10-Q 1 form10q1qtr10.htm form10q1qtr10.htm



FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

(Mark One)
(X)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2010
OR
(  )
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period  ___________________________  to  __________________________________                                         

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

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 whether the registrant is a large accelerated filer, an accelerated filer, or 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 ]

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 April 16, 2010 
Common Stock, $0.15 par value per share
   8,695,948 


 
 

 

MEDTOX SCIENTIFIC, INC.

INDEX
     
 Page
Part I
Financial Information:
 
       
 
Item 1:
Financial Statements (Unaudited)
 
       
   
Consolidated Statements of Income – Three
 
   
Months Ended March 31, 2010 and 2009
3
       
   
Consolidated Balance Sheets – March 31, 2010
 
   
and December 31, 2009
4
       
   
Consolidated Statements of Cash Flows – Three
 
   
Months Ended March 31, 2010 and 2009
5
       
   
Notes to Consolidated Financial Statements
6
       
 
Item 2:
Management's Discussion and Analysis of
 
   
Financial Condition and Results of Operations
10
       
 
Item 3:
Quantitative and Qualitative Disclosures
 
   
About Market Risk
21
       
 
Item 4:
Controls and Procedures
21
       
Part II
Other Information
22
       
 
Item 1A:
Risk Factors
22
       
 
Item 5:
Other Information
22
       
 
Item 6:
Exhibits
23
       
   
Signatures
24
       
   
Exhibit Index
25

 
- 2 -

 

PART I                 FINANCIAL INFORMATION

Item 1:                 FINANCIAL STATEMENTS (UNAUDITED)

MEDTOX SCIENTIFIC, INC.
CONSOLIDATED STATEMENTS OF INCOME
(In thousands, except share and per share data)
(Unaudited)

   
Three Months Ended
 
   
March 31, 2010
   
March 31, 2009
 
REVENUES:
           
   Laboratory services:
           
      Drugs-of-abuse testing services
  $ 8,796     $ 8,446  
      Clinical & other laboratory services
    6,890       5,397  
      Clinical trial services
    833       2,315  
   Product sales
    4,642       4,500  
      21,161       20,658  
                 
COST OF REVENUES:
               
  Cost of services
    11,033       11,117  
  Cost of sales
    2,028       1,898  
      13,061       13,015  
                 
GROSS PROFIT
    8,100       7,643  
                 
OPERATING EXPENSES:
               
   Selling, general and administrative
    7,433       6,221  
   Research and development
    549       570  
      7,982       6,791  
                 
INCOME FROM OPERATIONS
    118       852  
                 
OTHER INCOME (EXPENSE):
               
   Interest expense
    (1 )     (6 )
   Other income (expense)
    5       (184 )
      4       (190 )
                 
INCOME BEFORE INCOME TAX EXPENSE
    122       662  
                 
INCOME TAX EXPENSE
    (45 )     (242 )
                 
NET INCOME
  $ 77     $ 420  
                 
BASIC EARNINGS PER COMMON SHARE
  $ 0.01     $ 0.05  
                 
DILUTED EARNINGS PER COMMON SHARE
  $ 0.01     $ 0.05  
                 
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING:
               
          Basic
    8,632,574       8,496,350  
          Diluted
    8,847,337       8,693,042  

See Notes to Consolidated Financial Statements (Unaudited).

 
- 3 -

 

MEDTOX SCIENTIFIC, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(Unaudited)


   
March 31,
2010
   
December 31,
2009
 
ASSETS
           
CURRENT ASSETS:
           
   Cash and cash equivalents
  $ 4,448     $ 4,165  
   Accounts receivable:
               
