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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

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 from              to             

 

Commission file number 0-31271

 


 

REGENERATION TECHNOLOGIES, INC.

 


 

Delaware   59-3466543

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

11621 Research Circle

Alachua, Florida 32615

(386) 418-8888

 


 

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 Securities Exchange Act of 1934).    Yes  x    No  ¨

 

Shares of common stock, $0.001 par value, outstanding on November 1, 2004: 26,634,763

 



Table of Contents

REGENERATION TECHNOLOGIES, INC.

FORM 10-Q For the Quarter Ended September 30, 2004

Index

 

          Page #

Part I Financial Information     

Item 1

   Financial Statements    1 – 9

Item 2

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    10 – 14

Item 3

   Quantitative and Qualitative Disclosures About Market Risk    15

Item 4

   Controls and Procedures    16
Part II Other Information     

Item 1

   Legal Proceedings    17

Item 2

   Unregistered Sales of Equity Securities and Use of Proceeds    17

Item 3

   Defaults upon Senior Securities    17

Item 4

   Submission of Matters to a Vote of Security Holders    17

Item 5

   Other Information    17

Item 6

   Exhibits    18


Table of Contents

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

REGENERATION TECHNOLOGIES, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share data)

 

     September 30,
2004


    December 31,
2003


 
Assets                 

Current Assets:

                

Cash and cash equivalents

   $ 10,459     $ 10,051  

Restricted deposits

     —         14,757  

Accounts receivable - less allowances of $1,456 in 2004 and $4,456 in 2003

     10,029       5,942  

Inventories

     41,679       41,655  

Prepaid and other current assets

     1,504       940  

Deferred tax assets - current

     4,203       5,237  
    


 


Total current assets

     67,874       78,582  

Property, plant and equipment - net

     42,558       43,689  

Deferred tax assets

     1,152       2,466  

Goodwill

     2,863       2,863  

Other assets - net

     9,836       8,816  
    


 


     $ 124,283     $ 136,416  
    


 


Liabilities and Stockholders’ Equity                 

Current Liabilities:

                

Accounts payable

   $ 8,355     $ 18,919  

Accrued expenses

     5,956       5,928  

Current portion of deferred revenue

     364       364  

Note payable

     —         12,068  

Current portion of long-term debt

     2,467       1,607  
    


 


Total current liabilities

     17,142       38,886  

Long-term debt - less current portion

     6,863       621  

Derivative liabilities

     —         1,552  

Deferred revenue

     2,686       2,960  
    


 


Total liabilities

     26,691       44,019  
    


 


Stockholders’ Equity:

                

Common stock, $.001 par value: 50,000,000 shares authorized; 26,633,371 and 26,517,865 shares issued and outstanding, respectively

     26       26  

Additional paid-in capital

     102,493       102,018  

Accumulated deficit

     (4,836 )     (9,377 )

Deferred compensation

     (77 )     (256 )

Less treasury stock, 133,296 shares

     (14 )     (14 )
    


 


Total stockholders’ equity

     97,592       92,397  
    


 


     $ 124,283     $ 136,416  
    


 


 

See notes to unaudited condensed consolidated financial statements.

 

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REGENERATION TECHNOLOGIES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Income

(Unaudited)

(In thousands, except share and per share data)

 

     Three Months Ended
September 30,


   

Nine Months Ended

September 30,


 
     2004

    2003

    2004

    2003

 

Net Revenues:

                                

Fees from tissue distribution

   $ 22,289     $ 19,675     $ 67,771     $ 61,529  

Other revenues

     479       479       1,725       1,538  
    


 


 


 


Total net revenues

     22,768       20,154       69,496       63,067  

Costs of processing and distribution

     13,347       10,856       41,675       34,422  
    


 


 


 


Gross profit

     9,421       9,298       27,821       28,645  
    


 


 


 


Expenses:

                                

Marketing, general and administrative

     5,576       5,732       17,151       17,880  

Research and development

     951       937       2,965       2,034  

Asset abandonments

     —         111       —         111  
    


 


 


 


Total expenses

     6,527       6,780       20,116       20,025  
    


 


 


 


Operating income

     2,894       2,518       7,705       8,620  
    


 


 


 


Other (expense) income:

                                

Interest expense

     (217 )     (34 )     (726 )     (924 )

Interest income

     19       54       66       197  
    


 


 


 


Net interest (expense) income

     (198 )     20       (660 )     (727 )
    


 


 


 


