SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the Quarterly Period Ended September 30, 20092010

Or

 

¨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: 000-30975

 

 

TRANSGENOMIC, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 911789357

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

12325 Emmet Street, Omaha, Nebraska 68164
(Address of principal executive offices) (Zip Code)

(402) 452-5400

(Registrant’s telephone number, including area code)

 

 

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). )    Yes  ¨    No  ¨

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

 

Large accelerated filer ¨  Accelerated filer ¨
Non-accelerated filer ¨  (Do not check if a smaller reporting company)  Smaller Reporting Company 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

As of November 5, 2009,15, 2010, the number of shares of common stock outstanding was 49,189,672.49,289,672.

 

 

 


TRANSGENOMIC, INC.

INDEX

 

         Page No.    
PART I. 

FINANCIAL INFORMATION

  3

Item 1.

 

Financial Statements

  3
 

Condensed Consolidated Balance Sheets as of September 30, 20092010 (Unaudited) and December 31, 20082009 (Audited)

  3
 

Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 20092010 and 20082009

  4
 

Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the Nine Months Ended September 30, 20092010

  5
 

Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 20092010 and 20082009

  6
 

Notes to Unaudited Condensed Consolidated Unaudited Financial Statements

  7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations  17
Item 3.

Quantitative and Qualitative Disclosures About Market Risk

2419
Item 4T. 

Controls and Procedures

  2426
PART II. 

OTHER INFORMATION

  2527
Item 1. 

Legal Proceedings

  2527
Item 1A. 

Risk Factors

  25
Item 5.

Other Information

2527
Item 6. 

Exhibits

  2627
Signatures  2728

PART I. FINANCIAL INFORMATION

 

Item 1.Financial Statements

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(Dollars in thousands except per share data)

 

  September 30, 2009
(unaudited)
 December 31,
2008
   September 30,  2010
(unaudited)
 December 31,
2009
 
ASSETS      

CURRENT ASSETS:

      

Cash and cash equivalents

  $4,661   $4,771    $4,589   $5,642  

Accounts receivable (net of allowances for bad debts of $345 and $388, respectively)

   4,145    5,385  

Inventories (net of allowances for obsolescence of $353 and $108, respectively)

   4,134    4,775  

Accounts receivable (net of allowances for bad debts of $335 and $310, respectively)

   3,536    4,522  

Inventories (net of allowances for obsolescence of $520 and $507, respectively)

   3,658    3,552  

Prepaid expenses and other current assets

   655    654     646    738  
              

Total current assets

   13,595    15,585     12,429    14,454  
       

PROPERTY AND EQUIPMENT:

      

Equipment

   10,276    10,059     10,371    9,972  

Furniture, fixtures & leasehold improvements

   3,931    3,920     3,836    3,834  
              
   14,207    13,979     14,207    13,806  

Less: accumulated depreciation

   (13,148  (12,781   (13,160  (12,839
              
   1,059    1,198     1,047    967  
       

OTHER ASSETS:

      

Other assets (net of accumulated amortization of $478 and $425, respectively)

   701    773  

Other assets (net of accumulated amortization of $524 and $525, respectively)

   461    583  
              
  $15,355   $17,556    $13,937   $16,004  
              
LIABILITIES AND STOCKHOLDERS’ EQUITY      

CURRENT LIABILITIES:

      

Accounts payable

  $795   $905    $889   $1,013  

Other accrued expenses

   2,330    2,810     2,722    2,517  

Accrued compensation

   538    520     668    573  
              

Total current liabilities

   3,663    4,235     4,279    4,103  

Other long-term liabilities

   202    116     351    239  
              

Total liabilities

   3,865    4,351     4,630    4,342  
       

STOCKHOLDERS’ EQUITY:

      

Preferred stock, $.01 par value, 15,000,000 shares authorized, none outstanding

                  

Common stock, $.01 par value, 100,000,000 shares authorized, 49,189,672 shares outstanding

   497    497  

Common stock, $.01 par value, 100,000,000 shares authorized, 49,289,672 and 49,189,672 shares outstanding, respectively

   498    497  

Additional paid-in capital

   139,652    139,501     139,715    139,703  

Accumulated other comprehensive income

   1,653    1,470     1,644    1,645  

Accumulated deficit

   (130,312  (128,263   (132,550  (130,183
              

Total stockholders’ equity

   11,490    13,205     9,307    11,662  
              
  $15,355   $17,556    $13,937   $16,004  
              

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Dollars in thousands except per share data)

 

  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
  2009 2008 2009 2008   2010 2009 2010 2009 

NET SALES

  $5,046   $5,367   $15,508   $17,869    $4,419   $5,046   $14,956   $15,508  

COST OF GOODS SOLD

   2,293    2,448    7,291    7,570     2,402    2,293    7,568    7,291  
                          

Gross profit

   2,753    2,919    8,217    10,299     2,017    2,753    7,388    8,217  

OPERATING EXPENSES:

          

Selling, general and administrative

   2,215    2,757    7,922    8,824     2,159    2,215    7,623    7,922  

Research and development

   938    684    2,468    1,816     613    938    1,952    2,468  

Restructuring Costs

               8  

Restructuring charges

   72        72      
                          
   3,153    3,441    10,390    10,648     2,844    3,153    9,647    10,390  
                          

LOSS FROM OPERATIONS

   (400  (522  (2,173  (349   (827  (400  (2,259  (2,173

OTHER INCOME (EXPENSE):

          

Interest income, net of interest expense

   1    22    14    80  

Interest, net

       1    1    14  

Other, net

   (1  14    (4  13         (1      (4
                          
       36    10    93             1    10  
                          

LOSS BEFORE INCOME TAXES

   (400  (486  (2,163  (256   (827  (400  (2,258  (2,163

INCOME TAX EXPENSE (BENEFIT)

   (34  13    (114  20     71    (34  109    (114
                          

NET LOSS

  $(366 $(499 $(2,049 $(276  $(898 $(366 $(2,367 $(2,049
                          

BASIC AND DILUTED LOSS PER SHARE

  $(0.01 $(0.01 $(0.04 $(0.01  $(0.02 $(0.01 $(0.05 $(0.04
                          

BASIC AND DILUTED WEIGHTED AVERAGE SHARES OUTSTANDING

   49,189,672    49,189,672    49,189,672    49,189,672     49,289,672    49,189,672    49,228,561    49,189,672  

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Nine Months Ended September 30, 20092010

(Dollars in thousands except per share data)

 

  Common Stock             Common Stock           
  Outstanding
Shares
  Par
Value
  Additional
Paid-in
Capital
  Accumulated
Deficit
 Accumulated
Other
Comprehensive
Income (Loss)
 Total   Outstanding
Shares
   Par
Value
   Additional
Paid-in
Capital
 Accumulated
Deficit
 Accumulated
Other
Comprehensive
Income (Loss)
 Total 

Balance, January 1, 2009

  49,189,672  $497  $139,501  $(128,263 $1,470   $13,205  

Balance, January 1, 2010

   49,189,672    $497    $139,703   $(130,183 $1,645   $11,662  

Net loss

           (2,049  (2,049  (2,049                 (2,367  (2,367  (2,367

Other comprehensive income (loss):

                   

Foreign currency translation adjustment, net of tax

               183    183                       (1  (1
                       

Comprehensive (loss)

          (1,866 

Comprehensive loss

         (2,368 
         ��              

Non-cash stock-based compensation

        151           151               (29          (29

Issuance of shares for employee stock options

   100,000     1     41            42  
                                        

Balance, September 30, 2009

  49,189,672  $497  $139,652  $(130,312 $1,653   $11,490  

Balance, September 30, 2010

   49,289,672    $498    $139,715   $(132,550 $1,644   $9,307  
                                        

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Dollars in thousands)

 

  Nine Months Ended
September 30,
   Nine Months Ended
September 30,
 
        2009             2008               2010             2009       

CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:

     

Net loss

  $(2,049 $(276  $(2,367 $(2,049

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

     

Depreciation and amortization

   615    494  

Depreciation, amortization and disposals

   523    615  

Non-cash, stock based compensation

   151    209     (29  151  

Loss on sale of investment and assets

       6  

Changes in operating assets and liabilities:

     

Accounts receivable

   1,461    151     969    1,461  

Inventories

   709    (335   (167  709  

Prepaid expenses and other current assets

   20    32     90    20  

Accounts payable

   (142  (429   (121  (142

Accrued expenses and accrued compensation

   (557  (324   242    (557

Other long term liabilities

   29         (44  29  

Long term deferred income taxes

   20      
              

Net cash flows provided by (used in) operating activities

   237    (472   (884  237 
              

CASH FLOWS USED IN INVESTING ACTIVITIES:

     

Purchase of property and equipment

   (327  (215   (141  (327

Change in other assets

   (20  (39   (25)  (20)
              

Net cash flows used in investing activities

   (347  (254   (166  (347
       

CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:

   

Issuance of common stock

   42      

Principal payments on capital lease obligations

   (57    
       

Net cash flows provided by financing activities

   (15    
              

EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH

       (210   12      
              

NET CHANGE IN CASH AND CASH EQUIVALENTS

   (110  (936   (1,053  (110

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD

   4,771    5,723     5,642    4,771  
              

CASH AND CASH EQUIVALENTS AT END OF PERIOD

  $4,661   $4,787    $4,589   $4,661  
              

SUPPLEMENTAL CASH FLOW INFORMATION

     

Cash paid during the period for:

     

Interest

  $   $    $   $  

Income taxes, net

   163    61     4    163  

SUPPLEMENTAL DISCLOSURE OF NON-CASH INFORMATION

   

Acquisition of equipment through capital leases

  $286      

See notes to unaudited condensed consolidated financial statements.

A.BUSINESS DESCRIPTION

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Nine Months Ended September 30, 2010 and 2009

A. BUSINESS DESCRIPTION

Business Description.

Transgenomic, Inc. provides innovative products for the purification and analysis of nucleic acids used in the life sciences industry for research focused on molecular genetics and diagnostics. We also provide genetic variation analytical services to the medical research, clinical and pharmaceutical markets. Net sales are categorized as Instrument Related Business and Laboratory Services.

Instrument Related Business:

 

  

Bioinstruments. Our flagship product is the WAVE® System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There is a worldwide installed base of over 1,450nearly 1,500 WAVE Systems as of September 30, 2009.2010. We also distribute bioinstruments produced by other manufacturers (“OEM Equipment”) through our sales and distribution network. Service contracts to maintain installed systems are sold and supported by technical support personnel.

 

  

Bioconsumables. The installed WAVE base and some third-party installed platforms generate a demand for consumables that are required for the continued operation of the bioinstruments. We develop, manufacture and sell these consumable products. In addition, we manufacture and sell consumable products that can be used on multiple, independent platforms. These products include SURVEYOR® Nuclease and a range of HPLC separation columns.

Laboratory Services:

 

Molecular Clinical Reference Laboratory. The molecular clinical reference laboratory specializes in mitochondrial and molecular diagnostic testing including genetic testing for oncology, hematology and inherited disorders. Located in Omaha, Nebraska, the molecular clinical reference laboratory operates in a Good Laboratory Practices compliant environment and is certified under the Clinical Laboratory Improvement Amendment (CLIA) as a high complexity lab and is accredited by CAP (College of American Pathologists).

 

Pharmacogenomics Research Services. Pharmacogenomics research services are provided by our Contract Research Organization located in Omaha, Nebraska. It specializes in pharmocogenomic, biomarker and mutation discovery research serving the pharmaceutical and biomedical industries world-wide for disease research, drug and diagnostic development and clinical trial support.

