Attached files

file filename
EX-32.1 - EX-32.1 - DJO Finance LLCa10-1894_1ex32d1.htm
EX-31.1 - EX-31.1 - DJO Finance LLCa10-1894_1ex31d1.htm
EX-31.2 - EX-31.2 - DJO Finance LLCa10-1894_1ex31d2.htm
EX-32.2 - EX-32.2 - DJO Finance LLCa10-1894_1ex32d2.htm
EX-21.1 - EX-21.1 - DJO Finance LLCa10-1894_1ex21d1.htm
EX-12.1 - EX-12.1 - DJO Finance LLCa10-1894_1ex12d1.htm

Table of Contents

 

 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2009

 

or

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                      to                     .

 

Commission file number 333-142188

 

DJO Finance LLC

(Exact name of Registrant as specified in its charter)

 

Delaware

 

20-5653965

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification Number)

 

 

 

1430 Decision Street

 

 

Vista, California

 

92081

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (800) 336-5690

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Name of each exchange on which registered

None

 

None

 

Securities registered pursuant to Section 12(g) of the Act:

None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes o  No x

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes o  No x

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x  No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes o No o

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x

 

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.

 

Large accelerated filer  o

 

Accelerated filer  o

 

 

 

Non-accelerated filer  x

 

Smaller reporting company  o

(Do not check if a smaller reporting company)

 

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes o  No x

 

As of March 5, 2010, 100% of the issuer’s membership interests were owned by DJO Holdings LLC.

 

 

 



Table of Contents

 

DJO FINANCE LLC

FORM 10-K

TABLE OF CONTENTS

 

 

 

Page
No.

 

PART I

 

Item 1.

Business

3

Item 1A.

Risk Factors

20

Item 2.

Properties

41

Item 3.

Legal Proceedings

41

Item 4.

(Removed and Reserved)

42

 

 

 

 

PART II

 

Item 5.

Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

43

Item 6.

Selected Financial Data

43

Item 7.

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

44

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

62

Item 8.

Financial Statements and Supplementary Data

63

Item 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

107

Item 9A.

Controls and Procedures

107

Item 9B.

Other Information

107

 

 

 

 

PART III

 

Item 10.

Directors, Executive Officers and Corporate Governance

108

Item 11.

Executive Compensation

111

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

122

Item 13.

Certain Relationships and Related Transactions, and Director Independence

123

Item 14.

Principal Accounting Fees and Services

124

 

 

 

 

PART IV

 

Item 15.

Exhibits, Financial Statement Schedules

125

SIGNATURES

 

130

 

2



Table of Contents

 

FORWARD-LOOKING STATEMENTS

 

This Annual Report on Form 10-K (“Annual Report”) of DJO Finance LLC (“DJOFL”, or “the Company”) for the year ended December 31, 2009 contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are intended to be covered by the safe harbors created thereby. To the extent that any statements are not recitations of historical fact, such statements constitute forward-looking statements that, by definition, involve risks and uncertainties.  Specifically, the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business”  may contain forward-looking statements.  These statements can be identified because they use words like “anticipates,” “believes,” “estimates,” “expects,” “forecasts,” “future,” “intends,” “plans,” and similar terms.  These statements reflect only our current expectations.  Forward-looking statements include statements concerning our plans, objectives, goals, strategies, future events, capital expenditures, future results, our competitive strengths, our business strategy, the trends in our industry and the benefits of our acquisitions.

 

Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy, and actual results may differ materially from those we anticipated due to a number of uncertainties, many of which are unforeseen, including, among others, the risks we face as described elsewhere in this filing.  You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Annual Report.  In any forward-looking statement where we express an expectation or belief as to future results or events, such expectation or belief is expressed in good faith and is believed to have a reasonable basis, but there can be no assurance that any future results or events expressed by the statement of expectation or belief will be achieved or accomplished.

 

We believe it is important to communicate our expectations to our security holders.  There may be events in the future, however, that we are unable to predict accurately or over which we have no control.  The risk factors listed in Item 1A below, as well as any cautionary language in this Annual Report, provide examples of risks, uncertainties and events that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements.

 

PART I.

 

ITEM 1.  BUSINESS

 

Overview

 

We are a global provider of high-quality orthopedic devices, with a broad range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products. We are one of the largest non-surgical orthopedic rehabilitation device companies in the world, as measured by revenues. Many of our products have leading market positions. We believe that our strong brand names, comprehensive range of products, focus on quality, innovation and customer service, extensive distribution network, and our strong relationships with orthopedic and physical therapy professionals have contributed to our leading market positions. We believe that we are one of only a few orthopedic device companies that offer healthcare professionals and patients a diverse range of orthopedic rehabilitation products addressing the complete spectrum of preventative, pre-operative, post-operative, clinical and home rehabilitation care. Our products are used by orthopedic specialists, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals to treat patients with musculoskeletal conditions resulting from degenerative diseases, deformities, traumatic events and sports-related injuries. In addition, many of our non-surgical medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment.

 

Our current business activities are the result of a combination of two companies with broad orthopedic product offerings in the United States and foreign countries.  One of those companies, ReAble Therapeutics, Inc. (“ReAble”), was a leading manufacturer and distributor of electrotherapy products for pain therapy and rehabilitation, a broad range of clinical devices for the treatment of patients in physical therapy clinics, and a broad range of knee, hip and shoulder implant products.  In 2006, ReAble was acquired by an affiliate of Blackstone Capital Partners V L.P. (“Blackstone”). The other company, DJO Opco Holdings, Inc. (“DJO Opco”), formerly named DJO Incorporated, was a leading manufacturer and distributor of orthopedic rehabilitation products, including rigid knee bracing, orthopedic soft goods, cold therapy systems, vascular systems and bone growth stimulation devices. On November 20, 2007, ReAble acquired DJO Opco through a merger transaction (the “DJO Merger”).  ReAble then changed its name to DJO Incorporated (“DJO”) and continues to be owned primarily by affiliates of Blackstone.

 

Historical financial results include results of ReAble and its subsidiaries before and after its acquisition by Blackstone and include the results of DJO Opco from the date of the DJO Merger through December 31, 2009.

 

3



Table of Contents

 

Except as otherwise indicated, references to “us”, “we”, “our”, or “our Company” in this Annual Report refers to DJOFL and its consolidated subsidiaries. Each one of the following trademarks, trade names or service marks, which is used in this Annual Report, is either (i) our registered trademark, (ii) a trademark for which we have a pending application, (iii) a trade name or service mark for which we claim common law rights or (iv) a registered trademark or application for registration which we have been licensed by a third party to use: Cefar®, Empi®, Ormed®, Compex®, Aircast®, DonJoy®, OfficeCare®, ProCare®, SpinaLogic®, CMF™, OL1000™, and OL1000 SC™.  All other trademarks, trade names or service marks of any other company appearing in this Annual Report belong to their respective owners.

 

Noncontrolling interests on our consolidated balance sheets as of December 31, 2009 and 2008 reflect a 50% separate ownership interest in Medireha GmbH (“Medireha”) which is not attributable, directly or indirectly, to us.  We have consolidated Medireha for financial reporting purposes due to our controlling interest, which consists of our 50% ownership interest, our control of one of the two director seats, our rights to prohibit certain business activities that are not consistent with our plans for the business and our exclusive distribution rights for products manufactured by Medireha. All significant intercompany balances and transactions have been eliminated in consolidation.

 

The DJO Merger

 

On July 15, 2007, we entered into an Agreement and Plan of Merger with DJO Opco providing for the DJO Merger pursuant to which DJO Opco became a wholly owned subsidiary of DJOFL. The total purchase price for the DJO Merger, which was consummated on November 20, 2007, was approximately $1.3 billion and consisted of $1.2 billion paid to former equity holders (or $50.25 in cash for each share of common stock of DJO Opco sold), $15.2 million related to the fair value of stock options held by DJO Opco management that were exchanged for options to purchase DJO common stock, and $22.8 million in direct acquisition costs. The DJO Merger was financed through a combination of equity contributed by our primary shareholder, Blackstone, borrowings under our senior secured credit facility (the “Senior Secured Credit Facility”) and proceeds from the 10.875% Senior Notes due 2014 issued by DJOFL and DJO Finance Corporation (“Finco”) (see Note 9 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).

 

Discontinued Operations

 

On June 12, 2009 we sold our Empi Therapy Solutions (“ETS”) catalog business, formerly known as Rehab Medical Equipment, or RME, to Patterson Medical Supply, Inc. for approximately $21.8 million. As such, results of the ETS business for periods prior to the date of sale have been presented as discontinued operations in our consolidated financial statements and the accompanying notes.

 

Operating Segments

 

We provide a broad array of orthopedic rehabilitation and regeneration products, as well as implants to customers in the United States and abroad.  In the first quarter of 2009, we changed how we report financial information to senior management.  Prior to 2009, we included the international components of the Surgical Implant, Chattanooga, and Empi businesses in either the Surgical Implant or Domestic Rehabilitation segments, as their operations were managed domestically.  During the fourth quarter of 2008, we effected an operational reorganization which resulted in the non-U.S. components of all of our businesses being managed abroad.  As a result, the segment financial data for the year ended December 31, 2009 reflects this new segmentation and the data for the years ended December 31, 2008 and 2007, has been restated to reflect this change.  We currently develop, manufacture and distribute our products through the following three operating segments:

 

Domestic Rehabilitation Segment

 

Our Domestic Rehabilitation Segment, which generates its revenues in the United States, is divided into five main businesses:

 

·                  Bracing and Supports.  Our Bracing and Supports business unit offers our DonJoy, ProCare and Aircast products, including rigid knee bracing, orthopedic soft goods, cold therapy products, and vascular systems. This business unit also includes our OfficeCare business, through which we maintain an inventory of soft goods and other products at healthcare facilities, primarily orthopedic practices, for immediate distribution to patients.

 

·                  Empi.  Our Empi business unit offers our home electrotherapy, iontophoresis, and home traction products. We primarily sell these products directly to patients or to physical therapy clinics. For products sold to patients, we arrange billing to the patients and their third party payors.

 

4



Table of Contents

 

·                  Regeneration.  Our Regeneration business unit sells our bone growth stimulation products. We sell these products either directly to patients or to independent distributors. For products sold to patients, we arrange billing to the patients and their third party payors.

 

·                  Chattanooga.  Our Chattanooga business unit offers products in the clinical rehabilitation market in the categories of clinical electrotherapy devices, clinical traction devices, and other clinical products and supplies such as treatment tables, continuous passive motion (“CPM”) devices and dry heat therapy.

 

·                  Athlete Direct.  Our Athlete Direct business unit offers our Compex electrostimulation device to consumers, which range from people interested in improving their fitness to competitive athletes, to assist in athletic training programs through muscle development and to accelerate muscle recovery after training sessions.

 

International Segment

 

Our International Segment, which generates most of its revenues in Europe, sells all of our products and certain third party products through a combination of direct sales representatives and independent distributors.

 

Domestic Surgical Implant Segment

 

Our Domestic Surgical Implant Segment develops, manufactures and markets a wide variety of knee, hip and shoulder implant products that serve the orthopedic reconstructive joint implant market in the United States.

 

Acquisitions

 

Our growth has been driven both by the introduction of products facilitated by our research and development efforts and by selected acquisitions of businesses or products primarily related to our Domestic Rehabilitation and International Segments.  We completed the following acquisitions in 2009, each of which represents an expansion of our international business:

 

On August 4, 2009 we acquired Chattanooga Group Inc., a Canadian distributor of certain of our products (“Chattanooga Canada”), for $7.2 million.  Pursuant to the terms of the acquisition agreement and included within the purchase price, is a $1.4 million holdback and a $1.4 million promissory note. The holdback provides security for potential indemnification claims and, if not used for that purpose, will be paid to the sellers. The holdback amount accrues interest at an annual rate of 2.5% for the first 18 months and a variable rate thereafter. Half of any holdback amount not used to cover indemnification claims will be paid with interest in January 2011 and the remainder of the balance with interest is due approximately three years after closing, upon expiration of a statutory period provided for under relevant tax law.  The promissory note accrues interest at an annual rate of 6% with the principal and interest due in August 2010.

 

On August 4, 2009 we acquired Empi Canada Inc., a Canadian distributor of certain of our products (“Empi Canada”), for $7.4 million. Pursuant to the terms of the acquisition agreement and included within the purchase price, is a $1.4 million holdback and a $1.4 million promissory note. The holdback provides security for potential indemnification claims and, if not used for that purpose, will be paid to the sellers. The holdback amount accrues interest at an annual rate of 2.5% for the first 18 months and a variable rate thereafter. Half of any holdback amount not used to cover indemnification claims will be paid with interest in January 2011 and the remainder of the balance with interest is due approximately three years after closing, upon expiration of a statutory period provided for under relevant tax law. The promissory note accrues interest at an annual rate of 6% with the principal and interest due in August 2010.

 

On February 3, 2009 we acquired DonJoy Orthopaedics Pty., Ltd., an Australian distributor of certain of our products (“DJO Australia”), for a total cash compensation of $3.4 million. Pursuant to the terms of the acquisition agreement and included within the purchase price, is $0.8 million, the acquisition date fair value of the additional amount expected to be paid to the selling shareholder of DJO Australia if certain revenue targets were met by December 31, 2009. Such revenue targets were met, and the additional amount of $0.8 million, which was included in accrued liabilities in the consolidated balance sheet at December 31, 2009, was paid in the first quarter of fiscal year 2010.

 

2010 Debt Offering

 

On January 20, 2010, we issued $100.0 million aggregate principal amount of new 10.875% Senior Notes which mature on November 15, 2014, pursuant to the indenture governing our existing 10.875% Senior Notes due 2014 that were issued on November 20, 2007 (collectively, the “10.875% Notes”). The net proceeds of the issuance (excluding approximately $2.0 million of interest accrued from November 16, 2009 to January 19, 2010, which will be included in the first interest payment to be made on May 15, 2010), along with cash on hand, were used to repay $101.5 million aggregate principal amount of existing term loans under the Senior Secured Credit Facility.

 

5



Table of Contents

 

Industry Background

 

Market Opportunities

 

We participate globally in the rehabilitation, pain management, bone growth stimulation and reconstruction segments of the orthopedic device market. In the United States, we estimate these segments accounted for approximately $8.4 billion of total industry sales in 2008. We believe that several factors are driving growth in the orthopedic products industry, including the following:

 

·                  Favorable demographics.  An aging population is driving growth in the orthopedic products market. Many conditions that result in rehabilitation, physical therapy or orthopedic surgery are more likely to affect people in middle age or later in life.  According to a 2009 United States Census Bureau — International Data Base projection, the aging baby boomer generation will result in the percentage of the North American population aged 65 and over to grow from 13.2% in 2010 to 16.4% in 2020 and to 19.8% by 2030. In Western Europe, the population aged 65 and over is expected to grow from 18.2% in 2010 to 20.9% in 2020 and to 24.7% by 2030.  In addition, according to the 2009 United States Census Bureau — International Data Base projection, the average life expectancy in North America is 78.5 years in 2010 and is expected to grow to 80.9 years by 2030.  In Western Europe, the average life expectancy is 79.9 years in 2010 and is expected to grow to 82.0 years by 2030.  As life expectancy increases, we believe people will remain active longer, causing the number of injuries requiring orthopedic rehabilitation, bone growth stimulation and reconstructive implants to increase.

 

·                  Shift toward non-surgical rehabilitation devices and at-home physical therapy.  We believe the growing awareness and clinical acceptance by healthcare professionals of the benefits of non-surgical, non-pharmaceutical treatment and rehabilitation products, combined with the increasing interest by patients in rehabilitation solutions that minimize risk and recuperation time and provide greater convenience, will continue to drive demand for these products. For example, Transcutaneous electrical nerve stimulation (“TENS”) and Neuromuscular electrical nerve stimulation (“NMES”) devices are increasingly being recognized as effective solutions for pain management and rehabilitation therapy, respectively. In addition, we believe that orthopedic surgeons are increasingly utilizing braces that assist in rehabilitation and bone growth stimulation devices that enable in-home treatment as viable alternatives to surgery. Many of our orthopedic rehabilitation products are designed for at-home use, which we believe should allow us to benefit from the market shift toward these treatment alternatives.

 

·                  Lower cost alternatives appeal to third party payors.  With the cost of healthcare rising in the United States and internationally, third party payors are seeking more cost-effective therapies without reducing quality of care. For example, third party payors seek to reduce clinic visits and accommodate patients’ preference for therapies that can be conveniently administered at home. We believe that many of our orthopedic rehabilitation products offer cost-effective alternatives to surgery, pharmaceutical and other traditional forms of physical therapy and pain management.

 

·                  Increased need for rehabilitation due to increased orthopedic surgical volume.  The combination of increased prevalence of degenerative joint disease (such as osteoarthritis), an increased number of sports-related injuries, an aging population and improvements in orthopedic surgical technique (such as arthroscopy) has contributed to an increase in the number of orthopedic surgeries. We believe that orthopedic surgical volume will continue to increase, which should result in an increase in the need for our products.

 

Competitive Strengths

 

We believe that we have a number of competitive strengths that will enable us to further enhance our position in the orthopedic rehabilitation device market:

 

·                  Leading market positions.  We estimate we have leading market positions for many of our products. We believe our orthopedic and physical therapy rehabilitation products marketed under the DonJoy, Aircast, ProCare, Chattanooga, Empi, Cefar, Compex and Ormed brands have a reputation for quality, durability and reliability among healthcare professionals. We believe the strength of our brands and our focus on customer service have allowed us to establish market leading positions in the highly fragmented and growing orthopedic rehabilitation market.

 

·                  Comprehensive range of orthopedic products.  We offer a diverse range of orthopedic devices, including orthopedic rehabilitation, pain management and physical therapy products, bone growth stimulation and surgical reconstructive implant products, to orthopedic specialists and patients for hospital, clinical and at-home therapies. Our broad product offering meets many of the needs of orthopedic professionals and patients and enables us to leverage our brand loyalty with our customer and distributor base. Our products are available across various stages of the orthopedic patient’s continuum of care.

 

6



Table of Contents

 

·                  Extensive and diverse distribution network.  We use multiple channels to distribute our products to our customers. We use over 9,700 dealers and distributors and a direct sales force of over 500 employed sales representatives and approximately 700  independent sales representatives to supply our products to physical therapy clinics, orthopedic surgeons and practices, orthotic and prosthetic centers, hospitals, surgery centers, athletic trainers, chiropractors, other healthcare professionals and retail outlets. We believe that our distribution network provides us with a significant competitive advantage in selling our existing products and in introducing new products.

 

·                  Strong relationships with managed care organizations and rehabilitation healthcare providers.  Our leading market positions in many of our orthopedic rehabilitation product lines and the breadth of our product offerings have enabled us to secure important preferred provider and managed care contracts. Our database includes over 8,700 different insurance companies and other payors, including approximately 1,400 active payor contracts. We have developed a proprietary third party billing system that is designed to reduce our reimbursement cycles, improve relationships with managed care organizations and physicians and track patients to improve quality of care and create subsequent selling opportunities. Further, our OfficeCare business maintains inventory at over 1,350 healthcare facilities, primarily orthopedic practices, which further strengthens our relationships with these healthcare providers.

 

·                  National contracts with group purchasing organizations.  We enjoy strong relationships with a meaningful number of group purchasing organizations (“GPOs”) due to our significant scale. We believe that our broad range of products is well suited to the goals of these buying groups. Under these national contracts, we provide favorable pricing to the buying group and are designated a preferred purchasing source for the members of the buying group for specified products. As we have made acquisitions and expanded our product range, we have been able to add incremental products to our national contracts. During 2009, we signed or renewed over 25 national contracts.

 

·                  Low cost, high quality manufacturing capabilities.  We have a major manufacturing facility in Tijuana, Mexico that has been recognized for operational excellence. The Mexico facility and our other manufacturing facilities employ lean manufacturing, Six Sigma concepts and continuous improvement processes to drive manufacturing efficiencies and lower costs.

 

·                  Ability to generate significant cash flow. Historically, our strong competitive position, brand awareness and high quality products and service as well as our low cost manufacturing have allowed us to generate attractive operating margins before non-cash amortization expense. These operating margins, together with limited capital expenditures and modest working capital requirements, significantly benefit our ability to generate cash flow.

 

·                  Experienced management team. The members of our management team have an average of over 26 years of relevant experience. This team has successfully integrated a number of acquisitions in the last several years.

 

Our Strategy

 

Our strategy is to increase our leading position in key products and markets, increase revenues and profitability and enhance cash flow. Our key initiatives to implement this strategy include the following:

 

·                  Increase our leading market positions.  We believe we are the market leader in many of the markets in which we compete. We intend to continue to increase our market share by leveraging the cross-selling and other opportunities created by the DJO Merger and by implementing the initiatives described below. The DJO Merger has allowed us to offer customers a more comprehensive range of products to better meet their evolving needs. We believe our size, scale, brand recognition, comprehensive and integrated product offerings and leading market positions enable us to capitalize on the growth in the orthopedic product industry.

 

·                  Focus sales force on entire range of DJO products.  Our products address the full continuum of a patient’s care, from preventative measures to pre-operative steps to post-operative care and rehabilitation.  Our strategy is to train and incentivize our sales force, which consists of agents and representatives familiar with a particular set of products, to work cooperatively and collaboratively with all segments of our sales force to introduce their customers to the full range of our products of which the customer is typically using only a portion.  We believe that this represents a significant opportunity to expand our business among customers who are already satisfied with the performance of some of our products.

 

7



Table of Contents

 

·                  Continue to develop and launch new products and product enhancements.  We have a history of developing and introducing innovative products into the marketplace, and we expect to continue future product launches by leveraging our internal research and development platforms. We believe our ability to develop new technology and to advance existing technology to create new products will position us to further diversify our revenues and to expand our target markets by providing viable alternatives to surgery or medication. We believe that product innovation through effective and focused research and development, as well as our relationships with a number of widely recognized orthopedic surgeons and professionals who assist us in product research, development and marketing, will provide a significant competitive advantage. During 2009, we launched 18 new products, which generated over $12.3 million in revenues.

 

·                  Maximize existing and secure additional national accounts.  We plan to capitalize on the growing practice in healthcare in which hospitals and other large healthcare providers seek to consolidate their purchasing activities to national buying groups. Contracts with these national accounts represent a significant opportunity for revenue growth. We believe that our existing relationships with national buying groups and our broad range of products position us well not only to pursue additional national contracts, but also to expand the scope of our existing contracts.

 

·                  Expand international sales.  In recent years, we have successfully established direct distribution capabilities in several major international markets. We believe that sales to European and other markets outside the United States continue to represent a significant growth opportunity, and we intend to continue to expand our direct and independent distribution capabilities in attractive foreign markets. For example, in 2009, we acquired an unaffiliated Australian distributor and two unaffiliated Canadian distributors, for approximately $3.4 million, $7.2 and $7.4 million, respectively as part of our strategy to expand our international sales. The DJO Merger and several of the acquisitions we made have substantially increased our international revenues and operating infrastructure and have provided us with opportunities to expand our international product offerings.

 

·                  Drive operating efficiency.  We plan to continue to apply the principles of lean operations to our manufacturing sites as well as in our operating and administrative functions to increase speed and efficiency and reduce waste. We have instilled a culture of continuous improvement throughout the Company and are pursuing a regular schedule of addressing operations and processes in the Company to improve efficiency. We believe these lean principles and continuous improvement efforts will enhance our operating efficiencies and our ability to compete in an increasingly price-sensitive health care industry.

 

Our Products

 

Our products are used by orthopedic specialists, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals to treat patients with musculoskeletal conditions resulting from degenerative diseases, deformities, traumatic events and sports related injuries. In addition, many of our non-surgical medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment.

 

Domestic Rehabilitation Segment

 

Our Domestic Rehabilitation Segment generated net sales of $640.8 million, $634.6 million, and $273.6 million for the years ended December 31, 2009, 2008, and 2007, respectively.  (See Note 12 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein for net sales, gross profit and operating income for each segment).

 

The following table summarizes many of our Domestic Rehabilitation Segment product categories:

 

8



Table of Contents

 

Product Category

 

Description

Home Electrotherapy Devices

 

Transcutaneous electrical nerve stimulation (TENS)
Neuromuscular electrical stimulation (NMES)
Interferential electrical nerve stimulation

Clinical Electrotherapy

 

TENS
NMES
Ultrasound
Laser
Light therapy
Shortwave Diathermy

Patient Care

 

Nutritional supplements
Patient safety devices
Pressure care products
Vascular systems products
Continuous passive motion devices
Hyalauronic acid medical devices

Rigid Bracing and Soft Goods

 

Soft goods
Lower extremity fracture boots
Dynamic splinting
Ligament braces
Post-operative braces
Osteoarthritic braces
Ankle bracing
Shoulder, elbow and wrist braces
Back braces
Neck braces

Hot, Cold and Compression Therapy

 

Dry heat therapy
Hot/cold therapy
Paraffin wax therapy
Moist heat therapy
Cold therapy
Compression therapy

Physical Therapy Tables and Traction Products

 

Treatment tables
Traction
Cervical traction
Lumbar traction

Iontophoresis

 

Needle-free transdermal drug delivery

Regeneration

 

Non-union fracture bone growth stimulation devices
Spine bone growth stimulation devices

 

International Segment

 

Our International Segment generated net sales of $241.5 million, $252.3 million, and $133.8 million for the years ended December 31, 2009, 2008, and 2007, respectively.  The product categories for our International Segment are similar to the product categories for our domestic segments but certain products are tailored to international market requirements and preferences. In addition, our International Segment sells a number of product categories, none of which are individually significant, that we do not sell domestically.

 

Domestic Surgical Implant Segment

 

Our Domestic Surgical Implant Segment generated net sales of approximately $63.9 million, $61.6 million, and $57.5 million for the years ended December 31, 2009, 2008 and 2007, respectively.

 

The following table summarizes our Domestic Surgical Implant Segment product categories:

 

Product Categories

 

Description

Knee implant

 

Primary total joint replacement
Revision total joint replacement
Unicondylar joint replacement

 

 

 

Hip implants

 

Primary replacement stems
Acetabular cup system
Revision joint replacement

 

 

 

Shoulder implants

 

Primary total joint replacement
Fracture repair system
Revision total joint replacement (including reverse shoulder)

 

9



Table of Contents

 

Research and Development

 

Our research and development programs focus on the development of new products, as well as the enhancement of existing products with the latest technology and updated designs. We seek to develop new technologies to improve durability, performance and usability of existing products, and to develop our manufacturing process to improve product performance and reduce manufacturing costs. In addition to our own research and development, we receive new product and invention ideas from orthopedic surgeons and other healthcare professionals. We also seek to obtain rights to ideas we consider promising from a clinical and commercial perspective through entering into either assignment or licensing agreements.

