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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 September 30, 2004

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
incorporated 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 is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes            No       X     

The number of shares of Common Stock, $.15 par value, outstanding as of October 26, 2004, was 7,535,191.

MEDTOX SCIENTIFIC, INC.

INDEX

Page
Part I        Financial Information:  
 
                  Item 1: Financial Statements (Unaudited)
 
                           Consolidated Statements of Operations - Three and Nine
                           Months Ended September 30, 2004 and 2003
 
                           Consolidated Balance Sheets - September 30, 2004
                           and December 31, 2003
 
                           Consolidated Statements of Cash Flows - Nine
                           Months Ended September 30, 2004 and 2003
 
                           Notes to Consolidated Financial Statements
 
                  Item 2:
 
                           Management's Discussion and Analysis of
                           Financial Condition and Results of Operations 11 
 
                  Item 3:
 
                           Quantitative and Qualitative Disclosures
                           About Market Risk 21 
 
                  Item 4:
 
                           Controls and Procedures 21 
 
Part II       Other Information 22 
 
                  Item 1: Legal Proceedings 22 
                  Item 2: Unregistered Sales of Equity Securities and Use of Proceeds 22 
                  Item 3: Defaults upon Senior Securities 22 
                  Item 4: Submission of Matters to a Vote of Security Holders 22 
                  Item 5: Other Information 22 
                  Item 6: Exhibits 22 
 
                           Signatures 23 
                           Exhibit Index 24 

2


PART I    FINANCIAL INFORMATION
Item 1:     FINANCIAL STATEMENTS (UNAUDITED)

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


Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
REVENUES:                    
   Laboratory services     $ 10,979   $ 10,391   $ 32,694   $ 30,010  
   Product sales       3,494     3,177     10,426     9,186  

        14,473     13,568   43,120     39,196  
COST OF REVENUES:    
  Cost of services       7,055     6,804     20,638     20,006  
  Cost of sales       1,386     1,304     4,096     3,925  

        8,441     8,108     24,734     23,931  

GROSS PROFIT       6,032     5,460     18,386     15,265  
     
OPERATING EXPENSES:    
   Selling, general and administrative       4,397     4,157     13,310     12,878  
   Research and development       354     401     1,189     1,233  

        4,751     4,558     14,499     14,111  

INCOME FROM OPERATIONS       1,281     902     3,887     1,154  
     
OTHER INCOME (EXPENSE):    
   Interest expense       (264 )   (281 )   (790 )   (876 )
   Other expense, net       (99 )   (129 )   (337 )   (363 )

        (363 )   (410 )   (1,127 )   (1,239 )

INCOME (LOSS) BEFORE INCOME    
TAX (EXPENSE) BENEFIT       918     492     2,760     (85 )
     
INCOME TAX (EXPENSE) BENEFIT       (349 )   (109 )   (1,049 )   15  

NET INCOME (LOSS)     $ 569   $ 383   $ 1,711   $ (70 )

BASIC EARNINGS (LOSS) PER    
COMMON SHARE (1)    $ 0.08   $ 0.05   $ 0.23   $ (0.01 )

DILUTED EARNINGS (LOSS) PER    
COMMON SHARE (1)    $ 0.07   $ 0.05   $ 0.22   $ (0.01 )

WEIGHTED AVERAGE NUMBER OF    
   SHARES OUTSTANDING:    
          Basic (1)      7,444,973     7,424,004     7,451,174     7,406,906  
          Diluted (1)      7,930,347     7,585,857     7,806,901     7,406,906  

(1)     Share and per share amounts for the three and nine months ended September 30, 2003 have been restated for the three-for-two stock split paid August 20, 2004.

See Notes to Consolidated Financial Statements (Unaudited).

3


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

September 30,
2004

December 31,
2003

ASSETS            
CURRENT ASSETS:  
   Cash and cash equivalents   $ 542   $ 711  
   Accounts receivable:  
        Trade, less allowance for doubtful accounts ($491 in 2004 and $372 in 2003)    9,089    7,922  
        Other    147    145  
        Note receivable from related party    --    300  


            Total accounts receivable    9,236    8,367  
   Inventories    3,547    3,564  
   Deferred income taxes    1,258    1,258  
   Prepaid expenses and other    796    1,406  


            Total current assets    15,379    15,306  
BUILDING, EQUIPMENT AND IMPROVEMENTS, net    16,526    15,092  
GOODWILL    15,967    15,967  
OTHER INTANGIBLE ASSETS, net    1,746    1,836  
DEFERRED INCOME TAXES, net    7,028    8,077  
OTHER ASSETS    204    240  


