over a remaining weighted-average vesting period of 2.9 years. Cash received from stock option exercises for the nine months ended September 30, 2007 and 2006, was $225,000 and $0, respectively. At September 30, 2007, there were 2,153,716 shares available for future option grants.

(7) Inventories

Inventories are stated at the lower of cost (first-in, first-out) or market value. Standard cost, which approximates actual cost, is used to value inventories. The components of inventories were (in thousands):

 

    

September 30,

2007

  

December 31,

2006

     (Unaudited)    (Audited)

Raw materials

   $ 1,578    $ 1,635

Work in process

     56      51

Finished goods

     1,170      881
             

Total

   $ 2,804    $ 2,567
             

Inventories are shown net of excess and obsolescence reserves of $1.2 million and $1.1 million at September 30, 2007 and December 31, 2006, respectively.

(8) Asset-backed Loan

On August 31, 2007, we signed an amendment to our existing asset-backed loan line that had previously expired. Under the terms of this amendment, we may elect to have individual minimum fundings of $100,000 up to an aggregate limit of $3.0 million through December 23, 2008. All borrowings will be secured by the underlying financed equipment.

As of September 30, 2007, we have $0.7 million outstanding on this asset-backed loan line relating to one funding at an interest rate of 10.05% to be repaid in 36 monthly installments.

(9) Acquisition and Integration Costs

As of September 30, 2007, we had approximately $0.8 million remaining in accrued acquisition costs, relating to the acquisition of Gemini Genomics, plc in 2001. The remaining acquisition liability relates to facility exit costs.

 

10


Table of Contents

The accrued acquisition cost activity in the nine months ended September 30, 2007 was as follows (in thousands):

 

    

Balance at
December 31,

2006

   Deductions    

Balance at
September 30,

2007

     (Audited)    (Unaudited)     (Unaudited)

Costs to close facilities and exit lease commitments

   $ 951    $ (173 )   $ 778

(10) Warranty Costs and Reserves

In accordance with FASB Interpretation No. 45, Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN No. 45), we provide a warranty provision related to the sales of our MassARRAY equipment based on our experience of returns and repairs required under the warranty period.

We generally provide a one-year warranty on our MassARRAY Compact system and related equipment. We establish an accrual for estimated warranty expenses associated with system sales based on historical amounts. This expense is recorded as a component of cost of product revenue in the statement of operations.

Changes in our warranty liability during the nine months ended September 30, 2007 were as follows (in thousands):

 

Balance as of December 31, 2006

   $ 680  

Additions charged to cost of revenues

     223  

Repairs and replacements

     (401 )
        

Balance as of September 30, 2007

   $ 502  
        

(11) Litigation

In November 2001, we and certain of our current or former officers and directors were named as defendants in a class action shareholder complaint filed by Collegeware USA in the U.S. District Court for the Southern District of New York (now captioned In re Sequenom, Inc. IPO Securities Litigation) Case No. 01-CV-10831. Similar complaints were filed in the same District Court against hundreds of other public companies that conducted initial public offerings of their common stock in the late 1990s and 2000. In the complaint, the plaintiffs allege that our underwriters, certain of our officers and directors and we violated the federal securities laws because our registration statement and prospectus contained untrue statements of material fact or omitted material facts regarding the compensation to be received by and the stock allocation practices of the underwriters. The plaintiffs seek unspecified monetary damages and other relief. In October 2002, our officers and directors were dismissed without prejudice pursuant to a stipulated dismissal and tolling agreement with the plaintiffs. In February 2003, the District Court dismissed the claim against us brought under Section 10(b) of the Securities Exchange Act of 1934, without giving the plaintiffs leave to amend the complaint with respect to that claim. The District Court declined to dismiss the claim against us brought under Section 11 of the Securities Act of 1933.

In September 2003, pursuant to the authorization of a special litigation committee of our board of directors, we approved in principle a settlement offer by the plaintiffs. In September 2004, we entered into a settlement agreement with the plaintiffs. In February 2005, the District Court issued a decision certifying a class action for settlement purposes and granting preliminary approval of the settlement subject to modification of certain bar orders contemplated by the settlement. In August 2005, the District Court reaffirmed class certification and preliminary approval of the modified settlement. In February 2006, the District Court dismissed litigation filed against certain underwriters in connection with the claims to be assigned to the plaintiffs under the settlement. In April 2006, the District Court held a final fairness hearing to determine whether to grant final approval of the settlement. In December 2006, the U.S. Court of Appeals for the Second Circuit vacated the District Court’s decision certifying as class actions the six lawsuits designated as “focus cases.” Thereafter the District Court ordered a stay of all proceedings in all of the lawsuits pending the outcome of plaintiffs’ petition to the Second Circuit for rehearing en banc. In April 2007, the Second Circuit denied plaintiffs’ rehearing petition, but clarified that the plaintiffs may seek to certify a more limited class in the District Court. Accordingly, the settlement as originally negotiated will not receive final approval. In August 2007, the plaintiffs filed amended complaints in the six focus cases and moved to certify the new, narrower classes alleged therein.

On August 3, 2007, we received a demand letter dated July 31, 2007, demanding on behalf of an alleged stockholder, Vanessa Simmonds, that our board of directors prosecute a claim against our IPO underwriters, in addition to certain unnamed officers, directors and principal stockholders as identified in our IPO prospectus, for violations of sections 16(a) and 16(b) of the Securities Exchange Act of 1934. The demand letter asserts

 

11


Table of Contents

purchases and sales of our common stock within periods of less than six months and failure to report such transactions, and seeks unspecified disgorgement of profits. We requested further information from Ms. Simmonds in order to evaluate the demand and although Ms. Simmonds provided a response, we still do not have adequate information to evaluate the demand.

We do not anticipate that the ultimate outcome of either of the events set forth above will have a material adverse impact on our financial position.

In addition, from time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business.

(12) Income Taxes

In July 2006, the FASB issued FIN No. 48, Accounting for Uncertainty in Income Taxes (FIN No. 48), which prescribes a recognition threshold and measurement process for recording in the financial statements uncertain tax positions taken or expected to be taken in a tax return. Additionally, FIN No. 48 provides guidance on de-recognition, classification, accounting in interim periods and disclosure requirements for uncertain tax positions. The accounting provisions of FIN No. 48 became effective for us beginning January 1, 2007.

At December 31, 2006, we had federal and state tax net operating loss (NOL) carryforwards of approximately $229.2 and $130.0 million, respectively, which will begin to expire in 2008 and 2007 unless previously utilized. We also had federal and state research and development (R&D) credit carryforwards of $7.9 and $7.1 million, respectively. The federal R&D tax credits will begin to expire in 2011 unless previously utilized. Because realization of such tax benefits is uncertain, we have provided a 100% valuation allowance as of September 30, 2007 and December 31, 2006. Utilization of the NOL and R&D credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that have occurred previously or that could occur in the future as provided by Sections 382 and 383 of the Internal Revenue Code of 1986, as well as similar state and foreign provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 percent over a three-year period. Since our formation, we have raised capital through the issuance of capital stock on several occasions, which combined with the purchasing shareholders’ subsequent disposition of those shares, may have resulted in a change of control, as defined by Section 382, or could result in a change of control in the future upon subsequent disposition. We have not completed an updated study to assess whether a change in control has occurred or whether there have been multiple changes of control since our formation due to the significant complexity and cost associated with such a study and because there could be additional changes in the future. If we have experienced a change of control at any time since our formation, utilization of our NOL or R&D credit carryforwards would be subject to an annual limitation under Sections 382 and 383, which is determined by first multiplying the value of our stock at the time of the ownership change by the applicable long-term tax-exempt rate, which then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the NOL or R&D credit carryforwards before utilization. Further, until the study is updated and any limitation known, no amounts are being presented as an uncertain tax position under FIN No. 48. Interest and penalties related to uncertain tax positions will be reflected in income tax expense. Tax years 1994 to 2007 remain subject to future examination by the major tax jurisdictions in which we are subject to tax.

(13) Change in Accounting Estimate

During review of our revenue recognition policies, we determined that deferring a portion of those sales for potential software maintenance costs on proprietary software was no longer appropriate. As a result, as of July 1, 2007, we no longer recognize an estimate for potential maintenance costs associated with the sale of software included with our sale of MassARRAY systems as a deferral of revenue. The effect of this change in estimate was to recognize previously deferred revenue of $284,000 as an increase to Other Product Related Revenues for the three and nine months ended September 30, 2007, respectively, and a decrease in net loss per share of $0.01 and $0.01 for the three and nine months ended September 30, 2007, respectively.

 

12


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

All statements in this report that are not historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 (the Exchange Act). These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plans,” “believes,” “anticipates,” “expects,” “estimates,” “predicts,” “potential,” “continue,” “opportunity,” “goals,” or “should,” the negative of these words or words of similar import. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects are also forward-looking statements. These forward-looking statements are or will be, as applicable, based largely on our expectations and projections about future events and future trends affecting our business, and so are or will be, as applicable, subject to risks and uncertainties including but not limited to the risk factors discussed in this report, that could cause actual results to differ materially from those anticipated in the forward-looking statements. We caution investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements. Our views and the events, conditions and circumstances on which these future forward-looking statements are based, may change.

SEQUENOM®, SpectroCHIP®, and MassARRAY® are registered trademarks and iPLEX and EpiTYPER are trademarks of SEQUENOM, Inc. This report may also refer to trade names and trademarks of other organizations.

Sequenom was incorporated in 1994 under the laws of the State of Delaware.

Overview

We are a genetics company committed to providing genetic analysis products and services that translate genomic science into superior solutions for biomedical research, agricultural, molecular medicine applications and diagnostic applications including non-invasive prenatal diagnostics. Our proprietary MassARRAY system, comprised of hardware, software applications, consumable chips and reagents, is a high performance nucleic acid analysis platform that quantitatively and precisely measures genetic target material and variations therein. In late 2005, we launched our services business, which provides genetic analysis services to customers as a complement and as an alternative to our systems product offerings. Our research and development efforts are committed to producing new and improved components and applications for our MassARRAY system that will deliver greater system versatility and also reduce the cost per data point generated. Our research and development efforts are also directed to the development of diagnostic tests, particularly non-invasive prenatal diagnostics, for use on the MassARRAY system and other platforms.

We derive revenue primarily from sales of our MassARRAY hardware, software and consumable products. Our standard MassARRAY system combines four basic components:

 

   

proprietary analytical reaction technology and sample preparation and dispensing hardware to prepare DNA for analysis;

 

   

a coated silicon chip known as the SpectroCHIP bioarray;

 

   

a mass spectrometer, which uses an established analytical method that we have adapted for DNA analysis; and

 

   

bioinformatics software that records, calculates, and reports the data generated by the mass spectrometer.

