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Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended October 2, 2010

 

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)

 

State of Delaware

 

20-5653965

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer 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

 

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 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 Exchange Act).  Yes o No x

 

As of November 4, 2010, 100% of the issuer’s membership interests were owned by DJO Holdings, LLC.

 

 

 



Table of Contents

 

DJO Finance LLC

 

INDEX

 

 

 

Page
Number

PART I—FINANCIAL INFORMATION

 

 

 

 

Item 1.

Financial Statements

 

 

Unaudited Condensed Consolidated Balance Sheets as of October 2, 2010 and December 31, 2009

1

 

Unaudited Condensed Consolidated Statements of Operations for the three and nine months ended October 2, 2010 and September 26, 2009

2

 

Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended October 2, 2010 and September 26, 2009

3

 

Notes to Unaudited Condensed Consolidated Financial Statements

4

Item 2.

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

30

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

43

Item 4.

Controls and Procedures

43

PART II—OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

44

Item 1A.

Risk Factors

46

Item 6.

Exhibits

53

 



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidated Balance Sheets

(in thousands)

 

 

 

October 2,
2010

 

December 31,
2009

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

50,244

 

$

44,611

 

Accounts receivable, net

 

141,664

 

146,212

 

Inventories, net

 

108,888

 

95,880

 

Deferred tax assets, net

 

39,552

 

40,448

 

Prepaid expenses and other current assets

 

26,221

 

14,725

 

Total current assets

 

366,569

 

341,876

 

Property and equipment, net

 

83,866

 

86,714

 

Goodwill

 

1,190,694

 

1,191,497

 

Intangible assets, net

 

1,130,778

 

1,187,677

 

Other assets

 

37,404

 

42,415

 

Total assets

 

$

2,809,311

 

$

2,850,179

 

 

 

 

 

 

 

Liabilities and Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

53,036

 

$

42,144

 

Accrued interest

 

36,740

 

10,968

 

Current portion of debt and capital lease obligations

 

9,634

 

15,926

 

Other current liabilities

 

85,662

 

90,608

 

Total current liabilities

 

185,072

 

159,646

 

Long-term debt and capital lease obligations

 

1,795,754

 

1,796,944

 

Deferred tax liabilities, net

 

298,006

 

321,131

 

Other long-term liabilities

 

12,654

 

14,089

 

Total liabilities

 

2,291,486

 

2,291,810

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Equity:

 

 

 

 

 

DJO Finance LLC membership equity:

 

 

 

 

 

Member capital

 

830,315

 

827,617

 

Accumulated deficit

 

(313,405

)

(272,275

)

Accumulated other comprehensive income (loss)

 

(1,833

)

518

 

Total membership equity

 

515,077

 

555,860

 

Noncontrolling interests

 

2,748

 

2,509

 

Total equity

 

517,825

 

558,369

 

Total liabilities and equity

 

$

2,809,311

 

$

2,850,179

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

1



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidated Statements of Operations

(in thousands)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

233,559

 

$

236,186

 

$

716,162

 

$

688,951

 

Cost of sales (exclusive of amortization of intangible assets of $9,230 and $27,211 for the three and nine months ended October 2, 2010 and $9,495 and $28,499 for the three and nine months ended September 26, 2009, respectively)

 

84,147

 

86,039

 

256,066

 

247,195

 

Gross profit

 

149,412

 

150,147

 

460,096

 

441,756

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Selling, general and administrative (SG&A)

 

102,672

 

101,413

 

328,913

 

310,618

 

Research and development

 

5,892

 

5,616

 

16,923

 

17,581

 

Amortization of intangible assets

 

19,403

 

19,560

 

58,128

 

57,862

 

Impairment of assets held for sale

 

 

 

1,147

 

 

 

 

127,967

 

126,589

 

405,111

 

386,061

 

Operating income

 

21,445

 

23,558

 

54,985

 

55,695

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense

 

(37,240

)

(39,173

)

(114,867

)

(117,319

)

Interest income

 

92

 

211

 

232

 

749

 

Other income, net

 

4,981

 

1,422

 

1,364

 

3,009

 

 

 

(32,167

)

(37,540

)

(113,271

)

(113,561

)

Loss from continuing operations before income taxes

 

(10,722

)

(13,982

)

(58,286

)

(57,866

)

Income tax benefit

 

3,191

 

2,969

 

17,983

 

19,901

 

Loss from continuing operations

 

(7,531

)

(11,013

)

(40,303

)

(37,965

)

Loss from discontinued operations, net of tax

 

 

(267

)

 

(434

)

Net loss

 

(7,531

)

(11,280

)

(40,303

)

(38,399

)

Net income attributable to noncontrolling interests

 

(184

)

(94

)

(827

)

(368

)

Net loss attributable to DJO Finance LLC

 

$

(7,715

)

$

(11,374

)

$

(41,130

)

$

(38,767

)

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

2



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)

 

 

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

OPERATING ACTIVITIES:

 

 

 

 

 

Net loss

 

$

(40,303

)

$

(38,399

)

 

 

 

 

 

 

Adjustments to reconcile net loss to net cash provided by operating activities:

 

 

 

 

 

Depreciation

 

19,626

 

20,572

 

Amortization of intangible assets

 

58,128

 

57,862

 

Amortization of debt issuance costs and non-cash interest expense

 

9,137

 

9,597

 

Stock-based compensation expense

 

1,309

 

2,335

 

Loss on disposal of assets, net

 

839

 

465

 

Deferred income tax benefit

 

(21,417

)

(22,574

)

Provision for doubtful accounts and sales returns

 

25,549

 

25,433

 

Inventory reserves

 

4,602

 

6,296

 

Impairment of assets held for sale

 

1,147

 

 

Gain on disposal of discontinued operations

 

 

(393

)

Changes in operating assets and liabilities, net of acquired assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(21,428

)

(19,423

)

Inventories

 

(17,452

)

(1,164

)

Prepaid expenses and other assets

 

(12,593

)

(36

)

Accrued interest

 

25,772

 

31,209

 

Accounts payable and other current liabilities

 

8,716

 

(9,213

)

Net cash provided by operating activities

 

41,632

 

62,567

 

 

 

 

 

 

 

INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property and equipment

 

(20,277

)

(19,133

)

Cash paid in connection with acquisitions, net of cash acquired

 

(2,045

)

(12,846

)

Proceeds received upon disposition of discontinued operations, net

 

 

21,846

 

Other investing activities, net

 

(717

)

(76

)

Net cash used in investing activities

 

(23,039

)

(10,209

)

 

 

 

 

 

 

FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from issuance of debt

 

127,130

 

65,173

 

Repayments of debt and capital lease obligations

 

(136,161

)

(94,834

)

Payment of debt issuance costs

 

(3,454

)

 

Investment by parent

 

1,389

 

 

Dividend paid by subsidiary to owners of noncontrolling interests

 

(557

)

 

Net cash used in financing activities

 

(11,653

)

(29,661

)

Effect of exchange rate changes on cash and cash equivalents

 

(1,307

)

(1,901

)

Net increase in cash and cash equivalents

 

5,633

 

20,796

 

Cash and cash equivalents at beginning of period

 

44,611

 

30,483

 

Cash and cash equivalents at end of period

 

$

50,244

 

$

51,279

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

Cash paid for interest

 

$

81,834

 

$

76,366

 

Cash paid for taxes, net

 

$

3,614

 

$

1,859

 

Non-cash investing and financing activities:

 

 

 

 

 

Increases in property and equipment and other liabilities in connection with capitalized ERP costs

 

$

1,069

 

$

3,568

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

3



Table of Contents

 

DJO Finance LLC

Notes to Unaudited Condensed Consolidated Financial Statements

 

1.  BASIS OF PRESENTATION

 

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 believe that we 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 ReAble Therapeutics, Inc. (ReAble), which was acquired by an affiliate of Blackstone Capital Partners V L.P. (Blackstone), and DJO Opco Holdings, Inc. (DJO Opco), formerly named DJO Incorporated. On November 20, 2007, ReAble acquired DJO Opco through a merger transaction (the DJO Merger). ReAble then changed its name to DJO Incorporated and continues to be owned primarily by affiliates of Blackstone. As a result of the DJO Merger, DJO Opco (which on December 31, 2009, was merged into DJO, LLC) became a subsidiary of DJO Finance LLC (DJOFL), the entity filing this Quarterly Report on Form 10-Q, which is itself a subsidiary of DJO Incorporated. Except as otherwise indicated, references to “us”, “we”, “our”, or “our Company”, refers to DJOFL and its consolidated subsidiaries.

 

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 the three and nine month periods ended September 26, 2009 have been presented as discontinued operations in our unaudited condensed consolidated financial statements.

 

In the second quarter of 2010, we changed how we report our segment financial information to senior management. Prior to the second quarter of 2010, our Bracing and Supports and Recovery Sciences businesses were reported together within the Domestic Rehabilitation Segment. During the second quarter, as a result of our recent sales and marketing leadership reorganization, these businesses are now separately evaluated and managed. Segment information for all periods presented has been restated to reflect this change.

 

We market and distribute our products through four operating segments, Bracing and Supports, Recovery Sciences, Surgical Implant, and International. Our Bracing and Supports Segment offers to customers in the United States, orthopedic soft goods; rigid knee braces; cold therapy devices and vascular systems which include products intended to prevent deep vein thrombosis following surgery. Our Recovery Sciences Segment offers to customers in the United States, non-invasive medical products that are used before and after surgery to assist in the repair and rehabilitation of soft tissue and bone, and to protect against further injury; electrotherapy devices and accessories used to treat pain and restore muscle function; iontophoretic devices and accessories used to deliver medication; clinical therapy tables, traction equipment and other clinical therapy equipment; and orthotic devices used to treat joint and spine conditions. Our Surgical Implant Segment offers a comprehensive suite of reconstructive joint products to customers in the United States. Our International segment offers all of our products to customers outside the United States.

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Estimates and assumptions are used in accounting for, among other things, contractual allowances, rebates, product returns, warranty obligations, allowances for doubtful accounts, valuation of inventories, self-insurance reserves, income taxes, loss contingencies, fair values of derivative instruments, fair values of long-lived assets and any related impairments, capitalization of costs associated with internally developed software, and stock-based compensation. Actual results could differ from those estimates.

 

The accompanying unaudited condensed consolidated financial statements include our accounts and all voting interest entities where we exercise a controlling financial interest through the ownership of a direct or indirect majority voting interest. All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Our unaudited condensed consolidated financial statements have been prepared in accordance with GAAP and with the instructions to Form 10-Q and Article 10 of Regulation S-X for interim financial information. Accordingly, these financial statements do not include all of the information required by GAAP or Securities and Exchange Commission rules and regulations for complete financial statements. In the opinion of management, these financial statements reflect all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the results of operations for the interim periods presented. The results of operations for any interim period are not necessarily indicative of results for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2009.

 

4



Table of Contents

 

Certain prior period amounts have been reclassified to conform to the current year presentation.

 

We operate our business on a manufacturing calendar, with our fiscal year always ending on December 31. Each quarter is 13 weeks, consisting of two four-week periods and one five-week period. Our first and fourth quarters may have more or fewer shipping days from year to year based on the days of the week on which holidays and December 31 fall. The three months ended October 2, 2010 and September 26, 2009 each included 63 shipping days. The nine months ended October 2, 2010 and September 26, 2009 included 192 and 188 shipping days, respectively.

 

2.  RECENT ACCOUNTING PRONOUNCEMENTS

 

In January 2010, we adopted the provisions of the Improvement to Financial Reporting by Enterprises Involved with Variable Interest Entities Topic of the Financial Accounting Standards Board (FASB) Codification. This Topic requires a qualitative approach to identifying a controlling interest financial interest in a variable interest entity (VIE), and requires ongoing assessment of whether an entity is a VIE, and whether an interest in a VIE makes the holder the primary beneficiary of the VIE. The adoption of this Topic had no impact on our consolidated financial statements.

 

In January 2010, we adopted the provisions of the FASB Codification which, among other matters, removes the concept of a qualifying special-purpose entity; creates more stringent conditions for reporting a transfer of a portion of a financial asset as a sale; establishes conditions for reporting a transfer of a portion of a financial asset as a sale; and changes the initial measurement of a transferor’s interest in transferred financial assets. The adoption of this Topic had no impact on our consolidated financial statements.

 

In September 2009, the FASB issued guidance concerning the determination of whether an arrangement involving multiple deliverables contains more than one unit of accounting and the manner in which consideration should be measured and allocated to the separate units of accounting in the multiple-element arrangement. This guidance is effective for fiscal years beginning on or after June 15, 2010. We are currently evaluating the impact, if any, this issue will have on our consolidated financial statements. However, we do not expect that this issue will have a material effect on our financial position, results of operations, or cash flows.

 

3.  ACCOUNTS RECEIVABLE RESERVES

 

A summary of activity in our accounts receivable reserves for doubtful accounts and sales returns is presented below (in thousands):

 

 

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
 2009

 

Balance, beginning of period

 

$

48,306

 

$

36,521

 

Provision for doubtful accounts and sales returns

 

25,549

 

25,433

 

Write-offs, net of recoveries

 

(21,400

)

(16,334

)

Balance, end of period

 

$

52,455

 

$

45,620

 

 

4.  INVENTORIES

 

Inventories consist of the following (in thousands):

 

 

 

October 2,
2010

 

December 31,
2009

 

Components and raw materials

 

$

 28,949

 

$

 29,967

 

Work in process

 

6,154

 

3,745

 

Finished goods

 

64,044

 

51,110

 

Inventory held on consignment

 

22,428

 

24,121

 

 

 

121,575

 

108,943

 

Less inventory reserves

 

(12,687

)

(13,063

)

 

 

$

 108,888

 

$

 95,880

 

 

5



Table of Contents

 

A summary of the activity in our reserves for estimated slow moving, excess, obsolete and otherwise impaired inventory is presented below (in thousands):

 

 

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

Balance, beginning of period

 

$

13,063

 

$

17,798

 

Provision charged to cost of sales

 

4,602

 

6,296

 

Write-offs, net of recoveries

 

(4,978

)

(6,895

)

Balance, end of period

 

$

12,687

 

$

17,199

 

 

The write-offs to the reserve were primarily related to the disposition of fully reserved inventory.

 

5.  LONG-LIVED ASSETS

 

Goodwill

 

Changes in the carrying amount of our goodwill for the nine months ended October 2, 2010 are set forth below (in thousands):

 

Balance, beginning of period

 

$

1,191,497

 

Acquisition (1)

 

113

 

Translation adjustments

 

(916

)

Balance, end of period

 

$

1,190,694

 

 


(1)          On September 20, 2010 we acquired certain assets and contractual rights from our South African distributor for total consideration of $1.9 million, which included (i) a cash payment of $1.2 million on the closing date, (ii) forgiveness of $0.4 million of accounts receivable from the distributor and (iii) holdbacks of $0.3 million related primarily to potential indemnification claims, which will be paid in September 2011 if there are no such claims. Our primary reason for this acquisition was to improve the profitability of our sales in South Africa and expand the range of our products sold in this market, which will be aided by participating directly in the market, instead of through an independent distributor. The purchase price was allocated to the acquired tangible and identifiable intangible assets consisting of $0.4 million of inventory, $0.3 million of fixed assets and $1.1 million of finite-lived intangible assets. The $0.1 million excess of the purchase price over the fair value of these identifiable assets was recorded as goodwill.

 

Intangible assets, net

 

Identifiable intangible assets consisted of the following as of October 2, 2010 (in thousands):

 

 

 

Gross
Carrying
Amount

 

Accumulated
Amortization

 

Net
Carrying
Amount

 

Intangible assets subject to amortization:

 

 

 

 

 

 

 

Technology-based

 

$

447,456

 

$

(110,865

)

$

336,591

 

Customer-based

 

485,533

 

(120,829

)

364,704

 

 

 

$

932,989

 

$

(231,694

)

701,295

 

Indefinite-lived intangible assets:

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

429,483

 

 

 

 

 

 

 

$

1,130,778

 

 

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Table of Contents

 

Identifiable intangible assets consisted of the following as of December 31, 2009 (in thousands):

 

 

 

Gross
Carrying
Amount

 

Accumulated
Amortization

 

Net
Carrying
Amount

 

Intangible assets subject to amortization:

 

 

 

 

 

 

 

Technology-based

 

$

458,732

 

$

(94,346

)

$

364,386

 

Customer-based

 

490,589

 

(97,067

)

393,522

 

 

 

$

949,321

 

$

(191,413

)

757,908

 

Indefinite-lived intangible assets:

 

 

 

 

 

 

 

Trademarks and trade names

 

 

 

 

 

429,769

 

 

 

 

 

 

 

$

1,187,677

 

 

Our intangible assets with finite useful lives are being amortized using the straight-line method over their estimated useful lives ranging from one to 20 years. Based on our amortizable intangible asset balance as of October 2, 2010, we estimate that amortization expense will be as follows for the next five years and thereafter (in thousands):

 

Remaining 2010

 

$

19,390

 

2011

 

76,975

 

2012

 

75,659

 

2013

 

69,719

 

2014

 

68,148

 

Thereafter

 

391,404

 

 

 

$

701,295

 

 

6.  OTHER CURRENT LIABILITIES

 

Other current liabilities consist of the following (in thousands):

 

 

 

October 2,
2010

 

December 31,
2009

 

Wages and related expenses

 

$

25,008

 

$

20,668

 

Commissions and royalties

 

11,758

 

12,953

 

Interest rate swap derivatives

 

8,113

 

9,701

 

Other accrued liabilities

 

40,783

 

47,286

 

 

 

$

85,662

 

$

90,608

 

 

7



Table of Contents

 

7.  DERIVATIVE INSTRUMENTS

 

We use derivative financial instruments to manage interest rate risk related to our variable rate credit facilities and risk related to foreign currency exchange rates. Our objective is to reduce the risk to earnings and cash flows associated with changes in interest rates and changes in foreign currency exchange rates. Before acquiring a derivative instrument to hedge a specific risk, we evaluate potential natural hedges. Factors considered in the decision to hedge an underlying market exposure include the materiality of the risk, the volatility of the market, the duration of the hedge, and the availability, effectiveness and cost of derivative instruments. We do not use derivative instruments for speculative or trading purposes.