TOTAL ASSETS   $ 56,850   $ 56,518  


LIABILITIES AND STOCKHOLDERS' EQUITY   
CURRENT LIABILITIES:  
   Line of credit   $ 5,510   $ 5,126  
   Accounts payable    1,853    2,236  
   Accrued expenses    3,982    3,649  
   Current portion of long-term debt    1,511    2,725  
   Current portion of capital leases    79    73  


             Total current liabilities    12,935    13,809  
LONG-TERM DEBT, net of current portion    6,347    7,526  
LONG-TERM PORTION OF CAPITAL LEASES, net of current portion    52    113  
   
STOCKHOLDERS' EQUITY:  
   Preferred stock, $1.00 par value; authorized shares, 50,000; none issued and  
         outstanding    --    --  
   Common stock, $0.15 par value; authorized shares, 14,400,000; issued and  
         outstanding shares, 7,534,661 in 2004 and 4,977,221 in 2003    1,130    746  
   Additional paid-in capital    82,020    81,666  
   Deferred stock-based compensation    (626 )  (995 )
   Accumulated deficit    (44,832 )  (46,171 )
   Treasury stock    (176 )  (176 )


             Total stockholders' equity    37,516    35,070  


TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY   $ 56,850   $ 56,518  


See Notes to Consolidated Financial Statements (Unaudited).

4


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

Nine Months Ended
September 30,

2004
2003
CASH FLOWS PROVIDED BY OPERATING ACTIVITIES:            
   Net income (loss)   $ 1,711   $ (70 )
   Adjustments to reconcile net income (loss) to net cash provided by  
           operating activities:  
      Depreciation and amortization    2,332    2,124  
      Provision for losses on accounts receivable    210    566  
      Loss on sale of equipment    7    --  
      Deferred compensation    336    396  
      Deferred income taxes    1,049    --  
      Changes in operating assets and liabilities:  
         Accounts receivable    (1,079 )  (263 )
         Inventories    17    860  
         Prepaid expenses and other current assets    610    213  
         Other assets    (157 )  97  
         Accounts payable and accrued expenses    (50 )  (2,034 )


                Net cash provided by operating activities    4,986    1,889  
   
CASH FLOWS USED IN INVESTING ACTIVITIES:   
   Capital expenditures    (3,447 )  (2,136 )
   Proceeds from sale of equipment    46    --  


                Net cash used in investing activities    (3,401 )  (2,136 )
   
CASH FLOWS PROVIDED BY (USED IN) FINANCING ACTIVITIES:   
   Net proceeds from sale of common stock    547    44  
   Net proceeds on revolving credit facility    384    751  
   Proceeds from long-term debt    --    1,641  
   Principal payments on long-term debt    (2,481 )  (1,994 )
   Principal payments on capital leases    (55 )  (66 )
   Payment of taxes from traded shares    (149 )  --  


              Net cash provided by (used in) financing activities    (1,754 )  376  


INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS    (169 )  129  
   
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD    711    439  


CASH AND CASH EQUIVALENTS AT END OF PERIOD   $ 542   $ 568  


SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:  
   Cash paid for:  
          Interest   $ 789   $ 846  

See Notes to Consolidated Financial Statements (Unaudited).

5


MEDTOX SCIENTIFIC, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
September 30, 2004

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 nine-month period ended September 30, 2004 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, 2003.

Stock-Based Compensation — Statement of Financial Accounting Standards (SFAS) No. 123, “Accounting for Stock-Based Compensation,” requires companies to measure employee stock compensation plans and non-employee stock-based compensation based on the fair value method of accounting. However, for stock compensation granted to employees, SFAS No. 123 allows the alternative of continued use of Accounting Principles Board Opinion (APBO) No. 25, “Accounting for Stock Issued to Employees,” with pro forma disclosure of net income and earnings per share determined as if the fair value method had been applied in measuring compensation cost. The Company has elected the continued use of APBO No. 25.

