UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-K

(Mark One)

 

x

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

For the fiscal year ended December 31, 20072010

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 91-1789357

(State or Other Jurisdiction of

Incorporation or Organization)

 

(IRS Employer

Identification Number)

12325 Emmet Street

Omaha, NE 68164

 68164
(Address of Principal Executive Offices) (Zip Code)

(402) 452-5400

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

 

Name of Each Exchange On Which Registered

None

 N/A

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, par value $.01 per share

(Title of Class)

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes                 No      X    

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.

Yes                 No      X    

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes      X         No          

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes     No 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K  Form10-K            

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

Large Accelerated Filer¨     Accelerated Filer¨     Non-Accelerated Filer¨     Smaller Reporting Companyx

(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2).

Yes                 No      X    

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant based on the last reported closing price per share of Common Stock as reported on the OTC Bulletin Board on the last business day of the registrant’s most recently completed second quarter was approximately $27.9$10.0 million.

At March 30, 2008,14, 2011, the registrant had 49,189,67249,299,672 shares of Common Stock outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant Proxy Statement relating to its 20082011 Annual Meeting of Stockholders (the “Proxy Statement”) have been incorporated into Part III of this Report on Form 10-K.

 

 

 


TRANSGENOMIC, INC.

Index to Form 10-K for the Fiscal Year Ended December 31, 20072010

 

PART I

      

Item 1.

Business

K-2
  

Item 1A.

1.
  

Risk FactorsBusiness

  K-6K-2
  

Item 1B.

1A.
  

Risk Factors

K-6
Item 1B.Unresolved Staff Comments

  K-11K-13
  

Item 2.

  

Properties

  K-11K-13
  

Item 3.

  

Legal Proceedings

  K-11K-14
  

Item 4.

  

Submission of Matters to a Vote of Security HoldersRemoved and Reserved

  K-11K-14

PART II

      
  

Item 5.

  

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

  K-12K-15
  

Item 6.

  

Selected Consolidated Financial Data

  K-13K-15
  

Item 7.

  

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

  K-14K-17
  

Item 7A.

  

Quantitative and Qualitative Disclosures About Market Risk

  K-26K-27
  

Item 8.

  

Financial Statements and Supplementary Data

Report of Independent Registered Public Accounting Firm

  K-27K-28
    

Consolidated Balance Sheets as of December 31, 20072010 and 20062009

 K-29
    

Consolidated Statements of Operations for the Years Ended December 31, 2007, 20062010 and 20052009

 K-30
    

Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2007, 20062010 and 20052009

 K-31
    

Consolidated Statements of Cash Flows for the Years Ended December 31, 2007, 20062010 and 20052009

 K-32
    

Notes to the Consolidated Financial Statements for the Years Ended December 31, 2007, 20062010 and 20052009

 K-33
  

Item 9.

9
  

Changes in and DisagreementDisagreements with Accountants on Accounting and Financial DisclosureDisclosures

  K-50K-57
  

Item 9AT.

9A.
  

Controls and Procedures

  K-50K-57
  

Item 9B.

  

Other Information

  K-52K-58

PART III

      
  

Item 10.

  

Directors, Executive Officers and Corporate Governance

  K-53K-59
  

Item 11.

  

Executive Compensation

  K-53K-59
  

Item 12.

  

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

  K-53K-60
  

Item 13.

  

Certain Relationships and Related Transactions, and Director Independence

  K-54K-60
  

Item 14.

  

Principal AccountantAccounting Fees and Services

  K-54K-60

PART IV

      
  

Item 15.

  

Exhibits, and Financial Statement Schedules

  K-54K-60

SIGNATURES

  K-58K-64

This Annual Report on Form 10-K references the following registered trademarks which are the property of Transgenomic:Transgenomic, Inc.: DNASEP® Columns,Cartidges, WAVE® System, WAVEMAKER® Software, TRANSFORMING THE WORLD® for Laboratory Equipment, TRANSGENOMIC® and the Globe Logo®; MutationDiscovery.com® Website, OLIGOSEP® Cartidges for Systems and Reagents, OPTIMASE® Polymerase, RNASEP® Columns, SURVEYOR®Cartidges, WAVE OPTIMIZED® reagents, and WAVE® MD Systems. Additionally, this Annual Report on Form 10-K references the following trademarks which are the property of Transgenomic: MitoScreenSystems, MitoScreen™ Kits, ProtocolWriterProtocolWriter™ Software, NavigatorNavigator™ Software, THE POWER OF DISCOVERY® for Lab Reagents and Educational Programs, and SurveyorSURVEYOR® Nuclease.Nuclease, andFAMILION®. All other trademarks or trade names referred to in this Annual Report on Form 10-K are the property of their respective owners.

PART I

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-Kreport, including Management’s Discussion & Analysis, contains or incorporates by reference certain forward-looking statements. ManyThese statements are based on management’s current views, assumptions or beliefs of these forward-looking statements refer to our plans, objectives, expectationsfuture events and intentions, as well as our future financial resultsperformance and are subject to riskuncertainty and uncertainty. You can identifychanges in circumstances. Readers of this report should understand that these statements are not guarantees of performance or results. Many factors could affect our actual financial results and cause them to vary materially from the expectations contained in the forward-looking statements. These factors include, among other things: our expected revenue, income (loss), receivables, operating expenses, supplier pricing, availability and prices of raw materials, Medicare/Medicaid/Insurance reimbursements, product pricing, foreign currency exchange rates, sources of funding operations and acquisitions, our ability to raise funds, sufficiency of available liquidity, future interest costs, future economic circumstances, industry conditions, our ability to execute our operating plans, the success of our cost savings initiatives, competitive environment and related market conditions, actions of governments and regulatory factors affecting our business and other risks as described in our reports filed with the Securities and Exchange Commission. In some cases these statements byare identifiable through the use of words such as “expects,“anticipate,“anticipates,“believe,“intends,“estimate,“plans,“expect,” “intend,” “plan,” “project,” “target,” “can,” “could,” “may,” “should,” “will,” “believes,” “seeks,” “estimates”“would” and similar expressions. Because

You are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements involvewe make are not guarantees of future performance and are subject to various assumptions, risks and uncertainties, there are manyother factors that could cause our actual results to differ materially from those expressed or impliedsuggested by these forward-looking statements. Actual results may differ materially from those suggested by the forward-looking statements that we make for a number of reasons including those discussed underdescribed in Item 1A, “Risk Factors”Factors,” and other factors identified by cautionary language used elsewhere in this report.

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

The following discussion should be read together with our financial statements and related notes contained in this report. Results for the Annual Report on Form 10-K.year ended December 31, 2010 are not necessarily indicative of results that may be attained in the future.

 

Item 1.

Our Business

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

Laboratory Services:

Molecular Clinical Reference Laboratory.    The molecular clinical reference laboratory specializes in genetic variation analyticaltesting for oncology, cardiology, hematology, inherited disorders and

diseases of aging. Located in New Haven, Connecticut and Omaha, Nebraska the molecular clinical reference laboratories are certified under the Clinical Laboratory Improvement Amendment (CLIA) as high complexity labs and our Omaha facility is accredited by CAP (College of American Pathologists).

Pharmacogenomics Research Services.    Pharmacogenomics research services toare provided by our Contract Research Organization located in Omaha, Nebraska. This lab specializes in pharmacogenomic, biomarker and mutation discovery research serving the medicalpharmaceutical and biomedical industries world-wide for disease research, drug and diagnostic development and clinical and pharmaceutical markets. Net sales are categorized as bioinstruments, bioconsumables and discovery services.trial support.

Instrument Related Business:

 

 

·

 

Bioinstruments.    Our flagshipproprietary product is the WAVE® System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There is a world-wideworldwide installed base of over 1,4001,500 WAVE Systems as of December 31, 2007.2010. We also distribute bioinstruments produced by other manufacturers (“OEM Equipment”) through our sales and distribution network. Service contracts to maintain installed systems are sold and supported by our technical support personnel.

 

 

·

 

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

·

Discovery Services.    Our Pharmacogenomics Research Service group is a contract research lab in Gaithersburg, Maryland that primarily provides genomic biomarker analysis services to pharmaceutical and biopharmaceutical companies to support preclinical and clinical development of targeted therapeutics. Our Molecular Clinical Reference Laboratory, in Omaha, Nebraska provides molecular-based testing for hematology, oncology and certain inherited diseases for physicians and third-party laboratories. The Molecular Clinical Reference Laboratory operates in a Good Laboratory Practices (“GLP”) compliant environment and is certified under the Clinical Laboratory Improvement Amendment.

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

Business Strategy

Since inception, ourOur business strategy has beenis to provide products and services to biomedical researchers, medical institutions, and diagnostic and pharmaceutical companies that are tied to advancements in the field of genomics.genomics and, increasingly, personalized medicine. Advances in genomics have fueled our efforts to understand individual differences in disease susceptibility, disease progression, and response to therapy. Accordingly, a principal component of our strategy has and continues to be to establish our WAVE System as an industry standard in the biomedical research market and to develop additional markets for the WAVE System such as clinical research and diagnostics. Through an expanding base of installed systems, we expect to increase the sales of consumable products used with theFor continued high quality support for our WAVE System and create opportunitiesassociated bioconsumables, we attained ISO90001:2000 certification for our Omaha manufacturing site in the fourth quarter of 2008 and have since been certified to market additional products to this customer base.the ISO9001:2008 standard in 2009.

Over the last yearfew years an increasingly important part of our strategy has shifted somewhatbeen to include another area of strategic focus that we believe can provide significant opportunity. Throughexpand our Discoverytwo Laboratory Services offerings, webusinesses. We have gained exposure to the translational and clinical research markets, laying the foundation for increasing our participation in the full valuefull-value chain associated with activities ranging from basic biomedical research to development of diagnostic and therapeutic products.products to increasing opportunities for developing and manufacturing companion diagnostics. During the fourth quarter of 2005, our laboratory in Omaha, Nebraska was certified under the Clinical Laboratory Improvement Amendments and we received our first patient samples for molecular-based testing for hematology, oncology and certain inherited diseases for physicians and third-party laboratories.laboratories to aid in patient diagnoses or pharmaceutical drug development and drug clinical trials. In

December of 2008 our Omaha laboratory was awarded an accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists (CAP) based on the results of an onsite inspection.

In December 2010 we acquired another CLIA certified laboratory in New Haven, Connecticut that specializes in genetic disorders associated with cardiomyopathies and channelopathies. We believe there is a significant opportunity for us to capitalize oncontinue growing the increasing demand for molecular-based personalized medicinetesting by leveraging on our technologies, experience and experience gained from the genomicexpertise in biomarker analysis that our Discovery Services Group has and willanalysis. In addition, we continue to provide to pharmaceuticalseek out and biopharmaceutical companies.

Significant Recent Events

We have continued to work to reduce operating costs

On February 20, 2007, we announced a cost reduction plan designed to alignevaluate new technologies and new laboratory tests that will further extend our cost structure with anticipated revenues. The closing of the Company’s Cramlington, England production facility was the principal component of this plan. All production is now being done in the United States at our Omaha, NE and San Jose, CA facilities. All administrative functions that were previously performed in France are now being performed in either the United States orofferings in our one remaining international site, Glasgow, Scotland. Restructure charges were $1.5 million for the year ended December 31, 2007, relating primarily to severance, benefitsMolecular Diagnostics Laboratory and facility closure costs.

Our stock has been delisted from the Nasdaq Capital Market and is now trading on the OTC Bulletin Board (OTCBB)

On February 1, 2007, we received a staff determination letter from Nasdaq’s Listing Qualifications Department indicating that we no longer met the minimum bid price requirement for continued listing on the Nasdaq Capital Market. As a result, our common stock on the Nasdaq Capital Market was ended on February 22, 2007. Trading information about our common stock became available on the OTC Bulletin Board beginning on February 26, 2007.Pharmacogenomics Services Lab.

Sales and Marketing

Our Laboratory Services sales team consists of regionally based sales people in the United States and Canada. We have sold our products to customers in over 50 countries. We use a direct sales and support staff for sales in the U.S., U.K. and most countries in WesternEurope. Our sales and support team consists of regionally-based sales people, service engineers and applications scientists to support our sales and marketing activities throughout the U.S. and Europe. For the rest of the world, we sell our products through dealers and distributors located in thosewithin local markets. We have over 35 dealers and distributors. We also maintain regionally-based technical support staffs and applications scientists to support our sales and marketing activities throughout the U.S. and Europe. The nature of our instruments and bioconsumables business does not generally lend itself to tracking and reporting sales backlog.

Customers

Physicians requesting testing for their patients are our primary source of laboratory services. Fees for laboratory testing services rendered for these physicians are billed either to the physician, to the patient or the patient’s third-party payer such as an insurance company, Medicare or Medicaid. Billings are typically on a fee-for-service basis. The patient or third-party payer is billed at the laboratory’s patient fee schedule, subject to third-party payer limitations. Revenues received from Medicare and Medicaid billings are based on government-set fee schedules and reimbursement rules.

Customers include numerous leading academic and medical institutions in the U.S. and abroad. In addition, our customers also include a number of large, established U.S. and foreign pharmaceutical, biotech and commercial companies.companies both in the U.S. and abroad. No customer accountsaccounted for more than 10% of our consolidated net sales.sales for the years ended December 31, 2010 and 2009. For the years ended December 31, 2010 and 2009 one customer made up 15% and 20% of the laboratory services net sales, respectively.

Research and Development

We will need to continue to invest in research and development activities in order to remain competitive and to take advantage of new business opportunities as they arise. Accordingly, weWe maintain an activea program of research and development with respect to bioinstruments, consumablesinstruments and discovery services. Areasservices, engaging existing and new technologies to create scientific and medical applications that will have significant commercial value. Major areas of focus include the improvement of the DNA separation media used in our WAVE System, the refinement of the hardware and software components of the WAVE System, the creation of unique enzymes and WAVE-Optimized enzymes, and the development of SURVEYOR based oncology mutation kits for therapeutic assessment of TKI inhibitors utilizing multiple instrument platforms; a new discovery in high sensitivity DNA mutation detection for Sanger Sequencing; development of ICE COLD PCR applications for ultra-high sensitivity mutation detection in tissue and blood; a “toolbox” of mitochondrial DNA assays onto assess damage, copy number, deletion and mutation for applications ranging from toxicology to diabetes to aging; and development of a biomarker for FC Gamma receptor to aid in the WAVE System. We have also focused on further refinements and process manufacturing improvementsselection of therapeutic options for our Surveyor DNA mismatch cutting enzyme. A significant area of research in discovery services is the area ofmonoclonal antibody cancer detection screening and mitochondrial disease diagnosis.drugs.

For the years ended December 31, 2007, 20062010 and 2005,2009, our research and development expenses were $3.0 million, $2.4$2.3 million and $2.2$3.2 million, respectively.

Manufacturing

We manufacture bioconsumable products including our separation columns, liquid reagents, and enzymes. The major components of our WAVE Systems are manufactured for us by a third party. We integrate our own hardware and software with these third party manufactured components. Our manufacturing facilities for our WAVE Systems and bioconsumables are located in Omaha, Nebraska and San Jose, California.

Intellectual Property

To establish and protect our proprietary technologies and products, we rely on a combination of patent, copyright, trademark and trade-secret laws, as well as confidentiality provisions in our contracts. We presently own rights to 68 issued patents and 14 pending applications in both the U.S. and abroad. Our WAVE System and related consumables are protected by patents and in-licensed technologies that expire in various periods beginning in 2013 through 2022.2030. On December 29, 2010 we acquired the FAMILION family of genetic tests. As part of the transaction, we acquired the exclusive rights to the FAMILION family of genetic tests for inherited disease, including the patents protecting this technology. We will continue to file patent applications and seek new licenses as warranted to protect and develop new technologies of interest to our customer base in the coming years.

Competition

The markets in which we operate are highly competitive and characterized by rapidly changing technological advances. A number of our competitors possess substantialsubstantially greater resources than us and are able to develop and offer a much greater breadth of products and/or services, coupled with significant marketing and distribution capabilities. We compete principally on the basis of uniquely enabling technical advantages in specific but significant market segments.

Our Laboratory Services division faces competition from a number of companies offering contract DNA sequencing and other genomic analysis services, including Genzyme, SeqWright and others. In addition, several clinical diagnostics service providers, such as Labcorp, Quest, Athena and Baylor College of Medicine, also offer related laboratory services. Finally, additional competition arises from academic core laboratory facilities. Competition for our WAVE Systems arises primarily from DNA sequencing and genotyping technologies. Competitors in these areas include Applied Biosystems, Idaho Technologies, Roche, Sequenom, and others. Competition for some of our non-WAVE consumable products comes from numerous well-diversified life sciences reagents providers, including, among others, Invitrogen, Qiagen, Roche, Stratagene, and Promega. Our discovery services face competition from a number of companies offering contract DNA sequencing and other genomic analysis services, including Genizon, Clinical Data, SeqWright and others. In addition, several clinical diagnostics service providers, such as Labcorp, Quest, Athena and Specialty Laboratories, also offer related laboratory services in support of clinical trials. Finally, additional competition arises from academic core laboratory facilities.

Employees

As of December 31, 2007, 20062010 and 2005,2009, we had employees focused in the following areas of our operation:

 

  December 31,  December 31, 
  2007  2006  2005  2010   2009 

Manufacturing

  30  47  56

Manufacturing and Laboratory

   62     36  

Sales, Marketing and Administration

  76  65  73   88     53  

Research and Development

  10  16  10   12     14  
                 
  116  128  139   162     103  

Personnel associated with discontinued operations

      17
                 
  116  128  156
         

Our employees were employed in the following geographical locations:

 

  December 31,  December 31, 
  2007  2006  2005  2010   2009 

United States

  89  84  94   136     78  

Europe (other than the United Kingdom)

  13  23  23   15     12  

United Kingdom

  14  21  39   10     13  

Canada

   1       
                 
  116  128  156   162     103  
                 

General Information

We were incorporated in Delaware on March 6, 1997. Our principal office is located at 12325 Emmet Street, Omaha, Nebraska 68164 (telephone: 402-452-5400). This facility houses our administrative staff and laboratories. We maintain manufacturing facilities in Omaha, Nebraska and San Jose, California. We maintain research and development offices in Gaithersburg, Maryland and Omaha, Nebraska. We maintain a CLIA laboratory in New Haven, Connecticut.

We make reports filed by us with the SEC available free of charge on our website as soon as reasonably practicable after these reports are filed. The address of our website iswww.transgenomic.com. Information on our website, including any SEC report, is not part of this Annual Report on Form 10-K.

Item 1A. Risk Factors

Risk Factors

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

We have historically operated at a loss and have not consistently generated sufficient cash from operating activities to cover our operating and other cash expenses. Whileexpenditures. On December 29, 2010 we have been able to historically finance our operating losses through borrowings oracquired the FAMILION family of genetic tests from the issuancePGxHealth, a subsidiary of additional equity, we currently have no plans to borrow additional funds or to issue additional equity securities for this purpose.Clinical Data. At December 31, 2007,2010, we had cash and cash equivalents of $5.7$3.5 million. While we believe that existing sources of liquidity are sufficient to meet expected cash needs through 2008,2011, we will need to increase our revenues or further reduce our operating expensesnet sales and successfully integrate the FAMILION acquisition in order to be assured of meeting our liquidity needs on a long-term basis. This acquisition was funded with debt and preferred stock. However, we cannot assure you that we will be able to increase our revenues ornet sales, further reduce our expenses, or raise further capital or equity and, accordingly, we may not have sufficient sources of liquidity to continue the operations of the Company indefinitely.

We have a history of operating losses and may incur losses in the future.

We have experienced annual losses from continuing operations since inception of our operations. Our losses from continuing operationsnet loss for the years ended December 31, 2007, 20062010 and 20052009 were $2.2 million, $3.0$3.1 million and $5.0$1.9 million, respectively. These historical losses have been due principally to the high levels of research and development expenses and sales and marketing expenses that we have incurred in order to develop and market our products, the fixed nature of our manufacturing costs, restructuring charges and impairment charges.charges and merger and acquisition costs. On December 29, 2010 we acquired the FAMILION family of genetic tests. The acquisition was completed due to the opportunity for synergies in combining the laboratories and potential for revenue growth. We will need to quickly and

successfully implement our integration plan to reduce the net loss in the future. In addition, markets for our products and services have developed more slowly than expected in many cases and may continue to do so. As a result, we may incur operating losses in the future.

Markets forWe may not have adequate top executive talent to execute our business plan.

Prior to the acquisition of FAMILION, in order to reduce our operating costs, we have reduced the number of employees in most areas of our business. In addition, we may lose key management, scientific, technical, sales and manufacturing personnel from time to time. It may be difficult to recruit and retain executive management if they are needed in the future, and the loss of top executive talent could harm our business and operating results. We cannot assure you that our employee reductions will not impair our ability to develop new products and refine existing products in order to remain competitive or meet our customers’ needs. In addition, these reductions could prevent us from successfully marketing our products and developing our customer base.

We might enter into new acquisitions that are difficult to integrate, disrupt our business, dilute stockholder value or divert management attention.

Our success will depend in part on our ability to continually enhance and broaden our product offerings in response to changing technologies, customer demands and competitive pressures. We expect to seek to acquire businesses, technologies or products that will complement or expand our existing business, including acquisitions that could be material in size and scope. Any acquisition we might make in the future might not provide us with the benefits we anticipated in entering into the transaction. Any future acquisitions involve various risks, including:

Difficulties in integrating the operations, technologies, products and personnel of the acquired entities;

The risk of diverting management’s attention from normal daily operations of the business;

Potential difficulties in completing projects associated with in-process research and development;

Risks of entering markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions;

Initial dependence on unfamiliar supply chains or relatively small supply partners;

Unexpected expenses resulting from the acquisition;

Potential unknown liabilities associated with acquired businesses;

Insufficient revenues to offset increased expenses associated with the acquisition; and

The potential loss of key employees of the acquired entities.

An acquisition could result in the incurrence of debt, restructuring charges and large one-time write-offs. Acquisitions also could result in goodwill and other intangible assets that are subject to impairment tests, which might result in future impairment charges. Furthermore, if we finance acquisitions by issuing convertible debt or equity securities, our existing stockholders may be diluted.

From time to time, we might enter into negotiations for acquisitions that are not ultimately consummated. Those negotiations could result in diversion of management time and potentially

significant out-of-pocket costs. If we fail to evaluate and execute acquisitions accurately, we could fail to achieve our anticipated level of growth and our business and operating results could be adversely affected.

Continued weakness in U.S. or global economic conditions could have an adverse effect on our businesses.

The economies of the United States and other regions of the world in which we do business have experienced significant weakness which, in the case of the U.S., has resulted in significant unemployment and slower growth in economic activity. A continued decline in economic conditions may adversely affect demand for our services and products, thus reducing our revenue. These conditions could also impair the ability of those with whom we do business to satisfy their obligations to us.

Sales of our Laboratory Services have been variable.

Laboratory Services include services performed by both our Molecular Clinical Reference Laboratory and our Pharmacogenomics Research Services. Testing volumes at the Molecular Clinical Reference Laboratory are dependent on patient visits to doctors’ offices and other providers of health care and tends to fluctuate on a seasonal basis. Testing volume generally declines during the year-end holiday periods, other major holidays and the summer. The Pharmacogenomics Research Services depends on project-based work that changes from quarter to quarter. Therefore, comparison of the results of successive quarters may not accurately reflect trends or results for the full year.

Changes in payer mix could have a material adverse impact on our net sales and profitability.

Testing services are billed to private patients, Medicare, Medicaid and insurance companies. Tests may be billed to different payers depending on a particular patient’s medical insurance benefits. Increases in the percentage of services billed to government payors could have an adverse impact on our net sales.

Governmental payers and healthcare plans have taken steps to control costs.

Medicare, Medicaid and private insurers have increased their efforts to control the costs of health care services, including clinical testing services. They may reduce fee schedules or limit/exclude coverage for tests that we perform. Medicaid reimbursement varies by state and is subject to administrative and billing requirements and budget pressures. We expect efforts to reduce reimbursements, to impose more stringent cost controls and to reduce utilization of testing services will continue. These efforts, including changes in law or regulations, may have a material adverse impact on our business.

Our Laboratory requires ongoing CLIA certification.

The Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) extended federal oversight to virtually all clinical laboratories by requiring that they be certified by the federal government or by a federally approved accreditation agency. CLIA requires that all clinical laboratories meet quality assurance, quality control and personnel standards. Laboratories also must undergo proficiency testing and are subject to inspections.

The sanctions for failure to comply with CLIA requirements include suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, cancellation or suspension of the laboratory’s approval to receive Medicare and/or Medicaid reimbursement, as well as significant fines and/or criminal penalties. The loss or suspension of a CLIA certification, imposition of a fine or other penalties, or future changes in the CLIA law or regulations (or interpretation of the law or regulations) could have a material adverse effect on us.

We believe that we are in compliance with all applicable laboratory requirements, but no assurances can be given that our laboratories will pass all future certification inspections.

Failure to comply with HIPAA could be costly.

The Health Insurance Portability and Accountability Act (HIPAA) and associated regulations protect the privacy and security of certain protected health information and establish standards for electronic healthcare transactions in the United States. These privacy regulations establish federal standards regarding the uses and disclosures of protected health information. Our Molecular Clinical Reference Laboratory is subject to HIPAA and its associated regulations. If we fail to comply with these laws and regulations we could suffer civil and criminal penalties, fines, exclusion from participation in governmental healthcare programs and the loss of various licenses, certificates and authorizations necessary to operate our Laboratory Services business. We could also incur liabilities from third party claims.

Our business could be adversely impacted by healthcare reform.

Government attention to the healthcare industry in the United States is significant and may increase. The Patient Protection and Affordable Care Act passed by Congress and signed into law by the President in March 2010 could adversely impact our business. While the ultimate impact of the legislation on the healthcare industry is unknown, it is likely to be extensive and could result in significant change.

We may be subject to client lawsuits.

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

Market demand is outside of our control.

There are many factors that affect the market demand for our products and services that we cannot control. Demand for our WAVE System is affected by the needs and budgetary resources of research institutions, universities, hospitals and others who use the WAVE System for genetic-variation research. The WAVE System represents a significant expenditure by these types of customers and often requires a long sales cycle. Similarly, the sales cycle for the OEM equipment that we sell can be lengthy. If revenues from thenet sales of our products and services continue at current levels, we may need to take steps to further reduce operating expenses or raise additional working capital. We cannot assure you that sales will increase or that we will be able to reduce operating expenses or raise additional working capital. Similarly, the sales cycle for the OEM equipment that we sell can also be a lengthy

Sales of our Discovery Services have been variable.

Discovery services includes services performed by both our Molecular Clinical Reference Laboratory and our Pharmacogenomics Research Services. Testing volumes at the Molecular Clinical Reference Laboratory is dependent on patient visits to doctor’s offices and other providers of health

care and tends to fluctuate on a seasonal basis. Volume of testing generally declines during the year end holiday periods, other major holidays and the summer. The Pharmocogenomics Laboratory depends on project based work which will change from quarter to quarter. Therefore, comparison of the results of successive quarters may not accurately reflect trends or results for the full year.

Compliance with HIPPA is time consuming and costly.

The Health Insurance Portability and Accountability Act (HIPAA) and associated regulations protect the privacy and security of certain healthcare information and establish standards for electronic healthcare transactions in the United States. The privacy regulations establish federal standards regarding the uses and disclosures of protected health information. Our Molecular Clinical Reference Laboratory is subject to HIPAA and its associated regulations and if we fail to comply with these laws and regulations we could suffer civil and criminal penalties, fines, exclusion from participation in governmental healthcare programs and the loss of various licenses, certificates and authorizations necessary to operate this business. We could also incur liabilities from third party claims.

The sale of our products and business operations in international markets subjects us to additional risks.

During the past several years, international sales have represented more than half of our total net sales. As a result, a major portion of our revenuesnet sales are subject to risks associated with international sales and operations. These risks include:

 

Ÿ

payment cycles in foreign markets are typically longer than in the U.S., and capital spending budgets for research agencies can vary over time with foreign governments;

payment cycles in foreign markets are typically longer than in the U.S., and capital spending budgets for research agencies can vary over time with foreign governments;

 

Ÿ

changes in foreign currency exchange rates can make our products more costly in local currencies since our foreign sales are typically paid for in British Pounds or the Euro; and

changes in foreign currency exchange rates can make our products more costly in local currencies since our foreign sales are typically paid for in British Pounds or the Euro;

 

Ÿ

the potential for changes in U.S. and foreign laws or regulations that result in additional import or export restrictions, higher tariffs or other taxes, more burdensome licensing requirements or similar impediments to our ability to sell products and services profitably in these markets.

the potential for changes in U.S. and foreign laws or regulations that result in additional import or export restrictions, higher tariffs or other taxes, more burdensome licensing requirements or similar impediments to our ability to sell products and services profitably in these markets; and

the fluctuation of foreign currency to the US Dollar and the Euro to the British Pound can cause our net sales and expenses to increase or decrease which adds risk to our financial statements.

Our WAVE System includes hardware components and instrumentation manufactured by a single supplier and if we are no longer able to obtain these components and instrumentation our ability to manufacture our products could be impaired.

We rely on a single supplier, Hitachi High Technologies America, to provide the basic instrument modules used in our WAVE Systems. While other suppliers of instrumentation are available, we believe that our arrangement with Hitachi offers strategic advantages. We have successfully converted the latest model of WAVE systemsSystems to utilize Hitachi’s newest instrument line. If we were required to seek alternative sources of supply, it could be more time consuming or expensive or require significant and costly modification of our WAVE System. Also, if we were unable to obtain instruments from Hitachi in sufficient quantities or in a timely manner, our ability to manufacture our products could be impaired, which could limit our future revenues.net sales.

WeThe current economy may cause suppliers of products to not have adequate personnelbe able to execute our business plan.perform.

We rely on various suppliers for products and materials needed to produce our products. In orderthe event that they would be unable to reduce our operating costs, we have reduced the number of employees in all areas of the business. In addition,deliver those items due to product shortage or business closure, we may lose other key management, scientific, technical, sales and

manufacturing personnel from timebe unable to time. Itdeliver our products or may be very difficultneed to replace personnel if they are needed in the future, and the lossincrease our prices. The current economy poses additional risk of key personnel could harm our business and operating results. We cannot assure you that our employee reductions will not impair oursuppliers’ ability to continue to develop new products and refine existing products in order to remain competitive. In addition, these reductions could prevent us from successfully marketing our products and developing our customer base.their businesses as usual.

Our markets are very competitive.

Many of our competitors have greater resources than we do and/orand may enjoy other competitive advantages. This may allow them to more effectively market their products to our customers or potential customers, to develop products that make our products obsolete or to produce and sell products less expensively than us. As a result of these competitive factors, demand for and pricing of our products and services could be negatively affected.

Our patents may not protect us from others using our technology that could harm our business and competitive position.

Patent law relating to the scope of claims in the technology fields in which we operate is still evolving. The degree of future protection for our proprietary rights is uncertain. Furthermore, we cannot be certain that others will not independently develop similar or alternative products or technology, duplicate any of our products, or, if patents are issued to us, design around the patented products developed by us. Our patents or licenses could be challenged by litigation and, if the outcome of such litigation were adverse to us, our competitors could be free to use our technology. We may not be able to obtain additional patents for our technology, or if we are able to do so, patents may not provide us with substantialadequate protection or be commercially beneficial. In addition, we could incur substantial costs in litigation if we are required to defend ourselves in patent suits brought by third parties or if we initiate such suits.

We cannot be certain that other measures taken to protect our intellectual property will be effective.

We rely upon trade secret protection,secrets, copyright and trademark laws, non-disclosure agreements and other contractual provisions for some of our confidential and proprietary information that is not subject matter for which patent protection is being sought. Such measures, however, may not provide adequate protection for our trade secrets or other proprietary information. If such measures do not protect our rights, third parties could use our technology and our ability to compete in the market would be reduced.

We are dependent upon our licensed technologies and may need to obtain additional licenses in the future to offer our products and remain competitive.

We have licensed key components of our technologies from third parties. If these agreements were to terminate prematurely due to our breach of the terms of these licenses or we otherwise fail to maintain our rights to such technology, we may lose the right to manufacture or sell a substantial portion of our products. In addition, we may need to obtain licenses to additional technologies in the future in order to keep our products competitive. If we fail to license or otherwise acquire necessary technologies, we may not be able to develop new products that we need to remain competitive.

The protection of intellectual property in foreign countries is uncertain.

A significant percentage of our sales are to customers located outside the U.S. The patent and other intellectual property laws of some foreign countries may not protect our intellectual property rights to the same extent as U.S. laws. We may need to bring proceedings to defend our patent rights or to determine the validity of our competitors’ foreign patents. These proceedings could result in substantial cost and diversion of our efforts. Finally, some of our patent protection in the U.S. is not available to us in foreign countries due to the laws of those countries.

Our products could infringe on the intellectual property rights of others.

There are a significant number of U.S. and foreign patents and patent applications submitted for technologies in, or related to, our area of business. As a result, any application or exploitation of our technology could infringe patents or proprietary rights of others and any licenses that we might need as a result of such infringement might not be available to us on commercially reasonable terms, if at all. This may lead others to assert patent infringement or other intellectual property claims against us.

Our failure to comply with any applicable government regulations or otherwise respond to claims relating to improper handling, storage or disposal of hazardous chemicals that we use may adversely affect our results of operations.

Our research and development and manufacturing activities involve the controlled use of hazardous materials and chemicals. We are subject to federal, state, local and international laws and regulations governing the use, storage, handling and disposal of hazardous materials and waste products. If we fail to comply with applicable laws or regulations, we could be required to pay penalties or be held liable for any damages that result and this liability could exceed our financial resources. We cannot assure you that accidental contamination or injury will not occur. Any such accident could damage our research and manufacturing facilities and operations, resulting in delays and increased costs.

The price for our common stock is volatile and may drop.

The trading price for our common stock has fluctuated significantly over recent years. The volatility in the price of our stock is attributable to a number of factors, not all of which relate to our operating results and financial position. The delisting of our stock from the NASDAQ may negatively affect the volume of shares traded and the price for our stock. Continued volatility in the market price for our stock should be expected and we cannot assure you that the price of our stock will not decrease in the future. Fluctuations or further declines in the price of our stock may affect our ability to sell shares of our stock and to raise capital through future equity financing.

Our common stock is deemed to be “penny stock”, which may make it more difficult for investors to sell their shares due to suitability requirements.

Our common stock is classified as a “penny stock” under the rules of the SEC. The Securities and Exchange Commission has adopted Rule 3a51-1 whichthat establishes the definition of a “penny stock”, for the purposes relevant to us, as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, Rule 15g-9 requires:requires that:

 

·

that a broker or dealer approve a person’s account for transactions in penny stocks; and

·

that the broker or dealer receives from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

the broker or dealer receives from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

In order to approve a person’s account for transactions in penny stocks, the broker or dealer must:

 

·

obtain financial information and investment experience objectives of the person; and

obtain financial information and investment experience objectives of the person; and

 

·

make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

The broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which is in highlight form:

 

·

sets forth the basis on which the broker or dealer made the suitability determination; and

sets forth the basis on which the broker or dealer made the suitability determination; and

 

·

that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules. This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock.

Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.

We may issue a substantial amount of our common stock to holders of options and warrants and this could reduce the market price for our stock.

At December 31, 2007,2010, we had obligations to issue 12,583,87918,607,229 shares of common stock includingupon exercise of outstanding stock options representing 4,535,0642,565,001 shares, convertible preferred stock representing 10,344,820 shares and warrants representing 8,048,8155,697,408 shares. The issuance of these additional shares of common stock may be dilutive to our current shareholders and could negatively impact the market price of our common stock.

Our common stock is thinly traded and a large percentage of our shares are held by a small group of unrelated, institutional owners.

At December 31, 2007,2010, we had 49,189,67249,289,672 shares of common stock outstanding. Fewer than ten unrelated, institutional holders own more than 50% of these sharesshares. The sale of a significant number of shares into the public market has potential to cause significant downward pressure on the price of our common stock. This is particularly the case if the shares being placed into the market exceed the market’s ability to absorb the stock. Such an event could place further downward pressure on the price of our common stock. This presents an opportunity for short sellers to contribute to the further decline of our stock price. If there are significant short sales of our stock, the price decline that would result from this activity will

cause the share price to decline more so, which, in turn, may cause long holders of the stock to sell their shares thereby contributing to sales of stock in the market.

 

Item 1B.

Unresolved Staff Comments

None.

 

Item 2.

Properties

We currently lease and occupy a total of six facilities throughout the world under non-cancelable leases with various terms. The following table summarizes certain information regarding the leased facilities. Annual rent amounts presented in the table are reflected in thousands.

 

Location

 

Function

 

Square
Footage

 

2008
Scheduled
Rent

 

Lease Term
Expires

 

Function

 

Square
Footage

 

2011

Scheduled
Rent

 

Lease Term
Expires

Omaha, Nebraska

 WAVE and Consumable Manufacturing 25,000 $130 June 2009 WAVE and Consumable Manufacturing  25,000   $81   July 2011

San Jose, California

 Consumable Manufacturing 14,360 $165 October 2010 Consumable Manufacturing  9,110   $46   February 2016

Cramlington, England

 Consumable Manufacturing 10,818 $19 March 2008

Glasgow, Scotland

 Multi Functional(1) 5,059 $31 March 2012 Multi Functional(1)  5,059   $48   March 2012

Omaha, Nebraska

 Multi Functional(1) 18,265 $188 July 2012 Multi Functional(1)  18,265   $200   July 2012

Paris, France

 Multi Functional(1) 4,753 $104 January 2014

Gaithersburg, Maryland

 Multi Functional(1) 8,404 $145 May 2012

New Haven, Connecticut

 Laboratory  23,123   $477   March 2013

 

(1)

Multi Functional facilities include functions related to manufacturing, services, sales and marketing, research and development and/or administration.

The leases on

We believe that these facilities are adequate to meet our current and planned needs. We expect that the Cramlington, England facility will expireOmaha lease which expires in March 2008, and we2011 will be vacating the property atreplaced with a lease of equivalent nature. We believe that time. We have vacated the Paris, France facility and areif additional space is needed in the process of finding a tenant to sublease this facility.future, we could find alternate space at competitive market rates without substantial increase in cost.

 

Item 3.

Legal ProceedingsProceedings.

On January 23, 2009, Transgenomic and Power 3 Medical Products, Inc. (“Power3”) entered into a Collaboration and Exclusive License Agreement (the “Agreement”). On January 29, 2010, Transgenomic received a letter from Power3 terminating the Agreement. Power3’s alleged basis for terminating the Agreement was, among other claims, that Transgenomic committed a material breach of the Agreement by its alleged unauthorized disclosure of confidential information concerning the licensed technology. Transgenomic denies it has breached the Agreement. Transgenomic has sued Power 3 in the United States District Court for the District of Nebraska, Case No. 8:10CV-00079 (the “Action”) claiming that Power3 wrongfully terminated the Agreement. Power3 has not yet filed a counterclaim against Transgenomic in the action and no discovery has taken place in the Action. At this time, Transgenomic and Power3 have stayed the Action and have agreed to commence mediation proceedings to attempt to resolve the matters involved in the Action. Since Power3 has not filed a counterclaim against Transgenomic in the Action, we are not in a position to assess the merits of Power3’s threatened claims against Transgenomic. However, based upon the facts known to Transgenomic at this time, we do not believe the Action will have a material adverse effect on our financial position, results of operations or cash flows.

The Company is not a party to any other pending legal proceedings which,that, if decided adversely to the Company, will have a material adverse effect on our financial position, results of operations or cash flows.

 

Item 4.

Submission of Matters to a Vote of Security Holders.(Removed and Reserved)

We did not submit any matters to our stockholders for a vote or other approval during the fourth quarter of the fiscal year covered by this report.

PART II

 

Item 5.

Market for the Registrant’s Common Stock,Equity, Related Stockholder Matters and Issuer RepurchasesPurchases of Equity SecuritiesSecurities.

Market Information.    Share price information for our common stock is available on the OTC Bulletin Board under the symbol TBIO.OB. Prior to February 22, 2007, our common stock was listed for trading on the Nasdaq Capital Market under the symbol TBIO. The following table sets forth the high and low closing prices for our common stock during each of the quarters of 20062010 and 2007.2009.

 

  High  Low  High   Low 

Year Ended December 31, 2006

    

Year Ended December 31, 2010

    

First Quarter

  $    1.03  $    0.62  $0.88    $0.61  

Second Quarter

  $0.84  $0.39  $0.86    $0.49  

Third Quarter

  $.77  $0.31  $0.59    $0.33  

Fourth Quarter

  $.89  $0.40  $0.71    $0.32  

Year Ended December 31, 2007

    

Year Ended December 31, 2009

    

First Quarter

  $.80  $.42  $0.42    $0.21  

Second Quarter

  $.88  $.61  $0.58    $0.32  

Third Quarter

  $.75  $.49  $0.70    $0.35  

Fourth Quarter

  $.72  $.41  $0.74    $0.58  

Holders.    At December 31, 2007,2010, there are 49,189,67249,289,672 shares of our common stock outstanding and approximately 3,3102,800 holders of record.

Dividends.    We have never declared or paid any cash dividends on our common stock and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. We expect to retain all earnings, if any, for investment in our business. Dividends on our common stock will be paid only if and when declared by our Board of Directors. The Board’s ability to declare a dividend is subject to limits imposed by Delaware corporate law. In determining whether to declare dividends, the Board may consider our financial condition, results of operations, working capital requirements, future prospects and other relevant factors. The Series A Preferred Stock holders are entitled to receive quarterly dividends.

Sale of Unregistered SecuritiesSecurities.    .    The Company made no sales of its common stock during the years ended December 31, 20072010 and 20062009 that were not registered under the Securities Act of 1933 (the “Securities Act”). Information regarding salesOn December 29, 2010 we issued 2,586,205 shares of equity securities by the Company during the years ended December 31, 2005Series A Convertible Preferred Stock that were not registered under the Securities Act“Securities Act”. The issuance of 1933 have been previously reportedsuch Convertible Preferred Stock was related to the financing for the Company’s acquisition of assets from PGxHealth. Please refer to the Series A Convertible Preferred Stock Purchase Agreement with affiliates of Third Security dated December 29, 2010 (incorporated by reference to the CompanyRegistrant’s Report on Form 8-Ks8-K (Registration No. 000-30975) filed on March 18, 2005, March 30, 2005 and October 31, 2005.January 4, 2011).

Issuer Purchase of Equity Securities.    The Company made no purchases of its common stock during the quarter ended December 31, 2007.2010. Therefore, tabular disclosure is not presented.

Item 6.

Selected Consolidated Financial DataData.

The selected consolidated balance sheet data as of December 31, 2010 and 2009 and the selected consolidated statements of operations data for each year ended December 31, 2010 and 2009 have been derived from our audited consolidated financial statements that are included elsewhere in

this Annual Report on Form 10-K. The selected consolidated balance sheet data as of December 31, 2008, 2007 and 2006 and the selected consolidated statements of operations data for each year ended December 31, 2008, 2007 2006 and 2005 have been derived from our audited consolidated financial statements that are included elsewhere in this Annual Report on Form 10-K. The selected consolidated balance sheet data as of December 31, 2005, 2004 and 2003 and the selected consolidated statements of operations data for each year ended December 31, 2004 and 20032006 have been derived from our audited consolidated financial statements that are not included in this Annual Report on Form 10-K. Dollar amounts, except per share data, are presented in thousands.

 

  Year Ended December 31,   Year Ended December 31, 
  

2007

 

2006

 

2005

 

2004

 

2003

   2010 2009 2008 2007 2006 

Statement of Operations Data:

            

Net sales

  $    23,176  $    23,415  $    25,828  $    25,243  $    26,044   $20,048   $22,023   $23,993   $23,176   $23,415  

Cost of good sold

   10,483   12,046   13,497   11,997   11,374    10,284    10,418    10,345    10,483    12,046  
                                

Gross profit

   12,693   11,369   12,331   13,246   14,670    9,764    11,605    13,648    12,693    11,369  

Selling, general and administrative

   11,466   12,138   12,218   15,961   16,586    10,933    10,319    10,795    11,466    12,138  

Research and development

   3,033   2,362   2,199   4,501   6,834    2,305    3,182    2,465    3,033    2,362  

Restructuring charges(1)

   1,516         1,267   516    138        118    1,516      

Impairment charges(2)

         425                  638          
                                

Operating expenses

   16,015   14,500   14,842   21,729   23,936    13,376    13,501    14,016    16,015    14,500  

Other income (expense)(3)

   1,391   198   (2,447)  (5,263)  (181)

Other income(3)

   628    18    86    1,391    198  
                                

Loss before income taxes

   (1,931)  (2,933)  (4,958)  (13,746)  (9,447)   (2,984  (1,878  (282  (1,931  (2,933

Income tax expense

   243   30   26   4   65    150    42    213    243    30  
                                

Loss from continuing operations

   (2,174)  (2,963)  (4,984)  (13,750)  (9,512)   (3,134  (1,920  (495  (2,174  (2,963

(Loss) income from discontinued operations, net of tax(4)

   67   (468)  (10,009)  (20,622)  (13,446)

Income (Loss) from discontinued operations, net of tax

               67    (468
                                

Net loss

  $(2,107) $(3,431) $(14,993) $(34,372) $(22,958)

Net Loss

  $(3,134 $(1,920 $(495 $(2,107 $(3,431
                                

Basic and diluted (loss) income per share:(4)

      

Basic and diluted Loss per share:

      

From continuing operations

  $(0.04) $(0.06) $(0.14) $(0.47) $(0.39)  $(0.06 $(0.04 $(0.01 $(0.04 $(0.06

From discontinued operations(4)

   (0.00)  (0.01)  (0.28)  (0.72)  (0.55)                   (0.01
                                
  $(0.04) $(0.07) $(0.42) $(1.19) $(0.94)  $(0.06 $(0.04 $(0.01 $(0.04 $(0.07
                                

Basic and diluted weighted average shares outstanding

   49,190 �� 49,188   35,688   29,006   24,484    49,244    49,190    49,190    49,190    49,188  
  As of December 31,   As of December 31, 
  

2007

 

2006

 

2005

 

2004

 

2003

   2010 2009 2008 2007 2006 

Balance Sheet Data:

            

Total assets

  $19,090  $21,367  $25,340  $37,458  $57,306    32,027   $16,004   $17,556   $19,090   $21,367  

Borrowings under credit line(5)

            6,514   2,142 

Current portion of long-term debt(5)

            825   1,693 

Long-term debt, less current portion(5)

            2,199    

Total stockholders’ equity

   14,102   16,038   17,906   16,535   45,058    8,500    11,662    13,205    14,102    16,038  

 

(1)

Restructuring plans were implemented in 20072010, 2008 and 20042007 to reduce and align our expenses with current business prospects. The plans included employee terminations, office closures, termination of collaborations and write-offs of abandoned intellectual property. As a result, restructuring charges were recorded and are included in operating expenses. Refer to Note D to the accompanying consolidated financial statements.

 

(2)

Impairment charges in 20052008 relate to the impairment of patent pursuits and write-down of inventory to net realizable value. Refer to Notes to the accompanying consolidated financial statements.goodwill.

(3)

Other income (expense) for all years presented primarily includes interest expense and interest income. Other income in 2010 includes $0.6 million awarded in a federal grant under the Qualifying Therapeutic Discovery Project Program related to 2009 projects. Other income in 2007 includes $.9 million from the sale of an investment security and $.2 million in insurance proceeds related to equipment destroyed in fire at our Cramlington, England facility. The loss on debt extinguishment of $0.5 million in 2005 related to the repayment of long-term debt and $2.9 million resulting from certain modifications to long-term borrowing agreements that were treated as extinguishments for financial reporting purposes.

(4)

During 2005, we decided to exit our Nucleic Acids operating segment and, as a result, we recorded impairment and exit charges of $8.8 million consisting of valuation adjustments to reflect the carrying value of related net assets at estimated fair market value. The results of this business segment are shown as discontinued operations for all periods presented. Refer to Note C to the accompanying consolidated financial statements.

(5)

The Laurus Loans were repaid during 2005 resulting in a loss on debt extinguishment of $.5 million.

Item 7.