Each of these components contributes to a high level of performance in terms of speed, accuracy, and cost efficiency. We have been selling MassARRAY products since 2000.

Our MassARRAY technology is accepted as a leading high-performance DNA analysis system for the fine mapping genotyping market. Our customers include clinical research laboratories, biotechnology companies, academic institutions and government agencies. To maximize market penetration and provide customer support for our expanding user base, we have established direct sales and support personnel serving North America, Europe, India and Asia, in addition to regional distribution partners in France, Israel, Japan, South Korea, New Zealand, Singapore, Taiwan, and Turkey.

Genetic analysis is primarily conducted in two key biomedical research market sectors: the research market, where we have many customers, and the clinical analysis market, where we are expanding. The research market is mainly comprised of academic and government institutions, which make initial genetic discoveries. However, it is the source of discoveries of new genetic content. The clinical analysis market is significantly larger and takes the genetic analysis a step further to establish the use of genes and genetic markers for the potential benefit of the general population.

The needs of these markets differ significantly. The academic research market, which requires the highest data density per sample, is more tolerant to inconsistencies in data and error rates, and typically has a shorter window of opportunity. Sample throughput is very high. The academic research market is extremely price competitive. The clinical analysis market is

 

13


Table of Contents

typically interested in a defined number of markers per sample, is not as tolerant to inconsistencies and error rates, typically has a longer development cycle, and is less price competitive. Sample throughput requirements are not nearly as high. Considering the clinical analysis market’s requirements and the strengths of the MassARRAY system, including its high sensitivity, specificity, and reproducibility, we believe there is significant opportunity to be more competitive in the clinical analysis market.

We have targeted customers conducting quality genotyping and performing fine mapping studies, candidate gene studies, comparative sequencing, gene expression analysis, and epigenetic analysis in the molecular medicine market. Epigenetic analysis, also known as DNA methylation analysis, is the study of changes in DNA in the form of chromatin modifications and/or changes in the presence or absence of methyl groups in specific areas of the DNA. Epigenetic analysis is an important part of cancer and other research areas.

We are targeting customers across four segments: clinical research and clinical marker validation, the emerging field of molecular medicine, diagnostic service laboratories, and animal testing laboratories. We believe the market and opportunities for growth for fine mapping genotyping are increasing as more researchers are completing their larger genomic studies such as whole genome scans. Epigenetic analysis is a relatively new and emerging market, that, along with gene expression analyses, are increasingly being utilized by researchers in conjunction with genotyping to attempt to fully understand genetic cause and effect.

As of September 30, 2007, our revenues consisted of sales of MassARRAY hardware, software, consumables, maintenance agreements, and from services contracts through our genetic analysis contract research services business. The impact of our product offerings and contract research services business on future revenues, margins, expenses, and cash flows remains uncertain and depends on many factors as described in Item 1A of this report under the caption “Risk Factors”.

We expect revenues from out-licensing and commercialization of our non-invasive prenatal diagnostics technology, including technology for Rhesus D incompatibility using a real-time polymerase chain reaction platform, to be minimal for the foreseeable future. To the extent that revenues are realized from our non-invasive prenatal diagnostics technology or from our prior disease gene discoveries, if at all, they may fluctuate significantly as revenues will be based upon the occurrence of certain milestones, our reliance upon and the progress made by our collaborative partners, successful product development and commercialization, and product demand, all of which are uncertain and difficult to predict. As a result, our entitlement to, and the timing and amounts of, any licensing and milestone payments and royalty or revenue sharing payments on future product sales are uncertain and difficult to predict. To achieve such revenues we will likely be dependent upon the efforts, resources and success of present and future collaborators and licensees who may need to invest significant dollar amounts in research and development efforts, commercialization efforts, clinical trials, and obtaining regulatory approvals over several years. Such revenues, if any, are uncertain and also depend on many factors as described in Item 1A of this report under the caption “Risk Factors.”

We have a history of recurring losses from operations and have an accumulated deficit of $474.2 million as of September 30, 2007. Our capital requirements to sustain operations, including research and development projects, have been and will continue to be significant. As of September 30, 2007, we had available cash, cash equivalents and short-term investments totaling $29.1 million and working capital of $31.8 million.

On April 30, 2007, we closed a $20.0 million registered direct offering of our common stock to several new and existing investors. Under the terms of the transaction, we issued and sold 6,666,666 shares at $3.00 per share, with net aggregate proceeds of approximately $18.3 million after deducting placement agents’ fees and transaction expenses.

In October 2007, we closed a private placement of our common stock for approximately $30.5 million to certain investors. Under the terms of the transaction we issued and sold 3,383,335 shares at $9.00 per share, with anticipated net aggregate proceeds of approximately $28.1 million after deducting placement agents’ fees and estimated transaction expenses.

Results of Operations for the Three and Nine Months Ended September 30, 2007 and 2006

Revenues

Total revenues for the three months ended September 30, 2007 increased to $9.8 million from $6.5 million in the comparative period in 2006. Total revenues for the nine months ended September 30, 2007 increased to $29.9 million from $20.6 million for the same period in 2006. The increase in revenues for the three and nine months ended September 30, 2007, are from increases in consumables and product related revenues, as well as increased contract services revenues compared to the prior period. Product revenues are derived from sales of consumables including our SpectroCHIP bioarray chips used with our iPLEX and other assays, MassARRAY systems, maintenance agreements, sales and licensing of our proprietary software, and license fees from end-users.

 

14


Table of Contents

For the three and nine months ended September 30, 2007, compared to the three and nine months ended September 30, 2006, consumable revenues increased to $4.0 million and $12.0 million, respectively, from $3.2 million and $9.2 million, primarily due to an increased installed base of MassARRAY Compact systems, and adoption of our iPLEX Gold assay.

Other product related revenue was $4.9 million and $15.3 million, respectively, for the three and nine months ended September 30, 2007, compared to $2.9 million and $10.5 million, respectively, for the same periods in 2006. The increase of $2.0 million for the three months ended September 30, 2007 as compared to the same period in 2006, was primarily due to an increase in MassARRAY system sales to $4.3 million for the three months ended September 30, 2007 from $2.4 million for the same period in 2006. The increase of $4.8 million for the nine months ended September 30, 2007, compared to the nine months ended September 30, 2006 was primarily due to an increase in MassARRAY system sales to $13.5 million from $8.8 million for the respective periods. Revenue from other product sales and MassARRAY system maintenance contracts for the three months ended September 30, 2007 and 2006 was $0.6 million and $0.5 million, respectively. Revenue from other product sales and MassARRAY system maintenance contracts for the nine months ended September 30, 2007 and 2006 was $1.8 million and $1.6 million, respectively. The increase in other product sales and MassARRAY system maintenance contract revenues are primarily attributable to higher software sales in connection with increased system placements, as well as increased maintenance contract sales to customers during both the three and nine months ended September 30, 2007, compared to the prior periods.

We recorded contract research service revenues of $0.9 million and $2.6 million, respectively, for the three and nine months ended September 30, 2007, compared to $0.4 million and $0.6 million, respectively, for the comparative periods in 2006. The increase of $0.5 million and $2.0 million in the three and nine months ended September 30, 2007, from the comparative periods is attributable to growth in our contract research service business primarily in the clinical analysis and academic research markets.

Research and other revenues were approximately $0 and $18,000, respectively, for the three and nine months ended September 30, 2007 compared to $29,000 and $0.4 million, respectively, for the three and nine months ended September 30, 2006. Research and other revenues during the nine months ended September 30, 2006, related to the license of certain proprietary genetic content of $0.3 million.

Our revenues have historically fluctuated from period to period and likely will continue to fluctuate substantially in the future based upon the unpredictable sales cycle for the MassARRAY Compact system, revenue recognition criteria, and the overall acceptance and demand for our new and existing commercial products and services.

Cost of product and service revenues and gross margin

Cost of product revenues for the three and nine months ended September 30, 2007 were $3.4 million and $10.5 million, respectively, compared to $2.7 million and $8.4 million, respectively, for the same periods in 2006. Gross margins on product sales for the three and nine months ended September 30, 2007 were 62% and 62%, respectively, compared to 56% and 59%, respectively, for the same periods in 2006. Gross margins primarily increased due to higher systems sales with a favorable mix of new systems at higher margins versus trade-ins and strategic system placements at lower margins, as well as increased consumable sales that sell at higher average gross margins compared to systems sales.

We believe that gross margin in future periods will be affected by, among other things, the selling price for systems and consumables, consumable sales per MassARRAY system sold, the mix of products and contract research services sold, the mix of systems and consumables sold, competitive conditions, costs of goods, sales volumes, discounts offered, sales through distributors, inventory reserves and obsolescence charges required and royalty payment obligations on in-licensed technologies.

Cost of contract research service revenues for the three and nine months ended September 30, 2007 were $1.1 million and $2.6 million, respectively, compared to $188,000 and $253,000, respectively, for the same periods in 2006. During the three months ended September 30, 2007, our genetic analysis contract research service business incurred higher expenses, primarily in salaries and related personnel expenses, as operations continue to become fully functional in anticipation of service contract requirements. Gross margins on contract research service revenues are dependent on the particular contract terms of the work undertaken.

For the three and nine months ended September 30, 2007, the Company’s overall gross margin was 55% and 56%, respectively, compared to 55% and 58% in the comparative periods in 2006. The increase in overall gross margin for the three months ended September 30, 2007 is attributable to increased consumables sales that sell at higher average gross margins, slightly offset by lower margins on system hardware sales compared to the prior period. The decrease in overall gross margin for the nine months ended September 30, 2007 is attributable to increased system hardware sales at lower margins compared to the comparative period in 2006, offset by an overall increase in consumables sales that sell at higher average gross margins, as well as lower margins within contract research services as we increase operations to become fully functional .

 

15


Table of Contents

Research and development expenses

Research and development expenses decreased to $2.8 million for the three months ended September 30, 2007 from $3.0 million for the same period in 2006, and increased to $9.9 million for the nine months ended September 30, 2007 from $7.9 million for the same period in 2006. These expenses consisted primarily of salaries and related personnel expenses, product development costs, and expenses relating to work performed under research contracts.