Had the Company determined compensation expense for its stock options under SFAS No. 123, (as amended by SFAS No. 148), the Company’s net income (loss) and earnings (loss) per share would have been changed to the pro forma amounts indicated below:


(In thousands, except per share data) Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
Net income (loss)......................................     As reported     $ 569   $ 383   $ 1,711   $ (70 )
    Less: Total stock-based compensation  
     expense, net of related tax effect        (60 )  (154 )  (214 )  (462 )




    Pro forma    509    229    1,497    (532 )
 
Basic earnings (loss) per share...............   As reported   $ 0.08   $ 0.05   $ 0.23   $ (0.01 )
    Pro forma    0.07    0.03    0.20    (0.07 )
 
Diluted earnings (loss) per share............   As reported   $ 0.07   $ 0.05   $ 0.22   $ (0.01 )
    Pro forma    0.06    0.03    0.19    (0.07 )

6


New Accounting Standards: On March 31, 2004, the Financial Accounting Standards Board (FASB) issued a proposed Statement, “Share-Based Payment—an amendment of Statements No. 123 and 95,” that addresses the accounting for share-based payment transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise’s equity instruments or that may be settled by the issuance of such equity instruments. The proposed Statement would eliminate the ability to account for share-based compensation transactions using APBO No. 25 and generally would require instead that such transactions be accounted for using a fair-value-based method. The Company is currently in the process of evaluating the impact of the proposed Statement.

In January 2003, the FASB issued Interpretation No. 46, “Consolidation of Variable Interest Entities,” as revised in December 2003 (FIN 46R).  FIN 46R addresses consolidation by business enterprises of variable interest entities and significantly changes the consolidation application of consolidation policies to variable interest entities and, thus improves comparability between enterprises engaged in similar activities when those activities are conducted through variable interest entities.  The consolidation requirements of FIN 46R applied to variable interest entities as of March 31, 2004. The Company does not hold an interest in any variable interest entities.

2.     SEGMENTS

The Company has two reportable segments: Laboratory Services and Product Sales. The Laboratory Services segment consists of MEDTOX Laboratories Inc. Services provided include workplace drugs-of-abuse testing and specialty laboratory services, which include clinical toxicology, clinical testing for the pharmaceutical industry, pediatric lead testing, heavy metals analyses and courier delivery. The Product Sales segment, which includes POC (point of care) disposable diagnostics 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-II ER®, and VERDICT®-II, in addition to a variety of agricultural testing products. MEDTOX Diagnostics Inc. also provides contract manufacturing services in its Food and Drug Administration/Good Manufacturing Practices (FDA/GMP) 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.

7


(In thousands) Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
Laboratory Services:                    
   
  Revenues   $ 10,979   $ 10,391   $ 32,694   $ 30,010  
  Depreciation and amortization    692    581    1,900    1,750  
  Income from operations    795    603    2,727    699  
  Segment assets    41,706    40,367    41,706    40,367  
  Capital expenditures for segment assets    675    92    3,152    805  
   
Product Sales:  
   
  Revenues   $ 3,494   $ 3,177   $ 10,426   $ 9,186  
  Depreciation and amortization    144    143    432    374  
  Income from operations    486    299    1,160    455  
  Segment assets    6,858    7,132    6,858    7,132  
  Capital expenditures for segment assets    139    435    295    1,331  
   
Corporate (unallocated):  
   
  Other expense   $ (363 ) $ (410 ) $ (1,127 ) $ (1,239 )
  Deferred tax assets, net    8,286    9,337    8,286    9,337  
   
Company:  
   
  Revenues   $ 14,473   $ 13,568   $ 43,120   $ 39,196  
  Depreciation and amortization    836    724    2,332    2,124  
  Income from operations    1,281    902    3,887    1,154  
  Other expense    (363 )  (410 )  (1,127 )  (1,239 )
  Income (loss) before income taxes    918    492    2,760    (85 )
  Total assets    56,850    56,836    56,850    56,836  
  Capital expenditures for assets    814    527    3,447    2,136  

The following is a summary of revenues from external customers for each group of services provided within the Laboratory Services segment:


(In thousands) Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
Workplace drugs-of-abuse     $ 7,228   $ 6,343   $ 21,050   $ 18,357  
Other specialty laboratory services    3,751    4,048    11,644    11,653  




    $ 10,979   $ 10,391   $ 32,694   $ 30,010  





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

8


(In thousands) Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
POC on site testing products     $ 2,890   $ 2,720   $ 8,658   $ 7,790  
Contract manufacturing services    582    375    1,581    1,127  
Other diagnostic products    22    82    187    269  




    $ 3,494   $ 3,177   $ 10,426   $ 9,186  




3.     INVENTORIES

Inventories consisted of the following:

(In thousands) September 30,
2004

December 31,
2003

Raw materials     $ 1,022   $ 1,082        
Work in process    333    533      
Finished goods    645    535      
Supplies, including off-site inventory    1,547    1,414      


    $ 3,547   $ 3,564      


4.     EARNINGS (LOSS) PER SHARE

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


(In thousands, except share and
per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
Net income (loss) (A)     $ 569   $ 383   $ 1,711   $ (70 )




