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, 2008March 31, 2009

Or

 

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

For the transition period from             toto

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 definitionthe definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Securities Exchange Act of 1934.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 Securities Exchange Act of 1934)Act)    Yes  ¨    No  x

As of October 30, 2008,May 14, 2009, the number of shares of common stock outstanding was 49,189,672.

 

 

 


TRANSGENOMIC, INC.

INDEX

 

      Page No.
PART I.  FINANCIAL INFORMATION  3

Item 1.

  

Financial Statements

  3
  

Condensed Consolidated Balance Sheets as of September 30, 2008March 31, 2009 (Unaudited) and December 31, 20072008 (Audited)

  3
  

Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30,March 31, 2009 and 2008 and 2007

  4
  

Unaudited Condensed Consolidated Statements of Stockholders’ Equity for the NineThree Months Ended September 30, 2008March 31, 2009

  5
  

Unaudited Condensed Consolidated Statements of Cash Flows for the NineThree Months Ended September 30,March 31, 2009 and 2008 and 2007

  6
  

Notes to Condensed Consolidated Unaudited Financial Statements

  7
Item 2.  

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

  16
Item 3.Quantitative and Qualitative Disclosures About Market Risk20
Item 4T.  

Controls and Procedures

  2220
PART II.  OTHER INFORMATION  2321
Item 1.  

Legal Proceedings

  2321
Item 1A.  

Risk Factors

  2321
Item 6.  

Exhibits

  2321
Signatures  2422

PART I. FINANCIAL INFORMATION

 

Item 1.Financial Statements

TRANSGENOMIC, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Dollars in thousands except per share data)

 

  Sept. 30, 2008
(unaudited)
 December 31,
2007
   March 31, 2009
(unaudited)
 December 31,
2008
 
ASSETS      

CURRENT ASSETS:

      

Cash and cash equivalents

  $4,787  $5,723   $4,845  $4,771 

Accounts receivable (net of allowances for bad debts of $501 and $703, respectively)

   4,944   5,095 

Accounts receivable (net of allowances for bad debts of $356 and $388, respectively)

   4,376   5,385 

Inventories

   4,921   4,586    4,847   4,775 

Prepaid expenses and other current assets

   727   759    736   654 
              

Total current assets

   15,379   16,163    14,804   15,585 
              

PROPERTY AND EQUIPMENT:

      

Equipment

   10,708   10,857    10,092   10,059 

Furniture, fixtures & leasehold improvements

   4,085   4,056    3,919   3,920 
              
   14,793   14,913    14,011   13,979 

Less: accumulated depreciation

   13,517   13,334    (12,749)  (12,781)
              
   1,276   1,579    1,262   1,198 
              

OTHER ASSETS:

      

Goodwill

   638   638 

Other assets, net

   657   710 

Other assets (net of accumulated amortization of $437 and $425, respectively)

   741   773 
       
         $16,807  $17,556 
  $17,950  $19,090        
       
LIABILITIES AND STOCKHOLDERS’ EQUITY      

CURRENT LIABILITIES:

      

Accounts payable

  $816  $1,245   $1,243  $905 

Other accrued expenses

   2,526   3,152    2,653   2,810 

Accrued compensation

   752   450    535   520 
              

Total current liabilities

   4,094   4,847    4,431   4,235 

Other long-term liabilities

   141   141    118   116 
              

Total liabilities

   4,235   4,988    4,549   4,351 
              

COMMITMENTS AND CONTINGENCIES

      

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    497   497 

Additional paid-in capital

   139,308   139,099    139,552   139,501 

Accumulated other comprehensive income

   1,954   2,274    1,425   1,470 

Accumulated deficit

   (128,044)  (127,768)   (129,216)  (128,263)
              

Total stockholders’ equity

   13,715   14,102    12,258   13,205 
              
  $17,950  $19,090   $16,807  $17,556 
              

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Dollars in thousands except per share data)

 

   Three Months Ended
Sept. 30,
  Nine Months Ended
Sept. 30,
 
   2008  2007  2008  2007 

NET SALES

  $5,367  $5,151  $17,869  $16,645 

COST OF GOODS SOLD

   2,448   2,500   7,570   7,872 
                 

Gross profit

   2,919   2,651   10,299   8,773 

OPERATING EXPENSES:

     

Selling, general and administrative

   2,757   2,672   8,824   8,719 

Research and development

   684   720   1,816   2,270 

Restructuring costs

   —     681   8   1,305 
                 
   3,441   4,073   10,648   12,294 
                 

LOSS FROM OPERATIONS

   (522)  (1,422)  (349)  (3,521)

OTHER INCOME (EXPENSE):

     

Interest income, net of interest expense

   22   75   80   215 

Other, net

   14   4   13   8 

Gain on sale of investment

   —     —     —     938 
                 
   36   79   93   1,161 
                 

LOSS BEFORE INCOME TAXES

   (486)  (1,343)  (256)  (2,360)

INCOME TAX EXPENSE

   13   6   20   25 
                 

LOSS FROM CONTINUING OPERATIONS

   (499)  (1,349)  (276)  (2,385)

INCOME FROM DISCONTINUED OPERATIONS, NET OF TAX

   —     —     —     66 
                 

NET LOSS

  $(499) $(1,349) $(276) $(2,319)
                 

COMPREHENSIVE LOSS

   (723)  (1,217)  (596)  (2,032)
                 

BASIC AND DILUTED LOSS PER SHARE:

     

From continuing operations

  $(0.01) $(0.03) $(0.01) $(0.05)

From discontinued operations

   —     (0.00)  —     (0.00)
                 
  $(0.01) $(0.03) $(0.01) $(0.05)
                 

BASIC AND DILUTED WEIGHTED AVERAGE SHARES OUTSTANDING

   49,189,672   49,189,672   49,189,672   49,189,672 
   Three Months Ended
March 31,
 
   2009  2008 

NET SALES

  $4,989  $6,254 

COST OF GOODS SOLD

   2,176   2,614 
         

Gross profit

   2,813   3,640 

OPERATING EXPENSES:

   

Selling, general and administrative

   2,975   2,975 

Research and development

   844   572 
         
   3,819   3,547 
         

INCOME (LOSS) FROM OPERATIONS

   (1,006)  93 

OTHER INCOME (EXPENSE):

   

Interest income, net of interest expense

   12   33 

Other, net

   —     (1)
         
   12   32 
         

INCOME (LOSS) BEFORE INCOME TAXES

   (994)  125 

INCOME TAX EXPENSE (BENEFIT)

   (41)  3 
         

NET INCOME (LOSS)

  $(953) $122 
         

BASIC AND DILUTED INCOME (LOSS) PER SHARE

  $(0.02) $0.00 
         

BASIC WEIGHTED AVERAGE SHARES OUTSTANDING

   49,189,672   49,189,672 
         

DILUTED WEIGHTED AVERAGE SHARES OUTSTANDING

   49,189,672   49,192,571 
         

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

NineThree Months Ended September 30, 2008March 31, 2009

(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, 2008

  49,189,672  $497  $139,099  $(127,768) $2,274  $14,102 

Balance, January 1, 2009

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

Net loss

  —     —     —     (276)  (276)  (276)  —     —     —     (953)  (953)  (953)

Other comprehensive income (loss):

                    

Foreign currency translation adjustment, net of tax

  —     —     —     —     (320)  (320)  —     —     —     —     (45)  (45)
                        

Comprehensive loss

          (596)           (998) 
                        