Income before income tax expense

     2,696       2,538       7,045       7,893  

Income tax expense

     (1,043 )     (919 )     (2,504 )     (2,994 )
    


 


 


 


Net income

   $ 1,653     $ 1,619     $ 4,541     $ 4,899  
    


 


 


 


Net income per common share - basic

   $ 0.06     $ 0.06     $ 0.17     $ 0.19  
    


 


 


 


Net income per common share - diluted

   $ 0.06     $ 0.06     $ 0.17     $ 0.18  
    


 


 


 


Weighted average shares outstanding - basic

     26,625,999       26,442,783       26,575,956       26,318,618  
    


 


 


 


Weighted average shares outstanding - diluted

     27,053,585       27,304,880       27,070,782       26,972,226  
    


 


 


 


 

See notes to unaudited condensed consolidated financial statements.

 

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REGENERATION TECHNOLOGIES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

     Three Months Ended
September 30,


    Nine Months Ended
September 30,


 
     2004

    2003

    2004

    2003

 

Cash flows from operating activities:

                                

Net income

   $ 1,653     $ 1,619     $ 4,541     $ 4,899  

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

                                

Depreciation and amortization expense

     1,135       1,117       3,333       3,530  

(Reduction of) provision for bad debts

     (140 )     45       (220 )     135  

Provision for (reduction of) inventory writedowns

     385       (700 )     385       (1 )

Reduction of product returns

     (11 )     —         —         (182 )

Amortization of deferred revenue

     (91 )     (93 )     (274 )     (279 )

Deferred income tax provision

     996       160       2,348       2,231  

Deferred stock-based compensation and nonqualified option expense

     50       742       179       961  

Derivative (gain) loss

     —         (304 )     61       (177 )

Loss on asset abandonments

     —         111       —         111  

Changes in assets and liabilities:

                                

Accounts receivable

     (2,458 )     (409 )     (3,867 )     2,343  

Inventories

     (792 )     (1,831 )     (409 )     (7,255 )

Prepaid and other current assets

     (86 )     (115 )     (564 )     1,174  

Other assets

     (74 )     (265 )     (182 )     (330 )

Accounts payable

     808       (2,294 )     (10,564 )     (5,888 )

Accrued expenses

     (103 )     1,213       28       (159 )
    


 


 


 


Net cash provided by (used in) operating activities

     1,272       (1,004 )     (5,205 )     1,113  
    


 


 


 


Cash flows from investing activities:

                                

Purchases of property, plant and equipment

     (1,126 )     (76 )     (2,188 )     (1,352 )

Additional cash paid for purchases of assets

     —         —         —         (250 )
    


 


 


 


Net cash used in investing activities

     (1,126 )     (76 )     (2,188 )     (1,602 )
    


 


 


 


Cash flows from financing activities:

                                

Stock issuance costs

     —         —         —         (29 )

Proceeds from exercise of stock options

     337       1,409       475       1,742  

Payment made to terminate swap agreement

     —         —         (1,613 )     —    

Payments on capital lease and note obligations

     (787 )     (427 )     (1,898 )     (1,443 )

Payment on note payable

     —         —         (12,068 )     —    

Proceeds from issuance of term loan

     —         —         9,000       —    

Debt issuance costs

     (20 )     —         (852 )     —    

Decrease in restricted deposits

     —         534       14,757       133  
    


 


 


 


Net cash (used in) provided by financing activities

     (470 )     1,516       7,801       403  
    


 


 


 


Net (decrease) increase in cash and cash equivalents

     (324 )     436       408       (86 )

Cash and cash equivalents, beginning of period

     10,783       9,289       10,051       9,811  
    


 


 


 


Cash and cash equivalents, end of period

   $ 10,459     $ 9,725     $ 10,459     $ 9,725  
    


 


 


 


 

See notes to unaudited condensed consolidated financial statements.

 

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REGENERATION TECHNOLOGIES, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For the Three Months and Nine Months Ended September 30, 2004 and 2003

(Unaudited)

(In thousands, except share and per share data)

 

1. Basis of Presentation and Summary of Significant Accounting Policies

 

The accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, which the Company considers necessary for a fair presentation of the results of operations for the periods shown. The condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and, therefore, do not include all information and footnotes necessary for a fair presentation of consolidated financial position, results of operations and cash flows in conformity with accounting principles generally accepted in the United States of America. All intercompany balances and transactions have been eliminated in consolidation. The results of operations for any interim period are not necessarily indicative of the results to be expected for the full year. For further information, refer to the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003.

