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EX-10.43 - MEDTOX SCIENTIFIC INCex10-43.htm


SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2010

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

Commission file number 1-11394

MEDTOX SCIENTIFIC, INC.
(Exact name of Registrant as specified in its charter)
Delaware
95-3863205
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification No.)
 
402 West County Road D, St. Paul, Minnesota
55112
(Address of principal executive offices)
(Zip Code)

Registrant's telephone number, including area code:  (651) 636-7466

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

Common Stock, par value $0.15 per share
NASDAQ Global Select Market
(Title of Class)
Name of Exchange on Which Registered

Securities registered pursuant to Section 12(g) of the Act:  None

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 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. [  ]
 
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 definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer [  ]                                  Accelerated filer [X ]                                  Non-accelerated filer [  ]                                    Smaller reporting company [  ]
 
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes [  ]  No [X]

As of June 30, 2010, the aggregate market value of the registrant’s Common Stock held by non-affiliates of the registrant was $91,859,844 on the closing price as reported on the NASDAQ Global Select Market.

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

Class
 
Outstanding at February 22, 2011
Common Stock, $0.15 par value per share
 
8,919,428 shares

DOCUMENTS INCORPORATED BY REFERENCE
Document
 
Parts Into Which Incorporated
Definitive Proxy Statement for the 2011 Annual Meeting of Stockholders to be held June 9, 2011 (Proxy Statement)
 
Part III
 
 

 

MEDTOX SCIENTIFIC, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2010

Table of Contents
ITEM NO.
 
PAGE
Part I
   
     
   1.
Business. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5
     
1A.
Risk Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16
     
   2.
Properties. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
   
 
   3.
Legal Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
     
   4.
[Removed and Reserved.] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
     
Part II
   
     
   5.
Market for the Registrant's Common Equity, Related Stockholder
 
 
 Matters and Issuer Purchases of Equity Securities. . . . . . . . . . . . . . . . .
22
     
   6.
Selected Financial Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24
     
   7.
Management's Discussion and Analysis of Financial Condition and
 
 
 Results of Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25
     
 7A.
Quantitative and Qualitative Disclosures About Market Risk . . . . . . . .
36
     
   8.
Financial Statements and Supplementary Data . . . . . . . . . . . . . . . . . . .
36
     
   9.
Changes in and Disagreements With Accountants on
 
 
 Accounting and Financial Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . .
36
     
 9A.
Controls and Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
36
     
 9B.
Other Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
37
     
Part III
   
 
   
   10.
Directors, Executive Officers and Corporate Governance . . . . . . . . . . . .
38
     
   11.
Executive Compensation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
38
     
   12.
Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters. . .  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  .
38
     
   13.
Certain Relationships and Related Transactions, and Director
Independence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
38
 
 
 
   14.
Principal Accountant Fees and Services . . . . . . . . . . . . . . . . . . . . . . . . .
38
     
Part IV
   
     
   15.
Exhibits, Financial Statement Schedules. . . . . . . . . . . . . . . . . . . . . . . . . .
39
     
 
Signatures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
44

 
- 2 -

 

PART I

CAUTIONARY STATEMENT IDENTIFYING IMPORTANT FACTORS
THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER
FROM THOSE PROJECTED IN FORWARD LOOKING STATEMENTS

In connection with the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, readers of this document and any document incorporated by reference herein are advised that this document and documents incorporated by reference into this document contain both statements of historical facts and forward looking statements.  Forward looking statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from those indicated by the forward looking statements.  Examples of forward looking statements include, but are not limited to (i) projections of, or statements regarding, future revenues, income or loss, earnings or loss per share, capital expenditures, dividends, capital structure, margins and other financial items, (ii) statements regarding our plans and objectives and the impacts thereof, including planned introductions of new products and services, planned exiting of lines of business and planned regulatory filings, or estimates or predictions of actions by customers, suppliers, competitors or regulatory authorities, (iii) estimates of market sizes and market opportunities, (iv) statements regarding economic conditions, (v) statements regarding the sufficiency of our existing resources to fund our planned operations through 2011 and the sufficiency of future profitable operations and access to additional capital to fund our operations beyond 2011, and (vi) statements of assumptions underlying other statements and statements about our business.

This document and any documents incorporated by reference herein also identify important factors which could cause actual results to differ materially from those indicated by the forward looking statements.  The factors that could affect our actual results include the following:

·  
changes in federal, state, local and third party payer regulations or policies or other future reforms in the health care system (or in the interpretation of current regulations), affecting governmental and third-party coverage or reimbursement for  laboratory testing

·  
loss or suspension of a license or imposition of a fine or penalties under, or future changes in, or interpretations of, the law or regulations of the Clinical Laboratory Improvement Act of 1967, the Clinical Laboratory Improvement Amendments of 1988, the Substance Abuse and Mental Health Services Administration (SAMHSA), or those of Medicare, Medicaid, the False Claims Act or other federal, state or local agencies

·  
failure to comply with HIPAA, including changes to federal and state privacy and security obligations and changes to HIPAA, including those changes included within HITECH and any subsequent amendments, which could result in increased costs, denial of claims and/or significant penalties

·  
failure to maintain the security of customer-related information could damage our reputation with customers, cause it to incur substantial additional costs and become subject to litigation

·  
changes in FDA regulations or policies (or in the interpretation of current regulations) affecting laboratory developed tests and the 510(k) clearance process

·  
increased competition, including price competition

·  
changes in demand for our services and products by our customers

·  
changes in general economic and business conditions, both nationally and internationally, which can influence the level of job growth and, in turn, the level of pre-employment drug screening activity

·  
technological or regulatory developments, or evolving industry standards, that could affect or delay the sale of our products

 
- 3 -

 

·  
our ability to attract and retain experienced and qualified personnel

·  
risks and uncertainties with respect to our patents and proprietary rights, including:
o  
other companies challenging our patents
o  
patents issued to other companies that may harm our ability to do business
o  
other companies designing around technologies we have developed
o  
our inability to obtain appropriate licenses from third parties
o  
our inability to protect our trade secrets
o  
risk of infringement upon the proprietary rights of others
o  
our inability to prevent others from infringing on our proprietary rights

·  
our inability to control the costs in our business

·  
our inability to obtain sufficient financing to continue to sustain or expand our operations

·  
adverse results in litigation matters

·  
our inability to continue to develop innovative products and services

·  
our inability to provide our services in a timely manner

·  
an unforeseen decrease in the acceptance of current new products and services, including in the market for clinical laboratory testing for physicians offices and patients

·  
fluctuations in clinical trial activities, including cancellations of signed protocols

·  
inaccurate information regarding market opportunities

·  
failure to receive regulatory approvals and clearances

·  
other factors, including those set forth in Item 1A of this Annual Report on Form 10-K

Many factors could cause our actual results, performance or achievements to be materially different from those anticipated in our forward looking statements.  Any written or oral forward looking statements made by us or on our behalf are subject to these factors.  Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those described in this Annual Report on Form 10-K as intended, planned, anticipated, believed, estimated or expected.  The risk factors included in this Annual Report on Form 10-K are not necessarily all of the important factors that could cause actual results to differ materially from those expressed in any of our forward looking statements.  Other unknown or unpredictable factors could also harm our future results.  Given these uncertainties, readers are cautioned not to place undue reliance on such forward looking statements.

The forward looking statements included in this Annual Report on Form 10-K are made only as of the date of this Annual Report on Form 10-K.  We do not intend, and do not assume any obligations, to update these forward looking statements, except as required by law.



 
- 4 -

 

ITEM 1.                  BUSINESS.

1.             General.

MEDTOX Scientific, Inc., a Delaware corporation, was organized in September 1986. MEDTOX Scientific, Inc. and its wholly-owned subsidiaries: MEDTOX Laboratories, Inc., MEDTOX Diagnostics, Inc. and New Brighton Business Center, LLC are collectively referred to herein as the “Company”, “MEDTOX”, “we”, “us” or “our”.

We are engaged primarily in two distinct, but related businesses.  MEDTOX Laboratories, Inc., based in St. Paul, Minnesota, provides forensic and clinical laboratory services.  MEDTOX Diagnostics, Inc., based in Burlington, North Carolina, manufactures and distributes diagnostic devices and other similar products.  For the year ended December 31, 2010, MEDTOX Laboratories, Inc. and MEDTOX Diagnostics, Inc. accounted for 79% and 21% of our consolidated revenues, respectively.
 
        2.   Principal Services, Products and Markets.
 
General.  We have two reportable segments: “Laboratory Services”, which consists of the activities conducted by MEDTOX Laboratories, Inc. and New Brighton Business Center, LLC, and “Product Sales”, conducted by MEDTOX Diagnostics, Inc.  Laboratory Services includes drugs of abuse testing services.  MEDTOX Laboratories also provides clinical and other laboratory services which consist of clinical toxicology, clinical testing for occupational health clinics, clinical testing for physician offices, pediatric lead testing, and analysis of heavy and trace metal.  We also provide services in the area of logistical support, data management and overall program management services.  Additionally, MEDTOX Laboratories provides clinical trial services which include central laboratory services, assay (test) development, bio-analytical, bio-equivalence and pharmacokinetic testing.  The Product Sales segment includes sales of a variety of on-site drug screening products and contract manufacturing.  For financial information relating to our segments, see Note 2 of notes to the consolidated financial statements included in this Annual Report on Form 10-K.

Laboratory Services

A.           Drugs-of-Abuse Testing Services.  As reflected in the table below, our Laboratory Services segment derives a substantial percentage of its revenues from laboratory testing services for the identification of drugs-of-abuse.

(In thousands)
2010
2009
2008
       
Drugs-of-abuse testing services revenues
$   39,624
$   36,040
$  40,021
       
% of Laboratory Services revenues
51%
55%
61%

Industry analysts have estimated that the industry-wide revenues derived from workplace laboratory-based drugs-of-abuse testing in the United States are in excess of $500 million.  Public information highlights the motivations behind such testing.  For example, according to results of a National Institute of Drug Abuse-sponsored survey, drug using employees are 2.2 times more likely to require early dismissal or request time off, 2.5 times more likely to have absences of eight days or more, 3 times more likely to be late for work, 3.6 times more likely to be involved in a workplace accident, and 5 times more likely to file a workers’ compensation claim.  We believe the percentage of employers with drug testing programs has remained fairly consistent over the past five years, with drug testing more prevalent among larger employers. The number of SAMHSA (Substance Abuse Mental Health Services Administration)-certified laboratory service providers has declined in recent years, providing opportunities for the remaining industry participants.


 
- 5 -

 

Drugs-of-abuse testing remains predominately laboratory-based.  However, we do offer on-site drug testing devices through our Product Sales segment.  Our sale of on-site drug testing devices supports our Laboratory Services business as confirmation testing, logistics, data and program management services are often sold along with on-site testing devices.

Our customers for substance abuse testing include public and private companies, as well as service firms; such as, drug treatment counseling centers, criminal justice facilities, occupational health clinics, third party administrators and hospitals.

B.           Clinical & Other Laboratory Services.   As reflected in the table below, our Laboratory Services segment also derives revenues from other services, including: clinical toxicology; heavy metal, trace element and solvent analyses; pain management; physician office-based clinical testing; and logistics, data and program management services.

(In thousands)
2010
2009
2008
       
Clinical & Other Laboratory Services revenues
$   29,923
$   22,885
$   19,306
       
% of Laboratory Services revenues
39%
35%
29%

The services we provide within the clinical laboratory industry market enable us to leverage our core competencies and expertise.

Clinical Toxicology.  We have a fully certified clinical toxicology reference laboratory specializing in esoteric therapeutic drug monitoring and emergency toxicology.  Esoteric tests are more sophisticated tests used to obtain information not provided by routine tests and generally involve a higher level of complexity and more substantial human involvement than routine tests.  The tests performed in the clinical laboratory are conducted using methodologies such as various immunoassays (a test that uses binding of antibodies to antigens to identify and measure certain substances), gas liquid chromatography, high performance liquid chromatography, gas chromatography/mass spectrometry and tandem mass spectrometry.  Chromatography is a technique for separating, identifying and quantifying the individual chemical components of substances based on the physical and chemical characteristics specific to each component.  Mass spectrometry is a technique for analyzing the individual chemical components of substances by breaking molecules into multiple electrically charged ions that are then sorted for analysis according to their mass-to-charge ratios.

We perform analytical testing for a wide variety of drug classes including: analgesic, antianxiety, anticholinergic, anticoagulant, anticonvulsant, antidepressant, antidiabetic, antiemetic, antihistamine, antiinflammatory, antimicrobial, antipsychotic, bronchodilator, cardiovascular, stimulant, decongestant, immunosuppressant, local anesthetic, muscle relaxant, narcotic analgesic and sedative medications.  Clients for our clinical toxicology services consist of hospitals, clinics and other laboratories.

Clinical Testing for Occupational Health Clinics.  We perform basic clinical testing for our occupational clinic clients that send us drug testing samples.  The most common clinical testing includes blood chemistries, complete blood cell counts, lead/zinc protoporphyrin (ZPP) testing, urinalysis and lipid panels.

Clinical Testing for Physician Offices.  We offer laboratory tests used by physicians and other healthcare providers for the purpose of diagnosing or treating disease or illness or the assessment of health in humans.  Testing is performed on blood, body fluids or tissues.  Our comprehensive clinical laboratory services include clinical chemistry, hematology, coagulation, urinalysis, immunology/serology (viruses, infectious diseases, immune system), immunohematology (blood typing, antibody screens), microbiology (bacteria, parasites), anatomical pathology/cytology (tissue biopsies, cancer) molecular diagnostics (infectious diseases, genetic disorders) and sub-specialties of these categories.


 
- 6 -

 

Heavy Metal, Trace Element and Solvent Analyses.  We operate a laboratory in which blood and urine are tested for heavy metals (for example, lead), trace elements and solvents.  Our clients for these services are other laboratories, occupational health clinics, companies that are required to comply with OSHA (Occupational Safety and Health Administration) guidelines for monitoring occupational exposure to hazardous materials, and pediatricians who test children for exposure to lead. Current Centers for Medicare and Medicaid Services policy requires a screening blood lead test for all Medicaid-eligible children at 12 and 24 months of age.  In addition, children over the age of 24 months, up to 72 months of age, should receive a lead screening test if there is no record of a previous test.

Pain Management.  We continued to expand our Pain Management product line in 2010.  Our original client base was primarily comprised of local hospital-based pain management groups.  In the past few years, there has been a rapidly growing number of pain management clinics and other physician practices involved in the management of chronic pain throughout the United States.  We now offer a comprehensive testing program serving this market under the name ToxAssure®.

Logistics, Data and Program Management Services.  We also provide services in the areas of logistics management, data management and program management.  These services support our underlying business of laboratory analysis and provide added value to our clients.  Value-added services include courier services for medical specimen transportation, management programs for laboratory-based and on-site drug testing, coordination of specimen collection sites, and data collection/reporting services including the use of our WEBTOX® internet-based reporting system.  In the data management area, we offer our clients the eChain® System, our web-based electronic chain-of-custody and donor tracking system.

C.           Clinical Trial Services.  We provide central laboratory services, assay (test) development, bio-analytical, bio-equivalence and pharmacokinetic testing (a process by which a drug is absorbed, distributed, metabolized and eliminated by the body) for Phase I-IV clinical trials.  Phase I clinical trials focus primarily on testing the safety of the drug and involve generally only a small number of patients.  In Phase II trials, the results of people taking a new treatment are compared with results of people taking standard treatment or a placebo.  A Phase II trial typically involves hundreds of patients.  A Phase III trial involves several thousands of patients and is designed to further evaluate the efficacy and safety of the drug.  Phase IV clinical trials involve further evaluation of the study drug generally after the drug is already approved and in the market place.  Central laboratory services include tests that are used to monitor the safety and efficacy of a drug.  These tests or “safety labs” include tests that are performed in our general clinical laboratory and pathology laboratory such as clinical chemistries (liver function, kidney function, cardiac and bone), hematology (blood count), immunology (immune status), and flow cytometry (cell identification).  Assay development, bio-analytical and bio-equivalence studies are performed in our bio-analytical laboratory.  These tests are conducted using methodologies such as immunoassay, gas chromatography, high performance liquid chromatography, gas chromatography/mass spectrometry and tandem mass spectrometry. MEDTOX Laboratories is a FDA registered establishment and adheres to applicable GLP (Good Laboratory Practices) requirements.

Clients for our clinical testing services include clinical trial sponsors (pharmaceutical and biotech companies), clinical research organizations (CROs), research organizations, and investigators with trial management, patient recruitment/enrollment and site management.

(In thousands)
2010
2009
2008
       
Clinical Trial Services revenues
$   7,500
$   6,926
$  4,538
       
% of Laboratory Services revenues
10%
10%
7%

Clinical trial services revenues can fluctuate from quarter-to-quarter based on the project nature, size, and the actual timing of clinical trials as shown in the table below:


 
- 7 -

 


 
First
Second
Third
Fourth
(In thousands)
Quarter
Quarter
Quarter
Quarter
         
Clinical Trial Services revenues:
       
         
2010
$         833
$      2,037
   $     2,358
    $      2,272
         
2009
     2,315
      1,592
       2,000
        1,019

Product Sales

A.           Substance Abuse Testing Products. The table below reflects information regarding the revenues derived by our Product Sales segment during the last three years from the sale of point-of-collection testing (POCT) products for drugs-of-abuse, the primary component of Product Sales segment revenues.

(In thousands)
2010
2009
2008
       
POCT product revenues
$   17,796
$  16,431
$   17,787
       
% of Product Sales revenues
89%
90%
91%
 
The primary markets for our POCT products for drugs-of-abuse are workplace drugs-of-abuse testing and testing in support of hospital emergency departments, the criminal justice system and rehabilitation centers.  We manufacture and distribute our PROFILE®-II, PROFILE®-II A, PROFILE®-III, and PROFILE®-III A POCT products into this market.  These products are often sold in conjunction with confirmation testing, logistic, data management, and program management services provided by our Laboratory Services segment.  Our customers for substance abuse testing products include public and private companies, as well as occupational health clinics and third party administrators.

Drug abuse is frequently a factor in emergency room treatment of patients. We manufacture and distribute the PROFILE-II ER® and PROFILE®-III ER, PROFILE®-IV, and PROFILE®-V line of diagnostic drug screening products to hospital markets for drug detection in patients seen in the hospital and emergency rooms.  The PROFILE-II ER®, PROFILE®-III ER, and PROFILE®-IV devices are Food and Drug Administration (FDA)-cleared one step qualitative screening assays for the detection of the following drugs and/or their metabolites (any substance produced by metabolism):

·  
amphetamines
·  
methamphetamines/methylenedioxymethyl amphetamine (ecstasy, speed, crystal)
·  
barbiturates (Phenobarbital)
·  
benzodiazepines (Valium, Librium, Halcion)
·  
cannabinoids/THC (pot, marijuana)
·  
cocaine (crack)
·  
methadone (Methadose)
·  
opiates (heroin)
·  
oxycodone
·  
phencyclidine/PCP (angel dust)
·  
propoxyphene (Darvon)
·  
tricyclic antidepressants

We also market the MEDTOXScan® Reader, an electronic reader, for use with our new PROFILE®-V device in hospital laboratories and emergency rooms.