ManagementAlthough we have experienced recurring net losses (resulting in an accumulated deficit of $132.6 million at September 30, 2010) management believes existing sources of liquidity, including cash and cash equivalents of $4.7$4.6 million, are sufficient to meet expected cash needs during 2009. Our business consolidation efforts, recent reductionthrough 2011. We will need to increase net sales in force and cost containment management over the last few years have helped controlorder to meet our liquidity needs on a long-term basis. If we cannot increase net sales, further reductions to operating costs, however, we have added sales and marketing costs over the last two years in an effort to drive increased sales. In addition we have increased our research expenditures to drive development of new products and to support business opportunities and collaborations.expenses will be needed. In future periods, there is no assurance that we will be able to increase net sales or further reduce expenses and, accordingly, we may not have sufficient sources of liquidity to continue operations indefinitely.

B. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

B.SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation.

The consolidated financial statements include the accounts of Transgenomic, Inc. and its wholly-owned subsidiaries.subsidiary. All intercompany balances and transactions have been eliminated in consolidation.

Risks and Uncertainties.

Certain risks and uncertainties are inherent in our day-to-day operations and to the process of preparing our financial statements. The more significant of those risks are presented below and throughout the notes to the financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

1.Use of Estimates.

The preparation of consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of net sales and expenses during the reporting period. In addition, estimates and assumptions associated with the determination of the fair value of certain assets and related impairments require considerable judgment by management. Actual results could differ from the estimates and assumptions used in preparing these consolidated financial statements.

 

2.Concentration of Revenue Risk.

No customer accounted for more than 10% of consolidated net sales during the three and nine months ended September 30, 20092010 and 2008.2009. For the three and nine months ended September 30, 2010 one customer accounted for more than 10% of the Laboratory Services net sales. This customer represented 16% of the Laboratory Services net sales for the three months ended September 30, 2010 and 15% of the Laboratory Services net sales for the nine months ended September 30, 2010. For the three and nine months ended September 30, 2009 one customer made upaccounted for more than 10% of the Laboratory Services net sales. This customer represented 18% of the Laboratory Services net sales for the three months ended September 30, 2009 and 20% for the nine months ended September 30, 2009. For the three and nine months ended September 30, 2008 two customers each made up more than 10% of the Laboratory Services net sales. Combined for the nine months they represented 35% of the Laboratory Services net sales.

Fair Value.

Unless otherwise specified, book value approximates fair market value.

Concentrations of Cash.

From time to time, we may maintain a cash position with financial institutions in amounts that exceed federally insured limits. We have not experienced any losses on such accounts as of September 30, 2009.2010.

Basis of Presentation.

The condensed consolidated balance sheet as of December 31, 20082009 was derived from our audited balance sheet as of that date. The accompanying consolidated financial statements as of and for the three and nine months ended September 30, 20092010 and 20082009 are unaudited and reflect all adjustments which are, in the opinion of management, necessary for a fair presentation of the financial position and operating results for the interim periods. These unaudited consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 20082009 contained in our Annual Report on Form 10-K. The results of operations for the interim periods presented are not necessarily indicative of the results for the entire year.

Cash and Cash Equivalents.

Cash and cash equivalents include cash and investments with original maturities at acquisition of three months or less. Such investments presently consist of only temporary overnight investments.

Accounts Receivable.

Accounts receivable are shown net of allowance for doubtful accounts. The following is a summary of activity for the allowance for doubtful accounts during the three and nine months ended September 30, 20092010 and 2008:2009:

 

   Dollars in Thousands  Dollars in Thousands 
   Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
   2009  2008  2009  2008 

Beginning balance

  $358   $501   $388   $703  

Provision

   (5  20    27    185  

Write offs

   (8  (20  (70  (387
                 

Ending balance

  $345   $501   $345   $501  
                 
   Dollars in Thousands 
   Beginning
Balance
   Provision  Write Offs  Ending
Balance
 

Three Months Ended September 30, 2010

  $295    $40   $—     $335  

Three Months Ended September 30, 2009

  $358    $(5 $(8 $345  

Nine Months Ended September 30, 2010

  $310    $29   $(4 $335  

Nine Months Ended September 30, 2009

  $388    $27   $(70 $345  

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

While payment terms are generally 30 days, we have also provided extended payment terms of up to 90 days in certain cases. We operate globally and some of the international payment terms may be greater than 90 days. Accounts receivable are carried at original invoice amount less anand shown net of allowance for doubtful accounts. The estimate made for doubtful receivablesaccounts is based on a review of all outstanding amounts on a quarterly basis. We determine the allowance for doubtful accounts by regularly evaluating individual customer receivables and considering a customer’s financial condition, credit history and current economic conditions. Accounts receivable are written off when deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when received.

Inventories.

Inventories are stated at the lower of cost or market net of an allowance for obsolete inventory. Cost is computed using standard costs for finished goods and average or latest actual cost for raw materials and work in process.process, which approximates the first-in, first-out (FIFO) method.

The following is a summary of activity for the allowance for obsolete inventory during the three and nine months ended September 30, 20092010 and 2008:2009:

 

   Dollars in Thousands  Dollars in Thousands
   Three Months Ended
September 30,
  Nine Months Ended
September 30,
   2009  2008  2009  2008

Beginning balance

  $123   $13   $108   $12

Provision

   257    2    298    2

Write offs

   (27  (1  (53  
                

Ending balance

  $353   $14   $353   $14
                
   Dollars in Thousands 
   Beginning
Balance
   Provision   Write Offs  Ending
Balance
 

Three Months Ended September 30, 2010

  $536    $12    $(28 $520  

Three Months Ended September 30, 2009

  $123    $257    $(27 $353  

Nine Months Ended September 30, 2010

  $507    $78    $(65 $520  

Nine Months Ended September 30, 2009

  $108    $298    $(53 $353  

We determine the allowance for obsolete inventory by regularly evaluating quarterly the inventory for items deemed to be slow moving or obsolete. DuringIncluded in our provision is the three months ended September 30, 2009 we recorded $0.2 million related to control plasmids used forforeign currency impact of the consolidation of our surveyor kits.subsidiary.

Property and Equipment.

Property and equipment are carried at cost.cost less accumulated depreciation. Depreciation is computed by the straight-line method over the estimated useful lives of the related assets as follows:

 

Leasehold improvements

  1 to 10 years

Furniture and fixtures

  3 to 7 years

Production equipment

  3 to 7 years

Computer equipment

  3 to 7 years

Research and development equipment

  2 to 7 years

Depreciation during the three months ended September 30, 2009 and 2008 was $0.1 million and $0.2 million, respectively. Depreciation during both the nine months ended September 30, 2009 and 2008 was $0.5 million related to depreciation of property and equipment.

Other Assets.

Other assets include intellectual property, patents and other long-term assets.

Intellectual Property.�� 

1.Intellectual Property.

Initial costs paid to license intellectual property from independent third parties are capitalized and amortized using the straight-line method over the license period. Ongoing royalties related to such licenses are expensed as incurred.

Patents.

2.Patents.

We capitalize legal costs, filing fees and other expenses associated with obtaining patents on new discoveries and amortize these costs using the straight-line method over the shorter of the legal life of the patent or its economic life beginning on the date the patent is issued. We expense all costs incurred prior to the filing of the patent application.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

Each of these assets is treated as long-lived assets. Long-lived assets will be tested for impairment on an annual basis or when a significant event occurs which may impact impairment. We periodically review the carrying value of our long-lived assets to assess recoverability and impairment. We recorded no impairment in the three andor nine months ended September 30, 2009 and 2008.2010 or 2009.

3.Other Long-Term Assets.

Other Assets. Otherlong-term assets include USU.S. security deposits and deferred tax assets.assets, net of applicable valuation allowances.

Stock Based Compensation.

All stock options awarded to date have exercise prices equal to the market price of our common stock on the date of grant and have ten-year contractual terms. Unvested options as of September 30, 20092010 had vesting periods of three years from date of grant. None of the stock options outstanding at September 30, 20092010 are subject to performance or market-based vesting conditions.

We measure and recognize compensation expense for all stock-based awards made to employees and directors, including stock options. Compensation expense is based on the calculated fair value of the awards as measured at the grant date and is expensed ratably over the service period of the awards (generally the vesting period).

During the nine months ended September 30, 2010, we recorded compensation expense recovery of less than $0.1 million within the selling, general and administrative expense. The vesting of options exercisable for the purchase of 1.3 million shares was offset by the expense recovery for stock options which were forfeited due to the requisite service not being rendered. During the nine months ended September 30, 2009, we recorded compensation expense of $0.2 million within the selling, general and administrative expense as a result of the vesting of options exercisable for the purchase of 1,745,000 shares. During the nine months ended September 30, 2008, we recorded compensation expenses of $0.2 million within selling, general and administrative expense as a result of the vesting of options exercisable for the purchase of 1,560,0001.7 million shares. As of September 30, 2009,2010, there was $0.2less than $0.1 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of nearly three years.

No stock options were granted during the quarters ended September 30, 2010 and 2009. The fair value of the options granted during the quarternine months ended September 30, 20082010 and 2009 was estimated on their respective grant dates using the Black-Scholes option pricing model. There were no75,000 stock options granted during the quarternine months ended September 30, 2009.2010. The Black-Scholes model was used with the following assumptions: risk-free interest rates of 2.12% to 3.99%,1.98% based on the U.S. Treasury yield in effect at the time of grant; dividend yields of zero percent; expected liveslife of 2 to 10five years, based on historical exercise activity behavior; and volatility of 106.08% and 80.03% based on the historical volatility of our stock over a time that is consistent with the expected life of the option. A small group of senior executives hold the majority of the stock options and are expected to hold the options until they are vested. Therefore, no forfeitures were assumed.Forfeitures of 2.2% have been assumed in the calculation.

Capital Leases

The following is an analysis of the leased property under capital leases.

   Dollars in Thousands 
   Asset Balances at September 30 

Classes of Property

      2010           2009     

Equipment

  $286    $  

Less: Accumulated amortization

          
          

Total

  $286    $  
          

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

The following is a schedule by years of future minimum lease payments under capital leases together with the present value of the net minimum lease payments as of September 30, 2010.

Year ending December 31:

   Dollars in Thousands 

2010

  $14  

2011

   86  

2012

   86  

2013

   71  
     

Total minimum lease payments

  $257  

Less: Amount representing interest

   (28
     

Present value of net minimum lease payments

  $229  
     

Income Taxes.

Deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities at each balance sheet date using tax rates expected to be in effect in the year the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent that it is more likely than not that they will not be realized.

Net Sales Recognition.

Net sales of products are recognized in accordance with the terms of the sales arrangement. Such recognition is based on receipt of an unconditional customer order and transfer of title and risk of ownership to the customer, typically upon shipment of the product under a purchase order. Our sales terms do not provide for the right of return unless the product is damaged or defective. Net sales from certain services associated with the analytical instruments, to be performed subsequent to shipment of the products, is deferred and recognized when the services are provided. Such services, mainly limited to installation and training services that are not essential to the functionality of the instruments, typically are performed in a timely manner subsequent to shipment of the instrument. We also enter into various service contracts that cover installed instruments. These contracts cover specific time periods and netperiods. Net sales associated with these contracts are deferred and recognized ratably over the service period. At September 30, 20092010 and September 30, 2008,2009, deferred net sales, mainly associated with our service contracts, included in the balance sheet in other accrued expenses, werewas approximately $1.5 million and $1.4 million and $1.6 million, respectively.respectively for each of the periods.

Net sales from our Molecular Clinical Reference Laboratory Services are recognized on an individual test basis and takes place when the test report is completed, reviewed and sent to the client less the reserve for insurance, Medicare and Medicaid expected payment.reimbursement. There are no deferred net sales associated with our Molecular Clinical Reference Laboratory. Adjustments to the allowances, based on actual receipts from third party payers, are recorded upon settlement. In our Pharmacogenomics Research Services Group, we recognize net sales basedperform services on a proportionate performance measurement for each project.project by project basis. When we get payment in advance we recognize revenue when we deliver the service. These projects typically do not extend beyond one year. At September 30, 20092010 and 2008,2009, deferred net sales associated with the pharmacogenomics research projects included in the balance sheet in other accrued expenses, was less than $0.1 million for each period.

