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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(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 from                     to                    

Commission file number: 000-32883

WRIGHT MEDICAL GROUP, INC.

(Exact name of registrant as specified in its charter)
     
Delaware   13-4088127
(State or other jurisdiction   (IRS employer
of incorporation or organization)   identification number)
     
5677 Airline Road    
Arlington, Tennessee   38002
(Address of principal executive offices)   (Zip code)
     
Registrant’s telephone number, including area code:   (901) 867-9971

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. [X] Yes [   ] No

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). [X] Yes [   ] No

As of October 27, 2004, there were 33,479,843 shares of common stock outstanding.

 


WRIGHT MEDICAL GROUP, INC.

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 Ex-10.14 Severance Agreement dated as of August 31, 2004
 Ex-31.1 Section 302 Certification of the CEO
 Ex-31.2 Section 302 Certification of the CFO
 Ex-32 Section 906 Certification of the CEO and CFO

SAFE-HARBOR STATEMENT

This quarterly report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this quarterly report, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends. We wish to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including the factors discussed in our filings with the Securities and Exchange Commission (including those described in Item 7 of our annual report on Form 10-K for the year ended December 31, 2003, under the heading, “Factors Affecting Future Operating Results,” and in this and other quarterly reports), which could cause our actual results to materially differ from those described in the forward-looking statements. Although we believe that the forward-looking statements are accurate, there can be no assurance that any forward-looking statement will prove to be accurate. A forward-looking statement should not be regarded as a representation by us that the results described therein will be achieved. We wish to caution readers not to place undue reliance on any forward-looking statement. The forward-looking statements are made as of the date of this quarterly report. We assume no obligation to update any forward-looking statement after this date.

 


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PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

WRIGHT MEDICAL GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
                 
    September 30,   December 31,
    2004
  2003
    (unaudited)    
Assets:
               
Current assets:
               
Cash and cash equivalents
  $ 73,914     $ 66,571  
Accounts receivable, net
    59,979       55,821  
Inventories
    74,794       64,204  
Prepaid expenses
    6,541       5,046  
Deferred income taxes
    9,106       15,591  
Other current assets
    3,503       3,291  
 
   
 
     
 
 
Total current assets
    227,837       210,524  
Property, plant and equipment, net
    67,420       66,915  
Goodwill
    8,760       11,248  
Intangible assets, net
    17,115       18,646  
Deferred income taxes
    16,463       13,398  
Other assets
    1,125       1,372  
 
   
 
     
 
 
 
  $ 338,720     $ 322,103  
 
   
 
     
 
 
Liabilities and stockholders’ equity:
               
Current liabilities:
               
Accounts payable
  $ 13,976     $ 14,227  
Accrued expenses and other current liabilities
    42,365       42,814  
Current portion of long-term obligations
    6,239       6,228  
 
   
 
     
 
 
Total current liabilities
    62,580       63,269  
Long-term obligations
    8,496       11,096  
Deferred income taxes
          1,203  
Other liabilities
    6,095       8,217  
 
   
 
     
 
 
Total liabilities
    77,171       83,785  
 
   
 
     
 
 
Commitments and contingencies (Note 9)
               
Stockholders’ equity:
               
Common stock, $.01 par value, shares authorized – 100,000,000; shares issued and outstanding – 33,473,867 in 2004, 33,040,747 in 2003
    335       330  
Additional paid-in capital
    268,703       263,455  
Deferred compensation
    (450 )     (1,452 )
Accumulated other comprehensive income
    14,919       15,675  
Accumulated deficit
    (21,958 )     (39,690 )
 
   
 
     
 
 
Total stockholders’ equity
    261,549       238,318  
 
   
 
     
 
 
 
  $ 338,720     $ 322,103  
 
   
 
     
 
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

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WRIGHT MEDICAL GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Net sales
  $ 69,299     $ 59,268     $ 219,832     $ 180,042  
Cost of sales
    19,998       15,453       61,767       48,379  
 
   
 
     
 
     
 
     
 
 
Gross profit
    49,301       43,815       158,065       131,663  
Operating expenses:
                               
