UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-QSB

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


For the Quarterly Period Ended March 31, 2008
Commission File
Number 1-11700


HEMAGEN DIAGNOSTICS, INC.
(Exact name of Small Business Issuer as
Specified in its Charter)

Delaware
04-2869857
(State of Organization)
(I.R.S. Employer Number)


9033 Red Branch Road, Columbia, Maryland 21045-2105
(Address of principal executive offices, Zip Code)


(443) 367 5500
(Issuer’s telephone number, including area code)

 
Check whether the issuer (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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 a shell company (as defined in Rule 12b-2 of the Exchange Act.

           Yes   ¨                                 No   x

As of April 30, 2008, the issuer had 15,225,281 shares of Common Stock, $.01 par value per share outstanding.

Transitional Small Business Disclosure Format:  Yes    ¨              No    x

 
 

 

HEMAGEN DIAGNOSTICS, INC. AND SUBSIDIARIES

INDEX

 

       
Page
Number
  PART I.    FINANCIAL INFORMATION
 
 
Item 1.
Financial Statements
 
       
   
Consolidated Balance Sheets; March 31, 2008 (unaudited) and September 30, 2007
3
       
   
Consolidated Statements of Operations; Three and Six Months Ended March 31, 2008 (unaudited) and 2007
5
       
   
Consolidated Statements of Cash Flows; Six Months Ended March 31, 2008 (unaudited) and 2007
6
       
   
Notes to Consolidated Financial Statements
7
       
 
Item 2.
Management’s Discussion and Analysis and Plan of Operation
13
       
 
Item 3.
Controls and Procedures
17
     
PART II .
OTHER INFORMATION
 
       
 
Item 2.
Unregistered Sales of Equity Securities and Use Of Proceeds
17
       
 
Item 6.
Exhibits
18
       
  SIGNATURES
19
   
  CERTIFICATIONS  


 

 

PART I      Financial Information

Item 1.              Financial Statements

HEMAGEN DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS


   
March 31, 2008
(unaudited)
   
September 30,
2007
 
ASSETS
           
             
CURRENT ASSETS:
           
Cash
  $ 215,006     $ 6,592  
Accounts receivable, less allowance for doubtful accounts of $63,287 and $51,316 at March 31,
   2008 and September 30, 2007, respectively
    1,138,124       1,000,652  
Inventories, net
    2,014,606       2,554,881  
Current portion of Note Receivable
    210,000       --   
Prepaid expenses and other current assets
    215,510       265,633  
Assets Held for Sale
    --       5,183  
                 
             Total current assets
    3,793,246       3,832,941  
                 
PROPERTY AND EQUIPMENT; net of accumulated depreciation and amortization of $ 5,923,873
   and $5,883,861 at March 31, 2008 and September 30, 2007, respectively
    525,695       221,990  
                 
OTHER ASSETS:
               
                 
Note Receivable - non-current
    560,000       --  
Other Assets
    83,840       80,160  
             Total other assets
    643,840       80,160  
                 
Total Assets
  $ 4,962,781     $ 4,135,091  

The accompanying notes are an integral part of the financial statements.


 

 

HEMAGEN DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS (continued)

 

   
March 31,
2008
(unaudited)
   
September 30,
2007
 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
           
     CURRENT LIABILITIES:
           
     Accounts payable and accrued liabilities
  $ 1,149,291     $ 1,332,302  
     Revolving line of credit
    283,231       340,000  
     Deferred revenue
    26,283       17,691  
     Note Payable – Itau Bank
    78,739       16,388  
                Total Current Liabilities
    1,537,544       1,706,381  
     LONG TERM LIABILITIES:
               
     Note Payable – Itau Bank
    137,813       18,200  
     Senior subordinated secured convertible notes due September 30,  2009, net of unamortized discount of
     $107,377 and $143,575 at  March 31, 2008 and September 30, 2007, respectively
    3,942,473       3,906,275  
                Total Long Term Liabilities
    4,080,286       3,924,475  
                Total liabilities
    5,617,830       5,630,856  
                 
 
STOCKHOLDERS’ DEFICIT
               
                 
     Preferred stock, $0.01 par value - 1,000,000 shares authorized;  none issued
    --       --  
     Common stock, $.01 par value - 30,000,000 shares authorized;  issued and outstanding:  15,325,281 at
     March 31, 2008  and September 30, 2007
    153,252       153,252  
     Additional paid-in capital
    22,845,515       22,842,290  
     Accumulated deficit
    (23,552,463 )     (24,353,140 )
     Accumulated other comprehensive loss- currency translation loss
    (11,716 )     (48,530 )
     Less treasury stock at cost; 100,000 shares at March 31, 2008  and September 30, 2007, respectively.
    (89,637 )     (89,637 )
 
 
     Total Stockholders’ Deficit
    (655,049 )     (1,495,765 )
     Total Liabilities and Stockholders’ Deficit
  $ 4,962,781     $ 4,135,091  

The accompanying notes are an integral part of the financial statements.