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

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

You are cautioned not to Consolidated Financial Statementsplace undue reliance on these forward-looking statements. The forward-looking statements we make are not guarantees of future performance and are subject to various assumptions, risks and other information in this report,factors that could cause actual results to differ materially from those suggested by these forward-looking statements. Actual results may differ materially from those suggested by the forward-looking statements that we make for a number of reasons including Risk Factors set forththose described in Item 1A, “Risk Factors,” and Critical Accounting Policies at the endother factors identified by cautionary language used elsewhere in this report.

We expressly disclaim any obligation to update or revise any forward-looking statements, whether as a result of this Item 7.new information, future events or otherwise, except as required by law.

Our continuing operations consist of Laboratory Services and Instrument Related Business, including the manufacture and sale of our WAVE System and related consumable products and discovery services which make use of(see the Company’s WAVE System to perform genomic research on a contract basis and disease testing services. These functions are categorized as one reportable operating segment. Although revenue is analyzed by type, the Company’s net financial results are analyzed as a single segment due to the integrated nature of the products and services that we sell. The Consolidated Financial Statements also reflect the assets and resultsdescription of our former Nucleic Acids operating segment, whichbusiness in Item 1). We have broken out our business into two reportable segments: Laboratory Services and Instrument Related business. There are shown as discontinued operationsestimates involved in all periods as a resultbreaking out the expenses and other disclosures.

The following discussion should be read together with our financial statements and related notes contained in this report. Results for the year ended December 31, 2010 are not necessarily indicative of the implementation of a plan to exit this operating segmentresults that may be attained in the fourth quarter of 2005.future.

Executive Summary

20072010 Results

Full year revenuenet sales for 20072010 of $23.2$20.0 million was consistentdecreased by 9% compared with total revenuenet sales for 20062009 of $23.4$22.0 million. Our Laboratory Services business grew 9% over the prior year, while the Instrument Related Business decreased 14% from 2009 to 2010. Overall gross margins decreased from 53% to 49%. Operating expenses were $13.4 million for the year ended December 31, 2010 compared

to $13.5 million for the same period of 2009, but note that 2010 included $0.8 million in deal costs related to our acquisition of the FAMILION family of genetic tests of PGxHealth and $0.1 million in restructuring costs related to the consolidation of our Gaithersburg, Maryland facility into Omaha that was offset by a decrease in research and development costs of $0.9 million.

On December 29, 2010 we acquired the FAMILION family of genetic tests from PGxHealth, a subsidiary of Clinical Data. This strategic acquisition provided us with proprietary genetic commercial tests that have an established revenue base, proprietary biomarker assays, an additional fully integrated CLIA certified laboratory operation, and established test reimbursement and coverage policies that offer access to testing.

2011 Outlook

We continue to leverage our core instrument business declinedfor on-going instrument sales worldwide as well as employing our instruments and related expertise in 2007 dueour two laboratory services businesses. We anticipate strengthening growth in both of our laboratory services businesses and we continue to fewerseek out new assay technologies and tests to license or develop internally to expand our menu offerings for both of these service businesses. In particular, we have substantially increased our footprint in the molecular diagnostics laboratory market through our recent acquisition of the Clinical Data FAMILION product line, which includes a CLIA laboratory business. This acquisition brings us approximately $13.0 million in new annual revenues and a much larger presence both with insurers and patients. This acquisition also provides us access to higher throughput technologies and an expert staff to aid us in growing our reference laboratory business.

In our Pharmacogenomics Lab, we have completed cancer pathway gene mutation projects for a number of high visibility pharmaceutical companies. Employing our recently licensed ultra sensitive DNA mutation detection technology, termed Cold-PCR, we have added the significant addition of utilizing blood as a mutation detection sample source rather than just testing patients’ tumors. This is a significant achievement and should, we believe, lead to much faster expansion of our service testing for pharmaceutical partners as they adopt this novel approach. In addition to Cold-PCR, which offers sensitivity improvements as much as 10,000 times higher than routine testing technology, we have recently discovered a technique to further improve mutation detection sensitivity of standard sequencing technology. We are combining this new discovery with our Cold-PCR program to bring what we believe to be the most accurate and sensitive mutation detection technology available in the market today. We believe that this combination of technologies will offer us the ability to develop tests for earlier cancer detection using blood or even saliva and to measure recurrence for a very early warning to better manage patients suffering from cancer as well as support earlier drug selection or drug resistance determinations for these patients.

Although the WAVE system sales. The bioconsumable business hadSystem is a slight increase of 2% from 2006 to 2007. Thefully matured technology, and both it and its corresponding consumable sales growth in our discovery services was 149% overtraditional markets are shrinking, we are expanding our opportunities by selling systems into new geographic areas, including the prior year. These revenues, coupled with our recently completed cost reduction efforts enabled us to achieve a profit in the fourth quarter of 2007 of $.2 million. The pharmacogenomics business increased from the third quarter of 2007 to the fourth quarter of 2007 by $.4 million. We believe this is due to our increased focus on pharmaceutical companies that we initiated at the beginning of 2007.

Although we have taken significant steps to reduce our operating expenses, we continued to operate at a lossMiddle East and to generate a negative cash flow during the year. However, our loss and use of cash were reduced over each of the last three years. Our losses from continuing operations have gone from $5.0 million and $3.0 million in 2005 and 2006, respectively, to $2.2 million in 2007. We were able to maintain our cash level of $5.7 million, avoid new debt and improve our gross margins.

2008 Outlook

We are forecasting revenue growth of 10-15% over 2007 and to be profitable in 2008. To accomplish these goals we must generate sequential growth in net sales and continue to better control operating expenses. We are investing in all parts of our business to drive improved sales in 2008 and have added experienced sales staff. We have worked hard to develop a significant number of exciting collaboration opportunities. In addition, we have strengthened our Board of Directors, added key senior management and formed a Scientific Advisory Board to advise us on the latest developments and scientific opportunities in cancer detection screening and mitochondrial disease diagnosis.

Develop sequential growth in net sales.

We will workAsia, to continue to leverage on and strengthenthe revenue from our core instrument business. Challenges exist for WAVE System and consumable growth in traditional markets.related business segment. We continue to look for emerging markets and novel applications to provide us with new opportunities for our WAVE System.System such as our newly launched K-RAS mutation detection kit. We have launched our CE IVD labeled K-RAS mutation detection kit into Europe and the U.S. and will soon follow that with additional assay kits for BRAF, PIK3CA and P-53 mutation assay kits. These are all key cancer pathway mutation assessment tools and through our proprietary technologies bring noteworthy improvements in sensitivity and cost

efficiency to the market compared to competing technologies. We intend to continue to look for opportunities to diversify into new markets, including the personalized medicine market, (particularlyparticularly in oncology),oncology, where the sensitivities of our technologies are essential. InA recently licensed technology that could provide the short-term, we believe thathighest sensitivity available in the introduction of the newest generation ofmarketplace is being refined for use on our flagship product, the WAVE System 4500 will provide upgrade opportunities to our current installed base.Wave Systems. In addition, we are also selling refurbished WAVESystems in order to allow an opportunity for customers thatwho may not be able to afford the full cost of a new system. In the intermediatesystem to longer-term, we believe that newly developed “targeted” consumable products will increase usability ofpurchase and utilize our installed base and enhance net sales of consumables.WAVE technology. Additionally, we have developed credibility and momentum with third-party platforms that will allow us to leverage on our direct sales force and distribution network.

On the discovery services front, we have hired two new business development directors to develop pharmaceutical and clinical research organization customers. We have entered into agreements with two major pharmaceutical companies for three Phase II trials representing more than $.5 millionhistorically operated at a loss and have not consistently generated sufficient cash from operating activities to cover our operating and other cash expenditures. On December 29, 2010 we acquired the FAMILION family of revenues in the first halfgenetic tests from PGxHealth, a subsidiary of 2008Clinical Data. At December 31, 2010, we had cash and cash equivalents of $3.5 million. While we believe that existing sources of liquidity are focused on maintaining this momentum in our pharmacogenomics business. To compliment our mutation detection expertise,sufficient to meet expected cash needs through 2011, we also have strong capabilities in biomarker development and mutation detection in cancer pathway genes which will aid in the development of true personalized medicine for our pharmaceutical partners. We have also focused increased efforts to expand our Molecular Clinical Reference Laboratory sales by hiring three experienced sales representatives.

Continue to control operating expenses.

Operating expenses include selling, general and administrative expenses and research and development expenses. We will need to continue to invest in researchincrease our net sales and development activitiessuccessfully integrate the FAMILION acquisition in order to remain competitivebe assured of meeting our liquidity needs on a long-term basis. This acquisition was funded with debt and preferred stock. However, we cannot assure that we will be able to take advantageincrease our net sales, further reduce our expenses, or raise further capital or equity and, accordingly, we may not have sufficient sources of new business opportunities as they arise. During 2008, we expect operating expenses, including research and development expense,liquidity to be approximately equal to 2007 levels.continue operations indefinitely.

Results of Continuing Operations

Years Ended December 31, 20072010 and 20062009

Net Sales.    Net sales for the years ended December 31, 20072010 and 20062009 consisted of the following (dollars in thousands):

 

        Change           Change 
  

2007

  

2006

  $   %   2010   2009   $   % 

Laboratory Services:

        

Molecular Clinical Reference Laboratory Services

  $3,606    $3,541    $65     2

Pharmacogenomics Research Services

   1,373     1,025     348     34
                
   4,979     4,566     413     9

Instrument Related Business:

        

Bioinstruments

  $11,551  $13,604  $(2,053)  (15)%   8,320     10,175     (1,855   (18)% 

Bioconsumables

   8,901   8,719   182   2%   6,749     7,282     (533   (7)% 

Discovery Services

   2,724   1,092       1,632   149%
                            

Net sales

  $  23,176  $  23,415  $239   (1)%
               15,069     17,457  ��  (2,388   (14)% 
                

Total Net Sales

  $  20,048    $  22,023    $  (1,975   (9)% 
                

Laboratory Services net sales increased during the year ended December 31, 2010 compared to 2009 by $0.4 million or 9%. Laboratory Services sales includes both the Molecular Clinical Reference Laboratory Services and the Pharmacogenomics Research Services. The Molecular Clinical Reference Laboratory Services net sales of $3.6 million increased 2% over the year ended December 31, 2009. The Molecular Clinical Reference Laboratory average revenue per test has decreased by 4% due to the mix of tests performed and the increased Medicare and Medicaid test volumes which generates lower reimbursement for these tests. The decrease in average revenue per test is offset by a 6% increase in volume. The Pharmacogenomics Research Services net sales of $1.4 million during 2010 increased

34% over the year ended December 31, 2009. The increase in Pharmacogenomics Research Services is largely due to an increase in the number of clients and average revenue billed per client for the year ended December 31, 2010 compared to the same period of 2009. The Pharmacogenomics Research Services net sales have peaks due to the nature of this project-related business. Each period for Pharmacogenomics Research Services should be considered on a stand-alone basis and is not indicative of future net sales.

Bioinstrument sales consist of sales of our WAVE System and associated equipment that we manufacture or assemble, revenuesnet sales from service contracts that we enter into with purchasers of our instruments, as well as sales of instruments we distribute for other manufacturers (“OEM equipment”). We also sell refurbished WAVE Systems in order to access customers that may not be able to afford new systems. Bioinstrument net sales are down $1.9 million, or 18% during the year ended December 31, 2010 as compared to the same period in 2009. We sold 5625 WAVE Systems during the year ended December 31, 20072010 compared to 6832 systems during 2009. We sold 10 OEM instruments during the year ended December 31, 2010 compared to 11 in the same period of 2006. This2009. The decrease resulted fromin bioinstrument net sales was due to the lower demandvolume of instruments sold and lower average sales price on both our WAVE and OEM instruments. Service contract sales were down $0.2 million for the year ended December 31, 2010 compared to the same period of 2009 due to lower volumes in all major geographic marketsboth the European and among both researchU.S. markets. Parts, freight and diagnostic users particularly in our largest markets throughout Western Europe.miscellaneous income was lower by $0.5 million for the year ended December 31, 2010 as compared to the same period of 2009. Demand for WAVE systems has beenSystems continues to be affected by significant competitive challenges from traditional (i.e. sequencing) and evolving technologies. In addition, there were decreasedInstrument related revenue is subject to many factors such as type of instrument sold and the country of sale. Due to these factors each period should be considered on a stand alone basis and is not indicative of future net sales from product upgrades.streams.

Bioconsumable net sales increaseddecreased during the year ended December 31, 20072010 compared to 2006.2009 by $0.5 million or 7%. The installed base of WAVE instruments increased from 1,358 units at December 31, 2006 to 1,414 units at December 31, 2007, which is an increase of 4%. However, consumable usage increased by just 2%. We believe that this is reflective of the fact that not all of the installed instruments are being fully utilized. In addition, consumable products are available from other manufacturers which can be usedprimary decrease in place of many of our consumable products. Some of these competitive products sell at prices below the prices we charge for our products, which have caused us to have some price compression, principally in Europe

Discovery Services net sales increased during the year ended December 31, 2007 compared to 2006 by approximately $1.6 million. Discovery Services sales includes both the Molecular Clinical Reference Laboratory and the Pharmocogenomics Research Services. The Molecular Clinical Reference Laboratory net sales of $1.7 million increased 300% over the year ended December 31, 2006. The increased revenue is attributable to new customers with one of the new customers representing approximately 50% of the 2007 revenue. The Pharmacogenomics Research Services net sales of $1.1 million increased 47% over the year ended December 31, 2006. Revenue in the fourth quarter of 2007 was $.6 million for the Pharacogenomics Research Services which represents approximately 50% of the annual revenue. Thisconsumables is due to the completion of 13 projects for 5 pharmaceutical partners during the fourth quarter of 2007.lower volume in our European market offset by higher volume in our U.S. market.

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) as well as the wholesale price we pay manufacturers of OEM equipment that we distribute. It also includes direct costs (primarily personnel costs, test outsourcing fees, rent, supplies and depreciation) associated with our discovery servicesLaboratory Services operations. Cost of goods sold for the years ended December 31, 20072010 and 20062009 consisted of the following (dollars in thousands):

 

        Change           Change 
  

2007

  

2006

  $  %   2010   2009   $   % 

Laboratory Services:

        

Molecular Clinical Reference Laboratory Services

  $2,125    $2,018    $107     5

Pharmacogenomics Research Services

   1,416     820     596     73
                
   3,541     2,838     703     25

Instrument Related Business:

        

Bioinstruments

  $4,318  $5,745  $(1,427)  (25)%   3,560     3,801     (241   (6)% 

Bioconsumables

       4,054       4,530   (476)  (11)%   3,183     3,779     (596   (16)% 

Discovery Services

   2,111   1,771           340  19%
                           

Cost of goods sold

  $10,483  $12,046  $(1,563)  (13)%
              6,743     7,580     (837   (11)% 
                

Total Cost of Goods Sold

  $  10,284    $  10,418    $  (134     (1)% 
                

Gross profit equaled $12.7$9.8 million or 55%49% of total net sales during the year ended December 31, 20072010 compared to $11.4$11.6 million and 49%or 53% during the same period of 2006.2009. The increasedecrease in gross profit as a percent of revenuenet sales is largely attributable to changes in the composition of products sold. Margins on bioinstruments improved from 58% to 63% from 2006 to 2007 due to the change in the mix of instruments sold. We were also able to improveThe Laboratory Services business segment margins on bioconsumables from 48% in 2006 to 54% in 2007 due our focus on cost containment. The discovery services group improved marginsdecreased for the year ended December 31, 20072010 to 22%29% as compared to a negative 62%38% for the year ended December 31, 20062009. The erosion in the Laboratory Services gross margin is driven by the lower average net sales reimbursement per test due primarily to being ableincreased Medicare and Medicaid test volume. In addition, Laboratory Services had higher operating supplies cost in 2010 than the same period in 2009 related to leveragethe higher volume of tests and work required on the Pharmacogenomic projects. Margins on bioinstruments declined from 63% to 57% from 2009 to 2010 due to fewer instruments sold, a decline in service contract revenue and lower parts, freight and miscellaneous income. The instruments business has a fixed cost structure withcomponent in cost of goods sold, therefore lower revenue will cause the margin to deteriorate. Margins on bioconsumables increased sales revenue.from 48% in 2009 to 53% in 2010 primarily related to a 2009 one time obsolescence reserve of $0.4 million for control plasmids used in our SURVEYOR kits and the transition from a steel syringe delivery method to a disposable delivery method.

Selling, General and Administrative Expenses.    Selling, general and administrative expenses primarily include personnel costs, marketing, travel and entertainment costs, professional fees, facility costs and facility costs. These costs decreased in 2007 compared to 2006,foreign currency revaluation. Selling, general and decreasedadministrative expenses increased as a percentage of net sales from 52%47% in 2009 to 49%. These reductions were primarily due55% in 2010. For the year ended December 31, 2010 we incurred $0.8 million in expenses that related to lower personnel costsour acquisition of the FAMILION family of genetic tests. Selling, general and facilities costs resulting from our restructuring plan. In addition, foreign currency transaction adjustments decreased operatingadministrative expenses by approximately $.1would have been $10.3 million for the year ended December 31, 2007 compared2010 excluding the deal costs to 2006.acquire the FAMILION family of genetic tests which would be comparable to SG&A expenses for the year ended December 31, 2009 of $10.3 million. Foreign currency translation expense was $0.3 million in each of the periods ended December 31, 2010 and 2009. We recorded restructuring charges of $0.1 million in 2010 related to the consolidation of research and development into Omaha, which included closing the Gaithersburg, Maryland facility and the elimination of positions in our manufacturing group. There were no restructuring charges in 2009.

Research and Development Expenses.    Research and development expenses primarily include personnel costs, collaboration costs, legal fees, supplies, and facility costs. These costs totaled $3.0$2.3 million during the year ended December 31, 20072010 compared to $2.4$3.2 million during the same period of 2006, an increase2009, a decrease of $0.7$0.9 million or 28%. The decrease is primarily due to expenses in 2009 related to collaboration expenses for NuroPro assay development related to the diagnosis of Alzheimer’s and Parkinson’s diseases, the development of high sensitivity mutation detection technology called Cold-PCR and purchases of samples related to research work in progress. As a percentage of net sales, research and development expenses totaled 13%11% and 10%14% of net sales during the year ended December 31, 20072010 and 20062009 respectively. We expect to continue to invest approximately 10% of our net sales in research and development activities. Research and development costsexpenses are expensed in the year in which they are incurred.

Restructuring Charges.    We recorded restructuring charges totaling $1.5 million during 2007. The restructuring charges were comprised of severance payments totaling $.9 million, facility closure costs totaling $.5 million and other costs totaling $.1 million. Restructuring charges related to three events: A restructuring plan completed in the second quarter of 2007, which resulted in the termination of four employees in Omaha, Nebraska; the closure of the Cramlington, England bioconsumable production facility and consolidation of this production in the Omaha, Nebraska facility; and the closure of an administrative office outside Paris, France and combining those operations with those functions performed elsewhere in the organization. We substantially completed these restructuring activities as of December 31, 2007. These restructuring charges do not relate to any activities taken by

us during 2007 or prior periods in connection with the termination of our Nucleic Acids business segment. All costs associated with these activities are included in income (loss) from discontinued operations.

Other Income (Expense).    Other income during the year ended December 31, 2007 of $1.4 million represented an increase of $1.2 million from 2006. The increase was attributable to the sale of an investment in equity securities. On May 10, 2007, we sold 250,000 shares of stock in Pinnacle Pharmaceuticals, Inc. which we acquired in connection with a prior business acquisition. Gross proceeds realized from the sale were $.9 million and because our carrying cost in this stock was $0, the sale resulted in a gain of $.9 million. Other income also includes $.2 million in insurance proceeds related to equipment destroyed in the fire at our Cramlington facility. In addition we received $.3 millionconsists primarily of interest income from cash and cash equivalents invested in overnight instruments. Other income in the year ended December 31, 2010 includes an award of a federal grant under the Qualifying Therapeutic Discovery Project. Other income related to this federal grant was offset by a nominal amount$0.6 million net of interest expense in both 2007 and 2006.consulting fees. Other income for the year ended December 31, 2009 was less than $0.1 million.

Income Tax Expense.    Income tax expense recorded during the years ended December 31, 20072010 and 20062009 related to income taxes in states, foreign countries and other local jurisdictions. Due tojurisdictions and

totaled less than $0.2 million and $0.1 million, respectively. The effective tax rate for the our cumulative losses and inability to utilize any additional losses as carrybacks, we did not provide for an income tax benefit during the yearsyear ended December 31, 2007 or 2006 based on2010 is 5.0%, which is primarily the result of valuation allowances against net operating losses for the United States, partially adjusted by permanent differences related to intercompany foreign currency exchange of our determination that itsubsidiary outside the United States. The effective tax rate for the year ended December 31, 2009 was more likely2.2%.

A net deferred tax liability was recorded during 2010 relating to the UK income taxes of less than not that such benefits would not be realized.$0.1 million compared to a net deferred tax liability of $0.1 million at year end 2009. We will continue to assess the recoverability of deferred tax assets and the related valuation allowance. To the extent we begin to generate taxable income in future periods and determine that such valuation allowance is no longer required, the tax benefit of the remaining deferred tax assets will be recognized at such time. Our net operating loss carryforwards from continuing and discontinued operations of $109.2$104.3 million will expire at various dates from 20082012 through 2027,2029, if not utilized. We also had state income tax loss carryforwards from continuing and discontinued operations of $40.7$36.0 million at December 31, 2007.2010. These carryforwards will also expire at various dates if not utilized.

Years Ended December 31, 2006 and 2005

Net Sales.    Net sales for the years ended December 31, 2006 and 2005 consisted of the following (dollars in thousands):

         Change 
   

2006

  

2005

  $  % 

Bioinstruments

  $13,604  $14,427  $(823)  (6)%

Bioconsumables

   8,719   8,981   (262)  (3)%

Discovery Services

   1,092   2,420   (1,328)  (55)%
              

Net sales

  $  23,415  $  25,828  $   (2,413)  (9)%
              

WAVE Systems sold totaled 68 during the year ended December 31, 2006 compared to 97 during the same period of 2005. The increase in the installed base of instruments continued to drive increases in sales of bioconsumables used with these instruments. The decrease in discovery services net sales was primarily attributable to the expiration of certain research contracts with a large pharmaceutical company in 2005.

Costs of Goods Sold.    Cost of goods sold for the years ended December 31, 2006 and 2005 consisted of the following (dollars in thousands):

         Change 
   

2006

  

2005

  $  % 

Bioinstruments

  $5,745  $6,442  $(697)  (11)%

Bioconsumables

   4,530   4,762   (232)  (5)%

Discovery Services

   1,771   2,293   (522)  (23)%
              

Cost of goods sold

  $  12,046  $  13,497  $   (1,451)  (11)%
              

Gross profit equaled $11.3 million or 49% of total net sales during the year ended December 31, 2006 compared to $12.3 million and 48% during the same period of 2005. The increase in gross profit as a percent of revenue is largely attributable to changes in the composition of products sold. Sales of OEM instruments provided for higher gross profit in 2006, while gross profit on WAVE sales was down, due to the lower number of instruments sold and the fixed base of cost associated with this area. Gross profit from discovery services was significantly less in 2006 due to the decrease in net sales to a large pharmaceutical customer which produced net sales of $2.1 million in 2005.

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 remained essentially flat in 2006 compared to 2005, but increased as a percentage of net sales from 47% to 52% as a result of reduced sales. Foreign currency transaction adjustments increased operating expenses by approximately $.08 million compared to the year ended December 31, 2005

Research and Development Expenses.    Research and development expenses primarily include personnel costs, supplies, and facility costs. These costs totaled $2.4 million during the year ended December 31, 2006 compared to $2.2 million during the same period of 2005, an increase of $0.2 million or 7%. As a percentage of net sales, research and development expenses totaled 10% and 9% of net sales during the years ended December 31, 2006 and 2005 respectively. We expect to continue to invest up to 10% of our net sales in research and development activities. Research and development costs are expensed in the year in which they are incurred.

Impairment Charges.    We did not record any charges in 2006 for impairment of goodwill or long lived assets subject to annual evaluations of impairment. However, impairment charges totaled $0.4 million during the year ended December 31, 2005 and consisted of $0.2 million associated with certain international patent pursuits that were no longer consistent with our strategic plan and $0.2 million related to certain inventory associated with third party platforms.

