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 JuneSeptember 30, 2005

 

Or

 

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

 

For the transition period from            to            

 

Commission file number: 000-30975

 


 

TRANSGENOMIC, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware 911789357

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

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

 

(402) 452-5400

(Registrant’s telephone number, including area code)

 


 

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

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of 1934)    Yes  ¨    No  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)    Yes  ¨    No  x

As of August 15,November 14, 2005, the number of shares of common stock outstanding was 34,241,281.49,172,079.

 



TRANSGENOMIC INC.

 

INDEX

 

    Page No.

PART I.

 FINANCIAL INFORMATION 1

Item 1.

 

Financial Statements

1
Unaudited Condensed Consolidated Balance Sheets as of September 30, 2005 and December 31, 2004 1
  

Unaudited Consolidated Balance Sheets as of June 30, 2005 and December 31, 2004

1

UnauditedCondensed Consolidated Statements of Operations for the Three and SixNine Months Ended JuneSeptember 30, 2005 and 2004

 2
  

Unaudited Condensed Consolidated Statements of Cash Flows for the SixNine Months Ended JuneSeptember 30, 2005 and 2004

 3
  

Notes to Unaudited Condensed Consolidated Financial Statements

 4

Item 2.

 

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

 1315

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 2426

Item 4.

 

Controls and Procedures

 2426

PART II.

 

OTHER INFORMATION

 26

Item 1.

 

Legal Proceedings

 2426

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 2526

Item 6.

 

Exhibits

 2527

Signatures

 2628


TRANSGENOMIC INC.

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

(Dollars in thousands except per share data)

 

  

June 30,

2005


 December 31,
2004


   September 30,
2005


 December 31,
2004


 
ASSETS        

CURRENT ASSETS:

      

Cash and cash equivalents

  $1,714  $1,002   $1,361  $1,002 

Accounts receivable (net of allowances for bad debts of $998 and $1,051, respectively)

   8,682   10,197 

Short-term investments

   1,556   —   

Accounts receivable (net of allowances for bad debts of $896 and $1,051, respectively)

   8,729   10,197 

Inventories

   4,585   5,366    4,101   5,366 

Prepaid expenses and other current assets

   912   1,343    652   1,343 
  


 


  


 


Total current assets

   15,893   17,908    16,399   17,908 
  


 


  


 


PROPERTY AND EQUIPMENT:

      

Land and buildings

   2,274   2,427    2,221   2,427 

Equipment

   18,528   19,263    18,066   19,263 

Furniture and fixtures

   5,876   5,781    5,833   5,781 
  


 


  


 


   26,678   27,471    26,120   27,471 

Less: accumulated depreciation

   14,941   13,946    15,509   13,946 
  


 


  


 


   11,737   13,525    10,611   13,525 

GOODWILL

   638   638    638   638 

OTHER ASSETS

   4,697   5,387    4,141   5,387 
  


 


  


 


  $32,965  $37,458   $31,789  $37,458 
  


 


  


 


LIABILITIES AND STOCKHOLDERS’ EQUITY        

CURRENT LIABILITIES:

      

Accounts payable

  $2,501  $3,431   $2,463  $3,431 

Accrued expenses

   5,430   7,318    4,383   7,318 

Accrued compensation

   761   636    530   636 

Line of credit

   6,570   6,514    6,935   6,514 

Current portion of long-term debt

   450   825    675   825 
  


 


  


 


Total current liabilities

   15,712   18,724    14,986   18,724 

Long-term debt

   1,494   2,199    1,226   2,199 
  


 


  


 


Total liabilities

   17,206   20,923    16,212   20,923 
  


 


  


 


COMMITMENTS AND CONTINGENCIES (Note F)

      

STOCKHOLDERS’ EQUITY:

      

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

   —     —      —     —   

Common stock, $.01 par value, 60,000,000 shares authorized, 34,241,281 and 29,330,874 shares outstanding, respectively

   348   299 

Common stock, $.01 par value, 60,000,000 shares authorized, 34,246,336 and 29,330,874 shares outstanding, respectively

   348   299 

Additional paid-in capital

   124,993   120,798    125,058   120,798 

Accumulated other comprehensive income

   1,409   2,539    1,051   2,539 

Accumulated deficit

   (110,991)  (107,101)   (110,880)  (107,101)
  


 


  


 


Total stockholders’ equity

   15,759   16,535    15,577   16,535 
  


 


  


 


  $32,965  $37,458   $31789  $37,458 
  


 


  


 


 

See notes to consolidated financial statements.

TRANSGENOMIC INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Dollars in thousands except per share data)

 

  

Three Months Ended

June 30,


 

Six Months Ended

June 30,


   Three Months Ended
September 30,


 Nine Months Ended
September 30,


 
  2005

 2004

 2005

 2004

   2005

 2004

 2005

 2004

 

Net sales

  $7,633  $9,011  $15,005  $17,640   $8,706  $8,194  $23,711  $25,834 

Cost of goods sold

   4,450   5,858   8,848   11,627    4,761   6,857   13,609   18,484 
  


 


 


 


  


 


 


 


Gross profit

   3,183   3,153   6,157   6,013    3,945   1,337   10,102   7,350 

Operating expenses:

      

Selling, general and administrative

   3,537   4,268   7,138   8,513    2,885   4,353   10,023   12,866 

Research and development

   581   1,672   1,186   3,601    510   1,743   1,696   5,344 

Impairment charges (Note C)

   —     11,964   —     11,964 

Impairment charges (Notes C and D)

   247   —     247   11,964 
  


 


 


 


  


 


 


 


   4,118   17,904   8,324   24,078    3,642   6,096   11,966   30,174 

Loss from operations

   (935)  (14,751)  (2,167)  (18,065)
  


 


 


 


Income (Loss) from operations

   303   (4,759)  (1,864)  (22,824)

Other income (expense):

      

Interest expense (Note E)

   (83)  (346)  (1,738)  (935)   (181)  (723)  (1,919)  (1,684)

Loss on debt extinguishment

   —     (2,859)  —     (2,859)

Other income (expense), net

   34   (33)  34   (87)   (3)  (100)  31   (161)
  


 


 


 


  


 


 


 


   (49)  (379)  (1,704)  (1,022)   (184)  (3,682)  (1,888)  (4,704)

Loss before income taxes

   (984)  (15,130)  (3,871)  (19,087)
  


 


 


 


Income(loss) before income taxes

   119   (8,441)  (3,752)  (27,528)

Current income tax expense (benefit)

   14   2   19   (95)   8   1   27   (94)
  


 


 


 


  


 


 


 


Net loss

  $(998) $(15,132) $(3,890) $(18,992)

Net income (loss)

  $111  $(8,442) $(3,779) $(27,434)
  


 


 


 


  


 


 


 


Basic and diluted weighted average shares outstanding

   34,237,042   29,053,226   32,122,502   28,887,334    34,242,966   29,077,789   32,837,078   28,951,230 

Net loss per common share—basic and diluted

  $(0.03) $(0.52) $(0.12) $(0.66)

Net income (loss) per common share—basic and diluted

  $0.00  $(0.29) $(0.12) $(0.95)

 

See notes to consolidated financial statements.

TRANSGENOMIC INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

(Dollars in thousands except per share data)

 

  Six Months Ended June 30,

   

Nine Months Ended

September 30,


 
  2005

 2004

   2005

 2004

 

CASH FLOWS FROM OPERATING ACTIVITIES:

      

Net loss

  $(3,890) $(18,992)  $(3,779) $(27,434)

Adjustments to reconcile net loss to net cash flows from operating activities:

      

Depreciation and amortization

   2,101   2,410    3,294   3,607 

Impairment charges

   —     11,964    247   11,964 

Loss on debt extinguishment

   —     2,859 

Non-cash financing costs

   1,434   622    1,298   759 

(Gain)/Loss on sale of securities

   (9)  27    (9)  370 

Other

   2   —      2   12 

Changes in operating assets and liabilities:

      

Accounts receivable

   1,241   (1,926)   (626)  (2,469)

Inventories

   611   (422)   960   819 

Prepaid expenses and other current assets

   399   (362)   650   (69)

Accounts payable

   (841)  61    (912)  100 

Accrued expenses

   (2,220)  (334)   (3,101)  774 
  


 


  


 


Net cash flows from operating activities

   (1,172)  (6,952)   (1,976)  (8,708)

CASH FLOWS FROM INVESTING ACTIVITIES:

      

Proceeds from the maturities and sale of available for sale securities

   617   932    617   2,768 

Purchase of property and equipment

   (671)  (1,133)   (554)  (1,250)

Proceeds from sales of property and equipment

   139   —      139   —   

Change in other assets

   (1)  (1)   34   26 
  


 


  


 


Net cash flows from investing activities

   84   (202)   236   1,544 

CASH FLOWS FROM FINANCING ACTIVITIES:

      

Advances on line of credit

   10,790   14,600    15,367   19,691 

Payments on line of credit

   (8,740)  (9,014)   (12,848)  (13,594)

Proceeds from long-term debt

   —     2,750    —     2,750 

Payments on long-term debt

   (178)  (1,729)   (178)  (1,729)

Issuance of common stock, net of expenses

   7   45    (35)  67 
  


 


  


 


Net cash flows from financing activities

   1,879   6,652    2,306   7,185 

EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH

   (79)  (83)   (207)  (137)
  


 


  


 


NET CHANGE IN CASH AND CASH EQUIVALENTS

   712   (585)   359   (116)

CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

   1,002   1,241    1,002   1,241 
  


 


  


 


CASH AND CASH EQUIVALENTS AT END OF PERIOD

  $1,714  $656   $1,361  $1,125 
  


 


  


 


SUPPLEMENTAL CASH FLOW INFORMATION

      

Cash paid during the period for:

      

Interest

  $316  $237   $491  $390 

Income taxes, net

   18   (95)   27   (94)

Non-cash transactions:

      

Available for sale securities acquired for goods and services

   608   959 

Available for sale securities received for goods and services

   2,099   3,137 

Conversions of debt to equity

   2,579   2,000    2,535   2,000 

 

See notes to consolidated financial statements.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

 

(Dollars in thousands except per share data)

 

A. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The accompanying unaudited condensed consolidated financial statements of Transgenomic, Inc. and Subsidiaries (the “Company”) have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to such rules and regulations. In the opinion of management of the Company, all adjustments (consisting of only normal and recurring items) have been made to present fairly the financial positions, the results of operations and cash flows for the periods presented.

 

The results of operations for the three and sixnine months ended JuneSeptember 30, 2005 and 2004 are not necessarily indicative of the results to be expected for the full year.

 

Although the Company believes that the disclosures are adequate to make the information presented not misleading, these financial statements should be read in conjunction with the consolidated financial statements that are included in the Company’s annual report on Form 10-K for the year ended December 31, 2004, as amended.

 

TheAs discussed in Note L, the Company hascompleted a private placement of additional common stock and warrants subsequent to September 30, 2005 which allowed it to repay outstanding indebtedness to Laurus Master Funds Ltd. (“Laurus”) and provided $5,374 in additional working capital. While we believe that existing sources of liquidity are sufficient to meet expected cash needs through 2006, we have experienced recurring net losses and had an accumulated deficit of $110,991 at June 30, 2005. Based onhave historically relied upon cash flows from investing and financing activities to offset significant cash outflows from operating activities. To the Company’s operating plan, management believes its existing sources of liquidity will be sufficient to meet its cash needs during 2005. Ifextent necessary, the Company’s management believes that they can manage costs and expenses at reduced levels to conserve working capital. The need for any such cost and expense reductions would likely delay implementation of the Company’s business plan. Additionally, management may pursue financing alternatives. Ultimately, the Companywe must achieve sufficient revenue levelsrevenues in order to generate positive net earnings and cash flows from operations.

Business Description

The Company develops, manufactures and sells innovative products for the analysis, synthesis and purification of nucleic acids through two operating segments, BioSystems and Nucleic Acids.

The BioSystems operating segment develops, assembles, manufactures and markets versatile products and provides analytical services to the medical research, clinical and pharmaceutical markets for use in genetic variation analysis. Products and services are sold through a direct sales force in the United States and throughout much of Western Europe. For the rest of the world, products and services are sold through more than 25 dealers and distributors located in those local markets. Net sales from this operating segment are categorized as bioinstruments, bioconsumables and Discovery Services.

Bioinstruments. The flagship product of the BioSystems operating segment is the WAVE system which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There was a world-wide installed base of 1,241 WAVE systems as of September 30, 2005. Additionally, this operating segment utilizes its sales and distribution network to sell a number of independent, third party equipment platforms. Service contracts to maintain installed systems are sold and supported by technical support personnel.

Bioconsumables. The installed WAVE base generates a demand for consumables that are required for the system’s continued operation. These products are developed, manufactured and sold by this operating segment. In addition, the BioSystems operating segment manufactures and sells consumable products that can be used on multiple, independent platforms. These products include SURVEYOR Nuclease and a range of HPLC separation columns.

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

Discovery Services. The BioSystems operating segment provides various genetic laboratory services through a contract research lab in Gaithersburg, Maryland and a second laboratory in Omaha, Nebraska that operates in a Good Laboratory Practices (“GLP”) compliant environment and is certified under the Clinical Laboratory Improvement Amendment. The services provided primarily include (1) genomic biomarker analysis services to pharmaceutical and biopharmaceutical companies to support its cost structure.preclinical and clinical development of targeted therapeutics; and (2) molecular-based testing for hematology, oncology and certain inherited diseases for physicians and third-party laboratories.

