UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark one)

 

 

 

 

 

x

 

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

 

 

 

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 29, 2007

 

 

 

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 001-16757

 

DJO INCORPORATED

(Exact name of registrant as specified in its charter)

 

DELAWARE

 

33-0978270

(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: (760) 727-1280

 

 

 

Not Applicable

(Former name, former address and former fiscal year, if changed, since last report)

 

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 is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check One):

 

Large accelerated filer  x

Accelerated filer  o

Non-accelerated filer  o

 

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

 

The number of shares of the registrant’s Common Stock outstanding at October 25, 2007 was 23,657,860 shares.

 

 



 

DJO INCORPORATED

FORM 10-Q INDEX

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Balance Sheets as of September 29, 2007 and December 31, 2006

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Statements of Income for the three and nine months ended September 29, 2007 and September 30, 2006

 

 

 

 

 

 

 

Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended September 29, 2007 and September 30, 2006

 

 

 

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

 

 

 

 

 

Item 2.

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

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

 

 

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

 

 

 

 

 

Item 1A.

Risk Factors

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

 

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

 

 

 

 

 

Item 4.

Submission of Matters to a Vote of Security Holders

 

 

 

 

 

 

Item 5.

Other Information

 

 

 

 

 

 

Item 6.

Exhibits

 

 

 

 

 

 

SIGNATURES

 

 

 

2



 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

DJO INCORPORATED

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and par value data)

 

 

 

September 29,
2007

 

December 31,
2006

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

11,956

 

$

7,006

 

Accounts receivable, net of provisions for contractual allowances and doubtful accounts of $49,753 and $38,602 at September 29, 2007 and December 31, 2006, respectively

 

96,348

 

90,236

 

Inventories, net

 

43,422

 

47,214

 

Deferred tax asset, net, current portion

 

10,813

 

10,797

 

Prepaid expenses and other current assets

 

10,730

 

14,521

 

Total current assets

 

173,269

 

169,774

 

Property, plant and equipment, net

 

30,226

 

32,699

 

Goodwill

 

281,176

 

277,495

 

Intangible assets, net

 

144,764

 

160,124

 

Debt issuance costs, net

 

4,899

 

5,634

 

Deferred tax asset, net

 

10,288

 

18,251

 

Other assets

 

5,135

 

4,357

 

Total assets

 

$

649,757

 

$

668,334

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

13,675

 

$

17,338

 

Accrued compensation

 

11,123

 

14,171

 

Accrued commissions

 

4,870

 

4,133

 

Accrued interest

 

3,116

 

3,984

 

Accrued taxes

 

4,148

 

3,738

 

Long-term debt, current portion

 

 

831

 

Other accrued liabilities, current portion

 

18,215

 

22,967

 

Total current liabilities

 

55,147

 

67,162

 

 

 

 

 

 

 

Long-term debt, less current portion

 

285,500

 

326,419

 

Other accrued liabilities, long-term

 

5,354

 

4,484

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.01 par value; 1,000,000 shares authorized, none issued and outstanding at September 29, 2007 and December 31, 2006

 

 

 

Common stock, $0.01 par value; 39,000,000 shares authorized, 23,657,860 shares and 23,317,934 shares issued and outstanding at September 29, 2007 and December 31, 2006, respectively

 

237

 

233

 

Additional paid-in-capital

 

179,863

 

163,711

 

Accumulated other comprehensive income

 

4,009

 

1,984

 

Retained earnings

 

119,647

 

104,341

 

Total stockholders’ equity

 

303,756

 

270,269

 

Total liabilities and stockholders’ equity

 

$

649,757

 

$

668,334

 

 

See accompanying Notes.

