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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

     
(Mark One)
 
   
þ
  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
 
   
  For the quarterly period ended March 31, 2005
 
   
or
 
   
o
  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. þ Yes o No

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

As of April 27, 2005, there were 33,902,288 shares of common stock outstanding.

 
 

 


WRIGHT MEDICAL GROUP, INC.

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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 the “Factors Affecting Future Operating Results” section of Item 7 of our annual report on Form 10-K for the year ended December 31, 2004, and elsewhere in this quarterly report), 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, and 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)
                 
    March 31,     December 31,  
    2005     2004  
    (unaudited)          
Assets:
               
Current assets:
               
Cash and cash equivalents
  $ 88,036     $ 83,470  
Accounts receivable, net
    63,386       61,662  
Inventories
    78,500       76,269  
Prepaid expenses
    4,570       4,822  
Deferred income taxes
    25,444       24,082  
Other current assets
    4,427       4,717  
 
           
Total current assets
    264,363       255,022  
 
               
Property, plant and equipment, net
    70,414       70,207  
Goodwill
    8,489       8,845  
Intangible assets, net
    15,873       17,140  
Deferred income taxes
    9,358       8,873  
Other assets
    1,369       1,071  
 
           
 
               
 
  $ 369,866     $ 361,158  
 
           
Liabilities and Stockholders’ Equity:
               
Current liabilities:
               
Accounts payable
  $ 15,476     $ 13,969  
Accrued expenses and other current liabilities
    48,465       45,256  
Current portion of long-term obligations
    6,230       6,331  
 
           
Total current liabilities
    70,171       65,556  
 
               
Long-term obligations
    5,639       5,952  
Deferred income taxes
    146       26  
Other liabilities
    13,318       13,555  
 
           
Total liabilities
    89,274       85,089  
 
           
 
               
Commitments and contingencies (Note 8)
               
 
               
Stockholders’ equity:
               
Common stock, voting, $.01 par value, authorized: 100,000,000 shares; issued and outstanding: 33,898,252 shares at March 31 and 33,850,202 shares at December 31
    339       339  
Additional paid-in capital
    270,583       269,944  
Deferred compensation
    (39 )     (188 )
Accumulated other comprehensive income
    18,108       21,642  
Accumulated deficit
    (8,399 )     (15,668 )
 
           
Total stockholders’ equity
    280,592       276,069  
 
           
 
               
 
  $ 369,866     $ 361,158  
 
           

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  
    March 31,  
    2005     2004  
Net sales
  $ 82,601     $ 74,917  
Cost of sales
    22,777       20,386  
 
           
Gross profit
    59,824       54,531  
Operating expenses:
               
Selling, general and administrative
    41,668       37,134  
Research and development
    4,897       4,982  
Amortization of intangible assets
    1,059       942  
Stock-based expense 1
    212       424  
 
           
Total operating expenses
    47,836       43,482  
 
           
 
               
Operating income
    11,988       11,049  
Interest expense, net
    90       284  
Other expense, net
    174       38  
 
           
Income before income taxes
    11,724       10,727  
Provision for income taxes
    4,455       4,113  
 
           
Net income
  $ 7,269     $ 6,614  
 
           
 
               
Net income per share (Note 6):
               
Basic
  $ 0.21     $ 0.20  
 
           
Diluted
  $ 0.21     $ 0.19  
 
           
 
               
Weighted-average number of shares outstanding-basic
    33,875       33,077  
 
           
 
               
Weighted-average number of shares outstanding-diluted
    35,201       35,241  
 
           


1   Amounts presented as stock-based expense consist of cost of sales totaling $11 and $27 for the three months ended March 31, 2005 and 2004, respectively; selling, general and administrative expenses of $201 and $371 for the three months ended March 31, 2005 and 2004, respectively; and research and development expenses of $0 and $26 for the three months ended March 31, 2005 and 2004, 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)
                 
    Three Months Ended  
    March 31,  
    2005     2004  
Operating activities:
               
Net income
  $ 7,269     $ 6,614  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Depreciation
    4,414       4,067  
Amortization of intangible assets
    1,059       942  
Deferred income taxes
    (1,314 )     2,355  
Stock-based expenses
    212       424  
Other
    298       (20 )
Changes in assets and liabilities:
               
Accounts receivable
    (3,210 )     (4,649 )
Inventories
    (3,081 )     (3,564 )
Other current assets
    (62 )     (551 )
Accounts payable
    1,867       2,919  
Accrued expenses and other liabilities
    3,881       (1,664 )
 
           
Net cash provided by operating activities
    11,333       6,873  
 
               
Investing activities:
               
Capital expenditures
    (5,863 )     (4,424 )
Purchase of tangible and intangible assets
          (161 )
Other
          3  
 
           
Net cash used in investing activities
    (5,863 )     (4,582 )
 
               
Financing activities:
               
Issuance of common stock
    209       808  
Payments of bank and other financing
    (334 )     (508 )
Financing under factoring agreements, net
    (576 )     1,910  
 
           
Net cash (used in) provided by financing activities
    (701 )     2,210  
 
               
Effect of exchange rates on cash and cash equivalents
    (203 )     (56 )
 
           
Net increase in cash and cash equivalents
  $ 4,566     $ 4,445  
 
               
Cash and cash equivalents, beginning of period
  $ 83,470     $ 66,571  
 
           
 
               
Cash and cash equivalents, end of period
  $ 88,036     $ 71,016  
 
           

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, 2004, 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. At March 31, 2005, 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 March 31,  
    2005     2004  
Net income, as reported
  $ 7,269     $ 6,614  
Add: Stock-based employee compensation cost recognized under intrinsic value method, net of tax
    86       208  
 
               
Less: Stock-based employee compensation expense determined under fair value based method, net of tax
    (2,720 )     (1,819 )
 
           
Pro forma net income
  $ 4,635     $ 5,003  
 
           
 
               
Income per share:
               
 
               
Basic, as reported
  $ 0.21     $ 0.20  
 
           
 
               
Basic, pro forma
  $ 0.14     $ 0.15  
 
           
 
               
Diluted, as reported
  $ 0.21     $ 0.19  
 
           
 
               
Diluted, pro forma
  $ 0.14     $ 0.14  
 
           

In April 2005, the SEC amended Rule 4-01(a) of Regulation S-X regarding the compliance date for SFAS No. 123 (Revised 2004), “Share Based Payment” (“SFAS No. 123R”). This amendment modified the effective dates of SFAS No. 123R, requiring adoption of this standard on the first interim or annual reporting period of the first fiscal year beginning on or after June 15, 2005. Accordingly, the Company will adopt SFAS No. 123R effective January 1, 2006. The Company anticipates that it will record material amounts of incremental non-cash stock-based expense in future periods following the adoption of SFAS No. 123R. However, the exact amount cannot be determined until management’s evaluation of SFAS No. 123R is complete and an appropriate valuation model has been selected and applied to determine the fair value of its stock options outstanding. The effect of expensing the fair value of the Company’s stock options using the Black-Scholes model and the provisions of SFAS No. 123 is presented in the table above.

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

Derivative Instruments. The Company accounts for derivative instruments in accordance with SFAS No. 133, “Accounting for Derivative Instruments and Hedging Activities” as amended by SFAS No. 138. Accordingly, all of the Company’s derivative instruments are recorded on the balance sheet as either an asset or liability and measured at fair value. The changes in the derivative’s fair value are recognized currently in earnings unless specific hedge accounting criteria are met.

During the second half 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 No. 133. Accordingly, the changes in the fair value and settlement of the contracts are recognized in the period incurred in the accompanying consolidated statement of operations.

For the three months ended March 31, 2005, the Company recorded approximately $420,000 in net gains on foreign currency contracts, which are included in “Other expense, net” in the Company’s condensed consolidated statement of operations. These gains substantially offset translation losses recorded on the Company’s intercompany receivable and payable balances, also included in “Other expense, net.” At March 31, 2005, and December 31, 2004, the Company did not have any outstanding foreign currency contracts.

2. Inventories

Inventories consist of the following (in thousands):

                 
    March 31,     December 31,  
    2005     2004  
Raw materials
  $ 4,086     $ 3,373  
Work-in-process
    13,872       14,306  
Finished goods
    60,542       58,590  
 
           
 
  $ 78,500     $ 76,269  
 
           

3. Property, Plant and Equipment, Net

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

                 
    March 31,     December 31,  
    2005     2004  
Property, plant and equipment, at cost
  $ 129,886     $ 127,257  
Less: Accumulated depreciation
    (59,472 )     (57,050 )
 
           
 
  $ 70,414     $ 70,207  
 
           

4. Long-Term Obligations

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

                 
    March 31,     December 31,  
    2005     2004  
Notes payable
  $ 8,750     $ 8,750  
Capital lease obligations
    3,119       3,533  
 
           
 
    11,869       12,283  
Less: current portion
    (6,230 )     (6,331 )
 
           
 
  $ 5,639     $ 5,952  
 
           

At March 31, 2005, the Company’s senior credit facility consisted of $8.8 million in outstanding term loan borrowings and availability under a revolving loan facility, after considering outstanding letters of credit, totaling $59.7 million. At the Company’s option, borrowings under the credit facility bear interest either at a rate equal to a

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

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 current annual rate of 5.3%.