The Nucleic Acids operating segment develops, manufactures and markets chemical building blocks for nucleic acid synthesis to biotechnology, pharmaceutical, oligonucleotide synthesis companies and research institutions throughout the world. These products are produced primarily in this operating segment’s only facility in Glasgow, Scotland. Prior to November 11, 2004, this operating segment also manufactured synthesized segments of large-scale, GMP nucleic acids (known as oligonucleotides) in a facility in Boulder, Colorado. On November 11, 2004, the assets associated with this facility were sold to an unaffiliated, third party. As a result, the Nucleic Acids operating segment no longer manufactures and sells these specialized oligonucleotides. A substantial portion of this operating segment’s revenues during 2005 and 2004 have been derived from one customer.

 

Principles of Consolidation.

 

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

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 revenues and expenses during the reporting period. In particular, estimates of the valuation of long-term inventory are subject to considerable estimation error due to the inherent uncertainty in projecting sales of this product over a period of years. In addition, estimates and assumptions associated with the determination of 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.

 

Cash and Cash Equivalents.

 

For purposes of reporting cash flows, cash and cash equivalents include cash and temporary investments with original maturities at acquisition of three months or less.

 

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 of the three and six months ended June 30, 2005 and 2004.accounts.

 

  Three Months Ended

  Six Months Ended

  Three Months Ended

  Nine Months Ended

  

June 30,

2005


  

June 30,

2004


  

June 30,

2005


  

June 30,

2004


  

September 30,

2005


  

September 30,

2004


  

September 30,

2005


  

September 30,

2004


Beginning balance

  $1,030  $550  $1,051  $549  $998  $550  $1,051  $549

Charges to income

   —     30   —     46   —     30   —     46

Deductions from reserves

   32   —     53   15   102   —     155   15
  

  

  

  

  

  

  

  

Ending balance

  $998  $580  $998  $580  $896  $580  $896  $580
  

  

  

  

  

  

  

  

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

 

Revenue Recognition.

 

Revenue 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. Our sales terms do not provide for the right of return unless the product is damaged or defective. Revenues from certain services associated with our analytical instruments, to be performed subsequent to shipment of the products, is deferred and recognized when the services are provided. Such

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

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. The Company also enters into various service contracts that cover installed WAVE systems. These contracts cover specific time periods and revenue associated with these contracts is deferred and recognized over the service period. At JuneSeptember 30, 2005 and December 31, 2004, deferred revenue associated with the Company’s service contracts was approximately $1,856$1,600 and $1,478$1,432 respectively, and is included in “accrued expenses” in the accompanying unaudited consolidated balance sheets.

 

During the sixnine months ended JuneSeptember 30, 2004, the Company recognized approximately $196$646 of product sales under bill-and-hold arrangements. Under these arrangements, the customer had accepted title and risk of ownership to the product, but had requested that the Company store the product on behalf of the customer, in a rented freezer, until the sixnine months ended JuneSeptember 30, 2004. There were no sales under bill-and –holdbill-and-hold arrangements recognized during the sixnine months ended JuneSeptember 30, 2005.

 

Stock Based Compensation.

 

The Company accounts for its employee stock option grants under the provisions of Accounting Principles Board Opinion No. 25,Accounting for Stock Issued to Employees, which utilizes the intrinsic value method. Accordingly, compensation cost for stock options is measured as the excess, if any, of the fair market value of the Company’s common stock at the date of grant over the stock option exercise price. Stock option grants to non-employees are accounted for using the fair value method of accounting in accordance with SFAS No. 123,Accounting for Stock-Based Compensation, using the Black-Scholes model.

 

The following table illustrates the effect on net loss and loss per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock based employee compensation.

 

  Three Months Ended

 Six Months Ended

   Three Months Ended

 Nine Months Ended

 
  

June 30,

2005


 

June 30,

2004


 

June 30,

2005


 

June 30,

2004


   

September 30,

2005


 

September 30,

2004


 

September 30,

2005


 

September 30,

2004


 

Net Loss:

   

Net Income (Loss):

   

As reported

  $(998) $(15,132) $(3,890) $(18,992)  $111  $(8,442) $(3,779) $(27,434)

Less pro forma stock-based employee compensation expense determined under fair value method, net of related tax

   (73)  (221)  (143)  (484)   (361)  (280)  (504)  (764)
  


 


 


 


  


 


 


 


Pro forma

  $(1,071) $(15,353) $(4,033) $(19,476)  $(250) $(8,722) $(4,283) $(28,198)

Basic and Diluted Loss Per Share:

   
  


 


 


 


Basic and Diluted Income (Loss) Per Share:

   

As reported

  $(0.03) $(0.52) $(0.12) $(0.66)  $0.00  $(0.29) $(0.12) $(0.95)

Pro forma

  $(0.03) $(0.53) $(0.13) $(0.67)  $0.00  $(0.30) $(0.13) $(0.97)

The weighted average fair value of options granted during the nine months ended September 30, 2005 and 2004 was $0.63 per share and $1.34 per share, respectively. The fair value of each stock option granted is estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions for options granted during the nine months ended September 30, 2005 and 2004: no common stock dividends; risk-free interest rates of 4.14% to 4.79%; 95% volatility in 2005 and 85% in 2004; and an expected option life of 3 years. At September 30, 2005, the weighted average remaining contractual life of options outstanding was 5.5 years.

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

 

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 other comprehensive income. Foreign currency transaction gains or losses resulting from changes in currency exchange rates are included in the determination of net income.income(loss). Foreign currency transaction adjustments adversely affected loss from operationsreduced operating expenses by approximately $228$191 and $8 for$263 during the three months ended JuneSeptember 30, 2005 and 2004, respectively, andrespectively. Foreign currency transaction adjustments increased operating expenses by approximately $428 and $128 for$237 during the sixnine months ended JuneSeptember 30, 2005 and reduced operating expenses by approximately $135 during the nine months ended September 30, 2004.

 

Earnings or Loss Per Share.

 

Basic earnings or loss per share areis calculated based on the weighted-average number of common shares outstanding during each period. Diluted earnings or loss per share includes shares issuable upon exercise of outstanding stock options and warrants or conversion of convertible notes, where dilutive. For all periods presented, basic and diluted weighted average shares outstanding and loss per share are identical, since all potentially dilutive securities are antidilutive. Potentially dilutive securities consist of stock options and warrants representing 4,759,5475,5541,015 and 1,159,421 shares of

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

common stock, respectively, at JuneSeptember 30, 2005, respectively.. Additionally, certain portions of the Company’s debt aregross indebtedness to Laurus totaling $8,263 at September 30, 2005 is convertible into the Company’s common stock at prices that were greater than$1.00 per share, which was the marketclosing price of the Company’s common stock at Juneon September 30, 2005. As described in Note L, this indebtedness was repaid subsequent to September 30, 2005.

 

Recently Issued Accounting Pronouncements

 

On December 16, 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123R, Share-Based Payment.“Share-Based Payment”. SFAS No.123R addresses the accounting for share-based payment transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise’s equity instruments or that may be settled by the issuance of such equity instruments. SFAS No. 123R eliminates the ability to account for share-based compensation transactions using Accounting Principles Board Opinion No. 25 and generally requires that such transactions be accounted for using a fair-value-based method. The Company expects to adopt this standard on January 1, 2006. The Company is currently assessing the final impact of this standard on its financial position, results of operations or cash flows. This assessment includes evaluating option valuation methodologies and assumptions as well as potential changes to compensation strategies.

 

On November 24, 2004, the FASB issued SFAS No. 151, Inventory Costs“Inventory Costs” – an amendment of ARB No. 43. SFAS No. 151 requires idle facility expenses, freight, handling costs, and wasted material (spoilage) costs to be excluded from the cost of inventory and expensed when incurred. It also requires that allocation of fixed production overhead to be based on the normal capacity of the production facilities. SFAS No. 151 will be effective atfor the beginning ofCompany on January 1, 2006. The Company is currently assessing the final impact of this standard on its financial position, results of operations or cash flows.

 

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 revenues and expenses during the reporting period. Actual results could differ from those estimates.

B. INVENTORIES

 

Inventories consisted of the following at June 30, 2005 and December 31, 2004:following:

 

  BioSystems Operating
Segment


  Nucleic Acids Operating
Segment


  Total

  BioSystems Operating
Segment


  Nucleic Acids Operating
Segment


  Total

  June 30,
2005


  December 31,
2004


  June 30,
2005


  December 31,
2004


  June 30,
2005


  December 31,
2004


  September 30,
2005


  December 31,
2004


  September 30,
2005


  December 31,
2004


  September 30,
2005


  December 31,
2004


Finished goods

  $2,260  $2,637  $2,159  $2,380  $4,419  $5,017

Finished Goods

  $2,155  $2,637  $1,529  $2,380  $3,684  $5,017

Raw materials and work in process

   504   780   2,217   2,275   2,721   3,055   516   780   2,393   2,275   2,909   3,055

Demonstration inventory

   123   153   —     —     123   153   123   153   —     —     123   153
  

  

  

  

  

  

  

  

  

  

  

  

   2,887   3,570   4,376   4,655   7,263   8,225   2,794   3,570   3,922   4,655   6,716   8,225

Less inventory classified as a long-term asset

   —     —     2,678   2,859   2,678   2,859   —     —     2,615   2,859   2,615   2,859
  

  

  

  

  

  

  

  

  

  

  

  

Net Inventory

  $2,887  $3,570  $1,698  $1,796  $4,585  $5,366  $2,794  $3,570  $1,307  $1,796  $4,101  $5,366
  

  

  

  

  

  

  

  

  

  

  

  

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

 

The Nucleic Acids operating segment inventory at JuneSeptember 30, 2005 and December 31, 2004 consisted primarily of chemical building blocks for synthetic nucleic acids (know as phosphoramadites) and the raw materials to produce phosphoramadites which are used and produced at the Company’s facility in Glasgow, Scotland. As of JuneSeptember 30, 2005, the Company has classified a portion of this inventory as a long-term other asset based on its existing sales forecasts for these products.

 

The Company periodically evaluates its inventory of phosphoramadites to determine whether they continue to meet quality and other specifications and over what time period such products are expected to be sold. Product that does not meet quality and other specifications can generally be re-worked to enhance purity. Costs to purify such product and related yield losses are expensed as incurred.

C. GOODWILL

Goodwill totaled $638 at September 30, 2005 and December 31, 2004 and related entirely to the BioSystems operating segment. The following summarizes goodwill adjustments for the nine months ended September 30, 2005 and 2004.

   Nine Months Ended

 
   

September 30,

2005


  

September 30,

2004


 

Beginning balance

  $638  $10,503 

Adjustments

   —     (9,865)
   

  


Ending balance

  $638  $638 
   

  


The Company recorded a charge of $9,865 during the nine months ended September 30, 2004 related to the impairment of goodwill associated with the Nucleic Acids operating segment. The amount of the impairment charges was based, in part, on an independent valuation performed by an unaffiliated valuation firm. The charge resulted from an interim period impairment test performed during the second quarter of 2004.

The interim period impairment test became necessary after the Company’s Board of Directors directed management during the second quarter of 2004 to explore strategic alternatives for the Nucleic Acids operating segment. This process included significant due diligence by management, third-party advisors and prospective independent buyers and other interested parties. Information obtained through this process indicated that it was more likely than not that the assets associated with the Nucleic Acids operating segment were impaired.

The Company also recorded a charge of $2,100 during the nine months ended September 30, 2004 related to the impairment of property and equipment associated with the Nucleic Acids operating segment.

D. OTHER ASSETS

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

   September 30, 2005

  December 31, 2004

   Cost

  

Accumulated

Amortization


  

Net Book

Value


  Cost

  

Accumulated

Amortization


  

Net Book

Value


Finite Lived Intangible Assets

                        

Capitalized software

  $2,132  $1,978  $154  $2,132  $1,468  $664

Intellectual property

   765   518   247   765   476   289

Patents

   651   114��  537   1,071   194   877
   

  

  

  

  

  

    3,548   2,610   938   3,968   2,138   1,830
   

  

  

  

  

  

Other Assets

                        

Long Term Inventory

   2,615   —     2,615   2,859   —     2,859

Deferred Financing Costs

   576   326   250   576   183   393

Other

   543   205   338   452   147   305
   

  

  

  

  

  

    3,734   531   3,203   3,887   330   3,557
   

  

  

  

  

  

Total

  $7,282  $3,141  $4,141  $7,855  $2,468  $5,387
   

  

  

  

  

  

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

 

(Dollars in thousands except per share data)

 

C. GOODWILL

Goodwill totaled $638 at June 30, 2005 and December 31, 2004 and related entirely to the BioSystem operating segment. The following summarizes goodwill adjustments for the three and six months ended June 30, 2005 and 2004.

   Three Months Ended

  Six Months Ended

 
   

June 30,

2005


  

June 30,

2004


  

June 30,

2005


  

June 30,

2004


 

Beginning balance

  $638  $10,502  $638  $10,502 

Adjustments

   —     (9,864)  —     (9,864)
   

  


 

  


Ending balance

  $638  $638  $638  $638 
   

  


 

  


During the three months ended March 31, 2004, the Company’s Board of Directors directed management to explore strategic alternatives for the Nucleic Acids operating segment. The process included significant due diligence by management, its advisors and prospective independent buyers and other interested parties. Based upon information obtained through this process during the three months ended JuneSeptember 30, 2004,2005, management determined that it was more likely than not thatcertain international patent pursuits were no longer consistent with the assets of the Nucleic Acids business were impaired.Company’s strategic plan. Accordingly, the Company engagedrecorded an external valuation firm to assist with the completion of a mid-year impairment test. As a result, the Company recorded a non-cash charge of $11,964 related to its Nucleic Acids segment during the three months ended June 30, 2004. The charge consisted of $9,864$247 related to the impairmentabandonment of goodwill and $2,100 related to the impairment of property and equipment.such pursuits.