 

All derivatives, whether designated as hedging relationships or not, are recorded on the balance sheet at fair value. The fair value of our derivatives is determined through the use of models that consider various assumptions, including time value, yield curves and other relevant economic measures which are inputs that are classified as Level 2 in the valuation hierarchy. The classification of gains and losses resulting from changes in the fair values of derivatives is dependent on the intended use of the derivative and its resulting designation. Our interest rate swap agreements are designated as cash flow hedges, and accordingly, effective portions of changes in the fair value of the derivatives are recorded in accumulated other comprehensive income (loss) and subsequently reclassified into our consolidated statement of operations when the hedged forecasted transaction affects income (loss). Ineffective portions of changes in the fair value of cash flow hedges are recognized in income (loss). Our foreign exchange contracts have not been designated as hedges, and accordingly, changes in the fair value of the derivatives are recorded in income (loss).

 

Interest Rate Swap Agreements.  Our senior secured credit facilities are subject to floating interest rates. We manage the risk of unfavorable movements in interest rates by hedging a portion of the outstanding loan balance, thereby locking in a fixed rate on a portion of the principal, reducing the effect of possible rising interest rates and making interest expense more predictable over the term of the credit facilities. We have five interest rate swap agreements which we have designated as cash flow hedges for accounting purposes, and the hedges are considered effective. As such, the effective portion of the gain or loss on the derivative instrument is reported as a component of accumulated other comprehensive income (loss) and is reclassified into interest expense in our unaudited condensed consolidated statement of operations in the period in which it affects income (loss).

 

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Information regarding our interest rate swap agreements as of October 2, 2010 is presented below (in thousands):

 

Maturity Date (1)

 

Notional
Amount

 

Pay
Fixed

 

Receive
Floating

 

Estimated loss
expected to be
reclassified into
earnings within the
next twelve months

 

December 2010

 

$

750,000

 

1.88%

 

1 month LIBOR

 

$

3,086

 

January - December 2011

 

75,000

 

2.55%

 

1 month LIBOR

 

1,238

 

January - December 2011

 

75,000

 

2.60%

 

1 month LIBOR

 

1,267

 

January - December 2011

 

75,000

 

2.585%

 

1 month LIBOR

 

1,258

 

January - December 2011

 

75,000

 

2.595%

 

1 month LIBOR

 

1,264

 

 

 

 

 

 

 

 

 

$

8,113

 

 


(1)          For derivative instruments that were in effect as of October 2, 2010, we present a single date that represents the applicable final maturity date. For derivative instruments that become effective subsequent to October 2, 2010, we present a range of dates that represent the period covered by the applicable derivative instrument.

 

Foreign Exchange Rate Contracts.  We utilize Mexican Peso (MXP) foreign exchange forward contracts to hedge a portion of our exposure to fluctuations in foreign exchange rates, as our Mexico-based manufacturing operations incur costs that are largely denominated in MXP. These foreign exchange forward contracts expire weekly throughout fiscal year 2010.While our foreign exchange forward contracts act as economic hedges, we have not designated such instruments as hedges for accounting purposes. Therefore, gains and losses resulting from changes in the fair values of these derivative instruments are recorded in other income, net, in our unaudited condensed consolidated statements of operations.

 

Information regarding the notional and fair value of our foreign exchange forward contracts as of October 2, 2010 and December 31, 2009 is presented in the table below (in thousands):

 

October 2, 2010

 

December 31, 2009

 

Notional Value
MXP

 

Notional Value
USD

 

Fair Value
USD

 

Notional Value
MXP

 

Notional Value
USD

 

Fair Value
USD

 

143,400

 

$

10,759

 

$

11,279

 

190,745

 

$

14,242

 

$

14,331

 

 

The following table summarizes the fair value of derivative instruments in our unaudited condensed consolidated balance sheets (in thousands):

 

 

 

Balance Sheet Location

 

October 2,
2010

 

December 31,
2009

 

Derivative assets:

 

 

 

 

 

 

 

Foreign exchange forward contracts not designated as hedges

 

Other current assets

 

$

520

 

$

89

 

 

 

 

 

 

 

 

 

Derivative liabilities:

 

 

 

 

 

 

 

Current portion of interest rate swap agreements designated as cash flow hedges

 

Other current liabilities

 

$

8,113

 

$

9,701

 

Long-term portion of interest rate swap agreements designated as cash flow hedges

 

Other long-term liabilities

 

1,570

 

1,543

 

 

 

 

 

$

9,683

 

$

11,244

 

 

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The following table summarizes the effect of derivative instruments on our unaudited condensed consolidated statements of operations (in thousands):

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

Location of gain (loss)

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

Interest rate swap agreements designated as cash flow hedges

 

Interest expense (1)

 

$

(2,988

)

$

(5,001

)

$

(9,181

)

$

(12,629

)

Foreign exchange forward contracts not designated as hedges

 

Other income, net

 

407

 

427

 

431

 

(2,945

)

 

 

 

 

$

(2,581

)

$

(4,574

)

$

(8,750

)

$

(15,574

)

 


(1)          Represents the loss on derivative instruments designated as cash flow hedges, which has been reclassified from accumulated other comprehensive income (loss) into interest expense during the periods presented.

 

The pre-tax loss on derivative instruments designated as cash flow hedges recognized in accumulated other comprehensive income (loss) is presented below (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

Interest rate swaps designated as cash flow hedges

 

$

1,750

 

$

5,748

 

$

7,619

 

$

17,957

 

 

8.  FAIR VALUE MEASUREMENTS

 

Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. Our assessment of the significance of a particular input to the fair value measurements requires judgment, and may affect the valuation of the assets and liabilities being measured and their placement within the fair value hierarchy. The following tables present the balances of assets and liabilities measured at fair value on a recurring basis (in thousands):

 

As of October 2, 2010

 

Level 1 (1)

 

Level 2 (2)

 

Level 3 (3)

 

Total

 

Total Assets:

 

 

 

 

 

 

 

 

 

Foreign exchange forward contracts not designated as hedges

 

$

 

$

520

 

$

 

$

520

 

 

 

 

 

 

 

 

 

 

 

Total Liabilities:

 

 

 

 

 

 

 

 

 

Interest rate swap agreements designated as cash flow hedges

 

$

 

$

9,683

 

$

 

$

9,683

 

 

As of December 31, 2009

 

 

 

 

 

 

 

 

 

Total Assets:

 

 

 

 

 

 

 

 

 

Foreign exchange forward contracts not designated as hedges

 

$

 

$

89

 

$

 

$

89

 

 

 

 

 

 

 

 

 

 

 

Total Liabilities:

 

 

 

 

 

 

 

 

 

Interest rate swap agreements designated as cash flow hedges

 

$

 

$

11,244

 

$

 

$

11,244

 

 


(1)   Fair value measurements based on quoted prices in active markets for identical assets or liabilities.

(2)   Fair value measurements based on observable inputs other than quoted prices in active markets for identical assets and liabilities.

(3)   No observable valuation inputs in the market.

 

9.  DEBT AND CAPITAL LEASE OBLIGATIONS

 

Debt and capital lease obligations consists of the following (in thousands):

 

 

 

October 2,
2010

 

December 31,
2009

 

Senior Secured Credit Facility:

 

 

 

 

 

$100.0 million revolving credit facility

 

$

 

$

 

Term loan facility, net of unamortized original issue discount ($7.2 million and $9.3 million, respectively)

 

925,840

 

1,034,427

 

10.875% Senior Notes, including unamortized original issue premium ($4.5 million as of October 2, 2010)

 

679,456

 

575,000

 

11.75% Senior Subordinated Notes (see Note 18)

 

200,000

 

200,000

 

Notes payable for acquisitions

 

 

2,860

 

Capital lease obligations

 

92

 

228

 

Other

 

 

355

 

Total debt and capital lease obligations

 

1,805,388

 

1,812,870

 

Current maturities

 

(9,634

)

(15,926

)

Long-term debt and capital lease obligations

 

$

1,795,754

 

$

1,796,944

 

 

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Senior Secured Credit Facility

 

On November 20, 2007, we entered into the Senior Secured Credit Facility consisting of a $1,065.0 million term loan facility maturing May 2014 and a $100.0 million revolving credit facility maturing November 2013. We issued the term loan facility at a 1.2% discount, resulting in net proceeds of $1,052.4 million. We are amortizing the $12.6 million discount using the effective interest method, thereby increasing the reported outstanding balance through the maturity date of the term loan facility.

 

On January 14, 2010, we entered into Amendment No. 1 to the Senior Secured Credit Facility, which permitted us to issue up to an additional $150.0 million in aggregate principal amount of new 10.875% Notes on or prior to March 1, 2010, as long as the net cash proceeds were used to make a voluntary prepayment of the term loans. In connection with this amendment, we incurred $1.1 million of arrangement and lender consent fees, which we expensed during the first quarter of 2010. On January 20, 2010, we issued $100.0 million of new 10.875% Notes, as described below, and made a $101.5 million voluntary prepayment of the term loans in accordance with the terms of Amendment No. 1 to the Senior Secured Credit Facility. In addition, pursuant to the excess cash flow provisions of the Senior Secured Credit Facility, as described below, we also made a $2.0 million prepayment of the term loans during March 2010. In connection with these prepayments, we accelerated $0.8 million of amortization of the then remaining unamortized original issue discount during the first quarter of 2010. Additionally, we recognized a non-cash loss of $1.9 million attributable to the write off of the then remaining unamortized debt issuance costs related to the portion of the term loans that were repaid.

 

As of October 2, 2010, the market value of our term loan facility was $898.0 million. We determine market value using trading prices for our term loan on or near that date.

 

Interest Rates.  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, as defined 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 initial applicable margin 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 our 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 7).

 

Fees.  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 with respect to the unutilized commitments thereunder. The current commitment fee rate is 0.50% per annum. The commitment fee rate may be reduced subject to our attaining certain leverage ratios. We must also pay customary letter of credit fees.

 

Principal Payments.  We are required to pay annual payments in equal quarterly installments on the term loan facility in an amount equal to 1.00% of the funded total principal amount through February 2014, with any remaining amount payable in full at maturity in May 2014.

 

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 to be agreed upon, 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 issuance or incurrence of debt by DJOFL and its restricted subsidiaries, other than proceeds from debt permitted to be incurred under the Senior Secured Credit Facility and related amendments. Any mandatory prepayments are applied to the term loan facility in direct order of maturity. We reinvested the net proceeds from our 2009 asset sales and, as such, our calculation of 2009 excess cash flows excluded those net proceeds. We may voluntarily prepay outstanding loans under the Senior Secured Credit Facility at any time without premium or penalty, provided that voluntary prepayments of Eurodollar loans made on a date other than the last day of an interest period applicable thereto shall be subject to customary breakage costs.

 

Guarantee and Security.  All obligations under the Senior Secured Credit Facility are unconditionally guaranteed by DJO Holdings LLC (DJO Holdings) and each existing and future direct and indirect wholly-owned domestic subsidiary of DJOFL other than immaterial subsidiaries, unrestricted subsidiaries and subsidiaries that are precluded by law or regulation from guaranteeing the obligations (collectively, the Guarantors).

 

All obligations under the Senior Secured Credit Facility, and the guarantees of those obligations, are secured by pledges of 100% of the capital stock of DJOFL, 100% of the capital stock of each wholly owned domestic subsidiary and 65% of the capital stock of each wholly owned foreign subsidiary that is, in each case, directly owned by DJOFL or one of the Guarantors; and a security interest in, and mortgages on, substantially all tangible and intangible assets of DJO Holdings, DJOFL and each Guarantor.

 

Certain Covenants and Events of Default.  The Senior Secured Credit Facility contains 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 other restricted payments,

·                  make investments, loans or advances,

 

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·                  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.

 

In addition, the Senior Secured Credit Facility requires us to maintain a maximum senior secured leverage ratio of 3.75:1 for the trailing twelve months ended October 2, 2010, stepping down to 3.25:1 beginning with the trailing twelve months ended December 31, 2011. The Senior Secured Credit Facility also contains certain customary affirmative covenants and events of default. As of October 2, 2010, our maximum senior secured leverage ratio was within the covenant level, and we were in compliance with all other applicable covenants.

 

10.875% Senior Notes

 

On November 20, 2007, DJOFL and DJO Finance Corporation (DJO Finco) (collectively, the Issuers) issued $575.0 million aggregate principal amount of 10.875% Senior Notes (the 10.875% Notes) due 2014, under an agreement dated as of November 20, 2007 (the 10.875% Indenture) among the Issuers, the guarantors party thereto and The Bank of New York Mellon (formerly known as The Bank of New York), as trustee.

 

On January 20, 2010, the Issuers issued $100.0 million aggregate principal amount of new 10.875% Notes, pursuant to the 10.875% Indenture that governs our existing 10.875% Notes due 2014. We issued the new 10.875% Notes at a 5.0% premium, resulting in gross proceeds of $105.0 million. We are amortizing the premium over the term of the new 10.875% Notes using the effective interest method, thereby decreasing the reported outstanding balance through the maturity date. Net proceeds from the issuance (excluding approximately $2.0 million of interest accrued from November 15, 2009 to January 19, 2010, which was included in the interest payment we made to holders of the new 10.875% Notes on May 15, 2010), along with cash on hand, were used to repay $101.5 million of existing term loans under the Senior Secured Credit Facility. The 10.875% Notes require semi-annual interest payments of approximately $36.7 million each May 15 and November 15 and are due November 15, 2014.

 

As of October 2, 2010, the market value of the 10.875% Notes was $730.7 million. We determine market value using trading prices for the 10.875% Notes on or near that date. We believe the trading prices as of October 2, 2010 reflect certain differences between prevailing market terms and conditions and the actual terms of our 10.875% Notes.

 

Optional Redemption.  Under the 10.875% Indenture, prior to November 15, 2011, the Issuers have the option to redeem some or all of the 10.875% Notes for cash at a redemption price equal to 100% of the then outstanding principal balance plus an applicable make-whole premium plus accrued and unpaid interest. Beginning on November 15, 2011, the Issuers may redeem some or all of the 10.875% Notes at a redemption price of 105.438% of the then outstanding principal balance plus accrued and unpaid interest. The redemption price decreases to 102.719% and 100% of the then outstanding principal balance at November 2012 and November 2013, respectively. Additionally, from time to time, before November 15, 2010, the Issuers may redeem up to 35% of the 10.875% Notes at a redemption price equal to 110.875% of the principal amount then outstanding, in each case, with proceeds we raise, or a direct or indirect parent company raises, in certain offerings of equity of DJOFL or its direct or indirect parent companies, as long as at least 65% of the aggregate principal amount of the notes issued remains outstanding.

 

Change of Control.  Upon the occurrence of a change of control, unless DJOFL has previously sent or concurrently sends a notice exercising its optional redemption rights with respect to all of the then-outstanding 10.875% Notes, DJOFL will be required to make an offer to repurchase all of the then-outstanding 10.875% Notes at 101% of their principal amount, plus accrued and unpaid interest.

 

Covenants.  The 10.875% Indenture contains covenants limiting, among other things, our and our restricted subsidiaries’ ability to incur additional indebtedness or issue certain preferred and convertible shares, pay dividends on, redeem, repurchase or make distributions in respect of the capital stock of DJO, or make other restricted payments, make certain investments, sell certain assets, 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 affiliates, and designate our subsidiaries as unrestricted subsidiaries. As of October 2, 2010, we were in compliance with all applicable covenants.

 

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11.75% Senior Subordinated Notes

 

The Issuers issued $200.0 million aggregate principal amount of 11.75% Senior Subordinated Notes in November 2006 (the 11.75% Notes). The 11.75% Notes required semi-annual interest payments of approximately $11.8 million each May 15 and November 15.

 

As of October 2, 2010, the market value of the 11.75% Notes was approximately $212.5 million. We determine market value using trading prices for the 11.75% Notes on or near that date.

 

The 11.75% Notes contained provisions similar to the 10.875% Notes with respect to change of control and covenant requirements. Under the Indenture governing the 11.75% Notes (the 11.75% Indenture), prior to November 15, 2010, the Issuers had the option to redeem some or all of the 11.75% Notes for cash at a redemption price equal to 100% of the then outstanding principal balance plus an applicable make-whole premium plus accrued and unpaid interest.