Other Income (Expense).    Other income during the year ended December 31, 2006 of $0.2 million consisted of interest income. Other expense during the year ended December 31, 2005 consisted of interest expense of $2.0 million and a loss on debt extinguishment of $0.5 million which was partially offset by interest income of $0.1 and other income of $0.1 million. Interest expense consisted of the following for the years ended December 31, 2006 and 2005 (dollars in thousands):

   

2006

  

2005

 

Interest paid or accrued on outstanding debt

  $    —    $553 

Amortization of debt premiums

   —     (857)

Amortization of debt discounts—warrants

   —     28 

Amortization of debt discount—beneficial conversion feature

   —     725 

Fair value of incremental shares received by Laurus

   —     1,365 

Other

   11   164 
         
  $11  $    1,978 
         

We had previously entered into a $7.5 million line of credit (the “Credit Line”) and a $2.8 million convertible note (the “Term Note,” and collectively with the Credit Line the “Laurus Loans”) from Laurus Master Fund, Ltd. (“Laurus”). On March 18, 2005, Laurus converted $1.9 million of the outstanding principal balance under the Credit Line into 3,600,000 shares of our common stock at $0.52 per share. In addition, on March 24, 2005, Laurus converted $.7 million of the outstanding principal balance of the Term Note into 1,250,000 shares of our common stock at $0.52 per share. In conjunction with these conversions, we accelerated amortization of $.4 million of related debt premiums and discounts and recorded a charge to interest expense of $1.4 million related to the fair value of incremental shares received by Laurus. Contemporaneously with the closing of a private offering of common stock in November 2005 (the “2005 Private Placement”), we repaid all outstanding principal and accrued interest on the Laurus Loans. In conjunction with this prepayment, we recorded a loss on debt extinguishment of $.5 million. This loss consisted of prepayment penalties and fees paid to Laurus to facilitate the 2005 Private Placement of $.8 million offset by the elimination of associated net debt premiums of $.3 million.

Income Tax Expense.    Income tax expense recorded during the years ended December 31, 2006 and 2005 related to income taxes in states, foreign countries and other local jurisdictions. Due to our cumulative losses, expected losses in future years and inability to utilize any additional losses as carrybacks, we did not provide for an income tax benefit during the years ended December 31, 2006 or 2005 based on our determination that it was more likely than not that such benefits would not be realized. We will continue to assess the recoverability of deferred tax assets and the related valuation allowance. To the extent we begin to generate taxable income in future periods and determine that such valuation allowance is no longer required, the tax benefit of the remaining deferred tax assets will be recognized at such time.

Results of Discontinued Operations

On December 22, 2005, the Company’s Directors voted to either sell or close and liquidate the Nucleic Acids operating segment, which consists primarily of a manufacturing facility in Glasgow, Scotland. This decision was made after an evaluation of, among other things, short and long-term sales projections for products sold by this operating segment, including estimates of 2006 sales to the operating segment’s largest customer. In conjunction with the decision to exit this operating segment,

the Company recorded impairment charges of $.4 million and $8.0 million in 2006 and 2005, respectively, consisting of valuation adjustments to reflect the carrying value of the related net assets at estimated fair market value. Accordingly, the results of this business segment are shown as discontinued operations for all periods presented. Expenses that are not directly identified to this operating segment or are considered corporate overhead have not been allocated to this segment in determining the results from discontinued operations. Summary results of operations of the former Nucleic Acids operating segment were as follows (dollars in thousands):

   Years Ended December 31,
   

2007

  

2006

  

2005

NET SALES

  $    —  $1,142  $3,881

COST OF GOODS SOLD

      912   4,004
            

Gross profit (loss)

      230   (123)

OPERATING EXPENSES:

      

Selling, general and administrative

   (67)   264   1,054

Research and development

         

Restructuring charges

         

Exit and disposal charges

         866

Impairment charges

      436   8,022

Gain on sale of facility

         
            
   (67)   700   9,942
            

INCOME (LOSS) FROM OPERATIONS

   67   (470)   (10,065)

OTHER INCOME (EXPENSE)

      2   56
            

INCOME (LOSS) BEFORE INCOME TAXES

   67   (468)   (10,009)

INCOME TAX BENEFIT

         
            

INCOME (LOSS) FROM DISCONTINUED OPERATIONS

  $67  $(468)  $(10,009)
            

Assets associated with the Nucleic Acids segment consisted principally of our facility in Glasgow, Scotland. During 2007 we completed the sale of the Glasgow facility and the associated equipment for $2.9 million, net of selling expenses, which resulted in a gain of $.1 million.

The Company accepted common stock from a customer of the former Nucleic Acids operating segment, Geron Corporation (“Geron”) as payment for goods and services. These shares were classified as available-for-sale securities. Net realized gains on these securities during 2005 of $.1 million was reflected as other income. Proceeds from the sales of these available for sale securities were reflected within net cash flows from investing activities in 2005. During 2005 product sales to Geron totaled $1.9 million representing 50% of net sales within this business segment.

Liquidity and Capital Resources

Our working capital positions at December 31, 20072010 and 20062009 were as follows (in thousands):

 

   December 31,   
   

2007

  

2006

  

Change

Current assets(including cash and cash equivalents of $5,723 and $5,868, respectively)

  $16,163  $15,605  $558

Current liabilities

   4,847   5,329   (482)
            

Working capital

  $  11,316  $  10,276  $    1,040
            

   December 31,     
   2010   2009   Change 

Current assets(including cash and cash equivalents of $3,454 and $5,642, respectively)

  $15,034    $14,454    $580  

Current liabilities

   8,253     4,103     (4,150
               

Working capital

  $  6,781    $  10,351    $  (3,570
               

We have historically operated at a loss and have not consistently generated sufficient cash from operating activities to cover our operating and other cash expenses. In 2010 we had a net loss of $3.1 million and needed to use $1.7 million in operating activities. While we have been able to historically finance our operating losses through borrowings or from the issuance of additional equity, we currently have no plans to increase borrowings and have no plansor to issue additional equity securities for this purpose. At December 31, 20072010 and December 31, 2006,2009, we had cash and cash equivalents of $5.7$3.5 and $5.9$5.6 million, respectively. While we believe that existing sources of liquidity are sufficient to meet expected cash needs during 2008,2011, we will need to increase our revenues or furthernet sales and focus on the integration of the FAMILION acquisition to reduce our operating expenses in order to be assured of meetingmeet our liquidity needs on a long-term basis. However, we cannot assure you that we will be able to increase our revenuesnet sales or further reduce our expenses, or raise further capital or equity and, accordingly, we may not have sufficient sources of liquidity to continue the operations indefinitely. We continue to explore additional sources of the Company indefinitely.liquidity.

Analysis of Cash Flows

Years Ended December 31, 20072010 and 20062009

Net Change in Cash and Cash Equivalents.    Cash and cash equivalents decreased $0.1$2.2 million during the year ended December 31, 20072010 primarily as a result of $1.7 million being used in operating

activities, net cash used in investing activities of $6.2 million and $5.8 million provided by financing activities. Cash and cash equivalents increased $0.9 million during the year ended December 31, 2009 as a result of net cash of $2.9$1.3 million being usedprovided by operating activities and changes in foreign currency exchanges of $.3 million which was offset by net cash provided byused in investing activities of $3.1$0.4 million.

Cash Flows Used In Operating Activities.    Cash flows used in operating activities totaled $2.9$1.7 million for the year ended December 31, 2010 compared to cash flows provided in operating activities of $1.3 million during the year ended December 31, 2007 compared2009. The cash flows used in operating activities in 2010 relate to $1.2 million during the same period of 2006. The use in 2007 resulted from our net loss of $2.1$3.1 million which is offset by an increase in accounts payable of $0.4 million and higher inventory levelsnoncash items of $1.4 million related$0.7 million. The cash flows provided by operating activities in 2009 primarily relate to the acquisition of an inventory of OEM instruments. This was offset byincreased accounts receivable collections of $1.5$1.1 million, gain on salethe decrease in inventory of an investment in equity securties of $.9$1.3 million and non-cash chargesnoncash items of $1.1 million. The use in 2006 resulted primarily from our net loss of $3.43 million, offset by non-cash chargesthe loss of $2.55$1.9 million and lower accrued expenses of $0.4 million. Non-cash charges consisted primarily of depreciation and amortization, impairment charges and non-cash stock based compensation. Working capital and other adjustments decreased cash flows from operating activities by $0.34 million during 2006.

Cash Flows Used In Investing Activities.    Cash flows provided byused in investing activities totaled $3.1$6.2 million during the year ended December 31, 2007 compared to $.22010. This included the acquisition costs for FAMILION of $6.0 million and purchases of cash flowproperty and equipment of $0.2 million. Cash flows used in investing activities totaled $0.4 million during the same period of 2006.year ended December 31, 2009. Cash flows provided byused in investing activities in 20072009 consisted primarily of sales proceeds from our Glasgow facility and equipment of $2.9 and proceeds from the sale of an investment in equity securities of $.9 million. This was offset by purchases of $0.7 million of property and equipment. The cash used in 2006 was for purchases, offset by sales, of property and equipment.

Cash Flows fromProvided by Financing Activities.    Cash flows fromprovided by financing activities were minimal during$5.8 million for the yearsyear ended December 31, 2007 and 2006.2010. This resulted in the issuance of preferred stock to fund the acquisition of FAMILION. Also, we issued common stock due to the exercise of stock options for 100,000 shares during the second quarter of 2010. There were no cash flows provided by or used in financing activities for the year ended December 31, 2009.

Off Balance Sheet Arrangements

At December 31, 20072010 and 2006,2009, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Critical Accounting Policies

Accounting policies used in the preparation of the consolidated financial statements may involve the use of management judgments and estimates. Certain of our accounting policies are considered critical as they are both important to the portrayal of our financial statements and they require significant or complex judgments on the part of management. Our judgments and estimates are based on experience and assumptions that we believe are reasonable under the circumstances. Further, we evaluate our judgments and estimates from time to time as circumstances change. Actual financial results based on judgment or estimates may vary under different assumptions or circumstances. The following are certain critical accounting policies that may involve the use of judgment or estimates.

Allowance for Doubtful AccountAccounts and Contractual Allowances.    Accounts receivable are shown net of an allowance for doubtful accounts. In determining an allowance for doubtful accounts, we consider the following:

The age of the accounts receivable,

Customer customer credit history,

Customer customer financial information,

Reasons reasons for non-payment, and

Our our knowledge of the customer.

Management also evaluates contract terms and history of collections with third party payors. If our customers’ financial condition were to deteriorate, resulting in a change in their ability to make payment, additional allowances may be required.

Inventories.    Inventories are stated at the lower of cost or market.market net of allowance for obsolete inventory. Cost is computed using standard costs for finished goods and average or latest actual cost for raw materials and work in process.process, which approximates the first-in, first-out (FIFO) method. We write down slow-moving and obsolete inventory by the difference between the value of the inventory and our estimate of the reduced value based on potential future uses, the likelihood that overstocked inventory will be sold and the expected selling prices of the inventory. If our ability to realize value on slow-moving or obsolete inventory is less favorable than assumed, additional write-downs of the inventory may be required.

Depreciation and Amortization of Long-Lived Assets.    Our long-lived assets consist primarily of property and equipment, patents and intellectual property and capitalized software development costs.property. We believe the useful lives we assigned to these assets are reasonable. If our assumptions about these assets change as a result of events or circumstances and we believe the assets may have declined in value we may record impairment charges resulting in an increase to operating expenses. Property and equipment are carried at cost. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the related assets ranging from 31 to 1510 years. We capitalize legal costs and filing fees associated with obtaining patents on our new discoveries and amortize these costs using the straight-line method over the shorter of the legal life of the patent or its economic life generally 17 years, beginning on the date the patent is issued. Intellectual property which is purchased technology, is recorded at cost and is amortized over its estimated useful life.

Preferred Stock.    We entered into a Series A Convertible Preferred Stock Purchase Agreement on December 29, 2010, as discussed in Note L, selling shares of preferred stock and issuing warrants to purchase a certain number of shares of Series A Preferred Stock. The Series A Preferred Stock meets the definition of mandatorily redeemable stock as it is preferred capital stock which is redeemable at the option of the holder and should be reported outside of equity. Preferred stock is accreted to its redemption value. The warrants do not qualify to be treated as equity, and accordingly, are recorded as a liability. A preferred stock conversion feature is embedded within the Series A Preferred Stock that meets the definition of a derivative. The preferred stock, warrant liability and preferred stock conversion feature are all recorded separately and were initially recorded at fair value using the Black Scholes model. We are required to record these instruments at fair value at each reporting date and changes will be recorded as an adjustment to earnings. The warrant liability and preferred stock conversion feature are considered level three financial instruments.

Impairment of Long-Lived Assets.    We evaluate long lived assets including such things as goodwill for impairment on an annual basis. We assess the recoverability of long-lived assets whenever events or changes in circumstances indicate

that the carrying amount of an asset may not be recoverable. These computations utilize judgments and assumptions inherent in our estimate of future undiscounted and discounted cash flows to determine recoverability of these assets. If our assumptions about these assets were to change as a result of events or circumstances, we may be required to record an impairment loss.

RevenueNet Sales Recognition.    Revenue onis realized and earned when all of the following criteria are met:

Persuasive evidence of an arrangement exists

Delivery has occurred or services have been rendered

The seller’s price to the buyer is fixed or determinable, and

Collectability is reasonably assured.

Net sales of our instrument and bioconsumable products isare 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 normal sales terms do not provide for the right of return unless the product is damaged or defective. RevenuesNet Sales 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 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. RevenueWe also enter into various service contracts that cover installed instruments. These contracts cover specific time period and net sales associated with these contracts are deferred and ratably recognized over the service period.

Net sales recognition for our Molecular Clinical Reference Laboratory is on an individual test basis and takes place when the test report is compete, all sign offs have been completed, reviewed and the report is sent to the client. client and is recorded net of the allowance for insurance, Medicare and Medicaid contractual adjustments. There are no deferred net sales associated with our Molecular Clinical Reference Laboratory. Adjustments to the allowances, based on actual receipts from the third party payers, are recorded upon settlement.

In our Pharmacogenomics research group we recognize revenue basedperform services on a percentproject by project basis. When payment is received in advance, revenue is recognized upon delivery of completion method for each project. the service. These projects typically do not extend beyond one year.

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

Recently Issued Accounting Pronouncements

Effective January 1,2007, we began to measure and record tax contingency accruals in accordance with Financial Accounting Standards Board (“FASB”) InterpretationIn October 2009, the FASB issued ASU No. 48,2009-13,Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement No. 109 (“FIN 48”). Under FIN 48, tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured as the largest amount of benefit that is more likely than not to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in our tax returns that do not meet these recognition and measurement standards. For additional information on the adoption of FIN 48, see Note H of this report.

In September 2006, the SEC issued Staff Accounting Bulletin. 108,Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements (SAB 108). SAB 108 provides interpretive guidance on how the effects of prior-year uncorrected misstatements should be considered when quantifying misstatements in current year financial statements. SAB 108 requires registrants to quantify misstatements using both an income statement and balance sheet approach and then evaluate whether either approach results in a misstatement that, when all relevant quantitative and qualitative factors are considered, is material. If prior year errors that had been previously considered immaterial are now considered material based on either approach, no restatement is required so long as management properly applied its previous approach and all relevant facts and circumstances were considered. If prior year’s financial statements are not restated, the cumulative effect adjustment is recorded in opening accumulated earnings (deficit) asRevenue Recognition (ASC 605): Multiple-Deliverable Revenue Arrangements (a consensus of the FASB Emerging Issues Task Force); effective for years beginning of the fiscal year of adoption. SAB 108after June 15, 2010. This standard update became effective for us on January 1, 2011. Vendors often provide multiple products and/or services to their customers as part of a single arrangement. These deliverables may be provided at different points in time or over different time periods. The existing guidance regarding how and whether to separate these deliverables and how to allocate the endoverall arrangement consideration to each was originally captured in EITF Issue 00-21,RevenueArrangements with Multiple Deliverables, which is now codified at ASC 605-25,Revenue Recognition—Multiple-Element Arrangements. The issuance of 2006. ThereASU 2009-13 amends ASC (FASB Accounting Standards Codification) 605-25 and represents a significant shift from the existing guidance that was no material impact to our Consolidated Financial Statements as a result of adoptionconsidered abuse-preventative and heavily geared toward ensuring that revenue recognition was not accelerated. The application of this pronouncement.new guidance is expected to result in accounting for multiple-deliverable revenue arrangements that better reflects their economics as more arrangements will be separated into individual units of accounting. We are in the final stages of analyzing the impact of ASU 2009-13.

In September 2006,October 2009, the FASB issued SFASASU No. 157 “Fair Value Measurements” (“SFAS 157”). SFAS 157 provides a new single authoritative definition2009-14,Software (ASC 985): Certain Revenue Arrangements That Include Software Elements (a consensus of fair value and provides enhanced

guidance for measuring the fair value of assets and liabilities and requires additional disclosures related to the extent to which companies measure assets and liabilities at fair value, the information used to measure fair value, and the effect of fair value measurements on earnings. SFAS 157 is effective as of January 1, 2008 for financial assets and financial liabilities within its scope and it is not expected to have a material impact on our consolidated financial statements. In February 2008, the FASB issued FASB Staff Position No. FAS 157-2 “Effective Date of FASB Statement No. 157” (“FSP FAS 157-2”), which defers theEmerging Issues Task Force); effective date of SFAS 157 for all non-financial assets and non-financial liabilities, except those that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually), for fiscal years beginning after NovemberJune 15, 20082010. This standard update became effective for us on January 1, 2011. ASU 2009-14 modifies the existing scope guidance in ASC 985-605,Software Revenue Recognition, for revenue arrangements with tangible products that include software elements.

This modification was made primarily due to the changes in ASC 605-25 noted previously, which further differentiated the separation and interim periods within those fiscal yearsallocation guidance applicable to non-software arrangements as compared to software arrangements. Prior to the modification of ASC 605-25, the separation and allocation guidance for items withinsoftware and non-software arrangements was more similar. Under ASC 985-605, which was originally issued as AICPA Statement of position 97-2,Software Revenue Recognition, an arrangement to sell a tangible product along with software was considered to be in its scope if the scope of FSP FAS 157-2.software was more than incidental to the product as a whole. We are currently assessingin the final stages of analyzing the impact if any, of SFAS 157 and FSP FAS 157-2 on our consolidated financial statements.ASU 2009-14.

In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities” (“SFAS 159”). SFAS 159 provides companies with an option to irrevocably elect to measure certain financial assets and financial liabilities at fair value on an instrument-by-instrument basis with the resulting changes in fair value recorded in earnings. The objective of SFAS 159 is to reduce both the complexity in accounting for financial instruments and the volatility in earnings caused by using different measurement attributes for financial assets and financial liabilities. SFAS 159 is effective as of January 1, 2008. We currently have no financial assets or financial liabilities for which SFAS 159 would be applicable.

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

In December 2007, the FASB issued SFAS No. 160 “Noncontrolling Interests in Consolidated Financial Statements, an Amendment of ARB No. 51” (“SFAS 160”). SFAS 160 establishes accounting and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. SFAS 160 requires noncontrolling interests in subsidiaries initially to be measured at fair value and classified as a separate component of equity. SFAS 160 also requires a new presentation on the face of the consolidated financial statements to separately report the amounts attributable to controlling and non-controlling interests. SFAS 160 is effective as of January 1, 2009. We do not expect SFAS No. 160 to have an impact on our consolidated financial statements.

Use of Estimates

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

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

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

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

Impact of Inflation

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

Item 7A.

Quantitative and Qualitative Disclosure about Market RiskRisk.

Foreign Currency Translation Risk.During the last threetwo fiscal years, our international sales have represented more than 50% of our net sales. These sales of products in foreign countries are mainly completed in either British Pounds Sterling or the Euro. Additionally, we have twothe British Pound Sterling is the functional currency of our wholly owned subsidiaries,subsidiary, Transgenomic Limited, and Cruachem Limited, whose operating currency is British Pounds SterlingLimited. Results of operation and the Euro.Balance Sheet are translated from the functional currency of the subsidiary to our reporting currency of the US Dollar. Results of operations for the Company’s foreign subsidiaries are translated using the average exchange rate during the period. Assets and liabilities are translated at the exchange rate in effect at the balance sheet date. In addition, we have revaluation risk which occurs when the transaction is consummated in a currency other than the British Pound Sterling. This transaction must be revalued within the Transgenomic Limited ledger, whose functional currency is the British Pound Sterling. The majority of the transactions on this ledger are in Euro. As a result we are subject to exchange rate risk. The 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 we do not have a material exposure to foreign currency rate fluctuations at this time.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMReport of Independent Registered Public Accounting Firm

To the Board of Directors and Stockholders

Transgenomic, Inc.

We have audited the accompanying consolidated balance sheetsheets of Transgenomic, Inc. and subsidiariesSubsidiary as of December 31, 20072010 and 2009, and the related consolidated statements of operations, stockholders’ equity, and cash flows for the year ended December 31, 2007. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. We were not engaged to examine management’s assertion about the effectiveness of Transgenomic, Inc’s internal control over financial reporting as of December 31, 2007 included in the accompanying Management’s Report on Internal Control Over Financial Reporting and, accordingly, we do not express an opinion thereon. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Transgenomic, Inc. and subsidiaries as of December 31, 2007, and the results of their operations and their cash flows for year ended December 31, 2007 in conformity with U.S. generally accepted accounting principles.

/s/ McGladrey & Pullen, LLP

Omaha, Nebraska

March 26, 2008

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders

of Transgenomic, Inc.

Omaha, Nebraska

We have audited the accompanying consolidated balance sheets of Transgenomic, Inc. and subsidiaries (the “Company”) as of December 31, 2006 and 2005, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2006.then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our auditsaudit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, suchthe consolidated financial statements referred to above present fairly, in all material respects, the financial position of Transgenomic, Inc. and subsidiaries atSubsidiary as of December 31, 20062010 and 2005,2009, and the results of their operations and their cash flows for each of the three years in the periodthen ended December 31, 2006, in conformity with accounting principlesU.S. generally accepted in the United States of America.accounting principles.