 

We conduct research and development programs at our facilities in Austin, Texas; Vista, California; and Ecublens, Switzerland. The research and development activities conducted in our facility in Chattanooga, Tennessee will be moved to Vista and Ecublens in the first part of 2010, in connection with the closure of the Chattanooga facility. We spent approximately $23.5 million, $26.9 million, and $18.0 million in 2009, 2008 and 2007 (excluding approximately $3.0 million of acquired in-process research and development (“IPR&D”)) for research and development activities, respectively. As of December 31, 2009, we had approximately 40 employees in our research and development departments.

 

Marketing and Sales

 

Our products reach our customers, including hospitals and other healthcare facilities, physicians and other healthcare providers and end user patients, through several sales and distribution channels.

 

Domestic Rehabilitation Segment

 

We market and sell our Domestic Rehabilitation Segment products in several different ways. The DonJoy sales channel is responsible for selling rigid knee braces, cold therapy products, and certain soft goods. Certain DonJoy sales representatives also sell our Regeneration products. The DonJoy channel consists of approximately 260 independent commissioned sales representatives who are employed by approximately 29 independent sales agents.  In the first half of 2008, we converted the Northern and Southern California and Pacific Northwest regions to a direct sales model for products in the DonJoy channel and Regeneration products.  We now cover those regions with approximately 45 employed sales representatives. The DonJoy channel is primarily dedicated to the sale of our products to orthopedic surgeons, podiatrists, orthotic and prosthetic centers, hospitals, surgery centers, physical therapists, athletic trainers and other healthcare professionals. Because the DonJoy product lines generally require customer education in the application and use of the product, our sales representatives are technical specialists who receive extensive training both from us and the agent, and use their expertise to help fit the patient with the product and assist the orthopedic professional in choosing the appropriate product to meet the patient’s needs. After a sales representative receives a product order, we generally ship and bill the product directly to the orthopedic professional, and pay a sales commission to the agent. For certain custom rigid braces and other products, we sell directly to the patient and bill a third party payor, if applicable, on behalf of the patient. We enjoy long-standing relationships with most of our agents and sales representatives. Under the arrangements with the agents, each agent is granted an exclusive geographic territory for sales of our products and is not permitted to market products, or represent competitors who sell or distribute products, that compete with our existing products. The agents receive a commission, which varies based on the type of product being sold.  If an agent fails to achieve specified sales quotas, we have the right to terminate our relationship with the agent.

 

The ProCare/Aircast channel consists of approximately 120 direct and independent sales representatives that manage approximately 260 distributors focused on primary and acute care facilities. Eight vascular systems specialists are also included in this channel. Products in this channel consist primarily of our soft goods, vascular systems and other products, which are generally sold in non-exclusive territories to third party distributors as well as through our direct sales force. Our distributors include large, national third party distributors such as Owens & Minor Inc., McKesson/HBOC, Allegiance Healthcare and Physician Sales and Service Inc., regional medical and surgical distributors, outpatient surgery centers and medical products buying groups that consist of a number of health care providers who make purchases through the buying group. These distributors and our direct sales force generally sell our products to large hospital chains, primary care networks and orthopedic physicians for use by the patients. In addition, we sell our products through GPOs that are a preferred purchasing source for members of a buying group.  Unlike our DonJoy products, our ProCare/Aircast products generally do not require significant customer education for their use. Our vascular systems pumps and related equipment are typically consigned to hospitals, and the hospitals then purchase the cuffs that are applied to each patient.

 

Our OfficeCare business provides stock and bill arrangements for physician practices. Through OfficeCare, we maintain an inventory of soft goods at over 1,350 orthopedic practices and other healthcare facilities for immediate distribution to patients. We then bill the patient or, if applicable, a third party payor. For certain facilities, we provide on-site technical representatives.  The OfficeCare channel is managed by our DonJoy sales force.

 

10



Table of Contents

 

Through our Empi channel, we market our prescription home therapy products primarily to physicians and physical therapy clinics, which include hospital physical therapy departments, sports medicine clinics and pain management centers, through our sales force of over 200 direct and independent sales representatives. In connection with these product lines, we currently have more than 660 managed care contracts. Our electrotherapy and orthotics products are generally prescribed to patients by a physician such as an orthopedic surgeon. The physician will typically direct the patient to a physical therapy clinic to meet with a trained physical therapist who provides the patient with the prescribed product from our consigned inventory at the clinic. This sales process is facilitated by our relationships with third party payors, such as managed care organizations, who ultimately pay us for the products prescribed to patients. For these reasons, we view physical therapists, physicians and third party payors as key decision makers in product selection and patient referral. Our home therapy products generally are eligible for third party reimbursement by government payors, such as Medicare and Medicaid, and private payors. In addition, we have an outbound telemarketing sales force of six representatives, who sell reimbursed electrotherapy supplies and other products directly to our patients.

 

Through our Regeneration business, our non-union fracture bone growth stimulator devices (“OL1000”) are sold primarily by approximately 180 employed and independent sales representatives specially trained to sell the product. The spine bone growth stimulator device (“SpinaLogic”) is sold by a few of our direct sales representatives and a network of independent spine products distributors. Most of our bone growth stimulator products are sold directly to the patient and a third party payor is billed, if applicable, on behalf of the patient.

 

Through our Chattanooga business, we sell our clinical rehabilitation product lines to physical therapy clinics, primarily through a national network of approximately 3,800 independent distributors, which are managed by our internal sales managers. These distributors sell our clinical rehabilitation products to a variety of healthcare professionals, including physical therapists, athletic trainers, chiropractors, and sports medicine physicians. Except for distributors outside of the United States, we do not maintain formal distribution contracts for our clinical rehabilitation products. These distributors purchase products from us at discounts off our published list price. We maintain an internal marketing and sales support program to support our distributor network. This program comprises a group of individuals who provide distributor and end-user training, develop promotional materials, and attend approximately 35 trade shows each year.

 

No particular customer or distributor accounted for 10% or more of product sales in the Domestic Rehabilitation Segment for the year ended December 31, 2009.  Medicare and Medicaid together accounted for approximately 10.0% of our 2009 net sales in the Domestic Rehabilitation Segment.

 

International Segment

 

We sell our rehabilitation products internationally through a network of wholly-owned subsidiaries and independent distributors. In Europe, we use sales forces aggregating approximately 150 direct and independent salespersons and a network of independent distributors who call on healthcare professionals, as well as consumer retail stores, such as sporting equipment providers, and pharmacies, to sell our products.  We intend to continue to expand our direct and indirect distribution capabilities in attractive foreign markets. Our surgical implant products are sold outside the United States through independent distributors, principally in Japan and select countries in Europe. Recent examples of our strategy to expand our international sales are our acquisitions of our two unaffiliated Canadian distributors in August 2009 and the acquisition of our unaffiliated Australian distributor in February 2009.

 

Domestic Surgical Implant Segment

 

We currently market and sell the products of our Domestic Surgical Implant Segment to hospitals and orthopedic surgeons through a network of approximately180 independent commissioned sales representatives who are employed by approximately 40 sales agents. Generally, our independent sales representatives sell a range of reconstructive joint products, including our products. We usually enter into agreements with sales agents for a term of one to five years. Agents are typically paid a sales commission and are eligible for bonuses if sales exceed certain preset objectives. Our independent sales representatives work for these agents. We assign our sales agents to an exclusive sales territory. Substantially all of our sales agents agree not to sell competitive products. Typically we can only terminate our agreements with sales agents prior to the expiration of the agreements for cause, which includes failure to meet specified periodic sales targets. We provide our sales agents with product inventories on consignment for their use in marketing our products and filling customer orders.

 

To a significant extent, sales of our surgical implant products depend on the preference of orthopedic surgeons. We maintain contractual relationships with orthopedic surgeons who assist us in developing our products and provide consulting services in connection with our products. In addition to providing design input into our new products, some of these orthopedic surgeons may give demonstrations using our products, speak about our products at medical seminars, train other orthopedic surgeons in the use of our products, and provide us with feedback on the acceptance of our products. We have also established relationships with surgeons who conduct clinical studies on various products, establish protocols for use of the products and participate at various symposia. Surgeons who assist us in developing our products are generally compensated with a royalty payment. Consulting surgeons are paid consulting fees for their services.

 

11



Table of Contents

 

Manufacturing

 

We use both in-house manufacturing capabilities and relationships with third party vendors to supply our products. Generally, we use third party vendors only when they have special manufacturing capabilities or when we believe it is appropriate based on certain factors, including our in-house capacity, lead time control and cost. Although we have certain sole source supply agreements, we believe alternate vendors are available, and we believe that adequate capacity exists at our current vendors to meet our anticipated needs.

 

Our manufacturing facilities are generally certified by the International Organization for Standardization (“ISO”) and generally comply with the U.S. Food and Drug Administration (“FDA”) current Good Manufacturing Practice (“cGMP”) and Quality System Regulations (“QSR”) requirements, which provide standards for safe and consistent manufacturing of medical devices and appropriate documentation of the manufacturing and distribution process. Many of our products carry the European Community Medical Device Directive (“CE”) certification mark.

 

Domestic Rehabilitation Segment

 

Our manufacturing facility in Tijuana, Mexico is our largest manufacturing facility. Our Mexico facility has achieved ISO 9001 and ISO 13485 certification. These certifications are internationally recognized quality standards for manufacturing and assist us in marketing our products in certain foreign markets.  Our Vista, California facility has achieved ISO 9001 certification, and certification to the Canadian Medical Device Regulation (ISO 13485) and the European Medical Device Directive.  Products manufactured at the Vista, California facility include our custom rigid knee bracing products, the pump portion of our vascular systems products and our regeneration products. Within both our Vista and Tijuana facilities, we operate vertically integrated manufacturing and cleanroom packaging operations and many subassemblies and components can be produced in-house. These include metal stamped parts, injection molding components and fabric-strapping materials. We also have extensive in-house tool and die fabrication capabilities, which typically provide savings in the development of tools and molds as well as flexibility to respond to and capitalize on market opportunities as they are identified.

 

We make Chattanooga division products, including electrotherapy devices, patient care products and physical therapy treatment tables and CPM devices, in our manufacturing facilities located in Chattanooga, Tennessee. These facilities use various manufacturing processes, including metal fabrication, coating, electronic assembly, mechanical assembly, woodworking and sewing.  Our Chattanooga, Tennessee facility has achieved ISO 13485 certification.   In June 2009, we announced our plans to close our Chattanooga manufacturing and distribution facility and to integrate the operations of the Chattanooga site into our other existing sites, mainly our Mexico facility. The transition of Chattanooga activities is expected to be completed during the first six months of 2010.

 

Our home electrotherapy devices sold in the United States and certain components and related accessories are manufactured at our Clear Lake, South Dakota facility. Manufacturing activities at the Clear Lake facility include electronic and mechanical assembly, electrode fabrication and assembly and fabric sewing processes. Our electrotherapy products comprise a variety of components, including die cast metal parts, injection molded plastic parts, printed circuit boards, electronic components, lead wires, electrodes and other components. Parts for these components are purchased from outside suppliers and are, in some instances, manufactured on a custom basis. Our Clear Lake facility has achieved the ISO 13485:2003 certification. Our home electrotherapy devices which are sold outside the United States are primarily manufactured by outside third party vendors.

 

Many of the component parts and raw materials we use in our manufacturing and assembly operations are available from more than one supplier and are generally available on the open market.  We source some of our finished products from manufacturers in China as well as other third party manufacturers.  We also currently purchase certain CPM devices from a single supply source, Medireha, which is 50% owned by us. Our distribution agreement with Medireha grants us exclusive rights to the distribution of products that Medireha manufactures. The distribution agreement also requires that we purchase a certain amount of product annually and that we seek Medireha’s approval if we choose to manufacture or distribute products that are identical or similar, or otherwise compete with the products that are the subject of the distribution agreement.

 

International Segment

 

Many of the products for our International Segment are manufactured in the same facilities as our domestic segments.  We operate a manufacturing facility in Tunisia that provides bracing products for the French and other European markets.  In addition, our Ormed and Cefar-Compex businesses source certain of the products they sell from third party suppliers. Cefar-Compex currently utilizes a single vendor for many of its home electrotherapy devices.

 

12



Table of Contents

 

Domestic Surgical Implant Segment

 

In our Domestic Surgical Implant Segment, we manufacture our products in our Austin, Texas facility. This manufacturing facility includes computer controlled machine tools, belting, polishing, cleaning, packaging and quality control. Our Austin facility has achieved the ISO 13485:2003 certification. The primary raw materials used in the manufacture of our surgical implant products are cobalt chromium alloy, stainless steel alloys, titanium alloy and ultra high molecular weight polyethylene. All Domestic Surgical Implant Segment products go through in-house quality control, cleaning and packaging operations.

 

Intellectual Property

 

We own or have licensing rights to U.S. and foreign patents covering a wide range of our products and have filed applications for additional patents. We have numerous trademarks registered in the United States, a number of which are also registered in countries around the world. We also assert ownership of numerous unregistered trademarks, some of which have been submitted for registration in the United States and foreign countries. In the future, we will continue to apply for such additional patents and trademarks as we deem appropriate. Additionally, we seek to protect our non-patented know-how, trade secrets, processes and other proprietary confidential information, through a variety of methods; including having our vendors, employees and consultants sign invention assignment agreements, proprietary information agreements and confidentiality agreements and having our independent sales agents and distributors sign confidentiality agreements. Because many of our products are regulated, proprietary information created during our development of a new or improved product may have to be disclosed to the FDA or another U.S. or foreign regulatory agency in order for us to have the lawful right to market such product.  We have distribution rights for certain products that are manufactured by others and hold both exclusive and nonexclusive licenses under third party patents and trade secrets that cover some of our existing products and products under development.

 

The validity of any of the patents or other intellectual property owned by or licensed to us may not be upheld if challenged by others in litigation. Due to these and other risks described in this Annual Report, we do not rely solely on our patents and other intellectual property to maintain our competitive position. We believe that the development and marketing of new products and improvement of existing ones is, and will continue to be, more important to our competitive position than relying solely on existing products and intellectual property.

 

Competition

 

The orthopedic devices market is highly competitive and fragmented. Some of our competitors, either alone or in conjunction with their respective parent corporate groups, have greater research and development, sales, marketing and manufacturing capabilities than we do, and thus may have a competitive advantage over us.  Although we believe that the design and quality of our products compare favorably with those of our competitors, if we are unable to offer products with the latest technological advances at competitive prices, our ability to compete successfully could be materially and adversely affected.

 

Given our sales history, our history of product development and the experience of our management team, we believe we are capable of effectively competing in the orthopedic devices market in the future. Further, we believe the comprehensive range of products we offer enables us to reach a diverse customer base and to use multiple distribution channels in an attempt to increase our growth across the orthopedic devices market. In addition, we believe the acquisition of the various companies and product lines which primarily now comprise our Domestic Rehabilitation Segment continues to improve the name recognition of our company and our products.

 

Among other things, our ability to compete is affected by our ability to:

 

·                  develop new products and innovative technologies;

 

·                  obtain regulatory clearance and compliance for our products;

 

·                  manufacture and sell our products cost-effectively;

 

·                  meet all relevant quality standards for our products and their markets;

 

·                  respond to competitive pressures specific to each of our geographic markets, including our ability to enforce non-compete agreements;

 

13



Table of Contents

 

·                  protect the proprietary technology of our products and manufacturing processes;

 

·                  market our products;

 

·                  attract and retain skilled employees and sales representatives; and

 

·                  maintain and establish distribution relationships.

 

Domestic Rehabilitation Segment

 

Our Domestic Rehabilitation Segment competes with large, diversified corporations and companies that are part of corporate groups that have significantly greater financial, marketing and other resources than we do, as well as numerous smaller niche companies. The primary competitors of Empi and Chattanooga are Dynatronics Corporation, Mettler Electronics Corporation, Rich-Mar, Patterson Medical, Enraf-Nonius, Gymna-Uniphy, Acorn Engineering, International Rehabilitation Sciences, Inc. (d/b/a RS Medical) and Care Rehab. The physical therapy products market is highly competitive and fragmented. Our competitors in the CPM devices market include several multi-product companies with significant market share and numerous smaller niche competitors.  Competition in these markets is based primarily on the quality and technical features of products, product pricing and contractual arrangements with third party payors and national accounts.

 

Our primary competitors in the rigid knee bracing market include companies such as Össur hf., Orthofix International, N.V., Bledsoe Brace Systems and Townsend Industries Inc. In the soft goods products market, our competitors include Biomet, Inc., DeRoyal Industries, Össur hf. and Zimmer Holdings, Inc. In the cold therapy products market, our competitors include Orthofix, Bledsoe Brace Systems and Stryker Corporation. Our primary competitor in the dynamic splinting market is Dynasplint Systems, Inc. Several competitors have initiated stock and bill programs similar to our OfficeCare program, and there are numerous regional stock and bill competitors. Competition in the rigid knee brace market is primarily based on product technology, quality and reputation, relationships with customers, service and price. Competition in the soft goods and pain management markets is less dependent on innovation and technology and is primarily based on product range, quality, service and price.

 

Our competitors for regeneration products are large, diversified orthopedic companies. In the nonunion bone growth stimulation market, our competitors include Orthofix International, N.V., Biomet, Inc. and Smith & Nephew, and in the spinal fusion market, we compete with Biomet, Inc. and Orthofix International, N.V. Competition in bone growth stimulation devices is limited as higher regulatory thresholds provide a barrier to market entry.

 

International Segment

 

Competition for our International products arises from many of the companies and types of companies that compete with our domestic segments and from foreign manufacturers whose costs may be lower due to their ability to manufacture products within their respective countries.  Competition is based primarily on quality, innovative design and technical capability, breadth of product line, availability of and qualification for reimbursement, and price.

 

Domestic Surgical Implant Segment

 

The market for orthopedic products similar to those produced by our Domestic Surgical Implant Segment is dominated by a number of large companies, including Biomet, Inc., DePuy, Inc. (a Johnson & Johnson company), Smith & Nephew plc, Stryker Corporation and Zimmer Holdings, Inc., which are much larger and have significantly greater financial resources than we do. Our Domestic Surgical Implant Segment also faces competition from U.S.-based companies similar in size to ours, such as Wright Medical Group, Inc. and Exactech, Inc. Competition in the market in which our Domestic Surgical Implant Segment participates is based primarily on price, quality, innovative design and technical capability, breadth of product line, scale of operations and distribution capabilities. Our current and future competitors may have greater resources, more widely accepted and innovative products, less-invasive therapies, greater technical capabilities, and stronger name recognition than we do.

 

Government Regulation

 

FDA and Similar Foreign Government Regulations

 

Our products are subject to rigorous government agency regulation in the United States and in other countries. In the United States, the FDA regulates the development, testing, labeling, manufacturing, storage, recordkeeping, premarket clearance or approval, promotion, distribution and marketing of medical devices to ensure that medical products distributed in the United States are safe and effective for their intended uses. The FDA also regulates the export of medical devices manufactured in the United States to international markets. Our medical devices are subject to such FDA regulation.

 

14



Table of Contents

 

Under the Food, Drug and Cosmetic Act, as amended, medical devices are classified into one of three classes depending on the degree of risk to patients using the device. Class I devices are those for which safety and effectiveness can be assured by adherence to General Controls, which include compliance with FDA QSRs, facility and device registrations and listings, reporting of adverse medical events, and appropriate truthful and non-misleading labeling, advertising and promotional materials. Some Class I devices also require pre-market review and clearance by the FDA through the Pre-market Notification 510(k) process described below. Class II devices are subject to General Controls, as well as pre-market demonstration of adherence to certain performance standards or other special controls as specified by the FDA. Pre-market review and clearance by the FDA is accomplished through the Pre-market Notification 510(k) procedure. In the 510(k) procedure, the manufacturer submits certain required information to the FDA in order to establish that the device is “substantially equivalent” to a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted or to another similar commercially available device subsequently cleared through the 510(k) process. Upon establishment of such substantial equivalence, the FDA may grant clearance to commercially market the device. If the FDA determines that the device, or its intended use, is not “substantially equivalent,” the FDA will automatically place the device into Class III.

 

A Class III device is a product that has a new intended use or is based on technology that is not substantially equivalent to a use or technology with respect to a legally marketed device for which the safety and effectiveness of the device cannot be assured solely by the General Controls, performance standards and special controls applied to Class I and II devices. These devices generally require clinical trials involving human subjects to assess their safety and effectiveness. A Pre-Market Approval (“PMA”) from the FDA is required before the manufacturer of a Class III product can proceed in marketing the product. The PMA process is much more extensive than the 510(k) process. In order to obtain a PMA, Class III devices, or a particular intended use of any such device, must generally undergo clinical trials pursuant to an application submitted by the manufacturer for an Investigational Device Exemption (“IDE”). An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA application or a 510(k) submission to the FDA. The PMA process generally takes significantly longer than the 510(k) process and can take up to several years.  In approving a PMA application, the FDA may require additional clinical data and may also require some form of post-market surveillance whereby the manufacturer follows certain patient groups for a number of years, making periodic reports to the FDA on the clinical status of those patients.

 

Our products include both pre-amendment and post-amendment Class I, II and III medical devices. All our currently marketed devices are either exempt from the FDA clearance and approval process (based on our interpretation of those regulations) or we have obtained the requisite clearances or approvals (including all modifications, amendments and changes), or pre-market clearances or approvals, as appropriate, required under federal medical device law. The FDA may disagree with our conclusion that clearances or approvals were not required for specific products and may require clearances or approval for such products. In these circumstances, we may be required to cease distribution of the product, the devices may be subject to seizure by the FDA or to a voluntary or mandatory recall, and we also could be subject to significant fines and penalties.

 

Our manufacturing processes are also required to comply with the FDA’s current Good Manufacturing Practice (“cGMP”) and Quality System Regulation (“QSR”) requirements that cover the methods and documentation of the design, testing, production processes, control, quality assurance, labeling, packaging and shipping of our products. Furthermore, our facilities, records and manufacturing processes are subject to periodic unscheduled inspections by the FDA and other agencies. Failure to comply with applicable QSR or other U.S. medical device regulatory requirements could result in, among other things, warning letters, fines, injunctions, civil penalties, repairs, replacements, refunds, recalls or seizures of products, total or partial suspensions of production, refusal of the FDA to grant future pre-market clearances or PMA approvals, withdrawals or suspensions of current clearances or approvals, and criminal prosecution. We are also required to report to the FDA if our products cause or contribute to death or serious injury or malfunction in a way that would likely cause or contribute to death or serious injury were the malfunction to recur; the FDA or other agencies may require the recall of products in the event of material defects or deficiencies in design or manufacturing. The FDA can also withdraw or limit our product approvals or clearances in the event of serious unanticipated health or safety concerns.

 

In the first quarter of 2008, we received a Form FDA-483 “Inspectional Observations” in connection with an FDA audit of the Chattanooga division of our Domestic Rehabilitation Segment, stating that we failed to report certain customer complaints claiming that our muscle stimulator devices malfunctioned, and that we did not adequately implement corrective and preventive action to prevent recurrence of potential product failures relating to our muscle stimulator devices.  The auditor also recommended that we recall a series of ultrasound devises that had experienced operating issues in 2005, and we are implementing such a recall. We received a warning letter from the FDA in June 2008 relating to reporting issues on the muscle stimulator device complaints and requesting software verification and validation plans and reports regarding the correction of problems associated with the ultrasound product.  We believe we have addressed these areas of concern adequately.  In a recent FDA audit of our Chattanooga facility, as a follow-up to the warning letter we received in June 2008, the FDA issued no Form FDA 483 “Inspectional Observations” and the FDA has formally withdrawn the warning letter.

 

15



Table of Contents

 

In the third quarter of 2009, we received a Form FDA-483 “Inspectional Observations” in connection with an FDA audit of our Domestic Surgical Implant Segment, stating that: (1) we failed to follow our standard operating procedures to ensure that the designs of certain products were correctly transferred into production; (2) we failed to adequately analyze certain quality data to identify existing and potential causes of nonconforming product and quality problems, resulting in disposal or reworking of certain nonconforming parts in the later stages of our production processes; (3) our complaint handling procedures were not well defined to ensure that all complaints are processed in a uniform and timely manner; and (4) we failed to follow our standard operating procedures related to procurement to minimize receipt of nonconforming materials from suppliers. We promptly implemented corrective actions that we believe adequately address each Inspectional Observation and submitted a timely response to the FDA. We are reviewing these inspectional observations to determine the appropriate remedial action. We cannot assure you that the FDA will agree with our actions or will not take further action in the future, including issuing a warning letter related to these observations, seeking injunction, initiating seizure, or delaying review of pending applications.

 

Even if regulatory approval or clearance of a medical device is granted, the FDA may impose limitations or restrictions on the use and indications for which the device may be labeled or promoted. Medical devices may be marketed only for the uses and indications for which they are cleared or approved. FDA regulations prohibit a manufacturer from promotion for an unapproved or off-label use.

 

The FDA has broad regulatory and enforcement powers. If the FDA determines we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions, from warning letters, fines, injunctions, consent decrees, and civil penalties, to suspension or delayed issuance of applications, seizure or recall of our products, total or partial shutdowns, withdrawals of approvals or clearances already granted, and criminal prosecution. The FDA can also require us to repair or replace or refund the costs of devices we manufactured or distributed.

 

We must obtain export certificates from the FDA before we can export certain of our products. We are also subject to extensive regulations that are similar to those of the FDA in many of the foreign countries in which we sell our products, including those in Europe, our largest foreign market. These include product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. The regulation of our products in the European Economic Area (which consists of the twenty-seven member states of the European Union, as well as Iceland, Liechtenstein and Norway) is governed by various directives and regulations promulgated by the European Commission and national governments. Only medical devices that comply with certain conformity requirements are allowed to be marketed within the European Economic Area. In addition, the national health or social security organizations of certain countries, including certain countries outside Europe, require our products to be qualified before they can be marketed in those countries.

 

We have also implemented policies and procedures allowing us to position ourselves for the changing international regulatory environment. Our international surgical implant activities received an ISO 13485:2003 certification for its facilities and an EC Certificate for its many products. Receiving ISO 13485:2003 certification assists us in meeting international regulatory requirements to allow for export of products to Japan, countries in Europe, Australia and Canada. Our international surgical implant activities have also met the requisites for the Canadian Medical Device Requirements.  Our International Segment has received ISO 9001 certification, EN46001 certification and certification to the Canadian Medical Device Regulation (ISO 13485) and the European Medical Device Directive.