The decrease in expenses of $0.2 million for the three months ended September 30, 2007, compared to the same period in 2006 primarily relates to approximately $0.8 million in the absorption of cost of service revenue as our contract research service operations become fully functional during 2007 and by an adjustment of $1.1 million relating to research and development purchase commitments associated with our MassARRAY system offset by increased headcount, travel and recruiting costs of $0.8 million, increased consulting services for various research and development projects associated with our non-invasive prenatal diagnostic technology of $0.3 million, higher share-based compensation charges of $0.1 million and increased operating supplies of $0.5 million.

The increase in research and development expenses of $2.0 million for the nine months ended September 30, 2007, compared to the same period in 2006 primarily relates to increased salaries, travel and personnel costs of $1.7 million, increased consulting services for various research and development projects associated with our non-invasive prenatal technology of $1.2 million, increased expenditures for collaborative agreements of $0.6 million, higher share-based compensation charges of $0.1 million, higher equipment charges of $0.1 million and increased operating supplies of $1.7 million. These increases were offset by approximately $2.3 million in the absorption of cost of service revenue as our contract research service operations become fully functional during 2007 and by an adjustment of $1.1 million relating to research and development purchase commitments associated with our MassARRAY system.

Selling and marketing expenses

Selling and marketing expenses for the three and nine months ended September 30, 2007 were $4.6 million and $11.9 million, respectively, compared to $2.7 million and $7.8 million for the same periods in 2006. These expenses consist primarily of salaries and related expenses for sales and marketing, customer support, and business development personnel and their related department expenses.

The increase of $1.9 million in sales and marketing expenses for the three months ended September 30, 2007 compared to the same period in 2006 was primarily comprised of increased costs of $0.1 million for advertising and public relations expenses, $1.5 million for increased headcount, travel and recruiting expenses, $0.1 million of consultant expenses for sales and marketing projects associated with our non-invasive prenatal diagnostic technology, higher share-based compensation charges of $0.2 million and increased headcount-based expense allocation charges of $0.2 million, offset by reduced expenses for legal and miscellaneous selling and marketing expenses of $0.1 million and $0.1 million, respectively.

The increase of $4.1 million in sales and marketing expenses for the nine months ended September 30, 2007 compared to the same period in 2006 was primarily comprised of $2.7 million for increased headcount, travel and recruiting expenses, $0.5 million for advertising and public relations expenses, $0.6 million of consultant expenses for sales and marketing projects associated with our non-invasive prenatal technology and $0.3 million for higher share-based compensation charges and increased headcount-based expense allocation charges of $0.3 million, offset by reduced expenses for legal and miscellaneous selling and marketing expenses of $0.1 million and $0.2 million, respectively.

We expect our sales and marketing headcount and associated expenses to increase during the remainder of 2007 as we strengthen our sales force and as we continue building our commercial development team for our non-invasive prenatal diagnostic technology.

General and administrative expenses

General and administrative expenses for the three and nine months ended September 30, 2007 were $3.9 million and $10.1 million, compared to $2.7 million and $8.3 million for the same periods in 2006. These expenses consisted primarily of salaries and related expenses for finance, legal and human resource personnel and their related department expenses.

The increase of $1.2 million for the three months ended September 30, 2007 from the same period in 2006 was primarily due to $0.4 million for increased headcount, travel and recruiting expenses, $0.2 million in increased legal costs related to our patent portfolio, increase in our bad debt expense of $0.1 million and $0.4 million for higher share-based compensation charges.

 

16


Table of Contents

The increase of $1.8 million for the nine months ended September 30, 2007 from the same period in 2006 was primarily due to $1.0 million for increased headcount, travel and recruiting expenses, $0.4 million in increased intellectual property expenses related to our patent portfolio, $0.7 million for higher share-based compensation charges, $0.3 million for increased consultant labor associated with various administrative projects, offset by decreases in public relation expenditures of $0.2 million and $0.4 million of higher absorption of overhead costs.

We expect general and administrative costs to increase for 2007 compared to 2006, as we continue to build our infrastructure in order to support our future growth plans.

Amortization of acquired intangibles and other

In connection with the acquisition of Gemini Genomics, plc in 2001, we acquired approximately $18.7 million of intangible assets, including clinical data collections and patent rights. These intangible assets were amortized over three to five years and as of December 31, 2006, were fully amortized. Amortization for the three and nine months ended September 30, 2006 was $0.5 million and $1.5 million, respectively.

Other expenses for the three and nine months ended September 30, 2007 and comparative periods for 2006 consist of restructuring costs incurred during 2006. These expenses were in connection with our cost reduction plan initiated during the third quarter of 2005 related to our genetic systems business and consisted of headcount reduction charges. We incurred no restructuring charges for the three and nine months ended September 30, 2007, compared to $2,000 and $6,000 for the comparative periods. At December 31, 2006, we no longer had an accrued balance in respect to the restructuring charges and anticipate no further expenses related to this cost reduction plan.

Interest income, net

Net interest income was $0.4 million and $1.1 million, respectively, for the three and nine months ended September 30, 2007, compared to $0.4 million and $0.5 million, respectively, for the same periods in 2006, as our cash, cash equivalents and short-term investment balances were higher during the nine month period due to the closing of our private placement funding that raised net proceeds of $30.0 million in June 2006 and the closing of our registered direct offering that raised net proceeds of $18.3 million in April 2007.

Income tax (expense) benefit

The deferred tax benefit of $0.2 million and $0.7 million, respectively, for the three and nine months ended September 30, 2006 was due to the tax effects related to amortization on our intangible assets, including clinical data collections and patent rights acquired from Gemini Genomics, plc. There was no comparable benefit in the period ended September 30, 2007.

Share-based compensation

We maintain a current stock option plan (the 2006 Plan) and continue to have obligations under our former plan (the 1999 Plan), under which we have and may grant incentive stock options and non-qualified stock options to employees, consultants and non-employee directors. The benefits provided under all of these plans are subject to the provisions of SFAS No. 123(R). Share-based compensation expense recognized under SFAS No. 123(R) was $1.0 and $2.0 million, respectively, for the three and nine months ended September 30, 2007, compared to $0.4 million and $0.9 million, respectively, for the same periods in 2006. For more information about our accounting for share-based compensation expense, see Note 5 to the Financial Statements in Item 1 of this report.

Liquidity and Capital Resources

As of September 30, 2007, cash, cash equivalents and short-term investments totaled $29.1 million, compared to $24.9 million at December 31, 2006. Our cash reserves are held primarily in a variety of interest-bearing instruments, including auction rate securities and money market accounts.

We have a history of recurring losses from operations and have an accumulated deficit of $474.2 million as of September 30, 2007. Our capital requirements to sustain operations, including research and development projects, have been and will continue to be significant. As of September 30, 2007, we had working capital of $31.8 million.

On April 30, 2007, we closed a $20.0 million registered direct offering of our common stock to several new and existing investors. Under the terms of the transaction, we issued and sold 6,666,666 shares at $3.00 per share, with net aggregate proceeds of approximately $18.3 million, after deducting placement agents’ fees and estimated expenses.

 

17


Table of Contents

In October 2007, we closed a private placement of our common stock for approximately $30.5 million to certain investors. Under the terms of the transaction we issued and sold 3,383,335 shares at $9.00 per share, with anticipated net aggregate proceeds of approximately $28.1 million after deducting placement agents’ fees and estimated transaction expenses.

We consider the material drivers of our cash flow to be sales volumes, inventory management and operating expenses. Our principal sources of liquidity are our cash, cash equivalents and short-term investments. Cash used in operations for the nine months ended September 30, 2007 was $12.8 million compared to $8.1 million for the same period in 2006. The use of cash was primarily a result of the net loss of $14.1 million for the nine months ended September 30, 2007, adjusted for non-cash depreciation and amortization of $1.4 million, other non-cash items which is comprised primarily of deferred rent of $1.7 million and $2.0 million of share-based compensation expenses, as well changes in our operating assets and liabilities primarily consisting of a decrease in accounts receivable of $3.4 million, other current assets of $1.4 million and deferred revenue of $0.6 million. These decreases were offset by increases in accounts payable and accrued expenses and other liabilities totaling $1.3 million. At our current and anticipated level of operating loss, we expect to continue to incur an operating cash outflow on a quarterly basis for the foreseeable future.

Investing activities, other than the changes in our short-term investments and restricted cash that utilized $1.7 million, consists of purchases for capital equipment that used $2.8 million in cash during the nine months ended September 30, 2007.

Net cash provided by financing activities was $19.5 million for the nine months ended September 30, 2007, compared to cash provided of $29.5 million for the same period in 2006. Financing activities during the nine months ended September 30, 2007, included the receipt of proceeds from the exercise of stock options and employee stock purchase plan purchases during the period of $0.3 million, proceeds from our equipment financing line of $0.7 million, net aggregate proceeds of approximately $18.3 million associated with closing a registered direct offering of our common stock on April 30, 2007, and $0.2 million from the exercising of outstanding warrants.

The following table summarizes our contractual obligations as of September 30, 2007 (Unaudited):

 

Contractual obligations

(In thousands)

   Total   

Less than

one year

  

1-3

years

  

After

3 years

Operating leases

   $ 42,577    $ 6,176    $ 17,679    $ 18,722

Open purchase orders

     6,317      6,317      —        —  
                           

Total contractual obligations

   $ 48,894    $ 12,493    $ 17,679    $ 18,722
                           

Future operating lease commitments for leases have not been reduced by future minimum sublease rentals to be received through December 2010 aggregating $0.9 million. Open purchase orders are primarily for inventory items and research and development supplies.

In September 2005, we entered into an amendment to our lease for our corporate headquarters in San Diego. The lease amendment provides for the deferral of approximately $3.2 million of the monthly rent payments by reducing the monthly payments through September 30, 2007 and increasing the aggregate monthly payments by the deferred amount for the remaining term of the lease, from October 1, 2007 to September 30, 2012. The total obligation under the lease remains unchanged. The contractual obligation table above reflects the deferral of these rent payments.

Based on our current plans, we believe our cash, cash equivalents and short-term investments, including the net proceeds from our 2007 financing and private placement will be sufficient to fund our operating expenses and capital requirements through at least 2009. However, the actual amount of funds that we will need will be determined by many factors, some of which are beyond our control, and we may need funds sooner than currently anticipated. These factors include but are not limited to:

 

   

the size of our future operating losses;

 

   

the level of our success in selling our MassARRAY products and services;

 

   

our ability to introduce and sell new products and services, and successfully reduce inventory levels of earlier products;

 

   

the level of our selling, general and administrative expenses;

 

   

our success in and the expenses associated with researching, developing and commercializing diagnostic products, alone or in collaboration with our partners, and obtaining any required regulatory approval for those products;

 

18


Table of Contents
   

the extent of our research and development pursuits, including our level of investment in MassARRAY product research and development, and diagnostic research and development, particularly for non-invasive prenatal diagnostics;

 

   

the extent to which we enter into, maintain, and derive revenues from licensing agreements, including agreements to out-license our non-invasive prenatal diagnostic technology, research and other collaborations, joint ventures and other business arrangements;

 

   

the extent to which we acquire, and our success in integrating, technologies or companies;

 

   

the level of our legal expenses including those expenses associated with litigation and with intellectual property protection; and

 

   

regulatory changes and technological developments in our markets.