Selling, general and administrative1
    36,611       32,292       111,459       94,560  
Research and development 2
    4,302       4,397       13,808       11,840  
Amortization of intangible assets
    975       900       2,845       2,627  
Stock-based expense
    271       482       1,160       1,311  
Acquired in-process research and development costs (Note 2)
                      4,558  
 
   
 
     
 
     
 
     
 
 
Total operating expenses
    42,159       38,071       129,272       114,896  
 
   
 
     
 
     
 
     
 
 
Operating income
    7,142       5,744       28,793       16,767  
Interest expense, net
    283       274       868       852  
Other income, net
    (5 )     (155 )     (19 )     (666 )
 
   
 
     
 
     
 
     
 
 
Income before income taxes
    6,864       5,625       27,944       16,581  
Provision for income taxes
    2,434       1,974       10,212       5,931  
 
   
 
     
 
     
 
     
 
 
Net income
  $ 4,430     $ 3,651     $ 17,732     $ 10,650  
 
   
 
     
 
     
 
     
 
 
Net income per share (Note 7):
                               
Basic
  $ 0.13     $ 0.11     $ 0.53     $ 0.32  
 
   
 
     
 
     
 
     
 
 
Diluted
  $ 0.13     $ 0.11     $ 0.50     $ 0.31  
 
   
 
     
 
     
 
     
 
 
Weighted-average number of shares outstanding-basic
    33,461       32,932       33,296       32,807  
 
   
 
     
 
     
 
     
 
 
Weighted-average number of shares outstanding-diluted
    35,311       34,695       35,355       34,378  
 
   
 
     
 
     
 
     
 
 


1 Amounts presented are exclusive of $262 and $455 in stock-based expense for the three months ended September 30, 2004 and 2003, respectively, and $1,100 and $1,232 in stock-based expense for the nine months ended September 30, 2004 and 2003, respectively.
 
2 Amounts presented are exclusive of $9 and $27 in stock-based expense for the three months ended September 30, 2004 and 2003, respectively, and $60 and $79 in stock-based expense for the nine months ended September 30, 2004 and 2003, respectively.

The accompanying notes are an integral part of these condensed consolidated financial statements.

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WRIGHT MEDICAL GROUP, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
                 
    Nine Months Ended
    September 30,
    2004
  2003
Operating activities:
               
Net income
  $ 17,732     $ 10,650  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Depreciation
    12,347       10,317  
Amortization of deferred financing costs
    196       196  
Amortization of intangible assets
    2,845       2,627  
Deferred income taxes
    3,619       5,170  
Stock-based expenses
    1,160       1,311  
In-process research and development
          4,558  
Other
    70       (51 )
Changes in assets and liabilities, net of acquisitions:
               
Accounts receivable
    (4,618 )     (2,606 )
Inventories
    (8,698 )     (1,955 )
Other current assets
    (4,059 )     (1,826 )
Accounts payable
    (160 )     1,174  
Accrued expenses and other liabilities
    (1,583 )     4,503  
 
   
 
     
 
 
Net cash provided by operating activities
    18,851       34,068  
Investing activities:
               
Capital expenditures
    (12,365 )     (10,658 )
Purchase of tangible and intangible assets (Note 2)
    (161 )     (7,779 )
Other
    48       68  
 
   
 
     
 
 
Net cash used in investing activities
    (12,478 )     (18,369 )
Financing activities:
               
Issuance of common stock
    3,342       1,204  
Payments of bank and other financing
    (3,400 )     (3,358 )
Proceeds from bank and other financing
    1,094        
 
   
 
     
 
 
Net cash provided by (used in) financing activities
    1,036       (2,154 )
Effect of exchange rates on cash and cash equivalents
    (66 )     269  
 
   
 
     
 
 
Net increase in cash and cash equivalents
  $ 7,343     $ 13,814  
Cash and cash equivalents, beginning of period
  $ 66,571     $ 51,373  
 
   
 
     
 
 
Cash and cash equivalents, end of period
  $ 73,914     $ 65,187  
 
   
 
     
 
 

The accompanying notes are an integral part of these condensed consolidated financial statements.