 

Third Party Reimbursement

 

Our home therapy products, rigid knee braces, regeneration products, and certain of our soft goods are generally prescribed by physicians and are eligible for third party reimbursement by government payors, such as Medicare and Medicaid, and private payors. Customer selection of our products depends, in part, on coverage of our products and whether third party payment amounts will be adequate. We believe that Medicare and other third party payors will continue to focus on measures to contain or reduce their costs through managed care and other methods. Medicare policies are important to our business because private payors often model their policies after the Medicare program’s coverage and reimbursement policies.  In December 2008, Medicare issued a notice to its contractors responsible for reimbursement of orthotics, among other products, to the effect that elastic braces that are not rigid or semi-rigid are not considered “braces” for Medicare coverage purposes and will no longer be reimbursed, effective January 1, 2009.  We are seeking a redetermination by Medicare of the application of this notice to several braces we sell that, while not composed of rigid material, operate to support and correct physical issues, particularly relating to the knee cap, and should be continued to be classified as braces for coverage purposes.  This decision by Medicare is likely to eventually be adopted by private third-party payers and, subject to our success in seeking the redetermination, could adversely impact our sales in the bracing and soft goods product line of our Domestic Rehabilitation Segment.

 

16



Table of Contents

 

In recent years, Congress has enacted a number of laws that impact Medicare reimbursement for and coverage of durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”), including many of our products. For instance, the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (“Medicare Modernization Act”) mandated a temporary freeze in annual increases in payments for durable medical equipment from 2004 through 2008, and established new clinical conditions for payment and quality standards. Under a competitive bidding structure provided in the Medicare Modernization Act, Medicare no longer reimburses for certain products and services based on the Medicare fee schedule amount in designated competitive bidding areas. Instead, the Medicare program will provide reimbursement for these items and services based on a competitive bidding process. Only those suppliers selected through the competitive bidding process within each designated region will be eligible to have their products reimbursed by Medicare. Bidding was conducted in 2007 for the first phase of competitive bidding in ten metropolitan statistical areas for ten product categories, and bid prices briefly went into effect on effect July 1, 2008. The program was scheduled to be expanded to an additional 70 areas in 2009, and additional areas thereafter. On July 15, 2008, the U.S. Congress enacted the Medicare Improvements for Patients and Providers Act of 2008 (“MIPPA”), which terminated round one contracts and required the Centers for Medicare and Medicaid services (“CMS”), the agency responsible for administering the Medicare program, to rebid those areas in 2009. The legislation also delays round two bidding until 2011 and makes a series of changes to program requirements. The delay in bidding is financed by nationwide reductions in Medicare DMEPOS fee schedule payments for 2009 for items that were subject to the first round of bidding. CMS conducted the rebidding of the first round of the competitive bidding program in 2009, with the program scheduled to go into effect January 1, 2011. While none of our products are included in the initial round of items subject to bidding, off-the-shelf orthotics could eventually be subject to the bidding process. The competitive bidding process may reduce the number of suppliers providing certain items and services to Medicare beneficiaries and the amounts paid for such items and services within a given geographic area. In addition, CMS may use payment information from regions subject to competitive bidding to reduce Medicare reimbursement in regions not subject to competitive bidding. CMS also has proposed revising the way Medicare sets payment amounts for all new durable medical equipment, orthotics, prosthetics, and supplies, under which reimbursement could be based in part or in whole on functional assessments, price comparisons, and medical benefits assessments, although that methodology has not yet been finalized.  While the program is currently delayed, once it is back in effect, we expect it will be expanded to additional areas and additional product categories may be selected.

 

In addition, as mandated by the Medicare Modernization Act, in August 2006, CMS issued quality standards for suppliers, which are being applied by independent accreditation organizations. Suppliers must be accredited as meeting supplier standards as a condition of participation in competitive bidding, but all Medicare suppliers eventually must be accredited to participate in Medicare, with different deadlines based on when the supplier applies for enrollment. Those portions of our business that act as Medicare suppliers have been accredited. Moreover, the Medicare Modernization Act requires that new clinical conditions for payment of durable medical equipment be established. CMS issued a proposed rule to implement this provision in August 2004, but the agency to date only has finalized such standards for power mobility devices. Some of our products could be impacted by this requirement in the future. At this time, we cannot predict what clinical conditions will be adopted, the timing of such adoption, or the impact that the new quality standards or any new clinical conditions that are adopted may have on our business.

 

CMS also published a rule on January 2, 2009 requiring most Medicare suppliers of durable medical equipment, prosthetics, orthotics and supplies to post a $50,000 surety bond from an authorized surety, with higher amounts required for certain “high-risk” suppliers.  The rule provides an exception from the surety bond requirement for the provision of orthotics, prosthetics, and supplies by (1) state-licensed orthotic and prosthetic personnel and (2) state-licensed physical and occupational therapists providing such items to their own patients. This exception applies only to personnel and therapists operating in private practice; medical supply companies employing such personnel or therapists do not qualify for this exception.  The rule became effective March 3, 2009.  Existing suppliers were required to comply with the surety bond requirement by October 2, 2009), while new enrolling suppliers or suppliers seeking to change ownership after the effective date must meet this requirement by May 4, 2009.

 

On August 7, 2009, CMS issued Transmittal 297 entitled ‘‘Compliance Standards for Consignment Closets and Stock and Bill Arrangements’’ (the ‘‘Transmittal’’), requiring a change in procedures in stock and bill arrangements for Medicare beneficiaries. When implemented, the Transmittal will require products dispensed to a Medicare beneficiary from the inventory in our OfficeCare accounts in physician office settings to be fitted and billed to Medicare by the physician rather than by us. Title to the product must pass to the physician at the time the product is dispensed to the patient. The effect of this change in most instances would be to convert a billing opportunity by us into a sale to the physician at a wholesale price. The Transmittal was originally scheduled to go into effect on September 8, 2009. CMS first delayed the effective date until March 1, 2010, and on February 4, 2010 CMS rescinded the Transmittal in order to consider other implementation dates. If the Transmittal goes into effect as written, it could adversely affect the revenue and, to a lesser extent, profitability of our OfficeCare business.

 

Our international sales also depend in part upon the eligibility of our products for reimbursement through third party payors, the amount of reimbursement and the allocation of payments between the patient and third party payors. Reimbursement practices vary significantly by country, with certain countries requiring products to undergo a lengthy regulatory review in order to be eligible for third party reimbursement. In addition, healthcare cost containment efforts similar to those we face in the United States are

 

17



Table of Contents

 

prevalent in many of the foreign countries in which our products are sold, and these efforts are expected to continue in the future, possibly resulting in the adoption of more stringent reimbursement standards. For example, in Germany, our largest foreign market, new regulations generally require adult patients to pay a portion of the cost of each medical technical device prescribed. This may adversely affect our sales and profitability by making it more difficult for patients in Germany to pay for our products. Any developments in our foreign markets that eliminate, reduce or materially modify coverage of, and reimbursement rates for, our products could have an adverse effect on our ability to sell our products.

 

Fraud and Abuse

 

We are subject to various federal and state laws and regulations pertaining to healthcare fraud and abuse. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, exclusion from participation in federal and state healthcare programs, including Medicare, Medicaid, Veterans Administration health programs and TRICARE (the health care program for active duty military, retirees and their families managed by the Department of Defense). We have no reason to believe that our operations are not in material compliance with such laws. However, because these laws and regulations are broad in scope and may change, we may be required to alter one or more of our practices to be in compliance with these laws. In addition, the occurrence of one or more violations of these laws or regulations, a challenge to our operations by a governmental authority under these laws or regulations or a change in the laws or regulations may have a material adverse effect on our financial condition and results of operations.

 

Anti-Kickback and Other-Fraud Laws

 

Our operations are subject to federal and state anti-kickback laws. Certain provisions of the Social Security Act, commonly referred to as the Anti-Kickback Statute, prohibit persons from knowingly and willfully soliciting, receiving, offering or providing remuneration directly or indirectly to induce either the referral of an individual, or the furnishing, recommending, or arranging for a good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid. The definition of “remuneration” has been broadly interpreted to include anything of value, including such items as gifts, discounts, waiver of payments, and providing anything at less than its fair market value. The U.S. Department of Health and Human Services (“HHS”) has issued regulations, commonly known as safe harbors, that set forth certain conditions which, if fully met, will assure healthcare providers and other parties that they will not be prosecuted under the Anti-Kickback Statute. Although full compliance with these provisions ensures against prosecution under the Anti-Kickback Statute, the failure of a transaction or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or arrangement is illegal or that prosecution under the Anti-Kickback Statute will be pursued. The penalties for violating the Anti-Kickback Statute include imprisonment for up to five years, fines of up to $25,000 per violation and possible exclusion from federal healthcare programs such as Medicare and Medicaid. Many states have adopted prohibitions similar to the Anti-Kickback Statute, some of which apply to the referral of patients for healthcare services reimbursed by any source, not only by the Medicare and Medicaid programs.

 

Recently, certain manufacturers of implant products entered into monetary settlement agreements, corporate integrity agreements and deferred prosecution agreements with the U.S. Department of Justice (“DOJ”) based upon allegations that, among other things, they entered into a variety of consulting and other agreements with physicians as improper inducements to those physicians to use the manufacturers’ products in violation of federal anti-kickback laws. We believe that remuneration paid to surgeons with which we have agreements represents fair market value for legitimate designing, consulting and advisory services rendered on our behalf.

 

Our OfficeCare program is a stock and bill arrangement through which we make products and services available in the offices of physicians or other providers. In conjunction with the OfficeCare program, we may pay participating physicians a fee for rental space and support services provided by such physicians to us. In a February 2000 Special Fraud Alert, the Office of Inspector General (“OIG”) indicated that it may scrutinize stock and bill programs involving excessive rental payments or rental space for possible violation of the Anti-Kickback Statute, but noted that legitimate arrangements, including fair market value rental arrangements, will not be considered violations of the statute. We believe that we have structured our OfficeCare program to comply with the Anti-Kickback Statute.

 

The Health Insurance Portability and Accountability Act of 1995 (“HIPAA”) created two new federal crimes effective as of August 21, 1996, relating to healthcare fraud and false statements regarding healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing or attempting to execute a scheme or artifice to defraud any healthcare benefit program, including private payors. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. HIPAA applies to any healthcare benefit plan, not just Medicare and Medicaid. Additionally, HIPAA granted expanded enforcement authority to HHS and the DOJ and provided enhanced resources to support the activities and responsibilities of the HHS, OIG and DOJ by authorizing large increases in funding for investigating fraud and abuse violations relating to healthcare delivery and payment. In addition, HIPAA mandates the adoption of standards for the electronic exchange of health information, as described below in greater detail under “Federal Privacy and Transaction Law and Regulations.”

 

18



Table of Contents

 

Physician Self-Referral Laws

 

We may also be subject to federal and state physician self-referral laws. Federal physician self-referral legislation, commonly known as the Stark Law, prohibits, subject to certain exceptions, physician referrals of Medicare and Medicaid patients to an entity providing certain “designated health services” if the physician or an immediate family member of the physician or a physician organization in which the physician participates has any financial relationship with the entity. Durable medical equipment and orthotics are included as designated health services. The Stark Law also prohibits the entity receiving the referral from billing any good or service furnished pursuant to an unlawful referral, and any person collecting any amounts in connection with an unlawful referral is obligated to refund such amounts. A person who engages in a scheme to circumvent the Stark Law’s referral prohibition may be fined up to $100,000 for each such arrangement or scheme. The penalties for violating the Stark Law also include civil monetary penalties of up to $15,000 per referral and possible exclusion from federal healthcare programs such as Medicare and Medicaid. Various states have corollary laws to the Stark Law, including laws that require physicians to disclose any financial interest they may have with a healthcare provider to their patients when referring patients to that provider. Both the scope and exceptions for such laws vary from state to state.

 

False Claims Laws

 

Under multiple state and federal statutes, submissions of claims for payment that are “not provided as claimed” may lead to civil money penalties, criminal fines and imprisonment and/or exclusion from participation in Medicare, Medicaid and other federally funded state health programs. These false claims statutes include the federal False Claims Act, which prohibits the knowing filing of a false claim or the knowing use of false statements to obtain payment from the federal government. When an entity is determined to have violated the False Claims Act, it must pay three times the actual damages sustained by the government, plus mandatory civil penalties of between $5,500 and $11,000 for each separate false claim. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as whistleblowers, may share in any amounts paid by the entity to the government in fines or settlement. In addition, certain states have enacted laws modeled after the federal False Claims Act. Qui tam actions have increased significantly in recent years, causing greater numbers of healthcare companies to have to defend a false claim action, pay fines or be excluded from Medicare, Medicaid or other federal or state healthcare programs as a result of an investigation arising out of such action.

 

Governmental Audits

 

Because we participate in governmental programs as a supplier of medical devices, our operations are subject to periodic surveys and audits by governmental entities or contractors to assure compliance with Medicare and Medicaid standards and requirements. To maintain our billing privileges, we are required to comply with certain supplier standards, including licensure and documentation requirements for our claims submissions. From time to time in the ordinary course of business, we, like other healthcare companies, are audited by, or receive claims documentation requests from, governmental entities, which may identify certain deficiencies based on our alleged failure to comply with applicable supplier standards or other requirements. Medicare contractors and Medicaid agencies periodically conduct pre- and post-payment reviews and other audits of claims and are under increasing pressure to more closely scrutinize healthcare claims and supporting documentation. We have historically been subject to pre and post-payment reviews as well as audits of claims and may experience such reviews and audits of claims in the future. We review and assess such audits or reports and attempt to take appropriate corrective action. We are also subject to surveys of our facilities for compliance with the supplier standards.

 

We have also been subject to periodic audits of our compliance with other federal requirements for our facilities and related quality and manufacturing processes.  Our Surgical Implant facility in Austin, Texas received an FDA warning letter received in 2009 and our facility in Chattanooga received a warning letter following an FDA audit in early 2008.  Both of these warning letters are described above in the section “FDA and Similar Foreign Government Regulations”.

 

Federal Privacy and Transaction Law and Regulations

 

HIPAA impacts the transmission, maintenance, use and disclosure of certain individually identifiable health information (referred to as “protected health information” or “PHI”). Since HIPAA was enacted in 1996, numerous implementing regulations have been issued, including, but not limited to: (1) standards for the privacy of individually identifiable health information (the “Privacy Rule”), (2) security standards (the “Security Rule”), (3) standards for electronic transactions (the “Transactions Rule”), and (4) standard unique national provider identifier (“NPI Rule”). We refer to these rules as the Administrative Simplification Rules. CMS has also issued regulations governing the enforcement of the Administrative Simplification Rules. Sanctions for violation of HIPAA and /or the Administrative Simplification Rules include criminal and civil penalties.

 

19



Table of Contents

 

HIPAA applies to “covered entities,” which includes certain health care providers who conduct certain transactions electronically. As such, HIPAA and the Administrative Simplification Rules apply to certain aspects of our business. The effective date for all of the Administrative Simplification Rules outlined above has passed, and, as such, all of the Administrative Simplification Rules are in effect. To the extent applicable to our operations, we are currently in compliance with HIPAA and the applicable Administrative Simplification Rules.

 

On February 17, 2009, President Obama signed into law the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”) as part of the American Recovery and Reinvestment Act.  This economic stimulus package includes many health care policy provisions, including strengthened federal privacy and security provisions to protect personally-identifiable health information, such as notification requirements for health data security breaches.  Many of the details of the new requirements are being implemented through regulations, including an interim final rule on the HITECH health information security enforcement provisions published October 30, 2009. We are reviewing these new requirements to assess the potential impact on our operations.

 

Employees

 

As of December 31, 2009, we had approximately 4,480 employees. Of these, approximately 3,040 were engaged in production and production support, approximately 40 in research and development, approximately 1,020 in sales and support, and approximately 380 in various administrative capacities including third party billing.  Of these employees, approximately 1,970 were located in the United States, approximately 1,920 were located in Mexico and approximately 590 were located in various other countries, primarily in Europe.  Our workforce in the United States is not unionized; however, portions of our workforce in Europe are unionized.  We have not experienced any strikes or work stoppages, and our management considers our relationship with our employees to be good.

 

Segment and Geographic Information

 

Information about our segments and geographic areas can be found in Note 12 “Segment and Geographic Information” of the  notes to the audited consolidated financial statements included in Part II, Item 8, herein.

 

Available Information

 

We have made available free of charge through our website, www.DJOglobal.com, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, other Exchange Act reports and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with the Securities and Exchange Commission (“SEC”).  This information can be found under the “Investors-SEC Reports” page of our website.  DJO uses its website as a channel of distribution of material Company information.  Financial and other material information regarding the Company is routinely posted and accessible on our website. Our SEC reports are also available free of charge on the SEC website at, www.sec.gov.  Our Code of Business Conduct and Ethics is available free of charge on our website.  It may be found under the “Investors-Corporate Governance” page of our website.

 

ITEM 1A.  RISK FACTORS

 

Our ability to achieve our operating and financial goals is subject to a number of risks, including risks arising from the current economic downturn and risks relating to our business operations, our debt level and government regulations.  If any of the following risks actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected.  The risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business operations.

 

Risks Related To Our Indebtedness

 

Our substantial leverage could adversely affect our ability to raise additional capital to fund our operations, limit our ability to react to changes in the economy or our industry, expose us to interest rate risk to the extent of our variable rate debt and prevent us from meeting our obligations under our indebtedness.

 

We are highly leveraged. As of December 31, 2009, our total indebtedness was $1,812.9 million. We have an additional $100.0 million available for borrowing under our revolving credit facility, for which no amounts were drawn as of December 31, 2009.

 

20



Table of Contents

 

Our high degree of leverage could have important consequences, including:

 

·                  making it difficult for us to make payments on our 10.875% Notes and our 11.75% Notes (collectively, the “Notes”) and other debt;

 

·                  increasing our vulnerability to general economic and industry conditions;

 

·                  requiring a substantial portion of cash flow from operations to be dedicated to the payment of principal and interest on our indebtedness, therefore reducing our ability to use our cash flow to fund our operations, capital expenditures and future business opportunities;

 

·                  exposing us to the risk of increased interest rates as certain of our borrowings, including certain borrowings under our Senior Secured Credit Facility, will be subject to variable rates of interest;

 

·                  limiting our ability to make strategic acquisitions or causing us to make non-strategic divestitures;

 

·                  limiting our ability to obtain additional financing for working capital, capital expenditures, product development, debt service requirements, acquisitions and general corporate or other purposes; and

 

·                  limiting our ability to adjust to changing market conditions and placing us at a competitive disadvantage compared to our competitors who are less highly leveraged.

 

We may be able to incur substantial additional indebtedness in the future. Although our Senior Secured Credit Facility and each of the indentures governing the Notes, which we refer to as the 10.875% Indenture and the 11.75% Indenture (or collectively, the “Indentures”), contain restrictions on the incurrence of additional indebtedness, these restrictions are subject to a number of significant qualifications and exceptions, and under certain circumstances, the amount of indebtedness that could be incurred in compliance with these restrictions could be substantial. If new indebtedness is added to our current debt levels, the related risks that we now face could intensify. In addition, the Indentures will not prevent us from incurring obligations that do not constitute indebtedness under the Indentures.

 

Our cash paid for interest for the years ended December 31, 2009 and 2008 was $144.2 million and $158.8 million, respectively.  As of December 31, 2009, we had $1,044.1million of debt subject to floating interest rates, including $1,043.7 million under the Senior Secured Credit Facility.  Although we currently have interest rate swaps in place to hedge against rising interest rates (see Note 9 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein), any additional borrowings we make under the Senior Secured Credit Facility will also be subject to floating interest rates.

 

Our debt agreements contain restrictions that limit our flexibility in operating our business.

 

Our Senior Secured Credit Facility and the Indentures governing the Notes contain various covenants that limit our ability to engage in specified types of transactions. These covenants limit our and our subsidiaries’ ability to, among other things:

 

·                  incur additional indebtedness or issue certain preferred shares;

 

·                  pay dividends on, repurchase or make distributions in respect of our capital stock or make other restricted payments;

 

·                  make certain investments;

 

·                  sell certain assets;

 

·                  create liens;

 

·                  consolidate, merge, sell or otherwise dispose of all or substantially all of our assets; and

 

·                  enter into certain transactions with our affiliates.

 

In addition, we are required to satisfy and maintain a specified senior secured leverage ratio, which becomes more restrictive over time. This covenant could materially and adversely affect our ability to finance our future operations or capital needs. Furthermore, it may restrict our ability to conduct and expand our business and pursue our business strategies.  Our ability to meet this senior secured leverage ratio can be affected by events beyond our control, including changes in general economic and business conditions, and we cannot assure you that we will meet the senior secured leverage ratio in the future or at all.

 

21



Table of Contents

 

A breach of any of these covenants could result in a default under one or more of these agreements, including as a result of cross default provisions. Upon the occurrence of an event of default under the Senior Secured Credit Facility, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facility to be immediately due and payable and terminate all commitments to extend further credit. Such actions by those lenders could cause cross defaults under our other indebtedness. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facility could proceed against the collateral granted to them to secure that indebtedness. We have pledged a significant portion of our assets as collateral under the Senior Secured Credit Facility. If the lenders under the Senior Secured Credit Facility accelerate the repayment of borrowings, we cannot assure you that we will have sufficient assets to repay the amounts borrowed under the Senior Secured Credit Facility, as well as our unsecured indebtedness.

 

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 cannot assure you that we will 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.

 

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. These alternative measures could affect the operation and growth of our business and may not be successful and may not permit us to meet our scheduled debt service obligations. If our operating results and available cash are insufficient to meet our debt service obligations, 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. In that case, we may not be able to consummate those dispositions or to obtain the proceeds that we could realize from them, and the proceeds from those dispositions may not be adequate to meet any debt service obligations then due. Additionally, our Senior Secured Credit Facility and the Indentures governing the Notes limit the use of the proceeds from dispositions of assets; as a result, we may not be permitted, under our Senior Secured Credit Facility and the Indentures governing the Notes, to use the proceeds from such dispositions to satisfy all current debt service obligations.

 

Risks Related To Our Business

 

The current US and global economic downturn and related credit and financial market problems may pose additional risks and exacerbate existing risks to our business.

 

The serious slowdown in the US and global economy, as well as the dramatic problems in the current credit and financial markets, had and may continue to have a negative effect on demand for our products, availability and reliability of vendors and third party contract manufacturers, our ability to timely collect our accounts receivable and the availability of financing for acquisitions and working capital requirements. We experienced an overall slowing of our revenue growth in 2009 from prior years and significant slowdown in sales of our products that our customers consider to be included in their discretionary capital spending. Continued or renewed deterioration of the general economic slowdown in the United States and overseas could contribute to those trends remaining a problem or becoming worse.

 

The slowing of economic activity and lack of available financing has impacted and could continue to impact our business in a variety of ways, including the following:

 

·      Loss of jobs and lack of health insurance as a result of the economic slowdown could depress demand for health care services and demand for our products.

 

·      Weakened demand for health care services, reduction in the number of insured patients and lack of available credit could result in the inability of private insurers to satisfy their reimbursement obligations, lead to delays in payment or cause the insurers to increase their scrutiny of our claims.

 

·      Shortage of available credit for working capital could lead customers who buy capital goods from us to curtail their purchases or have difficulty meeting payment obligations.

 

22



Table of Contents

 

·      Tightening of credit and disruption in the financial markets could disrupt or delay performance by our third party vendors and contractors and adversely affect our business.

 

·      Problems in the credit and financial markets could limit the availability and size of alternative or additional financing for our working capital or other corporate needs and could make it more difficult and expensive to obtain waivers under or make changes to our existing credit arrangements.

 

Any of these risks, among others, could adversely affect our business and operating results, and the risks could become more pronounced if the problems in the US and global economies and the credit and financial markets continue or become worse.

 

Changes in Medicare coverage and reimbursement policies for our products by Medicare or reductions in reimbursement rates for our products could adversely affect our business and results of operations.

 

In recent years, Congress has enacted a number of laws that impact Medicare reimbursement for and coverage of DMEPOS, including many of our products. For instance, the Medicare Modernization Act mandated a temporary freeze in annual increases in payments for durable medical equipment from 2004 through 2008, and established new clinical conditions for payment and quality standards.

 

The Medicare Modernization Act also established a new competitive bidding program for DMEPOS, which eventually could impact prefabricated orthotic devices and other of our products. Under competitive bidding, Medicare will no longer reimburse for certain products and services based on the Medicare fee schedule amount in designated competitive bidding areas. Instead, the Medicare program will provide reimbursement for these items and services based on a competitive bidding process. Only those suppliers selected through a competitive bidding process within each designated region will be eligible to have their products reimbursed by Medicare. Bidding was conducted in 2007 for the first phase of competitive bidding in ten metropolitan statistical areas for ten product categories, and bid prices briefly went into effect on July 1, 2008. The program was scheduled to be expanded to 70 additional areas in 2009 and additional areas thereafter. On July 15, 2008, the U.S. Congress enacted MIPPA, which terminated round one contracts and required CMS to rebid those areas in 2009. The legislation also delays round two bidding until 2011 and makes a series of changes to program requirements. The delay in bidding is financed by nationwide reduction in Medicare DMEPOS for 2009 fee schedule payments for items that were subject to the first round of bidding. CMS conducted the rebidding of the first round of the competitive bidding program in 2009, with the program scheduled to go into effect January 1, 2011. While none of our products is included in the initial round of items subject to bidding; there is no assurance they will not be included in the future. When it is eventually implemented, the competitive bidding process may reduce the number of suppliers providing certain items and services to Medicare beneficiaries and the amounts paid for such items and services within a given geographic area. Inclusion of any of our products in Medicare competitive bidding or other Medicare reimbursement or coverage reductions could result in such products being sold in lesser quantities or for a lower price. Further, CMS may use competitive bid pricing information to adjust the payment amounts otherwise in effect for an area that is not a competitive acquisition area. Any of these developments could have a material adverse effect on our results of operations. In addition, if we are not selected to participate in the competitive bidding program in a particular region, it could have a material adverse effect on our sales and profitability.

 

Initiatives sponsored by government agencies, legislative bodies and the private sector to limit the growth of healthcare costs, including price regulation and competitive pricing, are ongoing in markets where we do business. We could experience a negative impact on our operating results due to increased pricing pressure in the United States and certain other markets. Governments, hospitals and other third party payors could reduce the amount of approved payment for the company’s products. Reductions in reimbursement levels or coverage, or other cost-containment measures could unfavorably affect our future operating results.