         Trade, less allowance for doubtful accounts ($639 in 2010 and $529 in 2009)
    16,308       14,916  
         Other
    1,295       1,257  
             Total accounts receivable
    17,603       16,173  
   Inventories
    3,597       3,593  
   Prepaid expenses and other
    1,526       1,429  
   Deferred income taxes
    3,558       3,603  
             Total current assets
    30,732       28,963  
BUILDING, EQUIPMENT AND IMPROVEMENTS, net
    28,515       29,509  
GOODWILL
    15,967       15,967  
OTHER INTANGIBLE ASSETS, net
    254       273  
OTHER ASSETS
    955       1,405  
TOTAL ASSETS
  $ 76,423     $ 76,117  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
CURRENT LIABILITIES:
               
   Accounts payable
  $ 3,918     $ 4,143  
   Accrued expenses
    4,903       4,670  
   Current portion of long-term debt
    133       302  
             Total current liabilities
    8,954       9,115  
LONG-TERM LIABILITIES
    3,035       3,224  
DEFERRED INCOME TAXES, net
    2,346       2,346  
                 
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, 8,799,379
               
         in 2010 and 8,675,510 in 2009
    1,320       1,301  
   Additional paid-in capital
    88,638       88,078  
   Accumulated deficit
    (22,846 )     (22,923 )
   Common stock held in trust, at cost, 367,911 shares in 2010 and 2009
    (4,024 )     (4,024 )
   Treasury stock, at cost, 103,431 shares in 2010 and 2009
    (1,000 )     (1,000 )
             Total stockholders' equity
    62,088       61,432  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  $ 76,423     $ 76,117  

See Notes to Consolidated Financial Statements (Unaudited).

 
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MEDTOX SCIENTIFIC, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

   
Three Months Ended
 
   
March 31,
2010
   
March 31,
2009
 
             
CASH FLOWS PROVIDED BY OPERATING ACTIVITIES:
           
   Net income
  $ 77     $ 420  
   Adjustments to reconcile net income to net cash provided by
               
           operating activities:
               
      Depreciation and amortization
    1,420       1,299  
      Provision for losses on accounts receivable
    230       158  
      Loss on sale of equipment
    -       9  
      Deferred and stock-based compensation
    244       203  
      Deferred income taxes
    45       242  
      Changes in operating assets and liabilities:
               
         Accounts receivable
    (1,660 )     (1,474 )
         Inventories
    (4 )     (47 )
         Prepaid expenses and other current assets
    (97 )     (138 )
         Other assets
    17       11  
         Accounts payable and accrued expenses
    649       (146 )
                Net cash provided by operating activities
    921       537  
                 
CASH FLOWS USED IN INVESTING ACTIVITIES:
               
    Purchase of building, equipment and improvements
    (1,048 )     (720 )
                Net cash used in investing activities
    (1,048 )     (720 )
                 
CASH FLOWS PROVIDED BY (USED IN) FINANCING ACTIVITIES:
               
    Principal payments on long-term debt
    (169 )     (169 )
    Purchase of common stock for incentive plan
    -       (392 )
    Net proceeds from the exercise of stock options
    579       224  
              Net cash provided by (used in) financing activities
    410       (337 )
                 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    283       (520 )
                 
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
    4,165       4,069  
                 
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 4,448     $ 3,549  
                 
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
               
   Cash paid for:
               
          Interest
  $ 1     $ 7  
          Income taxes
    25       11  
                 
Supplemental noncash activities:
               
          Asset additions and related obligations in payables
    118       727  

See Notes to Consolidated Financial Statements (Unaudited).

 
- 5 -

 

MEDTOX SCIENTIFIC, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
March 31, 2010

1.  BASIS OF PRESENTATION

The accompanying unaudited consolidated financial statements of MEDTOX Scientific, Inc. (the Company) have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, they do not include all of the information and notes required by generally accepted accounting principles.  In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of financial condition and results of operations have been included.  Operating results for the three month period ended March 31, 2010 are not necessarily indicative of the results that may be attained for the entire year.  These consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2009.

2.  SEGMENTS

The Company has two reportable segments:  Laboratory Services and Product Sales.  The Laboratory Services segment consists of MEDTOX Laboratories and New Brighton Business Center, LLC (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.