Non-cash stock-based compensation

  —     —     209   —     —     209   —     —     51   —     —     51 
                                      

Balance, September 30, 2008

  49,189,672  $497  $139,308  $(128,044) $1,954  $13,715 

Balance, March 31, 2009

  49,189,672  $497  $139,552  $(129,216) $1,425  $12,258 
                                      

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Dollars in thousands)

 

  Nine Months Ended
Sept. 30,
   Three Months Ended
March 31,
 
  2008 2007   2009 2008 

CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:

      

Net loss

  $(276) $(2,319)

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

   

Net income (loss)

  $(953) $122 

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

   

Depreciation and amortization

   494   978 ��  209   197 

Non-cash, stock based compensation

   209   87    51   65 

(Gain) Loss on sale of investment and assets

   6   (1,034)

Loss on sale of investment and assets

   —     (3)

Changes in operating assets and liabilities:

      

Accounts receivable

   151   1,041    968   (1,259)

Inventories

   (335)  (1,800)   (133)  287 

Prepaid expenses and other current assets

   32   (344)   (87)  222 

Accounts payable

   (429)  124    344   (33)

Accrued expenses and accrued compensation

   (324)  615    (110)  627 

Other long term liabilities

   4   —   

Long term deferred income taxes

   6   —   
              

Net cash flows used in operating activities

   (472)  (2,652)

Net cash flows provided by operating activities

   299   225 
              

CASH FLOWS PROVIDED BY (USED IN) INVESTING ACTIVITIES:

      

Purchase of property and equipment

   (215)  (523)   (209)  (43)

Change in other assets

   (39)  (133)   (5)  (42)

Proceeds from asset sales

   —     3,935 
              

Net cash flows provided by (used in) investing activities

   (254)  3,279 

Net cash flows used in investing activities

   (214)  (85)
              

EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH

   (210)  48    (11)  (59)
              

NET CHANGE IN CASH AND CASH EQUIVALENTS

   (936)  675    74   81 

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD

   5,723   5,868    4,771   5,723 
              

CASH AND CASH EQUIVALENTS AT END OF PERIOD

  $4,787  $6,543   $4,845  $5,804 
              

SUPPLEMENTAL CASH FLOW INFORMATION

      

Cash paid during the period for:

      

Interest

  $—    $5   $—    $—   

Income taxes, net

   61   25    2   13 

See notes to unaudited condensed consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NineThree Months Ended September 30,March 31, 2009 and 2008 and 2007

 

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 relatedInstrument 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 1,4251,450 WAVE Systems as of September 30, 2008.March 31, 2009. 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 system’s continued operation.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 Laboratorymolecular 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.

 

Pharmacogenomics Research Services. Pharmacogenomics Research Services is aresearch 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.

Historically, we operated a segment (the “Nucleic Acids operating segment”) that developed, manufactured and marketed chemical building blocks for nucleic acid synthesis. In the fourth quarter of 2005, we implemented a plan to exit the Nucleic Acids operating segment and during the three months ended March 31, 2007, we completed the sale of the remaining assets associated with this segment. Accordingly, the assets and results of the Nucleic Acids operating segment are reflected as discontinued operations for all periods presented in this filing.

Management believes existing sources of liquidity, including cash and cash equivalents of $4.8 million, are sufficient to meet expected cash needs intoduring 2009. Our business consolidation efforts, recent reduction in force and cost containment management have helped control our operating costs, however, we have added sales and marketing costs over the last two years in an effort to drive increased sales. 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

Principles of Consolidation.

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

UseRisks and Uncertainties.

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

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

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Nine Months Ended September 30, 2008 and 2007

and assumptions associated with the determination of the fair value of certain assets and related impairments and the determination of goodwill impairments require considerable judgment by management. Actual results could differ from the estimates and assumptions used in preparing these financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Three Months Ended March 31, 2009 and 2008

2.Concentration of Revenue Risk.

No customer accounted for more than 10% of consolidated net sales during the three months ended March 31, 2009 and 2008. For the three months ended March 31, 2009 one customer made up more than 10% of the Laboratory Services net sales. This customer represented 17% of the Laboratory Services net sales.

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 March 31, 2009.

Basis of Presentation.

The consolidated balance sheet as of December 31, 20072008 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,March 31, 2009 and 2008 and 2007 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, 20072008 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, 2008March 31, 2009 and 2007:2008:

 

  Dollars in Thousands Dollars in Thousands   Dollars in Thousands
  Three Months Ended
Sept. 30,
 Nine Months Ended
Sept. 30,
   Three Months Ended
March 31,
  2008 2007 2008 2007   2009 2008

Beginning balance

  $501  $649  $703  $613   $388  $703

Charges to income

   20   (64)  185   (27)   (4)  36

Deductions from reserves

   (20)  —     (387)  (1)   28   367
                   

Ending balance

  $501  $585  $501  $585   $356  $372
                   

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 an estimate made for doubtful receivables based on a review of all outstanding amounts on a monthly basis. We reviewdetermine 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 on a quarterly basis and adjust our bad debt reserve accordingly.previously written off are recorded when received.

Inventories.

Inventories are stated at the lower of cost or market. Cost is computed using standard costs for finished goods and average or latest actual cost for raw materials and work in process.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Three Months Ended March 31, 2009 and 2008

Property and Equipment.

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

 

Leasehold improvements

  21 to 10 years

Furniture and fixtures

  53 to 7 years

Production equipment

  53 to 7 years

Computer equipment

  3 to 57 years

Research and development equipment

  32 to 5 years

Demonstration equipment

3 to 57 years

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Nine Months Ended September 30, 2008 and 2007

Depreciation and amortization during the three months ended September 30,March 31, 2009 and 2008, and 2007, respectively, included $0.2 million, for each period related to depreciation of property and equipment. Depreciation and amortization during the nine months ended September 30, 2008 and 2007, respectively, included $0.5 million and $1.0 million, respectively, related to depreciation of property and equipment.

Goodwill.

Goodwill is not amortized, but is tested for impairment annually. We perform this impairment analysis during the fourth quarter of each year. Impairment occurs when the carrying value is determined to be not recoverable thereby causing the fair value of the goodwill to exceed the carrying value. If impaired, the asset’s carrying value is reduced to its fair value.

Other Assets.

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

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. 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 economic life or the legal life of the patent.patent or its economic life beginning on the date the patent is issued.

Other Intangible Assets. Identifiable intangible assets with definite lives are amortized over their estimated useful lives.

AllEach of these assets areis treated as long-lived assets for purposes of SFASFAS No. 144, which provides that long-lived assets will be tested for impairment on an annual basis.basis or when a significant event occurs which may impact impairment. We periodically review the carrying value of our long-lived assets during the fourth quarter of each year to assess whether eventsrecoverability and impairment. We recorded no impairment in the three months ended March 31, 2009 or changes in circumstances indicate the carrying amount of these2008.

Other Assets. Other assets may be impaired.include US security deposits and deferred tax assets.

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, 2008March 31, 2009 had vesting periods of three years from date of grant. None of the stock options outstanding at September 30, 2008March 31, 2009 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 optionsoptions. 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 ninethree months ended September 30, 2008,March 31, 2009, we recorded compensation expense of $0.2$0.1 million within the selling, general and administrative expense related toas a result of the vesting of 1,560,000 options.options exercisable for the purchase of 1,715,000 shares. During the ninethree months ended September 30, 2007,March 31, 2008, we recorded compensation expenses of $0.1 million related towithin selling, general and administrative expense as a result of the vesting of 870,000 options.options exercisable for the purchase of 1,410,000 shares. As of September 30, 2008,March 31, 2009, there was $0.5$0.2 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.