D. OTHER ASSETS

At June 30, 2005 and December 31, 2004, finite lived intangible assets and other assets consisted of the following:

   June 30, 2005

  December 31, 2004

   Cost

  

Accumulated

Amortization


  

Net Book

Value


  Cost

  

Accumulated

Amortization


  

Net Book

Value


Finite Lived Intangible Assets

                        

Capitalized software

  $2,132  $1,824  $308  $2,132  $1,468  $664

Intellectual property

   765   503   262   765   476   289

Patents

   1,077   205   872   1,071   194   877
   

  

  

  

  

  

    3,974   2,532   1,442   3,968   2,138   1,830
   

  

  

  

  

  

Other Assets

                        

Long Term Inventory

   2,678   —     2,678   2,859   —     2,859

Deferred Financing Costs

   576   279   297   576   183   393

Other

   448   168   280   452   147   305
   

  

  

  

  

  

    3,702   447   3,255   3,887   330   3,557
   

  

  

  

  

  

Total

  $7,676  $2,979  $4,697  $7,855  $2,468  $5,387
   

  

  

  

  

  

 

Amortization expense for intangible assets was approximately $245$222 and $242 during the three months ended JuneSeptember 30, 2005 and 2004, respectively, and $495$717 and $486$728 for the sixnine months ended JuneSeptember 30, 2005 and 2004, respectively. Amortization expense for intangible assets is expected to be approximately $518$297 for the remainder of 2005, $342 in 2006, $331 in 2007, $62 in 2008, $134 in 2009, $134 in 2010 and $26 in 2011.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

 

E. DEBT

 

At June 30, 2005 and December 31, 2004, debtDebt consisted of the following:

 

  June 30,
2005


 December 31,
2004


   September 30,
2005


 December 31,
2004


 

Credit Line (“Credit Line”) with Laurus Master Funds, Ltd (“Laurus”)

   

Gross amount due (accruing interest at 2% above prime or 8.00% and 7.25% at June 30, 2005 and December 31, 2004, respectively, due December 2006)

  $6,119  $5,948 

Credit Line (“Credit Line”) with Laurus

   

Gross amount due (accruing interest at 2% above prime or 8.75% and 7.25% at September 30, 2005 and December 31, 2004, respectively, due December 2006)

  $6,588  $5,948 

Debt premium

   516   1,004    435   1,004 

Debt discount - warrants

   (65)  (85)   (61)  (85)

Debt discount - beneficial conversion premium

   —     (353)   (27)  (353)
  


 


  


 


  $6,570  $6,514   $6,935  $6,514 
  


 


  


 


Long-Term Debt with Laurus (“Term Note”)

      

Convertible debt (accruing interest at 2% above prime or 8.00% and 7.25% at June 30, 2005 and December 31, 2004, respectively, due February 2007)

  $1,675  $2,550 

Debt Premium

   269   474 

Convertible debt (accruing interest at 2% above prime or 8.75% and 7.25% at September 30, 2005 and December 31, 2004, respectively, due February 2007)

  $1,675  $2,550 

Debt premium

   226   474 

Less current portion

   (450)  (825)   (675)  (825)
  


 


  


 


  $1,494  $2,199   $1,226  $2,199 
  


 


  


 


 

Funds available under the Credit Line are determined by a borrowing base equal to 90% of eligible accounts receivable balances plus up to $1,000 related to inventory balances.

On August 31, 2004, Laurus agreed to extend a then existing borrowing base waiver, defer certain payments due under the Term Note and reduce the interest rate on both of the Laurus Loans to 0% for any day the closing sale price of the Company’s common stock is at or above $1.75 per share. In return, the Company lowered the conversion price on each of the Laurus Loans to $1.00 per share and issued a warrant to Laurus covering an additional 400,000 common shares at an exercise price of $1.25 per share. The closing price of the Company’s common stock on August 31, 2004 was $1.20 per share.

The August 31, 2004 Laurus modifications were treated as extinguishments for financial reporting purposes since the change in present value of expected cash flows between the original and modified agreements is greater than 10%. As such, the Company recorded a loss on extinguishment of debt of $2,859 at August 31, 2004 reflecting the difference between (i) the recorded amount of debt, net of related discounts, of $7,427 and (ii) the fair value of

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

the new debt instrument of $10,287 plus the fair value of the new warrants of $111. The difference between the fair value of the new debt of $10,287 and the face value of the debt of $8,572 represents a premium, which will be reflected as a reduction of interest expense over the life of the new debt.

On March 18, 2005, Laurus agreed to further extend an existingthe waiver of the borrowing base until March 31, 2006. In connection with this extension, the Company agreed to allow Laurus to convert $1,879 of the outstanding principal balance under the Credit Line into 3,600,000 shares of its common stock at $0.52 per share. In addition, on March 24, 2005 the Company agreed to allow Laurus to convert $650 of the outstanding principal balance of the Term Note into 1,250,000 shares of common stock at $0.52 per share. Laurus agreed to apply this Term Note conversion against substantially all remaining 2005 scheduled principal payments on such loan. The closing market price of the Company’s common stock the day before each of these conversions was $0.58 per share. No other provisions of the Company’s Credit Line or Term Note (collectively, the “Laurus Loans”) were modified, including the $1.00 conversion price for remaining debt. In conjunction with these conversions, the Company accelerated amortization of $409 of related debt premiums and discounts and recorded a charge of $1,365 related to the fair value of incremental shares received by Laurus.

 

Interest expense consisted of the following:

 

  Three Months Ended

  Six Months Ended

  Three Months Ended

  Nine Months Ended

  

June 30,

2005


 

June 30,

2004


  

June 30,

2005


 

June 30,

2004


  

September 30,

2005


 

September 30,

2004


  

September 30,

2005


 September 30,
2004


Interest paid or accrued on outstanding debt

  $134  $152  $305  $237  $172  $494  $477  $761

Amortization of debt premiums

   (124)  —     (692)  —     (124)  —     (816)  —  

Amortization of debt discounts – warrants

   9   —     20   —     4   —     24   —  

Amortization of debt discount – beneficial conversion feature

   15   158   644   618   81   191   725   809

Fair value of incremental shares received by Laurus

   —     —     1,365   —     —     —     1,365   —  

Deferred Financing Costs

   49   36   96   80   48   38   144   114
  


 

  


 

  


 

  


 

  $83  $346  $1,738  $935  $181  $723  $1,919  $1,684
  


 

  


 

  


 

  


 

 

PrincipalAs of September 30, 2005 principal repayments under the Term Note are scheduled as follows: $0 for the remainder of 2005, $875 in 2006, and $800 in 2007. As describe in Note L, the Company repaid the entire principal balance and terminated the Laurus Loans subsequent to September 30, 2005 with the proceeds from the private placement. Accordingly, the Company no longer has any borrowings which require scheduled principal and interest payments.

 

F. COMMITMENTS AND CONTINGENCIES

 

The Company was named as a defendant in a lawsuit filed in Spain by a prospective distributor who claims that the Company breached a promise to grant the plaintiff a distributorship for certain of the Company’s products in a specific geographic area in Europe. The plaintiff was seeking monetary relief of approximately $500. During the three months ended June 30, 2005, a court dismissed this matter in favor of the Company.

The Company is subject to a number of other claims of various amounts, which arise out of the normal course of business. In the opinion of management, the disposition of claims currently pending will not have a material adverse effect on the Company’s financial position, results of operations or cash flows, after considering amounts already reflected in the consolidated financial statements.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)flows.

 

The Company leases certain equipment, vehicles and operating facilities. The Company’s leases related to its operating facilities currently expire on various dates through 2010. At JuneSeptember 30, 2005, the future minimum lease payments required under non-cancellablenon-cancelable lease provisions arewere approximately $858$359 for the remainder of 2005, $1,230$1,233 in 2006, $441$443 in 2007, $187$189 in 2008, $191$193 in 2009, and $165$167 in 2010. Rent expense related to all operating leases was approximately $306 and $521 for the three months ended JuneSeptember 30, 2005 and 2004, was approximately $310 and $588, respectively, and $663$968 and $1,173$1,689 for the sixnine months ended JuneSeptember 30, 2005 and 2004, respectively.

 

At JuneSeptember 30, 2005, the Company had firm commitments totaling $468 to a vendor$872 to purchase components used in WAVE Systems.

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

 

G. INCOME TAXES

 

Income tax recorded during the three and sixnine months ended JuneSeptember 30, 2005 and 2004 related to income taxes in states, foreign countries and other local jurisdictions offset by refunds received.

 

Due to the Company’s cumulative losses, expected losses in future years and inability to utilize any additional losses as carrybacks, the Company has not provided for an income tax benefit during the three and sixnine months ended JuneSeptember 30, 2005 or 2004 based on management’s determination that it was more likely than not that such benefits would not be realized. The Company will continue to assess the recoverability of deferred tax assets and the related valuation allowance. To the extent the Company begins to generate taxable income in future periods and it determines that such valuation allowance is no longer required, the tax benefit of the remaining deferred tax assets will be recognized at such time. As of JuneSeptember 30, 2005 and December 31, 2004, the Company’s deferred tax assets were offset by a valuation allowance of approximately $39,747$41,227 and $38,287, respectively.

 

H. STOCKHOLDERS’ EQUITY

 

The following shows changes to the components of stockholders’ equity during the sixnine months ended JuneSeptember 30, 2005.

 

  Common Stock

  

Additional

Paid in

Capital


  

Accumulated

Deficit


  

Accumulated Other

Comprehensive

Income (Loss)


  Total

   Common Stock

  

Additional

Paid in

Capital


  Accumulated
Deficit


  Accumulated Other
Comprehensive
Income (Loss)


  Total

 
  

Outstanding

Shares


  

Par

Value


     Outstanding
Shares


  

Par

Value


   

Balance, January 1, 2005

  29,330,874  $299  $120,798  $(107,101) $2,539  $16,535   29,330,874  $299  $120,798  $(107,101) $2,539  $16,535 

Net loss

  —     —     —     (3,890)  (3,890)  (3,890)  —     —     —     (3,779)  (3,779)  (3,779)

Other comprehensive income (loss):

                        

Foreign currency translation adjustment

  —     —     —     —     (1,130)  (1,130)  —     —     —     —     (1,553)  (1,553)

Unrealized gain on available for sale securities

  —     —     —     —     65   65 
  
  

  

  


 


 


Comprehensive loss

  —     —     —     —     (5,020)   —     —     —     —     (5,267) 

Beneficial conversion premium

  —     —     292   —     —     292   —     —     399   —     —     399 

Issuance and shares upon conversion of Laurus Loans

  4,900,000   48   2,531   —     —     2,579 

Issuance of shares upon conversion of Laurus Loans

  4,900,000   48   2,487   —     —     2,535 

Fair value of incremental shares issued

  —     —     1,365   —     —     1,365   —     —     1,365   —     —     1,365 

Issuaance of shares for employee stock purchase plan

  10,407   1   7   —     —     8 
  
  

  

  


 


 


Balance, June 30, 2005

  34,241,281  $348  $124,993  $(110,991) $1,409  $15,759 

Issuance of shares for employee stock purchase plan

  15,462   1   9   —     —     10 
  
  

  

  


 


 


  
  

  

  


 


 


Balance, September 30, 2005

  34,246,336  $348  $125,058  $(110,880) $1,051  $15,577 
  
  

  

  


 


 


 

During the three and sixnine months ended JuneSeptember 30, 2005, the Company issued zero and 4,900,000 shares, respectively, of common stock in conjunction with conversions under the Laurus Loans.

 

Date


  Price

  Shares Issued

  Proceeds

  

Facility


  

Applied To


  Price

  Shares Issued

  Proceeds

  Facility

  Applied To

January 2005

  $1.00  50,000  $50  Term Note  Principal  $1.00  50,000  $50  Term Note  Principal

March 2005

  $0.52  3,600,000   1,879  Credit Line  Principal  $0.52  3,600,000   1,835  Credit Line  Principal

March 2005

  $0.52  1,250,000   650  Term Note  Principal  $0.52  1,250,000   650  Term Note  Principal
     
  

           
  

      
     4,900,000  $2,579           4,900,000  $2,535      
     
  

           
  

      

I. STOCK OPTIONS

Options representing 951,000 and 1,123,500 shares of the Company’s common stock were granted during the three and nine months ended September 30, 2005, respectively, with weighted average exercise prices of $1.03 per share and $1.04 per share, respectively. The following table summarizes activity under the 1997 Stock Option Plan during the nine months ended September 30, 2005.

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

 

(Dollars in thousands except per share data)

I. STOCK OPTIONS

No options were granted during the three months ended June 30, 2005. The following table summarizes activity under the 1997 Stock Option Plan during the six months ended June 30, 2005.

   

Number of

Options


  

Weighted

Average

Exercise Price


Balance at December 31, 2004

  5,088,037  $5.09

Granted

  172,500   1.09

Forfeited

  (500,990)  3.95
   

 

Balance at June 30, 2005

  4,759,547  $5.07
   

 

Exercisable at June 30, 2005

  4,170,266  $5.44
   

 

The weighted average fair value of options granted during the six months ended June 30, 2005 was $0.61 per share. The fair value of each stock option granted is estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions for options granted during the six months ended June 30, 2005: no common stock dividends; risk-free interest rates of 4.14% to 4.79%; 85% volatility; and an expected option life of 3 years. At June 30, 2005, the weighted average remaining contractual life of options outstanding was 4.7 years.