 

 

HEMAGEN DIAGNOSTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
 
   
Three Months Ended
   
Six Months Ended
 
   
March 31,
2008
   
March 31, 2007
   
March 31,
2008
   
March 31,
2007
 
                         
Net Sales
  $ 1,793,465     $ 1,155,242     $ 3,333,311     $ 2,161,788  
Cost of Sales
    1,015,305       554,684       1,903,941       1,234,005  
Gross Profit
    778,160       600,558       1,429,370       927,783  
Operating Expenses:
                               
        Selling, general and administrative
    590,882       593,473       1,167,246       1,151,402  
       Research and development
    50,515       8,854       91,593       10,884  
                Total operating expenses
    641,397       602,327       1,258,839       1,162,286  
                Total operating income (loss) from continuing operations
    136,763       (1,769 )     170,531       (234,503 )
Other income (expenses):
                               
       Interest expense (net), including $17,626 and $16,658,
            respectively of debt discount amortization
    (87,659 )     (98,857 )     (176,069 )     (191,777 )
        Other income (expense)
    5,995       5,337       6,347       (4,275 )
                Total other expense
    (81,664 )     (93,520 )     (169,722 )     (196,052 )
                                 
      Net loss, before income taxes, from continuing operations
    55,099       (95,289 )     809       (430,555 )
                                 
      Income Tax expense
    27,030       15,943       56,578       21,492  
      Net income (loss), from continuing operations
    28,069       (111,232 )     (55,769 )     (452,047 )
                                 
      Income (Loss), from Discontinued Operations (includes a gain
           on sale of assets in the amount of $1,094,817 for the six months
           ending March 31, 2008)
    --       (199,094 )     856,446       (218,671 )
Net income (loss):
  $ 28,069     $ (310,326 )   $ 800,677     $ (670,718 )
                                 
Other comprehensive loss, net of tax:
                               
Foreign currency translation adjustments
    13,393       15,907       36,814       10,509  
Comprehensive income (loss):
  $ 41,462     $ (294,419 )   $ 837,491     $ (660,209 )
                                 
Earnings (loss) per share, from continuing operations - Basic
  $ 0.00     $ (0.01 )   $ 0.00     $ (0.03 )
Earnings (loss) per share, from continuing operations - Diluted
  $ 0.00     $ (0.01 )   $ 0.00     $ (0.03 )
Earnings (loss) per share, from discontinued operations - Basic
  $ 0.00     $ (0.01 )   $ 0.05     $ (0.01 )
Earnings (loss) per share, from discontinued operations - Diluted
  $ 0.00     $ (0.01 )   $ 0.05     $ (0.01 )
Earnings (loss) per share - Basic
  $ 0.00     $ (0.02 )   $ 0.05     $ (0.04 )
Earnings (loss) per share - Diluted
  $ 0.00     $ (0.02 )   $ 0.05     $ (0.04 )
Weighed average common shares used in calculation of earnings (loss) per share - Basic
    15,225,281       15,225,281       15,225,281       15,225,281  
Weighed average common shares used in calculation of earnings (loss) per share – Diluted
    15,225,281       15,225,281       15,225,281       15,225,281  
 

 
 

 

HEMAGEN DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

   
Six Months Ended
March 31
 
   
2008
   
2007
 
Cash flows from operating activities:
           
     Net Income (Loss)
  $ 800,677     $ (670,718 )
      Adjustments to reconcile net loss to net cash provided by operating activities:
               
         Depreciation
    28,842       19,043  
         Amortization of debt discount
    36,198       31,681  
         (Gain) loss on sale of assets
    (838,907 )     --  
         Provision for Bad Debts
    (21,028 )     --  
         Stock Based Compensation
    3,225       6,112  
     Changes in operating assets and liabilities:
               
         Accounts receivable
    (116,444 )     118,890  
          Prepaid expenses and other current assets
    50,123       103,274  
         Inventories
    540,275       (49,000 )
         Accounts payable and accrued expenses
    (183,011 )     285,146  
         Other assets
    (3,680 )     (59,445 )
         Deferred revenue
    8,592       5,154  
            Net cash provided by (used in) operating activities
    304,862       (209,863 )
                 
Cash flows from investing activities:
               
     Purchase of property and equipment
    (322,843 )     (52,314 )
     Proceeds from sale of assets
    4,090       --  
     Payments Received on Notes Receivable
    70,000       --  
           Net cash used in investing activities
    (248,753 )     (52,314 )
                 