The fair value of the options issuedgranted during the quarters ended September 30,March 31, 2009 and 2008 and 2007 was estimated on their respective grant dates using the Black-Scholes option pricing model. The Black-Scholes model was used with the following assumptions: risk-free interest rates of 1.78%1.36% to 4.97%1.55%, based on the U.S. Treasury yield in effect at the time of grant; dividend yields of zero percent; expected lives of 2 to 10 years, based on historical exercise activity behavior; and volatility of 76.48%101.92% and 89.14%62.93% 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.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NineThree Months Ended September 30,March 31, 2009 and 2008 and 2007

 

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.

RevenueNet Sales Recognition.

Revenue (referred to as “net sales”)Net sales on the sales of products is 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 net sales associated with these contracts are deferred and recognized over the service period. At September 30,March 31, 2009 and March 31, 2008, and 2007, deferred revenue,net sales, mainly associated with our service contracts, included in the balance sheet in other accrued expenses, was approximately $1.6$1.4 million and $1.9$2.0 million, respectively.

RevenueNet sales from our Molecular Clinical Reference Laboratory isServices are recognized on an individual test basis and takes place when the test report is completed, reviewed and sent to the client.client less the reserve for insurance, Medicare and Medicaid expected payment. There are no deferred net sales associated with our Molecular Clinical Reference Laboratory. In our Pharmacogenomics Research Services Group, we recognize revenuenet sales based on a proportionate performance measurement for each project. At September 30,March 31, 2009 and 2008, and 2007, deferred revenuenet 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 revenuenet 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 using the local currency as the functional currency. The adjustments to translate those amounts into U.S. dollars are accumulated in a separate account in stockholders’ equity and are included in accumulated other comprehensive income. Foreign currency translationrevaluation gains or losses resulting from changes in currency exchange rates are included in the determination of net income. Foreign currency translationrevaluation adjustments from continuing operations had a nominal impact onincreased operating expenses and net loss by $0.2 million for the three months ended September 30, 2008,March 31, 2009, and decreased operating expenses and increased net lossincome by $0.5 million for the nine months ended September 30, 2008. Foreign currency translation adjustments from continuing operations decreased net loss by $0.1 million and $0.2 million during the three and nine months ended September 30, 2007, respectively.March 31, 2008.

Comprehensive Income.

Accumulated other comprehensive income at September 30, 2008March 31, 2009 and December 31, 20072008 consisted of foreign currency translation adjustments, net of applicable tax.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 is 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, 2008,March 31, 2009, there were outstanding options, warrants and conversion rights pertaining to 12,046,70411,500,720 shares of our common stock all of which were excluded from the

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NineThree Months Ended September 30,March 31, 2009 and 2008 and 2007

 

all of which were excluded from the computation of diluted earnings per share because the effect would be anti-dilutive due to the net loss from continuing operations in that period. At September 30, 2007,March 31, 2008 there were outstanding options, warrants and conversion rights pertaining to 12,201,14112,223,879 shares of our common stock all of which options to acquire 33,334 shares were excluded fromincluded in the computationcalculation of diluted earnings per share because the effect would be anti-dilutive due to the net loss from continuing operations in that period.share.

Recently Issued Accounting Pronouncements.

In September 2006, the FASB issued Statement No. 157,Fair Value Measurement (“FAS 157”). While this Statement does not require new fair value measurements, it provides guidance on applying fair value and expands required disclosures. SFASFAS 157 is effective as of January 1, 2008 for financial assets and financial liabilities within its scope and it is not expected to have a material impact on our consolidated financial statements.scope. In February 2008, the FASB issued FASB Staff Position No. FAS 157-2 “Effective Date of FASB Statement No. 157” (“FSP FAS 157-2”), which defers the effective date of SFASFAS 157 for all non-financial assets and non-financial liabilities, except those that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually), for fiscal years beginning after November 15, 2008 and interim periods within those fiscal years for items within the scope of FSP FAS 157-2. We are currently assessing the impact, if any, of SFAShave implemented FAS 157 and FSP FAS 157-2 and FSP 157-3 onwith no impact to our consolidated financial statements.

In February 2007, the FASB issued Statement No. 159,The Fair Value Option for Financial Assets and Financial Liabilities (“FAS 159”). This Statement, which is expected to expand fair value measurement, permits entities to choose to measure many financial instruments and certain other items at fair value.FAS 159 became effective for us beginning with the first quarter of 2008. We currently have no financial assets or financial liabilities for which SFAS 159 would be applicable.

In December 2007, the FASB issued SFASFAS No. 141(R) “Business Combinations” (“SFASFAS 141(R)”). SFASFAS 141(R) changes several underlying principles in applying the purchase method of accounting. Among the significant changes, SFASFAS 141(R) requires a redefining of the measurement date of a business combination, expensing direct transaction costs as incurred, capitalizing in-process research and development costs as an intangible asset and recording a liability for contingent consideration at the measurement date with subsequent re-measurements recorded in the results of operations. SFASFAS 141(R) also requires that costs for business restructuring and exit activities related to the acquired company will be included in the post-combination financial results of operations and also provides new guidance for the recognition and measurement of contingent assets and liabilities in a business combination. In addition, SFASFAS 141(R) requires several new disclosures, including the reasons for the business combination, the factors that contribute to the recognition of goodwill, the amount of acquisition related third-party expenses incurred, the nature and amount of contingent consideration, and a discussion of pre-existing relationships between the parties. SFASFAS 141(R) is effective as of January 1, 2009. We currently do not have any plans for a business combination, therefore FAS No. 141 (R) has no impact on our consolidated financial statements.

In December 2007, the FASB issued SFASFAS No. 160 “Noncontrolling Interests in Consolidated Financial Statements, an Amendment of ARB No. 51”, (“SFASFAS 160”). SFASFAS 160 establishes accounting and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. SFASFAS 160 requires noncontrolling interests in subsidiaries initially to be measured at fair value and classified as a separate component of equity. SFASFAS 160 also requires a new presentation on the face of the consolidated financial statements to separately report the amounts attributable to controlling and non-controlling interests. SFASFAS 160 iswas effective as of January 1, 2009. We currently do not expect SFAS No.have a noncontrolling interest in a subsidiary nor have we deconsolidated a subsidiary, therefore, FAS 160 to have an impact on our Consolidated Financial Statements.is not applicable at this time.

In April 2008, the FASB issued FASB Staff Position No. FAS 142-3, Determination of the Useful Life of Intangible Assets (“FSP No. FAS 142-3”). FSP No. FAS 142-3 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 as adjusted for SFASFAS No. 142’s, Goodwill and Other Intangible Assets, entity-specific factors. FSP No. FAS 142-3 is effective for fiscal years beginning after December 15, 2008 (fiscal 2010 for the Company). We are currently assessing thewas adopted on January 1, 2009 and had no impact if any, of FAS 142-3 on our consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Nine Months Ended September 30, 2008 and 2007

In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162, The Hierarchy of Generally Accepted Accounting Principles (“FAS 162”). This Standard identifiesidentified the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements of nongovernmental entities that are presented in conformity with generally accepted accounting principles. FAS 162 directs the hierarchy to the entity, rather than the independent auditors, as the entity is responsible for selecting accounting principles for financial statements that are presented in conformity with generally accepted accounting principles. The Standard isFAS 162 was effective November 15, 2008. FAS 162 is2008 and did not expected to have an impact on our financial statements.