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.

 
- 6 -

 


(In thousands)
 
Three Months Ended
 
   
March 31, 2010
   
March 31,
 2009
 
Laboratory Services:
           
   Revenues
  $ 16,519     $ 16,158  
   Depreciation and amortization
    1,223       1,151  
   Income (loss) from operations
    (561 )     74  
   Capital expenditures for segment assets
    1,001       623  
                 
Product Sales:
               
   Revenues
  $ 4,642     $ 4,500  
   Depreciation and amortization
    197       148  
   Income from operations
    679       778  
   Capital expenditures for segment assets
    47       97  
                 
Corporate (unallocated):
               
   Other income (expense)
  $ 4     $ (190 )
                 
Company:
               
   Revenues
  $ 21,161     $ 20,658  
   Depreciation and amortization
    1,420       1,299  
   Income from operations
    118       852  
   Other income (expense)
    4       (190 )
   Income before income tax expense
    122       662  
   Capital expenditures for assets
    1,048       720  

(In thousands)
 
March 31, 2010
   
December 31, 2009
 
Assets:
           
  Laboratory Services
  $ 60,037     $ 60,630  
  Product Sales
    12,828       11,884  
  Corporate (unallocated)
    3,558       3,603  
  Company
  $ 76,423     $ 76,117  

The following is a summary of revenues from external customers for each group of products and services provided within the Product Sales segment:

(In thousands)
 
Three Months Ended
 
   
March 31,
2010
   
March 31,
2009
 
             
POC on site testing products
  $ 4,109     $ 4,025  
Contract manufacturing services
    395       378  
Other diagnostic products
    138       97  
    $ 4,642     $ 4,500  
 
 
- 7 -

 
3.  INVENTORIES

Inventories consisted of the following:

(In thousands)
 
March 31,
2010
   
December 31,
2009
 
             
Raw materials
  $ 746     $ 653  
Work in process
    361       400  
Finished goods
    323       360  
Supplies, including off-site inventory
    2,167       2,180  
    $ 3,597     $ 3,593  

4.  EARNINGS PER SHARE

The following table sets forth the computation of basic and diluted earnings per common share:

(In thousands, except share and per share data)
 
Three Months Ended
 
   
March 31,
2010
   
March 31,
2009
 
             
Net income (A)
  $ 77     $ 420  
Weighted average number of basic common shares outstanding (B)
    8,632,574       8,496,350  
Dilutive effect of stock options computed based on the treasury stock method using average market price
    214,763       196,692  
Weighted average number of diluted common shares outstanding (C)
    8,847,337       8,693,042  
Basic earnings per common share (A/B)
  $ 0.01     $ 0.05  
Diluted earnings per common share (A/C)
  $ 0.01     $ 0.05  

5.  INCOME TAXES

At December 31, 2009, the Company had federal net operating loss carryforwards (NOLs) of approximately $9.0 million, which are available to offset future taxable income.  The Company's federal NOLs expire in varying amounts each year from 2018 through 2028 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.


 
- 8 -

 

6.  CONTINGENCIES

Leases - The Company leases 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 operating expenses and real estate taxes are charged as additional rent.

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.


 
- 9 -

 

Item 2:  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Form 10-Q 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 “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 Form 10-Q containing the words “believes”, “anticipates”, “plans”, “expects”, and similar expressions constitute forward looking statements, although not all forward looking statements contain such identifying words.  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 2010 and the sufficiency of future profitable operations and access to additional capital to fund our operations beyond 2010, and (vi) statements of assumptions underlying other statements and statements about our business.

The forward looking statements contained in this Form 10-Q 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 the next paragraph, 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 Form 10-Q.  In light of the significant uncertainties inherent in the forward looking statements included in this Form 10-Q, 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.  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.