 

3



 

DJO INCORPORATED

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(In thousands, except per share data)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 29,
2007

 

September 30,
2006

 

September 29,
2007

 

September 30,
2006

 

 

 

 

 

 

 

 

 

 

 

Net revenues

 

$

119,784

 

$

113,205

 

$

354,869

 

$

302,293

 

Costs of goods sold

 

45,501

 

45,340

 

140,841

 

119,961

 

Gross profit

 

74,283

 

67,865

 

214,028

 

182,332

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Sales and marketing

 

35,621

 

33,398

 

111,795

 

92,375

 

General and administrative

 

11,336

 

13,075

 

35,229

 

35,709

 

Research and development

 

2,018

 

2,580

 

6,185

 

6,745

 

Amortization of acquired intangibles

 

4,503

 

4,510

 

13,490

 

10,651

 

Merger costs

 

2,539

 

 

2,539

 

 

Total operating expenses

 

56,017

 

53,563

 

169,238

 

145,480

 

Income from operations

 

18,266

 

14,302

 

44,790

 

36,852

 

Interest expense, net of interest income

 

(5,321

)

(6,284

)

(16,932

)

(15,684

)

Other income, net

 

322

 

439

 

1,227

 

254

 

Income before income taxes

 

13,267

 

8,457

 

29,085

 

21,422

 

Provision for income taxes

 

(6,552

)

(4,098

)

(12,974

)

(9,790

)

Net income

 

$

6,715

 

$

4,359

 

$

16,111

 

$

11,632

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.28

 

$

0.19

 

$

0.68

 

$

0.51

 

Diluted

 

$

0.28

 

$

0.18

 

$

0.67

 

$

0.50

 

Weighted average shares outstanding used to calculate per share information:

 

 

 

 

 

 

 

 

 

Basic

 

23,641

 

22,968

 

23,536

 

22,620

 

Diluted

 

24,251

 

23,598

 

24,082

 

23,330

 

 

See accompanying Notes.

 

4



 

DJO INCORPORATED

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

 

 

Nine Months Ended

 

 

 

September 29,
2007

 

September 30,
2006

 

 

 

 

 

 

 

Operating activities

 

 

 

 

 

Net income

 

$

16,111

 

$

11,632

 

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

 

 

 

 

 

Provision for contractual allowances and doubtful accounts

 

41,997

 

30,146

 

Provision for excess and obsolete inventories

 

1,473

 

1,167

 

Depreciation and amortization

 

22,595

 

18,645

 

Amortization of debt issuance costs

 

735

 

618

 

Excess tax benefits from stock options exercised

 

(1,819

)

 

Stock-based compensation expense

 

8,058

 

6,836

 

Step-up to fair value of inventory charged to costs of goods sold

 

 

1,498

 

Write-off of debt issuance costs

 

 

2,347

 

Other

 

 

47

 

Changes in operating assets and liabilities, net

 

(41,676

)

(35,927

)

Net cash provided by operating activities

 

47,474

 

37,009

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of property, plant and equipment

 

(5,467

)

(12,485

)

Purchase of businesses, net of cash acquired

 

(5,977

)

(313,634

)

Proceeds from disposal of asset held for sale

 

3,365

 

 

Changes in other assets

 

(1,554

)

(958

)

Net cash used in investing activities

 

(9,633

)

(327,077

)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from long-term debt

 

7,000

 

366,000

 

Repayment of long-term debt

 

(48,750

)

(79,250

)

Debt issuance costs

 

 

(6,328

)

Net proceeds from issuance of common stock

 

6,303

 

12,020

 

Excess tax benefits from stock options exercised

 

1,819

 

 

Net cash (used in) provided by financing activities

 

(33,628

)

292,442

 

Effect of exchange rate changes on cash and cash equivalents

 

737

 

176

 

Net increase in cash and cash equivalents

 

4,950

 

2,550

 

Cash and cash equivalents at beginning of period

 

7,006

 

1,107

 

Cash and cash equivalents at end of period

 

$

11,956

 

$

3,657

 

 

See accompanying Notes.