   

Number of

Options


  

Weighted

Average

Exercise Price


Balance at January 1, 2005

  5,088,037  $5.09

Granted

  1,123,500  $1.04

Cancelled

  (670,522) $4.21
   

   

Balance at September 30, 2005

  5,541,015  $4.37
   

   

Exercisable at September 30, 2005

  4,396,281  $5.11
   

   

 

The following table summarizes information about options outstanding as of JuneSeptember 30, 2005:

 

  Options Outstanding

  Options Exercisable

  Options Outstanding

  Options Exercisable

Range of Exercise Prices


  

Number

Outstanding


  

Weighted-Average

Remaining

Contractual Life


  

Weighted-Average

Exercise Price


  

Number

Exercisable


  

Weighted-Average

Exercise Price


  

Number

Outstanding


  

Weighted-Average

Remaining

Contractual Life


  

Weighted-Average

Exercise Price


  

Number

Exercisable


  

Weighted-Average

Exercise Price


     (in years)              (in years)         

$ 1.00—$ 1.30

  448,333  7.3  $1.23  258,333  $1.26  1,360,167  9.2  $1.08  558,384  $1.12

$ 1.31—$ 2.60

  849,833  7.6  $1.90  521,518  $1.89  798,167  7.6  $1.91  510,682  $1.92

$ 2.61—$ 3.90

  35,000  7.3  $2.90  23,334  $2.90  35,000  7.1  $2.90  23,334  $2.90

$ 3.91—$ 5.20

  2,086,200  2.5  $5.00  2,086,200  $5.00  2,074,700  2.3  $5.00  2,074,700  $5.00

$ 5.21—$ 6.50

  718,950  5.8  $6.15  688,350  $6.15  692,750  5.6  $6.15  662,150  $6.15

$ 6.51—$ 9.10

  10,000  5.9  $9.00  10,000  $9.00  10,000  5.6  $9.00  10,000  $9.00

$ 9.11—$10.40

  316,500  5.6  $9.89  312,500  $9.89  300,500  5.3  $9.88  296,500  $9.88

$10.41—$13.00

  294,731  4.5  $12.82  270,031  $12.84  269,731  4.6  $12.80  260,531  $12.83
  
  
  

  
  

  
        
   
  4,759,547  4.7  $5.07  4,170,266  $5.44  5,541,015  5.5  $4.37  4,396,281  $5.11
  
  
  

  
  

  
        
   

 

J. OPERATING SEGMENT AND GEOGRAPHIC INFORMATION

 

The Company operates in two reportable segments,Operations for the BioSystems and Nucleic Acids. Operations for theseAcids operating segments are evaluated based upon specific identification of revenues and expenses associated with the business activities resulting in a segment operating income. Expenses that cannot be directly identified to an operating activity or are considered corporate overhead are not allocated to the segments in arriving at operating income for the segment. Generally, decisions regarding asset allocation, financing, taxes or other items impacting the Company’s balance sheet are made at the corporate level and, accordingly, operating segment balance sheet information is not typically reviewed by operating decision makers.

 

The BioSystemsfollowing table sets forth net sales and operating segment generates revenue from the sale of automated instrument systems and associated consumable products and services. This segment’s products are based upon two of the Company’s three core competencies: separations chemistries and enzymology. Specifically, this segment’s main products are the WAVE system, related bioconsumables and research services.

income (loss) by segment.

   Three Months Ended

  Nine Months Ended

 
   

September 30,

2005


  

September 30,

2004


  

September 30,

2005


  

September 30,

2004


 

Net Sales

                 

BioSystems

  $6,663  $5,501  $20,479  $18,450 

Nucleic Acids

   2,043   2,693   3,232   7,384 
   


 


 


 


Total

  $8,706  $8,194  $23,711  $25,834 
   


 


 


 


Income (Loss) from Operations

                 

BioSystems

  $875  $(634) $2,227  $(1,309)

Nucleic Acids

   637   (2,512)  (630)  (17,073)

Corporate

   (1,209)  (1,613)  (3,461)  (4,442)
   


 


 


 


Total

  $303  $(4,759) $(1,864) $(22,824)
   


 


 


 


TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

 

(Dollars in thousands except per share data)

 

The Nucleic Acids operating segment generates revenue from the sale of products and services based upon all three of the Company’s core competencies: nucleic acid chemistries, separations chemistries and enzymology. Specifically, this segment’s main products are nucleic acid building blocks or “phosphoramidites,” fluorescent markers, dyes and associated reagents and novel chemistry and process development services.

The following table sets forth net sales and operating income (loss) by segment.

   Three Months Ended

  Six Months Ended

 
   

June 30,

2005


  

June 30,

2004


  

June 30,

2005


  

June 30,

2004


 

Net Sales

                 

BioSystems

  $6,889  $6,563  $13,816  $12,948 

Nucleic Acids

   744   2,448   1,189   4,692 
   


 


 


 


Total

  $7,633  $9,011  $15,005  $17,640 
   


 


 


 


Income (Loss) from Operations

                 

BioSystems

  $767  $(158) $1,347  $(675)

Nucleic Acids

  $(535) $(13,178) $(1,266) $(14,561)

Corporate

   (1,167)  (1,415)  (2,248)  (2,829)
   


 


 


 


Total

  $(935) $(14,751) $(2,167) $(18,065)
   


 


 


 


During the three and sixnine months ended JuneSeptember 30, 2005, sales to Novartis Pharmaceuticals, Inc. (“Novartis”)a large pharmaceutical company totaled $667$599 and $1,410,$2,009, respectively, and represented 9.7%9.0% and 10.2%9.8%, respectively, of net sales within the Company’s BioSystems operating segment and 8.7%6.9% and 9.4%8.5%, respectively, of total consolidated net sales. Sales to Novartisthis customer are governed by a non-binding master services agreement dated August 22, 2002.

 

During the three and sixnine months ended JuneSeptember 30, 2005, sales to Geron Corporation (“Geron”) totaled $54$1,624 and $105,$1,729, respectively, and represented 7.3%79.5% and 8.8%53.5%, respectively, of net sales within the Company’s Nucleic Acids operating segment and less than 1% of18.7% and 7.3%, respectively, total net consolidated sales. During the three and sixnine months ended JuneSeptember 30, 2004, sales to Geron totaled $1,174$1,695 and $1,896,$3,591, respectively, and represented 48%62.9% and 40%48.6%, respectively, of net sales within the Company’s Nucleic Acids operating segment and 13%20.7% and 11%13.9%, respectively, of total consolidated net sales. Sales to Geron are governed by a non-binding supply agreement dated June 15, 2002, as amended. Under the supply agreement and related addendums, Geron has historically paid the Company for goods and services with its common stock. The terms of each addendum generally provide that Geron pre-pay 50% of the total sales price of goods sold under the addendum upon execution of the addendum and the remaining 50% upon acceptance of the related goods and services. Geron shares received by the Company are restricted for resale until they are registered with the Securities and Exchange Commission. The Company assumes all market risk related to the value of these securities and any selling costs are paid by the Company. Once registered, it has been the Company’s intent and practice to sell such securities as soon as practical.

 

The following is a summary of Geron shares received and sold during the sixnine months ended JuneSeptember 30, 2005 and 2004.

 

Date Received


  Shares

  Product
Sales Price


  Date Sold

  Net
Proceeds


  Gain (Loss)

 

January 2004

  85,855  $959  February 2004  $932  $(27)

March 2004

  33,662  $289  July 2004  $263  $(26)

April 2005

  101,801  $608  May 2005  $617  $9 

The 101,801 Geron shares received by the Company in April 2005 were a prepayment for products that are expected to be completed and delivered to Geron in the second half of 2005. The related deferred revenue of $608 is included in “accrued expenses” in the accompanying unaudited consolidated balance sheet at June 30, 2005.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

Date Received


  Shares

  Product Sales
Price


  Date Sold

  Net
Proceeds


  Gain (Loss)

 

January 2004

  85,855  $959  February 2004  $932  $(27)

March 2004

  33,662  $289  July 2004  $263  $(26)

April 2005

  101,801  $608  May 2005  $617  $9 

August 2005

  151,550  $1,491  October 2005  $1,534  $43 

 

K. RESTRUCTURING PLAN

 

The Company had accrued expenses associated with its 2004 restructuring plan of $581$368 and $1,910$1,909 at JuneSeptember 30, 2005 and December 31, 2004, respectively. The balance at JuneSeptember 30, 2005 relates primarily to future rents on closed facilities (net of projected sublease rents) of which $283$27 is expected to be paid during the remainder of 2005 and $272$341 in 2006 and thereafter.

L. SUBSEQUENT EVENT

On October 31, 2005, the Company closed on a private placement of securities to institutional investors. The securities issued consisted of: (i) 14,925,743 shares of the Company’s common stock, plus (ii) five-year, non-callable warrants to purchase another 5,970,297 shares of common stock with an exercise price of $1.20 per share (the “Offering”). The aggregate purchase price for the securities sold in the private placement was $1.01 per share of common stock initially being sold (the “Purchase Price”) or $15,075. In conjunction with the private placement, the Company issued a warrant to Oppenheimer & Co., Inc. (“Oppenheimer”) to purchase 932,859 shares at $1.20 per share as part of their placement fee for the private placement.

Contemporaneously with the closing of the private placement, the Company repaid all outstanding principal and accrued interest on the Laurus Loans, including fees to facilitate the private placement and prepayment penalties to Laurus in the sum of $824. As a result, the Credit Line with Laurus has been cancelled and is no longer available to the Company.

TRANSGENOMIC INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)

(Dollars in thousands except per share data)

The Company is required to register all shares of common stock sold in the Offering and issuable upon exercise of the warrants. The common stock issued to these institutional investors may be sold in the secondary market at any time once such registration is effective. Failure to register these shares in a timely manner will subject the Company to liquidated damages of 1.5% of the aggregate purchase price per month for each successive 30-day period, calculated on a pro rata basis for any partial 30-day period.

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

 

Overview

 

We provideThe Company develops, manufactures and sells innovative products for the analysis, synthesis and purification of nucleic acids through two operating segments, BioSystems and Nucleic Acids.

The BioSystems operating segment develops, assembles, manufactures and markets versatile products and provides analytical services to the medical research, clinical and pharmaceutical markets for use in genetic variation analysis. Products and services are sold through a direct sales force in the United States and throughout much of Western Europe. For the rest of the world, products and services are sold through more than 25 dealers and distributors located in those local markets. Net sales from this operating segment are categorized as bioinstruments, bioconsumables and discovery services.

Bioinstruments. The flagship product of the BioSystems operating segment is the WAVE system which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There was a world-wide installed base of 1,269 WAVE systems as of September 30, 2005. Additionally, this operating segment utilizes its sales and distribution network to sell a number of independent, third party equipment platforms. Service contracts to maintain installed systems are sold and supported by technical support personnel.

Bioconsumables. The installed WAVE base generates a demand for consumables that are required for the synthesis, purificationsystem’s continued operation. These products are developed, manufactured and analysis of nucleic acids. Our operations fall into two principal business units,sold by this operating segment. In addition, the BioSystems operating segment manufactures and Nucleic Acids. Our BioSystemssells consumable products that can be used on multiple, independent platforms. These products include our WAVE® automated instrument systems, WAVE associated consumable productsSURVEYOR Nuclease and other related consumable products. Oura range of HPLC separation columns.

Discovery Services. The BioSystems operating segment provides various genetic laboratory services through a contract research lab in Gaithersburg, Maryland and a second laboratory in Omaha, Nebraska that operates in a Good Laboratory Practices (“GLP”) compliant environment and is certified under the Clinical Laboratory Improvement Amendment. The services provided primarily include (1) genomic biomarker analysis services to pharmaceutical and biopharmaceutical companies to support preclinical and clinical development of targeted therapeutics; and (2) molecular-based testing for hematology, oncology and certain inherited diseases for physicians and third-party laboratories.

The Nucleic Acids products consist principally ofoperating segment develops, manufactures and markets chemical building blocks for nucleic acid synthesis. Both business units have service offerings as well, including genetic variation discovery and analysis services and custom synthesis of specialty nucleic acids.

Our technologies center around three core competencies: separation chemistries, enzymology, and nucleic acid chemistries. In our first core competency, separations chemistry, we employ novel chemistries for separating nucleic acids, proteins, peptides, amino acids and carbohydrates. Our most significant separation technology is currently embodied in the WAVE System. The WAVE System is a versatile instrument that can be used for genetic variation detection, size-based double-strand DNA separation and analysis, single-strand DNA separation and analysis and DNA purification. The WAVE System requires the use of various consumable products that we manufacture and sell separately.

Our second core competency is expertise in developing novel enzymes. Enzymes are proteins that act as catalysts for biochemical reactions. Several of these reactions are useful in genomics. The ability to develop enzymes useful in the experimental manipulation of genes provides powerful tools for producing genetic material in the form needed for further analysis or incorporation into diagnostics and therapeutics. These products can also expand the sale of consumable products to WAVE System users and may also be sold for other applications. Our SURVEYOR® product line of mutation detection kits allow for the cleaving of DNA at points where DNA sequence variations exists. The resulting DNA fragments can then be analyzed by our WAVE System, fluorescent capillary electrophoresis or standard gel electrophoresis. SURVEYOR Kits provide a simple and robust method of scanning relatively large DNA fragments for both known and novel sequence variations.