As discussed in Note B to the consolidated financial statements, in 2006 the Company adopted Statement of Financial Accounting Standards No. 123(R),Share-Based Payment.Omaha, Nebraska

March 14, 2011

/s/ Deloitte & Touche LLP

Omaha, Nebraska

March 30, 2007

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

CONSOLIDATED BALANCE SHEETS

As of December 31, 20072010 and 20062009

(Dollars in thousands except per share data)

 

  

2007

 

2006

   2010 2009 
ASSETS      

CURRENT ASSETS:

      

Cash and cash equivalents

  $5,723  $5,868   $3,454   $5,642  

Accounts receivable (net of allowances for bad debts of $703 and $444, respectively)

   5,095   6,525 

Inventories

   4,586   2,672 

Prepaid expenses and other current assets

   759   540 

Accounts receivable (net of allowances for bad debts of $334 and $310, respectively)

   7,601    4,522  

Inventories (net of allowances for obsolescence of $518 and $507, respectively)

   3,344    3,552  

Other current assets

   635    738  
              

Total current assets

   16,163   15,605    15,034    14,454  

PROPERTY AND EQUIPMENT:

      

Equipment

   10,857   10,345    9,820    9,972  

Furniture and fixtures

   4,056   3,820 

Furniture, fixtures and leasehold improvements

   3,479    3,834  
              
   14,913   14,165    13,299    13,806  

Less: accumulated depreciation

   13,334   12,667    (11,697  (12,839
              
   1,579   1,498    1,602    967  

OTHER ASSETS:

      

Goodwill

   638   638    6,275      

Other assets (net of accumulated depreciation of $1,117 and $1,293, respectively)

   710   853 

Non-current assets of discontinued operations

      2,773 

Intangibles (net of accumulated amortization of $519 and $525, respectively)

   8,962    383  

Other assets

   154    200  
              
  $19,090  $21,367   $32,027   $16,004  
              
LIABILITIES AND STOCKHOLDERS’ EQUITY      

CURRENT LIABILITIES:

      

Accounts payable

  $1,245  $1,558   $1,360   $1,013  

Other accrued expenses

   3,152   2,898 

Accrued compensation

   450   689    875    573  

Current liabilities of discontinued operations

      184 

Short term debt

   989      

Accrued expenses

   3,231    2,517  

Contractual obligation

   1,628      

Current portion of lease obligations

   170      
              

Total current liabilities

   4,847   5,329    8,253    4,103  

Long term debt less current maturities

   8,640      

Redeemable Series A convertible preferred stock, $.01 par value, 3,879,307 shares authorized, 2,586,205 shares issued and outstanding

   1,457      

Preferred stock conversion feature

   1,983      

Warrant liability

   2,351      

Other long term liabilities

   141       843    239  
              

Total liabilities

   4,988   5,329    23,527    4,342  

STOCKHOLDERS’ EQUITY:

      

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

       

Common stock, $.01 par value, 100,000,000 and 60,000,000 shares authorized, respectively, 49,189,672 and 49,189,672 shares outstanding, respectively

   497   497 

Preferred stock, $.01 par value, 15,000,000 shares authorized, 2,586,205 shares issued and outstanding

         

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

   498    497  

Additional paid-in capital

   139,099   138,966    139,730    139,703  

Accumulated other comprehensive income

   2,274   2,100    1,589    1,645  

Accumulated deficit

   (127,768)  (125,525)   (133,317  (130,183
              

Total stockholders’ equity

   14,102   16,038    8,500    11,662  
              
  $19,090  $21,367   $32,027   $16,004  
              

See notes to consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

CONSOLIDATED STATEMENTS OF OPERATIONS

Years Ended December 31, 2007, 20062010 and 20052009

(Dollars in thousands except per share data)

 

  

2007

 

2006

 

2005

   2010 2009 

NET SALES

  $23,176  $23,415  $25,828   $20,048   $22,023  

COST OF GOODS SOLD

   10,483   12,046   13,497    10,284    10,418  
                 

Gross profit

   12,693   11,369   12,331    9,764    11,605  

OPERATING EXPENSES:

       

Selling, general and administrative

   11,466   12,138   12,218    10,933    10,319  

Research and development

   3,033   2,362   2,199    2,305    3,182  

Restructuring charges

   1,516          138      

Impairment charges

         425 
                 
   16,015   14,500   14,842    13,376    13,501  
                 

LOSS FROM OPERATIONS

   (3,322)  (3,131)  (2,511)   (3,612  (1,896

OTHER INCOME (EXPENSE):

    

OTHER INCOME:

   

Interest income (expense)

   270   205   (1,951)   (4  15  

Loss on debt extinguishment

         (541)

Other, net

   1,121   (7)  45    632    3  
                 
   1,391   198   (2,447)   628    18  
                 

LOSS BEFORE INCOME TAXES

   (1,931)  (2,933)  (4,958)   (2,984  (1,878

INCOME TAX EXPENSE

   243   30   26    150    42  
                 

LOSS FROM CONTINUING OPERATIONS

   (2,174)  (2,963)  (4,984)

DISCONTINUED OPERATIONS:

    

Income (Loss) from discontinued operations before income tax

   67   (468)  (10,009)

Income tax benefit of discontinued operations

          
          

INCOME (LOSS) FROM DISCONTINUED OPERATIONS

   67   (468)  (10,009)
          

NET LOSS

  $(2,107) $(3,431) $(14,993)  $(3,134 $(1,920
                 

COMPREHENSIVE LOSS

  $(1,933) $(2,034) $(16,829)
          

BASIC AND DILUTED LOSS PER SHARE:

    

From continuing operations

  $(0.04) $(0.06) $(0.14)

From discontinued operations

   (0.00)  (0.01)  (0.28)
          

BASIC AND DILUTED LOSS PER SHARE

  $(0.06 $(0.04
  $(0.04) $(0.07) $(0.42)       
          

BASIC AND DILUTED WEIGHTED AVERAGE SHARES OUTSTANDING

   49,189,672   49,188,451   35,687,580    49,243,839    49,189,672  

See notes to consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Years Ended December 31, 2007, 20062010 and 20052009

(Dollars in thousands except share data)

 

 

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 

Balance, January 1, 2009

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

Other comprehensive income (loss):

      

Net loss

      (14,993)  (14,993)  (14,993)              (1,920  (1,920  (1,920

Other comprehensive income (loss):

      

Foreign currency translation adjustment

         (1,836)  (1,836)
        

Comprehensive loss

      (16,829) 
        

Beneficial conversion premium

     399       399 

Conversion of Laurus Loans

 4,900,000  49  2,507       2,556 

Fair value of incremental shares issued

     1,365       1,365 

Issuance of shares in private placement, net of expenses of $1,213

 14,925,743  149  13,713       13,862 

Issuance of shares for employee stock purchase plan

 25,504    18       18 
               

Balance, December 31, 2005

 49,182,121  497  138,800 (122,094)   703   17,906 

Net loss

      (3,431)  (3,431)  (3,431)

Other comprehensive income (loss):

      

Foreign currency translation adjustment

         1,397   1,397 
        

Comprehensive loss

      (2,034) 
        

Non-cash stock based compensation

     161       161 

Issuance of shares for employee stock purchase plan

 7,551    5       5 
               

Balance, December 31, 2006

 49,189,672  497  138,966 (125,525)   2,100   16,308 

Net loss

      (2,107)  (2,107)  (2,107)

FIN 48 Adjustment

      (129)     (129)

Other, net

      (7)  7  

Other comprehensive income (loss):

      

Foreign currency translation adjustment

         167   167                   175    175  
                

Comprehensive loss

      (1,933)       (1,745 
                

Non-cash stock based compensation

     133       133           202            202  
                                 

Balance, December 31, 2007

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

Balance, December 31, 2009

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

Other comprehensive income (loss):

      

Net loss

     (3,134  (3,134  (3,134

Foreign currency translation adjustment

      (56  (56
                       

Comprehensive loss

      (3,190 
        

Non-cash stock based compensation

          (14          (14

Issuance of shares for employee stock options

  100,000    1    41            42  
                  

Balance, December 31, 2010

  49,289,672   $498   $139,730   $(133,317 $1,589   $8,500  
                  

See notes to consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Years Ended December 31, 2007, 20062010 and 20052009

(Dollars in thousands)thousands except share data)

 

   

2007

  

2006

  

2005

 

CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:

    

Net loss

  $(2,107) $(3,431) $(14,993)

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

    

Depreciation and amortization

   950   1,949   4,283 

Impairment charges

      437   8,447 

Non-cash financing costs

         1,281 

Non-cash debt extinguishment charges

         (303)

Non-cash stock based compensation

   133   161    

(Gain)/loss on sale of investment and assets

   (1,034)     (50)

Other

   13   18    

Changes in operating assets and liabilities:

    

Accounts receivable

   1,479   1,634   139 

Inventories

   (1,436)  397   514 

Prepaid expenses and other current assets

   (217)  200   574 

Accounts payable

   (576)  (731)  (1,129)

Accrued expenses

   (144)  (1,846)  (2,390)
             

Net cash flows provided by (used in) operating activities

   (2,939)  (1,212)  (3,627)

CASH FLOWS PROVIDED BY (USED IN) INVESTING ACTIVITIES:

    

Proceeds from the maturities and sale of available for sale securities

         2,151 

Purchase of property and equipment

   (720)  (250)  (641)

Change in other assets

   (132)  (64)  (3)

Proceeds from asset sales

   3,935   119   139 
             

Net cash flows provided by (used in) investing activities

   3,083   (195)  1,646 

CASH FLOWS PROVIDED BY (USED IN) FINANCING ACTIVITIES:

    

Net change in line of credit

         (4,069)

Payments on long-term debt

         (1,850)

Issuance of common stock, net of expenses

      5   13,836 
             

Net cash flows provided by (used in) financing activities

      5   7,917 

EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH

   (289)  534   (202)
             

NET CHANGE IN CASH AND CASH EQUIVALENTS

   (145)  (868)  5,734 

CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

   5,868   6,736   1,002 
             

CASH AND CASH EQUIVALENTS AT END OF YEAR

  $5,723  $5,868  $6,736 
             

SUPPLEMENTAL CASH FLOW INFORMATION

    

Cash paid during the year for:

    

Interest

  $5  $11  $553 

Income taxes, net

   178   30   12 

Non-cash transactions:

    

Available for sale securities acquired for goods and services

         2,099 

Conversions of debt to equity

         2,536 
   2010  2009 

CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:

   

Net loss

  $    (3,134 $    (1,920

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

   

Depreciation, amortization and disposals

   708    852  

Non-cash stock based compensation

   (14  202  

Changes in operating assets and liabilities, net of effects of acquisition:

   

Accounts receivable

   72    1,113  

Inventories

   97    1,290  

Prepaid expenses and other current assets

   95    (60

Accounts payable

   364    60  

Accrued expenses and accrued compensation

   92    (401

Other long term liabilities

   (24  109  

Deferred income taxes

   26    22  
         

Net cash flows provided by (used) in operating activities

   (1,718  1,267  
         

CASH FLOWS USED IN INVESTING ACTIVITIES:

   

Acquisition

   (6,000    

Purchase of property and equipment

   (192  (351

Change in other assets

   (34  (26
         

Net cash flows used in investing activities

   (6,226  (377
         

CASH FLOWS PROVIDED BY FINANCING ACTIVITIES:

   

Issuance of preferred stock and related warrants

   6,000      

Stock issuance costs

   (209    

Issuance of common stock

   42      

Principal payments on capital lease obligations

   (72    
         

Net cash flows provided by financing activities

   5,761      
         

EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH

   (5  (19

NET CHANGE IN CASH AND CASH EQUIVALENTS

   (2,188  871  

CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

   5,642    4,771  
         

CASH AND CASH EQUIVALENTS AT END OF YEAR

  $    3,454   $    5,642  
         

SUPPLEMENTAL CASH FLOW INFORMATION

   

Cash paid during the year for:

   

Interest

  $7   $  

Income taxes

   29    163  

SUPPLEMENTAL DISCLOSURE OF NON-CASH INFORMATION

   

Acquisition of equipment through capital leases

  $394   $  

See notes to consolidated financial statements.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Years Ended December 31, 2007, 20062010 and 20052009

A.         BUSINESS DESCRIPTION

Business Description.

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

Laboratory Services:

Molecular Clinical Reference Laboratory.    The molecular clinical reference laboratory specializes in genetic testing for oncology, hematology and inherited disorders. Located in New Haven, Connecticut and Omaha, Nebraska the molecular clinical reference laboratories are certified under the Clinical Laboratory Improvement Amendment (CLIA) as high complexity labs and our Omaha facility is accredited by CAP (College of American Pathologists).

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

Instrument Related Business:

 

 

·

 

Bioinstruments.    Our flagshipproprietary product is the WAVE® System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There is a worldwide installed base of over 1,4001,500 WAVE Systems as of December 31, 2007.2010. We also distribute bioinstruments produced by other manufacturers (“OEM Equipment”) through our sales and distribution network. Service contracts to maintain installed systems are sold and supported by our technical support personnel.

 

 

·

 

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

·

Discovery Services.    Our Pharmacogenomics Research Service is a contract research lab in Gaithersburg, Maryland that primarily provides genomic biomarker analysis services to pharmaceutical and biopharmaceutical companies to support preclinical and clinical development of targeted therapeutics. Our Molecular Clinical Reference Laboratory, in Omaha, Nebraska provides molecular-based testing for hematology, oncology and certain inherited diseases for physicians and third-party laboratories. The Molecular Clinical Reference Laboratory operates in a Good Laboratory Practices (“GLP”) compliant environment and is certified under the Clinical Laboratory Improvement Amendment.

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

Although we have experienced declining sales and recurring net losses (resulting in an accumulated deficit of $128$133.3 million at December 31, 2007)2010), management believes existing sources of liquidity, including cash and cash equivalents of $5.7$3.5 million, are sufficient to meet expected cash needs during 2008.2011. Our business consolidation efforts have helped control our operating costs, however we will need to increase net sales in order to meet our liquidity needs on a long-term basis. If

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

we cannot increase net sales, further reductions to operating expenses will be needed. In future periods, there is no assurance that we will be able to increase net sales or further reduce expenses and, accordingly, we may not have sufficient sources of liquidity to continue operations indefinitely.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006 and 2005

B.         SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Principles of Consolidation.

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

UseRisks and Uncertainties.

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

1.

Use of Estimates.

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

2.

Concentration of Revenue Risk.

No customer accounted for more than 10% of consolidated net sales during the years ended December 31, 2010 and 2009. For the year ended December 31, 2010 one customer made up 15% of the Laboratory Services net sales. For the year ended December 31, 2009 one customer made up more than 20% of the Laboratory Services net sales.

Fair Value.

Unless otherwise specified, book value approximates fair market value.

Cash and Cash Equivalents.

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

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

Concentrations of Cash.

From time to time, we may maintain a cash position with financial institutions in amounts that exceed federally insured limits. We have not experienced any losses on such accounts.accounts as of December 31, 2010.

Accounts Receivable.

Accounts receivable are shown net of allowance for doubtful accounts. The following is a summary of activity for the allowance for doubtful accounts during the years ended December 31, 2007, 20062010 and 2005:2009:

 

   Dollars in Thousands
   

Beginning
Balance

  

Additional
Charges to
Income

  

Deductions
from
Reserve

  

Ending
Balance

Year Ended December 31, 2007

  $    444  $753  $    494  $    703

Year Ended December 31, 2006

  $615  $92  $263  $444

Year Ended December 31, 2005

  $701  $    —  $86  $615
   Dollars in Thousands 
   Beginning
Balance
   Provision  Write
Offs
  Ending
Balance
 

Year Ended December 31, 2010

  $310    $28   $(4 $334  

Year Ended December 31, 2009

  $388    $(8 $(70 $310  

While payment terms are generally 30 days, we have also provided extended payment terms of up to 90 days in certain cases. We operate globally and some of the international payment terms may be greater than 90 days. Accounts receivable are carried at original invoice and shown net of allowance for doubtful accounts and contractual allowances. The estimate made for doubtful accounts is based on a review accounts receivableof all outstanding amounts on a quarterly basisbasis. We determine the allowance for doubtful accounts and adjust our bad debt reserve accordingly.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006contractual allowances by regularly evaluating individual customer receivables and 2005

considering a customer’s financial condition, credit history and current economic conditions. Account receivables are written off when deemed uncollectible. Recoveries of account receivables previously written off are recorded when received. Management also evaluates contract terms and history of collections with third party payors. We do not charge interest on past due accounts.

Inventories.

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

The following is a summary of activity for the allowance for obsolete inventory during the twelve months ended December 31, 2010 and 2009:

   Dollars in Thousands 
   Beginning
Balance
   Provision   Write
Offs
  Ending
Balance
 

Year Ended December 31, 2010

  $507    $100    $(89 $518  

Year Ended December 31, 2009

  $108    $482    $(83 $507  

We determine the allowance for obsolete inventory by quarterly evaluating the inventory for items deemed to be slow moving or obsolete.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

Property and Equipment.

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

 

Leasehold improvements

  

21 to 10 years

Furniture and fixtures

  

53 to 7 years

Production equipment

  

53 to 7 years

Computer equipment

  

3 to 57 years

Research and development equipment

  

32 to 57 years

Demonstration equipment

3 to 5 years

Depreciation of property and equipment totaled $.8 million, $1.3 million and $1.8$0.4 million in 2007, 2006,the year ended 2010 and 2005 respectively.$0.6 million in the year ended 2009. Included in depreciation for the year ended December 31, 2010 is less than $0.1 million related to capital leases. We did not have any capital leases during 2009.

Goodwill.

StatementGoodwill is the excess of Financial Accounting Standards (“SFAS”) No. 142,the purchase price over fair value of assets acquired and is not amortized. Goodwill and Other Intangible Assets,provides that goodwill will not be amortized, but will beis tested for impairment annually. We perform this impairment analysis during the fourth quarter of each year.year or when a significant event occurs which may impact goodwill. Impairment occurs when the carrying value is determined to be not recoverable thereby causing the faircarrying value of the goodwill to exceed the carryingits fair value. If impaired, the asset’s carrying value is reduced to its fair value. No impairment existed at December 31, 2007 or 2006.2010.

Other Assets.Intangibles.

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

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

2. Patents.    We capitalize legal costs, filing fees and other expenses associated with obtaining patents on new discoveries and amortize these costs using the straight-line method over the shorter of the legal life of the patent or its economic life generally 17 years, beginning on the date the patent is issued.

Other Intangible Assets.    Identifiable intangible assets with definite lives are3. Intangibles.    As a part of the FAMILION acquisition we acquired technology, in process technology, trademarks/tradenames and third party relationships. These costs will be amortized straight line over their estimated useful lives and tested for impairment as events or changes in circumstances indicate the carrying amounteconomic life of the asset may be impaired.

seven to eight years. See Footnote F.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006 and 2005

Each of theseThese assets are treated as long-lived assets for purposes of SFAS No. 144, which provides that long-livedassets. Long-lived assets will be tested for impairment on an annual basis.basis or when a significant event occurs, which may impact impairment. We periodicallyquarterly review the carrying value of our long-lived assets to assess recoverability and impairment. We recorded no impairments during 2007 or 2006.2010. In 2009 we recorded less than $0.1 million related to accelerated amortization on two license agreements that we terminated in the first quarter of 2010.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

Other Long Term Assets.

Other long term assets include US security deposits and deferred tax assets.

Stock Based Compensation.

All stock options awarded to date have exercise prices equal to the market price of our common stock on the date of grant and have ten-year contractual terms. Unvested options as of December 31, 20072010 had vesting periods of three years from date of grant. None of the stock options outstanding at December 31, 20072010 are subject to performance or market-based vesting conditions.

We adopted FASB123(R), on January 1, 2006. FASB 123(R) requires us to measure and recognize compensation expense for all stock-based awards made to employees and directors, including stock options. Compensation expense is based on the calculated fair value of the awards as measured at the grant date and is expensed ratably over the service period of the awards (generally the vesting period).

On December 28, 2005, our Directors approved a plan to accelerate the vesting of all outstanding stock options. Aside from the acceleration of the vesting date, the terms and the conditions of the stock option award agreements governing the underlying stock option grants remained unchanged. As a result of this plan, options to purchase approximately 1,081,845 shares became immediately exercisable. All such options were out-of-the-money and, accordingly, the accelerated vesting resulted in no compensation expense since there was no intrinsic value associated with these fixed awards at the date of modification. Accelerating the vesting of these options allowed us to avoid recognition of compensation expense associated with these options in future periods.

For the year ended December 31, 2007,2010, we recorded compensation expense recovery of less than $0.1 million within selling, general and administrative expense. Two executive officers departed during the second quarter of 2010. All stock options that were unvested were forfeited at the time of their departure as their requisite services period was not completed. The vesting of options exercisable for the purchase of 1.3 million shares was offset by the expense recovery for stock options that were forfeited due to the requisite service not being rendered. For the year ended December 31, 2009, we recorded compensation expense of $.1$0.2 million within selling, general and administrative expense as a result of the vesting of 1.4options exercisable for the purchase of 1.7 million optionsshares during the year. No options vested during the year ended December 31 2006, however we recorded compensation expense of $.2 million during the year as result of the extension of the post-termination exercise period for .5 million options from 90 days after termination to the remaining contractual term of the original option grants. As of December 31, 2007,2010, there was $.4$0.1 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of nearly three years.

The fair value of the options granted during 20072010 was estimated on their respective grant dates using the Black-Scholes option pricing model. The Black-Scholes model was used with the following assumptions: risk-free interest rates of 3.34%1.17% to 5.08%1.98%, based on the U.S. Treasury yield in effect at the time of grant; dividend yields of zero percent; expected lives of 2 to 105 years, based on historical exercise activity behavior;activity; and volatility of 89.14% and 67.58%103% to 105% for grants made during the year ended December 31, 20072010 based on the historical volatility of our stock over a time that is consistent with the expected life of the option. A small group of senior executives hold the majority of the stock options and are expected to hold the options until they are vested. Forfeitures of 2.2% to 2.5% have been assumed in the calculation due to the turnover of senior executives in 2010.

The fair value of the options granted during 2009 was estimated on their respective grant dates using the Black-Scholes option pricing model. The Black-Scholes model was used with the following assumptions: risk-free interest rates of 2.12% to 3.99%, based on the U.S. Treasury yield in effect at the time of grant; dividend yields of zero percent; expected lives of 5 to 10 years, based on historical exercise activity; and volatility of 80.03% to 106.00% for grants made during the year ended December 31, 2009 based on the historical volatility of our stock over a time that is consistent with the expected life of the option. A small group of senior executives held the majority of the stock options and are expected to hold the options until they are vested therefore no forfeitures have been assumed.

were assumed in 2009.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

Income Taxes.

Deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax basis of assets and liabilities at each balance sheet date using tax rates expected to be in effect in the year the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent that it is more likely than not that they will not be realized. We had no material unrecognized tax benefits, interest, or penalties during fiscal 2010 or fiscal 2009, and we do not anticipate any such items during the next twelve months. Our policy is to record interest and penalties directly related to income taxes as income tax expense in the Consolidated Statements of Operations.

RevenueNet Sales Recognition.

Revenue (referredis realized and earned when all of the following criteria are met:

Persuasive evidence of an arrangement exists

Delivery has occurred or services have been rendered

The seller’s price to as “net sales”)the buyer is fixed or determinable, and

Collectability is reasonably assured.

Net sales on the sales of products isare recognized in accordance with the terms of the sales arrangement. Such recognition is based on receipt of an unconditional customer order and transfer of title and risk of ownership to the customer, typically upon shipment of the product under a purchase order. Our normal sales terms do not provide for the right of return unless the product is damaged or defective. Net sales from certain services associated with the analytical instruments, to be performed subsequent to shipment of the products, is deferred and recognized when the services are provided. Such services, mainly limited to installation and training services that are not essential to the functionality of the instruments, typically are performed in a timely manner subsequent to shipment of the instrument. We also enter into various service contracts that cover installed instruments. These contracts cover specific time periods and net sales associated with these contracts are deferred and ratably recognized over the service period. At December 31, 2007 and December 31, 2006, deferred revenueDeferred net sales mainly associated with our service contracts, included in the balance sheet in other accrued expenses, was approximately $1.6$1.4 million for each of the years ended December 31, 2010 and $1.6 million, respectively.2009.

Revenue recognition forNet Sales from our Molecular Clinical Reference Laboratory isServices are recognized on an individual test basis and takes place when the test report is compete, all sign offs have been completed, reviewed and the report is sent to the client. client and is recorded net of the allowance for insurance, Medicare and Medicaid contractual adjustments. There are no deferred net sales associated with our Molecular Clinical Reference Laboratory. Adjustments to the allowances, based on actual receipts from the third party payers, are recorded upon settlement.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

In our Pharmacogenomics research groupResearch Services Group, we recognize revenue basedperform services on a percentageproject by project basis. When payment is received in advance, revenue is recognized upon delivery of completion methodthe service. These projects typically do not extend beyond one year. At December 31, 2010 and 2009, deferred net sales associated with the pharmacogenomics research projects included in the balance sheet in other accrued expenses, was less than $0.1 million for each project.period.

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

Research and Development.

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

Preferred Stock.

We entered into a Series A Convertible Preferred Stock Purchase Agreement on December 29, 2010, as discussed in Note L, selling shares of preferred stock and issuing warrants to purchase a certain number of shares of Series A Preferred Stock. The Series A Preferred Stock meets the definition of mandatorily redeemable stock as it is preferred capital stock which is redeemable at the option of the holder and should be reported outside of equity. Preferred stock is accreted to its redemption value. The warrants do not qualify to be treated as equity, and accordingly, are recorded as a liability. A preferred stock conversion feature is embedded within the Series A Preferred Stock that meets the definition of a derivative. The preferred stock, warrant liability and preferred stock conversion feature are all recorded separately and were initially recorded at fair value using the Black Scholes model. We are required to record these instruments at fair value at each reporting date and changes will be recorded as an adjustment to earnings. The warrant liability and preferred stock conversion feature are considered level three financial instruments.

Translation of Foreign Currency.