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WRIGHT MEDICAL GROUP, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Summary of Significant Accounting Policies

Basis of Presentation. The unaudited condensed consolidated interim financial statements of Wright Medical Group, Inc. (the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States (“U.S.”) for interim financial information and the instructions to Quarterly Report on Form 10-Q and Rule 10-01 of Regulation S-X. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to these rules and regulations. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s consolidated financial statements and related notes included in the Company’s annual report on Form 10-K for the year ended December 31, 2003, as filed with the Securities and Exchange Commission (“SEC”).

In the opinion of management, these unaudited condensed consolidated interim financial statements reflect all adjustments necessary for a fair presentation of the Company’s interim financial results. All such adjustments are of a normal and recurring nature. The results of operations for any interim period are not necessarily indicative of results for the full fiscal year.

The accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned domestic and international subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Stock Based Compensation. As of September 30, 2004, the Company has two stock-based employee compensation plans. The Company accounts for those plans under the intrinsic value method in accordance with the provisions of Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees.” Accordingly, compensation cost related to stock option grants to employees has been recognized only to the extent that the fair market value of the stock exceeds the exercise price of the stock option at the date of grant. Nonemployee stock-based compensation is accounted for in accordance with Statement of Financial Accounting Standards (“SFAS”) No. 123, “Accounting for Stock-Based Compensation.”

The following table illustrates the effect on net income and earnings per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation (in thousands, except per share amounts):

                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Net income, as reported
  $ 4,430     $ 3,651     $ 17,732     $ 10,650  
Add: Stock-based employee compensation expense recognized under intrinsic value method, net of tax effects
    167       239       561       713  
Less: Stock-based employee compensation expense determined under fair value based method, net of tax effects
    (2,388 )     (1,031 )     (6,026 )     (2,945 )
 
   
 
     
 
     
 
     
 
 
Pro forma net income
  $ 2,209     $ 2,859     $ 12,267     $ 8,418  
 
   
 
     
 
     
 
     
 
 
Net income per share:
                               
Basic, as reported
  $ 0.13     $ 0.11     $ 0.53     $ 0.32  
 
   
 
     
 
     
 
     
 
 
Basic, pro forma
  $ 0.07     $ 0.09     $ 0.37     $ 0.26  
 
   
 
     
 
     
 
     
 
 
Diluted, as reported
  $ 0.13     $ 0.11     $ 0.50     $ 0.31  
 
   
 
     
 
     
 
     
 
 
Diluted, pro forma
  $ 0.06     $ 0.08     $ 0.35     $ 0.25  
 
   
 
     
 
     
 
     
 
 

Derivative Instruments. The Company accounts for its derivative instruments in accordance with SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities” as amended by SFAS No. 138. During the third quarter of 2004, the Company began a derivative program using 30-day foreign currency forward contracts to mitigate the risk of currency fluctuations on its intercompany receivable and payable balances that are denominated in foreign currencies. These forward contracts are expected to offset the transactional gains and losses on the related intercompany balances. These forward contracts are not designated as hedging instruments under SFAS 133. Accordingly, the changes in the fair value and the settlement of the contracts are recognized in the period incurred.

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WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (CONTINUED)

2. Acquisition of Assets

On March 5, 2003, the Company completed an acquisition of certain assets from Gliatech Inc. related to its ADCON® Gel technology for $8.4 million in cash. Additionally, the Company entered into a royalty agreement that requires the Company to pay a royalty on future product sales. The Company paid $840,000 of the purchase price as a deposit in the fourth quarter of 2002, and $3.4 million in the first quarter of 2003. The remaining $4.2 million was paid in the second quarter of 2003 upon final receipt of all assets. The following table summarizes the allocation of the purchase price (in thousands):

         
Inventories
  $ 1,312  
Property, plant and equipment
    160  
Acquired in-process research and development
    4,558  
Intangible assets:
       
Completed technology
    1,575  
Trademarks
    554  
Other
    286  
 
   
 
 
 
  $ 8,445  
 
   
 
 

In connection with the acquisition of these assets, the Company engaged an independent third party to conduct a valuation of the intangible assets acquired. The value assigned to acquired in-process research and development (“IPRD”) was $4.6 million of the purchase price. Accordingly, this amount was expensed in the three-month period ended March 31, 2003. The value assigned to IPRD was determined by estimating the costs to develop the IPRD into commercially viable products, estimating the resulting cash flows from such projects, and discounting the net cash flows utilizing a 32% risk adjusted discount rate. This discount rate reflected uncertainties surrounding the successful development of the IPRD.