C.DISCONTINUED OPERATIONS

In June 2008 the fourth quarter of 2005, we implemented a planFASB issued Abstract Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) is Indexed to exitan Entity’s Own Stock” (“EITF 07-5”). EITF 07-5 clarifies the Nucleic Acids operating segment. Accordingly, we now reflect the results related to this operating segment as discontinued operations for all periods presented. Expensesexceptions that are not directly identified to the Nucleic Acids operating segmentallowable under FAS 133, “Accounting for Derivative Instruments and Hedging Activities” in paragraph 11A. Under FAS 133 most derivatives are recorded as assets or that are considered corporate overhead have not been allocatedliabilities with changes in arriving at the loss from discontinued operations. Income for the nine months ended September 30, 2007 was less than $0.1 million. No income or loss has been reported in 2008.

Assets associated with the Nucleic Acids segment consisted principally of our facility in Glasgow, Scotland. During the quarter ended March 31, 2007, we completed the saletheir fair value being recorded through earnings. One of the Glasgow facility and the associated equipment for $2.9 million, netexceptions outlined in paragraph 11A of selling expenses, which resulted in a gain of $0.1 million.

The only remaining asset of the former Nucleic Acids operating segment is $0.2 million in Accounts Receivable which is fully reserved at September 30, 2008. There are no liabilities associated with the former Nucleic Acids operating segment at September 30, 2008.

D.RESTRUCTURING CHARGES

We recorded restructuring charges totaling $.7 and $1.3 million for the three and nine months ended September 30, 2007. The restructuring charges were comprised of severance totaling $0.9 million, facility closure costs totaling $0.3 million and other costs totaling $0.2 million. Restructuring charges related to three events: A restructuring plan completed in the second quarter of 2007, which resulted from the termination of four employees in Omaha, Nebraska; facility closure activities to close the Cramlington, England production facility and consolidate production in the Omaha, Nebraska facility; and facility closure activities to close an administrative office outside Paris, France, and combine those operations with those functions performed elsewhere in the organization.

Restructuring charges of less than $0.1 million during the first nine months of 2008 related to the relocation of laboratory personnel from Gaithersburg, Maryland to Omaha, Nebraska.

E.INVENTORIES

Inventories consisted of the following:

   Dollars in Thousands
   Sept. 30,
2008
  December 31,
2007

Finished goods

  $3,868  $3,123

Raw materials and work in process

   982   1,370

Demonstration inventory

   71   93
        
  $4,921  $4,586
        

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NineThree Months Ended September 30,March 31, 2009 and 2008

FAS 133 states that if a derivative is indexed to the entity’s own stock and 2007is classified in shareholder’s equity, the derivative accounting is avoided. EITF 07-5 clarifies whether or not a derivative is indexed to an entity’s own stock. EITF 07-5 was adopted on January 1, 2009. We have assessed our warrants and determined the fair value is $0 so there is no impact to our financial statements.

 

F.C.INVENTORIES

Inventories consisted of the following:

   Dollars in Thousands
   March 31,
2009
  December 31,
2008

Finished goods

  $3,131  $2,911

Raw materials and work in process

   1,683   1,658

Demonstration inventory

   33   206
        
  $4,847  $4,775
        

D.OTHER ASSETS

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

 

  Dollars in Thousands  Dollars in Thousands
  Sept. 30, 2008  December 31, 2007  March 31, 2009  December 31, 2008
  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

  $865  $750  $115  $865  $715  $150  $310  $205  $105  $310  $195  $115

Patents

   683   215   468   659   185   474   670   232   438   679   230   449

Other

   268   194   74   303   217   86   198   —     198   209   —     209
                                    

Total

  $1,816  $1,159  $657  $1,827  $1,117  $710  $1,178  $437  $741  $1,198  $425  $773
                                    

Amortization expense for intangible assets was less than $0.1 million during the three months ended September 30,March 31, 2009 and 2008, and 2007, respectively, and less than $0.1 million during the nine months ended September 30, 2008 and 2007, respectively. Amortization expense for intangible assets is expected to be less thanapproximately $0.1 million for each of the years 20082009 through 2014.2013.

 

G.E.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. The future minimum lease payments required under these leases are approximately $0.3$0.7 million for the remainder of 2008,2009, $0.9 million in 2009, $0.7 million in 2010, $0.5$0.6 million in 2011, $0.3 million in 2012, and $0.1 million thereafter. Rent expense for continuing operations related allrelating to operating leases for the three months ended September 30,March 31, 2009 and 2008 and 2007 was approximately $0.2 million and $0.3 million, respectively and for the nine months ended September 30, 2008 and 2007 was approximately $0.6 million and $0.8$0.2 million, respectively.

At September 30, 2008,March 31, 2009, firm commitments to vendors to purchase components used in WAVE Systems and instruments manufactured by others totaled $0.8$0.4 million.

 

H.F.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 2004 through2005 and 2007. We have state income tax returns subject to examination primarily for tax years 20032005 through 2007. 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 2005 through 2007. Our examination by the Internal Revenue Service for the tax year ending December 31, 2006 is now complete. There were no material adjustments found in the audit.

During the three and nine months ended September 30, 2008,March 31, 2009, there were no material changes to the liability for uncertain tax positions.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Three Months Ended March 31, 2009 and 2008

 

I.G.EMPLOYEE BENEFIT PLAN

We maintain an employee 401(k) retirement savings plan that allows for voluntary contributions into designated investment funds by eligible employees. We currently match the employees’employee’s contributions at the rate of 50% on the first 6% of contributions. The Transgenomic, Inc. Savings and Retirement Plan was modified to state that the employer may make a discretionary matching contribution equal to a uniform percentage or dollar amount of the employee’s elective payroll deferral. Each year we will determine the formula for the discretionary matching contribution. We may, at the discretion of our Board of Directors, make additional contributions on behalf of the Plan’s participants. Effective June 1, 2009, Transgenomic will not match employee 401(k) contributions. Contributions to the 401(k) plan were less than $0.1 million for each of the three months ended September 30, 2008March 31, 2009 and 2007, and $0.1 million for each of the nine months ended September 30, 2008 and 2007.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Nine Months Ended September 30, 2008 and 20072008.

 

J.H.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, 2008March 31, 2009 or 2007.2008. At September 30, 2008,March 31, 2009, there were warrants outstanding which were exercisable to purchase 8,039,6407,978,156 shares of common stock.

 

Warrant Holder

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

Various Institutional Holders (1)

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

Laurus Master Fund, Ltd. (2)

  2003  2010  200,000  $1.92  2003  2010  200,000  $1.92

Laurus Master Fund, Ltd. (2)

  2003  2010  200,000  $2.07  2003  2010  200,000  $2.07

Laurus Master Fund, Ltd. (2)

  2003  2010  150,000  $2.35  2003  2010  150,000  $2.35

Laurus Master Fund, Ltd. (2)

  2004  2011  125,000  $2.57  2004  2011  125,000  $2.57

Laurus Master Fund, Ltd. (2)

  2004  2011  400,000  $1.18  2004  2011  400,000  $1.18

TN Capital Equities, Ltd.

  2003  2008  45,918  $2.94

TN Capital Equities, Ltd.

  2004  2009  15,566  $3.18
                  

Total

      8,039,640        7,978,156  
                  

 

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

Preferred Stock.