The following is a listing of some of the important factors that could cause actual results to differ materially from those indicated by the forward looking statements contained in this Form 10-Q:

·  
increased competition, including price competition

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


 
- 10 -

 

·  
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

·  
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

·  
inaccurate information regarding market opportunities

·  
failure to receive regulatory approvals and clearances

·  
other factors, including those set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009

The above listing should not be construed as exhaustive; we cannot predict all the factors that could cause results to differ materially from those indicated by the forward looking statements.


 
- 11 -

 

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.

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.


 
- 12 -

 

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.

In January 2008, we announced that we were voluntarily recalling approximately 400 MEDTOXScan® electronic readers because of mis-branding.  The PROFILE®-III ER devices sold for use with the readers and which are properly cleared for sale by the FDA, can be read visually without the reader.  The readers were provided to customers at no cost, therefore the direct financial impact of the recall is limited to shipping fees which are estimated to be less than $10,000.  It had been our original intention to replace these readers with a new generation of reader having over-the-counter (OTC) approval in 2008.  As a result of the recall, we sought “prescription use” clearance for the new reader.  We filed a 510(k) application in March 2008.  In February 2009, we received 510(k) clearance from the FDA to market our MEDTOXScan® electronic readers to be used with nine drugs.  In May 2009, we filed a 510(k) application with the FDA for three more drugs to be added to the reader menu.  In July 2009, we received 510(k) clearance from the FDA to market our PROFILE®-V MEDTOXScan® Drugs-of-Abuse Test System with the three additional drugs.  In April 2010, we received 510(k) clearance from the FDA for two additional drugs for our MEDTOXScan® Drugs-of-Abuse Test System.  The total number of drugs detectable on the system is now fourteen.   Currently, we have between 300 to 400 hospital clients utilizing our PROFILE® visually read cassettes for drugs-of-abuse detection.  The new Test System will be marketed not only to those clients, but to the broader hospital market which is estimated in excess of 2,500 hospitals.  Since receiving FDA clearance for the expanded panel, we have shipped over 500 units.

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 the first quarter of 2010, testing volume from our existing workplace drugs-of-abuse clients was lower than in the prior year period, 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.

 
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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 four years, we have expanded our number of sales representatives from 23 to 51.  The increase in sales representatives 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.

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

In 2007, 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.  In 2007, we initiated a relationship with one private label client.

In 2006, we developed and introduced MEDTOXScan®, an electronic reader, which we provide to hospitals for use with our PROFILE-II ER® and PROFILE®-III ER POCT devices in hospital laboratories and emergency rooms.

In 2005, we developed and introduced eChain®, our web-based electronic chain-of-custody and donor tracking system.  We currently have over 1,500 clinics and collection sites utilizing eChain® throughout the country.

In 2005, we also introduced SURE-SCREEN®, our lower detection level POCT device targeted for the government and rehabilitation markets and our PROFILE®-III device, an integrated cup and testing device for sale to the workplace drug testing market.

ClearCourse®, another innovative solution we offer, is a 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.

Critical Accounting Policies
 
There were no significant changes to our critical accounting policies during the quarter ended March 31, 2010 from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2009.

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 the first quarter of 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.

 
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Three Months Ended March 31, 2010 Compared to Three Months Ended March 31, 2009

Revenues

   
Three Months Ended
   
Quarter-over-Quarter
 
(In thousands, except percentages)
 
March 31, 2010
   
March 31, 2009
   
$ Change
   
% Change
 
Revenues:
                       
                         
Laboratory Services
                       
   Drugs-of-abuse testing  services
  $ 8,796     $ 8,446     $ 350       4 %
   Clinical & other laboratory services
    6,890       5,397       1,493       28 %
   Clinical trial services
    833       2,315       (1,482 )     (64 )%
                                 
Product Sales
    4,642       4,500       142       3 %
                                 
    $ 21,161     $ 20,658     $ 503       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 4% to $8.8 million in the first quarter of 2010 primarily as a result of an increase in new account revenues, partially offset by a 6% decline in revenues from our existing drug-of-abuse clients due to challenging economic conditions affecting hiring decisions.  We expect a continuing negative impact on revenues from our drugs-of-abuse clients in 2010 caused by the negative economic conditions affecting hiring.  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 in our clinical and other laboratory services increased 28% to $6.9 million in the first quarter of 2010 due to continued strong growth generated by our expanded clinical laboratory capabilities and diversification initiatives undertaken in 2008.