Cash flows from financing activities:
               
     Net (payments) borrowings on Line of Credit
    (56,769 )     250,000  
     Borrowings on Notes – Itau Bank
    181,964       --  
           Net cash provided by financing activities
    125,195       250,000  
                 
Effects of foreign exchange rate
    27,110       10,960  
                 
                 Net increase (decrease) in cash and cash equivalents
    208,414       (1,217 )
                 
Cash and cash equivalents at beginning of period
    6,592       150,663  
                 
Cash and cash equivalents at end of period                                 
  $ 215,006     $ 149,446  
Supplemental disclosure of cash flow information:
               
 
Cash paid during the period for interest                                        
  $ 164,211     $ 165,325  
   
 
The accompanying notes are an integral part of the financial statements.

 

 

HEMAGEN DIAGNOSTICS, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
FOR THE SIX MONTHS ENDED MARCH 31, 2008 and 2007

NOTE 1 – BASIS OF PRESENTATION

Hemagen Diagnostics, Inc.  (“Hemagen” or the “Company”) has prepared the accompanying unaudited consolidated financial statements in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission instructions to Form 10-QSB and Item 310(b) of regulation S-B.  These financial statements should be read together with the financial statements and notes in the Company’s 2007 Annual Report on Form 10-KSB filed with the Securities and Exchange Commission.  Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted.  The accompanying financial statements reflect all adjustments and disclosures, which, in the Company’s opinion, are necessary for fair presentation.  All such adjustments are of a normal recurring nature.  The results of operations for the interim periods are not necessarily indicative of the results of the entire year.

The Company sold the assets of its wholly owned Subsidiary Reagents Applications Inc. on October 8, 2007.  The results of operations for this segment of the business are presented as discontinued operations in the accompanying financials.  Additional information can be obtained by referencing the Form 10-KSB for the year ended September 30, 2007.

NOTE 2- RECENT ACCOUNTING PRONOUNCEMENTS

Financial Accounting Standards No. 157 (“SFAS 157”) .  In September 2006, Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standard No. 157, “Fair Value Measurements”. SFAS 157 defines fair values, establishes a framework for measuring fair value in generally accepted accounting principles (GAAP) and expands disclosures about fair value measurements. SFAS 157 is effective for financial statements issued for fiscal years beginning after November 15, 2007.  The Company does not expect the adoption of SFAS 157 to significantly affect its consolidated financial condition or results of operations.

Financial Accounting Standards No 159 (“SFAS 159”).  In February 2007, the FASB issued SFAS 159, “The Fair Value Option for Financial Assets and Financial Liabilities – Including the amendment of FASB Statement 115” , which provides companies with an option to measure eligible financial assets and liabilities in their entirety at fair value.  The fair value option may be applied instrument by instrument, and may be applied only to entire instruments.  If a company elects the fair value option for an eligible item, changes in the item’s fair value must be report as unrealized gains and losses in earnings at each subsequent reporting date.  SFAS 159 is effective for fiscal years beginning after November 15, 2007.  The Company does not expect the adoption of SFAS 159 to significantly affect its consolidated financial condition or results of operations.

 

 


In December 2007, the FASB issued SFAS 141 (R), “ Business Combinations (SFAS 141 (R))”. The standard changes the accounting for business combinations including the measurement of acquirer shares issued in consideration for a business combination, the recognition of contingent consideration, the accounting for preacquisition gain and loss contingencies, the recognition of capitalized in-process research and development, the accounting for acquisition-related restructuring of cost accruals, the treatment of acquisition related transaction costs and the recognition of changes in the acquirer’s income tax valuation allowance. SFAS 141 (R) is effective for fiscal years beginning after December 15, 2008, with early adoption prohibited.  We are currently evaluating the impact of the pending adoption of SFAS 141 (R) on our consolidated financial statements.

In December 2007, the FASB issued SFAS No. 160, “ Noncontrolling Interests in Consolidated Financial Statements”. SFAS No. 160 will change the accounting for minority interests, which will be recharacterized as noncontrolling interests and classified by the parent company as a component of equity.  This statement is effective for fiscal years beginning on or after December 15, 2008, with early adoption prohibited.  Upon adoption, SFAS No. 160 requires retroactive adoption of the presentation and disclosure requirements for existing minority interests and prospective adoption for all other requirements.  The Company is currently assessing the impact of SFAS No. 160 on the Company’s financial statements.

In April 2008, the FASB issued Final FASB Staff Position (FSP), FAS 142-3, “ Determination of the Useful Life of Intangible Assets ”, which amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, “ Goodwill and Other Intangible Assets ”. This FSP shall be effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years.  Early adoption is prohibited.  The Company will ascertain its impact, if any, during the three-month period ending March 31, 2009.