 

Future federal and state health reform and cost control efforts could include provisions that adversely impact our business and results of operations.

 

The U.S. House of Representatives and the U.S. Senate have approved separate health reform bills designed to expand access to affordable health insurance, control health care spending, and improve health care quality. Specific provisions of the legislation vary, but both versions include a number of provisions that could, if enacted, impact manufacturers and suppliers of DMEPOS.  Provisions adopted by the House and/or Senate would, among other things: establish a public health insurance plan to compete with private insurers; impose a new annual federal fee on certain medical device manufacturers and importers; require medical supply and device manufacturers to report certain payments made to physicians and other referral sources; reduce Medicare DMEPOS fee schedule updates and apply a new ‘‘productivity adjustment’’ to Medicare DMEPOS payments; expand and accelerate the Medicare DMEPOS competitive bidding program; study the establishment of a competitive bidding program for manufacturers of durable medical equipment and supplies; and establish new Medicare and Medicaid program integrity provisions, including a number of safeguards focusing on Medicare orders for DMEPOS.  Although the timing and ultimate outcome of the health reform efforts are still uncertain, it is possible that provisions of the pending health reform legislation, if enacted, could have a material adverse impact on our business.

 

23



Table of Contents

 

Likewise, many states have adopted or are considering changes in state health care legislative and regulatory policies as a result of state budgetary shortfalls. These changes have included reductions in provider and supplier reimbursement levels under state Medicaid programs, including in some cases reduced reimbursement for DMEPOS items, and/or other Medicaid coverage restrictions. As states continue to face significant financial pressures, it is possible that state health policy changes will adversely affect our profitability.

 

If we fail to meet Medicare accreditation and surety bond requirements, it could negatively impact our business operations.

 

Medicare DMEPOS suppliers (other than certain exempted professionals) must be accredited by an approved accreditation organization as meeting DMEPOS Quality Standards adopted by CMS including specific requirements for suppliers of custom-fabricated and custom-fitted orthoses and certain prosthetics. Medicare suppliers also are required to meet surety bond requirements. We believe we are in compliance with current requirements in this area. If in the future we fail to maintain our Medicare accreditation status and/or do not comply with Medicare surety bond requirements, or if these requirements are expanded in the future, it could adversely impact our profits and results of operation.

 

If we fail to comply with the FDA Quality System Regulation, our manufacturing could be delayed, and our product sales and profitability could suffer.

 

Our manufacturing processes are required to comply with the FDA’s Quality System Regulation, which covers current Good Manufacturing Practice requirements and the procedures concerning (and documentation of) the design, testing, production processes, controls, quality assurance, labeling, packaging, storage and shipping of our devices. We also are subject to state requirements and licenses applicable to manufacturers of medical devices. In addition, we must engage in extensive recordkeeping and reporting and must make available our manufacturing facilities and records for periodic unscheduled inspections by governmental agencies, including the FDA, state authorities and comparable agencies in other countries. Moreover, if we fail to pass a Quality System Regulation inspection or to comply with these and other applicable regulatory requirements, we may receive a warning letter or could otherwise be required to take corrective action and, in severe cases, we could suffer a disruption of our operations and manufacturing delays. If we fail to take adequate corrective actions, we could be subject to certain enforcement actions, including, among other things, significant fines, suspension of approvals, seizures or recalls of products, operating restrictions and criminal prosecutions. We cannot assure you that the FDA or other governmental authorities would agree with our interpretation of applicable regulatory requirements or that we have in all instances fully complied with all applicable requirements. Any failure to comply with applicable requirements could adversely affect our product sales and profitability.  We have received FDA warnings letters in the past and we cannot assure you that the FDA will not take further action in the future.

 

We may not be able to successfully integrate businesses that we have recently acquired, or businesses we may acquire in the future, and we may not be able to realize the anticipated cost savings, revenue enhancements or other synergies from such acquisitions.

 

Our ability to successfully implement our business plan and achieve targeted financial results is highly dependent on our ability to successfully integrate businesses that we have recently acquired and other businesses we acquire in the future. The process of integrating such acquired businesses involves risks. These risks include, but are not limited to:

 

·                  demands on management related to the significant increase in the size of our business;

 

·                  diversion of management’s attention from the management of daily operations to the integration of newly acquired operations;

 

·                  difficulties in the assimilation of different corporate cultures, practices and sales and distribution methodologies;

 

·                  difficulties in conforming the acquired company’s accounting policies to ours;

 

·                  increased exposure to risks relating to business operations outside the United States;

 

·                  retaining the loyalty and business of the customers of acquired businesses;

 

·                  retaining employees who may be vital to the integration of the acquired business or to the future prospects of the combined businesses;

 

24



Table of Contents

 

·                  difficulties and unanticipated expenses related to the integration of departments, information technology systems, including accounting systems, technologies, books and records and procedures;

 

·                  maintaining uniform standards, such as internal accounting controls, procedures and policies; and

 

·                  costs and expenses associated with any undisclosed or potential liabilities.

 

We have announced the closure of our facility in Chattanooga, Tennessee, and the transfer of its production operations principally to our Mexico facility. The administrative activities formerly carried on in the Chattanooga facility will be moved to our operations in Vista, California and Indianapolis, Indiana. Failure to successfully transfer these business operations and to otherwise integrate the former operations of ReAble with the operations of DJO Opco or any other acquired businesses may result in reduced levels of revenue, earnings or operating efficiency than we have achieved or might have achieved if we had not acquired such businesses, and loss of customers of the acquired businesses.

 

In addition, an important part of our strategy is to generate revenue growth by cross selling products through the expanded distribution network achieved following the acquisition of businesses. Our ability to successfully cross sell our products to the extent we anticipate or at all is subject to considerable uncertainty. To the extent we are not successful in our cross selling efforts, our revenues and income will be adversely affected.

 

Furthermore, even if we are able to integrate successfully the operations of DJO Opco with the operations of ReAble, including the closure of the Chattanooga facility and the transfer of operations,  we may not be able to realize the potential cost savings, synergies and revenue enhancements that were anticipated from the integration, either in the amount or within the time frame that we expect, and the costs of achieving these benefits may be higher than, and the timing may differ from, what we expect. Our ability to realize anticipated cost savings, synergies and revenue enhancements may be affected by a number of factors, including, but not limited to, the following:

 

·                  the use of more cash or other financial resources on integration and implementation activities than we expect;

 

·                  increases in other expenses unrelated to the acquisitions, which may offset the cost savings and other synergies from the acquisitions;

 

·                  our ability to eliminate effectively duplicative back office overhead and overlapping and redundant selling, general and administrative functions, rationalize manufacturing capacity and shift production to more economical facilities; and

 

·                  our ability to avoid labor disruptions in connection with any integration, particularly in connection with any headcount reduction.

 

Specifically, the DJO Merger created significant opportunities to reduce our manufacturing and other costs. We took steps to achieve cost savings by leveraging newly acquired low-cost manufacturing capabilities, rationalizing our combined manufacturing and distribution footprints, increasing procurement savings and eliminating duplicative overhead functions. We also expect to receive cost savings from initiatives we have undertaken in connection with a number of our previously completed acquisitions. However, while we anticipate cost savings based on estimates and assumptions made by our management as to the benefits and associated expenses with respect to our cost savings initiatives, it is possible that these estimates and assumptions may not ultimately reflect actual results. In addition, these estimated cost savings are only estimates and may not actually be achieved in the timeframe anticipated or at all.

 

If we fail to realize anticipated cost savings, synergies or revenue enhancements, our financial results will be adversely affected, and we may not generate the cash flow from operations that we anticipated, or that is sufficient to repay our indebtedness.

 

We may experience substantial fluctuations in our quarterly operating results and you should not rely on them as an indication of our future results.

 

Our quarterly operating results may vary significantly due to a combination of factors, many of which are beyond our control. These factors include:

 

·                  demand for many of our products, which historically has been higher in the fourth quarter when scholastic sports and ski injuries are more frequent;

 

25



Table of Contents

 

·                  our ability to meet the demand for our products;

 

·                  the direct distribution of our products in foreign countries that have seasonal variations;

 

·                  the number, timing and significance of new products and product introductions and enhancements by us and our competitors, including delays in obtaining government review and clearance of medical devices;

 

·                  our ability to develop, introduce and market new and enhanced versions of our products on a timely basis;

 

·                  the impact of any acquisitions that occur in a quarter;

 

·                  the impact of any changes in generally accepted accounting principles;

 

·                  changes in pricing policies by us and our competitors and reimbursement rates by third party payors, including government healthcare agencies and private insurers;

 

·                  the loss of any of our significant distributors;

 

·                  changes in the treatment practices of orthopedic and spine surgeons, primary care physicians, and pain-management specialists, and their allied healthcare professionals; and

 

·                  the timing of significant orders and shipments.

 

Accordingly, our quarterly sales and operating results may vary significantly in the future and period-to-period comparisons of our results of operations may not be meaningful and should not be relied upon as indications of future performance. We cannot assure you that our sales will increase or be sustained in future periods or that we will be profitable in any future period.

 

We operate in a highly competitive business environment, and our inability to compete effectively could adversely affect our business prospects and results of operations.

 

We operate in highly competitive and fragmented markets. Our Domestic Rehabilitation Segment and International Segment compete with both large and small companies, including several large, diversified companies with significant market share and numerous smaller niche companies, particularly in the physical therapy products market. Our Surgical Implant Segment competes with a small number of very large companies that dominate the market, as well as other companies similar to our size. We may not be able to offer products similar to, or more desirable than, those of our competitors or at a price comparable to that of our competitors. Compared to us, many of our competitors have:

 

·                  greater financial, marketing and other resources;

 

·                  more widely accepted products;

 

·                  a larger number of endorsements from healthcare professionals;

 

·                  a larger product portfolio;

 

·                  superior ability to maintain new product flow;

 

·                  greater research and development and technical capabilities;

 

·                  patent portfolios that may present an obstacle to the conduct of our business;

 

·                  stronger name recognition;

 

·                  larger sales and distribution networks; and/or

 

·                  international manufacturing facilities that enable them to avoid the transportation costs and foreign import duties associated with shipping our products manufactured in the United States to international customers.

 

26



Table of Contents

 

Accordingly, we may be at a competitive disadvantage with respect to our competitors. These factors may materially impair our ability to develop and sell our products.

 

If we are unable to develop or license new products or product enhancements or find new applications for our existing products, we will not remain competitive.

 

The markets for our products are characterized by continued new product development and the obsolescence of existing products. Our future success and our ability to increase revenues and make payments on our indebtedness will depend, in part, on our ability to develop, license, acquire and distribute new and innovative products, enhance our existing products with new technology and find new applications for our existing products. However, we may not be successful in developing, licensing or introducing new products, enhancing existing products or finding new applications for our existing products. We also may not be successful in manufacturing, marketing and distributing products in a cost-effective manner, establishing relationships with marketing partners, obtaining coverage of and satisfactory reimbursement for our future products or product enhancements or obtaining required regulatory clearances and approvals in a timely fashion or at all. If we fail to keep pace with continued new product innovation or enhancement or fail to successfully commercialize our new or enhanced products, our competitive position, financial condition and results of operations could be materially and adversely affected.

 

In addition, if any of our new or enhanced products contain undetected errors or design defects, especially when first introduced, or if new applications that we develop for existing products do not work as planned, our ability to market these and other products could be substantially delayed, and we could ultimately become subject to product liability litigation, resulting in lost revenues, potential damage to our reputation and/or delays in regulatory clearance. In addition, approval of our products or obtaining acceptance of our products by physicians, physical therapists and other healthcare professionals that recommend and prescribe our products could be adversely affected.

 

The success of our surgical implant products depends on our relationships with leading surgeons who assist with the development and testing of our products.

 

A key aspect of the development and sale of our surgical implant products is the use of designing and consulting arrangements with orthopedic surgeons who are well recognized in the healthcare community. These surgeons assist in the development and clinical testing of new surgical implant products. They also participate in symposia and seminars introducing new surgical implant products and assist in the training of healthcare professionals in using our new products. We may not be successful in maintaining or renewing our current designing and consulting arrangements with these surgeons or in developing similar arrangements with new surgeons. In that event, our ability to develop, test and market new surgical implant products could be adversely affected.

 

In addition, federal legislation has been proposed and is included in current health reform bills that would increase disclosure requirements regarding financial arrangements between manufacturers and physicians, including physicians who serve as consultants.  A number of states also have enacted specific marketing and payment disclosure requirements and other may do so in the future. Likewise, voluntary industry guidelines have been adopted regarding device manufacturer financial arrangements with physicians and other health care professionals. We cannot determine at this time the impact, if any, of such requirements or voluntary guidelines on our relationships with surgeons, but there can be no assurances that such requirements and guidelines would not impose additional costs on us and/or adversely impact our consulting and other arrangements with surgeons.

 

Implementation of CMS’s ‘‘Consignment Closet’’ policy could require changes in our OfficeCare business model that could adversely affect our business.

 

On August 7, 2009, CMS issued the Transmittal, requiring a change in procedures in stock and bill arrangements for Medicare beneficiaries. When implemented, the Transmittal will require products dispensed to a Medicare beneficiary from the inventory in our OfficeCare accounts in physician office settings to be fitted and billed to Medicare by the physician rather than by us. Title to the product must pass to the physician at the time the product is dispensed to the patient. The effect of this change in most instances would be to convert a billing opportunity by us into a sale to the physician at a wholesale price. The Transmittal was originally scheduled to go into effect on September 8, 2009.  CMS first delayed the effective date until March 1, 2010, and on February 4, 2010 CMS rescinded the Transmittal in order to consider other implementation dates. If the Transmittal goes into effect as written, it could adversely affect the revenue and, to a lesser extent, profitability of our OfficeCare business.

 

Proposed laws that would limit the types of orthopedic professionals, who can fit, sell or seek reimbursement for our products could, if adopted, adversely affect our business.

 

27



Table of Contents

 

In response to pressure from certain groups (mostly orthotists), the United States Congress and state legislatures have periodically considered proposals that limit the types of orthopedic professionals who can fit or sell our orthotic device products or who can seek reimbursement for them. Several states have adopted legislation which imposes certification or licensing requirements on the measuring, fitting and adjusting of certain orthotic devices. Although some of these state laws exempt manufacturers’ representatives, other states’ laws subject the activities of such representatives to certification or licensing requirements. Additional states may be considering similar legislation. Such laws could reduce the number of potential customers by restricting the activities of our sales representatives in those jurisdictions where such legislation or regulations are enacted. Furthermore, because the sales of orthotic devices are driven in part by the number of professionals who fit and sell them, laws that limit these activities could reduce demand for these products. We may not be successful in opposing the adoption of such legislation or regulations and, therefore, such laws could have a material adverse effect on our business.

 

In addition, efforts have been made to establish similar requirements at the federal level for the Medicare program. For example, in 2000, Congress passed the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (“BIPA”). BIPA contained a provision requiring, as a condition for payment by the Medicare program, that certain certification or licensing requirements be met for individuals and suppliers furnishing certain, but not all, custom-fabricated orthotic devices. Although CMS has not implemented this requirement to date, Medicare follows state requirements in those states that require the use of an orthotist or prosthetist for furnishing of orthotics or prosthetics. We cannot predict the effect of implementation of BIPA or implementation of other such laws will have on our business.

 

If we fail to establish new sales and distribution relationships or maintain our existing relationships, or if our third party distributors and independent sales representatives fail to commit sufficient time and effort or are otherwise ineffective in selling our products, our results of operations and future growth could be adversely impacted.

 

The sales and distribution of certain of our orthopedic products, regeneration products and our surgical implant products depend, in part, on our relationships with a network of third party distributors and independent commissioned sales representatives. These third party distributors and independent sales representatives maintain the customer relationships with the hospitals, orthopedic surgeons, physical therapists and other healthcare professionals that purchase, use and recommend the use of our products. Although our internal sales staff trains and manages these third party distributors and independent sales representatives, we do not directly monitor the efforts that they make to sell our products. In addition, some of the independent sales representatives that we use to sell our surgical implant products also sell products that directly compete with our core product offerings. These sales representatives may not dedicate the necessary effort to market and sell our products. If we fail to attract and maintain relationships with third party distributors and skilled independent sales representatives or fail to adequately train and monitor the efforts of the third party distributors and sales representatives that market and sell our products, or if our existing third party distributors and independent sales representatives choose not to carry our products, our results of operations and future growth could be adversely affected.

 

We rely on our own direct sales force for certain of our products, which may result in higher fixed costs than our competitors and may slow our ability to reduce costs in the face of a sudden decline in demand for our products.

 

We rely on our own direct sales force of approximately 390 representatives in the United States and approximately 110 representatives in Europe to market and sell certain of the orthopedic rehabilitation products which are intended for use in the home and in rehabilitation clinics. Some of our competitors rely predominantly on independent sales agents and third party distributors. A direct sales force may subject us to higher fixed costs than those of companies that market competing products through independent third parties, due to the costs that we will bear associated with employee benefits, training and managing sales personnel. As a result, we could be at a competitive disadvantage. Additionally, these fixed costs may slow our ability to reduce costs in the face of a sudden decline in demand for our products, which could have a material adverse effect on our results of operations.

 

The success of all of our products depends heavily on acceptance by healthcare professionals who prescribe and recommend our products, and our failure to maintain a high level of confidence by key healthcare professionals in our products could adversely affect our business.

 

We have maintained customer relationships with numerous orthopedic surgeons, primary care physicians, other specialist physicians, physical therapists, athletic trainers, chiropractors and other healthcare professionals. We believe that sales of our products depend significantly on their confidence in, and recommendations of, our products. Acceptance of our products depends on educating the healthcare community as to the distinctive characteristics, perceived benefits, clinical efficacy and cost-effectiveness of our products compared to the products offered by our competitors and on training healthcare professionals in the proper use and application of our products. Failure to maintain these customer relationships and develop similar relationships with other leading healthcare professionals could result in a less frequent recommendation of our products, which may adversely affect our sales and profitability.

 

28



Table of Contents

 

Our international operations expose us to risks related to conducting business in multiple jurisdictions outside the United States.

 

The international scope of our operations exposes us to economic, regulatory and other risks in the countries in which we operate. We generated 25.5% of our net revenues from customers outside the United States for the year ended December 31, 2009. Doing business in foreign countries exposes us to a number of risks, including the following:

 

·                  fluctuations in currency exchange rates;

 

·                  imposition of investment, currency repatriation and other restrictions by foreign governments;

 

·                  potential adverse tax consequences, including the imposition or increase of withholding and other taxes on remittances and other payments by foreign subsidiaries, which, among other things, may preclude payments or dividends from foreign subsidiaries from being used for our debt service, and exposure to adverse tax regimes;

 

·                  difficulty in collecting accounts receivable and longer collection periods;

 

·                  the imposition of additional foreign governmental controls or regulations on the sale of our products;

 

·                  intellectual property protection difficulties;

 

·                  changes in political and economic conditions;

 

·                  difficulties in attracting high-quality management, sales and marketing personnel to staff our foreign operations;

 

·                  labor disputes;

 

·                  import and export restrictions and controls, tariffs and other trade barriers;

 

·                  increased costs of transportation or shipping;

 

·                  exposure to different approaches to treating injuries;

 

·                  exposure to different legal, regulatory and political standards; and

 

·                  difficulties of local governments in responding to severe weather emergencies, natural disasters or other such similar events.

 

In addition, as we grow our operations internationally, we will become increasingly dependent on foreign distributors and sales agents for our compliance and adherence to foreign laws and regulations that we may not be familiar with, and we cannot assure you that these distributors and sales agents will adhere to such laws and regulations or adhere to our own business practices and policies. Any violation of laws and regulations by foreign distributors or sales agents or a failure of foreign distributors or sales agents to comply with our business practices and policies could result in legal or regulatory sanctions against us or potentially damage our reputation in that respective international market. If we fail to manage these risks effectively, we may not be able to grow our international operations, and our business and results of operations may be materially adversely affected.

 

Fluctuations in foreign exchange rates may adversely affect our financial condition and results of operations and may affect the comparability of our results between financial periods.

 

Our foreign operations expose us to currency fluctuations and exchange rate risks. We are exposed to the risk of currency fluctuations between the U.S. Dollar and the Euro, Pound Sterling, Canadian Dollar, Mexican Peso, Swiss Franc, Australian Dollar, Yen, Norwegian Krone, Danish Krone and Swedish Krona. Sales denominated in foreign currencies accounted for approximately 22.8% of our consolidated net sales for the year ended December 31, 2009, of which 17.9% were denominated in the Euro. Our exposure to fluctuations in foreign currencies arises because certain of our subsidiaries’ results are recorded in these currencies and then translated into U.S. Dollars for inclusion in our consolidated financial statements and certain of our subsidiaries enter into purchase or sale transactions using a currency other than our functional currency. In addition, certain costs associated with our Mexico-based manufacturing operations are incurred in Mexican Pesos.  As of December 31, 2009, we had outstanding hedges in the form of forward contracts to purchase Mexican Pesos aggregating a U.S. dollar equivalent of $14.3 million.  As we continue to distribute and manufacture our products in selected foreign countries, we expect that future sales and costs associated with our activities in these markets will continue to be denominated in the applicable foreign currencies, which could cause currency fluctuations to materially impact our operating results.  Changes in currency exchange rates may adversely affect our financial condition and results of operations and may affect the comparability of our results between reporting periods.

 

29



Table of Contents

 

We may not be able to effectively manage our currency translation risks, and volatility in currency exchange rates may adversely affect our financial condition and results of operations.

 

If adequate levels of reimbursement coverage from third party payors for our products are not obtained, healthcare providers and patients may be reluctant to use our products, and our sales may decline.

 

Our sales depend largely on whether there is adequate reimbursement coverage by government healthcare programs, such as Medicare and Medicaid, and by private payors. We believe that surgeons, hospitals, physical therapists and other healthcare providers may not use, purchase or prescribe our products and patients may not purchase our products if these third party payors do not provide satisfactory coverage of and reimbursement for the costs of our products or the procedures involving the use of our products. Consequently, we may be unable to sell our products on a profitable basis if third party payors deny coverage, reduce their current levels of reimbursement or fail to cause their levels of reimbursement to rise quickly enough to cover cost increases.

 

Changes in the coverage of, and reimbursement for, our products by these third party payors could have a material adverse effect on our results of operations. Third party payors continue to review their coverage policies carefully for existing and new therapies and can, without notice, decide not to reimburse for treatments that include the use of our products. They may attempt to control costs by (i) authorizing fewer elective surgical procedures, including joint reconstructive surgeries, (ii) requiring the use of the least expensive product available or (iii) reducing the reimbursement for or limiting the number of authorized visits for rehabilitation procedures. For example, in the United States, Congress and CMS, frequently engage in efforts to contain costs, which may result in a reduction of coverage of, and reimbursement for, our products. Because many private payors model their coverage and reimbursement policies on Medicare policies, third party payors’ coverage of, and reimbursement for, our products could be negatively impacted by discussions like this one and by legislative, regulatory or other measures that reduce Medicare coverage and reimbursement generally.

 

Our international sales also depend in part upon the coverage and eligibility for reimbursement of our products through government-sponsored healthcare payment systems and third party payors, the amount of reimbursement and the cost allocation of payments between the patient and government-sponsored healthcare payment systems and third party payors. Coverage and reimbursement practices vary significantly by country, with certain countries requiring products to undergo a lengthy regulatory review in order to be eligible for third party coverage and reimbursement. In addition, healthcare cost containment efforts similar to those we face in the United States are prevalent in many of the foreign countries in which our products are sold, and these efforts are expected to continue in the future, possibly resulting in the adoption of more stringent reimbursement standards. For example, in Germany, our largest foreign country market, new regulations generally require adult patients to pay a portion of the cost of each medical technical device purchased. This may adversely affect our sales and profitability by making it more difficult for patients in Germany to pay for our products.

 

Any developments in the United States or our foreign markets that eliminate, reduce or materially modify coverage of, and reimbursement rates for, our products could have a material effect on our ability to sell our products.

 

Our success depends on receiving regulatory approval for our products, and failure to do so could adversely affect our growth and operating results.

 

Our products are subject to extensive regulation in the United States by the FDA and by similar governmental authorities in the foreign countries where we do business. The FDA regulates virtually all aspects of a medical device’s development, testing, manufacturing, labeling, promotion, distribution and marketing. In general, unless an exemption applies, a medical device must receive either pre-market approval or pre-market clearance from the FDA before it can be marketed in the United States. While in the past we have received such approvals and clearances, we may not be successful in the future in receiving such approvals and clearances in a timely manner or at all. The FDA recently asked the Institute of Medicine (‘‘IOM’’) to conduct a two-year study of the clearance process for devices under § 501(k) of the Food Drug, and Cosmetic Act, as amended, and to provide recommendations for changes, if necessary. In addition, the FDA has implemented an internal review process of the clearance process, which could lead to changes in the review of medical device products seeking clearance for marketing before the IOM completes its study in 2012. Many of our products are cleared for marketing under the 501(k) process that the FDA and the IOM are reviewing. If we begin to have significant difficulty obtaining such FDA approvals or clearances in a timely manner or at all, it could have a material adverse effect on our revenues and growth.

 

30



Table of Contents

 

If we fail to obtain regulatory approval for the modification of, or new uses for, our products, our growth and operating results could suffer.

 

In order to market modifications to our existing products or market our existing products for new indications, we may be required to obtain pre-market approvals, pre-market supplement approvals or pre-market clearances. The FDA requires device manufacturers themselves to make and document a determination of whether or not a modification requires a new approval or clearance; however, the FDA can review and disagree with a manufacturer’s decision. We may not be successful in receiving such approvals or clearances or the FDA may not agree with our decisions not to seek approvals or clearances for any particular device modification. The FDA may require an approval or clearance for any past or future modification or a new indication for our existing products. The FDA may also require additional clinical or preclinical data in such submissions, which may be time consuming and costly, and may not ultimately approve or clear one or more of our products for marketing. If the FDA requires us to obtain pre-market approvals, pre-market supplement approvals or pre-market clearances for any modification to a previously cleared or approved device, we may be required to cease manufacturing and marketing the modified device or to recall such modified device until we obtain FDA clearance or approval, and we may be subject to significant regulatory fines or penalties. In addition, the FDA may not clear or approve such submissions in a timely manner, if at all. Because a significant portion of our revenues is generated by products that are modified or used for new treatments, delays or failures in obtaining such approvals could reduce our revenue and adversely affect our operating results.