Weighted average number of basic  
  common shares outstanding (B)    7,444,973    7,424,004    7,451,174    7,406,906  
Dilutive effect of stock options and  
  warrants computed based on the  
  treasury stock method using  
  average market price    485,374    161,853    355,726    --  




Weighted average number of diluted  
  common shares outstanding (C)    7,930,347    7,585,857    7,806,901    7,406,906  




Basic earnings (loss) per common  
share (A/B)   $ 0.08   $ 0.05   $ 0.23   $ (0.01 )




Diluted earnings (loss) per common  
share (A/C)   $ 0.07   $ 0.05   $ 0.22   $ (0.01 )





Options and warrants to purchase 8,682, 1,338,243, 2,027,517 and 2,558,645 shares of common stock were outstanding during the three and nine months ended September 30, 2004 and 2003, respectively, but were not included in the computation of diluted earnings per share as their exercise prices were greater than the average market price of the common shares, or because they were antidilutive in the nine months ended September 30, 2003 due to a net loss.

9


5.     INCOME TAXES

At December 31, 2003, the Company had federal operating loss carryforwards (NOLs) of approximately $27.9 million, which are available to offset taxable income in 2004 through 2023. In addition, at December 31, 2003 the Company had state NOLs of approximately $10.8 million, which are available to offset taxable income in 2004 through 2029. For financial reporting purposes, a valuation allowance has been recorded to offset deferred tax assets that, more likely than not, will not be realized based on the Company’s projected future taxable income, the timing of expiring NOLs, and the Company’s tax planning strategies. Section 382 of the Internal Revenue Code restricts the annual utilization of certain NOLs incurred prior to a change in ownership. Although the Section 382 limitation is not expected to impair the realization of these NOLs, other factors could, such as projected future taxable income, the timing of expiring NOLs, and the Company’s tax planning strategies.

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.

10


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

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 revenues, income or loss, earnings or loss per share, capital expenditures, dividends, capital structure and other financial items, (ii) statements of the plans and objectives of the Company or its management or Board of Directors, including the introduction of new products, or estimates or predictions of actions by customers, suppliers, competitors or regulatory authorities, (iii) statements of future economic performance, and (iv) statements of assumptions underlying other statements and statements about the Company or its 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:


  o

increased competition, including price competition


  o

general economic and business conditions, both nationally and internationally


  o

changes in business strategy or development plans


  o

technological, evolving industry standards, or other problems that could delay the sale of our products


  o

risks and uncertainties with respect to our patents and proprietary rights including:

  o

lack of meaningful protection from claims of any patents issued to the Company

  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


  o

our inability to obtain sufficient financing to continue to expand operations


  o

changes in demand for products and services by our customers


11


  o

our failure to obtain and retain new customers and alliance partners, or a reduction in tests ordered or specimens submitted by existing customers


  o

adverse results in litigation matters


  o

our ability to attract and retain experienced and qualified personnel


  o

losses due to bad debt


The cautionary statements made pursuant to the Private Litigation Securities Reform Act of 1995 above and elsewhere by the Company should not be construed as exhaustive or as any admission regarding the adequacy of disclosures made by the Company prior to the effective date of such Act. Forward looking statements are beyond the ability of the Company to control, and in many cases the Company cannot predict what factors would cause results to differ materially from those indicated by the forward looking statements.

General

MEDTOX Scientific, Inc. (formerly EDITEK, Inc.), a Delaware corporation, was organized in September 1986. MEDTOX Scientific, Inc. and its subsidiaries, MEDTOX Laboratories, Inc., MEDTOX Diagnostics, Inc., and New Brighton Business Center, LLC are referred to herein as “the Company.” The Company is engaged primarily in two distinct, but very much related businesses. The business of forensic and clinical laboratory services is conducted by MEDTOX Laboratories, Inc. at its facility in St. Paul, Minnesota, and the business of manufacturing and distribution of diagnostic devices is executed by MEDTOX Diagnostics, Inc. from its facility in Burlington, North Carolina.

The Company has two reportable segments: “Laboratory Services” conducted by the Company’s wholly owned subsidiary, MEDTOX Laboratories, Inc. and “Products Sales” conducted by the Company’s wholly owned subsidiary MEDTOX Diagnostics, Inc. Laboratory Services include workplace drugs-of-abuse testing and specialty laboratory services, including clinical toxicology, clinical testing for the pharmaceutical industry (central laboratory services, bioanalytical and pharmacokinetic testing), and analysis of heavy and trace metals. In addition, the Laboratory Services segment provides logistical support, data management and overall program management services. Product Sales include sales of a variety of on-site screening products and contract manufacturing. For financial information relating to the Company’s segments, see Note 2 of Notes to the Consolidated Financial Statements. For the three and nine months ended September 30, 2004, Laboratory Services revenue accounted for 76% of the Company’s revenues, compared with 77% for the same periods in 2003. Revenue from Product Sales accounted for 24% of the Company’s revenues for the three and nine months ended September 30, 2004 compared with 23% for the same periods in 2003.