K.STOCK OPTIONS

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 table summarizeswith respect to shares of such class or 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 option activity duringmay be issued with a preference over the nine months ended September 30, 2008:

   Number of
Options
  Weighted Average
Exercise Price

Balance at January 1, 2008:

  4,535,064  $3.26

Granted

  205,000   .73

Exercised

  —     —  

Forfeited/Expired

  (733,000)  3.93
     

Balance at September 30, 2008:

  4,007,064  $2.97
     

Exercisable at September 30, 2008:

  2,708,702  $4.07
     

Duringcommon stock as to the nine months ended September 30, 2008, we granted 205,000payment of dividends. The Company has no current plans to issue any series of preferred stock. Classes of stock options atsuch 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 weighted average exercise pricemerger or otherwise to gain control of $0.73 under our 2006 Equity Incentive Plan. The weighted average grant date fair value per sharethe Company. For the foregoing reasons, any preferred stock issued by the Company could have an adverse effect on the rights of options granted during the nine months ended September 30, 2008 was $0.60.holders of the common stock.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

NineThree Months Ended September 30,March 31, 2009 and 2008 and 2007

 

L.I.STOCK OPTIONS

The following table summarizes stock option activity during the three months ended March 31, 2009:

   Number of
Options
  Weighted Average
Exercise Price

Balance at January 1, 2009:

  3,531,064  $2.54

Granted

  25,000   .36

Exercised

  —     —  

Forfeited/Expired

  33,500   1.53
       

Balance at March 31, 2009:

  3,522,564  $2.53
       

Exercisable at March 31, 2009:

  2,399,370  $3.42
       

During the three months ended March 31, 2009, we granted 25,000 stock options at a weighted average exercise price of $0.36 under our 2006 Equity Incentive Plan. The weighted average fair value per share on grant date of options granted during the three months ended March 31, 2009 was $0.28.

J.OPERATING SEGMENT AND GEOGRAPHIC INFORMATION

Our company’s chief decision-maker as defined in FAS 131, Disclosures about Segments of an Enterprise and Related Information, is the Chief Executive Officer, who regularly evaluates our performance based on net sales and gross profit. The preparation of this segment analysis required 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 onetwo reportable operating segment. Although net sales are analyzed by type, net financial results are analyzedsegments.

Segment information for the three months ended March 31, 2009 and 2008 is as one segment due to the integrated nature of the products. follows:

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

Net Sales

  $3,733  $1,256  $4,989  $5,281  $973  $6,254

Gross Profit

   2,202   611   2,813   3,250   390   3,640

Net Income/(Loss) before Taxes

   (433)  (561)  (994)  327   (201)  125

Income Tax Expense (Benefit)

   (41)  —     (41)  3   —     3
                        

Net Income/(Loss)

  $(392) $(561) $(953) $324  $(201) $122
                        

Depreciation/Amortization

   130   60   190   139   51   190

Interest Income, Net

   9   3   12   28   5   33

   3/31/2009  12/31/08

Total Assets

  $9,682  $7,125  $16,807  $10,226  $7,330  $17,556

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Three Months Ended March 31, 2009 and 2008

Net sales by product were as follows:

 

  Dollars in Thousands  Dollars in Thousands  Dollars in Thousands
  Three Months Ended
Sept. 30,
  Nine Months Ended
Sept. 30,
  Three Months Ended
March 31,
  2008  2007  2008  2007  2009  2008

Instrument Related Business:

            

Bioinstruments

  $2,196  $2,371  $7,987  $8,377  $1,912  $3,028

Bioconsumables

   2,199   2,113   6,920   6,561   1,821   2,253
      
               3,733  $5,281
   4,395  $4,484   14,907  $14,938

Laboratory Services:

            

Molecular Clinical Reference Laboratory

   736   443   1,950   1,259   953   506

Pharmacogenomics Research Services

   236   224   1,012   448   303   467
                  
   972   667   2,962   1,707   1,256   973
                  

Total Net Sales

  $5,367  $5,151  $17,869  $16,645  $4,989  $6,254
                  

Net cost of goods sold was as follows:

 

  Dollars in Thousands  Dollars in Thousands
  Three Months Ended
Sept. 30,
  Nine Months Ended
Sept. 30,
  Three Months Ended
March 31,
  2008  2007  2008  2007  2009  2008

Instrument Related Business:

            

Bioinstruments

  $767  $783  $2,710  $3,142  $658  $1,029

Bioconsumables

   1,097   1,119   3,133   3,197   873   1,002
      
              $1,531  $2,031
  $1,864  $1,902  $5,843  $6,339

Laboratory Services:

            

Molecular Clinical Reference Laboratory

   429   285   1,196   856   486   347

Pharmacogenomics Research Services

   155   313   531   677   159   236
                  
   584   598   1,727   1,533   645   583
                  

Total Cost of Goods Sold

  $2,448  $2,500  $7,570  $7,872  $2,176  $2,614
                  

Net sales for the three months ended March 31, 2009 by geographic regioncountry were as follows:

 

   Dollars in Thousands
   Three Months Ended
Sept. 30,
  Nine Months Ended
Sept. 30,
   2008  2007  2008  2007

United States

  $2,180  $2,005  $7,044  $5,663

Europe

   2,491   2,216   9,653   8,865

Pacific Rim

   191   381   618   1,022

Other

   505   549   554   1,095
                

Total Net Sales by Geographic Region

  $5,367  $5,151  $17,869  $16,645
                
   3/31/2009
(Dollars in Thousands)
  

United States

  $2,183

Italy

   841

China

   309

Germany

   293

France

   283

United Kingdom

   242

All Other Countries

   838
    

Total

  $4,989
    

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, 2008March 31, 2009 and 2007.2008. For the ninethree months ended September 30, 2008 two customers eachMarch 31, 2009 one customer made up more than 10% of the Laboratory Services net sales. Combined they represent 35%This customer represented 17% of the Laboratory Services net sales.

Substantially all80% of theour long-lived assets are within the United States. Substantially all of the remaining long-lived assets are within Europe.

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

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 1,4251,450 WAVE Systems as of September 30, 2008.March 31, 2009. 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 system’s continued operation.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 Laboratorymolecular 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.

 

Pharmacogenomics Research Services. Pharmacogenomics Research Services is aresearch 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.

Historically, we operated a segment (the “Nucleic Acids operating segment”) that developed, manufactured and marketed chemical building blocks for nucleic acid synthesis. In the fourth quarter of 2005, we implemented a plan to exit the Nucleic Acids operating segment and during the three months ended March 31, 2007, we completed the sale of the remaining assets associated with this segment. Accordingly, the assets and results of the Nucleic Acids operating segment are reflected as discontinued operations for all periods presented in this filing.

Executive Summary

Net sales for the nine months ended September 30, 2008 increased by $1.2 million or 7% compared to the same period in 2007. Net sales from bioinstruments were down 5% and net sales of consumables were up 5% for the comparable nine month periods. During the nine months ended September 30, 2008, net sales from Laboratory Services grew 74%, or $1.3 million, compared to the same nine month period in 2007. The Clinical Reference Laboratory showed growth of 55% and Pharmacogenomics Research Services grew by 126%. Gross margins improved year over year. Our gross profit margin improved from 53% for the nine months ended September 30, 2007 to 58% for the same period in 2008. The largest contributor to our improved gross margin was our Laboratory Services product line which went from 10% gross profit in the nine months ended September 30, 2007 to 42% for the same period in 2008. Net loss was $0.3 million for the nine months ended September 30, 2008 compared to a net loss of $2.3 million for the nine months ended September 30, 2007.