Our third core competency is nucleic acid chemistries. Our synthetic nucleic acid products consist of chemical building blocks of nucleic acids (known as phosphoramidites). We also manufacture related specialty chemicals such as fluorescent markers and molecular tags, dyes, quenchers, linkers, and solvents used to modify nucleic acids for subsequent detection or manipulation. These products are used by research organizations, diagnosticbiotechnology, pharmaceutical, oligonucleotide synthesis companies and pharmaceutical companies.research institutions throughout the world. These products are produced primarily in ourthis operating segment’s only facility in Glasgow, Scotland facility.Scotland. Prior to November 11, 2004, we hadthis operating segment also manufactured synthesized segments of large-scale, GMP nucleic acids (known as oligonucleotides) in a facility in Boulder, Colorado. On November 11, 2004, we sold the assets associated with this facility were sold to a subsidiary of Eyetech Pharmaceuticals, Inc.an unaffiliated, third party. As a result, of this sale, wethe Nucleic Acids operating segment no longer manufacturemanufactures and sellsells these specialized oligonucleotides.

Our operations are managed based upon the nature A substantial portion of the productsthis operating segment’s revenues during 2005 and services provided. Accordingly, we operate in two reportable segments, BioSystems and Nucleic Acids. Operations for these segments are evaluated based upon specific identification of revenues and expenses associated with the business activities resulting in a segment operating income or loss. See the Notes to the accompanying unaudited consolidated financial statements for detailed segment information.2004 have been derived from one customer.

 

Since 2000 (the year of our initial public offering), we have incurred net losses of $98.15$98.54 million largely related to our Nucleic Acids operating segment. We instituted significant changes during the fourth quarter of 2004 designed to, among other things, better align our cost structure with projected revenues, focus on opportunities in our BioSystems operating segment, and minimize the adverse financial effect of our Nucleic Acids operating segment. Specifically, during the fourth quarter of 2004, we sold our manufacturing facility in Boulder, Colorado and implemented a restructuring plan (the “2004 Restructuring Plan”). While the primarily goals of these changes were to provide the foundation for a self-sustaining, growth-oriented company with positive cash flows and earnings, there can be no assurance that we can achieve these goals.

Our liquidity and working capital positions improved during the first sixnine months of 2005 due principally to conversions of $2.53 million of borrowings under our credit line (“Credit Line”) and term note (“Term Note”) (collectively, the “Laurus Loans”) with Laurus Master Fund, Ltd. (“Laurus”) into common stock. At JuneSeptember 30, 2005, we had working capital of $1.21 million and an accumulated deficit of $110.99$110.88 million. Subsequent to

September 30, 2005, we finalized the private placement of securities to institutional investors that resulted in gross proceeds of $15.08 million that were used to repay the Laurus Loans and for our future general working capital purposes.

 

Executive Summary

 

As discussed more thoroughly below and throughout this report, the quarter was one of progress on many fronts. From a product perspective, we introduced a new WAVE platform. We achieved a numberexpect this will provide for additional instrument sales and upgrade opportunities in the coming quarters. We also enhanced our laboratory infrastructure and product offerings in order to capitalize on the increasing demand for molecular-based personalized medicine. For the first time in our history, we reported positive quarterly income from operations and net income. These results were driven by 21% year-over-year revenue growth in our BioSystems operating segment and the production and sale of significant milestones duringamount of customized phosperamidates from our Nucleic Acids operating segment. Lastly, we completed a private placement of common stock and warrants on October 31, 2005 that allowed us to eliminate our debt with Laurus Master Funds, Ltd. (“Laurus”), enhanced our existing institutional shareholder base and added approximately $5.40 million of cash to our consolidated balance sheet.

We introduced the second quarternewest version of 2005.our WAVE platform, the WAVE 4500.The WAVE 4500 includes enhancements that are designed to optimize sensitivity and throughput for our customers while reducing our overall product and maintenance cost. In addition to new product sales, certain enhanced components of the WAVE 4500, including the oven and software, will provide modular upgrade opportunities for our existing customers.

 

Our losslaboratory in Omaha, Nebraska has been certified under the Clinical Laboratory Improvement Amendments, and beginning in the fourth quarter of this year, we will receive the first patient samples for molecular-based testing for hematology, oncology and certain inherited diseases for physicians and third-party laboratories.We believe there is a significant opportunity for us to capitalize on the increasing demand for molecular-based personalized medicine by leveraging on our technologies and experience gained from the genomic biomarker analysis that our Discovery Services Group has and will continue to provide to pharmaceutical and biopharmaceutical companies.

We generated quarterly income from operations and net loss duringincome which continues a positive trend that began in the first quarter ended June 30, 2005 of $0.94 million and $1.00 million, respectively, were the best in our public-company history.this year.

   2005 Quarters Ended

  Nine Months Ended
September 30, 2005


 
   September 30

  June 30

  March 31

  

Income (loss) from operations

  $303  $(935) $(1,232) $(1,864)

Net income (loss)

  $111  $(998) $(2,892) $(3,779)

Year-over-year net sales increases of 5%21% in our BioSystems operating segment, together withsales from our Nucleic Acids operating segment to Geron Corporation (“Geron”), and cost reductions fromassociated with our 2004 Restructuring Plan led to our record performance. Recurring net sales (consumables plus service contract revenue) associated with our increasing installed base of 1,269 WAVE systems grew to represent 40%32% of consolidated net sales and nearly 45%42% of net sales in our BioSystemBioSystems operating segment. We expect that we can leverage on our existing cost structureconsider net sales of consumables and service contracts to support annual revenues ranging up to $40.00.be recurring.

 

Operating cash flows continueSubsequent to validateSeptember 30, 2005, we finalized the effectivenessprivate placement of our 2004 Restructuring Plan.securities to institutional investors that resulted in gross proceeds to the Company of $15.08 million. Cash used in operationsOn October 31, 2005, we closed a private placement of the following securities to institutional investors: (i) 14,925,743 shares of the Company’s common stock, plus (ii) five-year, non-callable warrants to purchase another 5,970,297 shares of common stock with an exercise price of $1.20 per share. The aggregate purchase price for the threesecurities sold in the private placement was $1.01 per share of common stock initially being sold for $15.08 million. The proceeds from the private placement allowed us to enhance our liquidity and six months ended June 30, 2005 totaled $1.03overall working capital positions by eliminating all convertible debt with Laurus and adding approximately $5.37 million and $1.17 million, respectively. This represents significant improvement over historical levels of cash used in operations that have ranged from $1.76 million to $5.73 million and demonstrates significant progress toward a major goal of neutral to positive operating cash flows by the end of 2005.

We completed testing of our new generation WAVE platform and expect to roll it out during the third quarter of 2005.There are significant technical and functional enhancements designed into the WAVE 4500 (our fourth generation WAVE platform) that offer users enhanced flexibility, speed and ease of operation, throughput, and sensitivity. We expect the WAVE 4500 to drive new product and upgrade sales in the second half of 2005 and into 2006.consolidated balance sheet.

Our investment in Discovery Services continues to yield significant growth.For the six months ended June 30, 2005, net sales from Discovery Services totaled $1.45 million compared to $0.89 million for the same period of 2004, an increase of 63%. These contract research service offerings represent a relatively new area of business for us. We plan to continue to seek opportunities to provide genetic variation discovery and analysis services to pharmaceutical and other customers and believe that these services provide us significant opportunities to expand revenue in the future.

Results of Operations Three Months Ended JuneSeptember 30, 2005 and 2004

 

Amounts in thousands


  2005

  2004

  Change

 %
Change


 

Dollars in thousands


  2005

 2004

 Change

 %
Change


 

Net Sales

            

Bioinstruments

  $3,734  $3,966  $(232) (6)%  $3,745  $2,932  $813  28%

Bioconsumables

   2,494   2,059   435  21%   2,210   2,057   153  7%

Discovery Services

   661   538   123  23%   708   512   196  38%
  

  

  


 

  


 


 


 

Total BioSystems Business Unit

   6,889   6,563   326  5%   6,663   5,501   1,162  21%
  

  

  


 

Chemical Building Blocks

   744   1,740   (996) (57)%   2,043   2,280   (237) (10)%

Specialty Oligonucleotides and Services

   —     708   (708) (100)%   —     413   (413) (100)%
  

  

  


 

  


 


 


 

Total Synthetic Nucleic Acids Business Unit

   744   2,448   (1,704) (70)%   2,043   2,693   (650) (24)%
  

  

  


 

  


 


 


 

Total Net Sales

   7,633   9,011   (1,378) (15)%   8,706   8,194   512  6%
  

  

  


 

  


 


 


 

Cost of Goods Sold

            

Bioinstruments

   1,753   1,656   97  6%   1,818   1,198   620  52%

Bioconsumables

   1,065   982   83  9%   1,116   1,077   39  4%

Discovery Services

   583   327   256  78%   611   386   225  58%
  

  

  


 

  


 


 


 

Total BioSystems Business Unit

   3,401   2,965   436  15%   3,545   2,661   884  33%
  

  

  


 

Chemical Building Blocks

   1,049   1,335   (286) (21)%   1,216   2,659   (1,443) (54)%
  

  

  


 

Specialty Oligonucleotides and Services

   —     1,558   (1,558) (100)%   —     1,537   (1,537) (100)%
  

  

  


 

  


 


 


 

Total Synthetic Nucleic Acids Business Unit

   1,049   2,893   (1,844) (64)%   1,216   4,196   (2,980) (71)%
  


 


 


 

Total Cost of Goods Sold

   4,450   5,858   (1,408) (24)%   4,761   6,857   (2,096) (31)%
  

  

  


 

Selling, General and Administrative Expenses

   3,537   4,268   (731) (17)%   2,885   4,353   (1,468) (34)%

Research and Development Expenses

   581   1,672   (1,091) (65)%   510   1,743   (1,233) (71)%

Impairment Charges

   —     11,964   (11,964) (100)%

Impairment charge

   247   —     247  100%

Other Income (Expense)

   (184)  (3,682)  (3,498) (95)%

 

Net Sales. Net sales for the quarter ended JuneSeptember 30, 2005 decreased $1.38increased $0.51 million or 15%6% from the same period of 2004 as a result of a $0.33$1.16 million or 5%21% increase in sales in our BioSystems operating segment offset by a $1.70$0.65 million or 70%24% decrease in sales in our Nucleic Acids operating segment.

 

The increase in sales in our BioSystems operating segment resulted from an decreaseincreases of $0.23$0.81 million or 6%28% from bioinstruments, increases in sales of bioconsumables of $0.44$0.15 million or 21%7% from bioconsumables and increases$0.20 million or 38% from Discovery Services of $0.12 million or 23%.Services. WAVE Systems sold totaled 2528 during the quarter ended JuneSeptember 30, 2005 compared to 3419 during the same period of 2004. The selling prices of our instruments vary based on the specific model and optional accessories. We had an installed base of approximately 1,2411,269 units at JuneSeptember 30, 2005 compared to 1,193 units at December 31, 2004. The increase in the installed base of instruments continues to drive increases in sales of bioconsumables used with these instruments. The increase in Discovery Servicesdiscovery services revenue during 2005 was primarily attributable to the discovery services agreements that we entered into with Novartis Pharmaceuticals, Inc. (“Novartis”)a large pharmaceutical company to support their clinical development of oncology therapeutics. During the three months ended JuneSeptember 30, 2005, Discovery Services sales to Novartisthis customer totaled $0.67$0.60 million and represented 10%9% of net sales within the BioSystems operating segment and 9%7% of total consolidated net sales. We have no long-term agreement with Novartis,this customer, therefore, sales will fluctuate and may be zero. Future revenues from our BioSystems operating segment would be substantially reduced if Novartis’sthis customer’s need for our products declined.

Nucleic Acids operating segment sales decreased by $1.71$0.65 million or 70%24% during the quarter ended JuneSeptember 30, 2005 compared to the same period of 2004 as a result of fewer chemical building block sales to Geron Corporation (“Geron”) and the sale of our specialty oligonucleotides facility in Boulder, Colorado. Sales to Geron during the secondthird quarter of 2005 totaled $0.05$1.62 million compared to $1.17$1.73 million during the secondthird quarter of 2004. Net sales to Geron during the quarter ended JuneSeptember 30, 2005 represented 7%80% of net sales in our Nucleic Acids operating segment and did not represent a significant portion19% of total consolidated net sales. Net sales to Geron during the quarter ended JuneSeptember 30, 2004 represented 48%63% of net sales within our Nucleic Acids operating segment and 13%21% of total consolidated net sales. We have no long-term agreement with Geron, therefore, sales will fluctuate and may be zero. Future revenuesrevenue from our Nucleic Acids operating segment would be substantially reduced if Geron’s need for our products declined. As a result of the sale of our facility in Boulder, Colorado, net sales of specialty oligonucleotides decreased by $0.71$0.41 million. We no longer manufacture or sell oligonucleotides.

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 and supplies) associated with our Discovery Services operations. Depreciation expense included in costs of goods sold totaled $0.56$0.70 million and $0.59$0.76 million during the quarters ended JuneSeptember 30, 2005 and 2004, respectively.

 

Costs of goods sold during the quarter ended JuneSeptember 30, 2005 decreased $1.41$2.10 million or 24%31% from the same period of 2004 as a result of a $0.43$2.98 million or 15% increase71% decrease in our BioSystemsNucleic Acids operating segment offset by a $1.84$0.88 million or 64% decrease33% increase in our Nucleic AcidsBioSystems operating segment. The overall decrease was primarily attributable to the sale of our oligonucleotide facility and from termination of associated personnel and the elimination of facilities related costs in conjunction with our 2004 Restructuring Plan.