 
- 8 -

 

We also manufacture and distribute diagnostic drug screening products within the criminal justice and drug rehabilitation markets.  Our VERDICT®-II and SURE-SCREEN® product lines are primarily sold within these markets and are sold alone or as part of our comprehensive drug testing program solution, ClearCourse®.  ClearCourse® is a unique and comprehensive drug testing program that combines four essential components: Drug Abuse Recognition System (DARS™) training, SURE-SCREEN® on-site drug screening devices, laboratory based confirmation testing and WEBTOX® online data management.

SURE-SCREEN® is a diagnostic device utilizing lower drug cut-off levels that assists criminal justice agencies in their "no drug use" mandate and supports efforts at early intervention.  The chart below shows the specific cut-offs for the SURE-SCREEN® device as compared to the traditional National Institute of Drug Abuse (NIDA) cut-offs:

Drug
Screening Cut-Off
 
Traditional
SURE-SCREEN®
Amphetamine
1000 ng/ml
300 ng/ml
Methamphetamine
1000 ng/ml
300 ng/ml
Benzoylecgonine
300 ng/ml
100 ng/ml
Morphine
 NA
100 ng/ml
Methadone
 NA
200 ng/ml
Phencyclidine
25 ng/ml
25 ng/ml
Benzodiazepines
 NA
200 ng/ml
Cannabinoids
50 ng/ml
40 ng/ml

B.           Contract Manufacturing Services and Other Diagnostic Products. In addition to the sale of POCT products for drugs-of-abuse, our Product Sales segment derives revenues from the manufacture of coagulation (blood clotting) market controls for various customers.  We anticipate that our activity relative to manufacturing and sales of coagulation controls will decline and we are phasing out contract manufacturing services.  We also distribute other diagnostic tests, including the NexScreen 12 panel diagnostic test, as well as  diagnostic tests for the detection of alcohol with the EZ-SCREEN® Breath Alcohol Test.  The table below reflects information regarding the revenues derived by our Product Sales segment from contract manufacturing services and the distribution of other diagnostic products.

(In thousands)
2010
2009
2008
       
Contract manufacturing services revenues
$   1,567
$  1,391
$  1,469
% of Product Sales revenues
8%
8%
7%
       
Other diagnostic products revenues
$      691
$     435
$     430
% of Product Sales revenues
3%
2%
2%

3.           Marketing and Sales.

We believe that the combined operations of the Laboratory Services business and the on-site test kits manufactured by the Product Sales segment have created synergy in the marketing of comprehensive, on-site and laboratory testing programs to a common customer base. We are in a position to offer a full line of products and services for the substance abuse testing and occupational medicine marketplace, including (1) on-site tests for the detection of drugs-of-abuse; (2) SAMHSA (Substance Abuse Mental Health Services Administration) certified laboratory testing (screening and confirmation); (3) biological monitoring of occupational toxins; (4) consultation; and (5) logistics, data management and program management services.

 
- 9 -

 

We have expanded our sales effort in the pharmaceutical market by offering testing services for Phase I-IV clinical trials and working with sponsors and CROs on assay development and bio-analytical and pharmacokinetic studies.  In addition, we have begun to market clinical diagnostic testing services to clinics, hospitals and physician offices on a regional basis.
 
We use several distribution channels to sell our products and services.  We employ a direct sales force which consists of 52 sales representatives and six sales managers. In addition, we are a party to a distribution agreement with Cardinal Health for our PROFILE® products sold into the hospital laboratory market.  We also benefit from sales efforts on our behalf conducted by third party administrator organizations and occupational health clinic groups.

We have a strategic relationship in the area of pediatric lead testing with Sustainable Resource Center (SRC), a not-for-profit organization dedicated to the eradication of lead exposure in homes within the United States.  We provide annual funding to SRC which is primarily utilized for educational purposes.

We have developed strategic sales plans for each of the primary markets served.  These plans include the utilization of supporting materials for advertising and direct marketing efforts, lead generation activities and attending pertinent industry tradeshows.

Major Customers.  No single customer had sales that amounted to more than 10% of our consolidated revenues during 2010, 2009 or 2008.

4.           New Products, Research and Development.

Laboratory Services.  Our Laboratory Services’ research and development group develops: assays for new drugs and compounds; new assays for existing drugs and other toxins; and improves existing assays with the goal of improving assay robustness, sensitivity, accuracy, precision, specificity and efficiency.  This group also investigates and develops assays for commonly tested compounds in alternative matrices and novel formats.  During 2010, this group developed and validated approximately 97 new laboratory-based assays using immunochemistry, liquid chromatography (LC), gas chromatography (GC), gas chromatography with mass spectrometry (GC/MS), inductively coupled plasma mass spectrometry (ICP/MS), and LC with tandem mass spectrometry (LC/MS/MS).  These activities continue to enhance our test menu and ability to realize efficiencies of new technologies.

We have made efforts to enter the market for full service clinical laboratory testing for physicians offices and patients on a regional basis.  As mentioned in prior reports, we added to our test menu in clinical chemistry and diagnostic immunology (immune system) virology (viruses), endocrinology (hormones), serology (infectious diseases) and allergy.  We added staffing, state of the art instrumentation and laboratory build out for full service pathology/histology/cytology, molecular diagnostics and microbiology. These new specialties include tests for infectious diseases, viruses, tissue biopsies, cancer, genetic disorders, bacteria and parasites.   Based on our local presence, company-owned courier network and advanced instrumentation and technology, we believe we will be able to offer superior turn-around times for physicians and patients than our national competitors.

Product Sales.  We continue to develop new and innovative products and services for the drug testing market.  We are continually improving our product performance, result hold time (length of time the result is readable on the device) and cost effectiveness in order to meet the evolving demands of the marketplace.

In 2010, we continued improvement in our manufacturing processes in the diagnostic area, resulting in greater flexibility of product configurations for clients, increased efficiency in manufacturing and improved device performance.  We can now offer a higher degree of customization to our clients, both in terms of specific assays on a particular device, and supplying a “private label” device to large clients.
 
 
 
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In 2010, we continued to see growth of our PROFILE®-III cup products.  These products test for THC, cocaine, opiates, amphetamine, methamphetamine and PCP at standard SAMHSA sensitivity levels, and enzodiazepines, barbiturates, methadone, tricyclic antidepressants and propoxyphene at standard industry levels. The PROFILE®-III cup is targeted for the corporate and occupational health clinic markets.  The use of a cup format in these markets is advantageous due to the elimination of the standard pipette (laboratory instrument used to transport a measured quantity of liquid) used in a cassette device.  The cup format provides an enclosed system where the testing personnel are not exposed to the urine sample. The PROFILE®-III cup design adds simplicity and time savings to the drug screening process.

Research and Development.  We incurred costs of $2.3 million, $2.3 million, and $2.4 million for research and development activities in 2010, 2009, and 2008, respectively.  At December 31, 2010, we employed 16 scientists in research and development activities for the Laboratory Services and Product Sales segments. Their primary duties are focused on new methods and assay development for Laboratory Services and developing on-site, rapid in vitro diagnostic devices at the Product Sales facility.

 
5.
Raw Materials.

Laboratory Services.  The raw materials required by the laboratory for urine drug testing consist primarily of two types: specimen collection supplies and reagents for laboratory analysis.  The collection supplies include drug testing custody and control forms that identify the specimen and the client, as well as document the chain-of-custody.  Collection supplies also consist of specimen bottles and shipping supplies.  Reagents for drug testing are primarily immunoassay screening products and various chemicals used for confirmation testing.  We believe all of these materials are available at competitive prices from numerous suppliers.

Product Sales.  The primary raw materials required for the immunoassay-based test kits produced by us consist of antibodies, antigens and other reagents, plastic molded devices, wicking materials, filter materials, absorbent materials and packaging materials.  We maintain an inventory of raw materials which, to date, has been acquired primarily from third parties.  Currently, most raw materials are available from several sources.  The molds and tooling for plastic-molded components are owned by us, which provides supply chain management flexibility.  We possess the technical capability to produce our own antibodies and antigens and have initiated production of antibodies and antigens for certain tests.  Antibodies are part of the immune system and are proteins which are produced by white blood cells.  Their task is to circulate in the body and to attach themselves to any foreign particles (antigen) which they may come across.  If we were to change certain raw materials used in a specific test, additional development, validation and accompanying costs may be required to adapt the alternate material to the specific diagnostic test.

 
6.
Patents, Trademarks, Licensing and Other Proprietary Information.

Laboratory Services.  We believe that the basic technologies requisite to the production of antibodies are in the public domain and are not patentable.  We rely upon trade secret protection of certain proprietary information, rather than patents, where we believe disclosure could cause us to be vulnerable to competitors that could successfully replicate our techniques and processes.

Product Sales.  We file patent applications to protect our intellectual property as it relates to our technologies, inventions and improvements which can be utilized in the development and manufacture of our Product Sales business, as protection of this intellectual property is very important to our Product Sales segment.  These patents relate to our core technologies and designs for diagnostic testing, screening and services.  We hold seven United States issued patents with expiration dates ranging from 2012 to 2025.

General.  At December 31, 2010, we held 28 registered trade names and/or trademarks in reference to our products and corporate names.  Our trade names and/or trademarks range in duration from 10 to 20 years with expiration dates ranging from 2012 to 2020.  Applications have also been made for additional trade names.


 
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7.
Seasonality.

Laboratory Services.  We believe that the laboratory testing business is subject to seasonal fluctuations in pre-employment screening.  These seasonal fluctuations include reduced volume in the year-end holiday periods and other major holidays.  In addition, inclement weather may have a negative impact on volume thereby reducing revenues and cash flow.

Product Sales. We do not believe that seasonality is a significant factor in the sale of our on-site immunoassay testing devices.

 
8.
Backlog.

Laboratory Services.  At December 31, 2010, MEDTOX Laboratories, Inc. did not have any significant backlog.  We do not believe that sales backlog is a significant factor in the Laboratory Services segment of our business.  However, the time from when an account becomes a client to the time the laboratory starts receiving specimens may be up to four months.  The delay in receiving samples is primarily due to the necessity of establishing communication capabilities between the client and us, the requirement to ship out collection kits and forms, and the establishment of a collection site network.  At December 31, 2010, we had several accounts that were in the process of being set up where revenues will not be realized until 2011.

Product Sales.  At December 31, 2010, MEDTOX Diagnostics, Inc. did not have any significant backlog.  We do not believe that sales backlog is a significant factor in the Product Sales segment of our business.

 
9.
Competition.
 
Laboratory Services.  Our Laboratory Services segment competes in a fragmented, though highly competitive, industry.  At December 31, 2010, 38 labs, including MEDTOX Laboratories, Inc., were certified by the Department of Health and Human Services as having met the standards for Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR 29916, 29925) and were involved in workplace drugs-of-abuse testing.  Without ongoing certification in this program, a laboratory would not be permitted to conduct drug testing for Federal Workplace Drug Testing Programs such as testing for the Department of Transportation and other similar programs.  Competitors include Quest Diagnostics and Laboratory Corporation of America, as well as the testing units of other clinical laboratories, including independent laboratories, specialized laboratories and in-house testing facilities maintained by hospitals.
 
Our Laboratory Services segment competes on the basis of the reliability and accuracy of its test results, price structure, service, transportation and collection network, and the ability to establish relationships with hospitals, physicians and users of drug abuse testing programs.  Many of the segment’s competitors and potential competitors have substantially greater financial and other resources than we do.

The laboratory services drugs-of-abuse industry is consolidating.  The consolidation is being driven by customers’ desires to minimize the number of laboratories they work with, the need for operating efficiencies in the form of critical mass (testing volumes), required investment levels and government regulation.  In light of these forces, we face an increasing challenge to differentiate ourselves through our technology and value-added services, such as data management, collection site management, training and technical support and expertise.  Our ability to successfully compete in the future and maintain our margins will be based on our ability to maintain our quality and customer service while maintaining efficiencies and low cost operations.

Product Sales.  Many large companies with greater research and development, marketing, financial and other capabilities, as well as smaller research firms, are engaged in research, development and marketing of diagnostic assays for application in the areas for which we produce our products.

The diagnostics market has become highly competitive with respect to the price, quality and ease of use of various tests, and is characterized by rapid technological changes.  We have designed our diagnostic screening products to be inexpensive, on-site tests for use by unskilled personnel, and have not endeavored to compete with laboratory-based systems.  These laboratory-based systems consist of bench-top auto analyzers that have fast, automated throughput.  Our POCT devices are not designed to compete with such automated systems.
 
 
 
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The recent downturn in the economy has led to increased price competition for certain diagnostic testing devices.  Competitors of this nature include Phamatech, American Bio Medica, and Alere, Inc.

 
10.
Government Regulation.

Our products and services are subject to the regulations of a number of governmental agencies as listed below.  We believe we are currently in compliance with all applicable regulations.  We cannot predict whether future changes in governmental regulations might significantly increase compliance costs or adversely affect the time or cost required to develop and introduce new products.

A.           Substance Abuse and Mental Health Services Administration (SAMHSA). MEDTOX Laboratories, Inc. has been certified by SAMHSA since 1988.  SAMHSA certifies laboratories meeting strict standards under Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs.  Continued certification is accomplished through periodic inspection by SAMHSA to assure compliance with applicable regulations.  Without ongoing certification in this program, our laboratory would not be permitted to conduct drug testing for Federal Workplace Drug Testing Programs such as testing for the Department of Transportation and other similar programs. Testing performed under the SAMHSA program comprises 25% to 30% of our workplace drug testing customer base.
 
B.           Food and Drug Administration (FDA).  Certain tests for human diagnostic purposes must be cleared by the FDA prior to their marketing for in vitro diagnostic use in the United States.  In vitro diagnostic products are those reagents, instruments and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its complications.  Such products are intended for use in the collection, preparation and examination of specimens taken from the human body.  The FDA provides clear guidance that in vitro diagnostic devices used for workplace drug testing must be cleared by the FDA prior to being marketed.  The FDA-regulated products we produce are in vitro diagnostic products subject to FDA clearance through the Federal Food, Drug and Cosmetic Act, Section 510(k) process, which requires the submission of information and data to the FDA that demonstrates that the device to be marketed is substantially equivalent to a currently marketed device.  This data is generated by performing clinical studies comparing the results obtained using our device to those obtained using an existing test product.  Although no maximum statutory response time has been set for review of a 510(k) submission, as a matter of policy the FDA has attempted to complete review of 510(k) submissions within 90 days.  To date, we have received 510(k) clearance for 22 different products.  Products subject to 510(k) regulations may not be marketed for in vitro diagnostic use until the FDA issues a letter stating that a finding of substantial equivalence has been made.
 
As a registered manufacturer of FDA-regulated products, we are subject to a variety of FDA regulations including the Good Manufacturing Practices (GMP) regulations, which define the conditions under which FDA regulated products are to be produced.  These regulations are enforced by the FDA and failure to comply with GMP or other FDA regulations can result in the delay of pre-market product reviews, fines, civil penalties, recalls, seizures, injunctions and/or criminal prosecution.  With the exception of the forensic market, FDA clearance of our diagnostic products is required by our clients and regulatory agencies.
 
As an accredited laboratory performing testing for clinical trials, our laboratory is subject to FDA regulations including Good Laboratory Practices (GLP) and related requirements.

C.           Drug Enforcement Administration (DEA).  Our primary business involves either testing for drugs-of-abuse or developing test kits for the detection of drugs/drug metabolites in urine.  MEDTOX Laboratories, Inc. is registered with the DEA to conduct chemical analyses with controlled substances.  The MEDTOX Diagnostics, Inc. facility in Burlington, North Carolina is registered by the DEA to manufacture and distribute controlled substances and to conduct research with controlled substances.  Maintenance of these registrations requires that we comply with applicable DEA regulations.
 
 
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D.           Canadian Medical Devices Conformity Assessment System (CMDCAS). MEDTOX Diagnostics, Inc. maintains a quality system which satisfies the requirements for ensuring the safety and effectiveness of our products and meeting the customer needs in accordance with FDA requirements as described in 21 CFR Part 820 (Quality Systems), and that satisfies the requirements of the Canadian Medical Devices Regulations (CMDR) and CAN/CSA ISO 13485:1998 and ISO 9001:2003.  Our product sales to Canada are immaterial to our overall operations.
 
 CMDCAS addresses the quality system requirements found in the CMDR. To sell a medical device in Canada, manufacturers must meet the regulatory requirements as defined in the CMDR. The quality system implemented by the manufacturer for design and manufacture of medical devices must satisfy the quality system requirements of ISO 13485 and the manufacturer is required to have its quality system registered by an approved CMDCAS registrar. A CMDCAS approved registrar audits the manufacturer’s quality system to ISO 13485:1998 and ISO 9001:2003. MEDTOX Diagnostics, Inc. maintains a quality system fulfilling the requirements of EN ISO 13485 and CMDCAS ISO 13485, Quality Systems – Medical Devices and ISO 9001:2000 — Quality Management Systems – Requirements. MEDTOX Diagnostics, Inc. has been issued the TUV Rheinland Product Safety GmbH quality system certificate to EN ISO 13485:2000 and the TUV Rheinland of North America Inc. quality system certificate to ISO 13485 under CMDCAS.

E.           Centers for Medicare and Medicaid Services (CMS).  The Clinical Laboratory Improvement Act (CLIA) introduced in 1992 requires that all in vitro diagnostic products be categorized as to level of complexity.  A request for CLIA categorization of any new clinical laboratory test system must be made simultaneously with FDA 510(k) submission.  The PROFILE®, PROFILE®-II, PROFILE®-III, PROFILE®-IV, PROFILE®-V, VERDICT®, VERDICT®-II and MEDTOXScan® drugs-of-abuse tests currently marketed by MEDTOX Diagnostics, Inc. have been categorized as moderately complex.  The complexity category to which a clinical laboratory test system is assigned may limit the number of laboratories qualified to use the test system, thus impacting product sales.  MEDTOX Laboratories, Inc. is a CLIA-licensed high complexity laboratory and is accredited by the College of American Pathologists (CAP) Laboratory Accreditation Program.  All laboratory specialties and sub-specialties, as they relate to the expanded laboratory test menu, have been added to MEDTOX Laboratories, Inc.’s CLIA/CAP certificates.

F.           Health Insurance Portability and Accountability Act (HIPAA). MEDTOX Laboratories, Inc. is committed to safeguarding the privacy and confidentiality of its patients’ protected health information.  Our policy is to be in compliance with the requirements of federal and Minnesota state law related to protecting the privacy of health information, including the Standards for Privacy of Individually Identifiable Health Information (45 CFR, Parts 160 and 164 - commonly called the “HIPAA Final Privacy Rule”).  MEDTOX Laboratories, Inc. complies with out-of-state regulations as applicable.  MEDTOX Laboratories, Inc. has compiled several policies and procedures that outline the steps that are taken to ensure compliance with the HIPAA privacy standards and Minnesota state laws related to protected health information.  All employees receive appropriate training on these policies and procedures, and it is the responsibility of each individual to follow the policies and procedures in the performance of their jobs.  The “Notice of Privacy Practices” and “HIPAA Privacy Policy” for MEDTOX Laboratories, Inc. are posted on our website (www.medtox.com).

G.           Additional Laboratory Regulations.  MEDTOX Laboratories, Inc. and certain of its laboratory personnel are licensed or otherwise regulated by certain federal agencies, states and localities in which it conducts business.  Federal, state and local laws and regulations require MEDTOX Laboratories, Inc., among other things, to meet standards governing the qualifications of laboratory owners and personnel, as well as the maintenance of proper records, facilities, equipment, test materials and quality control programs.  In addition, the laboratories are subject to a number of other federal, state and local requirements that provide for inspection of laboratory facilities and participation in proficiency testing, as well as govern the transportation, packaging and labeling of specimens tested.  The laboratories are also subject to laws and regulations prohibiting the unlawful rebate of fees and limiting the manner in which business may be solicited.
 