 

The condensed consolidated financial statements include the accounts of Regeneration Technologies, Inc. and its wholly owned subsidiaries, Alabama Tissue Center, Biological Recovery Group (inactive) and RTI Services, Inc. (collectively, the “Company”).

 

The condensed consolidated financial statements also include the accounts of RTI Donor Services, Inc., (“RTIDS”) which is a controlled entity. RTIDS is a taxable not for profit entity organized and controlled by the Company. RTIDS is the corporate entity that is responsible for procuring most of the tissue for the Company. Expenses incurred by RTIDS to procure tissue are passed through to the Company. RTIDS has no significant assets or liabilities except for its intercompany account and accounts payable to tissue recovery agencies. The Company pays all expenses of RTIDS.

 

Restricted Deposits— At September 30, 2004, the Company no longer has any restricted deposits. At December 31, 2003, the Company had $14,757 on deposit with a commercial bank in satisfaction of a collateral requirement contained in a credit agreement, which was fully repaid and terminated on February 20, 2004.

 

Debt Issuance Costs— Debt issuance costs include costs incurred to obtain financing. Upon funding of debt offerings, deferred financing costs are capitalized as debt issuance costs and amortized using the straight-line method, which approximates the effective interest method, over the life of the related debt. At September 30, 2004, debt issuance costs approximated $852 net of accumulated amortization of $92, which are included in other assets - net in the accompanying condensed consolidated balance sheets.

 

Reclassifications— Certain amounts in the condensed consolidated financial statements for the three and nine months ended September 30, 2003, as previously reported, have been reclassified to conform to the 2004 presentation.

 

2. Stock Based Compensation

 

Options to purchase approximately 3,142,716 shares of common stock at prices ranging from $1.30 to $14.95 per share were outstanding as of September 30, 2004.

 

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Had compensation cost for grants of options after March 31, 2000, the date with which all options granted to employees thereafter were issued with an exercise price equal to the fair market value on the date of the grant, been determined on the basis of fair value pursuant to Statement of Financial Accounting Standard (‘SFAS”) No. 123, Accounting for Stock Based Compensation, net income and net income per common share would have been affected as follows:

 

    

Three Months Ended

September 30,


   

Nine Months Ended

September 30,


 
     2004

    2003

    2004

    2003

 

Net income:

                                

As reported

   $ 1,653     $ 1,619     $ 4,541     $ 4,899  

Add: stock-based employee compensation expense included in reported net income, net of related tax effects

     7       11       19       35  

Deduct: total stock-based employee compensation expense determined under the fair value based method for all awards, net of related tax effects

     (375 )     (454 )     (1,167 )     (1,343 )
    


 


 


 


Pro forma net income

   $ 1,285     $ 1,176     $ 3,393     $ 3,591  
    


 


 


 


Net income per common share:

                                

Basic, as reported

   $ 0.06     $ 0.06     $ 0.17     $ 0.19  

Basic, pro forma

   $ 0.05     $ 0.04     $ 0.13     $ 0.14  

Diluted, as reported

   $ 0.06     $ 0.06     $ 0.17     $ 0.18  

Diluted, pro forma

   $ 0.05     $ 0.04     $ 0.13     $ 0.13  

 

The Company recorded deferred compensation expense for certain stock options granted to employees and non-employees prior to April 1, 2000 of $46 and $52 for the three months ended September 30, 2004 and 2003, respectively, and $156 and $167 for the nine months ended September 30, 2004 and 2003, respectively.

 

3. Earnings Per Share

 

A reconciliation of the weighted average number of shares of common stock used in the calculation of basic and diluted earnings per share is presented below:

 

     Three Months Ended
September 30,


   Nine Months Ended
September 30,


     2004

   2003

   2004

   2003

Basic shares

   26,625,999    26,442,783    26,575,956    26,318,618

Effect of dilutive stock options

   427,586    862,097    494,826    653,608
    
  
  
  

Diluted shares

   27,053,585    27,304,880    27,070,782    26,972,226
    
  
  
  

 

For the three months ended September 30, 2004 and 2003, approximately 1,651,000 and 888,000, respectively, and for the nine months ended September 30, 2004 and 2003, approximately 1,501,000 and 1,600,000, respectively, of issued stock options were not included in the computation of diluted earnings per share because they were anti-dilutive.