NOTE 3- EARNINGS (LOSS) PER SHARE

Basic earnings per common share are computed based upon the weighted average number of common shares outstanding during the three and six months ended March 31, 2008 and 2007.  Diluted earnings per common share is computed based on common shares outstanding plus the effect of dilutive stock options and other potentially dilutive common stock equivalents consisting of stock options and convertible debentures.  The dilutive effect of stock options and other potentially dilutive common stock equivalents is determined using the treasury stock and if-converted method based on the Company’s average stock price for the period.  Diluted net income per share does not include the effect of the following common stock equivalents related to outstanding convertible debentures and stock purchase options as their effect would be antidilutive:


 

 

NOTE 3- EARNINGS (LOSS) PER SHARE - continued

   
Three Months Ended
March 31,
   
Six Months Ended
March 31,
 
   
2008
   
2007
   
2008
   
2007
 
Convertible notes
    5,399,800       5,399,800       5,399,800       5,399,800  
Options to purchase common stock
    2,314,014       2,375,014       2,314,014       2,375,014  
Total antidilutive instruments
    7,713,814       7,774,814       7,713,814       7,774,814  

The weighted average common shares for all basic and diluted earnings (loss) per share calculations are 15,225,280 for the three and six month periods ended March 31, 2008 and 2007.  Net income available to common stockholders for basic and diluted earnings per share calculations was $ 28,069 and $800,677 for the three and six month periods ended March 31, 2008, respectively. Net (loss) available to common shareholders for basic and diluted earnings per share calculations was $(310,326) and $(670,718) for the three and six month periods ended March 31, 2007, respectively.


NOTE 4 – STOCK BASED COMPENSATION

The following table summarizes the Company’s stock option activity for the six months ended March 31, 2008:

   
 
Shares
   
Weighted average exercise price
   
Weighted average
life
 
                     
Options outstanding – October 1, 2007
    2,289,514      $ 1.11       2.39  
       Granted
    97,000       0.19       4.81  
       Exercised
    --       --       --  
       Forfeited, cancelled or expired
    (72,500 )     0.24       3.41  
Options outstanding – March 31, 2008
    2,314,014     $ 1.10       2.46  
Options exercisable – March 31, 2008
    2,132,014     $ 1.17       2.34  
                         


 

 

NOTE 4 – STOCK BASED COMPENSATION - continued

Under SFAS No. 123R, “Share-Based Payment” we use the Black-Scholes option pricing model to determine the fair value of our awards on the date of grant. The fair value of each option award is estimated on the date of grant using a Black-Scholes option-pricing formula that uses the assumptions noted in the table and discussion that follows:

   
Three and Six Months Ended
March 31,
 
   
2008
   
2007
 
Dividend yield
    --       --  
Expected volatility
    87.4 %     82 %
Risk-free interest rate
    4 %     4 %
Expected life in years
    10       10  

We have elected to incur stock-based compensation expense over the requisite service period.  We have estimated forfeitures and incur expense on shares we expect to vest.

As of March 31, 2008, there was $26,414 of unrecognized compensation cost related to share-based compensation arrangements that we expect to vest. This cost will be fully incurred within 5 years.  The options both issued and exercisable as of March 31, 2008 have no intrinsic value. All options granted have the same exercise price as the stock price on the date the options were granted.

NOTE 5 - INVENTORIES

     Inventories at March 31, 2008 and September 30, 2007 consist of the following:

   
March 31,
2008
   
September 30,
2007
 
             
Raw Materials
  $ 1,430,351     $ 1,510,204  
Work-in-process
    196,812       163,218  
Finished goods
    998,560       1,481,295  
      2,625,723       3,154,717  
Less reserves
    (611,117 )     (599,836 )
Inventories, net
  $ 2,014,606     $ 2,554,881  

NOTE 6 - LINE OF CREDIT

The Company has a revolving line of credit with a bank for the purpose of financing working capital needs as required.  The line of credit facility provides for borrowings up to $500,000 at an interest rate of Prime Rate plus .75% and expires March 31, 2009.   Maximum borrowings under the loan are based on the domestic receivables and inventory of the Company.  The line of credit facility has a first lien on all assets of the Company.  As of March 31, 2008, the outstanding balance on the line of credit was $283,231 and had an effective interest rate of 5.25%.   As of March 31, 2008 the Company was in compliance with its debt covanants.