 
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Our laboratory located in St. Paul, Minnesota receives and uses small quantities of hazardous chemicals and radioactive materials in its operations and is licensed to handle and dispose of such chemicals and materials.  We comply with all federal, state and local regulations regarding the safe handling, storage and disposal of such chemicals and materials.  Employees working with chemicals are trained initially regarding safe practices, procedures and policies and also participate in annual safety reviews.  Periodic inspections by laboratory accrediting agencies and local authorities assure adherence to safe practices and compliance with applicable regulations.

11.           Product and Professional Liability.

Laboratory Services.  Our laboratory testing services are primarily diagnostic and expose us to the risk of liability claims.  Our laboratories have maintained continuous professional and general liability insurance since 1984.  The insurance policy covers those amounts we are legally obligated to pay for damages resulting from a medical incident, which arises out of a failure to render professional services.  To date, we have not paid any material amounts for claims of this type and no material professional service claims are currently pending.

Product Sales.  Manufacturing and marketing of products by us entails a risk of product liability claims.  Since 1993, we have maintained insurance coverage against the risk of product liability arising out of events after such date. As of the date of filing this Annual Report on Form 10-K, no product liability claims are pending.

 
12.
Employees.

At December 31, 2010, we had a total of 633 full-time employee equivalents compared to 621 full-time employee equivalents at December 31, 2009.

Our employees are not covered by any collective bargaining agreements and we have not experienced any work stoppages. We believe that we maintain good relations with our employees.

 
13.
Available Information.
 
We make available free of charge on or through our website (www.medtox.com) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish it to, the U.S. Securities and Exchange Commission.

 
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ITEM 1A.                            RISK FACTORS.

A substantial portion of our revenue is derived from the provision of testing services for the identification of drugs-of-abuse in the workplace and government markets, a business that is influenced by general economic conditions.  As such, our operating results are subject to volatility.
 
In 2010, approximately 51% and 59% of our Laboratory Services and Product Sales segment’s revenues, respectively, were derived from the provision of testing services for the identification of drugs-of-abuse in the workplace and government markets.  We expect that a substantial percentage of our revenues will continue to be derived from the provision of such services for the foreseeable future.  This business is influenced by the strength of the U.S. economy.  When the U.S. economy is growing and characterized by job creation, this business tends to experience increased testing levels.  Conversely, lower testing levels tend to be associated with periods of job contraction in the U.S.  As a result, our revenues and operating results are subject to volatility.
 
The laboratory services drugs-of-abuse industry is consolidating.  With the market forces driving such consolidation tending to favor the larger industry participants, we face an increasing challenge to differentiate ourselves through our technology and value-added services.
 
Our Laboratory Services segment competes in what is currently a fragmented, but highly competitive, industry.  At December 31, 2010, 38 labs, including MEDTOX Laboratories, Inc., were certified by the Department of Health and Human Services as having met the standards for Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs and were involved in workplace drugs-of-abuse testing. Our major competitors include Quest Diagnostics, Laboratory Corporation of America as well as the testing units of other clinical laboratories, including independent laboratories, specialized laboratories, and in-house testing facilities maintained by hospitals.  Many of our competitors have substantially greater financial and other resources than we do.  The laboratory services, drugs-of-abuse industry is consolidating.  The consolidation is being driven by the larger laboratories whose greater resources enable them to be more responsive and better able to increase operating efficiencies in the form of critical mass (testing volumes) and required investment levels.    In light of these forces, we face an increasing challenge to differentiate ourselves through our technology and value-added services, such as data management, collection site management, training and technical support and expertise.  If we are unsuccessful in these differentiation efforts, we may experience declining revenues and gross margins, and reduced cash flows.
 
We are experiencing increased competition in our Product Sales business segment.  Such competition may have a negative effect on our business and future financial prospects.
 
We are experiencing increased competition, including increased price competition, in our Product Sales business segment.  We have experienced increased competition with respect to our immunoassay tests from systems and products developed by others, many of whom compete solely on price.  As the number of firms marketing diagnostic tests has grown, we have experienced increased price competition for certain diagnostic testing devices, particularly in the probation, parole and rehabilitation market.  A further increase in competition may reduce our ability to compete in the diagnostic market and have a negative effect on our financial results and future prospects.

Our quarterly operating results may vary.
 
Clinical trial services testing for the pharmaceutical industry is project-based, and as such, may vary from quarter to quarter due to factors over which we have little control such as the commencement, completion or cancellation of clinical trial contracts and the progress of ongoing clinical trial contracts.
 
Such variations may cause operating results to vary quarter to quarter, negatively or positively affecting the market price of our common stock.  We believe that such variations in any particular quarter are not necessarily a meaningful indication of future results and that these fluctuations may not be related to our future overall operating performance.
 
 
 
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If reimbursement for our services by third party payers is reduced, our net revenues could diminish.

There has been and will likely continue to be significant efforts by both federal and state agencies to reduce costs in government healthcare programs and otherwise implement government control of healthcare costs.  In addition, increasing emphasis on managed care in the U.S. may continue to put pressure on the pricing of healthcare services.  Third party payers, including state payers and Medicare, are challenging the prices charged for medical products and services. Government and other third party payers increasingly are limiting both coverage and the level of reimbursement for our services.  In 2010 and 2009, third party payers accounted for approximately 11.1% and 6.1%, respectively, of our net revenues.  A portion of the testing for which we bill our hospital and laboratory clients is ultimately paid by third party payers.  Any pricing pressure exerted by these third party payers on our customers may, in turn, be exerted by our customers on us.  If government and other third party payers do not provide adequate coverage and reimbursement for our services, our net revenues could decline. If we cannot offset additional reductions in the payments we receive for our services by reducing costs, increasing test volume and/or introducing new procedures, our net revenues and profitability could decline.

A significant increase in our days sales outstanding could increase bad debt expense and have an adverse effect on our business.

We are seeing an increase in the percentage of revenues that are billed to patients and third-party payers, including insurance companies and Medicaid and Medicare agencies.  The increase is a result of growth in our clinical laboratory.  Billing to third party payers is complex and is subject to extensive and non-uniform rules and administrative requirements.   It is subject to risks including delayed reimbursement, difficulties in gathering complete and accurate billing information, inabilities to collect and long collection cycles.  Failure to timely or correctly bill may lead to our not being reimbursed for our services or an increase in the aging of our accounts receivable, which could adversely affect our results of operations and cash flows.   In addition, we are experiencing more billing to patients.  Patient billing is increasing as a result of the growth patient copayments, coinsurance and deductibles and an increase in high deductible health plans.  Patient billings are subject risk of difficulties in gathering accurate billing information, inabilities to collect and long collection cycles which also could adversely affect our results of operations and cash flows. We believe our allowance for doubtful accounts is adequate.  However, we cannot assure that our ongoing assessment of accounts receivable will not result in the need for additional provisions, which would adversely affect our results of operations and cash flows.

FDA regulation of laboratory developed tests (LDTs)  and clinical laboratories may result in significant change, and our business could be adversely impacted if we fail to adapt.

During 2010, the FDA publicly announced that it has decided to exercise regulatory authority over LDTs, and that it plans to issue guidance to the industry regarding its regulatory approach. The FDA has indicated that it will use a risk-based approach to regulation and will direct more resources to tests with the highest risk of injury, but that it will be sensitive to the need to not adversely impact patient care or innovation. The FDA has not announced a framework or timetable for implementing its new regulatory approach. The regulatory approach adopted by the FDA may lead to an increased regulatory burden, including additional costs and delays in introducing new tests. While the ultimate impact of the FDA’s approach is unknown, there is an associated risk for us that some of the tests that we currently offer may be subject to approval by the FDA.

We could face significant monetary damages and penalties and/or exclusion from the Medicare and Medicaid programs if we violate health care anti-fraud and abuse laws.

We are subject to extensive government regulation at the federal, state and local levels.  Our failure to meet governmental requirements under these regulations, including those relating to billing practices and relationships with physicians and hospitals, could lead to civil and criminal penalties, exclusion from participation in Medicare and Medicaid and possible prohibitions or restrictions on the use of our laboratory.  While we believe that we conduct our operations and relationships with care in an effort to meet all statutory and regulatory requirements, there is a risk that government authorities might take a contrary position.  Such occurrences, regardless of their outcome, could damage our reputation and adversely affect important business relationships we have with third parties.

 
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Failure to maintain the security of customer-related information could damage our reputation with  customers and cause us to incur substantial additional costs and become subject to litigation.
 
               We receive certain personal information about our customers.  In addition, we depend upon the secure transmission of confidential information over public networks, including information permitting cashless payments.  A compromise in our security systems that results in customer personal information being obtained by unauthorized persons could adversely affect our reputation with our customers and others, as well as our results of operations, financial condition and liquidity.  It could also result in litigation against us or the imposition of penalties.

If we fail to keep up with technological advancements and fail to develop our products, we may be at a competitive disadvantage and our products may become less attractive or obsolete.

The continuing changes in modern biotechnology could render our products or services as unmarketable or obsolete.  These changes come in the form of technological innovation, changes in customer requirements, declining prices and evolving industry requirements.  Historically, our product and service obsolescence has not had a material impact on our profitability.  New products and services, as well as new technology, may render existing technology products and services obsolete, or too costly and unmarketable.  If we do not commit the resources necessary to develop and sell products incorporating new technologies as demanded by our markets, our products and services may be rendered obsolete, impacting our revenues and profitability.  Even with the development of new technologically advanced products and services, we cannot assure you that they will gain market acceptance.  Lack of market acceptance for any of these products and services could reduce our revenues and negatively affect our profitability.
 
Our business and products are subject to stringent laws and regulations and if we are unable to comply, our business may be significantly harmed.

 Our products and services are subject to the regulations of a number of governmental agencies as listed in Item I, “Business” under the heading “10. Government Regulation”.  We cannot predict whether future changes in governmental regulations might significantly increase compliance costs or adversely affect the time or cost required to develop and introduce new products.  In addition, our products are or may become subject to foreign regulations.  If we do not comply with existing or additional laws or regulations, or if we incur penalties, it could increase our expenses, prevent us from increasing net revenues, or hinder our ability to conduct our business.

 Our operations might be affected by the occurrence of a natural disaster or other catastrophic event.

We depend on our customers and our laboratory in St. Paul, Minnesota and the production facilities in Burlington, North Carolina for the continued operation of our business.  Although we have contingency plans in effect for natural disasters or other catastrophic events, these events could still disrupt our operations or those of our customers, which could also affect us.  Even though we carry business interruption insurance policies and typically have provisions in our contracts that protect us in certain events, we might suffer losses as a result of business interruptions that exceed the coverage available under our insurance policies or for which we do not have coverage.  Any natural disaster or catastrophic event affecting us or our customers could have a significant negative impact on our operations and financial performance.

We may be exposed to liability claims.

We are exposed to the risk of liability claims from our testing services and other aspects of our business.  We currently maintain insurance with coverage up to $10 million for all of our entities to cover professional and general liability claims.  In the past, all professional and general liability claims have been covered under our insurance policy.  However, in the future, we may be faced with litigation claims which exceed our insurance coverage or are not covered under our insurance policy, which could have a significant impact on our results of operations and financial condition.
 

 
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We may have product liability exposure not covered by insurance.

We face financial exposure to product liability claims if the use of our products results in an improper diagnosis, bodily injury or property damage. Potential product liability claims may exceed the amount of our insurance coverage or may be excluded from coverage under the terms of our insurance policy.  We currently maintain insurance with coverage up to $2 million to cover such product liability claims.  To the extent any such claim is uncovered or our insurance coverage is inadequate, we could be required to pay any and all costs associated with such claim, the cost of defense whatever the outcome of the action, and possible settlement or damages if a court rendered a judgment in favor of any plaintiff asserting such claim against us.  Damages assessed in connection with, and the costs of defending, any legal action could be substantial.  Damages may include punitive damages, which may substantially exceed actual damages.  The obligation to pay such damages could exceed our ability to pay such damages, which could have a significant impact on our results of operations and financial condition.

We rely on intellectual property, which we may not be able to protect fully or effectively.

We rely on a combination of patents, copyrights, trademarks, trade secret rights, employee confidentiality agreements and non-disclosure agreements in order to develop and protect our proprietary technology and information.  Notwithstanding our efforts to protect our proprietary rights, existing trade secret, copyright, and trademark laws afford only limited protection.  Despite our efforts to protect our proprietary rights and other intellectual property, unauthorized parties may attempt to copy aspects of our products, obtain and use information that we regard as proprietary or misappropriate our copyrights, trademarks, tradenames and similar proprietary rights.  Our means of protecting our proprietary rights may not be adequate.  In addition, our competitors might independently develop similar technology or duplicate our products or circumvent any patents or our other intellectual property rights.

The technologies used in all of our diagnostic POCT products are covered by one or more patents.  As these patents expire over the next several years, we will no longer have protection from competitors, unless we develop new technology, which could impact our ability to compete in the biotechnology industry and reduce our revenues.

If our tests and business processes infringe on the intellectual property rights of others, we could be forced to engage in costly litigation, pay substantial damages or be prohibited from selling certain tests or products.

Other companies or individuals, including our competitors, may obtain patents or other property rights that would prevent, limit or interfere with our ability to develop, perform or sell our tests or products or operate our business.  As a result, we may be involved in intellectual property litigation and we may be found to infringe on the proprietary rights of others, which could force us to do one or more of the following:

·  
cease developing, performing or selling tests of products that incorporate the challenged intellectual property;
·  
change our business processes; or
·  
pay substantial damages, court costs and attorneys' fees, including potentially increased damages for any infringement held to be willful.

Patents generally are not issued until several years after an application is filed. Our performing a test or other activity prior to the issuance of a patent to a third party is not a defense to an infringement claim.  Thus, even tests or products that we develop could become the subject of infringement claims if a third party obtains a patent covering those tests or products.

Infringement and other intellectual property claims, regardless of their merit, can be expensive and time consuming to litigate.  In addition, any requirement to reengineer our tests or products or change our business processes could substantially increase our costs, force us to interrupt product sales or delay new test releases.  In the past, we have not been subject to a dispute regarding infringement of intellectual property of third parties.  However, infringement claims could arise in the future as patents could be issued on tests or processes that we may be performing.

 
 
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Adverse results in material litigation matters could have a material adverse effect upon our business.
 
We may become subject in the ordinary course of business to material legal action related to, among other things, professional liability and employee-related matters, as well as inquiries from governmental agencies and Medicare or Medicaid carriers regarding billing issues.  Legal actions could result in substantial monetary damages as well as damage to our reputation with customers, which could have a material adverse effect upon our business.
 
If we lose our key personnel or are unable to attract and retain qualified personnel as necessary, our business could be harmed.

We are dependent on the expertise and experience of our senior management team, including Richard Braun, Chairman, President, and Chief Executive Officer; Kevin Wiersma, Vice President, Chief Financial Officer, Chief Administrative Officer and Chief Operating Officer of Forensic Laboratory Operations; James Schoonover, Vice President and Chief Marketing Officer; B. Mitchell Owens, Vice President and Chief Operating Officer of MEDTOX Diagnostics; and Susan Puskas, Vice President, Quality Assurance, Regulatory Affairs and Chief Operating Officer of Clinical Laboratory Operations, for our future success.  Although we have employment contracts with all members of our senior management team listed above, we do not maintain any key man life insurance policies on any management personnel.  The loss of services of any of our key employees could delay the development of our business and have a negative impact on our operating results and financial condition.
 


ITEM 2.                      PROPERTIES.

The administrative offices and laboratory operations for the Laboratory Services segment of our business are located primarily in a 109,000 square foot facility in St. Paul, Minnesota.  Until March 2001, we leased this space.  In March 2001, we purchased the entire three building complex with a total of 129,000 square feet, which includes the 109,000 square feet utilized by our Laboratory Services segment and an additional 4,300 square feet held for future expansion of our Laboratory Services segment.  The purchasing entity was New Brighton Business Center, LLC, a limited liability company, established by us for the sole purpose of purchasing the entire three building complex.  The facility includes other commercial tenants that have individual leases that range from ten years to less than one year in duration.  In 2010, the annual rent paid by such third-party tenants, excluding their pro-rata share of operating expenses, was approximately $128,000.

In addition, effective September 2000, the Laboratory Services segment entered into a seven year lease for a 30,000 square foot facility to be used in connection with its courier business and also as additional warehouse and shipping space.  As amended, this lease extends the term of the lease to August 31, 2012.  This building is a special purpose facility and enables us to store our vehicles indoors, when appropriate, and to perform routine maintenance on the vehicles. The annual base rent on this second facility, exclusive of operating expenses, is currently $152,000 per year.

The operations for the Product Sales segment of our business are located in Burlington, North Carolina where we maintain the offices, research and development laboratories, production operations and warehouse for MEDTOX Diagnostics, Inc.  We lease an entire building (approximately 39,500 square feet), as well as an additional 30,000 square feet of space located in an adjacent building, which we use for warehousing and distribution.  The lease for these buildings, as amended and restated, includes a term that expires on March 31, 2016.  In January 2008, we prepaid approximately $430,000 of the lease agreement for the facilities in Burlington, North Carolina relating to the leasehold improvements after determining that the prepayment would be financially beneficial to us.  The prepayment was recorded as prepaid rent and will continue to be amortized over the remaining life of the lease as additional rent.  In 2010, the annual base rent was approximately $401,000, exclusive of operating expenses, and including a Consumer Price Index adjustment and amortization of $600,000 of improvements made to the building by us.

 
- 20 -

 
The Burlington facilities have always been owned and leased to us by Dr. Samuel C. Powell, a member of our Board of Directors.  We believe we are renting these facilities in Burlington on terms similar to those available from third parties for equivalent premises based upon our review of prevailing market rates at the time of lease renewal.

We believe that our existing facilities are adequate for the purposes being used to accommodate our product development, manufacturing and laboratory testing requirements.


ITEM 3.                      LEGAL PROCEEDINGS.

Not applicable.


ITEM 4.                      [Removed and Reserved.]




 
- 21 -

 

PART II

ITEM 5.
MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Common Stock

Our common stock is listed on the Nasdaq Global Select Market under the symbol “MTOX”.  At February 22, 2011, the number of holders of record of our common stock was 853.  The following tables set forth, for the calendar quarters indicated, the high, low, and closing prices per share for our common stock, as reported by the Nasdaq Global Select Market.  The quotations shown represent inter dealer prices without adjustment for retail markups, markdowns or commissions, and do not necessarily reflect actual transactions.

2010:
 
High
 
Low
 
Close*
First Quarter.............................
$
10.25
$
7.01
$
10.25
Second Quarter........................
 
13.28
 
9.53
 
12.30
Third Quarter...........................
 
12.75
 
10.80
 
11.63
Fourth Quarter......................…
 
13.37
 
10.90
 
13.10

2009:
 
High
 
Low
 
Close*
First Quarter.............................
$
8.20
$
5.95
$
6.66
Second Quarter........................
 
10.30
 
5.98
 
9.43
Third Quarter...........................
 
10.19
 
8.25
 
9.10
Fourth Quarter......................…
 
10.25
 
7.30
 
7.75

*Closing price as of the last day of the calendar quarter

Dividends

On November 12, 2010, the Board of Directors declared a special one-time cash dividend of $1.25 per share, which was paid on December 1, 2010 to stockholders of record on November 22, 2010.  This was the first cash dividend declared or paid by the Board of Directors since our inception.  Our financial covenants under our credit agreement may effectively preclude us from paying cash dividends without approval.