 

4. Goodwill and Other Intangible Assets

 

The carrying value of goodwill was $2,863 at September 30, 2004 and December 31, 2003. The following table reflects the components of other intangible assets which are recorded as a component of noncurrent other assets – net in the condensed consolidated balance sheets:

 

     September 30, 2004

   December 31, 2003

     Gross
Carrying
Amount


   Accumulated
Amortization


   Gross
Carrying
Amount


   Accumulated
Amortization


Amortizable intangible assets:

                           

Patents

   $ 1,681    $ 161    $ 1,278    $ 150

Trademarks

     21      14      84      10
    

  

  

  

Total

   $ 1,702    $ 175    $ 1,362    $ 160
    

  

  

  

 

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Amortization expense for the nine months ended September 30, 2004 and 2003 was $15 and $24, respectively. Management estimates amortization expense of $20 for each of the next five years.

 

5. Inventories

 

Inventories by stage of completion are as follows:

 

     September 30,
2004


   December 31,
2003


Unprocessed donor tissue

   $ 6,058    $ 6,246

Tissue in process

     22,801      20,065

Implantable donor tissue

     11,559      14,176

Supplies

     1,261      1,168
    

  

     $ 41,679    $ 41,655
    

  

 

During the nine month periods ended September 30, 2004 and 2003, the Company had inventory write-downs of $385 and $699, respectively, due to estimated obsolescence. During the three month period ended September 30, 2003, the Company reduced its provision for inventory write-downs by $700 reflecting donated and destroyed inventory items which were previously reserved for.

 

During the three month period ended September 30, 2004, the Company recognized in net revenues $918,000 as a result of transferring remaining consignment inventories outstanding under the prior distribution agreement to Medtronic Sofamor Danek (MSD).

 

6. Investment in Organ Recovery Systems, Inc.

 

On November 2, 2001 the Company purchased 1,285,347 shares of convertible preferred stock issued by Organ Recovery Systems, Inc. (“ORS”), a privately held company, at a price of $3.89 per share. ORS is organized for the purpose of advancing organ transplantation technology. The Company invested in ORS to continue its commitment to the promotion of effective use and distribution of human tissue. The purchase was paid for in cash and recorded at a total cost of $5,250.

 

Realization of the Company’s investment in ORS is dependent upon ORS’s successful execution of its operational strategies and the continued industry acceptance of its current and future product developments. Management monitors progress towards these success factors on a continual basis and has concluded that its investment in ORS has not been negatively impacted by operational matters. Additionally, in mid 2004, ORS raised additional funds through a private placement convertible debt offering with a conversion value of the equity securities equivalent to the price the Company paid for its shares of preferred stock. Accordingly, management of the Company believes there has been no impairment of the Company’s investment.

 

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7. Derivatives

 

The following table summarizes the notional transaction amount and fair value for the outstanding derivative at December 31, 2003:

 

     December 31, 2003

     
     Notional
Amount


   Fair Value

    Maturity

Interest rate swap

   $ 15,383    $ (1,552 )   2007

 

On February 20, 2004, the Company terminated the interest rate swap agreement by paying off the fair value of the swap, or $1,613. The net increase in fair value for the derivative liability of the interest rate swap for the period from December 31, 2003 to the termination date was $61.

 

8. Income Taxes

 

The Company uses the asset and liability method of accounting for income taxes. Deferred income taxes are recorded to reflect the tax consequences in future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each period-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to amounts which are more likely than not to be realized.

 

At September 30, 2004, net deferred tax assets were approximately $5,355. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. The Company expects the deferred tax assets, net of the valuation allowance at September 30, 2004 of $500, to be realized through the generation of future taxable income and the reversal of existing taxable temporary differences.

 

9. Supplemental Cash Flow Information

 

Selected cash payments, receipts, and noncash activities are as follows:

 

    

Three Months Ended

September 30,


  

Nine Months Ended

September 30,


 
     2004

   2003

   2004

   2003

 

Income taxes paid (received) during the period

   $ 35    $ —      $ 105    $ (1,510 )

Interest paid during the period

   $ 176    $ 499    $ 684    $ 1,363  

Noncash insurance financing

   $ —      $ —      $ —      $ 15  

 

10. Segment Data

 

The Company processes human tissue received from various tissue recovery agencies and distributes the tissue through various channels. This one line of business represents 100% of consolidated fees from tissue distribution

 

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and is comprised of four primary product lines: spinal, sports medicine, cardiovascular and general orthopedic. The following table presents net revenues from tissue distribution and for other non-tissue revenues:

 

     Three Months Ended
September 30,


   Nine Months Ended
September 30,


     2004

   2003

   2004

   2003

Fees from tissue distribution:

                           

Spinal

   $ 14,969    $ 13,297    $ 45,816    $ 41,091

Sports medicine

     1,911      2,220      6,966      6,634

Cardiovascular

     2,047      1,372      5,179      3,890

General orthopedic

     3,362      2,786      9,810      9,914

Other non-tissue

     479      479      1,725      1,538
    

  

  

  

Total

   $ 22,768    $ 20,154    $ 69,496    $ 63,067
    

  

  

  

 

11. Note Payable

 

Note payable is as follows:

 

     December 31,
2003


Term loan

   $ 12,068

 

On February 20, 2004, the Company repaid the outstanding balance on the term loan with proceeds from a new long-term financing agreement. Previously restricted deposits were applied to the outstanding balance and the remaining amount of the restricted deposits, or $1,200, became unrestricted cash as under the new loan agreement cash no longer serves as collateral.

 

12. Long-Term Debt

 

Long-term debt is as follows:

 

     September 30,
2004


    December 31,
2003


 

Long-term debt

   $ 8,250     $ —    

Capital leases

     1,080       2,228  
    


 


       9,330       2,228  

Less current portion

     (2,467 )     (1,607 )
    


 


     $ 6,863     $ 621  
    


 


 

On February 20, 2004, the Company entered into a new long-term financing agreement with a major financial institution. The new agreement consists of a $9,000 five-year term loan and a five-year $16,000 revolving line of credit. The $9,000 term loan calls for monthly principal payments of $125. Interest on the new loan agreement is paid monthly at LIBOR plus 4.25% (6.09% at September 30, 2004). Under the $16,000 revolving line of credit, the Company can borrow up to the maximum eligible amount, based on certain outstanding receivables and inventories, of which $11,685 is available at September 30, 2004. Interest on outstanding amounts under the revolving line of credit is payable at LIBOR plus 3.75%. Principal and interest on the revolving line of credit are payable upon maturity. There is a .5% fee payable on the unused portion of the revolving credit facility. No amounts were outstanding under the revolving line of credit at September 30, 2004. The term loan and revolving line of credit are fully collateralized by substantially all of the assets of the Company, including accounts receivable, inventories and certain property and equipment.

 

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The credit agreement also contains various restrictive covenants which limit, among other things, indebtedness, liens and business combination transactions. In addition, the Company must maintain certain financial covenant ratios, including operating cash flows to fixed charges, senior debt to EBITDA, and total debt to EBITDA, as defined in the agreement. The Company is in compliance with the financial covenant ratios at September 30, 2004.

 

13. Related Party

 

During the three months ended September 30, 2004 and 2003, the Company recognized revenues of $1,595 and $1,256, respectively, from distributions to Stryker Endoscopy, a division of Stryker Corporation (Stryker), representing 7.0% and 6.2% of our total revenues. During the nine months ended September 30, 2004 and 2003, the Company recognized revenues of $5,265 and $2,748, respectively, from distributions to Stryker, representing 7.6% and 4.4% of our total revenues. A member of our board of directors serves as a non-executive officer of Stryker Corporation.

 

14. Commitment

 

During the nine months ended September 30, 2004, the Company paid $10,202 to MSD for management service fee obligations which were recognized under the terms of the prior distribution agreement.

 

The Company is in settlement discussions with MSD regarding its performance under the prior agreement based on the contractual terms including, among other things, responsibilities of the parties relative to consignment inventories and uncollected accounts receivable. The current distribution agreement calls for the Company and MSD to enter into arbitration to settle disputes if a settlement cannot otherwise be reached. The Company cannot predict whether it will be successful in pursuit of its claims; however, it believes that these matters will be resolved without going to arbitration. The Company further believes that the ultimate settlement of all outstanding claims will not exceed liabilities provided for in the accompanying condensed consolidated financial statements.

 

15. Legal Actions

 

The Company is, from time to time, involved in litigation relating to claims arising out of its operations in the ordinary course of business. The Company believes that none of the claims that were outstanding as of September 30, 2004 will have a material adverse impact on its financial position or results of operations.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Cautionary Statement Relating to Forward Looking Statements

 

Information contained in this filing contains “forward-looking statements” which can be identified by the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates” or comparable terminology, or by discussions of strategy. We cannot assure that the future results covered by these forward-looking statements will be achieved. Some of the matters described in the “Risk Factors” section of our Form 10-K constitute cautionary statements which identify factors regarding these forward-looking statements, including certain risks and uncertainties, that could cause actual results to vary materially from the future results indicated in these forward-looking statements. Other factors could also cause actual results to vary materially from the future results indicated in such forward-looking statements.