 

On October 18, 2010, we issued $300.0 million of new 9.75% Senior Subordinated Notes (9.75% Notes), and used a portion of the proceeds to repurchase $199.85 million aggregate principal amount of the 11.75% Notes for total consideration of $213.0 million plus $9.8 million of accrued interest through the settlement date. We intend to redeem the remaining $150,000 aggregate principal amount of the 11.75% Notes during November 2010 at a redemption price of 105.875% (see Note 18 for additional information).

 

Our ability to continue to meet the covenants related to our indebtedness specified above and in Note 18, in future periods will depend, in part, on events beyond our control, and we may not continue to meet those ratios. A breach of any of these covenants in the future could result in a default under the Senior Secured Credit Facility, the 10.875% Indenture, and the Indenture which governs the 9.75% Notes issued on October 18, 2010 (collectively, the Indentures), at which time the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facility to be immediately due and payable. Any such acceleration would also result in a default under the Indentures.

 

Debt Issuance Costs

 

As of October 2, 2010 and December 31, 2009, we had $34.8 million and $38.9 million, respectively, of unamortized debt issuance costs which were included in other non-current assets in our unaudited condensed consolidated balance sheets. We incurred $0.1 million, and $3.5 million of debt issuance costs which were capitalized, during the three and nine months ended October 2, 2010, respectively, in connection with the sale of the new 10.875% Notes and the registered exchange offer of the notes, which was completed in April 2010. For the three and nine months ended October 2, 2010, amortization of debt issuance costs was $1.7 million and $7.6 million, respectively. For the three and nine months ended September 26, 2009, amortization of debt issuance costs was $2.7 million and $8.4 million, respectively.

 

10.  INCOME TAXES

 

Income taxes for the interim periods presented have been included in our unaudited condensed consolidated financial statements on the basis of an estimated annual effective tax rate, adjusted for discrete items. The income tax benefit for these periods differed from the amount which would have been recorded using the U.S. statutory tax rate due primarily to the impact of nondeductible expenses, foreign taxes, deferred taxes on the assumed repatriation of foreign earnings, and the existence of valuation allowances in foreign jurisdictions.

 

For the three and nine months ended October 2, 2010, we recorded income tax benefits of approximately $3.2 million and $18.0 million, respectively, on pre-tax losses of approximately $10.7 million and $58.3 million, resulting in effective tax rates of 29.8% and 30.9%, respectively. For the three and nine months ended September 26, 2009, we recorded an income tax benefit of approximately $3.0 million and $19.9 million, respectively, on pre-tax losses of approximately $14.0 million and $57.9 million, respectively, resulting in effective tax rates of 20.8% and 34.3%, respectively.

 

We and our subsidiaries file income tax returns in the U.S. federal jurisdiction and various states and foreign jurisdictions. With few exceptions, we are no longer subject to U.S. federal, state and local, or non-U.S. income tax examinations by tax authorities for years before 2006. The Internal Revenue Service (IRS) completed its field examination of the 2005 and 2006 tax years during the first half of 2010. The IRS has proposed material adjustments related to transaction cost, stock option, and bad debt deductions included in our 2006 tax return. We intend to appeal each of the proposed adjustments vigorously through the IRS appeals process. However, should the IRS’ proposed adjustments be upheld in appeals, a material reduction in our currently unreserved net operating losses could result. At December 31, 2009, our gross unrecognized tax benefits were $19.1 million. For the nine months ended October 2, 2010, we increased our gross unrecognized tax benefits by $0.5 million. As of October 2, 2010, our total gross unrecognized tax benefits were $19.6 million, including a cumulative $2.1 million related to interest and penalties. There is a reasonable possibility that the closing of the IRS appeals process could result in a material reduction of our unrecognized tax benefits within the next twelve months. Due to the fact that the appeals process has not been finalized, the amount of the unrecognized tax benefits that may be reduced cannot be reasonably estimated. All unrecognized tax benefits will impact our effective tax rate upon recognition. We believe that it is reasonably possible that an increase of $0.4 million in unrecognized tax benefits related to various immaterial state exposures may be necessary within the next twelve months.

 

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11.  RESTRUCTURING AND RELATED CHARGES

 

In June 2009, we announced our plans to close our Chattanooga manufacturing and distribution facility, located in Hixson, Tennessee, and to integrate the operations of the Chattanooga site into our other existing sites. The transition of Chattanooga activities to our existing facilities was completed during the first half of 2010. A summary of the activity relating to the restructuring for the nine months ended October 2, 2010 is as follows (in thousands):

 

 

 

Severance &
Employee
Retention

 

Other

 

Total

 

Balance at December 31, 2009

 

4,049

 

405

 

4,454

 

Expensed during period

 

1,111

 

123

 

1,234

 

Payments made during period

 

(4,896

)

(502

)

(5,398

)

Adjustments to restructuring accrual

 

(130

)

(13

)

(143

)

Balance at October 2, 2010

 

$

134

 

$

13

 

$

147

 

 

Total severance and employee retention related expenses incurred to date as a result of the transition of our Chattanooga activities are $6.6 million, and are included in our unaudited condensed consolidated statements of operations. We do not expect to incur additional material severance and employee retention expenses in conjunction with the Chattanooga integration.

 

As a result of our integration of the operations of our Chattanooga division, we exited facilities in Hixson, and listed the buildings for sale during the first half of 2010.  Based on the current estimated fair market value of the buildings, we recorded an impairment charge of $1.1 million during the first half of 2010, which has been reflected as impairment of assets held for sale in our unaudited condensed consolidated statement of operations. The fair market value of the buildings held for sale is estimated to be approximately $2.8 million, and is included in other current assets in our unaudited condensed consolidated balance sheet at October 2, 2010.

 

12.  STOCK OPTION PLANS AND STOCK-BASED COMPENSATION

 

We have one active equity compensation plan, the DJO Incorporated 2007 Incentive Stock Plan (the 2007 Stock Option Plan), under which we are authorized to grant awards of stock, options, and other stock-based awards for up to 7,500,000 shares of Common Stock of our indirect parent, DJO Incorporated, subject to adjustment in certain events.

 

Options issued under the 2007 Stock Option Plan can be either incentive stock options or non-qualified stock options. The exercise price of stock options granted will not be less than 100% of the fair market value of the underlying shares on the date of grant, and will expire no more than ten years from the date of grant. We adopted a form of non-statutory stock option agreement (the DJO Form Option Agreement) for employee stock option awards under the 2007 Stock Option Plan. Under the DJO Form Option Agreement, one-third of stock options will vest over a specified period of time (typically five years) from the date of grant contingent solely upon the awardees’ continued employment with us (the Time-Based Tranche). As initially adopted, another one-third of stock options were to vest over a specified performance period (typically five years) from the date of grant upon the achievement of certain pre-determined annual performance targets based on Adjusted EBITDA and free cash flow, as defined (the Performance-Based Tranche). As amended in March 2009, the final one-third of stock options will vest based upon achieving a minimum internal rate of return (IRR) and a minimum return of money on invested capital (MOIC), as defined; each measured with respect to Blackstone’s aggregate investment in DJO Incorporated capital stock, to be achieved by Blackstone following a liquidation of all or a portion of its investment in DJO Incorporated capital stock (the Enhanced Market-Return Tranche).

 

In March 2010, the Compensation Committee approved further modifications to the terms of the outstanding options and the DJO Form Option Agreement. The vesting terms of the Time-Based Tranche and Enhanced Market-Return Tranche remain the same as discussed above. As modified, the financial performance targets for future years of the Performance-Based Tranche were replaced by new IRR and MOIC targets, similar to the Enhanced Market-Return Tranche, each measured with respect to Blackstone’s aggregate investment in DJO Incorporated capital stock, to be achieved by Blackstone following a liquidation of all or a portion of its investment in DJO Incorporated capital stock (referred to hereafter as the Market-Return Tranche). As a result of this modification, the Market-Return Tranche has both a performance component and a market condition component.

 

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Options granted under the 2007 Stock Option Plan contain change-in-control provisions that would result in accelerated vesting of the Time-Based Tranche upon the occurrence of a change-in-control. Specifically, the Time-Based Tranche would become immediately exercisable upon the occurrence of a change-in-control if the optionee remains in continuous employment of the Company until the consummation of the change-in-control. However, this change-in-control provision does not apply to the Market-Return or the Enhanced Market-Return Tranches.

 

During the three months ended October 2, 2010 we granted 107,500 stock options, including 5,000 to non-employee distributors, with a weighted average grant date fair value of $6.46 per share for the Time-Based Tranche, and an exercise price of $16.46 per share. We granted 138,150 stock options, including 24,000 to non-employee distributors, with a weighted average grant date fair value of $6.40 per share for the Time-Based Tranche, and an exercise price of $16.46 per share during the three months ended September 26, 2009.

 

During the nine months ended October 2, 2010 we granted 592,250 stock options, including 6,200 to non-employee distributors, with a weighted average grant date fair value of $6.66 per share for the Time-Based Tranche, and an exercise price of $16.46 per share. We granted 733,732 stock options, including 24,800 to non-employee distributors, with a weighted average grant date fair value of $6.31 per share for the Time-Based Tranche, and an exercise price of $16.46 per share during the nine months ended September 26, 2009.

 

The following table summarizes certain assumptions we used to estimate the fair value of the Time-Based Tranche of stock options granted during the periods presented:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

Expected volatility

 

34.3

%

34.7

%

34.2 – 34.5

%

34.4 – 34.7

%

Risk-free interest rate

 

2.0

%

2.8

%

2.0 - 3.0

%

2.3 – 2.8

%

Expected years until exercise

 

6.9

 

6.1

 

6.4 - 7.0

 

6.1 – 6.3

 

Expected dividend yield

 

0.0

%

0.0

%

0.0

%

0.0

%

 

We recorded non-cash stock-based compensation expense of $0.4 million and $1.3 million for the three and nine months ended October 2, 2010, respectively. We recorded non-cash compensation expense of $0.9 million and $2.3 million for the three and nine months ended September 26, 2009, respectively. For the each of the three and nine months periods ended October 2, 2010 and September 26, 2009, we only recognized non-cash compensation expense for options in the Time-Based Tranche, as the performance and market components of the Market-Return and Enhanced Market-Return Tranches are not deemed probable at this time.

 

13.  EQUITY

 

During the three and nine months ended October 2, 2010, DJO Incorporated sold 24,304 and 87,052 shares of its Common Stock, respectively, at $16.46 per share in an offering to certain accredited investors comprised of employees, directors and independent sales agents, subject to the execution of a stockholders agreement including certain rights and restrictions. Net proceeds from this offering during the three and nine months ended October 2, 2010 were approximately $0.4 million and $1.4 million, respectively. These proceeds were contributed by DJO Incorporated to us and have been included in member capital in our unaudited condensed consolidated balance sheet as of October 2, 2010. The proceeds will be used for working capital purposes.

 

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Comprehensive loss consists of the following for the periods presented (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(7,531

)

$

(11,280

)

$

(40,303

)

$

(38,399

)

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss), net of taxes:

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

6,723

 

5,499

 

(3,333

)

6,052

 

Unrealized losses on cash flow hedges

 

(1,066

)

(3,500

)

(4,640

)

(10,935

)

Reclassification adjustment for losses on cash flow hedges included in net loss

 

1,819

 

3,046

 

5,591

 

7,691

 

Other comprehensive income (loss)

 

7,476

 

5,045

 

(2,382

)

2,808

 

Comprehensive loss

 

(55

)

(6,235

)

(42,685

)

(35,591

)

Comprehensive income attributable to noncontrolling interests

 

(444

)

(186

)

(796

)

(472

)

Comprehensive loss attributable to DJO Finance LLC

 

$

(499

)

$

(6,421

)

$

(43,481

)

$

(36,063

)

 

14.  RELATED PARTY TRANSACTIONS

 

Blackstone Management Partners V L.L.C. (BMP), an affiliate of our major shareholder, provides certain monitoring, advisory and consulting services to us for an annual monitoring fee equal to the greater of $7.0 million or 2% of consolidated EBITDA as defined in the Transaction and Monitoring Fee Agreement, payable in the first quarter of each year. The monitoring fee agreement will continue until the earlier of November 2019, or such date as DJOFL and BMP may mutually determine. DJOFL has agreed to indemnify BMP and its affiliates, directors, officers, employees, agents and representatives from and against all liabilities relating to the services contemplated by the Transaction and Monitoring Fee Agreement and the engagement of BMP pursuant to, and the performance of BMP and its affiliates of the services contemplated by, the Transaction and Monitoring Fee Agreement. At any time in connection with or in anticipation of a change of control of DJOFL, a sale of all or substantially all of DJOFL’s assets or an initial public offering of common stock of DJOFL, BMP may elect to receive, in lieu of remaining annual monitoring fee payments, a single lump sum cash payment equal to the then-present value of all then-current and future annual monitoring fees payable under the Transaction and Monitoring Fee Agreement, assuming a hypothetical termination date of the agreement to be November 2019. For each of the three and nine month periods presented, we recognized $1.75 million and $5.25 million, respectively, related to the annual monitoring fee, which is recorded as a component of SG&A expense in our unaudited condensed consolidated statements of operations.

 

15.  COMMITMENTS AND CONTINGENCIES

 

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.

 

We are currently named as one of several defendants in approximately 100 product liability cases, including a lawsuit in Canada seeking class action status, related to a disposable drug infusion pump (pain pump) product manufactured by two third party manufacturers that we distributed through our Bracing and Supports 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. These lawsuits are about equally divided between the two manufacturers. Both manufacturers have rejected our tenders of indemnity. Until early 2010, the base policy for one of the manufacturers was paying for our defense, but that policy has been exhausted by defense costs of the Company and the manufacturer and by settlements, and a second policy has been significantly eroded by defense costs of the Company and the manufacturer and is expected to be exhausted by

 

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Table of Contents

 

settlements in the near future. This manufacturer has ceased operations, has little assets and no additional insurance coverage. The Company has asserted indemnification rights against the successor to this manufacturer and intends to pursue its claims appropriately. The base policy for the other manufacturer has been exhausted and the excess liability carriers for that manufacturer have not accepted coverage for the Company, and are not expected to provide for its defense. The Company and this manufacturer have been cooperating in jointly negotiating settlements of those lawsuits in which both parties are named. Our products liability carriers have 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. In August 2010, one of our excess carriers for the period ending July 1, 2010 and for the supplemental extended reporting period (SERP) discussed below, which is insuring $10 million in excess of $25 million, informed us that it has reserved its right to rescind the policy based on an alleged failure by us and our insurance broker to disclose material information. We disagree with this allegation and are seeking to resolve the issue with this carrier. The lawsuits allege damages ranging from unspecified amounts to claims between $1.0 million and $10.0 million. 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 unavailable or insufficient to pay the defense costs and settlements or judgments in these cases.

 

In mid-2010, we were named in three multi-plaintiff lawsuits alleging that the plaintiffs had been injured following use of certain cold therapy products manufactured by the Company. These lawsuits are in their early stages and were brought by 16, 11 and 19 plaintiffs, respectively. The complaints are not specific as to the nature of the injuries, but allege various product liability theories, including inadequate warnings regarding the risks associated with the use of cold therapy and failure to incorporate certain safety features into the design. No specific dollar amounts of damages are alleged. We could be exposed to material liabilities if our insurance coverage is not available or inadequate to pay the defense costs and settlements or judgments in these cases.

 

On August 2, 2010, we were served with a subpoena under the Health Insurance Portability and Accountability Act (HIPAA) seeking numerous documents related to our activities involving the pain pumps discussed above. The subpoena which was issued by the United States Attorney’s Office, Central District of California, refers to an official investigation by the U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) of Federal healthcare offenses. We are producing documents that are responsive to the subpoena. We believe that our actions related to our prior distribution of these pain pumps have been in compliance with applicable legal standards. We can make no assurance as to the resources that will be needed to respond to the subpoena or the final outcome of any investigation or further action.

 

We maintain product liability insurance that is subject to annual renewal. Our current policy covers claims reported between July 1, 2010 and June 30, 2011. No carriers were prepared to cover claims for this reporting period related to the pain pump products described above and therefore our current policies exclude coverage for those products. For the current policy year, we maintain coverage limits (together with excess policies) of up to $50 million, with self-insured retentions of $500,000 per claim for claims relating to our cold therapy units, $500,000 per claim for claims relating to invasive products, $75,000 per claim for claims relating to non-invasive products other than our cold therapy products, and an aggregate self-insured retention of $2.25 million. We purchased SERP coverage for our $80 million limit product liability program that expired on June 30, 2010, and this supplemental coverage is limited to pain pump claims. Except for the additional excess coverage mentioned below, this SERP coverage does not provide additional limits to the aggregate $80 million limit on the expiring program but does provide that the existing limits of the expiring program will remain available for claims reported for an extended period of time. Specifically, pain pump claims may be reported under the $10 million base policy for an indefinite period of time and for a period of five years under the excess layers. We also purchased additional coverage of $25 million excess of $80 million with a five year reporting period. Thus, the SERP coverage has a total limit of $105 million (less amounts paid for claims reported under the expiring program). This coverage is subject to a self-insured retention of $500,000 per claim for claims related to pain pumps, with an aggregate self-insured retention of $1.0 million for all product liability claims under either the expiring program or the SERP program. In addition, the layer of $25 million excess over $55 million has a separate self-insured retention of $50,000 per claim. Our two product liability programs prior to the program that expired on June 30, 2010 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 as well as the expiring program.