 

We may fail to receive positive clinical results for our products in development that require clinical trials, and even if we receive positive clinical results, we may still fail to receive the necessary clearance or approvals to market our products.

 

In the development of new products or new indications for, or modifications to, existing products, we may conduct or sponsor clinical trials. Clinical trials are expensive and require significant investment of time and resources and may not generate the data we need to support a submission to the FDA. Clinical trials are subject to regulation by the FDA and, if federal funds are involved or if an investigator or site has signed a federal assurance, are subject to further regulation by the Office for Human Research Protections and the National Institutes of Health. Failure to comply with such regulation, including, but not limited to, failure to obtain adequate consent of subjects, failure to adequately disclose financial conflicts or failure to report data or adverse events accurately, could result in fines, penalties, suspension of trials, and the inability to use the data to support an FDA submission.  In addition, the American Recovery and Reinvestment Act expands federal efforts to compare the effectiveness of different medical treatments, which could include some element of explicit cost or cost-effectiveness comparisons; research supported by these efforts eventually could be used to guide public and private coverage and reimbursement policies. In the international market, we are subject to regulations for clinical studies in each respective country.

 

If we fail to comply with the various regulatory regimes for the foreign markets in which we operate, our operational results could be adversely affected.

 

In many of the foreign countries in which we market our products, we are subject to extensive regulations, including those in Europe. The regulation of our products in the European Economic Area (which consists of the twenty-seven member states of the European Union, as well as Iceland, Liechtenstein and Norway) is governed by various directives and regulations promulgated by the European Commission and national governments. Only medical devices that comply with certain conformity requirements are allowed to be marketed within the European Economic Area. In addition, the national health or social security organizations of certain foreign countries, including certain countries outside Europe, require our products to be qualified before they can be marketed in those countries. Failure to receive or delays in the receipt of, relevant foreign qualifications in the European Economic Area or other foreign countries could have a material adverse effect on our business.

 

The FDA regulates the export of medical devices to foreign countries and certain foreign countries may require FDA certification that our products are in compliance with U.S. law.  If we fail to obtain or maintain export certificates required for the export of our products, we could suffer a material adverse effect on our revenues and growth.

 

We are subject to laws concerning our marketing activities in foreign countries where we conduct business. For example, within the EU, the control of unlawful marketing activities is a matter of national law in each of the member states of the EU. The member states of the EU closely monitor perceived unlawful marketing activity by companies. We could face civil, criminal and administrative sanctions if any member state determines that we have breached our obligations under its national laws. Industry associations also closely monitor the activities of member companies. If these organizations or authorities name us as having breached our obligations under their regulations, rules or standards, our reputation would suffer and our business and financial condition could be adversely affected. We are also subject to the U.S. Foreign Corrupt Practices Act (the ‘‘FCPA’’), antitrust and anticompetition laws, and similar laws in foreign countries, any violation of which could create a substantial liability for us and also cause a loss of reputation in the market. The FCPA prohibits U.S. companies and their officers, directors, employees, shareholders acting on their behalf and agents from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or

 

31



Table of Contents

 

retaining business abroad or otherwise obtaining favorable treatment.  Companies must also maintain records that fairly and accurately reflect transactions and maintain internal accounting controls. In many countries, hospitals and clinics are government-owned and 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. If we are found to have violated the FCPA, we may face sanctions including fines, criminal penalties, disgorgement of profits and suspension or debarment of our ability to contract with government agencies or receive export licenses. From time to time, we may face audits or investigations by one or more domestic or foreign government agencies, compliance with which could be costly and time-consuming, and could divert our management and key personnel from our business operations. An adverse outcome under any such investigation or audit could subject us to fines or other penalties, which could adversely affect our business and financial results.

 

If the HHS, Office of Inspector General (“OIG”), the FDA or another regulatory agency determines that we have promoted off-label use of our products, we may be subject to various penalties, including civil or criminal penalties, and the off-label use of our products may result in injuries that lead to product liability suits, which could be costly to our business.

 

The OIG, the FDA and other regulatory agencies actively enforce regulations prohibiting the promotion of a medical device for a use that has not been cleared or approved by the FDA. Use of a device outside its cleared or approved indications is known as “off-label” use. Physicians may use our products for off-label uses, as the FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine. However, if the OIG or the FDA or another regulatory agency determines that our promotional materials; training or activities constitutes improper promotion of an off-label use, it could request that we modify our promotional materials; training, or activities, or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties. Although our policy is to refrain from statements and activities that could be considered off-label promotion of our products, the FDA, another regulatory agency, or the U.S. Department of Justice could disagree and conclude that we have engaged in off-label promotion and, potentially, aided and abetted in the submission of false claims. In addition, the off-label use of our products may increase the risk of injury to patients, and, in turn, the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention and result in substantial damage awards against us.

 

Our compensation, marketing and sales practices may contain certain risks with respect to the manner in which these practices were historically conducted that could have a material adverse effect on us.

 

We have entered into written agreements for designing and consulting services with physicians for surgical implant products, and we compensate them under our designing physician agreements for services in developing products sold by us.  We also seek the assistance of physicians in the design and evaluation of bracing and other rehabilitative products. The form of compensation for such services has historically been a royalty on the sale of our products in the cases where the physician has contributed to the design of the product. We compensate the physicians under consulting agreements for assistance with product development and clinical efforts. We believe that in each instance remuneration paid to physicians represents fair market value for the services provided and is otherwise in compliance with applicable laws. We also use an independent sales force for products for which we provide compliance-related training. The sales force has generally been compensated on commission based on a percentage of revenues generated by products sold as is typical in our industry. We also pay physicians certain rental and office support fees under our OfficeCare program. Under applicable federal and state healthcare fraud and abuse, anti-kickback, false claims and self-referral laws, it could be determined that our designing and consulting arrangements with surgeons, our marketing and sales practices, and our OfficeCare program fall outside permitted arrangements, thereby subjecting us to possible civil and/or criminal sanctions (including exclusion from the Medicare and Medicaid programs), which could have a material adverse effect on our surgical implant business and possibly on our other lines of business. The federal government has significantly increased investigations of medical device manufacturers with regards to alleged kickbacks and other forms of remuneration to physicians who use and prescribe their products and recently has entered into settlement, deferred prosecution and corporate integrity agreements with such manufacturers. Such investigations and enforcement activities often arise based on allegations of violations of the federal Anti-Kickback Statute, and sometimes of the civil False Claims Act. Although we believe we maintain a satisfactory compliance program, it may not be adequate in the detection or prevention of violations. The form and effectiveness of our compliance program may be taken into account by the government in assessing sanctions, if any, should it be determined that violations of laws have occurred.

 

Audits or denials of our claims by government agencies could reduce our revenues or profits.

 

As part of our business operations, we submit claims on behalf of patients directly to, and receive payments directly from, the Medicare and Medicaid programs and private payors. Therefore, we are subject to extensive government regulation, including requirements for submitting reimbursement claims under appropriate codes and maintaining certain documentation to support our claims. Medicare contractors and Medicaid agencies periodically conduct pre- and post-payment reviews and other audits of claims and are under increasing pressure to more closely scrutinize healthcare claims and supporting documentation. We have historically been subject to pre-payment and post-payment reviews as well as audits of claims and may experience such reviews and audits of claims in the future. Such reviews and/or similar audits of our claims could result in material delays in payment, as well as material recoupments or denials, which would reduce our net sales and profitability, or in exclusion from participation in the Medicare or Medicaid programs. Private payors may from time to time conduct similar reviews and audits.

 

32



Table of Contents

 

Additionally, we participate in the government’s Federal Supply Schedule program for medical equipment, whereby we contract with the government to supply certain of our products. Participation in this program requires us to follow certain pricing practices and other contract requirements. Failure to comply with such pricing practices and/or other contract requirements could result in delays in payment or fines or penalties, which could reduce our revenues or profits.

 

Various federal and state agencies have become increasingly vigilant in recent years in their investigation of various business practices under various healthcare “fraud and abuse” laws with respect to our business arrangements with prescribing physicians and other health care professionals.

 

We are directly or indirectly through our customers, subject to various federal and state laws pertaining to healthcare fraud and abuse. These laws, which directly or indirectly affect our ability to operate our business include, but are not limited to, the following:

 

·                  the federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or the furnishing or arranging for or recommending of a good or service, for which payment may be made under federal healthcare programs, such as Medicare and Medicaid, Veterans Administration health programs, and TRICARE;

 

·                  several federal False Claims statutes, which impose civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government;

 

·                  HIPAA, which prohibits executing a scheme to defraud any healthcare benefit program, and also prohibits false statements, defined as knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;

 

·                  the federal physician self-referral prohibition, commonly known as the Stark Law, which, in the absence of a statutory or regulatory exception, prohibits the referral of Medicare and Medicaid patients by a physician to an entity for the provision of certain designated healthcare services, if the physician or a member of the physician’s immediate family has a direct or indirect financial relationship, including an ownership interest in, or a compensation arrangement with, the entity and also prohibits that entity from submitting a bill to a federal payor for services rendered pursuant to a prohibited referral; and

 

·                  state law equivalents to the Anti-Kickback Statute, the false claims provisions, the Stark Law and the physician self-referral prohibitions, some of which may apply even more broadly than their federal counterparts because they are not limited to government reimbursed items and include items or services reimbursed by any payor.

 

The federal government has significantly increased investigations of and enforcement activity involving medical device manufacturers with regard to alleged kickbacks and other forms of remuneration to physicians who use and prescribe their products. Such investigations often arise based on allegations of violations of the federal Anti-Kickback Statute and sometimes allege violations of the civil False Claims Act, in connection with off-label marketing of products to physicians and others.

 

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. Defendants determined to be liable under the False Claims Act may be required to pay three times the actual damages sustained by the government, plus mandatory civil penalties ranging between $5,500 and $11,000 for each false claim.

 

The fraud and abuse laws and regulations are complex and even minor, inadvertent irregularities in submissions can potentially give rise to investigations and claims that the law has been violated. Any violations of these laws or regulations could result in a material adverse effect on our business, financial condition and results of operations. If there is a change in law, regulation or administrative or judicial interpretations, we may have to change one or more of our business practices to be in compliance with these laws. Required changes could be costly and time consuming. Any failure to make required changes could result in our losing business or our existing business practices being challenged as unlawful.

 

33



Table of Contents

 

Our activities are subject to Federal Privacy and Transaction Law and Regulations, which could have an impact on our operations.

 

HIPAA impacts the transmission, maintenance, use and disclosure of certain individually identifiable health information (referred to as ‘‘protected health information’’ or ‘‘PHI’’). Since HIPAA was enacted in 1996, numerous implementing regulations have been issued, including, but not limited to: (1) standards for the privacy of individually identifiable health information (the ‘‘Privacy Rule’’), (2) security standards (the ‘‘Security Rule’’), (3) standards for electronic transactions (the ‘‘Transactions Rule’’), and (4) standard unique national provider identifier (‘‘NPI Rule’’). We refer to these rules as the Administrative Simplification Rules. CMS has also issued regulations governing the enforcement of the Administrative Simplification Rules. Sanctions for violation of HIPAA and /or the Administrative Simplification Rules include criminal and civil penalties.

 

HIPAA applies to ‘‘covered entities,’’ which includes certain health care providers who conduct certain transactions electronically. As such, HIPAA and the Administrative Simplification Rules apply to certain aspects of our business. The effective date for all of the Administrative Simplification Rules outlined above has passed, and, as such, all of the Administrative Simplification Rules are in effect. To the extent applicable to our operations, we believe we are currently in compliance with HIPAA and the applicable Administrative Simplification Rules.  Any failure to comply with applicable requirements could adversely affect our profitability.

 

On February 17, 2009, President Obama signed into law the HITECH Act as part of the American Recovery and Reinvestment Act. This economic stimulus package includes many health care policy provisions, including strengthened federal privacy and security provisions to protect personally-identifiable health information, such as notification requirements for health data security breaches. Many of the details of the new requirements are being implemented through regulations, including an interim final rule on the HITECH health information security enforcement provisions published October 30, 2009. We are reviewing these new requirements to assess the potential impact on our operations. Any failure to comply with applicable requirements could adversely affect our profitability.

 

Managed care and buying groups have put downward pressure on the prices of our products.

 

The growth of managed care and the advent of buying groups in the United States have caused a shift toward coverage and payments based on more cost-effective treatment alternatives. Buying groups enter into preferred supplier arrangements with one or more manufacturers of medical products in return for price discounts to members of these buying groups. Our failure to obtain new preferred supplier commitments from major group purchasing organizations or our failure to retain our existing preferred supplier commitments could adversely affect our sales and profitability. In international markets where we sell our products, we have historically experienced downward pressure on product pricing and other effects of healthcare cost control efforts that are similar to that which we have experienced in the United States. We expect a continued emphasis on healthcare cost controls and managed care in the United States and in these international markets, which could put further downward pressure on product pricing, which, in turn may adversely affect our sales and profitability.

 

Our marketed, approved, or cleared products are subject to the recall authority of U.S. and foreign regulatory bodies. Product recalls could harm our reputation and business.

 

We are subject to ongoing medical device reporting regulations that require us to report to the FDA and similar governmental authorities in other countries if we receive a report or otherwise learn that any of our products may have caused, or contributed to death or serious injury, or that any of our products has malfunctioned in a way that would be likely to cause, or contribute to, death or serious injury if the malfunction were to recur. The FDA and similar governmental authorities in other countries have the authority to require us to recall our products in the event of actual or potential material deficiencies or defects in design manufacturing, or labeling, and we have been subject to product recalls in the past. In addition, in light of an actual or potential material deficiency or defect in design, manufacturing, or labeling, we may voluntarily elect to recall our products. A government mandated recall or a voluntary recall initiated by us could occur as a result of actual or potential component failures, manufacturing errors, or design defects, including defects in labeling. Any recall would divert managerial and financial resources and could harm our reputation with our customers and with the healthcare professionals that use, prescribe and recommend our products. We could have product recalls that result in significant costs to us in the future, and such recalls could have a material adverse effect on our business.

 

Product liability claims may harm our business, particularly if the number of claims increases significantly or our product liability insurance proves inadequate.

 

The manufacture and sale of orthopedic devices and related products exposes us to a significant risk of product liability claims. From time to time, we have been, and we are currently, subject to a number of product liability claims alleging that the use of our products resulted in adverse effects. Even if we are successful in defending against any liability claims, such claims could nevertheless distract our management, result in substantial costs, harm our reputation, adversely affect the sales of all our products and otherwise harm our business. If there is a significant increase in the number of product liability claims, our business could be adversely affected.

 

34



Table of Contents

 

We maintain product liability insurance that is subject to annual renewal. Our current policy covers claims made between July 1, 2009 and June 30, 2010 and provides for coverage (together with excess policies) of up to a limit of $80 million, provided that the top layer of $25 million excess over $55 million covers only claims reported after February 25, 2010 and the next layer down of $10 million excess over $45 million covers only claims reported after February 18, 2010. This coverage is subject to a self-insured retention of $500,000 for pain pumps and the IceMan cold therapy product, a self-insured retention of $250,000 on all other invasive products and a self-insured retention of $50,000 on all of the non-invasive products, with an aggregate self-insured retention of $1.0 million for all product liability claims.  In addition, the top layer of $25 million excess over $55 million has a separate self-insured retention of $50,000 per claim.  If a product liability claim or series of claims is brought against us for uninsured liabilities or in excess of our insurance coverage, our business could suffer materially. In addition, in certain instances, a product liability claim could also result in our having to recall some of our products, which could result in significant costs to us. As of December 31, 2009, we have accrued approximately $2.0 million for expenses related to product liability claims based upon previous claim experience in part due to the fact that in 2003 we exceeded the coverage limits in effect at that time for certain historical product liability claims involving one of our discontinued surgical implant products and such products are excluded from coverage under our current policies.

 

As a result of the DJO Merger, our concentration of manufacturing operations in Mexico increases our business and competitive risks.

 

Our most significant manufacturing facility is our facility in Tijuana, Mexico, and we also have a relatively small manufacturing operation in Tunisia. Our current and future foreign operations are subject to risks of political and economic instability inherent in activities conducted in foreign countries. Because there are no readily accessible alternatives to these facilities, any event that disrupts manufacturing at or distribution or transportation from these facilities would materially adversely affect our operations. In addition, as a result of this concentration of manufacturing activities, our sales in foreign markets may be at a competitive disadvantage to products manufactured locally due to freight costs, custom and import duties and favorable tax rates for local businesses.

 

If we lose one of our key suppliers or one of our contract manufacturers stops making the raw materials and components used in our products, we may be unable to meet customer orders for our products in a timely manner or within our budget.

 

We rely on a limited number of foreign and domestic suppliers for the raw materials and components used in our products. One or more of our suppliers may decide to cease supplying us with raw materials and components for reasons beyond our control. FDA regulations may require additional testing of any raw materials or components from new suppliers prior to our use of those materials or components. In addition, in the case of a device which is the subject of a pre-market approval, we may be required to obtain prior FDA permission (which may or may not be given), which could delay or prevent our access or use of such raw materials or components. If we are unable to obtain materials we need from our suppliers or our agreements with our suppliers are terminated, and we cannot obtain these materials from other sources, we may be unable to manufacture our products to meet customer orders in a timely manner or within our manufacturing budget. In that event, our business and results of operations could be adversely affected.

 

In addition, we rely on third parties to manufacture some of our products. For example, Medireha, which is 50% owned by us, has been a supplier for a significant portion of our CPM devices. CPM devices represented approximately 3% of our net sales for the year ended December 31, 2009. If we encounter a cessation, interruption or delay in the supply of the products purchased from Medireha, we may be unable to obtain such products through other sources on acceptable terms, within a reasonable amount of time or at all. We also use a single source for many of the devices Cefar and Compex distribute. In addition, if our agreements with the manufacturing companies were terminated, we may not be able to find suitable replacements within a reasonable amount of time or at all. Any such cessation, interruption or delay may impair our ability to meet scheduled deliveries of our products to our customers and may cause our customers to cancel orders. In that event, our reputation and results of operations may be adversely affected.

 

Some of our important suppliers are in China and other parts of Asia and provide predominately finished soft goods products. In fiscal year 2009, we obtained approximately 20.2% of our total purchased materials from suppliers in China and other parts of Asia. Political and economic instability and changes in government regulations in these areas could affect our ability to continue to receive materials from suppliers there. The loss of suppliers in China and other parts of Asia, any other interruption or delay in the supply of required materials or our inability to obtain these materials at acceptable prices and within a reasonable amount of time could impair our ability to meet scheduled product deliveries to our customers and could hurt our reputation and cause customers to cancel orders.

 

In addition, we purchase the microprocessor used in the OL1000 and SpinaLogic devices from a single manufacturer. Although there are feasible alternate microprocessors that might be used immediately, all are produced by a single supplier. In addition, there are single suppliers for other components used in the OL1000 and SpinaLogic devices and only two suppliers for the magnetic field sensor employed in them. Establishment of additional or replacement suppliers for these components cannot be accomplished quickly.

 

35



Table of Contents

 

If our patents and other intellectual property rights do not adequately protect our products, we may lose market share to our competitors and may not be able to operate our business profitably.

 

We rely on a combination of patents, trade secrets, copyrights, trademarks, license agreements and contractual provisions to establish and protect our intellectual property rights in our products and the processes for the development, manufacture and marketing of our products.

 

We use non-patented, proprietary know-how, trade secrets, processes and other proprietary information and currently employ various methods to protect this proprietary information, including confidentiality agreements, invention assignment agreements and proprietary information agreements with vendors, employees, independent sales agents, distributors, consultants, and others. However, these agreements may be breached. The FDA or another governmental agency may require the disclosure of such information in order for us to have the right to market a product. The FDA may also disclose such information on its own initiative if it should decide that such information is not confidential business or trade secret information. Trade secrets, know-how and other unpatented proprietary technology may also otherwise become known to or independently developed by our competitors.

 

In addition, we also hold U.S. and foreign patents relating to a number of our components and products and have patent applications pending with respect to other components and products. We also apply for additional patents in the ordinary course of our business, as we deem appropriate. However, these precautions offer only limited protection, and our proprietary information may become known to, or be independently developed by, competitors, or our proprietary rights in intellectual property may be challenged, any of which could have a material adverse effect on our business, financial condition and results of operations. Additionally, we cannot assure you that our existing or future patents, if any, will afford us adequate protection or any competitive advantage, that any future patent applications will result in issued patents or that our patents will not be circumvented, invalidated or declared unenforceable. In addition, certain of our subsidiaries have not always taken commercially reasonable measures to protect their ownership of some of their patents. While such measures are currently employed and have been employed by us in the past, disputes may arise as to the ownership, or co-ownership, of certain of our patents. We do not consider patent protection to be a significant competitive advantage in the marketplace for electrotherapy devices. However, patent protection may be of significance with respect to our orthopedic technology.

 

Any proceedings before the U.S. Patent and Trademark Office could result in adverse decisions as to the priority of our inventions and the narrowing or invalidation of claims in issued or pending patents. We could also incur substantial costs in any such proceedings. In addition, the laws of some of the countries in which our products are or may be sold may not protect our products and intellectual property to the same extent as U.S. laws, if at all. We may also be unable to protect our rights in trade secrets, trademarks and unpatented proprietary technology in these countries.

 

In addition, we hold patent, trademark and other intellectual property licenses from third parties for some of our products and on technologies that are necessary in the design and manufacture of some of our products. The loss of such licenses could prevent us from manufacturing, marketing and selling these products, which in turn could harm our business.

 

Our operating results and financial condition could be adversely affected if we become involved in litigation regarding our patents or other intellectual property rights.

 

Litigation involving patents and other intellectual property rights is common in our industry, and companies in our industry have used intellectual property litigation in an attempt to gain a competitive advantage. We may become a party to lawsuits involving patents or other intellectual property. Such litigation is costly and time consuming. If we lose any of these proceedings, a court or a similar foreign governing body could invalidate or render unenforceable our owned or licensed patents, require us to pay significant damages, seek licenses and/or pay ongoing royalties to third parties (which may not be available under terms acceptable to us, or at all), require us to redesign our products, or prevent us from manufacturing, using or selling our products, any of which would have an adverse effect on our results of operations and financial condition.

 

We have brought, and may in the future also bring, actions against third parties for infringement of our intellectual property rights. We may not succeed in such actions. The defense and prosecution of intellectual property suits, proceedings before the U.S. Patent and Trademark Office or its foreign equivalents and related legal and administrative proceedings are both costly and time consuming. Protracted litigation to defend or enforce our intellectual property rights could seriously detract from the time our management would otherwise devote to running our business. Intellectual property litigation relating to our products could cause our customers or potential customers to defer or limit their purchase or use of the affected products until resolution of the litigation.

 

36



Table of Contents

 

Our business strategy relies on certain assumptions concerning demographic and other trends that impact the market for our products. If these assumptions prove to be incorrect, demand for our products may be lower than we currently expect.

 

Our ability to achieve our business objectives is subject to a variety of factors, including the relative increase in the aging of the general population and an increase in participation in exercise and sports and more active lifestyles. In addition, our business strategy relies on an increasing awareness and clinical acceptance of non-invasive, non-systemic treatment and rehabilitation products, such as electrotherapy. We believe that these trends will increase the need for our orthopedic, physical therapy, regenerative and surgical implant products. The projected demand for our products could materially differ from actual demand if our assumptions regarding these trends and acceptance of our products by healthcare professionals and patients prove to be incorrect or do not materialize. If our assumptions regarding these factors prove to be incorrect, we may not be able to successfully implement our business strategy, which could adversely affect our results of operations. In addition, the perceived benefits of these trends may be offset by competitive or business factors, such as the introduction of new products by our competitors or the emergence of other countervailing trends.

 

We may expand into new markets through the development of new products and our expansion may not be successful.

 

We may attempt to expand into new markets through the development of new product applications based on our existing specialized technology and design capabilities. These efforts could require us to make substantial investments, including significant research, development, engineering and capital expenditures for new, expanded or improved manufacturing facilities which would divert resources from other aspects of our business. Expansion into new markets may be costly and may not result in any benefit to us. Specific risks in connection with expanding into new markets include the inability to transfer our quality standards into new products, the failure of customers in new markets to accept our products and price competition in new markets. Such expansion efforts into new markets could be unsuccessful.

 

Consolidation in the healthcare industry could have an adverse effect on our revenues and results of operations.

 

Many healthcare industry companies, including medical device, orthopedic and physical therapy products companies, are consolidating to create larger companies. As the healthcare industry consolidates, competition to provide products and services to industry participants may become more intense. In addition, many of our customers are also consolidating, and our customers and other industry participants may try to use their purchasing power to negotiate price concessions or reductions for the products that we manufacture and market. If we are forced to reduce our prices because of consolidation in the healthcare industry, our revenues could decrease, and our business, financial condition and results of operations could be adversely affected.

 

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 use, manufacture, handling, storage and disposal of hazardous materials, discharge to air and water, the clean up 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 reported results may be adversely affected by increases in reserves for contractual allowances, rebates, product returns, rental credits, uncollectible accounts receivable and inventory.

 

Our net sales and profitability are affected by changes in reserves to account for contractual allowances, rebates, product returns, rental credits, uncollectible accounts receivable and inventory. Any increase in our reserves for contractual allowances, rebates, product returns, rental credits, uncollectible accounts receivable or inventory could adversely affect our reported financial results by reducing our net revenues and/or profitability for the reporting period.

 

37



Table of Contents

 

We have established reserves to account for contractual allowances, rebates, product returns and reserves for rental credits.  Significant management judgment must be used and estimates must be made in connection with establishing the reserves for contractual allowances, rebates, product returns, rental credits and other allowances in any accounting period.

 

We maintain provisions for estimated contractual allowances for reimbursement amounts from our third party payor customers based on negotiated contracts and historical experience for non-contracted payors.  We provide for these reserves by reducing our gross revenue.  We estimate the amount of the reduction based on historical experience and invoices generated in the period, and we consider the impact of new contract terms or modifications of existing arrangements with our customers.  We have contracts with certain third party payors for our third party reimbursement billings, which call for specified reductions in reimbursement of billed amounts based upon contractual reimbursement rates.

 

Our reserve for doubtful accounts is based upon estimated losses from customers who are billed directly and the portion of third party reimbursement billings that ultimately become the financial responsibility of the end user patients. Our third party reimbursement customers including insurance companies, managed care companies and certain governmental payors, such as Medicare, include all of our OfficeCare customers and certain other customers of our Domestic Rehabilitation Segment. We estimate bad debt expense based upon historical experience and current relationships with our customers and providers.  If the financial condition of our customers were to deteriorate resulting in an impairment of their ability to make payments or if third-party payors were to deny claims for late filings, incomplete information or other reasons, additional provisions may be required.