At September 30, 2007, we had outstanding stand-by letters of credit with financial institutions totaling $1.2 million related to our building and operating leases. Letters of credit amounting to $0.1 million will not be drawn down unless we default upon our obligations under the respective agreements. At September 30, 2007, the Company was in compliance with the respective agreements. An operating lease letter of credit of $1.1 million will remain in place until the expiration of our Newton, Massachusetts building lease agreement in December 2010.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Short-term Investments

The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our investments without significantly increasing risk. Some of the securities that we invest in may have market risk. This means that a change in prevailing interest rates may cause the fair value of the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the then-prevailing rate and interest rates later rise, the fair value of the principal amount of our investment will probably decline. To minimize this risk in the future, we intend to maintain our portfolio of cash equivalents and short-term investments in a variety of securities, including commercial paper, money market funds, government and non-government debt securities rated BBB or above by Standard & Poors. Our investment policy includes a minimum quality rating for all new investments. If an investment we hold falls below this level, we research the reasons for the fall and determine if we should continue to hold the investment in order to minimize our exposure to market risk of the investment. We have not experienced any significant losses in our investment portfolio as a result of rating changes. The average duration of all of our investments has generally been less than one year. Due to the short-term nature of these investments, we believe we have no material exposure to interest rate risk arising from our investments. Therefore, no quantitative tabular disclosure is provided.

Foreign currency rate fluctuations

We have foreign subsidiaries whose functional currencies are the Great British Pound, or GBP, and the Euro, or EUR. The subsidiaries’ accounts are translated from the relevant functional currency to the U.S. dollar using the current exchange rate in effect at the balance sheet date, for balance sheet accounts, and using the average exchange rate during the period for revenues and expense accounts. The effects of translation are recorded as a separate component of stockholders’ equity. Our subsidiaries conduct their business with customers in local currencies. Exchange gains and losses arising from these transactions are recorded using the actual exchange differences on the date of the transaction. We have not taken any action to reduce our exposure to changes in foreign currency exchange rates, such as options or futures contracts, with respect to transactions with our subsidiaries or transactions with our customers where the invoicing currency is not the U.S. dollar.

The table below sets forth our currency exposure (i.e., those transactional exposures that give rise to the net currency gains and losses recognized in the income and expenditure account) on our net monetary assets and liabilities. These exposures consist of our monetary assets and liabilities that are not denominated in the functional currency used by us or our subsidiary having the asset or liability.

 

     As of September 30, 2007
     Net foreign monetary
assets/(liabilities)

Functional currency of operations

   US dollars    GBP
     ($ in millions)

Euro

   $ 0.7    $ —  

A movement of 10% in the US dollar to Euro exchange rate would create an unrealized gain or loss of approximately $70,000.

 

19


Table of Contents

We had no off balance sheet, or unrecognized, gains and losses in respect of financial instruments used as hedges at the beginning or end of the nine month period ended September 30, 2007. We had no deferred gains or losses during the period covered.

Inflation

We do not believe that inflation has had a material adverse impact on our business or operating results during the periods presented.

 

Item 4. Controls and Procedures

We have established and maintain disclosure controls and procedures that are designed to ensure that we record, process, summarize, and report information we are required to disclose in our periodic reports filed with the Securities and Exchange Commission in the manner and within the time periods specified in the Security and Exchange Commission’s rules and forms. We also design our disclosure controls to ensure that the information is accumulated and communicated to our management, including the principal executive officer and the principal financial officer, as appropriate to allow timely decisions regarding required disclosure. We also maintain internal controls and procedures that are designed to ensure that we comply with applicable laws and our established financial policies. We design our internal controls to provide reasonable assurance that (1) our transactions are properly authorized; (2) our assets are safeguarded against unauthorized or improper use; and (3) our transactions are properly recorded and reported in conformity with accounting principles generally accepted in the United States.

We have evaluated the design and operation of our disclosure controls and procedures to determine whether they are effective in ensuring that the disclosure of required information is timely made in accordance with the Exchange Act and the rules and regulations of the Securities and Exchange Commission. This evaluation was made under the supervision and with the participation of management, including our principal executive officer and principal financial officer as of September 30, 2007. Our management does not expect that our disclosure controls or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our principal executive officer and principal financial officer have concluded, based on their review, that our disclosure controls and procedures, as defined by Exchange Act Rules 13a-15(e) and 15d-15(e), were effective as of September 30, 2007 to ensure that information required to be disclosed by us in reports that we file under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.

An evaluation was also performed under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of any change in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. That evaluation did not identify any such change.

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

In November 2001, we and certain of our current or former officers and directors were named as defendants in a class action shareholder complaint filed by Collegeware USA in the U.S. District Court for the Southern District of New York (now captioned In re Sequenom, Inc. IPO Securities Litigation) Case No. 01-CV-10831. Similar complaints were filed in the same District Court against hundreds of other public companies that conducted initial public offerings of their common stock in the late 1990s and 2000. In the complaint, the plaintiffs allege that our underwriters, certain of our officers and directors and we violated the federal securities laws because our registration statement and prospectus contained untrue statements of material fact or omitted material facts regarding the compensation to be received by and the stock allocation practices of the

 

20


Table of Contents

underwriters. The plaintiffs seek unspecified monetary damages and other relief. In October 2002, our officers and directors were dismissed without prejudice pursuant to a stipulated dismissal and tolling agreement with the plaintiffs. In February 2003, the District Court dismissed the claim against us brought under Section 10(b) of the Securities Exchange Act of 1934, without giving the plaintiffs leave to amend the complaint with respect to that claim. The District Court declined to dismiss the claim against us brought under Section 11 of the Securities Act of 1933.

In September 2003, pursuant to the authorization of a special litigation committee of our board of directors, we approved in principle a settlement offer by the plaintiffs. In September 2004, we entered into a settlement agreement with the plaintiffs. In February 2005, the District Court issued a decision certifying a class action for settlement purposes and granting preliminary approval of the settlement subject to modification of certain bar orders contemplated by the settlement. In August 2005, the District Court reaffirmed class certification and preliminary approval of the modified settlement. In February 2006, the District Court dismissed litigation filed against certain underwriters in connection with the claims to be assigned to the plaintiffs under the settlement. In April 2006, the District Court held a final fairness hearing to determine whether to grant final approval of the settlement. In December 2006, the U.S. Court of Appeals for the Second Circuit vacated the District Court’s decision certifying as class actions the six lawsuits designated as “focus cases.” Thereafter the District Court ordered a stay of all proceedings in all of the lawsuits pending the outcome of plaintiffs’ petition to the Second Circuit for rehearing en banc. In April 2007, the Second Circuit denied plaintiffs’ rehearing petition, but clarified that the plaintiffs may seek to certify a more limited class in the District Court. Accordingly, the settlement as originally negotiated will not receive final approval. In August 2007, the plaintiffs filed amended complaints in the six focus cases and moved to certify the new, narrower classes alleged therein.

On August 3, 2007, we received a demand letter dated July 31, 2007, demanding on behalf of an alleged stockholder, Vanessa Simmonds, that our board of directors prosecute a claim against our IPO underwriters, in addition to certain unnamed officers, directors and principal stockholders as identified in our IPO prospectus, for violations of sections 16(a) and 16(b) of the Securities Exchange Act of 1934. The demand letter asserts purchases and sales of our common stock within periods of less than six months and failure to report such transactions, and seeks unspecified disgorgement of profits. We requested further information from Ms. Simmonds in order to evaluate the demand and although Ms. Simmonds provided a response, we still do not have adequate information to evaluate the demand.

We do not anticipate that the ultimate outcome of either of the events set forth above will have a material adverse impact on our financial position.

In addition, from time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business.

 

Item 1A. Risk Factors

Before deciding to invest in us or to maintain or increase your investment, you should carefully consider the risks described below, in addition to the other information contained in this report and in our other filings with the SEC. The risks and uncertainties described below and in our other filings are not the only ones facing us. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our business. If any of these known or unknown risks or uncertainties actually occurs, our business, financial condition and results of operations could be seriously harmed. In that event, the market price for our common stock could decline and you may lose your investment. The risk factors in this report have been revised to incorporate changes to our risk factors from those included in our annual report on Form 10-K for the year ended December 31, 2006. The risk factors set forth below with an asterisk (*) next to the title are new risk factors or risk factors containing changes, including any material changes, from the risk factors previously disclosed in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2006, as filed with the SEC.

We may need additional capital to support our growth, which will result in additional dilution to our stockholders. *

Our business may require additional investment that we have not yet secured. As of September 30, 2007, we had available cash, cash equivalents and short-term investments of approximately $29.1 million. On April 30, 2007, we closed a $20.0 million registered direct offering of our common stock to several new and existing investors, resulting in net aggregate proceeds of $18.3 million, after deducting placement agents’ fees and transaction expenses. In October 2007, we closed a private placement of our common stock for approximately $30.5 million to certain investors. Under the terms of the transaction we issued and sold 3,383,335 shares at $9.00 per share, with anticipated net aggregate proceeds of approximately $28.1 million after deducting placement agents’ fees and estimated transaction expenses.

 

21


Table of Contents

We believe our cash, cash equivalents and short-term investments will be sufficient to fund our operating expenses and capital requirements through 2009. However, the actual amount of funds that we will need will be determined by many factors, some of which are beyond our control, and we may need funds sooner than currently anticipated. These factors include but are not limited to:

 

   

the size of our future operating losses;

 

   

the level of our and our distributors’ success in selling our MassARRAY products and services;

 

   

the terms and conditions of sales contracts, including extended payment terms;

 

   

our ability to introduce and sell new products and services, including iPLEX Gold, and successfully reduce inventory levels of earlier products;

 

   

the level of our selling, general and administrative expenses;

 

   

the extent of our investment in diagnostic technology, including non-invasive prenatal diagnostic technology, development, commercialization, and regulatory approval;

 

   

our success in and the expenses associated with researching, developing and commercializing diagnostic products, alone or in collaboration with our partners, and obtaining any required regulatory approval for those products;

 

   

the level of our success alone or in collaboration with our partners in launching and selling any diagnostic products and services;

 

   

the extent of our research and development pursuits, including our level of investment in MassARRAY product research and development, and diagnostic assay research and development;

 

   

the extent to which we enter into, maintain, and derive revenues from licensing agreements, including agreements to out-license our non-invasive prenatal analysis technology, research and other collaborations, joint ventures and other business arrangements;

 

   

the extent to which we acquire, and our success in integrating, technologies or companies;

 

   

the level of our legal expenses including those expenses associated with litigation and with intellectual property protection;

 

   

the level of our expenses associated with the audit of our consolidated financial statements as well as compliance with other corporate governance and regulatory developments or initiatives; and

 

   

regulatory changes and technological developments in our markets.