 

5



 

DJO INCORPORATED

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share data)

 

1.  General

 

Business and Organization

 

DJO Incorporated (the Company) is a global provider of solutions for musculoskeletal and vascular health, specializing in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements as of September 29, 2007 and for the three and nine months ended September 29, 2007 and September 30, 2006 have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006. The accompanying unaudited condensed consolidated financial statements as of September 29, 2007 and for the three and nine months ended September 29, 2007 and September 30, 2006 have been prepared on the same basis as the audited consolidated financial statements and include all adjustments (consisting of normal recurring accruals and the adjustments described in Note 3) which, in the opinion of management, are necessary for a fair presentation of the financial position, operating results and cash flows for the interim date and interim periods presented. Results for the interim periods are not necessarily indicative of the results to be achieved for the entire year or future periods.

 

The accompanying unaudited condensed consolidated financial statements present the historical financial position and results of operations of the Company and include the accounts of its operating subsidiary, DJO, LLC (DJO), DJO’s wholly owned Mexican subsidiary that manufactures a majority of DJO’s products under Mexico’s maquiladora program and DJO’s wholly owned subsidiaries in several international countries. These unaudited condensed consolidated financial statements also include the accounts of Aircast Incorporated and its wholly owned domestic and international subsidiaries from and subsequent to April 7, 2006, the date on which the Company acquired Aircast Incorporated (see Note 3). All intercompany accounts and transactions have been eliminated in consolidation.

 

The preparation of these unaudited condensed consolidated financial statements requires that the Company make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, including those related to contractual allowances, doubtful accounts, inventories, rebates, product returns, warranty obligations, income taxes, goodwill and other intangible assets, and stock based compensation. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.

 

The Company’s fiscal year ends on December 31. Each quarter consists of one five-week and two four-week periods.

 

Cash Equivalents

 

Cash equivalents are short-term, highly liquid investments and consist of investments in money market funds and commercial paper with maturities of three months or less at the time of purchase.

 

Financial Instruments

 

The Company utilizes derivative instruments, specifically an interest rate swap agreement and forward contracts to purchase foreign currencies, to manage its exposure to market risks such as changes in interest rates and foreign currency exchange rates. In accordance with the Financial Accounting Standards Board (FASB) Statement of Financial Accounting Standards (SFAS) No. 133, Accounting for Derivative Instruments and Hedging Activities , the Company records derivative instruments as assets or liabilities in the consolidated balance sheet, measured at fair value.

 

6



 

Per Share Information

 

Earnings per share are computed in accordance with SFAS No. 128, Earnings Per Share . Basic earnings per share are computed using the weighted average number of common shares outstanding during each period. Diluted earnings per share include the dilutive effect of weighted average common share equivalents potentially issuable upon the exercise of stock options. For purposes of computing diluted earnings per share, weighted average common share equivalents (computed using the treasury stock method) do not include stock options with an exercise price that exceeds the average fair market value of the Company’s common stock during the periods presented. The weighted average shares outstanding used to calculate basic and diluted share information consists of the following (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 29,
2007

 

September 30,
2006

 

September 29,
2007

 

September 30,
2006

 

Shares used in computations of basic net income per share – weighted average shares outstanding

 

23,641

 

22,968

 

23,536

 

22,620

 

Net effect of dilutive common share equivalents based on treasury stock method

 

610

 

630

 

546

 

710

 

Shares used in computations of diluted net income per share

 

24,251

 

23,598

 

24,082

 

23,330

 

 

Stock-Based Compensation

 

The Company records compensation expense associated with stock options and other equity-based compensation in accordance with SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123(R)). The Company recognizes these compensation costs on a straight-line basis over the requisite service period of the award, which is generally four years. The Company’s net income for each of the three month periods ended September 29, 2007 and September 30, 2006, have been reduced by stock-based compensation expense, net of taxes, of approximately $2.3 million. The Company’s net income for the nine months ended September 29, 2007 and September 30, 2006, has been reduced by stock-based compensation expense, net of taxes, of approximately $5.5 million and $5.3 million, respectively. See Note 7 for additional information regarding stock-based compensation.