Taxes collected from customers and remitted to government agencies for specific net sales producing transactions are recorded net with no effect on the income statement.

Research and Development.

Research and development and various collaboration costs are charged to expense when incurred.

Translation of Foreign Currency.

Financial statements of subsidiaries outside the U.S. are measured usingOur foreign subsidiary uses the local currency of the country in which they are located as thetheir functional currency. The adjustments to translate those amountsIts assets and liabilities are translated into U.S. dollars at the exchange rates in effect at the balance sheet date. Cumulative translation losses of less than $0.1 million are accumulated in a separate account in stockholders’ equity and are included inreported as accumulated other comprehensive income. Foreign currency revaluation gains or losses resulting from changes in currency exchange rates are included inincome on the determination of net income. Foreign currency revaluation adjustments decreased operating expenses and net loss by $0.1 million for the three months endedaccompanying

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 20092010 and increased operating expenses and net loss by $0.3 million2009

consolidated balance sheets for the nine months ended September 30, 2009,2010. Revenues and decreased operating expenses andare translated at the average exchange rates during the period. For transactions that are not denominated in the functional currency, we recognized net loss by $0.5losses of $0.3 million duringas foreign currency transaction losses in the determination of net income for each of the nine months endedending September 30, 2008. Foreign currency translation adjustments had a nominal impact on net loss for the three months ended September 30, 2008.2010 and 2009.

Comprehensive Income.

Accumulated other comprehensive income at September 30, 20092010 and December 31, 20082009 consisted of foreign currency translation adjustments, net of applicable tax of zero. We deem our foreign investments to be permanent in nature and do not provide for taxes on currency translation adjustments arising from converting investments in a foreign currency to U.S. dollars.

Earnings Per Share.

Basic earnings per share areis calculated based on the weighted average number of common shares outstanding during each period. Diluted earnings per share include shares issuable upon exercise of outstanding stock options, warrants or conversion rights that have exercise or conversion prices below the market value of our common stock. At September 30, 2009, there were outstanding options,Options, warrants and conversion rights exercisable forpertaining to 10,598,156 and 11,383,720 shares of our common stock all of which werehave been excluded from the computation of diluted earnings per share at September 30, 2010 and 2009, respectively. The options, warrants and conversion rights that were exercisable in 2010 and 2009 were not included because the effect would be anti-dilutive due to the net loss in that period. At September 30, 2008 there wereloss. As a result, none of our outstanding options, warrants andor conversion rights exercisable for 12,046,704 shares of our common stock all of which were excluded fromaffect the calculation of diluted earnings per share because the effect would be anti-dilutive due to the net loss in that period.share.

Recently Issued Accounting Pronouncements.

In JuneOctober 2009, the FASB issued FASB ASC 105, Generally Accepted Accounting Principles, which establishesASU No. 2009-13,Revenue Recognition (ASC 605): Multiple-Deliverable Revenue Arrangements (a consensus of the FASB Accounting Standards Codification as the sole source of authoritative generally accepted accounting principles. Pursuant to the provisions of FASB ASC 105, the Company has updated references to GAAP in its financial statements issuedEmerging Issues Task Force); effective for the period ended September 30, 2009. The adoption of FASB ASC 105 did not impact the Company’s financial position or results of operations.

ASC 820, “Fair Value Measurement and Disclosures” defines fair value, establishes a frameworkyears beginning after June 15, 2010. This standard update will be effective for measuring fair value and expands disclosures about fair value measurements. We have adopted ASC 820 with no impact on our financial statements.

ASC 350, “Intangibles – Goodwill and Other” requires companies estimating the useful life of a recognized intangible asset to consider their historical experience in renewing or extending similar arrangements or, in the absence of historical experience, to consider assumptions that market participants would use about renewal or extension. ASC 350 was adoptedus on January 1, 2011. Vendors often provide multiple products and/or services to their customers as part of a single arrangement. These deliverables may be provided at different points in time or over different time periods. The existing guidance regarding how and whether to separate these deliverables and how to allocate the overall arrangement consideration to each was originally captured in EITF Issue 00-21,Revenue Arrangements with Multiple Deliverables, which is now codified at ASC 605-25,Revenue Recognition – Multiple-Element Arrangements. The issuance of ASU 2009-13 amends ASC 605-25 and represents a significant shift from the existing guidance that was considered abuse-preventative and heavily geared toward ensuring that revenue recognition was not accelerated. The application of this new guidance is expected to result in accounting for multiple-deliverable revenue arrangements that better reflects their economics as more arrangements will be separated into individual units of accounting. We are currently evaluating the impact of adopting ASU 2009-13.

In October 2009, and had no impact on our financial statements.

ASC 815-40, “Derivatives and Hedging” addresses freestanding contracts that are indexed to, and potentially settled in, an entity’s own stock. We adopted ASC 815-40the FASB issued ASU No. 2009-14,Software (ASC 985): Certain Revenue Arrangements That Include Software Elements (a consensus of the FASB Emerging Issues Task Force); effective for years beginning after June 15, 2010. This standard update will be effective for us on January 1, 2009.2011. ASU 2009-14 modifies the existing scope guidance in ASC 985-605,Software Revenue Recognition, for revenue arrangements with tangible products that include software elements. This modification was made primarily due to the changes in ASC 605-25 noted previously, which further differentiated the separation and allocation guidance applicable to non-software arrangements as compared to software arrangements. Prior to the modification of ASC 605-25, the separation and allocation guidance for software and non-software arrangements was more similar. Under ASC 985-605, which was originally issued as AICPA Statement of position 97-2,Software Revenue Recognition, an arrangement to sell a tangible product along with software was considered to be in its scope if the software was more than incidental to the product as a whole. We are currently evaluating the impact of adopting ASU 2009-14.

C.RESTRUCTURING CHARGES

In the third quarter of 2010 we made a decision to consolidate our research and development activities in Omaha, Nebraska. We expect to substantially complete the transition by December 31, 2010. We have assessed our warrantsrecognized expenses for restructuring, including but not limited to, severance, facility costs and determined the fair value is $0 so there is no impactcosts to move equipment from Gaithersburg, Maryland to Omaha, Nebraska. These restructuring charges are attributable to our financial statements.lab services and instrument segments.

Accounting Standards Update No. 2009-13 addresses the accounting for multiple deliverable arrangements to enable vendors to account for products or services (deliverables) separately rather than as a combined unit. This update is effective for fiscal years on or after June 15, 2010.

TRANSGENOMIC, INC. AND SUBSIDIARY

Accounting Standards Update No. 2009-05 provides amendments to ASC Topic 820, “Fair Value MeasurementsNOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and Disclosure”2009

Restructuring charges include:

   Dollars in Thousands 
   Costs Incurred in  the
Three Months Ended
September 30, 2010
   Cumulative Costs
Incurred at

September 30, 2010
   Total
Expected  Costs
 

Severance and related costs

  $40    $40    $53  

Facility closure costs

   24     24     63  

Other

   8     8     66  
               

Restructuring charges

  $72    $72    $182  
               

Liabilities recorded for the fair value measurementconsolidation of liabilities. We have implemented ASU 2009-05 with no impact on our financial statements.

Gaithersburg, Maryland facility for the third quarter of 2010 consist of the following:

   Dollars in Thousands 
   Balance at
June 30,  2010
   Costs Incurred  and
Charged to Expense
   Costs Paid  or
Otherwise
Settled
  Changes  in
Estimates
   Balance at
September 30, 2010
 

Severance and related costs

  $    $40    $   $    $40  

Facility closure costs

        24     (8       16  

Other

        8     (8         
                        

Total

  $    $72    $(16 $    $56  
                        

C.D.INVENTORIES

Inventories (net of allowances for obsolescence) consisted of the following:

 

  Dollars in Thousands  Dollars in Thousands 
  September 30,
2009
  December 31,
2008
  September 30,
2010
 December 31,
2009
 

Finished goods

  $2,458  $2,911  $2,167   $2,322  

Raw materials and work in process

   1,300   1,658   1,590    1,588  

Demonstration inventory

   376   206   421    149  
             
  $4,134  $4,775   4,178    4,059  

Less allowance for obsolescence

   (520  (507
             

Total

  $3,658   $3,552  
       

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

 

D.E.OTHER ASSETS

Finite lived intangible assets and other assets consisted of the following:

 

  Dollars in Thousands  Dollars in Thousands 
  September 30, 2009  December 31, 2008  September 30, 2010   December 31, 2009 
  Cost  Accumulated
Amortization
  Net Book
Value
  Cost  Accumulated
Amortization
  Net Book
Value
  Cost   Accumulated
Amortization
   Net Book
Value
   Cost   Accumulated
Amortization
   Net Book
Value
 

Intellectual property

  $310  $226  $84  $310  $195  $115  $290    $273    $17    $310    $284    $26  

Patents

   664   252   412   679   230   449   531     251     280     598     241     357  

Other

   205      205   209      209   164     —       164     200     —       200  
                                          

Total

  $1,179  $478  $701  $1,198  $425  $773  $985    $524    $461    $1,108    $525    $583  
                                          

Other assets include U.S. security deposits and deferred tax assets.

Amortization expense for intangible assets was less than $0.1 million during the three and nine months ended September 30, 20092010 and 2008,2009, respectively. Amortization expense for intangible assets is expected to be approximatelyless than $0.1 million for each of the years 2009 through 2013.2010 and thereafter. During the nine months ended September 30, 2010 we abandoned patents of $0.1 million.

 

E.F.COMMITMENTS AND CONTINGENCIES

We are subject to a number of claims of various amounts, which arise out of the normal course of business. In the opinion of management, the disposition of pending claims will not have a material adverse effect on our financial position, results of operations or cash flows.

We lease certain equipment, vehicles and operating facilities under non-cancellable operating leases that expire on various dates through 2014. Some of our leases have early termination clauses.2016. The future minimum lease payments required under these leases are approximately $0.3 million for the remainder of 2009, $0.8 million in 2010, $0.6 million in 2011, $0.3 million in 2012, andless than $0.1 million in 2013.each of the years 2013 through 2016. Rent expense for each of the three months ended September 30, 2010 and 2009 and 2008 was approximately $0.2 million for each period.million. Rent expense for each of the nine months ended September 30, 20092010 and 20082009 was $0.6 million.

We have entered into an employment agreementsagreement with Craig J. Tuttle, our President and Chief Executive Officer, Debra A. Schneider, our Chief Financial Officer, Vice President, Secretary and Treasurer, and Eric P. Kaldjian M.D., our Chief Scientific Officer. The current term of Mr. Tuttle’s employment agreement ends on July 12, 2010.2011. The current term of Ms. Schneider’s employment agreement ends on December 4, 2009. The current term of Dr. Kaldjian’s employment agreement ends on December 31, 2009. Each employment agreement provides that the executive officerMr. Tuttle will be entitled to receive severance payments from the Company if his or her employment is terminated involuntarily except if such termination is based on “just cause”, as that term is defined in the employment agreement. The severance payment payable in the event of involuntary termination without just cause is equal to theirhis annual base salary at the time of termination and will be paid to them over a twelve-month period. The employment agreements provideagreement provides that the severance payment provisions will be honored if the Company is acquired by, or merged into, another company and their positions arehis position is eliminated as a result of such acquisition or merger. In addition we have one employee who is entitled to a severance payment of less than $0.1 million if the employee’s position is eliminated prior to July 2012.

We have entered into agreements for professional services related to our annual audit, quarterly SEC filings, tax preparation and Sarbanes Oxley compliance work. At September 30, 2009 our commitment for these services is $0.2 million.

At September 30, 2009,2010, firm commitments to vendors to purchase components used in WAVE Systems and instruments manufactured by others totaled $0.3 million.