10 
 

 
 

NOTE 7 – SENIOR SUBORDINATED SECURED CONVERTIBLE NOTES

The Notes pay interest quarterly at an annual rate of 8%, are convertible at the option of the holder at $0.75 per share into shares of the Company’s common stock and mature September 30, 2009.  The Notes are secured by a first lien on all real, tangible and intangible property except that the terms of the Notes provide that the following are subordinated to the security for the Notes: real estate financing obtained for a corporate headquarters subject to limitation; and up to $4.0 million for financing related to strategic acquisitions.  The Company has the right to require conversion of the Notes if the Company’s common stock has traded at or above $1.25 per share for a consecutive twenty-day trading period.  The Company may also prepay the Notes at their full face amount plus any accrued and unpaid interest. At March 31, 2008 and September 30, 2007, the unamortized discount of these notes was $107,377 and $143,575, respectively.

NOTE 8 – GEOGRAPHICAL INFORMATION

The Company considers its manufactured kits, tests and instruments as one operating segment, as defined under Statement of Financial Accounting Standards No. 131 “Disclosures about Segments of an Enterprise and Related Information.”

The following table sets forth revenue for the periods reported, from continuing operations, and assets by geographic location for the six months ended March 31, 2008 and 2007.

   
United*
States
   
Brazil
   
Consolidated
 
March 31, 2008:
                 
     Revenues
    2,254,242       1,079,069       3,333,311  
     Long-lived assets
    734,044       435,491       1,169,535  
                         
March 31, 2007:
                       
     Revenues
    1,540,768       621,020       2,161,788  
     Long-lived assets
    199,686       98,670       298,356  

* Includes export sales to countries other than Brazil.

NOTE 9 – NOTE RECEIVABLE

The Company received an $840,000 Note during the period ending December 31, 2007 related to the sale of assets of the Company’s wholly owned subsidiary Reagents Applications Inc.  The Note is payable in forty-eight monthly installments of principal of $17,500 plus accrued interest at the rate of 8% beginning on December 31, 2007. For the six months ending March 31, 2008, the Company has received $70,000 of payments against the Note.

11 
 

 


NOTE 10 – DISCONTINUED OPERATIONS

On October 8, 2007, the Company sold the assets of its wholly owned subsidiary Reagents Applications, Inc.  The results of operations for this division have been presented as discontinued operations in the accompanying financial statements for the periods ending March 31, 2008 and 2007.

Results from discontinued operations, net of income tax, for the three and six month periods ending March 31, 2008 and 2007 are as follows:

   
Three Months Ended
   
Six Months Ended
 
   
March 31,
2008
   
March 31,
2007
   
March 31,
2008
   
March 31,
2007
 
                         
Net sales
  $ 154,079     $ 539,700     $ 371,240     $ 921,439  
Costs of sales
    154,079       597,517       410,967       871,675  
Gross Profit
    --       (57,817 )     (39,727 )     49,764  
                                 
                                 
Operating expenses:
                               
    Selling, general and administrative
    --       57,992       196,936       121,236  
    Research and development
    --       83,284       1,708       147,198  
          Total operating costs and expenses
    --       141,276       198,644       268,434  
                                 
      Operating loss
    --       (199,093 )     (238,371 )     (218,670 )
                                 
Other income (expenses):
                               
      Other Income (expense)
    --       (1 )             (1 )
      Gain on Sale of Assets
    --       --       1,094,817       --  
             Total other income (expense)
    --       (1 )     1,094,817       (1 )
                                 
      Net income (loss) before income taxes
    --       (199,094 )     856,446       (218,671 )
                                 
          Income Tax
    --       --       --       --  
                                 
Net income (loss) from discontinued operations
    --       (199,094 )     856,446       (218,671 )

According to an inventory agreement pursuant the sale of Raichem, inventory is being sold to the purchaser at cost.  In addition, the Company recorded a reserve of $ 60,000 to cover obsolete inventory during the quarter ending December 31, 2007.  The Company also accrued $190,000 to cover additional expenses that are expected to be incurred as a result of the sale and the shutdown of the San Diego facility.  This accrual was also recorded during the quarter ended December 31, 2007.  The Company still has obligations for the San Diego facility under the current lease until May 31, 2008.

As of March 31, 2008 the Company had approximately $25,000 of accounts receivable remaining from the Raichem operation which has a reserve equal to the entire balance.

In addition, the Company has the following inventory consisting of Raichem products which is being sold pursuant to the inventory purchase agreement.

12 
 

 

NOTE 10 – DISCONTINUED OPERATIONS – continued

   
March 31,
2008
 
Raw Materials
  $ 209,849  
Work-in-process
    1,903  
Finished goods
    219,591  
      431,343  
Less reserves
    (108,451 )
Inventories, net
  $ 322,892  

Item 2.    Management’s Discussion and Analysis and Plan of Operation.

Certain statements in this report that are not historical facts constitute forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, and are intended to be covered by the safe harbors created by that Act. Reliance should not be placed on forward-looking statements because they involve unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to differ materially from those expressed or implied. Any forward-looking statement speaks only as of the date made. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date on which they are made.