Issuer Purchases of Equity Securities

The following table provides information with respect to purchases made by us of shares of our common stock during the fourth quarter of 2010.

Period
 
Total Number of Shares Purchased
 
Average Price Paid per Share
 
Total Number of Shares Purchased as part of Publicly Announced Plans or Programs (b)
 
Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs (b)
                 
October 1 - 31
 
16,697
 
$  11.74
 
16,697
 
-
November 1 - 30
 
26,759
 
12.19
 
26,759
 
-
December 1 - 31
 
40,065 (a)
 
   12.12
 
-
 
-
    Total
 
83,521
 
$  12.07
 
-
 
-
 
 
- 22 -

 
(a)  Represents the number of shares of common stock repurchased to contribute to our Long-Term Incentive Plan and Supplemental Executive Retirement Plan trust in payment of the special cash dividend payable on our common stock held in trust.

(b)      Represents shares of common stock surrendered by employees to satisfy the exercise price on stock option exercises of options granted under the MEDTOX Restated Equity Compensation Plan (the "Plan"), which was originally effective on October 26, 1993 and amended and restated as of May 10, 2000.  The Plan expired in 2003, and no shares remain available for issuance under the Plan, but exercise of outstanding options granted under the Plan still occurs in accordance with the terms of the individual option grants. Subject to the terms of the individual award agreements, the Plan allowed option holders to surrender shares of common stock they hold to satisfy the exercise price on stock option exercises, but the Plan did not approve any maximum dollar amount of shares that may be surrendered.  The number of shares to be surrendered under the Plan depends upon, and is limited by, the number of options issued and exercised, the exercise prices of those options, the market price of our common stock at any time when options are exercised, and the election of option holders to surrender shares that they hold rather than pay the exercise price through another method permissible under the Plan and their individual award agreements.


Securities Authorized For Issuance Under Equity Compensation Plans
 
For information on our equity compensation plans, refer to Item 12, “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”


 
- 23 -

 

ITEM 6.                      SELECTED FINANCIAL DATA.

The selected financial data for the five years ended December 31, 2010 have been derived from our audited consolidated financial statements. The selected financial data presented below are qualified in their entirety by, and should be read in conjunction with, the financial statements and notes thereto and other financial and statistical information referenced elsewhere herein including the information referenced under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

(In thousands, except share and per share data)
 
2010
   
2009
   
2008
   
2007
   
2006
                             
STATEMENT OF INCOME DATA:
                           
                             
Revenues
$
97,101
 
$
84,108
 
$
85,813
 
$
80,285
 
$
69,804
Cost of revenues
 
57,461
   
53,213
   
49,487
   
43,929
   
38,799
Selling, general, and administrative
 
32,691
   
26,663
   
24,327
   
23,737
   
20,648
Research and development
 
2,261
   
2,264
   
2,352
   
2,603
   
2,156
Other income (expense)
 
157
   
79
   
(991)
   
(707)
   
(1,006)
Income tax expense
 
1,828
   
748
   
3,084
   
2,619
   
2,647
Net income
$
3,017
 
$
1,299
 
$
5,572
 
$
6,690
 
$
4,548
                             
Basic earnings per common share
$
0.35
 
$
0.15
 
$
0.66
 
$
0.80
 
$
0.56
                             
Diluted earnings per common share
$
0.34
 
$
0.15
 
$
0.62
 
$
0.75
 
$
0.52
                             
Weighted average number of shares outstanding:
                           
Basic
 
8,715,391
   
8,536,768
   
8,455,092
   
8,322,092
   
8,148,726
Diluted
 
8,867,530
   
8,788,663
   
8,938,213
   
8,907,320
   
8,802,470
                             
BALANCE SHEET DATA:
                           
Total assets
$
75,457
 
$
76,117
 
$
73,526
 
$
69,949
 
$
59,874
Total debt
 
2,725
   
302
   
979
   
1,656
   
2,732
Total stockholders’ equity
 
54,119
   
61,432
   
60,465
   
55,656
   
47,944
                             
SEGMENT DATA:
                           
Net revenues:
                           
Laboratory Services
$
77,047
 
$
65,851
 
$
66,127
 
$
61,310
 
$
54,045
Product Sales
 
20,054
   
18,257
   
19,686
   
18,975
   
15,759
Total net revenues
$
97,101
 
$
84,108
 
$
85,813
 
$
80,285
 
$
69,804
Operating income (loss):
                           
Laboratory Services
$
1,187
 
$
(1,037)
 
$
5,364
 
$
6,387
 
$
6,139
Product Sales
 
3,501
   
3,005
   
4,283
   
3,629
   
2,062
Total operating income
$
4,688
 
$
1,968
 
$
9,647
 
$
10,016
 
$
8,201
Assets:
                           
Laboratory Services
$
64,193
 
$
60,630
 
$
59,812
 
$
56,430
 
$
47,259
Product Sales
 
7,499
   
11,884
   
10,102
   
8,701
   
6,737
Corporate (unallocated)
 
3,765
   
3,603
   
3,612
   
4,818
   
5,878
Total assets
$
75,457
 
$
76,117
 
$
73,526
 
$
69,949
 
$
59,874
                             
OTHER DATA:
                           
Cash dividends declared per common share
$
1.25
   
-
   
-
   
-
   
-
                             

 
 
- 24 -

 

ITEM 7.
MANAGEMENT'S DISCUSSION AND ANALYSIS
 
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

This Annual Report on Form 10-K contains certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are intended to be covered by the safe harbors created by such acts.  For this purpose, any statements that are not statements of historical fact may be deemed to be forward looking statements, including the statements under this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” regarding our strategy, future operations, future expectations and future estimates, future financial position or results and future plans and objectives of management.  Those statements in this Annual Report on Form 10-K containing the words “believes”, “anticipates”, “plans”, “expects” and similar expressions constitute forward looking statements, although not all forward looking statements contain such identifying words.

The forward looking statements contained in this Annual Report on Form 10-K are based on our current expectations, assumptions, estimates and projections about our Company and its businesses.  All such forward looking statements involve significant risks and uncertainties, including those risks identified in Item 1A of this Annual Report on Form 10-K and in the Cautionary Statement appearing at the beginning of Part I of this Annual Report on Form 10-K, many of which are beyond our control.  Although we believe that the assumptions underlying our forward looking statements are reasonable, any of the assumptions could prove inaccurate.  Actual results may differ materially from those indicated by the forward looking statements included in this Annual Report on Form 10-K.  In light of the significant uncertainties inherent in the forward looking statements included in this Annual Report on Form 10-K, you should not consider the inclusion of such information as a representation by us or anyone else that we will achieve such results.  Moreover, we assume no obligation to update these forward looking statements to reflect actual results or changes in assumptions, expectations or projections, except as otherwise required by law.  In addition, our financial and performance outlook concerning future revenues, margins, earnings, earnings per share and other operating or performance results does not include the impact of any future acquisitions, future acquisition-related expenses or accruals, or any future restructuring or other charges that may occur from time-to-time due to management decisions and changing business circumstances and conditions.

Executive Overview

Our Business

We are engaged primarily in distinct, but very much related businesses, which for financial reporting purposes are divided into two reportable segments: Laboratory Services and Product Sales. For financial information relating to our segments, see Note 2 of Notes to the Consolidated Financial Statements.

Laboratory Services

Our “Laboratory Services” business segment includes the activities of our wholly-owned subsidiary, MEDTOX Laboratories, Inc.  MEDTOX Laboratories, Inc. engages in drugs-of-abuse testing services, providing these services to private and public companies, drug treatment counseling centers, criminal justice facilities, occupational health clinics and hospitals, as well as third party administrators.

MEDTOX Laboratories, Inc. also provides clinical and other laboratory services which consist of clinical toxicology, clinical testing for occupational health clinics, and heavy metal, trace element and solvent analyses.  We provide these services to hospitals, clinics, HMOs and other laboratories.  Testing is conducted using methodologies that include various immunoassays, gas liquid chromatography, gas chromatography/mass spectrometry, and high performance liquid chromatography with tandem mass spectrometry.  We recently expanded our clinical & other laboratory services to include laboratory tests used by physicians and other healthcare providers for the purpose of diagnosing or treating disease or illness or the assessment of health in humans.  Testing is performed on blood, body fluids or tissues.  Our comprehensive clinical laboratory services include clinical chemistry, hematology, coagulation, urinalysis, immunology/serology (viruses, infectious diseases, immune system), immunohematology (blood typing, antibody screens), microbiology (bacteria, parasites), anatomical pathology/cytology (tissue biopsies, cancer), molecular diagnostics (infectious diseases, genetic disorders) and sub-specialties of these categories.  We also provide services in the areas of logistics management, data management and program management.  These services support our underlying business of laboratory analysis and provide added value to our clients.

 
- 25 -

 
MEDTOX Laboratories, Inc. also provides clinical trial services which includes central laboratory services, assay (test) development, bio-analytical, bio-equivalence and pharmacokinetic testing.  Central laboratory services include tests that are used to monitor the safety and efficacy of a drug.  These tests or “safety labs” include tests that are performed in our general clinical laboratory and pathology laboratory such as clinical chemistries (liver function, kidney function, cardiac and bone), hematology (blood count), immunology (immune status), and flow cytometry (cell identification).  Assay development, bio-analytical and bio-equivalence studies are performed in our bio-analytical laboratory.  These tests are conducted using methodologies such as immunoassay, gas chromatography, high performance liquid chromatography, gas chromatography/mass spectrometry and tandem mass spectrometry.  Clients for our clinical testing services include clinical trial sponsors (pharmaceutical and biotech companies), clinical research organizations (CROs), research organizations, and investigators with trial management, patient recruitment/enrollment and site management.

The New Brighton Business Center, LLC (NBBC) is a wholly-owned limited liability company formed for the sole purpose of acquiring the facilities in St. Paul, Minnesota, where our Laboratory Services administrative offices and laboratory operations are located.
 
 
Product Sales

Our “Product Sales” business segment consists of our wholly-owned subsidiary, MEDTOX Diagnostics, Inc.  MEDTOX Diagnostics, Inc. is engaged in the development, manufacturing, and distribution of a variety of POCT diagnostic drug screening devices, such as our PROFILE®-II, PROFILE®-II A, PROFILE®-III, PROFILE®-III A, PROFILE-II ER®, PROFILE®-III ER, PROFILE®-IV, PROFILE®-V, MEDTOXScan® reader, VERDICT®-II, and SURE-SCREEN® products, in addition to other diagnostic tests for the detection of alcohol.  MEDTOX Diagnostics, Inc. also provides contract manufacturing services, such as coagulation market controls.  The operations of the Product Sales segment are located in Burlington, North Carolina, where we maintain the offices, research and development laboratories, production operations, and warehouse/distribution facilities.

Key Trends Influencing Our Operating Results

Our management believes that there are several notable trends that are currently influencing, and are expected in the foreseeable future to continue to influence, our operating results.  These include:

Economic Uncertainties Causing Variability in Testing Volumes in the Laboratory Services and Product Sales, Drugs-of-Abuse Business

In 2010, testing volume from our existing workplace drugs-of-abuse clients was lower than in the prior year, which we primarily attributed to lower new job creation and reduced employment levels and corresponding drops in hiring caused by economic uncertainties.  We feel economic uncertainties may continue to cause variability in our workplace drugs-of-abuse testing volume in the foreseeable future.


 
- 26 -

 

Increased POCT Diagnostic Device Test Competition

We have experienced increased competition with respect to our POCT diagnostic tests from systems and products developed by others, many of whom compete solely on price.  Due to the recent downturn in the economy, we have experienced increased price competition for certain diagnostic testing devices, particularly in the probation, parole and rehabilitation market.

Our Strategy

Our strategy is to drive profitable growth by building market share, leveraging our existing infrastructure and technical expertise, and driving innovation.  We maintain a disciplined culture, focused on the successful execution of our strategy and plans.

Building Market Share

We have solid niche positions in large markets, relative to our size, that allow us to build market share by offering high quality products and services that are delivered rapidly, priced competitively, and supported by excellent customer service and value-added services.  Our value added services include data management, collection site management, training, technical support and expertise, as well as review of drug testing policies for clients.

Our success in penetrating new accounts has represented a significant component of our growth in market share.  Over the past few years, we have expanded our number of sales representatives which has increased our business from new accounts and helps offset risks from uncertain economic conditions that may cause lower activity from existing workplace drugs-of-abuse clients.

Leveraging Existing Infrastructure and Technical Expertise

We leverage our existing infrastructure and technical expertise to facilitate top line growth and improve operating margins.

In 2008, we expanded our clinical laboratory capabilities to include clinical and anatomic pathology, microbiology, molecular diagnostics, and other specialized testing capabilities.  This expansion leverages existing capabilities and opens up new revenue opportunities by offering full-service testing capabilities to the physician office market.

Our LEAN and Six-Sigma initiatives support our effort to leverage existing infrastructure by improving quality and productivity, cutting costs, and increasing throughput.  LEAN is a highly disciplined process that helps us focus on reducing waste and eliminating unnecessary steps in our business processes.  Our Six-Sigma initiatives address quality and variability within processes. While all key departments in the Laboratory Services and Product Sales segments have now been through initial LEAN processes, as an organization we recognize that LEAN is an ongoing philosophy, not a project to be “finished.”

Driving Innovation

We have introduced a number of innovative products and services.

For example, in 2009, we introduced the next generation PROFILE®-V MEDTOXScan® Drugs-of-Abuse Test System with added functionality for hospital laboratories and emergency rooms.

In addition, in 2008, we introduced ToxAssure®, a comprehensive program for effective pain management testing.

 
- 27 -

 

Critical Accounting Policies

We have identified the policies outlined below as critical to understanding our business and results of operations.  The listing is not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of a particular transaction is specifically dictated by accounting principles generally accepted in the United States of America, with no need for management's judgment in their application. The impact and any associated risks related to these policies on the Company’s business operations is discussed throughout Management's Discussion and Analysis of Financial Condition and Results of Operations where such policies affect reported and expected financial results.  For a detailed discussion on the application of these and other accounting policies, see Note 1 of Notes to the Consolidated Financial Statements in Item 15.  Note that the preparation of this Annual Report on Form 10-K requires management to make estimates and assumptions that affect the reported amount of assets and liabilities, disclosure of contingent assets and liabilities at the date of our consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. There can be no assurance that actual results will not differ from those estimates.

Our critical accounting policies are as follows:

Revenue Recognition, accounts receivable and allowance for doubtful accounts:

Our sales are generally billed to three types of payers – clients, patients and third parties, such as Medicare and Medicaid.  We are seeing an increase in the percentage of revenues that are billed to third-party payers and patients as a result of growth in our clinical laboratory.

Client sales are recorded at our list price, less any negotiated discount.  Receivables due from clients represented approximately 74% of our consolidated net accounts receivable balance at December 31, 2010.

Patients are billed at established patient fee schedules, net of any discounts negotiated with healthcare insurers or physicians on behalf of their patients. Patient billing is increasing as a result of the growth in patient copayments, coinsurance and deductibles and an increase in high deductible health plans.  Collection of receivables due from patients is subject to credit risk and ability of the patients to pay.  Receivables due from patients represented approximately 7% of our consolidated net accounts receivable balance at December 31, 2010.

We bill third-party payers at our list price and third-party revenue is recorded net of contractual discounts. These discounts are recorded at the transaction level at the time of sale based on a fee schedule that is maintained for each third-party payer.  Our third-party sales are recorded for each payer using a contracted fee schedule or an estimated fee schedule.  Adjustments to the estimated payment amounts are recorded at the time of final collection and settlement of each transaction as an adjustment to net revenues. These adjustments are not material to our results of operations in any period presented.  We periodically adjust these estimated fee schedules based upon historical payment trends.  Receivables due from third-parties represented approximately 19% of our consolidated net accounts receivable balance at December 31, 2010.

We have a standardized approach to estimate and review the collectability of our receivables based on the period of time they have been outstanding.  Our process for determining the appropriate level of the allowance for doubtful accounts involves judgment, and considers such factors as the age of the underlying receivables, specific account reviews, historical collection experience, and other external factors that could affect the collectability of our receivables.  Revisions to the allowances for doubtful accounts are recorded as an adjustment to bad debt expense within selling, general and administrative. Accounts are written off against the allowance for doubtful accounts when they are deemed to be uncollectible.  Our consolidated trade accounts receivable balance at December 31, 2010 was $18.6 million, net of allowance for doubtful accounts of $1.6 million.

 
- 28 -

 

Goodwill:
Goodwill is reviewed for impairment at least annually and between annual test dates if events or changes in circumstances indicate potential impairment.  We perform our annual impairment test for goodwill in the fourth quarter of each year.  The entire amount of goodwill is included within the Laboratory Services segment.

The impairment test is performed using a two-step process.  In the first step, the fair value of the reporting unit is compared with the carrying amount of the reporting unit, including goodwill.  If the estimated fair value is less than the carrying amount of the reporting unit, an indication that goodwill impairment exists and a second step must be completed in order to determine the amount of the goodwill impairment, if any that should be recorded.  In the second step, an impairment loss is recognized for any excess of the carrying amount of the reporting unit’s goodwill over the implied fair value of that goodwill.  The implied fair value of goodwill is determined by allocating the fair value of the reporting unit in a manner similar to a purchase price allocation.

The fair value of the reporting unit is determined using a discounted cash flow analysis.  Projected discounted future cash flows requires us to make significant estimates regarding future revenues and expenses, projected capital expenditures, changes in working capital and the appropriate discount rate.  In developing this discounted cash flow analysis, assumptions about future revenues and expenses, capital expenditures and changes in working capital are based on our annual forecast for the reporting unit, historical experience, and anticipated future economic conditions.  Discount rate assumptions for the reporting unit take into consideration our assessment of risks inherent in the future cash flows of the reporting unit and our weighted-average cost of capital.  To assess the reasonableness of the fair value of the reporting unit, we use a market approach which consists of comparisons to comparable publicly-traded companies in our industry.

At December 31, 2010, our goodwill was $16.0 million.  If we experience significant negative economic trends or disruptions to our business, we may be subject to future impairments.  Additionally, changes in assumptions regarding the future performance of our business, an increase in the discount rate used to determine the discounted cash flows, or significant declines in our stock price or the market as a whole could result in additional impairment indicators.  Any future impairment of goodwill could have a material adverse effect on our financial results.

Accounting for Income Taxes:
As part of the process of preparing the consolidated financial statements, we are required to estimate income taxes in each of the jurisdictions in which we operate. This process involves estimating actual current tax exposure together with assessing temporary differences resulting from differing treatment of items for tax and accounting purposes.  These differences result in deferred tax assets and liabilities.  We must then assess the likelihood that deferred tax assets will be recovered from future taxable income and tax planning strategies, and to the extent management believes that recovery is not likely, we must establish a valuation allowance.  To the extent we increase or decrease the valuation allowance in a period, we must include an expense or benefit within the tax provision in the consolidated statement of operations.

Significant management judgment is required in determining the provision for income taxes, deferred tax assets and liabilities, and any valuation allowance recorded against net deferred tax assets.  Our deferred tax assets primarily consist of certain net operating losses (NOLs) carried forward.  In the future, revisions to the estimated net realizable value of these deferred tax assets could cause the provision for income taxes to vary significantly from period-to-period, although our cash payments would remain unaffected until the benefit of the NOLs is completely utilized or expires unused.  At December 31, 2010, we did not have a valuation allowance on deferred tax assets.