 

F.G.INCOME TAXES

We file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and various foreign jurisdictions. We have statutes of limitation open for Federal income tax returns related to tax years 2007 and 2008.through 2009. We have state income tax returns subject to examination primarily for tax years 2006 through 2008.2009. Open tax years related to foreign jurisdictions remain subject to examination. Our primary foreign jurisdiction is the United Kingdom which has open tax years for 20052006 through 2008.2009.

Income tax benefitexpense for the nine months ended September 30, 20092010 was a benefit of $0.1 million. This is partially the result of the change in deferred tax assets and liabilities reported in financial statements of subsidiariesour subsidiary outside the U.S due primarily to foreign currency exchange losses. A refundable tax credit related to the 2008 Federal and State Income Tax returns was also recorded. This credit is anticipated to continue for 2009.U.S. This tax benefit is partially offset by tax expense related to

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

includes state and franchise taxes as well as reserves for uncertain income taxes. We believe theIncome tax benefit recorded will be partially offset in future periods by a tax expense related to income reported in financial statements of subsidiaries outside the United States. Income tax expense for the nine months ended September 30, 20082009 was less than $0.1 million. The effective tax rate for the nine months ended September 30, 20092010 is 5.3%,(4.84)% which is primarily the result of valuation allowances against the Net Operating Lossesnet operating losses for the United StatesU.S. partially offsetadjusted by the return to provision adjustment recorded in the financial statements and a refundable tax creditpermanent differences related to intercompany foreign currency exchange of our subsidiary outside the 2008 Federal and State Income Tax returns.U.S. The effective tax rate for the nine months ended September 30, 2009 was 5.27%.

During the three and nine months ended September 30, 2009,2010, there were no material changes to the liability for uncertain tax positions.

 

G.H.EMPLOYEE BENEFIT PLAN

We maintain an employee 401(k) retirement savings plan that allows for voluntary contributions into designated investment funds by eligible employees. Prior to June 1, 2009 we matchedWe currently match the employee’s contributions at the rate of 50% on the first 6% of contributions. Effective June 1, 2009, Transgenomic discontinued matching employee 401(k) contributions. We may, at the discretion of our Board of Directors, make additional contributions on behalf of the Plan’s participants. There were no contributions to the 401(k) plan in the third quarter of 2009. Contributions to the 401(k) plan were less than $0.1 million for each of the three and nine months ended September 30, 2009. Contributions to the 401(k) plan were less than $0.1 million for the three months ended September 30, 2008,2010 and $0.1 million for the nine months ended September 30, 2008.2009.

 

H.I.STOCKHOLDERS’ EQUITY

Common Stock.

The Company’s Board of Directors is authorized to issue up to 100,000,000 shares of common stock, from time to time, as provided in a resolution or resolutions adopted by the Board of Directors.

Common Stock Warrants.

No common stock warrants were issued or exercised during the three and nine months ended September 30, 2009 and 2008.2010 or 2009. At September 30, 2009,2010, there were warrants outstanding which were exercisable to purchase 7,978,156 shares of common stock.

 

Warrant Holder

  Issue Year  Expiration Year  Underlying Shares  Exercise Price  Issue Year   Expiration   Underlying Shares   Exercise Price 

Various Institutional Holders (1)

  2005  2010  6,903,156  $1.20   2005     Oct. 2010     6,903,156    $1.20  

Laurus Master Fund, Ltd. (2)

  2003  2010  200,000  $1.92   2003     Dec. 2010     200,000    $1.92  

Laurus Master Fund, Ltd. (2)

  2003  2010  200,000  $2.07   2003     Dec. 2010     200,000    $2.07  

Laurus Master Fund, Ltd. (2)

  2003  2010  150,000  $2.35   2003     Dec. 2010     150,000    $2.35  

Laurus Master Fund, Ltd. (2)

  2004  2011  125,000  $2.57   2004     Feb. 2011     125,000    $2.57  

Laurus Master Fund, Ltd. (2)

  2004  2011  400,000  $1.18   2004     Aug. 2011     400,000    $1.18  
                   

Total

      7,978,156         7,978,156    
                   

We are released from the liability when the stock warrants expire.

 

(1)These warrants were issued in conjunction with a private placement of common stock in October 2005 (the “2005 Private Placement”).2005.

(2)These warrants were issued in conjunction with two loans that had been made to us by Laurus Master Fund, Ltd. (the “Laurus Loans”), and subsequent modifications of these loans. In conjunction with the 2005 Private Placement,private placement, the exercise prices of these warrants were adjusted according to repricing provisions contained in the original warrant agreements. While the Laurus Loans have been terminated, the warrants remain outstanding. Due to the repricing provision, these warrants are considered liabilities for financial reporting purposes. We have assessed and determined the fair value is $0.

Preferred Stock.

The Company’s Board of Directors is authorized to issue up to 15,000,000 shares of preferred stock in one or more series, from time to time, with such designations, powers, preferences and rights and such qualifications, limitations and restrictions as may be provided in a resolution or resolutions adopted by the Board of Directors. The authority of the Board of Directors includes, but is not limited to, the determination or fixing of the following with respect to shares of such class or

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

any series thereof: (i) the number of shares; (ii) the dividend rate, whether dividends shall be cumulative and, if so, from which date; (iii) whether shares are to be redeemable and, if so, the terms and amount of any sinking fund providing for the purchase or redemption of such shares; (iv) whether shares shall be convertible and, if so, the terms and provisions thereof; (v) what restrictions are to apply, if any, on the issue or reissue of any additional preferred stock; and (vi) whether shares have voting rights. The preferred stock may be issued with a preference over the common stock as to the payment of dividends. The Company has no current plans to issue any series of preferred stock. Classes of stock such as the preferred stock may be used, in certain circumstances, to create voting impediments on extraordinary corporate transactions or to frustrate persons seeking to effect a merger or otherwise to gain control of the Company. For the foregoing reasons, any preferred stock issued by the Company could have an adverse effect on the rights of the holders of the common stock.

 

I.J.STOCK OPTIONS

The following table summarizes stock option activity during the nine months ended September 30, 2009:2010:

 

   Number of
Options
  Weighted Average
Exercise Price

Balance at January 1, 2009:

  3,531,064  $2.54

Granted

  70,000   .42

Exercised

     

Forfeited/Expired

  195,500   3.81
       

Balance at September 30, 2009:

  3,405,564  $2.42
       

Exercisable at September 30, 2009:

  2,425,838  $3.15
       
   Number of
Options
  Weighted Average
Exercise Price
 

Balance at January 1, 2010:

   3,331,731   $2.39  

Granted

   75,000    .58  

Exercised

   (100,000)  (.42

Forfeited

   (553,500  (.75

Expired

   (133,231  (12.50
         

Balance at September 30, 2010:

   2,620,000   $2.24  
         

Exercisable at September 30, 2010:

   2,363,334   $2.42  
         

During the nine months ended September 30, 2009,2010, we granted options exercisable to purchase 70,00075,000 shares of common stock at a weighted average exercise price of $0.42$0.58 under our 2006 Equity Incentive Plan. The weighted average fair value per share on grant date of options granted during the nine months ended September 30, 2009 was $0.35.

 

J.K.OPERATING SEGMENT AND GEOGRAPHIC INFORMATION

Our company’s chief operating decision-maker is the Chief Executive Officer, who regularly evaluates our performance based on net sales and gross profit. The preparation of this segment analysis requiredrequires management to make estimates and assumptions around expense below the gross profit level. While we believe the segment information to be directionally correct, actual results could differ from the estimates and assumptions used in preparing this information.

The accounting policies of the segments are the same as the policies discussed in Footnote B – Summary of Significant Accounting Policies.

We have two reportable operating segments.

Segment information for the three months ended September 30, 20092010 and 20082009 is as follows:

 

  Dollars in Thousands   Dollars in Thousands 
  2009 2008   2010 2009 
  Instrument
Business
 Lab
Services
 Total Instrument
Business
 Lab
Services
 Total   Instrument
Business
 Lab
Services
 Total Instrument
Business
 Lab
Services
 Total 

Net Sales

  $3,852   $1,194   $5,046   $4,395   $972   $5,367    $3,155   $1,264   $4,419   $3,852   $1,194   $5,046  

Gross Profit

   2,229    524    2,753    2,531    388    2,919     1,849    168    2,017    2,229    524    2,753  

Net Income/(Loss) before Taxes

   70    (470  (400  (109  (377  (486

Net Income (Loss) before Taxes

   (30  (797  (827  70    (470  (400

Income Tax Expense (Benefit)

   (34      (34  13        13     71        71    (34      (34
                                      

Net Income/(Loss)

  $104   $(470 $(366 $(122 $(377 $(499

Net Income (Loss)

  $(101 $(797 $(898 $104   $(470 $(366
                                      

Depreciation/Amortization

   92    74    166    130    53    183     47    77    124    92    74    166  

Restructure

                         

Restructuring Charges

   38   34    72              

Interest Income, Net

   1        1    18    4    22                 1        1  

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

Segment information for the nine months ended September 30, 20092010 and 20082009 is as follows:

 

   Dollars in Thousands 
   2009  2008 
   Instrument
Business
  Lab
Services
  Total  Instrument
Business
  Lab
Services
  Total 

Net Sales

  $11,794   $3,714   $15,508   $14,907  $2,962   $17,869  

Gross Profit

   6,692    1,525    8,217    9,064   1,235    10,299  

Net Income/(Loss) before Taxes

   (451  (1,712  (2,163  539   (795  (256

Income Tax Expense (Benefit)

   (114      (114  20       20  
                         

Net Income/(Loss)

  $(337 $(1,712 $(2,049 $519  $(795 $(276
                         

Depreciation/Amortization

   352    207    559    405   152    557  

Restructure

               8       8  

Interest Income, Net

   10    4    14    67   13    80  

    September 30, 2009  December 31, 2008

Total Assets

  $8,686  $6,669  $15,355  $10,226  $7,330  $17,556
   Dollars in Thousands 
   2010  2009 
   Instrument
Business
  Lab
Services
  Total  Instrument
Business
  Lab
Services
  Total 

Net Sales

  $11,180   $3,776   $14,956   $11,794   $3,714   $15,508  

Gross Profit

   6,320    1,068    7,388    6,692    1,525    8,217  

Net Loss before Taxes

   (343  (1,915  (2,258  (451  (1,712  (2,163

Income Tax Expense (Benefit)

   109        109    (114      (114
                         

Net Loss

  $(452 $(1,915 $(2,367 $(337 $(1,712 $(2,049
                         

Depreciation/Amortization

   151    229    380    352    207    559  

Restructuring Charges

   38    34    72              

Interest Income

   1        1    10    4    14  
   September 30, 2010  September 30, 2009 

Total Assets

  $7,072   $6,865   $13,937   $8,686   $6,669   $15,355  

Net sales by product were as follows:

 

   Dollars in Thousands  Dollars in Thousands
   Three Months Ended
September 30,
  Nine Months Ended
September 30,
   2009  2008  2009  2008

Instrument Related Business:

        

Bioinstruments

  $1,999  $2,196  $6,215  $7,987

Bioconsumables

   1,853   2,199   5,579   6,920
                
   3,852   4,395   11,794  $14,907

Laboratory Services:

        

Molecular Clinical Reference Laboratory

   923   736   2,886   1,950

Pharmacogenomics Research Services

   271   236   828   1,012
                
   1,194   972   3,714   2,962
                

Total Net Sales

  $5,046  $5,367   15,508  $17,869
                

   Dollars in Thousands   Dollars in Thousands 
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2010   2009   2010   2009 

Instrument Related Business:

        

Bioinstruments

  $1,356    $1,999    $5,925    $6,215  

Bioconsumables

   1,799     1,853     5,255     5,579  
                    
   3,155     3,852     11,180     11,794  

Laboratory Services:

        