Forward-looking statements may be identified by words such as “estimates”, “anticipates”, “projects”, “plans”, “expects”, “intends”, “believes”, “should”, and similar expressions and the negative versions thereof and by the context in which they are used.  Statements concerning the establishments of reserves and adjustments for dated and obsolete products, expected financial performance, on-going business strategies and possible future action which Hemagen intends to pursue to achieve strategic objectives constitute forward-looking information.  The sufficiency of such charges, implementation of strategies and the achievement of financial performance are each subject to numerous conditions, uncertainties and risk factors.  Factors which could cause actual performance to differ materially from these forward-looking statements, include, without limitation, management’s analysis of Hemagen’s assets, liabilities and operations, the failure to sell date–sensitive inventory prior to its expiration, competition, new product development by competitors which could render particular products obsolete, the inability to develop or acquire and successfully introduce new products or improvements of existing products, costs and difficulties in complying with laws and regulations administered by the U.S. Food and Drug Administration and the ability to assimilate successfully product acquisitions.

Overview

Hemagen Diagnostics, Inc., is a biotechnology company that develops, manufactures, and markets approximately 68 FDA-cleared proprietary medical diagnostic test kits.  Hemagen has two different product lines.  The Virgo® product line of diagnostic test kits is used to aid in the diagnosis of certain autoimmune and infectious diseases, using ELISA, Immunoflourescence, and hemagglutination technology.  The Analyst® product line is an FDA-cleared clinical   chemistry analyzer system, including consumables, that is used to measure important constituents in human and animal blood. The Company sells its products both directly and through distributors to reference labs, physicians, veterinarians, clinical laboratories and blood banks. The Company also sells its products on a private-label basis through multinational distributors. The Company was incorporated in 1985 and became a public company in 1993.

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Hemagen’s principal office is located at 9033 Red Branch Road, Columbia, Maryland 21045 and the telephone number is (443) 367-5500.  Hemagen maintains a website at www.hemagen.com .  Investors can obtain copies of our filings with the Securities and Exchange Commission from this site free of charge as well as from the Securities and Exchange Commission website at www.sec.gov.


Critical Accounting Policies
We have identified certain accounting policies as critical to our business operations and the understanding of our results of operations.  The impact and any associated risks related to the identified critical accounting policies on our business operations are discussed in our Annual Report on Form 10-KSB for the fiscal year ended September 30, 2007 filed with the Securities and Exchange Commission.

Results of Operations
 
The Three Month Period Ended March 31, 2008
Compared to the Three Month Period Ended March 31, 2007

Revenues from continuing operations for the three-month period ended March 31, 2008 increased by approximately $638,000 (55%) to approximately $1,793,000 from approximately $1,155,000 for the same period ended March 31, 2007.  The increase in revenues is attributable to an increase in sales volume of $360,000 in the Analyst line, of which approximately $300,000 is directly related to the sale of the new equipment during the second quarter accompanied with an increase in rotor sales. The increase in sales in the Virgo line by $217,000 is the result of increased sales due to the placement of equipment in several large labs. The Company expects to see a continued growth in revenues as a result of this initiative.

Cost of product sales from continuing operations increased approximately $460,000 (83%) to approximately $1,015,000 from approximately $555,000 for the same period last year.  Cost of product sales as a percentage of sales increased to 57% from 48% from the same period last year. This increase in cost of sales as a percentage of sales is attributed to higher costs related to the equipment sales with lower margins.  Special incentives are in place for customers who purchase the new Analyst® instrument which reduce margin in the short term.  Revenues from these incentives have been deferred until the shipment date.

Research and development expenses from continuing operations increased by approximately
$42,000 (467%) to approximately $51,000 from approximately $9,000 in 2007.  This increase was caused by the reclassification of an employee.

The Company is currently working to complete several research and development programs including:

·
Activities related to upgrading the Analyst instrument and product offerings such as evaluating and developing complimentary products for Hemagen’s Analyst product line to distribute to the veterinary market and alternative tests utilizing the Analysts’ rotor technology;

·
Developing new ELISA kits and enhancing existing ELISA kits; and

·
Developing and enhancing IFA kits.

14 
 

 

Selling, general and administrative expenses from continuing operations decreased by approximately $2,000 (3%) for the quarter ended March 31, 2008 to approximately $591,000 from approximately $593,000 in the previous period. The expenses for SG&A remained relatively constant during these periods.  The Company expects to see a reduction of expenses in this area during the third quarter, due primarily to the decrease in the insurance liability costs effective with the renewal in March 2008.