Net sales for the three months ended September 30, 2008 were upMarch 31, 2009 decreased by 4%$1.3 million or $0.2 million,20% compared to the same period in 2007. For2008. Net sales in our Instrument Related Business were down 29% or $1.5 million for the third quarter of 2008 netthree months ended March 31, 2009 compared to the same period in 2008. Net sales from bioinstruments were down 7%, while37% and net sales of consumables were up 4% compared todown 19% for the third quarter of 2007. Netcomparable three month periods. During the three months ended March 31, 2009, net sales from Laboratory Services grew 46%29%, or $0.3 million, compared to the same quarterthree month period in 2007.2008. The Molecular Clinical Reference Laboratory showed revenue growth of $0.3 million or 66%88% and net sales from Pharmacogenomics Research Services was flat. Gross margins improved year over year.decreased by 35%. Our gross profit margin decreased from 58% for the three months ended March 31, 2008 to 56% for the same period in 2009. Laboratory Services gross margin improved from 51%40% gross profit in the third quarter of 2007three months ended March 31, 2008 to 54%49% for the same period in the quarter ended September 30, 2008. The largest contributor to this increase is our Laboratory Services product line which went from a gross profit of 10% in the third quarter of 2007 to a gross profit margin of 40% in the quarter ended September 30, 2008.2009. Net loss was $0.5 million for the quarter ended September 30, 2008 compared to a net loss of $1.3$1.0 million for the three months ended September 30, 2007. March 31, 2009 compared to net income of $0.1 million for the three months ended March 31, 2008.

As of September 30, 2008,March 31, 2009, we had cash and cash equivalents of $4.8 million.

Outlook

We continue to work toward our objective of generating income from continuing operations and positive cash flows from continuing operations. To accomplish these goals, we must generate sequential growth in net sales and continue to control manufacturing and other operating expenses. We are investingAs a result of the current economic outlook in 2009 and our businessfirst quarter sales performance, we initiated a cost cutting initiative in April 2009. This was necessary to drive improved salesensure that we remain financially strong and try to maintain cash in 20082009. The cost cutting initiative included a reduction in force, a freeze on new hires and have added experienced sales staff. We continue to work on developmentbackfills, no merits or other bonuses, effective June 1, 2009 there will be no 401(k) company match, reduction in travel and elimination of collaborative opportunities for our Molecular Clinical Reference Laboratory and Pharmacogenomics Research Services business. In addition, during 2008 we have strengthened our Board of Directors, added key senior management and formed a Scientific Advisory Board to advise us on the latest developments and scientific opportunities in cancer detection screening and mitochondrial disease diagnosis.investor relations firm.

Uncertainties

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

* We may not have adequate financial resources to execute our business plan.

We have historically operated at a loss until recently and have 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 additional equity, we may not be able to obtain such funding due to the tightened credit markets. At September 30, 2008March 31, 2009 we had cash and cash equivalents of $4.8 million. We believe that existing sources of liquidity are sufficient to meet expected cash needs intoduring 2009.

* Markets for our instrument related products may develop slowly.

There are many factors that affect the market demand for our products and services that we cannot control. Demand for our instrument related businessInstrument 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.

Results of Continuing Operations

Three Months Ended September 30,March 31, 2009 and 2008 and 2007

Net Sales.Net sales consisted of the following:

 

  Dollars in Thousands   Dollars in Thousands 
  Three Months Ended
Sept. 30,
  Change   Three Months Ended
March 31,
  Change 
  2008  2007  $ %   2009  2008  $ % 

Instrument Related Business:

              

Bioinstruments

  $2,196  $2,371  $(175) (7)%  $1,912  $3,028  $(1,116) (37)%

Bioconsumables

   2,199   2,113   86  4%   1,821   2,253   (432) (19)%
                          
   4,395   4,484   (89) (2)%   3,733   5,281   (1,548) (29)%

Laboratory Services:

              

Molecular Clinical Reference Laboratory

   736   443   293  66%   953   506   447  88%

Pharmacogenomics Research Services

   236   224   12  5%   303   467   (164) (35)%
                          
   972   667   305  46%   1,256   973   283  29%
                          

Total Net sales

  $5,367  $5,151  $216  4%  $4,989  $6,254  $(1,265) (20)%
                          

The bioinstrumentBioinstrument sales consist of sales of our WAVE System and associated equipment that we manufacture or assemble, net sales decreasefrom service contracts that we enter into with purchasers of 7% was due to fewerour instruments, as well as sales of instruments we distribute for other manufacturers (“OEM equipment”). We also sell refurbished WAVE Systems being sold. Two WAVE Systems were soldin order to access customers that may not be able to afford new systems. Bioinstrument net sales are down $1.1 million, or 37%, during the three months ended September 30, 2008,March 31, 2009 as compared to fourteen during the same period of 2007.in 2008. The averagedecrease in bioinstrument net sales price of the WAVE’s increasedwas due to the fact that both sales were in our European market. WAVE sales in 2007 include sales of refurbished WAVEs. There were three OEM instrument sales in the third quarter of 2008. In 2007 there were nofewer OEM instruments sold in the third quarter. We continuefirst quarter of 2009. There was only one sold in 2009 and at a lower average sales price than the four in 2008. This accounted for the majority of the decrease. In addition, we sold two fewer WAVE instruments in the first quarter 2009 as compared to face2008, and the average sales price was lower due to the geographic make up of the sales. The foreign currency conversion rate difference between 2009 and 2008 impacted the average net sales price on our European sales. This decrease resulted from lower demand in all major geographic markets and among both research and diagnostic users particularly in our largest markets. Demand for WAVE Systems has been affected by significant competitive challenges for our instrument sales from traditional (i.e. sequencing) and evolving technologies. During the third quarter of 2008, net

Net sales of consumables related to our WAVE Systems and other third-party instruments increased 4%bioconsumables decreased during the three months ended March 31, 2009 compared to 2008. The primary decrease in consumables is due to the same quarter in 2007. The largest growth in netnegative impact of the foreign currency exchange rates, primarily the Great British Pound to the US Dollar.

Net sales was from ourof Laboratory Services group. The 46% increase was attributableincreased during the three months ended March 31, 2009 compared to growth in our2008 by approximately $0.3 million. 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 66% or $0.3 million. Pharmacogenomics research services was flat compared$1.0 million increased 88% over the three months ended March 31, 2008. The Molecular Clinical Reference Laboratory Services net sales growth is attributable to the sameincreased sales focus. We increased the number of sales employees during 2008. The Pharmacogenomics Research Services net sales of $0.3 million during the three months ended March 31, 2009 decreased 35% from the 3 months ended March 31, 2008. The decrease in Pharmacogenomics Research Services is due to one large customer in the first quarter in 2007.of 2008 which has completed their project. The Pharmacogenomics Research Services net sales has peaks due to the nature of project related business.