Molecular Clinical Reference Laboratory

   918     923     2,790     2,886  

Pharmacogenomics Research Services

   346     271     986     828  
                    
   1,264     1,194     3,776     3,714  
                    

Total Net Sales

  $4,419    $5,046    $14,956    $15,508  
                    

Net cost of goods sold was as follows:

 

   Dollars in Thousands  Dollars in Thousands
   Three Months Ended
September 30,
  Nine Months Ended
September 30,
   2009  2008  2009  2008

Instrument Related Business:

        

Bioinstruments

  $526  $767  $2,167  $2,710

Bioconsumables

   1,097   1,097   2,935   3,133
                
  $1,623  $1,864   5,102   5,843

Laboratory Services:

        

Molecular Clinical Reference Laboratory

   479   429   1,607   1,196

Pharmacogenomics Research Services

   191   155   582   531
                
   670   584   2,189   1,727
                

Total Cost of Goods Sold

  $2,293  $2,448  $7,291  $7,570
                

Net sales for the three and nine months ended September 30, 2009 and 2008 by country were as follows:

   Dollars in Thousands  Dollars in Thousands
   Three Months Ended
September 30,
  Nine Months Ended
September 30,
   2009  2008  2009  2008

United States

  $1,920  $2,180  $6,524  $7,044

Italy

   913   499   2,676   2,321

Germany

   441   359   973   1,279

France

   386   772   1,175   2,082

Netherlands

   296   71   388   318

United Kingdom

   230   315   666   1,509

China

   82   58   757   249

All Other Countries

   778   1,113   2,349   3,067
                

Total

  $5,046  $5,367  $15,508  $17,869
                
   Dollars in Thousands   Dollars in Thousands 
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2010   2009   2010   2009 

Instrument Related Business:

        

Bioinstruments

  $532    $526    $2,487    $2,167  

Bioconsumables

   774     1,097     2,373     2,935  
                    
   1,306     1,623     4,860     5,102  

Laboratory Services:

        

Molecular Clinical Reference Laboratory

   670     479     1,631     1,607  

Pharmacogenomics Research Services

   426     191     1,077     582  
                    
   1,096     670     2,708     2,189  
                    

Total Cost of Goods Sold

  $2,402    $2,293    $7,568    $7,291  
                    

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS—(Continued)

Nine Months Ended September 30, 2010 and 2009

Net sales for the three and nine months ended September 30, 2010 and 2009 by country were as follows:

   Dollars in Thousands   Dollars in Thousands 
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2010   2009   2010   2009 

United States

  $2,082    $1,920    $6,483    $6,254  

Italy

   813     913     2,300     2,676  

France

   209     386     812     1,175  

Germany

   194     441     1,099     973  

United Arab Emirates

   4          778       

United Kingdom

   224  ��  230     991     666  

All Other Countries

   893     1,156     2,493     3,764  
                    

Total

  $4,419    $5,046    $14,956    $15,508  
                    

No other country accounted for more than 5% of total net sales.

No customer accounted for more than 10% of consolidated net sales during the three and nine months ended September 30, 2009 and 2008. For the three and nine months ended September 30, 2009 one customer made up more than 10% of the Laboratory Services net sales. This customer represented 18% of the Laboratory Services net sales for the three months ended September 30, 2009 and 20% for the nine months ended September 30, 2009. For the three and nine months ended September 30, 2008 two customers each made up more than 10% of the Laboratory Services net sales. Combined they represent 35% of the Laboratory Services net sales.

Approximately 80% of our long-lived assets are within the United States. Substantially all of the remaining long-lived assets are within Europe.

 

K.L.SUBSEQUENT EVENTS

Events or transactions that occur after the balance sheet date, but before the financial statements are complete, are reviewed to determine if they should be recognized.

On October 27, 2010 6,903,156 common stock warrants to various institutional holders expired unexercised.

We have no material subsequent eventsbeen awarded a federal grant under the Qualifying Therapeutic Discovery Project Program related to be disclosed as2009 projects. Net of November 5, 2009 which isour consultant fees we expect to receive $0.6 million cash in the date our financial statements were issued.

fourth quarter of 2010.

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

Forward-Looking Information

This report, including Management’s Discussion & Analysis, contains forward-looking statements. These statements are based on management’s current views, assumptions or beliefs of future events and financial performance and are subject to uncertainty and changes in circumstances. Readers of this report should understand that these statements are not guarantees of performance or results. Many factors could affect our actual financial results and cause them to vary materially from the expectations contained in the forward-looking statements. These factors include, among other things: our expected revenue, income(loss), receivables, operating expenses, supplier pricing, availability and prices of raw materials, Medicare/Medicaid/Insurance reimbursements, product pricing, foreign currency exchange rates, sources of funding operations and acquisitions, our ability to raise funds, sufficiency of available liquidity, future interest costs, future economic circumstances, industry conditions, our ability to execute our operating plans, the success of our cost savings initiatives, competitive environment and related market conditions, actions of governments and regulatory factors affecting our business and other risks as described in our reports filed with the Securities and Exchange Commission. In some cases these statements are identifiable through the use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “target,” “can,” “could,” “may,” “should,” “will,” “would” and similar expressions.

You are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements we make are not guarantees of future performance and are subject to various assumptions, risks and other factors that could cause actual results to differ materially from those suggested by these forward-looking statements. Actual results may differ materially from those suggested by the forward-looking statements that we make for a number of reasons including those described in Part II, Item 1A, “Risk Factors,” of this report.

We expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

The following discussion should be read together with our financial statements and related notes contained in this report and with the financial statements, related notes, and Management’s Discussion & Analysis in our annual report on Form 10-K for the fiscal year ended December 31, 2008.2009. Results for the quarter ended September 30, 20092010 are not necessarily indicative of results that may be attained in the future.

Overview

Transgenomic, Inc. provides innovative products for the purification and analysis of nucleic acids used in the life sciences industry for research focused on molecular genetics and diagnostics. We also provide genetic variation analytical services to the medical research, clinical and pharmaceutical markets. Net sales are categorized as Instrument Related Business and Laboratory Services.

Instrument Related Business:

 

  

Bioinstruments. Our flagship product is the WAVE® System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There is a worldwide installed base of over 1,450nearly 1,500 WAVE Systems as of September 30, 2009.2010. We also distribute bioinstruments produced by other manufacturers (“OEM Equipment”) through our sales and distribution network. Service contracts to maintain installed systems are sold and supported by technical support personnel.

 

  

Bioconsumables. The installed WAVE base and some third-party installed platforms generate a demand for consumables that are required for the continued operation of the bioinstruments. We develop, manufacture and sell these consumable products. In addition, we manufacture and sell consumable products that can be used on multiple, independent platforms. These products include SURVEYOR® Nuclease and a range of HPLC separation columns.

Laboratory Services:

 

Molecular Clinical Reference Laboratory. The molecular clinical reference laboratory specializes in mitochondrial and molecular diagnostic testing including genetic testing for oncology, hematology and inherited disorders. Located in Omaha, Nebraska the molecular clinical reference laboratory operates in a Good Laboratory Practices compliant environment and is certified under the Clinical Laboratory Improvement Amendment (CLIA) as a high complexity lab and is accredited by CAP (College of American Pathologists).

Pharmacogenomics Research Services. Pharmacogenomics research services are provided by our Contract Research Organization located in Omaha, Nebraska. It specializes in pharmocogenomic, biomarker and mutation discovery research serving the pharmaceutical and biomedical industries world-wide for disease research, drug and diagnostic development and clinical trial support.

Although we have experienced recurring net losses (resulting in an accumulated deficit of $132.6 million at September 30, 2010) management believes existing sources of liquidity, including cash and cash equivalents of $4.6 million, are sufficient to meet expected cash needs during 2010. We will need to increase net sales in order to meet our liquidity needs on a long-term basis. If we cannot increase net sales, further reductions to operating expenses will be needed. In future periods, there is no assurance that we will be able to increase net sales or further reduce expenses and, accordingly, we may not have sufficient sources of liquidity to continue operations indefinitely.

Executive Summary

Net sales for the nine months ended September 30, 2009 decreased by $2.4 million or 13%2010 were down 4% compared to the same period in 2008.2009. Net sales in our Instrument Related Business were down 21%5% or $3.1$0.6 million for the nine months ended September 30, 20092010 compared to the same period in 2008. The difficult global economic climate has had an impact on our business in 2009. Net sales from bioinstruments were down 22%5% and net sales of consumables were down 19%6% for the comparable nine month periods. During the nine months ended September 30, 2009,2010, net sales from Laboratory Services grew 25%, or $0.8 million,were up 2% compared to the same nine month period in 2008.2009. The Clinical Reference Laboratory showed revenue growth of 48%decreased 3% and net sales from Pharmacogenomics Research Services decreasedincreased by 18%19%.

Our gross profit margin decreased from 58%by 4% for the nine months ended September 30, 20082010 compared to 53%the same period in 2009. The Instrument Related Business gross margin was flat at 57% for each of the nine months ended in 2010 and 2009. Laboratory Services gross margin decreased from 41% gross profit in the nine months ended September 30, 2009 to 28% for the same period in 2009. Our2010. Net loss was $2.4 million for the nine months ended September 30, 2010 compared to net loss wasof $2.0 million for the nine months ended September 30, 2009 compared to net loss of $0.3 million for the nine months ended September 30, 2008.

As of September 30, 2009, we had cash and cash equivalents of $4.7 million, compared to $4.8 million at December 31, 2008.2009.

Outlook

We continue to work towardleverage our objective of generating income from continuing operationscore instrument business for on-going instrument sales worldwide as well as employing our instruments and positive cash flows from continuing operations. To accomplish these goals, we must generate sequentialrelated expertise in our two laboratory services businesses. We anticipate continued growth in net salesboth of our laboratory services businesses and we continue to control manufacturingseek out new assay technologies and other operating expenses.tests to license or develop internally to expand our menu offerings for both service businesses. And although challenges do exist for WAVE System and consumable sales growth in our traditional markets, we are having some success with selling systems into new geographic areas, including the Middle East, to continue the revenue from our instrument related business segment. We continue to look for emerging markets and novel applications to provide us with new opportunities for our WAVE System such as our newly launched K-RAS mutation detection kit. During the third quarter we completed the requirements for CE IVD labeling of our SURVEYOR® Scan K-RAS mutation detection kit and have significantly expanded distribution throughout most of the European Union as a result. We intend to continue to look for opportunities to diversify into new markets, including the personalized medicine market (particularly in oncology), where the sensitivities of our technologies are essential. As discussed below, a recently licensed technology that could provide the highest sensitivity available in the marketplace is being refined for use on our Wave Systems. In addition, we are also selling refurbished WAVE Systems in order to allow an opportunity for customers who may not be able to afford the full cost of a new system to purchase and utilize our WAVE technology. Additionally, we have developed credibility and momentum with third-party platforms that will allow us to leverage our direct sales force and distribution network.

On the Laboratory Services front, we have completed cancer pathway gene mutation projects for a number of high visibility pharmaceutical companies which have continued to demonstrate the unique sensitivity of detecting DNA mutations in cancer genes which are central to effective therapy selection for current and future cancer therapeutics. To this end, we are now gaining clinical trial program contracts which we believe will more rapidly impact our revenue opportunities from this segment. To compliment our mutation detection expertise, we also have strengthened our capabilities in biomarker development and mutation detection in novel cancer pathway genes which will aid in the development of true personalized medicine for our pharmaceutical partners. We recently licensed and are developing a new technology for even greater DNA mutation enrichment and detection sensitivity which could prove to be the highest sensitivity technology in the market. In our Molecular Clinical Reference Laboratory we have continued to seek out or develop new tests to further expand our menu and growth opportunities for this business, including a test that would determine the likelihood of the sibling of an autistic child also developing autism.

Uncertainties

The uncertainty of the current general global economic conditions could negatively impact our business in the future.