Total other expenses for the three months ending March 31, 2008 decreased approximately $12,000 to approximately $82,000 from approximately $94,000 from the period ending March 31, 2007.  This decrease in net other expense is attributed to an increase in interest income from the note receivable and a slight decrease in interest expense on the line of credit.  The reduction in the Prime Rate is a contributing factor to this interest expense reduction.

Income tax expense for the quarter ended March 31, 2008 was approximately $27,000 as compared to approximately $16,000 for the quarter ended March 31, 2007.  This tax expense resulted from income realized at the Company’s Brazilian subsidiary.  The income before tax for the Company’s Brazilian subsidiary for the period ending March 31, 2008 was approximately $64,000 compared to net income before tax of approximately $114,000 for the prior year. The Brazilian income tax is calculated at an effective rate of approximately 22% which includes the fact that there are net loss carry forwards being utilized from prior periods.

Net income for the period increased by approximately $338,000 for the three months ended March 31, 2008 to net income of $28,000 compared to a net loss of approximately $310,000 in the same quarter of the prior year. Included in the quarter ending March 31, 2007 was a net loss on discontinued operations in the amount of $199,000 which was nonexistent in the current year quarter. Costs related to the shutdown of the San Diego facility were accrued in October 2007.  All remaining inventory is being sold at cost, in accordance with the inventory purchase agreement with the buyer, so there is no margin being reflected in the current quarter numbers. The remaining increase is a direct result of the higher sales revenues during the current quarter.

The Six Month Period Ended March 31, 2008
Compared to the Six Month Period Ended March 31, 2007

Revenues from continuing operations for the six month period ended March 31, 2008 increased by approximately $1,171,000 (54%) to approximately $3,333,000 from $2,162,000 for the same period ended March 31, 2007.  The increase in revenues is attributable to an increase in sales volume of $701,000 (80%) in the Analyst line, of which approximately $667,000 is directly related to the sale of the new equipment during the year along with an approximately $46,000 increase in rotor sales, offset by a decrease in sales in the Endocheck product line of approximately $26,000. Sales increased in the Virgo product line by approximately $464,000 (38%), driven primarily by increased sales due to the placement of instruments in several the large labs. The Company expects to see continued growth in revenues as a result of this initiative.

Cost of product sales from continuing operations increased approximately $670,000 (54%) to approximately $1,904,000 from approximately $1,234,000 for the same period last year.  Cost of product sales as a percentage of sales remained consistent at approximately 57% for both periods ending March 31, 2008 and 2007. Although the Company had seen a reduction of manufacturing payroll related costs and benefits, this has been offset by an increase in the cost of goods related to the Analyst ® equipment purchases sold at lower margins.

15 
 

 

Research and development expenses from continuing operations increased $ 81,000 (772%) to approximately 92,000 from $11,000 in 2007.  This increase was caused by the reclassification of an employee.

Selling, general and administrative expenses from continuing operations increased by approximately $16,000 (1%) for the six months ended March 31, 2008 to approximately $1,167,000 from approximately $1,151,000 in the previous period.

Total other expenses for the six months ending March 31, 2008 decreased approximately $26,000 to approximately $170,000 from approximately $196,000 from the six month period ending March 31, 2007.  This decrease in net other expense is attributed to an increase in interest income from the note receivable and a decrease in interest expense on the line of credit due to the reduction of the borrowing rate based on the Prime Rate.

Income tax expense for the six months ended March 31, 2008 was approximately $57,000 as compared to $21,000 for the six months ended March 31, 2007.  This tax expense resulted from income realized at the Company’s Brazilian subsidiary.  The income before tax for the Company’s Brazilian subsidiary for the six month period ending March 31, 2008 was $259,000 compared to a net income before tax of $88,000 for the prior year. The Brazilian income tax is calculated at an effective rate of approximately 22% which includes the fact we are utilizing some net loss carry forwards from prior periods.

Net income increased by approximately $1,472,000 for the six months ended March 31, 2008 to net income of approximately $801,000 compared to a net loss of approximately $671,000 in six month period ending March 31, 2007. Included in the six months ending March 31, 2008 was net income from discontinued operations in the amount of approximately $856,000. The remaining increase in net income was generated by the increase in sales and margin from continuing operations.

Liquidity and Capital Resources

At March 31 2008, Hemagen had $215,000 of cash, and working capital of $2,285,000.  At September 30, 2007, the Company had $6,592 of cash and working capital of $2,126,560.

Hemagen currently has a revolving line of credit with a bank for the purpose of financing working capital needs as required. This line of credit renewed on  March 31, 2008 and matures on March 31, 2009. The line of credit facility currently provides for borrowings up to $500,000, at an annual interest rate of the Prime plus .75%.  At March 31, 2008 the effective interest rate was 5.25%.    At March 31, 2008, and April 29, 2008, the Company had $283,231 and $323,231 respectively borrowed on its line of credit facility.