 

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

 

Net Revenues. Our net revenues increased by $2.6 million, or 13.0%, to $22.8 million for the three months ended September 30, 2004 from $20.2 million for the three months ended September 30, 2003. Net revenues from spinal allografts increased $1.7 million, cardiovascular increased $675,000, and general orthopedic increased $576,000, offset by a decrease in sports medicine of $309,000 for the three months ended September 30, 2004 compared to the three months ended September 30, 2003. Net revenues from spinal allografts increased as a result of continued demand for these allografts, the revenues from transferring consignment inventories, and new product introductions which represent 11.7% of net revenues for the quarter. Cardiovascular revenues increased 49.2% as a result of volume increases and a price increase instituted at the beginning of 2004. Net revenues from general orthopedic distributions increased due to a sharp increase in orthopedic bone paste demand from our distributor, Exactech, Inc. Net revenues from sports medicine decreased due to reductions in tissue distributed internationally, and a one-time distribution of $340,000, during the three months ended September 30, 2003, of tissues that were non-exclusive to Stryker Endoscopy.

 

Costs of Processing and Distribution. Costs of processing and distribution increased by $2.5 million, or 22.9%, to $13.3 million for the three months ended September 30, 2004 from $10.9 million for the three months ended September 30, 2003. Our costs of processing and distribution continue to be impacted by the increase in mix of new cervical units produced, which on a per unit basis are more costly to produce than our lumbar spinal product line, along with increases in tissue recovery costs, and the efficiency of our manufacturing plant. Our manufacturing plant efficiency was negatively impacted by interruptions in production due to BioCleanse system upgrades and down time related to the hurricanes that impacted Florida during the three months ended September 30, 2004. As a percentage of net revenues, costs of processing and distribution increased from 53.9% for the three months ended September 30, 2003 to 58.6% for the three months ended September 30, 2004.

 

Marketing, General and Administrative Expenses. Marketing, general and administrative expenses decreased by $156,000, or 2.7%, to $5.6 million for the three months ended September 30, 2004 from $5.7 million for the three months ended September 30, 2003. These expenses decreased as a percentage of net revenues from 28.4% for the three months ended September 30, 2003 to 24.5% for the three months ended September 30, 2004. The decrease was primarily due to a $200,000 reversal in our allowance for bad debts during the three months ended September 30, 2004, as these reserves are no longer deemed necessary for potential uncollectible accounts.

 

Research and Development Expenses. Research and development expenses increased by $14,000, or 1.5%, to $951,000 for the three months ended September 30, 2004 from $937,000 for the three months ended September 30, 2003. As a percentage of net revenues, research and development expenses decreased from 4.6% for the three months ended September 30, 2003 to 4.2% for the three months ended September 30, 2004 as a result of an increase in net revenues without a commensurate increase in research and development expenses.

 

Net Interest Expense. Net interest expense was $198,000 for the three months ended September 30, 2004 compared to net interest income of $20,000 for the three months ended September 30, 2003. Included in interest income for the three months ended September 30, 2003 was a $304,000 gain associated with our previously outstanding interest rate swap agreement. The swap agreement was terminated on February 20, 2004.

 

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Income Tax Expense. Income tax expense for the three months ended September 30, 2004 was $1.0 million compared to $919,000 for the three months ended September 30, 2003. Our effective tax rate for the three months ended September 30, 2004 was 39%, compared to 36% for the three months ended September 30, 2003. Our effective tax rate for the three months ended September 30, 2003 was reduced by the impact of a significant donation of tissue.

 

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

 

Net Revenues. Our net revenues increased by $6.4 million, or 10.2%, to $69.5 million for the nine months ended September 30, 2004 from $63.1 million for the nine months ended September 30, 2003. Spinal allografts increased $4.7 million, sports medicine allografts increased $332,000, and cardiovascular distributions increased $1.3 million, offset partially by a $104,000 decrease in our general orthopedic allografts. Spinal revenues increased as a result of a 15.3% increase in units distributed to our distributor, Medtronic Sofamor Danek, which is attributable to increased demand for these allografts, the revenues from transferring consignment inventories, and new product introductions which represented 11.9% of net revenues for the period. In addition, sports medicine revenues increased 5.0% primarily as the result of a price increase associated with the introduction of soft tissue BioCleanse. Cardiovascular revenues increased 33.1% as a result of volume increases, change in product mix, and a 7% price increase instituted at the beginning of 2004. General orthopedic revenues decreased 1.0% as a result of our allocation of tissue to support the increasing demand for our spinal allograft products.