3. Inventories

Inventories consist of the following (in thousands):

                 
    September 30,   December 31,
    2004
  2003
Raw materials
  $ 3,399     $ 2,816  
Work-in-process
    13,889       9,827  
Finished goods
    57,506       51,561  
 
   
 
     
 
 
 
  $ 74,794     $ 64,204  
 
   
 
     
 
 

4. Property, Plant and Equipment, Net

Property, plant and equipment consists of the following (in thousands):

                 
    September 30,   December 31,
    2004
  2003
Property, plant and equipment, at cost
  $ 118,263     $ 107,943  
Less: Accumulated depreciation
    (50,843 )     (41,028 )
 
   
 
     
 
 
 
  $ 67,420     $ 66,915  
 
   
 
     
 
 

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WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (CONTINUED)

5. Long-Term Obligations

Long-term obligations consist of the following (in thousands):

                 
    September 30,   December 31,
    2004
  2003
Notes payable
  $ 11,250     $ 13,250  
Capital lease obligations
    3,485       4,074  
 
   
 
     
 
 
 
    14,735       17,324  
Less: current portion
    (6,239 )     (6,228 )
 
   
 
     
 
 
 
  $ 8,496     $ 11,096  
 
   
 
     
 
 

At September 30, 2004, the Company’s senior credit facility consisted of $11.3 million in outstanding term loan borrowings and availability under a revolving credit facility of $59.7 million after considering outstanding letters of credit. At the Company’s option, borrowings under the credit facility bear interest either at a rate equal to a fixed base rate plus a spread of .75% to 1.25% or at a rate equal to an adjusted LIBOR plus a spread of 1.75% to 2.25%, depending on the Company’s consolidated leverage ratio, with a rate of 3.625% at September 30, 2004.

6. Goodwill and Intangible Assets

Changes in the carrying amount of goodwill during the nine months ended September 30, 2004 are as follows (in thousands):

         
Goodwill at December 31, 2003
  $ 11,248  
Less: Resolution of pre-acquisition foreign income tax contingency
    (2,344 )
Foreign currency translation
    (144 )
 
   
 
 
Goodwill at September 30, 2004
  $ 8,760  
 
   
 
 

During the first quarter of 2004, the Company favorably resolved a foreign income tax contingency associated with its December 1999 acquisition of Cremascoli Ortho Holding, S.A. (“Cremascoli”). This amount was established as an accrued liability in the purchase accounting associated with the acquisition of Cremascoli. Due to the favorable resolution of this matter, the Company reduced the previously recorded goodwill and the associated contingency accrual, which had been recorded in “Other liabilities” in the Company’s condensed consolidated balance sheet.

The components of the Company’s identifiable intangible assets are as follows (in thousands):

                                 
    September 30, 2004
  December 31, 2003
            Accumulated           Accumulated
    Cost
  amortization
  Cost
  amortization
Completed technology
  $ 5,280     $ 1,529     $ 5,288     $ 1,025  
Distribution channels
    19,079       9,058       19,296       7,708  
Trademarks
    657       133       657       75  
Other
    5,728       2,909       4,345       2,132  
 
   
 
     
 
     
 
     
 
 
 
    30,744     $ 13,629       29,586     $ 10,940  
 
           
 
             
 
 
Less: Accumulated amortization
    (13,629 )             (10,940 )        
 
   
 
             
 
         
Intangible assets, net
  $ 17,115             $ 18,646          
 
   
 
             
 
         

Based on the intangible assets held at September 30, 2004, the Company expects to recognize amortization expense of approximately $3.9 million for the full year of 2004, $3.7 million in 2005, $3.4 million in 2006, $2.7 million in 2007, and $2.6 million in 2008.