 

Gross profit was $3.18$3.95 million or 42%45% of total net sales during the secondthird quarter of 2005 compared to $3.15$1.34 million and 35%16% during the same period of 2004. A summary of gross profit by operating segment follows (dollars in thousands):

 

  Quarter Ended June 30,

   Quarter Ended September 30,

 
  2005

 2004

   2005

 2004

 
  Gross
Profit/(Loss)


 Percent of
Revenue


 Gross
Profit/(Loss)


 Percent of
Revenue


   Gross
Profit


  Percent of
Revenue


 Gross
Profit/(Loss)


 Percent of
Revenue


 

BioSystems operating segment

  $3,488  46% $3,598  40%  $3,118  47% $2,840  52%

Nucleic Acids operating segment

   (305) (4)%  (445) (5)%   827  41%  (1,503) (56)%
  


 

 


 

  

  

 


 

  $3,183  42% $3,153  35%  $3,945  45% $1,337  16%
  


 

 


 

  

  

 


 

 

The increasedecrease in BioSystems operating segment gross profit as a percentagepercent of revenue to 46%47% from 40%52% for the quarters ended JuneSeptember 30, 2005 and 2004, respectively, is largely attributable to changes in the composition of products sold. Generally, sales of WAVEs and ancillary instrumentation generate higher gross profits than sales of third party platforms. Sales of specialty consumables (SURVEYOR Nuclease, HPLC separation columns, etc.) generate higher gross profits than base buffers and enzymes. Gross profits from discovery services are currently less than expected due to the continuing build out of capacity and expansion of product offerings. Our Nucleic Acids operating segment continues to have excess capacity in its Glasgow, Scotland manufacturing facility that will adversely impact costs of goods sold and gross profit until demand for our Nucleic Acids building block products increase.

 

Selling, General and Administrative Expenses. Selling, general and administrative expenses primarily include personnel costs, marketing, travel and entertainment costs, professional fees, and facility costs. These costs totaled $3.54$2.89 million during the quarter ended JuneSeptember 30, 2005 compared to $4.27$4.35 million during the same period of 2004, a decrease of $0.73$1.47 million or 17%34%. As a percentage of net sales, selling, general and administrative expenses totaled 33% and 53% during the quarters ended September 30, 2005 and 2004, respectively. This decrease resulted primarily from termination of associated personnel and the elimination of facilities related costs in conjunction with the 2004 Restructuring Plan, offsetPlan. Foreign currency transaction adjustments reduced operating expenses by the effects of unfavorable foreign currency transactions that totaled $0.23approximately $0.19 million and $0.01$0.26 million during the quartersthree months ended JuneSeptember 30, 2005 and 2004, respectively.2004. Depreciation expense included in selling, general and administrative expenses totaled $0.19$0.14 million and $0.25$0.27 million during the quarters ended JuneSeptember 30, 2005 and 2004, respectively.

 

As a percentage of revenue, selling, general and administrative expenses totaled just over 46% and 47% during the quarters ended June 30, 2005 and 2004, respectively.

Research and Development Expenses. Research and development expenses primarily include personnel costs, supplies, and facility costs. These costs totaled $0.58$0.51 million during the quarter ended JuneSeptember 30, 2005 compared to $1.67$1.74 million during the same period of 2004, a decrease of $1.09$1.23 million or 65%71%. The decrease resulted primarily from the 2004 Restructuring Plan, which resulted in the elimination of substantially all research and development efforts associated with our Nucleic Acids operating segment. Depreciation expense included in research and development expenses included $0.12$0.13 million and $0.22$0.25 million during the quarters ended JuneSeptember 30, 2005 and 2004, respectively.

 

As a percentage of revenue,net sales, research and development expenses totaled 8%6% and 19%21% of revenue during the quarters ended JuneSeptember 30, 2005 and 2004.2004, respectively. We expect to continue to invest a substantial portionup to 10% of our revenues in research and development activities primarily associated with our BioSystems operating segment. Research and development costs are expensed in the period in which they are incurred.

Impairment Charge. During the quarter ended September 30, 2005, we determined that certain international patent pursuits were no longer consistent with our strategic plan. Accordingly, we recorded an impairment charge of $247 related to the abandonment of such pursuits.

 

Other Income (Expense). Other income/(expense)expense during the quarter ended JuneSeptember 30, 2005 of $0.04$0.18 million consisted primarily of interest expense of $0.08 million and other income net of $.03 million.expense. Other expense during the quarter ended JuneSeptember 30, 2004 consisted of interest expense of $0.35$0.72 million, loss on debt extinguishment of $2.86 million and $0.10 million of other expense, net of $0.03 million, which consisted primarily of net investment losses associated with sales of Geron stock.

 

Interest expense consisted of the following (dollars in(in thousands):

 

  Quarter Ended June 30,

  

Quarter Ended

September 30,


  2005

 2004

  2005

 2004

Interest paid or accrued on outstanding debt

  $134  $152  $172  $494

Amortization of debt premiums

   (124)  —     (124)  —  

Amortization of debt discounts – warrants

   9   —     4   —  

Amortization of debt discount – beneficial conversion feature

   15   158   81   191

Other

   49   36   48   38
  


 

  


 

  $83  $346  $181  $723
  


 

  


 

 

The decrease in interest paid or accrued on outstanding debt resulted from lower average debt balances partially offset by higher interest rates. Gross debt (before related premiums and discounts) totaled $7.79$8.26 million at JuneSeptember 30, 2005 with an interest rate of 8.75% compared to $8.50 million at December 31, 2004.2004 with an interest rate of 7.25%. Our Laurus Loans had average balances during the quarters ended JuneSeptember 30, 2005 and 2004 of $7.65$8.07 million and $8.25$9.15 million, respectively, with weighted average interest rates of 8.00% and 6.00%, respectively. The high and low borrowings under our Credit Line during the quarter ended JuneSeptember 30, 2005 were $6.49$6.83 million and $5.26$5.88 million, respectively.

 

Income Tax Expense.Income tax recorded during the three months ended JuneSeptember 30, 2005 and 2004 related to income taxes in states, foreign countries and other local jurisdictions, offset by refunds received.

 

Due to the Company’s cumulative losses, expected losses in future years and inability to utilize any additional losses as carrybacks, the Company hasdid not provided for an income tax benefit during the three months ended JuneSeptember 30, 2005 or 2004 based on management’s determination that it was more likely than not that such benefits would not be realized. The Company will continue to assess the recoverability of deferred tax assets and the related valuation allowance. To the extent the Company begins to generate taxable income in future periods and it determines that such valuation allowance is no longer required, the tax benefit of the remaining deferred tax assets will be recognized at such time. As of JuneSeptember 30, 2005, the Company’s deferred tax assets were offset by a valuation allowance of approximately $39.7$41.2 million.

Results of Operations SixNine Months Ended JuneSeptember 30, 2005 and 2004

 

Amounts in thousands


  2005

  2004

  Change

 %
Change


 

Dollars in thousands


  2005

 2004

 Change

 %
Change


 

Net Sales

            

Bioinstruments

  $7,598  $7,833  $(235) (3)%  $11,343  $10,766  $577  5%

Bioconsumables

   4,767   4,229   538  13%   6,977   6,286   691  11%

Discovery Services

   1,451   886   565  64%   2,159   1,398   761  54%
  

  

  


 

  


 


 


 

Total BioSystems Business Unit

   13,816   12,948   868  7%   20,479   18,450   2,029  11%

Chemical Building Blocks

   1,189   3,308   (2,119) (64)%   3,232   5,588   (2,356) (42)%

Specialty Oligonucleotides and Services

   —     1,384   (1,384) (100)%   —     1,796   (1,796) (100)%
  

  

  


 

  


 


 


 

Total Synthetic Nucleic Acids Business Unit

   1,189   4,692   (3,503) (75)%   3,232   7,384   (4,152) (56)%
  


 


 


 

Total Net Sales

   15,005   17,640   (2,635) (15)%   23,711   25,834   (2,123) (8)%

Cost of Goods Sold

            

Bioinstruments

   3,578   3,203   375  12%   5,396   4,401   995  23%

Bioconsumables

   2,217   1,903   314  17%   3,334   2,981   353  12%

Discovery Services

   1,133   655   478  73%   1,744   1,041   703  68%
  

  

  


 

  


 


 


 

Total BioSystems Business Unit

   6,928   5,761   1,167  20%   10,474   8,423   2,051  24%

Chemical Building Blocks

   1,920   2,794   (874) (31)%   3,135   5,452   (2,317) (43)%

Specialty Oligonucleotides and Services

   —     3,072   (3,072) (100)%   —     4,609   (4,609) (100)%
  

  

  


 

  


 


 


 

Total Synthetic Nucleic Acids Business Unit

   1,920   5,866   (3,946) (67)%   3,135   10,061   (6,926) 69%
  


 


 


 

Total Cost of Goods Sold

   8,848   11,627   (2,779) (24)%   13,609   18,484   (4,875) (26)%

Selling, General and Administrative Expenses

   7,138   8,513   (1,375) (16)%   10,023   12,866   (2,843) (22)%

Research and Development Expenses

   1,186   3,601   (2,415) (67)%   1,696   5,344   (3,648) (68)%

Impairment Charges

   —     11,964   (11,964) (100)%   247   11,964   (11,717) (98)%

Other Income (Expense)

   (1,888)  (4,704)  (2,816) (60)%

Net Sales. Net sales for the sixnine months ended JuneSeptember 30, 2005 decreased $2.64$2.12 million or 15%8% from the same period of 2004 as a result of a $0.87$4.15 million or 7% increase56% decrease in net sales infrom our BioSystemsNucleic Acids operating segment offset by a $3.50$2.03 million or 75% decrease11% increase in net sales in our Nucleic AcidsBioSystems operating segment.

 

The increase in net sales in our BioSystems operating segment resulted from a decreasean increase of $0.24$0.58 million or 3%5% from bioinstruments, increases in sales of bioconsumables of $0.54$0.69 million or 13%11% from bioconsumables, and increases from Discovery Services of $0.57$0.76 million or 64%.54% from discovery services. WAVE Systems sold totaled 4876 during the sixnine months ended JuneSeptember 30, 2005 compared to 6685 during the same period of 2004. The selling prices of our instruments vary based on the specific model and optional accessories. We had an installed base of approximately 1,269 units at September 30, 2005 compared to 1,193 units at December 31, 2004. The increase in the installed base of instruments continues to drive increases in sales of bioconsumables used with these instruments. The increase in Discovery Servicesdiscovery services revenue during 2005 was primarily attributable to the discovery services agreements that we entered into with Novartisa large pharmaceutical company to support their clinical development of oncology therapeutics. During the sixnine months ended JuneSeptember 30, 2005, Discovery Servicesdiscovery services sales to Novartisthis customer totaled $1.41$2.01 million and represented 10% of net sales within the BioSystems operating segment and 9% of total consolidated net sales. We have no long-term agreement with Novartis,customer, therefore, Salessales will fluctuate and may be zero. Future revenues from our Nucleic Acids operating segment would be substantially reduced if Geron’s need for our products declined. Future revenues from our BioSystems operating segment would be substantially reduced if Novartis’sthis customer’s need for our products declined.

 

Nucleic Acids operating segment sales decreased by $3.50$4.15 million or 75%56% during the sixnine months ended JuneSeptember 30, 2005 compared to the same period of 2004 as a result of fewer chemical building block sales to Geron and the sale of our specialty oligonucleotides facility in Boulder, Colorado. Net sales to Geron during the sixnine month ended JuneSeptember 30, 2005 totaled $0.10$1.73 million compared to $1.90$3.59 million during the same period of 2004. Net sales to Geron during the sixnine months ended JuneSeptember 30, 2005 represented 8%54% of net sales in our Nucleic Acids operating segment and did not represent a significant portion7% of total consolidated net sales. Net sales to Geron during the sixnine months ended JuneSeptember 30, 2004, represented 18%49% of net sales within our Nucleic Acids operating segment and 11%14% of total consolidated net sales. We have no long-term agreement with Geron, therefore, sales will fluctuate and may be zero. Future revenue from our Nucleic Acids operating segment would be substantially reduced if Geron’s need for our products declined. As a result of the sale of our facility in Boulder, Colorado, net sales of specialty oligonucleotides decreased by $1.38$1.80 million. We no longer manufacture or sell oligonucleotides

oligonucleotides.

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 and supplies) associated with our Discovery Services operations. Depreciation expense included in costs of goods sold totaled $1.14$2.23 million and $1.15$2.22 million during the sixnine months ended JuneSeptember 30, 2005 and 2004, respectively.

 

Costs of goods sold during the sixnine months ended JuneSeptember 30, 2005 decreased $2.78$4.88 million or 24%26% from the same period of 2004 as a result of a $1.17$6.93 million or 20% increase in our BioSystems operating segment and a $3.95 million or 67%69% decrease in our Nucleic Acids operating segment offset by a $2.05 million or 24% increase in our BioSystems operating segment. The overall decrease was primarily attributable to the sale of our oligonucleotide facility and from termination of associated personnel and the elimination of facilities related costs in conjunction with our 2004 Restructuring Plan.