We account for uncertain tax positions in accordance with generally accepted accounting principles.  The application of income tax law is inherently complex.  Laws and regulations in this area are voluminous and are often ambiguous.  As such, we are required to make many subjective assumptions and judgments regarding our income tax exposures.  Interpretations of and guidance surrounding income tax laws and regulations change over time.  As such, changes in our subjective assumptions and judgments can materially affect amounts recognized in the consolidated balance sheets and statements of income.  At December 31, 2010, we did not have any unrecognized tax benefits.

 
- 29 -

 
Results of Operations

In evaluating our financial performance, our management has primarily focused on three objectives: maximizing operating income, increasing our cash flows and strengthening our balance sheet.  The first of these objectives is discussed in this section.  The other two are addressed under “Liquidity and Capital Resources.”

To maximize our operating income, we have sought revenue growth, improved gross margin and reduced selling, general and administrative (SG&A) expense as a percentage of revenues. As discussed below, during 2010 we were able to achieve revenue growth and improved gross margin, but we experienced an increase in SG&A expenses as a percentage of revenues compared to the prior year period.

Revenues

 
Year Ended December 31
 
2010 vs 2009
2009 vs 2008
(In thousands)
2010
2009
2008
 
$
Change
%
Change
$
Change
%
Change
                 
Revenues:
               
                 
Laboratory Services
               
 Drugs-of-abuse testing services
$  39,624
$  36,040
 $ 40,021
 
$  3,584
  10%
$  (3,981)
 (10)%
 Clinical & other laboratory services
    29,923
     22,885
    19,306
 
     7,038
  31%
     3,579
    19%
 Clinical trial services
7,500
       6,926
      6,800
 
        574
   8%
        126
      2%
                 
Product Sales
20,054
18,257
19,686
 
1,797
10%
(1,429)
   (7)%
 
$  97,101
$   84,108
$  85,813
 
$   12,993
 15%
$   (1,705)
 (2)%

Our Laboratory Services segment includes revenues from drugs-of-abuse testing services, clinical & other laboratory services and clinical trial services.  Our revenues from drugs-of-abuse testing increased 10% to $39.6 million in 2010 and decreased 10% to $36.0 million in 2009.  The increase in 2010 was primarily due to revenue growth from new clients, partially offset by a decline in revenue from existing drugs-of-abuse clients.  The decrease in 2009 was primarily a result of a decline in revenues from our existing drug-of-abuse clients due to challenging economic conditions affecting hiring decisions, partially mitigated by an increase in revenues from new drugs-of-abuse clients.  Pricing for our workplace drugs-of-abuse testing services tends to be fairly stable overall; however, the average price per testing specimen can vary slightly from quarter-to-quarter.  Test price can vary by client based on the percentage of samples that test positive for drugs-of-abuse and the average number of samples per shipment.

Revenues from our clinical and other laboratory services increased 31% to $29.9 million and 19% to $22.9 million in 2010 and 2009, respectively.  The improvement in 2010 and 2009 was primarily due to growth generated by our expanded clinical laboratory capabilities and diversification initiatives undertaken in 2008.

 
- 30 -

 
Revenues from clinical trial services increased 8% to $7.5 million and 2% to $6.9 million in 2010 and 2009, respectively.  The increase in 2010 reflects the return to a more normalized level of activity after being negatively impact by our biopharmaceutical clients deferring projects and slowing down in research and development efforts in the fourth quarter of 2009 and first quarter of 2010.   In 2009, clinical trial services revenues were impacted, especially during the fourth quarter, by a slow-down of projects and a deferral of work into 2010.  Revenues from clinical trial services can fluctuate from quarter-to-quarter based on the project nature, size, and the actual timing of clinical trials as shown in the table below:

Revenues from clinical trial services:

 
First
Second
Third
Fourth
(In thousands)
Quarter
Quarter
Quarter
Quarter
         
Revenues:
       
         
2010
$         833
$       2,037
$     2,358
 $     2,272
         
2009
        2,315
         1,592
       2,000
        1,019

Our Product Sales segment includes revenues from point-of-collection on site testing products (POCT), contract manufacturing services and other diagnostic products.

Sales of POCT products, which consist of the PROFILE®-II, PROFILE®-II A, PROFILE-II ER®, PROFILE®-III ER, PROFILE®-III, PROFILE®-III A, PROFILE®-IV, PROFILE®-V, VERDICT®-II and SURE-SCREEN® on-site test kits and other ancillary products for the detection of abused substances, increased 8% to $17.8 million in 2010 and decreased 8% to $16.4 million in 2009.  The increase in 2010 was primarily due to strong sales in the workplace drugs-of-abuse market with our Profile®-II A and Profile®-III A products, and increased sales of Profile®-V sold into the hospital market with our MEDTOXScan® Reader.  The decrease in 2009 was due primarily to a decline in revenues from device sales in the workplace market attributable to tough economic conditions affecting hiring decisions.  Overall, pricing for our POCT devices in 2010 was slightly lower than the prior year.

Sales of contract manufacturing services increased 13% to $1.6 million in 2010 and decreased 5% to $1.4 million in 2009.  The increase in 2010 was due to additional revenue from one of our clients whose contract expired on June 30, 2010.  After an analysis of this product category in 2007, we concluded that it had diminishing opportunities for us, and we are phasing out contract manufacturing services.  Based on the expected increased sales of higher-margin POCT products, we do not anticipate a significant impact on our results of operations from exiting this business.

Sales of other diagnostic products increased 59% to $0.7 million due to the sale of the new NexScreen 12 panel diagnostic product.  Sales of other diagnostic products were flat at $0.4 million in 2009 compared to 2008.


 
- 31 -

 

Cost of Revenues and Gross Margin

 
Year Ended December 31
 
2010 vs 2009
2009 vs 2008
(In thousands)
2010
% of
Revenues
2009
% of
Revenues
2008
% of
Revenues
 
$
Change
%
Change
$
Change
%
Change
                       
Cost of Revenues:
                     
                       
Cost of  Services
$  49,036
63.6%*
$  45,432
69.0%*
$ 41,665
63.0%*
 
$ 3,604
8%
$  3,767
  9%
                       
Cost of Sales
8,425
    42.0%**
7,781
    42.6%**
7,822
    39.7%**
 
644
8%
(41)
(1)%
                       
 
$  57,461
59.2%
$  53,213
63.3%
$ 49,487
57.7%
 
$ 4,248
8%
$  3,726
8%

*       Cost of services as a percentage of Laboratory Services revenues
**     Cost of sales as a percentage of Product Sales revenues

Consolidated gross margin was 40.8% of revenues in 2010, compared to 36.7% of revenues in 2009 and 42.3% of revenues in 2008.

Laboratory Services gross margin was 36.4% in 2010, compared to 31.0% in 2009 and 37.0% in 2008. The increase in 2010 was primarily due to a change in test mix and an increase in volume.  The decrease in 2009 was due to the drop in drugs-of-abuse testing revenues over a highly fixed cost structure and higher costs associated with our clinical laboratory expansion.

Gross margin from Product Sales was 58.0% in 2010, compared to 57.4% in 2009 and 60.3% in 2008. The increase in 2010 primarily reflects a shift in sales mix of POCT devices, with an increase in higher margin Profile® devices sold into the workplace and hospital markets and a decrease in sales of lower margin SURE-SCREEN® devices into the government market.   The decrease in 2009 reflects a shift in sales mix of POCT devices, with a decrease in sales of higher margin PROFILE® devices in the workplace market and an increase in sales of lower margin SURE-SCREEN® devices in the government market.

Operating Expenses
 
 
Year Ended December 31
 
2010 vs 2009
2009 vs 2008
(In thousands)
2010
% of
Revenues
2009
% of
Revenues
2008
% of
Revenues
 
$
Change
%
Change
$
Change
%
Change
                       
Operating Expenses:
                     
                       
Selling, general and administrative
$  32,691
33.7%
$  26,663
31.7%
$  24,327
28.3%
 
$ 6,028
23%
$ 2,336
10%
                       
Research and development
2,261
  2.3%
2,264
  2.7%
2,352
  2.7%
 
(3)
  (1)%
(88)
  (4)%
 
$  34,592
36.0%
$  28,927
34.4%
$  26,679
31.1%
 
$ 6,025
  21%
$ 2,248
  8%
 
 
 
- 32 -

 
Selling, General and Administrative Expenses.  Selling, general and administrative expenses increased to $32.7 million, or 33.7% of revenues in 2010, compared to $26.7 million, or 31.7% of revenues in 2009 and $24.3 million, or 28.3% of revenues in 2008.  The increase in 2010 was primarily due to increased costs associated with the growth in clinical revenue and increased incentive-based compensation.  Increased expenses associated with the growth in our clinical & other laboratory services business include the expansion of our sales force in the second half of last year, higher sales related expenses including sales commissions and travel-related expenses, and an increase in bad debt and billing expenses related to increased third party and patient billing.  The increase in 2009 was due to an increase in sales and marketing expense and the reclassification of $525,000 from Other Income (Expense) which was determined to be more appropriately classified in SG&A expenses.  The increase was also due to an increase in retirement plan obligation which corresponds to an increase in the related marketable equity securities held in trust to fund this obligation.  The increase in retirement plan expense associated with the obligation was offset by a corresponding investment gain being recorded in Other Income (Expense).

Research and Development Expenses.  Research and development expenses were $2.3 million, $2.3 million and $2.4 million in 2010, 2009 and 2008, respectively.  The slight decrease in 2009 compared to 2008 was primarily due to decreased spending for on-going product development projects in our Product Sales segment.

Other Income (Expense)

Other income and expense consists primarily our investment gains/losses, the net expenses associated with our building rental activities and interest expense.  Other income was $157,000 in 2010 compared to $79,000 in 2009.  Other expense was $1.0 million in 2008.  The increase in 2010 was primarily due to the reclassification of $195,000 in the first quarter of 2010 from Other Income (Expense) which was determined to be more appropriately classified in SG&A expenses, partially offset by a decreased investment gain on our marketable equity securities held in trust for our deferred compensation plans.   Our investment gain is offset by a corresponding loss being recorded in SG&A expenses to reflect the change in the retirement plan obligation.  The income in 2009 compared to expense in 2008 was due to the reclassification of $525,000 from Other Income (Expense) which was determined to be more appropriately classified in SG&A expenses, as well as an investment gain on our marketable equity securities held in trust.

Income Taxes

In 2010, we recorded $1.8 million in income tax expense, or an effective rate of 37.7%, compared to an effective rate of 36.5% in 2009 and 35.6% in 2008.

Liquidity and Capital Resources

Our working capital requirements have been funded primarily by various combinations of profitable operations and cash received from our revolving credit facility.  Cash and cash equivalents were $1.3 million and $4.2 million at December 31, 2010 and 2009, respectively.

We are focusing on increasing our cash flow, while continuing to fund our capital investment, sales and marketing, and research and development initiatives. Our intent is to maintain a solid liquidity position.

Net cash provided by operating activities was $10.1 million in 2010 compared to $5.8 million and $12.3 million in 2009 and 2008, respectively.  The increase in 2010 was attributable to an increase in net earnings, excluding non-cash charges such as depreciation, amortization, deferred compensation and provision for losses on accounts receivable.  Our increased revenues in 2010 have continued to drive increases in working capital. The decrease in 2009 was primarily due to a decrease in net earnings.

Net cash used in investing activities, consisting of capital expenditures, was $5.1 million in 2010 compared to $4.9 million and $8.5 million in 2009 and 2008, respectively.  These expenditures included equipment purchased and costs incurred to upgrade equipment, improve efficiencies and increase service levels to our clients.   In 2008, we also invested in the expansion of our regional clinical laboratory capabilities.

 
- 33 -

 

We expect equipment and capital improvement expenditures to be between $6.5 million and $7.0 million in 2011, with increased investment in instrumentation and facility improvements.  Such expenditures are expected to be funded through cash provided by operating activities.

Net cash used in financing activities was $7.8 million in 2010, compared to $0.8 million and $1.9 million in 2009 and 2008, respectively.  The increase in 2010 was due to the payment of a special one-time cash dividend of $10.6 million, partially offset by advances of $2.7 million from our revolving line of credit.  The decrease in 2009 was primarily due to a decrease in the repurchase of shares of our common stock.

In 2010, we paid a special one-time cash dividend of $1.25 per share.  Cash for the dividend was funded from cash on hand and borrowings from our revolving credit facility.  We declared the dividend based upon our improving performance, cash balance and anticipated ability to generate cash flow from operations, and therefore believed it was appropriate to return some capital to stockholders through a one-time cash dividend.

In 2010 and 2009, we repurchased 63,355 and 60,644 shares, respectively, of our common stock in the open market for a cost of $0.8 million and $0.4 million, respectively.  In 2008, we repurchased 63,140 shares of our common stock from officers of our Company for a cost of $1.0 million.  The shares repurchased were placed in trust to fund our Long-Term Incentive Plan and Supplemental Executive Retirement Plan.

We are a party to a credit security agreement (the "Wells Fargo Credit Agreement") with Wells Fargo Bank, National Association (the “Bank”) which expires on August 31, 2011.  The Wells Fargo Credit Agreement, as amended, consists of a revolving line of credit ("Line of Credit") of up to $12.0 million bearing interest at a fluctuating rate of 2.25% above the daily three month LIBOR, as defined and calculated by the Bank.

Subject to certain conditions, the Wells Fargo Credit Agreement also provides for the issuance of letters of credit which, if drawn upon, would be deemed advances under the Line of Credit.  We are required to pay a fee equal to 0.25% per annum on the average daily unused amount of the Line of Credit.  We have granted the Bank a first priority security interest in all of the Company’s accounts receivable, other rights to payment, general intangibles, inventory, and equipment to secure all indebtedness of the Company to the Bank.

Extensions of credit under the Wells Fargo Credit Agreement are subject to certain conditions.  The Wells Fargo Credit Agreement also requires us to comply with certain financial covenants, including maintaining, on a consolidated basis:

·  
Tangible Net Worth not less than $35,000,000 at each month end, with “Tangible Net Worth” defined as the aggregate of total stockholders’ equity plus subordinated debt less any intangible assets.

·  
Current Ratio not less than 1.45 to 1.0 at each month end, with “Current Ratio” defined as total current assets divided by total current liabilities.

·  
Pre-tax profit of not less than $1,500,000 on a rolling four-quarter basis, determined as of each fiscal quarter-end.

We are relying on expected positive cash flow from operations and our Line of Credit to fund our future working capital and asset purchases.  At December 31, 2010, we had total borrowing capacity of $12.0 million on our Line of Credit, of which $2.7 million was borrowed, leaving a net availability of $9.3 million.

In the short term, we believe that the aforementioned resources will be sufficient to fund our planned operations through 2011.  While there can be no assurance that the available capital will be sufficient to fund our future operations beyond 2011, we believe that future profitable operations, as well as access to additional capital through debt or equity financings, will be the primary means for funding our operations for the long term.

 
- 34 -

 

We continue to follow a plan which includes (i) aggressively monitoring and controlling costs, (ii) increasing revenues from sales of our existing products and services, (iii) developing new products and services, as well as (iv) selectively pursuing synergistic acquisitions to increase our critical mass.  However, there can be no assurance that costs can be controlled, revenues can be increased, financing may be obtained, acquisitions successfully consummated, or that we will be profitable.

Disclosures about Contractual Obligations and Commercial Commitments

The following table aggregates all contractual commitments and commercial obligations that affect the Company’s financial condition and liquidity position at December 31, 2010:

 
Payments Due by Period
 
(In thousands)
 
Total
 
Less than 1 year
 
 
1-3 years
 
 
3-5 years
 
More than 5 years
                   
Line of credit (1)
$    2,774
 
$       2,774
           
                   
Operating leases
$    2,935
 
$          721
 
$       1,163
 
$           964
 
$            87
                   
Total contractual obligations
$    5,709
 
  $      3,495
 
$       1,163
 
$           964
 
$            87

(1)  
 Amounts include interest payments based upon contractual or prevailing interest rates.

The table above excludes our obligation for future payments to participants under our Supplemental Executive Retirement Plan of approximately $0.7 million at December 31, 2010 as the specific payment dates and amounts are unknown.

Off-Balance Sheet Transactions

We do not maintain any off-balance sheet transactions, arrangements, obligations or other relationships with unconsolidated entities or others that are reasonably likely to have a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Impact of Inflation and Changing Prices

The impact of inflation and changing prices in our last three fiscal years has been primarily limited to salary, laboratory and operating supplies and rent increases and has historically not been material to our operations.  In the future, we may not be able to increase the prices of laboratory testing by an amount sufficient to cover the cost of inflation, although we are responding to these concerns by offering the highest quality products and services, delivered rapidly, priced competitively and supported by value-added services for customers.

Seasonality

We believe that the laboratory testing business is subject to seasonal fluctuations in pre-employment screening.  These seasonal fluctuations include reduced volume in the year-end holiday periods, and other major holidays.  In addition, inclement weather may have a negative impact on volume thereby reducing net revenues and cash flow.
 
 
- 35 -

 
Impact of New Accounting Standards

There were no recently issued or newly adopted accounting standards that were applicable to the preparation of our consolidated financial statements for 2010 or that we expect will become applicable to the preparation of our consolidated financial statements in the future.
 
ITEM 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Market risk is the risk that we will incur losses due to adverse changes in interest rates or currency exchange rates and prices.  Our primary market risk exposures are to changes in interest rates.  During 2010, 2009, and 2008, we did not have sales denominated in foreign currencies nor did we have any subsidiaries located in foreign countries.  As such, we are not exposed to market risk associated with currency exchange rates and prices.

At December 31, 2010, we had approximately $2.7 million outstanding on our line of credit with Wells Fargo Bank and at December 31, 2009, we had approximately $0.3 million outstanding on a Term Note with Wells Fargo Bank.  The line of credit and Term Note with Wells Fargo Bank bears interest at a variable rate of 0.5% below the prime rate.  We have cash flow exposure on our committed and uncommitted line of credit and Term Note with Wells Fargo Bank due to its variable prime rate pricing.  At December 31, 2010, a 1 percentage point change in the prime rate would increase or decrease interest expense or cash flows by less than $0.1 million.

We do not enter into derivative or other financial instruments or hedging transactions for trading or speculative purposes.

ITEM 8.                 FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.

Reference is made to the consolidated financial statements, financial statement schedule, and notes thereto included later in this Annual Report on Form 10-K under Item 15.

ITEM 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
 
ON ACCOUNTING AND FINANCIAL DISCLOSURE.
 
Not Applicable.
 
ITEM 9A.
CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls Procedures

As of the end of the period covered by this report, we conducted an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rules 13a-15(b) and 15d-15(b) of the Securities Exchange Act of 1934 (the “Exchange Act”).  Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective to ensure that information that is required to be disclosed by us in reports that we file under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities Exchange Commission’s rules and forms.


 
- 36 -

 

Changes in Internal Controls

There were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Management’s Report on Internal Control Over Financial Reporting
 
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal controls over financial reporting based on the framework in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on this evaluation management has concluded that our internal control over financial reporting was effective as of December 31, 2010.

Deloitte & Touche LLP, the independent registered public accounting firm that audited the consolidated financial statements included in this Annual Report on Form 10-K, has also audited our internal control over financial reporting as of December 31, 2010, as stated in their attestation report included in Part IV, Item 15 of this Annual Report on Form 10-K.

Limitations on Controls

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met.  The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

ITEM 9B.
OTHER INFORMATION.