Critical Accounting Policies

The Company has identified the policies outlined below as critical to understanding its business and results of operations. The listing is not intended to be a comprehensive list of all 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 in the Notes to the Consolidated Financial Statements in Item 15 on Form 10-K for the year ended December 31, 2003. Note that the preparation of this Form 10-Q 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 financial statements, and the reported amounts of revenue and expenses during the reporting period. There can be no assurance that actual results will not differ from those estimates.

12


The Company’s critical accounting policies are as follows:

Accounts Receivable:
The Company performs ongoing credit evaluations of its customers and adjusts credit limits based upon payment history and the customers’ current credit worthiness, as determined by management’s review of their current credit information. The Company continuously monitors collections and payments from its customers and maintains a provision for estimated credit losses based upon the Company’s historical experience and any specific customer collection issues that have been identified. While such credit losses have generally been within the Company’s historical expectations and the provisions established, the Company cannot guarantee that it will continue to experience the same credit loss rates that have occurred in the past. The Company’s consolidated trade accounts receivable balance as of September 30, 2004 was $9.1 million, net of allowance for doubtful accounts of $0.5 million.

Some of the Company’s laboratory services revenues for certain types of tests are billed to third-party payors including insurance companies, state Medicaid and Medicare agencies. These payors pay for such services at established amounts, which are typically lower than gross amounts billed by the Company. However, the tests are sometimes billed directly to patients or other parties and paid at the gross amount billed for these tests. In addition, billings for the tests are occasionally re-billed to alternative payors in situations where incorrect billing information was submitted to the Company by the customer. The Company estimates a discount on the billings for these tests, and recognizes revenue and related accounts receivable at a net amount, after discount, in order to state revenue and accounts receivable at the amount expected to be paid. While the Company believes that estimated discounts and the related net revenue and net accounts receivable from these testing services are materially correct, there can be differences in amounts ultimately paid compared to estimated amounts. These differences are recorded upon payment and may affect previously recorded amounts. The Company considers historical discounts when estimating future discounts on a monthly basis.

Off-Site Supplies Inventory:
Off-site supplies represent collection kits and forms located at collections sites throughout the United States used by Laboratory Services’ customers to submit specimens for testing services. At September 30, 2004, off-site inventory was $0.8 million. The process for valuing off-site inventory involves significant assumptions regarding the average time that a collection site uses the inventory, as well as the amount of inventory expected to be scrapped.

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Goodwill and Other Intangible Assets:
In accordance with Statement of Financial Accounting Standards (SFAS) No. 142, “Goodwill and Other Intangible Assets,” goodwill and indefinite-lived intangible assets are no longer amortized, but are instead reviewed 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. 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 in future periods. During the nine months ended September 30, 2004, no circumstances occurred that required an impairment charge.

Accounting for Income Taxes:
As part of the process of preparing the consolidated financial statements, the Company is required to estimate income taxes in each of the jurisdictions in which it operates. 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. The Company 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, the Company must establish a valuation allowance. To the extent the Company increases or decreases the valuation allowance in a period, the Company 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. The Company’s deferred tax assets primarily consist of certain net operating losses (NOLs) carried forward. At September 30, 2004, the Company has a valuation allowance on deferred tax assets of $1.4 million, which represents the portion of its NOL carryforwards that will more likely than not expire unused in 2004 and future years. The valuation allowance is based on management’s estimate of taxable income, the period over which NOLs will be recoverable, and tax planning strategies. 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 NOL is completely utilized or expires unused.

Results of Operations

Total revenues for the third quarter of 2004 increased 7% over the third quarter of 2003, driven primarily by strong sample volume from both new and existing workplace and occupational health clients. Gross margin improved in the Laboratory Services segment primarily due to increased revenue. In the Diagnostic segment, gross margin was positively impacted by increased production levels. Operating expenses as a percentage of sales were also down slightly quarter over quarter. The following table sets forth the percentages of total revenues represented by certain items reflected in the Company’s Consolidated Statements of Operations:

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Three Months Ended
September 30,
Nine Months Ended
September 30,
2004
2003
2004
2003
Revenues      100 .0%  100 .0%  100 .0%  100 .0%
Cost of revenues    58 .3  59 .8  57 .4  61 .1