Financial statements of subsidiaries outside the U.S. are measured usingOur foreign subsidiary uses the local currenciescurrency of the country in which they are located as thetheir functional currency. The adjustments to translate those amountsIts assets and liabilities are translated into U.S. dollars at the exchange rates in effect at the balance sheet date. Cumulative translation losses of less than $0.1 are accumulated in a separate account in stockholders’ equity and are included inreported as accumulated other comprehensive income. Foreignloss on the accompanying consolidated balance sheets for the year ended December 31, 2010. Cumulative translation gains of $0.2 million were reported as accumulated other comprehensive income for the year ended December 31, 2009. Revenues and expenses are translated at the average rates during the period. For transactions that are not denominated in the functional currency, we recognized net losses of $0.3 million as foreign currency transaction gains or losses resulting from changes in currency exchange rates are included in the determination of net income. Foreign currency transaction adjustments decreased net loss by $.1 million duringfor each of the years ending December 31, 2010 and 2009.

Other Income.

Other income consists primarily of interest income from cash and cash equivalents invested in overnight instruments. Other income in the year ended December 31, 2007 and increased net loss by $.1 million and $.3 million during the years ended December 31, 2006 and 2005, respectively.

2010 includes an award of a

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

federal grant under the Qualifying Therapeutic Discovery Project related to COLD-PCR, Surveyor Scan kit development for key cancer pathway gene mutations and mtDNA damage assays. Other income related to this federal grant was $0.6 million net of consulting fees. Other income for the year ended December 31, 2009 was less than $0.1 million.

Comprehensive Income.

Accumulated other comprehensive income at December 31, 20072010 and 20062009 consisted of foreign currency translation adjustments, net of applicable tax of zero. We deem our foreign investments to be permanent in nature and do not provide for taxes on currency translation adjustments arising from converting investments in a foreign currency to U.S. dollars.

Earnings Per Share.

Basic earnings per share is calculated based on the weighted average number of common shares outstanding during each period. Diluted earnings per share include shares issuable upon exercise of outstanding stock options, warrants or conversion rights that have exercise or conversion prices below the market value of our common stock. Options, warrants and conversion rights pertaining to 12,583,879, 13,530,24118,607,229 and 13,625,67511,309,887 shares of our common stock have been excluded from the computation of diluted earnings per share at December 31, 2007, 20062010 and 2005, respectively,2009, respectively. The options, warrants and conversion rights that were exercisable in 2010 and 2009 were not included because the effect would be anti-dilutive due to the net loss from continuing operations in those periods.loss. As a result, none of our outstanding options, warrants or conversion rights affect the calculation of diluted earnings per share.

Recently Issued Accounting Pronouncements.

In July 2006,October 2009, the FASB issued InterpretationASU No. 48,2009-13,AccountingRevenue Recognition (ASC 605): Multiple-Deliverable Revenue Arrangements (a consensus of the FASB Emerging Issues Task Force); effective for Uncertaintyyears beginning after June 15, 2010. This standard update became effective for us on January 1, 2011. Vendors often provide multiple products and/or services to their customers as part of a single arrangement. These deliverables may be provided at different points in Income Taxes(“FIN 48”). FIN 48 appliestime or over different time periods. The existing guidance regarding how and whether to all tax positions within the scope of Statement 109 and clarifies whenseparate these deliverables and how to recognize tax benefitsallocate the overall arrangement consideration to each was originally captured in EITF Issue 00-21,Revenue Arrangements with Multiple Deliverables, which is now codified at ASC 605-25,Revenue Recognition—Multiple-Element Arrangements. The issuance of ASU 2009-13 amends ASC 605-25 and represents a significant shift from the existing guidance that was considered abuse-preventative and heavily geared toward ensuring that revenue recognition was not accelerated. The application of this new guidance is expected to result in accounting for multiple-deliverable revenue arrangements that better reflects their economics as more arrangements will be separated into individual units of accounting. We are in the financial statements with a two-step approachfinal stages of recognition and measurement. We adopted FIN 48 on January 1, 2007. Under FIN 48, tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The amount recognized is measured asanalyzing the largest amountimpact of benefit that is more likely than not to be realized upon ultimate settlement. Unrecognized tax benefits are tax benefits claimed in our tax returns that do not meet these recognition and measurement standards.ASU 2009-13.

In September 2006,October 2009, the FASB issued StatementASU No. 157,2009-14,Fair Value Measurement (“FAS 157”). While this Statement does not require new fair value measurements, it provides guidance on applying fair value and expands required disclosures. We are currently assessing the impact, if any,Software (ASC 985): Certain Revenue Arrangements That Include Software Elements (a consensus of SFAS 157 and FSP FAS 157-2 on our consolidated financial statements.

In February 2007, the FASB issued Statement No. 159,The Fair Value Option for Financial Assets and Financial LiabilitiesEmerging Issues Task Force) (“FAS 159”). This Statement, which is expected to expand fair value measurement, permits entities to choose to measure many financial instruments and certain other items at fair value. FAS 159 will become; effective for usyears beginning with the first quarter of 2008. We are currently have no financial assets or financial liabilitiesafter June 15, 2010. This standard update became effective for which SFAS 159 would be applicable.us

In December 2007, the FASB issued SFAS No. 141(R) “Business Combinations” (“SFAS 141(R)”). SFAS 141(R) changes several underlying principles in applying the purchase method of accounting. Among the significant changes, SFAS 141(R) requires a redefining of the measurement

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

dateon January 1, 2011. ASU 2009-14 modifies the existing scope guidance in ASC 985-605,Software Revenue Recognition, for revenue arrangements with tangible products that include software elements. This modification was made primarily due to the changes in ASC 605-25 noted previously, which further differentiated the separation and allocation guidance applicable to non-software arrangements as compared to software arrangements. Prior to the modification of ASC 605-25, the separation and allocation guidance for software and non-software arrangements was more similar. Under ASC 985-605, which was originally issued as AICPA Statement of position 97-2,Software Revenue Recognition, an arrangement to sell a business combination, expensing direct transaction coststangible product along with software was considered to be in its scope if the software was more than incidental to the product as incurred, capitalizing in-process research and development costs as an intangible asset and recording a liability for contingent consideration at the measurement date with subsequent re-measurements recordedwhole. We are in the resultsfinal stages of operations. SFAS 141(R) also requiresanalyzing the impact of ASU 2009-14.

C.         ACQUISITION

We acquired the FAMILION family of genetic tests from PGxHealth. PGxHealth is a subsidiary of Clinical Data, Inc. (NasdaqGM:CLDA) with a sales price of $18.8 million. We secured $6.0 million of financing from entities affiliated with Third Security, LLC, a leading life sciences investment firm, to fund the cash portion of our acquisition of Clinical Data’s diagnostic business. This strategic acquisition provides us with proprietary genetic commercial tests that costs for business restructuringhave an established revenue base, proprietary biomarker assays, an additional CLIA-certified laboratory operation and exit activities relatedestablished test reimbursement and coverage policies that offer access to thetesting. The acquired company will be included in the post-combination financial results of operations and also provides new guidance for the recognition and measurement of contingent assets and liabilities inassumed are reported as a business combination. In addition, SFAS 141(R) requires several new disclosures, includingcomponent of our laboratory services segment.

Under the reasons forterms of the business combination,financing with entities affiliated with Third Security, we issued an aggregate of 2,586,205 shares of the factors that contributeCompany’s newly created Series A convertible preferred stock to certain affiliates of Third Security. Additionally we issued such affiliates of Third Security warrants to purchase an aggregate of up to 1,293,102 shares of Series A preferred stock at an exercise price of $2.32 per share. The Series A preferred shares issuable pursuant to the recognitionpurchase agreement and upon exercise of goodwill,the warrants are convertible into shares of our common stock at a conversion price of $0.58 per share, for an aggregate of 15,517,228 million shares of common stock. Upon full exercise of the warrants, we will receive approximately $3.0 million. These securities were issued for an aggregate purchase price of $6.0 million.

We entered into two notes payable with PGxHealth as a part of the acquisition. The first note is a three year secured promissory note in the amount of acquisition related third-party expenses incurred, the nature and amount$8.6 million with interest accruing at 10%. The second note is a one year secured promissory note for facility improvements of contingent consideration, and a discussion of pre-existing relationships between the parties. SFAS 141(R) is effective as of January 1, 2009. We currently do not have any plans for a business combination, therefore SFAS No.141 (R) is expected to have no impact on our Consolidated Financial Statements.

In December 2007, the FASB issued SFAS No. 160 “Noncontrolling Interests$1.0 million with interest payable at 6.5%. See further information in Consolidated Financial Statements, an Amendment of ARB No. 51”, (“SFAS 160”). SFAS 160 establishes accounting and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. SFAS 160 requires noncontrolling interests in subsidiaries initially to be measured at fair value and classified as a separate component of equity. SFAS 160 also requires a new presentation on the face of the consolidated financial statements to separately report the amounts attributable to controlling and non-controlling interests. SFAS 160 is effective as of January 1, 2009. We do not expect SFAS No. 160 to have an impact on our Consolidated Financial Statements.

C.        DISCONTINUED OPERATIONS

In the fourth quarter of 2005, we implemented a plan to exit the Nucleic Acids operating segment. Accordingly, the results of this business segment are shown as discontinued operations for all periods presented. Expenses that are not directly identifiedNote G to the Nucleic Acids operating segment or that are considered corporate overhead have not been allocated in arriving atfinancial statements. Certain liabilities were assumed and various contingent liabilities recorded. The contingent liabilities include payments owed upon the loss from discontinued operations. Summary resultscollection of operations of the former Nucleic Acids operating segment were as follows:

   Years Ended December 31,
        (dollars in thousands)        
 
   

2007

  

2006

  

2005

 

NET SALES

  $—    $1,142  $3,881 

COST OF GOODS SOLD

   —     912   4,004 
             

Gross profit (loss)

   —     230   (123)

OPERATING EXPENSES

   (67)  700   9,942 
             

INCOME (LOSS) FROM OPERATIONS

   67   (470)  (10,065)

OTHER INCOME (EXPENSE)

   —     2   56 
             

INCOME (LOSS) BEFORE INCOME TAXES

   67   (468)  (10,009)

INCOME TAX

   —     —     —   
             

INCOME (LOSS) FROM DISCONTINUED OPERATIONS

  $67  $(468) $(10,009)
             
certain accounts receivable, retention bonuses for certain employees and royalties due to vendors based on milestone considerations.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

Assets associated withThe following table summarizes the Nucleic Acids segment consisted principally of our facility in Glasgow, Scotland. Duringconsideration paid for the quarter ended March 31, 2007, we completed the sale of the Glasgow facility and the associated equipment for $2.9 million, net of selling expenses, which resulted in a gain of $.1 million.

Theacquired assets and liabilities assumed at the acquisition date.

Consideration  Dollars in Thousands 

Cash

  $6,000  

Notes payable

   9,628  

Assumed liabilities

   452  

Contingent liabilities

   2,736  
     

Fair value of consideration transferred

  $18,816  
     

Acquisition related costs included in selling, general and administrative expenses in our Statement of Operations for the year ended December 31, 2010 were $0.8 million. We incurred $0.2 million in acquisition related costs to issue preferred stock which were recorded against the proceeds received upon the issuance of such preferred stock.

Recognized Amounts of Identifiable Assets Acquired and Liabilities Assumed  Dollars in Thousands 

Working capital, net

  $3,222  

Property and Equipment

   639  

Identifiable intangible assets

   8,680  
     

Total identifiable net assets

   12,541  

Goodwill

   6,275  
     

Total purchase price

   18,816  
     

The fair value of the former Nucleic Acids operating segment were as follows:

   Dollars in Thousands
   

December 31,

2007

  

December 31,

2006

Accounts receivable (net of allowances for doubtful accounts of $177 and $169, respectively)

  $—    $—  
        

Current assets of discontinued operations

  $—    $—  
        

Property and equipment, net

  $—    $2,773
        

Non-current assets of discontinued operations

  $—    $2,773
        

Accounts payable

  $—    $45

Other accrued expenses

   —     139
        

Current liabilities of discontinued operations

  $—    $184
        

Liabilities at December 31, 2006 related to expensesfinancial assets acquired includes accounts receivable with a fair value of $3.1 million. The gross amount due is $7.0 million, of which $3.9 million is expected to be paid during 2007 for final closing costsuncollectible.

The goodwill arising from the acquisition primarily relates to synergies of the Glasgow facility. These liabilities were settled through cash payments during 2007.combined companies. The goodwill has been assigned to our Laboratory Services segment and is expected to be deductible for tax purposes.

D.        RESTRUCTURING CHARGES

We recorded restructuring charges totaling $1.5 million during 2007. The restructuring charges were comprised of severance totaling $.9 million, facility closure costs totaling $.5 million and other costs totaling $.1 million. Restructuring charges related to three events: A restructuring plan completed in the second quarter of 2007, which charges resulted from the termination of four employees in Omaha, Nebraska; the closurefair value of the Cramlington, England bioconsumable production facilitypreferred stock and consolidationrelated securities issued as a part of this production in the Omaha, Nebraska facility; andconsideration paid was determined on the closurebasis of an administrative office outside Paris, France, and combining those operations with those performed elsewhere in the organization. We substantially completed these restructuring activities as of December 31, 2007. These restructuring charges do not relate to any activities taken by us during 2007 or prior periods in connection with the terminationclosing market price of our Nucleic Acids business segment. All costs associated with these activities are included in income(loss) from discontinued operations. There were no restructuring charges in 2006 or 2005.

common stock on the acquisition date, December 29, 2010.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

The following table sets forth the pro forma revenue and earnings of the combined entity if the acquisition had occurred as of the beginning of our prior fiscal year. No revenue or net income was included in our actual results for the year ended December 31, 2010 or 2009. These pro forma amounts do not purport to be indicative of the actual results that would have been obtained had the acquisition occurred at that time.

   Dollars in Thousands 
   Year Ended December 31, 
       2010          2009     

Revenue—Supplemental pro forma results

  $33,733   $35,112  

Net loss—Supplemental pro forma results

   (7,716  (13,071

D.         RESTRUCTURING CHARGES

In the third quarter of 2010 we made a decision to consolidate our research and development activities in Omaha, Nebraska. We substantially completed the transition at December 31, 2010. We have recognized expenses for restructuring, including but not limited to, severance, facility costs and costs to move equipment from Gaithersburg, Maryland to Omaha, Nebraska. These restructuring charges are attributable to our lab services and instrument segments.

Restructuring charges include:

   Dollars in Thousands 
  Costs Incurred in  the
Three Months Ended
December 31, 2010
   Cumulative Costs
Incurred at

December 31, 2010
   Total
Expected  Costs
 

Severance and related costs

  $12    $53    $53  

Facility closure costs

   22     45     63  

Other

   32     40     66  
               

Restructuring charges

  $66    $138    $182  
               

In the fourth quarter of 2010 we had a reduction in workforce of five employees with severance payments of less than $0.1 million which was attributable to our instrument segment.

E.         INVENTORIES

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

 

  Dollars in Thousands  Dollars in Thousands 
  

December 31,

2007

  

December 31,

2006

  December 31,
2010
 December 31,
2009
 

Finished goods

  $  3,123  $2,146  $2,119   $2,322  

Raw materials and work in process

   1,370   443   1,531    1,588  

Demonstration inventory

   93   83   212    149  
             
  $  4,586  $  2,672  $3,862   $4,059  

Less allowance for obsolescence

   (518  (507
             

Total

  $3,344   $3,552  
       

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

F.         INTANGIBLES AND OTHER ASSETS

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

 

  Dollars in Thousands  Dollars in Thousands 
  December 31, 2007  December 31, 2006  December 31, 2010   December 31, 2009 
  

Cost

  Accumulated
Amortization
  

Net Book

Value

  

Cost

  Accumulated
Amortization
  

Net Book

Value

  Cost   Accumulated
Amortization
   Net Book
Value
   Cost   Accumulated
Amortization
   Net Book
Value
 

Intellectual property

  $865  $715  $150  $765  $677  $88  $290    $274    $16    $310    $284    $26  

Patents

   659   185   474   676   155   521   511     245     266     598     241     357  

Other

   303   217   86   705   461   244

Intangibles—acquired technology

   6,535          6,535                 

Intangibles—third party payor relationships

   367          367                 

Intangibles—assay royalties

   1,434          1,434                 

Intangibles—tradenames and trademarks

   344          344                 
                        
   9,481     519     8,962     908     525     383  

Other assets

   154          154     200          200  
                                          

Total

  $  1,827  $  1,117  $  710  $  2,146  $  1,293  $  853  $9,635    $519    $9,116    $1,108    $525    $583  
                                          

Estimated Useful Life

Intellectual property

10 years

Patents

7 years

Intangibles—acquired technology

7 – 8 years

Intangibles—third party payor relationships

N/A

Intangibles—assay royalties

7 years

Intangibles—tradenames and trademarks

7 years

During 2009 we accelerated amortization on two intellectual property license agreements that we terminated in the first quarter of 2010. In addition we accelerated amortization on another license agreement, however; we are not terminating that agreement. In total the change to the net book value of intellectual property was less than $0.1 million. We wrote off less than $0.1 million in patents that we are no longer using.

Other assets include US security deposits and deferred tax assets.

Amortization expense for intangible assets was $.1 million, $.2 million, and $1.2less than $0.1 million during theboth years ended December 31, 2007, 20062010 and 2005, respectively.2009. Amortization expense for intangible assets is expected to be approximately $.1$1.2 million in each of years 20082011 through 2013.2017.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

G.         DEBT

   Dollars in Thousands 
   Year Ended December 31, 
       2010           2009     

PGxHealth note payable (1)

  $8,640    $  

PGxHealth note payable (2)

   989       
          
  $9,629    $  
          

(1)

The First Note is a three year senior secured promissory note to PGxHealth, LLC entered into on December 29, 2010 in conjunction with our acquisition of the FAMILION family of genetic tests from PGxHealth. Interest is payable at 10% per year with quarterly interest payments through March 29, 2012. Thereafter, quarterly installments will include both principal and interest through December 30, 2013.

(2)

The Second Note is a one year senior secured promissory note to PGxHealth, LLC entered into on December 31, 2010 for facility improvements made to the CLIA certified laboratory in New Haven, Connecticut. Interest is payable at 6.5% per year with the principal and interest payable in twelve monthly installments with the final payment due on December 31, 2011.

The entire unpaid balance of the Notes will become immediately due and payable if: (i) we fail to make timely payments under the Notes; (ii) we make an assignment for the benefit of creditors; (iii) we file for bankruptcy; or (iv) upon any event of default under the Security Agreement. Additionally, under the terms of the First Note, if we consummate an equity financing that involves the receipt by us of net proceeds of not less than $6,000,000, then we shall, upon the consummation of such equity financing, pay to PGxHealth the lesser of: (i) 25% of the gross proceeds received from such financing; and (ii) the then-outstanding balance under the First Note. Under the terms of the Second Note, in the event of a sale of all or substantially all of the assets of the Company, we shall pay PGxHealth the lesser of: (i) 100% of the proceeds, less certain fees, received pursuant to such sale; and (ii) the then-outstanding balance under the Second Note.

The notes are secured by the assets of Transgenomic.

The aggregate minimum principal maturities of the debt for each of the three fiscal years following December 31, 2010 are as follows:

2011

  $989  

2012

   3,703  

2013

   4,937  
     
  $9,629  
     

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

H.         CAPITAL LEASES

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

   Dollars in Thousands 
   Asset Balances at December 31 
Classes of Property      2010           2009     

Equipment

  $394    $  

Less: Accumulated amortization

   13       
          

Total

  $381    $    —  
          

The following is a schedule by years of future minimum lease payments under capital leases together with the present value of the net minimum lease payments as of December 31, 2010.

Year ending December 31:

   Dollars in Thousands 

2011

  $190  

2012

   92  

2013

   76  
     

Total minimum lease payments

  $358  

Less: Amount representing interest

   (32
     

Present value of net minimum lease payments

  $326  
     

I.         COMMITMENTS AND CONTINGENCIES

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

We lease certain equipment, vehicles and operating facilities under non-cancellable operating leases that expire on various dates through 2014.2016. The future minimum lease payments required under these leases are approximately $.9 million in 2008, $.8 million in 2009, $.7 million in 2010, $.5$1.2 million in 2011, $.3$0.8 million in 2012, $0.2 million in 2013, $0.1 million in 2014, $0.1 million in 2015 and $.1less than $0.1 million thereafter.in 2016. Rent expense for continuing operations related to operating leases foreach of the years ended December 31, 2007, 2006,2010 and 20052009 was $1.1$0.8 million.

We have entered into an employment agreement with Craig J. Tuttle, our President and Chief Executive Officer. The current term of Mr. Tuttle’s employment agreement ends on July 12, 2011. The employment agreement provides that Mr. Tuttle will be entitled to receive severance payment from the Company if his employment is terminated involuntarily except if such termination is based on “just cause”, as that term is defined in his employment agreement. The severance payment payable in the event of involuntary termination without just cause is equal to his annual base salary at the time of termination and will be paid over a twelve-month period. The employment agreement provides that the severance payment provision will be honored if the Company is acquired by, or merged into, another

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

company and his position is eliminated as a result of such acquisition or merger. In addition we have one employee who is entitled to a severance payment of less than $0.1 million $1.0 million and $1.3 million, respectively.if the employee’s position is eliminated prior to July 2012.

At December 31, 2007,2010, firm commitments to vendors to purchase components used in WAVE Systems and instruments manufactured by others totaled $0.1 million.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006 and 2005

H.J.         INCOME TAXES

The Company’s provision for income taxes for the years ended December 31, 2007, 20062010 and 20052009 relates to income taxes in states, foreign countries and other local jurisdictions is all current and differs from the amounts determined by applying the statutory Federal income tax rate to loss before income taxes for the following reasons:

 

  Dollars in Thousands   Dollars in Thousands 
   2007   2006   2005       2010         2009     

Benefit at federal rate

  $(648) $(997) $(1,687)  $(1,015 $(639

Increase (decrease) resulting from:

       

State income taxes—net of federal benefit

   (101)  (210)  (192)   20    (10

Foreign subsidiary tax rate difference

   (29)  (135)  (81)   (27  (50

Research and development tax credit

          

Tax contingency

   45    48  

Net operating loss expiration

       1,258  

Earnings repatriation

   1,479      

Miscellaneous permanent differences

   60    93  

Other—net

   231   62   191    86    (33

Valuation allowance

       790     1,310     1,795    (498  (625
                 

Current income tax expense

  $243  $30  $26   $150   $42  
                 

   Dollars in Thousands 
       2010           2009     

Federal:

    

Current

  $4    $(58

Deferred

          
          

Total Federal

  $3    $(58

State:

    

Current

  $29    $(16

Deferred

          
          

Total State

  $29    $(16

Foreign:

    

Current

  $111    $(60

Deferred

   6     176  
          

Total Foreign

  $117    $116  
          

Total Tax Provision

  $150    $42  
          

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

The Company’s deferred income tax asset from continuing and discontinued operations at December 31, 20072010 and 20062009 is comprised of the following temporary differences:

 

  Dollars in Thousands   Dollars in Thousands 
  

2007

 

2006

       2010         2009     

Deferred Tax Asset:

   

Net operating loss carryforward

  $39,597  $40,377   $38,201   $38,688  

Research and development credit carryforwards

   1,340   1,328    1,232    1,355  

Deferred revenue

   256   249 

Accrued vacation

   59   69 

Deferred net sales

   151    194  

Inventory

   188    186  

Other

   993   2,175    473    350  
              
     42,245     44,198    40,245    40,773  

Less valuation allowance

   (42,245)  (44,198)   (40,141  (40,639
              

Deferred Tax Asset

  $104   $134  
  $  $ 

Deferred Tax Liability:

   

Uninstalled instruments

  $159   $183  
              

Deferred Tax Liability

  $159   $183  

Net Deferred Liability

  $(55 $(49
       

At December 31, 2007,2010, we had total unused federal tax net operating loss carryforwards from continuing and discontinued operations of $106.2$104.3 million of which $1.8$2.8 million expire in 2008, $3.7 million expire in 2009, $3.0 million expire in 2010, $.9 million expire in 2011, $3.4 million expireexpires in 2012, $1.8 million expireexpires in 2018, $8.2 million expireexpires in 2019, $9.7 million expireexpires in 2020, $8.2 million expireexpires in 2021, $16.9 million expireexpires in 2022, $16.2 million expireexpires in 2023, $17.4 million expireexpires in 2024, $8.2 million expireexpires in 2025, $6.8 million expires in 2026, $3.2 million expires in 2027, $1.3 million expires in 2028, $2.1 million expires in 2029, and $6.9$1.5 million expireexpires in 2026.2030. Of these federal net operating loss carryforwards, $11.8$6.4 million were obtained in the acquisition of Annovis, Inc. and may be subject to certain restrictions. At December 31, 2007,2010, we had unused state tax net operating loss carryforwards from continuing and discontinued operations of approximately $39.6$36.0 million that expire at various times beginning in 2011. At December 31, 2010, we had unused research and development credit carryforwards from continuing and discontinued operations of $1.2 million that expire at various times between 20082011 and 2025. At December 31, 2007, we had unused research and development credit

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006 and 2005

carryforwards from continuing and discontinued operations of $1.3 million that expire at various times between 2008 and 2024. A net deferred tax liability was recorded during 2010 related to the UK income taxes for $0.1 million. A valuation allowance has been provided for the remaining deferred tax assets, due to the our cumulative losses in recent years and an inability to utilize any additional losses as carrybacks. We will continue to assess the recoverability of deferred tax assets and the related valuation allowance. To the extent we begin to generate income in future years and it is determined that such valuation allowance is no longer required, the tax benefit of the remaining deferred tax assets will be recognized at such time.