Not Applicable.



 
- 37 -

 

PART III

ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERANCE.

The information required by this Item is incorporated by reference from the section labeled “Proposal 1 - Election of Directors” that will appear in the Definitive Proxy Statement to be used in connection with the 2011 Annual Meeting of Stockholders of MEDTOX Scientific, Inc.

The Company has adopted the MEDTOX Scientific, Inc. Code of Ethics for senior financial and executive officers and directors ("Code of Ethics").  The Code of Ethics is available on the Company's website at www.medtox.com or at no charge to anyone who sends a request for a paper copy to: MEDTOX Scientific, Inc. 402 West County Road D, St. Paul, Minnesota, 55112.  If the Company makes any substantive amendments to the Code of Ethics or grants any waiver, including any implicit waiver from a provision of the Code of Ethics to its directors or executive officers, the Company will disclose the nature of such amendments or waiver on its website at www.medtox.com or in a report on Form 8-K.

ITEM 11.
EXECUTIVE COMPENSATION.

The information required by this Item is incorporated by reference from the sections labeled “Executive Compensation” and “Summary Compensation Table” that will appear in the Definitive Proxy Statement to be used in connection with the 2011 Annual Meeting of Stockholders of MEDTOX Scientific, Inc.

ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

The information required by this Item is incorporated by reference from the sections labeled “Common Stock Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” that will appear in the Definitive Proxy Statement to be used in connection with the 2011 Annual Meeting of Stockholders of MEDTOX Scientific, Inc.

ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPEDENCE.

The information required by this Item is incorporated by reference from the section labeled “Certain Relationships and Related Transactions” that will appear in the Definitive Proxy Statement to be used in connection with the 2011 Annual Meeting of Stockholders of MEDTOX Scientific, Inc.

ITEM 14.
PRINCIPAL ACCOUNTANT FEES AND SERVICES.

The information required by this Item is incorporated by reference from the section labeled “Fees to Independent Registered Public Accounting Firm” that will appear in the Definitive Proxy Statement to be used in connection with the 2011 Annual Meeting of Stockholders of MEDTOX Scientific, Inc.



 
- 38 -

 

PART IV

ITEM 15.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES.

a.
Financial Statements
Page
     
 
Reports of Independent Registered Public Accounting Firm. . .  .
45
     
 
Consolidated Balance Sheets at December 31, 2010 and 2009. . .
48
     
 
Consolidated Statements of Income for the Years Ended
December 31, 2010, 2009 and 2008. . . . . . . . . . . . . . . . . . . . . . .
49
     
 
Consolidated Statements of Stockholders' Equity for the Years
Ended December 31, 2010, 2009 and 2008. . . . . . . . . . . . . . . . . .
50
     
 
Consolidated Statements of Cash Flows for the Years Ended
December 31, 2010, 2009 and 2008. . . . . . . . . . . . . . . . . . . . . . .
 
51
     
 
Notes to Consolidated Financial Statements. . . . . . . . . . . . . . . . .
52
     
b.
Consolidated Financial Statements Schedule
 
     
 
Schedule II - Valuation and Qualifying Accounts. . . . . . . . . . . .
65
     
All other financial statement schedules normally required under Regulation S-X are omitted as the required
information is not applicable.
     
c.
Exhibits
 

The exhibits included in the Report are set forth on the exhibit index and follow the signature page of this Annual Report on Form 10-K.

3.1  
Bylaws of the Registrant, as amended.   (Incorporated by reference to exhibit 3.1 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2007).

3.2  
Restated Certificate of Incorporation, as amended. (Incorporated by reference to exhibit 3.2 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2005).

3.3  
Amended Certificate of Designations of Preferred Stock (Series A Convertible Preferred Stock) of the Registrant, filed with the Delaware Secretary of State on January 29, 1996 (incorporated by reference to Exhibit 3.1 filed with the Registrant’s report on Form 8-K dated January 30, 1996, Commission File No. 001-11394).

10.1  
Second Amendment dated December 31, 1986 to Exclusive License Agreement amending and restating exclusive license granted by the Registrant to Disease Detection International, Inc. (incorporated by reference to Exhibit 10.25 filed with the Registration Statement on Form S-1 dated August 26, 1987, Commission File No. 33-15543).

 
- 39 -

 


10.2  
Agreement regarding rights to “MEDTOX” name dated as of January 30, 1996 between the Registrant and Harry G. McCoy.  (Incorporated by reference to Exhibit 10.38 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 1995, Commission File No. 001-11394).

10.3  
Registrant’s Restated Equity Compensation Plan dated May 10, 2000.  (Incorporated by reference to exhibit 10.46 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2000, Commission File No. 001-11394).**

10.4  
Registration Rights Agreement dated July 31, 2000 among the Registrant, certain investors, and Miller, Johnson, & Kuehn, Inc. (“MJK”).  (Incorporated by reference to exhibit 10.50 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2000, Commission File No. 001-11394).

10.5  
Employment Agreement dated January 1, 2003, between the Registrant and Richard J. Braun. (Incorporated by reference to exhibit 10.59 filed with the Registrant’s Report on Form 10-K for the year ended December 31, 2002, Commission File No. 001-11394).**

10.6  
Amended and Restated Nova Building Lease dated November 1, 2003 by and between Powell Enterprises and MEDTOX Diagnostics, Inc. (Incorporated by reference to exhibit 10.23 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2003).

10.7  
Credit Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1, 2005.  (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated December 6, 2005).

10.8  
Revolving Line of Credit Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1, 2005.  (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated December 6, 2005).

10.9  
Security Agreement:  Equipment between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1, 2005.  (Incorporated by reference to exhibit 10.3 filed with the Registrant’s Report on Form 8-K dated December 6, 2005).

10.10  
Continuing Security Agreement:  Rights to Payment and Inventory between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1, 2005.  (Incorporated by reference to exhibit 10.4 filed with the Registrant’s Report on Form 8-K dated December 6, 2005).

10.11  
Term Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1, 2005.  (Incorporated by reference to exhibit 10.5 filed with the Registrant’s Report on Form 8-K dated December 6, 2005).

 
- 40 -

 


10.12  
Agreement and Acknowledgment of Security Interest between Wells Fargo Bank, MEDTOX Diagnostics, Inc., and Powell Enterprises, Inc. dated December 1, 2005.  (Incorporated by reference to exhibit 10.6 filed with the Registrant’s Report on Form 8-K dated December 6, 2005).

10.13  
Term Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated March 16, 2006. (Incorporated by reference to exhibit 10.23 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2005).

10.14  
Continuing Guaranty between New Brighton Business Center, LLC and Wells Fargo Bank dated March 16, 2006. (Incorporated by reference to exhibit 10.24 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2005).

10.15  
First Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated March 16, 2006.  (Incorporated by reference to exhibit 10.25 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2005).

10.16  
Negative Pledge Agreement between New Brighton Business Center, LLC and Wells Fargo Bank dated March 16, 2006.  (Incorporated by reference to exhibit 10.26 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2005).

10.17  
Employment Agreement dated December 27, 2006, between the Registrant and B. Mitchell Owens. (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated January 4, 2007).**

10.18  
Employment Agreement dated December 27, 2006, between the Registrant and Susan E. Puskas. (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated January 4, 2007).**

10.19  
Employment Agreement dated December 27, 2006, between the Registrant and James A. Schoonover. (Incorporated by reference to exhibit 10.3 filed with the Registrant’s Report on Form 8-K dated January 4, 2007).**

10.20  
Employment Agreement dated December 27, 2006, between the Registrant and Kevin J. Wiersma. (Incorporated by reference to exhibit 10.4 filed with the Registrant’s Report on Form 8-K dated January 4, 2007).**

10.21  
Registrant’s Executive Incentive Compensation Plan dated December 27, 2006, (Incorporated by reference to exhibit 10.5 filed with the Registrant’s Report on Form 8-K dated January 4, 2007).**

10.22  
Commercial Lease between MEDTOX Laboratories, Inc. and St. Paul Properties, Inc. dated July 28, 2000.  (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated May 30, 2007).

10.23  
Amendment to Lease between MEDTOX Laboratories, Inc. and St. Paul Properties, Inc. dated May 25, 2007.  (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated May 30, 2007).

 
- 41 -

 


10.24  
Second Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated July 31, 2007.  (Incorporated by reference to exhibit 10.29 filed with the Registrant’s Report on Form 10-Q for the quarter ended June 30, 2007).

10.25  
Third Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated October 25, 2007.  (Incorporated by reference to exhibit 10.30 filed with the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2007).

10.26  
Registrant’s Long-Term Incentive Plan as Amended and Restated dated December 31, 2007, (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated January 7, 2008).**

10.27  
Registrant’s Supplemental Executive Retirement Plan as Amended and Restated dated December 31, 2007, (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated January 7, 2008).**

10.28  
Amendment to Employment Agreement, effective January 1, 2009, between the Registrant and B. Mitchell Owens. (Incorporated by reference to exhibit 10.5 filed with the Registrant’s Report on Form 8-K dated December 23, 2008).**

10.29  
Amendment to Employment Agreement, effective January 1, 2009, between the Registrant and Susan E. Puskas. (Incorporated by reference to exhibit 10.4 filed with the Registrant’s Report on Form 8-K dated December 23, 2008).**

10.30  
Amendment to Employment Agreement, effective January 1, 2009, between the Registrant and James A. Schoonover. (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated December 23, 2008).**

10.31  
Amendment to Employment Agreement, effective January 1, 2009, between the Registrant and Kevin J. Wiersma. (Incorporated by reference to exhibit 10.3 filed with the Registrant’s Report on Form 8-K dated December 23, 2008).**

10.32  
Amendment to Employment Agreement, effective January 1, 2009, between the Registrant and Richard J. Braun. (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated December 23, 2008).**

10.33  
Fourth Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated October 29, 2009.  (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 10-Q for the quarter ended September 30, 2009).

10.34  
Registrant’s Supplemental Executive Retirement Plan as Amended and Restated dated January 1, 2010. (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated January 7, 2010).**

10.35  
Director Compensation for Fiscal Year 2010.  (Incorporated by reference to exhibit 10.36 filed with the Registrant’s Report on Form 10-K for the fiscal year ended December 31, 2009).**


 
- 42 -

 

10.36  
Executive Salaries for Fiscal Year 2010.  (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 10-Q for the quarter ended March 31, 2010).**

10.37  
Target Financial Objectives for Fiscal Year 2010 under the Annual Incentive Plan and Long Term Incentive Plan.  (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 10-Q for the quarter ended March 31, 2010).**

10.38  
Form of Restricted Stock Agreement under 2010 Stock Incentive Plan. (Incorporated by reference to exhibit 99.2 filed with the Registrant’s Registration Statement on Form S-8 filed on August 18, 2010).**

10.39  
Registrant’s Supplemental Executive Retirement Plan as Amended and Restated dated October 29, 2010. (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated November 3, 2010).**

10.40  
Registrant’s 2010 Stock Incentive Plan as Amended and Restated dated October 29, 2010 (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated November 3, 2010).**

10.41  
Fifth Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated November 23, 2010.  (Incorporated by reference to exhibit 10.1 filed with the Registrant’s Report on Form 8-K dated November 24, 2010).

10.42  
First Modification to Promissory Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated November 23, 2010.  (Incorporated by reference to exhibit 10.2 filed with the Registrant’s Report on Form 8-K dated November 24, 2010).

10.43  
Director Compensation for Fiscal Year 2011.* & **

21.1  
Subsidiaries of Registrant*

23  
Consent of Independent Registered Public Accounting Firm*

31.1  
Section 302 Certification of Chief Executive Officer pursuant to the Sarbanes-Oxley Act of 2002.*

31.2  
Section 302 Certification of Chief Financial Officer pursuant to the Sarbanes-Oxley Act of 2002.*

32.1  
Section 906 Certification of Chief Executive Officer pursuant to the Sarbanes-Oxley Act of 2002.*

32.2  
Section 906 Certification of Chief Financial Officer pursuant to the Sarbanes-Oxley Act of 2002.*

*  
**  
Filed herewith
Denotes a management contract or compensatory plan or arrangement
 
 
- 43 -

 

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized on the 14th of March, 2011.

MEDTOX Scientific, Inc.
Registrant

By: /s/ Richard J. Braun
Richard J. Braun
President, Chief Executive Officer and
Chairman of the Board of Directors

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.


Signature
Title
Date
/s/ Richard J. Braun
President, Chief Executive Officer, and
March 14, 2011
Richard J. Braun
Chairman of the Board of Directors (Principal Executive Officer)
 
     
/s/ Kevin J. Wiersma
Vice President and Chief Financial Officer
March 14, 2011
Kevin J. Wiersma
(Principal Financial Officer)
 
     
/s/ Angela M. Lacis
Corporate Controller
March 14, 2011
Angela M. Lacis
(Principal Accounting Officer)
 
     
/s/ Brian P. Johnson
Director
March 14, 2011
Brian P. Johnson
   
     
/s/ Robert J. Marzec
Director
March 14, 2011
Robert J. Marzec
   
     
/s/ Samuel C. Powell
Director
March 14, 2011
Samuel C. Powell, Ph.D.
   
     
/s/ Robert A. Rudell
Director
March 14, 2011
Robert A. Rudell
   
     

 
- 44 -

 

 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
To the Board of Directors and Stockholders of
MEDTOX Scientific, Inc.
St. Paul, Minnesota
 
We have audited the internal control over financial reporting of MEDTOX Scientific, Inc. and subsidiaries (the "Company") as of December 31, 2010, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.  The Company's management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control Over Financial Reporting.  Our responsibility is to express an opinion on the Company's internal control over financial reporting 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 effective internal control over financial reporting was maintained in all material respects.  Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances.  We believe that our audit provides a reasonable basis for our opinion.
 
A company's internal control over financial reporting is a process designed by, or under the supervision of, the company's principal executive and principal financial officers, or persons performing similar functions, and effected by the company's board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.  A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) 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.
 
Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material misstatements due to error or fraud may not be prevented or detected on a timely basis.  Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
 
In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2010, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.
 

 
- 45 -

 

 
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements and financial statement schedule as of and for the year ended December 31, 2010, of the Company and our report dated March 14, 2011 expressed an unqualified opinion on those financial statements and financial statement schedule.
 
 
DELOITTE & TOUCHE LLP
 
Minneapolis, Minnesota
March 14, 2011

 
- 46 -

 

 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
To the Board of Directors and Stockholders of
MEDTOX Scientific, Inc.
St. Paul, Minnesota

We have audited the accompanying consolidated balance sheets of MEDTOX Scientific, Inc. and subsidiaries (the “Company”) as of December 31, 2010 and 2009, and the related consolidated statements of income, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2010. Our audits also included the financial statement schedule listed in the Index at Item 15.b. These financial statements and financial statement schedule are the responsibility of the Company’s management. Our responsibility is to express an opinion on the financial statements and financial statement schedule 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. 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 audits provide a reasonable basis for our opinion.

In our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of MEDTOX Scientific, Inc. and subsidiaries as of December 31, 2010 and 2009, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2010, in conformity with accounting principles generally accepted in the United States of America. Also, in our opinion, the financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.

We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control over financial reporting as of December 31, 2010, based on the criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated March 14, 2011, expressed an unqualified opinion on the Company’s internal control over financial reporting.

 
DELOITTE & TOUCHE LLP
 
Minneapolis, Minnesota
March 14, 2011
 

 

 
- 47 -

 

MEDTOX SCIENTIFIC, INC.

CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2010 AND 2009
(In thousands, except share and per share data)

   
2010
   
2009
 
ASSETS
           
CURRENT ASSETS:
           
Cash and cash equivalents
$
1,285
 
$
4,165
 
Accounts receivable:
           
Trade, less allowance for doubtful accounts ($1,592 in 2010 and $529 in 2009)
 
18,618
   
14,916
 
Other
 
957
   
1,257
 
Total accounts receivable
 
19,575
   
16,173
 
Inventories
 
3,902
   
3,593
 
Prepaid expenses
 
1,532
   
1,429
 
Deferred income taxes
 
3,765
   
3,603
 
Total current assets
 
30,059
   
28,963
 
BUILDING, EQUIPMENT AND IMPROVEMENTS, net
 
28,164
   
29,509
 
GOODWILL
 
15,967
   
15,967
 
OTHER INTANGIBLE ASSETS, net
 
198
   
273
 
OTHER ASSETS
 
1,069
   
1,405
 
TOTAL ASSETS
$
75,457
 
$
76,117
 
             
LIABILITIES AND STOCKHOLDERS’ EQUITY
           
CURRENT LIABILITIES:
           
Line of credit
$
2,725
 
$
-
 
Accounts payable
 
4,079
   
4,143
 
Accrued expenses
 
7,101
   
4,670
 
Current portion of long-term debt
 
-
   
302
 
Total current liabilities
 
13,905
   
9,115
 
OTHER LONG-TERM LIABILITIES
 
3,871
   
3,224
 
DEFERRED INCOME TAXES, net
 
3,562
   
2,346
 
COMMITMENTS AND CONTINGENCIES (Note 13)
           
STOCKHOLDERS' EQUITY:
           
Preferred stock, $1.00 par value; authorized shares, 50,000; none issued and outstanding
 
-
   
-
 
Common stock, $0.15 par value; authorized shares, 28,000,000; issued shares, 9,022,888
           
in 2010 and 8,675,510 in 2009
 
1,353
   
1,301
 
Additional paid-in capital
 
78,425
   
88,078
 
Accumulated deficit
 
(19,906
)
 
(22,923
)
Common stock held in trust, at cost,  428,596 shares in 2010 and 367,911 shares in 2009
 
(4,753
)
 
(4,024
)
Treasury stock, at cost, 103,460 shares in 2010 and 103,431 shares in 2009
 
(1,000
)
 
(1,000
)
Total stockholders' equity
 
54,119
   
61,432
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
75,457
 
$
76,117
 
 
See notes to consolidated financial statements.

 
- 48 -

 

MEDTOX SCIENTIFIC, INC.

CONSOLIDATED STATEMENTS OF INCOME
YEARS ENDED DECEMBER 31, 2010, 2009, AND 2008
(In thousands, except share and per share data)                                                                                                                                          

   
2010
   
2009
   
2008
 
REVENUES:
                 
Laboratory services:
                 
   Drugs-of-abuse testing services
$
39,624
 
$
36,040
 
$
40,021
 
   Clinical & other laboratory services
 
29,923
   
22,885
   
19,306
 
   Clinical trial services
 
7,500
   
6,926
   
6,800
 
Product sales
 
20,054
   
18,257
   
19,686
 
   
97,101
   
84,108
   
85,813
 
COST OF REVENUES:
                 
Cost of services
 
49,036
   
45,432
   
41,665
 
Cost of sales
 
8,425
   
7,781
   
7,822
 
   
57,461
   
53,213
   
49,487
 
                   
GROSS PROFIT
 
39,640
   
30,895
   
36,326
 
                   
OPERATING EXPENSES:
                 
Selling, general and administrative
 
32,691
   
26,663
   
24,327
 
Research and development
 
2,261
   
2,264
   
2,352
 
   
34,952
   
28,927
   
26,679
 
                   
INCOME FROM OPERATIONS
 
4,688
   
1,968
   
9,647
 
                   
OTHER INCOME (EXPENSE):
                 
Interest expense
 
(10
)
 
(17
)
 
(77
)
Other income (expense)
 
167
   
96
   
(914
)
   
157
   
79
   
(991
)
                   
INCOME BEFORE INCOME TAX EXPENSE
 
4,845
   
2,047
   
8,656
 
                   
INCOME TAX EXPENSE
 
(1,828
)
 
(748
)
 
(3,084
)
                   
NET INCOME
$
3,017
 
$
1,299
 
$
5,572
 
                   
BASIC EARNINGS PER COMMON SHARE
$
0.35
 
$
0.15
 
$
0.66
 
                   
WEIGHTED AVERAGE NUMBER OF BASIC SHARES
OUTSTANDING
 
 
8,715,391
   
 
8,536,768
   
 
8,455,092
 
                   
DILUTED EARNINGS PER COMMON SHARE
$
0.34
 
$
0.15
 
$
0.62
 
                   
WEIGHTED AVERAGE NUMBER OF DILUTED SHARES
OUTSTANDING
 
 
8,867,530
   
 
8,788,663
   
 
8,938,213
 

See notes to consolidated financial statements.