Revenues in clinical trial services decreased 64% to $0.8 million in the first quarter of 2010 and continue to be impacted by a slow-down of projects and deferral of work into future quarters. Revenues from clinical trial services can fluctuate from quarter-to-quarter based on the project nature, size, and the actual timing of clinical trials.

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 2% to $4.1 million in the first quarter of 2010.  The increase was due primarily an increase in revenues from device sales in the workplace market.  Overall, pricing for our POCT devices was stable quarter over quarter.


 
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Sales of contract manufacturing services were flat at $0.4 million in the first quarter of 2010 compared to the same period in 2009.

Sales of other diagnostic products were flat at $0.1 million in the first quarter of 2010 compared to the same period in 2009.

Cost of Revenues and Gross Margin

   
Three Months Ended
   
Quarter-over-Quarter
 
   
March 31, 2010
   
% of Revenues
   
March 31, 2009
   
% of Revenues
   
$ Change
   
%
Change
 
Cost of Revenues:
                                   
                                     
Cost of Services
  $ 11,033       66.8 %*   $ 11,117       68.8 %*   $ (84 )     (1 )%
                                                 
Cost of Sales
    2,028       43.7 %**     1,898       42.2 %**     130       7 %
                                                 
    $ 13,061       61.7 %   $ 13,015       63.0 %   $ 46       - %

-      Less than 1%
*     Cost of services as a percentage of Laboratory Services revenues
**   Cost of sales as a percentage of Product Sales revenues

Consolidated gross margin increased to 38.3% of revenues in the first quarter of 2010, compared to 37.0% of revenues for the same period in 2009.

Laboratory Services gross margin was 33.2% in the first quarter of 2010, up from 31.2% in the first quarter of 2009.  Cost of services was relatively flat in the first quarter of 2010 compared to the same period in 2009.  The increase in gross margin was due to increased volume through a stable cost structure.   Gross margin from Product Sales decreased to 56.3% in the first quarter of 2010, down from 57.8% in the same period of 2009.

Operating Expenses

   
Three Months Ended
   
Quarter-over-Quarter
 
   
March 31, 2010
   
% of Revenues
   
March 31, 2009
   
% of Revenues
   
$
Change
   
% Change
 
Operating Expenses:
                                   
                                     
Selling, general and
   administrative
  $ 7,433       35.1 %   $ 6,221       30.1 %   $ 1,212       20 %
                                                 
Research and
   development
    549       2.6 %     570       2.8 %     (21 )     (4 )%
                                                 
    $ 7,982       37.7 %   $ 6,791       32.9 %   $ 1,191       18 %
 
 
 
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Selling, General and Administrative Expenses.  Selling, general and administrative (SG&A) expenses increased to $7.4 million, or 35.1% of revenues in the first quarter of 2010, compared to $6.2 million, or 30.1% of revenues in the first quarter of 2009.  This increase was primarily associated with an increase in sales and marketing expense and the reclassification of $195,000 from other expenses which were determined to be more appropriately classified in SG&A expenses.  Our SG&A expenses of $7.4 million in the first quarter of 2010 compared more closely to the previous two quarters, where SG&A expenses were $6.8 million and $7.1 million respectively.  The increase in the current quarter, over the previous two quarters, was due primarily to the timing of expenses relating to our year-end financial audit, as well as incentive based compensation expense.
 
Research and Development Expenses.  Research and development expenses decreased 4% to $549,000 in the first quarter of 2010, primarily due to decreased spending for on-going projects in our Product Sales segment.