 

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. Our condensed consolidated balance sheets as of October 2, 2010 (unaudited) and December 31, 2009, include accrued liabilities of approximately $1.7 million and $2.0 million, respectively, for expenses related to products liability claims for products other than our pain pump products. The amounts accrued are based upon previous claims 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.

 

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Table of Contents

 

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. The relator filed a second amended complaint in May 2010 that, among other things, dropped The Blackstone Group as a defendant. We have filed another motion to dismiss directed at the second amended complaint. 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 we 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 of such action.

 

16. SEGMENT AND GEOGRAPHIC INFORMATION

 

We provide a broad array of orthopedic rehabilitation and regeneration products, as well as surgical implants to customers in the United States and abroad. In the second quarter of 2010, we changed how we report our segment financial information to senior management. Prior to the second quarter of 2010, our Bracing and Supports and Recovery Sciences businesses were reported together within the Domestic Rehabilitation Segment. During the second quarter, as a result of our recent sales and marketing leadership reorganization, these businesses are now separately evaluated and managed. Segment information for all periods presented has been restated to reflect this change. We currently develop, manufacture and distribute our products through the following four operating segments:

 

Bracing and Supports Segment

 

Our Bracing and Supports Segment, which generates its revenues in the United States, offers our DonJoy, ProCare and Aircast products, including rigid knee bracing, orthopedic soft goods, cold therapy products, and vascular systems. This segment 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.

 

Recovery Sciences Segment

 

Our Recovery Sciences Segment, which generates its revenues in the United States, is divided into four main businesses:

 

·                  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 primarily 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 consumers ranging from fitness enthusiasts to competitive athletes our Compex electrostimulation device, which is used in athletic training programs to aid muscle development and to accelerate muscle recovery after training sessions.

 

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Table of Contents

 

Surgical Implant Segment

 

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

 

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.

 

Information regarding our reportable business segments is presented below (in thousands). Segment results exclude the impact of certain general corporate expenses and charges related to various integration activities, as defined. All prior periods presented have been restated to reflect our current reportable segments.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

Net sales:

 

 

 

 

 

 

 

 

 

Bracing and Supports

 

$

78,156

 

$

76,388

 

$

232,087

 

$

219,224

 

Recovery Sciences

 

85,884

 

85,794

 

257,361

 

249,767

 

Surgical Implant

 

14,559

 

15,416

 

46,735

 

47,097

 

International

 

54,960

 

58,588

 

179,979

 

172,863

 

 

 

$

233,559

 

$

236,186

 

$

716,162

 

$

688,951

 

 

 

 

 

 

 

 

 

 

 

Gross profit:

 

 

 

 

 

 

 

 

 

Bracing and Supports

 

$

42,521

 

$

44,146

 

$

127,865

 

$

122,748

 

Recovery Sciences

 

66,753

 

64,377

 

195,773

 

188,162

 

Surgical Implant

 

10,258

 

11,779

 

34,533

 

36,541

 

International

 

30,697

 

32,434

 

106,097

 

98,645

 

Expenses not allocated to segments and eliminations

 

(817

)

(2,589

)

(4,172

)

(4,340

)

 

 

$

149,412

 

$

150,147

 

$

460,096

 

$

441,756

 

 

 

 

 

 

 

 

 

 

 

Operating income:

 

 

 

 

 

 

 

 

 

Bracing and Supports

 

$

17,188

 

$

20,687

 

$

50,428

 

$

51,577

 

Recovery Sciences

 

30,962

 

27,715

 

85,441

 

75,962

 

Surgical Implant

 

401

 

2,805

 

4,545

 

8,982

 

International

 

9,752

 

10,625

 

40,787

 

33,556

 

Expenses not allocated to segments and eliminations

 

(36,858

)

(38,274

)

(126,216

)

(114,382

)

 

 

$

21,445

 

$

23,558

 

$

54,985

 

$

55,695

 

 

The accounting policies of the reportable segments are the same as the accounting policies of the Company. We allocate resources and evaluate the performance of segments based on net sales, gross profit, operating income and other non-GAAP measures as defined. We do not allocate assets to reportable segments because a significant portion of our assets are shared by segments.

 

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Table of Contents

 

Geographic Area

 

Following are our net sales by geographic area, based on location of customer (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

Net sales:

 

 

 

 

 

 

 

 

 

United States

 

$

185,530

 

$

177,598

 

$

533,274

 

$

516,088

 

Germany

 

15,998

 

18,612

 

55,319

 

53,312

 

Other Europe, Middle East and Africa

 

16,623

 

25,528

 

68,225

 

81,174

 

Asia Pacific

 

3,764

 

3,429

 

16,911

 

10,277

 

Other

 

11,644

 

11,019

 

42,433

 

28,100

 

 

 

$

233,559

 

$

236,186

 

$

716,162

 

$

688,951

 

 

17.  SUPPLEMENTAL GUARANTOR CONDENSED CONSOLIDATING FINANCIAL STATEMENTS

 

DJOFL and its direct wholly-owned subsidiary, DJO Finco, issued the 10.875% Notes with aggregate principal amounts of $575.0 million and $100.0 million on November 20, 2007 and January 20, 2010, respectively. On November 3, 2006, DJOFL and DJO Finco issued the 11.75% Notes with an aggregate principal amount of $200.0 million. DJO Finco was formed solely to act as a co-issuer of the notes, has only nominal assets and does not conduct any operations. The Indentures generally prohibit DJO Finco from holding any assets, becoming liable for any obligations, or engaging in any business activity. The 10.875% Notes are jointly and severally, fully and unconditionally guaranteed, on an unsecured senior basis by all of the DJOFL’s domestic subsidiaries (other than DJO Finco) that are 100% owned, directly or indirectly, by DJOFL (the Guarantors). The 11.75% Notes, redeemed in October 2010 upon issuance of our 9.75% Notes (see Note 18), were jointly and severally, fully and unconditionally guaranteed, on an unsecured senior subordinated basis by the Guarantors. Our foreign subsidiaries (the Non-Guarantors) do not guarantee these notes. The Guarantors also unconditionally guarantee the Senior Secured Credit Facility.

 

The following tables present the financial position, results of operations and cash flows of DJOFL, the Guarantors, the Non-Guarantors and certain eliminations for the periods presented.

 

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Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Balance Sheets

As of October 2, 2010

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non —
Guarantors

 

Eliminations

 

Consolidated

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

7,442

 

$

22,802

 

$

20,000

 

$

 

$

50,244

 

Accounts receivable, net

 

 

110,067

 

31,507

 

90

 

141,664

 

Inventories, net

 

 

90,925

 

27,308

 

(9,345

)

108,888

 

Deferred tax assets, net

 

 

35,472

 

4,226

 

(146

)

39,552

 

Prepaid expenses and other current assets

 

29

 

20,594

 

2,972

 

2,626

 

26,221

 

Total current assets

 

7,471

 

279,860

 

86,013

 

(6,775

)

366,569

 

Property and equipment, net

 

 

75,062

 

13,665

 

(4,861

)

83,866

 

Goodwill

 

 

1,108,702

 

112,437

 

(30,445

)

1,190,694

 

Intangible assets, net

 

 

1,092,720

 

36,937

 

1,121

 

1,130,778

 

Investment in subsidiaries

 

1,297,701

 

1,660,184

 

69,621

 

(3,027,506

)

 

Intercompany receivables

 

1,026,793

 

 

 

(1,026,793

)

 

Other non-current assets

 

34,827

 

530

 

2,010

 

37

 

37,404

 

Total assets

 

$

2,366,792

 

$

4,217,058

 

$

320,683

 

$

(4,095,222

)

$

2,809,311

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

 

$

46,747

 

$

6,011

 

$

278

 

$

53,036

 

Current portion of debt and capital lease obligations

 

9,594

 

40

 

 

 

9,634

 

Other current liabilities

 

44,849

 

54,196

 

20,719

 

2,638

 

122,402

 

Total current liabilities

 

54,443

 

100,983

 

26,730

 

2,916

 

185,072

 

Long-term debt and capital lease obligations

 

1,795,702

 

52

 

 

 

1,795,754

 

Deferred tax liabilities, net

 

 

283,187

 

14,819

 

 

298,006

 

Intercompany payables, net

 

 

894,280

 

132,513

 

(1,026,793

)

 

Other long-term liabilities

 

1,570

 

9,558

 

1,526

 

 

12,654

 

Total liabilities

 

1,851,715

 

1,288,060

 

175,588

 

(1,023,877

)

2,291,486

 

Noncontrolling interests

 

 

 

2,748

 

 

2,748

 

Total membership equity

 

515,077

 

2,928,998

 

142,347

 

(3,071,345

)

515,077

 

Total liabilities and equity

 

$

2,366,792

 

$

4,217,058

 

$

320,683

 

$

(4,095,222

)

$

2,809,311

 

 

21



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Statements of Operations

For the Three Months Ended October 2, 2010

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

 

$

201,837

 

$

43,453

 

$

(11,731

)

$

233,559

 

Cost of sales (exclusive of amortization of intangible assets of $9,230)

 

 

71,429

 

23,654

 

(10,936

)

84,147

 

Gross profit

 

 

130,408

 

19,799

 

(795

)

149,412

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

83,231

 

19,391

 

50

 

102,672

 

Research and development

 

 

4,870

 

1,022

 

 

5,892

 

Amortization of intangible assets

 

 

18,436

 

960

 

7

 

19,403

 

 

 

 

106,537

 

21,373

 

57

 

127,967

 

Operating income (loss)

 

 

23,871

 

(1,574

)

(852

)

21,445

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(37,160

)

(10,702

)

(886

)

11,508

 

(37,240

)

Interest income

 

6,922

 

4,531

 

147

 

(11,508

)

92

 

Other income, net

 

22,523

 

2,647

 

2,327

 

(22,516

)

4,981

 

 

 

(7,715

)

(3,524

)

1,588

 

(22,516

)

(32,167

)

Income (loss) before income taxes

 

(7,715

)

20,347

 

14

 

(23,368

)

(10,722

)

Income tax benefit (expense)

 

 

3,589

 

(398

)

 

3,191

 

Net income (loss)

 

(7,715

)

23,936

 

(384

)

(23,368

)

(7,531

)

Net income attributable to noncontrolling interests

 

 

 

(184

)

 

(184

)

Net income (loss) attributable to DJO Finance LLC

 

$

(7,715

)

$

23,936

 

$

(568

)

$

(23,368

)

$

(7,715

)

 

22



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Statements of Operations

For the Nine Months Ended October 2, 2010

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

 

$

617,701

 

$

146,567

 

$

(48,106

)

$

716,162

 

Cost of sales (exclusive of amortization of intangible assets of $27,211)

 

 

229,725

 

74,622

 

(48,281

)

256,066

 

Gross profit

 

 

387,976

 

71,945

 

175

 

460,096

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

269,378

 

59,485

 

50

 

328,913

 

Research and development

 

 

14,144

 

2,779

 

 

16,923

 

Amortization of intangible assets

 

 

55,229

 

2,892

 

7

 

58,128

 

Impairment of assets held for sale

 

 

1,147

 

 

 

1,147

 

 

 

 

 

339,898

 

65,156

 

57

 

405,111

 

Operating income

 

 

48,078

 

6,789

 

118

 

54,985

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(114,626

)

(31,953

)

(2,682

)

34,394

 

(114,867

)

Interest income

 

26,877

 

7,304

 

445

 

(34,394

)

232

 

Other income (expense), net

 

46,619

 

(18,178

)

(615

)

(26,462

)

1,364

 

 

 

(41,130

)

(42,827

)

(2,852

)

(26,462

)

(113,271

)

Income (loss) before income taxes

 

(41,130

)

5,251

 

3,937

 

(26,344

)

(58,286

)

Income tax benefit (expense)

 

 

20,668

 

(2,685

)

 

17,983

 

Net income (loss)

 

(41,130

)

25,919

 

1,252

 

(26,344

)

(40,303

)

Net income attributable to noncontrolling interests

 

 

 

(827

)

 

(827

)

Net income (loss) attributable to DJO Finance LLC

 

$

(41,130

)

$

25,919

 

$

425

 

$

(26,344

)

$

(41,130

)

 

23



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Statements of Cash Flows

For the Nine Months Ended October 2, 2010

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(41,130

)

$

25,919

 

$

1,252

 

$

(26,344

)

$

(40,303

)

 

 

 

 

 

 

 

 

 

 

 

 

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

 

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

16,131

 

3,559

 

(64

)

19,626

 

Amortization of intangible assets

 

 

55,228

 

2,893

 

7

 

58,128

 

Amortization of debt issuance costs and non-cash interest expense

 

9,137

 

 

 

 

9,137

 

Stock-based compensation expense

 

 

1,309

 

 

 

1,309

 

Loss on disposal of assets, net

 

 

720

 

423

 

(304

)

839

 

Deferred income tax benefit (expense)

 

 

(79,209

)

57,792

 

 

(21,417

)

Non-cash income (loss) from subsidiaries

 

(43,854

)

512,494

 

20,880

 

(489,520

)

 

Provision for doubtful accounts and sales returns

 

 

24,987

 

562

 

 

25,549

 

Inventory reserves

 

 

3,980

 

622

 

 

4,602

 

Impairment of assets held for sale

 

 

1,147

 

 

 

1,147

 

 

 

 

 

 

 

 

 

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(22,130

)

789

 

(87

)

(21,428

)

Inventories

 

 

(10,322

)

(4,417

)

(2,713

)

(17,452

)

Prepaid expenses and other assets

 

132

 

13,933

 

(24,033

)

(2,625

)

(12,593

)

Accounts payable and other current liabilities

 

25,205

 

5,996

 

641

 

2,646

 

34,488

 

Net cash provided by (used in) operating activities

 

(50,510

)

550,183

 

60,963

 

(519,004

)

41,632

 

 

 

 

 

 

 

 

 

 

 

 

 

INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(18,991

)

(3,854

)

2,568

 

(20,277

)

Cash paid in connection with acquisitions, net of cash acquired

 

 

(810

)

 

(1,235

)

(2,045

)

Other investing activities, net

 

 

531

 

(1,248

)

 

(717

)

Net cash used in investing activities

 

 

(19,270

)

(5,102

)

1,333

 

(23,039

)

 

 

 

 

 

 

 

 

 

 

 

 

FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Intercompany

 

60,102

 

(524,172

)

(53,601

)

517,671

 

 

Proceeds from issuance of debt

 

127,000

 

 

130

 

 

127,130

 

Repayments of debt and capital lease obligations

 

(132,695

)

(2,717

)

(749

)

 

(136,161

)

Payment of debt issuance costs

 

(3,454

)

 

 

 

(3,454

)

Investment by parent

 

 

1,389

 

 

 

1,389

 

Dividend paid by subsidiary to owners of noncontrolling interests

 

 

 

(557

)

 

(557

)

Net cash provided by (used in) financing activities

 

50,953

 

(525,500

)

(54,777

)

517,671

 

(11,653

)

Effect of exchange rate changes on cash and cash equivalents

 

 

 

(1,307

)

 

(1,307

)

Net increase (decrease) in cash and cash equivalents

 

443

 

5,413

 

(223

)

 

5,633

 

Cash and cash equivalents at beginning of period

 

6,999

 

17,389

 

20,223

 

 

44,611

 

Cash and cash equivalents at end of period

 

$

7,442

 

$

22,802

 

$

20,000

 

$

 

$

50,244

 

 

24



Table of Contents

 

DJO Finance LLC

Condensed Consolidating Balance Sheets

As of December 31, 2009

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

Assets

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

6,999

 

$

17,389

 

$

20,223

 

$

 

$

44,611

 

Accounts receivable, net

 

 

113,258

 

32,954

 

 

146,212

 

Inventories, net

 

 

80,491

 

23,705

 

(8,316

)

95,880

 

Deferred tax assets, net

 

 

40,474

 

993

 

(1,019

)

40,448

 

Prepaid expenses and other current assets

 

162

 

11,368

 

3,195

 

 

14,725

 

Total current assets

 

7,161

 

262,980

 

81,070

 

(9,335

)

341,876

 

Property and equipment, net

 

 

76,883

 

12,811

 

(2,980

)

86,714

 

Goodwill

 

 

1,108,703

 

82,794

 

 

1,191,497

 

Intangible assets, net

 

 

1,147,504

 

40,173

 

 

1,187,677

 

Investment in subsidiaries

 

1,275,652

 

2,362,165

 

71,566

 

(3,709,383

)

 

Intercompany receivables

 

1,065,693

 

 

 

(1,065,693

)

 

Other non-current assets

 

38,946

 

(1,913

)

5,382

 

 

42,415

 

Total assets

 

$

2,387,452

 

$

4,956,322

 

$

293,796

 

$

(4,787,391

)

$

2,850,179

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and Equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

 

$

34,750

 

$

7,393

 

$

1

 

$

42,144

 

Current portion of debt and capital lease obligations

 

12,568

 

140

 

3,218

 

 

15,926

 

Other current liabilities

 

22,165

 

60,992

 

18,419

 

 

101,576

 

Total current liabilities

 

34,733

 

95,882

 