 
- 49 -

 

MEDTOX SCIENTIFIC, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
YEARS ENDED DECEMBER 31, 2010, 2009, AND 2008
(In thousands, except share data)
 
 
 
Common Stock
 
Additional
Paid-in
Capital
 
Accumulated
Deficit
Common Stock Held in Trust
 
Treasury
Stock
 
Total
 
Shares
 
Par Value
                                       
BALANCE AT DECEMBER 31, 2007
8,538,281
 
$
1,281
 
$
87,780
 
$
(29,794)
 
$
(2,611)
 
$
(1,000)
 
$
55,656
                                       
Exercise of stock options
24,713
   
3
   
8
                     
11
Traded shares for payment of taxes
           
(225)
                     
(225)
Share-based compensation
           
13
                     
13
Purchase of common stock for incentive
plan
                       
(1,003)
         
(1,003)
Tax benefit related to stock-based
compensation plans
           
441
                     
441
Share exchange
93
                                   
Net income
                 
5,572
               
5,572
                                       
BALANCE AT DECEMBER 31, 2008
8,563,087
 
$
1,284
 
$
88,017
 
$
(24,222)
 
$
(3,614)
 
$
(1,000)
 
$
60,465
                                       
Exercise of stock options
114,302
   
17
   
328
                     
345
Traded shares for payment of taxes
(1,879)
         
(72)
                     
(72)
Share-based compensation
           
5
                     
5
Purchase of common stock for incentive
plan
                       
(410)
         
(410)
Tax expense related to stock-based
compensation plans
           
(200)
                     
10
Net income
                 
1,299
               
1,299
                                       
BALANCE AT DECEMBER 31, 2009
8,675,510
 
$
1,301
 
$
88,078
 
$
(22,923)
 
$
(4,024)
 
$
(1,000)
 
$
61,432
                                       
Exercise of stock options
278,178
   
42
   
1,027
                     
1,069
Issuance of nonvested share awards
69,200
   
10
   
(10)
                     
-
Share-based compensation
           
12
                     
12
Purchase of common stock for incentive
plans
                       
(774)
         
(774)
Tax benefit related to stock-based
compensation plans
           
192
                     
192
Tax benefit related to participating dividends
           
177
                     
177
Issuance of common stock shares held in trust
                       
45
         
45
Dividend declared
           
(11,051)
                     
(11,051)
Net income
                 
3,017
               
3,017
                                       
BALANCE AT DECEMBER 31, 2010
9,022,888
 
$
1,353
 
$
78,425
 
$
(19,906)
 
$
(4,753)
 
$
(1,000)
 
$
54,119

See notes to consolidated financial statements.

 
- 50 -

 

MEDTOX SCIENTIFIC, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS
YEARS ENDED DECEMBER 31, 2010, 2009, AND 2008
(In thousands)                                                                                                                                          

     
2010
   
2009
   
2008
 
CASH FLOWS PROVIDED BY OPERATING ACTIVITIES:
                   
Net income
 
$
3,017
 
$
1,299
 
$
5,572
 
 Adjustments to reconcile net income to net cash provided by operating activities:
                   
Depreciation and amortization
   
5,815
   
5,437
   
4,838
 
Provision for losses on accounts receivable
   
2,050
   
640
   
544
 
Loss on sale of equipment
   
12
   
14
   
7
 
Deferred and stock-based compensation
   
1,135
   
1,172
   
390
 
Deferred income taxes
   
1,666
   
748
   
2,725
 
Changes in operating assets and liabilities:
                   
Accounts receivable
   
(5,452
)
 
(2,731
)
 
(816
)
Inventories
   
(309
)
 
307
   
10
 
Prepaid expenses
   
(103
)
 
(76
)
 
(171
)
Other assets
   
(97
)
 
(466
)
 
(397
)
Accounts payable and accrued expenses
   
2,615
   
(833
)
 
(451
)
Other
   
(243
)
 
329
   
-
 
Net cash provided by operating activities
   
10,106
   
5,840
   
12,251
 
                     
CASH FLOWS USED IN INVESTING ACTIVITIES:
                   
Purchase of building, equipment and improvements
   
(5,138
)
 
(4,930
)
 
(8,508
)
Net cash used in investing activities
   
(5,138
)
 
(4,930
)
 
(8,508
)
                     
CASH FLOWS USED IN FINANCING ACTIVITIES:
                   
Principal payments on long-term debt
   
(302
)
 
(677
)
 
(677
)
Payments on line of credit
   
(4,275
)
 
-
   
-
 
Proceeds from line of credit
   
7,000
   
-
   
-
 
Purchase of common stock for incentive plans
   
(774
)
 
(410
)
 
(1,003
)
Net proceeds from the exercise of stock options
   
1,069
   
345
   
11
 
Payment of taxes from traded shares
   
-
   
(72
)
 
(225
)
Payment of cash dividend
   
(10,566
)
 
-
   
-
 
Net cash used in financing activities
   
(7,848
)
 
(814
)
 
(1,894
)
                     
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
(2,880
)
 
96
   
1,849
 
                     
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
   
4,165
   
4,069
   
2,220
 
                     
CASH AND CASH EQUIVALENTS AT END OF YEAR
 
$
1,285
 
$
4,165
 
$
4,069
 
                     
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
                   
                     
  Cash paid during the year for:
                   
       Interest
 
$
2
 
$
19
 
$
84
 
       Income taxes
   
73
   
49
   
405
 
                     
  Supplemental noncash activities:
                   
       Asset additions and related obligations in payables
 
$
508
 
$
1,239
 
$
541
 

See notes to consolidated financial statements.

 
- 51 -

 

MEDTOX SCIENTIFIC, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS ENDED DECEMBER 31, 2010, 2009, AND 2008

1.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company The consolidated financial statements include the accounts of MEDTOX Scientific, Inc. and its wholly-owned subsidiaries: MEDTOX Laboratories, Inc. (MEDTOX Laboratories), MEDTOX Diagnostics, Inc. (MEDTOX Diagnostics) and New Brighton Business Center, LLC (NBBC) (collectively referred to as the "Company").

MEDTOX Laboratories provides drugs-of-abuse testing services; clinical & other laboratory services, which include clinical toxicology, clinical testing for occupational health clinics, clinical testing for physician offices, pediatric lead testing, heavy metals analyses, courier delivery, and medical surveillance; and clinical trial services which include central laboratory services, assay development, bio-analytical, bio-equivalence and pharmacokinetic testing.

MEDTOX Diagnostics is engaged in the research, development and sale of products based upon enzyme immunoassay technology for the detection of antibiotic residues, mycotoxins, drugs-of-abuse and other hazardous substances as well as distribution of agridiagnostic and food safety testing products.

NBBC conducts the Company’s building rental activities that are not related to the Company’s operations.  The operations of NBBC are shown in the statements of operations as “other expense”.

All significant intercompany transactions and balances have been eliminated.

Use of Estimates - The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes.  The more significant estimates include the valuation of accounts receivable, inventories, goodwill and other intangible assets, deferred income taxes and the recorded amounts for certain accruals.  Actual results could differ from those estimates.

Cash and Cash Equivalents - Cash equivalents include highly liquid investments with original maturities of three months or less from the date of purchase.

Accounts Receivable and allowance for doubtful accounts - Accounts receivable are reported at realizable value, net of allowances for doubtful accounts, which is estimated and recorded in the period the related revenue is recorded. The Company has a standardized approach to estimate and review the collectability of its receivables based on the period of time they have been outstanding.  The Company’s process for determining the appropriate level of the allowance for doubtful accounts involves judgment, and considers such factors as the age of the underlying receivables, specific account reviews, historical collection experience, and other external factors that could affect the collectability of its receivables.  Revisions to the allowances for doubtful accounts are recorded as an adjustment to bad debt expense within selling, general and administrative. Accounts are written off against the allowance for doubtful accounts when they are deemed to be uncollectible.  Recoveries of receivables previously written-off are recorded as credits to the allowance for doubtful accounts.

Inventories - Inventories are valued at the lower of cost (first-in, first-out method) or market.


 
- 52 -

 

Equipment and Improvements Equipment and improvements are stated at cost.  Provisions for depreciation have been computed using the straight-line method to amortize the cost of depreciable assets over their estimated useful lives as follows:

Furniture and equipment:  3 – 10 years
Building and improvements:  10 – 39 years
Leasehold improvements:  lesser of 10 years or life of lease

Goodwill and Other Intangible AssetsThe Company reviews goodwill and indefinite-lived intangible assets for impairment at least annually and between annual test dates in certain circumstances.  The Company performs its annual impairment test for goodwill and other intangible assets in the fourth quarter of each year after the Company’s annual forecasting process.  No impairments were indicated as a result of the annual impairment reviews for goodwill and other intangible assets in 2010, 2009 or 2008.  In assessing the recoverability of goodwill and other intangible assets, projections regarding estimated future cash flows and other factors are made to determine the fair value of the respective assets.  If these estimates or related projections change in the future, the Company may be required to record impairment charges for these assets.

Goodwill and other intangible assets are allocated to the Company’s reporting units, which are either the operating segment or one reporting level below the operating segment.  The Company compares the fair value of the reporting unit to its carrying amount on an annual basis to determine if there is potential impairment.  If the fair value of the reporting unit is less than its carrying value, impairment is indicated to the extent that the fair value of the goodwill and other intangible assets within the reporting unit is less than their carrying value.  If the carrying amount of the goodwill and other intangible assets exceeds their fair value, an impairment loss is recognized.  Fair values for the reporting units and other intangible assets are determined based on discounted cash flows.

Amortizable intangible assets consist of customer lists, technology, patents and trademarks and are amortized on a straight-line or accelerated basis based upon estimated useful or contractual lives, ranging from 5 to 20 years.

Revenue Recognition - Revenues from Laboratory Services are recognized as earned at such time as the Company has completed services.  The Company’s services are considered to be complete when it has performed the applicable laboratory testing services and the results have been sent to the Company’s customers or posted to the Company’s secure website.  Billings for services reimbursed by third-party payers, including Medicare and Medicaid, are recorded as revenues net of allowances for differences between amounts billed and the estimated receipts from such payers. Adjustments to the allowances, based on actual receipts from the third-party payers, are recorded upon settlement.

Revenues from Product Sales are recognized FOB shipping point net of an allowance for estimated returns.  When shipment occurs, the sales price is fixed and determinable, and collection of the resulting receivable is reasonably assured.

Freight charges to customers are included in product sales and freight costs are included in cost of sales.

Research and Development – Research and development expenditures are charged to expense as incurred.

Income Taxes – The Company uses the liability method of accounting for income taxes.  Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.

 
- 53 -

 

 
The Company recognizes in its financial statements the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position.

Share-Based Compensation – The Company recognizes compensation expense related to the cost of employee services received in exchange for Company equity interests over the award’s vesting period based on the award’s fair value at the date of grant.

Earnings per Common Share Basic earnings per common share equals net earnings divided by the weighted average common shares outstanding during the period.  Diluted earnings per common share equals net earnings divided by the weighted average common shares outstanding during the period, including the dilutive effects of stock options and non-vested share awards.

Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses are considered to be representative of their respective fair values due to their short-term nature.  The carrying amount of the line of credit at December 31, 2010 and long-term debt at December 31, 2009 approximated fair value due to the variable interest rate.

Concentrations of Credit Risk – Concentrations of credit risk with respect to accounts receivable are limited due to the diversity of the Company’s clients as well as their dispersion across many different geographic regions.  The Company had no customers that accounted for more than 10% of consolidated revenues in 2010, 2009, or 2008 or accounts receivable at December 31, 2010 or 2009.

Comprehensive Income – Comprehensive income is a measure of all non-owner changes in shareholders’ equity and includes such items as net income, certain foreign currency translation items, minimum pension liability adjustments, and changes in the value of available-for-sale securities.  In 2010, 2009, and 2008, comprehensive income for the Company was equal to net income as reported.

New Accounting Standards There were no recently issued or newly adopted accounting standards that were applicable to the preparation of the Company’s consolidated financial statements for 2010 or that the Company expects will become applicable to the preparation of its consolidated financial statements in the future.

2.
SEGMENTS

The Company has two reportable segments:  Laboratory Services and Product Sales.  The Laboratory Services segment consists of MEDTOX Laboratories and NBBC.  Services provided include drugs-of-abuse testing services; clinical & other laboratory services, which include clinical toxicology, clinical testing for occupational health clinics, clinical testing for physician offices, pediatric lead testing, heavy metals analyses, courier delivery, and medical surveillance; and clinical trial services which include central laboratory services, assay development, bio-analytical, bio-equivalence and pharmacokinetic testing.  The Product Sales segment, which includes POCT (point-of-collection testing) disposable diagnostic devices, consists of MEDTOX Diagnostics, Inc.  Products manufactured include easy to use, inexpensive, on-site drug tests such as PROFILE®-II, PROFILE®-II A, PROFILE®-III, PROFILE®-III A, PROFILE-II ER®, PROFILE®-III ER, PROFILE®-IV, PROFILE®-V, MEDTOXScan®, VERDICT®-II and SURE-SCREEN®, in addition to a variety of other diagnostic tests for the detection of alcohol.  MEDTOX Diagnostics also provides contract manufacturing services in its Food and Drug Administration (FDA) registered/ISO 13845 certified facility.


 
- 54 -

 

The Company’s reportable segments are strategic business units that offer different products and services. They are managed separately as each business requires different products, services and marketing strategies.

In evaluating financial performance, management focuses on income from operations as a segment’s measure of profit or loss.  The accounting policies of the segments are the same as those described in the summary of significant accounting policies (see Note 1).

The following is a summary of certain segment information for the years ended December 31:

(In thousands)
 
   
2010
 
2009
 
2008
Laboratory Services:
           
 Revenues
$
77,047
$
65,851
$
66,127
 Depreciation and amortization
 
5,020
 
4,744
 
4,211
 Income (loss) from operations
 
1,187
 
(1,037)
 
5,364
 Segment assets
 
64,193
 
60,630
 
59,812
 Capital expenditures for segment assets
 
4,775
 
4,561
 
7,322
             
Product Sales:
           
 Revenues
$
20,054
$
18,257
$
19,686
 Depreciation and amortization
 
795
 
693
 
627
 Income from operations
 
3,501
 
3,005
 
4,283
 Segment assets
 
7,499
 
11,884
 
10,102
 Capital expenditures for segment assets
 
363
 
369
 
1,186
             
Corporate (unallocated):
           
 Other income (expense)
$
157
$
79
$
(991)
 Net deferred tax assets
 
3,765
 
3,603
 
3,612
             
Company:
           
 Revenues
$
97,101
$
84,108
$
85,813
 Depreciation and amortization
 
5,815
 
5,437
 
4,838
 Income from operations
 
4,688
 
1,968
 
9,647
 Other income (expense)
 
157
 
79
 
(991)
 Income before income taxes
 
4,845
 
2,047
 
8,656
 Total assets
 
75,457
 
76,117
 
73,526
 Capital expenditures for assets
 
5,138
 
4,930
 
8,508
 
 
    The following is a summary of revenues from external customers for each group of products and services provided within the Product Sales segment for the years ended December 31:
 

(In thousands)
               
   
2010
   
2009
   
2008
                 
POC on-site testing products
$
17,796
 
$
16,431
 
$
17,787
Contract manufacturing services
 
1,567
   
1,391
   
1,469
Other diagnostic products
 
691
   
435
   
430
 
$
20,054
 
$
18,257
 
$
19,686

 
- 55 -

 

3.
INVENTORIES

Inventories consisted of the following at December 31:

(In thousands)
 
2010
   
2009
           
Raw materials
$
786
 
$
653
Work in process
 
406
   
400
Finished goods
 
390
   
360
Supplies, including off-site inventory
 
2,320
   
2,180
 
$
3,902
 
$
3,593

4.
GOODWILL AND OTHER INTANGIBLE ASSETS

Intangible assets, resulting primarily from acquisitions, include the value assigned to customer lists, trademarks and goodwill.  Amortizable intangible assets are amortized on a straight-line or accelerated basis based upon their estimated useful lives.

The entire amount of goodwill is included in the Laboratory Services segment, which is tested annually for impairment during the fourth quarter after the Company’s annual forecasting process.  No goodwill impairment was recognized in 2010, 2009 or 2008.  There were no other changes in the carrying amount of goodwill in 2010, 2009 or 2008.

The components of other intangible assets were as follows at December 31:

(In thousands)
 
2010
2009
 
Weighted
average
useful life
 
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net
Carrying
Amount
   
Gross
Carrying
Amount
 
Accumulated
Amortization
 
Net
Carrying
Amount
                                     
Amortizable intangible assets:
                                   
Customer lists
11.1 years   
 
2,416
   
(2,256)
   
160
   
2,416
   
(2,188)
   
228
Trademarks and other
13.7 years
 
87
   
(49)
   
38
   
87
   
(42)
   
45
Total
11.2 years
 
$
 
2,503
 
 
$
 
(2,305)
 
 
$
 
198
 
 
$
 
2,503
 
 
$
 
(2,230)
 
 
$
 
273

Amortization expense for amortizable intangible assets was approximately $75,000, $127,000 and $215,000 during 2010, 2009 and 2008, respectively.  Future amortization expense for amortizable intangible assets is estimated to be as follows for the years ending December 31:

(In thousands)
   
     
2011
$
48
2012
 
21
2013
 
19
2014
 
15
2015
 
15
2016 and thereafter
 
80
 
$
198


 
- 56 -

 

5.
BUILDING, EQUIPMENT AND IMPROVEMENTS

Building, equipment and improvements consisted of the following at December 31:

(In thousands)
 
2010
   
2009
           
Furniture and equipment
$
38,291
 
$
35,107
Building and improvements
 
8,490
   
8,490
Leasehold improvements
 
8,603
   
7,523
   
55,384
   
51,120
Less accumulated depreciation
 
(27,220)
   
(21,611)
 
$
28,164
 
$
29,509

    Depreciation expense was approximately $5,740,000, $5,310,000 and $4,623,000 during 2010, 2009 and 2008, respectively.

6.
ACCRUED EXPENSES

Accrued expenses consisted of the following at December 31:

(In thousands)
 
2010
   
2009
           
Accrued clinic fees
$
1,594
 
$
1,300
Accrued bonus
 
1,399
   
-
Accrued salaries, wages and commissions
 
1,573
   
1,571
Accrued health insurance
 
309
   
337
Deferred compensation obligation
 
484
   
-
Other accrued expenses
 
1,742
   
1,462
 
$
7,101
 
$
4,670
 
7.
DEBT

Long-term debt consisted of the following at December 31:

(In thousands)
 
2010
   
2009
           
Term loan, paid June 2010
$
-
 
$
302
Less current portion
 
-
   
(302)
 
$
-
 
$
-

Wells Fargo Credit Agreement – The Company is party to a credit security agreement (the "Wells Fargo Credit Agreement") with Wells Fargo Bank, National Association (the “Bank”) which expires on August 31, 2011.  The Wells Fargo Credit Agreement, as amended, consists of a revolving line of credit ("Line of Credit") of up to $12.0 million bearing interest at a fluctuating rate of 2.25% above the daily three month LIBOR, as defined and calculated by the Bank.

