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WMGI > SEC Filings for WMGI > Form 10-Q on 28-Apr-2009All Recent SEC Filings

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Form 10-Q for WRIGHT MEDICAL GROUP INC


28-Apr-2009

Quarterly Report


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, 2009. 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, 2008, which includes additional information about our critical accounting policies and practices and risk factors.
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 increased 4% in the first quarter of 2009 to $120.9 million, compared to net sales of $115.9 million in the first quarter of 2008. Our net income decreased to $3.3 million in the first quarter of 2009 from $4.1 million in the first quarter of 2008 as a result of lower levels of interest income, increased costs associated with the ongoing U.S. government inquiries, and the impact of lower currency exchange rates for the euro and the British pound against the U.S. dollar, partially offset by a decrease in restructuring expenses and non-cash, stock-based compensation. Our first quarter domestic sales increased 11% in 2009 as a result of growth within all of our product lines, in particular our extremity line which increased 34% compared to prior year. Our domestic extremities growth is attributable to INBONE™ product sales following our acquisition in the second quarter of 2008, the continued success of our CHARLOTTE™ Foot and Ankle System, and increased sales of our DARCO® line of plating systems and our SIDEKICK™ external fixation systems.
Our international sales decreased 4% to $46.6 million in the first quarter of 2009, compared to $48.6 million in the first quarter of 2008. This decrease in the first quarter of 2009 is the result of an unfavorable currency impact of approximately $3.3 million, which was partially offset by growth in our Asian and Latin American markets.
Our first quarter 2009 gross profit, which declined as a percentage of sales by 3.4 points, was negatively impacted by unfavorable foreign currency exchange rates as compared to the first quarter of 2008, particularly the euro and the British pound. Additionally, our first quarter 2009 gross profit included higher levels of provisions for excess and obsolete inventory and the cost of inventories sold was higher than prior year due to increased raw material and other manufacturing costs.
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 governmental regulation, primarily by the United States Food and Drug Administration. Failure to comply with regulatory requirements could have a material adverse effect on our business. Additionally, our industry is highly competitive and has recently experienced increased pricing pressures, specifically in the areas of reconstructive joint devices. We devote significant resources to assessing and analyzing competitive, regulatory and economic risks and opportunities.
In December 2007, we received a subpoena from the U.S. Attorney's Office for the District of New Jersey requesting certain documents related to consulting agreements with orthopaedic surgeons. This subpoena was served


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shortly after several of our knee and hip competitors agreed to resolutions with the U.S. Department of Justice (DOJ) after being subjects of investigation involving the same subject matter. We continue to cooperate fully with the investigation by the DOJ, and we anticipate that we will continue to incur significant expenses related to this inquiry.
In June 2008, we received a letter from the U.S. Securities and Exchange Commission (SEC) informing us that it is conducting an informal investigation regarding potential violations of the Foreign Corrupt Practices Act in the sale of medical devices in a number of foreign countries by companies in the medical device industry. We understand that several other medical device companies have received similar letters. We are cooperating fully with the SEC inquiry. A detailed discussion of these risks and other factors is provided in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008, and elsewhere in this report.
Results of Operations
Comparison of three months ended March 31, 2009 to three months ended March 31, 2008
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)
                                                          2009                                  2008
                                               Amount           % of Sales           Amount           % of Sales

Net sales                                     $ 120,912               100.0 %       $ 115,865               100.0 %
Cost of sales 1                                  38,021                31.4 %          32,438                28.0 %

Gross profit                                     82,891                68.6 %          83,427                72.0 %
Operating expenses:
Selling, general and administrative 1            66,609                55.1 %          66,589                57.5 %
Research and development 1                        8,906                 7.4 %           7,999                 6.9 %
Amortization of intangible assets                 1,317                 1.1 %           1,041                 0.9 %
Restructuring charges                                66                 0.1 %           1,815                 1.5 %

Total operating expenses                         76,898                63.6 %          77,444                66.8 %


Operating income                                  5,993                 5.0 %           5,983                 5.2 %
Interest expense (income), net                    1,253                 1.0 %            (363 )              (0.3 %)
Other income, net                                  (363 )              (0.3 %)         (1,026 )              (0.9 %)

Income before income taxes                        5,103                 4.2 %           7,372                 6.4 %
Provision for income taxes                        1,786                 1.5 %           3,314                 2.9 %

Net income                                    $   3,317                 2.7 %       $   4,058                 3.5 %

1 These line items include the following amounts of non-cash, stock-based compensation expense, expressed in dollar amounts (in thousands) and as percentages of net sales, for the periods indicated:

                                                     Three Months Ended March 31,
                                                   2009                        2008
                                           Amount      % of Sales     Amount      % of Sales
   Cost of sales                          $   292           0.2 %    $   344           0.3 %
   Selling, general and administrative      2,101           1.7 %      2,971           2.6 %
   Research and development                   395           0.3 %        249           0.2 %


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The following table sets forth our net sales by product line for the periods indicated (in thousands) and the percentage of year-over-year change:

                                      Three Months Ended
                                           March 31,
                                      2009          2008         % change
               Hip products         $  41,914     $  39,900            5.0 %
               Knee products           30,388        30,176            0.7 %
               Extremity products      25,941        20,461           26.8 %
               Biologics products      19,771        20,678           (4.4 %)
               Other                    2,898         4,650          (37.7 %)

               Total net sales      $ 120,912     $ 115,865            4.4 %

The following graphs illustrate our product line net sales as a percentage of total net sales for the three months ended March 31, 2009 and 2008:

2009 2008

[[Image Removed: (PIE CHART)]] [[Image Removed: (PIE CHART)]]

Net Sales. Our overall net sales growth of 4% in the first quarter of 2009 was attributable to our continued success in our extremity product line, which increased 27% over prior year, and expansion in our hip product line. Geographically, our domestic net sales totaled $74.4 million in the first quarter of 2009 and $67.2 million in the first quarter of 2008, representing 61% and 58% of total net sales, respectively, and growth of 11% in 2009 compared to 2008. Our international net sales totaled $46.6 million in the first quarter of 2009, compared to $48.6 million in the first quarter of 2008. International sales in 2009 include an unfavorable currency impact of $3.3 million, principally resulting from the performance of the euro against the U.S. dollar in the first quarter of 2009 compared to the same period of 2008. Additionally, increased sales in most of our international markets were offset by declines in the United Kingdom, France, and Turkey.
Our hip product net sales totaled $41.9 million during the first quarter of 2009, representing an increase of 5% over the prior year. Our domestic hip sales increased 8% over prior year, while our international hip sales increased 3% over prior year. Our domestic growth was primarily due to sales of revision hip stems under a distribution agreement signed during the second quarter of 2008, and increased sales of our DYNASTY® acetabular cup system. Growth in our international markets was primarily driven by sales of our PROFEMUR® hip systems in Japan. Our international hip sales include a $1.0 million unfavorable currency impact in 2009.
Our knee product net sales totaled $30.4 million in the first quarter of 2009 as compared to $30.2 in the same period in 2008. Year-over-year knee sales increased 2% domestically as increased unit sales and increased pricing had a relatively even impact on our sales growth. International knee sales decreased slightly due to an $0.8 million unfavorable currency impact.
Our extremity product net sales increased to $25.9 million in the first quarter of 2009, representing growth of 27% over the first quarter of 2008. This year-over-year growth was driven by sales of our INBONE™ products acquired


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in the second quarter of 2008, the continued success of our CHARLOTTE™ Foot and Ankle system, and increased sales of our DARCO® plating systems and our SIDEKICK™ external fixation systems. Our domestic extremity product sales increased 34% in 2009, while our international extremity sales increased 3% as compared to prior year. Our international extremity sales growth included a $0.7 million unfavorable currency impact.
Net sales of our biologics products totaled $19.8 million in the first quarter of 2009, representing a year-over-year decline in sales of 4%. In the U.S., biologics sales increased 2% in 2009 due to increased sales of our PRO-DENSE®injectable regenerative graft and our CANCELLO-PURE™ wedge products, partially offset by the continued decline in sales of our ALLOMATRIX® line of injectable tissue-based bone graft substitutes. Our international biologics sales decline was primarily due to decreased sales to our stocking distributor in Turkey and the discontinuation of our biologics distribution in Belgium, as well as an unfavorable currency impact of $0.4 million.
Cost of Sales. Our cost of sales as a percentage of net sales increased from 28.0% in the first quarter of 2008 to 31.4% in the first quarter of 2009. This increase is primarily attributable to higher levels of excess and obsolete inventory provisions, increased raw material and other manufacturing costs, and unfavorable currency exchange rates compared to the first quarter of 2008. Our cost of sales included 0.2 percentage points and 0.3 percentage points of non-cash, stock-based compensation expense in 2009 and 2008, respectively. Our cost of sales and corresponding gross profit percentages can be expected to fluctuate in future periods depending upon changes in our product sales mix and prices, distribution channels and geographies, manufacturing yields, period expenses, levels of production volume, and currency exchange rates. Selling, General and Administrative. Our selling, general and administrative expenses as a percentage of net sales totaled 55.1% in the first quarter of 2009, a 2.4 percentage point decrease from 57.5% in the first quarter of 2008. Our 2009 and 2008 selling, general and administrative expenses include $4.1 million (3.4% of net sales) and $1.7 million (1.5% of net sales), respectively, of costs, primarily legal fees, associated with the ongoing U.S. government inquiries. In addition, $2.1 million and $3.0 million of non-cash, stock-based compensation expense was recognized in the first quarter of 2009 and 2008, respectively, representing 1.7% and 2.6% of net sales in each of the years, respectively. The remaining decrease in selling, general and administrative expenses as a percentage of sales was driven by expense savings, primarily in our European subsidiaries, and lower levels of cash incentive compensation.
We anticipate that our selling, general and administrative expenses will increase in absolute dollars to the extent that additional growth in net sales results in increases in sales commissions and royalty expense associated with those sales and requires us to expand our infrastructure. Further, in the near term, we anticipate that these expenses may increase as a percentage of net sales as we make strategic investments in order to grow our business, as we continue to incur expenses associated with the U.S. government inquiries, which we believe will continue to be significant, and as our spending related to the global compliance requirements of our industry increases.
Research and Development. Our investment in research and development activities represented approximately 7.4% of net sales in the first quarter of 2009, as compared to 6.9% of net sales in the first quarter of 2008. Our research and development expenses include approximately $0.4 million (0.3% of net sales) and $0.2 million (0.2% of net sales) of non-cash, stock-based compensation expense in the first quarter of 2009 and 2008, respectively. The increase in research and development is primarily attributable to increased investments in product development initiatives and clinical studies to support regulatory approvals and provide expanded proof of the efficacy of our products.
We anticipate that our research and development expenditures may increase as a percentage of net sales and will increase in absolute dollars as we continue to increase our investment in product development initiatives and clinical studies to support regulatory approvals and provide expanded proof of the efficacy of our products.
Amortization of Intangible Assets. Charges associated with the amortization of intangible assets in the first quarter of 2009 increased to $1.3 million from $1.0 million in the first quarter of 2008. Based on the intangible assets held at March 31, 2009, we expect to recognize amortization expense of approximately $5.1 million for the full year of 2009, $2.3 million in 2010, $2.2 million in 2011, $2.1 million in 2012, and $1.8 million in 2013.
Interest Expense (Income), Net. Interest expense (income), net, consists of interest expense of $1.7 million during both 2009 and 2008, primarily from borrowings under our convertible debt issued in November 2007, our capital lease agreements, and certain of our factoring agreements, offset by interest income of $400,000 and $2.1 million during the first quarter of 2009 and 2008, respectively, generated by our invested cash balances and investments in marketable securities.


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The amounts of interest income we realize in 2009 and beyond are subject to variability, dependent upon both the rate of invested returns we realize and the amount of excess cash balances on hand.
Provision for Income Taxes. We recorded tax provisions of $1.8 million and $3.3 million in the first quarter of 2009 and 2008, respectively. During the first quarter of 2009, our effective tax rate was approximately 35.0%, as compared to 45.0% in the first quarter of 2008, primarily attributable to the reinstatement of the U.S. Federal Research and Development tax credit during the fourth quarter of 2008 and lower levels of nondeductible stock-based compensation expense during 2009.
Seasonal Nature of Business
We traditionally experience lower sales volumes in the third quarter than throughout the rest of the year as many of our products are used in elective procedures, which generally decline during the summer months, typically resulting in selling, general and administrative expenses and research and development expenses as a percentage of sales that are higher than throughout the rest of the year. In addition, our first quarter selling, general and administrative expenses include additional expenses that we incur in connection with the annual meeting held by the American Academy of Orthopaedic Surgeons. This meeting, which is the largest orthopaedic meeting in the world, features the presentation of scientific papers and instructional courses for orthopaedic surgeons. During this 3-day event, we display our most recent and innovative products to these surgeons.
Restructuring
In June 2007, we announced our plans to close our facilities in Toulon, France. This announcement came after a thorough evaluation in which it was determined that we had excess manufacturing capacity and redundant distribution and administrative resources that would be best eliminated through the closure of this facility. The majority of our restructuring activities were complete by the end of 2007, with Toulon's production being transferred to our existing manufacturing facility in Arlington, Tennessee and its distribution activities being transferred to our European headquarters in Amsterdam, the Netherlands. We have estimated that total pre-tax restructuring charges will be approximately $28 to $32 million, of which we have recognized $25.6 million through March 31, 2009. We have seen the benefits from this restructuring within selling, general and administrative expenses since 2008, and we anticipate seeing additional benefits within cost of sales in 2009. See Note 9 to our condensed consolidated financial statements for further discussion of our restructuring charges. Liquidity and Capital Resources
The following table sets forth, for the periods indicated, certain liquidity measures (in thousands):

                                               As of           As of
                                             March 31,     December 31,
                                               2009            2008
              Cash and cash equivalents     $  96,831            87,865
              Marketable securities            51,694            57,614
              Working capital                 403,045           401,406
              Line of credit availability     100,000           100,000

Operating Activities. Cash provided by operating activities was $15.3 million for the first quarter of 2009, as compared to $12.8 million for the first quarter of 2008. The increase in operating cash flow is primarily attributable to changes in working capital, as favorable variances in accounts receivable and inventory were mostly offset by unfavorable variances in accrued expenses and marketable securities.
Investing Activities. Our capital expenditures totaled approximately $9.8 million and $9.9 million in the first quarter of 2009 and 2008, respectively. Our industry is capital intensive, particularly as it relates to surgical instrumentation. Historically, our capital expenditures have consisted of purchased manufacturing equipment, research and testing equipment, computer systems, office furniture and equipment, and surgical instruments. We expect to incur capital expenditures of approximately $40 million in 2009 for routine capital expenditures, as well as approximately $3 million for the expansion of facilities in Arlington, Tennessee.
Financing Activities. During the first three months of 2009, cash used in financing activities totaled $94,000 compared to the first three months of 2008, where cash provided by financing activities totaled $2.7 million. This decrease is primarily attributable to a $3.4 million decrease in proceeds from stock option exercises. During the first


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quarter of 2009, we terminated our factoring agreements. While our factoring agreements were active, the cash proceeds received from these factoring agreements, net of the amount of factored receivables collected, were reflected as cash flows from financing activities in our consolidated statements of cash flows.
On March 31, 2009, our revolving credit facility had availability of $100 million, which can be increased by up to an additional $50 million at our request and subject to the agreement of the lenders. We currently have no borrowings outstanding under the credit facility. Borrowings under the credit facility will bear interest at the sum of a base annual rate plus an applicable annual rate that ranges from 0% to 1.75% depending on the type of loan and our consolidated leverage ratio, with a current annual base rate of 3.25%. During 2007, we issued $200 million of Convertible Senior Notes due 2014, which generated net proceeds of $193.5 million. The notes pay interest semiannually at an annual rate of 2.625%. The notes are convertible into shares of our common stock at an initial conversion rate of 30.6279 shares per $1,000 principal amount of the notes, which represents a conversion price of $32.65 per share. We will make scheduled interest payments in 2009 related to the notes totaling $5.3 million.
Other Liquidity Information
We have funded our cash needs since 2000 through various equity and debt issuances and through cash flow from operations. In 2007, we issued $200 million of Convertible Senior Notes due 2014, which generated net proceeds totaling $193.5 million.
Although it is difficult for us to predict our future liquidity requirements, we believe that our current cash and cash equivalents balance of $96.8 million, our marketable securities balance of $51.7 million, our existing available credit line of $100 million, and our expected cash flow from our 2009 operations will be sufficient for the foreseeable future to fund our working capital requirements and operations, permit anticipated capital expenditures in 2009 of approximately $43 million, and meet our contractual cash obligations in 2009. Critical Accounting Policies and Estimates Information on judgments related to our most critical accounting policies and estimates is discussed in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2008. Certain of our more critical accounting estimates require the application of significant judgment by management in selecting the appropriate assumptions in determining the estimate. By their nature, these judgments are subject to an inherent degree of uncertainty. We develop these judgments based on our historical experience, terms of existing contracts, our observance of trends in the industry, information provided by our customers, and information available from other outside sources, as appropriate. Actual results may differ from these judgments under different assumptions or conditions. Different, reasonable estimates could have been used for the current period. Additionally, changes in accounting estimates are reasonably likely to occur from period to period. Both of these factors could have a material impact on the presentation of our financial condition, changes in financial condition or results of operations. All of our significant accounting policies are more fully described in Note 2 to our consolidated financial statements set forth in our Annual Report on Form 10-K for the year ended December 31, 2008. There have been no significant modifications to the policies related to our critical accounting estimates since December 31, 2008.


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