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
Sept. 30,
  Change   Three Months Ended
March 31,
  Change 
  2008  2007  $ %   2009  2008  $ % 

Instrument Related Business:

              

Bioinstruments

  $767  $783  $(16) (2)%  $658  $1,029  $(371) (36)%

Bioconsumables

   1,097   1,119   (22) (2)%   873   1,002   (129) (13)%
                          
   1,864   1,902   (38) (2)%   1,531   2,031   (500) (25)%

Laboratory Services:

              

Molecular Clinical Reference Laboratory

   429   285   144  51%   486   347   139  40%

Pharmacogenomics Research Services

   155   313   (158) (50)%   159   236   (77) (33)%
                          
   584   598   (14) (2)%   645   583   62  11%
                          

Cost of goods sold

  $2,448  $2,500  $(52) (2)%  $2,176  $2,614  $(438) (17)%
                          

Gross profit was $2.9$2.8 million or 54%56% of total net sales during the three months ended September 30, 2008,first quarter of 2009, compared to $2.7$3.6 million or 51%58% during the same period of 2007. Gross profit as2008. Cost of sales for the Instrument Related Business decreased by only 25% for the first quarter of 2009 compared to the same period of 2008 on a percentage of net sales increaseddecrease of 29%. This reflects a largely fixed expense base. This is primarily due to fewer instruments sold during the leverage related toquarter. The Laboratory Services revenue increased 29% for the first quarter of 2009 over the first quarter of 2008, while cost of goods sold increased only 11%. During the three months ended March 31, 2009, the gross margin for the Laboratory Services net sales. The reductionwas 49% as compared to 40% in manufacturing costs is attributable to our restructuring plan which was executed in 2007.the same period of 2008. Laboratory Services costs have a large fixed component, so increases in net sales drive gross profit improvement. The Laboratory Services revenue increased 46% for the third quarter of 2008 over the third quarter of 2007, while there was a decrease in cost of goods sold of 2%. During the 3 months ended September 30, 2008, the gross margin for the Laboratory Services was 40% as comparedcontinue to 10% in the same period of 2007.

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. For the third quarter of 2008 these costs increased by $0.1 million compared to the same period of 2007. The increase is due to the additions of executive staff, sales team and the Scientific Advisory Board.

Research and Development Expenses.Research and development expenses primarily include personnel costs, outside services, collaboration expenses, supplies, and facility costs and are expensed in the period in which they are incurred. For the third quarter of 2008 these costs remained flat compared to the same period of 2007. They totaled $0.7 million during the three months ended September 30, 2008 and September 30, 2007.

Research and development expenses totaled 13% and 14% of net sales during the three months ended September 30, 2008 and 2007, respectively.

Other Income (Expense).Other income consists primarily of interest income from cash and cash equivalents invested in overnight instruments. Other income during the three months ended September 30, 2008 was less than $0.1 million as compared to $0.1 million for the three months ended September 30, 2007.

Income Tax Expense.In July 2006, the FASB issued Interpretation No. 48,Accounting for Uncertainty in Income Taxes(“FIN 48”). FIN 48 applies to all tax positions within the scope of Statement 109 and clarifies when and how to recognize tax benefits in the financial statements with a two-step approach of recognition and measurement. We adopted FIN 48 on January 1, 2007. Under FIN 48, tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is more likely than not to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in our tax returns that do not meet these recognition and measurement standards.

Nine Months Ended Sept. 30, 2008 and 2007

Net Sales. Net sales consisted of the following:

   Dollars in Thousands 
   Nine Months Ended
Sept. 30,
  Change 
   2008  2007  $  % 

Instrument Related Business:

       

Bioinstruments

  $7,987  $8,377  $(390) (5)%

Bioconsumables:

   6,920   6,561   359  5%
                
   14,907   14,938   (31) 0%

Laboratory Services:

       

Molecular Clinical Reference Laboratory

   1,950   1,259   691  55%

Pharmacogenomics Research Services

   1,012   448   564  126%
                
   2,962   1,707   1,255  74%
                

Net Sales

  $17,869  $16,645  $1,224  7%
                

The net sales of bioinstruments decreased 5% or $0.4 million compared to the same period in 2007. Sixteen WAVE Systems were sold during the nine months ended September 30, 2008, compared to forty-four in the nine months ended September 30, 2007. Offsetting this decline was an increase in the average sales price of WAVE instruments which was 70% higher in 2008 due to geographic mix and type of instrument mix. WAVE sales in each nine month period include sales of refurbished WAVEs. This decrease in instruments sold resulted from lower demand in all major geographic markets and among both research and diagnostic users, particularly in our largest markets throughout Western Europe. There are significant competitive challenges from traditional (i.e. sequencing) and evolving technologies. There were ten OEM instruments sold during the nine months ended September 30, 2008 compared to three during the same period in 2007. In the nine months ended September 30, 2008, net sales of consumables related to our WAVE Systems and other third-party instruments increased over the same period in 2007 due to slight growth primarily in our international business. The largest growth, an increase of 74%, was in Laboratory Services. Net sales from the Clinical Reference Laboratory increased 55% or $0.7 million over the same period in 2007. Net sales from Pharmacogenomics Services increased 126% or $0.6 million over the nine months ended September 30, 2007.

Cost of Goods Sold.Cost 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 discovery services operations. Cost of goods sold consisted of the following:

   Dollars in Thousands 
   Nine Months Ended
Sept. 30,
  Change 
   2008  2007  $  % 

Instrument Related Business:

       

Bioinstruments

  $2,710  $3,142  $(432) (14)%

Bioconsumables

   3,133   3,197   (64) (2)%
                
   5,843   6,339   (496) (8)%

Laboratory Services:

       

Molecular Clinical Reference Laboratory

   1,196   856   340  40%

Pharmacogenomics Research Services

   531   677   (146) (22)%
                
   1,727   1,533   194  13%
                

Cost of Goods Sold

  $7,570  $7,872  $(302) (4)%
                

Gross profit was $10.3 million or 58% of total net sales during the nine months ended September 30, 2008 compared to $8.8 million or 53% during the same period of 2007. Gross profits as a percentage of net sales increased due to lower manufacturing costs and the leverage related to the Laboratory Services net sales. The reduction in manufacturing costs is attributable to our restructuring plan which was implemented in 2007. Laboratory Services costs have a large fixed component, so increases in net sales drive gross profit improvement.

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. These costs totaled $8.8In addition, foreign currency revaluation is included here. Excluding foreign currency revaluation gains or losses, which were a loss of $0.2 million duringin the ninethree months ended September 30, 2008, compared to $8.7March 31, 2009 and a gain of $0.2 million duringin the same period of 2007. Foreign currency translation adjustments decreased2008, our selling, general and administrative expenses by $0.5costs decreased from $3.1 million in the period ending September 30, 2008. This offset the increase in selling, general and administrative expensesto $2.7 million. The primary decrease is due to the additions of executive staff, sales teamno bonus accrual, open positions not filled, lower travel and the Scientific Advisory Board.lower 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. TheseFor the first quarter of 2009 these costs totaled $1.8$0.8 million duringcompared to $0.6 million for the ninethree months ended September 30, 2008, compared to $2.3 million during the same period of 2007, a decrease of $0.5 million. Such costs for the nine month period ended September 30, 2007 were higherMarch 31, 2008. The increase is primarily due to collaboration expense on new WAVE applicationswith Power3 for their NuroPro assay development related to the diagnosis of Alzheimer’s and patent costs for Laboratory Services.Parkinsons’ diseases.

Research and development expenses totaled 10%17% and 14%9% of net sales during the ninethree months ended September 30,March 31, 2009 and 2008, and 2007, respectively.

Restructuring Charges.Restructuring charges in 2007 consisted of costs related to a reduction in work force at our Omaha, Nebraska facility, activities to close a production facility in Cramlington, England, and activities to close an administrative office outside of Paris, France. Restructuring charges during the nine months of 2008 related to the relocation of laboratory personnel from Gaithersburg, Maryland to Omaha, Nebraska.