29,030

 

1

 

159,646

 

Long-term debt and capital lease obligations

 

1,796,859

 

83

 

2

 

 

1,796,944

 

Deferred tax liabilities, net

 

 

302,870

 

15,272

 

2,989

 

321,131

 

Intercompany payables, net

 

 

960,790

 

104,903

 

(1,065,693

)

 

Other non-current liabilities

 

 

11,162

 

2,927

 

 

14,089

 

Total liabilities

 

1,831,592

 

1,370,787

 

152,134

 

(1,062,703

)

2,291,810

 

Noncontrolling interests

 

 

 

2,509

 

 

2,509

 

Total membership equity

 

555,860

 

3,585,535

 

139,153

 

(3,724,688

)

555,860

 

Total liabilities and equity

 

$

2,387,452

 

$

4,956,322

 

$

293,796

 

$

(4,787,391

)

$

2,850,179

 

 

25



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Statements of Operations

For the Three Months Ended September 26, 2009

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

Net sales

 

$

 

$

208,258

 

$

63,491

 

$

(35,563

)

$

236,186

 

Cost of sales (exclusive of amortization of intangible assets of $9,495)

 

 

74,148

 

42,564

 

(30,673

)

86,039

 

Gross profit

 

 

134,110

 

20,927

 

(4,890

)

150,147

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

82,853

 

18,560

 

 

101,413

 

Research and development

 

 

5,049

 

567

 

 

5,616

 

Amortization of intangible assets

 

 

18,639

 

921

 

 

19,560

 

 

 

 

106,541

 

20,048

 

 

126,589

 

Operating income

 

 

27,569

 

879

 

(4,890

)

23,558

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(38,978

)

(4,370

)

(885

)

5,060

 

(39,173

)

Interest income

 

4,351

 

753

 

175

 

(5,068

)

211

 

Other income (expense), net

 

23,253

 

(56,348

)

1,418

 

33,099

 

1,422

 

 

 

(11,374

)

(59,965

)

708

 

33,091

 

(37,540

)

Income (loss) from continuing operations before income taxes

 

(11,374

)

(32,396

)

1,587

 

28,201

 

(13,982

)

Income tax benefit (expense)

 

 

3,895

 

(926

)

 

2,969

 

Loss from discontinued operations, net

 

 

(267

)

 

 

(267

)

Net income (loss)

 

(11,374

)

(28,768

)

661

 

28,201

 

(11,280

)

Net income attributable to noncontrolling interests

 

 

 

(94

)

 

(94

)

Net income (loss) attributable to DJO Finance LLC

 

$

(11,374

)

$

(28,768

)

$

567

 

$

28,201

 

$

(11,374

)

 

26



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Statements of Operations

For the Nine Months Ended September 26, 2009

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

Net sales

 

$

 

$

589,554

 

$

192,241

 

$

(92,844

)

$

688,951

 

Cost of sales (exclusive of amortization of intangible assets of $28,499)

 

 

212,781

 

126,963

 

(92,549

)

247,195

 

Gross profit

 

 

376,773

 

65,278

 

(295

)

441,756

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

252,494

 

58,124

 

 

310,618

 

Research and development

 

 

15,539

 

2,042

 

 

17,581

 

Amortization of intangible assets

 

 

55,917

 

1,945

 

 

57,862

 

 

 

 

323,950

 

62,111

 

 

386,061

 

Operating income

 

 

52,823

 

3,167

 

(295

)

55,695

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(116,818

)

(13,835

)

(2,489

)

15,823

 

(117,319

)

Interest income

 

13,737

 

2,190

 

656

 

(15,834

)

749

 

Other income (expense), net

 

64,314

 

(47,719

)

1,860

 

(15,446

)

3,009

 

 

 

(38,767

)

(59,364

)

27

 

(15,457

)

(113,561

)

Income (loss) from continuing operations before income taxes

 

(38,767

)

(6,541

)

3,194

 

(15,752

)

(57,866

)

Income tax benefit (expense)

 

 

21,385

 

(1,484

)

 

19,901

 

Loss from discontinued operations, net

 

 

(434

)

 

 

(434

)

Net income (loss)

 

(38,767

)

14,410

 

1,710

 

(15,752

)

(38,399

)

Net income attributable to noncontrolling interests

 

 

 

(368

)

 

(368

)

Net income (loss) attributable to DJO Finance LLC

 

$

(38,767

)

$

14,410

 

$

1,342

 

$

(15,752

)

$

(38,767

)

 

27



Table of Contents

 

DJO Finance LLC

Unaudited Condensed Consolidating Statements of Cash Flows

For the Nine Months Ended September 26, 2009

(in thousands)

 

 

 

DJOFL

 

Guarantors

 

Non-
Guarantors

 

Eliminations

 

Consolidated

 

OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(38,767

)

$

14,410

 

$

1,710

 

$

(15,752

)

$

(38,399

)

 

 

 

 

 

 

 

 

 

 

 

 

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

 

 

 

 

 

 

 

 

 

 

 

Depreciation

 

 

17,253

 

3,711

 

(392

)

20,572

 

Amortization of intangible assets

 

 

55,917

 

1,945

 

 

57,862

 

Amortization of debt issuance costs and non-cash interest expense

 

9,597

 

 

 

 

9,597

 

Stock-based compensation expense

 

 

2,335

 

 

 

2,335

 

Loss on disposal of assets, net

 

 

270

 

270

 

(75

)

465

 

Gain on disposal of discontinued operations

 

 

(496

)

 

 

(393

)

Deferred income tax benefit

 

 

(24,012

)

(711

)

2,149

 

(22,574

)

Non-cash income (loss) from subsidiaries

 

(64,314

)

86,249

 

 

(21,935

)

 

Provision for doubtful accounts and sales returns

 

 

24,728

 

705

 

 

25,433

 

Inventory reserves

 

 

5,449

 

847

 

 

6,296

 

 

 

 

 

 

 

 

 

 

 

 

 

Changes in operating assets and liabilities, net of acquired assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(18,154

)

(1,269

)

 

(19,423

)

Inventories

 

 

(3,404

)

(1,762

)

4,002

 

(1,164

)

Prepaid expenses and other assets

 

273

 

(4,826

)

4,855

 

(338

)

(36

)

Accounts payable and other current liabilities

 

31,190

 

(8,856

)

(591

)

253

 

21,996

 

Net cash provided by (used in) operating activities

 

(62,021

)

146,863

 

9,710

 

(31,985

)

62,567

 

 

 

 

 

 

 

 

 

 

 

 

 

INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(15,558

)

(4,129

)

554

 

(19,133

)

Cash paid in connection with acquisitions, net of cash acquired

 

 

(2,417

)

(10,429

)

 

(12,846

)

Proceeds received upon disposition of discontinued operations, net

 

 

21,846

 

 

 

21,846

 

Other investing activities, net

 

 

(25

)

(51

)

 

(76

)

Net cash provided by (used in) investing activities

 

 

3,846

 

(14,609

)

554

 

(10,209

)

 

 

 

 

 

 

 

 

 

 

 

 

FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Intercompany

 

94,878

 

(136,731

)

10,422

 

31,431

 

 

Proceeds from issuance of debt and revolving line of credit

 

65,000

 

(3

)

176

 

 

65,173

 

Repayments of debt and capital lease obligations

 

(94,325

)

(26

)

(483

)

 

(94,834

)

Net cash provided by (used in) financing activities

 

65,553

 

(136,760

)

10,115

 

31,431

 

(29,661

)

Effect of exchange rate changes on cash and cash equivalents

 

 

 

(1,901

)

 

(1,901

)

Net increase in cash and cash equivalents

 

3,532

 

13,949

 

3,315

 

 

20,796

 

Cash and cash equivalents at beginning of period

 

 

14,373

 

16,110

 

 

30,483

 

Cash and cash equivalents at end of period

 

$

3,532

 

$

28,322

 

$

19,425

 

$

 

$

51,279

 

 

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18.  SUBSEQUENT EVENTS

 

On October 1, 2010, we commenced a cash tender offer for any and all of our $200 million of outstanding 11.75% Notes (see Note 9) due 2014 with a final tender expiration date of October 29, 2010. The total tender offer consideration of $1,065 for each $1,000 principal amount of 11.75% Notes validly tendered included an early tender premium of $30 per $1,000 principal amount of 11.75% Notes validly tendered by October 15, 2010. In addition, holders who validly tendered their 11.75% Notes were entitled to receive accrued interest from and including the last interest payment date through the applicable settlement date.

 

On October 5, 2010, we entered into Amendment No. 2 to the Senior Secured Credit Facility, which permitted us to (1) issue $300.0 million in aggregate principal amount of new subordinated notes to be co-issued by DJOFL and DJO Finco; (2) use the proceeds from the offering to repurchase or redeem all of our existing 11.75% Notes due 2014; (3) prepay a portion of the term loans under our Senior Secured Credit Facility; and (4) pay related premiums, fees and expenses, all without utilizing existing debt incurrence capacity under our Senior Secured Credit Facility. In connection with this amendment, we incurred $0.7 million of fees and expenses, which will be expensed during the fourth quarter of 2010.

 

On October 18, 2010, we issued $300.0 million aggregate principal amount of new 9.75% Senior Subordinated Notes (9.75% Notes) maturing on October 15, 2017, realizing net proceeds of $293.2 million after deducting $6.8 million of debt issuance costs, which were capitalized and will be amortized using the effective interest method through the maturity data. Semi-annual interest of approximately $14.6 million, related to the 9.75% Notes will be payable in cash on April 15 and October 15 of each year, commencing on April 15, 2011, and will accrue from and including October 18, 2010. The 9.75% Notes are guaranteed jointly and severally and on an unsecured senior basis by each of DJOFL’s existing and future direct and indirect wholly owned domestic subsidiaries that guarantee any of DJOFL’s indebtedness or any indebtedness of DJOFL’s domestic subsidiaries or is an obligor under DJOFL’s Senior Secured Credit Facility.

 

On October 18, 2010, we used a portion of the proceeds from the issuance of the 9.75% Notes to repurchase $199.85 million aggregate principal amount of our 11.75% Notes for total consideration of $222.8 million, which includes applicable premiums and accrued interest from the last interest payment date to the settlement date. We intend to redeem the remaining $150,000 aggregate principal amount of the 11.75% Notes, and expect to do so during November 2010, at a redemption price of 105.875%. In connection with the repayment of the 11.75% Notes we incurred $0.6 million of fees, which will be expensed during the fourth quarter of 2010.

 

During October 2010, we prepaid a total $79.0 million of term loans under our Senior Secured Credit Facility. In connection with this prepayment, during the fourth quarter we expect to (1) accelerate $0.6 million of amortization of the unamortized original issue discount as of the prepayment date and (2) recognize a non-cash loss of $1.2 million attributable to the write off of unamortized debt issuance costs as of the prepayment date relating to the portion of the term loans that were repaid.

 

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Table of Contents

 

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

 

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 unaudited condensed consolidated financial statements and related notes thereto as well as the other financial data included elsewhere in this Form 10-Q.

 

Forward Looking Statements

 

The following management’s discussion and analysis contains “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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. The section entitled “Risk Factors” in Part II, Item 1A of this report and in our 2009 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 5, 2010, describes these and other important risk factors that may affect our business, financial condition, results of operations, and/or liquidity. Results actually achieved may differ materially from expected results included in these statements as a result of these or other factors.

 

Overview of Business

 

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

 

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 the three and nine month periods ended September 26, 2009 have been presented as discontinued operations in our unaudited condensed consolidated financial statements.

 

We provide a broad array of orthopedic rehabilitation and regeneration products, as well as surgical implants to customers in the United States and abroad. In the second quarter of 2010, we changed how we report financial information to senior management. Prior to the second quarter of 2010, our Bracing and Supports and Recovery Sciences businesses were reported together within the Domestic Rehabilitation Segment. During the second quarter, as a result of our recent sales and marketing leadership reorganization, these businesses are now separately evaluated and managed. Segment information for all periods presented has been restated to reflect this change. We currently develop, manufacture and distribute our products through four operating segments.

 

Bracing and Supports Segment

 

Our Bracing and Supports Segment, which generates its revenues in the United States, offers our DonJoy, ProCare and Aircast products, including rigid knee bracing, orthopedic soft goods, cold therapy products, and vascular systems. This segment 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.

 

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Table of Contents

 

Recovery Sciences Segment

 

Our Recovery Sciences Segment, which generates its revenues in the United States, is divided into four main businesses:

 

·                  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 category 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 consumers ranging from fitness enthusiasts to competitive athletes our Compex electrostimulation device, which is used in athletic training programs to aid muscle development and to accelerate muscle recovery after training sessions.

 

Surgical Implant Segment

 

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

 

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.

 

Our four 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 medical devices and related products to orthopedic specialists and other healthcare professionals operating in a variety of patient treatment settings. These four segments constitute our reportable segments. See Note 16 to our unaudited condensed consolidated financial statements for additional information regarding our segments.

 

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Table of Contents

 

The tables below present financial information for our reportable segments for the periods presented. Segment results exclude the impact of certain general corporate expenses and charges related to various integration activities, as defined. All prior periods presented have been restated to reflect our current reportable segments.

 

 

 

Three Months Ended

 

Nine Months Ended

 

($ in thousands)

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

 

 

 

 

 

 

 

 

 

 

Bracing and Supports:

 

 

 

 

 

 

 

 

 

Net sales

 

$

78,156

 

$

76,388

 

$

232,087

 

$

219,224

 

Gross profit

 

$

42,521

 

$

44,146

 

$

127,865

 

$

122,748

 

Gross profit margin

 

54.4

%

57.8

%

55.1

%

56.0

%

Operating income

 

$

17,188

 

$

20,687

 

$

50,428

 

$

51,577

 

Operating income as a percent of net segment sales

 

22.0

%

27.1

%

21.7

%

23.5

%

 

 

 

 

 

 

 

 

 

 

Recovery Sciences:

 

 

 

 

 

 

 

 

 

Net sales

 

$

85,884

 

$

85,794

 

$

257,361

 

$

249,767

 

Gross profit

 

$

66,753

 

$

64,377

 

$

195,773

 

$

188,162

 

Gross profit margin

 

77.7

%

75.0

%

76.1

%

75.3

%

Operating income

 

$

30,962

 

$

27,715

 

$

85,441

 

$

75,962

 

Operating income as a percent of net segment sales

 

36.1

%

32.3

%

33.2

%

30.4

%

 

 

 

 

 

 

 

 

 

 

Surgical Implant:

 

 

 

 

 

 

 

 

 

Net sales

 

$

14,559

 

$

15,416

 

$

46,735

 

$

47,097

 

Gross profit

 

$

10,258

 

$

11,779

 

$

34,533

 

$

36,541

 

Gross profit margin

 

70.5

%

76.4

%

73.9

%

77.6

%

Operating income

 

$

401

 

$

2,805

 

$

4,545

 

$

8,982

 

Operating income as a percent of net segment sales

 

2.8

%

18.2

%

9.7

%

19.1

%

 

 

 

 

 

 

 

 

 

 

International:

 

 

 

 

 

 

 

 

 

Net sales

 

$

54,960

 

$

58,588

 

$

179,979

 

$

172,863

 

Gross profit

 

$

30,697

 

$

32,434

 

$

106,097

 

$

98,645

 

Gross profit margin

 

55.9

%

55.4

%

58.9

%

57.1

%

Operating income

 

$

9,752

 

$

10,625

 

$

40,787

 

$

33,556

 

Operating income as a percent of net segment sales

 

17.7

%

18.1

%

22.7

%

19.4

%

 

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Table of Contents

 

Results of Operations

 

We operate our business on a manufacturing calendar, with our fiscal year always ending on December 31. Each quarter is 13 weeks, consisting of two four-week periods and one five-week period. Our first and fourth quarters may have more or fewer shipping days from year to year based on the days of the week on which holidays and December 31 fall. The quarters ended October 2, 2010 and September 26, 2009 each included 63 shipping days. The nine months ended October 2, 2010 and September 26, 2009 included 192 and 188 shipping days, respectively.