Gross profit was $6.16$10.10 million or 41%43% of total net sales during the sixnine months ofended September 30, 2005 compared to $6.01$7.35 million and 34%28% during the same period of 2004. A summary of gross profit by operating segment follows (dollars in thousands):

 

  Six Months Ended June 30,

   Nine Months Ended September 30,

 
  2005

 2004

   2005

 2004

 
  Gross
Profit (Loss)


 Percent of
Revenue


 Gross
Profit (Loss)


 Percent of
Revenue


   Gross
Profit


  Percent of
Revenue


 Gross
Profit/(Loss)


 Percent of
Revenue


 

BioSystems operating segment

  $6,888  46% $7,187  41%  $10,005  49% $10,027  54%

Nucleic Acids operating segment

   (731) (5)%  (1,174) (7)%   97  3%  (2,677) (36)%
  


 

 


 

  

  

 


 

  $6,157  41% $6,013  34%  $10,102  43% $7,350  28%
  


 

 


 

  

  

 


 

 

The increasedecrease in BioSystems operating segment gross profit as a percentagepercent of revenue to 46%49% from 41%54% for the sixnine months ended JuneSeptember 30, 2005 and 2004, respectively, is largely attributable to changes in the composition of products sold. Generally, sales of WAVEs and ancillary instrumentation generate higher gross profits than sales of third party platforms. Sales of specialty consumables (SURVEYOR Nuclease, HPLC separation columns, etc.) generate higher gross profits than base buffers and enzymes. Gross profits from discovery services are currently less than expected due to the continuing build out of capacity and expansion of product offerings. Our Nucleic Acids operating segment continues to have excess capacity in its Glasgow, Scotland manufacturing facility that will adversely impact costs of goods sold and gross profit until demand for our Nucleic Acids building block products increase.

 

Selling, General and Administrative Expenses. Selling, general and administrative expenses primarily include personnel costs, marketing, travel and entertainment costs, professional fees, and facility costs. These costs totaled $7.14$10.02 million during the sixnine months ended JuneSeptember 30, 2005 compared to $8.51$12.87 million during the same period of 2004, a decrease of $1.37$2.85 million or 16%22%. This decrease related primarily to the 2004 Restructuring Plan, offset by the effects of unfavorable foreign currency transactions that totaled $0.43 million and $0.12 million during the six months ended June 30, 2005 and 2004, respectively. Depreciation expense included in selling, general and administrative expenses totaled $0.36 million and $0.52 million during the six months ended June 30, 2004 and 2004, respectively.

As a percentage of revenue, selling, general and administrative expenses totaled just over 48%42% and 50% during the sixnine months ended JuneSeptember 30, 2005 and 2004.2004, respectively. This decrease resulted primarily from termination of associated personnel and the elimination of facilities related costs in conjunction with the 2004 Restructuring Plan. Foreign currency transaction adjustments increased operating expenses by approximately $0.24 million during the nine months ended September 30, 2005 compared to the same period of 2004 when foreign currency transaction adjustments reduced operating expenses by approximately $0.14 million. Depreciation expense included in selling, general and administrative expenses totaled $0.50 million and $0.74 million during the nine months ended September 30, 2004 and 2004, respectively.

 

Research and Development Expenses. Research and development expenses primarily include personnel costs, supplies, and facility costs. These costs totaled $1.19$1.70 million during the sixnine months ended JuneSeptember 30, 2005 compared to $3.60$5.34 million during the same period of 2004, a decrease of $2.41$3.65 million or 67%68%. The decrease related primarily to the 2004 Restructuring Plan, which resulted in the elimination of substantially all research and development efforts associated with our Nucleic Acids operating segment. Depreciation expense included in research and development expenses included $0.25$0.42 million and $0.43$0.75 million during the sixnine months ended JuneSeptember 30, 2005 and 2004, respectively.

 

As a percentage of revenue, research and development expenses totaled 8%7% and 20%21% of revenue during the sixnine months ended JuneSeptember 30, 2005 and 2004, respectively. We expect to continue to invest a substantial portionup to 10% of our revenues in research and development activities primarily associated with our BioSystems operating segment. Research and development costs are expensed in the year in which they are incurred.

 

Impairment Charges.During the nine months ended September 30, 2005, we determined that certain international patent pursuits were no longer consistent with our strategic plan. Accordingly, we recorded an impairment charge of $247 related to the abandonment of such pursuits.

During the second quarter of 2004, our Board of Directors directed us to explore strategic alternatives for the Nucleic Acids operating segment. The process included significant due diligence by us, our advisors and prospective independent buyers and other interested parties. Based upon information obtained through this process, we determined that it was more likely than not that the value of the assets associated with this business was impaired. We engaged an external valuation firm to assist us in conducting an interim period impairment test that resulted in us recording a non-cash charge of $11.96 million related to these assets during the nine months ended September 30, 2004. The charge consisted of $9.87 million related to the impairment of goodwill and $2.10 million related to the impairment of property and equipment.

Other Income (Expense). Other expense during the sixnine months ended JuneSeptember 30, 2005 of $1.70$1.89 million consisted of interest expense of $1.74$1.92 million and other income net of $.04$0.03 million. Other expense during the sixnine months ended JuneSeptember 30, 2004 consisted of interest expense of $0.94$1.68 million, loss on debt extinguishment of $2.86 million and other income netexpense of $0.07$0.16 million, which consisted primarily of net investment losses associated with sales of Geron stock.

Interest expense consisted of the following (dollars in(in thousands):

 

  Six months Ended June 30,

  

Nine months Ended

September 30,


  2005

 2004

  2005

 2004

Interest paid or accrued on outstanding debt

  $305  $237  $477  $761

Amortization of debt premiums

   (692)  —     (816)  —  

Amortization of debt discounts – warrants

   20   —     24   —  

Amortization of debt discount – beneficial conversion feature

   644   618   725   809

Valuation charge associated with March 2005 conversions

   1,365   —     1,365   —  

Other

   96   80   144   114
  


 

  


 

  $1,738  $935  $1,919  $1,684
  


 

  


 

 

The increase in interest paid or accrued on outstanding debt resulted from higher average debt balances and interest rates. Gross debt (before related premiums and discounts) totaled $7.79$8.26 million at JuneSeptember 30, 2005 with an interest rate of 8.75% compared to $8.50 million at December 31, 2004.2004 with an interest rate of 7.25%. During the sixnine months ended JuneSeptember 30, 2005 and 2004, we had average debt of $8.01$8.03 million and $7.01$7.81 million, respectively, with weighted average interest rates of 7.67% and 6.0%, respectively. The high and low borrowings under our Credit Line during the sixnine months ended JuneSeptember 30, 2005 were $6.90 million and $4.75 million, respectively.

 

On March 18, 2005, the Company agreed to allow Laurus to convert $1.88 million of the outstanding principal balance under the Credit Line into 3,600,000 shares of its common stock at $0.52 per share. In addition, on March 24, 2005 the Company agreed to allow Laurus to convert $0.65 million of the outstanding principal balance of the Term Note into 1,250,000 shares of common stock at $0.52 per share. Laurus agreed to apply this Term Note conversion against substantially all remaining 2005 scheduled principal payments on such loan. The closing market price of the Company’s common stock the day before each of these conversions was $0.58 per share. No other provisions of our Credit Line or Term Note were modified, including the $1.00 conversion price for remaining debt. In conjunction with these conversions we accelerated amortization of $0.41 million of related debt premiums and discounts and recorded a charge of $1.37 million related to the fair value of incremental shares received by Laurus.

 

Loss on debt extinguishment totaled $2.86 million during the nine months ended September 30, 2004. As described in Note E to the accompanying consolidated financial statements, certain August 31, 2004 modifications to our Laurus Loans were treated as extinguishments for financial reporting purposes since the change in present value of expected cash flows between the original and modified agreements was greater than 10%. As such, we recorded a loss on extinguishment of debt of $2.86 million at August 31, 2004 reflecting the difference between (i) the recorded amount of debt, net of related discounts, of $7.43 million and (ii) the fair value of the new debt instrument of $10.29 million plus the fair value of the new warrants of $0.11 million. The difference between the fair value of the new debt of $10.29 million and the face value of the debt of $8.57 million represents a premium, which will be reflected as a reduction of interest expense over the life of the new debt.

Income Tax Expense.Income tax recorded during the sixnine months ended JuneSeptember 30, 2005 and 2004 related to income taxes in states, foreign countries and other local jurisdictions, offset by refunds received.

 

Due to the Company’s cumulative losses, expected losses in future years and inability to utilize any additional losses as carrybacks, the Company hasdid not provided for an income tax benefit during the sixnine months ended JuneSeptember 30, 2005 or 2004 based on management’s determination that it was more likely than not that such benefits would not be realized. The Company will continue to assess the recoverability of deferred tax assets and the related valuation allowance. To the extent the Company begins to generate taxable income in future periods and it

determines that such valuation allowance is no longer required, the tax benefit of the remaining deferred tax assets will be recognized at such time. As of JuneSeptember 30, 2005, the Company’s deferred tax assets were offset by a valuation allowance of approximately $39.7$41.2 million.

 

Liquidity and Capital Resources

 

Our working capital positions at JuneSeptember 30, 2005 and December 31, 2004 were as follows (amounts are in(in thousands):

 

  

June 30,

2005


  

December 31,

2004


 Change

   

September 30,

2005


  

December 31,

2004


 Change

 

Current assets(1)

  $15,893  $17,908  $(2,015)  $16,399  $17,908  $(1,509)

Current liabilities

   15,712   18,724   (3,012)   14,986   18,724   (3,738)
  

  


 


  

  


 


Working Capital

  $181  $(816) $997   $1,413  $(816) $2,229 
  

  


 


  

  


 



(1)Current assets include cash and cash equivalents of $1.71$1.32 million and $1.00 million at June 30, 2005 and December 31, 2004, respectively. We had $1.38 million and $1.55 million available under our Credit Line at JuneSeptember 30, 2005 and December 31, 2004, respectively.

The improvement in our working capital position during the first sixnine months of 2005 was due primarily to conversions of $2.58 million of borrowings under our Laurus Loans into shares of our common stock.

While we expect We had $0.91 million available under our existing sources of liquidity to be sufficient to meet our cash needs for the remainder of 2005 and beyond, there can be no assurances that they will be, especially if we do not generate net positive cash flows from operations. It is essential that we achieve revenue growth in our BioSystems operating segment and manage costs according to our existing plan. Our projected liquidity needs may or may not be realized based upon actual operating results and capital project requirements. Accordingly, if our existing cash balances, cash generated by operations, and available borrowings under the Credit Line are insufficientat September 30, 2005. On October 31, 2005, we closed the private placement of securities to satisfy our liquidity requirements, we may need to sell additional equity or debt securities or obtain additional credit arrangements, sell certain assets or further reduce expenses. We are monitoring our liquidity position and are prepared to take appropriate measures, as needed, to address liquidity. We cannot assure youinstitutional investors that any financing arrangement will be availableresulted in amounts or on terms acceptable to us. Our failure to raise additional capital, if needed, would harm our financial condition, results of operations and our business.

Laurus Loans. The Credit Line is a $7.50 million line of credit that we entered into with Laurus in December 2003. The term of the Credit Line is three years carrying an interest rate of 2.0% over the prime rate or a minimum of 6.0% (8.00% at June 30, 2005). Funds available under the Credit Line are determined by a borrowing base equal to 90% of eligible accounts receivable balances plus up to $1.00 million related to inventory balances. The Credit Line is secured by most of our assets. Prior to amendmentsgross proceeds to the Credit Line discussed below, paymentCompany of interest and principal could, under certain circumstances, be made with shares$15.08 million. The securities sold in the private placement consisted of our common stock at a fixed conversion price of $2.20 per share. Conversion of this debt to common stock may be made at the election of Laurus or the Company. We could elect to convert only if our shares trade at a price exceeding $2.42 per share for ten consecutive trading days, and such conversion is further subject to trading volume limitations and a limitation on the total beneficial ownership by Laurus of our common stock. Upon entering into the Credit Line, we issued warrants to Laurus to acquire 550,000(i) 14,925,743 shares of the ourCompany’s common stock, atand (ii) five-year, non-callable warrants to purchase another 5,970,297 shares of common stock with an exercise price exceedingof $1.20 per share. The aggregate purchase price for the average trading pricesecurities sold in the private placement was $1.01 per share of our common stock overinitially being sold. Contemporaneously with the ten trading days prior to the dateclosing of the warrant.

In February 2004,private placement, we entered into the $2.75 million Term Note with Laurus. The Term Note carries an interest rate of 2.0% over the prime rate or a minimum of 6.0% (8.00% at June 30, 2005) and has a term of 3 years. Prior to amendments to the Term Note discussed below, therepaid all outstanding principal and accrued interest on the Term Note could be converted into our common stock at a fixed conversion price of $2.61 per share. Upon entering into the Term Note, we issued warrants to Laurus to acquire 125,000 shares of our common stock. Borrowings under the Term Note were primarily used to retire the mortgage debt on our Glasgow, Scotland facility. Remaining borrowings of approximately $0.75 million were used to complete the build-out of the Glasgow facility, complete the consolidation our Glasgow operations into the new facility and provide funds for operations.

In February 2004, Laurus waived the borrowing base limitation on the Credit Line, thereby making the full $7.50 million facility available to us regardless of the available collateral. On August 31, 2004, Laurus agreed to extend the borrowing base waiver on the Credit Line through March 19, 2005. In addition, Laurus deferred certain payments due under the Term Note and reduced the interest rate on both of the Laurus Loans, including fees to 0% for any dayfacilitate the closing sale price of our common stock is at or above $1.75 per share. In return, we lowered the conversion price on each of the Laurus Loans to $1.00 per shareprivate placement and issued a warrantprepayment penalties to Laurus covering an additional 400,000 common shares at an exercise pricein the sum of $1.25 per share. The closing price of our common stock on August 31, 2004 was $1.20 per share.