Gross margin    41 .7  40 .2  42 .6  38 .9
Operating expenses:  
  Selling, general, and administrative    30 .4  30 .6  30 .9  32 .9
  Research and development    2 .4  3 .0  2 .7  3 .1




     32 .8  33 .6  33 .6  36 .0




Income from operations    8 .9  6 .6  9 .0  2 .9
Other expense    (2 .6)  (3 .0)  (2 .6)  (3 .1)




Income (loss) before income tax expense    6 .3  3 .6  6 .4  (0 .2)
Income tax expense    (2 .4)  (0 .8)  (2 .4)  --  




Net income (loss)    3 .9%  2 .8%  4 .0%  (0 .2)%





Three Months Ended September 30, 2004 Compared to Three Months Ended September 30, 2003

Revenues

Revenues increased 7% to $14.5 million for the three months ended September 30, 2004, driven by a $0.6 million, or 6% increase in Laboratory Services revenues and a $0.3 million, or 10% increase in Product Sales revenues.

In the Laboratory Services segment, revenues from workplace and occupational health clients grew 14% due to increased sample volume from both new and existing clients. This positive impact was partially offset by a 7% decline in revenues from the Company’s specialty laboratory services which tends to fluctuate based upon the timing of clinical trials.

In the Product Sales segment, sales of POC on site testing products, which incorporates the PROFILE®-II, PROFILE-II ER®, PROFILE®-II A and VERDICT®-II on-site test kits and other ancillary products for the detection of abused substances, increased 6% to $2.9 million in the third quarter of 2004. This growth reflects strong sales of PROFILE®-II products, which grew 29% quarter over quarter. However, sales within the VERDICT®-II product line to government clients for probation, parole and rehabilitation continue to trail the prior year and were down 18% quarter over quarter.

Sales of contract manufacturing services, microbiological and associated products increased 55% to $0.6 million in the quarter and were positively impacted by the timing of orders from existing clients. Product sales from agricultural diagnostic products were down $60,000, or 73% during the quarter due to decreased purchases from the U.S. Department of Agriculture (USDA) for the Company’s products. The USDA’s needs for the Company’s products vary from year-to-year and sales to the USDA are expected to fluctuate accordingly.

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Gross Profit

Consolidated gross margin increased to 41.7% of revenues for the three months ended September 30, 2004 from 40.2% of revenues for the same period in 2003, driven by improvement in both Laboratory Services and Product Sales gross margins.

Laboratory Services gross margin was 35.7% for the three months ended September 30, 2004, up from 34.5% for the same period in 2003. The margin improvement was primarily attributable to increased revenue spread over relatively stable fixed costs. Gross margin from Product Sales improved to 60.3% for the three months ended September 30, 2004, from 59.0% in the comparable period of 2003, largely due to the impact of fixed-type costs on increased production levels. The Company has ongoing LEAN projects within the Product Sales segment and the Company is currently in the planning process for additional LEAN projects in the Laboratory Services segment.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $4.4 million, or 30.4% of revenues in the third quarter of 2004, compared to $4.2 million or 30.6% of revenues in the third quarter of 2003.

Income Taxes

The Company’s tax provision was based upon an effective tax rate of 38% for the three months ended September 30, 2004 compared to a tax rate of 22% for the same period of 2003. The Company records a provision for income taxes based upon the anticipated effective rate for the full year. At September 30, 2004, the Company has a valuation allowance on deferred tax assets of $1.4 million, which represents the portion of its net operating loss (NOL) carryforwards that will more likely than not expire unused in 2004 and future years. Should operating results for the remainder of 2004 and future years fail to meet expectations, the valuation allowance against the Company’s NOL carryforwards and the related deferred tax asset may require adjustment in future periods.


Nine Months Ended September 30, 2004 Compared to Nine Months Ended September 30, 2003

Revenues

Revenues increased 10% to $43.1 million for the nine months ended September 30, 2004, driven by a $2.7 million, or 9% increase in Laboratory Services revenues and a $1.2 million, or 14% increase in Product Sales revenues.

In the Laboratory Services segment, revenues from workplace and occupational health clients grew 15% due to increased sample volume from both new and existing clients. The increased sample volume was slightly offset by a lower average price. Revenues from the Company’s specialty laboratory services were essentially flat with the first nine months of 2003.

In the Product Sales segment, sales of POC on site testing products, which incorporates the PROFILE®-II, PROFILE-II ER®, PROFILE®-II A and VERDICT®-II on-site test kits and other ancillary products for the detection of abused substances, increased 11% to $8.7 million in the first nine months of 2004. This growth reflects strong sales of PROFILE®-II products, which grew 36% from the prior year period. However, sales within the VERDICT®-II product line to government clients for probation, parole and rehabilitation continue to trail the prior year and were down 19% year over year.