 

The following table presents results of operations as a percentage of net sales for the periods presented ($ in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

October 2,
2010

 

September 26,
2009

 

Net sales

 

$

233,559

 

100.0

%

$

236,186

 

100.0

%

$

716,162

 

100.0

%

$

688,951

 

100.0

%

Cost of sales (exclusive of amortization of intangible assets (1))

 

84,147

 

36.0

 

86,039

 

36.4

 

256,066

 

35.8

 

247,195

 

35.9

 

Gross profit

 

149,412

 

64.0

 

150,147

 

63.6

 

460,096

 

64.2

 

441,756

 

64.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

102,672

 

44.0

 

101,413

 

42.9

 

328,913

 

45.9

 

310,618

 

45.1

 

Research and development

 

5,892

 

2.5

 

5,616

 

2.4

 

16,923

 

2.4

 

17,581

 

2.6

 

Amortization of intangible assets

 

19,403

 

8.3

 

19,560

 

8.3

 

58,128

 

8.1

 

57,862

 

8.4

 

Impairment of assets held for sale

 

 

 

 

 

1,147

 

0.2

 

 

 

 

 

127,967

 

54.8

 

126,589

 

53.6

 

405,111

 

56.5

 

386,061

 

56.0

 

Operating income

 

21,445

 

9.2

 

23,558

 

10.0

 

54,985

 

7.7

 

55,695

 

8.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(37,240

)

(15.9

)

(39,173

)

(16.6

)

(114,867

)

(16.0

)

(117,319

)

(17.0

)

Interest income

 

92

 

0.0

 

211

 

0.1

 

232

 

0.0

 

749

 

0.1

 

Other income, net

 

4,981

 

2.1

 

1,422

 

0.6

 

1,364

 

0.2

 

3,009

 

0.4

 

 

 

(32,167

)

(13.8

)

(37,540

)

(15.9

)

(113,271

)

(15.8

)

(113,561

)

(16.5

)

Loss from continuing operations before income taxes

 

(10,722

)

(4.6

)

(13,982

)

(5.9

)

(58,286

)

(8.1

)

(57,866

)

(8.4

)

Income tax benefit

 

3,191

 

1.4

 

2,969

 

1.3

 

17,983

 

2.5

 

19,901

 

2.9

 

Loss from discontinued operations, net

 

 

 

(267

)

(0.1

)

 

 

(434

)

(0.1

)

Net loss

 

(7,531

)

(3.2

)

(11,280

)

(4.8

)

(40,303

)

(5.6

)

(38,399

)

(5.6

)

Net income attributable to noncontrolling interests

 

(184

)

(0.1

)

(94

)

(0.0

)

(827

)

(0.1

)

(368

)

(0.0

)

Net loss attributable to DJO Finance LLC

 

$

(7,715

)

(3.3

)%

$

(11,374

)

(4.8

)%

$

(41,130

)

(5.7

)%

$

(38,767

)

(5.6

)%

 


(1)          Cost of sales is exclusive of amortization of intangible assets of $9,230 and $27,211 for the three and nine months ended October 2, 2010, respectively, and $9,495 and $28,499 for the three and nine months ended September 26, 2009, respectively.

 

Three Months Ended October 2, 2010 compared to Three Months Ended September 26, 2009

 

Net Sales.  Our net sales for the three months ended October 2, 2010 were $233.6 million as compared to $236.2 million for the three months ended September 26, 2009, representing a 1.1% decrease. This decrease was driven primarily by a $3.3 million impact from unfavorable changes in foreign currency exchange rates in effect for the three months ended October 2, 2010, as compared to rates in effect for the three months ended September 26, 2009, the impact of the sale or discontinuation of certain product lines in 2009, which were included in revenue during the three months ended September 26, 2009 in the amount of approximately $2.3 million, and a decrease in sales in our Surgical Implant Segment. These decreases were partially offset by an increase in sales in our Bracing and Supports Segment.

 

For the three months ended October 2, 2010, we generated 23.5% of our net sales from customers outside the United States as compared to 24.8% for the three months ended September 26, 2009.

 

Sales of new products, which include products that have been on the market less than one year, were $4.0 million for the three months ended October 2, 2010 compared to new product sales of $5.1 million for the three months ended September 26, 2009.

 

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Table of Contents

 

The following table sets forth the mix of our net sales for the three months ended October 2, 2010 compared to the three months ended September 26, 2009 ($ in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

 

 

October 2,
2010

 

% of Net
Sales

 

September 26,
2009

 

% of Net
Sales

 

Increase (decrease)

 

Bracing and Supports

 

$

78,156

 

33.5

%

$

76,388

 

32.4

%

$

1,768

 

2.3

%

Recovery Sciences

 

85,884

 

36.8

 

85,794

 

36.3

 

90

 

0.1

 

Surgical Implant

 

14,559

 

6.2

 

15,416

 

6.5

 

(857

)

(5.6

)

International

 

54,960

 

23.5

 

58,588

 

24.8

 

(3,628

)

(6.2

)

 

 

$

233,559

 

100.0

%

$

236,186

 

100.0

%

$

(2,627

)

(1.1

)%

 

Net sales in our Bracing and Supports Segment of $78.2 million for the three months ended October 2, 2010, increased $1.8 million, or 2.3%, as compared to the three months ended September 26, 2009. The increase was driven primarily by increased unit sales across most product lines, and increased revenue under our new soft goods contract with the Novation group purchasing organization. Partially offsetting these gains, growth in our Bracing and Supports segment was impacted by the conversion of certain units previously billed to insurance at higher average selling prices to units sold at reduced average selling prices to clinics choosing to do their own insurance billing.

 

Net sales in our Recovery Sciences Segment were $85.9 million for the three months ended October 2, 2010, essentially flat compared to net sales for the three months ended September 26, 2009 of $85.8 million. Increases in sales of new products in our Empi business unit were offset by decreases in sales of our Chattanooga products, and the impact of discontinuing certain Chattanooga products which contributed revenue of $0.9 million in the three months ended September 26, 2009.

 

Net sales in our Surgical Implant Segment decreased to $14.6 million for the three months ended October 2, 2010 from $15.4 million for the three months ended September 26, 2009, representing a 5.6% decrease over the same period in the prior year. The decrease was primarily due to the loss of a few key customers resulting in decreased sales of our hip and knee products, and the impact of the sale of a non-core spine product line which contributed revenue of $0.5 million in the three months ended September 26, 2009. These decreases were partially offset by increased sales of our shoulder products.

 

Net sales in our International Segment for the three months ended October 2, 2010 were $55.0 million, a decrease of 6.2% from net sales of $58.6 million for the three months ended September 26, 2009. The decrease is primarily attributable to unfavorable changes in foreign exchange rates compared to rates in effect for the three months ended September 26, 2009, which impacted net sales by $3.3 million. Excluding the impact of foreign exchange rates, net sales in our International Segment were essentially flat compared to the same period in the prior year, as strong sales of our Bracing and Supports products and continued improvement in sales of our Chattanooga products were offset by the impact of the discontinuation of certain Chattanooga products sold in international markets, which contributed revenue of $0.9 million in the three months ended September 26, 2009.

 

Gross Profit.  Consolidated gross profit as a percentage of net sales was 64.0%, for the three months ended October 2, 2010, compared to 63.6% for the three months ended September 26, 2009. Our gross profit margin for the three months ended October 2, 2010 was favorably impacted by cost savings achieved in connection with various integration activities, partially offset by unfavorable changes in foreign currency exchange rates compared to the rates in effect for the prior year.

 

Gross profit in our Bracing and Supports Segment as a percentage of net sales was 54.4% for the three months ended October 2, 2010 as compared to 57.8% for the three months ended September 26, 2009. The decrease was primarily due to a lower margin mix of products sold.

 

Gross profit in our Recovery Sciences Segment as a percentage of net sales increased to 77.7% for the three months ended October 2, 2010 from 75.0% for the three months ended September 26, 2009. The increase was primarily driven by cost savings resulting from the integration of our Chattanooga business operations.

 

Gross profit in our Surgical Implant Segment as a percentage of net sales decreased to 70.5% for the three months ended October 2, 2010 from 76.4% for the three months ended September 26, 2009. The decrease was primarily driven by lower sales volume and the unfavorable impact of certain non-recurring inventory adjustments.

 

Gross profit in our International Segment as a percentage of net sales increased slightly to 55.9% for the three months ended October 2, 2010 from 55.4% for the three months ended September 26, 2009. The increase was primarily driven by a more favorable mix of products sold, and cost savings achieved in connection with the integration of our Chattanooga business operations, partially offset by unfavorable changes in foreign exchange rates.

 

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Table of Contents

 

Selling, General and Administrative (SG&A).  Our SG&A increased to $102.7 million for the three months ended October 2, 2010 from $101.4 million for the three months ended September 26, 2009. Our SG&A expenses were impacted by significant non-recurring integration charges and other adjustments related to ongoing restructuring activities and acquisitions. We incurred the following SG&A expenses in connection with such activities during the periods presented (in thousands):

 

 

 

Three Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

Integration charges:

 

 

 

 

 

Employee severance and relocation

 

$

270

 

$

2,649

 

U.S commercial sales and marketing reorganization

 

2,540

 

 

Chattanooga integration

 

10

 

1,959

 

DJO Merger and other integration

 

943

 

2,344

 

International integration

 

16

 

415

 

Litigation costs and settlements, net

 

1,982

 

78

 

ERP implementation

 

4,676

 

2,740

 

 

 

$

10,437

 

$

10,185

 

 

Research and Development.  Our research and development expense increased to $5.9 million for the three months ended October 2, 2010 from $5.6 million for the three months ended September 26, 2009. As a percentage of net sales, research and development expense increased slightly to 2.5% for the three months ended October 2, 2010 from 2.4% in the three months ended September 26, 2009.

 

Amortization of Intangible Assets. Amortization of intangible assets was $19.4 million and $19.6 million for the three months ended October 2, 2010 and September 26, 2009, respectively.

 

Interest Expense.  Our interest expense decreased to $37.2 million for the three months ended October 2, 2010 from $39.2 million for the three months ended September 26, 2009, primarily due to lower weighted average interest rates on our outstanding debt.

 

Other Income, Net.  Other income, net, was $5.0 million and $1.4 million for the three months ended October 2, 2010 and September 26, 2009, respectively. Results for both periods were primarily associated with net realized and unrealized foreign currency transaction gains.

 

Income Tax Benefit.  For the three months ended October 2, 2010, we recorded an income tax benefit of approximately $3.2 million on a pre-tax loss of approximately $10.7 million, resulting in a 29.8% effective tax rate. For the three months ended September 26, 2009, we recorded an income tax benefit of approximately $3.0 million on a pre-tax loss of approximately $14.0 million, resulting in a 21.2% effective tax rate.

 

Nine Months Ended October 2, 2010 compared to Nine Months Ended September 26, 2009

 

Net Sales.  Our net sales for the nine months ended October 2, 2010 were $716.2 million, representing an increase of 3.9% from net sales of $689.0 million for the nine months ended September 26, 2009. This increase was driven by increased sales across most business units, as well as the benefit of four additional shipping days as compared to the nine months ended September 26, 2009. These increases were partially offset by a $0.9 million impact from unfavorable changes in foreign exchange rates in effect for the nine months ended October 2, 2010 as compared to rates in effect for the nine months ended September 26, 2009, and the impact of the sale or discontinuation of certain product lines in 2009, which were included in revenue during the nine months ended September 26, 2009 in the amount of approximately $7.3 million.

 

For the nine months ended October 2, 2010, we generated 25.1% of our net sales from customers outside the United States as compared to 25.1% for the nine months ended September 26, 2009.

 

Sales of new products, which include products that have been on the market less than one year, were $15.4 million for the nine months ended October 3, 2010 compared to new product sales of $12.4 million for the nine months ended September 26, 2009.

 

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The following table sets forth the mix of our net sales for the nine months ended October 2, 2010 compared to the nine months ended September 26, 2009 ($ in thousands):

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

October 2,
2010

 

% of Net
Sales

 

September 26,
2009

 

% of Net
Sales

 

Increase (decrease)

 

Bracing and Supports

 

$

232,087

 

32.4

%

$

219,224

 

31.9

%

$

12,863

 

5.9

%

Recovery Sciences

 

257,361

 

35.9

 

249,767

 

36.2

 

7,594

 

3.0

 

Surgical Implant

 

46,735

 

6.5

 

47,097

 

6.8

 

(362

)

(0.8

)

International

 

179,979

 

25.1

 

172,863

 

25.1

 

7,116

 

4.1

 

 

 

$

716,162

 

100.0

%

$

688,951

 

100.0

%

$

27,211

 

3.9

%

 

Net sales in our Bracing and Supports Segment were $232.1 million for the nine months ended October 2, 2010, reflecting an increase of $12.9 million, or 5.9% from net sales of $219.2 million for the nine months ended September 26, 2009. The increase was driven primarily by increased unit sales, which were favorably impacted by the benefit of four additional shipping days in the nine months ended October 2, 2010 as compared to the nine months ended September 26, 2009, as well as our new soft goods contract with the Novation group purchasing organization. Partially offsetting these gains, growth in our Bracing and Supports segment was impacted by the conversion of certain units previously billed to insurance at higher average selling prices to units sold at reduced average selling prices to clinics choosing to do their own insurance billing.

 

Net sales in our Recovery Sciences Segment increased to $257.4 million for the nine months ended October 2, 2010 from $249.8 million for the nine months ended September 26, 2009, representing a 3.0% increase over the same period in the prior year. The increase is primarily due to continued improvement in sales in our Chattanooga business unit, sales of new products in our Empi business unit, and the benefit of four additional shipping days in the nine months ended October 2, 2010 as compared to the nine months ended September 26, 2009. These increases were partially offset by the impact of discontinuing certain Chattanooga products which contributed revenue of $2.9 million in the nine months ended September 26, 2009.

 

Net sales in our Surgical Implant Segment were $46.7 million for the nine months ended October 2, 2010, a slight decrease from net sales of $47.1 million for the nine months ended September 26, 2009. The decrease was driven primarily by the loss of a few key customers resulting in decreased sales of our hip and knee products, and the impact of the sale of a non-core spine product line which contributed revenue of $1.4 million in the nine months ended September 26, 2009. These decreases were partially offset by increased sales of our shoulder products, and the benefit of four additional shipping days in the nine months ended October 2, 2010 as compared to the nine months ended September 26, 2009.

 

Net sales in our International Segment for the nine months ended October 2, 2010 were $180.0 million, reflecting an increase of 4.1% from net sales of $172.9 million for the nine months ended September 26, 2009. The increase was driven primarily by strong sales of our bracing and supports products, improving sales of our Chattanooga products, and the benefit of four additional shipping days in the nine months ended October 2, 2010 as compared to the nine months ended September 26, 2009. The increases were partially offset by $0.9 million of unfavorable changes in foreign exchange rates compared to rates in effect for the nine months ended September 26, 2009, and the impact of discontinuing certain Chattanooga products which contributed revenue in 2009.

 

Gross Profit.  Consolidated gross profit as a percentage of net sales was 64.2%, for the nine months ended October 2, 2010 as compared to 64.1% for the nine months ended September 26, 2009. Our gross profit margin for the nine months ended October 2, 2010 is consistent with the prior year period as cost savings resulting from integration activity were offset by certain other non-recurring integration related costs, and unfavorable changes in foreign exchange rates compared to rates in effect for the nine months ended September 26, 2009.

 

Gross profit in our Bracing and Supports Segment as a percentage of net sales was 55.1% for the nine months ended October 2, 2010 compared to 56.0% for the nine months ended September 26, 2009. The decrease was primarily driven by a lower margin mix of products sold.

 

Gross profit in our Recovery Sciences Segment as a percentage of net sales was 76.1% for the nine months ended October 2, 2010 compared to 75.3% for the nine months ended September 26, 2009. The decrease was primarily driven by a lower margin mix of products sold, partially offset by cost savings achieved in connection with the integration of our Chattanooga business operations.

 

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Gross profit in our Surgical Implant Segment as a percentage of net sales decreased to 73.9% for the nine months ended October 2, 2010 from 77.6% for the nine months ended September 26, 2009. The decrease was primarily driven by lower sales volume and certain non recurring inventory adjustments.

 

Gross profit in our International Segment as a percentage of net sales increased to 58.9% for the nine months ended October 2, 2010 from 57.1% for the nine months ended September 26, 2009. The increase was primarily driven by the impact of a more favorable mix of products sold, and cost savings achieved in connection with the integration of our Chattanooga business operations. These increases were partially offset by unfavorable changes in foreign currency exchange rates compared to rates in effect for the nine months ended September 26, 2009.

 

Selling, General and Administrative (SG&A).  Our SG&A expenses increased to $328.9 million for the nine months ended October 2, 2010 from $310.6 million for the nine months ended September 26, 2009. Our SG&A expenses were impacted by significant non-recurring integration charges and other adjustments related to ongoing restructuring activities and acquisitions. We incurred the following SG&A expenses in connection with such activities during the periods presented (in thousands):

 

 

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

Integration charges:

 

 

 

 

 

Employee severance and relocation

 

$

2,411

 

$

5,771

 

U.S commercial sales and marketing reorganization

 

7,877

 

 

Chattanooga integration

 

3,614

 

21

 

DJO Merger and other integration

 

2,967

 

10,590

 

International integration

 

79

 

4,357

 

Litigation costs and settlements, net

 

4,496

 

78

 

Additional product liability insurance premiums

 

11,138

 

 

ERP implementation

 

11,682

 

14,822

 

 

 

$

44,264

 

$

35,639

 

 

During the nine months ended October 2, 2010, we incurred $11.1 million of expenses related to additional product liability insurance premiums, which were primarily attributable to supplemental extended reporting period coverage for product liability claims related to our discontinued pain pump products, for which annual insurance coverage was otherwise unavailable when our existing coverage expired on June 30, 2010.

 

Research and Development.  Our research and development expense decreased to $16.9 million for the nine months ended October 2, 2010 from $17.6 million for the nine months ended September 26, 2009. As a percentage of net sales, research and development expense decreased slightly to 2.4% for the nine months ended October 2, 2010 from 2.6% in the nine months ended September 26, 2009.

 

Amortization of Intangible Assets. Our amortization of intangible assets was $58.1 million and $57.9 million for the nine months ended October 2, 2010 and September 26, 2009, respectively.