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

Upon adoption of FIN 48 on January 1, 2007, the Company recognized a $.1 million increase in the liability for unrecognized tax benefits. This increase in the liability was offset by an increase to the January 1, 2007 balance in the accumulated deficit. The gross amount ofWe had no material unrecognized tax benefits, as ofinterest, or penalties during fiscal 2009 or 2008, and we do not anticipate any such items during the date of adoption was $.1 million, all of which would affect the effective tax rate if recognized. Included in this amount is an aggregate of $.1 of interest and penalties. The Company’snext twelve months. Our policy is to recognizerecord interest and penalties directly related to income taxes as part of income tax expense.

The Company filesexpense in the Consolidated Statements of Operations. We file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

and various foreign jurisdictions. The Company hasWe have statutes of limitation open for Federal income tax returns related to tax years 2004 through 2006. The Company has2007, 2008 and 2009. We have state income tax returns subject to examination primarily for tax years 20032006 through 2006.2009. Open tax years related to foreign jurisdictions remain subject to examination. The Company’sOur primary foreign jurisdiction is the United Kingdom which has open tax years for 20052006 through 2006. The Company is currently under examination by the Internal Revenue Service for the tax year ending December 31, 2006.2009.

During the yearyears ended December 31, 2007,2010 and 2009, there were no material changes to the liability for uncertain tax positions. The liability for uncertain tax positions relates to potential uncertain tax positions in foreign jurisdictions.

I.K.        EMPLOYEE BENEFIT PLAN

We maintain an employee 401(k) retirement savings plan that allows for voluntary contributions into designated investment funds by eligible employees. We matchPrior to October 1, 2010 we matched the employees’employee’s contributions at the rate of 50% on the first 6% of contributions. Effective October 1, 2010, Transgenomic discontinued matching employee 401(k) contributions. We may, at the discretion of our Board of Directors, make additional contributions on behalf of the plan’sPlan’s participants. Contributions to the 401(k) plan were $.2 million, $.2 million, and $.2$0.1 million for the yearsyear ended December 31, 2007, 2006 and 2005 respectively.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended2010. Contributions to the 401(k) plan were less than $0.1 million for the year ended December 31, 2007, 2006 and 2005

2009.

J.L.         STOCKHOLDERS’ EQUITY

Common Stock.

On October 31, 2005, the Company completed the 2005 Private Placement. The securities issued consisted of: (i) 14,925,743 sharesCompany’s Board of the Company’s common stock, plus (ii) five-year, non-callable warrantsDirectors is authorized to purchase another 5,970,297issue up to 100,000,000 shares of common stock, with an exercise price of $1.20 per share. The aggregate purchase price for the securities soldfrom time to time, as provided in the 2005 Private Placement was $1.01 per share of common stock initially being sold (the “Purchase Price”)a resolution or $15,075,000. In conjunction with the 2005 Private Placement, the Company issued a warrant to Oppenheimer & Co., Inc. to purchase 932,859 shares at $1.20 per share as part of their placement fee.

During 2005 and 2004, the Company issued 4,900,000 and 1,134,850 shares, respectively, of common stock in conjunction with conversions under the Laurus Loans as follows.

Date

  

Price

  

Shares Issued

  

Net Proceeds

  

Facility

  

Applied To

   (Dollars in Thousands)

January 2005

  $    1.00       50,000  $        50  Term Note  Principal

March 2005

  $    0.52  3,600,000       1,835  Credit Note  Principal

March 2005

  $    0.52  1,250,000          650  Term Note  Principal
            

Total 2005

    4,900,000  $   2,535    
            

January 2004

  $    2.20     650,000  $   1,422  Credit Line  Principal

February 2004

  $    2.20     259,091          570  Credit Line  Principal

December 2004

  $    1.00     150,000          146  Term Note  Principal

December 2004

  $    1.00       75,759            72  Term Note  Interest
            

Total 2004

    1,134,850  $    2,210    
            

Each of the foregoing stock sales was exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”) as a sale not involving a public offering.

In May 2001, Company shareholders approved the adoption of the Transgenomic, Inc. 2001 Employee Stock Purchase Plan that was subsequently implemented in November 2001 and terminated in December 2005. Substantially all of the Company’s U.S. employees were eligible to participate in the Plan. Eligible employees authorized payroll deductions to be made for the purchase of shares. Such deductions were accumulated during a defined participation period at the end of which each participant was deemed to have been granted an option to purchase shares of stock from the Company at 85% of the fair market value of the Company stock as measuredresolutions adopted by the closing priceBoard of the stock on either the first or last business day of the participation period, whichever was lower. The number of shares purchased under the option was based upon the participant’s elected withholding amount. At the end of the participation period such option was automatically exercised. This plan was structured to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code of 1986, as amended. The Company issued 0, 25,504, and 76,902 shares under this plan, during the years ended December 31, 2007, 2006 and 2005, respectively.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006 and 2005

Directors.

Common Stock Warrants.

No common stock warrants were issued during 2007 or 2006. Warrants covering 6,903,1565,172,408 shares of common stock were issued during 2005.2010. No common stock warrants were exercised during 2010. No common stock warrants were issued or exercised during 2009. At December 31, 2007, we had 8,048,8152010, there were warrants outstanding that were exercisable to purchase 5,697,408 shares of common stock warrants outstanding.stock.

 

Warrant Holder

  Issue Year  Expiration Year  Underlying Shares  Exercise Price

Various Institution Holders(1)

  2005  2010  6,903,156  $    1.20

Laurus Master Fund, Ltd.(2)

  2003  2010  200,000  $1.92

Laurus Master Fund, Ltd.(2)

  2003  2010  200,000  $2.07

Laurus Master Fund, Ltd.(2)

  2003  2010  150,000  $2.35

Laurus Master Fund, Ltd.(2)

  2004  2011  125,000  $2.57

Laurus Master Fund, Ltd.(2)

  2004  2011  400,000  $1.18

TN Capital Equities, Ltd.(2)

  2003  2008  45,918  $2.94

TN Capital Equities, Ltd.(2)

  2004  2009  15,566  $3.18

GE Capital(3)

  2003  2008  9,175  $3.27
         

Total

      8,048,815  
         

Warrant Holder

  Issue Year   Expiration Year   Underlying Shares   Exercise Price 

Laurus Master Fund, Ltd.(1)

   2004     2011     125,000    $    2.39  

Laurus Master Fund, Ltd.(1)

   2004     2011     400,000    $1.13  

Affiliates of Third Security,
LLC
 (2)

   2010     2015     5,172,408    $.58  
           

Total

       5,697,408    

 

 

(1)

These warrants were issued in conjunction with the 2005 Private Placement described earlier in this Note.

(2)

These warrants were issued in conjunction with thetwo loans that had been made to us by Laurus LoansMaster Fund, Ltd. (the “Laurus Loans”), and subsequent modifications.modifications of these loans. In conjunction with the 2005 Private Placement,private placement, the exercise prices of these warrants were adjusted according to repricing provisions contained in the original warrant agreements.

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

 

(3)While the Laurus Loans have been terminated, the warrants remain outstanding. Due to the repricing provision, these warrants are considered liabilities for financial reporting purposes.

(2)

These warrants were issued in conjunction with operating leasesthe Series A stock financing with GE Capital. Whilecertain entities affiliated with Third Security. The number of shares shown reflects the leases have since been terminated, the warrants are still outstanding.post conversion shares.

Preferred Stock.

The Company’s Board of Directors is authorized to issue up to 15,000,000 shares of preferred stock in one or more series, from time to time, with such designations, powers, preferences and rights and such qualifications, limitations and restrictions as may be provided in a resolution or resolutions adopted by the Board of Directors. The authority of the Board of Directors includes, but is not limited to, the determination or fixing of the following with respect to shares of such class or any series thereof: (i) the number of shares; (ii) the dividend rate, whether dividends shall be cumulative and, if so, from which date; (iii) whether shares are to be redeemable and, if so, the terms and amount of any sinking fund providing for the purchase or redemption of such shares; (iv) whether shares shall be convertible and, if so, the terms and provisions thereof; (v) what restrictions are to apply, if any, on the issue or reissue of any additional preferred stock; and (vi) whether shares have voting rights. The preferred stock may be issued with a preference over the common stock as to the payment of dividends. The Company has no current plans to issue any series of preferred stock. Classes of stock such as the preferred stock may be used, in certain circumstances, to create voting impediments on extraordinary corporate transactions or to frustrate persons seeking to effect a merger or otherwise to gain control of the Company. For the foregoing reasons, any preferred stock issued by the Company could have an adverse effect on the rights of the holders of the common stock.

On December 29, 2010, we entered into a Series A Convertible Preferred Stock Purchase Agreement with Third Security pursuant to which we: (i) sold an aggregate of 2,586,205 shares of Series A Convertible Preferred Stock; and (ii) issued warrants to purchase up to an aggregate of 1,293,102 shares of Series A Preferred Stock with an exercise price of $2.32 per share. The Warrants may be exercised at any time from December 29, 2010 until December 28, 2015 and contain a “cashless exercise” feature. The shares of Series A Preferred Stock issuable pursuant to the Series A Purchase Agreement and upon exercise of the Warrants are initially convertible into shares of our common stock at a rate of 4-for-1, which conversion rate is subject to further adjustment as set forth in the Certificate of Designation. The aggregate gross proceeds from the issuance was $6.0 million.

The Series A Preferred Stock meets the definition of mandatorily redeemable stock as it is preferred capital stock which is redeemable at the option of the holder and should be reported outside of equity. Preferred stock is accreted to its redemption value. The warrants do not qualify to be treated as equity, and accordingly, are recorded as a liability. A preferred stock conversion feature is embedded within the Series A Preferred Stock that meets the definition of a derivative. The preferred stock, warrant liability and preferred stock conversion feature are all recorded separately and were initially recorded at fair value using the Black Scholes model. We are required to record these instruments at fair value at each reporting date and changes will be recorded as an adjustment to earnings. The warrant liability and preferred liability are considered level three financial instruments.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

The analysis produced a valuation for the three components of the instrument:

Redeemable Preferred Stock

  $ 1,666 

Preferred Stock Conversion Feature

   1,983  

Warrants

   2,351  
     
  $6,000  
     

The costs to secure the Preferred Stock were taken against the preferred stock. For the year ended December 31, 2010 these costs were $0.2 million.

We used the net proceeds from the financing to acquire the FAMILION family of genetic tests from PGxHealth, a subsidiary of Clinical Data.

In connection with the Financing, we filed a Certificate of Designation of Series A Convertible Preferred Stock with the Secretary of State of the State of Delaware, designating 3,879,307 shares of our Preferred Stock as Series A Preferred Stock. Certain rights of the holders of the Series A Preferred Stock are senior to the rights of the holders of Common Stock. The Series A Preferred Stock has a liquidation preference equal to its original price per share, plus any accrued and unpaid dividends thereon. The Series A Preferred Stock accrues cumulative dividends at the rate of 10.0% of the original price per share per annum.

Generally, the holders of the Series A Preferred Stock are entitled to vote together as a single group with the holders of Common Stock on an as-converted basis. However, the Certificate of Designation provides that we shall not perform some activities, subject to certain exceptions, without the affirmative vote of a majority of the holders of the outstanding shares of Series A Preferred Stock.

In connection with the Financing, we also entered into a registration rights agreement with the Investors (the “Registration Rights Agreement”). Pursuant to the terms of the Registration Rights Agreement, the Company has granted the Investors certain demand, “piggyback” and S-3 registration rights covering the resale of the shares of Common Stock underlying the Series A Preferred Stock issued pursuant to the Series A Purchase Agreement and issuable upon exercise of the Warrants and all shares of Common Stock issuable upon any dividend or other distribution with respect thereto. The holders of the Series A Preferred Stock are entitled to receive quarterly dividends which will accrue whether or not declared, shall compound annually and shall be cumulative. In any calendar quarter we shall be required to pay from funds legally available a cash dividend in the amount of 50% of the distributable cash flow or aggregate amount of dividends accrued on the Series A Preferred Stock.

K.M.         EQUITY INCENTIVE PLAN

The Company’s 2006 Equity Incentive Plan (the “Plan”) allows the Company to make awards of various types of equity-based compensation, including stock options, dividend equivalent rights (“DERs”), stock appreciation rights (“SARs”), restricted stock, restricted stock units, performance units, performance shares and other awards, to employees and directors of the Company. The Plan was adopted in 2006 as a modification of the Company’s 1997 Stock Option Plan (the “Prior Plan”). In addition to providing for additional types of equity-based awards, the Plan increased the total number

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

of shares of common stock that the Company may issue from 7,000,000 under the Prior Plan to 10,000,000 shares under the Plan; provided, that no more than 5,000,000 of such shares may be used for grants of restricted stock, restricted stock units, performance units, performance shares and other awards.

The Plan is administered by the Compensation Committee of the Board of Directors (the “Committee”) which has the authority to set the number, exercise price, term and vesting provisions of the awards granted under the Plan, subject to the terms thereof. Either incentive or non-qualified stock options may be granted to employees of the Company, but only nonqualified stock options may be granted to nonemployee directors and advisors. However, in either case, the Plan requires that stock options must be granted at exercise prices not less than the fair market value of the common stock on the date of the grant. Options issued under the plan vest over periods as determined by the Compensation Committee and expire 10 years after the date the option was granted. If the option holder ceases to be employed by the Company, the Company will have the right to terminate any outstanding but unexercised options. To date, the only awards made under the Plan (and the Prior Plan) have been non-incentive stock options.

For the year ended December 31, 2007,2010, we recorded compensation expense recovery of $.1less than $0.1 million within selling, general and administrative expense. Two executive officers departed during the general administrativesecond quarter of 2010. All stock options that were unvested were forfeited at the time of their departure as their requisite services periods were not completed. The vesting of options exercisable for the purchase of 1.3 million shares was offset by the expense relatedrecovery for stock options that were forfeited due to the vesting of 1.4 million options.requisite service not being rendered. For the year ended December 31, 2006,2009, we recorded compensation expensesexpense of $0$0.2 million within selling, general and administrative expense as a result of the vesting of options exercisable for the purchase of 1.7 million shares. As of December 31, 2010, there was less than $0.1 million of unrecognized compensation expense related to 340,000 new option grants and $.2 million relatedunvested stock options, which is expected to an extensionbe recognized over a weighted average period of the post-termination exercise period for 450,000 options from 90 days after termination to the remaining contractual term of the original option grants. nearly three years.

The fair value of the options granted during 2010 was estimated on their respective grant dates using the Black-Scholes option-pricing model. The Black-Scholes model was used with the following assumptions: risk-free interest rates of 1.17% to 1.98%, based on the U.S. Treasury yield in effect at the time of grant; dividend yields of zero percent; expected lives of five years, based on historical exercise activity; and volatility of 103% to 105% for grants made during the year ended December 31, 2010 based on the historical volatility of our stock over a time that is consistent with the expected life of the option. A small group of senior executives hold the majority of the stock options and are expected to hold the options until they are vested. Forfeitures of 2.2% to 2.5% have been assumed in the calculation.

The fair value of the options granted during 2009 was estimated on their respective grant dates using the Black-Scholes option pricing model. The Black-Scholes model was used with the following assumptions: risk-free interest rates of 3.34%2.12% to 5.08%3.99%, based on the U.S. Treasury yield in effect at the time of grant; dividend yields of zero percent; expected lives of 25 to 10 years, based on historical exercise activity behavior;activity; and volatility of 89.14% and 67.58%106.08% to 80.03% for grants made during the year ended December 31, 20072009 based on the historical volatility of our stock over a time that is consistent with the expected life of the option. AsA small group of December 31, 2007, there was $.4 millionsenior executives hold the majority of unrecognized compensation expense related to unvestedthe stock options which isand are expected to be recognized over a weighted average period of nearly three years.

hold the options until they are vested therefore minimal forfeitures were assumed in 2009.

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

The following table summarizes activity under the Plan (and the Prior Plan) during the year ended December 31, 2006:2010:

 

   

Number of
Options

  

Weighted Average
Exercise Price

Balance at January 1, 2006:

  5,570,432   4.31

Granted

  340,000   .62

Exercised

     

Forfeited/Expired

  (442,768)  4.45
       

Balance at December 31, 2006:

  5,467,664  $4.08
       

Exercisable at December 31, 2006

  5,127,664  $    4.30
       
   Number of
Options
  Weighted Average
Exercise Price
 

Balance at January 1, 2010:

   3,331,731   $2.39  

Granted

   125,000    .50  

Exercised

   (100,000  (.42

Forfeited

   (593,499  (.73

Expired

   (198,231  (11.07
         

Balance at December 31, 2010:

   2,565,001   $2.08  
         

Exercisable at December 31, 2010

   2,358,334   $    2.22  
         

The following table summarizes activity under the Plan (and the Prior Plan) during the year ended December 31, 2007:2009:

 

   

Number of
Options

  

Weighted Average
Exercise Price

Balance at January 1, 2007:

  5,467,664   4.07

Granted

  1,030,000   .66

Exercised

     

Forfeited/Expired

  (1,962,600)  4.17
       

Balance at December 31, 2007:

  4,535,064  $3.26
       

Exercisable at December 31, 2007

  3,243,231  $    4.29
       
   Number of
Options
  Weighted Average
Exercise Price
 

Balance at January 1, 2009:

   3,531,064   $2.54  

Granted

   70,000    .42  

Exercised

         

Forfeited

   (72,833  (1.39

Expired

   (196,500  (4.85
         

Balance at December 31, 2009:

   3,331,731   $2.39  
         

Exercisable at December 31, 2009

   2,518,671   $      2.96  
         

DuringThe following table summarizes the stock options that were issued during the year ended December 31, 2007 we issued 200,000 options at exercise prices of $0.75 on January 17, 2007; 45,000 options at exercise prices of $0.70 on May 23, 2007; 100,000 options at exercises prices of $0.71 on June 1, 2007; 200,000 options at exercise prices of $0.66 on July 12, 2007; 25,000 options at exercise prices of $0.57 on August 16, 2007; 250,000 options at exercise prices of $0.67 on October 4, 2007; 110,000 options at exercise prices of $0.53 on December 7, 2007 and 100,000 options at exercise prices of $0.53 on December 31, 2007. 2010:

   Number of
Options
   Exercise Price 

June 7, 2010

   75,000    $      0.58  

October 29, 2010

   50,000    $0.39  
       
   125,000    
       

The weighted average grant date fair value per share of options granted during the years ended December 31, 2007, 2006,2010 and 20052009 was $0.53, $0.31$0.38 and $0.63,$0.33 respectively.

Options issued and outstanding to employees and outside directors are summarized below:

Exercise Price Range

 

Number of Options
Outstanding

 

Number of Options
Exercisable

 

Aggregate Intrinsic Value

December 31, 2007

$  0.00—$  1.30      

 2,215,500    923,667 $0.00

$  1.31—$  2.60      

    564,833    564,833 $0.00

$  2.61—$  3.90      

      10,000      10,000 $0.00

$  3.91—$  5.20      

    830,000    830,000 $0.00

$  5.21—$  6.50      

    512,000    512,000 $0.00

$  7.81—$  9.10      

      10,000      10,000 $0.00

$  9.11—$10.40      

    208,000    208,000 $0.00

$11.71—$13.00      

    184,731    184,731 $0.00
     
 4,535,064 3,243,231 $  0.00
     

TRANSGENOMIC, INC. AND SUBSIDIARIESSUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 20062010 and 20052009

 

The following summarizes all stock options outstanding at December 31, 2007.2010:

 

Exercise Price Range

 Number of
Options
Outstanding
 Remaining
Weighted-
Average
Contractual Life
 Weighted-
Average
Exercise
Price
 Number of
Options
Exercisable
 Aggregate
Intrinsic Value

December 31, 2007
  

Number of

Options
Outstanding

  

Remaining

Weighted-Average
Contractual Life

  

Weighted–Average

Exercise Price

  

Number of

Options
Exercisable

$ 0.00—$ 1.30  2,215,500 8.2 years $.82 923,667 $0.00  1,755,668  5.8 years  $  0.80  1,549,001
$ 1.31—$ 2.60  564,833 4.9 years $1.92 564,833 $0.00     308,333  1.9 years  $  1.94     308,333
$ 2.61—$ 3.90  10,000 4.8 years $2.90 10,000 $0.00       10,000  0.0 years  $  2.90       10,000
$ 3.91—$ 5.20  830,000 .7 years $5.00 830,000 $0.00
$ 5.21—$ 6.50  512,000 3.1 years $6.15 512,000 $0.00     401,500    .4 years  $  6.07     401,500
$ 7.81—$ 9.10  10,000 3.4 years $9.00 10,000 $0.00       10,000    .4 years  $  9.00       10,000
$ 9.11—$10.40  208,000 3.0 years $9.87 208,000 $0.00
$11.71—$13.00  184,731 2.1 years $    12.81 184,731 $    0.00

$ 9.11—$10.00

       79,500    .5 years  $  9.90       79,500
                 
 4,535,064   3,243,231   2,565,001      2,358,334
                 

All stock options outstanding were issued to employees or outside directors.

The aggregate intrinsic value of stock options exercisable was less than $0.1 million at December 31, 2010. The aggregate intrinsic value of stock options outstanding was less than $0.1 million at December 31, 2010. During the year ended December 31, 2010, 100,000 stock options were exercised. No stock options were exercised in the year ended December 31, 2009.