General market conditions or the market price of our common stock may not support capital raising transactions such as an additional public or private offering of our common stock or other securities. In addition, our ability to raise additional capital may be dependent upon our stock being quoted on the NASDAQ Global Market or upon obtaining shareholder approval. There can be no assurance that we will be able to satisfy the criteria for continued listing on NASDAQ or that we will be able to obtain shareholder approval if it is necessary. If we are unable to obtain additional funds on a timely basis or on terms favorable to us, we may be required to cease or reduce further commercialization of our products, to cease or reduce certain research and development projects, to sell some or all of our technology or assets or business units or to merge all or a portion of our business with another entity. If we raise additional funds by selling shares of our capital stock, the ownership interest of our current stockholders will be diluted. Insufficient funds may require us to delay, scale back, or eliminate some or all of our activities.

We have limited experience.

Many of our technologies, particularly our non-invasive prenatal and other molecular diagnostic technologies, are at an early stage of discovery and development. We continue to commercialize new products and create new applications for our products. We are developing research-use-only and diagnostic applications for our MassARRAY platform and for other platforms, including non-invasive prenatal tests, and plan to eventually commercialize ourselves, or with a partner, a research-use-only test for Rhesus D using a real-time PCR platform, in addition to other tests. We have limited or no experience in these applications of our technology and operating in these markets. You should evaluate us in the context of the uncertainties and complexities affecting an early stage company developing products and applications for the life science industries and experiencing the challenges associated with entering into new markets that are highly competitive. We need to make significant investments to ensure our products perform properly and are cost-effective, and we will likely need to apply for and obtain certain regulatory approvals to sell our products for diagnostic applications and it is uncertain whether such approvals will be granted. Even if we develop products for commercial use and obtain all necessary regulatory approval, we may not be able to develop products that are accepted in the genomic, diagnostic, non-invasive prenatal, clinical research, pharmaceutical, or other markets or the emerging field of molecular medicine and that can be marketed and sold successfully.

 

22


Table of Contents

We have a history of operating losses, anticipate future losses and may never become profitable. *

We have experienced significant operating losses in each period since our inception. At September 30, 2007, our accumulated deficit was approximately $474.2 million. These losses have resulted principally from expenses incurred in research and development, from selling, general, and administrative expenses associated with our operations, our significant lease obligations, and the write-down to the carrying value of acquired goodwill and intangibles. We expect to incur operating losses in the future as a result of expenses associated with research and product development, production, marketing and selling, general and administrative expenses, and our significant lease obligations, as well as expenses associated with consolidating and completing the integration of any business or technology that we may acquire in the future. To achieve profitability, we would need to generate significant additional revenue with significant gross margins. It is uncertain when, if ever, we will become profitable, or cash-flow positive. Even if we were to become profitable, we might not be able to sustain or increase profitability on a quarterly or annual basis.

Our operating results may fluctuate significantly. *

Our revenues and results of operations may fluctuate significantly, depending on a variety of factors, including the following:

 

   

our ability to manage costs and expenses and effectively implement our business strategy;

 

   

our and our distributors’ success in selling, and changes in the demand for, our products and services including our MassARRAY Compact platform and iPLEX Gold multiplexing application and related consumables, and demand for products and services for genotyping, DNA methylation (epigenetic analysis) and QGE (gene expression analysis) applications;

 

   

our success in selling genetic analysis contract research services;

 

   

our success in depleting or reducing current product inventories in view of new or upcoming product introductions;

 

   

the pricing of our products and services and those of our competitors;

 

   

variations in the timing of payments from customers and collaborative partners and the recognition of these payments as revenues;

 

   

the timing and cost of any new product or service offerings by us;

 

   

our ability to develop new applications and products, such as non-invasive prenatal or other diagnostic assays, the success of such applications and products, and our ability to improve current products to increase demand for such products;

 

   

the potential need to acquire licenses to new technology, including genetic markers that may be useful in diagnostic applications, or to use our technology in new markets, which could require us to pay unanticipated license fees and royalties in connection with licenses we may need to acquire;

 

   

our research and development progress and how rapidly we are able to achieve technical milestones, including the milestone of sufficient fetal DNA enrichment with respect to our non-invasive prenatal technologies;

 

   

the cost, quality and availability of our consumable chips, also known as SpectroCHIP bioarrays, oligonucleotides, DNA samples, tissue samples, reagents and related components and technologies;

 

   

material developments in our customer and supplier relationships including our ability to successfully transition in a timely manner during 2007, to a new nanodispenser apparatus for our MassARRAY system with a new vendor and to successfully maintain that relationship;

 

   

our ability to clinically validate any potential non-invasive prenatal or other diagnostic related products and obtain regulatory approval of any potential products; and

 

   

expenses related to, and the results of, any litigation or other legal proceedings.

Further, our revenues and operating results are difficult to predict because they depend on the number, timing, and type of MassARRAY system placements that we make during the year, the number, timing, and types of software licensed or sold, and the quantity and timing of consumables sales for the installed base of systems and the number, timing and type of contract research services agreements that we enter into. Changes in the relative mix of our MassARRAY system and consumables sales and service agreements can have a significant impact on our gross margin, as consumable sales and service agreements typically have margins significantly different than MassARRAY system sales. Our revenues and operating results are also difficult to predict because they depend upon the activities of our distributors. The absence of or delay in generating revenues could cause significant variations in our operating results from year to year and could result in increased operating losses.

 

23


Table of Contents

We believe that period-to-period comparisons of our financial results will not necessarily be meaningful. You should not rely on these comparisons as an indication of our future performance. If our operating results in any future period fall below the expectations of securities analysts and investors, our stock price will likely fall.

We have a history of generating a large percentage of our revenue at the end of each quarterly accounting period.

Due to the manner in which many customers in our target markets allocate and spend their budgeted funds for acquisition of our products, a large percentage of our sales are booked at the end of each quarterly accounting period. Because of this timing of our sales, we may not be able to reliably predict order volumes and our quarterly revenues. A sales delay of only a few days may significantly impact our quarter-to-quarter comparisons. If our quarterly revenues fall below the expectations of securities analysts and investors, our stock price may decline. Similarly, if we are unable to ship our customer orders on time, or if extended payment terms are required, there could be a material adverse effect on revenues for a given quarter.

A reduction in revenues from sales of MassARRAY products and contract research services would harm our business. *

The demand for MassARRAY systems and consumables and contract research services has changed over time, and any decline in demand will reduce our total revenues. We expect that sales of MassARRAY systems and consumables will account for most of our total revenues for the foreseeable future. Also, our competitors have offered low priced fee-for-service genotyping services and technologies to the DNA analysis marketplace. These factors and the following factors, among others, would reduce the demand for MassARRAY products and services:

 

   

competition from other products and service providers or failure of our products or applications or services;

 

   

changes in fiscal policies and the economy which negatively impact customer buying decisions; and

 

   

negative publicity or evaluations, particularly with respect to product warranty and repair and troubleshooting services provided to existing customers and with respect to our license rights to perform gender testing for social or lifestyle purposes.

Our revenues are subject to the risks faced by biotechnology and diagnostic companies, pharmaceutical companies, and governmental and other research institutions.

We expect that our revenues in the foreseeable future will be derived primarily from MassARRAY system products provided to academic institutions, biotechnology, diagnostic, and pharmaceutical companies, laboratories, companies and institutions that service the livestock industry, and governmental and other research institutions. Our operating results could fluctuate substantially due to reductions and delays in research and development expenditures by these customers. These reductions and delays could result from factors such as:

 

   

changes in economic conditions and possible country-based boycotts;

 

   

changes in government programs that provide funding;

 

   

changes in the regulatory environment affecting health care and health care providers, and for example, recent draft FDA guidance which, if effected, may impose additional restrictions on CLIA licensed laboratories performing research-use-only tests;

 

   

pricing pressures and reimbursement policies;

 

   

market-driven pressures on companies to consolidate and reduce costs;

 

   

other factors affecting research and development spending; and

 

   

uncertainty about our ability to fund operations and supply products to customers.

None of these factors are within our control. We have broadened the markets to which we sell our products and applications and continue to develop new applications and products for use in new markets. We are targeting customers in clinical research and clinical marker validation, the emerging field of molecular medicine, genetic service laboratories, and animal testing laboratories. We have limited or no experience operating in these potential markets and, as a result, may be unable to develop products and applications that allow us to penetrate these markets or successfully generate any revenue from sales in these markets. We will have limited ability to forecast future demand for our existing and any new products and applications in these markets.

 

24


Table of Contents

We depend on sales of our consumable chips and other MassARRAY consumables for a significant portion of our revenues. *

Sales of our consumable chips and other consumables for the MassARRAY system are an important source of revenue. It is possible that our new iPLEX Gold multiplexing application may, over time, result in lower volumes of consumable chip purchases by customers on a per system basis, which in turn could cause revenues to decline. Revenues from MassARRAY consumables totaled approximately 41% and 40% of our total revenues for the three and nine months ended September 30, 2007, compared to 49% and 44% of our total revenues for the three and nine months ended September 30, 2006. Factors which may limit the use of our consumable chips and other consumables or otherwise adversely affect our revenues from consumables include:

 

   

the extent of our customers’ level of utilization of their MassARRAY systems;

 

   

our ability to provide timely repair services and our ability to secure replacement parts, such as lasers, for our MassARRAY systems;

 

   

the extent to which customers increase multiplexing levels using the iPLEX Gold application;

 

   

failure to sell additional MassARRAY systems;

 

   

the termination of contracts with or adverse developments in our relations with suppliers of our consumables;

 

   

the training of customer personnel;

 

   

the acceptance of our technology by our customers; and

 

   

the ability to maintain necessary quality standards and specifications for our SpectroCHIP products.