 

Interest Expense.  Our interest expense was $114.9 million and $117.3 million for the nine months ended October 2, 2010 and September 26, 2009, respectively. Lower weighted average interest rates on our outstanding debt in the nine months ended October 2, 2010 were offset by accelerated amortization of original issue discount and deferred financing costs in connection with the prepayments of our Senior Secured Credit Facility during the first quarter of 2010.

 

Other Income, Net.  Other income, net, was $1.4 million and $3.0 million for the nine months ended October 2, and September 26, 2009 respectively. Results for both periods were primarily attributable to net realized and unrealized foreign currency transaction gains.

 

Income Tax Benefit. For the nine months ended October 2, 2010, we recorded an income tax benefit of approximately $18.0 million on a pre-tax loss of approximately $58.3 million, resulting in a 30.9% effective tax rate. For the nine months ended September 26, 2009, we recorded an income tax benefit of $19.9 million on a pre-tax loss of $57.8 million, resulting in a 34.4% effective tax rate.

 

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Liquidity and Capital Resources

 

As of October 2, 2010, our primary source of liquidity consisted of cash and cash equivalents totaling $50.2 million and $100.0 million of available borrowings under our revolving credit facility. Working capital at October 2, 2010 was $181.5 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 repayment and interest 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 would be able to obtain 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 the changes in our cash and cash equivalents for the nine months ended October 2, 2010 and September 26, 2009 is as follows:

 

 

 

Nine Months Ended

 

 

 

October 2,
2010

 

September 26,
2009

 

Cash provided by operating activities

 

$

41,632

 

$

62,567

 

Cash used in investing activities

 

(23,039

)

(10,209

)

Cash used in financing activities

 

(11,653

)

(29,661

)

Effect of exchange rate changes on cash and cash equivalents

 

(1,307

)

(1,901

)

Net increase in cash and cash equivalents

 

$

5,633

 

$

20,796

 

 

Cash Flows

 

Operating activities provided cash of $41.6 million and $62.6 million for the nine months ended October 2, 2010 and September 26, 2009, respectively. Cash provided by operating activities for the nine months ended October 2, 2010 primarily reflected our net loss excluding $98.9 million of non-cash items, and an unfavorable change in operating assets of $17.0 million. Cash provided by operating activities for the nine months ended September 26, 2009 consisted of our net loss excluding $99.6 million of non-cash items, and a favorable change in operating assets of $1.4 million.

 

Investing activities used $23.0 million of cash for the nine months ended October 2, 2010 and $10.2 million for the nine months ended September 26, 2009. Cash used in investing activities for the nine months ended October 2, 2010 primarily consisted of $20.3 million of purchases of property and equipment, including $11.6 million for our new ERP system, $1.2 million for the acquisition of our South African distributor, and a $0.8 million payment related to an earn-out provision associated with the 2009 acquisition of our Australian distributor. Cash used in investing activities for the nine months ended September 26, 2009 primarily consisted of $21.8 million of proceeds from the sales of assets, partially offset by purchases of property and equipment totaling $19.3 million, including $4.3 million for our new ERP system, and the acquisition of businesses for a total of $12.9 million, net of cash acquired.

 

We used $11.7 million and $29.7 million of cash for financing activities during the nine months ended October 2, 2010 and September 26, 2009, respectively. Cash used in financing activities for the nine months ended October 2, 2010 was primarily related to net payments on long-term debt of $9.0 million and the payment of $3.5 million of debt issuance costs incurred in connection with the issuance of our new 10.875% Senior Notes in January 2010. In addition, during the nine months ended October 2, 2010, we received an investment of approximately $1.4 million from our indirect parent, from the issuance of DJO Incorporated common stock to certain accredited investors. Cash used in financing activities for the nine months ended September 26, 2009 represented net payments on long-term debt and revolving lines of credit.

 

For the remainder of 2010, we expect to spend total cash of approximately $58.5 million for the following:

 

· $13.2 million for scheduled principal and estimated interest payments on our senior secured credit facility,

· $36.7 million for scheduled interest payments on our 10.875% senior notes, and

· $8.6 million for capital expenditures, including $3.3 million for our ERP system.

 

In addition, we expect to incur additional costs implementing our new ERP system over the remainder of the project, which will be expensed as incurred in our consolidated statements of operations.

 

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Table of Contents

 

On October 18, 2010, we issued $300.0 million aggregate principal amount of new 9.75% Senior Subordinated Notes. We used proceeds from the issuance of the 9.75% Notes, along with cash on hand, to repurchase $199.85 million aggregate principal amount of our 11.75% Notes for total consideration of $222.8 million (which includes applicable premiums and accrued interest from the last interest payment date to the settlement date), prepay a total $79.0 million of term loans under our Senior Secured Credit Facility, and pay related fees and expenses (see Note 18 to our unaudited condensed consolidating financial statements).

 

Indebtedness

 

As of October 2, 2010, we had approximately $1,805.4 million in aggregate indebtedness outstanding.

 

Senior Secured Credit Facility

 

Overview.  The Senior Secured Credit Facility originally provided senior secured financing of $1,165.0 million, consisting of a $1,065.0 million term loan facility, of which $933.0 million remains outstanding as of October 2, 2010, and a $100.0 million revolving credit facility. We issued the term loan 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 as defined, 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 initial 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 7 to our unaudited condensed consolidated financial statements). As of October 2, 2010, our weighted average interest rate for all borrowings under the Senior Secured Credit Facility was 4.56%.

 

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 there under. 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.

 

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.

 

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.

 

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Table of Contents

 

Pursuant to the terms of the credit agreement relating to the Senior Secured Credit Facility, we are required to maintain a maximum senior secured leverage ratio consolidated senior debt to Adjusted EBITDA, of 3.75:1 for the trailing 12 months ended October 2, 2010, stepping down over time to 3.25:1 by the end of 2011. Adjusted EBITDA is defined as net income (loss) attributable to DJO Finance LLC plus(income) loss from discontinued operations,  interest expense, net, provision (benefit) for income taxes and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items, including the addition of pre-acquisition EBITDA from businesses acquired during the period and certain future cost savings expected to be achieved related to acquisitions, all as permitted in calculating covenant compliance under our Senior Secured Credit Facility and the Indentures (Adjusted EBITDA). As of October 2, 2010 our actual senior secured leverage ratio was within the required ratio at 3.32:1.

 

10.875% Senior Notes and 11.75% Senior Subordinated 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,

·                  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 improving our ratio of Adjusted EBITDA to fixed charges, as defined, or having a ratio of 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 a ratio of Adjusted EBITDA to fixed charges of at least 2.00:1 on a pro forma basis, as defined. Our ratio of Adjusted EBITDA to fixed charges for the twelve months ended October 2, 2010, measured on that date on a pro forma basis giving effect to our January 2010 issuance of $100 million principal amount of 10.875% Notes and the use of proceeds there from, as if those transactions had occurred at the beginning of such twelve month period, was 1.82:1. 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 4.00:1. 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.

 

Covenant Compliance

 

The following is a summary of our covenant requirement ratios as of October 2, 2010:

 

 

 

Covenant
Requirements

 

Actual
Ratios

 

Senior Secured Credit Facility

 

 

 

 

 

Maximum ratio of consolidated net senior secured debt to Adjusted EBITDA

 

3.75:1

 

3.32:1

 

10.875% Senior Notes and 11.75% Senior Subordinated Notes

 

 

 

 

 

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

 

2.00:1

 

1.82:1

 

 

As described above, our Senior Secured Credit Facility consisting of a term loan facility of $933.0 million as of October 2, 2010 and a $100.0 million revolving credit facility, along with 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. 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

 

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Table of Contents

 

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 note holders 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.

 

Adjusted EBITDA is defined as net income (loss) attributable to DJO Finance LLC, plus income (loss) from discontinued operations, interest expense, net, provision (benefit) for income taxes and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items, including the addition of pre-acquisition EBITDA from businesses acquired during the period and certain future cost savings expected to be achieved related to acquisitions, all as 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 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 three and twelve months ended October 2, 2010 (in thousands). The terms and related calculations are defined in the credit agreement relating to our Senior Secured Credit Facility and the Indentures.

 

 

 

Three Months
Ended
October 2, 2010

 

Twelve Months 
Ended
October 2, 2010

 

 

 

 

 

 

 

Net loss attributable to DJO Finance LLC

 

$

(7,715

)

$

(52,796

)

Net income from discontinued operations, net of tax

 

 

(115

)

Interest expense, net

 

37,148

 

154,064

 

Income tax benefit

 

(3,191

)

(19,760

)

Depreciation and amortization

 

25,924

 

111,468

 

Non-cash charges (a)

 

659

 

3,885

 

Non-recurring and restructuring charges (b)

 

11,406

 

62,509

 

Other adjustment items (c)

 

(2,971

)

4,454

 

Adjusted EBITDA

 

$

61,260

 

$

263,709

 

 

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Table of Contents

 


(a)          Non-cash charges are comprised of the following (in thousands):

 

 

 

Three Months
Ended
October 2, 2010

 

Twelve Months
Ended
October 2, 2010

 

 

 

 

 

 

 

Impairment of assets held for sale (1)

 

$

 

$

1,147

 

Stock compensation expense

 

444

 

2,356

 

Losses on disposal of assets, net

 

215

 

382

 

Total non-cash charges

 

$

659

 

$

3,885

 

 


(1)        As a result of our integration of the operations of our Chattanooga division, we exited facilities in Hixson, Tennessee and listed the buildings for sale during the nine months ended October 2, 2010. Based on the current estimated fair market value of the buildings, we recorded a $1.1 million non-cash charge during the nine months ended October 2, 2010, which has been reflected as impairment of assets held for sale.

 

(b)         Non-recurring and integration charges are comprised of the following (in thousands):

 

 

 

Three Months
Ended
October 2, 2010

 

Twelve Months
Ended
October 2, 2010

 

 

 

 

 

 

 

Integration charges:

 

 

 

 

 

Employee severance and relocation

 

$

270

 

$

4,847

 

Chattanooga integration

 

567

 

7,837

 

DJO Merger and other integration

 

1,355

 

7,287

 

U.S Commercial Sales and Marketing reorganization

 

2,540

 

7,877

 

International integration

 

16

 

1,237

 

Litigation costs and settlements, net

 

1,982

 

7,263

 

Additional products liability insurance premiums (1)

 

 

11,138

 

ERP implementation

 

4,676

 

15,023

 

Total non-recurring and integration charges

 

$

11,406

 

$

62,509

 

 


(1)        Primarily consists of insurance premiums related to a supplemental extended reporting period for product liability claims related to our discontinued pain pump products, for which annual insurance coverage was not renewed.

 

(c)                                  Other adjustment items are comprised of the following (in thousands):

 

 

 

Three Months
Ended
October 2, 2010

 

Twelve Months
Ended
October 2, 2010

 

 

 

 

 

 

 

Blackstone monitoring fees

 

$

1,750

 

$

7,000

 

Noncontrolling interests

 

184

 

1,182

 

Pre-acquisition Adjusted EBITDA (1)

 

 

443

 

Pre-disposition Adjusted EBITDA (2)

 

 

(100

)

Other (3)

 

(4,905

)

(4,071

)

Total other adjustment items

 

$

(2,971

)

$

4,454

 

 


(1)        Pre-acquisition Adjusted EBITDA for the twelve months ended October 2, 2010 related to the acquisition of the bracing and supports and vascular systems business of our South African distributor.

 

(2)        Pre-disposition Adjusted EBITDA for the twelve months ended October 2, 2010 related to certain immaterial product lines sold in fiscal year 2009.

 

(3)        Other adjustment items consist primarily of net realized and unrealized foreign currency transaction gains. The twelve months ended October 2, 2010 also included a $3.1 million gain related to the sale of certain product lines.

 

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Critical Accounting Policies and Estimates

 

We have disclosed in our unaudited condensed consolidated financial statements and in “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2009 Annual Report on Form 10-K, those accounting policies that we consider to be significant in determining our results of operations and financial condition. There have been no material changes to those policies that we consider to be significant since the filing of our 2009 Annual Report on Form 10-K. We believe that the accounting principles utilized in preparing our unaudited condensed consolidated financial statements conform in all material respects to GAAP.

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are exposed to certain market risks as part of our ongoing business operations, primarily risks from changing interest rates and foreign currency exchange rates that could impact our financial condition, results of operations, and cash flows.

 

Interest Rate Risk

 

Our primary exposure is to changing interest rates. We have historically managed our interest rate risk by balancing the amounts of our fixed and variable rate debt. For our fixed rate debt, interest rate changes may affect the market value of the debt but do not impact our earnings or cash flow. Conversely, for our variable rate debt, interest rate changes generally do not affect the fair market value of the debt but do impact future earnings and cash flow, assuming other factors are constant. Our senior notes of $875.0 million principal consist of fixed rate notes, while our borrowings under the Senior Secured Credit Facility bear interest at floating rates based on LIBOR or the prime rate, as defined. As of October 2, 2010, we had $933.0 million of borrowings under the Senior Secured Credit Facility. 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 Notes 7 and 9 to our unaudited condensed consolidated financial statements). A hypothetical 1% increase in variable interest rates for the portion of the Senior Secured Credit Facility not covered by interest rate swap agreements would have impacted our earnings and cash flow for the nine months ended October 2, 2010, by approximately $1.4 million. We may use additional derivative financial instruments where appropriate to manage our interest rate risk. However, as a matter of policy, we do not enter into derivative or other financial investments for trading or speculative purposes.

 

Foreign Currency Risk

 

Due to the global reach of our business, we are exposed to market risk from changes in foreign currency exchange rates, particularly with respect to the U.S. dollar compared to the Euro and the Mexican Peso (MXP). Our wholly owned foreign subsidiaries are consolidated into our financial results and are subject to risks typical of an international business including, but not limited to, differing economic conditions, changes in political climate, differing tax structures, other regulations and restrictions and foreign exchange volatility. To date, we have not used international currency derivatives to hedge against our investment in our European subsidiaries or their operating results, which are converted into U.S. Dollars at period-end and average foreign exchange rates, respectively. However, as we continue to expand our business through acquisitions and organic growth, the sales of our products that are denominated in foreign currencies has increased, as well as the costs associated with our foreign subsidiaries which operate in currencies other than the U.S. dollar. Accordingly, our future results could be materially impacted by changes in these or other factors. For the three and nine months ended October 2, 2010, sales denominated in foreign currencies accounted for approximately 20.8% and 22.0% of our consolidated net sales, respectively, of which 15.1% and 16.5% respectively, were denominated in the Euro. In addition, our exposure to fluctuations in foreign currencies arises because certain of our subsidiaries enter into purchase or sale transactions using a currency other than its functional currency. Accordingly, our future results could be materially impacted by changes in foreign exchange rates or other factors. Occasionally, we seek to reduce the potential impact of currency fluctuations on our business through hedging transactions. During the nine months ended October 2, 2010, we utilized Mexican Peso (MXP) foreign exchange forward contracts to hedge a portion of our exposure to fluctuations in foreign exchange rates, as our Mexico-based manufacturing operations incur costs that are largely denominated in MXP (see Note 7 to our unaudited condensed consolidated financial statements). These foreign exchange forward contracts expire weekly throughout fiscal year 2010.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as the term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act) that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

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Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on this evaluation and subject to the foregoing, our Chief Executive Officer and our Chief Financial Officer concluded that, as of the end of the quarter covered by this report, the design and operation of our disclosure controls and procedures were effective to accomplish their objectives at a reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

During the first quarter of 2010 we made changes to our internal control over financial reporting in connection with the transition to the new ERP system for our Surgical Implant business. This ongoing implementation has materially changed how transactions are being processed and has also changed the structure and operation of some internal controls. While the ERP changes materially affected our internal control over financial reporting during the first quarter of 2010, the implementation has proceeded to date without material adverse effects on our internal control over financial reporting. Additionally, we established additional temporary compensating controls, including transactional validation and additional reconciliation procedures to ensure the accuracy of the reported amounts. We expect to maintain certain of these additional temporary compensating controls for a period of time.

 

Except for those changes made in connection with the new ERP system, there were no other changes in the Company’s internal control over financial reporting (as that term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Part II. OTHER INFORMATION

 

ITEM 1.  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.

 

We are currently named as one of several defendants in approximately 100 product liability cases, including a lawsuit in Canada seeking class action status, related to a disposable drug infusion pump product (pain pump) manufactured by two third party manufacturers that we distributed through our Bracing and Supports 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. These lawsuits are about equally divided between the two manufacturers. Both manufacturers have rejected our tenders of indemnity. Until early 2010, the base policy for one of the manufacturers was paying for our defense, but that policy has been exhausted by defense costs of the company and the manufacturer and by settlements, and a second policy has been significantly eroded by defense costs of the company and the manufacturer and is expected to be exhausted by settlements in the near future. This manufacturer has ceased operations, has little assets and no additional insurance coverage. The Company has asserted indemnification rights against the successor to this manufacturer and intends to pursue its claims appropriately. The base policy for the other manufacturer has been exhausted and the excess liability carriers for that manufacturer have not accepted coverage for the Company and are not expected to provide for its defense. The Company and this manufacturer have been cooperating in jointly negotiating settlements of those lawsuits in which both parties are named. Our products liability carriers have 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. In August 2010, one of our excess carriers for the period ending July 1, 2010 and for the supplemental extended reporting period (SERP) discussed below, which is insuring $10 million in excess of $25 million, informed us that it has reserved its

 

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right to rescind the policy based on an alleged failure by us and our insurance broker to disclose material information. We disagree with this allegation and are seeking to resolve the issue with this carrier. The lawsuits allege damages ranging from unspecified amounts to claims between $1 million and $10 million. 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 unavailable or insufficient to pay the defense costs and settlements or judgments in these cases.