 

Costs of Processing and Distribution. Costs of processing and distribution increased by $7.3 million, or 21.1%, to $41.7 million for the nine months ended September 30, 2004 from $34.4 million for the nine months ended September 30, 2003. Our costs of processing and distribution were primarily impacted by an increase in the proportion of new cervical units produced as compared to our lumbar spinal line, which on a per unit basis are more costly to produce than our lumbar spinal product line, along with increases in tissue recovery costs, lower units produced from donated tissue, and lower productivity in our processing facility as we have balanced distribution needs with controlled inventory levels. As a percentage of net revenues, costs of processing and distribution increased from 54.6% for the nine months ended September 30, 2003 to 60.0% for the nine months ended September 30, 2004.

 

Marketing, General and Administrative Expenses. Marketing, general and administrative expenses decreased by $729,000, or 4.1%, to $17.2 million for the nine months ended September 30, 2004 from $17.9 million for the nine months ended September 30, 2003. These expenses decreased as a percentage of net revenues from 28.4% for the nine months ended September 30, 2003 to 24.7% for the nine months ended September 30, 2004. The decrease primarily was due to a reversal of $400,000 in our allowance for bad debts in 2004, as these reserves are no longer deemed necessary for potential uncollectible accounts and a $321,000 decrease in consulting expense which we incurred in connection with marketing our patented BioCleanse tissue sterilization process in 2003.

 

Research and Development Expenses. Research and development expenses increased by $931,000, or 45.8%, to $3.0 million for the nine months ended September 30, 2004 from $2.0 million for the nine months ended September 30, 2003. As a percentage of net revenues, research and development expenses increased from 3.2% for the nine months ended September 30, 2003 to 4.3% for the nine months ended September 30, 2004, as we increased our spending on personnel and studies associated with new product development initiatives.

 

Net Interest Expense. Net interest expense was $660,000 for the nine months ended September 30, 2004 compared to $727,000 for the nine months ended September 30, 2003. This decrease was primarily the result of our lower outstanding debt balance and no longer having interest expense associated with an outstanding interest rate swap agreement. The swap agreement was terminated on February 20, 2004.

 

Income Tax Expense. Income tax expense for the nine months ended September 30, 2004 was $2.5 million compared to $3.0 million for the nine months ended September 30, 2003. Our effective tax rate for the nine months

 

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ended September 30, 2004 was 36%, which was lower than our 38% effective tax rate for the nine months ended September 30, 2003, due to a tax credit we recognized for qualified research and development expenses incurred during the six months ended June 30, 2004.

 

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Liquidity and Capital Resources

 

Cash Flows.

 

Our net cash used in operating activities was $5.2 million for the nine months ended September 30, 2004, compared to $1.1 million of net cash provided by operating activities for the nine months ended September 30, 2003. During the nine months ended September 30, 2004, cash was provided by net income of $4.5 million and primary uses of cash were a reduction in accounts payable of $10.6 million, which included a $10.2 million payment to Medtronic Sofamor Danek for management service fee obligations which were recognized under the terms of the prior distribution agreement and an increase in accounts receivable of $3.9 million. Significant non-cash adjustments to operating activities for the nine months ended September 30, 2004 included depreciation and amortization expense of $3.3 million and a deferred income tax provision of $2.3 million primarily reflecting the utilization of income tax carryforwards. Our accounts receivable days sales outstanding were 40 for the nine months ended September 30, 2004 and 29 at year ended December 31, 2003. The increase reflects a higher accounts receivable balance and not due to a deterioration of credit quality. Our inventory days outstanding were 264 annualized for the nine months ended September 30, 2004, compared to 289 for year ended December 31, 2003. The reduced inventory days were the result of maintaining inventories at similar levels to the end of 2003 while increasing annualized revenues.

 

Our cash used in investing activities was $2.2 million for the nine months ended September 30, 2004 compared to $1.6 million for the nine months ended September 30, 2003. Our investing activities in 2004 consisted of purchases of property, plant, and equipment.