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Sales of contract manufacturing services, microbiological and associated products increased 40% to $1.6 million in the first nine months of 2004 and were positively impacted by the timing of orders from existing clients. Product sales from agricultural diagnostic products were down $82,000, or 30% due to decreased purchases from the U.S. Department of Agriculture (USDA) for the Company’s products. The USDA’s needs for the Company’s products vary from year-to-year and sales to the USDA are expected to fluctuate accordingly.

Gross Profit

Consolidated gross margin increased to 42.6% of revenues for the nine months ended September 30, 2004 from 38.9% of revenues for the same period in 2003, driven by improvement in both Laboratory Services and Product Sales gross margins.

Laboratory Services gross margin was 36.9% for the nine months ended September 30, 2004, up from 33.3% for the same period in 2003. The margin improvement was attributable to increased revenue spread over relatively stable fixed costs, as well as improved operating efficiencies realized from the Company’s LEAN projects initiated in 2003. Gross margin from Product Sales improved to 60.7% for the nine months ended September 30, 2004, from 57.3% in the comparable period of 2003, largely due to the impact of fixed-type costs on increased production levels. The Company has ongoing LEAN projects within the Product Sales segment and the Company is currently in the planning process for additional LEAN projects in the Laboratory Services segment.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $13.3 million, or 30.9% of revenues in the first nine months of 2004, compared to $12.9 million or 32.9% of revenues in the same period of 2003. The lower rate reflects the increase in revenue on relatively flat year over year expenses. In addition, the improvement reflects the impact of LEAN projects, staff reductions and expense control measures initiated at the Laboratory Services segment in 2003.

Income Taxes

The Company recorded a tax provision for the nine months ended September 30, 2004 based upon an effective tax rate of 38%. The Company recorded a tax benefit for the nine months ended September 30, 2003 that reflects the anticipated effective tax rate for the full year. At September 30, 2004, the Company has a valuation allowance on deferred tax assets of $1.4 million, which represents the portion of its net operating loss (NOL) carryforwards that will more likely than not expire unused in 2004 and future years. Should operating results for the remainder of 2004 and future years fail to meet expectations, the valuation allowance against the Company’s NOL carryforwards and the related deferred tax asset may require adjustment in future periods.

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Liquidity and Capital Resources

The working capital requirements of the Company have historically been funded primarily by cash received from bank and debt financing and the sale of equity securities.

Net cash provided by operating activities was $5.0 million for the nine months ended September 30, 2004 compared to $1.9 million for the same period of 2003. The increase was primarily due to an improvement in operating results and an increase in accounts payable and accrued expenses, partially offset by an increase in accounts receivable.

Accounts payable and accrued expenses decreased $0.1 million in the first nine months of 2004, compared to a decrease of $2.0 million in 2003. The significant decrease in 2003 was primarily due to a high level of accounts payable as of December 31, 2002, with subsequent payments on such outstanding balances during the first few months of 2003.

Accounts receivable increased $1.1 million in the first nine months of 2004 compared to an increase of $0.3 million in the same period of 2003. The significant increase in 2004 was primarily due to strong third quarter sales.

Net cash used in investing activities, consisting primarily of capital expenditures, was $3.4 million for the nine months ended September 30, 2004 compared to $2.1 million in the same period of 2003. The increased spending in 2004 reflects equipment purchased and costs incurred in redesigning the laboratory operations to improve operating efficiencies in connection with the Company’s LEAN initiatives.

Net cash used in financing activities was $1.8 million for the nine months ended September 30, 2004, compared to net cash provided by financing activities of $0.4 million in the prior year period. In the first nine months of 2004, the Company made principal payments on long-term debt of $2.5 million, including $1.0 million in subordinated notes due September 2004. During the nine months ended September 30, 2003, the Company made payments on long-term debt of $2.0 million and received proceeds from long-term debt of $1.6 million to finance capital equipment purchases.

The Company has a Credit Security Agreement (the Wells Fargo Credit Agreement) with Wells Fargo Business Credit, Inc. (Wells Fargo). The Wells Fargo Credit Agreement, as amended, consists of (i) a revolving line of credit, payable on demand, of not more than $8.0 million or 85% of the Company’s eligible trade accounts receivable bearing interest at prime + 1.0%; and (ii) a capex note of up to $1.5 million for the purchase of capital equipment bearing interest at prime + 0.75%. According to the terms of the agreement, the capex note may be amended, supplemented or restated from time to time and is generally done so on an annual basis.