Other Income (Expense).Other income during the nine month periods ended September 30, 2008 and September 30, 2007 was less than $0.1 million and $1.1 million, respectively. The decrease was attributable to the sale of an investment in equity securities. On May 10, 2007, the Company sold 250,000 shares of stock in Pinnacle Pharmaceuticals, Inc. at a price of $3.75 per share. Gross proceeds realized from the sale were $.9 which resulted in a gain of $.9 and is reflected in other income during the period. Remaining other income consistedconsists primarily of interest income from cash and cash equivalents invested in overnight instruments. Other income during the three months ended March 31, 2009 and March 31, 2008 was less than $0.1 million for each period.

Income Tax Expense.Expense (Benefit).In July 2006, Income tax benefit for the three months ended March 31, 2009 was a benefit of less than $0.1 million. This is 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. This tax benefit is partially offset by tax expense related to state and franchise taxes as well as reserves for uncertain income taxes, recorded in accordance with FASB issued Interpretation No. 48,Accounting for Uncertainty in Income Taxes(“ (“FIN 48”48’). FIN 48 appliesWe believe the tax benefit recorded will be offset in future periods by a tax expense, related to all tax positions within the scope of Statement 109 and clarifies when and how to recognize tax benefitsincome reported in the financial statements with a two-step approach of recognition and measurement. We adopted FIN 48 on January 1, 2007. Under FIN 48,subsidiaries outside the U.S Income tax benefits are recognized onlyexpense for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is more likely than not to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in our tax returns that do not meet these recognition and measurement standards.

Results of Discontinued Operations

In the fourth quarter of 2005, we implemented a plan to exit the Nucleic Acids operating segment. Accordingly, we now reflect the related results as discontinued operations for all periods presented. Expenses that were not directly identified to the Nucleic Acids operating segment or that were considered corporate overhead were not allocated in arriving at the loss from discontinued operations. 2008 results have no impact from these discontinued operations. For the three months ended September 30, 2007, thereMarch 31, 2008 was a loss from discontinued operations of $0 and for the nine months ended September 30, 2007 there was a gain ofless than $0.1 million.

The only remaining asset of the former Nucleic Acids operating segment is $0.2 million in Accounts Receivable which is fully reserved at September 30, 2008. There are no liabilities at September 30, 2008 associated with this discontinued operating segment..

Liquidity and Capital Resources

Our working capital positions at September 30, 2008March 31, 2009 and December 31, 20072008 were as follows:

 

  Dollars in Thousands   Dollars in Thousands 
  Sept. 30,
2008
  December 31,
2007
  Change   March 31,
2009
  December 31,
2008
  Change 

Current assets (including cash and cash equivalents of $4,787 and $5,723, respectively)

  $15,379  $16,163  $(784)

Current assets (including cash and cash equivalents of $4,845 and $4,771, respectively)

  $14,804  $15,585  $(781)

Current liabilities

   4,094   4,847   (753)   4,431   4,235   196 
                    

Working capital

  $11,285  $11,316  $(31)  $10,373  $11,350  $(977)
                    

The working capital decrease is primarily a result of lower accounts receivable of $1.0 million at March 31, 2009 compared to December 31, 2008.

Management believes existing sources of liquidity, including cash and cash equivalents of $4.8 million, are sufficient to meet expected cash needs intoduring 2009. We have added experienced sales staff in our business in an effort to drive improved sales intoin 2009. WeAs a result of the current economic outlook in 2009 we cannot assure you that we will be able to increasemaintain our net sales or further reduce our expenses and, accordingly, we may not have sufficient sources of liquidity to continue 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

NineThree Months Ended Sept. 30,March 31, 2009 and 2008 and 2007

Net Change in Cash and Cash Equivalents.Cash and cash equivalents decreasedincreased by $0.9$0.1 million during both of the ninethree months ended September 30, 2008 compared to an increase of $0.7 million during the nine months ended September 30, 2007.March 31, 2009 and March 31, 2008. In 20082009 net cash usedprovided by operating activities was $0.5$0.3 million andoffset by $0.2 million of net cash flow used in investing activities was $0.3 million (largely purchases of property and equipment). Thewith minimal impact of foreign currency exchange rates was a use of cash of $0.2 million in 2008. The 2007 increase was the result ofrates. In 2008 net cash provided by investing activities of $3.3 million, offset by net cash used by operating activities of $2.6 million. These were minimallywas $0.2 million which was largely offset by the net cash flow used in investing activities with a minimal impact of foreign currency exchange rates.

Cash Flows fromProvided by Operating Activities. Cash flows used inprovided by operating activities totaled $0.5$0.3 million during the ninethree months ended September 30, 2008,March 31, 2009, compared to cash flows used inprovided by operating activities of $2.7$0.2 million during the same period of 2007.2008. The cash flows used inprovided by operating activities in 20082009 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 and accrued expenses decreased by $0.3 million. The use of cash flows in 2007 related primarily to the net loss of $2.3 million and the higher inventory levels of $1.8 million related primarily to the OEM instruments. This was offset by accounts receivable collections of $1.0 million and decreasedaccounts payable increase of $0.3 million offset by the loss of $1.0 million. The cash flows provided in 2008 related to the net income of $0.1 million. In addition, the increase in accounts receivable of $1.3 million was offset by the decrease in accrued expenses of $0.6 million.and compensation.

Cash Flows fromUsed In Investing Activities. Cash flows used in investing activities totaled $0.3$0.2 million during the ninethree months ended September 30, 2008March 31, 2009 compared to cash flows provided byused in investing activities of $3.3$0.1 million during the same period of 2007.2008. Cash flows used in investing activities in 2009 and 2008 consisted primarily of purchases of property and equipment. Cash flows provided by investing activities in 2007 consisted primarily of sales proceeds from our Glasgow facility and equipment of $2.9 million and sales proceeds of an investment in equity securities of $0.9 million. These proceeds were offset by the purchases of property and equipment.

Off-Balance Sheet Arrangements

At September 30, 2008March 31, 2009 and December 31, 2007,2008, 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, 2007.2008.

Recently Issued Accounting Pronouncements

Please refer to our annual report on Form 10-K for the fiscal year ended December 31, 2007.2008. 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 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, our wholly owned subsidiary, Transgenomic Limited, operating currency is British Pounds. 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. As a result we are subject to exchange rate risk. The foreign exchange rates have had large variances during 2008. At January 1, 2008 the Euro to Great British Pound exchange rate was .73650 as compared to March 31, 2009 rate of .9296. The Great British Pound to US Dollar exchange rate was 1.9970 at January 1, 2008 compared to 1.42140 at March 31, 2009. This is a decrease of 29%. 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 evaluated the design and operating effectiveness of our disclosure controls and procedures as of September 30, 2008March 31, 2009 pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, because 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, 2007,2008, our disclosure controls and procedures as defined in Rule 13a-15(e) continued to not be 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, 2008,March 31, 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 have been no changes 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 of 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

There have been no material changes in our risk factors from those described in Item 1A of our annual report on Form 10-K for the fiscal year ended December 31, 2007, other than the2008. The uncertainty of the current general economic conditions continues to be a significant risk and could negatively impact our business in the future.

 

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)
10.1 Employment Agreement Extension between the Company and Craig Tuttle dated July 12, 2008 (incorporated by reference to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on July 16, 2008)
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: October 30, 2008May 14, 2009 By: 

/s/ CRAIG J. TUTTLE

  Craig J. Tuttle
  President and Chief Executive Officer

 

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