 

   

our inability to transition to a new supplier for the nanodispenser for our MassARRAY system and/or our ability to maintain such relationships;

We may not be able to generate any revenue from non-invasive prenatal research-use only or diagnostic tests, or any other tests we may develop. *

We have committed significant research and development resources to the development of research-use only and diagnostic tests, particularly non-invasive prenatal tests, for use on our MassARRAY system and other platforms. Although our licensed partner anticipates launching the first research use only test, a test for Rhesus D using a real-time PCR platform, by the end of 2007, there is no guarantee that our partner or we will successfully launch this or any other tests for any use. We have no experience in licensing, manufacturing, selling, marketing or distributing diagnostic or other tests. If we, or our partners, are not able to successfully market or sell non-invasive prenatal research-use only or diagnostic tests or other tests we may develop for any reason, including the failure to obtain any required regulatory approvals, we will not generate any revenue from the sale of such tests. Even if we are able to develop non-invasive prenatal research-use only or diagnostic or other tests for sale in the marketplace, a number of factors could impact our ability to generate any significant revenue from the sale of such tests, including the following:

 

   

reliance on third-party CLIA-certified (Clinical Laboratory Improvement Amendments, 1988) laboratories, which are subject to routine governmental oversight and inspections for continued operation pursuant to CLIA, to process tests that we develop;

 

   

reliance on third parties to manufacture any non-invasive prenatal research-use only or diagnostic or other tests that we may develop;

 

   

our non-invasive prenatal Rhesus D test, if successfully launched, will be for research use only and may never be approved for commercial use;

 

   

the availability of alternative and competing tests or products;

 

   

compliance with federal, state (including New York state) and foreign regulations for the sale and marketing of research-use only or diagnostic or other tests, including non-invasive prenatal tests;

 

   

the accuracy rates of such tests, including rates of false-negatives and/or false-positives;

 

   

concerns regarding the safety or effectiveness of non-invasive prenatal or other tests;

 

   

changes in the regulatory environment affecting health care and health care providers, including changes in laws regulating laboratory testing and/or device manufacturers;

 

   

the extent and success of our sales and marketing efforts;

 

   

pricing pressures and changes in third-party payor reimbursement policies;

 

25


Table of Contents
   

general changes or developments in the market for women’s and/or prenatal health diagnostic, or diagnostics in general;

 

   

ethical and legal issues concerning the appropriate use of the information resulting from the diagnostic or other tests; and

 

   

the refusal by women to undergo such tests for moral, religious or other reasons, or based on perceptions about the safety or reliability of such tests.

If our customers are unable to adequately prepare samples for our MassARRAY system, the overall market demand for our products may decline.

Before using the MassARRAY system, customers must prepare samples by following several steps that are subject to human error, including DNA isolation and DNA amplification. If DNA samples are not prepared appropriately, or the proposed assays are too complex, the MassARRAY system may not generate a reading or a correct reading. If our customers experience these difficulties, they might achieve lower levels of throughput than specified for the system. If our customers are unable to generate expected levels of throughput, they might not continue to purchase our consumables, they could express their discontent with our products to others, or they could collaborate with others to jointly benefit from the use of our products. Any or all of these actions would reduce the overall market demand for our products. From time to time, we have experienced customer complaints regarding data quality and difficulty in processing more complex assays.

The sales cycles for our products are lengthy, and we may expend substantial funds and management effort with no assurance of successfully selling our products or services.

The sales cycles for our MassARRAY system products are typically lengthy. Our sales and licensing efforts require the effective demonstration of the benefits, value, and differentiation and validation of our products and services, and significant education and training of multiple personnel and departments within a customer organization. We may be required to negotiate agreements containing terms unique to each prospective customer or licensee which would lengthen the sales cycle. We may expend substantial funds and management effort with no assurance that we will sell our products or services. In addition, this lengthy sales cycle makes it more difficult for us to accurately forecast revenue in future periods and may cause revenues and operating results to vary significantly in such periods.

We may not be able to successfully adapt our products for commercial applications.

A number of potential applications of our MassARRAY technology, including research-use-only and diagnostic applications for non-invasive prenatal and other molecular testing, may require significant enhancements in our core technology or the in-licensing of intellectual property rights or technologies. If we are unable to complete the development, introduction, or scale-up of any product, or if any of our new products or applications, such as gene expression analysis, epigenetic analysis or iPLEX Gold multiplexing, do not achieve a significant level of market acceptance, our business, financial condition and results of operations could be seriously harmed. Achieving market acceptance will depend on many factors, including demonstrating to customers that our technology is cost competitive or superior to other technologies and products that are available now or that may become available in the future. We believe that our revenue growth and profitability will substantially depend on our ability to overcome significant technological challenges and successfully introduce our newly developed products, applications, and services into the marketplace.

We have limited commercial production capability and experience and may encounter production problems or delays, which could result in lower revenue.

We partially assemble the MassARRAY system and partially manufacture our consumable chips and MassARRAY kits. To date, we have only produced these products in moderate quantities. We may not be able to maintain acceptable quality standards as we continue or ramp up production. For example, we have experienced crystallized matrix on some of our chips, which has interfered with chip performance. To achieve anticipated customer demand levels, we will need to scale-up our production capability and maintain adequate levels of inventory while manufacturing our products at a reasonable cost. We may not be able to produce sufficient quantities to meet market demand or manufacture our product at a reasonable cost. If we cannot achieve the required level and quality of production, we may need to outsource production or rely on licensing and other arrangements with third parties. This reliance could reduce our gross margins and expose us to the risks inherent in relying on others. We might not be able to successfully outsource our production or enter into licensing or other arrangements with these third parties, which would adversely affect our business.

 

26


Table of Contents

We depend on third-party products and services and limited sources of supply to develop and manufacture our products. *

We rely on outside vendors to supply certain products and the components and materials used in our products. Some of these products, components and materials are obtained from a single supplier or a limited group of suppliers. Our MassARRAY system is comprised of several components, of which the following are currently obtained from a single supplier: Bruker Daltonics, Inc. supplies our mass spectrometers, PSI, Inc. supplies our chips and Majer Precision Engineering, Inc. supplies the pins for the pintools. We are currently in negotiations with vendors regarding manufacture of a new nanodispenser product that will replace the former product. We cannot be assured that we will successfully complete these negotiations and secure supply of a replacement nanodispenser product, and if we are unable to do so, our business could be harmed.

We also have sole suppliers for certain of our consumable products. In the event of any adverse developments with these vendors, our product supply may be interrupted, which would have an adverse impact on our business. In the past, we have experienced quality problems with and delays in receiving components used to produce our consumable chips, problems with laser reliability in our mass spectrometers supplied by Bruker and lengthy delays in obtaining lasers for replacement, problems with matrix crystallization on our chips, and also had technical difficulties with our pin-tool nanoliter dispenser device. We have also experienced software and operational difficulties with our MassARRAY Compact system. Our reliance on outside vendors generally and a sole or a limited group of suppliers in particular involves several risks, including:

 

   

the inability to obtain an adequate supply of properly functioning, required products, components, and materials due to capacity constraints, product defects, a discontinuance of a product by a supplier, or other supply constraints;

 

   

reduced control over quality and pricing of products, components, and materials; and

 

   

delays and long lead times in receiving products, components, or materials from vendors.

We and our licensees and collaborators may not be successful in developing or commercializing diagnostic products, including non-invasive prenatal diagnostic products, or other products using our products, services, or discoveries. *

Development of diagnostic or other products by us, our licensees, or our collaborators are subject to risks of failure inherent in the development and commercial viability of any such product, such as demand for such product. These risks further include the possibility that such product would:

 

   

be found to be ineffective, unreliable, or otherwise inadequate or otherwise fail to receive regulatory approval;

 

   

be difficult or impossible to manufacture on a commercial scale;

 

   

be uneconomical to market;

 

   

fail to be successfully commercialized if adequate reimbursement from government health administration authorities, private health insurers, and other organizations for the costs of these products is unavailable;

 

   

be impossible to commercialize because they infringe on the proprietary rights of others or compete with products marketed by others that are superior; or

 

   

fail to be commercialized prior to the successful marketing of similar products by competitors.

If a licensee discovers or develops diagnostic products or we or a collaborator discover or develop diagnostic or other products using our technology, products, services, or discoveries, we may rely on that licensee or collaborator (hereafter referred to as “partner”) for product development, regulatory approval, manufacturing, and marketing of those products before we can realize revenue and some or all of the milestone payments, royalties, or other payments we may be entitled to under the terms of the licensing or collaboration agreement. If we are unable to successfully achieve milestones or our partners fail to develop successful products, we will not earn the revenues contemplated and we may also lose exclusive (as in the case of our license agreement with Isis Innovation Ltd, under which we in-license our fundamental non-invasive prenatal diagnostic technology) or non-exclusive license rights to intellectual property that are required to commercialize such products. Our agreements may allow our partners significant discretion in electing whether to pursue any of these activities. We cannot control the amount and timing of resources our partners may devote to our programs or potential products. As a result, we cannot be certain that our partners will choose to develop or commercialize any products or will be successful in doing so. In addition, if a partner is involved in a business combination, such as a merger or acquisition, or changes its business focus, its performance under its agreement with us may suffer and, as a result, we may not generate any revenues or only limited revenues from the royalty, milestone, and similar payment provisions contained in our agreement with that partner.

We may not successfully obtain regulatory approval of any non-invasive prenatal or other diagnostic product or other product which we or our licensing or collaborative partners develop and we may not be able to successfully partner with CLIA licensed laboratories with respect to research-use-only products.

Products that we or our collaborators develop in the molecular medicine, diagnostic, non-invasive prenatal diagnostic, or other markets, depending on their intended use, may be regulated as medical devices by the FDA and comparable agencies of other countries and require either premarket approval (PMA) or 510(k) clearance from the FDA, prior to marketing. The

 

27


Table of Contents

510(k) clearance process usually takes from three to twelve months from submission, but can take longer. The premarket approval process is much more costly, lengthy, uncertain, and generally takes from nine months to two years or longer from submission. Also, recent draft guidance from the FDA suggests changes in regulations that would be applicable to CLIA laboratories which, if such regulations become effective, could burden and delay our ability to partner or collaborate with CLIA laboratories with respect to our commercialization plans for research-use-only products. In addition, commercialization of any diagnostic or other product that our licensees or collaborators or we develop would depend upon successful completion of preclinical testing and clinical trials. Preclinical testing and clinical trials are long, expensive, and uncertain processes, and we do not know whether we, our licensees, or any of our collaborators, would be permitted or able to undertake clinical trials of any potential products. It may take us or our licensees or collaborators many years to complete any such testing, and failure could occur at any stage. Preliminary results of trials do not necessarily predict final results, and acceptable results in early trials may not be repeated in later trials. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. Delays or rejections of potential products may be encountered based on changes in regulatory policy for product approval during the period of product development and regulatory agency review. If our projects reach clinical trials, we or our licensees or collaborators could decide to discontinue development of any or all of these projects at any time for commercial, scientific, or other reasons.