Other Income (Expense)

Other income (expense) consists primarily of interest expense, our investment gains/losses, and the net expenses associated with our building rental activities.  Other income was $4,000 in the first quarter of 2010 compared to other expense of $190,000 for the same period in 2009.  The variance was due to the reclassification of $195,000 for the three months ended March 31, 2010 from Other Income (Expense) which was determined to be more appropriately classified in SG&A expenses.

Liquidity and Capital Resources

Our working capital requirements have been funded primarily by profitable operations.  Cash and cash equivalents at March 31, 2010 were $4.4 million, compared to $4.2 million at December 31, 2009.

Net cash provided by operating activities was $0.9 million for the three months ended March 31, 2010 compared to $0.5 million for the same period of 2009.  The increase was primarily due to an increase in accounts payable in the first quarter of 2010 compared to a decrease in the same period of 2009, primarily due to the timing of scheduled payments.

Net cash used in investing activities, consisting of capital expenditures, was $1.0 million for the three months ended March 31, 2010 compared to $0.7 million for the same period of 2009.  In both periods, these expenditures included equipment purchased and costs incurred to upgrade equipment, improve efficiencies and increase service levels to our clients.

Net cash provided by financing activities was $0.4 million for the three months ended March 31, 2010 compared to cash used in financing activities of $0.3 million in the prior year period.   The change was partly due to an increase in the net proceeds from the exercise of stock options and the absence of costs incurred in the first quarter of 2010 related to the repurchase of shares of our common stock.  In the first quarter of 2009, we repurchased 58,054 shares of our common stock in the open market for a cost of $0.4 million which were placed in trust to fund our Long-Term Incentive Plan.

We are party to a credit security agreement (the "Wells Fargo Credit Agreement") with Wells Fargo Bank, National Association (the “Bank”).  The Wells Fargo Credit Agreement, as amended, consists of a revolving line of credit ("Line of Credit") of up to $8.0 million bearing interest at a fluctuating rate of 2.25% above the daily three month LIBOR, as defined and calculated by the Bank.

 
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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 $40,000,000 at any time, with “Tangible Net Worth” defined as the aggregate of total stockholders’ equity plus subordinated debt less any intangible assets.

·  
Current Ratio not less than 1.3 to 1.0 at each month end, with “Current Ratio” defined as total current assets divided by total current liabilities.

·  
Total Liabilities divided by Tangible Net Worth not greater than 1.75 to 1.0 at any time, with “Total Liabilities” defined as the aggregate of current liabilities and non-current liabilities less subordinated debt, and with “Tangible Net Worth” as defined above.

·  
A Debt Service Coverage Ratio not less than 1.5 to 1.0 as of each fiscal quarter end, determined on a rolling four-quarter basis, with “Debt Service Coverage Ratio” defined as the aggregate of net income before non-cash tax expense plus depreciation expense and amortization expense, divided by the aggregate of the current maturity of long-term debt for the previous four fiscal quarters plus current capital lease obligations for the previous four fiscal quarters.

We are relying on expected positive cash flows from operations and our Line of Credit to fund our future working capital and asset purchases.  As of March 31, 2010, we had total borrowing capacity of $8.0 million on our line of credit.  We did not have an outstanding balance on our Line of Credit at March 31, 2010.

In the short term, we believe that the aforementioned resources will be sufficient to fund our planned operations through 2010.  While there can be no assurance that the available capital will be sufficient to fund our future operations beyond 2010, 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.

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.


 
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Off-Balance Sheet Transactions

The Company does 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 the Company’s 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 on the Company has been primarily limited to salary, laboratory and operating supplies and rent increases and has historically not been material to the Company’s operations.  In the future, the Company may not be able to increase the prices of laboratory testing by an amount sufficient to cover the cost of inflation, although the Company is responding to these concerns by refocusing the laboratory operations towards higher margin testing (including clinical and pharmaceutical trials) as well as emphasizing the marketing, sales and operations of the Product Sales business.

Seasonality

The Company believes 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 flows.