The Wells Fargo Credit Agreement requires the Company to comply with certain financial covenants, including a minimum annual debt service coverage ratio and a minimum quarterly pre-tax net income level. It also sets a maximum level for capital expenditures, as well as a limitation on the year-over-year increase in compensation of any director, shareholder or consultant. At September 30, 2004, the Company was in compliance with the financial covenants of the Wells Fargo Credit Agreement.

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The Company is relying on expected positive cash flow from operations and its line of credit to fund its future working capital and asset purchases. The amount available on the revolving line of credit is based primarily on the receivables of the Company and, as such, varies with accounts receivable. As of September 30, 2004, the Company had total borrowing capacity of $6.7 million on its line of credit, of which $5.5 million was borrowed, leaving a net availability of $1.2 million and a cash balance of $0.5 million.

In the short term, the Company believes that the aforementioned capital will be sufficient to fund the Company’s planned operations through 2004. While there can be no assurance that the available capital will be sufficient to fund the future operations of the Company beyond 2004, the Company believes that future profitable operations, as well as access to additional capital through debt or equity financings, will be the primary means for funding the operations of the Company for the long term.

The Company continues to follow a plan which includes (i) aggressively monitoring and controlling costs, (ii) increasing revenue from sales of the Company’s existing products and services (iii) developing new products and services, as well as (iv) continuing to selectively pursue synergistic acquisitions to increase the Company’s 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 the Company 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 as of September 30, 2004:


Payments Due by Period
(In thousands) Total
Less than
1 year

1-3 years
4-5 years
More than
5 years

Long-term debt     $ 7,858   $ 1,511   $ 1,277   $ 473   $ 4,597  
 
Capital lease obligations    131    79    42    10    --  
 
Operating leases    5,196    710    1,174    772    2,540  





Total contractual obligations   $ 13,185   $ 2,300   $ 2,493   $ 1,255   $ 7,137  






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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 summer months, 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.

Impact of New Accounting Standards

On March 31, 2004, the Financial Accounting Standards Board (FASB) issued a proposed Statement, “Share-Based Payment—an amendment of Statements No. 123 and 95,” that addresses the accounting for share-based payment transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprise’s equity instruments or that may be settled by the issuance of such equity instruments. The proposed Statement would eliminate the ability to account for share-based compensation transactions using APBO No. 25, “Accounting for Stock Issued to Employees,” and generally would require instead that such transactions be accounted for using a fair-value-based method. The Company is currently in the process of evaluating the impact of the proposed Statement.

In January 2003, the FASB issued Interpretation No. 46, “Consolidation of Variable Interest Entities,” as revised in December 2003 (FIN 46R).  FIN 46R addresses consolidation by business enterprises of variable interest entities and significantly changes the consolidation application of consolidation policies to variable interest entities and, thus improves comparability between enterprises engaged in similar activities when those activities are conducted through variable interest entities.  The consolidation requirements of FIN 46R apply to variable interest entities as of March 31, 2004. The Company does not hold an interest in any variable interest entities.

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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 September 30, 2004. For additional information refer to Item 7A of our 2003 Annual Report on Form 10-K.

Item 4.    CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls Procedures.

As of the end of the period covered by this report, the Company conducted an evaluation under the supervision and with the participation of the company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of the design and operation of the Company’s disclosure controls and procedures pursuant to Rules 13a-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 the Company’s disclosure controls and procedures are effective to ensure that information that is required to be disclosed by the Company in reports that it files under the Exchange Act is recorded, processed, summarized and reported within the time period specified in the rules of the Securities Exchange Commission.

Changes in Internal Controls.

There were no changes in the Company’s 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, the Company’s internal control over financial reporting.

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PART II    OTHER INFORMATION


ITEM 1 LEGAL PROCEEDINGS.  Inapplicable

ITEM 2

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.   Inapplicable


ITEM 3 DEFAULTS UPON SENIOR SECURITIES.  Inapplicable

ITEM 4 SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.  Inapplicable

ITEM 5 OTHER INFORMATION.  Inapplicable

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 October 28, 2004
Richard J. Braun Chairman of the Board of Directors
  (Principal Executive Officer)
 
/s/ Kevin J. Wiersma Vice President and Chief Financial Officer October 28, 2004
Kevin J. Wiersma (Principal Financial Officer)


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EXHIBIT INDEX

MEDTOX SCIENTIFIC, INC.

FORM 10-Q FOR QUARTER ENDED SEPTEMBER 30, 2004


Exhibit number
Description
   
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.


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