 

Our reserve for rebates accounts for incentives that we offer to certain of our distributors.  These rebates generally are attributable to sales volume, sales growth and to reimburse the distributor for certain discounts.  We record estimated reductions to revenue for customer rebate programs based upon historical experience and estimated revenue levels.

 

The reserve for product returns accounts for estimated customer returns of our products after purchase. These returns are mainly attributable to a third party payor’s refusal to provide a patient release or reimbursement for the product or the inability of the product to adequately address the patient’s condition. If we increase the percentage of our sales made pursuant to agreements providing for reimbursement below invoice price or if customers return products at a higher than estimated rate, we may be required to increase our sales allowance and product return reserves beyond their current levels.

 

Our reserve for rental credits recognizes a timing difference between billing of a purchase and processing of a rental credit associated with some of our electrotherapy and traction devices. Many insurance providers require patients to rent our rehabilitation devices for a period of one to three months prior to purchase. If the patient has a long-term need for the device, these insurance companies may authorize purchase of the device after such time period. When the device is purchased, most providers require that rental payments previously made on the device be credited toward the purchase price. These credits are processed at the time the payment is received for the purchase of the device, which creates a time lag between billing of the purchase and processing of the rental credit. Our rental credit reserve accounts for unprocessed rental credits based on the number of devices converted to purchase. If the frequency of rental to purchase conversion increases, we may be required to increase our rental credit reserve beyond its current level.

 

The nature of our business requires us to maintain sufficient inventory on hand at all times to meet the requirements of our customers.  We provide reserves for estimated excess or obsolete inventories equal to the difference between the cost of inventories on hand plus future purchase commitments and the estimated market value based upon assumptions about future demand.  If future demand is less favorable than currently projected by management, additional inventory write-downs may be required.  We also provide reserves for newer product inventories, as appropriate, based on any minimum purchase commitments and our level of sales of the new products.

 

All of our segments consign a portion of their inventory to allow their products to be immediately dispensed to patients.  This requires a large amount of inventory to be on hand for the products we sell on consignment.  It also increases the sensitivity of these products to obsolescence reserve estimates. As this inventory is not in our possession, we maintain additional reserves for these products based on the results of periodic inventory counts and historical trends.

 

Certain administrative functions relating to the OfficeCare sales channel have been outsourced to a third party contractor and this arrangement may not prove successful.

 

The OfficeCare sales channel maintains a range of products (mostly soft goods) on hand at over 1,350 healthcare facilities, primarily orthopedic practices, for immediate distribution to patients. In the OfficeCare sales channel, patients or their third party payors are billed after the product is provided to the patient. The revenue cycle of this program is outsourced, from billing to collections, to an independent third party contractor. The outsource contractor that we have used has undergone significant changes in its business operations in the last two years, including relocating some administrative functions overseas, in order to improve performance from order entry to collections. The contractor may also upgrade the software system used in these revenue cycle processes. The inability of this provider to successfully upgrade its processes or demonstrate acceptable billing and collection results could have an adverse effect on our operations and financial results in the OfficeCare sales channel.

 

38



Table of Contents

 

If a natural or man-made disaster strikes our manufacturing facilities, we will be unable to manufacture our products for a substantial amount of time and our sales will decline.

 

A significant portion of our rehabilitation products are manufactured in a facility in Tijuana, Mexico, with a number of products for the European market manufactured in a Tunisian facility. In Vista, California we manufacture our custom rigid bracing products, which remain in the United States to facilitate quick turnaround on custom orders, vascular products, and our regeneration product line. Our clinical electrotherapy devices, patient care products, physical therapy and chiropractic treatment tables and certain CPM devices are manufactured in our facilities located in Chattanooga, Tennessee, and the production of these products with the exception of physical therapy treatment tables, is being moved to our facility in Tijuana, Mexico, in connection with our closure of the Chattanooga facility, which is expected to be completed in the first half of 2010. Our home electrotherapy devices sold in the United States as well as some components and related accessories are manufactured at our facility in Clear Lake, South Dakota. In our Surgical Implant Segment, we manufacture our products in our manufacturing facility at Austin, Texas. These facilities and the manufacturing equipment we use to produce our products would be difficult to repair or replace. Our facilities may be affected by natural or man-made disasters. If one of our facilities were affected by a disaster, we would be forced to rely on third party manufacturers or shift production to another manufacturing facility. In such an event, we would face significant delays in manufacturing which would prevent us from being able to sell our products. In addition, our insurance may not be sufficient to cover all of the potential losses and may not continue to be available to us on acceptable terms, or at all.

 

We may pursue, but may not be able to identify, finance or successfully complete, other strategic acquisitions.

 

Our growth strategy may include the pursuit of acquisitions, both domestically and internationally. However, we may not be able to identify acceptable opportunities or complete acquisitions of targets in a timely manner or on acceptable terms. In addition, acquisitions involve a number of risks, including those set forth under the risk factor captioned “We may not be able to successfully integrate businesses that we have recently acquired, or businesses we may acquire in the future, and we may not be able to realize the anticipated cost savings, revenue enhancements or other synergies from such acquisitions.” To the extent we are unable to consummate acquisitions, we will experience slower than expected growth.

 

In addition, we may require additional debt or equity financing for future acquisitions, and such financing may not be available on favorable terms, if available at all. We may not be able to successfully integrate or operate profitably any new business we acquire, and we cannot assure you that any such acquisition will meet our expectations. Finally, in the event we decide to discontinue pursuit of a potential acquisition, we will be required to immediately expense all costs incurred in pursuit of the possible acquisition that could have an adverse effect on our results of operations in the period in which the expense is recognized. If we complete acquisitions, or obtain financing for them, on unfavorable terms, or if we fail to properly integrate an acquired business, our financial condition and results of operations would be adversely affected.

 

If we do not effectively manage our growth, our existing infrastructure may become strained, and we may be unable to increase sales of our products or generate revenue growth.

 

The growth that we have experienced, and in the future may experience, including due to acquisitions, may provide challenges to our organization, requiring us to expand our personnel, manufacturing and distribution operations. Future growth may strain our infrastructure, operations, product development and other managerial and operating resources. If our business resources become strained, we may be unable to increase sales of our products or generate revenue growth.

 

The loss of the services of our key management and personnel could adversely affect our ability to operate our business.

 

Our future success will depend, in part, upon the continued service of key managerial, research and development staff and sales and technical personnel. In addition, our future success will depend on our ability to continue to attract and retain other highly qualified personnel. Our executive officers have substantial experience and expertise in our industry. Our future success depends, to a significant extent, on the abilities and efforts of our executive officers and other members of our management team. We compete for such personnel with other companies, academic institutions, government entities and other organizations. We may not be successful in retaining our current personnel or in hiring or retaining qualified personnel in the future. Our failure to do so could have a material adverse effect on our business.

 

39



Table of Contents

 

Affiliates of Blackstone own substantially all of the equity interest in us and may have conflicts of interest with us or investors in the future.

 

Investment funds affiliated with Blackstone collectively beneficially own 98.82% of our capital stock. As a result, affiliates of Blackstone have control over our decisions to enter into any corporate transaction and have the ability to prevent any transaction that requires the approval of stockholders regardless of whether holders of the Notes believe that any such transactions are in their own best interests. For example, affiliates of Blackstone could collectively cause us to make acquisitions that increase the amount of indebtedness or to sell assets, or could cause us to issue additional capital stock or declare dividends. So long as investment funds affiliated with Blackstone continue to directly or indirectly own a significant amount of the outstanding shares of our common stock, affiliates of Blackstone will continue to be able to strongly influence or effectively control our decisions. In addition, Blackstone has no obligation to provide us with any additional debt or equity financing.

 

Additionally, Blackstone is in the business of making investments in companies and may from time to time acquire and hold interests in businesses that compete directly or indirectly with us. Blackstone may also pursue acquisition opportunities that may be complementary to our business and, as a result, those acquisition opportunities may not be available to us.

 

If we do not achieve and maintain effective internal controls over financial reporting, we could fail to accurately report our financial results.

 

During the course of the preparation of our financial statements, we evaluate our internal controls to identify and correct deficiencies in our internal controls over financial reporting. In the event we are unable to identify and correct deficiencies in our internal controls in a timely manner, we may not record, process, summarize and report financial information accurately and within the time periods required for our financial reporting under the terms of the agreements governing our indebtedness.

 

We have completed a significant number of acquisitions in the past several years, and may continue to pursue growth through strategic acquisitions. Among the risks associated with acquisitions are the risks of control deficiencies that result from the integration of the acquired business. In connection with the integration of our recent acquisitions and our continuous assessment of internal controls, including with respect to acquired foreign operations, we have identified certain internal control deficiencies that we have remedied or for which we have undertaken steps to remediate.

 

It is possible that control deficiencies could be identified by our management or independent registered public accounting firm in the future or may occur without being identified. Such a failure could negatively impact the market price and liquidity of the Notes, cause security holders to lose confidence in our reported financial condition, lead to a default under our Senior Secured Credit Facility and otherwise materially adversely affect our business and financial condition.

 

We may not be successful in the design and implementation of a Company-wide ERP system.

 

In 2008 we launched a major software design and installation project to replace six legacy accounting and finance systems and numerous other software systems with a single-entry ERP system that will be used by all locations and functions of the Company. This project is scheduled to be completed in three years and will require the dedication of significant financial and human resources. While we have designed the system and completed our first installation in our Surgical operation in Austin, Texas, our ability to complete this project in all of our operations successfully is subject to a variety of risks and uncertainties, among which are the following:

 

·      we may have underestimated the time it will take to complete the design and installation and the project could extend on past the expected completion date;

 

·      we may have underestimated the aggregate cost of the design and installation of the ERP system, whether due to the need for additional scope to the project, a requirement for additional consulting assistance, the extension of the completion date, or other similar issues;

 

·      we may have underestimated the extent and difficulty in adapting the Company’s business processes to function within and use effectively the new ERP system; and

 

·      we may discover that the functionality of the new ERP system is not adequate to process and manage the extensive and varied functions, operations and processes within the Company that we use to conduct our current and future business;

 

If the ERP project were to become subject to any one of these or similar risks, the result could be a significant increase in the costs of the project, a significant delay in completion of the project, with the resultant delay in our realization of the operational and financial benefits of the new system, or even the risk that the project would ultimately fail in its basic goal of a companywide, single-entry system. Any of these outcomes could have a material, adverse impact on our business operations, operating results and financial condition.

 

40



Table of Contents

 

ITEM 2. PROPERTIES

 

Our corporate headquarters are in Vista, California. The operations of our Domestic Rehabilitation Segment are based in Vista, California; Chattanooga, Tennessee; and Shoreview, Minnesota. Our International Segment headquarters is in Guildford, United Kingdom. We operate manufacturing facilities in Tijuana, Mexico; Sfax, Tunisia; Chattanooga, Tennessee; Clear Lake, South Dakota; and Austin, Texas. Our warehouse and distribution centers are in Clear Lake, South Dakota; Chattanooga, Tennessee (c); Indianapolis, Indiana; Tijuana, Mexico; Freiburg, Germany; Guildford, United Kingdom; Malmo, Sweden; Herentals, Belgium; Mouguerre, France; and various other cities throughout the world. The manufacturing facilities and operations for our Domestic Surgical Implant Segment are in Austin, Texas. Additional information about our material facilities and certain other foreign facilities is set forth in the following table:

 

Location

 

Use

 

Owned/
Leased

 

Lease Termination
Date

 

Size in
Square
Feet

 

Vista, California

 

Corporate Headquarters, Domestic Rehabilitation Segment Operations, Manufacturing Facility, Research and Development

 

Leased

 

August 2021

 

123,398

 

Tijuana, Mexico

 

Manufacturing and Distribution Facility

 

Leased

 

September 2016

 

286,133

 

Chattanooga, Tennessee

 

Domestic Rehabilitation Segment Operations, Manufacturing and Distribution Facility, Research and Development (c)

 

Owned

 

n/a

 

164,542

 

Indianapolis, Indiana

 

Distribution Facility

 

Leased

 

October 2016

 

109,782

 

Shoreview, Minnesota

 

Domestic Rehabilitation Segment Operations, Medical Billing

 

Leased

 

October 2011(a)

 

93,666

 

Austin, Texas

 

Domestic Surgical Implant Segment Operations and Manufacturing Facility, Warehouse, Research and Development

 

Leased

 

March 2012(b)

 

52,800

 

Clear Lake, South Dakota

 

Manufacturing, Distribution and Refurbishment and Repair Facility

 

Owned

 

n/a

 

54,000

 

Mouguerre, France

 

Office and Distribution

 

Leased

 

October 2016

 

22,050

 

Freiburg, Germany

 

International Segment Distribution Facility

 

Leased

 

November 2014

 

26,479

 

Freiburg, Germany

 

International Segment Operations

 

Leased

 

December 2014

 

22,195

 

Herentals, Belgium

 

Warehouse

 

Leased

 

December 2013

 

25,800

 

Sfax, Tunisia

 

Manufacturing Facility

 

Leased

 

December 2013

 

47,300

 

Malmö, Sweden

 

International Segment Operations, Warehouse and Distribution Facility

 

Leased

 

March 2011

 

16,081

 

Guildford, United Kingdom

 

International Segment Headquarters and Distribution Facility

 

Leased

 

July 2016

 

8,234

 

Other various locations

 

 

 

Leased

 

Various

 

156,085

 

 


(a) Renewable, at our option, for one additional five-year term.

(b) Renewable, at our option, for two additional five-year terms.

(c) Ongoing operations of our Chattanooga facility were ended in connection with the transition of our Chattanooga activities into other existing sites. We plan to exit the facility in mid-2010.  The buildings are currently listed for sale.

 

ITEM 3. LEGAL PROCEEDINGS

 

From time to time, we are plaintiffs or defendants in various litigation matters in the ordinary course of our business, some of which involve claims for damages that are substantial in amount. We believe that the disposition of claims currently pending will not have a material adverse effect on our financial position or results of operations.

 

The manufacture and sale of orthopedic devices and related products exposes us to a significant risk of product liability claims. From time to time, we have been, and we are currently, subject to a number of product liability claims alleging that the use of our products resulted in adverse effects. Even if we are successful in defending against any liability claims, such claims could nevertheless distract our management, result in substantial costs, harm our reputation, adversely affect the sales of all our products and otherwise harm our business. If there is a significant increase in the number of product liability claims, our business could be adversely affected.

 

41



Table of Contents

 

We are currently defendants in approximately 80 product liability cases, including lawsuits in Canada and Texas seeking class action status, related to a disposable drug infusion pump product manufactured by two third party manufacturers that we distributed through our Bracing and Supports business unit of our Domestic Rehabilitation segment. We discontinued our sale of these products in the second quarter of 2009. These cases have been brought against the manufacturers and certain distributors of these pumps, and in some cases, the manufacturers of the anesthetics used in these pumps. All of these lawsuits allege that the use of these pumps with certain anesthetics in certain shoulder surgeries over prolonged periods have resulted in cartilage damage to the plaintiffs. We have sought indemnity and tendered the defense of these cases to the two manufacturers who supplied these pumps to us, to their products liability carriers and to our products liability carriers. The products liability carriers for both manufacturers has accepted coverage for our defense of these claims; however, both manufacturers have rejected our tenders of indemnity. The base policy for one of the manufacturers has been exhausted and the excess liability carriers for that manufacturer are not obligated to provide a defense until a $5 million self-insured retention has been paid. Our products liability carrier has accepted coverage of these cases, subject to a reservation of the right to deny coverage for customary matters, including punitive damages and off-label promotion. The lawsuits allege damages ranging from unspecified amounts to claims between $1.0 million and $10.0 million. These cases are in varying stages of discovery. We could be exposed to material liabilities if our insurance coverage is not available or inadequate and the resources of the two manufacturers, including their respective products liability insurance policies, are insufficient to pay the defense costs and settlements or judgments in these cases.

 

We maintain products liability insurance that is subject to annual renewal. Our current policy covers claims reported between July 1, 2009 and June 30, 2010 and provides for coverage (together with excess policies) of up to a limit of $80 million, provided that the top layer of $25 million excess over $55 million covers only claims reported after February 25, 2010 and the next layer down of $10 million excess over $45 million covers only claims reported after February 18, 2010. This coverage is subject to a self-insured retention of $500,000 for claims related to pain pumps described above and claims related to the IceMan cold therapy product, a self-insured retention of $250,000 on claims related to all other invasive products and a self-insured retention of $50,000 on claims related to all other non-invasive products, with an aggregate self-insured retention of $1.0 million for all products liability claims. In addition, the top layer of $25 million excess over $55 million has a separate self-insured retention of $50,000 per claim.  Our prior two products liability policies cover claims reported between July 1, 2007 and February 15, 2008 and between February 15, 2008 and July 1, 2009, respectively.  The 2007-2008 policy provides for coverage (together with excess policies) of up to a limit of $20 million and the 2008-2009 policy provides for coverage (together with excess policies) of up to a limit of $25 million.  Certain of the pain pump cases described above were reported under and are covered by these two policies.  If a products liability claim or series of claims is brought against us for uninsured liabilities or in excess of our insurance coverage, our business could suffer materially. In addition, in certain instances, a products liability claim could also result in our having to recall some of our products, which could result in significant costs to us. On our consolidated balance sheet of December 31, 2009, we have accrued approximately $2.0 million for expenses related to products liability claims.  The amount accrued is based upon previous claim experience in part due to the fact that in 2003 we exceeded the coverage limits in effect at that time for certain historical product liability claims involving one of our discontinued surgical implant products and such products are excluded from coverage under our current policies.

 

On April 15, 2009, we became aware of a qui tam action filed in Federal Court in Boston, Massachusetts in March 2005 and amended in December 2007 that names us as a defendant along with each of the other companies that manufactures and sells external bone growth stimulators, as well as our principal stockholder, The Blackstone Group, and the principal stockholder of one of the other companies in the bone growth stimulation business. This case is captioned United States ex rel. Beirman v. Orthofix International, N.V., et al., Civil Action No. 05-10557 (D. Mass.). The case was sealed when originally filed and unsealed in March 2009. The plaintiff, or relator, alleges that the defendants have engaged in Medicare fraud and violated Federal and state false claims acts from the time of the original introduction of the devices by each defendant to the present by seeking reimbursement for bone growth stimulators as a purchased item rather than a rental item. The relator also alleges that the defendants are engaged in other marketing practices constituting violations of the Federal and various state anti-kickback statutes. On December 4, 2009, we filed a motion to dismiss the relator’s complaint, and we are currently awaiting a response from the relator. Shortly before becoming aware of the qui tam action, we were advised that our bone growth stimulator business was the subject of an investigation by the DOJ, and on April 10, 2009, we were served with a subpoena under HIPAA seeking numerous documents relating to the marketing and sale by us of bone growth stimulators. On September 21, 2009, we were served with a second HIPAA subpoena related to this DOJ investigation seeking additional documents relating to the marketing and sale by us of bone growth stimulators. We believe that these subpoenas are related to the DOJ’s investigation of the allegations in the qui tam action, although the DOJ has decided not to intervene in the qui tam action at this time. We believe that our marketing practices in the bone growth stimulation business are in compliance with applicable legal standards and intend to defend this case and investigation vigorously. We can make no assurance as to the resources that will be needed to respond to these matters or the final outcome.

 

ITEM 4. (REMOVED AND RESERVED)

 

42



Table of Contents

 

PART II.

 

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES

 

As a result of the acquisition of ReAble by Blackstone on November 4, 2006 (“the Prior Transaction”), the common stock of DJO is privately held, and there is no established trading market for our common stock. As of March 5, 2010, there were four holders of DJO’s common stock.

 

ITEM 6. SELECTED FINANCIAL DATA

 

Selected financial data set forth below is presented for the five years ended December 31, 2009. The following table sets forth selected financial data as of and for the periods indicated and has been derived from the audited historical consolidated financial statements. The selected financial data for the predecessor period represents ReAble’s financial data prior to the Prior Transaction, and the selected financial data for the successor periods represents financial data of DJOFL after the consummation of the Prior Transaction. For the year ended December 31, 2006, we have combined the predecessor period and the successor period and presented the unaudited results of operations on a combined basis because we believe it is useful to compare our financial results on an annualized basis. The successor period reflects the acquisition of ReAble by Blackstone using the purchase method of accounting pursuant to the provision of Statement of the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) Topic 805 (formerly referred to as FASB No. 141, “Business Combinations”).  Accordingly, the comparability of the results of the successor period for the full year 2007 to the combined results of the successor and the predecessor periods for the full year 2006 is affected by differences in the basis of presentation, which reflects purchase accounting in the successor periods and historical cost in the predecessor periods. In addition, the comparability of the combined results is impacted by changes in our capital structure which occurred on the date the Prior Transaction was completed.  Furthermore, on June 12, 2009 we sold our Empi Therapy Solutions (“ETS”) catalog business.  As such, the results of the ETS business for periods prior to the date of the sale have been presented as discontinued operations.

 

The selected financial data should be read in conjunction with the audited consolidated financial statements and related notes thereto, and Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Annual Report.

 

 

 

Successor

 

Predecessor

 

Combined
Basis

 

Predecessor

 

($ in thousands) 

 

Year Ended
December 31,
2009

 

Year Ended
December 31,
2008

 

Year Ended
December 31,
2007

 

November 4,
2006 through
December 31,
2006

 

January 1,
2006 through
November 3,
2006

 

(unaudited)
Year Ended
December 31,

 

Year Ended
December 31,

 

2006

 

2005

 

Statement of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales (1)

 

$

946,126

 

$

948,469

 

$

464,811

 

$

55,104

 

$

287,124

 

$

342,228

 

$

274,909

 

Gross profit

 

607,407

 

598,292

 

279,613

 

30,569

 

173,384

 

203,953

 

174,659

 

Income (loss) from continuing operations

 

(49,391

)

(97,683

)

(83,455

)

(41,663

)

(46,953

)

(88,616

)

8,217

 

Net income (loss) attributable to DJO Finance LLC

 

(50,433

)

(97,786

)

(82,422

)

(41,634

)

(46,776

)

(88,410

)

12,330

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Financial Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization (2)

 

112,148

 

122,447

 

48,141

 

6,402

 

14,772

 

21,174

 

13,719

 

Ratio of earnings to fixed charges (unaudited) (3)

 

 

 

 

 

 

 

1.45x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance Sheet Data (at period end):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

44,611

 

$

30,483

 

$

63,471

 

$

30,903

 

NA

 

NA

 

$

17,200

 

Total assets

 

2,850,179

 

2,940,130

 

3,086,272

 

1,060,636

 

NA

 

NA

 

552,037

 

Long-term debt, net of current portion

 

1,796,944

 

1,832,044

 

1,818,598

 

548,037

 

NA

 

NA

 

307,794

 

DJO Finance LLC membership equity

 

555,860

 

598,366

 

704,988

 

335,208

 

NA

 

NA

 

167,107

 

 


(1)          The data reported for each period includes net sales from businesses acquired in such period from the effective date of the acquisition. See Note 2 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein for additional information related to these acquisitions.

 

43



Table of Contents

 

(2)          The 2009 and 2008 data includes intangible asset impairment charges of approximately $7.0 million, and $22.4 million, respectively.

 

(3)          For purposes of calculating the ratio of earnings to fixed charges, (a) earnings consist of income (loss) before provision (benefit) for income taxes plus fixed charges and (b) fixed charges is defined as interest expense (including capitalized interest and amortization of debt issuance costs) and the estimated portion of rent expense deemed by management to represent the interest component of rent expense. For the successor years ended December 31, 2009, 2008 and 2007 and the period November 4, through December 31, 2006, and the predecessor period January 1, 2006 through November 3, 2006, our earnings were insufficient to cover fixed charges by $71.8 million, $148.4 million, $127.5 million, $50.6 million, and $59.3 million, respectively.

 

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Forward Looking Statements

 

The following management’s discussion and analysis contains “forward looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act that represent our expectations or beliefs concerning future events, including, but not limited to, statements regarding growth in sales of our products, profit margins and the sufficiency of our cash flow for future liquidity and capital resource needs. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors are described in Item 1A, Risk Factors, noted above. Results actually achieved may differ materially from expected results included in these statements as a result of these or other factors.

 

Introduction

 

This management’s discussion and analysis of financial condition and results of operations is intended to provide an understanding of our results of operations, financial condition and where appropriate, factors that may affect future performance.

 

The following discussion should be read in conjunction with the audited consolidated financial statements and related notes to those financial statements as well as the other financial data included elsewhere in this Annual Report.

 

Overview of Business

 

We are a leading global provider of high-quality orthopedic devices, with a broad range of products used for rehabilitation, pain management and physical therapy. We also develop, manufacture and distribute a broad range of surgical reconstructive implant products. We are one of the largest non-surgical orthopedic rehabilitation device companies in the world, as measured by revenues. Many of our products have leading market positions. We believe that our strong brand names, comprehensive range of products, focus on quality, innovation and customer service, extensive distribution network, and our strong relationships with orthopedic and physical therapy professionals have contributed to our leading market positions. We believe that we are one of only a few orthopedic device companies that offer healthcare professionals and patients a diverse range of orthopedic rehabilitation products addressing the complete spectrum of preventative, pre-operative, post-operative, clinical and home rehabilitation care. Our products are used by orthopedic specialists, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals to treat patients with musculoskeletal conditions resulting from degenerative diseases, deformities, traumatic events and sports-related injuries. In addition, many of our non-surgical medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment.

 

On June 12, 2009 we sold our Empi Therapy Solutions (“ETS”) catalog business to Patterson Medical Supply, Inc. for approximately $21.8 million. As such, results of the ETS business for periods prior to the date of sale have been presented as discontinued operations.

 

We provide a broad array of orthopedic rehabilitation and regeneration products, as well as implants to customers in the United States and abroad.  In the first quarter of 2009, we changed how we report financial information to our senior management.  Prior to 2009, we included the international components of the Surgical Implant, Chattanooga, and Empi businesses in either the Surgical Implant or Domestic Rehabilitation segments, as their operations were managed domestically.  During the fourth quarter of 2008, we effected an operational reorganization which resulted in the non-U.S. components of all of our businesses being managed abroad.  As a result, the segment financial data for the year ended December 31, 2009 reflects this new segmentation and the data for the years ended December 31, 2008 and 2007 has been restated to reflect this change. We currently develop, manufacture and distribute our products through the following three operating segments:

 

44



Table of Contents

 

Domestic Rehabilitation Segment

 

Our Domestic Rehabilitation Segment, which generates its revenues in the United States, is divided into five main businesses:

 

·                  Bracing and Supports.  Our Bracing and Supports business unit offers our DonJoy, ProCare and Aircast products, including rigid knee bracing, orthopedic soft goods, cold therapy products, and vascular systems.  This business unit also includes our OfficeCare business, through which we maintain an inventory of soft goods and other products at healthcare facilities, primarily orthopedic practices, for immediate distribution to patients.