We have historically operated at a loss and have not consistently generated sufficient cash from operating activities to cover our operating expenses and other cash expenses.needs. While we have been able to historically finance our operating losses through borrowings or from the issuance of additional equity, there is the risk that we may not be able to obtain such funding due toin the tightened credit markets.future. At September 30, 20092010 we had cash and cash equivalents of $4.7$4.6 million. We do believe that existing sources of liquidity are sufficient to meet expected cash needs during 2009.into 2011.

The uncertainty of the current general economic conditions could negatively impact our business in the future. There are many factors that affect the market demand for our products and services that we cannot control. Demand for our Instrument Related Business is affected by the needs and budgetary resources of research institutions, universities and hospitals. The instrument purchase represents a significant expenditure by these types of customers and often requires a long sales cycle. These customers may not have the funding available to purchase our instruments. Competition and new instruments introduced in the marketplace also may impact our sales.

We have foreign currency revaluation risk, which occurs when thea transaction is doneoccurs in a currency other than the British Pound. This transaction must be revalued within the Transgenomic, Limited ledger, whose functional currency is the British Pound Sterling.entity’s “functional currency”. The majority of our international sales are transacted in the transactions on this ledger are in Euro. As a result we are subject to exchange rate risk. The foreign exchange rates have had large variances recently.euro, which must be first converted into British pound sterling, and then into U.S. dollars. At January 1, 20082009 the Euro to Great British Pound exchange rate was .73650.9690 as compared to the September 30, 20092010 rate of .91660..8613. The Great British Pound to USU.S. Dollar exchange rate was 1.99701.4501 at January 1, 20082009 compared to 1.592201.5809 at September 30, 2009. These large changes2010. Fluctuations in the foreign exchange rates may negativelycould impact our business inresults. Foreign currency revaluation adjustments decreased operating expenses and net loss by $0.2 million and $0.1 million for the three months ended September 30, 2010 and 2009, respectively and foreign currency revaluation adjustments increased operating expenses and net loss by $0.3 million during each of the nine months ended September 30, 2010 and 2009.

Results of Continuing Operations

Three Months Ended September 30, 20092010 and 20082009

Net Sales. Net sales consisted of the following:

 

  Dollars in Thousands   Dollars in Thousands 
  Three Months Ended
September 30,
  Change   Three Months Ended
September 30,
   Change 
      2009          2008          $     %       2010           2009           $     % 

Instrument Related Business:

              

Bioinstruments

  $1,999  $2,196  $(197 (9)%   $1,356    $1,999    $(643  (32)% 

Bioconsumables

   1,853   2,199   (346 (16)%    1,799     1,853     (54  (3)%
             
   3,852   4,395   (543 (12)%                
   3,155     3,852     (697  (18)% 

Laboratory Services:

              

Molecular Clinical Reference Laboratory

   923   736   187   25   918     923     (5  (1)% 

Pharmacogenomics Research Services

   271   236   35   15   346     271     75    28
                            
   1,194   972   222   23   1,264     1,194     70    6
                            

Total Net sales

  $5,046  $5,367  $(321 (6)%   $4,419    $5,046    $(627  (12)% 
                            

Bioinstrument sales consist of sales of our WAVE System and associated equipment that we manufacture or assemble, net sales from service contracts that we enter into with purchasers of our instruments, as well as sales of instruments we distribute for other manufacturers (“OEM equipment”). We also sell refurbished WAVE Systems in order to access customers that may not be able to afford new systems. Bioinstrument net sales are down $0.2$0.6 million, or 9%32%, during the three months ended September 30, 20092010 as compared to the same period in 2008. In 2009 we2009. The decrease in bioinstrument net sales was due to changes in the product mix sold 6 totalduring the quarter as well as fewer instruments sold. No OEM instruments were sold in 2010 compared to 5one OEM sale in the third quarter of 2009. We sold four WAVE instruments in the same periodthird quarter 2010 as compared to five WAVE instruments in the third quarter of 2008. There2009. The average sales price was one OEM instrument soldhigher in the third quarter of 2009 compareddue to three OEM instrumentthe geographic location of the sales. Service contract sales in the third quarter of 2008. Five WAVE systems were soldflat during the three months ended September 30, 2009,2010 as compared to two during the same period of 2008. The WAVE instruments have ain 2009. Parts, freight and miscellaneous income was lower average sales price compared to the OEM instruments. Accordingly, the combination of an increase in sales of WAVE instruments and the decrease in sales of OEM instrumentsby $0.1 million in the third quarter of 2009 contributed to our overall decline in net sales for the three months ended September 30, 20092010 as compared to the same period of 2008. There was also a reduction in service contract net sales primarily in the European market. This reduction was due to lower sales volume and a foreign currency exchange impact of $0.1 million. Instrument related revenue is subject to many factors such as type of instrument sold and the country of sale. Due to these factors each quarter should be considered on a stand alone basis and is not indicative of future net sales streams.2009.

Net sales of bioconsumables decreasedwere down less than $0.1 million, or 3%, during the three months ended September 30, 20092010 compared to 2008. The foreign currency exchange impact included2009. This decrease is related to lower sales volume in this decrease was $0.2 million.our European markets.

Net sales of Laboratory Services increased 6% during the three months ended September 30, 20092010 compared to 2008 by approximately $0.2 million.2009. Laboratory Services sales includes both the Molecular Clinical Reference Laboratory Services and the Pharmacogenomics Research Services. The Molecular Clinical Reference Laboratory Services net sales of $0.9 million increased 25% overwere down 1% compared to the three months ended September 30, 2008. The Pharmacogenomics Research Services net sales of $0.3 million increased 15% over the three months ended September 30, 2008.2009. The Molecular Clinical Reference Laboratory revenue has increased due to increased test volume. Our test volume has increased by 42% due to our increased sales focus. The average revenue per test has decreased by 12%4% due to the mix of tests performed and increased Medicare and Medicaid test volumes which drivesgenerates lower reimbursementsreimbursement for these tests. DuringThe decrease in average revenue per test is offset by a 4% increase in sales volume. The Pharmacogenomics Research Services net sales of $0.3 million during the three months ended September 30, 2009 and 20082010 was up 28% compared to 2009. The increase in Pharmacogenomics Research Services net sales consistedis largely due to an increase in the number of many midsize customers.customers for the third quarter of 2010 compared to 2009. The Pharmacogenomics Research Services net sales have peaks due to the project related nature of project relatedthe business. Each quarterperiod for Pharmacogenomics Research Services should be considered on a stand alone basis and is not indicative of future net sales.

Costs of Goods Sold.Costs of goods sold include material costs for the products that we sell and substantially all other costs associated with our manufacturing facilities (primarily personnel costs, rent and depreciation). It also includes direct costs (primarily personnel costs, rent, supplies and depreciation) associated with our Laboratory Services operations. Cost of goods sold consisted of the following:

 

  Dollars in Thousands   Dollars in Thousands 
  Three Months Ended
September 30,
  Change   Three Months Ended
September 30,
   Change 
      2009          2008          $     %       2010           2009           $     % 

Instrument Related Business:

              

Bioinstruments

  $526  $767  $(241 (31)%   $532    $526    $6    1

Bioconsumables

   1,097   1,097         774     1,097     (323  (29)% 
             
   1,623   1,864   (241 (13)%                
   1,306     1,623     (317  (20)% 

Laboratory Services:

              

Molecular Clinical Reference Laboratory

   479   429   50   12   670     479     191    40

Pharmacogenomics Research Services

   191   155   36   23   426     191     235    123
                            
   670   584   86   15   1,096     670     426    64
                            

Cost of goods sold

  $2,293  $2,448  $(155 (6)%   $2,402    $2,293    $109    5
                            

Gross profit was $2.8$2.0 million or 55%46% of total net sales during the third quarter of 2009,2010, compared to $2.9$2.8 million or 54%55% during the same period of 2008.2009. Margins on the instrument related business are up by 1% compared to the same period in 2009. The grossbioinstrument margin for the Instrument Related Business was 58% for bothdecreased from 74% in the three months ended September 30, 2009 to 61% in the same period of 2010. This decrease is driven by the composition of products sold and 2008. Cost of sales for the Instrument Related Business decreased $0.2 million forfewer instruments sold in the third quarter of 2010. Margins on bioconsumables increased from 41% for the three months ended September 30, 2009 compared to 57% in the same period of 2008 which was offset by net sales which were lower by $0.5 million.2010. During the three months ended September 30, 2009,2010, the gross margin for the Laboratory Services was 44%13% as compared to 40%44% in the same period of 2008.2009. The Laboratory Services gross margin increase is attributed to leverage inon the organization. Net sales increased $0.2 million and costsClinical Reference Laboratory was 27% for the third quarter of goods increased less than $0.1 million. The decrease in average net revenue per test is a result of test mix and increased Medicare and Medicaid test volume which drives lower reimbursements. Test volume during this period grew by 42% as2010 compared to net sales growth48% for the third quarter of 25%.2009. Pharmacogenomics gross margin decreased from 30% for the three months ended September 30, 2009 to a negative 23% for the three months ended September 30, 2010. These decreases are due to staff added along with higher operating supplies cost.

Selling, General and Administrative Expenses. Selling, general and administrative expenses primarily consist of personnel costs, marketing, travel and entertainment costs, professional fees, and facility costs. In addition, foreign currency revaluation is included here. Excluding foreign currency revaluation gains or losses, which was a gainour selling, general and administrative costs were down less than $0.1 million compared to the same period of $0.1 million2009. Foreign currency revaluation gains in the three months ended September 30, 2009 and nominal in the same period of 2008, our selling, general and administrative costs decreased from $2.82010 were $0.2 million compared to $0.1 million in 2008 to $2.3 million inrevaluation gains for the three months ended September 30, 2009. The primary decrease is due to open employment positions not being filled, lower commissions, and lower travel and stock option expense.

Research and Development Expenses.Research and development expenses primarily include personnel costs, legal fees, outside services, collaboration expenses, supplies, and facility costs and are expensed in the period in which they are incurred. For the three months ended September 30,third quarter of 2010 and 2009 these costs totaled $0.6 million and $0.9 million compared to $0.7 million for the three months ended September 30, 2008.respectively. The increase is primarily due to2009 research and development costs included collaboration expenses with the Dana-Farber Cancer Institute related to the development of high-sensitivityhigh sensitivity mutation detection technology called Cold-PCRCOLD-PCR (coamplification at lower denaturation temperature PCR).

Research and development expenses totaled 19%14% and 13%19% of net sales during the three months ended September 30, 20092010 and 2008,2009, respectively.

Other Income (Expense).Other income consists primarily of interest income from cash and cash equivalents invested in overnight instruments. Other incomeexpense during the three months ended September 30, 20092010 and September 30, 20082009 was less than $0.1 million for each period.

Income Tax Expense (Benefit). Income tax expense for the three months ended September 30, 2010 was less than $0.1 million. This is the result of the change in deferred tax assets and liabilities reported in financial statements of our subsidiary outside the U.S. This tax expense includes state taxes as well as reserves for uncertain income taxes. Income tax benefit for the three months ended September 30, 2009 was a benefit of less than $0.1 million. This is primarily the result of a refundable tax credit anticipated for the 2009 Federal and State Income Tax returns recorded this period. This tax benefit is partially offset by tax expense related to subsidiaries outside the United States and state taxes as well as reserves for uncertain income taxes. We believe the tax benefit recorded will be partially offset in future periods by a tax expense, related to income reported in financial statements of subsidiaries outside the United States. Income tax expense for the three months ended September 30, 2008 was less than $0.1 million.