 

Our net cash provided by financing activities was $7.8 million for the nine months ended September 30, 2004 compared to $403,000 for the nine months ended September 30, 2003. Cash provided by financing activities for the nine months ended September 30, 2004 consisted of a $14.8 million decrease in restricted deposits, proceeds of $9.0 million from issuance of our new term loan, and proceeds from exercise of stock options of $475,000. Cash used in financing activities for the nine months ended September 30, 2004 consisted of the repayment of our previous term loan of $12.1 million, a $1.6 million payment made to terminate a swap agreement, $852,000 associated with debt issuance costs, and payments on capital lease and note obligations of $1.9 million.

 

Liquidity.

 

As of September 30, 2004, we had $10.5 million of cash and cash equivalents. We believe that our working capital as of September 30, 2004, together with our borrowing ability under our revolving line of credit, will be adequate to fund our operations for at least the next 12 months.

 

Certain Commitments.

 

We are in discussions with MSD regarding its performance under the prior agreement based on the contractual terms including, among other things, responsibilities of the parties relative to consignment inventories and uncollected accounts receivable. The current distribution agreement calls for us and MSD to enter into arbitration to settle disputes if we cannot otherwise reach a settlement. We cannot predict whether we will be successful in pursuit of our claims; however, we believe that these matters will be resolved without going to arbitration. We further believe that the ultimate settlement of all outstanding claims will not exceed liabilities provided for in the accompanying condensed consolidated financial statements.

 

On February 20, 2004, we entered into a new long-term financing agreement with a major financial institution. The new agreement consists of a $9.0 million five-year term loan and a five-year $16.0 million revolving line of credit. The $9.0 million term loan calls for monthly principal payments of $125,000. Interest on the new loan agreement is paid monthly at LIBOR plus 4.25% (6.09% at September 30, 2004). Under the $16.0 million revolving line of credit, we can borrow up to the maximum eligible amount, based on certain outstanding receivables and inventories, of which $11.7 million is available at September 30, 2004. Interest on outstanding amounts under the revolving credit loan is payable at LIBOR plus 3.75%. Principal and interest on the revolving credit loan are

 

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payable upon maturity. There is a .5% fee payable on the unused portion of the revolving credit facility. No amounts were outstanding under the revolving line of credit September 30, 2004. The term loan and revolving line of credit are collateralized by substantially all of our assets, including accounts receivable, inventories and certain property and equipment.

 

The credit agreement also contains various restrictive covenants, which limit, among other things, indebtedness, liens and business combination transactions. In addition, we must maintain certain financial covenant ratios, including operating cash flows to fixed charges, senior debt to EBITDA, and total debt to EBITDA, as defined in the agreement. We were in compliance with the financial covenants at September 30, 2004.

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

We are subject to market risk from exposure to changes in interest rates based upon our financing, investing and cash management activities. We use a mix of debt maturities along with variable-rate debt to manage our exposure to changes in interest rates. We do not expect changes in interest rates to have a material adverse effect on our income or our cash flows in 2004. However, we cannot assure that interest rates will not significantly change in 2004. We do not enter into derivatives or other financial instruments for trading or speculative purposes.

 

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Item 4. Controls and Procedures

 

We carried out an evaluation, under the supervision and with the participation of management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report pursuant to Exchange Act Rule 13a-15 and 15d-15. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure that material information is recorded, processed, summarized and reported by management on a timely basis in order to comply with our disclosure obligations under the Securities Exchange Act of 1934 and the SEC rules thereunder. There have not been any changes in our internal controls over financial reporting during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

We refer you to Item 1, note 15 entitled “Legal Actions.”

 

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

 

None.

 

Item 3. Defaults upon Senior Securities

 

Not applicable.

 

Item 4. Submission of Matters to a Vote of Security Holders

 

Not applicable.

 

Item 5. Other Information

 

Not applicable.

 

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Item 6. Exhibits

 

Exhibits

 

31.1    Certification of the Chief Executive Officer Under Section 302 of the Sarbanes-Oxley Act of 2002.
31.2    Certification of the Chief Financial Officer Under Section 302 of the Sarbanes-Oxley Act of 2002.
32.1    Certification of Periodic Financial Report by Chief Executive Officer Under Section 906 of the Sarbanes-Oxley Act of 2002.
32.2    Certification of Periodic Financial Report by Chief Financial Officer Under Section 906 of the Sarbanes-Oxley Act of 2002.

 

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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.

 

REGENERATION TECHNOLOGIES, INC. (Registrant)
By:  

/s/ Brian K. Hutchison


   

Brian K. Hutchison

Chairman, President and Chief Executive Officer

By:  

/s/ Thomas F. Rose


   

Thomas F. Rose

Vice President, Chief Financial Officer and

Secretary

 

Date: November 8, 2004