 

Recently Issued Accounting Standards

 

In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes – an interpretation of SFAS No. 109, Accounting for Income Taxes (FIN 48). FIN 48 prescribes a comprehensive model for how companies should recognize, measure, present, and disclose in their financial statements uncertain tax positions taken or expected to be taken on a tax return. Under FIN 48, tax positions shall initially be recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. FIN 48 also revises disclosure requirements to include an annual tabular rollforward of unrecognized tax benefits. The provisions of this interpretation were required to be adopted for fiscal periods beginning after December 15, 2006. The Company adopted FIN 48 on January 1, 2007. See Note 5 for further details.

 

In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements , which provides a single definition of fair value, a framework for measuring fair value, and expanded disclosures concerning fair value. Previously, different definitions of fair value were contained in various accounting pronouncements creating inconsistencies in measurement and disclosures. SFAS No. 157 applies under those previously issued pronouncements that prescribe fair value as the relevant measure of value, except for Statement No. 123(R) and related interpretations and pronouncements that require or permit measurement similar to fair value but are not intended to measure fair value. This pronouncement is effective for fiscal years beginning after November 15, 2007. The Company does not expect the adoption of SFAS No. 157 to have a material impact on its consolidated financial statements.

 

In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities - Including an Amendment of FASB Statement No. 115. This standard permits an entity to choose to measure many financial instruments and certain other items at fair value. Most of the provisions in SFAS No. 159 are elective; however, the amendment to SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities, applies to all entities with available-for-sale and trading securities. The fair value option established by SFAS No. 159 permits all entities to choose to measure eligible items at fair value at specified

 

7



 

election dates. A business entity will report unrealized gains and losses on items for which the fair value option has been elected in earnings (or another performance indicator if the business entity does not report earnings) at each subsequent reporting date. The fair value option: (a) may be applied instrument by instrument, with a few exceptions, such as investments otherwise accounted for by the equity method; (b) is irrevocable (unless a new election date occurs); and (c) is applied only to entire instruments and not to portions of instruments. SFAS No. 159 is effective as of the beginning of an entity’s first fiscal year that begins after November 15, 2007.  The Company does not expect the adoption of SFAS No. 159 to have a material impact on its consolidated financial statements.

 

Foreign Currency Translation

 

The financial statements of the Company’s international subsidiaries, where the local currency is the functional currency, are translated into U.S. dollars using period-end exchange rates for assets and liabilities and average exchange rates during the period for revenues and expenses. Cumulative translation gains and losses are excluded from results of operations and recorded as a separate component of consolidated stockholders’ equity. Gains and losses resulting from foreign currency transactions (transactions denominated in a currency other than the entity’s local currency) are included in the consolidated statements of income as either a component of costs of goods sold or other income or expense, depending on the nature of the transaction. The Company incurred an aggregate foreign currency transaction gain in the three and nine months ended September 29, 2007 of approximately $0.3 million and $0.8 million, respectively. The aggregate foreign currency transaction gain included in determining net income for both the three and nine months ended September 30, 2006 was approximately $0.4 million.

 

Proposed Merger

 