Results of Continuing Operations

Nine Months Ended September 30, 20092010 and 20082009

Net Sales. Net sales consisted of the following:

 

  Dollars in Thousands   Dollars in Thousands 
  Nine Months Ended
September 30,
  Change   Nine Months Ended
September 30,
   Change 
      2009          2008          $     %       2010           2009           $     % 

Instrument Related Business:

              

Bioinstruments

  $6,215  $7,987  $(1,772 (22)%   $5,925    $6,215    $(290  (5)% 

Bioconsumables

   5,579   6,920   (1,341 (19)%    5,255     5,579     (324  (6)% 
             
   11,794   14,907   (3,113 (21)%                
   11,180     11,794     (614  (5)% 

Laboratory Services:

              

Molecular Clinical Reference Laboratory

   2,886   1,950   936   48   2,790     2,886     (96  (3)% 

Pharmacogenomics Research Services

   828   1,012   (184 (18)%    986     828     158    19
                            
   3,714   2,962   752   25   3,776     3,714     62    2%
                            

Total Net Sales

  $15,508  $17,869  $(2,361 (13)%   $14,956    $15,508    $(552  (4)% 
                            

Bioinstrument sales consist of sales of our WAVE System and associated equipment that we manufacture or assemble, net sales from service contracts that we enter into with purchasers of our instruments, as well as sales of instruments we distribute for other manufacturers (“OEM equipment”). We also sell refurbished WAVE Systems in order to access customers that may not be able to afford new systems. Bioinstrument net sales are down $1.8$0.3 million, or 22%5%, during the nine months ended September 30, 20092010 as compared to the same period in 2008.2009. The decrease in bioinstrument net sales was due to a change in product mixlower average sales price in the nine months ended September 30, 2009.2010. We sold tenfive OEM instruments in each of the nine months ended September 30, 2008 compared to five in the nine months ended2010 and September 30, 2009. The average sales price was lower on our OEM instruments sold in 2010 as compared to 2009. We sold eighteentwenty-two WAVE Systems in the nine months ended September 30, 20092010 as compared to sixteeneighteen in the nine months ended September 30, 2008. The WAVE instruments have a lower2009, and the average sales price compared to the OEM instruments. The average sales price also was lower due to the geographic make uplocation of the sales. Service contract sales which accountedwere down $0.1 million for the majoritynine months ended September 30, 2010 compared to the same period of 2009 due to lower volumes in both the decrease. The foreign currency conversion rate difference between 2009European and 2008 impacted the average net sales price on our European sales. ThereU.S. markets. Parts, freight and miscellaneous income was also a reduction in service contract net sales, primarilylower by $0.3 million in the European market. This reduction was primarily relatednine months ended September 30, 2010 as compared to foreign currency exchange impact. Demand for WAVE Systems continues to be affected by significant competitive challenges from traditional (i.e. sequencing) and evolving technologies. Instrument related revenue is subject to many factors such as typethe same period of instrument sold and the country of sale. Due to these factors each quarter should be considered on a stand alone basis and is not indicative of future net sales streams.2009.

Net sales of bioconsumables decreased during the nine months ended September 30, 20092010 compared to 2008.2009. The primary decrease in consumables is due to the negative impact of the foreign currency exchange rates, primarily the Great British Pound to the US Dollar. There is also some negativelower volume impact in our European market offset by higher volume in our U.S. market.

Net sales of Laboratory Services increased duringby 2% for the nine months ended September 30, 20092010 compared to 2008 by approximately $0.8 million.2009. Sales of Laboratory Services sales includesinclude both the Molecular Clinical Reference Laboratory Services and the Pharmacogenomics Research Services. The Molecular Clinical Reference Laboratory Services net sales of $2.9$2.8 million increased 48%represented a decrease of 3% over the nine months ended September 30, 2008.2009. The Molecular Clinical Reference Laboratory average revenue per test has decreased by 6% due to the mix of tests performed and the increased Medicare and Medicaid test volumes which generates lower reimbursement for these tests. The decrease in average revenue per test is offset by a 3% increase in volume. The Pharmacogenomics Research Services net sales of $0.8$1.0 million during the nine months ended September 30, 2009 decreased 18%2010 represented an increase of 19% from the nine months ended September 30, 2008.2009. The decreaseincrease in Pharmacogenomics Research Services is largely due to one large customeran increase in the first halfnumber of 2008 which has completed its project.clients for the nine months ended September 30, 2010 compared to the same period of 2009. The Pharmacogenomics Research Services net sales have peaks due to the project related nature of project relatedthe business. Each quarterperiod for Pharmacogenomics Research Services should be considered on a stand alone basis and is not indicative of future net sales.

Costs of Goods Sold.Costs of goods sold include material costs for the products that we sell and substantially all other costs associated with our manufacturing facilities (primarily personnel costs, rent and depreciation). It also includes direct costs (primarily personnel costs, rent, supplies and depreciation) associated with our Laboratory Services operations. Cost of goods sold consisted of the following:

 

  Dollars in Thousands   Dollars in Thousands 
  Nine Months Ended
September 30,
  Change   Nine Months Ended
September 30,
   Change 
      2009      2008  $ %       2010           2009           $     % 

Instrument Related Business:

              

Bioinstruments

  $2,167  $2,710  $(543 (20)%   $2,487    $2,167    $320    15

Bioconsumables

   2,935   3,133   (198 (6)%    2,373     2,935     (562  (19)% 
             
   5,102   5,843   (741 (13)%                
   4,860     5,102     (242  (5)% 

Laboratory Services:

              

Molecular Clinical Reference Laboratory

   1,607   1,196   411   34   1,631     1,607     24    1

Pharmacogenomics Research Services

   582   531   51   10   1,077     582     495    85
                            
   2,189   1,727   462   27   2,708     2,189     519    24
                            

Cost of goods sold

  $7,291  $7,570  $(279 (4)%   $7,568    $7,291    $277    4
                            

Gross profit was $8.2$7.4 million or 53%49% of total net sales during the nine months ended September 30, 2009,2010, compared to $10.3$8.2 million or 58%53% during the same period of 2008. Cost of sales for2009. Margins on the Instrument Related Business decreased by 13%were flat for the nine months ended September 30, 20092010 compared to the same period of 2008 on a net sales decrease of 21%. This margin erosion is related to a lower average instrument sales price globally and lower service net sales, primarily in the European market. While we did reduce costs somewhat, we do have a fixed cost base related to the instrument related business in addition to more variable costs directly related to the acquisition of products. The Laboratory Services cost of goods sold increased 27% for the nine months ended September 30, 2009 over the same period of 2008.2009. During the nine months ended September 30, 2009,2010, the gross margin for the Laboratory Services was relatively flat at 41%28% as compared to 42%41% in the same period of 2008. Gross2009. The erosion in the gross margin is impacteddriven by the mix of tests sold and the lower average net sales reimbursement per test due to increased Medicare and Medicaid test volume which is largely offset by leverage on the cost side. Test volume during this nine month period grew by 80%. Our direct variable costs per test can be significantly different for some of the tests we offer. For instance, the “CMA” test, our fastest growing test, has aand higher direct variable cost than many other of our tests.operating costs.

Selling, General and Administrative Expenses. Selling, general and administrative expenses primarily consist of personnel costs, marketing, travel and entertainment costs, professional fees, and facility costs. In addition, foreign currency revaluation is included here. Excluding foreign currency revaluation gains or losses, which was a loss of $0.3 million in each of the nine months ended September 30, 2009 and a gain of $0.5 million in the same period of 2008,2010, our selling, general and administrative costs decreased from $9.3$7.7 million to $7.7$7.3 million. The primary decrease is due to no employee bonus accrual, reductions in stafflower salary and open positions not filled, lower travel expenses, lower stock option expense and a reduction in bad debt expense.

Research and Development Expenses.Research and development expenses primarily include personnel costs, legal fees, outside services, collaboration expenses, supplies, and facility costs and are expensed in the period in which they are incurred. For the nine months ended September 30, 2009 these costs totaledResearch and development expenses were $2.0 million and $2.5 million compared to $1.8 million for the nine months ended September 30, 2008. The increase is primarily due to collaboration expenses with Power3 for their NuroPro assay development related to the diagnosis of Alzheimer’s2010 and Parkinson’s diseases, the Dana-Farber Cancer Institute related to the development of high sensitivity mutation detection technology called Cold-PCR and purchases of samples related to research work in progress.2009, respectively.

Research and development expenses totaled 16%13% and 10%16% of net sales during the nine months ended September 30, 20092010 and 2008,2009, respectively.

Other Income (Expense).Other income consists primarily of interest income from cash and cash equivalents invested in overnight instruments. Other income during the nine months ended September 30, 20092010 and September 30, 20082009 was less than $0.1 million for each period.

Income Tax Expense (Benefit). Income tax benefitexpense for the nine months ended September 30, 20092010 was a benefit of $0.1 million. This is partially the result of the change in deferred tax assets and liabilities reported in financial statements of subsidiaries outside the U.S due primarily to foreign currency exchange losses. A refundable tax credit related to the 2008 Federal and State Income Tax returns was also recorded. This credit is anticipated to continue for 2009.U.S. This tax benefit is partially offset by tax expense related toincludes state taxes as well as reserves for uncertain income taxes. We believe theIncome tax benefit recorded will be partially offset in future periods by a tax expense, related to income reported in financial statements of subsidiaries outside the United States. Income tax expense for the nine months ended September 30, 20082009 was less than $0.1 million.

Liquidity and Capital Resources

Our working capital positions at September 30, 20092010 and December 31, 20082009 were as follows:

 

  Dollars in Thousands   Dollars in Thousands 
  September 30,
2009
  December 31,
2008
  Change   September 30,
2010
   December 31,
2009
   Change 

Current assets (including cash and cash equivalents of $4,661 and $4,771, respectively)

  $13,595  $15,585  $(1,990

Current assets (including cash and cash equivalents of $4,589 and $5,642, respectively)

  $12,429    $14,454    $(2,025

Current liabilities

   3,663   4,235   (572   4,279     4,103     176  
                      

Working capital

  $9,932  $11,350  $(1,418  $8,150    $10,351    $(2,201
                      

The working capital decrease at September 30, 20092010 compared to December 31, 20082009 is primarily a result of lower accounts receivableour net loss of $1.2$2.4 million for the nine months ended September 30, 2010.

We have historically operated at a loss and lower inventorieshave not consistently generated sufficient cash from operating activities to cover our operating and other cash expenses. While we have been able to historically finance our operating losses through borrowings or from the issuance of $0.6 million offset by lower accrued expenses of $0.5 million.

Management believes existing sources of liquidity, includingadditional equity, we currently have no borrowings and have no plans to issue additional equity securities for this purpose. At September 30, 2010 we had cash and cash equivalents of $4.7 million,$4.6 million. We believe that existing sources of liquidity are sufficient to meet expected cash needs during 2009.into 2011. We have added experiencedwill need to increase our net sales, stafffocus on receivables and inventory management or further reduce our operating expenses in order to be assured of meeting our business in an effort to drive improved sales in 2009. We have also increased our research costs to drive new products and collaborations which should drive future growth. Asliquidity needs on a result of the current economic outlook in 2009long-term basis. However, we cannot assure you that we will be able to maintainincrease our net sales or further reduce our expenses, or raise further capital or equity and, accordingly, we may not have sufficient sources of liquidity to continue our operations indefinitely. If necessary, management believes they can further reduce costs and expenses to conserve working capital. However, such cost and expense reductions could have an adverse impact on our new product pipeline and ultimately net sales. We could also pursue additional financing, but optimally, our goal is to achieve sufficient net sales to consistently generate net income and positive cash flow.

Analysis of Cash Flows

Nine Months Ended September 30, 20092010 and 20082009

Net Change in Cash and Cash Equivalents.Cash and cash equivalents decreased $0.1by $1.1 million during the nine months ended September 30, 20092010 to $4.6 million compared to a decrease of $0.9$0.1 million in cash balances during the nine months ended September 30, 2008.2009. In 2010 net cash used in operating activities was $0.7 million and $0.5 million was used in investing activities which was offset by less than $0.1 million provided by financing activities. The impact of foreign currency exchange revaluation was nominal. In 2009 net cash provided by operating activities was $0.2 million offset by $0.3 million of net cash flow used in investing activities with nominimal impact of foreign currency exchange rates. In 2008 net cash

Cash Flows Used in Operating Activities. Cash flows used in operating activities was $0.5 million and net cash flow used in investing activities was $0.3 million. The impact of foreign currency exchange rates was a use of cash of $0.2 million in 2008.