If the validity of the consents from volunteers were to be challenged, we could be forced to stop using some of our resources, which would hinder our gene discovery out-licensing efforts and our diagnostic product development efforts.

We have attempted to ensure that all clinical data and genetic and other biological samples that we receive from our subsidiaries and our clinical collaborators have been collected from volunteers who have provided our collaborators or us with appropriate consents for the data and samples provided for purposes which extend to include diagnostic product development activities. We have attempted to ensure that data and samples that have been collected by our clinical collaborators are provided to us on an anonymous basis. We have also attempted to ensure that the volunteers from whom our data and samples are collected do not retain or have conferred on them any proprietary or commercial rights to the data or any discoveries derived from them. Our clinical collaborators are based in a number of different countries, and to a large extent we rely upon our clinical collaborators for appropriate compliance with the voluntary consents provided and with local law and regulation. That our data and samples come from and are collected by entities based in different countries results in complex legal questions regarding the adequacy of consents and the status of genetic material under a large number of different legal systems. The consents obtained in any particular country could be challenged in the future, and those consents could prove invalid, unlawful or otherwise inadequate for our purposes. Any findings against us, or our clinical collaborators, could deny us access to or force us to stop using some of our clinical or genetic resources, which would hinder our diagnostic product development efforts. We could become involved in legal challenges, which could consume a substantial proportion of our management and financial resources.

If we cannot obtain licenses to patented SNPs and genes, we could be prevented from obtaining significant revenue or becoming profitable.

The U.S. Patent and Trademark Office has issued and continues to issue patents claiming SNP and gene discoveries and their related associations and functions. If certain SNPs and genes are patented, we will need to obtain rights to those SNPs and genes to develop, use, and sell related assays and other types of products or services utilizing such SNPs and genes. Required licenses may not be available on commercially acceptable terms. If we were to fail to obtain licenses to certain patented SNPs and genes, we might never achieve significant revenue from our diagnostic product development.

If the medical relevance of SNPs is not demonstrated or is not recognized by others, we may have less demand for our products and services and may have less opportunity to enter into diagnostic product development and commercialization collaborations with others.

Some of the products we hope to develop involve new and unproven approaches or involve applications in markets that we are only beginning to explore. They are based on the assumption that information about genes and SNPs may help scientists better understand conditions or complex disease processes. Scientists generally have a limited understanding of the role of genes and SNPs in diseases, and few products based on gene discoveries have been developed. We cannot be certain that genetic information will play a key role in the development of diagnostics or other products in the future, or that any genetic-based findings would be accepted by diagnostic, pharmaceutical, or biotechnology companies or by any other potential market or industry segment. If we or our customers or collaborators are unable to generate valuable information that can be used to develop diagnostics or other products, the demand for our products, applications, and services will be reduced and our business will be harmed.

 

28


Table of Contents

We may not be able to form and maintain the collaborative relationships or the rights to third-party intellectual property and technologies that our business strategy requires and such relationships may lead to disputes over technology rights or product revenue, royalties, or other payments. *

We form research collaborations and licensing arrangements with collaborators to operate our business successfully. To succeed, we will have to maintain our existing relationships and establish additional collaborations and licensing arrangements. Our current strategy includes pursuing partnering opportunities with larger companies interested in or involved in the development of pharmaceutical and diagnostic products to potentially advance our disease gene discoveries and related targets toward drug or diagnostic development. Our strategy also includes obtaining licenses to third-party intellectual property rights and technologies, such as our exclusive license to non-invasive prenatal analysis rights that we acquired from Isis Innovation Ltd, to potentially expand our product portfolio and generate additional sources of revenue. If we do not achieve certain milestones in a timely manner, we risk losing our exclusive license rights from Isis Innovation Ltd. We cannot be sure that we will be able to establish any additional research collaborations, licensing arrangements, or other partnerships necessary to develop and commercialize products or that we can do so on terms favorable to us. If we are unable to establish these collaborations or licensing arrangements, we may not be able to successfully develop any diagnostic or other products or applications and generate any milestone, royalty, or other revenue from sales of these products or applications. If our collaborations or licensing arrangements are not successful or we are not able to manage multiple collaborations successfully, our programs will suffer and we may never generate any revenue from sales of products based on licensed rights or technologies or under these collaborative or licensing arrangements. If we increase the number of collaborations or licensing agreements, it will become more difficult to manage the various relationships successfully and the potential for conflicts among the collaborators and licensees or licensors will increase. Conflicts with our collaborators, licensees or licensors, or other factors may lead to disputes over technology or intellectual property rights or product revenue, royalties, or other payments, which may adversely effect our business.

In addition, our government grants provide the government certain license rights to inventions resulting from funded work. Our business could be harmed if the government exercises those rights.

Because we exclusively licensed our non-invasive prenatal diagnostic and gender determination testing rights from Isis Innovation Ltd any dispute with Isis may adversely affect our ability to develop and commercialize diagnostic tests based on these licensed rights. *

In October 2005, we entered into an exclusive license to non-invasive prenatal diagnostic rights with Isis Innovation Ltd, which we amended in October 2006 and in November 2007 to also include exclusive rights to intellectual property for non-invasive prenatal gender determination testing for social and lifestyle purposes. We intend to use the rights that we acquired under the license to develop non-invasive prenatal nucleic acid based tests, including gender determination tests. If there is any dispute between us and Isis regarding our rights under the license agreement, or we do not achieve certain milestones, in a timely manner, our ability to develop and commercialize these diagnostic tests may be adversely affected and could delay or completely terminate our product development efforts for these diagnostic tests.

If we do not succeed in obtaining development and marketing rights for products developed in collaboration with others, our revenue and profitability could be reduced.

Our business strategy includes, in part, the development of non-invasive prenatal diagnostic and other products in collaboration with others, or utilizing the technology of others, and we intend to obtain commercialization or royalty rights to those products or technologies. If we are unable to obtain such rights, or are unable to do so on favorable financial terms, our revenue and profitability could be reduced. To date, we have initiated limited activities towards commercializing products developed in collaboration with, or utilizing the technology of, others. Even if we obtain commercialization rights, commercialization of products may require resources that we do not currently possess and may not be able to develop or obtain, or commercialization may be financially unattractive based upon the revenue-sharing terms offered by potential licensors or provided for in the relevant agreement.

Ethical, privacy, or other concerns about the use of genetic information could reduce demand for our products and services.

Genetic testing, including gender determination testing, has raised ethical issues regarding privacy and the appropriate uses of the resulting information. For these reasons, governmental authorities may limit or otherwise regulate the use of genetic testing or prohibit testing for genetic predisposition to certain conditions, particularly for those that have no known cure. Such concerns may lead individuals to refuse to use genetics tests even if permitted. Any of these scenarios could reduce the potential markets for our products and services, which would seriously harm our business, financial condition, and results of operations.

 

29


Table of Contents

If we breach any of the terms of our license or supply agreements, or these agreements are otherwise terminated or modified, the termination or modification of such agreements could result in our loss of access to critical components and could delay or suspend our commercialization efforts.

We have sourced or licensed components of our technology from other parties. For example, Bruker Daltonics supplies our mass spectrometers, PSI, Inc. supplies our chips and Majer Precision Engineering supplies the pins for our present nanodispenser (pintool) product. We are in the process of securing a new vendor to supply us with our newly designed replacement nanodispenser product. Our failure to maintain continued supply of such components, particularly in the case of sole suppliers, or the right to use these components would seriously harm our business, financial condition, and results of operations. In November 2006, we entered into a new supply agreement with Bruker to purchase a minimum number of mass spectrometers. We have minimum purchase obligations under our supply agreement with Bruker. As a result, in the event that demand for our products declines or does not meet our forecasts, we could have excess inventory or increased expenses or our margins could decrease which could have an adverse impact on our financial condition and business. In the event of any adverse developments with these vendors, our product supply may be interrupted, which would have an adverse impact on our business. Changes to or termination of our agreements or inability to renew our agreements with these parties or enter into new agreements with other suppliers could result in the loss of access to these aspects of our technology or other intellectual property rights or technologies that we may acquire from time to time and could impair, delay, or suspend our commercialization efforts. While we negotiate for agreement periods or notice of termination periods that provide us reasonable periods of time to secure alternative supplies, and require that such agreements may not be terminated without advance notice arbitrarily or without good reason, such as uncured breach or insolvency, such provisions may not provide us with adequate time to secure alternative supplies, provide us with access to alternative technologies on commercially acceptable terms, or otherwise provide us with adequate protection.

We may not successfully integrate acquired businesses.

We may acquire additional businesses or technologies, or enter into other strategic transactions. Managing acquisitions entails numerous operational and financial risks, including:

 

   

the inability to retain key employees of any acquired businesses or hire enough qualified personnel to staff any new or expanded operations;

 

   

the impairment of relationships with key customers of acquired businesses due to changes in management and ownership of the acquired businesses;

 

   

the inability to sublease on financially acceptable terms excess leased space or terminate lease obligations of acquired businesses that are not necessary or useful for the operation of our business;

 

   

the exposure to federal, state, local and foreign tax liabilities in connection with any acquisition or the integration of any acquired businesses;

 

   

the exposure to unknown liabilities;

 

   

higher than expected acquisition and integration expenses that would cause our quarterly and annual operating results to fluctuate;

 

   

increased amortization expenses if an acquisition results in significant intangible assets;

 

   

combining the operations and personnel of acquired businesses with our own, which would be difficult and costly;

 

   

disputes over rights to acquired technologies or with licensors or licensees of those technologies; and

 

   

integrating or completing the development and application of any acquired technologies, which would disrupt our business and divert management’s time and attention.

We may not be able to successfully compete in the biotechnology industry.

The biotechnology industry is highly competitive. We expect to compete with a broad range of companies in the United States and other countries that are engaged in the development and production of products, applications, services, and strategies to analyze genetic information and strategies to develop and commercialize diagnostic, non-invasive prenatal diagnostic, and other products for customers in the clinical research and clinical marker validation and molecular medicine fields as well as diagnostic service laboratories, animal testing & food safety labs, and customers in other markets. They include:

 

   

biotechnology, pharmaceutical, diagnostic, chemical, and other companies;

 

   

academic and scientific institutions;

 

   

governmental agencies; and

 

30


Table of Contents
   

public and private research organizations.