 

·                  Empi.  Our Empi business unit offers our home electrotherapy, iontophoresis, and home traction products. We primarily sell these products directly to patients or to physical therapy clinics. For products sold to patients, we arrange billing to the patients and their third party payors.

 

·                  Regeneration.  Our Regeneration business unit sells our bone growth stimulation products. We sell these products either directly to patients or to independent distributors. For products sold to patients, we arrange billing to the patients and their third party payors.

 

·                  Chattanooga.  Our Chattanooga business unit offers products in the clinical rehabilitation market in the categories of clinical electrotherapy devices, clinical traction devices, and other clinical products and supplies such as treatment tables, continuous passive motion (“CPM”) devices and dry heat therapy.

 

·                  Athlete Direct.  Our Athlete Direct business unit offers our Compex electrostimulation device to consumers, which range from people interested in improving their fitness to competitive athletes, to assist in athletic training programs through muscle development and to accelerate muscle recovery after training sessions.

 

International Segment

 

Our International Segment, which generates most of its revenues in Europe, sells all of our products and certain third party products through a combination of direct sales representatives and independent distributors.

 

Domestic Surgical Implant Segment

 

Our Domestic Surgical Implant Segment develops, manufactures and markets a wide variety of knee, hip and shoulder implant products that serve the orthopedic reconstructive joint implant market in the United States.

 

Our three operating segments enable us to reach a diverse customer base through multiple distribution channels and give us the opportunity to provide a wide range of orthopedic devices and related products to orthopedic specialists operating in a variety of patient treatment settings. These three segments constitute our three reportable segments. See Note 12 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein for additional information regarding our segments.

 

Set forth below is net revenue, gross profit and operating income information for our reporting segments for the years ended December 31. This information excludes the impact of certain expenses not allocated to segments, primarily general corporate expenses and non-recurring charges related to our integration activities.  All prior periods presented have been reclassified to reflect our current reportable segments.

 

45



Table of Contents

 

($ in thousands)

 

2009

 

2008

 

2007

 

Domestic Rehabilitation:

 

 

 

 

 

 

 

Net revenues

 

$

640,785

 

$

634,559

 

$

273,562

 

Gross profit

 

$

425,475

 

$

403,740

 

$

167,092

 

Gross profit margin

 

66.4

%

63.6

%

61.1

%

Operating income

 

$

177,962

 

$

138,556

 

$

11,772

 

Operating income as a percent of net segment revenues

 

27.8

%

21.8

%

4.3

%

International:

 

 

 

 

 

 

 

Net revenues

 

$

241,464

 

$

252,313

 

$

133,757

 

Gross profit

 

$

137,142

 

$

151,901

 

$

70,225

 

Gross profit margin

 

56.8

%

60.2

%

52.5

%

Operating income

 

$

49,051

 

$

55,295

 

$

9,422

 

Operating income as a percent of net segment revenues

 

20.3

%

21.9

%

7.0

%

Domestic Surgical Implant:

 

 

 

 

 

 

 

Net revenues

 

$

63,877

 

$

61,597

 

$

57,492

 

Gross profit

 

$

49,799

 

$

50,469

 

$

46,172

 

Gross profit margin

 

78.0

%

81.9

%

80.3

%

Operating income

 

$

12,955

 

$

12,815

 

$

11,656

 

Operating income as a percent of net segment revenues

 

20.3

%

20.8

%

20.3

%

 

Recent Acquisitions, Dispositions and Other Transactions

 

Acquisition of Chattanooga Group Inc. (Canada)

 

On August 4, 2009 we acquired Chattanooga Group Inc., a Canadian distributor of certain of our products (“Chattanooga Canada”), for $7.2 million. Pursuant to the terms of the acquisition agreement and included within the purchase price, is a $1.4 million holdback and a $1.4 million promissory note. The holdback provides security for potential indemnification claims and, if not used for that purpose, will be paid to the sellers. The holdback amount accrues interest at an annual rate of 2.5% for the first 18 months and a variable rate thereafter. Half of any holdback amount not used to cover indemnification claims will be paid with interest in January 2011 and the remainder of the balance with interest is due approximately three years after closing, upon expiration of a statutory period for under relevant tax law. The promissory note accrues interest at an annual rate of 6% with the principal and interest due in August 2010 (see Note 2 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).

 

Acquisition of Empi Canada Inc.

 

On August 4, 2009 we acquired Empi Canada Inc., a Canadian distributor of certain of our products (“Empi Canada”), for $7.4 million.  Pursuant to the terms of the acquisition agreement and included within the purchase price, is a $1.4 million holdback and a $1.4 million promissory note. The holdback provides security for potential indemnification claims and, if not used for that purpose, will be paid to the sellers. The holdback amount accrues interest at an annual rate of 2.5% for the first 18 months and a variable rate thereafter. Half of any holdback amount not used to cover indemnification claims will be paid with interest in January 2011 and the remainder of the balance with interest is due approximately three years after closing, upon expiration of a statutory period for under relevant tax law. The promissory note accrues interest at an annual rate of 6% with the principal and interest due in August 2010 (see Note 2 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).

 

Sale of Empi Therapy Solutions

 

On June 12, 2009 we sold our ETS catalog business to Patterson Medical Supply, Inc. for approximately $21.8 million. As such, results of the ETS business for periods prior to the date of sale have been presented as discontinued operations (see Note 3 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).

 

Acquisition of DonJoy Orthopaedics Pty. Ltd.

 

On February 3, 2009 we acquired DonJoy Orthopaedics Pty., Ltd., an Australian distributor of certain of our products (“DJO Australia”), for a total cash compensation of $3.4 million. Pursuant to the terms of the acquisition agreement and included within the purchase price, is $0.8 million, representing the acquisition date fair value of the additional amount expected to be paid to the selling shareholder of DJO Australia if certain revenue targets were met by December 31, 2009. Such revenue targets were met, and the additional amount of $0.8 million, which was included in accrued liabilities in the consolidated balance sheet at December 31, 2009, was paid in the first quarter of fiscal year 2010.

 

46



Table of Contents

 

Sale of Other Product Lines

 

During the fourth quarter of 2009 we sold all rights, title and interest to our spinal implant business and related property for $2.9 million.  In addition, also during the fourth quarter of 2009, we sold our line of chiropractic tables known as the Ergostyle line, and the TE-CH3 product (together referred to as “product line”) and other assets used in or otherwise related to the manufacture, sale and marketing of the product line for approximately $0.8 million.

 

DJO Merger

 

On July 15, 2007, we entered into the Agreement and Plan of Merger with DJO Opco providing for a merger transaction pursuant to which DJO Opco became a wholly owned subsidiary of DJOFL, the entity filing this Annual Report. The total purchase price for the DJO Merger, which was consummated on November 20, 2007, was approximately $1.3 billion and consisted of $1.2 billion (at $50.25 a share) paid to former equity holders of DJO Opco, $15.2 million related to the fair value of stock options held by DJO Opco management that were exchanged for options to purchase DJO common stock, and $22.8 million in direct acquisition costs. The DJO Merger was financed through a combination of equity contributed by Blackstone, borrowings under the Senior Secured Credit Facility, and proceeds from the newly issued 10.875% senior Notes due 2014 (“10.875% Notes”) issued by DJOFL and DJO Finance Corporation (see Note 2 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).

 

Acquisition of IOMED, Inc.

 

On August 9, 2007, we acquired IOMED, which develops, manufactures and markets active drug delivery systems used primarily to treat acute local inflammation in the physical and occupational therapy and sports medicine markets. The purchase price was $23.3 million and consisted of $21.1 million in cash payments to former IOMED equity holders at $2.75 per share, $0.8 million related to the fair value of vested stock options that were outstanding at the time of the acquisition, and $1.4 million in direct acquisition costs. The acquisition was primarily financed with borrowings under our then existing senior secured credit facility (see Note 2 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).  The IOMED business has been completely integrated with our Empi and Chattanooga business units.

 

Acquisition of The Saunders Group

 

On July 2, 2007, we completed the purchase of substantially all of the assets of The Saunders Group (“Saunders”) for total cash consideration of $40.9 million, including $0.9 million of acquisition costs. Saunders is a supplier of rehabilitation products to physical therapists, chiropractors, athletes, athletic trainers, physicians and patients, with a specialty in patented traction devices, back supports, and equipment for neck and back disorders. The acquisition was financed with funds borrowed under our then existing senior secured credit Facility (see Note 2 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein). The Saunders business has been completely integrated with our Empi and Chattanooga business units.

 

47



Table of Contents

 

Results of Operations

 

The following table sets forth our statements of operations as a percentage of sales for the periods indicated:

 

 

 

Year Ended December 31,

 

($ in thousands)

 

2009

 

2008

 

2007

 

Net sales

 

$

946,126

 

100.0

%

$

948,469

 

100.0

%

$

464,811

 

100.0

%

Cost of sales

 

338,719

 

35.8

 

350,177

 

36.9

 

185,198

 

39.8

 

Gross profit

 

607,407

 

64.2

 

598,292

 

63.1

 

279,613

 

60.2

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

420,758

 

44.5

 

439,059

 

46.3

 

266,907

 

57.4

 

Research and development

 

23,540

 

2.5

 

26,938

 

2.8

 

21,047

 

4.5

 

Amortization and impairment of acquired intangibles

 

84,252

 

8.9

 

98,954

 

10.4

 

33,496

 

7.2

 

Operating income (loss)

 

78,857

 

8.3

 

33,341

 

3.5

 

(41,837

)

(9.0

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

1,033

 

0.1

 

1,662

 

0.2

 

1,132

 

0.2

 

Interest expense

 

(157,032

)

(16.6

)

(173,162

)

(18.3

)

(72,409

)

(15.6

)

Other (expense) income, net

 

6,073

 

0.6

 

(9,205

)

(1.0

)

742

 

0.2

 

Loss on early extinguishment of debt

 

 

0.0

 

 

0.0

 

(14,539

)

(3.1

)

Loss from continuing operations before income taxes

 

(71,069

)

(7.5

)

(147,364

)

(15.5

)

(126,911

)

(27.3

)

Benefit for income taxes

 

(21,678

)

(2.3

)

(49,681

)

(5.2

)

(43,456

)

(9.4

)

Income (loss) from discontinued operations, net

 

(319

)

0.0

 

946

 

0.1

 

1,448

 

0.3

 

Net loss

 

(49,710

)

(5.3

)

(96,737

)

(10.2

)

(82,007

)

(17.6

)

Less: Income attributable to noncontrolling interest

 

723

 

0.1

 

1,049

 

0.1

 

415

 

0.1

 

Net loss attributable to DJO Finance LLC

 

$

(50,433

)

(5.3

)%

$

(97,786

)

(10.3

)%

$

(82,422

)

(17.7

)%

 

Year Ended December 31, 2009 Compared to Year Ended December 31, 2008

 

Net Sales. Our net sales for the year ended December 31, 2009 were $946.1 million, compared to net sales of $948.5 million for the year ended December 31, 2008.  Net sales for the year ended December 31, 2009 were negatively impacted by $13.9 million of unfavorable changes in foreign exchange rates compared to the rates in effect for the year ended December 31, 2008. On the basis of constant currency rates, net sales increased 1.2% for the year ended December 31, 2009 compared to the year ended December 31, 2008.

 

For the year ended December 31, 2009, we generated 25.5% of our net sales from customers outside the United States as compared to 26.6% for the year ended December 31, 2008.  Additionally, sales of new products, which include products that have been on the market less than one year, were $12.3 million for the year ended December 31, 2009, compared to new product sales of $27.2 million for the year ended December 31, 2008.

 

The following table sets forth the mix of our net sales for the years ended December 31, 2009 and 2008:

 

 

 

Years Ended

 

 

 

 

 

($ in thousands)

 

December 31,
2009

 

% of Net
Revenues

 

December 31,
2008

 

% of Net
Revenues

 

Increase (Decrease)

 

% Increase (Decrease)

 

Domestic Rehabilitation Segment

 

$

640,785

 

67.7

%

$

634,559

 

66.9

%

$

6,226

 

1.0

%

International Segment

 

241,464

 

25.5

 

252,313

 

26.6

 

(10,849

)

(4.3

)

Domestic Surgical Implant Segment

 

63,877

 

6.8

 

61,597

 

6.5

 

2,280

 

3.7

 

Consolidated net sales

 

$

946,126

 

100.0

%

$

948,469

 

100.0

%

$

(2,343

)

(0.2

)%

 

Net sales in our Domestic Rehabilitation Segment were $640.8 million for the year ended December 31, 2009, reflecting an increase of 1.0% over net sales of $634.6 million for the year ended December 31, 2008. The increase was driven primarily by growth across the majority of our product lines, offset primarily by declines in revenues in our Chattanooga business due to the economic downturn and constraints in the credit markets which compelled customers to reduce purchases of capital equipment items supplied by our Chattanooga business unit, and a slowdown in certain customer purchasing during the first quarter due to the overall global economic decline.

 

48



Table of Contents

 

Net sales in our International Segment for the year ended December 31, 2009 were $241.5 million, reflecting a decrease of 4.3% from net sales of $252.3 million for the year ended December 31, 2008. The decrease was driven primarily by $13.9 million of unfavorable changes in foreign exchange rates compared to rates in effect for the year ended December 31, 2008 and reduced sales of consumer products and clinical physical therapy equipment, partially offset by revenues from distributors acquired in 2009 in Australia and Canada.  On the basis of constant currency rates, sales in our International Segment increased 1.2% for the year ended December 31, 2009 compared to the year ended December 31, 2008.

 

Net sales in our Domestic Surgical Implant Segment increased to $63.9 million from $61.6 million for the year ended December 31, 2009, representing a 3.7% increase over the prior year. The increase was driven primarily by an increase in sales of our shoulder products.

 

Gross Profit.  Consolidated gross profit as a percentage of net sales increased to 64.2% for the year ended December 31, 2009 from 63.1% for the year ended December 31, 2008. The increase in our gross profit margin is primarily attributable to cost improvement initiatives implemented in 2008 and 2009 and the benefits of a more favorable mix of products sold, partially offset by unfavorable changes in foreign exchange rates of approximately $10.5 million. Additionally, the increase in consolidated gross profit was partially driven by a reduction of $4.7 million in amortization of purchased inventory fair value adjustments related to acquisitions.

 

Gross profit in our Domestic Rehabilitation Segment as a percentage of net sales increased to 66.4% for the year ended December 31, 2009 from 63.6% for the year ended December 31, 2008. The increase in our gross margin was primarily attributable to cost improvement initiatives implemented in 2008 and 2009 and the benefits of a more favorable mix of products sold, and a reduction of $4.7 million in amortization of purchased inventory fair value adjustments related to acquisitions.

 

Gross profit in our International Segment as a percentage of net sales decreased to 56.8% for the year ended December 31, 2009 from 60.2% for the year ended December 31, 2008. The decrease was primarily driven by unfavorable changes in foreign exchange rates of approximately $10.5 million and the impact of a less favorable mix of products sold.

 

Gross profit in our Domestic Surgical Implant Segment as a percentage of net sales decreased to 78.0% for the year ended December 31, 2009 from 81.9% for the year ended December 31, 2008. The decrease was primarily driven by lower margin mix of products sold and higher inventory obsolescence costs.

 

Selling, General and Administrative.  Our selling, general and administrative expenses decreased to $420.8 million for the year ended December 31, 2009 from $439.1 million for the year ended December 31, 2008 primarily due to overall cost savings initiatives, lower non-recurring costs as a result of our integration activities, decreases in overall wage expenses related to headcount reductions and facilities consolidations and reduced commissions expense. Additionally, 2009 was favorably impacted by the reversal of a $6.0 million accrual made in 2008 as part of purchase accounting related to the DJO Merger for alleged over payment to Medicare claims due to the favorable settlement of the dispute. These expense decreases were partially offset by $12.8 million of increased costs related to the implementation of our new global ERP system. The following table sets forth certain non-recurring costs associated with our integration and ERP implementation:

 

($ in thousands)

 

Years Ended

 

 

December 31,
2009

 

December 31,
2008

 

Increase
(Decrease)

 

% Increase
(Decrease)

 

 

 

 

 

 

 

 

 

 

 

Employee severance and relocation expenses

 

$

8,619

 

$

11,237

 

$

(2,618

)

(23.3

)%

Integration expenses

 

26,827

 

27,750

 

(923

)

(3.3

)

Reversal of reimbursement claims

 

(6,000

)

 

(6,000

)

NM

 

ERP implementation

 

18,074

 

5,247

 

12,827

 

NM

 

 

 

$

47,520

 

$

44,234

 

$

3,286

 

7.4

%

 

Employee severance and relocation expenses for the year ended December 31, 2009 included $5.4 million of severance and retention in connection with our Chattanooga integration, $1.8 million of severance in connection with our recent company-wide headcount reduction, $1.1 million related to the DJO Merger, and $0.4 million related to restructuring at our international locations.  Employee severance and relocation expenses for the year ended December 31, 2008 consisted of $5.7 million of severance related to the DJO Merger, $2.7 million of severance in connection with other acquisitions and $2.8 million of payments and other expenses in connection with the termination of a former executive officer.  Integration expenses for the year ended December 31, 2009 included $20.3 million of integration costs incurred in connection with the DJO Merger, and $6.4 million related to the restructuring at our international locations. Integration expenses for the year ended December 31, 2008 included $23.1 million and $4.3 million of integration costs accrued in connection with the DJO Merger and other recent acquisitions, respectively.

 

49



Table of Contents

 

Research and Development.  Our research and development expense decreased to $23.5 million for the year ended December 31, 2009 from $26.9 million for the year ended December 31, 2008, primarily reflecting cost savings initiatives, and lower wages from reduced headcount. As a percentage of net sales, research and development expense decreased to 2.5% compared to 2.8% in the year ended December 31, 2008.

 

Amortization and Impairment of Acquired Intangibles.  Amortization and impairment of acquired intangible assets decreased to $84.3 million for the year ended December 31, 2009 from $99.0 million for the year ended December 31, 2008.  Included within the year ended December 31, 2009 are charges of approximately $7.0 million related to two indefinite lived intangible assets which were determined to be impaired. In the year ended December 31, 2008, there were charges of approximately $10.1 million related to an indefinite lived intangible asset which was deemed to be impaired and approximately $12.3 million resulting from the abandonment of a trade name. We test intangible assets with indefinite lives annually in accordance with ASC Topic 350 (formerly SFAS No. 142, “Goodwill and Other Intangible Assets”). This test compares the fair value of the intangible with its carrying amount.  To determine the fair value, we applied the relief from royalty method (“RFR”). Under the RFR method, the value of the trade name is determined by calculating the present value of the after-tax cost savings associated with owning the asset and therefore not being required to pay royalties for its use during the asset’s indefinite life. Significant judgments inherent in this analysis include the selection of appropriate discount rates, estimating the amount and timing of estimated future cash flows and the identification of appropriate terminal growth rate assumptions. Discount rate assumptions are based on an assessment of the risk inherent in the projected future cash flows generated by the respective intangible assets. Also subject to judgment are assumptions about royalty rates, which are based on the estimated rates at which similar brands and trademarks are being licensed in the marketplace.

 

Amortization of acquired intangibles includes amortization expense related to intangible assets recognized in the Prior Transaction and acquired in connection with our acquisitions. The intangible assets are being amortized over the estimated lives ranging from two to twenty years. Our amortization of acquired intangibles increased slightly to $77.3 million for the year ended December 31, 2009 compared to $76.5 million for the year ended December 31, 2008. At December 31, 2009, we expect the future amortization of intangibles to be approximately $77.2 million in 2010, $75.7 million in 2011, $74.4 million in 2012, $69.2 million in 2013, $67.4 million in 2014, and $391.6 million for the periods thereafter. Future acquisitions of businesses or intangible assets may cause these estimated future expenses to differ materially.

 

Interest Expense.  Our interest expense decreased to $157.0 million for the year ended December 31, 2009 compared to interest expense of $173.2 million for the year ended December 31, 2008. The decrease is primarily related to lower debt levels and reduced interest rates on our variable rate debt.  Additionally, we manage the risk of unfavorable movements in interest rates by hedging a portion of the outstanding loan balance.

 

Other Income and Expense.  We generated other income of $6.1 million for the year ended December 31, 2009 compared to other expense of $9.2 million for the year ended December 31, 2008. Included in the year ended December 31, 2009 is a $3.1 million gain related to the sales of certain immaterial product lines, as well as net foreign currency translation gains. For the year ended December 31, 2008, the amount primarily reflects net foreign currency transaction losses.

 

Benefit for Income Taxes.  The effective tax rate for the years ended December 31, 2009 and December 31, 2008 was 30.5% and 33.7%, respectively.  For the year ended December 31, 2009, we recorded a $21.7 million income tax benefit, net of tax expense related to foreign operations, deferred taxes on the assumed repatriation of foreign earnings, and other non-deductible items. For the year ended December 31, 2008, we recorded a $49.7 million income tax benefit, net of tax expense related to foreign operations, deferred taxes on the assumed repatriation of foreign earnings, and other non-deductible items.

 

Year Ended December 31, 2008 Compared to Year Ended December 31, 2007

 

Net Sales. Our net sales for the year ended December 31, 2008 were $948.5 million, representing an increase of 104.1% from net sales of $464.8 million for the year ended December 31, 2007. The increase was primarily driven by business acquisitions, including the DJO Merger (November 2007), IOMED (August 2007) and Saunders (July 2007) and continued growth across our product lines. Revenues associated with these business acquisitions were approximately $458.9 million for the full year ended December 31, 2008 compared to $54.2 million for post-closing period of 2007. Net sales were also positively impacted for the year ended December 31, 2008 by $11.7 million due to favorable changes in foreign exchange rates compared to rates in effect for the year ended December 31, 2007. For the year ended December 31, 2008 and December 31, 2007, we generated 26.6% and 28.8%, respectively, of our net sales from customers outside the United States.

 

50



Table of Contents

 

Sales of new products, which include products that have been on the market less than one year, were $27.2 million for the year ended December 31, 2008, compared to new product sales of $34.1 million for the year ended December 31, 2007.

 

The following table sets forth the mix of our net sales for the years ended December 31, 2008 and 2007:

 

 

 

Years Ended

 

 

 

 

 

($ in thousands)

 

December 31,
2008

 

% of Net
Revenues

 

December 31,
2007

 

% of Net
Revenues

 

Increase

 

% Increase

 

Domestic Rehabilitation Segment

 

$

634,559

 

66.9

%

$

273,562

 

58.9

%

$

360,997

 

132.0

%

International Segment

 

252,313

 

26.6

 

133,757

 

28.8

 

118,556

 

88.6

 

Domestic Surgical Implant Segment

 

61,597

 

6.5

 

57,492

 

12.3

 

4,105

 

7.1

 

Consolidated net sales

 

$

948,469

 

100.0

%

$

464,811

 

100

%

$

483,658

 

104.1

%

 

Net sales in our Domestic Rehabilitation Segment were $634.6 million for the year ended December 31, 2008, reflecting an increase of 132.0% over net sales of $273.6 million for the year ended December 31, 2007. The increase was driven primarily by the addition of sales from the DJO Merger and the IOMED and Saunders acquisitions as discussed above and growth in our core product lines.

 

Net sales in our International Segment for the year ended December 31, 2008 were $252.3 million, reflecting an increase of 88.6% from net sales of $133.8 million for the year ended December 31, 2007. The increase was driven primarily by the addition of sales from the DJO Merger and continued growth in our core international markets. Net sales were also positively impacted by $11.7 million for the year ended December 31, 2008 due to favorable changes in foreign exchange rates compared to rates in effect for the year ended December 31, 2007.

 

Net sales in our Domestic Surgical Implant Segment increased to $61.6 million from $57.5 million for the year ended December 31, 2008, representing a 7.1% increase over the prior year. The increase was driven primarily by growth in our knee, shoulder and hip implant product lines.

 

Gross Profit.  Consolidated gross profit as a percentage of net sales increased to 63.1% for the year ended December 31, 2008 from 60.2% for the year ended December 31, 2007. The increase in our gross profit margin is primarily attributable to cost improvement initiatives implemented in the past year, favorable changes in the mix of products we sell as a result of our recent acquisitions of businesses with higher margin products, and favorable changes in foreign exchange rates of approximately $3.8 million. Additionally, the increase in consolidated gross profit was driven by reduced amortization of purchased inventory fair value adjustments related to acquisitions. The amortization of purchased inventory fair value adjustments included in cost of sales was $4.7 million and $14.0 million for the years ended December 31, 2008 and 2007, respectively.

 

Gross profit in our Domestic Rehabilitation Segment as a percentage of net sales increased to 63.6% for the year ended December 31, 2008 from 61.1% for the year ended December 31, 2007. The increase in our gross margin was primarily attributable to cost improvement initiatives implemented in the past year and favorable changes in the mix of products we sell as a result of our recent acquisitions of businesses with higher margin products. Additionally, the increase in domestic rehabilitation gross profit was driven by reduced amortization of purchased inventory fair value adjustments related to acquisitions.  The amortization of purchased inventory fair value adjustments included in cost of sales was $4.7 million and $8.6 million for the years ended December 31, 2008 and 2007, respectively.

 

Gross profit in our International Segment as a percentage of net sales increased to 60.2% for the year ended December 31, 2008 from 52.5% for the year ended December 31, 2007. The increase was primarily driven by cost improvement initiatives implemented in the past year, favorable changes in the mix of products we sell as a result of our recent acquisitions of businesses with higher margin products, and favorable changes in foreign exchange rates of approximately $3.8 million. Additionally, the increase in international rehabilitation gross profit was driven by reduced amortization of purchased inventory fair value adjustments related to acquisitions. The amortization of purchased inventory fair value adjustments included in cost of sales was $2.1 million for the year ended December 31, 2007 and we had no such amortization in 2008.

 

Gross profit in our Domestic Surgical Implant Segment as a percentage of net sales increased to 81.9% for the year ended December 31, 2008 from 80.3% for the year ended December 31, 2007. The increase was primarily driven by cost improvement initiatives implemented in the past year and reduced amortization of purchased inventory fair value adjustments related to acquisitions of $3.3 million. The amortization of purchased inventory fair value adjustments included in cost of sales was $3.3 million for the year ended December 31, 2007.