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WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (CONTINUED)

7. Earnings Per Share

SFAS No. 128, “Earnings Per Share,” requires the presentation of basic and diluted earnings per share. Basic earnings per share is calculated based on the weighted-average shares of common stock outstanding during the period. Diluted earnings per share is calculated to include any dilutive effect of the Company’s common stock equivalents. The Company’s common stock equivalents consist of stock options and warrants. The dilutive effect of such instruments is calculated using the treasury-stock method.

The weighted-average number of common shares outstanding for basic and diluted earnings per share is as follows (in thousands):

                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Weighted-average number of shares outstanding, basic
    33,461       32,932       33,296       32,807  
Common stock equivalents
    1,850       1,763       2,059       1,571  
 
   
 
     
 
     
 
     
 
 
Weighted-average number of shares outstanding, diluted
    35,311       34,695       35,355       34,378  
 
   
 
     
 
     
 
     
 
 

8. Other Comprehensive Income

The difference between the Company’s net income and its comprehensive income is wholly attributable to foreign currency translation. The following table provides a reconciliation of net income to comprehensive income (in thousands):

                                 
    Three Months Ended   Nine Months Ended
    September 30,
  September 30,
    2004
  2003
  2004
  2003
Net income
  $ 4,430     $ 3,651     $ 17,732     $ 10,650  
Changes in foreign currency translation
    1,287       1,476       (756 )     6,308  
 
   
 
     
 
     
 
     
 
 
Comprehensive income
  $ 5,717     $ 5,127     $ 16,976     $ 16,958  
 
   
 
     
 
     
 
     
 
 

9. Commitments and Contingencies

Legal Proceedings. On June 30, 1993, prior to the December 1999 recapitalization and inception of the Company in its current form, the Company’s predecessor company, Wright Medical Technology, Inc. (the “Predecessor Company”), acquired substantially all of the assets of the large joint orthopaedic implant business from Dow Corning Corporation (DCC). DCC retains liability for matters arising from certain conduct of DCC prior to June 30, 1993. As such, DCC has agreed to indemnify the Predecessor Company against all liability for all products manufactured prior to the acquisition except for products provided under the Predecessor Company’s 1993 agreement with DCC pursuant to which the Predecessor Company purchased certain small joint orthopaedic implants for worldwide distribution. The Predecessor Company was notified in May 1995 that DCC, which filed for reorganization under Chapter 11 of the U.S. Bankruptcy Code, would no longer defend the Predecessor Company in such matters until it received further direction from the bankruptcy court. Based on the most recent plan of reorganization submitted to the court, it appears that the Predecessor Company would be considered an unsecured creditor and, under the terms of the plan, would receive 24% of any such claim as a cash payment with the remainder to be paid by a senior note due within ten years. There are several appeals regarding the confirmed plan of reorganization pending before the U.S. District Court in Detroit, Michigan, which have delayed implementation of the plan. There can be no assurance that DCC will indemnify the Predecessor Company or the Company on any claims in the future. Although neither the Predecessor Company nor the Company maintains insurance for claims arising on products sold by DCC, the Company does not believe the outcome of any of these matters will have a material adverse effect on the Company’s financial position or results of operations.

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WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (CONTINUED)

In March 2000, Howmedica Osteonics Corp. sued the Company alleging patent infringement. The lawsuit seeks an order of infringement, injunctive relief, unspecified damages and various other costs and relief. The claims could impact a substantial portion of our knee product line. The Company believes it has strong defenses against these claims and intends to vigorously defend this lawsuit. The Company also believes these claims are, in part, covered pursuant to the Company’s patent infringement insurance. During the second quarter of 2004, a Markman hearing was held regarding interpretation of the patent claims that have been asserted by Howmedica in this lawsuit. The judge in this case has taken the issue of claim interpretation under advisement and both parties await the decision of the court on this issue. No additional significant developments related to this matter have occurred during 2004. Management is unable to estimate the potential liability, if any, with respect to these claims; and accordingly no provision has been made for this contingency as of September 30, 2004. However, management does not believe that the outcome of this lawsuit will have a material adverse effect on the Company’s financial position or results of operations.