 

In mid-2010, we were named in three multi-plaintiff lawsuits alleging that the plaintiffs had been injured following use of certain cold therapy products manufactured by the Company. These lawsuits are in their early stages and were brought by 16, 11 and 19 plaintiffs, respectively. The complaints are not specific as to the nature of the injuries, but allege various product liability theories, including inadequate warnings regarding the risks associated with the use of cold therapy and failure to incorporate certain safety features into the design. No specific dollar amounts of damages are alleged. We could be exposed to material liabilities if our insurance coverage is not available or inadequate to pay the defense costs and settlements or judgments in these cases.

 

On August 2, 2010, we were served with a subpoena under the Health Insurance Portability and Accountability Act (HIPAA) seeking numerous documents related to our activities involving the pain pumps discussed above. The subpoena which was issued by the United States Attorney’s Office, Central District of California, refers to an official investigation by the U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) of Federal health care offenses. We are producing documents that are responsive to the subpoena. We believe that our actions related to our prior distribution of these pain pumps have been in compliance with applicable legal standards. We can make no assurance as to the resources that will be needed to respond to the subpoena or the final outcome of any investigation or further action.

 

We maintain product liability insurance that is subject to annual renewal. Our current policy covers claims reported between July 1, 2010 and June 30, 2011. No carriers were prepared to cover claims for this reporting period related to the pain pump products described above and therefore our current policies exclude coverage for those products. For the current policy year, we maintain coverage limits (together with excess policies) of up to $50 million, with self-insured retentions of $500,000 per claim for claims relating to our cold therapy units, $500,000 per claim for claims relating to invasive products, $75,000 per claim for claims relating to non-invasive products other than our cold therapy products, and an aggregate self-insured retention of $2.25 million. We purchased SERP coverage for our $80 million limit product liability program that expired on June 30, 2010, and this supplemental coverage is limited to pain pump claims. Except for the additional excess coverage mentioned below, this SERP coverage does not provide additional limits to the aggregate $80 million limit on the expiring program but does provide that the existing limits of the expiring program will remain available for claims reported for an extended period of time. Specifically, pain pump claims may be reported under the $10 million base policy for an indefinite period of time and for a period of five years under the excess layers. We also purchased additional coverage of $25 million excess of $80 million with a five year reporting period. Thus, the SERP coverage has a total limit of $105 million (less amounts paid for claims reported under the expiring program). This coverage is subject to a self-insured retention of $500,000 per claim for claims related to pain pumps, with an aggregate self-insured retention of $1.0 million for all products liability claims under either the expiring program or the SERP program. In addition, the layer of $25 million excess over $55 million has a separate self-insured retention of $50,000 per claim. Our two product liability programs prior to the program that expired on June 30, 2010 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 as well as the expiring program.

 

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. Our condensed consolidated balance sheets as of October 2, 2010 (unaudited) and December 31, 2009, include accrued liabilities of approximately $1.7 million and $2.0 million, respectively, for expenses related to products liability claims for products other than our pain pump products. The amounts accrued are based upon previous claims 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

 

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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. The relator filed a second amended complaint in May 2010 that, among other things, dropped The Blackstone Group as a defendant. We have filed another motion to dismiss directed at the second amended complaint. 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 we 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 of such action.

 

ITEM 1A.  RISK FACTORS

 

For a discussion of the Company’s potential risks or uncertainties, please see Part I, Item IA, of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 filed with the Commission on March 5, 2010. Except for the following factors, there have been no material changes to the risk factors disclosed in such Form 10-K.

 

Risks Related to Our Business

 

Changes in Medicare coverage and reimbursement policies 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 durable medical equipment (DME), prosthetics, orthotics and supplies (DMEPOS). Such legislation has included temporary freezes or reductions in payments for DME and other payment reforms, new clinical conditions for payment, quality standards, enhanced supplier screening measures, and other reforms.

 

The Medicare Prescription Drug, Improvement and Modernization Act of 2003 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, none of which included our products, 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, Congress enacted the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), which terminated round one contracts and required the Centers for Medicare & Medicaid Services (CMS) to rebid those areas in 2009. The legislation also delayed round two bidding until 2011 and made a series of changes to program requirements. The delay in bidding was financed by nationwide reduction 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, there is no assurance they will not be included in the future, since the statute authorizes off-the-shelf orthotics and transcutaneous electrical nerve stimulation (TENS) devices to be included in the program. When it is eventually implemented, the competitive bidding process will 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 is required to use competitive bid pricing information to adjust the payment amounts otherwise in effect for an area that is not a competitive acquisition area by 2016. 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.

 

On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act, which was amended by a second bill signed into law on March 30, 2010, known as the Health Care and Education Reconciliation Act (collectively referred to as the Affordable Care Act or ACA). Among other things, the ACA eliminates the full inflation update to the DME fee schedule for the years 2011 through 2014. In addition, beginning in 2011, the ACA reduces the inflation update for DMEPOS by a “productivity adjustment” factor intended to reflect productivity gains in delivering health care services. The productivity adjustment is to be based on the change in the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity, which CMS currently estimates will be 1.6 percent in 2011. The ACA also increases to 100 the number of geographic areas to be included in round two of the DMEPOS competitive bidding program.

 

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Government agencies, legislative bodies and the private sector continue to propose initiatives to limit the growth of healthcare costs, including price regulation and competitive pricing, 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.

 

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

 

The ACA is a sweeping measure designed to expand access to affordable health insurance, control health care spending, and improve health care quality. Several provisions of the ACA specifically impact the medical equipment industry. In addition to changes in Medicare DMEPOS reimbursement and an expansion of the DMEPOS competitive bidding program, the ACA imposes a new annual federal excise tax on certain medical device manufacturers and importers. Specifically, for sales on or after January 1, 2013, manufacturers, producers, and importers of taxable medical devices must pay as an excise tax 2.3% of the price for which the devices are sold. The ACA also requires medical supply and device manufacturers to report certain payments made to physicians and other referral sources, effective March 31, 2013. The ACA also establishes new Medicare and Medicaid program integrity provisions, including expanded documentation requirements for Medicare DMEPOS orders and more stringent procedures for screening Medicare and Medicaid DMEPOS suppliers, along with broader expansion of federal fraud and abuse authorities. Although the eventual impact of the health reform provisions of the ACA are still uncertain, it is possible that the legislation will have a material adverse impact on our business.

 

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 or DMEPOS supplier standards, 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. CMS also recently clarified and expanded the requirements that DMEPOS suppliers must meet to establish and maintain Medicare billing privileges. On August 27, 2010, CMS published a final rule that, among other things, prohibits suppliers from sharing a practice location in certain circumstances, imposes new physical facility requirements on suppliers, clarifies the prohibition on the direct solicitation of Medicare beneficiaries, generally prohibits suppliers from contracting with another individual to perform licensed services, and clarifies a number of other supplier operational requirements. The rule generally is effective September 27, 2010 (although there are separate deadlines for compliance with the physical facility standards for existing suppliers with leases that expire after that date). We believe we are in compliance with the requirements of the new rule. If in the future we fail to maintain our Medicare accreditation status and/or do not comply with Medicare surety bond or supplier standard requirements, or if these requirements are expanded in the future, it could adversely impact our profits and results of operation.

 

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.

 

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In addition, the ACA establishes new disclosure requirements regarding financial arrangements between medical device and supplies manufacturers and physicians, including physicians who serve as consultants, effective March 31, 2013. A number of states also have enacted specific marketing and payment disclosure requirements and others 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 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, but 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. CMS has indicated that it would not enforce any policy on consignment closets without issuing a new transmittal. 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.

 

In response to pressure from certain groups (mostly orthotists), the U.S. 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 most 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 that implementation of BIPA or implementation of other such laws will have on our business and can provide no assurance that such laws will not have a material adverse impact on our business.

 

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 and reimbursement policies carefully for existing and new therapies and can, without notice, decide not to reimburse for treatments that include the use of our products. For example, some third party payors have ceased reimbursing us for one of our bone growth stimulators for certain indications. They may also 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

 

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visits for rehabilitation procedures. For example, in the United States, Congress and CMS frequently engage in efforts to contain costs, which may result in limitations in Medicare coverage of, and/or reduced reimbursement for, our products. Additionally, 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 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 adverse 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 § 510(k) of the Food, Drug, and Cosmetic Act, as amended, and to provide recommendations for changes, if necessary. In addition, the FDA completed an internal review of the clearance process and issued a 510(k) Preliminary Report and Recommendations on August 4, 2010. Among other things, the FDA report recommends the development of a subset of moderate-risk (Class II) devices called “Class IIb,” for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination required for clearance of a device. The 510(k) Preliminary Report also recommends that FDA consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know regarding the safety and effectiveness of the device under review. This is not required now for 510(k) submissions. In addition, the IOM is expected to complete its study in 2012, in which additional changes may be recommended. Many of our products are cleared for marketing under the 510(k) process that the FDA and the IOM are reviewing and the FDA’s recommended changes would make this process more onerous, time consuming and expensive. If we begin to have significant difficulty obtaining such FDA approvals or clearances in a timely manner or at all, we could suffer a material adverse effect on our revenues and growth.

 

If we fail to obtain regulatory approval for the modification of, or new uses for, our products, or if safety concerns emerge for any of our marketed products, or if our any of our product clearances or approvals are withdrawn, 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 application 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. In addition, the FDA may require additional data after a device has been approved or cleared for marketing, or withdraw clearance or approval, if any new safety concerns emerge after the product enters the market. If the FDA requires us to obtain pre-market approvals, pre-market supplement approvals, pre-market clearances for any modification to a previously cleared or approved device, or if the FDA requires us to obtain additional post-marketing data or withdraws approval or clearance, 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.

 

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On April 5, 2010, the FDA proposed a rule titled, “Neurological and Physical Medicine Devices, Designation of Special Controls for Certain Class II Devices and Exemption from Premarket Notification,” that would, among other things, exempt certain class II neurological medical devices from 510(k) premarket notification requirements. Included in this subset are “limited output” TENS devices for pain relief, TENS devices for aesthetic purposes, neuromuscular electrical nerve stimulation (NMES) devices for rehabilitation, and NMES devices for muscle conditioning. We manufacture and market these types of devices. If the FDA decides to finalize the rule as proposed, there could be an influx of TENS and NMES devices into the market which would increase competition and which could have a material adverse effect on our business.

 

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 be required to 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, we will be 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 the Department of Health and Human Services (HHS), the 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 DOJ 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.

 

On August 2, 2010, we were served with a subpoena under HIPAA seeking numerous documents related to our activities involving the manufacture and distribution of pain pumps. The subpoena, which was issued by the United States Attorney’s Office, Central District of California, refers to an official investigation by the DOJ and the FDA of federal health care offenses. We are producing documents that are responsive to the subpoena. We believe that our actions related to our prior distribution of these pain pumps have been in compliance with applicable legal standards. We can make no assurance as to the resources that will be needed to respond to the subpoena or the final outcome of any investigation or further action.

 

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, including our interactions 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:

 

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· 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, or fail to return amounts received from a government payor within 60 days of identifying the overpayment;

 

· 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.

 

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. The relator filed a second amended complaint in May 2010 that, among other things, dropped The Blackstone Group as a defendant. We have filed another motion to dismiss directed at the second amended complaint. 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 we 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 of such action.

 

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.

 

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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 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 (1) an interim final rule published October 30, 2009, enhancing the enforcement provisions of the Administrative Simplification Rules, (2) an interim final rule published August 24, 2009, addressing the obligations associated with a breach of unsecured protected health information committed by a “covered entity” or “business associate” and (3) a proposed rule published on July 14, 2010, modifying the HIPAA Privacy, Security, and Enforcement Rules in furtherance of the associated privacy and security related provisions of the HITECH Act. 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.

 

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.

 

We are currently named as one of several defendants in approximately 100 product liability cases, including a lawsuit in Canada seeking class action status, related to a disposable drug infusion pump product (pain pump) manufactured by two third party manufacturers that we distributed through our Bracing and Supports 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. These lawsuits are about equally divided between the two manufacturers. Both manufacturers have rejected our tenders of indemnity. Until early 2010, the base policy for one of the manufacturers was paying for our defense, but that policy has been exhausted by defense costs of the company and the manufacturer and by settlements, and a second policy has been significantly eroded by defense costs of the company and the manufacturer and is expected to be exhausted by settlements in the near future. This manufacturer has ceased operations, has little assets and no additional insurance coverage. The Company has asserted indemnification rights against the successor to this manufacturer and intends to pursue its claims appropriately. The base policy for the other manufacturer has been exhausted and the excess liability carriers for that manufacturer have not accepted coverage for the company or provided for its defense. Our products liability carriers have 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. In August 2010, one of our excess carriers for the period ending July 1, 2010 and for the supplemental extended reporting period (SERP) discussed below, which is insuring $10 million in excess of $25 million, informed us that it has reserved its right to rescind the policy based on an alleged failure by us and our insurance broker to disclose material information. We disagree with this allegation and are

 

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seeking to resolve the issue with this carrier. The lawsuits allege damages ranging from unspecified amounts to claims between $1 million and $10 million. These cases are in varying stages from initial pleading and discovery to pre-trial preparation. 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 unavailable or insufficient to pay the defense costs and settlements or judgments in these cases.

 

In mid-2010, we were named in three multi-plaintiff lawsuits alleging that the plaintiffs had been injured following use of certain cold therapy products manufactured by the Company. These lawsuits are in their early stages and were brought by 16, 11 and 19 plaintiffs, respectively. The complaints are not specific as to the nature of the injuries, but allege various product liability theories, including inadequate warnings regarding the risks associated with the use of cold therapy and failure to incorporate certain safety features into the design. No specific dollar amounts of damages are alleged. We could be exposed to material liabilities if our insurance coverage is not available or inadequate to pay the defense costs and settlements or judgments in these cases.

 

We maintain product liability insurance that is subject to annual renewal. Our current policy covers claims reported between July 1, 2010 and June 30, 2011. No carriers were prepared to cover claims for this reporting period related to the pain pump products described above and therefore our current policies exclude coverage for those products. For the current policy year, we maintain coverage limits (together with excess policies) of up to $50 million, with self-insured retentions of $500,000 per claim for claims relating to our cold therapy units, $500,000 per claim for claims relating to invasive products, $75,000 per claim for claims relating to non-invasive products other than our cold therapy products, and an aggregate self-insured retention of $2.25 million. We purchased SERP coverage for our $80 million limit product liability program that expired on June 30, 2010, and this supplemental coverage is limited to pain pump claims. Except for the additional excess coverage mentioned below, this SERP coverage does not provide additional limits to the aggregate $80 million limit on the expiring program but does provide that the existing limits of the expiring program will remain available for claims reported for an extended period of time. Specifically, pain pump claims may be reported under the $10 million base policy for an indefinite period of time and for a period of five years under the excess layers. We also purchased additional coverage of $25 million excess of $80 million with a five year reporting period. Thus, the SERP coverage has a total limit of $105 million (less amounts paid for claims reported under the expiring program). This coverage is subject to a self-insured retention of $500,000 per claim for claims related to pain pumps, with an aggregate self-insured retention of $1.0 million for all products liability claims under either the expiring program or the SERP program. In addition, the layer of $25 million excess over $55 million has a separate self-insured retention of $50,000 per claim. Our two products liability programs prior to the program that expired on June 30, 2010 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 as well as the expiring program. If our existing products liability insurance proves insufficient to cover our existing or future claims, including those related to the pain pump products discussed above, we could suffer a material adverse impact to our business and results of operations.

 

ITEM 6.  EXHIBITS

 

(a)                    Exhibits

 

3.1

 

Certificate of Formation of DJOFL and amendments thereto (incorporated by reference to Exhibit 3.1 to DJOFL’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007, filed on March 28, 2008).

3.2

 

Limited Liability Company Agreement of DJOFL (incorporated by reference to Exhibit 3.2 to DJOFL’s Registration Statement on Form S-4, filed April 18, 2007 (File No. 333-142188)).

31.1+

 

Certification (pursuant to Securities Exchange Act Rule 13a-14a) by Chief Executive Officer.

31.2+

 

Certification (pursuant to Securities Exchange Act Rule 13a-14a) by Chief Financial Officer.

32.1+

 

Section 1350—Certification (pursuant to Section 906 of the Sarbanes-Oxley Act of 2002) by Chief Executive Officer.

32.2+

 

Section 1350—Certification (pursuant to Section 906 of the Sarbanes-Oxley Act of 2002) by Chief Financial Officer.

 


+          Filed herewith

 

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

DJO FINANCE LLC

 

 

 

Date: November 4, 2010

 

By:

/s/ LESLIE H. CROSS

 

 

 

Leslie H. Cross
President and Chief Executive Officer

 

 

 

Date: November 4, 2010

 

By:

/s/ VICKIE L. CAPPS

 

 

 

Vickie L. Capps
Executive Vice President, Chief Financial Officer and Treasurer

 

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