 

51



Table of Contents

 

Selling, General and Administrative.  Our selling, general and administrative expenses increased to $439.1 million for the year ended December 31, 2008 from $266.9 million for the year ended December 31, 2007 primarily due to approximately $166.0 million of expenses, including wages, commissions, professional fees, and other expenses incurred by businesses we acquired and $4.1 million increase in non-recurring costs associated with the integration of our acquisitions partially offset by a favorable $1.1 million settlement of a litigation contingency related to one of our foreign subsidiaries. The following table sets forth certain non-recurring selling, general and administrative costs associated with the integration of our recent acquisitions:

 

 

 

Years Ended

 

($ in thousands)

 

December 31,
2008

 

December 31,
2007

 

Increase
(Decrease)

 

% Increase
(Decrease)

 

 

 

 

 

 

 

 

 

 

 

Management retention bonuses

 

$

5,775

 

$

542

 

$

5,233

 

NM

 

Severance and relocation expenses

 

11,237

 

16,372

 

(5,135

)

(31.4

)

Integration expenses

 

32,997

 

17,087

 

15,910

 

93.1

 

Charges to bad debt expense related to revaluation of accounts receivable and anticipated integration related collection issues

 

 

11,870

 

(11,870

)

NM

 

 

 

$

50,009

 

$

45,871

 

$

4,138

 

9.0

%

 

Management retention bonuses related to the DJO Merger were recorded and amortized over the period from the close of the transaction to December 31, 2008, resulting in expenses of $5.8 million and $0.5 million in 2008 and 2007, respectively. For the year ended December 31, 2008, severance and relocation consisted of $5.7 million of severance expenses related to the DJO Merger, $2.7 million of severance payments to employees in connection with other acquisitions, and $2.8 million of payments and other expenses in connection with the termination of a former executive officer. Severance expenses for the year ended December 31, 2007 include $13.3 million of payments made to former executives of ReAble.  Remaining severance expenses are related to restructuring activities in connection with recent acquisitions.  Integration expenses for the year ended December 31, 2008 included $23.1 million and $4.3million of integration costs incurred in connection with the DJO Merger and other recent acquisitions, respectively. Also included within integration expense for the year ended December 31, 2008 is $5.2 million related to the implementation of our new global ERP system.  Integration expense for the year ended December 31, 2007 included costs incurred with the DJO Merger, Prior Transaction and other recent acquisitions.  The year ended December 31, 2007 included a $11.9 million charge related to the impact of changes in methodologies used to estimate accounts receivable reserves, primarily in connection with the DJO Merger.

 

Research and Development.  Our research and development expense increased to $26.9 million for the year ended December 31, 2008 from $21.0 million for the year ended December 31, 2007. The increase was primarily due to wages, facility and project costs incurred by businesses we acquired. As a percentage of net sales, research and development expense decreased to 2.8% compared to 4.5% in the year ended December 31, 2007.

 

Amortization and Impairment of Acquired Intangibles.  Amortization and impairment of acquired intangible assets increased to $99.0 million for the year ended December 31, 2008 from $33.5 million for the year ended December 31, 2007.  Included within the year ended December 31, 2008 are charges of approximately $10.1 million related to an indefinite lived intangible asset which was deemed to be impaired and approximately $12.3 million resulting from the abandonment of a trade name.  Amortization of acquired intangibles includes amortization expense related to intangible assets acquired in connection with our acquisitions. The intangible assets are being amortized over the estimated lives ranging from two to twenty years. Our amortization of acquired intangibles increased to $76.5 million for the year ended December 31, 2008 compared to $33.5 million for the year ended December 31, 2007.

 

Interest Expense.  Our interest expense increased to $173.2 million for the year ended December 31, 2008 compared to interest expense of $72.4 million for the year ended December 31, 2007. The increase was principally driven by incremental borrowings to fund the DJO Merger and other recent acquisitions.

 

Other Income and Expense.  Other expense was $9.2 million for the year ended December 31, 2008 compared to other income of $0.7 million for the year ended December 31, 2007. The 2008 expense was principally comprised of foreign currency transaction losses and the write-off of a strategic investment determined to have no value.

 

Benefit for Income Taxes.  The effective tax rate for the years ended December 31, 2008 and December 31, 2007 was 33.7% and 34.2%, respectively.  For the year ended December 31, 2008, we recorded a $49.7 million income tax benefit, net of tax expense related to foreign operations, deferred taxes on the assumed repatriation of foreign earnings, and other non-deductible items. For the year ended December 31, 2007, we recorded a $43.5 million income tax benefit, net of tax expense related to foreign operations, deferred taxes on the assumed repatriation of foreign earnings, and other non-deductible items.

 

52



Table of Contents

 

Pro Forma Financial Information.   The unaudited financial information in the table below summarizes the combined results of our operations and those of DJO Opco, IOMED, and The Saunders Group on a pro forma basis, as though the companies acquired had been combined as of the beginning of 2007. The pro forma financial information excludes the impact of other acquisitions made during 2007 with a total purchase price of $7.2 million and is presented for informational purposes only and is not indicative of the results of operations that would have been achieved if the acquisitions had taken place at the beginning of each of the years presented. The pro forma adjustments include the effect of purchase accounting adjustments, interest expense, and related tax effects, among others. In addition, on June 12, 2009 we sold our Empi Therapy Solutions catalog business.  As such, results of the ETS business for periods prior to the date of sale have been presented as discontinued operations.

 

 

 

Years Ended

 

($ in thousands)

 

December 31,
2008

 

December 31,
2007

 

Change

 

% Change

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

948,469

 

$

901,033

 

$

47,436

 

5.3

%

Loss from continuing operations before income taxes

 

(147,364

)

(242,545

)

95,181

 

39.2

 

Benefit for income taxes

 

(49,681

)

(77,016

)

27,335

 

35.5

 

Noncontrolling interest

 

946

 

415

 

531

 

128.0

 

Loss from continuing operations

 

$

(96,737

)

$

(165,114

)

$

68,377

 

41.4

%

 

Recent Accounting Pronouncements

 

For information on recent accounting pronouncements impacting our business, see Note 1 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein.

 

Liquidity and Capital Resources

 

On January 20, 2010, we issued $100.0 million aggregate principal amount of new 10.875% Senior Notes due 2014. The net proceeds of the issuance (excluding approximately $2.0 million of interest accrued from November 16, 2009 to January 19, 2010 which will be included in the first interest payment to be made on May 15, 2010), along with cash on hand, were used to repay $101.5 million aggregate principal amount of existing term loans under the Senior Secured Credit Facility.

 

As of December 31, 2009, our primary source of liquidity consisted of cash and cash equivalents totaling $44.6 million and $100 million of available borrowings under our revolving credit facility, described below. Working capital at December 31, 2009 was $182.2 million. We believe that our existing cash, plus the amounts we expect to generate from operations and amounts available through our revolving credit facility, will be sufficient to meet our operating needs for the next twelve months, including working capital requirements, capital expenditures, and debt and interest repayment obligations. While we currently believe that we will be able to meet all of our financial covenants imposed by our Senior Secured Credit Facility, there is no assurance that we will in fact be able to do so or that, if we do not, we will be able to obtain from our lenders waivers of default or amendments to the Senior Secured Credit Facility in the future. We and our subsidiaries, affiliates or significant shareholders (including Blackstone and its affiliates) may from time to time, in our or their sole discretion, purchase, repay, redeem or retire any of our outstanding debt or equity securities (including any publicly issued debt securities), in privately negotiated or open market transactions, by tender offer or otherwise.

 

A summary of our changes in cash and cash equivalents for the years ended December 31, 2009 and 2008 is as follows (in thousands):

 

 

 

Years Ended December 31,

 

 

 

2009

 

2008

 

2007

 

Cash provided by (used in) operating activities

 

$

67,794

 

$

(12,061

)

$

(28,759

)

Cash used in investing activities

 

(16,000

)

(29,596

)

(1,323,064

)

Cash (used in) provided by financing activities

 

(35,261

)

8,865

 

1,383,558

 

Effect of exchange rate changes on cash and cash equivalents

 

(2,405

)

(196

)

833

 

Net increase (decrease) in cash and cash equivalents

 

$

14,128

 

$

(32,988

)

$

32,568

 

 

Cash Flows

 

Operating activities provided $67.8 million of cash for the year ended December 31, 2009, compared to $12.1 million of cash used for the year ended December 31, 2008. Cash provided by operating activities for the year ended December 31, 2009 primarily reflected our net income after adjustment for non-cash charges partially offset by a favorable net change in operating assets and liabilities. Cash used for operating activities for the year ended December 31, 2008 primarily reflected an unfavorable net change in operating assets and liabilities, substantially offset by our net income after adjustment for non-cash charges. Cash used in operating activities for the year ended December 31, 2007 primarily reflected our net loss and a negative net change in operating assets and liabilities.  Cash paid for interest was $144.2 million for the year ended December 31, 2009, $158.8 million for the year ended December 31, 2008, and $70.2 million for the year ended December 31, 2007.

 

53



Table of Contents

 

Investing activities used $16.0 million of cash for the year ended December 31, 2009, compared to $29.6 million for the year ended December 31, 2008. Cash used in investing activities for the year ended December 31, 2009 primarily consisted of $28.9 million of purchases of property and equipment, including $7.8 million for our new ERP system, and the acquisition of businesses for a total of $13.1 million, net of cash,  partially offset by $25.7 million of proceeds from the sales of assets, primarily ETS.  Cash used in investing activities for the year ended December 31, 2008 primarily consisted of purchases of property and equipment totaling $25.9 million, including $5.3 million for our new ERP system and the acquisition of businesses, including payments for 2007 acquisitions, totaling $5.1 million.   Cash used in investing activities for the year ended December 31, 2007 principally consisted of the acquisition of businesses for $1,313.1 million, mainly related to the DJO Merger.

 

Financing activities used $35.3 million of cash for the year ended December 31, 2009, compared to $8.9 million of cash provided by financing activities for the year ended December 31, 2008. Cash used in financing activities for the year ended December 31, 2009 primarily represented net payments on long-term debt and revolving lines of credit.  Cash provided by financing activities for the year ended December 31, 2008 represented net proceeds of $9.2 million on long-term debt and revolving lines of credit.  Cash provided by financing activities for the year ended December 31, 2007 included net proceeds of $1,005.9 million from long-term debt and revolving credit lines mainly related to net borrowings under the Senior Secured Credit Facility.

 

Indebtedness

 

As of December 31, 2009, we had approximately $1,812.9 million in aggregate indebtedness outstanding.

 

Senior Secured Credit Facility

 

Overview.  The Senior Secured Credit Facility provides senior secured financing of $1,165.0 million, consisting of a $1,065.0 million term loan facility and a $100.0 million revolving credit facility. We issued the term loan facility of the Senior Secured Credit Facility at a 1.2% discount, resulting in net proceeds of $1,052.4 million. In addition, we are permitted, subject to receipt of additional commitments from participating lenders and certain other conditions, to incur up to an additional $150.0 million of borrowings under the Senior Secured Credit Facility.

 

Interest Rate and Fees.  Borrowings under the Senior Secured Credit Facility bear interest at a rate equal to an applicable margin plus, at our option, either (a) a base rate determined by reference to the higher of (1) the prime rate of Credit Suisse and (2) the federal funds rate plus 0.50% or (b) the Eurodollar rate determined by reference to the costs of funds for deposits in U.S. dollars for the interest period relevant to each borrowing adjusted for required reserves. The current applicable margins for borrowings under the term loan facility and the revolving credit facility is 2.00% with respect to base rate borrowings and 3.00% with respect to Eurodollar borrowings. The applicable margin for borrowings under the term loan facility and the revolving credit facility may be reduced subject to us attaining certain leverage ratios.

 

We use interest rate swap agreements in an effort to hedge our exposure to fluctuating interest rates related to a portion of our Senior Secured Credit Facility (See Note 9 of the notes to the audited consolidated financial statements included in Part II, Item 8, herein).  On November 20, 2007, we entered into an interest rate swap agreement for a notional amount of $515.0 million at a fixed LIBOR rate of 4.205% which expired at December 31, 2009. In February 2009, we entered into two additional non-amortizing interest rate swap agreements. The first agreement was for a notional amount of $550.0 million at a fixed LIBOR rate of 1.04% beginning February 2009 and expired December 31, 2009. The second is for a notional amount of $750.0 million at a fixed LIBOR rate of 1.88% beginning January 2010 through December 2010.  In August 2009, we entered into four new non-amortizing interest swap agreements with notional amounts aggregating $300.0 million.  Each of the four agreements has a term beginning January 2011 through December 2011. The four agreements are at a weighted average fixed LIBOR rate of 2.5825%.   As of December 31, 2009, our weighted average interest rate for all borrowings under the Senior Secured Credit Facility was 4.42%.

 

In addition to paying interest on outstanding principal under the Senior Secured Credit Facility, we are required to pay a commitment fee to the lenders under the revolving credit facility in respect of the unutilized commitments thereunder. The initial commitment fee rate is 0.50% per annum. The commitment fee rate may be reduced subject to us attaining certain leverage ratios. We must also pay customary letter of credit fees.

 

54



Table of Contents

 

Amortization.  We are required to pay annual amortization (payable in equal quarterly installments) on the loans under the term loan facility in an amount equal to 1.00% of the funded total principal amount through February 2014 with the remaining amount payable in May 2014. Principal amounts outstanding under the revolving credit facility are due and payable in full at maturity, which is six years from the date of the closing of the Senior Secured Credit Facility.

 

Prepayments.  The Senior Secured Credit Facility requires us to prepay outstanding term loans, subject to certain exceptions, with (1) 50% (which percentage can be reduced to 25% or 0% upon our attaining certain leverage ratios) of our annual excess cash flow, as defined; (2) 100% of the net cash proceeds above an annual amount of $25.0 million from non-ordinary course asset sales (including insurance and condemnation proceeds) by DJOFL and its restricted subsidiaries, subject to certain exceptions, including a 100% reinvestment right if reinvested or committed to reinvest within 15 months of such sale or disposition so long as reinvestment is completed within 180 days thereafter; and (3) 100% of the net cash proceeds from issuances or incurrences of debt by DJOFL and its restricted subsidiaries, other than proceeds from debt permitted to be incurred under the Senior Secured Credit Agreement. The foregoing mandatory prepayments will be applied to the term loan facilities in direct order of maturity. 

 

Certain Covenants and Events of Default.  The Senior Secured Credit Facility contains a number of covenants that, among other things, restrict, subject to certain exceptions, our and our subsidiaries’ ability to:

 

·      incur additional indebtedness;

 

·      create liens on assets;

 

·      change fiscal years;

 

·      enter into sale and leaseback transactions;

 

·      engage in mergers or consolidations;

 

·      sell assets;

 

·      pay dividends and make other restricted payments;

 

·      make investments, loans or advances;

 

·      repay subordinated indebtedness;

 

·      make certain acquisitions;

 

·      engage in certain transactions with affiliates;

 

·      restrict the ability of restricted subsidiaries that are not Guarantors to pay dividends or make distributions;

 

·      amend material agreements governing our subordinated indebtedness; and

 

·      change our lines of business.

 

Pursuant to the terms of the credit agreement relating to the Senior Secured Credit Facility, we are required as of December 31, 2009 to maintain a ratio of consolidated senior secured debt to Adjusted EBITDA (or senior secured leverage ratio) of a maximum of 4.25:1 stepping down over time to 3.25:1 by the end of 2011. Adjusted EBITDA represents net income (loss) attributable to DJOFL, plus losses from discontinued operations, interest expense, net, provision (benefit) for income taxes and depreciation and amortization, further adjusted for non-cash items, non-recurring items and other adjustment items permitted in calculating covenant compliance under our Senior Secured Credit Facility and the Indentures (“Adjusted EBITDA”). As of December 31, 2009 our actual senior secured leverage ratio was within the required ratio at 3.88:1.

 

10.875% Notes and 11.75% Notes

 

The Indentures governing the $675.0 million principal amount of 10.875% Notes and the $200.0 million principal amount of 11.75% Notes limit our (and most or all of our subsidiaries’) ability to:

 

·      incur additional debt or issue certain preferred shares;

 

·      pay dividends on or make other distributions in respect of our capital stock or make other restricted payments;

 

·      make certain investments;

 

·      sell certain assets;

 

55



Table of Contents

 

·      create liens on certain assets to secure debt;

 

·      consolidate, merge, sell or otherwise dispose of all or substantially all of our assets;

 

·      enter into certain transactions with our affiliates; and

 

·      designate our subsidiaries as unrestricted subsidiaries.

 

Under the Indentures governing our 10.875% Notes and our 11.75% Notes, our ability to incur additional debt, subject to specified exceptions, is tied to either improving the ratio of our Adjusted EBITDA to fixed charges or having this ratio be at least 2.00:1 on a pro forma basis after giving effect to such incurrence. Additionally, our ability to make certain restricted payments is also tied to having an Adjusted EBITDA to fixed charges of at least 2.00:1 on a pro forma basis. Our ratio of Adjusted EBITDA to fixed charges for the twelve months ended December 31, 2009, measured on that date, was 1.78:1. Notwithstanding these limitations, the aggregate amount of term loan increases and revolving commitment increases shall not exceed the greater of (i) $150.0 million and (ii) the additional aggregate amount of secured indebtedness which would be permitted to be incurred as of any date of determination (assuming for this purpose that the full amount of any revolving credit increase had been utilized as of such date) such that, after giving pro forma effect to such incurrence (and any other transactions consummated on such date), the senior secured leverage ratio for the immediately preceding test period would not be greater than 4.0:1. Fixed charges is defined in the Indentures as consolidated interest expense plus all cash dividends or other distributions paid on any series of preferred stock of any restricted subsidiary and all dividends or other distributions accrued on any series of disqualified stock.

 

On January 20, 2010, we issued $100.0 million aggregate principal amount of new 10.875% Senior Notes which mature on November 15, 2014, pursuant to the indenture, governing our existing 10.875% Senior Notes due 2014 that were issued on November 20, 2007 (collectively the “10.875% Notes”). The net proceeds of the issuance (excluding approximately $2.0 million of interest accrued from November 16, 2009 to January 19, 2010, which amount will be included in the first interest payment to be made on May 15, 2010), along with cash on hand, were used to repay $101.5 million aggregate principal amount of existing term loans under the Senior Secured Credit Facility.

 

Covenant Compliance

 

The following is a summary of our covenant requirements and pro forma ratios as of December 31, 2009:

 

 

 

Covenant
Requirements

 

Actual Ratios

 

Senior Secured Credit Facility

 

 

 

 

 

Maximum ratio of consolidated net senior secured debt to Adjusted EBITDA

 

4.25:1

 

3.88:1

 

10.875% Notes and 11.75% Notes

 

 

 

 

 

Minimum ratio of Adjusted EBITDA to fixed charges required to incur additional debt pursuant to ratio provision

 

2.00:1

 

1.78:1

 

 

As described above, our Senior Secured Credit Facility consisting of a $1,065.0 million term loan facility and a $100.0 million revolving credit facility and the Indentures governing the $675.0 million of senior notes and the $200.0 million of senior subordinated notes represent significant components of our capital structure. Under our Senior Secured Credit Facility, we are required to maintain specified senior secured leverage ratios, which become more restrictive over time, and which are determined based on our Adjusted EBITDA. If we fail to comply with the senior secured leverage ratio under our Senior Secured Credit Facility, we would be in default under the credit facility. Upon the occurrence of an event of default under the Senior Secured Credit Facility, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facility to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facility could proceed against the collateral granted to them to secure that indebtedness. We have pledged a significant portion of our assets as collateral under the Senior Secured Credit Facility. Any acceleration under the Senior Secured Credit Facility would also result in a default under the Indentures governing the Notes, which could lead to the noteholders electing to declare the principal, premium, if any, and interest on the then outstanding Notes immediately due and payable. In addition, under the Indentures governing the Notes, our ability to engage in activities such as incurring additional indebtedness, making investments, refinancing subordinated indebtedness, paying dividends and entering into certain merger transactions is governed, in part, by our ability to satisfy tests based on Adjusted EBITDA.

 

56



Table of Contents

 

Adjusted EBITDA is defined as net income (loss) attributable to DJOFL, plus losses from discontinued operations, interest expense, net, provision (benefit) for income taxes and depreciation and amortization, further adjusted for non-cash items, non-recurring items and other adjustment items permitted in calculating covenant compliance under our Senior Secured Credit Facility and Indentures. We believe that the presentation of Adjusted EBITDA is appropriate to provide additional information to investors about the calculation of, and compliance with, certain financial covenants in our Senior Secured Credit Facility and the Indentures. Adjusted EBITDA is a material component of these covenants.

 

Adjusted EBITDA should not be considered as an alternative to net income or other performance measures presented in accordance with GAAP, or as an alternative to cash flow from operations as a measure of our liquidity. Adjusted EBITDA does not represent net income (loss) or cash flow from operations as those terms are defined by GAAP and does not necessarily indicate whether cash flows will be sufficient to fund cash needs. In particular, the definition of Adjusted EBITDA in the Indentures and our Senior Secured Credit Facility allows us to add back certain non-cash, extraordinary, unusual or non-recurring charges that are deducted in calculating net loss. However, these are expenses that may recur, vary greatly and are difficult to predict. While Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation.

 

Our ability to meet the covenants specified above will depend on future events, many of which are beyond our control, and we cannot assure you that we will meet those covenants. A breach of any of these covenants in the future could result in a default under our Senior Secured Credit Facility and the Indentures, at which time the lenders could elect to declare all amounts outstanding under our Senior Secured Credit Facility to be immediately due and payable. Any such acceleration would also result in a default under the Indentures.

 

The following table provides a reconciliation from our net loss to Adjusted EBITDA for the years ended December 31, 2009, 2008, and 2007. The terms and related calculations are defined in the credit agreement relating to our Senior Secured Credit Facility and the Indentures.

 

 

 

(unaudited)

 

 

 

Year Ended December 31,

 

(in thousands)

 

2009

 

2008

 

2007

 

Net loss attributable to DJO Finance LLC

 

$

(50,433

)

$

(97,786

)

$

(82,422

)

Loss from discontinued operations, net

 

319

 

(946

)

(1,476

)

Interest expense, net

 

155,999

 

171,500

 

71,277

 

Loss on early extinguishment of debt

 

 

 

14,539

 

Income tax benefit

 

(21,678

)

(49,681

)

(43,456

)

Depreciation and amortization

 

112,148

 

122,451

 

48,140

 

Non-cash items (a)

 

4,208

 

6,081

 

18,782

 

Non-recurring items (b)

 

53,520

 

44,234

 

40,286

 

Other adjustment items, before cost savings (c)

 

(2,280

)

16,887

 

115,957

 

Other adjustment items—future cost savings (d)

 

3,600

 

45,200

 

66,673

 

Adjusted EBITDA

 

$

255,403

 

$

257,940

 

$

248,300

 

 


(a)           Non-cash items are comprised of the following:

 

 

 

(unaudited)

 

 

 

Year Ended December 31,

 

(in thousands)

 

2009

 

2008

 

2007

 

Stock compensation expense

 

$

3,382

 

$

1,381

 

$

1,541

 

Purchase accounting adjustments (1)

 

 

4,700

 

17,003

 

Loss on disposal of assets

 

826

 

 

238

 

Total non-cash items

 

$

4,208

 

$

6,081

 

$

18,782

 

 


(1)   Purchase accounting adjustments for the year ended December 31, 2008 included expense related to the write-up to fair market value of acquired inventory in connection with the DJO Merger. Purchase accounting adjustments for the year ended December 31, 2007 included $4.7 million, $4.8 million and $4.5 million related to the write-up to fair market value of acquired inventory in connection with the DJO Merger, the Prior Transaction, and certain other acquisitions, respectively. Also included for the year ended December 31, 2007 is $3.0 million of expense related to the write-off of in-process research and development in connection with the DJO Merger.

 

57



Table of Contents

 

(b)           Non-recurring items are comprised of the following:

 

 

 

(unaudited)

 

 

 

Year Ended December 31,

 

(in thousands)

 

2009

 

2008

 

2007

 

Employee severance and relocation (1)

 

$

8,619

 

$

11,237

 

$

16,372

 

Integration expense (2)

 

26,827

 

27,750

 

10,917

 

Reserve methodology change (3)

 

 

 

12,997

 

ERP implementation

 

18,074

 

5,247

 

 

Total non-recurring items

 

$

53,520

 

$

44,234

 

$

40,286

 

 


(1)           Employee severance and relocation for the year ended December 31, 2009 included $5.4 million of severance and retention in connection with our Chattanooga integration, $1.8 million of severance in connection with our company-wide headcount reduction, $1.1 million related to the DJO Merger, and $0.4 million related to restructuring at our international locations. Employee severance and relocation for the year ended December 31, 2008 included $2.8 million in connection with the termination of a former executive officer, and $5.7 million and $2.7 million of employee severance incurred in connection with the DJO Merger and other acquisitions, respectively. Employee severance and relocation for the year ended December 31, 2007 included severance payments to former ReAble executives in the amount of $13.3 million and $0.7 million related to other severance related items and employee relocation.  Also included for the year ended December 31, 2007 is $0.7 million and $1.7 million related to the DJO Merger and other acquisitions, respectively.

 

(2)           Integration expense for the year ended December 31, 2009 included $20.3 million of integration costs incurred in connection with the DJO Merger and $6.4 million related to restructuring at our international locations. Integration expense for the year ended December 31, 2008 included $23.1 million and $4.3 million of integration costs incurred in connection with the DJO Merger and other recent acquisitions, respectively. Integration expense for the year ended December 31, 2007 includes $2.2 million, $0.4 million, and $8.3 million incurred in connection with the Prior Transaction, the DJO Merger and other acquisitions, respectively.

 

(3)           Represents $9.8 million related to additional allowances for doubtful accounts receivable acquired in connection with the DJO Merger due to anticipated integration related collection issues, $1.1 million related to the revaluation of inventory acquired in connection with the DJO Merger, and $2.1 million related to additional allowance for doubtful accounts due to a change in an accounting reserve methodology in connection with the DJO Merger.

 

(c)           Other adjustment items, before future cost savings, are comprised of the following:

 

 

 

(unaudited)

 

 

 

For the Year Ended December 31,

 

(in thousands)

 

2009

 

2008

 

2007

 

Blackstone monitoring fee

 

$

7,000

 

$