On July 15, 2007, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with ReAble Therapeutics Finance LLC, a Delaware limited liability company (“Parent”), and Reaction Acquisition Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Parent (“Merger Sub”). Parent is controlled by affiliates of The Blackstone Group (“Blackstone”). The Merger Agreement and the transactions contemplated thereby were unanimously approved by the Company’s Board of Directors (the “Board”) and a Transaction Committee of the Board comprised entirely of independent directors and are subject to certain closing conditions, including the approval of the Company’s stockholders. Under the terms of the Merger Agreement, Merger Sub will be merged with and into the Company (the “Merger”), with the Company continuing as the surviving corporation and becoming a wholly-owned subsidiary of Parent. As of the effective time of the Merger, each issued and outstanding share of common stock of the Company will generally be cancelled and converted into the right to receive $50.25 in cash, without interest. The Merger Agreement also provides that, at the effective time of the Merger, each outstanding option to purchase common stock, vested and unvested, will be cancelled and the holders will be entitled to receive a cash payment equal to the excess, if any, of the per share merger price of the option multiplied by the number of shares subject to the option, less applicable withholding taxes. Parent has provided the Company an equity commitment from an affiliate of Blackstone and obtained debt financing commitments, the proceeds of which will provide for the necessary funds to consummate the transactions contemplated by the Merger Agreement. The Merger Agreement provided for a 50-day “go-shop” provision during which the Company was permitted to solicit competing takeover proposals. This go-shop period ended on September 4, 2007 and the Company did not receive any takeover proposals during the go-shop period. Commencing with the completion of the go-shop period, the Company is subject to a “no-shop” provision, which restricts its ability to solicit, discuss or negotiate competing proposals. The no-shop restriction does not apply to any party that submits a written takeover proposal after the go-shop period that the Board determines in good faith constitutes or could reasonably be expected to lead to a “Superior Proposal” as defined in the Merger Agreement, and that failure to enter into discussions or negotiations with such party would reasonably be expected to result in a breach of the Board’s fiduciary duties.

 

The Merger Agreement contains certain termination rights for both the Company, including if the Company receives a takeover proposal that the Board determines in good faith constitutes a Superior Proposal and that failure to terminate would reasonably be expected to result in a breach of its fiduciary duties, and otherwise complies with the terms of the Merger Agreement, and Parent under specified circumstances. The Merger Agreement further provides that, upon termination of the Merger Agreement under specified circumstances, the Company will be required to pay a fee of $37.4 million to Parent. If the Company’s stockholders do not approve the Merger, the Company will be required to reimburse up to $5.0 million of Parent’s expenses. If the Merger does not occur because Parent is unable to obtain debt financing, Parent will be required to pay a fee of $37.4 million to the Company. An affiliate of Blackstone has delivered to the Company a limited guaranty of Parent’s obligation to pay certain amounts under the Merger Agreement (including the $37.4 million fee), up to a maximum amount equal to $100 million. Consummation of the Merger remains subject to several conditions, including the adoption of the Merger Agreement by the Company’s stockholders, the absence of certain legal impediments and other customary closing conditions. Subject to the completion of these closing conditions, the proposed merger is expected to close in the fourth quarter of 2007.

 

8



 

On August 31, 2007 and September 6, 2007, two purported shareholder class action lawsuits were filed in California Superior Court, in the County of San Diego, on behalf of the Company’s public stockholders, challenging the Company’s proposed merger with Parent. The court ordered the two lawsuits consolidated for all purposes on September 21, 2007. See Note 8 for further details.

 

Merger Costs

 

Merger costs of $2.5 million included in the accompanying statements of income for the three and nine months ended September 29, 2007 consist of certain costs related to the proposed merger with ReAble Therapeutics Finance LLC discussed above.

 

2.  Financial Statement Information

 

Inventories consist of the following (in thousands):

 

 

 

September 29,
2007

 

December 31,
2006

 

 

 

 

 

 

 

Raw materials

 

$

16,183

 

$

17,920

 

Work-in-progress

 

1,435

 

753

 

Finished goods

 

28,432

 

30,615

 

 

 

46,050

 

49,288

 

Less reserves, primarily for excess and obsolete inventories

 

(2,628

)

(2,074

)

Inventories, net

 

$

43,422

 

$

47,214

 

 

Prepaid expenses and other current assets consist of the following (in thousands):

 

 

 

September 29,
2007

 

December 31,
2006

 

 

 

 

 

 

 

Held-for-sale assets

 

$

1,904

 

$

6,960

 

Prepaid expenses

 

5,374

 

4,050

 

Other current assets

 

3,452

 

3,511

 

Prepaid expenses and other current assets, net

 

$

10,730

 

$

14,521

 

 

Held-for-sale assets as of September 29, 2007 consisted of the Aircast Germany facility. Held-for-sale assets as of December 31, 2006 also included the Aircast manufacturing facility in New Jersey. These held-for-sale facilities were vacated in connection with the Company’s integration of the Aircast business and are no longer in use. In August 2007, the Company sold the former Aircast manufacturing building and land in New Jersey for net proceeds of $3.4 million.