L.N.         OPERATING SEGMENT AND GEOGRAPHIC INFORMATION

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

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

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

Segment information for the years ended December 31, 2010 and 2009 is as follows:

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

Net Sales

  $    4,979   $    15,069   $    20,048   $    4,566   $    17,457    $    22,023  

Gross Profit

   1,438    8,326    9,764    1,728    9,877     11,605  

Net Income/(Loss) before Taxes

   (2,526  (459  (2,984  (2,273  395     (1,878

Income Taxes

       150    150        42     42  
                          

Net Income/(Loss)

  $(2,526 $(608 $(3,134 $(2,273 $353    $(1,920
                          

Depreciation/Amortization

   304    190    495    296    450     746  

Restructure

   65    73   138               

Interest Income (Expense)

   (1  (3  (4  4    11     15  

Net Assets

  $24,631   $7,396   $32,027   $7,457   $8,547    $16,004  
                          

We have onetwo reportable operating segment. Although revenue is analyzed by type, net financial results are analyzed as one segment due to the integrated nature of the products.segments. Net sales by product were as follows:

 

  Dollars in Thousands  Dollars in Thousands 
  Years Ended December 31,  Years Ended December 31, 
  

2007

  

2006

  

2005

          2010                   2009         

Laboratory Services:

    

Molecular Clinical Reference Laboratory

  $    3,606    $    3,541  

Pharmacogenomics Research Services

   1,373     1,025  
        
   4,979     4,566  

Instrument Related Business:

    

Bioinstruments

  $    11,551  $    13,604  $    14,427   8,320     10,175  

Bioconsumables

   8,901   8,719   8,981   6,749     7,282  

Discovery Services

   2,724   1,092   2,420
                 
  $23,176  $23,415  $25,828   15,069     17,457  
                 

Total Net Sales

  $20,048    $22,023  
        

TRANSGENOMIC, INC. AND SUBSIDIARY

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2010 and 2009

Net sales by geographic regioncost of goods sold were as follows:

 

   Dollars in Thousands
   Years Ended December 31,
   

2007

  

2006

  

2005

United States

  $7,807  $6,780  $7,069

Europe

   12,511   14,262   14,979

Pacific Rim

   1,531   1,390   2,297

Other

   1,327   983   1,483
            

Total

  $    23,176  $    23,415  $    25,828
            
   Dollars in Thousands 
   Years Ended December 31, 
   2010   2009 

Laboratory Services:

    

Molecular Clinical Reference Laboratory

  $2,125    $2,018  

Pharmacogenomics Research Services

   1,416     820  
          
   3,541     2,838  

Instrument Related Business:

    

Bioinstruments

   3,560     3,801  

Bioconsumables

   3,183     3,779  
          
   6,743     7,580  
          

Total Cost of Goods Sold

  $    10,284    $    10,418  
          

Net sales for the year ended December 31, 2010 and 2009 by country were as follows:

   Dollars in Thousands 
   Years Ended December 31, 
   2010   2009 

United States

  $8,729    $8,777  

Italy

   3,294     3,683  

United Kingdom

   1,412     842  

Germany

   1,366     1,383  

France

   1,160     1,545  

Netherlands

   56     1,464  

All Other Countries

   4,031     4,329  
          

Total

  $    20,048    $    22,023  
          

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

No customer accounted for more than 10% of consolidated net sales for any period presented.during the years ended December 31, 2010 and 2009. For the year ended December 31, 2010 one customer made up 15% of the Laboratory Services net sales. For the year ended December 31, 2009 one customer made up 20% of the Laboratory Services net sales.

Substantially allMore than 95% of our long-lived assets are within the United States.

TRANSGENOMIC, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - Continued

Years Ended December 31, 2007, 2006 and 2005

M.        QUARTERLY RESULTS (UNAUDITED)

Unaudited quarterly consolidated statements of operations data was as follows:

   Year Ended December 31, 2007 
   Dollars in Thousands 
   

1st Quarter

  

2nd Quarter

  

3rd Quarter

  

4th Quarter

  

Total

 

Net Sales

  $5,222  $6,272  $5,151  $6,531  $23,176 

Gross Profit

  $    2,708  $    3,413  $    2,651  $    3,921  $    12,693 

Income (Loss) from continuing operations

  $(1,270) $233  $(1,349) $212  $(2,174)

Income (Loss) from discontinued operations

   74   (7)  —     —     67 
                     

Net Income (Loss)

  $(1,196) $226  $(1,349) $212  $(2,107)
                     

Basic and diluted loss per share:

      

From continuing operations

  $(0.02) $(0.00) $(0.03) $(0.00) $(0.04)

From discontinued operations

   —     —     —     —     —   
                     
  $(0.02) $(0.00) $(0.03) $(0.00) $(0.04)
                     

Basic and Diluted Weighted Average Shares Outstanding (in thousands)

   49,190   49,190   49,190   49,190   49,190 

   Year Ended December 31, 2006 
   Dollars in Thousands 
   

1st Quarter

  

2nd Quarter

  

3rd Quarter

  

4th Quarter

  

Total

 

Net Sales

  $    6,497  $    6,189  $    4,919  $    5,810  $    23,415 

Gross Profit

  $2,982  $3,049  $2,312  $3,026  $11,369 

Loss from continuing operations

  $(304) $(258) $(1,525) $(876) $(2,963)

Income(Loss) from discontinued operations

   (14)  (125)  (164)  (165)  (468)
                     

Net Loss

  $(318) $(383) $(1,689) $(1,041) $(3,431)
                     

Basic and diluted loss per share:

      

From continuing operations

  $(0.01) $(0.01) $(0.03) $(0.02) $(0.06)

From discontinued operations

   —     —     —     —     (0.01)
                     
  $(0.01) $(0.01) $(0.03) $(0.02) $(0.07)
                     

Basic and Diluted Weighted Average Shares Outstanding (in thousands)

   49,185   49,190   49,190   49,190   49,188 

Earnings per share are computed independently for each Substantially all of the quarters presented. Therefore,remaining long-lived assets are within Europe.

O.         SUBSEQUENT EVENTS

Events or transactions that occur after the sum ofbalance sheet date, but before the quarterly per share losses may not equal the annual loss per share.

financial statements are complete, are reviewed to determine if they should be recognized. On February 19, 2011, 125,000 common stock warrants to Laurus Fund, Ltd expired unexercised. We have no other material subsequent events to be disclosed.

Item 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.Disclosures.

On May 16, 2007, the Audit Committee, acting on behalf of our Board of Directors, dismissed Deloitte & Touche (the “Former Accountant”) as our principal independent accountant. May 16, 2007 is also the date that our relationship with Deloitte & Touche ended for purposes of performing audit services. The Former Accountant’s reports for the past two fiscal years did not contain any adverse opinion or disclaimer of opinion, and such reports were not qualified or modified as to uncertainty, audit scope or accounting principals.

During the two most recent fiscal years and any subsequent interim period through May 16, 2007, there have been no disagreements between us and the Former Accountant on any matter of accounting principles or practices, financial statement disclosure or auditing scope of procedures, which disagreements, if not resolved to the satisfaction of the Former Accountant, would have caused the Former Accountant to make reference to the subject matter thereof in its report. No “reportable events” (as defined by Item 304(a)(1)(v) of Regulation S-K) occurred during the two most recent fiscal years and through May 16, 2007.

On May 16, 2007, the Audit Committee, acting on behalf of our Board of Directors, engaged McGladrey & Pullen, LLP (the “New Accountant”) as our principal independent accountant subject to the completion of the New Accountant’s normal client acceptance procedures. We did not, nor did anyone on our behalf, consult the New Accountant during our two most recent fiscal years and during the subsequent interim period prior to our engagement of the New Accountant regarding the application of accounting principles to a specified transaction (completed or proposed), the type of audit opinion that might be rendered on our financial statements, any matter being the subject of a disagreement or “reportable event” or any other matter described in Item 304(a)(2) of Regulation S-K.

None.

 

Item 9A(T).9A.

Controls and Procedures.

(a)

Evaluation of Disclosure Controls and Procedures. We evaluated the design and operating effectiveness of our disclosure controls and procedures as of December 31, 2007, pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, because of the material weakness in our internal control over financial reporting described below, our disclosure controls and procedures as defined in Rule 13a-15(e) were not effective. Notwithstanding the material weakness in our internal control over financial reporting as of December 31, 2007 described below, we believe that the consolidated financial statements contained in this report present fairly our financial condition, results of operations, and cash flows for the fiscal years covered thereby in all material respects. To address the material weakness in our internal control over financial reporting described below, management performed additional manual procedures and analysis and other post-closing procedures in order to prepare the consolidated financial statements included in this Annual Report on Form 10-K.(a)         Evaluation of Disclosure Controls and Procedures

(b)

Management’s Report on Internal Control Over Financial Reporting. Management is responsible for establishing and maintaining an adequate system of internal control

over financial reporting, pursuant to Rule 13a-15(c) of the Securities Exchange Act, in orderAs of the end of the period covered by this Annual Report, management performed, with the participation of our Chief Executive Officer and Chief Financial Officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the report we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s forms, and that such information is accumulated and communicated to management including our Chief Executive Officer and our Chief Financial Officer, to allow timely decisions regarding required disclosures. Based on the evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2010, Transgenomic’s disclosure controls and procedures were effective.

(b)         Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining an adequate system of internal control over financial reporting. Our system of internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States (“GAAP”). A company’s internal control over financial reporting includes policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company, (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with accounting principles generally accepted in the United States, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company, and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.

In accordance with accounting principles generally accepted in the United States of America.

Our internal control over financial reporting requirementsincludes those policies and procedures that:

pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;

provide reasonable assurance that our transactions are recorded as necessary to permit preparation of our financial statements in accordance with accounting principles generally accepted in the SecuritiesUnited States of America, and Exchange Commission,that our receipts and expenditures are being made only in accordance with authorizations of our management completedand our directors; and

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.

Because of its inherent limitations, a system of internal control over financial reporting can provide only reasonable assurance and may not prevent or detect misstatements. Further, because of changes in conditions, effectiveness of internal controls over financial reporting may vary over time. Our system contains self-monitoring mechanisms, and actions are taken to correct deficiencies as they are identified.

Management has conducted, with the participation of our Chief Executive Officer and our Chief Financial Officer, an assessment, including testing of the effectiveness of our internal control over financial reporting as of December 31, 2007. In making this2010. Management’s assessment management usedof internal control over financial reporting was conducted using the criteria set forth in the Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). The COSO framework summarizes each of the components of a company’s internal control system, including the: (i) control environment, (ii) risk assessment, (iii) information and communication, and (iv) monitoring (collectively, the “entity-level controls”), as well as (v) a company’s control activities (“process-level controls”). Management’s evaluation of the design and operating effectiveness of our internal controls over financial reporting identified a material weakness resulting from the combination of more than one significant deficiency. Based on this evaluation, our Chief Executive Officer and Chief Financial Officerthat assessment, management has concluded that because of the material weakness in ourCompany’s internal control over financial reporting ourwas effective as of December 31, 2010.

This Annual Report does not include an attestation report of Transgenomic’s registered public accounting firm regarding internal control over financial reporting as defined rule 13a-15(f) was not effective. Policies and procedures that were not formally documented, lack of segregation of duties, access authorization to our computer systems and financial reporting all were areas that were assessed as having a significant deficiency. A “material weakness” is defined as a significant deficiency or combination of significant deficiencies, that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. A “significant deficiency” is a deficiency or a combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit attention by those responsible for oversight of our financial reporting.

We are taking the following steps to remediate the material weakness in 2007:

We hired a replacement corporate controller in December 2007.

We consolidated the international accounting functions from numerous locations to Glasgow, Scotland.

We are taking the following steps to remediate the material weakness in 2008:

We will document formal security and business policies and procedures.

We will review the functions of the employees in the accounting department to determine the cost benefit associated with proper segregation of duties. The accounting staff is small and complete segregation of duties may not be possible.

We will develop standard procedures for granting user access to our computer system.

We will develop additional procedures to ensure proper financial reporting.

Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rulesItem 308(b) of the Securities and Exchange Commission that permitRegulation S-K which permits the Company to provide only management’s report in this annual report. Accordingly, this annual report does not include an attestation report ofAnnual Report.

(c)         Changes in internal control over financial reporting

There have been no changes in internal control over financial reporting that occurred during the Company’s registered public accounting firm regardingquarter ended December 31, 2010 that have materially affected, or are reasonably likely to materially affect, Transgenomic’s internal control over financial reporting.

 

(c)

Change in Internal Control Over Financial Reporting. There have been no changes in the Company’s internal control over financial reporting during the year that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting other than those discussed above in Management’s Report on Internal Control Over Financial Reporting.

Item 9B.

Other InformationInformation.

None.

Part III

 

Item 10.

Directors, Executive Officers and Corporate Governance.

Information relating to our Board of Directors, including information regarding Craig Tuttle, our President and Chief Executive Officer who is also a director, and other information related to corporate governance, required by this item is incorporated by reference to the Proxy Statement for the Company’s 20082011 Annual Meeting of Stockholders (the “Proxy Statement”) under the caption “Board of Directors and Committees.” Information regarding our other executive officerofficers who isare not a directordirectors is set forth below.

Debra A SchneiderChad Richards..    Ms. Schneider,    Mr. Richards, age 49,41, joined Transgenomic Inc. in December, 2006 and currently serves as Vice President and Chief Financial Officer. She also is its Secretary and Treasurer. Prior to joining Transgenomic, Ms. Schneider spent seventeen years at First Data Corporation in a number of roles, including finance, planning, accounting and Chief Financial Officer roles for various business units. Most recently, she servedOctober 2007 as Senior Vice President, Sales and Marketing and was promoted to Chief Commercial Officer in January 2011. Before joining Transgenomic, Mr. Richards was the National Sales Director for Anatomic Pathology with Quest Diagnostics. During his career with Quest Diagnostics, Mr. Richards held a variety of Finance.sales management roles in both their physician and hospital business segments. Before joining Quest Diagnostics, Mr. Richards held different marketing and sales management roles with Roche Diagnostics Ventana Medical Systems Division, one of the world’s leading developers and manufacturers of immunohistochemistry and in-situ hybridization instruments and reagent systems. Before embarking on a career in diagnostics, Mr. Richards served in the United States Marine Corps.

Brett Frevert. Mr. Frevert, age 48, was appointed as the Chief Financial Officer of Transgenomic by the Board of Directors on June 28, 2010. Since 2004 Mr. Frevert has been Managing Director of CFO Systems, LLC, which he founded in 2004. During that time he has served as CFO of several Midwestern companies, including SEC registrants and private companies. Prior to her tenure atfounding CFO Systems, Mr. Frevert was CFO of a regional real estate firm and also served as Interim CFO of First Data Corporation, she worked as Controller at Creative Financing, Inc.Europe. Mr. Frevert began his career with Deloitte & Touche, serving primarily SEC clients in the food and as an accountant with KPMG LLP.insurance industries.

 

Item 11.

Executive Compensation.

Certain information required by this Item is incorporated by reference to the Proxy Statement under the caption “Executive Compensation.”

Securities authorized for issuance under equity compensation plans.

The following equity compensation plan information summarizes plans and securities approved and not approved by security holders as of December 31, 2007.2010.

 

  (a)  (b)  (c)  (a)   (b)   (c) 

PLAN CATEGORY

  

Number of
securities to be
issued upon
exercise of
outstanding options,
warrants and rights

  

Weighted-average
exercise price of
outstanding
options, warrants
and rights

  Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a)
  Number of
securities to be
issued upon
exercise of
outstanding options,
warrants and rights
   Weighted-average
exercise price of
outstanding
options, warrants
and rights
   Number of securities
remaining available for
future issuance under
equity compensation plans
(excluding securities
reflected in column (a)
 

Equity compensation plans approved by security holders(1)

  4,535,064  $3.26  2,748,567
Equity compensation plans approved by security holders(1)   2,565,001    $2.08     6,581,230  

Equity compensation plans not approved by security holders

                     
              

Total

  4,535,064  $3.26  2,748,567   2,565,001    $2.08     6,581,230  
              

(1)

Consists of our 2006 Equity Compensation Plan

Item 12.

Security Ownership of Certain Beneficial Owners and Management.Management and Related Stockholder Matters.

Information required by this Item is incorporated by reference to the Proxy Statement under the caption “Voting Securities and Beneficial Ownership by Principal StockholderStockholders and our Directors and Officers.”

Item 13.

Certain Relationships and Related Transactions, and Director IndependenceIndependence.

Information required by this Item is incorporated by reference to the Proxy Statement under the captions “Certain Relationships and Related Transactions” and “Board of Directors and Committees”.

 

Item 14.

Principal AccountantAccounting Fees and ServicesServices.

Information required by this Item is incorporated by reference to the Proxy Statement under the caption “Accounting Fees and Services.”

PARTPart IV

 

Item 15.

Exhibits, and Financial Statement Schedules.

 

 

(a)

The following documents are filed as part of this report:

 

 

1.

Financial Statements. The following financial statements of the Registrant are included in response to Item 8 of this report:

Report of Independent Registered Public Accounting Firm.

Consolidated Balance Sheets of the Registrant and SubsidiariesSubsidiary as of December 31, 20072010 and 2006.2009.

Consolidated Statements of Operations of the Registrant and SubsidiariesSubsidiary for the years ended December 31, 2007, 20062010 and 2005.2009.

Consolidated Statements of Stockholders’ Equity of the Registrant and SubsidiariesSubsidiary for the years ended December 31, 2007, 20062010 and 2005.2009.

Consolidated Statements of Cash Flows of the Registrant and SubsidiariesSubsidiary for the years ended December 31, 2007, 20062010 and 2005.2009.

Notes to Consolidated Financial Statements of the Registrant and Subsidiaries.Subsidiary.

 

 

2.

Financial Statement Schedules.

NoneNone.

 

3.

Exhibits. The following exhibits were filed as required by Item 15(a)(3) of this report. Exhibit numbers refer to the paragraph numbers under Item 601 of Regulation S-K:

3.1       Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to Registrant’s Report on Form 10-Q (Registration No. 000-30975) filed on November 14, 2005.

3.2       Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to Registration Statement on Form S-1 (Registration No. 333-32174) 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) filed on March 10, 2000).

10.1       2006 Equity Incentive Plan of the Registrant (incorporated by reference to Exhibit 4(b) to Registration on Form S-8 (Registration No. 333-139999) filed on January 16, 2007.

10.2     1999 UK Approved Stock Option Sub Plan of the Registrant (incorporated by reference to Exhibit 10.7 to Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000).

10.3    Employee Stock Purchase Plan of the Registrant (incorporated by reference to Exhibit 4(b) to Registration Statement on Form S-8 (Registration No. 333-71866) filed on October 19, 2001)

10.4       Employment Agreement between the Company and Craig J. Tuttle dated July 12, 2006 (incorporated by reference to Exhibit 10.1 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on July 12, 2006.

10.510.4       Amendment No. 1 to the Employment Agreement between the Company and Craig J. Tuttle, effective July 12, 2006 (incorporated by reference to Exhibit 10.1 to Registrant’s Report on Form 10-Q (Registration No. 000-30975) filed on November 14, 2006.

10.610.5       Employment Agreement between the Company and Debra A. Schneider, effective December 14,4, 2006, (incorporated by reference to Exhibit 10.1 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on November 15, 2006.

10.710.6       License Agreement, dated September 1, 1994, between Registrant and Professor Dr. Gunther Bonn, et. al. and Amendment thereto, dated March 14, 1997 (incorporated by reference to Exhibit 10.14 to Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000).

10.810.7       License Agreement, dated August 20, 1997, between the Registrant and Leland Stanford Junior University (incorporated by reference to Exhibit 10.15 to Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000).

10.910.8       License Agreement, dated December 1, 1989, between Cruachem Holdings Limited (a wholly owned subsidiary of the Registrant) and Millipore Corporation (incorporated by reference to Exhibit 10.13 to Registrant’s Annual Report on Form 10-K filed on March 25, 2002).

10.10

10.9       Sublicense Agreement, dated October 1, 1991, between Cruachem Holdings Limited (a wholly owned subsidiary of the Registrant) and Applied Biosystems, Inc. (incorporated by reference to Exhibit 10.14 to Registrant’s Annual Report on Form 10-K filed on March 25, 2002)

.

10.1110.10     Missives, dated May 17, 2002, between Cruachem Limited (a wholly-owned subsidiary of the Registrant) and Robinson Nugent (Scotland) Limited (incorporated by reference to Exhibit 10.1 to Registrant’s Quarterly Report on Form 10-Q filed on August 14, 2002).

10.1210.11     License Amendment Agreement, dated June 2, 2003, by and between Geron Corporation and the Registrant (incorporated by reference to Exhibit 10.2 to Registrant’s Quarterly Report on Form 10-Q filed on August 12, 2003).

10.1310.12     Supply Agreement, dated January 1, 2000, between the Registrant and Hitachi Instruments (incorporated by reference to Exhibit 10.16 to Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000).

10.1410.13     Common Stock Purchase Warrant by and between the Registrant and Laurus Master Fund, Ltd., dated December 3, 2003 (incorporated by reference to Exhibit 10.4 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-111442) filed on December 22, 2003).

10.1510.14     Registration Rights Agreement by and between the Registrant and Laurus Master Fund, Ltd., dated December 3, 2003 (incorporated by reference to Exhibit 10.5 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-111442) filed on December 22, 2003).

10.16    Common Stock Purchase Warrant by and between the Registrant and TN Capital Equities, Ltd., dated December 3, 2003 (incorporated by reference to Exhibit 10.6 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-111442) filed on December 22, 2003)

10.1710.15     Securities Purchase Agreement by and between the Registrant and Laurus Master Fund, Ltd., dated February 19, 2004, as amended on April 15, 2004 (incorporated by reference to Exhibit 10.1 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-114661) filed on April 21, 2004).

10.1810.16     Amendment to Securities Purchase Agreement and Related Document by and between the Registrant and Laurus Master Fund, Ltd., dated August 31, 2004 (incorporated by reference to Exhibit 10.1 to the Registration Statement on Form S-3 (Registration No. 333-118970) as filed on September 14, 2004).

10.1910.17     Common Stock Purchase Warrant by and between the Registrant and Laurus Master Fund, Ltd., dated February 19, 2004, as amended on April 15, 2004 (incorporated by reference to Exhibit 10.3 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-114661) filed on April 21, 2004).

10.2010.18     Registration Rights Agreement by and between the Registrant and Laurus Master Fund, Ltd., dated February 19, 2004 (incorporated by reference to Exhibit 10.4 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-114661) filed on April 21, 2004).

10.21    Common Stock Purchase Warrants by and between the Registrant and TN Capital Equities, Ltd., dated March 1, 2004 (incorporated by reference to Exhibit 10.2 to the Registration Statement on Form S-3 of the Registrant (Registration No. 333-114661) filed on April 21, 2004)

10.2210.19     Common Stock Purchase Warrant by and between the Registrant and Laurus Master Fund, Ltd., dated August 31, 2004 (incorporated by reference to Exhibit 10.3 to the Registration Statement on Form S-3 (Registration No. 333-118970) as filed on September 14, 2004).

10.2310.20     Form of Securities Purchase Agreement by and between the Registrant and various counterparties dated September 22, 2005 (incorporated by reference to Exhibit 10.1 to the Registrants Quarterly Report on Form 10-Q filed on November 14, 2005).

10.2410.21     Common Stock Purchase Warrant by and between the Registrant and Oppenheimer & Co., Inc. dated October 27, 2005 (incorporated by reference to Exhibit 10.34 to the Registrants Annual Report on Form 10-K filed on March 31, 2006).

10.2510.22     Letter Agreement by and between the Registrant and Laurus Master Fund, Ltd. dated October 31, 2005 (incorporated by reference to Exhibit 10.36 to the Registrants Annual Report on Form 10-K filed on March 31, 2006).

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

10.24     License Agreement between the Company and the Dana-Farber Cancer Institute dated October 8, 2009 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on November 5, 2009).

10.25     License Agreement between the Company and Power3 Medical Products, Inc. dated January 23, 2009 (incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on November 5, 2009).

10.26     Series A Convertible Preferred Stock Purchase Agreement with Third Security dated December 29, 2010 (incorporated by reference to the Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011).

21     Subsidiaries of the RegistrantRegistrant.

23     Consent of Independent Registered Public Accounting FirmFirm.

24     Powers of AttorneyAttorney.

31     Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 20022002.

32     Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 20022002.

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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 on this 28th14th day of March 2008.2011.

 

TRANSGENOMIC, INC.

By:

 

/s/    CRAIG J. TUTTLE

 

Craig J. Tuttle,

President and Chief Executive Officer

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on this 28th14th day of March 2008.2011.

 

Signature

  

Title

/s/ CRAIG J. TUTTLE

Craig J. Tuttle

  

Director, President and Chief Executive Officer (Principal Executive Officer)

/s/ DEBRA A. SCHNEIDERBRETT L. FREVERT

Debra A. SchneiderBrett L. Frevert

  

Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

/s/ GREGORY J. DUMAN*

Gregory J. Duman

Director

/s/ JEFFREY L. SKLAR*

Jeffrey L. Sklar

Director

/s/ RODNEY S. MARKIN*

Rodney S. Markin

  

Director

/s/ GREGORY T. SLOMA*ANTONIUS P. SCHUH*

Gregory T. SlomaAntonius P. Schuh

  

Director

/s/ FRANK R. WITNEY*ROBERT M. PATZIG*

Frank R. WitneyRobert M. Patzig

  

Director

/s/ DOIT L. KOPPLER II*

David P. PauluzziDoit L. Koppler II

  

Director

*By Craig J. Tuttle, as attorney-in-fact  

/s/ CRAIG J. TUTTLE

Craig J. Tuttle

Attorney-in-fact for the individuals as indicated.

  

 

K-58K-64