On March 18, 2005, Laurus agreed to extend the borrowing base waiver on$0.82 million. As a result, the Credit Line until March 31, 2006. In connection with this waiver,Laurus has been cancelled and is no longer available to the Company.

While we agreedbelieve that existing sources of liquidity are sufficient to allow Laurusmeet expected cash needs through 2006, we have experienced recurring net losses and have historically relied upon cash flows from investing and financing activities to convert $1.87 millionoffset significant cash outflows from operating activities. To the extent necessary, we believe that we can manage costs and expenses at reduced levels to conserve working capital. The need for any such cost and expense reductions would likely delay implementation of our business plan. Ultimately, we must achieve sufficient revenues in order to generate positive net earnings and cash flows from operations.

The following shows the actual and as adjusted effects of the outstanding principalprivate placement and debt repayment on the Company’s September 30, 2005 consolidated balance undersheet as if the Credit Line into 3,600,000 shares of our common stock at $0.52 per share. In addition,transaction had occurred on March 24,September 30, 2005 we agreed to allow Laurus to convert $0.65 million of the outstanding principal balance of the Term Note into 1,250,000 shares of our common stock at $0.52 per share. Laurus agreed to apply this Term Note

conversion against substantially all remaining 2005 scheduled principal payments on such loan. The market price of our common stock on March 18 and 24, 2005 was $0.58. No other provisions of our loans with Laurus were modified, including the $1.00 conversion price on remaining debt.(in thousands).

 

   September 30, 2005

 
   Actual

  As Adjusted

 

Cash and cash equivalents

  $1,322  $ 6,696(1)(3)
   

  


Line of credit

  $6,935  $—  (1)(2)
   

  


Current portion of long-term debt

  $675  $ —  (1)(2)
   

  


Long-term debt

  $1,226  $ —  (1)(2)
   

  


Total stockholder’s equity

  $15,662  $ 29,415(1)(2)(3)
   

  



(1)Net proceeds from the private placement (after transaction costs of $1.18 million,) totaled $13.90 million and were used in part to prepay all indebtedness and prepayment fees to Laurus totaling $8.52 million. The remaining proceeds of $5.37 million will be used for the future working capital needs of the Company. Transaction costs included fees to Oppenheimer of $1.06 million and other transaction specific costs of approximately $0.13 million.
(2)The as adjusted presentation assumes that net premiums related to the Laurus Loans totaling $0.57 million at September 30, 2005 will result in a gain upon prepayment of these loans. This gain will be offset by fees to Laurs of $0.50 million to facilitate the private placement and prepayment penalties of $0.32 million.
(3)At November 14, 2005, we have 49,172,079 shares outstanding and 13,603,592 potentially dilutive securities consisting of 5,541,015 options issued under our stock option plan and warrants representing 8,062,577 shares.

Analysis of Cash Flows

 

Net Change in Cash and Cash Equivalents.Cash and cash equivalents increased $0.71$0.32 million during the sixnine months ended JuneSeptember 30, 2005 as a result of net cash from investing activities and financing activities of $0.08$0.24 million and $1.88$2.35 million, respectively, offset by net cash used in operating activities of $1.17$2.06 million, and changes in foreign currency exchange rates of $0.08$0.21 million.

 

Cash Flows from Operating Activities. Cash flows used in operating activities totaled $1.17$2.06 million during the sixnine months ended JuneSeptember 30, 2005 compared to $7.0$8.71 million during the same period of 2004. The use in 2005 related primarily to a net loss of $3.89$3.78 million offset by non-cash charges of $3.53$4.59 million. Non-cash charges consisted primarily of depreciation and amortization and certain financing costs. Working capital and other adjustments decreased cash flows from operating activities by $0.81$2.87 million. We spent $1.33$1.54 million during the sixnine months ended JuneSeptember 30, 2005 related to the 2004 Restructuring Plan. We had accrued expenses associated with this plan of $0.58$0.37 million at JuneSeptember 30, 2005. This balance relates primarily to future rents on closed facilities (net of projected sublease rents) of which $0.28$0.03 million is expected to be paid during the remainder of 2005 and $0.27$0.34 million in 2006 and thereafter.

 

Cash Flows from Investing Activities. Cash flows provided by investing activities totaled $0.84$0.24 million during the sixnine months ended JuneSeptember 30, 2005 compared to cash flows used in investing activities of $0.20$1.54 million during the same period of 2004. The useprincipal source of cash flows from investing activities in 2005 related primarily towere sales of available for sale securities (Geron stock) of $0.62 million that were offset by purchases totaling $0.67of $0.55 million of property and equipment primarily associated with the build out of our Glasgow, Scotland manufacturing facility that is substantially complete, offset by sales of available for sale securities (Geron stock) of $0.62 million. We do not anticipate this level of capital expenditures to recur during any remaining quarter in 2005.complete. We currently estimate that consolidated capital expenditures will not exceed $0.50$0.25 million for the remainder of 2005.

 

Cash Flows from Financing Activities. Cash flows from financing activities totaled $1.88$2.35 million during the sixnine months ended JuneSeptember 30, 2005 compared to $6.65$7.19 million during 2004. The principal source of cash flows from financing activities in 2005 related primarily towas net draws on our Credit Line that were offset by payments on our Term Note. There are no scheduled principal payments for the remainder of 2005 on our Term Note.

 

Obligations and Commitments

 

Our ongoing capital commitments consist of debt service requirements and obligations under capital leases. The following table sets forth our contractual obligations as of JuneSeptember 30, 2005 along with cash payments due in each period indicated:indicated (in thousands):

 

  Payments Due by Period

  Total

  2005

  2006

  2007

  2008

  2009 and
thereafter


  Payments Due by Period

  In Thousands  Total

  2005

  2006

  2007

  2008

  2009 and
thereafter


Credit Line(1)

  $6,119  $6,119  $—    $—    $ —    $ —    $6,119  $6,119  $—    $—    $—    $—  

Term Note(1)

   1,675   —     875   800   —     —     1,675   —     875   800   —     —  

Operating lease payments(2)

   4,178   1,964   1,230   441   187   356   2,584   359   1,233   443   189   360

Purchase obligations

   468   468   —     —     —     —     872   248   370   254   —     —  
  

  

  

  

  

  

  

  

  

  

  

  

Total contractual obligations

  $12,440  $8,551  $2,105  $1,241  $187  $356  $11,250  $6,726  $2,478  $1,497  $189  $360
  

  

  

  

  

  

  

  

  

  

  

  


(1)Interest payments underIn conjunction with the Laurus Loans are paid monthly based on outstanding debtprivate placement that was consummated subsequent to September 30, 2005, we repaid the Term Note and prevailing interest rates.repaid and terminated the Credit Line. We currently expect to pay totalhave no significant indebtedness that requires scheduled principal and interest on these loans of between $0.50 million and $0.60 million for the remainder of 2005. This interest is not included in this table.payments.

(2)These are gross lease commitments. Certain facilities underlying these commitments are sublet to independent third parties. Annual rents from these subtenants are expected to total $0.32$0.04 million, $0.17 million, and $0.02 million in for the remainder of 2005, 2006 and thereafter, respectively.
(3)At June 30, 2005, we had firm commitments totaling $0.47 million to Hitachi High Technologies America to purchase components used in our WAVE Systems. These commitments will be fulfilled during 2005.

 

At September 30, 2005, we had firm commitments totaling $0.88 million to purchase components used in our WAVE Systems.

Off Balance Sheet Arrangements

 

At JuneSeptember 30, 2005 and December 31, 2004, 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

 

Accounting policies used in the preparation of the consolidated financial statements may involve the use of management judgments and estimates. Certain of the Company’s accounting policies are considered critical as they are both important to the portrayal of the Company’s 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 judgment or estimates may vary under different assumptions or circumstances. The Company’s critical accounting policies are discussed in our annual report on Form 10-K, as amended, for the year ended December 31, 2004. There have been no significant changes with respect to these estimates during the sixnine months ended JuneSeptember 30, 2005.

 

Recently Issued Accounting Pronouncements

 

On December 16, 2004, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (“SFAS”) No. 123R, Share-Based Payment.“Share-Based Payment”. SFAS No.123R addresses the accounting for share-based payment transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise’s equity instruments or that may be settled by the issuance of such equity instruments. SFAS No. 123R eliminates the ability to account for share-based compensation transactions using Accounting Principles Board Opinion No. 25 and generally requires that such transactions be accounted for using a fair-value-based method. We expect to adopt this standard on January 1, 2006. We are currently assessing the final impact of this standard on our financial position, results of operations or cash flows. This assessment includes evaluating option valuation methodologies and assumptions as well as potential changes to compensation strategies.

 

On November 24, 2004, the FASB issued SFAS No. 151, Inventory“Inventory Costs – an amendment of ARB No. 43.43”. SFAS No. 151 requires idle facility expenses, freight, handling costs, and wasted material (spoilage) costs to be excluded from the cost of inventory and expensed when incurred. It also requires that allocation of fixed production overhead to be based on the normal capacity of the production facilities. SFAS No. 151 will be effective atfor the beginning ofCompany on January 1, 2006. We are currently assessing the final impact of this standard on our financial position, results of operations or cash flows.

 

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.

Foreign Currency Rate Fluctuations

 

During the last three fiscal years, our international sales have represented approximately 50-65% of our net sales. These sales of products in foreign countries are mainly completed in either British Pounds Sterling or the Euro. Additionally, we have two wholly owned subsidiaries, Transgenomic, LTD., and Cruachem, LTD., whose operating currency is British Pounds Sterling and the Euro. 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 on the balance sheet dates. As a result we are subject to exchange rate risk. The operational expenses of our foreign subsidiaries help to reduce the currency exposure we have based on our sales denominated in foreign currencies by converting foreign currencies directly into goods and services. As such, we feel do not have a material exposure to foreign currency rate fluctuations at this time.

Forward-looking Information

 

This report contains a number of “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Many of these forward-looking statements refer to our plans, objective, expectations and intentions, as well as our future financial results. You can identify these forward-looking statements by forward-looking words such as “expects,” “anticipates,” “intends,” “plans,” “may,” “will,” “believes,” “feels,” “seeks,” “estimates,” and similar expressions. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Such factors would include the growth of the markets for DNA analysis technology and consumable products, the acceptance of our technology, our ability to continue to improve our products, the development of competing technologies, and our ability to protect our intellectual property rights.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

OurPreviously, our principal market risk was interest rate risk on our variable-rate borrowings under the Laurus Loans. Subsequent to September 30, 2005, we repaid the entire principal balance of the Laurus Loans carry a variablewith the proceeds from the private placement and have terminated these loans. Accordingly, we no longer have any borrowings which subject us to material interest rate of 2% over the prime rate or a minimum of 6% (8.00% at June 30, 2005), and therefore, expose us to interest rate risk. Based on the outstanding balance of these loans at June 30, 2005 of $6.91 million, a 1% increase in the prime rate would increase our interest expense by approximately $0.07 million annually.

 

Item 4. Controls and Procedures

 

(a)Evaluation of Disclosure Controls and Procedures. A review and evaluation was performed by the Company’s management, including the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as defined in 240.13a-15(e) or 240.15d-15(e) as of the end of the period covered by this quarterly report. Based on that review and evaluation, the CEO and CFO concluded that the Company’s current disclosure controls and procedures, as designed and implemented, were effective in assuring that information required to be disclosed is recorded, processed, summarized and reported in the reports the Company submits under the Securities Exchange Act of 1934.

A review and evaluation was performed by the Company’s management, including the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), of the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of the end of the period covered by this quarterly report. Based on that review and evaluation, the CEO and CFO concluded that the Company’s current disclosure controls and procedures, as designed and implemented, were effective. There have been no changes in the Company’s internal control over financial reporting subsequent to the date of their evaluation. There were no material weaknesses identified in the course of such review and evaluation and, therefore, no corrective measures were taken by the Company.

(b)Change in Internal Control Over Financial Reporting. There have been no changes in the Company’s internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

The Company was named as a defendant in a lawsuit filed in Spain by a prospective distributor who claims that the Company breached a promise to grant the plaintiff a distributorship for certain of the Company’s products in a specific geographic area in Europe. The plaintiff was seeking monetary relief of approximately $500. During the three months ended June 30, 2005, a court dismissed this matter in favor of the Company.

The Company is subject to a number of other claims of various amounts, which arise out of the normal course of its business. In the opinion of management, the disposition of claims currently pending will not have a material adverse effect on the Company’s financial position, results of operations or cash flows after considering amounts already reflected in the consolidated financial statements.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

The Company made no repurchases of its common stock during the secondthird quarter of 2005; therefore, tabular disclosure is not presented.

Item 6. Exhibits

 

(a) Exhibits

(a)Exhibits

 

(3.1) SecondThird Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 2 to Amendment No. 1 to Registration Statement on Form S-1 (Registration No. 333-32174) as filed on May 17, 2000)
(3.2) Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to Registration Statement on Form S-1 (Registration No. 333-32174) as filed on March 10, 2000)
(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) as filed on March 10, 2000)
(31)(10.1) CertificationsForm of Securities Purchase Agreement by and between the Registrant and various counterparties dated September 22, 2005
(31.1)Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
(32)(31.2) CertificationsCertification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
(32.1)Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)
(32.2)Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350)

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: August 15,November 14, 2005 By: 

/s/ MICHAEL A. SUMMERS


    

Michael A. Summers

Chief Financial Officer

(authorized officer and principal financial officer)

 

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