 

Other accrued liabilities, current portion, consists of the following (in thousands):

 

 

 

September 29,
2007

 

December 31,
2006

 

 

 

 

 

 

 

Accrued contract fees

 

$

3,997

 

$

2,626

 

Accrued professional fees

 

1,607

 

1,326

 

Deferred rent, current portion

 

474

 

453

 

Other accrued liabilities, current portion

 

12,137

 

18,562

 

Other accrued liabilities, current portion

 

$

18,215

 

$

22,967

 

 

9



 

Other accrued liabilities, long-term, consists of the following (in thousands):

 

 

 

September 29,
2007

 

December 31,
2006

 

 

 

 

 

 

 

Deferred rent, long-term

 

$

3,301

 

$

3,355

 

Fair value of interest rate swap

 

1,782

 

928

 

Accrued pension

 

271

 

201

 

Other accrued liabilities, long-term

 

$

5,354

 

$

4,484

 

 

Deferred rent relates primarily to the Company’s headquarters in Vista, California.

 

3.  Acquisitions and Investments

 

Aircast Acquisition

 

On April 7, 2006, the Company completed the acquisition, under an agreement signed on February 27, 2006, of all the outstanding capital stock of Aircast Incorporated (Aircast) for approximately $291.6 million in cash. The Company also incurred approximately $4.9 million in transaction costs and other expenses in connection with the acquisition and accrued approximately $10.5 million of estimated costs in connection with the Company’s plan to integrate the acquired business, including severance expenses.

 

In April 2006, the Company began its integration of the Aircast business. The integration plan consisted of:  1) integrating the Aircast sales force into the Company’s existing sales force, 2) closing the Aircast New Jersey manufacturing facility and moving the manufacturing of the Aircast products to the Company’s Tijuana, Mexico manufacturing facility, with the exception of Aircast’s vascular systems products, which were moved to the Company’s Vista, California facility, 3) closing the Aircast New Jersey corporate headquarters and integrating the administrative functions into the Company’s Vista facility and the Company’s distribution facility in Indianapolis, Indiana, and 4) closing various international Aircast locations and integrating their operations into the Company’s existing locations in those countries including France, Germany and the United Kingdom. In conjunction with this integration plan, the Company accrued approximately $10.8 million in severance costs for approximately 300 Aircast employees. The Company completed the termination of the affected Aircast employees in March 2007. Of this total estimated amount, approximately $2.0 million of severance payments have not been paid out as of September 29, 2007, and are not expected to be fully paid out until the first quarter of 2008. This amount is included in accrued compensation in the accompanying unaudited consolidated balance sheet at September 29, 2007.

 

Severance costs accrued as of September 29, 2007 for Aircast employees as a result of the Company’s integration of the acquired business are as follows (in thousands):

 

 

 

Total Costs
Incurred

 

Cash
Payments

 

Accrued Liability At
September 29, 2007

 

Employee severance

 

$

10,752

 

$

(8,744

)

$

2,008

 

 

10



 

The accompanying consolidated statements of income reflect the operating results of the Aircast business since April 7, 2006. Assuming the acquisition of Aircast had occurred on January 1, 2006, the pro forma unaudited results of operations would have been as follows (in thousands):

 

 

 

Nine Months
Ended
September 30,
2006

 

Net revenues

 

$

327,215

 

Net income

 

$

9,626

 

Net income per share:

 

 

 

Basic

 

$

0.43

 

Diluted

 

$

0.41

 

Weighted average shares outstanding used to calculate per share information:

 

 

 

Basic

 

22,620

 

Diluted

 

23,330

 

 

The above pro forma unaudited results of operations do not include pro forma adjustments relating to costs of integration or post-integration cost reductions that might have been incurred or realized by the Company in excess of actual amounts incurred or realized through September 30, 2006.