 
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Item 3:  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

There have been no material changes in our market risk during the quarter ended March 31, 2010.  For additional information refer to Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2009.

Item 4:  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 and Exchange Commission’s rules and forms.
 
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.
 



 
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PART II                      OTHER INFORMATION

ITEM 1A                    RISK FACTORS.  There have been no material changes to our risk factors during the quarter ended March 31, 2010.  For additional information refer to Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009.
 
 
ITEM 5
OTHER INFORMATION.

Executive Salaries for 2010

On March 22, 2010, the Compensation Committee of the Board of Directors of the Company (the “Committee”) approved 2010 base salaries for the executive officers, effective April 1, 2010, as set forth below:

Executive Officer
Title
 
Salary
 
Richard J. Braun
President and Chief Executive Officer
  $ 390,000  
Kevin J. Wiersma
Chief Financial Officer, Vice President and Chief Operating Officer of MEDTOX Laboratories, Inc.
  $ 235,800  
James A. Schoonover
Vice President and Chief Marketing Officer
  $ 235,800  
B. Mitchell Owens
Vice President and Chief Operating Officer of MEDTOX Diagnostics, Inc.
  $ 223,100  
Susan E. Puskas
Vice President Quality, Regulatory Affairs, and Human Resources
  $ 235,800  

Target Financial Objectives for Fiscal Year 2010 under the Annual Incentive Plan and Long Term Incentive Plan
 
On March 29, 2010, the Committee approved weighted target financial objectives for the Company’s 2010 Annual Incentive Plan and Long-Term Incentive Plan (LTIP). Awards will be based on the target payouts set forth below, which are expressed as a percentage of base salary. Specific payments to individuals could exceed the following targets if the Company achieves more than 100% of its target financial objectives, but in no event will the Annual Incentive Payment or LTIP individually exceed two times base salary.

Title
 
Target Payout %
 
Chief Executive Officer
  
100
%
       
Chief Financial Officer and Chief Operating Officer of MEDTOX Laboratories, Inc.
  
60
%
       
Vice President and Chief Marketing Officer
 
60
%
       
Vice President and Chief Operating Officer of MEDTOX Diagnostics, Inc.
 
60
%
       
Vice President Quality, Regulatory Affairs, and Human Resources
 
60
%
 
 
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Employees must be employed by the Company as of December 31, 2010, and at the time of the awards in order to participate in the Plans, and awards may be adjusted on a pro rata basis to the extent any employee is employed for only a portion of the year 2010. The Chief Executive Officer will recommend individual awards for all participating employees (except for the Chief Executive Officer) for approval by the Committee based on an assessment of each individual’s performance. The Committee may approve or disapprove any recommended awards in whole or in part in its sole discretion. The Committee shall determine the award for the Chief Executive Officer based on an assessment of his performance for 2010.
 
ITEM 6
EXHIBITS.  See Exhibit Index on page following signature page

 
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SIGNATURES


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

Signature
Title
Date
     
/s/ Richard J. Braun
President, Chief Executive Officer, and
May 4, 2010
Richard J. Braun
Chairman of the Board of Directors (Principal Executive Officer)
 
     
/s/ Kevin J. Wiersma
Vice President and Chief Financial Officer
May 4, 2010
Kevin J. Wiersma
(Principal Financial Officer)
 
     
/s/ Angela M. Lacis
Corporate Controller
May 4, 2010
Angela M. Lacis
(Principal Accounting Officer)
 
     






 
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EXHIBIT INDEX
MEDTOX SCIENTIFIC, INC.
FORM 10-Q FOR QUARTER ENDED MARCH 31, 2010

Exhibit
Number                   Description

 
10.1
Executive Salaries for 2010.**

 
10.2
Target Financial Objectives for Fiscal Year 2010 under the Annual Incentive Plan and Long Term Incentive Plan.**

 
31.1  
Section 302 Certification

 
31.2  
Section 302 Certification

 
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.

 
 ** Denotes a management contract or compensatory plan or arrangement

 
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