The Company believes that cash flow from operations, cash on hand at March 31, 2008, and the availability of the line of credit will be sufficient to finance its operations for fiscal 2008.  However, the Company can give no assurances that it will have sufficient cash flow to finance its operations.  The Company has no off-balance sheet financing arrangements.

In 2004, the Company issued $4,033,225 principal amount of Senior Subordinated Secured Convertible Notes due September 30, 2009 and 5,079,438 shares of common stock in exchange for $6,065,000 principal amount of its Senior Subordinated Secured Convertible Notes due April 17, 2005.  The new Notes issued are convertible into Common Stock at $0.75 per share. The new Notes carry an effective interest rate of 8% and mature September 30, 2009.

16 
 

 


Net cash provided by operating activities during the six months ended March 31, 2008 was approximately $305,000 compared to cash used of approximately $210,000 during the six months ended March 31, 2007.  The increase in cash provided by operations is the result of increased margins of approximately $442,000 and lower expenses due to the sale of Raichem, offset by an increase in accounts receivable of approximately $ 116,000, a reduction of inventory resulting primarily from the sale of inventory held in the San Diego facility, along with the reduction in payables of approximately $183,000.

Approximately $249,000 of cash was used in investing activities during the six months ended March 31, 2008 as compared to $52,000 of cash used for investing activities during the six months ended March 31, 2007.  The cash used in 2008 in the amount of $323,000 was for the purchase of lab equipment and computers for the Brazilian subsidiary, manufacturing equipment, and trade show equipment.

In accordance with the terms on the Note with the purchaser of Raichem, the Company received payments in the amount of $70,000 for the six months ended March 31, 2008 against the Note receivable.

Cash provided by financing activities was $125,000 in the six months ending March 31, 2008, compared to $250,000 for the six months ending March 31, 2007.  During the year the Company’s Brazilian subsidiary secured financing in the amount $211,000 to purchase lab equipment for use with our products.

Item 3.    Controls and Procedures.

The Company’s Chief Executive Officer, William P. Hales and Principal Financial Officer, Catherine Davidson have evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures as of March 31, 2008. Based upon this evaluation, Mr. Hales believes that the Company’s disclosure controls and procedures were effective as of March 31, 2008 except for the matters described below.

Management is aware that there is a lack of segregation of duties due to the small number of employees within the financial and administrative functions of the Company. As a result of the limitations of the resources and segregation of duties, Stegman and Company, the Company’s current auditor, has informed the company that these limitations represent a material weakness in internal controls. Management will continue to evaluate this segregation of duties issue. In addition, management is aware that many of the   internal controls that are in place at the Company are undocumented. The Company is currently working to appropriately document these internal controls.

There has been no change in the Company’s internal control over financial reporting identified in connection with the evaluation of internal controls that occurred during the last fiscal quarter that has materially affected, or is reasonably likely to affect, Hemagen’s internal control over financial reporting.

PART II.    OTHER INFORMATION

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

17 
 

 



Period
 
( a )
Total Number of Shares Purchased
   
(b)
Average
Price Paid per Share
   
(c)
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs(1)
   
(d)
Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs (2)
 
January 1-31, 2008
    3,375     $ 0.19       3,375       -  
February 1-29, 2008
    --       --       --       -  
March 1-31, 2008
    --       --       --       -  
Total
    3,375     $ 0.19       3,375       -  

 
(1)
Represents shares of Company’s Common Stock purchased pursuant to the Company’s Employee Stock Ownership Plan (ESOP) that was established October 1, 2003 with no expiration.  The purpose of the plan is not to repurchase, but rather it is an employee benefit plan.
 
(2)
There is no maximum number of shares that may be purchased under the Company’s Employee Stock Ownership Plan.


18 
 

 

Item 6.   Exhibits.

 (a)         Exhibits

Exhibit 31.1
Certification of Chief Executive Officer pursuant to Rule 13a-14(a)
   
Exhibit 31.2
Certification of Principal Financial Officer pursuant to Rule 13a-14(a)
   
Exhibit 32.1
Certification of Chief Executive Officer pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code
   
Exhibit 32.2
Certification of Principal Financial Officer pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code

19 
 

 


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 of the undersigned thereunto duly authorized.

 
Hemagen Diagnostics, Inc.
(Registrant)
 
 
 
       
May 14, 2008
By:
/s/William P. Hales  
    William P. Hales  
    Preisdent and Chief Executive Officer  
       
       
May 14, 2008
By:
/s/Catherine M. Davidson   
    Catherine M. Davidson  
    Principal Financial Officer  
       

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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