 

Purchase of Rights to Distributor Territories

 

From time to time the Company purchases rights to certain distributor territories in the U.S. and then sells the distribution rights to another party for similar amounts. These distribution reorganizations are intended to achieve several objectives, including improvement of sales results within the affected territories. The Company generally receives promissory notes for the resale amounts, which are recorded as notes receivable and included in other current and long-term assets in the accompanying unaudited consolidated balance sheet. For the nine months ended September 29, 2007, the Company purchased and resold territory rights for amounts aggregating $1.4 million and did not record any material gains or losses from the transfer of these distribution rights.

 

Full90 Note Investment

 

In March 2007, the Company entered into a Note Purchase Agreement (“Agreement”) with Full90 Sports, Inc. (“Full90”) under which the Company agreed to loan to Full90 a total of $1.5 million in exchange for a Secured Convertible Promissory Note (“Note”). The Note bears interest at the rate of 12% per annum, with accrued interest payable quarterly and all principal payable on the third anniversary of the Note. The Note is secured by all assets of Full90 and is convertible at the option of the Company into 2,573,781 shares of Series C Preferred Stock of Full90, representing approximately 14% of the equity of Full90. The Agreement provides that, prior to conversion of the Note, the Company shall have the right of first refusal on any acquisition of Full90 and on future debt or equity financings by Full90. Full90 is a manufacturer of orthopedic products, including a patented protective soccer headgear, and has appointed the Company a world-wide distributor of the protective soccer headgear. The Note is included in other long-term assets in the accompanying unaudited consolidated balance sheet.

 

4.  Comprehensive Income

 

Comprehensive income consists of the following components (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 29,
2007

 

September 30,
2006

 

September 29,
2007

 

September 30,
2006

 

 

 

 

 

 

 

 

 

 

 

Net income, as reported

 

$

6,715

 

$

4,359

 

$

16,111

 

$

11,632

 

Foreign currency translation adjustment

 

1,694

 

(53

)

2,879

 

1,521

 

Change in fair value of interest rate swap

 

(1,769

)

(2,208

)

(854

)

(1,197

)

Comprehensive income

 

$

6,640

 

$

2,098

 

$

18,136

 

$

11,956

 

 

11



 

5.  Income Taxes

 

As discussed in Note 1, the Company adopted the provisions of FIN 48 on January 1, 2007. No previously unrecognized tax benefits were recorded as of the date of adoption. As a result of the implementation of FIN 48, the Company recognized a $1.4 million increase in unrecognized tax benefits. A portion of the transition adjustment related to historical exposures of the Company and was recorded as permitted by FIN 48 as a reduction of retained earnings in the amount of approximately $0.8 million. A portion of the transition adjustment related to Aircast exposures created prior to the Company’s acquisition of Aircast and was therefore recorded as an increase of approximately $0.6 million in goodwill related to the Aircast acquisition. The offset of the transition adjustment was recorded as a reduction to deferred tax assets and additional taxes payable.

 

The transition adjustment included approximately $0.2 million of interest and approximately $0.1 million of penalties related to the unrecognized tax benefits. Interest costs and penalties related to income taxes are classified as part of the income tax provision in the Company’s financial statements.

 

Of the transition adjustment, a portion related to estimated possible transfer pricing exposures. Such estimates will be evaluated each quarter based on changes to transfer pricing and changes in foreign exchange rates. An estimate of the range of reasonably possible future changes cannot be made. United States federal and most state tax returns for all years after 2002 are subject to future examination by tax authorities. Open tax years for foreign jurisdictions vary.

 

The Company’s balance of unrecognized tax benefits as of September 29, 2007 remained unchanged at $1.4 million. There were no changes required to be made to the balance as there were no new tax positions taken by the Company during the current period, no settlements with taxing authorities and no lapses of applicable statutes of limitations. Included in the balance of unrecognized tax benefits is $0.8 million of tax benefits that, if recognized, would impact the effective tax rate.  Also included in the balance of unrecognized tax benefits is $0.6 million of tax benefits that, if recognized, would result in adjustments to other tax accounts, primarily deferred taxes and goodwill.