Cash Flows Provided by Operating Activities. Cash flows provided by operating activities totaled $0.2were $0.7 million during the nine months ended September 30, 2010, compared to cash flows provided by operating activities of $0.2 million during the same period of 2009. The cash flows used in operating activities in 2010 relate to the net loss of $2.4 million which is offset by the timely collection of accounts receivable of $1.0 million and noncash items of $0.5 million. The cash flows provided by operating activities in 2009 primarily relate to the accounts receivable collections of $1.5 million the decrease in inventory of $0.7 million and noncash items of $0.8 million offset by the loss of $2.0 million and lower accrued expenses and accounts payable of $0.7 million. Cash flows used in operating activities totaled $0.5 million during the nine months ended September 30, 2008. The cash flows used in operating activities in 2008 primarily relate to the net loss of $0.3 million. In addition, accounts receivable decreased by $0.2 million, inventory increased by $0.3 million, accounts payable decreased by $0.4 million, accrued expenses decreased by $0.3 million and noncash items totaled $0.7 million.

Cash Flows Used In Investing Activities. Cash flows used in investing activities totaled $0.3$0.5 million for each ofduring the nine months ended September 30, 2009 and September 30, 2008.2010 compared to cash flows used in investing activities of $0.3 million during the same period of 2009. Cash flows used in investing activities in 20092010 and 20082009 consisted primarily of purchases of property and equipment.

Cash Flows Provided by Financing Activities. Cash flows provided by financing activities were less than $0.1 million for the nine months ended September 30, 2010. This resulted from the issuance of common stock due to the exercise of stock options for 100,000 shares during the second quarter of 2010. There were no cash flows provided by or used in financing activities for the nine months ended September 30, 2009.

Off-Balance Sheet Arrangements

At September 30, 20092010 and December 31, 2008,2009, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Critical Accounting Policies and Estimates

Accounting policies used in the preparation of the consolidated financial statements may involve the use of management judgments and estimates. Certain of our accounting policies are considered critical as they are both important to the portrayal of our financial statements and they require significant or complex judgments on the part of management. Our judgments and estimates are based on experience and assumptions that we believe are reasonable under the circumstances. Further, we evaluate our judgments and estimates from time to time as circumstances change. Actual financial results based on judgments or estimates may vary under different assumptions or circumstances. Our critical accounting policies are discussed in our annual report on Form 10-K for the fiscal year ended December 31, 2008.2009.

Recently Issued Accounting Pronouncements

Please refer to our annual report on Form 10-K for the fiscal year ended December 31, 2008.2009. There have been no changes to those accounting pronouncements listed except as noted in note B to the financial statements contained in this report.

Impact of Inflation

We do not believe that price inflation or deflation had a material adverse effect on our financial condition or results of operations during the periods presented.

Item 3.  Quantitative and Qualitative Disclosures about Market Risk

Foreign Currency Translation Risk.  During the last two fiscal years, our international sales have represented more than 50% of our net sales. These sales of products in foreign countries are mainly completed in either British Pounds Sterling or the Euro. Additionally, the British Pound is the functional currency of our wholly owned subsidiary, Transgenomic Limited. Results of operation and the Balance Sheet are translated from the functional currency of the subsidiary, Great British Pounds, to our reporting currency of the US Dollar. Results of operations for the Company’s foreign subsidiaries are translated using the average exchange rate during the period. Assets and liabilities are translated at the exchange rate in effect at the balance sheet date. In addition, we have revaluation risk which occurs when the transaction is done in a currency other than the British Pound. This transaction must be revalued within the Transgenomic, Limited ledger, whose functional currency is the British Pound Sterling. The majority of the transactions on this ledger are in Euro. As a result we are subject to exchange rate risk. The foreign exchange rates have had large variances recently. At January 1, 2008 the Euro to Great British Pound exchange rate was .73650 as compared to September 30, 2009 rate of .91660. The Great British Pound to US Dollar exchange rate was 1.9970 at January 1, 2008 compared to 1.59220 at September 30, 2009. These large changes in foreign exchange rates may negatively impact our business in 2009.

Item 4T.  Controls and Procedures

Evaluation of Disclosure Controls and Procedures.  We evaluatedManagement performed, under the designdirection of our Chief Executive Officer and operatingInterim Chief Financial Officer, an evaluation of the effectiveness of our disclosure controls and procedures as of September 30, 2009 pursuant to Rule 13a-15(b)defined in Rules 13a-15(e) and 15d-15(e) of the SecuritiesExchange Act. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act of 1934. Based on this evaluation,are recorded, processed, summarized, and reported within the time periods specified in the SEC’s forms, and that such information is accumulated and communicated to our management including our Chief Executive Officer and our Interim Chief Financial Officer, to allow timely decisions regarding required disclosures. Based on the evaluation, the Company’s Chief Executive Officer and our Interim Chief Financial Officer concluded that, becauseas of the material weakness in our internal control over financial reporting described in item 9A(T) of our report on Form 10-K for the fiscal year ended December 31, 2008, ourSeptember 30, 2010 Transgenomic’s disclosure controls and procedures as defined in Rule 13a-15(e) continued to not bewere effective. To address the material weakness in our internal control over financial reporting, management performed additional manual procedures and analysis and other post-closing procedures in order to prepare the consolidated financial statements included in this report. Notwithstanding the material weakness in our internal control over financial reporting as of September 30, 2009, we believe that the consolidated financial statements contained in this report present fairly our financial condition, results of operations, and cash flows for the fiscal years covered thereby in all material respects.

Change in Internal Control Over Financial Reporting.  There hashave been no changechanges in our internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

 

Item 1.Legal Proceedings

We are subject to a number ofoccasional claims of various amounts which arise out of the normal course of our business. In our opinion, the disposition of pending claims will not have a material adverse effect on our financial position, results of operations or cash flows.

 

Item 1A.Risk Factors

An investment in our common stock involves a number of risks. You should carefully consider each of the risks described in Item 1A of our annual report on Form 10-K for the fiscal year ended December 31, 20082009 before deciding to invest in our common stock. If any of the risks actually occur, our business, financial condition or results of operations could be negatively affected, the market price of our common stock or other securities could decline and you may lose all or part of your investment.

In addition to the risks described in Item 1A of our annual report on Form 10-K for the fiscal year endedEnded December 31, 20082009 please consider the following risks before deciding to invest in our common stock:

Providers of clinical testing services may be subject to lawsuits alleging negligence or other similar legal claims. Potential suits could involve claims for substantial damages. Litigation could also have an adverse impact on our client base and reputation. We maintain liability insurance coverage for certain claims that could result from providing or failing to provide clinical testing services, including inaccurate testing results and other exposures. Our insurance coverage limits our maximum exposurerecovery on individual claims and, therefore, there is no assurance that such coverage will be adequate.

The clinical laboratory testing industry is subject to extensive regulation. Potential sanctions for violation of statutes and regulations include significant fines and the loss of various licenses, certificates and authorizations. We believe that we are in compliance in all material respects with all statutes, regulations and other requirements applicable to our clinical laboratory operations.

The United States government may pass a public health insurance option. In the event this occurs we would need to do extensive evaluation of the plan to determine the impact of our revenue streams.

Note Regarding Risk Factors

The risk factors presented above and in Item 1A of our annual report on Form 10-K for the fiscal year ended December 31, 20082009 are all of the ones that we currently consider material. However, they are not the only ones facing our company. Additional risks not presently known to us, or which we currently consider immaterial, may also adversely affect us. There may be risks that a particular investor views differently from us, and our analysis might be wrong. If any of the risks that we face actually occur, our business, financial condition and operating results could be materially adversely affected and could differ materially from any possible results suggested by any forward-looking statements that we have made or might make. In such case, the trading price of our common stock could decline, and you could lose part or all of your investment.We expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

Item 5.Other Information

The Dana-Farber Cancer Institute

On October 8, 2009 we announced that we licensed a high-sensitivity mutation detection technology called Cold-PCR from the Dana-Farber Cancer Institute (DFCI), Boston, MA. This variation of the standard PCR technology enriches mutations in DNA samples and is a much more sensitive technique for finding low level mutations in tissue and body fluids that are involved with a variety of diseases. Cold-PCR was invented at DFCI by Dr. Mike Makrigiorgos who has demonstrated its effectiveness in enriching for mutations in cancer-related genes in samples where standard DNA sequencing is not sensitive enough to detect these very low concentration somatic DNA mutations. The licensing terms include exclusive rights to commercialize Cold-PCR technology combined with Sanger sequencing as well as all applications for mitochondrial DNA analysis.

Cold-PCR will have applicability in detection of cancer-related mutations where critical mutations are present at a very low percentage compared to normal DNA. Examples would be in blood and urine or where the tissue collected contains mostly normal cells. This would allow clinicians to use less intrusive methods for genetic analysis or allow more efficient use of tumor tissue samples. Additionally the method could enhance the detection of the emergence of cancer-drug resistance mutations, allowing early detection of relapse.

We believe that Cold-PCR is a critical addition to our high-sensitivity mutation detection portfolio of cutting edge technologies. It will allow us to continue offering affordable, state-of-the-art solutions to challenging areas of genetic analysis and, we hope, allow us to be able to screen patient blood for early detection of cancer, detect cancer drug resistance or relapse earlier as well as expand our mitochondrial DNA analysis toolbox. We have long wanted a technology that would permit us to screen patients earlier in their development of cancer and we hope that Cold-PCR provides us the sensitivity and analytical accuracy to achieve this goal. Discovering cancers at a much earlier phase of development will have a huge impact on cancer diagnosis and treatment.

The expense recorded for our license with the Dana-Farber Cancer Institute during the three and nine months ended September 30, 2009 was $0.2 million.

Power3 Medical Products, Inc.

On January 23, 2009 we signed a definitive collaboration and exclusive license agreement with Power3 Medical Products, Inc. for the rights to Power3 Medical’s neurodegenerative biomarkers.

The agreement grants us exclusive rights in the U.S. and certain international markets to neurodegenerative biomarkers from Power3 Medical including NuroPro®, a proposed diagnostic for Alzheimer’s and Parkinson’s diseases based on Power3’s proteomics platform. We will pay Power3 Medical an up-front license fee, milestone payments, royalties, and will also provide development funding and resources.

We will offer the NuroPro tests in our CLIA-certified molecular diagnostics laboratory and will add to our portfolio of molecular diagnostics used for mitochondrial disorders, oncology, hematology molecular pathology, and inherited diseases.

The expense recorded for payments made to Power3 Medical Products, Inc. during the three and nine months ended September 30, 2009 was less than $0.1 million and $0.2 million, respectively.

Item 6.Exhibits

 

(a)Exhibits

  3.1  Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to Registrant’s Report on Form 10-Q (Registration No. 000-30975) filed on November 14, 2005)
  3.2  Amended and Restated Bylaws of the Registrant (incorporated by reference to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on May 25, 2007)
  4  Form of Certificate of the Registrant’s Common Stock (incorporated by reference to Exhibit 4 to Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000)
10.1License Agreement between the Company and the Dana-Farber Cancer Institute dated October 8, 2009
10.2License Agreement between the Company and Power3 Medical Products, Inc. dated January 23, 2009
31  Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32  Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

SIGNATURES

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

 

  TRANSGENOMIC, INC.
Date: November 5, 200915, 2010  By: /S/ CRAIG J. TUTTLE
    

Craig J. Tuttle

President and Chief Executive Officer

 

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