Subject to certain conditions, the Wells Fargo Credit Agreement also provides for the issuance of letters of credit which, if drawn upon, would be deemed advances under the Line of Credit.  We are required to pay a fee equal to 0.25% per annum on the average daily unused amount of the Line of Credit.  We have granted the Bank a first priority security interest in all of the Company’s accounts receivable, other rights to payment, general intangibles, inventory, and equipment to secure all indebtedness of the Company to the Bank.

 
- 57 -

 

Extensions of credit under the Wells Fargo Credit Agreement are subject to certain conditions.  The Wells Fargo Credit Agreement also requires us to comply with certain financial covenants, including maintaining, on a consolidated basis:

·  
Tangible Net Worth not less than $35,000,000 at each month end, with “Tangible Net Worth” defined as the aggregate of total stockholders’ equity plus subordinated debt less any intangible assets.

·  
Current Ratio not less than 1.45 to 1.0 at each month end, with “Current Ratio” defined as total current assets divided by total current liabilities.

·  
Pre-tax profit of not less than $1,500,000 on a rolling four-quarter basis, determined as of each fiscal quarter-end.

At December 31, 2010, the Company had $2,700,000 outstanding under its revolving line of credit, due August 31, 2011, and $9,300,000 was available for future borrowings.  The Company did not have any borrowings during 2009 under its revolving line of credit.  The weighted average interest rate on borrowings outstanding during the year under the revolving line of credit was 2.65% and 4.9% during 2010, and 2008, respectively.

Term Loan – The Company had a Term Note (the "Note") with the Bank for $3,400,000 which required payment over a five year term in monthly installments of approximately $56,000 plus interest, commencing May 2006.  Interest was calculated at either (i) a variable rate of 0.5% below the prime rate or (ii) a fixed rate of 1.9% above LIBOR in effect on the first day of the applicable fixed rate term.  The Note was repaid in full in 2010.
 
 
8.
STOCK BASED-COMPENSATION

In June 2010, the 2010 Stock Incentive Plan (the “Plan”) was approved by shareholders.  The purpose of the Plan is the grant of nonvested share awards (referred to in the Plan as “Restricted Stock”) to officers (excluding senior management) and employees (“Participants”).  The Plan permits the issuance of up to 500,000 shares of common stock.   No Participant may be granted awards for more than 5,000 shares during any calendar year.  Share awards are awarded with a vesting period of at least three years.

The Company’s Restated Equity Compensation Plan provided incentives to eligible employees, officers and directors in the form of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, performance shares and other stock-based awards.   The Restated Equity Compensation Plan expired in 2003 and no options or awards are available for future grant, however, exercises of options will still occur in accordance with the terms of the various grants.

The Company recorded approximately $12,000, $5,000 and $13,000 in total share-based compensation expense in 2010, 2009, and 2008, respectively.

Stock Options - The Compensation Committee of the Board of Directors determined the exercise price (not to be less than the fair market value of the underlying stock) of stock options at the date of grant.  Options generally become exercisable in installments over a period of one to five years and expire ten years from the date of grant.  The Company estimated the fair value of its stock options using the Black-Scholes option-pricing model.  There were no options granted during 2010, 2009 or 2008.


 
- 58 -

 

The following table summarizes the stock option transactions for 2010:

 
Number of Shares Underlying Options
 
Weighted-Average Exercise Price of Options
 
Weighted-Average Remaining Contractual Life
of Options
 
Aggregate Intrinsic
Value of Options
             
(In thousands)
Outstanding at December 31, 2009
575,218
 
 $  4.70
       
Granted
-
 
-
       
Exercised
(321,634)
 
$  4.95
       
Forfeited/cancelled
(3,000)
 
$  3.70
       
               
Outstanding, vested and exercisable at
December 31, 2010
250,584
 
  $  4.40
 
2.37
 
$  2,180

The aggregate intrinsic value of options outstanding at December 31, 2010, is calculated as the difference between the market price of the Company’s common stock at December 31, 2010, and the exercise price of the underlying options, multiplied by the number of in-the-money options.  The total intrinsic value of options exercised was approximately $1,822,000, $546,000 and $615,000 in 2010, 2009, and 2008, respectively.  Cash received from option exercises was approximately $1,069,000, $345,000, and $11,000, in 2010, 2009, and 2008, respectively.  The actual tax benefit realized for the tax deductions from option exercises was approximately $111,000, $10,000 and $7,000 in 2010, 2009 and 2008, respectively.

Nonvested Share Awards – Share awards are issued to Participants as an incentive for the performance of future services that will contribute materially to the successful operation of the Company.  Owners of share awards have the rights of shareowners, including the right to vote.  Share awards are awarded with a vesting period of at least three years.

A summary of the status of the Company’s nonvested share awards at December 31, 2010 and changes during 2010 is presented below:

 
Shares
 
Weighted-Average Grant Date Fair Value
 
Outstanding at December 31, 2009
-
   
Granted
69,200
 
$     12.94
Vested
-
   
Forfeited
-
   
       
Outstanding and expected to vest at December 31, 2010
69,200
 
$   12.94

At December 31, 2010, there was approximately $883,000 of total unrecognized compensation cost related to nonvested share awards that is expected to be recognized over a weighted-average period of approximately 37.5 months.  The total fair value of share awards vested was approximately $45,000 and $844,000 in 2009, and 2008, respectively.  No share awards vested in 2010.

 
- 59 -

 

9.
STOCKHOLDERS’ EQUITY

Incentive Plans - In 2010, 2009 and 2008, the Company repurchased 23,290, 60,644 and 63,140 shares of the Company’s common stock, respectively, at a cost of approximately $288,000, $410,000 and $1,003,000, respectively.  The shares repurchased were placed in trust to fund the Long-Term Incentive Plan and Supplemental Executive Retirement Plan.  In 2010, the Company repurchased 40,065 shares of its own stock for $486,000 to contribute to the trust in payment of the special cash dividend payable on the common stock held in trust.

On November 12, 2010, the Board of Directors declared a special one-time cash dividend of $1.25 per share, which was paid on December 1, 2010 to stockholders of record on November 22, 2010.  The dividend was recorded as a reduction to additional paid-in capital of approximately $11,051,000.

At December 31, 2010, 250,584 shares of common stock were reserved for future issuances related to the exercise of stock options previously granted under the stock option plans discussed in Note 8.

10.  
EARNINGS PER SHARE

The following table sets forth the computation of basic and diluted earnings per common share for the years ended December 31:
 
(In thousands, except share and per share data)
 
2010
   
2009
   
2008
                 
Net income (A)
$
3,017
 
$
1,299
 
$
5,572
Weighted average number of basic common shares outstanding (B)
 
8,715,391
   
8,536,768
   
8,455,092
Dilutive effect of stock options computed based on the treasury stock method using average market price
 
152,139
   
251,895
   
483,121
Weighted average number of diluted common shares outstanding (C)
 
8,867,530
   
8,788,663
   
8,938,213
Basic earnings per common share (A/B)
$
0.35
 
$
0.15
 
$
0.66
Diluted earnings per common share (A/C)
$
0.34
 
$
0.15
 
$
0.62
 
11.
INCOME TAXES

Income tax expense was as follows for the years ended December 31:
                 
(In thousands)
 
2010
   
2009
   
2008
                 
Current:
               
Federal
$
151
 
$
(298)
 
$
341
State and local
 
11
   
(22)
   
25
Deferred
 
1,666
   
1,068
   
2,718
 
$
1,828
 
$
748
 
$
3,084


 
- 60 -

 

Following is a reconciliation of federal income tax at the statutory rate of 34% to the actual income taxes provided for the years ended December 31:

(In thousands)
 
2010
   
2009
   
2008
                 
Computed expected federal income tax expense (benefit)
$
1,647
 
$
696
 
$
2,943
State tax, net of federal effect
 
121 
   
52 
   
216 
Other, net
 
60 
   
-
   
(75)
 
$
1,828
 
$
748
 
$
3,084

Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred assets (liabilities) were as follows at December 31:

(In thousands)
 
2010
   
2009
           
Deferred income tax assets:
         
Accounts receivable allowances
$
715
 
$
298
Inventories
 
145 
   
133 
Accrued expenses
 
423
   
430
Deferred compensation
 
1,580
   
1,165
Research and experimental credit carryforwards
 
705
   
602
Federal alternative minimum tax credit carryforwards
 
110
   
106
Net operating loss carryforwards
 
1,659
   
3,086
Other
 
8
   
-
Total deferred tax assets
 
5,345
   
5,820
           
Deferred income tax liabilities:
         
Building, equipment and improvements
 
(1,049)
   
(999)
Goodwill and other intangible assets
 
(4,093)
   
(3,564)
Total deferred tax liabilities
 
(5,142)
   
(4,563)
Net deferred tax assets
$
203
 
$
1,257

At December 31, 2010, the Company had federal net operating loss carryforwards (NOLs) of approximately $4,800,000, which are available to offset future taxable income.  The Company's federal NOLs expire in varying amounts each year from 2023 through 2029 in accordance with applicable federal tax regulations and the timing of when the NOLs were incurred. Section 382 of the Internal Revenue Code restricts the annual utilization of certain NOLs incurred prior to a change in ownership.  However, such limitation is not expected to impair the realization of these NOLs.  In the future, subsequent revisions to the estimated net realizable value of these deferred tax assets could cause the provision for income taxes to vary significantly from period to period, although the Company’s cash payments would remain unaffected until the benefit of the NOLs is completely utilized or expires unused.

In 2010, income tax benefits attributable to share-based compensation of approximately $192,000 and participating dividends of $177,000 were allocated as an increase to additional paid-in capital in stockholder’s equity in the accompanying consolidated balance sheet.  In 2009, the Company utilized $200,000 of deferred tax assets associated with nonvested share awards and stock options and recorded a corresponding reduction to additional paid-in capital.

The Company does not have any unrecognized tax benefits at December 31, 2010 or 2009.

 
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The tax years 2004-2009 remain open to examination by the major taxing jurisdictions to which the Company is subject.

The Company records income tax related interest expense, interest income and penalties in income tax expense in its Consolidated Statements of Income.  The Company did not have any accrued interest related to uncertain tax positions at December 31, 2010 or 2009.

12.
EMPLOYEE BENEFIT PLANS

Retirement Savings Plan - The Company has a defined contribution benefit plan that covers substantially all employees who meet certain age and length of service requirements.  Contributions to the plan are at the discretion of the Company’s Board of Directors.  The 401(k) expense was approximately $364,000, $316,000 and $222,000 in 2010, 2009 and 2008, respectively.
 
 Long-Term Incentive Plan (LTIP) - The Company adopted the LTIP to provide performance-based compensation to selected officers of the Company and compensation to non-employee members of the Board of Directors.  Under the LTIP, an officer becomes eligible for an annual long-term incentive contribution amount based upon performance objectives established by the Compensation Committee of the Board of Directors.  A non-employee director receives 50% of his or her annual retainer in the form of an annual LTIP contribution.  Annual contribution amounts for both officers and directors are subject to three to five year restriction periods with a risk of forfeiture if a participant terminates service prior to becoming vested.  Participants may elect to allocate LTIP awards in investment options authorized by the Committee, including shares of the Company’s common stock.

The Compensation Committee determined the total 2010, 2009 and 2008 contribution amounts to be $100,000, $410,000 and $1,070,000, respectively, allocated among all participants.  To fund the 2010 and 2009 contribution amounts, the Company purchased $100,000 or 8,085 shares and $410,000 or 60,644 shares, respectively, of its own stock, which were contributed to a grantor trust.  To fund the 2008 contribution amount, the Company purchased $1,003,000 or 63,140 shares of its own stock and $67,000 of money market funds, which were contributed to a grantor trust.  The acquired stock was recorded at historical cost and classified as common stock held in trust in stockholders’ equity in the accompanying consolidated balance sheet.  In 2008, the purchase of the money market funds was recorded in other assets in the accompanying consolidated balance sheet.  The Company records compensation expense on a straight-line basis over the three to five year vesting periods, which is recorded as a deferred compensation obligation in other long-term liabilities in the accompanying consolidated balance sheet.  The Company recorded approximately $766,000, $714,000 and $553,000 of compensation expense (recorded in selling, general and administrative expenses) in 2010, 2009 and 2008, respectively, in conjunction with the LTIP.
 
Supplemental Executive Retirement Plan (SERP) – The Company adopted the SERP, which provides supplemental retirement benefits and allows deferral of a portion of base salary and performance based short-term bonuses for selected officers of the Company.  The annual supplemental retirement contribution amount to which an officer is entitled for a plan year is a discretionary amount determined by the Compensation Committee of the Board of Directors. Under the SERP, supplemental retirement benefit contribution amounts vest over one to three year periods.    Participants may elect to allocate SERP awards in investment options authorized by the Committee, including shares of the Company’s common stock.

 
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The Compensation Committee determined the 2010, 2009 and 2008 contribution amounts to be $218,000, $235,000 and $242,000, respectively, allocated among all participants.  To fund the 2010 contribution amount, the Company purchased $188,000 or 15,205 shares of its own stock and $30,000 of marketable equity securities, which were contributed to a grantor trust.  In 2009 and 2008, the plan participants elected to allocate their contribution amounts into various marketable equity securities, which were contributed to a grantor trust.  In 2010, the acquired stock was recorded at historical cost and classified as common stock held in trust in stockholders’ equity.  The purchase of the marketable equity securities was recorded in other assets.  The Company recorded compensation expense (recorded in selling, general and administrative expenses) of $232,000, $159,000 and $81,000 in 2010, 2009 and 2008, respectively, which was classified as a deferred compensation obligation in other long-term liabilities.  In 2010 and 2009, the deferred compensation liability was increased $125,000 and $294,000, respectively, with a corresponding charge to compensation expense, to reflect the change in the fair value of the amount owed to the participant.  The fair value of the marketable equity security also increased $125,000 and $294,000 in 2010 and 2009, respectively, to reflect the investment earnings (recorded in other expense).   In 2008, the deferred compensation liability was reduced $257,000 with a corresponding credit to compensation expense, to reflect the change in the fair value of the amount owed to the participant.  The fair value of the marketable equity security also decreased approximately $257,000 in 2008 to reflect the investment loss.

In 2010, the Company purchased 40,065 shares of its own stock for $486,000 to contribute to the trust in payment of the special cash dividend payable on the common stock held in trust.  The purchase of the stock was recorded as an increase in common stock held in trust with a corresponding increase to the deferred compensation obligation.

13.
COMMITMENTS AND CONTINGENCIES

Leases - The Company leases office and research facilities from a director under a fixed term operating lease.  Rental payments to the director were approximately $349,000, $349,000, and $779,000 during 2010, 2009, and 2008, respectively.  In January 2008, the Company prepaid approximately $430,000 of the lease agreement for the office and research facilities leased from the director, which is included in the 2008 rental payment.

The Company leases other offices and facilities and office equipment under certain operating leases, which expire on various dates through March 2016.  Under the terms of the facility leases, a pro rata share of the facilities’ operating expenses and real estate taxes are charged as additional rent.

At December 31, 2010, the Company was obligated for future minimum lease payments without regard to sublease payments under noncancelable leases as follows for the years ending December 31:

(In thousands)
   
   
Operating Leases
     
2011
$
721
2012
 
652 
2013
 
511
2014
 
511
2015
 
453
2016
 
87
 
$
2,935

Rent expense (including amounts for the facilities leased from the director) amounted to $842,000, $848,000, and $1,722,000 during 2010, 2009, and 2008, respectively.

Legal - The Company is party to various legal proceedings arising in the normal course of business activities, none of which, in the opinion of management, are expected to have a material adverse impact on the Company's consolidated financial position or results of operations.


 
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14.
RELATED PARTY TRANSACTIONS

In March 2001, the Company entered into a 10-year lease of the Burlington, North Carolina production facility for an annual base rent of $197,000, exclusive of operating expenses.  In addition, under the lease $600,000 of tenant improvements made to the building by the Company are being amortized over the life of the lease as additional rent.  The Company received $300,000 for reimbursement of tenant improvements completed in 2001.  Effective February 2003, the Company entered into a month-to-month lease of a warehousing and distribution facility in an adjacent building for a monthly rent of $9,400, exclusive of operating expenses.  These facilities have always been owned and leased to the Company by a director of the Company.  In 2003, the Company completed additional tenant improvements to the premises of $300,000.  In November 2003, the Company amended and restated these leases.  Under the terms of the amended and restated lease, the original leases have been combined and the expiration of the amended and restated lease has been extended to March 31, 2016.  In January 2008, the Company prepaid approximately $430,000 of the lease agreement for the facilities leased from the director relating to the leasehold improvements after determining that the prepayment would be financially beneficial to the Company.  The prepayment was recorded as prepaid rent in other assets (long-term) in the accompanying consolidated balance sheet and will continue to be amortized over the remaining life of the lease as additional rent.  In 2010, the annual base rent was approximately $401,000, exclusive of operating expenses, and including a Consumer Price Index adjustment and amortization of the $600,000 of improvements.  The Company believes it is renting these facilities on terms similar to those available from third parties for equivalent premises based upon review of prevailing market rates at the time of lease renewal.

15.
QUARTERLY INFORMATION (UNAUDITED)
    (In thousands, except per share amounts)

 
2010
 
First
Quarter
 
Second
Quarter
 
Third
Quarter
 
Fourth
Quarter
 
                   
Revenues
$
21,161
$
25,185
$
25,799
$
24,956
 
Gross profit
 
8,100
 
10,341
 
10,812
 
10,387
 
Net income
 
77
 
1,012
 
1,148
 
780 
 
Basic earnings per share
 
0.01
 
0.12
 
0.13
 
0.09
 
Diluted earnings per share
 
0.01
 
0.11
 
0.13
 
0.09
 

 
2009
 
First
Quarter
 
Second
Quarter
 
Third
Quarter
 
Fourth
Quarter
 
                   
Revenues
$
20,658
$
21,332
$
22,261
$
19,857
 
Gross profit
 
7,643
 
7,666
 
8,686
 
6,900
 
Net income (loss)
 
420
 
311
 
758
 
(190) 
 
Basic earnings (loss) per share
 
0.05
 
0.04
 
0.09
 
(0.02)
 
Diluted earnings (loss) per share
 
0.05
 
0.04
 
0.09
 
(0.02)
 


 
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SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS

 
Balance at Beginning
of Period
Charged to
Costs and
Expenses
 
Deductions
 
Balance at
the End of
Period
Year ended December 31, 2010
                   
Allowance for Doubtful Accounts
$
529,000
$
2,050,000
 
$
987,000
 (1)
$
1,592,000
                     
Year ended December 31, 2009
                   
Allowance for Doubtful Accounts
$
362,000
$
640,000
 
$
473,000
 (1)
$
529,000
                     
Year ended December 31, 2008
                   
Allowance for Doubtful Accounts
$
264,000
$
544,000
 
$
446,000
 (1)
$
362,000
                     

(1)
Uncollectible accounts written off, net of recoveries.


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