Many of our competitors have much greater financial, technical, research, marketing, sales, distribution, service, and other resources than we do. Our competitors may offer broader product lines and services and have greater name recognition than we do. Several companies are currently making or developing products that compete with our products. Our competitors may develop or market technologies or products that are more effective or commercially attractive than our current or future products, or that may render our technologies or products obsolete.

We may potentially compete with our customers, which may adversely affect our business.

We have sold MassARRAY systems worldwide to pharmaceutical and biotechnology companies, academic research centers, and government laboratories. Some of our customers use our DNA analysis products to perform contract research services, or to perform genetics studies on their own disease populations for potential diagnostic utility in the same or similar manner as we have done. Although there are many potential contract research services opportunities and disease areas and diagnostic applications, our customers may seek service work or develop diagnostic assays or may target diseases areas that may overlap with those that we have chosen to pursue. In such cases we may potentially compete against our customers. Competition from our customers may adversely affect our services business or our ability to successfully commercialize diagnostic products.

Our ability to compete in the market may decline if we lose some of our intellectual property rights. *

Our success will depend on our ability to obtain and protect patents on our technology, to protect our trade secrets, and to maintain our rights to licensed intellectual property or technologies. Our patent applications or those of our licensors may not result in the issue of patents in the United States or other countries. Our patents or those of our licensors may not afford meaningful protection for our technology and products. Others may challenge our patents or those of our licensors, and as a result, our patents or those of our licensors could be narrowed or invalidated or become unenforceable. Competitors may develop products similar to ours that do not conflict with our patents or patent rights. Others may develop non-invasive prenatal tests or other products or methods in violation of our patents or those of our licensors, or by operating around our patents or license agreements, which could reduce sales of our consumables or reduce or remove our non-invasive prenatal and other diagnostic commercialization opportunities. To protect or enforce our patent rights, we may initiate interference proceedings, oppositions, or litigation against others. However, these activities are expensive, take significant time and divert management’s attention from other business concerns. The patent position of biotechnology companies generally is highly uncertain and involves complex legal and factual questions that are often the subject of litigation. No consistent policy has emerged from the U.S. Patent and Trademark Office, the offices of foreign countries or the courts regarding the breadth of claims allowed or the degree of protection afforded under biotechnology patents. There is a substantial backlog of biotechnology patent applications at the U.S. Patent and Trademark Office and of the equivalent offices around the world and the approval or rejection of patent applications may take several years.

Our success will depend partly on our ability to operate without infringing on or misappropriating the proprietary rights of others.

We may be accused of infringing on the patent rights or misappropriating the proprietary rights of others. From time to time, we receive letters from companies regarding their issued patents and patent applications alleging or suggesting possible infringement. Generally these letters are offers to license and fail to provide adequate evidence or state the basis for a reasonable claim that we are engaging in any infringing activity. Intellectual property litigation is costly, and, even if we prevail, the cost of such litigation would adversely affect our business, financial condition, and results of operations. Litigation is also time consuming and would divert management’s attention and resources away from our operations and other activities. If we were not to prevail in any litigation, in addition to any damages we would have to pay, we could be required to stop the infringing activity or obtain a license. Any required license might not be available to us on acceptable terms. Some licenses might be non-exclusive, and our competitors could have access to the same technology licensed to us. If we were to fail to obtain a required license or were unable to design around a patent, we would be unable to sell or continue to develop some of our products, which would have a material adverse affect on our business, financial condition, and results of operations.

The rights we rely upon to protect the intellectual property underlying our products may not be adequate, which could enable others to use our technology and reduce our ability to compete with them. *

We require our employees, consultants, advisors, and collaborators to execute confidentiality agreements and in certain cases, assignment or license agreements. We cannot guarantee that these agreements will provide us with adequate intellectual property ownership or protection against improper or unauthorized use or disclosure of confidential information or inventions. In some situations, these agreements may conflict with or be subject to the rights of others with whom our

 

31


Table of Contents

employees, consultants, advisors, or collaborators have prior employment or consulting relationships. In some situations, as is the case with our employees in Germany, these types of agreements or relationships are subject to foreign law, which provides us with less favorable rights or treatment than under U.S. law. Others may gain access to our inventions, trade secrets or independently develop substantially equivalent proprietary materials, products, information, and techniques.

If we cannot attract and retain highly-skilled personnel, our growth might not proceed as rapidly as we intend.

The success of our business will depend on our ability to identify, attract, hire, train, retain, maintain, and motivate highly skilled personnel, particularly sales, scientific, medical, and technical personnel, for our future success. Competition for highly skilled personnel is intense, and we might not succeed in attracting and retaining these employees. If we cannot attract and retain the personnel we require, we would not be able to expand our business as rapidly as we intend. In particular, if we lose any key member of our management team, we may not be able to find suitable replacements and our business may be harmed as a result. During the past several years, we have had significant turnover in our management team and have engaged in substantial headcount reductions. If our management team is not able to effectively manage us through these restructuring changes and transitions, our business, financial condition, and results of operations may be adversely affected. We do not carry “key person” insurance covering any of our officers or other employees.

If we do not effectively manage our business as it evolves, it could affect our ability to pursue opportunities and expand our business.

Evolution in our business has placed and may continue to place a significant strain on our personnel, facilities, management systems, and resources. We will need to continue to improve our operational and financial systems and managerial controls and procedures and train and manage our workforce. We will have to maintain close coordination among our various departments. If we fail to effectively manage the evolution of our business and the significant restructuring changes that we have experienced, our ability to pursue business opportunities, expand our business, and sell our products and applications in new markets may be adversely affected.

We are subject to risks associated with our foreign operations. *

We expect that a significant portion of our sales will continue to be made outside the United States. Approximately 44% of our sales were made outside of the United States during the nine months ended September 30, 2007. A successful international effort will require us to develop relationships with international customers and collaborators, including distributors. We may not be able to identify, attract, retain, or maintain suitable international customers or collaborators. Expansion into international markets will require us to establish and grow foreign operations, hire additional personnel to run these operations, and maintain good relations with our foreign customers and collaborators or distributors. International operations also involve a number of risks not typically present in domestic operations, including:

 

   

currency fluctuation risks;

 

   

changes in regulatory requirements;

 

   

costs and risks of deploying systems in foreign countries;

 

   

licenses, tariffs, and other trade barriers;

 

   

political and economic instability and possible country-based boycotts;

 

   

difficulties in staffing and managing foreign operations;

 

   

potentially adverse tax consequences;

 

   

the burden of complying with a wide variety of complex foreign laws and treaties; and

 

   

different rules, regulations, and policies governing intellectual property protection and enforcement.

Our international operations are also subject to the risks associated with the imposition of legislation and regulations relating to the import or export of high technology products. We cannot predict whether tariffs or restrictions upon the importation or exportation of our products will be implemented by the United States or other countries.

If our production and laboratory facilities are damaged, our business would be seriously harmed.

Our only production facility is located in San Diego, California, where we also have laboratories. Damage to our facilities due to war, fire, natural disaster, power loss, communications failure, terrorism, unauthorized entry, or other events could prevent us from conducting our business for an indefinite period, could result in a loss of important data or cause us to cease development and production of our products. We cannot be certain that our limited insurance to protect against business interruption would be adequate or would continue to be available to us on commercially reasonable terms, or at all.

 

32


Table of Contents

Responding to claims relating to improper handling, storage or disposal of hazardous chemicals, and radioactive and biological materials which we use could be time consuming and costly.

We use controlled hazardous and radioactive materials in the conduct of our business, as well as biological materials that have the potential to transmit disease. The risk of accidental contamination or injury from these materials cannot be completely eliminated. If an accident with these substances occurs, we could be liable for any damages that result, which could seriously harm our business. Additionally, an accident could damage our research and manufacturing facilities and operations, resulting in delays and increased costs. Such damage and any expense resulting from delays, disruptions, or any claims may not be covered by our insurance policies.

We may not have adequate insurance if we become subject to product liability or other claims.

Our business exposes us to potential product liability and other types of claims and our exposure will increase as we and our partners and collaborators prepare to commercialize research-use-only or other types of non-invasive prenatal tests and diagnostics. We have product and general liability insurance that covers us against specific product liability and other claims up to an annual aggregate limit of $5 million. Any claim in excess of our insurance coverage would have to be paid out of our cash reserves, which would have a detrimental effect on our financial condition. It is difficult to determine whether we have obtained sufficient insurance to cover potential claims. Also, we cannot assure you that we can or will maintain our insurance policies on commercially acceptable terms, or at all.

Our stock price has been and may continue to be volatile, and your investment could suffer a decline in value. *

The trading price of our common stock has been volatile and could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including but not limited to:

 

   

actual or anticipated variations in quarterly and annual operating results;

 

   

announcements of technological innovations by us or our competitors;

 

   

our success in entering into, and the success in performing under, licensing and product development and commercialization agreements with others;

 

   

securities analysts’ earnings projections or securities analysts’ recommendations;

 

   

general market conditions out of our control.

The stock market in general, and The NASDAQ Global Market and the market for life sciences companies in particular, have experienced extreme price and volume fluctuations that may have been unrelated or disproportionate to the operating performance of the listed companies. There have been dramatic fluctuations in the market prices of securities of biotechnology companies. These price fluctuations may be rapid and severe and may leave investors little time to react. Broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. Sharp drops in the market price of our common stock expose us to securities class-action litigation. Such litigation could result in substantial expenses and a diversion of management’s attention and resources, which would seriously harm our business, financial condition, and results of operations.

 

33


Table of Contents
Item 6. Exhibits

 

(a) Exhibits

 

Exhibit
Number
  

Description of Document

      3.1 (1)    Restated Certificate of Incorporation of the Registrant
      3.2 (1)    Bylaws of Registrant, as amended
      4.1 (1)    Specimen common stock certificate
 10.54*    Amendment to Exclusive License of Technology Agreement dated November 5, 2007, by and between the Registrant and ISIS Innovation, Limited.
31.1      Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a).
31.2      Certification of Principal Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a).
32.1      Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(b) and 15d-14(b).
32.2      Certification of Principal Financial Officer pursuant to Exchange Act Rules 13a-14(b) and 15d-14(b).

 * Certain confidential portions of this Exhibit have been omitted pursuant to a request for confidential treatment. Omitted portions have been filed separately with the Securities and Exchange Commission.

 

(1) Incorporated by reference to the Current Report on Form 8-K filed September 6, 2006.

SIGNATURE

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.

 

    Sequenom, Inc.
Dated:   November 13, 2007     By:   /s/ PAUL HAWRAN
        Paul Hawran
        Chief Financial Officer

 

34

Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki