S-1 1 d680066ds1.htm FORM S-1 Form S-1
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As filed with the U.S. Securities and Exchange Commission on March 6, 2014

Registration No.        

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

LVB ACQUISITION, INC.*

(Exact name of registrant as specified in its charter)

 

 

Delaware   3842   26-0499682

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

  (IRS Employer Identification No.)

56 East Bell Drive

Warsaw, Indiana 46582

Telephone: (574) 267-6639

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Bradley J. Tandy

Senior Vice President, General Counsel and Secretary

Biomet, Inc.

56 East Bell Drive

Warsaw, Indiana 46582

Telephone: (574) 267-6639

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies To:

 

Robert P. Davis

Jeffrey D. Karpf

Helena K. Grannis

Cleary Gottlieb Steen & Hamilton LLP

One Liberty Plaza

New York, New York 10006

(212) 225-2000

 

Joshua Ford Bonnie

John C. Ericson

Simpson Thacher & Bartlett LLP

425 Lexington Avenue

New York, New York 10017

(212) 455-2000

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date hereof.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one):

 

Large accelerated filer  ¨   Accelerated filer  ¨    Non-accelerated filer  x   Smaller reporting company  ¨
     (Do not check if a smaller reporting company)  

 

 

CALCULATION OF REGISTRATION FEE

 

 

 

Title of each class of

securities to be registered

   Proposed
maximum
aggregate
offering price  (1)(2)
   Amount of
registration fee

Common stock, $0.01 par value per share

   $100,000,000    $12,880.00(2)

 

 

(1) Includes              shares that the underwriters have an option to purchase from the registrant to cover overallotments, if any.
(2) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(o) promulgated under the Securities Act of 1933, as amended (the “Securities Act”).

 

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

* LVB Acquisition, Inc. is the registrant filing this Registration Statement with the Securities and Exchange Commission. Prior to the closing of the offering, LVB Acquisition, Inc. will be renamed Biomet Group, Inc. The securities issued to investors in connection with this offering will be shares of common stock of Biomet Group, Inc.

 

 

 


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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

Subject to Completion,

Preliminary Prospectus dated March 6, 2014

PROSPECTUS

            Shares

LOGO

Biomet Group, Inc.

Common Stock

 

 

This is our initial public offering of common stock. Biomet Group, Inc. is offering                      shares of common stock.

Prior to this offering, there has been no public market for our common stock. The initial public offering price of the common stock is expected to be between $              and $              per share. We have applied to list our common stock on the              under the symbol “BMET”.

Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 16.

 

 

 

    

Per Share

      

Total

 

Public offering price

   $           $     

Underwriting discount

   $           $     

Proceeds to us (before expenses)

   $           $     

We have granted the underwriters the right to purchase up to                      additional shares of common stock at the offering price less the underwriting discount if the underwriters sell more than                      shares of common stock in this offering. The underwriters can exercise this right at any time and from time to time, in whole or in part, within 30 days after the offering.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Delivery of the shares of common stock will be made on or about                     .

 

 

 

BofA Merrill Lynch   Goldman, Sachs & Co.   J.P. Morgan

Citigroup        

 

            Wells Fargo Securities

              Barclays  

Morgan Stanley

 

 

The date of this prospectus is                     , 2014.


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We are responsible for the information contained and incorporated by reference in this prospectus and in any related free-writing prospectus we may prepare or authorize to be delivered to you. We have not authorized anyone to give you any other information, and we take no responsibility for any other information that others may give you. We are not, and the underwriters are not, making an offer of these securities in any jurisdiction where the offer is not permitted. You should not assume that the information contained in this prospectus is accurate as of any date other than the date on the front of this prospectus, regardless of the time of delivery of this prospectus or any sale of our common stock.

TABLE OF CONTENTS

 

Prospectus

  

Page

 

Market and Industry Data and Forecasts

     ii   

Summary

     1   

Risk Factors

     16   

Cautionary Note Regarding Forward-Looking Statements

     47   

Use of Proceeds

     50   

Dividend Policy

     51   

Capitalization

     52   

Dilution

     53   

Selected Historical Consolidated Financial Data

     55   

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     61   

Business

     102   

Management

     131   

Executive Compensation

     139   

Principal Stockholders

     168   

Certain Relationships and Related Party Transactions

     173   

Description of Capital Stock

     178   

Description of Certain Indebtedness

     181   

Shares Eligible for Future Sale

     192   

Material U.S. Federal Income and Estate Tax Considerations to Non-U.S. Holders

     194   

Underwriting (Conflicts of Interest)

     197   

Legal Matters

     205   

Experts

     205   

Where You Can Find More Information

     206   

Index to Financial Statements

     F-1   

The information contained on our website or that can be accessed through our website will not be deemed to be incorporated into this prospectus or the registration statement of which this prospectus forms a part, and investors should not rely on any such information in deciding whether to purchase our common stock. We have included our website address in this prospectus only as an inactive textual reference and do not intend it to be an active link to our website.

We have a number of registered marks in various jurisdictions (including the United States), and we have applied to register a number of other marks in various jurisdictions. Trademarks, except as indicated, belong to our company. See “Business—Patents and Trademarks.”

 

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MARKET AND INDUSTRY DATA AND FORECASTS

This prospectus includes industry data and forecasts that we obtained from industry and government publications and surveys, studies conducted by third parties, public filings and internal company sources. Industry publications, surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but there can be no assurance as to the accuracy or completeness of the included information. Statements as to our ranking, market position and market estimates are based on independent industry publications, government publications, third party forecasts and management’s estimates and assumptions about our markets and our internal research. See “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” While we are not aware of any misstatements regarding our market, industry or similar data presented herein, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed in “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” in this prospectus.

 

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SUMMARY

This summary highlights information contained elsewhere in this prospectus. It may not contain all the information that may be important to you. You should read the entire prospectus carefully, including the section entitled “Risk Factors” and our financial statements and the related notes included elsewhere in this prospectus before making an investment decision to purchase shares of our common stock.

In this prospectus, unless we indicate otherwise or the context requires:

 

    “our company,” “we,” “our,” “ours” and “us” refer to LVB Acquisition, Inc. and its consolidated subsidiaries;

 

    “LVB” refers to LVB Acquisition, Inc.; and

 

    “Biomet” refers to Biomet, Inc., our direct operating subsidiary.

We refer to a fiscal year ending on May 31 of any year as a “fiscal” year. For example, we refer to the year ended May 31, 2013 as “fiscal 2013.”

Biomet Group

Overview

We are one of the largest orthopedic medical device companies in the world, with operations in more than 50 locations and distribution in more than 90 countries. We design, manufacture and market surgical and non-surgical products used primarily by orthopedic surgeons and other musculoskeletal medical specialists.

Since our founding in 1977, we have grown to nearly 9,000 employees and generated more than $3.0 billion of net sales in our most recent fiscal year. We have continually increased annual revenues, with fiscal 2013 representing our 36th consecutive year of net sales growth. We believe our success is largely attributable to our dedication to excellence in product engineering and innovation, and our responsiveness to our customers through service and support. In recent years, we have built on our core competencies in hip and knee products by expanding our business in higher-growth categories, such as sports medicine, extremities and trauma, and in our higher-growth international markets. We operate globally in markets that we estimate collectively exceed $40 billion in annual sales.

Our product categories include:

 

    Reconstructive Products—Hips and Knees: Orthopedic reconstructive implants are used to replace joints that have deteriorated as a result of disease (principally osteoarthritis) or injury. Our fiscal 2013 net sales were $632.7 million (20.7% of total net sales) for hip products and $940.0 million (30.8% of total net sales) for knee products, representing a combined increase of over two additional percentage points of global market share since the beginning of 2007.

 

    Sports, Extremities and Trauma (S.E.T.) Products: In sports medicine, we primarily manufacture and market a line of procedure-specific products for the repair of soft tissue injuries, most commonly used in the knee and shoulder. Extremity systems comprise a variety of joint replacement systems, primarily for the shoulder, elbow and wrist. Trauma hardware includes internal and external fixation devices used by orthopedic surgeons to set and stabilize fractures. Our fiscal 2013 net sales for S.E.T. products were $600.1 million (19.7% of total net sales).

 

   

Spine, Bone Healing and Microfixation Products: Our spinal products include traditional, minimally-invasive and lateral access spinal fusion and fixation systems, implantable electrical

 

 

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stimulation products for spinal applications and osteobiologics (including allograft services). Our bone healing products include non-invasive electrical stimulation devices designed to stimulate bone growth in the posterior lumbar spine and appendicular skeleton. Our microfixation products primarily include neuro, craniomaxillofacial, or CMF, and cardiothoracic products for fixation and reconstructive procedures. Our fiscal 2013 net sales for spine, bone healing and microfixation products were $408.8 million (13.4% of total net sales).

 

    Dental Reconstructive Products: Our dental reconstructive products are designed to enhance oral rehabilitation through the replacement of teeth and the repair of hard and soft tissues. These products include dental reconstructive products and related instrumentation, bone substitute materials, regenerative products and materials, computer-aided design/computer-aided manufacturing, or CAD/CAM, copings and implant bridges. Our fiscal 2013 net sales for Dental Reconstructive products were $257.0 million (8.4% of total net sales).

 

    Cement, Biologics and Other Products: We manufacture and distribute numerous other products, including bone cement and accessories, autologous blood therapy products and services, operating room supplies, general surgical instruments, wound care products and other surgical products. Our fiscal 2013 net sales for cement, biologics and other products were $214.3 million (7.0% of total net sales).

Consistent with our heritage of engineering excellence and innovation, our product portfolio incorporates a number of advanced, highly-differentiated technologies that are applicable across multiple product categories, allowing us to magnify their market impact and leverage our research and development investments. These cross-platform technologies include specialized materials designed to improve the longevity of implants, proprietary surfaces and coatings to promote biologic fixation, and patient-specific implants and positioning guides designed using CT or MRI imaging data.

We believe our culture promotes teamwork, decentralized decision-making and the empowerment of our “can-do family” of team members. Our “One Surgeon. One Patient.”® philosophy reminds us that each device we make represents a singular event that will change a patient’s life, encouraging us to approach our work as if each patient were a friend or family member. We owe our engineering-driven, entrepreneurial spirit in large measure to the inspiration of our founders, including Dane A. Miller, Ph.D., a materials science and biomedical engineer who served as our former long-term CEO and remains a member of our Board of Directors.

Our products are marketed by more than 3,000 sales representatives worldwide. We believe that the strength and stability of our sales force differentiates us and creates opportunities for us to further penetrate our markets. In the United States, our products are marketed primarily through a network of exclusive independent distributors and sales agents who carry a broad range of our products. Outside the United States, we tailor our approach to distribution by product group and geographic market, and we utilize a combination of direct sales representatives, independent third-party distributors and independent commissioned sales agents.

Our Business Improvement Initiatives

In connection with the 2007 acquisition of our company by funds affiliated with our Principal Stockholders, which we refer to as the 2007 Acquisition, we strengthened our existing management team with additional experienced medical device executives. Our management team has driven net sales growth in constant currency at or above market in 22 of 27 quarters beginning in fiscal year 2007 in our core hip and knee businesses through innovation, which has resulted in net sales for these products growing by over $500 million to $1,572.7 million for fiscal 2013—a combined increase of over two additional percentage points of global market share. In addition, we have put in place a number of significant ongoing improvement initiatives designed to continue to position us for success, including:

 

   

Growing our S.E.T. business. Increasing scale, through internal development and acquisitions, in our higher-growth S.E.T. businesses, which we have grown to over $600 million of net sales in

 

 

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fiscal 2013, representing approximately 20% of our total net sales and a compound annual growth rate, or CAGR, of 11.4%, excluding the effect of our 2012 acquisition of Johnson & Johnson/DePuy’s trauma business, which we refer to as the 2012 Trauma Acquisition.

 

    Expanding international presence. Expanding our market presence globally through increased product penetration in both developed and emerging markets. Our net sales outside the United States and Europe have grown from $205.1 million for fiscal 2007 to $480.5 million for fiscal 2013, representing a CAGR of 15%.

 

    Repositioning spine, bone healing and microfixation. Repositioning our spine, bone healing and microfixation business (including our former EBI business) for future growth by divesting our low-growth bracing business, optimizing the management of our trauma business by moving it into S.E.T. and bolstering our spine business with our acquisition of Lanx, Inc. in 2013, which we refer to as the 2013 Spine Acquisition.

 

    Redeploying capital for attractive growth opportunities. Redeploying capital, including investing $520.2 million for acquisitions in markets and products where we see attractive growth opportunities, such as the 2012 Trauma Acquisition and the 2013 Spine Acquisition.

 

    Investing in research and development. Increasing our investment in research and development spending to expand and further develop our continuing pipeline of products. For example, we recently launched our G7TM Acetabular System for hips and expect to launch our Vanguard XP Knee System in the second half of calendar year 2014. We also are investing in programs beyond our core markets, including longer-term opportunities in biologics (biologically derived products) that have the potential to address significant unmet clinical needs. Since fiscal 2007, our research and development spending has grown by more than 59% to $150.3 million for fiscal 2013.

 

    Enhancing our efficiency. Implementing operational initiatives to enhance growth and profitability, including the rationalization of our manufacturing operations, enhancement of strategic sourcing programs and improvement of our global supply chain. For example, by June 30, 2014 we will have reduced our global manufacturing footprint from 18 plants in fiscal 2007 to 11 plants, while increasing worldwide manufacturing production. These and other initiatives have resulted to date in annual cash savings of more than $170 million.

Our Markets

We operate globally in markets that we estimate collectively exceed $40 billion in annual sales. Based on industry data for 2013, we believe the total sales in these markets include approximately $13 billion for hip and knee products, approximately $10 billion for S.E.T. products, approximately $11 billion for spine, bone healing and microfixation products, approximately $3.5 billion for dental reconstructive products and approximately $5 billion for cement, biologics and other products. We believe that numerous factors will continue to drive growth within our markets, including, but not limited to:

 

    Favorable demographics of an active, aging population.

 

    Growing evidence of the health benefits and cost effectiveness of joint replacement.

 

    Relatively low, but growing, penetration rates for orthopedic implant procedures.

 

    Increased global demand for reconstructive products from younger patients.

 

    Technological advances expanding the addressable market.

 

 

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Our Competitive Strengths

We believe the following strengths provide us with a number of significant, long-term competitive advantages:

Strong global brand and reputation among clinical thought leaders. We believe that the Biomet brand is one of the most recognized names in orthopedics. Since our founding, our name has become associated with innovation, customer and clinician responsiveness, teamwork, clinical success and technological advances.

Engineering excellence, innovation and clinical success. For over 35 years, we have applied advanced engineering and manufacturing technology to the development of highly durable joint replacement systems. We have introduced a number of innovative products—a “history of firsts”— that have advanced joint replacement. For example, we were the first and only company to receive FDA approval for a free-floating meniscal-bearing partial knee; the first company to infuse Vitamin E into polyethylene hip, knee and shoulder bearings designed to improve implant longevity; and an early and leading proponent of using porous plasma spray titanium alloy coating to allow for biologic fixation in reconstructive products. In addition, we have a track record, demonstrated by a large body of clinical data, of developing durable and long-lasting products. We continue to innovate by adding new products to our pipeline, including our Vanguard XP Knee System, which we expect to launch commercially in the second half of calendar year 2014.

Strong, enduring relationships with clinicians. As a result of surgeon satisfaction with our products, responsiveness and service, we enjoy long-standing relationships with surgeons that often commence during the surgeons’ residency training programs. Our support of medical education programs provides important training opportunities for orthopedic surgeons early in their careers. Supporting “hands-on” training provides opportunities for residents, fellows and attending surgeons to experience the benefits of our products. We offer surgeons numerous options to allow them to provide the best available care to their patients through training programs and service offerings as well as by creating uniquely-designed instruments and implant products.

Breadth of product portfolio. We provide our customers with products across a broad spectrum of musculoskeletal procedures. We believe the breadth of our product offerings creates opportunities for our sales force to develop and strengthen surgeon relationships. For example, a surgeon who has experienced clinical success with our reconstructive hips and knees may be more inclined to use our S.E.T. products than the products of a competitor that does not have as complete a product offering. In addition, we believe our ability to provide a large portfolio of products is attractive to hospitals as they consolidate sourcing. We also believe that the breadth of our product portfolio allows us to leverage innovative, cross-platform technologies across product categories.

Experienced and stable sales force. We have worked to attract and retain a qualified, well-trained and motivated sales force of 3,000 sales representatives throughout the world. Our sales representatives provide a high level of customer service and support to surgeons and hospitals. This comprehensive support includes providing tools to assist the surgeon and hospital in pre-operative planning, ensuring delivery of required instruments and implants, working alongside the operating room staff to streamline intra-operative workflow, and product and technical support as needed during surgical procedures. We believe the strength of the relationship between our sales representatives and our customers is a differentiating factor driving our success.

Global reach and scale of operations. We have a global footprint with worldwide distribution and products sold in more than 90 countries around the world. In fiscal 2013, 39% of our net sales were outside the United States. Our global infrastructure, scale and reach, including manufacturing facilities in eight countries, enable us to sell and support our products in orthopedic device markets around the world.

Proven and experienced leadership team. We have a highly experienced management team at both the corporate and operational levels, with significant expertise in the orthopedic industry. Members of our senior

 

 

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management team, which consists of 11 executives, have an average of 22 years of healthcare industry experience, predominantly in orthopedics. Together with our heritage of engineering and clinical excellence, our management team is an important part of our success with our customers.

Our Strategies for Growth

We intend to enhance our position as a leading orthopedic medical device company by pursuing the following growth strategies:

Drive above-market growth in our core hip and knee businesses through innovation. We plan to continue to innovate to address unmet clinical needs in our hip and knee replacement markets, which have been our largest product categories and are expected to grow steadily. Since fiscal 2007, we have launched numerous new technologies within our hip and knee businesses, including our G7TM Acetabular System for hips, and we expect to launch our Vanguard XP Knee System in the second half of calendar year 2014.

Continue to invest in and grow our S.E.T. business. With a market-leading brand in each of sports medicine, extremities and trauma, we believe that our S.E.T. business is well-positioned to expand. We are focused on growing the S.E.T. business through internal development and complementary acquisitions, such as our 2012 Trauma Acquisition. We intend to continue leveraging our technologies in each category to cross-sell a broad portfolio of products.

Further penetrate attractive international markets where we have an established presence. We intend to expand the geographic presence of each of our product categories. We believe there are considerable opportunities for global expansion as healthcare spending increases in international markets, which accounted for more than 40% of the global orthopedic market in 2012. We plan to strengthen our position in under-penetrated regions, including both developed and emerging markets, where we believe there are further opportunities for meaningful growth. We intend to deploy incremental resources to capture attractive market opportunities including through increased investment in medical education and training.

Continue to transform our Spine, Bone Healing and Microfixation business. We have repositioned our Spine, Bone Healing and Microfixation business (including our former EBI business) and enhanced our competitive position by, among other things: divesting our low-growth bracing business; optimizing the management of our trauma business by moving it into S.E.T.; enhancing our spinal product offering with the 2013 Spine Acquisition; and increasing our investment in microfixation. The result of these changes is three well-positioned, focused businesses, each with dedicated marketing, medical education, research and development and sales force units.

Restore profitable growth in Dental. We have taken steps to restore profitable growth in our dental business, which is under new leadership. For example, we are introducing differentiated products, such as our recently introduced T3® dental implant; supporting clinicians with practice building, training and education offerings; and investing in sales force expansion in key markets. Weaker economic conditions in recent years have decreased patient demand for dental implants, but we are beginning to see global sales growth return and we believe that we are well-positioned to grow market share.

Invest in longer-term biologics opportunities. We are making considerable investments in programs in our biologics business that have the long-term potential to address significant unmet clinical needs in new markets, including: an autologous therapy to treat early stage osteoarthritis; an autologous treatment for critical limb ischemia that has the potential to help patients avoid amputation; and a red blood cell processing solution for restoring the ability of aged, donated red blood cells to carry oxygen. We continue to evaluate markets internally and externally that provide opportunities to drive future growth.

 

 

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Focus on cost effective clinical solutions to address the evolving healthcare market. We are intensely focused on developing technologies and systems to meet the evolving needs of our customers, including reducing costs and improving patient experience by increasing operating room efficiency and shortening patient recovery times.

Leverage existing infrastructure and sales growth to increase operating profits and net income. Since fiscal 2007, we have implemented operational initiatives to enhance growth and profitability, resulting in annual cash savings to date of more than $170 million. We intend to continue to implement operational improvements to reduce our cost of sales and selling, general and administrative expenses.

Selectively pursue strategic acquisitions. We intend to selectively pursue strategic acquisitions that meet our return objectives, provide us with new or complementary technologies, enable us to compete further in market segments where we already have a presence and allow us to leverage our distribution capability or increase market penetration.

Principal Stockholders

Following the completion of this offering, private equity funds affiliated with the Blackstone Group, Goldman, Sachs & Co., Kohlberg Kravis Roberts & Co. and TPG (which we refer to collectively as our Principal Stockholders), and their co-investors, will together own through LVB Acquisition Holding, LLC, or LVB Holding, approximately         % of our outstanding common stock, or         % if the underwriters’ option to purchase additional shares is fully exercised.

The Blackstone Group. Blackstone is a leading global alternative asset manager and provider of financial advisory services, with Total Assets Under Management of $265.8 billion as of December 31, 2013. As a steward of public funds, Blackstone looks to drive outstanding results for investors and clients by deploying capital and ideas to help businesses succeed and grow. Blackstone’s alternative asset management businesses include investment vehicles focused on private equity, real estate, hedge fund solutions, non-investment grade credit, secondary funds and multi-asset class exposures falling outside of other funds’ mandates. We also provide a wide range of financial advisory services, including financial and strategic advisory, restructuring and reorganization advisory, capital markets and fund placement services.

Goldman, Sachs & Co. Founded in 1869, Goldman, Sachs & Co., or Goldman Sachs, is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals. Since 1986, the Goldman Sachs Merchant Banking Division through its Principal Investment Area, or GS PIA, and its predecessor business areas have raised 18 private equity and principal debt investment funds aggregating over $84 billion of capital (including leverage). A global leader in private corporate equity investing, GS PIA focuses on large, high quality companies with strong management in order to fund acquisition or expansion across a range of industries and geographies. Since 1986, GS PIA and its predecessor business areas have invested approximately $90 billion through a combination of external investment funds and firm capital. GS Capital Partners VI fund, the sixth in a series of global diversified private equity funds formed since 1992, was formed in 2007 with $20.3 billion in commitments.

Kohlberg Kravis Roberts & Co. Founded in 1976 and led by Henry Kravis and George Roberts, Kohlberg Kravis Roberts & Co., or KKR, is a leading global investment firm with $94.3 billion in assets under management as of December 31, 2013. With offices around the world, KKR manages assets through a variety of investment funds and accounts covering multiple asset classes. KKR seeks to create value by bringing operational expertise to its portfolio companies and through active oversight and monitoring of its investments. KKR complements its investment expertise and strengthens interactions with fund investors through its client relationships and capital markets platform. KKR & Co. L.P. is publicly traded on the New York Stock Exchange (NYSE: KKR) and “KKR,” as used in this prospectus, includes its subsidiaries, their managed investment funds and accounts, and/or their affiliated investment vehicles, as appropriate.

 

 

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TPG. TPG is a leading global private investment firm founded in 1992 with $55.7 billion of assets under management as of September 30, 2013 and offices in San Francisco, Fort Worth, Austin, Beijing, Chongqing, Hong Kong, London, Luxembourg, Melbourne, Moscow, Mumbai, New York, Paris, São Paulo, Shanghai, Singapore and Tokyo. TPG has extensive experience with global public and private investments executed through leveraged buyouts, recapitalizations, spinouts, growth investments, joint ventures and restructurings. The firm’s investments span a variety of industries, including healthcare, financial services, travel and entertainment, technology, energy, industrials, retail, consumer, real estate and media and communications.

Corporate Information

Our business, in the form of Biomet, Inc., an Indiana corporation, was founded in 1977. From October 1982 to September 2007, Biomet, Inc.’s common stock traded under the symbol “BMET” on the NASDAQ Global Market. In September 2007, Biomet, Inc. de-listed its common stock from the NASDAQ Global Market upon completion of the second-step merger effected in connection with the 2007 Acquisition. To effect the second-step merger, a subsidiary of a LVB Acquisition, Inc. merged with and into Biomet, Inc., with Biomet, Inc. continuing as the surviving company after the merger as a wholly-owned subsidiary of LVB Acquisition, Inc. Prior to the closing of this offering, LVB Acquisition, Inc. will be renamed Biomet Group, Inc. Biomet, Inc., which is our operating entity, will remain a wholly owned subsidiary of Biomet Group, Inc.

Our principal executive offices are located at 56 East Bell Drive, Warsaw, Indiana, and our telephone number is (574) 267-6639. Our corporate website address is www.biomet.com. The information contained on our website or that can be accessed through our website will not be deemed to be incorporated into this prospectus or the registration statement of which this prospectus forms a part, and investors should not rely on any such information in deciding whether to purchase our common stock.

Risk Factors

Our business may be subject to numerous risks. See “Risk Factors.” In particular, our business may be adversely affected by:

 

    any event adversely affecting the sale of our key hip and knee products;

 

    our inability to continue to develop and market new products and technologies in a timely manner;

 

    government regulation related to the research, development, testing, labeling and manufacturing of our products;

 

    our dependence on payments from third-party payors;

 

    the impact of the Patient Protection and Affordable Health Care Act;

 

    interruptions in the supply chain used to manufacture our products;

 

    ongoing governmental investigations by various federal and state authorities;

 

    compliance with the deferred prosecution agreement we have entered into with the Department of Justice, or DOJ;

 

    further governmental investigations or actions by other third parties;

 

    product liability, intellectual property and other litigation;

 

    global economic uncertainties that affect demand for our products; and

 

    cost-containment efforts of group purchasing organizations.

 

 

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The Offering

 

Common stock we are offering

                     shares.

 

Common stock to be outstanding after this offering

                     shares.

 

Use of proceeds

We estimate that our net proceeds from this offering, after deducting estimated underwriting discounts and commissions and offering expenses, will be approximately $              at an assumed initial public offering price of $              per share (the midpoint of the range set forth on the cover page of this prospectus).

 

  We expect to use the net proceeds of this offering as follows:

 

    approximately $              to reduce outstanding indebtedness (through repayments, redemptions or repurchases); and

 

    approximately $              for general corporate purposes.

See “Use of Proceeds.”

 

Underwriters’ option to purchase additional shares

We have granted the underwriters a 30-day option to purchase up to                      additional shares.

 

Dividend policy

We have not declared or paid any dividends or distributions on our common stock. We are currently restricted in our ability to pay dividends under various covenants of our debt agreements, including our credit facilities and the indentures governing the notes issued by Biomet, Inc. We do not expect for the foreseeable future to pay dividends on our common stock. Any future determination to pay dividends will be at the discretion of our board of directors, or the Board of Directors, and will depend upon, among other factors, our results of operations, financial condition, cash flows, capital requirements, any contractual restrictions and any other considerations our Board of Directors deems relevant. See “Dividend Policy.”

 

Risk Factors

Investing in our common stock involves a high degree of risk. See “Risk Factors” for a discussion of factors you should carefully consider before deciding to invest in our common stock.

 

Proposed              symbol

“BMET”.

 

 

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Conflicts of interest

Certain affiliates of Goldman, Sachs & Co. own more than 10% of LVB Holding, a principal stockholder of our company. Goldman, Sachs & Co. is an underwriter in this offering and will be deemed to have a “conflict of interest” within the meaning of Rule 5121 of the Financial Industry Regulatory Authority, Inc., or FINRA. Accordingly, this offering will be made in compliance with the applicable provisions of FINRA Rule 5121. The rule requires that a “qualified independent underwriter” meeting certain standards participate in the preparation of the registration statement and prospectus and exercise the usual standards of due diligence with respect thereto.                      has agreed to act as a “qualified independent underwriter” within the meaning of Rule 5121 in connection with this offering.

The number of shares of common stock to be outstanding after this offering does not take into account an aggregate of 38,520,000 shares of common stock reserved for future issuance under our 2007 Management Equity Incentive Plan, as may be amended from time to time,              of which remain available for grant and 14,000,000 shares of common stock reserved for future issuance under our 2012 Restricted Stock Unit Plan, as may be amended from time to time,              of which remain available for grant.

In addition, except as otherwise noted, all information in this prospectus assumes no exercise by the underwriters of their option to purchase additional shares.

Figures in the tables included in this prospectus may not total due to rounding.

 

 

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SUMMARY HISTORICAL CONSOLIDATED FINANCIAL AND OPERATING DATA

The following tables summarize our historical consolidated financial and other data for our business for the periods presented. You should read this summary of financial and other data along with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and our financial statements and the related notes, all included elsewhere in this prospectus.

The summary consolidated statement of operations data for the years ended May 31, 2013, May 31, 2012 and May 31, 2011 and the summary consolidated balance sheet data as of May 31, 2013 and May 31, 2012 have been derived from our audited consolidated financial statements included elsewhere in this prospectus. The summary consolidated statement of operations data for the six months ended November 30, 2013 and November 30, 2012 and the summary consolidated balance sheet data as of November 30, 2013 have been derived from our unaudited condensed consolidated financial statements included elsewhere in this prospectus. In the opinion of management, the unaudited condensed consolidated financial statements included herein include all adjustments (consisting of normal recurring accruals) necessary to state fairly the information set forth herein. Our historical results are not necessarily indicative of the results to be expected in the future, and the results for the six months ended November 30, 2013 are not necessarily indicative of the results to be expected for the full year.

Statement of Operations Data

 

    

Six Months Ended November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

 

Net sales

   $ 1,556.4      $ 1,497.5      $ 3,052.9      $ 2,838.1      $ 2,732.2   

Cost of sales

     522.2        464.1        996.5        894.4        838.7   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     1,034.2        1,033.4        2,056.4        1,943.7        1,893.5   

Selling, general and administrative expense

     594.6        592.9        1,189.4        1,053.3        1,041.7   

Research and development expense

     78.9        72.2        150.3        126.8        119.4   

Amortization

     150.7        156.1        313.8        327.2        367.9   

Goodwill impairment charge

     —          —          473.0        291.9        422.8   

Intangible assets impairment charge

     —          —          94.4        237.9        518.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss)

     210.0        212.2        (164.5     (93.4     (576.9

Interest expense

     193.3        222.0        398.8        479.8        498.9   

Other (income) expense

     5.9        161.5        177.8        17.6        (11.2
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     10.8        (171.3     (741.1     (590.8     (1,064.6

Benefit from income taxes

     (25.2     (73.6     (117.7     (132.0     (214.8
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Earnings (Loss) Per Share

 

    

Six Months Ended November 30,

   

Fiscal Year Ended May 31,

 
(shares in millions)   

2013

    

2012

   

2013

   

2012

   

2011

 

Earnings (loss) per share—basic(1)

   $ 0.07       $ (0.18   $ (1.13   $ (0.83   $ (1.54

Earnings (loss) per share—diluted(1)

   $ 0.07       $ (0.18   $ (1.13   $ (0.83   $ (1.54

Weighted average shares—basic

     551.9         551.8        551.8        551.9        552.1   

Weighted average shares—diluted

     552.1         551.8        551.8        551.9        552.1   

 

 

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Balance Sheet Data

 

(in millions)   

November 30, 2013

    

May 31, 2013

    

May 31, 2012

 

Cash and cash equivalents

   $ 176.2       $ 355.6       $ 492.4   

Current assets less current liabilities

     1,159.3         1,208.5         1,200.8   

Total assets

     9,737.4         9,794.7         10,420.4   

Total debt

     5,896.8         5,966.4         5,827.8   

Shareholders’ equity

     2,068.8         1,968.6         2,682.1   

Summary of Cash Flow Data

 

    

Six Months Ended November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

 

Net cash provided by (used in):

          

Operating activities

   $ 170.9      $ 128.6      $ 468.5      $ 377.3      $ 380.1   

Investing activities

     (248.6     (409.3     (488.6     (144.0     (205.0

Financing activities

     (101.2     (51.3     (134.7     (38.1     (51.4

Other Financial Data

 

    

Six Months Ended November 30,

    

Fiscal Year Ended May 31,

 
(in millions)   

2013

    

2012

    

2013

    

2012

    

2011

 

Depreciation and amortization

   $  242.5       $  242.1       $ 495.4       $ 509.4       $ 549.0   

Capital expenditures

     98.5         106.9         204.0         179.3         174.0   

Adjusted EBITDA(2)

     529.0         532.2         1,075.9         1,013.5         1,021.6   

Adjusted net income(2)

     202.2         164.8         365.7         251.8         205.2   

 

(1) Basic earnings per common share amounts are calculated using the weighted average number of common shares outstanding for the period. Diluted earnings per common share amounts are calculated using the weighted average number of common shares outstanding for the period and include the dilutive impact of stock options using the treasury stock method. Diluted earnings per common share excludes the impact of any restricted stock units as a liquidity event is required for both the time and performance restricted stock units to vest. As of November 30, 2013, 1.8 million time-based shares were available to vest upon a liquidity event, and 3.5 million performance-based restricted shares were available to vest at November 30, 2013 upon occurrence of a liquidity event and achievement of certain investment return metrics as detailed in the 2012 Restricted Stock Unit Plan. See “Executive Compensation.”
(2)

We have included certain non-GAAP financial measures including Adjusted EBITDA and Adjusted net income, each as defined below, that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles, or GAAP. These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP. Management exercises judgment in determining which types of charges or other items should be excluded from non-GAAP financial measures. Management uses this non-GAAP information internally to evaluate the performance of the core operations, establish operational goals and forecasts that are used in allocating resources and to evaluate our performance period-over-period. Additionally, our management is evaluated on the basis of some of these non-GAAP financial measures when determining achievement of their incentive compensation performance targets. We believe that our disclosure of these non-GAAP financial measures provides investors greater transparency to the information used by management for its financial and operational decision-making and enables investors to better understand our period-to-period operating performance. We also believe Adjusted EBITDA and Adjusted net income are widely used by investors and securities analysts to measure a company’s operating performance without regard to items that can vary

 

 

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  substantially from company to company depending upon financing and accounting methods, book values of assets, tax jurisdictions, capital structures and the methods by which assets were acquired.

 

     We define “Adjusted EBITDA” to mean earnings before interest, taxes, depreciation and amortization, as adjusted for certain expenses. We define “Adjusted net income” to mean earnings as adjusted for certain expenses. The term “as adjusted,” a non-GAAP financial measure, refers to financial performance measures that exclude certain income statement line items, such as interest, taxes, depreciation or amortization, and/or exclude certain expenses, such as stock-based compensation charges, certain litigation expenses, acquisition expenses, operational restructuring charges, advisory fees paid to the Principal Stockholders, asset impairment charges, losses on extinguishment of debt, purchase accounting costs, losses on swap liabilities and other related charges. In “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Disclosures,” we provide further information about our calculation of Adjusted EBITDA and Adjusted net income, as well as information about where these expenses are reflected in the line items of our income statement prepared in accordance with GAAP.

 

     Adjusted EBITDA and Adjusted net income do not represent, and should not be a substitute for, net income or cash flows from operations as determined in accordance with GAAP. Adjusted EBITDA and Adjusted net income have limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of our results as reported under GAAP. Some of the limitations are:

 

    Adjusted EBITDA and Adjusted net income do not reflect our cash expenditures, or future requirements for capital expenditures or contractual commitments;

 

    Adjusted EBITDA and Adjusted net income do not reflect changes in, or cash requirements for, our working capital needs;

 

    Adjusted EBITDA does not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt; and

 

    several of the adjustments that we use in calculating Adjusted EBITDA and Adjusted net income, such as asset impairment charges, while not involving cash expense, do have a negative impact on the value our assets as reflected in our consolidated balance sheet prepared in accordance with GAAP.

 

     Adjusted EBITDA, as calculated below, differs from Adjusted EBITDA as calculated for purposes of compliance with our senior secured credit facilities.

 

 

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     Reconciliations of historical net income (loss) to Adjusted EBITDA and Adjusted net income are set forth in the following table:

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

 
Adjusted EBITDA:           

Net income (loss), as reported

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8

Plus (minus):

          

Interest expense

     193.3        222.0        398.8        479.8        498.9   

Benefit from income taxes

     (25.2     (73.6     (117.7     (132.0     (214.8

Depreciation and amortization

     242.5        242.1        495.4        509.4        549.0   

Special items, before amortization and depreciation from purchase accounting, interest and tax(a)

     82.4        239.4        922.8        615.1        1,038.3   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 529.0      $ 532.2      $ 1,075.9      $ 1,013.5      $ 1,021.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income:

          

Net income (loss), as reported

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8

Plus:

          

Special items, after tax(b)

     166.2        262.5        989.1        710.6        1,055.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income

   $ 202.2      $ 164.8      $ 365.7      $ 251.8      $ 205.2   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(a) A reconciliation of special items, before amortization and depreciation from purchase accounting, interest and tax is as follows:

 

    

Six Months Ended
November 30,

    

Fiscal Year Ended May 31,

 
(in millions)   

2013

    

2012

    

2013

    

2012

    

2011

 

Special items

              

Stock-based compensation(1)

   $ 9.2       $ 26.5       $ 39.6       $ 16.0       $ 12.7   

Certain litigation expenses(2)

     29.5         9.4         57.9         8.6         12.5   

Acquisition expenses(3)

     8.7         10.1         16.7         4.6         —     

Operational restructuring(4)

     23.0         20.3         59.1         45.8         61.6   

Principal Stockholders fee(5)

     5.4         5.4         11.0         10.3         10.1   

Asset impairment(6)

     —           —           567.4         529.8         941.4   

Loss on extinguishment of debt(7)

     6.6         167.7         171.1         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 82.4       $ 239.4       $ 922.8       $ 615.1       $ 1,038.3   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

 

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(b) A reconciliation of special items, after tax is as follows:

 

     Six Months Ended
November 30,
    Fiscal Year Ended May 31,  
(in millions)    2013     2012     2013     2012     2011  

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 82.4      $ 239.4      $ 922.8      $ 615.1      $ 1,038.3   

Amortization and depreciation from purchase accounting(8)

     144.3        148.9        299.6        325.6        376.3   

Loss on swap liability(9)

     21.8        —          —          —          —     

Tax effect(10)

     (82.3     (125.8     (233.3     (230.1     (359.6
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Special items, after tax

   $ 166.2      $ 262.5      $ 989.1      $ 710.6      $ 1,055.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

  (1) Stock-based compensation expense is excluded from non-GAAP financial measures primarily because it is a non-cash expense and because it is not used by management to assess ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (2) Certain litigation, including expenses, settlements and adjustments to reserves during the year, including the metal-on-metal hip products litigation described in “Business—Legal Matters,” that we believe are not reflective of our ongoing operational performance are excluded from non-GAAP financial measures. We incur legal and settlement expenses in the ordinary course of our business, but we believe the items included in this line are unusual either in amount or subject matter. We believe this information is useful to investors in that it aids period-over-period comparability.
  (3) We exclude acquisition-related expenses for the 2012 Trauma Acquisition and 2013 Spine Acquisition from non-GAAP financial measures that are not reflective of our ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (4) Operational restructuring charges relate principally to employee severance, facility consolidation costs and building impairments resulting from the closure of facilities. Operational restructuring charges include abnormal manufacturing variances related to temporary redundant overhead costs within our plant network as we continue to rationalize and move production to our larger operating locations in order to increase manufacturing efficiency. Operational restructuring also includes consulting expenses related to operational initiatives and other related costs. Operational restructuring also includes product rationalization charges to increase efficiencies among our products and reduce product overlap, including steps we take to integrate products we acquire. Operational restructuring also includes the loss on the divestiture of our bracing business in fiscal year 2013. We exclude these costs from non-GAAP financial measures primarily because they are not reflective of ongoing operating results, and they are not used by management to assess ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (5) Upon completion of the 2007 Acquisition, we entered into a management services agreement with certain affiliates of our Principal Stockholders, pursuant to which such affiliates of our Principal Stockholders or their successors, assigns, affiliates, officers, employees, and/or representatives and third parties (collectively, the “Managers”) provide management, advisory, and consulting services to us. Pursuant to such agreement, our Principal Stockholders receive a quarterly monitoring fee equal to 1% of our quarterly Adjusted EBITDA (as defined by our credit agreement) as compensation for the services rendered and reimbursement for out-of-pocket expenses incurred by the Managers in connection with the agreement. We exclude these costs from non-GAAP financial measures primarily because they are not reflective of ongoing operating results and they are not used by management to assess ongoing operational performance. In addition, we have excluded these costs from non-GAAP financial measures because the management services agreement will terminate in connection with the completion of this offering. We believe this information is useful to investors in that it provides period-over-period comparability.

 

 

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  (6) Non-cash asset impairment charges are excluded from non-GAAP financial measures because they are not reflective of our ongoing operational performance or liquidity.

 

    During fiscal year 2013, we recorded a $473.0 million goodwill impairment charge and a $94.4 million definite and indefinite-lived intangible asset impairment charge associated with our dental reconstructive and Europe reporting units.

 

    During fiscal year 2012, we recorded a $291.9 million goodwill impairment charge and a $237.9 million definite and indefinite-lived intangible asset impairment charge primarily associated with our dental reconstructive and spine and bone healing reporting units.

 

    During fiscal year 2011, we recorded a $422.8 million goodwill impairment charge and a $518.6 million definite and indefinite-lived intangible asset impairment charge primarily associated with our Europe reporting unit.

We believe this information is useful to investors in that it provides period-over-period comparability.

  (7) Loss on extinguishment of debt charges include write off of deferred financing fees, dealer manager fees and tender/call premium on retirement of bonds. We exclude these charges from non-GAAP measures because they are not reflective of our ongoing operational performance or liquidity. We believe this information is useful to investors in that it provides period-over-period comparability.
  (8) Amortization and depreciation from purchase accounting adjustments that is related to the 2007 Acquisition, 2012 Trauma Acquisition and 2013 Spine Acquisition are excluded from non-GAAP financial measures. These amortization amounts represent the additional amortization expenses in each period attributable to the step-up of amortizable assets to fair value due to the application of purchase accounting. We believe this information is useful to investors in that it provides period-over-period comparability. Further, these amounts are not used by management to assess ongoing operational performance.
  (9) Loss on swap liability charges include a one-time charge to interest expense related to the termination of our euro-denominated term loans. We believe this information is useful to investors in that it provides period-over-period comparability.
  (10) Tax effect is calculated based upon the tax rates applicable to the jurisdictions where the special items were incurred.

 

 

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RISK FACTORS

This offering and investing in our common stock involves a high degree of risk. You should carefully consider the following risks and uncertainties described below, as well as the other information contained in this prospectus, including our consolidated financial statements and related notes included elsewhere in this prospectus, before deciding to invest in our common stock. The occurrence of any of the following risks could materially and adversely affect our business, prospects, financial condition or results of operations, in which case the trading price of our common stock could decline and you could lose all or part of your investment.

Risks Related to Our Business

A majority of our net sales is derived from our sales of hip and knee reconstructive products.

Sales of our hip and knee products accounted for approximately 51.5%, 55.5%, 55.4% and 51.8% of our net sales for each of the three fiscal years ended May 31, 2013, 2012 and 2011 and six months ended November 30, 2013, respectively. We expect sales of hip and knee products to continue to account for a significant portion of our net sales. Any event adversely affecting the sale of hip and knee products may, as a result, adversely affect our business, financial condition, results of operations and cash flows.

If we are unable to continue to develop and market new products and technologies in a timely manner, the demand for our products may decrease or our products could become obsolete, and our revenue and profitability may decline.

The market for our products is highly competitive and dominated by a small number of large companies. We are continually engaged in product development, research and improvement efforts. New products and line extensions of existing products represent a significant component of our historical growth. Our ability to continue to grow sales effectively depends on our capacity to keep up with existing or new products and technologies in the musculoskeletal products market.

In addition, if our competitors’ new products and technologies reach the market before our products, our competitors may gain a competitive advantage or our products may be rendered obsolete.

The ultimate success of our product development efforts will depend on many factors, including, but not limited to, our ability to create innovative designs and materials, provide innovative surgical techniques, accurately anticipate and meet customers’ needs, commercialize new products in a timely manner, differentiate our offerings from competitors’ offerings, achieve positive clinical outcomes with new products, satisfy the increased demands by healthcare payors, providers and patients for shorter hospital stays, faster post-operative recovery and lower-cost procedures, provide adequate medical education relating to new products and manufacture and deliver products and instrumentation in sufficient volumes on time. Moreover, research and development efforts may require a substantial investment of time and resources before we are adequately able to determine the commercial viability of a new product, technology, material or other innovation. Our competition may respond more quickly to new or emerging technologies, undertake more effective marketing campaigns, adopt more aggressive pricing policies, have greater financial, marketing and other resources than us or may be more successful in attracting potential customers, employees and strategic partners.

Even in the event that we are able to successfully develop innovations, they may not produce revenue in excess of the costs of development and may be quickly rendered obsolete as a result of changing customer preferences, changing demographics, slowing industry growth rates, declines in the reconstructive implant market, the introduction of new products and technologies, evolving surgical philosophies, evolving industry standards or the introduction by our competitors of products embodying new technologies or features. New materials, product designs and surgical techniques that we develop may not be accepted or may not be accepted quickly, in some or all markets, because of, among other factors, entrenched patterns of clinical practice, the need

 

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for regulatory clearance and uncertainty with respect to third-party reimbursement. If actual product life cycles, product demand or acceptance of new product introductions are less favorable than projected by management, a higher level of inventory write downs may result. Given these factors, we may be unable to continue our level of success in the industry.

We rely on payments from third-party payors for payment on our products.

In the United States, healthcare providers that purchase our products (e.g., hospitals, physicians, dentists and other healthcare providers) generally rely on payments from third-party payors (principally federal Medicare, state Medicaid and private health insurance plans) to cover all or a portion of the cost of our musculoskeletal products. These third-party payors may deny reimbursement if they determine that a device used in a procedure was not in accordance with cost-effective treatment methods, as determined by the third-party payor, or was used for an unapproved indication. Third-party payors may also decline to reimburse for experimental procedures and devices. Further, third-party payors are continuing to carefully review their coverage policies with respect to existing and new therapies and can, without notice, deny coverage for treatments that may include the use of our products. In the event that third-party payors deny coverage or reduce their current levels of reimbursement, demand for our products may decline or we may experience increased pressure to reduce the prices of our products, and we may be unable to sell certain products on a profitable basis, thereby materially adversely impacting our results of operations.

Our results of operations since January 1, 2013 have been and will continue to be impacted by the enactment of the Patient Protection and Affordable Health Care Act (P.L. 111-148). In addition, our business, financial condition, results of operations and cash flows could be significantly and adversely affected if this legislation ultimately results in lower reimbursements for our products or reduced medical procedure volumes or if certain other types of healthcare reform programs are adopted in our key markets.

In March 2010, the U.S. Congress adopted and President Obama signed into law comprehensive healthcare reform legislation through the passage of the Patient Protection and Affordable Health Care Act (P.L. 111-148) and the Healthcare and Education Reconciliation Act (P.L. 111-152). Among other initiatives, these bills impose a 2.3% excise tax on domestic sales of certain medical devices, including most of our products, following December 31, 2012. The excise tax applies to a majority of our medical device products. We do not expect to be able to pass along the cost of the tax to hospitals, which continue to face cuts to their Medicare reimbursement per the healthcare law and the recently enacted fiscal cliff legislation, nor do we expect to be able to offset the cost of the tax through higher sales volumes resulting from the expansion of health insurance coverage because of the demographics of the current uninsured population. The medical device excise tax regulations and interim guidance issued in late 2012 by the U.S. Department of Treasury did little to lessen the burden of complying with the excise tax statute. In addition, the law’s Medicare payment reforms, such as accountable care organizations and bundled payments, could provide additional incentives for healthcare providers to reduce spending on our medical device products and reduce utilization of hospital procedures that use our products. Various healthcare reform proposals have also emerged at the state level. Other than the excise tax, which has affected our results of since January 1, 2013, we cannot predict with certainty what healthcare initiatives, if any, will be implemented at the state level, or the ultimate effect that federal healthcare reform or any future legislation or regulation will have on us. However, an expansion in government’s role in the U.S. healthcare industry may lower reimbursements for procedures that involve our products, reduce medical procedure volumes and adversely affect our business and results of operations, possibly materially.

Outside of the United States, reimbursement systems vary significantly from country to country. In the majority of the international markets in which our products are sold, government-managed healthcare systems mandate the reimbursement rates and methods for medical devices and procedures. If adequate levels of reimbursement from third-party payors outside of the United States are not obtained, international sales of our products may decline. Many foreign markets, including Canada and some European and Asian countries, have

 

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tightened reimbursement rates. Our ability to continue to sell certain products profitably in these markets may diminish if the government-managed healthcare systems continue to reduce reimbursement rates.

As both the U.S. and foreign government regulators have become increasingly stringent, we may be subject to more rigorous regulation by governmental authorities in the future. Our products and operations are also often subject to the rules of industrial standards bodies, such as the International Standards Organization, or ISO. If we fail to adequately address any of these regulations, our business will be harmed.

If pricing pressures cause us to decrease prices for our goods and services and we are unable to compensate for such reductions through product mix and reductions to our expenses, our results of operations will suffer.

We have experienced and expect to continue to experience decreasing prices for the goods and services we offer due to pricing pressure exerted by our customers in response to initiatives sponsored by government agencies, legislative bodies and managed care organizations and other third-party payors to limit the growth of healthcare costs, including price regulation and competitive pricing. Pricing pressure has also increased in our markets due to increased market power of our customers from continued consolidation among healthcare providers, trends toward managed care, the shift towards governments becoming the primary payers of healthcare expenses, and government laws and regulations relating to reimbursement and pricing generally. Reductions in reimbursement levels or coverage or other cost containment measures could unfavorably affect our future operating results. If we are unable to offset such price reductions through product mix or reductions in our expenses, our business, financial condition, results of operations and cash flows will be adversely affected.

We have incurred losses in the past and may incur losses in the future. If we incur losses over an extended period of time, the value of our common stock could decline.

For each of the three fiscal years ended May 31, 2013, 2012 and 2011, we experienced net losses of $623.4 million, $458.8 million and $849.8 million, respectively. We may not be profitable in future periods. Any failure to become profitable could, among other things, impair our ability to complete future financings or the cost of obtaining financing, and have a material adverse effect on our business. In addition, a lack of profitability could adversely affect the price of our common stock.

Reduction or interruption in supply and an inability to develop alternative sources for supply may adversely affect our manufacturing operations and related product sales.

We purchase many of the components and raw materials used in manufacturing our products from numerous suppliers in various countries. Generally we have been able to obtain adequate supplies of such raw materials and components. We work closely with our suppliers to try to ensure continuity of supply while maintaining high quality and reliability. However, we cannot guarantee that these efforts will be successful. In addition, due to the stringent regulations and requirements of the FDA regarding the manufacture of our products, we may not be able to quickly establish additional or replacement sources for certain components or materials. Further, an increase in demand from other industries which use some of the same metallic alloys or other materials as us (such as the aerospace industry) could reduce the availability or increase the cost of materials used in our products. A reduction or interruption in supply, and an inability to develop alternative sources for such supply, could adversely affect our ability to manufacture our products in a timely or cost-effective manner and to make our related product sales.

We, like other companies in the orthopedic industry, are involved in ongoing governmental investigations, the results of which may adversely impact our business and results of operations.

We are subject to various federal and state laws concerning healthcare fraud and abuse, including false claims laws and anti-kickback laws, such as the Federal Anti-Kickback Statute and similar state laws. In addition, we are subject to various federal and foreign laws concerning anti-corruption and anti-bribery matters,

 

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sales to countries or persons subject to economic sanctions and other matters affecting our international operations. Violations of these laws are punishable by criminal and/or civil sanctions, including, in some instances, fines, imprisonment and, within the United States, exclusion from participation in government healthcare programs, including Medicare, Medicaid and VA health programs. These laws are administered by, among others, the DOJ, the Office of the Inspector General of the U.S. Department of Health and Human Services, or OIG-HHS, the Securities and Exchange Commission, or SEC, the Office of Foreign Assets Control, the Bureau of Industry and Security of the U.S. Department of Commerce and state attorneys general. The interpretation and enforcement of these laws and regulations are uncertain and subject to change.

In June 2013, we received a subpoena from the U.S. Attorney’s Office for the District of New Jersey requesting various documents relating to the fitting of custom-fabricated or custom-fitted orthoses, or bracing, to patients in New Jersey, Texas and Washington. We have produced responsive documents and are fully cooperating with the request of the U.S. Attorney’s Office. We may need to devote significant time and resources to this inquiry and can give no assurances as to its final outcome.

In September 2010, we received a Civil Investigative Demand, or CID, issued by the U.S. Department of Justice Civil Division pursuant to the False Claims Act. The CID requests that we provide documents and testimony related to allegations that OtisMed Corp., Stryker Corp. and our company have violated the False Claims Act relating to the marketing of, and payment submissions for, OtisMed’s OtisKnee® (a registered trademark of Otis Med) knee replacement system. We have produced responsive documents and are fully cooperating in the investigation. We may need to devote significant time and resources to this inquiry and can give no assurances as to its final outcome.

In February 2010, we received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services requesting various documents relating to agreements or arrangements between physicians and our Interpore Cross subsidiary for the period from 1999 through the present and the marketing and sales activities associated with Interpore Cross’s spinal products. We are cooperating with the request of the Office of the Inspector General. We may need to devote significant time and resources to this inquiry and can give no assurances as to its final outcome.

In April 2009, we received an administrative subpoena from the U.S. Attorney’s Office for the District of Massachusetts requesting various documents relating primarily to the Medicare reimbursement of and certain business practices related to our non-invasive bone growth stimulators. It is our understanding that competitors in the non-invasive bone growth stimulation market received similar subpoenas. We received subsequent subpoenas in connection with the investigation in September 2009, June 2010 and February 2011 along with several informal requests for information. We are producing responsive documents and are fully cooperating in the investigation. We may need to devote significant time and resources to this inquiry and can give no assurances as to its final outcome.

In April 2009, we became aware of a qui tam complaint alleging violations of the federal and various state False Claims Acts filed in the U.S. District Court for the District of Massachusetts, where it is currently pending. Biomet, LVB Acquisition, Inc. and several of our competitors in the non-invasive bone growth stimulation market were named as defendants in this action. The allegations in the complaint are similar in nature to certain categories of requested documents in the above-referenced administrative subpoenas. The U.S. government has not intervened in the action. We are vigorously defending this matter and intend to continue to do so. We may need to devote significant time and resources to this inquiry and can give no assurances as to its final outcome.

On September 25, 2007, we received a letter from the SEC informing us that it was conducting an informal investigation regarding possible violations of the Foreign Corrupt Practices Act, or FCPA, in the marketing and sale of medical devices in certain foreign countries by companies in the medical devices industry. The FCPA prohibits domestic concerns, including U.S. companies and their officers, directors, employees, shareholders acting on their behalf and agents, from offering, promising, authorizing or making payments to

 

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foreign officials for the purpose of obtaining or retaining business abroad or otherwise obtaining an improper advantage. This law also requires issuers of publicly registered securities to maintain records which fairly and accurately reflect transactions and to maintain an adequate system of internal controls. In many countries, hospitals and clinics are government-owned and, therefore, healthcare professionals employed by such hospitals and clinics, with whom we regularly interact, may meet the definition of a foreign official for purposes of the FCPA. On November 9, 2007, we received a letter from the DOJ requesting that any information provided to the SEC also be provided to the DOJ on a voluntary basis.

On March 26, 2012, Biomet resolved the DOJ’s and SEC’s investigations by entering into a Deferred Prosecution Agreement, or DPA, with the DOJ and a Consent to Final Judgment, or Consent, with the SEC. Pursuant to the DPA, the DOJ has agreed to defer prosecution of Biomet in connection with this matter, provided that Biomet satisfies its obligations under the agreement over the three-year term of the DPA. The DOJ has further agreed to not continue its prosecution and seek to dismiss its indictment should Biomet satisfy its obligations under the agreement over the three-year term of the DPA.

In addition, pursuant to the terms of the DPA, an independent external compliance monitor has been appointed to review Biomet’s compliance with the DPA, particularly in relation to Biomet’s international sales practices, for at least the first 18 months of the three-year term of the DPA. The monitor has divided his review into two phases. The first phase consisted of the monitor familiarizing himself with our global compliance program, assessing the effectiveness of the program and making recommendations for enhancement of our compliance program based on that review. The second phase commenced in June 2013 and consists of the monitor testing implementation of his recommended enhancements to our compliance program. The monitor recently identified that certain of our compliance enhancements have been implemented too recently to be satisfactorily tested, and we continue to work with the monitor to allow for such transactional testing. The Consent Biomet entered into with the SEC mirrors the DPA’s provisions with respect to the compliance monitor. Compliance with the DPA requires substantial cooperation of our employees, distributors and sales agents and the healthcare professionals with whom they interact. These efforts not only involve expense, but also require management and other key employees to focus extensively on these matters.

Biomet agreed to pay a monetary penalty of $17.3 million to resolve the charges brought by the DOJ. The terms of the DPA and the associated monetary penalty reflect Biomet’s full cooperation throughout the investigation. Biomet further agreed in its Consent to disgorge profits and pay prejudgment interest in the aggregate amount of $5.6 million.

From time to time, we are, and may continue to be, the subject of additional investigations. If, as a result of these investigations described above or any additional investigations, we are found to have violated one or more applicable laws, our business, financial condition, results of operations and cash flows could be materially adversely affected. If some of our existing business practices are challenged as unlawful, we may have to modify those practices, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

We could be subject to further governmental investigations or actions by other third parties as a result of our settlement with the DOJ and the OIG-HHS.

As a result of our settlement with the DOJ and SEC related to the FCPA investigation described above, we have been and may continue to be subject to further governmental investigations by foreign governments or other claims by third parties arising from the conduct subject to the investigation.

We intend to review and take appropriate actions with respect to any such investigations or proceedings; however, we cannot assure you that the costs of defending or fines imposed in resolving those civil or criminal investigations or proceedings would not have a material adverse effect on our financial condition, results of operations and cash flows.

 

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We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar anti-corruption laws

Our business operations and sales in countries outside the United States are subject to anti-corruption laws and regulations, including restrictions imposed by the FCPA and similar anti-corruption and anti-bribery laws in other jurisdictions. We operate and sell our products in many parts of the world that have experienced governmental corruption to some degree and, in certain circumstances, strict compliance with anti-corruption laws may conflict with local customs and practices. We train our employees concerning anti-corruption laws and issues and have internal controls and compliance policies and procedures in place for the maintenance of accurate books and records and that prohibit our employees or third-parties acting on our behalf from making improper payments.

From time to time we become aware of allegations of potential improper payments made by our employees or agents. When this happens, we investigate the allegations and, if necessary, remediate the issue and disclose the matter to the appropriate regulators. We cannot provide assurance that our internal controls and procedures will always protect us from reckless or criminal acts committed by our employees or third-parties with whom we work. If we are found to be liable for violations of the FCPA or similar anti-corruption laws in international jurisdictions, either due to our own acts or out of inadvertence, or due to the acts or inadvertence of others, we could suffer criminal or civil penalties which could have a material and adverse effect on our results of operations, financial condition and cash flows.

Our business may be harmed as a result of product liability litigation.

Our involvement in the design, manufacture and sale of medical devices creates exposure to risks of product liability claims alleging that component failures, manufacturing flaws, design defects or inadequate disclosure of product-related risks or product-related information resulted in an unsafe condition or injury to patients, particularly in the United States. In the past, we have received product liability claims relating to our products and anticipate that we will continue to receive claims in the future, some of which could have a material adverse impact on our business. These claims are subject to many uncertainties and outcomes are not predictable. We may incur significant legal expenses regardless of whether we are found to be liable. In addition, we could experience a material design or manufacturing failure in our products, a quality system failure, other safety issues or heightened regulatory scrutiny that would warrant a recall of some of our products. Our existing product liability insurance coverage may be inadequate to satisfy liabilities we might incur. Moreover, even if any product liability loss is covered by an insurance policy, these policies have substantial self-insured retentions or deductibles that we remain responsible for. Any product liability claim brought against us, with or without merit, can be costly to defend and may negatively impact our ability to obtain third-party insurance coverage in future periods on a cost effective basis or at all.

As of March 3, 2014, we are a defendant in 1,319 product liability lawsuits relating to metal-on-metal hip implants, most of which were filed in 2013. The majority of these cases involve the M2a-Magnum hip system, 284 cases involve the M2a-38 hip system, 45 involve the M2a-Taper system, and six involve the M2a-Ringloc system. The cases are currently venued in various state and federal courts. The cases in federal court have been consolidated in one multi-district proceeding in the U.S. District Court for the Northern District of Indiana.

On February 3, 2014, we announced the settlement of the Multi-District Litigation entitled MDL 2,391 – In Re: Biomet M2A Magnum Hip Implant Product Liability Litigation. As of March 3, 2014, there were 1,231 lawsuits pending in the MDL. Additional lawsuits filed in the MDL by April 15, 2014 may participate in the settlement. We continue to evaluate the inventory of lawsuits in the MDL pursuant to the categories and procedures set forth in the settlement agreement. The final amount of payments under the settlement is uncertain. However, we believe that the payments under the settlement will exhaust our self-insured retention under our insurance program, which is $50.0 million. If this should occur, we would submit an insurance claim for the amount by which ultimate losses under the settlement exceed the self-insured retention amount.

 

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We maintain $100.0 million of third-party insurance coverage. Our insurance carriers have been placed on notice of the claims associated with metal-on-metal hip products that are subject to the settlement and have been placed on notice of the terms of the settlement. As is customary in these situations, certain of our insurance carriers have reserved all rights under their respective policies and could still ultimately deny coverage for some or all of our insurance claims. We continue to believe our contracts with the insurance carriers are enforceable for these claims and the settlement agreement. However, we would be responsible for any amounts that our insurance carriers do not cover or for the amount by which ultimate losses exceed the amount of our third-party insurance coverage. The settlement does not affect certain other claims relating to our metal-on-metal hip products that are pending in various state courts or other claims may be filed in the future.

Our $50.0 million accrual for contingencies associated with metal-on-metal hip products is unchanged since November 30, 2013. We are currently assessing any necessary adjustments to the current accrual amount to cover the estimated full amount of the settlement, and assessing any potential receivables to be recorded for recoveries from the insurance carriers.

On August 27, 2013, we initiated a voluntary recall of 87,601 units of OSSEOTITE®, NanoTite and T3® dental implants, of which 34,744 units have been distributed. We have notified regulatory bodies of this recall, which was taken due to discoloration of some implants that did not meet our internal standard for visual inspection. The discoloration was caused by the affected implants coming into contact with residual machining fluid that may have been left on the metal packaging insert for the products. We have determined that there are no known health effects of the residue. The ultimate financial impact with respect to this matter will depend on many factors that are difficult to predict with the limited information received to date and may vary materially based on the number of and actual costs of patients seeking testing and treatment services and the number of and actual costs to settle any lawsuits filed against us.

Product liability lawsuits and claims, safety alerts or product recalls, regardless of their ultimate outcome, could have a material adverse effect on our business and reputation and on our ability to attract and retain customers. If a product liability claim or series of claims is brought against us for uninsured liabilities or is in excess of our insurance coverage limits, our business could suffer and our financial condition, results of operations and cash flow could be materially adversely impacted. Further, such product liability matters may negatively impact our ability to obtain insurance coverage or cost-effective insurance coverage in future periods.

We may be subject to intellectual property litigation and infringement claims, which could cause us to incur significant expenses or prevent us from selling our products.

The musculoskeletal products industry is highly litigious with respect to the enforcement of patents and other intellectual property rights. In some cases, intellectual property litigation may be used to gain a competitive advantage. We have in the past and may in the future become a party to lawsuits involving patents or other intellectual property. A successful claim of patent or other intellectual property infringement against us could adversely affect our growth and results of operations, in some cases materially. A legal proceeding, regardless of the outcome, could put pressure on our financial resources and divert the time, energy and efforts of our management.

From time to time, we receive notices from third parties of potential intellectual property infringement and receive claims alleging intellectual property infringement. We may be unaware of intellectual property rights of others that may cover some of our technology. If someone claims that our products infringed their intellectual property rights, any resulting litigation could be costly and time consuming and would divert the attention of management and key personnel from other business issues.

The complexity of the technology involved and the uncertainty of intellectual property litigation increase these risks. Claims of intellectual property infringement also might require us to enter into costly royalty or license agreements. However, we may be unable to obtain royalty or license agreements on terms acceptable

 

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to us or at all. We also may be subject to significant damages or an injunction preventing us from manufacturing, selling or using some of our products in the event of a successful claim of patent or other intellectual property infringement. Any of these adverse consequences could have a material adverse effect on our business, financial condition, results of operations and cash flows.

In January 2009, Heraeus Kulzer GmbH, or Heraeus, initiated legal proceedings in Germany against Biomet, Biomet Europe BV and certain other subsidiaries, alleging that we and Biomet Europe BV misappropriated Heraeus Kulzer trade secrets when developing our new lines of European bone cements. The lawsuit seeks injunctive relief to preclude us from producing and marketing our current line of European bone cements and a judgment requiring that we compensate Heraeus for any damages incurred (which they allege to be in excess of €30.0 million). On December 20, 2012, the trial court ruled that Biomet did not misappropriate trade secrets and consequently dismissed Biomet, Inc., Biomet Europe BV, Biomet Deutschland GmbH and other defendants from the lawsuit. Biomet Orthopaedics Switzerland GmbH or Biomet Switzerland, remains as the only defendant in the lawsuit and as to it the trial court has ruled that Heraeus Kulzer will not be permitted to review certification materials of Biomet Switzerland for purposes of determining whether there is any evidence that would support a claim of trade secret misappropriation by that entity. The trial court’s decision remains subject to appeal by Heraeus Kulzer and we are continuing to vigorously defend this matter. We can make no assurance as to the final outcome of this matter.

On May 3, 2013, Bonutti Skeletal Innovations LLC, a company formed to hold certain patents acquired from Dr. Peter M. Bonutti and an affiliate of patent licensing firm Acacia Research Group LLC, filed suit against us in the U.S. District Court for the Eastern District of Texas, alleging a failure to pay royalties due under a license agreement with Dr. Bonutti, misuse of confidential information and infringement of U.S. Patent Nos. 5,921,986; 6,099,531; 6,423,063; 6,638,279; 6,702,821; 7,070,557; 7,087,073; 7,104,996; 7,708,740; 7,806,896; 7,806,897; 7,828,852; 7,931,690; 8,133,229; and 8,147,514. The lawsuit seeks damages in an amount yet to be determined and injunctive relief. Prior to the filing of this lawsuit, on March 8, 2013 we had filed a complaint for declaratory judgment with the U.S. District Court for the Northern District of Indiana seeking a judgment of non-infringement and invalidity of the patents at issue. We are vigorously defending this matter and believe that our defenses against infringement and patent validity are valid and meritorious. We can make no assurances as to the time or resources that will be needed to devote to this litigation or its final outcome.

We are involved in legal proceedings that may result in adverse outcomes.

In addition to intellectual property and product liability claims and lawsuits, we are involved in various commercial litigation and claims and other legal proceedings that arise from time to time in the ordinary course of our business. Although we believe we have substantial defenses in these matters, litigation and other claims are subject to inherent uncertainties and management’s view of these matters may change in the future. Given the uncertain nature of legal proceedings generally, we are not able in all cases to estimate the amount or range of loss that could result from an unfavorable outcome. We could in the future incur judgments or enter into settlements of claims that could have a material adverse effect on our results of operations in any particular period.

The current global economic uncertainties may adversely affect our results of operations.

Our results of operations could be substantially affected not only by global economic conditions, but also by local operating and economic conditions, which can vary substantially by market. Although the U.S. economy continues to recover from the worst recession in decades, unemployment and consumer confidence have not rebounded as quickly as in some prior recessions, resulting in reduced numbers of insured patients and the deferral of elective reconstructive procedures. Global economic conditions remain uncertain. We believe that European austerity measures implemented to address the ongoing financial crisis contributed to decreased healthcare utilization and increased pricing pressure for some of our products. We cannot assure you that challenges in the global economy will not continue to negatively impact procedure volumes, average selling

 

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prices and reimbursement rates from third-party payors, any of which could adversely affect our results of operations. In addition, we have experienced delays in the collection of receivables from hospitals in certain countries that have national healthcare systems, including certain regions in Spain, Italy, Greece and Portugal, which are the countries most directly affected by economic difficulties in the euro zone. Repayment of these receivables is dependent upon the financial stability of the economies of those countries. Continuing high unemployment in the U.S., a worsening of the European financial crisis or a failure to receive payment of all or a significant portion of our European receivables could adversely affect our results of operations.

Unfavorable conditions can depress sales in a given market and may result in actions that adversely affect our margins, constrain our operating flexibility or result in charges which are unusual or non-recurring. Certain macroeconomic events, such as the continuing adverse conditions in the global economy, the recent recessions in Europe and the euro zone crisis could have a more wide-ranging and prolonged impact on the general business environment, which could also adversely affect us. These economic developments could affect us in numerous ways, many of which we cannot predict. Among the potential effects could be an increase in our variable interest rates, an inability to access credit markets should we require external financing, a reduction in the purchasing power of our European Union customers due to a deterioration of the value of the euro, and inventory issues due to financial difficulties experienced by our suppliers and customers, including distributors, delays in collection, greater bad debt expense and further impairments of our goodwill and other intangible assets. In addition, it is possible that further deteriorating economic conditions, and resulting federal budgetary concerns, could prompt the federal government to make significant changes in the Medicare program, which could adversely affect our results of operations. We are unable to predict the likely duration and severity of the current disruption in financial markets and adverse economic conditions, or the effects these disruptions and conditions could have on us.

We are subject to cost-containment efforts of group purchasing organizations, which may have a material adverse effect on our financial condition, results of operations and cash flows.

Many customers of our products have joined or developed group purchasing organizations in an effort to contain costs. Group purchasing organizations negotiate pricing arrangements with medical supply manufacturers and distributors, and these negotiated prices are made available to a group purchasing organization’s affiliated hospitals and other members. If we are not one of the providers selected by a group purchasing organization, affiliated hospitals and other members may be less likely to purchase our products, and if the group purchasing organization has negotiated a strict compliance contract for another manufacturer’s products, we may be precluded from making sales to members of the group purchasing organization for the duration of the contractual arrangement. Our failure to respond to the cost-containment efforts of group purchasing organizations may cause us to lose market share to our competitors and could have a material adverse effect on our sales, financial condition, results of operations and cash flows.

We conduct a significant amount of our sales activity outside of the United States, which subjects us to additional business risks and may adversely affect our results due to increased costs.

During the fiscal year ended May 31, 2013, we derived approximately 39% of our net sales from sales of our products outside of the United States, including in emerging markets. We intend to continue to pursue growth opportunities in sales internationally, which could expose us to additional risks associated with international sales and operations. Our international operations are, and will continue to be, subject to a number of risks and potential costs, including:

 

    changes in foreign medical reimbursement policies and programs;

 

    unexpected changes in foreign regulatory requirements;

 

    differing local product preferences and product requirements;

 

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    diminished protection of intellectual property in some countries outside the United States;

 

    differing payment cycles;

 

    trade protection measures, import or export licensing requirements and compliance with economic sanctions laws and regulations that may prevent us from shipping our products to a particular market and may increase our operating costs;

 

    foreign exchange controls that might prevent us from repatriating cash earned in countries outside the United States;

 

    complex data privacy requirements and labor relations laws;

 

    labor relations, including relations with Workers’ Councils;

 

    the application of U.S., U.K. and other foreign country regulatory and anti-corruption laws to our international operations;

 

    difficulty in staffing, training and managing foreign operations;

 

    differing legal regulations and labor relations;

 

    potentially negative consequences from changes in tax laws (including potential taxes payable on earnings of foreign subsidiaries upon repatriation); and

 

    political and economic instability.

In addition, we are subject to risks arising from currency exchange rate fluctuations, which could increase our costs, expose us to counterparty risks and may adversely affect our results. Cross border transactions, both with external parties and intercompany relationships, result in increased exposure to foreign exchange effects. In addition, our sales are translated into U.S. dollars for reporting purposes. The U.S. dollar value of our foreign-generated revenues varies with currency exchange rate fluctuations. Significant increases in the value of the U.S. dollar relative to foreign currencies could have a material adverse effect on our results of operations.

Any of these factors may, individually or collectively, have a material adverse effect on our business, financial condition, results of operations and cash flows. In addition, violations of foreign laws or regulations could result in fines, criminal sanctions against us, our officers or our employees, prohibitions on the conduct of our business and damage to our reputation.

We may have additional tax liabilities.

We are subject to income taxes in the United States and many foreign jurisdictions. In the ordinary course of our business, there are many transactions and calculations where the ultimate tax determination is uncertain, and we regularly are under audit by tax authorities. Although we believe our tax estimates are reasonable, the final determination of tax audits could be different from our historical income tax provisions and accruals. In addition, there have been proposals to change U.S. tax laws that would significantly impact how U.S. multinational corporations are taxed on foreign earnings. Although we cannot predict whether or in what form this proposed legislation will pass, if enacted it could have a material adverse impact on our tax expense and cash flow.

 

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Our global manufacturing operations, distribution warehouses, and sales offices are exposed to political and economic risks, commercial volatility, and events beyond our control in the countries in which we operate.

In addition to our principal executive offices, we maintain more than 50 other manufacturing facilities, offices and warehouse facilities in various countries and regions, including Canada, Europe, Asia Pacific and Latin America.

We currently conduct manufacturing operations in Jinhua, Zhejiang Province, China and Changzhou, Jiangsu Province, China. Our future business strategy may involve the operation of other manufacturing facilities in China. As a result of this initiative, we are exposed to all the risks inherent in operating in an emerging market like China. In recent years the Chinese economy has undergone various developments, including beginning the transition from a more heavily government influenced-planned economy to a more market-oriented economy. Despite this transition, the Chinese government continues to own significant production assets and exercises significant control over economic growth.

Our international operations, including any planned future expansion in China, may be subject to greater or new political, legal and economic risks than those faced by our operations in the United States, including such risks as those arising from:

 

    unexpected changes in foreign or domestic legal, regulatory or governmental requirements or approvals, such as those related to taxation, lending, import and tariffs, environmental regulations, land use rights, intellectual property and other matters;

 

    unexpected increases in taxes, tariffs and other assessments;

 

    diminished protection of intellectual property;

 

    trade protection measures and import or export licensing requirements;

 

    difficulty in staffing, training and managing foreign operations;

 

    differing legal and labor regulations;

 

    political and economic instability; and

 

    operating in a market with a less developed supply chain, transportation and distribution infrastructure.

Due to these inherent risks, there can be no assurance that we will achieve anticipated benefits from global operations because any of these factors may, individually or collectively, have a material adverse effect on our business, financial condition, results of operations and cash flows.

Our business relies on obtaining certain “conflict minerals.”

Certain provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act currently or in the future will require us to report on certain minerals and their derivatives, namely tin, tantalum, tungsten or gold, known as “conflict minerals,” used in our products and the due diligence plan we put in place to track whether such minerals originate from the Democratic Republic of Congo, or DRC, and adjoining countries. The implementation of these requirements could affect the sourcing, pricing and availability of minerals used in certain of our products. In addition, we may incur additional costs to comply with the disclosure requirements, including costs related to determining the source of any of the relevant minerals used in our products. Since our

 

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supply chain is complex, the procedures that we implement may not enable us to ascertain the origins for these minerals or determine that these minerals are DRC conflict free, which may harm our reputation. These new requirements also could have the effect of limiting the pool of suppliers from which we source these minerals. We may be unable to obtain conflict-free minerals at competitive prices, which could increase our costs and adversely affect our manufacturing operations and our profitability.

Inventory may become obsolete due to shortened product life cycles, reduced product demand or changes in market conditions, resulting in inventory write-downs that may adversely affect our results of operations, possibly materially.

In our industry, inventory is routinely placed at hospitals to provide the healthcare provider with the appropriate product when needed. Because product usage tends to follow a bell curve of sizes, larger and smaller sizes of inventory are provided, but infrequently used. In addition, the musculoskeletal market is highly competitive, with new products, raw materials and procedures being introduced continually, which may make those products currently on the market obsolete. We make estimates regarding the future use of these products and provide a provision for excess and obsolete inventory. If actual product life cycles, product demand or market conditions are less favorable than those projected by management, additional inventory write-downs may be required, which would adversely affect our business, financial condition, results of operations and cash flows.

We may not be able to protect our intellectual property rights, which could materially affect our business.

We rely on a variety of intellectual property rights (including patents, trademarks, copyrights and trade secrets) to protect our proprietary technology and products. These legal means, however, afford only limited protection and may not adequately protect our rights. The laws of some of the countries in which our products are or may be sold may not protect our intellectual property rights to the same extent as U.S. laws or at all or effective enforcement of such intellectual property rights may not be available. Our ability to obtain, protect and enforce our intellectual property rights is subject to general litigation or third-party opposition risks, as well as the uncertainty as to the registrability, patentability, validity and enforceability of our intellectual property rights in each applicable country.

The patents we own may not be of sufficient scope or strength to provide us with significant commercial protection or commercial advantage, and competitors may be able to design around our patents or develop products that provide outcomes that are similar to ours without infringing on our intellectual property rights. In addition, we cannot be certain that any of our pending patent applications will be issued or that the scope of the claims in our pending patent applications will not be significantly narrowed or determined to be invalid. In addition, each patent has a specific non-renewable term, which would allow a third party to make a product covered by an expired patent.

We rely on our trademarks to distinguish our products from the products of our competitors, and have registered or applied to register a number of these trademarks. However, our trademark applications may not be approved. Third parties may also oppose our trademark applications or otherwise challenge our use of the trademarks. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, which could result in loss of brand recognition and could require us to devote resources to advertising and marketing these new brands.

We seek to protect our trade secrets and know-how in part with confidentiality agreements with our vendors, employees, consultants and others who may have access to proprietary information. We cannot be certain, however, that these agreements will not be breached, adequate remedies for any breach would be available or our trade secrets and know-how will not otherwise become known to or be independently developed by our competitors.

If a competitor infringes our patents, trademarks or other intellectual property rights, enforcing those patents, trademarks and other rights may be difficult and time consuming. Even if successful, litigation to defend

 

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our patents and trademarks against challenges or to enforce our intellectual property rights could be expensive and time consuming and could divert management’s attention from managing our business. Moreover, we may not have sufficient resources or desire to defend our intellectual property rights against challenges or to enforce our intellectual property rights.

We rely on licenses from third parties to certain technology and intellectual property rights for some of our products and the licenses we currently have could terminate or expire.

We license from third parties intellectual property used in some of our products or services. Our licensors may breach or otherwise fail to perform their obligations. Furthermore, our licenses may expire or our licensors may claim that we have breached our agreement or may otherwise attempt to terminate their license agreements with us. Challenges to such third parties’ intellectual property rights may be brought against us directly or against the licensor, and we cannot guarantee that such third-party intellectual property rights provide us with meaningful protection. The expiration of intellectual property we license may further enable third parties to offer products that are competitive with ours. Further, we cannot guarantee that renewals of current licenses upon their expiration or that future third party intellectual property rights that we may need or that may be useful will be available to us for license or, even if they are, that the terms of such licenses will be financially and commercially viable.

The conditions of the U.S. and international capital markets may adversely affect our ability to access the credit or capital markets.

We believe that our cash, other liquid assets and operating cash flow, together with available borrowings and potential access to credit and capital markets, will be sufficient to meet our operating expenses, research and development costs and capital expenditures and service our debt requirements as they become due. However, our ongoing ability to meet our substantial debt service and other obligations will be dependent upon our future performance, which will be subject to business, financial and other factors. We will not be able to control many of these factors, such as economic conditions in the markets where we operate and pressure from competitors. We cannot be certain that our cash flow will be sufficient to allow us to pay principal and interest on our debt, support our operations and meet our other obligations. If we do not have enough money to support our operations and meet our obligations, we may be required to refinance all or part of our existing debt, sell assets or borrow more money. We may not be able to do so on terms acceptable to us, if at all. In addition, the terms of existing or future debt agreements may restrict us from pursuing any of these alternatives.

We rely on financial institutions to fund credit commitments to us.

If financial institutions that have extended credit commitments to us are adversely affected by the conditions of the U.S. and international capital markets, they may become unable to fund borrowings under their credit commitments to us, which could have a material adverse impact on our financial condition and our ability to borrow additional funds, if needed, for working capital, capital expenditures, acquisitions, research and development and other corporate purposes.

Loss of our key management and other personnel, or an inability to attract such management and other personnel, could impact our business.

We depend on our senior managers and other key personnel to run our business and on technical experts to develop new products and technologies. The loss of any of these senior managers or other key personnel could adversely affect our operations. Competition for qualified employees is intense, and the loss of qualified employees or an inability to attract, retain and motivate additional highly skilled employees required for the management, operation and expansion of our business could hinder our ability to expand, conduct research and development activities successfully and develop marketable products.

 

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If we fail to retain our existing relationships with our independent sales agents and distributors or establish relationships with different agents and distributors, our results of operations may be negatively impacted.

Our revenues and profitability depend largely on the ability of independent sales agents and distributors to sell our products to customers. Because the independent distributor manages the customer relationships within its territory (and, in certain countries outside the United States, the regulatory relationship), there is a risk that if our relationship with the distributor ends, our relationship with the customer will be lost. In addition, in certain countries outside the United States, we could experience delays in amending or transferring our product registrations. Also, because we do not control a distributor’s sales agents, there is a risk we will be unable to ensure that our sales processes and priorities will be consistently communicated and executed by the distributor. Typically, these agents and distributors have developed long-standing relationships with our customers and provide our customers with the necessary training and product support relating to our products. If we fail to retain our existing relationships with these agents and distributors or establish relationships with different agents and distributors, our business, financial condition, results of operations and cash flows may be negatively impacted.

We may record future goodwill and/or intangible impairment charges related to one or more of our reporting units, which could materially adversely impact our results of operations.

We test our goodwill and indefinite lived intangible asset balances as of March 31 of each fiscal year to determine whether events or changes in circumstances indicate that the carrying value of our intangible assets may not be recoverable. We test these balances more frequently if indicators are present or changes in circumstances suggest that impairment may exist. In evaluating the potential for impairment we make assumptions regarding revenue projections, growth rates, cash flows, tax rates and discount rates. These assumptions are uncertain and by nature can vary from actual results. Various future events could have a negative impact on the fair value of our reporting units’ goodwill and indefinite lived intangibles when the annual or interim impairment test is completed. The events include, but are not limited to:

 

    our ability to sustain sales and earnings growth;

 

    the effect of anticipated changes in the size, health and activities of the population or on the demand for our products;

 

    our ability and intent to expand in key international markets;

 

    the timing and anticipated outcome of clinical studies;

 

    assumptions concerning anticipated product developments and emerging technologies;

 

    our continued investment in new products and technologies;

 

    the ultimate marketability of products currently being developed;

 

    our success in achieving timely approval or clearance of our products with domestic and foreign regulatory entities; and

 

    the stability of certain foreign economic markets.

If the operating performance at one or more of our business units falls significantly below current levels, if competing or alternative technologies emerge, or if market conditions or future cash flow estimates for one or more of our businesses decline, we could be required, under current U.S. accounting rules, to record a non-cash charge to operating earnings for the amount of the impairment. Any write-off of a material portion of our unamortized intangible assets would negatively affect our results of operations.

 

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In fiscal year 2013, we recorded a $240.0 million goodwill asset impairment charge related to our Europe reporting unit, primarily related to the impact of continued austerity measures on procedural volumes and pricing in certain European countries when compared to our prior projections used to establish the fair value of goodwill.

In fiscal year 2013, we recorded a $327.4 million goodwill and definite and indefinite-lived intangible assets impairment charge related to our dental reconstructive reporting unit, primarily due to declining industry market growth rates in certain European and Asia Pacific markets and corresponding unfavorable margin trends when compared to our prior projections used to establish the fair value of goodwill and intangible assets.

We have $66 million of goodwill at our dental reconstructive reporting unit that is at a higher risk of impairment as the difference between the carrying value and fair value of the reporting unit was estimated to be approximately 10% as of November 30, 2013. We use the discounted cash flow model to value the reporting unit. The critical assumptions in the discounted cash flow model are revenues, operating margins and discount rate assumptions. These assumptions are developed by reporting unit management based on industry projections for the countries in which the reporting unit operates, as well as reporting unit specific facts. If the reporting unit were to experience sales declines in the U.S. market or be exposed to enhanced and sustained pricing and volume pressures in our international markets, there would be an increased risk of impairment of goodwill for the dental reporting unit.

A natural or man-made disaster could have a material adverse effect on our business.

We have manufacturing operations located throughout the world. However, a significant portion of our products are produced at and shipped from our facility in Warsaw, Indiana, including all of our production of E1® polyethylene components. In the event that this facility is severely damaged or destroyed as a result of a natural or man-made disaster, we would be forced to shift production to our other facilities and/or rely on third-party manufacturers and may result in our having to cease production of certain products, such as E1® polyethylene components, for a significant period of time. Our existing business interruption insurance coverage may be inadequate to satisfy liabilities we might incur in such a situation. If a business interruption claim or series of claims is in excess of our insurance coverage limits, or is not otherwise covered in whole or in part by our insurance coverage, our business could suffer and our financial condition, results of operations and cash flow could be materially adversely impacted.

Failure to successfully integrate acquired businesses into our operations or to otherwise successfully execute strategic transactions could adversely affect our business.

We may, from time to time, consider and take advantage of selected opportunities to grow by acquiring businesses whose operations or product lines fit well within our existing businesses or whose geographic location or market position would enable us to expand into new markets, as well as companies with whom we could form strategic alliances or enter into arrangements with to develop or exploit intellectual property rights. Our ability to implement this expansion strategy will, however, depend on whether any suitable businesses are available at suitable valuations and how much money we can spend. Any acquisition that we make could be subject to a number of risks, including failing to discover liabilities of the acquired company for which we may be responsible as a successor owner or operator despite any investigation we may make before the acquisition, our overvaluing the assets of the acquired company, our inability to assimilate the operations and personnel of the acquired company, the loss of key personnel in the acquired company and any adverse impact on our financial statements from the amortization of acquired intangible assets or the creation of reserves or write-downs. These risks could be increased if we need to integrate geographically separated organizations, personnel with disparate business backgrounds and companies with different corporate cultures. Any such acquisition and resulting integration process may result in the need to allocate more resources to integration and product development activities than originally anticipated, the diversion of management’s time (which could adversely affect management’s ability to focus on other more profitable projects), the inability to realize the expected benefits,

 

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savings or synergies from the acquisition or the incompatibility of the priorities of any strategic partners with ours. We may not be able to adequately meet these challenges, and any failure to do so could adversely affect our business, financial condition, results of operations and cash flows. In addition, if we incur additional indebtedness to finance these acquisitions, the related risks we face from our already substantial level of indebtedness could intensify.

On June 15, 2012, we announced the initial closing of the previously announced $280.0 million acquisition of the worldwide trauma business of DePuy Orthopaedics, Inc. During the first and second quarters of fiscal year 2013, subsequent closings in various foreign countries occurred on a staggered basis, with the final closing occurring on December 7, 2012. On October 5, 2013, we and our wholly-owned subsidiaries EBI Holdings, LLC, a Delaware limited liability company, or EBI, and LNX Acquisition, Inc., a Delaware corporation, or Merger Sub, entered into an Agreement and Plan of Merger with Lanx, Inc., a Delaware corporation, or Lanx. On October 31, 2013, Merger Sub merged with and into Lanx and the separate corporate existence of Merger Sub ceased. Our integration of the operations of the acquired businesses requires significant efforts, including the coordination of complex information technology environments, research and development, sales and marketing, operations, manufacturing and finance.

The integration efforts related to the acquisitions described above require significant resources and involve significant amounts of management’s time that cannot be dedicated to other initiatives. We may not be able to adequately meet these challenges, and any failure to do so could adversely affect our business, financial condition, results of operations and cash flows.

We are increasingly dependent on sophisticated information technology and if we fail to properly maintain the integrity of our data, our business could be adversely affected.

We are increasingly dependent on sophisticated information technology systems for our products and infrastructure. These systems include, but are not limited to, ordering and managing materials from suppliers, converting materials to finished products, shipping products to customers, processing transactions, summarizing and reporting results of operations, complying with regulatory, legal or tax requirements, providing data security and other processes necessary to manage our business. As a result of technology upgrades, recently enacted regulations, improvements in our system platforms and integration of new business acquisitions, we have been consolidating and integrating the number of systems we operate and have upgraded and expanded our information systems capabilities. Our information systems require an ongoing commitment of significant resources to maintain, protect, and enhance existing systems and keep information technology systems current. In addition, our obligations to protect patient and customer information have increased significantly. Third parties may attempt to hack into our products or systems and may obtain data relating to patients with our products or our proprietary information. If we fail to maintain or protect our information systems and data integrity effectively, we could lose existing customers, have difficulty preventing, detecting, and controlling fraud, have disputes with customers, physicians, and other health care professionals, have regulatory sanctions or penalties imposed, incur expenses or lose revenues as a result of a data privacy breach, or suffer other adverse consequences. While we have invested in the protection of data and information technology, there can be no assurance that our process of consolidating the number of systems we operate, upgrading and expanding our information systems capabilities, protecting and enhancing our systems and developing new systems keep pace with continuing changes in information processing technology, will be successful or that additional systems issues will not arise in the future. Any significant breakdown, intrusion, interruption, corruption or destruction of these systems could have a material adverse effect on our business.

We could incur significant costs complying with environmental and health and safety requirements, or as a result of liability for contamination or other harm caused by hazardous materials that we use.

Our research and development and manufacturing processes involve the use of hazardous materials. We are subject to federal, state, local and foreign environmental requirements, including regulations governing the

 

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use, manufacture, handling, storage and disposal of hazardous materials, discharge to air and water, the cleanup of contamination and occupational health and safety matters. We cannot eliminate the risk of contamination or injury resulting from hazardous materials, and we may incur liability as a result of any contamination or injury. Under some environmental laws and regulations, we could also be held responsible for costs relating to any contamination at our past or present facilities and at third party waste disposal sites where we have sent wastes. These could include costs relating to contamination that did not result from any violation of law, and in some circumstances, contamination that we did not cause. We may incur significant expenses in the future relating to any failure to comply with environmental laws. Any such future expenses or liability could have a significant negative impact on our financial condition. The enactment of stricter laws or regulations, the stricter interpretation of existing laws and regulations or the requirement to undertake the investigation or remediation of currently unknown environmental contamination at our own or third party sites may require us to make additional expenditures, which could be material.

Our substantial level of indebtedness could materially adversely affect our ability to generate sufficient cash to fulfill our obligations under our credit facilities, the notes and any other outstanding indebtedness, our ability to react to changes in our business and our ability to incur additional indebtedness to fund future needs.

We are highly leveraged. As of November 30, 2013 we had total indebtedness of $5,896.8 million (compared to total indebtedness of $5,966.4 million as of May 31, 2013). For more information regarding our existing indebtedness, see “Description of Certain Indebtedness.”

Our substantial level of indebtedness increases the possibility that we may be unable to generate cash sufficient to pay, when due, the principal of, interest on or other amounts due in respect of our indebtedness. Our substantial indebtedness, combined with our other financial obligations and contractual commitments, could have important consequences. For example, it could:

 

    make it more difficult for us to satisfy our obligations with respect to our indebtedness and any failure to comply with the obligations under any of our debt instruments, including restrictive covenants, could result in an event of default under such instruments;

 

    require us to dedicate a substantial portion of our cash flow from operations to payments on our indebtedness, thereby reducing funds available for working capital, capital expenditures, acquisitions, research and development and other purposes;

 

    increase our vulnerability to adverse economic and industry conditions, which could place us at a competitive disadvantage compared to our competitors that have relatively less indebtedness;

 

    increase the risk we assess with our counterparties which could affect the fair value of our derivative instruments related to our debt facilities noted above;

 

    place us at a competitive disadvantage compared to our competitors that are less highly leveraged and therefore able to take advantage of opportunities that our indebtedness prevents us from exploiting;

 

    limit our flexibility in planning for, or reacting to, changes in our business and the industries in which we operate; and

 

    limit our ability to borrow additional funds, or to dispose of assets to raise funds, if needed, for working capital, capital expenditures, acquisitions, research and development, debt service requirements, execution of our business strategy and other corporate purposes.

 

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Restrictions imposed by our indentures, our senior secured credit facilities and our other outstanding indebtedness may limit our ability to operate our business and to finance our future operations or capital needs or to engage in other business activities.

The agreements governing our indebtedness contain various covenants that limit our discretion in the operation of our business and also require us to meet financial maintenance tests and other covenants. The failure to comply with such tests and covenants could have a material adverse effect on us. The agreements governing our indebtedness restrict our and our restricted subsidiaries’ ability, among other things, to:

 

    incur additional indebtedness;

 

    pay dividends on our capital stock or redeem, repurchase or retire our capital stock or indebtedness;

 

    make investments, loans, advances and acquisitions;

 

    create restrictions on the payment of dividends or other amounts to us from our restricted subsidiaries;

 

    engage in transactions with our affiliates;

 

    sell assets, including capital stock of our subsidiaries;

 

    consolidate or merge;

 

    create liens; and

 

    enter into sale and lease-back transactions.

The terms of our senior secured credit facilities also restrict us from conducting any business or operations other than, among others, (i) owning Biomet, (ii) maintaining our legal existence, (iii) performing our obligations with respect to the senior secured credit facilities and the indentures governing the notes, (iv) publicly offering common stock of LVB Acquisition, Inc., (v) financing activities, including the issuance of securities, incurrence of debt, payment of dividends, making contributions to the capital of its subsidiaries and guaranteeing the obligations of its subsidiaries, or (vi) providing indemnification to our officers and directors.

In addition, if borrowing availability under our senior secured revolving credit facilities is less than 10% of the sum of aggregate commitments under our asset-based revolving credit facility and the revolving credit commitments under our cash flow credit facilities at any time, we are required to maintain a fixed charge coverage ratio as of the end of the most recently ended fiscal quarter that must be greater than or equal to 1.00 to 1.00. In the event of a default under any of our senior secured credit facilities, the lenders could elect to declare all amounts outstanding under the agreements governing our senior secured credit facilities to be immediately due and payable. If the indebtedness under our senior secured credit facilities, or our notes were to be accelerated, our assets may not be sufficient to repay such indebtedness in full.

We may not be able to generate sufficient cash to service all of our indebtedness and may be forced to take other actions to satisfy our obligations under our indebtedness, which may not be successful.

Our ability to make scheduled payments on or to refinance our debt obligations depends on our financial condition and operating performance, which is subject to prevailing economic and competitive conditions and to certain financial, business and other factors beyond our control. We may not be able to maintain a level of cash flows from operating activities sufficient to permit us to pay the principal, premium, if any, and interest on our indebtedness.

 

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If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay investments and capital expenditures or to sell assets, seek additional capital or restructure or refinance our indebtedness. Our ability to restructure or refinance our debt will depend on the condition of the capital markets and our financial condition at such time. Any refinancing of our debt could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. The terms of existing or future debt instruments, may restrict us from adopting some of these alternatives. In addition, any failure to make payments of interest and principal on our outstanding indebtedness on a timely basis would likely result in a reduction of our credit rating, which could limit our ability to incur additional indebtedness. In the absence of such operating results and resources, we could face substantial liquidity problems and might be required to dispose of material assets or operations to meet our debt service and other obligations. Our senior secured credit facilities and indentures restrict our ability to dispose of assets and use the proceeds from the disposition. We may not be able to consummate those dispositions or to obtain the proceeds that we could realize from them and these proceeds may not be adequate to meet any debt service obligations then due. These alternative measures may not be successful and may not permit us to meet our scheduled debt service obligations.

Risks related to Government Regulation of our Products

Our business, financial condition, results of operations and cash flows could be significantly and negatively affected by substantial government regulations.

Our products are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. Overall, there appears to be a trend toward more stringent regulation worldwide, and we do not anticipate this trend to dissipate in the near future.

In general, the development, testing, labeling, manufacturing and marketing of our products are subject to extensive regulation and review by numerous governmental authorities both in the United States and abroad. The regulatory process requires the expenditure of significant time, effort and expense to bring new products to market. We are also required to implement and maintain stringent reporting, labeling and record keeping procedures. More specifically, in the United States, both before and after a product is commercially released, we have ongoing responsibilities under FDA regulations. Compliance with the FDA’s requirements, including the Quality System regulation, recordkeeping regulations, labeling and promotional requirements and adverse event reporting regulations, is subject to continual review and is monitored rigorously through periodic inspections by the FDA, which may result in observations on Form 483, and in some cases warning letters, that require corrective action or other forms of enforcement.

In addition, the medical device industry also is subject to many complex laws and regulations governing Medicare and Medicaid reimbursement and targeting healthcare fraud and abuse, with these laws and regulations being subject to interpretation. In many instances, the industry does not have the benefit of significant regulatory or judicial interpretation of these laws and regulations. In certain public statements, governmental authorities have taken positions on issues for which little official interpretation was previously available. Some of these positions appear to be inconsistent with common practices within the industry but have not previously been challenged.

Various federal and state agencies have become increasingly vigilant in recent years in their investigation of various business practices. Governmental and regulatory actions against us can result in various actions that could adversely impact our operations, including:

 

    the recall or seizure of products;

 

    the suspension or revocation of the authority necessary for the production or sale of a product;

 

    the suspension of shipments from particular manufacturing facilities;

 

    the imposition of fines and penalties;

 

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    the delay of our ability to introduce new products into the market;

 

    the exclusion of our products from being reimbursed by federal and state healthcare programs (such as Medicare, Medicaid, Veterans Administration, or VA, health programs and Civilian Health and Medical Program Uniformed Service, or CHAMPUS; and

 

    other civil or criminal sanctions against us.

Any of these actions, in combination or alone, or even a public announcement that we are being investigated for possible violations of these laws, could have a material adverse effect on our business, financial condition, results of operations and cash flows.

In the United States, if the FDA were to conclude that we are not in compliance with applicable laws or regulations or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could ban such medical devices, detain or seize adulterated or misbranded medical devices, order a recall, repair, replacement, or refund of payment of such devices, refuse to grant pending premarket approval applications, refuse to provide certificates to foreign governments for exports, and/or require us to notify healthcare professionals and others that the devices present unreasonable risks of substantial harm to the public health. The FDA may also impose operating restrictions on a company-wide basis, enjoin and restrain certain violations of applicable law pertaining to medical devices and assess civil or criminal penalties against our officers, employees or us. The FDA may also recommend prosecution to the DOJ. Adverse regulatory action, depending on its magnitude, may restrict us from effectively marketing and selling our products.

In many of the foreign countries in which we market our products, we are subject to regulations affecting, among other things, clinical efficacy, product standards, packaging requirements, labeling requirements, import/ export restrictions, tariff regulations, duties and tax requirements. Many of the regulations applicable to our devices and products in these countries, such as the European Medical Devices Directive, are similar to those of the FDA. In addition, in many countries the national health or social security organizations require our products to be qualified before they can be marketed with the benefit of reimbursement eligibility. Failure to receive or delays in the receipt of relevant foreign qualifications also could have a material adverse effect on our business, financial condition, results of operations and cash flows.

As both the U.S. and foreign government regulators have become increasingly stringent, we may be subject to more rigorous regulation by governmental authorities in the future. Our products and operations are also often subject to the rules of industrial standards bodies, such as the International Standards Organization, or ISO. If we fail to adequately address any of these regulations, our business will be harmed.

If we fail to maintain regulatory approvals and clearances, or are unable to obtain, or experience significant delays in obtaining, FDA clearances or approvals for our future products or product enhancements, our ability to commercially distribute and market these products could suffer.

Our products are subject to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities. The process of obtaining regulatory clearances or approvals to market a medical device can be costly and time consuming, and we may not be able to obtain these clearances or approvals on a timely basis, if at all. In particular, the FDA permits commercial distribution of a new medical device only after the device has received clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act, or is the subject of an approved premarket approval application, or PMA, unless the device is specifically exempt from those requirements. The FDA will clear marketing of a lower risk medical device through the 510(k) process if the manufacturer demonstrates that the new product is substantially equivalent to other 510(k)-cleared products. High risk devices deemed to pose the greatest risk, such as life-sustaining or life-supporting devices, and devices not deemed substantially equivalent to a previously cleared device, require the approval of a PMA. The PMA process is more costly, lengthy and uncertain than the 510(k) clearance process. A PMA

 

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must be supported by extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the device for its intended use.

Our failure to comply with U.S. federal, state and foreign governmental regulations could lead to the issuance of warning letters or untitled letters, the imposition of injunctions, suspensions or loss of regulatory clearance or approvals, product recalls, termination of distribution, product seizures or civil penalties. In the most extreme cases, criminal sanctions or closure of our manufacturing facility are possible.

Foreign governmental authorities that regulate the manufacture and sale of medical devices have become increasingly stringent and, to the extent we market and sell our products internationally, we may be subject to rigorous international regulation in the future. In these circumstances, we would rely significantly on our foreign independent distributors to comply with the varying regulations, and any failures on their part could result in restrictions on the sale of our products in foreign countries.

Failure to receive clearance or approval for our new products would have an adverse effect on our business.

Modifications to our products may require new regulatory clearances or approvals or may require us to recall or cease marketing our products until clearances or approvals are obtained.

Modifications to our existing products may require new regulatory approvals or clearances, including 510(k) clearances or premarket approvals, or require us to recall or cease marketing the modified devices until these clearances or approvals are obtained. The FDA requires device manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplement or clearance.

If a manufacturer determines that a modification to an FDA-cleared device could significantly affect its safety or efficacy, or would constitute a major change in its intended use, then the manufacturer must file for a new 510(k) clearance or possibly a PMA. Where we determine that modifications to our products require a new 510(k) clearance or a PMA, we may not be able to obtain those additional clearances or approvals for the modifications or additional indications in a timely manner, or at all. For those products sold in the European Union, we must notify the agency that verified the product complies with relevant standards, if significant changes are made to the products or if there are substantial changes to our quality assurance systems affecting those products. Obtaining clearances and approvals can be a time consuming process, and delays in obtaining required future clearances or approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.

With respect to PMA approved products, a new PMA or PMA supplements are required for modifications that affect the safety or effectiveness of the device, including, for example, certain types of modifications to the device’s indication for use, manufacturing process, labeling and design. Premarket approval supplements often require submission of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA, and may not require as extensive clinical data or the convening of an advisory panel.

A manufacturer may determine that a modification does not require a new clearance or approval. However, the FDA can review a manufacturer’s decision and may disagree. The FDA may also on its own initiative determine that a new clearance or approval is required. We have made modifications to our products in the past and may make additional modifications in the future that we believe do not or will not require additional clearances or approvals. If the FDA disagrees and requires new clearances or approvals for the modifications, we may be required to recall and to stop marketing our products as modified, which could require us to redesign our products and harm our operating results. In these circumstances, we may be subject to significant enforcement actions.

 

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Failure to obtain regulatory approval in additional foreign jurisdictions will prevent us from expanding the commercialization of our products abroad.

We currently market, and intend to continue marketing, our products in a number of international markets. Although certain of our products have been approved for commercialization in many global markets, including, among others, the European Union, in order to market our products in other foreign jurisdictions, we must obtain separate regulatory approvals. The approval procedure varies among jurisdictions and can involve substantial additional testing. Approval or clearance by the FDA does not ensure approval by regulatory authorities in other jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign jurisdictions or by the FDA. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval in addition to other risks. In addition, the time required to obtain foreign approval may differ from that required to obtain FDA approval, and we may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in foreign markets.

Clinical trials necessary to support any future PMA will be expensive and will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any modified or new PMA products and will adversely affect our business, operating results and prospects.

Clinical trials are generally required to support a PMA and are sometimes required for 510(k) clearance. Such trials, if conducted in the United States, generally require an investigational device exemption application, or IDE, approved in advance by the FDA for a specified number of patients and study sites, unless the product is deemed an nonsignificant risk device eligible for more abbreviated IDE requirements. Clinical trials are subject to extensive monitoring, recordkeeping and reporting requirements. Clinical trials must be conducted under the oversight of an institutional review board, or IRB, for the relevant clinical trial sites and must comply with FDA regulations, including but not limited to those relating to good clinical practices. To conduct a clinical trial, we also are required to obtain the patients’ informed consent that complies with FDA requirements, state and federal privacy regulations and human subject protection regulations. We, the FDA or the IRB could suspend a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. Additionally, we may decide at any time, for business or other reasons, to terminate a study. Even if a trial is completed, the results of clinical testing may not adequately demonstrate the safety and efficacy of the device or may otherwise not be sufficient to obtain FDA clearance or approval to market the product in the United States. Following completion of a study, we would need to collect, analyze and present the data in an appropriate submission to the FDA, either a 510(k) premarket notification or a PMA. Even if a study is completed and submitted to the FDA, the results of our clinical testing may not demonstrate the safety and efficacy of the device, or may be equivocal or otherwise not be sufficient to obtain approval of our product. In addition, the FDA may perform a bioresearch monitoring inspection of a study and if it finds deficiencies, we will need to expend resources to correct those deficiencies, which may delay clearance or approval or the deficiencies may be so great that FDA could refuse to accept all or part of our data or trigger enforcement action. Indeed, if the FDA were to find that we or our clinical investigators are not operating in compliance with applicable regulations, we could be subject to FDA enforcement action as well as refusal to accept all or part of our data in support our 510(k) or PMA and/or we may need to conduct additional studies.

Conducting successful clinical studies will require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites and able to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures

 

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or follow-up to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to investigational products.

If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.

We do not have the ability to independently conduct our pre-clinical and clinical trials for our products and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or foreign authorities will agree with our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

If we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.

The manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for each of our products is subject to continued regulatory review, oversight and periodic inspections by the FDA and other domestic and foreign regulatory bodies. In particular, we and our suppliers are required to comply with FDA’s Quality System Regulations, or QSR, and International Standards Organization, or ISO, regulations for the manufacture of our products and other regulations which cover the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain clearance or approval. Regulatory bodies, such as the FDA, enforce the QSR and other regulations through periodic inspections. For example, from July 29, 2013 through August 2, 2013, the FDA conducted an inspection of our 3i facility in Palm Beach Gardens Florida. A Form 483 was provided to us at the conclusion of the inspection. In the FDA’s most recent Form 483, eight inspectional observations were identified. We submitted a response to the FDA on August 22, 2013, which identified our proposed corrective actions to address the FDA’s observations. We also have met with the agency regarding this response and have provided monthly updates regarding the status of our corrective action plan. Whether the FDA

 

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will accept our response is uncertain. If the FDA does not agree with our proposed corrective actions, or accepts them but finds that we have not implemented them adequately, or if we otherwise fail to comply with applicable regulatory requirements, the FDA could initiate an enforcement action, including any of the actions identified below.

The failure by us or one of our suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things, any of the following enforcement actions:

 

    untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

 

    unanticipated expenditures to address or defend such actions

 

    customer notifications for repair, replacement, refunds;

 

    recall, detention or seizure of our products;

 

    operating restrictions or partial suspension or total shutdown of production;

 

    refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;

 

    operating restrictions;

 

    withdrawing 510(k) clearances on PMA approvals that have already been granted;

 

    refusal to grant export approval for our products; or

 

    criminal prosecution.

If any of these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue. Furthermore, our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.In addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with medical device reporting requirements, including the reporting of adverse events and malfunctions related to our products. Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as QSR, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.

Our products may in the future be subject to product recalls that could harm our reputation, business and financial results.

The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design or manufacture. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious injury or death. In addition, foreign governmental bodies have the authority

 

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to require the recall of our products in the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations. The FDA requires that certain classifications of recalls be reported to FDA within 10 working days after the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. We have initiated certain voluntary recalls involving products that have been distributed to our customers and may take additional such actions in the future. Though we have reported a majority of these recalls to the FDA, we believe that certain of those recalls did not require notification of the FDA. If the FDA disagrees with our determinations, they could require us to report those actions as recalls. Any future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the FDA could take enforcement action, detailed above, for failing to report the recalls when they were conducted.

If our products, or malfunction of our products, cause or contribute to a death or a serious injury, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

Under the FDA medical device reporting regulations, medical device manufacturers are required to report to the FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. All manufacturers placing medical devices in the market in the European Union are legally bound to report any serious or potentially serious incidents involving devices they produce or sell to the relevant regulatory authority in whose jurisdiction the incident occurred. Were this to happen to us, the relevant regulatory authority would file an initial report, and there would then be a further inspection or assessment if there are particular issues. This would be carried out either by the relevant regulatory authority or it could require that the agency that verified the product complies with relevant standards carry out the inspection or assessment.

Any such adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Adverse events involving our products have been reported to us in the past, and we cannot guarantee that they will not occur in the future. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses.

Our promotional materials and training methods regarding surgeons must comply with FDA and other applicable laws and regulations. We believe that the specific surgical procedures and claims for which our products are marketed fall within the scope of their applicable 510(k) clearances or PMA approvals. However, the FDA could disagree and require us to stop promoting our products for specific procedures, uses or claims until we obtain FDA clearance or approval for them. In addition, if the FDA determines that our promotional materials or training constitutes promotion of an unapproved use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine and criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged and adoption of the products would be impaired.

 

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Legislative or regulatory reforms in the United States and abroad may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to produce, market and distribute our products after approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future products. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be. Such changes could, among other things, require:

 

    changes to manufacturing methods;

 

    additional studies, including clinical studies;

 

    recall, replacement, or discontinuance of one or more of our products;

 

    the payment of additional taxes; or

 

    additional record keeping.

For example, the FDA recently adopted rules to establish a Unique Device Identification, or UDI, system, which will require that most medical devices distributed in the United States carry a unique device identifier. We expect that adoption of the UDI system will result in significant cost to implement and to maintain compliance. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future. Each of these would likely entail substantial time and cost and could materially harm our business and our financial results.

Risks Related to our Organization and Structure

If the ownership of our common stock continues to be highly concentrated with our Principal Stockholders, our Principal Stockholders will continue to have substantial control over us and will maintain the ability to control the election of directors and other significant corporate decisions, which will limit or preclude your ability to influence corporate matters and may result in conflicts of interest.

Following the completion of this offering, our Principal Stockholders will together own approximately         % of our outstanding common stock, or         %, if the underwriters’ option to purchase up to              additional shares is fully exercised. As a result, our Principal Stockholders will be able to control the outcome of all matters requiring a stockholder vote, including: the election of directors; approval of mergers or a sale of all or substantially all of our assets; and the amendment of our Amended and Restated Certificate of Incorporation, or Certificate of Incorporation, and our Amended and Restated Bylaws, or Bylaws. Since our Principal Stockholders will have the ability to control the election of the members of our Board of Directors, our Principal Stockholders will thereby control our policies and operations, including the appointment of management, future issuances of our common stock or other securities, the payments of dividends, if any, on our common stock and the incurrence of indebtedness. This control may delay, deter or prevent acts that would be favored by our other stockholders, as the interests of our Principal Stockholders may not always coincide with our interests or the interests of our other stockholders. For example, our Principal Stockholders may seek to cause us to take courses of action that, in their judgment, could enhance their investment in us, but which might involve risks to our other stockholders or adversely affect us or our other stockholders, including investors in this offering.

 

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Our Principal Stockholders will be able to cause or prevent a change of control of us or a change in the composition of our Board of Directors and could preclude any unsolicited acquisition of us. This may have the effect of delaying, preventing or deterring a change in control. This concentration of share ownership may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning shares in a company with significant stockholders. See “Principal Stockholders” and “Description of Capital Stock—Anti-Takeover Effects of Provisions of Our Certificate of Incorporation, Our Bylaws and Delaware Law.”

We are a holding company with nominal net worth and will depend on dividends and distributions from our subsidiaries to pay any dividends.

LVB Acquisition, Inc. is a holding company with nominal net worth. We do not have any assets or conduct any business operations other than our investments in our subsidiaries. Our business operations are conducted primarily out of our direct operating subsidiary, Biomet. As a result, our ability to pay dividends, if any, will be dependent upon cash dividends and distributions or other transfers from our subsidiaries, including from Biomet. Payments to us by our subsidiaries will be contingent upon their respective earnings and subject to any limitations on the ability of such entities to make payments or other distributions to us. See “—Risks Related to our Business.” The terms of our credit facilities, our 6.500% senior notes, our 6.500% senior subordinate notes and any other indebtedness of ours may restrict our current and future operations, particularly our ability to respond to changes in our business or to take certain actions, including payments to LVB Acquisition, Inc. by its subsidiaries. For additional information regarding the limitations currently imposed by our credit facilities, 6.500% senior notes and 6.500% senior subordinated notes, see “Description of Certain Indebtedness.” In addition, our subsidiaries, including our direct operating subsidiary, Biomet, are separate and distinct legal entities and have no obligation to make any funds available to us.

We will be a “controlled company” within the meaning of the stock exchange rules and we will qualify for exemptions from certain corporate governance requirements.

Because our Principal Stockholders together will own a majority of our outstanding common stock following the completion of this offering, we will be considered a “controlled company” as that term is set forth in the              rules. Under these rules, a company of which more than 50% of the voting power is held by another person or group of persons acting together is a “controlled company” and may elect not to comply with certain stock exchange rules regarding corporate governance, including:

 

    the requirement that a majority of our Board of Directors consist of independent directors;

 

    the requirement that our Nominating Committee be composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities;

 

    the requirement that our Compensation Committee be composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities; and

These requirements will not apply to us as long as we remain a “controlled company.”

Certain of our stockholders have the right to engage in the same or similar business as us.

Our Principal Stockholders have other investments and business activities in addition to their ownership of us. Our Principal Stockholders have the right, and have no duty to abstain from exercising such right, to engage or invest in the same or similar businesses as us, do business with any of our clients, customers or vendors or employ or otherwise engage any of our officers, directors or employees. If our Principal Stockholders or any of their directors, officers or employees acquire knowledge of a potential transaction that could be a corporate opportunity, they have no duty, to the fullest extent permitted by law, to offer such corporate opportunity to us, our stockholders or our affiliates.

 

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In the event that any of our directors or officers who is also a director, officer or employee of our Principal Stockholders acquires knowledge of a corporate opportunity or is offered a corporate opportunity, such person will be, to the fullest extent permitted by law, deemed to have fully satisfied his or her fiduciary duties owed to us and will not be liable to us if our Principal Stockholders, individually or collectively, pursue or acquire the corporate opportunity or do not present the corporate opportunity to us so long as such knowledge was not acquired solely as the result of an express, written offer to such person his or her capacity as our director or officer and such person acts in good faith.

Risks Related to this Offering

An active trading market for our common stock may never develop or be sustained, which could impede your ability to sell your shares.

Although our common stock will have been approved for listing on the             , an active trading market for our common stock may not develop on that exchange or elsewhere or, if developed, that market may not be sustained. Accordingly, if an active trading market for our common stock does not develop or is not sustained, the liquidity of our common stock, your ability to sell your shares of common stock when desired and the prices that you may obtain for your shares of common stock will be adversely affected.

The market price of our common stock may fluctuate significantly following the offering, our common stock may trade at prices below the initial public offering price, and you could lose all or part of your investment as a result.

The initial public offering price of our common stock will be determined by negotiation between us and the representatives of the underwriters based on a number of factors as further described under “Underwriting (Conflicts of Interest)” and may not be indicative of prices that will prevail in the open market following completion of this offering. You may not be able to resell your shares at or above the initial public offering price due to a number of factors such as those listed in “—Risks Related to Our Business” and the following, some of which are beyond our control:

 

    quarterly variations in our results of operations;

 

    results of operations that vary from the expectations of securities analysts and investors;

 

    results of operations that vary from those of our competitors;

 

    changes in expectations as to our future financial performance, including financial estimates by securities analysts and investors;

 

    strategic actions by us or our competitors;

 

    announcements by us, our competitors or our vendors of significant contracts, acquisitions, joint marketing relationships, joint ventures or capital commitments;

 

    changes in business or regulatory conditions;

 

    investor perceptions or the investment opportunity associated with our common stock relative to other investment alternatives;

 

    changes in market valuations of similar companies;

 

    increases in market interest rates that may lead purchasers of our shares to demand a higher yield;

 

    the public’s response to press releases or other public announcements by us or third parties, including our filings with the SEC;

 

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    the contents of published research reports about us or our industry or the failure of securities analysts to cover our common stock after this offering;

 

    speculation or reports by the press or investment community with respect to us or our industry in general;

 

    guidance, if any, that we provide to the public, any changes in this guidance or our failure to meet this guidance;

 

    changes in accounting principles;

 

    announcements by third parties or governmental entities of significant claims or proceedings against us;

 

    new laws and governmental regulations applicable to the healthcare industry, including the Patient Protection and Affordable Health Care Act (P.L. 111-148) and the Health Care and Education Reconciliation Act (P.L. 111-152);

 

    a default under the agreements governing our indebtedness;

 

    any increased indebtedness we may incur in the future;

 

    additions or departures of key management personnel;

 

    future sales of our common stock by us, directors, executives and significant stockholders;

 

    changes in domestic and international economic and political conditions and regionally in our markets; and

 

    other events or factors, including those resulting from natural disasters, war, acts of terrorism or responses to these events.

Furthermore, the stock market has recently experienced volatility that, in some cases, has been unrelated or disproportionate to the operating performance of particular companies. These broad market and industry fluctuations may adversely affect the market price of our common stock, regardless of our actual operating performance. As a result, our common stock may trade at a price significantly below the initial public offering price.

In the past, following periods of market volatility, stockholders have instituted securities class action litigation. If we were involved in securities litigation, it could have a substantial cost and divert resources and the attention of executive management from our business regardless of the outcome of such litigation.

Future offerings of debt or equity securities by us may adversely affect the market price of our common stock.

In the future, we may attempt to obtain financing or to increase further our capital resources by issuing additional shares of our common stock or offering debt or other equity securities, including commercial paper, medium-term notes, senior or subordinated notes, debt securities convertible into equity or shares of preferred stock. Future acquisitions could require substantial additional capital in excess of cash from operations. We would expect to finance the capital required for acquisitions through a combination of additional issuances of equity, corporate indebtedness, asset-backed acquisition financing and/or cash from operations.

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common stock or both. Upon liquidation, holders of such debt securities and preferred shares, if issued, and lenders with respect to other borrowings would receive a distribution of our available assets prior to the holders of our common stock. Debt securities convertible into equity could be subject to adjustments in the conversion ratio pursuant to which certain events may increase the number of equity securities issuable upon conversion. Preferred shares, if issued, could have a preference with respect to liquidating distributions or a preference with respect to dividend payments that could limit our ability to pay dividends to the holders of our common stock. Our decision to issue securities in any future offering will depend on market conditions and other factors beyond our control, which may adversely affect the amount, timing or nature of our future offerings. Thus, holders of our common stock bear the risk that our future offerings may reduce the market price of our common stock and dilute their stockholdings in us. See “Description of Capital Stock.”

The future issuance of additional common stock in connection with our incentive plans, acquisitions or otherwise will dilute all other stockholdings and could negatively affect the market price of our common stock.

After this offering, assuming the underwriters exercise their option to purchase additional shares in full, we will have an aggregate of              shares of common stock authorized but unissued and not reserved for issuance under our incentive plans. We may issue all of these shares of common stock without any action or approval by our stockholders, subject to certain exceptions. We also intend to continue to evaluate acquisition opportunities and may issue common stock in connection with these acquisitions. Any common stock issued under our incentive plans, acquisitions, the exercise of outstanding stock options or otherwise would dilute the percentage ownership held by the investors who purchase common stock in this offering.

You will incur immediate and substantial dilution in the net tangible book value of the shares you purchase in this offering.

Prior investors have paid substantially less per share of our common stock than the price in this offering. The initial public offering price of our common stock is substantially higher than the net tangible book deficit per share of our outstanding common stock prior to completion of the offering. Based on our historical adjusted net tangible book deficit per share as of              of $             and upon the issuance and sale of              shares of common stock by us at an assumed initial public offering price of $             per share (the midpoint of the price range indicated on the cover of this prospectus), if you purchase our common stock in this offering, you will pay more for your shares than the amounts paid by our existing stockholders for their shares and you will suffer immediate dilution of approximately $             per share in net tangible book value, representing the difference between our pro forma net tangible book deficit per share after giving effect to this offering and the assumed initial public offering price per share. We also have a large number of outstanding stock options to purchase common stock with exercise prices that are below the estimated initial public offering price of our common stock.

If we or our existing investors sell additional shares of our common stock after this offering, the market price of our common stock could decline.

The market price of our common stock could decline as a result of sales of a large number of shares of common stock in the market after this offering, or the perception that such sales could occur. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

Upon the completion of this offering, we will have             shares of common stock outstanding,              shares if the underwriters’ option to purchase additional shares of our common stock is exercised in full.

Of these outstanding shares of common stock, we expect all of the shares of common stock sold in this offering will be freely tradable in the public market. We expect              shares of common stock, or shares if the underwriters’ option to purchase additional shares of our common stock is exercised in full, will be restricted

 

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securities as defined in Rule 144 under the Securities Act, or Rule 144, and may be sold by the holders into the public market from time to time in accordance with and subject to limitation on sales by affiliates under Rule 144.

We, our directors, our executive officers and our Principal Stockholders have agreed not to sell or transfer any common stock or securities convertible into, exchangeable for, exercisable for, or repayable with common stock, for              days after the date of this prospectus without first obtaining the written consent of                                                      .

Under our registration rights agreement, our Principal Stockholders and certain of our other stockholders have the right, under certain circumstances, to require us to register their shares of common stock under the Securities Act for sale into the public markets. See the information under the heading “Certain Relationships and Related Party Transactions—Registration Rights Agreement” for a more detailed description of the registration rights. Upon the completion of this offering, we will have              shares of our common stock outstanding, approximately             shares issuable upon the exercise of outstanding vested stock options under our equity incentive plans, approximately             million shares subject to outstanding unvested stock options and restricted stock units under our equity incentive plans, and approximately             million shares reserved for future grant under our equity incentive plans. Shares acquired upon the exercise of vested options or vesting of restricted stock units under our equity incentive plans may be sold by holders into the public market from time to time, in accordance with and subject to limitation on sales by affiliates under Rule 144. Sales of a substantial number of shares of our common stock following the vesting of outstanding equity awards could cause the market price of our shares of common stock to decline.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. While our debt securities are covered by securities and industry analysts, we do not currently have and may never obtain research coverage of our common stock by securities and industry analysts. If no securities or industry analysts commence coverage of our common stock, the trading price for our common stock would be negatively impacted. If we obtain securities or industry analyst coverage and if one or more of the analysts who covers us downgrades our common stock or publishes inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common stock could decrease, which could cause our stock price and trading volume to decline.

We do not expect to pay dividends on our common stock in the foreseeable future.

The terms of certain of our and our subsidiaries’ outstanding indebtedness substantially restrict our ability to pay dividends. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Credit Facilities and Notes.” These agreements governing the current and future indebtedness of ours or our subsidiaries may not permit us to make significant dividend payments or distributions to our stockholders. Accordingly, the restrictions above would limit our ability to make dividend payments to our stockholders, and investors must be prepared to rely on sales of their common stock after price appreciation to earn an investment return, which may never occur. Any future determination to pay dividends will be at the discretion of our Board of Directors and will depend upon, among other factors, our results of operations, financial condition, cash flows, capital requirements, any contractual restrictions and other considerations our Board of Directors deems relevant. See “Dividend Policy.”

Investors seeking cash dividends should not purchase our common stock. You may not receive any return on an investment in our common stock unless you sell our common stock for a price greater than that which you paid for it.

 

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements under “Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this prospectus may contain forward-looking statements that reflect our current views with respect to, among other things, future events and financial performance. These statements can be identified by the fact that they do not relate strictly to historical or current fact, and you can often identify these forward-looking statements by the use of forward-looking words such as “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “anticipate,” “plan,” “predict,” “possibly,” “project,” “potential,” “estimate,” “should,” “will,” “continue,” “seek,” “approximately,” “target,” “contemplate” or similar expressions. These statements include, but are not limited to, statements related to:

 

    the timing and number of planned new product introductions;

 

    the effect of anticipated changes in the size, health and activities of the population or on the demand for our products;

 

    assumptions and estimates regarding the size and growth of certain market categories;

 

    our ability and intent to expand in key international markets;

 

    the timing and anticipated outcome of clinical studies;

 

    assumptions concerning anticipated product developments and emerging technologies;

 

    the future availability of raw materials;

 

    the anticipated adequacy of our capital resources to meet the needs of our business;

 

    our continued investment in new products and technologies;

 

    the ultimate marketability of products currently being developed;

 

    our ability to successfully implement new technologies and transition certain manufacturing operations, including transitions to China;

 

    our ability to manage working capital and generate adequate cash flows to service outstanding debt;

 

    our ability to sustain sales and earnings growth;

 

    our success in achieving timely approval or clearance of our products with domestic and foreign regulatory entities;

 

    our success in implementing our operational improvement programs;

 

    the stability of certain foreign economic markets;

 

    the effect of foreign currency fluctuations on our results;

 

    the impact of anticipated changes in the musculoskeletal industry and our ability to react to and capitalize on those changes;

 

    our ability to successfully implement desired organizational changes;

 

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    the impact of our managerial changes;

 

    our ability to take advantage of technological advancements.

 

    our reliance on our private equity stockholders;

 

    our $5,896.8 million of total indebtedness outstanding as of November 30, 2013, and our ability to incur additional indebtedness in the future;

 

    our inability to generate sufficient cash in order to meet our debt service obligations;

 

    the fact that we are a “controlled company” within the meaning of              rules and as a result, our stockholders will not have certain corporate governance protections concerning the independence of our Board of Directors and certain board committees that would otherwise apply to us; and

 

    the fact that our Principal Stockholders will retain significant influence over us and key decisions about our business following the offering that could limit other stockholders’ ability to influence the outcome of matters submitted to stockholders for a vote.

Any forward-looking statements contained in this prospectus are based upon our historical performance and on our current plans, estimates and expectations in light of information currently available to us. The inclusion of this forward-looking information should not be regarded as a representation by us, our Principal Stockholders, the underwriters or any other person that the future plans, estimates or expectations contemplated by us will be achieved. Such forward-looking statements are subject to various risks and uncertainties and assumptions relating to our operations, financial results, financial condition, business, prospects, growth strategy and liquidity. Accordingly, there are or will be important factors that could cause our actual results to differ materially from those indicated in these statements. You should not place undue reliance on any forward-looking statement and should consider the following factors, as well as the factors discussed elsewhere in this prospectus, including under “Risk Factors”. We believe that these factors include:

 

    changes in general economic conditions and interest rates;

 

    changes in the availability of capital and financing sources;

 

    changes in competitive conditions and prices in our markets;

 

    changes to the regulatory environment for our products, including national health care reform;

 

    the effects of incurring or having incurred a substantial amount of indebtedness under our 6.500% senior notes, 6.500% senior subordinated notes and senior secured credit facilities;

 

    the effects upon us of complying with the covenants contained in our senior secured credit facilities and the indentures governing our 6.500% senior notes and 6.500% senior subordinated notes;

 

    restrictions that the terms and conditions of indentures governing our 6.500% senior notes and 6.500% senior subordinated notes and our senior secured credit facilities may place on our ability to respond to changes in our business or take certain actions;

 

    changes in the relationship between supply of and demand for our products;

 

    fluctuations in costs of raw materials and labor;

 

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    the effect of foreign currency fluctuations on our results;

 

    changes in other significant operating expenses;

 

    decreases in sales of our principal product lines;

 

    slowdowns or inefficiencies in our product research and development efforts;

 

    increases in expenditures related to increased government regulation of our business;

 

    developments adversely affecting our sales activities inside or outside the United States;

 

    decreases in reimbursement levels by our customers, including certain of our foreign government customers that are experiencing financial distress;

 

    differences in transitioning certain manufacturing operations to China and other locations;

 

    challenges in effectively implementing restructuring and cost saving initiatives;

 

    increases in cost-containment efforts from managed care organizations and other third-party payors;

 

    loss of our key management and other personnel or inability to attract such management and other personnel;

 

    increases in costs of retaining existing independent sales agents of our products;

 

    potential future goodwill and/or intangible impairment charges;

 

    inability to obtain, protect or enforce our intellectual property rights;

 

    unanticipated expenditures related to litigation; and

 

    failure to comply with the terms of the DPA.

We caution you not to place undue reliance on these forward-looking statements, which speak only as of the date they were made. We do not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events.

 

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USE OF PROCEEDS

We estimate that our net proceeds from the sale of              shares of common stock offered by us will be approximately $              or approximately $              if the underwriters exercise their option to purchase additional shares in full (in each case, at an assumed initial public offering price of $              per share of common stock, the midpoint of the price range set forth on the cover of this prospectus), after deducting underwriting discounts and estimated offering expenses payable by us of approximately $              or approximately $              if the underwriters exercise their option to purchase additional shares in full.

We intend to use the net proceeds from this offering as follows:

 

    approximately $              to reduce outstanding indebtedness (through repayments, redemptions or repurchases); and

 

    approximately $                      for general corporate purposes.

By establishing a public market for our common stock, this offering is also intended to facilitate our future access to public markets.

A $1 increase (decrease) in the assumed initial public offering price (the midpoint of the price range set forth on the cover of this prospectus) would increase (decrease) our estimated net proceeds from this offering by $            , assuming the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, a change in the number of shares of common stock we sell would increase or decrease our net proceeds. We believe that our intended use of proceeds would not be affected by changes in either our initial public offering price or the number of shares of common stock we sell.

 

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DIVIDEND POLICY

We are currently restricted in our ability to pay dividends under various covenants of our debt agreements, including our credit facilities and the indentures governing the notes issued by Biomet and did not declare or pay any dividends to our shareholders during the fiscal years ended May 31, 2013, 2012 and 2011 or the six months ended November 30, 2013.

We do not expect for the foreseeable future to pay dividends on our common stock. Any future determination to pay dividends will be at the discretion of our Board of Directors and will depend upon, among other factors, our results of operations, financial condition, cash flows, capital requirements, any contractual restrictions and any other considerations our Board of Directors deems relevant.

See “Risk Factors—Risks Related to this Offering—We do not expect to pay dividends on our common stock in the foreseeable future.”

 

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and our capitalization as of November 30, 2013:

 

  1. on an actual basis; and

 

  2. on an as adjusted basis to reflect:

 

    the sale of              shares of our common stock offered in this offering at an assumed initial public offering price of $              per share (the midpoint of the price range on the cover of this prospectus), after deducting underwriting discounts and commissions and estimated offering expenses; and

 

    the application of the net proceeds from this offering as described under the heading “Use of Proceeds.”

You should read the following table in conjunction with the sections titled “Summary—Summary Historical Consolidated Financial and Operating Data,” “Selected Historical Consolidated Financial Data,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Description of Certain Indebtedness” and our financial statements and related notes included elsewhere in this prospectus.

 

    

November 30, 2013

 
(in millions)   

Actual

   

Pro Forma As
Adjusted

 

Cash and cash equivalents

   $ 176.2      $     
  

 

 

   

 

 

 

Long-term debt:

    

Senior Secured Credit Facility

   $ 3,078.3      $                

Asset-based Revolving Credit Facility(1)

     155.0     

Cash Flow Revolving Credit Facility (USD)(2)

         

Cash Flow Revolving Credit Facility (USD/EUR)(3)

         

6.500% Senior Notes

     1,825.0     

6.500% Senior Subordinated Notes

     800.0     

China Facility(4)

     3.3     

Bond Premium

     35.2     
  

 

 

   

 

 

 

Total long-term debt

   $ 5,896.8      $     

Stockholders’ equity:

    

Common stock (par value $0.01 per share,              shares of common stock authorized and              shares of common stock issued and outstanding at November 30, 2013)(5)(6)

     5.5     

Additional paid-in capital

     5,670.9     

Accumulated other comprehensive income

     49.4     

Accumulated deficit

     (3,657.0  
  

 

 

   

 

 

 

Total stockholders’ equity

     2,068.8     
  

 

 

   

 

 

 

Total capitalization

   $ 7,965.6      $     
  

 

 

   

 

 

 

 

(1) At November 30, 2013, we had $286.6 million of unused borrowing availability under this facility.
(2) At November 30, 2013, we had $165.0 million of unused borrowing availability under this facility.
(3) At November 30, 2013, we had $165.0 million of unused borrowing availability under this facility.
(4) At November 30, 2013, we had $16.7 million of unused borrowing availability under this facility.
(5) At November 30, 2013, 10 million shares of preferred stock were authorized and no shares of preferred stock were issued and outstanding. See “Description of Capital Stock—Preferred Stock.”
(6) Upon completion of the offering, we intend to grant restricted shares (the “Restricted Share Grants”) with a grant date fair value of approximately $7,000,000 in the aggregate to approximately 7,000 of our employees (not including any executive officers), subject to local law. The specific terms and conditions of the Restricted Share Grants have not been finalized.

 

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DILUTION

If you invest in our common stock, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock in this offering and the pro forma net tangible book value per share of our common stock after this offering. Dilution results from the fact that the per share offering price of our common stock is substantially in excess of the net tangible book value per share attributable to the existing equity holders. Net tangible book value per share represents the amount of temporary equity and stockholders’ equity excluding intangible assets, divided by the number of shares of common stock outstanding at that date.

Our historical net tangible book value as of              was $              million, or approximately $              per share of common stock (assuming              shares of common stock outstanding).

Net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers of common stock in this offering and the pro forma as adjusted net tangible book value per share of common stock immediately after completion of this offering. Investors participating in this offering will incur immediate and substantial dilution. After giving effect to our sale of              shares of common stock in this offering at an assumed initial public offering price of $              per share (the midpoint of the price range set forth on the cover of this prospectus) and after deducting the estimated underwriting discounts and commissions and offering expenses, our pro forma net tangible book value as of              would have been approximately $              or approximately $              per share. This amount represents an immediate increase in pro forma net tangible book value of $              per share to existing stockholders and an immediate dilution in pro forma net tangible book value of $              per share to purchasers of common stock in this offering, as illustrated in the following table.

 

Assumed initial public offering price per share

  

Historical net tangible book value per share as of

  

Increase per share attributable to new investors

  
  

 

Pro forma net tangible book value per share after giving effect to this offering

  
  

 

Dilution in pro forma net tangible book value per share to new investors

  
  

 

A $1 increase or decrease in the assumed initial public offering price of $              per share would increase or decrease, as applicable, our pro forma net tangible book value by approximately $              or approximately $              per share, and the dilution in the pro forma net tangible book value per share to investors in this offering by approximately $              per share, assuming the number of shares offered by us, as set forth on the cover of this prospectus, remains the same and after deducting underwriting discounts and commissions and estimated offering expenses. This pro forma information is illustrative only, and following the completion of this offering, will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing.

 

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The following table summarizes, as of             , on the pro forma basis described above, the differences between existing stockholders and new investors with respect to the number of shares of common stock purchased from us, the total consideration paid, and the average price per share of our common stock paid by existing stockholders. The calculation with respect to shares purchased by new investors in this offering reflects the issuance of             shares of our common stock in this offering at an assumed initial public offering price of $              per share, the midpoint of the range set forth on the cover of this prospectus, before deducting the estimated underwriting discounts and commissions and offering expenses.

 

    

Shares

Purchased

  

Total Consideration

  

Average
Price Per

       Number      Percent      Amount      Percent      Share
     (in millions)

Existing Stockholders

              

New investors in this offering

              

Total

              

 

If the underwriters exercise their option to purchase additional shares in full, the number of shares of common stock held by new investors will increase to              , or             percent, of the total number of shares of our common stock outstanding after this offering.

The discussion and table above do not take into account an aggregate of 38,520,000 shares of common stock reserved for future issuance under our 2007 Management Equity Incentive Plan, as may be amended from time to time,              of which remain available for grant and 14,000,000 shares of common stock reserved for future issuance under our 2012 Restricted Stock Unit Plan, as may be amended from time to time,              of which remain available for grant.

 

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SELECTED HISTORICAL CONSOLIDATED FINANCIAL DATA

The following tables summarize our historical consolidated financial and other data for our business for the periods presented. You should read this summary of financial and other data along with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and our financial statements and the related notes, all included elsewhere in this prospectus.

The summary consolidated statement of operations data for the years ended May 31, 2013, May 31, 2012 and May 31, 2011 and the summary consolidated balance sheet data as of May 31, 2013 and May 31, 2012 have been derived from our audited consolidated financial statements included elsewhere in this prospectus. The summary consolidated statement of operations data for the years ended May 31, 2010 and May 31, 2009 and the summary consolidated balance sheet data as of May 31, 2011 and May 31, 2010 have been derived from our audited consolidated financial statements not included in this prospectus. The summary consolidated statement of operations data for the six months ended November 30, 2013 and November 30, 2012 and the summary consolidated balance sheet data as of November 30, 2013 have been derived from our unaudited condensed consolidated financial statements included elsewhere in this prospectus. In the opinion of management, the unaudited condensed consolidated financial statements included herein include all adjustments (consisting of normal recurring accruals) necessary to state fairly the information set forth herein. Our historical results are not necessarily indicative of the results to be expected in the future, and the results for the six months ended November 30, 2013 are not necessarily indicative of the results to be expected for the full year.

Statement of Operations Data

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

   

2010

   

2009

 

Net sales

   $ 1,566.4      $ 1,497.5      $ 3,052.9      $ 2,838.1      $ 2,732.2      $ 2,698.0      $ 2,504.1   

Cost of sales

     522.2        464.1        996.5        894.4        838.7        819.9        828.4   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     1,034.2        1,033.4        2,056.4        1,943.7        1,893.5        1,878.1        1,675.7   

Selling, general and administrative expense

     594.6        592.9        1,189.4        1,053.3        1,041.7        1,042.3        1,003.6   

Research and development expense

     78.9        72.2        150.3        126.8        119.4        106.6        93.5   

Amortization

     150.7        156.1        313.8        327.2        367.9        372.6        375.8   

Goodwill impairment charge

     —          —          473.0        291.9        422.8        —          495.6   

Intangible assets impairment charge

     —          —          94.4        237.9        518.6        —          55.5   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income (loss)

     210.0        212.2        (164.5     (93.4     (576.9     356.6        (348.3

Interest expense

     193.3        222.0        398.8        479.8        498.9        516.4        550.3   

Other (income) expense

     5.9        161.5        177.8        17.6        (11.2     (18.1     21.8   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     10.8        (171.3     (741.1     (590.8     (1,064.6     (141.7     (920.4

Benefit from income taxes

     (25.2     (73.6     (117.7     (132.0     (214.8     (94.1     (171.2
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8   $ (47.6   $ (749.2
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Earnings (Loss) Per Share

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(shares in millions)   

2013

    

2012

   

2013

   

2012

   

2011

   

2010

   

2009

 

Earnings (loss) per share—basic(1)

   $ 0.07       $ (0.18   $ (1.13   $ (0.83   $ (1.54   $ (0.09   $ (1.36

Earnings (loss) per share—diluted(1)

   $ 0.07       $ (0.18   $ (1.13   $ (0.83   $ (1.54   $ (0.09   $ (1.36

Weighted average shares—basic

     551.9         551.8        551.8        551.9        552.1        552.4        552.3   

Weighted average shares—diluted

     552.1         551.8        551.8        551.9        552.1        552.4        552.3   

 

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Balance Sheet Data

 

(in millions)   

November 30, 2013

    

May 31, 2013

    

May 31, 2012

    

May 31, 2011

    

May 31, 2010

 

Cash and cash equivalents

   $ 176.2       $ 355.6       $ 492.4       $ 327.8       $ 189.1   

Current assets less current liabilities

     1,159.3         1,208.5         1,200.8         1,079.0         786.5   

Total assets

     9,737.4         9,794.7         10,420.4         11,357.0         11,969.0   

Total debt

     5,896.8         5,966.4         5,827.8         6,020.3         5,896.5   

Shareholder’s equity

     2,068.8         1,968.6         2,682.1         3,175.1         3,733.5   

Summary of Cash Flow Data

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

   

2010

   

2009

 

Net cash provided by (used in):

              

Operating activities

   $ 170.9      $ 128.6      $ 468.5      $ 377.3      $ 380.1      $ 321.5      $ 243.8   

Investing activities

     (248.6     (409.3     (488.6     (144.0     (205.0     (182.0     (194.9

Financing activities

     (101.2     (51.3     (134.7     (38.1     (51.4     (159.9     42.5   
Other Financial Data   

 

   

 

 
    

Six Months Ended

November 30,

   

Fiscal Year Ended May 31,

 
    

 

   

 

   

 

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

   

2010

   

2009

 

Depreciation and amortization

   $ 242.5      $ 242.1      $ 495.4      $ 509.4      $ 549.0      $ 547.6      $ 537.7   

Capital expenditures

     98.5        106.9        204.0        179.3        174.0        186.4        185.0   

Adjusted EBITDA(2)

     529.0        532.2        1,075.9        1,013.5        1,021.6        1,018.1        904.6   

Adjusted net income(2)

     202.2        164.8        365.7        251.8        205.2        241.5        158.1   

 

(1) Basic earnings per common share amounts are calculated using the weighted average number of common shares outstanding for the period. Diluted earnings per common share amounts are calculated using the weighted average number of common shares outstanding for the period and include the dilutive impact of stock options using the treasury stock method. Diluted earnings per common share excludes the impact of any restricted stock units as a liquidity event is required for both the time and performance restricted stock units to vest. As of November 30, 2013, 1.8 million time-based shares were available to vest upon a liquidity event, and 3.5 million performance-based restricted shares were available to vest at November 30, 2013 upon occurrence of a liquidity event and achievement of certain investment return metrics as detailed in the 2012 Restricted Stock Unit Plan. See “Executive Compensation.”
(2)

We have included certain non-GAAP financial measures including Adjusted EBITDA and Adjusted net income, each as defined below, that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles, or GAAP. These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP. Management exercises judgment in determining which types of charges or other items should be excluded from non-GAAP financial measures. Management uses this non-GAAP information internally to evaluate the performance of the core operations, establish operational goals and forecasts that are used in allocating resources and to evaluate our performance period-over-period. Additionally, our management is evaluated on the basis of some of these non-GAAP financial measures when determining achievement of their incentive compensation performance targets. We believe that our disclosure of these non-GAAP financial measures provides investors greater transparency to the information used by Biomet management for its financial and operational decision-making and enables investors to better understand our period-to-period

 

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  operating performance. We also believe Adjusted EBITDA and Adjusted net income are widely used by investors and securities analysts to measure a company’s operating performance without regard to items that can vary substantially from company to company depending upon financing and accounting methods, book values of assets, tax jurisdictions, capital structures and the methods by which assets were acquired.

 

     We define “Adjusted EBITDA” to mean earnings before interest, taxes, depreciation and amortization, as adjusted for certain expenses. We define “Adjusted net income” to mean earnings as adjusted for certain expenses. The term “as adjusted,” a non-GAAP financial measure, refers to financial performance measures that exclude certain income statement line items, such as interest, taxes, depreciation or amortization, and/or exclude certain expenses, such as stock-based compensation charges, certain litigation expenses, acquisition expenses, operational restructuring charges, advisory fees paid to the Principal Stockholders, asset impairment charges, losses on extinguishment of debt, purchase accounting costs, losses on swap liabilities and other related charges. In “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Disclosures,” we provide further information about our calculation of Adjusted EBITDA and Adjusted net income, as well as information about where these expenses are reflected in the line items of our income statement prepared in accordance with GAAP.

 

     Adjusted EBITDA and Adjusted net income do not represent, and should not be a substitute for, net income or cash flows from operations as determined in accordance with GAAP. Adjusted EBITDA and Adjusted net income have limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of our results as reported under GAAP. Some of the limitations are:

 

    Adjusted EBITDA and Adjusted net income do not reflect our cash expenditures, or future requirements for capital expenditures or contractual commitments;

 

    Adjusted EBITDA and Adjusted net income do not reflect changes in, or cash requirements for, our working capital needs;

 

    Adjusted EBITDA does not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt; and

 

    several of the adjustments that we use in calculating Adjusted EBITDA and Adjusted net income, such as asset impairment charges, while not involving cash expense, do have a negative impact on the value our assets as reflected in our consolidated balance sheet prepared in accordance with GAAP.

Adjusted EBITDA, as calculated below, differs from adjusted EBITDA as calculated for purposes of compliance with our senior secured credit facilities.

 

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Reconciliations of historical net income (loss) to Adjusted EBITDA and Adjusted net income are set forth in the following table:

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

   

2010

   

2009

 

Adjusted EBITDA:

              

Net income (loss), as reported

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8   $ (47.6   $ (749.2

Plus (minus):

              

Interest expense

     193.3        222.0        398.8        479.8        498.9        516.4        550.3   

Benefit from income taxes

     (25.2     (73.6     (117.7     (132.0     (214.8     (94.1     (171.2

Depreciation and amortization

     242.5        242.1        495.4        509.4        549.0        547.6        537.7   

Special items, before amortization and depreciation from purchase accounting, interest and tax(a)

     82.4        239.4        922.8        615.1        1,038.3        95.8        737.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 529.0      $ 532.2      $ 1,075.9      $ 1,013.5      $ 1,021.6      $ 1,018.1      $ 904.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income:

              

Net income (loss), as reported

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8   $ (47.6   $ (749.2

Plus:

              

Special items, after tax(b)

     166.2        262.5        989.1        710.6        1,055.0        289.1        907.3   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income

   $ 202.2      $ 164.8      $ 365.7      $ 251.8      $ 205.2      $ 241.5      $ 158.1   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(a) A reconciliation of special items, before amortization and depreciation from purchase accounting, interest and tax is as follows:

 

    

Six Months Ended
November 30,

    

Fiscal Year Ended May 31,

 
(in millions)   

2013

    

2012

    

2013

    

2012

    

2011

    

2010

    

2009

 

Special items

                    

Stock-based compensation(1)

   $ 9.2       $ 26.5       $ 39.6       $ 16.0       $ 12.7       $ 22.4       $ 33.9   

Distributor agreements(2)

     —           —           —           —           —           —           2.0   

Certain litigation expenses(3)

     29.5         9.4         57.9         8.6         12.5         10.7         82.1   

Acquisition expenses(4)

     8.7         10.1         16.7         4.6         —           —           —     

Operational restructuring(5)

     23.0         20.3         59.1         45.8         61.6         43.3         58.7   

Principal Stockholders fee(6)

     5.4         5.4         11.0         10.3         10.1         10.1         9.2   

Asset impairment(7)

     —           —           567.4         529.8         941.4         —           551.1   

Loss on extinguishment of debt(8)

     6.6         167.7         171.1         —           —           —           —     

Greece bad debt expense(9)

     —           —           —           —           —           9.3         —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 82.4       $ 239.4       $ 922.8       $ 615.1       $ 1,038.3       $ 95.8       $ 737.0   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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(b) A reconciliation of special items, after tax is as follows:

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

   

2010

   

2009

 

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 82.4      $ 239.4      $ 922.8      $ 615.1      $ 1,038.3      $ 95.8      $ 737.0   

Amortization and depreciation from purchase accounting(10)

     144.3        148.9        299.6        325.6        376.3        386.2        392.8   

Loss on swap liability(l1)

     21.8        —          —          —          —          —          —     

Tax effect(12)

     (82.3     (125.8     (233.3     (230.1     (359.6     (192.9     (222.5
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Special items, after tax

   $ 166.2      $ 262.5      $ 989.1      $ 710.6      $ 1,055.0      $ 289.1      $ 907.3   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

  (1) Stock-based compensation expense is excluded from non-GAAP financial measures primarily because it is a non-cash expense and because it is not used by management to assess ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (2) Payments to distributors that are not in the ordinary course of business are excluded in non-GAAP measures as they are not reflective of our ongoing operational performance. We further believe the exclusion of this information in the applicable non-GAAP financial measure is useful to investors in that it provides period-over-period comparability.
  (3) Certain litigation, including expenses, settlements and adjustments to reserves during the year, including the metal-on-metal hip products litigation described in “Business—Legal Matters,” that we believe are not reflective of our ongoing operational performance are excluded from non-GAAP financial measures. We incur legal and settlement expenses in the ordinary course of our business, but we believe the items included in this line are unusual either in amount or subject matter. We believe this information is useful to investors in that it aids period-over-period comparability.
  (4) We exclude acquisition-related expenses for the 2012 Trauma Acquisition and 2013 Spine Acquisition from non-GAAP financial measures that are not reflective of our ongoing operational performance.
  (5) Operational restructuring charges relate principally to employee severance, facility consolidation costs and building impairments resulting from the closure of facilities. Operational restructuring charges include abnormal manufacturing variances related to temporary redundant overhead costs within our plant network as we continue to rationalize and move production to our larger operating locations in order to increase manufacturing efficiency. Operational restructuring also includes consulting expenses related to operational initiatives and other related costs. Operational restructuring also includes product rationalization charges to increase efficiencies among our products and reduce product overlap, including steps we take to integrate products we acquire. Operational restructuring also includes the loss on the divestiture of our bracing business in fiscal year 2013. We exclude these costs from non-GAAP financial measures primarily because they are not reflective of ongoing operating results, and they are not used by management to assess ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (6)

Upon completion of the 2007 Acquisition, we entered into a management services agreement with certain affiliates of our Principal Stockholders, pursuant to which such affiliates of our Principal Stockholders or their successors, assigns, affiliates, officers, employees, and/or representatives and third parties (collectively, the “Managers”) provide management, advisory, and consulting services to us. Pursuant to such agreement, our Principal Stockholders receive a quarterly monitoring fee equal to 1% of our quarterly Adjusted EBITDA (as defined by our senior secured credit facilities) as compensation for the services rendered and reimbursement for out-of-pocket expenses incurred

 

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  by the Managers in connection with the agreement. We exclude these costs from non-GAAP financial measures primarily because they are not reflective of ongoing operating results and they are not used by management to assess ongoing operational performance. In addition, we have excluded these costs from non-GAAP financial measures because the management services agreement will terminate in connection with the completion of this offering. We believe this information is useful to investors in that it provides period-over-period comparability.
  (7) Non-cash asset impairment charges are excluded from non-GAAP financial measures because they are not reflective of our ongoing operational performance or liquidity.

 

    During fiscal year 2013, we recorded a $473.0 million goodwill impairment charge and a $94.4 million definite and indefinite-lived intangible asset impairment charge associated with our dental reconstructive and Europe reporting units.

 

    During fiscal year 2012, we recorded a $291.9 million goodwill impairment charge and a $237.9 million definite and indefinite-lived intangible asset impairment charge primarily associated with our dental reconstructive and spine and bone healing reporting units.

 

    During fiscal year 2011, we recorded a $422.8 million goodwill impairment charge and a $518.6 million definite and indefinite-lived intangible asset impairment charge primarily associated with our Europe reporting unit.

 

    During fiscal year 2009, we recorded a $495.6 million goodwill impairment charge and a $55.5 million definite and indefinite-lived intangible asset impairment charge primarily associated with our dental reconstructive reporting unit.

 

     We believe this information is useful to investors in that it provides period-over-period comparability.
  (8) Loss on extinguishment of debt charges include write off of deferred financing fees, dealer manager fees and tender/call premium on retirement of bonds. We exclude these charges from non-GAAP measures because they are not reflective of our ongoing operational performance or liquidity. We believe this information is useful to investors in that it provides period-over-period comparability.
  (9) This charge is related to the proposal the Greek government announced on June 15, 2010 to settle its outstanding debts from 2007 through 2009 primarily by issuing zero-coupon bonds. We exclude this charge from non-GAAP measures primarily because it is not reflective of the ongoing operating results. We believe this information is useful to investors in that it provides period-over-period comparability.
  (10) Amortization and depreciation from purchase accounting adjustments that is related to the 2007 Acquisition, 2012 Trauma Acquisition and 2013 Spine Acquisition, are excluded from non-GAAP financial measures. These amortization amounts represent the additional amortization expenses in each period attributable to the step-up of amortizable assets to fair value due to the application of purchase accounting in the 2012 Trauma Acquisition and 2013 Spine Acquisition. We believe this information is useful to investors in that it provides period-over-period comparability. Further, these amounts are not used by management to assess ongoing operational performance.
  (11) Loss on swap liability charges include a one-time charge to interest expense related to the termination of our euro-denominated term loans. We believe this information is useful to investors in that it provides period-over-period comparability.
  (12) Tax effect is calculated based upon the tax rates applicable to the jurisdictions where the special items were incurred.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND

RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes thereto and other financial information appearing elsewhere in this prospectus. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. See “Cautionary Note Regarding Forward-Looking Statements.” Our actual results could differ materially from those contained in forward-looking statements as a result of many factors, including those discussed in “Risk Factors” and elsewhere in this prospectus. Unless the context otherwise indicates or requires, the terms the “Company,” “we,” “us,” and “our” refer to LVB Acquisition, Inc. and its consolidated affiliates and its consolidated subsidiaries. In addition, unless the context otherwise indicates or requires, the term “Biomet” refers to Biomet, Inc., our direct operating subsidiary.

Executive Overview

We are one of the largest orthopedic medical device companies in the world, with operations in more than 50 locations and distribution in more than 90 countries. We design, manufacture and market surgical and non-surgical products used primarily by orthopedic surgeons and other musculoskeletal medical specialists

We have grown to nearly 9,000 employees and generated more than $3.0 billion of net sales in our most recent fiscal year. In recent years, we have built on our core competencies in hip and knee products by expanding our business in higher-growth categories, such as sports medicine, extremities and trauma, and in our higher-growth International markets. We operate globally in markets that we estimate collectively exceed $40 billion in annual sales.

Opportunities and Challenges

We believe that growth opportunities exist in the global orthopedics market as a result of favorable demographics in major markets and underserved needs for musculoskeletal care in certain underpenetrated regions, including both developed and emerging markets. As the baby boomer population ages and life expectancy increases, the elderly will represent a higher percentage of the overall population. Many conditions that require orthopedic surgery affect people in middle age or later in life, which is expected to drive growth in procedural volumes. According to U.S. Census Bureau “2012 National Population Projections”, the U.S. population aged 65 and over is expected to grow more than four times the average rate of population growth from 47.7 million and 14.8% of the population in 2015 to 72.8 million and 20.3% of the population in 2030. We also believe there are considerable opportunities for global expansion as healthcare spending increases in international markets, which accounted for more than 40% of the global orthopedic market in 2012. We plan to strengthen our position in under-penetrated regions, and we believe significant orthopedic opportunities exist, as most people will need musculoskeletal care throughout their lives.

Our results of operations could be substantially affected not only by global economic conditions, but also by local operating and economic conditions, which can vary substantially by market. Unfavorable conditions can depress sales in a given market and may result in actions that adversely affect our margins, constrain our operating flexibility or result in charges which are unusual or non-recurring. Certain macroeconomic events, such as the continuing adverse conditions in the global economy, could have a more wide-ranging and prolonged impact on the general business environment, which could also adversely affect us.

In the United States, health and dental providers that purchase our products (e.g., hospitals, physicians, dentists and other health care providers) generally rely on payments from third-party payors (principally federal Medicare, state Medicaid and private health insurance plans) to cover all or a portion of the cost of our musculoskeletal products. In March 2010, comprehensive health care reform legislation was enacted through the passage of the Patient

 

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Protection and Affordable Health Care Act (P.L. 111-148) and the Health Care and Education Reconciliation Act (P.L. 111-152). Among other initiatives, these laws impose a 2.3% excise tax on domestic sales of medical devices after December 31, 2012. Various healthcare reform proposals have also emerged at the state level. Other than the excise tax, which has affected our results of operations and cash flows after December 31, 2012, we cannot predict with certainty what healthcare initiatives, if any, will be implemented at the state level, or what the ultimate effect of federal health care reform or any future legislation or regulation will have on us. However, an expansion of government’s role in the U.S. healthcare industry may lower reimbursements for procedures that involve our products, reduce medical procedure volumes and adversely affect our business, results of operations and cash flows, possibly materially.

Outside the United States, reimbursement systems vary significantly from country to country. If adequate levels of reimbursement from third-party payors outside the United States are not obtained, international sales of our products may decline. Many foreign markets, including Canada and some European and Asian countries, have decreased reimbursement rates in recent years. Our ability to continue to sell certain products profitably in these markets may diminish if government-managed healthcare systems continue to reduce reimbursement rates, which can decrease pricing and procedural volume.

Key Line Items

Net Sales

Net sales is our total revenue from the sale of goods and services rendered during the reporting period in the normal course of business, net of sales returns and allowances. We derive our net sales from the sale of surgical and non-surgical products used primarily by orthopedic surgeons and other musculoskeletal medical specialists. We include amounts billed for shipping and handling in net sales.

We report our net sales in six primary product categories: hips; knees; sports, extremities and trauma (S.E.T.) products; spine, bone healing and microfixation products; dental reconstructive products and cement, biologics and other products. We sell our products through four principal channels: (1) directly to healthcare institutions, (2) through stocking distributors and healthcare dealers, (3) indirectly through insurance companies and (4) directly to dental practices and dental laboratories. Sales through the direct and distributor/dealer channels account for a majority of net sales. Through these channels, inventory is consigned to sales agents or customers so that products are available when needed for surgical procedures. We generally record revenue for products consigned to sales agents or customers at the time our product is surgically implanted. At certain locations, revenue is recognized on sales to stocking distributors, healthcare dealers, dental practices and dental laboratories upon shipment.

Pricing for products is predetermined by contracts with customers, agents acting on behalf of customer groups or by government regulatory bodies, depending on the market. Price discounts under group purchasing contracts are linked to volume of implant purchases by customer healthcare institutions within a specified group. Price discounts may increase at negotiated thresholds within a contract buying period.

Cost of Sales

We manufacture a majority of the products we sell. Cost of sales includes raw materials, labor costs, product liability costs, manufacturing overhead expenses, instrument depreciation and shipping and handling costs.

Selling, general and administrative expense

Selling, general and administrative expense primarily consists of salaries, benefits, and other related costs for our sales force, sales administration, marketing, finance, legal, compliance, administrative, information technology, medical education and training, quality and human resource departments, as well as stock-based compensation for our employees and non-employee distributors, certain legal fees, and costs related to acquisitions.

 

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Research and development expense

Our research and development expenses primarily consist of engineering, product development, clinical and regulatory expenses, consulting services, outside prototyping services, outside research activities, materials, depreciation, and other costs associated with the development of our products. Research and development expenses also include related personnel and consultants’ compensation and stock compensation expense. We expense research and development costs as they are incurred.

Other (income)/expense

Our other (income)/expense is primarily comprised of the ineffective portion of derivatives designated as hedging instruments and the gains and losses related to derivatives not designated as hedging instruments and foreign currency exchange, as well as financing fees and impairment charges on investments.

Benefit from income taxes

Our effective income tax rate, tax provisions, deferred tax assets and deferred tax liabilities vary according to the jurisdictions in which profits are earned and taxed. Tax laws are complex and subject to different interpretations by management and the respective governmental taxing authorities, and require us to exercise judgment in determining our income tax. These estimates and judgments occur in the calculation of tax credits, benefits, and deductions, and such estimates and judgments also occur in the calculation of certain tax assets and liabilities that arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes, as well as the interest and penalties related to uncertain tax positions.

Seasonality

Our business is somewhat seasonal in nature as many of our products are used in elective procedures, which typically decline during the summer months, particularly in European countries.

Products

We offer one of the most comprehensive portfolios of products, as well as the associated instrumentation, in the orthopedic and dental markets, as described below:

Reconstructive Products—Hips and Knees. Orthopedic reconstructive implants are used to replace joints that have deteriorated as a result of disease (principally osteoarthritis) or injury. Reconstructive joint surgery involves the modification of the affected area of the joint and the implantation of one or more manufactured components.

Sports, Extremities and Trauma (S.E.T.) Products. In sports medicine, we primarily manufacture and market a line of procedure-specific products for the repair of soft tissue injuries, most commonly used in the knee and shoulder. Extremity systems comprise a variety of joint replacement systems, primarily for the shoulder, elbow and wrist. Trauma hardware includes internal and external fixation products used by orthopedic surgeons to set and stabilize fractures, used primarily for upper and lower extremities, including the foot and ankle.

Spine, Bone Healing and Microfixation Products. Our spinal products include traditional, minimally-invasive and lateral access spinal fusion and fixation systems, implantable electrical stimulation devices for spinal applications and osteobiologics (including allograft services). Our bone healing products include non-invasive electrical stimulation devices designed to stimulate bone growth in the posterior lumbar spine and appendicular skeleton. Our microfixation products primarily include neuro, craniomaxillofacial, or CMF, and cardiothoracic products for fixation and reconstructive procedures.

 

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Dental Reconstructive Products. Our dental reconstructive products are designed to enhance oral rehabilitation through the replacement of teeth and the repair of hard and soft tissues. These products include dental reconstructive products and related instrumentation, bone substitute materials, regenerative products and materials, CAD/CAM copings and implant bridges.

Cement, Biologics and Other Products. We manufacture and distribute numerous other products, including bone cement and accessories, autologous blood therapy products and services, operating room supplies, general surgical instruments, wound care products and other surgical products.

Constant Currency Reconciliation

Because we sell our products in many different countries in local currency, our net sales are affected by fluctuations in those currencies against the U.S. dollar during each period. We calculate the constant currency change by taking the current period local currency sales multiplied by the prior year currency rate for the corresponding period for a given country. The translated results are then used to determine period-over-period percentage increases or decreases that exclude the effect of changes in foreign currency exchange rates. The tables below set forth the currency impact of our net sales for the periods indicated.

For the Six Months Ended November 30, 2013 Compared to the Six Months Ended November 30, 2012

 

    

Six Months Ended
November 30, 2013
Net Sales Growth
As Reported

   

Currency
Impact

   

Six Months Ended
November 30, 2013
Net Sales Growth
in Local Currencies

 

Knees

     5.1     1.2     6.3

Hips

     2.1     1.7     3.8

Sports, Extremities, Trauma (S.E.T.)

     10.8     1.3     12.1

Spine, Bone Healing and Microfixation

     (2.3 )%      (0.1 )%      (2.4 )% 

Dental

     0.2     —       0.2

Cement, Biologics and Other

     2.8     (0.5 )%      2.3
  

 

 

   

 

 

   

 

 

 

Net Sales

     3.9     1.0     4.9
  

 

 

   

 

 

   

 

 

 

 

    

Six Months Ended
November 30, 2013
Net Sales Growth
As Reported

   

Currency
Impact

   

Six Months Ended
November 30, 2013
Net Sales Growth
Local Currencies

 

United States

     4.3     —       4.3

Europe

     7.9     (3.7 )%      4.2

International

     (3.2 )%      11.1     7.9
  

 

 

   

 

 

   

 

 

 

Total

     3.9     1.0     4.9
  

 

 

   

 

 

   

 

 

 

 

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For the Year Ended May 31, 2013 Compared to the Year Ended May 31, 2012

 

    

Year Ended
May 31, 2013
Net Sales Growth
As Reported

   

Currency
Impact

   

Year Ended
May 31, 2013
Net Sales Growth in
Local Currencies

 

Knees

     (0.2 )%      1.6     1.4

Hips

     —       2.1     2.1

Sports, Extremities, Trauma (S.E.T.)

     66.0     2.4     68.4

Spine, Bone Healing and Microfixation

     (0.7 )%      0.6     (0.1 )% 

Dental

     (4.0 )%      2.1     (1.9 )% 

Cement, Biologics and Other

     (3.7 )%      1.8     (1.9 )% 
  

 

 

   

 

 

   

 

 

 

Net Sales

     7.6     1.7     9.3
  

 

 

   

 

 

   

 

 

 

 

    

Year Ended
May 31, 2013
Net Sales Growth
As Reported

   

Currency
Impact

   

Year Ended
May 31, 2013
Net Sales Growth in
Local Currencies

 

United States

     8.7     —       8.7

Europe

     1.1     4.2     5.3

International

     13.8     4.6     18.4
  

 

 

   

 

 

   

 

 

 

Total

     7.6     1.7     9.3
  

 

 

   

 

 

   

 

 

 

For the Year Ended May 31, 2012 Compared to the Year Ended May 31, 2011

 

    

Year Ended
May 31, 2012
Net Sales Growth
As Reported

 

Currency
Impact

 

Year Ended
May 31, 2012
Net Sales Growth in
Local Currencies

Knees

   3.0%   (0.7)%   2.3%

Hips

   5.9%   (0.8)%   5.1%

Sports, Extremities, Trauma (S.E.T.)

   13.1%   (0.5)%   12.6%

Spine, Bone Healing and Microfixation

   (0.5)%   (0.1)%   (0.6)%

Dental

   (0.7)%   (0.6)%   (1.3)%

Cement, Biologics and Other

   2.7%   (0.6)%   2.1%
  

 

 

 

 

 

Net Sales

   3.9%   (0.6)%   3.3%
  

 

 

 

 

 

 

    

Year Ended
May 31, 2012
Net Sales Growth
As Reported

 

Currency
Impact

 

Year Ended
May 31, 2012
Net Sales Growth in
Local Currencies

United States

   3.3%   —  %   3.3%

Europe

   0.7%   (0.4)%   0.3%

International

   12.5%   (3.3)%   9.2%
  

 

 

 

 

 

Total

   3.9%   (0.6)%   3.3%
  

 

 

 

 

 

 

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Results of Operations

For the Six Months Ended November 30, 2013 Compared to the Six Months Ended November 30, 2012

 

(in millions, except percentages)   

Six Months
Ended November 30,
2013

   

Percentage
of Net Sales

   

Six Months
Ended November 30,
2012

   

Percentage
of

Net Sales

   

Percentage
Increase/
(Decrease)

 

Net sales

   $ 1,556.4        100.0   $ 1,497.5        100.0     3.9

Cost of sales

     522.2        33.6        464.1        31.0        12.5   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     1,034.2        66.4        1,033.4        69.0        0.1   

Selling, general and administrative expense

     594.6        38.2        592.9        39.6        0.3   

Research and development expense

     78.9        5.1        72.2        4.8        9.3   

Amortization

     150.7        9.7        156.1        10.4        (3.5
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating income

     210.0        13.5        212.2        14.2        (1.0

Interest expense

     193.3        12.4        222.0        14.8        (12.9

Other (income) expense

     5.9        0.4        161.5        10.8        (96.3
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net

     199.2        12.8        383.5        25.6        (48.1
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     10.8        0.7        (171.3     (11.4     (106.3

Benefit from income taxes

     (25.2     (1.6     (73.6     (4.9     (65.8
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 36.0        2.3   $ (97.7     (6.5 )%      (136.8 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income(1)

   $ 202.2        13.0   $ 164.8        11.0     22.7

Adjusted EBITDA(1)

   $ 529.0        34.0   $ 532.2        35.5     (0.6 )% 

 

(1) See “—Non-GAAP Disclosures.”

Sales

Net sales were $1,556.4 million for the six months ended November 30, 2013, and $1,497.5 million for the six months ended November 30, 2012.

The following tables provide net sales by geography and product category:

Sales by Geography Summary

 

(in millions, except percentages)   

Six Months
Ended November 30,
2013

    

Percentage of
Net Sales

   

Six Months
Ended November 30,
2012

    

Percentage of
Net Sales

   

Percentage
Increase/
(Decrease)

 

United States

   $ 963.0         61.9   $ 923.0         61.6     4.3

Europe

     363.3         23.3        336.8         22.5        7.9   

International(1)

     230.1         14.8        237.7         15.9        (3.2
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

   $ 1,556.4         100.0   $ 1,497.5         100.0     3.9
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

(1) International primarily includes Canada, Latin America and the Asia Pacific region.

 

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Product Category Summary

 

(in millions, except percentages)   

Six Months
Ended
November 30,
2013

    

Percentage of
Net Sales

   

Six Months
Ended
November 30,
2012

    

Percentage of
Net Sales

   

Percentage
Increase/
(Decrease)

 

Knees

   $ 489.1         31.4   $ 465.1         31.1     5.1

Hips

     317.4         20.4        311.0         20.8        2.1   

Sports, Extremities, Trauma (S.E.T.)

     309.8         19.9        279.5         18.7        10.8   

Spine, Bone Healing and Microfixation

     206.5         13.3        211.4         14.1        (2.3

Dental

     124.4         8.0        124.1         8.3        0.2   

Cement, Biologics & Other

     109.2         7.0        106.4         7.0        2.8   
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

   $ 1,556.4         100.0   $ 1,497.5         100.0     3.9
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Knees

Net sales of knee products for the six months ended November 30, 2013 were $489.1 million, or 31.4% of net sales, representing a 5.1% increase worldwide (6.3% increase on a constant currency basis) compared to net sales of $465.1 million, or 31.1% of net sales, during the six months ended November 30, 2012, with a 6.7% increase in the United States. Global pricing declined during the first and second quarters on a year-over-year basis in the low single digit range, which is generally consistent with pricing trends we have experienced over the last few years. Sales growth was driven by new product launches and instrument line extensions. Key products that received strong demand during the six months ended November 30, 2013 included our Oxford® Partial Knee, our Vanguard® SSK 360 Revision System, E1® Vitamin E infused polyethylene bearings, the Vanguard® Complete Knee System and the Signature Personalized Patient Care System. The Signature System was developed through a partnership with Materialise NV. The sales growth for our Oxford® Partial Knee was largely due to product line extensions, our increased communications highlighting the benefits of the Oxford® system, as well as our Oxford® knee lifetime implant replacement warranty in the United States, through our direct-to-consumer campaigns.

Hips

Net sales of hip products for the six months ended November 30, 2013 were $317.4 million, or 20.4% of net sales, representing a 2.1% increase worldwide (3.8% increase on a constant currency basis) compared to net sales of $311.0 million, or 20.8% of net sales, during the six months ended November 30, 2012, with a 3.1% increase in the United States. Global pricing declined during the first and second quarters on a year-over-year basis in the low single digit range, which is generally consistent with pricing trends we have experienced over the last few years. Sales of revision products, which are used in procedures to replace, repair or enhance an initial implant, contributed to our hip sales growth during the six months ended November 30, 2013, with strong demand for our Arcos® Modular Femoral Revision System and Regenerex® Porous Titanium Construct. The Taperloc® Complete Hip System and Echo® Hip System also contributed to our hip sales growth. Additionally, we launched our G7 Acetabular System during the second quarter of fiscal year 2014 in the United States and Japan, while we continued the limited launch of our Signature Personalized Patient Care System that is designated to assist with proper placement of acetabular cups.

S.E.T.

Worldwide net sales of S.E.T. products for the six months ended November 30, 2013 were $309.8 million, or 19.9% of net sales, representing a 10.8% increase (12.1% increase on a constant currency basis) compared to net sales of $279.5 million, or 18.7% of net sales, during the six months ended November 30, 2012, with an 11.8% increase in the United States. The key drivers of our S.E.T. sales increase included continued growth in our Comprehensive® Shoulder System including our Primary, Reverse, Fracture and S.R.S. (Segmental Revision System) products, our DVR® family of wrist fracture systems and our JuggerKnot soft anchors, as well as two additional weeks of trauma sales related to the 2012 Trauma Acquisition when comparing period over period, partially offset by unfavorable foreign currency fluctuations.

 

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Spine, Bone Healing and Microfixation

Worldwide net sales of spine, bone healing and microfixation products for the six months ended November 30, 2013 were $206.5 million, or 13.3% of net sales, representing a 2.3% decrease (2.4% decrease on a constant currency basis) compared to net sales of $211.4 million, or 14.1% of net sales, for the six months ended November 30, 2012. The decrease in net sales was primarily driven by the divestiture of our bracing business, which closed on February 28, 2013, and decreased spine royalty revenue. These decreases were partially offset by increases due to distribution optimization efforts in spine, increased microfixation sales and the benefit of one month of sales related to the 2013 Spine Acquisition.

Dental

Worldwide net sales of dental reconstructive products for the six months ended November 30, 2013 were $124.4 million, or 8.0% of net sales, representing a 0.2% increase (0.2% increase on a constant currency basis) compared to net sales of $124.1 million, or 8.3% of net sales, during the six months ended November 30, 2012. Dental sales in the United States increased 6.7%. Sales growth was primarily driven by increased U.S. sales and the launch of our T3® implant. Our sales were negatively impacted by back orders that we experienced late in the first quarter due to a packaging issue that led to a recall. We have taken corrective action and the supply issue has been eliminated.

Cement, Biologics and Other

Worldwide net sales of cement, biologics and other products for the six months ended November 30, 2013 were $109.2 million, or 7.0% of net sales, representing a 2.8% increase (2.3% increase on a constant currency basis) compared to net sales of $106.4 million, or 7.0% of net sales, during the six months ended November 30, 2012, with a 1.5% decrease in the United States. Cement product sales were primarily driven by demand for the Optipac® Pre-Packed Cement Mixing System, the Optivac® Vacuum Mixing System and StageOne Knee and Modular Hip Cement Spacer Molds, as well as strong market acceptance of Cobalt bone cement in Japan. These increases were partially offset by a decrease in sales of autologous therapies.

Cost of Sales

Cost of sales for the six months ended November 30, 2013 increased to $522.2 million, as compared to cost of sales for the six months ended November 30, 2012 of $464.1 million, or 33.6% and 31.0% of net sales, respectively, an increase of $58.1 million or 2.6% of net sales. Cost of sales as a percentage of net sales increased 1.3% due primarily to the medical device tax, higher depreciation on instruments and unfavorable foreign currency translation. Cost of sales as a percentage of net sales increased 1.3% attributable to product liability charges and costs of operational improvement initiatives in the plant network, partially offset by product rationalization charges in the prior year which reflected product redundancies related to the 2012 Trauma Acquisition.

Gross Profit

Gross profit for the six months ended November 30, 2013 increased to $1,034.2 million, as compared to gross profit for the six months ended November 30, 2012 of $1,033.4 million, or 66.4% and 69.0% of net sales, respectively, an increase of $0.8 million, or a decrease of 2.6% of net sales. Gross profit as a percentage of net sales decreased 1.3% primarily due to lower average selling prices, higher depreciation on instruments, the medical device tax and unfavorable foreign currency translation. Gross profit as a percentage of net sales decreased 1.3% attributable to product liability charges and costs of operational improvement initiatives in the plant network.

Selling, General and Administrative Expense

Selling, general and administrative expense during the six months ended November 30, 2013 and 2012 was $594.6 million and $592.9 million, respectively, or 38.2% and 39.6% of net sales, respectively, an increase

 

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of $1.7 million or a decrease of 1.4% of net sales. Expense as a percentage of net sales decreased by 0.4% due to the leveraging of sales and marketing expenses partially offset by increased spending on direct-to-consumer advertising. Expense as a percentage of net sales decreased by 1.0% related to lower stock-based compensation expense and costs related to the 2012 Trauma Acquisition, partially offset by costs related to the 2013 Spine Acquisition.

Research and Development Expense

Research and development expense increased during the six months ended November 30, 2013 to $78.9 million, or 5.1% of net sales, from $72.2 million, or 4.8% of net sales for the six months ended November 30, 2012, an increase of $6.7 million or 0.3% of net sales. An increase of 0.5% is attributable to investments in new product development, regulatory affairs and clinical investments in both our core businesses as well as emerging technology areas, offset by a decrease of 0.2% due to lower stock-based compensation expense.

Amortization

Amortization expense for the six months ended November 30, 2013 was $150.7 million, or 9.7% of net sales, compared to $156.1 million for the six months ended November 30, 2012, or 10.4% of net sales. This decrease of $5.4 million is primarily due to the intangible asset impairment charge taken in the third quarter of fiscal year 2013 related to our Dental Reconstructive reporting unit, partially offset by additional amortization expense related to the 2013 Spine Acquisition.

Interest Expense

Interest expense was $193.3 million for the six months ended November 30, 2013, compared to interest expense of $222.0 million for the six months ended November 30, 2012. Interest expense was impacted by a charge of $21.8 million related to the termination of our euro-denominated interest rate swaps in connection with the refinancing of our euro-denominated debt described in “Note 7—Debt” to the condensed consolidated financial statements contained elsewhere in this prospectus. This expense was more than offset by lower average interest rates on our term loans and lower bond interest as a result of refinancing activities in fiscal years 2013 and 2014.

Other (Income) Expense

Other (income) expense was an expense of $5.9 million for the six months ended November 30, 2013, compared to an expense of $161.5 million for the six months ended November 30, 2012. The decrease in the amount of the expense was primarily due to our recording fees related to our refinancing activities of $167.7 million in the six months ended November 30, 2012.

Benefit from Income Taxes

The effective income tax rate was (233.3)% for the six months ended November 30, 2013, compared to 43.0% for the six months ended November 30, 2012. Primary factors in determining the effective tax rate include the mix of various jurisdictions in which profits are projected to be earned and taxed, as well as assertions regarding the expected repatriation of earnings of our foreign operations. Fluctuations in effective tax rates between comparable periods also reflect the discrete tax benefit or expense of items in continuing operations that represent tax effects not attributable to current-year ordinary income. Discrete items, consisting primarily of changes in deferred taxes due to state and international reorganizations, release of valuation allowance on state net operating loss carryforwards and the prospective reduction of the United Kingdom statutory corporate tax rate enacted in July 2013, impacted the quarterly income tax provision by $(26.1) million, or (242.1)%, in the six

 

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months ended November 30, 2013. Discrete items impacted the quarterly income tax provision by $(3.6) million, or 2.1%, in the six months ended November 30, 2012, primarily as a result of changes in deferred tax balances due to an earlier reduction of the United Kingdom statutory corporate tax rate enacted in July 2012.

Non-GAAP Financial Measures

Adjusted Net Income

Adjusted net income increased to $202.2 million for the six months ended November 30, 2013 compared to $164.8 million for the six months ended November 30, 2012, or 13.0% and 11.0% of net sales, respectively.

Operating income decreased Adjusted net income by $2.3 million, and 1.2% as a percentage of net sales, driven by:

 

    Cost of sales as a percentage of net sales increased 1.3% due to lower average selling prices, higher depreciation on instruments, the medical device tax and unfavorable foreign currency translation.

 

    Selling, general and administrative expense as a percentage of net sales decreased by 0.4% due to the leveraging of sales and marketing expenses partially offset by increased spending on direct-to-consumer advertising.

 

    Research and development expense increased as a percentage of net sales by 0.5% as a result of investments in new product development, regulatory affairs and clinical investments in both our core businesses as well as emerging technology areas.

Interest expense increased Adjusted net income $50.5 million, or 3.8% as a percentage of net sales, reflecting the favorable impact of lower average interest rates on our term loans and bonds as a result of our 2013 refinancing activities.

Other (income) expense decreased Adjusted net income by $5.9 million, or 0.4% as a percentage of net sales. Other (income) expense represents primarily net currency gains and losses on intercompany amounts owed between our separate legal entities and such net gains were higher in the prior year.

The effective tax rate for the six months ended November 30, 2013 attributable to Adjusted net income decreased to 22.0% compared to 24.0% in the prior year period reflecting an increased mix of global pre-tax income generated in lower tax jurisdictions.

Adjusted EBITDA

Adjusted EBITDA was $529.0 million for the six months ended November 30, 2013 compared to $532.2 million for the six months ended November 30, 2012, or 34.0% and 35.5% of net sales, respectively. The decline in Adjusted EBITDA is attributable to lower average selling prices, the medical device tax and unfavorable foreign currency translation.

 

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For the Year Ended May 31, 2013 Compared to the Year Ended May 31, 2012

 

(in millions, except percentages)   

Year Ended
May 31, 2013

   

Percentages
of Net Sales

   

Year Ended
May 31, 2012

   

Percentages
of Net Sales

   

Percentage
Increase/

(Decrease)

 

Net sales

   $ 3,052.9        100.0   $ 2,838.1        100.0     7.6

Cost of sales

     996.5        32.6        894.4        31.5        11.4   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     2,056.4        67.4        1,943.7        68.5        5.8   

Selling, general and administrative expense

     1,189.4        39.0        1,053.3        37.1        12.9   

Research and development expense

     150.3        4.9        126.8        4.5        18.5   

Amortization

     313.8        10.3        327.2        11.5        (4.1

Goodwill impairment charge

     473.0        15.5        291.9        10.3        *   

Intangible assets impairment charge

     94.4        3.1        237.9        8.4        *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (164.5     (5.4     (93.4     (3.3     *   

Interest expense

     398.8        13.1        479.8        16.9        (16.9

Other (income) expense

     177.8        5.8        17.6        0.6        *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net

     576.6        18.9        497.4        17.5        *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (741.1     (24.3     (590.8     (20.8     *   

Benefit from income taxes

     (117.7     (3.9     (132.0     (4.6     *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ (623.4     (20.4 )%    $ (458.8     (16.2 )%      *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income(1)

   $ 365.7        12.0   $ 251.8        8.9     45.2

Adjusted EBITDA(1)

   $ 1,075.9        35.2   $ 1,013.5        35.7     6.2

 

(1) See “—Non-GAAP Disclosures.”

 

* The percentage change is not as meaningful as the change in the dollar value.

Sales

Net sales were $3,052.9 million for the year ended May 31, 2013, and $2,838.1 million for the year ended May 31, 2012. The following tables provide net sales by geography and product category:

Geography Sales Summary

 

(in millions, except percentages)   

Year Ended
May 31, 2013

    

Percentage of
Net Sales

   

Year Ended
May 31, 2012

    

Percentage of
Net Sales

   

Percentage
Increase/
Decrease

 

United States

   $ 1,862.2         61.0   $ 1,713.3         60.4     8.7

Europe

     710.2         23.3        702.7         24.8        1.1   

International(1)

     480.5         15.7        422.1         14.8        13.8   
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

     3,052.9         100.0   $ 2,838.1         100.0     7.6
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

(1) International primarily includes Canada, Latin America and the Asia Pacific region.

Product Category Summary

 

(in millions, except percentages)   

Year Ended
May 31, 2013

    

Percentage of
Net Sales

   

Year Ended
May 31, 2012

    

Percentage of
Net Sales

   

Percentage
Increase/
(Decrease)

 

Knees

   $ 940.0         30.8   $ 941.8         33.2     (0.2 )% 

Hips

     632.7         20.7        633.0         22.3        0.0   

Sports, Extremities, Trauma (S.E.T.)

     600.1         19.7        361.6         12.7        66.0   

Spine, Bone Healing and Microfixation

     408.8         13.4        411.5         14.5        (0.7

Dental

     257.0         8.4        267.7         9.4        (4.0

Cement, Biologics and Other

     214.3         7.0        222.5         7.8        (3.7
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

   $ 3,052.9         100.0   $ 2,838.1         100.0     7.6
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

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Knees

Net sales of knee products for the year ended May 31, 2013 were $940.0 million, or 30.8% of net sales, representing a 0.2% decrease worldwide (1.4% increase on a constant currency basis) compared to net sales of $941.8 million, or 33.2% of net sales, during the year ended May 31, 2012, with a 0.6% increase in the United States. Procedure volume and favorable product mix during the year were partially offset by low single digit price declines. Key products during the year ended May 31, 2013 included our Vanguard® SSK 360 Revision System, the Signature Personalized Patient Care System, E1® Vitamin E infused bearings and the OSS Orthopaedic Salvage System.

Hips

Net sales of hip products for the year ended May 31, 2013 were $632.7 million, or 20.7% of net sales were flat worldwide (2.1% increase on a constant currency basis) compared to net sales of $633.0 million, or 22.3% of net sales, during the year ended May 31, 2012, with a 1.8% increase in the United States. Procedure volume and favorable product mix during the year were partially offset by low single digit price declines. We continued to see strong market demand for our Arcos® Modular Femoral Revision System and our new Taperloc® Complete Hip Stem during the year ended May 31, 2013. In addition, the Microplasty® version of the Taperloc® Complete Hip Stem and the GTS (Global Tissue Sparing) short stem received strong market acceptance. Key acetabular products included the Ringloc®+ cup, E1® and ArCom XL® bearings, as well as our Active Articulation Systems that are available with E1® or ArCom XL® liners.

S.E.T.

Worldwide net sales of S.E.T. products for the year ended May 31, 2013 were $600.1 million, or 19.7% of net sales, representing a 66.0% increase (68.4% increase on a constant currency basis) compared to net sales of $361.6 million, or 12.7% of net sales, during the year ended May 31, 2012. S.E.T. sales, excluding the 2012 Trauma Acquisition, increased 9.1% worldwide and 11.8% in the United States. Sales of $205.6 million from the 2012 Trauma Acquisition were excluded in order to provide period-over-period comparability. The sales increase was primarily driven by strong demand for our JuggerKnot brand, which includes soft anchors to repair soft tissue in the shoulder, hand and wrist, and foot and ankle and strong market demand for our Comprehensive® shoulder product lines including our Primary, Reverse, Fracture and S.R.S. (Segmental Revision System) Shoulder Systems. Additional key products contributing to the sales growth were the TunneLoc® Tibial Fixation Device and the ToggleLoc Femoral Fixation Device with and without ZipLoop Technology. Key products acquired as a result of the 2012 Trauma Acquisition include the DVR® Anatomic Volar Plating Systems, the A.L.P.S Plating Systems and the AFFIXUS® Hip Fracture Nails.

Spine, Bone Healing and Microfixation

Worldwide net sales of spine, bone healing and microfixation products for the year ended May 31, 2013 were $408.8 million, or 13.4% of net sales, representing a 0.7% decrease (0.1% decrease on a constant currency basis) compared to net sales of $411.5 million, or 14.5% of net sales, for the year ended May 31, 2012. Spine and bone healing sales decreased during the year primarily due to the divestiture of our bracing business, mid-single-digit price erosion, soft volumes due to the general economy, a challenging reimbursement environment for some fusion procedures and competition from physician-owned distributorships. The sales decrease was partially offset by increased royalty revenue and continued strong sales in microfixation, which were driven by continued market acceptance of the iQ® Intelligent Delivery System, the TraumaOne Plating System and the SternaLock® Blu Primary Closure System, as well as the Pectus Bar product line.

Dental

Worldwide net sales of dental reconstructive products for the year ended May 31, 2013 were $257.0 million, or 8.4% of net sales, representing a 4.0% decrease (1.9% decrease on a constant currency basis) compared to net sales of $267.7 million, or 9.4% of net sales, during the year ended May 31, 2012. Dental sales

 

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in the United States increased 4.1% during the year ended May 31, 2013. While the U.S. dental market has been stronger than the market in Europe, there was continued softness worldwide as challenging economic conditions persisted. Dental sales were negatively impacted by unfavorable media reports in Japan related to the dental implant industry.

Cement, Biologics and Other

Worldwide net sales of cement, biologics and other products for the year ended May 31, 2013 were $214.3 million, or 7.0% of net sales, representing a 3.7% decrease (1.9% decrease on a constant currency basis) compared to net sales of $222.5 million, or 7.8% of net sales, during the year ended May 31, 2012. Cement sales grew due to demand for our Cobalt MV (Medium Viscosity) and HV (High Viscosity) cements with Gentamicin contributing to our sales in this category. The Optipac® Pre-Packed Cement Mixing System (not available in the United States) continued to be well received in the European market during the year ended May 31, 2013. Demand for our StageOne Knee and Modular Hip Cement Spacer Molds continued to increase. These increases were more than offset by a decrease in sales of autologous therapies.

Cost of Sales

Cost of sales for the year ended May 31, 2013 increased to $996.5 million as compared to cost of sales for the year ended May 31, 2012 of $894.4 million, or 32.6% and 31.5% of net sales, respectively, an increase of $102.1 million or 1.2% of net sales. Cost of sales as a percentage of net sales decreased 0.1% due to lower manufacturing costs resulting from improvements in our global plant network and improved geographic sales mix, partially offset by the medical device tax. Cost of sales as a percentage of net sales increased 1.3% due to increased litigation settlements and reserves and product rationalization charges in our global spine and trauma product lines. Product rationalization is related to more focused product offerings for spine through innovative product development and to product redundancies related to the 2012 Trauma Acquisition.

Gross Profit

Gross profit for the year ended May 31, 2013 increased to $2,056.4 million as compared to gross profit for the year ended May 31, 2012 of $1,943.7 million, or 67.4% and 68.5% of net sales, respectively, an increase of $112.7 million or a decrease of 1.1% of net sales. Gross profit as a percentage of net sales increased 0.1% due to lower manufacturing costs resulting from improvements in our global plant network and improved geographic sales mix, partially offset by the medical device tax and lower selling prices. Gross profit as a percentage of net sales decreased 1.2% due to increased litigation settlements and reserves and product rationalization charges in our global spine and trauma product lines. Product rationalization is related to more focused product offerings for spine through innovative product development and to product redundancies related to the 2012 Trauma Acquisition.

Selling, General and Administrative Expense

Selling, general and administrative expense during the year ended May 31, 2013 and May 31, 2012 was $1,189.4 million and $1,053.3 million, respectively, or 39.0% and 37.1% of net sales, respectively, an increase of $136.1 million or 1.9% of net sales. Expense as a percentage of net sales increased by 1.0% due to investments in our sales force related to the 2012 Trauma Acquisition and direct-to-consumer marketing campaign and increased bad debt expense primarily outside of the United States. Expense also increased as a percentage of net sales by 0.9% related to stock-based compensation expense, litigation and other legal fees, and costs related to the 2012 Trauma Acquisition. See “Note 12—Share-based Compensation and Stock Plans” to the consolidated financial statements contained elsewhere in this prospectus, for discussion of modifications contributing to increased stock-based compensation expense. Prior year litigation and other legal fees benefited from a legal settlement related to the Heraeus litigation. For a description of the Heraeus litigation, see “Business—Legal Matters.”

 

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Research and Development Expense

Research and development expense during the year ended May 31, 2013 and May 31, 2012 was $150.3 million and $126.8 million, respectively, or 4.9% and 4.5% of net sales, respectively, an increase of $23.5 million or 0.4% of net sales. Research and development increased as a percentage of net sales by 0.3% due to investments in both our core business, including the 2012 Trauma Acquisition within S.E.T., as well as targeted emerging technologies. Expense also increased as a percentage of net sales by 0.1% due to stock-based compensation expense.

Amortization

Amortization expense for the year ended May 31, 2013 was $313.8 million, or 10.3% of net sales, compared to $327.2 million for the year ended May 31, 2012, or 11.5% of net sales. This decrease was primarily due to intangible asset impairment charges taken during both fiscal years 2013 and 2012 as described below.

Goodwill Impairment Charge

In fiscal year 2013, we recorded a $473.0 million goodwill impairment charge, related to our dental reconstructive and Europe reporting units, primarily due to the impact of continued austerity measures on procedural volumes and pricing in certain European countries when compared to our prior projections used to establish the fair value of goodwill for our Europe reporting unit and primarily due to declining industry market growth rates in certain European and Asia Pacific markets and corresponding unfavorable margin trends when compared to our prior projections used to establish the fair value of goodwill for our dental reconstructive reporting unit. In fiscal year 2012, we recorded a $291.9 million goodwill impairment charge, primarily related to our spine, bone healing and microfixation and dental reconstructive reporting units, due primarily to evidence of declining industry market growth rates in certain European and Asia Pacific markets and unfavorable margin trends resulting from changes in product mix in our dental reconstructive reporting unit and growth rate declines as compared to the original purchase accounting assumptions at the time of the 2007 Acquisition for our spine and bone healing reporting unit.

Intangible Assets Impairment Charge

In fiscal year 2013, we recorded a $94.4 million definite and indefinite-lived intangible asset impairment charge, related to the factors discussed in the Goodwill Impairment Charge paragraph above. During fiscal year 2012, we recorded a $237.9 million definite and indefinite-lived intangible asset impairment charge, related to the factors discussed in the Goodwill Impairment Charge paragraph above.

Interest Expense

Interest expense was $398.8 million for the year ended May 31, 2013, compared to interest expense of $479.8 million for the year ended May 31, 2012. The decrease in interest expense was primarily due to lower average interest rates on our term loans and lower bond interest as a result of refinancing activities in fiscal year 2013.

Other (Income) Expense

Other (income) expense was expense of $177.8 million for the year ended May 31, 2013, compared to expense of $17.6 million for the year ended May 31, 2012. The expense for the year ended May 31, 2013 is primarily composed of the loss on retirement of bonds of $155.2 million and the write off of deferred financing fees related to the tender/retirement of our senior notes due 2017 of $17.1 million, while the year ended May 31, 2012 included an other-than-temporary impairment loss related to Greek bonds.

 

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Benefit from Income Taxes

The effective income tax rate was 15.9% for the year ended May 31, 2013 compared to 22.3% for the year ended May 31, 2012. The primary factor in determining the effective tax rate is the mix of various jurisdictions in which profits have to be earned and taxed. The effective tax rate was also impacted by non-deductible goodwill impairment. In fiscal years ended May 31, 2013 and 2012, $474.4 million and $291.9 million of goodwill impairment charges, respectively, were treated as non-deductible permanent differences and contributed significantly to the effective tax rate being lower than U.S. statutory tax rates. The effective tax rate for the year ended May 31, 2013 was decreased due to increases in valuation allowances relating to foreign net operating loss carryforwards, increases in the company’s state effective tax rate and an increase in liabilities for uncertain tax benefits, offset by reductions related to changes in assumptions regarding the permanent reinvestment of earnings of foreign operations and the reduction in United Kingdom tax rates. The May 31, 2012 effective tax rate decreased due to income inclusions related to U.S. anti-deferral provisions and updated assertions regarding the permanent reinvestment of earnings of foreign operations, offset by settlements relating to uncertain tax benefits and changes in statutory tax rates (particularly in the United Kingdom).

Non-GAAP Financial Measures

Adjusted Net Income

Adjusted net income increased to $365.7 million for the year ended May 31, 2013 compared to $251.8 million for the year ended May 31, 2012, or 12.0% and 8.9% of net sales, respectively. The $113.9 million improvement in Adjusted net income was driven by an increase of $30.0 million in operating income. On a percentage of sales basis, Adjusted net income was impacted unfavorably by 1.3% as a result of higher selling, general and administrative and research and development expenses. Interest expense was lower by $81.0 million or 3.8% of net sales due to lower average interest rates on our term loans and lower bond interest as a result of refinancing activities. The effective tax rate attributable to Adjusted net income decreased to 24.0% for the year ended May 31, 2013 from 28.0% for the year ended May 31, 2012. The effective tax rate decreased as a result of the impact of supply chain improvements on the mix of various jurisdictions in which profits were earned and taxed.

Adjusted EBITDA

Adjusted EBITDA increased to $1,075.9 million for the year ended May 31, 2013 compared to $1,013.5 million for the year ended May 31, 2012, or 35.2% and 35.7% of net sales, respectively. Gross profit increased Adjusted EBITDA as a percentage of net sales by 0.1% due to impacts of lower manufacturing costs resulting from improvements in our global plant network and improved geographic sales mix partially offset by the medical device tax and lower selling prices. Selling, general and administrative expense decreased Adjusted EBITDA as a percentage of net sales by 1.0% due to investments in our sales force related to the 2012 Trauma Acquisition and direct-to-consumer marketing campaign and increased bad debt expense primarily outside of the United States. Research and development expense decreased Adjusted EBITDA as a percentage of net sales by 0.3% due to investments in both our core business, including the 2012 Trauma Acquisition within S.E.T., as well as targeted emerging technologies.

 

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For the Year Ended May 31, 2012 Compared to the Year Ended May 31, 2011

 

(in millions, except percentages)   

Year Ended
May 31, 2012

   

Percentages
of Net Sales

   

Year Ended
May 31, 2011

   

Percentages
of Net Sales

   

Percentage

Increase/(Decrease)

 

Net sales

   $ 2,838.1        100.0   $ 2,732.2        100.0     3.9

Cost of sales

     894.4        31.5        838.7        30.7        6.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     1,943.7        68.5        1,893.5        69.3        2.7   

Selling, general and administrative expense

     1,053.3        37.1        1,041.7        38.1        1.1   

Research and development expense

     126.8        4.5        119.4        4.4        6.2   

Amortization

     327.2        11.5        367.9        13.5        (11.1

Goodwill impairment charge

     291.9        10.3        422.8        15.5        *   

Intangible assets impairment charge

     237.9        8.4        518.6        19.0        *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (93.4     (3.3     (576.9     (21.1     *   

Interest expense

     479.8        16.9        498.9        18.3        (3.8

Other (income) expense

     17.6        0.6        (11.2     (0.4     *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other expense, net

     497.4        17.5        487.7        17.9        2.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income taxes

     (590.8     (20.8     (1,064.6     (39.0     *   

Benefit from income taxes

     (132.0     (4.6     (214.8     (7.9     *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (458.8     (16.2 )%    $ (849.8     (31.1 )%      *   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income(1)

   $ 251.8        8.9   $ 205.2        7.5     22.7

Adjusted EBITDA(1)

   $ 1,013.5        35.7   $ 1,021.6        37.4     (0.8 )% 

 

(1) See “—Non-GAAP Disclosures.”

 

* The percentage change is not as meaningful as the change in the dollar value.

Sales

Net sales were $2,838.1 million for the year ended May 31, 2012, and $2,732.2 million for the year ended May 31, 2011. The following tables provide net sales by geography and product category:

Geography Sales Summary

 

(in millions, except percentages)   

Year Ended
May 31, 2012

    

Percentage of
Net Sales

   

Year Ended
May 31, 2011

    

Percentage
of Net Sales

   

Percentage
Increase/
Decrease

 

United States

   $ 1,713.3         60.4   $ 1,659.2         60.7     3.3

Europe

     702.7         24.8        697.8         25.5        0.7   

International(1)

     422.1         14.8        375.2         13.8        12.5   
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

   $ 2,838.1         100.0   $ 2,732.2         100.0     3.9
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

(1) International primarily includes Canada, Latin America and the Asia Pacific region.

 

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Product Category Summary

 

(in millions, except percentages)   

Year Ended
May 31,
2012

    

Percentage of
Net Sales

   

Year Ended
May 31, 2011

    

Percentage of
Net Sales

   

Percentage
Increase/
(Decrease)

 

Knees

   $ 941.8         33.2   $ 914.4         33.5     3.0

Hips

     633.0         22.3        598.0         21.9        5.9   

Sports, Extremities, Trauma (S.E.T.)

     361.6         12.7        319.8         11.7        13.1   

Spine, Bone Healing and Microfixation

     411.5         14.5        413.7         15.1        (0.5

Dental

     267.7         9.4        269.5         9.9        (0.7

Cement, Biologics and Other

     222.5         7.8        216.8         7.9        2.7   
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Total

   $ 2,838.1         100.0   $ 2,732.2         100.0     3.9
  

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Knees

Net sales of knee products for the year ended May 31, 2012 were $941.8 million, or 33.2% of net sales, representing a 3.0% increase worldwide (2.3% increase on a constant currency basis) compared to net sales of $914.4 million, or 33.5% of net sales, during the year ended May 31, 2011. The worldwide knee sales growth was primarily due to increased sales in Europe and our International countries. Europe knee sales increased primarily due to sales growth of primary and revision components of our Vanguard® Knee, as well as demand for OSS Orthopaedic Salvage System. Knee sales grew in our International countries principally from increased demand for our Vanguard® Complete Knee System. Worldwide knee sales growth was partially offset by decreased partial knee sales. We believe partial knee sales have declined due to macroeconomic conditions impacting patients and competition from others with partial knee product offerings in the marketplace during the last several years.

Hips

Net sales of hip products for the year ended May 31, 2012 were $633.0 million, or 22.3% of net sales, representing a 5.9% increase worldwide (5.1% increase on a constant currency basis) compared to net sales of $598.0 million, or 21.9% of net sales, during the year ended May 31, 2011. We believe the sales increase was primarily driven by the strong market acceptance of the new Arcos® Modular Femoral Revision System, our Taperloc® Complete Hip Stem, E1® Antioxidant Infused Acetabular Liners and the new Active Articulation E1® Hip System. Our worldwide hip sales growth was impacted by the industry-wide erosion of metal-on-metal hip sales.

S.E.T.

Worldwide net sales of S.E.T. products for the year ended May 31, 2012 were $361.6 million, or 12.7% of net sales, representing a 13.1% increase (12.6% increase on a constant currency basis) compared to net sales of $319.8 million, or 11.7% of net sales, during the year ended May 31, 2011. Sales growth was driven by the JuggerKnot Soft Anchor due to increased volumes. During the fourth fiscal quarter, we completed the commercial launch of the JuggerKnot Short Soft Anchor used for foot and ankle repair, which also contributed to the growth. The Comprehensive® Primary and Reverse Shoulder Systems continued to drive strong sales growth for the extremity product category. During the fourth fiscal quarter we launched a couple of line extensions, including a small base plate for the reverse shoulder and E1® bearings which contributed to our extremity sales. External fixation product sales declined due to a continued market shift from external fixation to internal fixation products and competitive pressures, partially offset by increased internal fixation sales. The increased internal fixation sales were primarily due to sales growth for the OptiLock® VL Distal Radius Plating System, the OptiLock® Humeral Plating System, and the Phoenix Ankle Arthrodesis Nail System.

 

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Spine, Bone Healing and Microfixation

Worldwide net sales of spine, bone healing and microfixation products for the year ended May 31, 2012 were $411.5 million, or 14.5% of net sales, representing a 0.5% decrease (0.6% decrease on a constant currency basis) compared to net sales of $413.7 million, or 15.1% of net sales, for the year ended May 31, 2011. We believe the spine market continued to be affected by mid-single-digit price erosion, soft volumes due to the general economy, a challenging reimbursement environment for some fusion procedures, and competition from physician-owned distributorships. The decreases were partially offset by increased microfixation product sales.

Dental

Worldwide net sales of Dental Reconstructive products for the year ended May 31, 2012 were $267.7 million, or 9.4% of net sales, representing a 0.7% decrease (1.3% decrease on a constant currency basis) compared to net sales of $269.5 million, or 9.9% of net sales, during the year ended May 31, 2011. The decreased dental sales were primarily due to weakness in the European market due to the economic uncertainty in the regions where we currently have the largest market share, which were partially offset by sales growth in the United States driven, in part, by increased average selling prices.

Cement, Biologics and Other

Worldwide net sales of cement, biologics & other products for the year ended May 31, 2012 were $222.5 million, or 7.8% of net sales, representing a 2.7% increase (2.1% increase on a constant currency basis) compared to net sales of $216.8 million, or 7.9% of net sales, during the year ended May 31, 2011. Sales of bone cement increased worldwide and in the United States during the year ended May 31, 2012, compared to the year ended May 31, 2011. Sales of Cobalt Bone Cement with Gentamicin, the Optipac® Pre-packed Vacuum Mixing System (not available in the United States) and our StageOne Hip and Knee Cement Spacer Molds, particularly the StageOne Select Modular Hip Spacer Molds, contributed to our sales growth in the bone cement and other reconstructive product category. The increased sales were partially offset by a decrease in sales of autologous therapies.

Cost of Sales

Cost of sales for the year ended May 31, 2012 increased to $894.4 million, compared to cost of sales for the year ended May 31, 2011 of $838.7 million, or 31.5% and 30.7% of net sales, respectively, an increase of $55.7 million or 0.8% of net sales. Cost of sales as a percentage of net sales increased primarily as a result of unfavorable manufacturing variances due to lower production volumes.

Gross Profit

Gross profit for the year ended May 31, 2012 increased to $1,943.7 million, compared to gross profit for the year ended May 31, 2011 of $1,893.5 million, or 68.5% and 69.3% of net sales, respectively, an increase of $50.2 million or a decrease of 0.8% of net sales. Gross profit as a percentage of net sales decreased primarily as a result of a decrease in average selling prices and unfavorable manufacturing due to lower production volumes.

Selling, General and Administrative Expense

Selling, general and administrative expense for the year ended May 31, 2012 and May 31, 2011 was $1,053.3 million and $1,041.7 million, respectively, or 37.1% and 38.1% of net sales, respectively, an increase of $11.6 million or a decrease of 1.0% of net sales. The expense decreased as a percentage of net sales during the year ended May 31, 2012 primarily due to our ability to leverage costs, operational restructuring and lower costs related to settlement of the FCPA investigation as compared to the year ended May 31, 2011, which were partially offset by a legal settlement related to the Heraeus litigation.

 

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Research and Development Expense

Research and development expense during the year ended May 31, 2012 and May 31, 2011 was $126.8 million and $119.4 million, respectively, or 4.5% and 4.4% of net sales, respectively, an increase of $7.4 million or 0.1% of net sales. The slight increase in research and development expense for the year ended May 31, 2012 primarily related to our ongoing commitment to increase investment in clinical research and regulatory affairs within our business. Our principal research and development efforts related to primary and revision large joint reconstructive devices, S.E.T. products, spinal products, dental products, resorbable technologies, biomaterial products and autologous therapies.

Amortization

Amortization expense for the year ended May 31, 2012 was $327.2 million, or 11.5% of net sales, compared to $367.9 million for the year ended May 31, 2011, or 13.5% of net sales. This decrease was primarily due to the intangible asset impairment charge taken in the fourth quarter of fiscal 2012 related to our spine and bone healing and dental reconstructive reporting units and the intangible asset impairment charge taken in the fourth quarter of fiscal 2011 related to our Europe business, both described below.

Goodwill Impairment Charge

During fiscal year 2012, we recorded a $291.9 million goodwill impairment charge, primarily related to our spine and bone healing and dental reconstructive reporting units, due primarily to evidence of declining industry market growth rates in certain European and Asia Pacific markets and unfavorable margin trends resulting from changes in product mix in our dental reconstructive reporting unit and growth rate declines as compared to the original purchase accounting assumptions at the time of the 2007 Acquisition for our spine and bone healing reporting unit. During fiscal year 2011, we recorded a $422.8 million goodwill impairment charge, primarily related to our Europe business due to the continued market slowdown in Europe relative to our original purchase accounting assumptions at the time of the 2007 Acquisition due to the continued financial and credit challenges in some European countries.

Intangible Assets Impairment Charge

During fiscal year 2012, we recorded a $237.9 million definite and indefinite- lived intangible asset impairment charge, related to the factors discussed in the Goodwill Impairment Charge paragraph above. During fiscal year 2011, we recorded a $518.6 million definite and indefinite-lived intangible asset impairment charge, related to the factors discussed in the Goodwill Impairment Charge paragraph above.

Interest Expense

Interest expense was $479.8 million for the year ended May 31, 2012, compared to interest expense of $498.9 million for the year ended May 31, 2011. The change in interest expense was primarily due to a lower average interest rate on our term loan facilities as our interest rate swaps continue to mature, moving more of our term loan facilities from fixed to floating rate debt.

Other (Income) Expense

Other (income) expense was expense of $17.6 million for the year ended May 31, 2012, compared to income of $11.2 million for the year ended May 31, 2011. The decrease is primarily due to an other-than-temporary impairment that was recorded on Greek bonds of $20.1 million for the year ended May 31, 2012 and $7.1 million of expense due to revaluation of our foreign cash accounts.

 

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Benefit from Income Taxes

The effective income tax rate was 22.3% for the year ended May 31, 2012 compared to 20.2% for the year ended May 31, 2011. The primary factor in determining the effective tax rate is the mix of various jurisdictions in which profits have to be earned and taxed. The effective tax rate was also impacted by non-deductible goodwill impairment. In fiscal 2012 and fiscal 2011, $291.9 million and $422.8 million of goodwill impairment charges, respectively, were treated as non-deductible permanent differences and contributed significantly to the effective tax rate being lower than U.S. statutory tax rates. Other items impacting the effective tax rate for the year ended May 31, 2012 include decreases due to income inclusions related to U.S. anti-deferral provisions and updated assertions regarding the permanent reinvestment of earnings of foreign operations, offset by settlements relating to uncertain tax benefits and changes in statutory tax rates (particularly in the United Kingdom). The May 31, 2011 effective tax rate was decreased due to an increase in valuation allowance relating to state and foreign net operating loss carryforwards and an increase in liabilities for uncertain tax benefits, offset by reductions to the company’s state effective tax rate (primarily due to New Jersey’s change to single-sales factor) as well as the reduction in United Kingdom corporate tax rates.

Non-GAAP Financial Measures

Adjusted Net Income

Adjusted net income increased to $251.8 million for the year ended May 31, 2012 compared to $205.2 million for the year ended May 31, 2011, or 8.9% and 7.5% of net sales, respectively. The $46.6 million improvement in Adjusted net income was impacted favorably by $9.5 million of additional operating income. On a percentage of net sales basis, Adjusted net income was unfavorably impacted by lower gross profit partially offset by lower selling, general and administrative and research and development expense. Interest expense was lower by $19.1 million or 1.4% of net sales due to a lower average interest rate on our term loan facilities as our interest rate swaps continue to mature, moving more of our term loan facilities from fixed to floating rate debt. The effective tax rate attributable to Adjusted net income decreased to 28.0% for the year ended May 31, 2012 from 41.4% for the year ended May 31, 2011. The effective tax rate decreased as a result of the impact of supply chain improvements on the mix of various jurisdictions in which profits were earned and taxed.

Adjusted EBITDA

Adjusted EBITDA was $1,013.5 million for the year ended May 31, 2012 compared to $1,021.6 million for the year ended May 31, 2011, or 35.7% and 37.4% of net sales, respectively. Gross profit decreased Adjusted EBITDA as a percentage of net sales primarily as a result of a decrease in average selling prices and unfavorable manufacturing variances due to lower production volumes. Selling, general and administrative expense increased Adjusted EBITDA as a percentage of net sales due to our ability to leverage costs and due to lower costs. A slight increase in research and development expense decreased Adjusted EBITDA as a percentage of net sales.

Liquidity and Capital Resources

The following is a summary of the cash flows by activity for the years-ended May 31, 2013, 2012 and 2011 and the six months ended November 30, 2013 and 2012:

 

     Six Months Ended
November 30,
    Fiscal Year Ended May 31,  
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

 

Net cash from (used in):

          

Operating activities

   $ 170.9      $ 128.6      $ 468.5      $ 377.3      $ 380.1   

Investing activities

     (248.6     (409.3     (488.6     (144.0     (205.0

Financing activities

     (101.2     (51.3     (134.7     (38.1     (51.4

Effect of exchange rate changes on cash

     (0.5     7.1        18.0        (30.6     15.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Change in cash and cash equivalents

   $ (179.4   $ (324.9   $ (136.8   $ 164.6      $ 138.7   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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Our cash and cash equivalents were $176.2 million as of November 30, 2013, compared to $167.5 million as of November 30, 2012. We generally maintain our cash and cash equivalents and investments in money market funds, corporate bonds and debt instruments. Cash and cash equivalents held outside of the United States were $66.2 million as of November 30, 2013. If we were to repatriate this cash back to the United States, additional tax of up to 35.0%, the maximum federal tax rate, could be incurred. In addition, we require a certain amount of cash to support on-going operations outside the United States.

Our cash and cash equivalents were $355.6 million as of May 31, 2013 compared to $492.4 million as of May 31, 2012. We generally maintain our cash and cash equivalents and investments in money market funds, corporate bonds and debt instruments. Cash and cash equivalents held outside of the United States were $320.3 million as of May 31, 2013. If we were to repatriate this cash back to the United States, additional tax of up to 35.0%, the maximum federal tax rate, could be incurred. In addition, we require a certain amount of cash to support on-going operations outside the United States.

Operating Cash Flows

Net cash provided by operating activities was $170.9 million for the six months ended November 30, 2013, compared to cash flows provided of $128.6 million for the six months ended November 30, 2012. The increase in cash from operating activities was primarily related to the $31.4 million decrease in cash paid for interest as a result of our refinancing activities in fiscal year 2013. Cash generated by operating activities continued to be a source of funds for deleveraging and investing in our growth.

Net cash provided by operating activities was $468.5 million for the year ended May 31, 2013, compared to cash flows provided of $377.3 million for the year ended May 31, 2012. Cash generated by operating activities continued to be a source of funds for deleveraging and investing in our growth. The increase in cash provided by operating activities of $91.2 million was primarily due to cash interest savings due to our refinancing activities.

Net cash provided by operating activities was $377.3 million for the year ended May 31, 2012, compared to cash flows provided of $380.1 million for the year ended May 31, 2011. The decrease in cash provided by operating activities of $2.8 million was primarily due to an increase in cash paid for taxes due to net operating losses being fully utilized in the United States and an increase in accounts receivable due to increased sales with an increase in days sales outstanding, which was offset by favorability in inventory and accounts payable.

Investing Cash Flows

Net cash used in investing activities was $248.6 million for the six months ended November 30, 2013, compared to cash used of $409.3 million for the six months ended November 30, 2012. The investing cash flow decrease was primarily due to the 2012 Trauma Acquisition purchase price of $280.0 million included in the six months ended November 30, 2012, partially offset by the 2013 Spine Acquisition purchase price of $148.8 million included in the six months ended November 20, 2013.

Net cash used in investing activities was $488.6 million for the year ended May 31, 2013 and $144.0 million for the year ended May 31, 2012. The investing cash flow decrease was primarily due to the 2012 Trauma Acquisition purchase price of $280.0 million and an increase in capital expenditures of $24.7 million during the year ended May 31, 2013, as compared to the year ended May 31, 2012. Additionally, during the year ended May 31, 2012 we received proceeds from the sales/maturities of investments of $42.1 million primarily related to the sale of a time deposit.

Net cash used in investing activities was $144.0 million for the year ended May 31, 2012 and $205.0 million for the year ended May 31, 2011. The decrease in cash used in investing activities year-over-year

 

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was primarily related to the investment in time deposits. During the fiscal year ended May 31, 2011 we invested in $78.7 million in time deposits and received proceeds of $44.3 million also related to the time deposits. During the fiscal year ended May 31, 2012 we received $33.4 million in proceeds related to the time deposits, but did not make any additional investments.

Financing Cash Flows

Net cash used in financing activities was $101.2 million for the six months ended November 30, 2013, compared to cash used in financing activities of $51.3 million for the six months ended November 30, 2012. The difference was primarily related to the refinancing activities during the fiscal year 2014 and 2013. Additional cash was used for discretionary debt paydown in the six months ended November 30, 2013, partially offset by increased proceeds under revolvers in fiscal year 2014 and lower refinancing fees of $15.5 million during the six months ended November 30, 2013, compared to the higher refinancing fees of $67.8 million during the six months ended November 30, 2012.

Net cash used in financing activities was $134.7 million for the year ended May 31, 2013, compared to $38.1 million for the year ended May 31, 2012. The difference was primarily related to the refinancing activities. We received proceeds of $3,396.2 million related to the offerings of our 6.500% senior notes due 2020 and 6.500% senior subordinated notes due 2020 and term loans and tendered or retired $3,423.0 million of senior notes due 2017 and term loans. Additionally, we incurred $79.0 million of fees related to the refinancing activities.

Net cash used in financing activities was $38.1 million for the year ended May 31, 2012, compared to $51.4 million for the year ended May 31, 2011. The decrease in cash used in financing activities year-over-year was primarily related to a discretionary repurchase of $10.0 million par value of senior cash pay notes for $11.2 million in the fiscal year ended May 31, 2011.

Balance Sheet Metrics

Cash flows from operations are impacted by profitability and changes in operating working capital. Management monitors operating working capital with particular focus on certain metrics, including days sales outstanding, or DSO, and inventory turns. The following is a summary of our DSO and inventory turns for the fiscal years ended May 31, 2013 and 2012, and six months ended November 30, 2013.

 

    

November 30,
2013

    

May 31,

2013

    

May 31,

2012

 

Days Sales Outstanding(1)

     61.7         62.7         61.6   

Inventory Turns(2)

     1.53         1.71         1.59   

 

(1) DSO is calculated by dividing the quarter-over-quarter average accounts receivable balance by the last quarter net sales multiplied by 91.25 days.
(2) Inventory turns are calculated by dividing the last twelve months cost of sales by the year-over-year average net inventory balance.

We use DSO as a measure that places emphasis on how quickly we collect our accounts receivable balances from customers. The decrease in DSOs compared to May 31, 2013 is primarily due to seasonality factors, partially offset by the 2013 Spine Acquisition impact. The increase in DSOs when comparing May 31, 2013 to May 31, 2012 was due to a slowdown in collections in both the United States and Europe.

We use inventory turns as a measure that places emphasis on how quickly we turn over our inventory. Inventory turns slowed compared to May 31, 2013 due largely to inventory builds to support new product launches and the 2013 Spine Acquisition. Inventory turns improved at May 31, 2013, compared to May 31, 2012, due to certain product rationalization efforts.

 

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Non-GAAP Disclosures

We use certain non-GAAP financial measures including Adjusted EBITDA and Adjusted net income that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles, or GAAP. These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP. Management exercises judgment in determining which types of charges or other items should be excluded from non-GAAP financial measures. Management uses this non-GAAP information internally to evaluate the performance of the core operations, establish operational goals and forecasts that are used in allocating resources and to evaluate our performance period-over-period. Additionally, our management is evaluated on the basis of some of these non-GAAP financial measures when determining achievement of their incentive compensation performance targets. We believe that our disclosure of these non-GAAP financial measures provides investors greater transparency to the information used by management for its financial and operational decision-making and enables investors to better understand our period-over-period operating performance. We also believe Adjusted EBITDA and Adjusted net income are widely used by investors and securities analysts to measure a company’s operating performance without regard to items that can vary substantially from company to company depending upon financing and accounting methods, book values of assets, tax jurisdictions, capital structures and the methods by which assets were acquired.

We define “Adjusted EBITDA” to mean earnings before interest, taxes, depreciation and amortization, as adjusted for certain expenses. We define “Adjusted net income” to mean earnings as adjusted for certain expenses. The term “as adjusted,” a non-GAAP financial measure, refers to financial performance measures that exclude certain income statement line items, such as interest, taxes, depreciation or amortization, and/or exclude certain expenses, such as stock-based compensation charges, certain litigation expenses, acquisition expenses, operational restructuring charges, advisory fees paid to the Principal Stockholders, asset impairment charges, losses on extinguishment of debt, purchase accounting costs, losses on swap liabilities and other related charges.

Adjusted EBITDA and Adjusted net income do not represent, and should not be a substitute for, net income or cash flows from operations as determined in accordance with GAAP. Adjusted EBITDA and Adjusted net income have limitations as an analytical tool, and you should not consider it in isolation, or as a substitute for analysis of our results as reported under GAAP. Some of the limitations are:

 

    Adjusted EBITDA and Adjusted net income do not reflect our cash expenditures, or future requirements for capital expenditures or contractual commitments;

 

    Adjusted EBITDA and Adjusted net income do not reflect changes in, or cash requirements for, our working capital needs;

 

    Adjusted EBITDA does not reflect the significant interest expense, or the cash requirements necessary to service interest or principal payments, on our debt; and

 

    several of the adjustments that we use in calculating Adjusted EBITDA and Adjusted net income, such as asset impairment charges, while not involving cash expense, do have a negative impact on the value our assets as reflected in our consolidated balance sheet prepared in accordance with GAAP.

 

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Reconciliations of historical net income (loss) to Adjusted EBITDA and Adjusted net income are set forth in the following table:

 

    

Six Months Ended
November 30,

   

Fiscal Year Ended May 31,

 
(in millions)   

2013

   

2012

   

2013

   

2012

   

2011

 
Adjusted EBITDA:           

Net income (loss), as reported

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8

Plus (minus):

          

Interest expense

     193.3        222.0        398.8        479.8        498.9   

Benefit from income taxes

     (25.2     (73.6     (117.7     (132.0     (214.8

Depreciation and amortization

     242.5        242.1        495.4        509.4        549.0   

Special items, before amortization and depreciation from purchase accounting, interest and tax(1)

     82.4        239.4        922.8        615.1        1,038.3   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 529.0      $ 532.2      $ 1,075.9      $ 1,013.5      $ 1,021.6   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income:

          

Net income (loss), as reported

   $ 36.0      $ (97.7   $ (623.4   $ (458.8   $ (849.8

Plus:

          

Special items, after tax(2)

     166.2        262.5        989.1        710.6        1,055.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted net income

   $ 202.2      $ 164.8      $ 365.7      $ 251.8      $ 205.2   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(1) A reconciliation of special items, before amortization and depreciation from purchase accounting, interest and tax is as follows:

 

    

Six Months Ended
November 30,

    

Fiscal Year Ended May 31,

 
(in millions)   

2013

    

2012

    

2013

    

2012

    

2011

 

Special items

              

Stock-based compensation(a)

   $ 9.2       $ 26.5       $ 39.6       $ 16.0       $ 12.7   

Certain litigation expenses(b)

     29.5         9.4         57.9         8.6         12.5   

Acquisition expenses(c)

     8.7         10.1         16.7         4.6         —     

Operational restructuring(d)

     23.0         20.3         59.1         45.8         61.6   

Principal Stockholders fee(e)

     5.4         5.4         11.0         10.3         10.1   

Asset impairment(f)

     —           —           567.4         529.8         941.4   

Loss on extinguishment of debt(g)

     6.6         167.7         171.1         —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 82.4       $ 239.4       $ 922.8       $ 615.1       $ 1,038.3   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(2) A reconciliation of special items, after tax is as follows:

 

     Six Months Ended
November 30,
    Fiscal Year Ended May 31,  
(in millions)    2013     2012     2013     2012     2011  

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 82.4      $ 239.4      $ 922.8      $ 615.1      $ 1,038.3   

Amortization and depreciation from purchase accounting(h)

     144.3        148.9        299.6        325.6        376.3   

Loss on swap liability(i)

     21.8        —          —          —          —     

Tax effect(j)

     (82.3     (125.8     (233.3     (230.1     (359.6
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Special items, after tax

   $ 166.2      $ 262.5      $ 989.1      $ 710.6      $ 1,055.0   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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  (a) Stock-based compensation expense is excluded from non-GAAP financial measures primarily because it is a non-cash expense and because it is not used by management to assess ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (b) Certain litigation, including expenses, settlements and adjustments to reserves during the year, including the metal-on-metal hip products litigation described in “Business—Legal Matters,” that we believe are not reflective of our ongoing operational performance are excluded from non-GAAP financial measures. We incur legal and settlement expenses in the ordinary course of our business, but we believe the items included in this line are unusual either in amount or subject matter. We believe this information is useful to investors in that it aids period-over-period comparability.
  (c) We exclude acquisition-related expenses for the 2012 Trauma Acquisition and 2013 Spine Acquisition from non-GAAP financial measures that are not reflective of our ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (d) Operational restructuring charges relate principally to employee severance, facility consolidation costs and building impairments resulting from the closure of facilities. Operational restructuring charges include abnormal manufacturing variances related to temporary redundant overhead costs within our plant network as we continue to rationalize and move production to our larger operating locations in order to increase manufacturing efficiency. Operational restructuring also includes consulting expenses related to operational initiatives and other related costs. Operational restructuring also includes product rationalization charges to increase efficiencies among our products and reduce product overlap, including steps we take to integrate products we acquire. Operational restructuring also includes the loss on the divestiture of our bracing business in fiscal year 2013. We exclude these costs from non-GAAP financial measures primarily because they are not reflective of ongoing operating results, and they are not used by management to assess ongoing operational performance. We believe this information is useful to investors in that it provides period-over-period comparability.
  (e) Upon completion of the 2007 Acquisition, we entered into a management services agreement with certain affiliates of our Principal Stockholders, pursuant to which such affiliates of our Principal Stockholders or their successors, assigns, affiliates, officers, employees, and/or representatives and third parties (collectively, the “Managers”) provide management, advisory, and consulting services to us. Pursuant to such agreement, our Principal Stockholders receive a quarterly monitoring fee equal to 1% of our quarterly Adjusted EBITDA (as defined by our senior secured credit facilities) as compensation for the services rendered and reimbursement for out-of-pocket expenses incurred by the Managers in connection with the agreement. We exclude these costs from non-GAAP financial measures primarily because they are not reflective of ongoing operating results and they are not used by management to assess ongoing operational performance. In addition, we have excluded these costs from non-GAAP financial measures because the management services agreement will terminate in connection with the completion of this offering. We believe this information is useful to investors in that it provides period-over-period comparability.
  (f) Non-cash asset impairment charges are excluded from non-GAAP financial measures because they are not reflective of our ongoing operational performance or liquidity.

 

    During fiscal year 2013, we recorded a $473.0 million goodwill impairment charge and a $94.4 million definite and indefinite-lived intangible asset impairment charge associated with our dental reconstructive and Europe reporting units.

 

    During fiscal year 2012, we recorded a $291.9 million goodwill impairment charge and a $237.9 million definite and indefinite-lived intangible asset impairment charge primarily associated with our dental reconstructive and spine and bone healing reporting units.

 

    During fiscal year 2011, we recorded a $422.8 million goodwill impairment charge and a $518.6 million definite and indefinite-lived intangible asset impairment charge primarily associated with our Europe reporting unit.

 

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We believe this information is useful to investors in that it provides period-over-period comparability.

  (g) Loss on extinguishment of debt charges include write off of deferred financing fees, dealer manager fees and tender/call premium on retirement of bonds. We exclude these charges from non-GAAP measures because they are not reflective of our ongoing operational performance or liquidity. We believe this information is useful to investors in that it provides period-over-period comparability.
  (h) Amortization and depreciation from purchase accounting adjustments that is related to the 2007 Acquisition, 2012 Trauma Acquisition and 2013 Spine Acquisition are excluded from non-GAAP financial measures. These amortization amounts represent the additional amortization expenses in each period attributable to the step-up of amortizable assets to fair value due to the application of purchase accounting. We believe this information is useful to investors in that it provides period-over-period comparability. Further, these amounts are not used by management to assess ongoing operational performance.
  (i) Loss on swap liability charges include a one-time charge to interest expense related to the termination of our euro-denominated term loans. We believe this information is useful to investors in that it provides period-over-period comparability.
  (j) Tax effect is calculated based upon the tax rates applicable to the jurisdictions where the special items were incurred.

Special Items

The following tables indicate how each of the special items noted above are reflected in our financial statements.

For the Six Months Ended November 30, 2013 and 2012

 

     Six Months Ended November 30, 2013  

(in millions)

   Cost of
Sales
     Selling,
general and
administrative
expense
     Research
and
development
expense
     Amortization      Interest
expense
     Other
(income)
expense
    Total  

Stock-based compensation(1)

   $ 0.4       $ 7.6       $ 1.2       $ —          $ —          $ —         $ 9.2   

Certain litigation(2)

     19.9         9.6         —            —            —            —           29.5   

Acquisition expenses(3)

     4.6         4.1         —            —            —            —           8.7   

Operational restructuring(4)

     19.7         3.6         0.1         —            —            (0.4     23.0   

Principal Stockholders fee(5)

     —            5.4         —            —            —            —           5.4   

Loss on extinguishment of debt(7)

     —            —            —            —            —            6.6        6.6   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Special items, before amortization and depreciation from purchase accounting, interest and tax

   $ 44.6       $ 30.3       $ 1.3       $ —          $ —          $ 6.2      $ 82.4   

Amortization and depreciation from purchase accounting(8)

     —            —            —            144.3         —            —           144.3   

Loss on swap liability(9)

     —            —            —            —            21.8         —           21.8   

Tax effect(10)

     —            —            —            —            —            —           (82.3
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Special items, after tax

   $ 44.6       $ 30.3       $ 1.3       $ 144.3       $ 21.8       $ 6.2      $ 166.2   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

 

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     Six Months Ended November 30, 2012  

(in millions)

   Cost
of
Sales
     Selling,
general and
administrative
expense
     Research
and
development
expense
     Amortization      Other
(income)
expense
     Total  

Stock-based compensation(1)

   $ 1.7       $ 20.7       $ 4.1       $ —          $ —          $ 26.5   

Certain litigation(2)

     4.9         4.5         —            —            —            9.4   

Acquisition expenses(3)

     2.5         7.6         —            —            —            10.1   

Operational restructuring(4)

     15.0         5.1         0.2         —            —            20.3   

Principal Stockholders fee(5)

     —            5.4         —            —            —            5.4   

Loss on extinguishment of debt(7)

     —            —            —            —            167.7         167.7