In July 2002, the Company entered into a license agreement to resolve an intellectual property dispute that, among other things, provided for a payment of up to $1.25 million if a particular patent re-issued by February 10, 2004, and certain other conditions, as defined in the license agreement, were satisfied. While the patent in question re-issued prior to February 10, 2004, based on its assessment, the Company has concluded that the other required conditions were not satisfied upon re-issuance and the consequential payment of any amount is not probable. Accordingly, no provision has been made for this contingency as of September 30, 2004.

In July 2002, pursuant to a purchase and royalty agreement with CERAbio LLC (“CERAbio”), the Company purchased assets consisting primarily of completed technology for $3.0 million and recorded this entire amount as an intangible asset. Of this purchase price, $1.5 million was paid upon signing the purchase agreement. The remaining $1.5 million is recorded in “Accrued expenses and other current liabilities” in the condensed consolidated balance sheet and is payable if certain conditions under the agreement are satisfied. The agreement also provides for specified future royalties contingent upon sales of products related to the acquired technology. The Company, believing that the contractual obligations for payment had not been met, disputed whether the second payment and royalties had been earned. In 2003, CERAbio and Phillips Plastics Corporation filed a lawsuit in United States District Court for the Western District of Wisconsin against the Company for payment of the additional $1.5 million purchase price and the royalties earned to date. During the fourth quarter of 2003, a jury returned a verdict in favor of CERAbio and ordered the Company to pay the remaining purchase price and the royalties earned to date. The royalties earned to date have been recorded within “Accrued expenses and other current liabilities” in the condensed consolidated balance sheet. The Company has appealed the verdict to the United States Court of Appeals for the Seventh Circuit and the appeal is pending. The Company intends to vigorously defend its position in this case and, in the opinion of management, does not believe that this claim will have a material adverse effect on its financial position or results of operations.

In September 2004, the Company announced a voluntary recall of a limited number of metal acetabular hip cups that are intended for use in the Company’s CONSERVE® hip systems. In connection with the product recall, the Company recorded $500,000 in product liability reserves for probable losses related to the recall. Management developed this estimate and believes that the amount recorded is appropriate based on assumptions with respect to estimated patient claims related to the recall and the acceptance of such claims by our insurer. The nature of a product recall and the associated claims are such that the claims will occur over an extended period of time. The Company’s estimate includes an assumption for unasserted claims based on management’s industry experience with similar circumstances. While the Company believes that the amount recorded related to the product recall is appropriate, it is possible that changes in assumptions related to potential claims or insurance coverage could have an adverse effect on the Company’s estimate.

The Company is currently involved in separate disputes, in Italy, with a former agent and two former employees. No lawsuits have been filed by a party in any of these matters. Management believes that is has meritorious defenses should any claim arise and that the payment of any amount is not probable and cannot be estimated at this time. Accordingly, no provisions have been made for these matters as of September 30, 2004.

In addition to those noted above, the Company is subject to various other legal proceedings, product liability claims and other matters which arise in the ordinary course of business. In the opinion of management, the amount of liability, if any, with respect to these matters will not materially affect the results of operations or financial position of the Company.

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WRIGHT MEDICAL GROUP, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - (CONTINUED)

Regulatory. In March 2004, the Company received marketing clearance from the United States Food and Drug Administration (the “FDA”) for its ALLOMATRIX® Injectable Putty. This clearance was obtained based on satisfaction of the FDA’s requirements pursuant to a 510(k) premarket notification process that began with the Company’s submission of a 510(k) in March 2002. This submission was in response to the FDA’s clarification to all allograft putty providers, including the Company, that such products are regulated under the medical device premarket notification provisions of the Food, Drug, and Cosmetic Act. Further, in July 2004, the Company received marketing clearance fr