5. Goodwill and Intangible Assets

Changes in the carrying amount of goodwill occurring during the three months ended March 31, 2005 are as follows (in thousands):

         
Goodwill at December 31, 2004
  $ 8,845  
Foreign currency translation
    (356 )
 
     
Goodwill at March 31, 2005
  $ 8,489  
 
     

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

                                 
    March 31, 2005     December 31, 2004  
            Accumulated             Accumulated  
    Cost     Amortization     Cost     Amortization  
         
Distribution channels
  $ 19,877     $ 10,436     $ 20,797       $10,399  
Completed technology
    5,311       1,884       5,348       1,733  
Licenses
    2,596       1,610       2,683       1,538  
Trademarks
    656       172       657       152  
Other
    3,582       2,047       3,303       1,826  
         
 
    32,022     $ 16,149       32,788       $15,648  
 
                           
Less: Accumulated amortization
    (16,149 )             (15,648 )        
 
                           
Intangible assets, net
  $ 15,873             $ 17,140          
 
                           

Based on the intangible assets held at March 31, 2005, the Company expects to recognize amortization expense of approximately $4.2 million for the full year of 2005, $3.9 million in 2006, $3.0 million in 2007, $2.8 million in 2008, and $2.6 million in 2009.

6. 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 shares outstanding for basic and diluted earnings per share is as follows (in thousands):

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Weighted-average number of shares outstanding, basic
    33,875       33,077  
Common stock equivalents
    1,326       2,164  
 
           
Weighted-average number of shares outstanding, diluted
    35,201       35,241  
 
           

For the three months ended March 31, 2005 and 2004, options to purchase approximately 2.5 million and 36,000 shares, respectively, of the Company’s common stock were excluded from the calculation of diluted earnings per share because the effect was antidilutive. These stock options were antidilutive because the exercise price of the options was greater than the average market price of common stock for the respective period.

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

7. 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  
    March 31,  
    2005     2004  
Net income
  $ 7,269     $ 6,614  
Changes in foreign currency translation
    (3,534 )     (852 )
 
           
Comprehensive income
  $ 3,735     $ 5,762  
 
           

8. Commitments and Contingencies

Legal Proceedings. 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 against the Company in United States District Court for the Western District of Wisconsin for payment of the remaining $1.5 million purchase price and the royalties earned to date. In November 2003, the trial court ruled 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. In 2004, the Company appealed the trial court’s judgment to the United States Court of Appeals for the Seventh Circuit, briefs and oral arguments were submitted, and the appeal is pending. The Company does not believe that the outcome of this lawsuit will have a material adverse effect on its 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 March 31, 2005.

In March 2000, Howmedica Osteonics Corp. (“Howmedica”) 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 in this case could impact a substantial portion of the Company’s knee product line. The Company believes, however, that it has strong defenses against the claims and that the claims are, in part, covered by the Company’s patent infringement insurance. In 2004, a Markman hearing was held regarding interpretation of the patent claims that have been asserted by Howmedica in this lawsuit. The court has taken the issue of claim interpretation under advisement and both parties await the decision of the court on this issue. Management is unable to estimate the potential liability, if any, with respect to the claims and accordingly, no provision has been made for this contingency as of March 31, 2005. 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.

On June 30, 1993, prior to the December 1999 recapitalization and inception of the Company in its present 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.

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

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.

In September 2004, the Company announced a voluntary market withdrawal of a limited number of metal acetabular hip cups that are intended for use in the Company’s CONSERVE® hip systems. In connection with this market withdrawal, the Company recorded $500,000 in product liability reserves for probable losses related to the market withdrawal. Management developed this estimate and believes that the amount recorded is appropriate based on assumptions with respect to estimated patient claims related to the market withdrawal and the acceptance of such claims by its insurer. The nature of a market withdrawal and the associated claims are such that the claims will occur over an extended period of time. The Company’s loss 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 market withdrawal 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 it 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 March 31, 2005.

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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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

General

The following management’s discussion and analysis of financial condition and results of operations describes the principal factors affecting the results of our operations, financial condition and changes in financial condition for the three months ended March 31, 2005. This discussion should be read in conjunction with the accompanying unaudited financial statements and our annual report on Form 10-K for the year ended December 31, 2004, which includes additional information about our critical accounting policies and practices and factors affecting future operating results.

Executive Overview

Company Description. We are a global orthopaedic medical device company specializing in the design, manufacture and marketing of reconstructive joint devices and biologics products. Reconstructive joint devices are used to replace knee, hip and other joints that have deteriorated through disease or injury. Biologics are used to replace damaged or diseased bone, to stimulate bone growth, to repair damaged or diseased soft tissue, and to provide other biological solutions for surgeons and their patients. We have been in business for over 50 years and have built a well-known and respected brand name and strong relationships with orthopaedic surgeons.

Principal Products. We primarily sell reconstructive joint devices and biologics products. Our reconstructive joint device sales are derived from three primary product lines: knees, hips and extremities. Our biologics sales encompass a broad portfolio of products designed to stimulate and augment the natural regenerative capabilities of the human body. We also sell various orthopaedic products not considered to be part of our knee, hip, extremity or biologics product lines.

Significant Quarterly Business Developments. Net sales grew 10% in the first quarter of 2005 to $82.6 million, as compared to net sales of $74.9 million in the first quarter of 2004. Our net income grew 10% in the first quarter of 2005 to $7.3 million from $6.6 million in the first quarter of 2004.

Our first quarter domestic sales gain of 12% was the result of continued growth of each of our major product lines, particularly within our reconstructive joint business, where our hip and knee product lines experienced growth rates of 28% and 10%, respectively, as compared to prior year, while our biologics and extremity product lines experienced growth rates below our historical levels. Our domestic hip growth continues to benefit from our innovative line of hip products, including our advanced bearing surfaces and proprietary modular neck technology. Additionally, growth in our domestic knee business benefited from expansion of our customer base of U.S surgeons and continued distribution of our minimally invasive surgical instrumentation for our knee products.

During the first quarter of 2005, our international sales continued to grow, however at a slower rate than prior quarters as a result of the impact of our on-going transition of certain management and distribution personnel in Southern Europe. Within our European markets, specifically France and Italy, we encountered year-over-year sales declines. Additionally, we incurred elevated levels of selling, general and administrative expenses as a result of this transition. We anticipate that the impact to our business of these factors is short-term and that the investments we are making will benefit us in the future.

Our performance outlook anticipates continued growth in our domestic business across all product lines for the remainder of 2005. The continued success of our domestic hip and knee product lines, combined with our recently launched extremities products and our anticipated product launches in the remainder of the year, position us well for 2005. Further, as we move through the transitions in Southern Europe, we anticipate that we will experience strengthened growth rates in our international business in the latter half of the year.

Significant Industry Factors. Our industry is impacted by numerous competitive, regulatory and other significant factors. The growth of our business relies on our ability to continue to develop new products and innovative technologies, obtain regulatory clearance and compliance for our products, protect the proprietary technology of our products and our manufacturing processes, manufacture our products cost-effectively, respond to competitive pressures specific to each of our geographic markets, including our ability to enforce non-compete agreements, and successfully market and distribute our products in a profitable manner. We, and the entire industry, are subject to extensive government regulation, primarily by the Food and Drug Administration (FDA). Failure to comply with regulatory requirements could have a material adverse effect on our business. Additionally, our industry is highly competitive and our success is dependent on our ability to compete successfully against our competitors. We devote significant resources to assessing and analyzing competitive, regulatory, industry and economic risks and

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opportunities. A detailed discussion of these and other factors is provided in the “Factors Affecting Future Operating Results” section of Item 7 of our annual report on Form 10-K for the year ended December 31, 2004.

In addition to the factors noted above, during the first quarter of 2005, a governmental inquiry into the orthopaedic industry resulted in several of our competitors receiving subpoenas from the United States Department of Justice (DOJ). Based on publicly available information, we believe that these subpoenas requested information related to these companies’ relationships with orthopaedic surgeons. As of the date of the filing of our quarterly report on Form 10-Q, we have not received a subpoena from the DOJ.

Results of Operations

Introduction. The following table sets forth, for the periods indicated, our results of operations expressed as dollar amounts (in thousands) and as percentages of net sales:

                                 
    Three Months Ended March 31,  
    (unaudited)  
    2005     2004  
    Amount     % of Sales     Amount     % of Sales