 

6. Segment and Related Information

 

The following are the Company’s reportable segments.

 

                  Domestic Rehabilitation consists of the sale of the Company’s rehabilitation products (rigid knee braces, soft goods, cold therapy and vascular systems products) in the United States through three sales channels, DonJoy, ProCare/Aircast and OfficeCare.

 

Through the DonJoy sales channel, the Company sells its rehabilitation products utilizing a few of the Company’s direct sales representatives and a network of approximately 392 independent commissioned sales representatives who are employed by approximately 44 independent sales agents. These sales representatives are primarily dedicated to the sale of the Company’s products to orthopedic surgeons, podiatrists, orthopedic and prosthetic centers, hospitals, surgery centers, physical therapists, athletic trainers and other healthcare professionals. Because certain of the DonJoy product lines require customer education on the application and use of the product, these sales representatives are technical specialists who receive extensive training both from the Company and the agent and use their expertise to help fit the patient with the product and assist the orthopedic professional in choosing the appropriate product to meet the patient’s needs. After a product order is received by a sales representative, the Company generally ships the product directly to the orthopedic professional and pays a sales commission to the agent. These commissions are reflected in sales and marketing expense in the Company’s consolidated financial statements. For certain custom rigid braces and other products, the Company sells directly to the patient and bill a third-party payor, if applicable, on behalf of the patient. The Company refers to this portion of its DonJoy channel as its Insurance channel.

 

Through the ProCare/Aircast sales channel, which is comprised of approximately 100 direct and independent representatives that manage over 380 dealers focused on primary and acute facilities, the Company sells its rehabilitation products to national third-party distributors, other regional medical supply dealers and medical product buying groups, generally at a discount from list prices. The majority of these products are soft goods which require little or no patient education. The distributors and dealers generally resell these products to large hospital chains, hospital buying groups, primary care networks and orthopedic physicians for use by the patients.

 

12



 

Through the OfficeCare sales channel, the Company maintains an inventory of rehabilitation products (mostly soft goods) on hand at orthopedic practices for immediate distribution to the patient. For these products, the Company arranges billing to the patient or third-party payor after the product is provided to the patient. As of September 29, 2007, the OfficeCare program was located at over 1,200 physician offices throughout the United States. The Company has contracts with over 750 third-party payors.

 

                  Regeneration consists of the sale of the Company’s bone growth stimulation products in the United States. The Company’s OL1000 product is sold through a combination of the DonJoy channel direct sales representatives and approximately 155 additional sales representatives dedicated to selling the OL1000 product, of which approximately 67 are employed by the Company. The SpinaLogic product is also included in this segment and is sold through a combination of several independent companies focused on selling spine products, including DePuy Spine and International Rehabilitative Science’s Inc. (which does business as RS Medical), and certain direct sales representatives. These products are sold either directly to the patient or to independent distributors. The Company arranges billing to the third-party payors or patients, for products sold directly to the patient.

 

                  International consists of the sale of the Company’s products in foreign countries through wholly owned subsidiaries or independent distributors. The Company sells its products in over 75 foreign countries, primarily in Europe, Canada, Japan and Australia.

 

Set forth below are net revenues, gross profit and operating income for the Company’s reporting segments for the three and nine months ended September 29, 2007 and September 30, 2006 (in thousands). This information excludes the impact of expenses not allocated to segments, which are comprised primarily of general corporate expenses.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 29,

 

September 30,

 

September 29,

 

September 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Net revenues:

 

 

 

 

 

 

 

 

 

Domestic rehabilitation

 

$

74,935

 

$

74,640

 

$

219,842

 

$

196,506

 

Regeneration

 

19,105

 

15,767

 

55,878

 

47,953

 

International

 

25,744

 

22,798

 

79,149

 

57,834

 

Consolidated net revenues

 

119,784

 

113,205

 

354,869

 

302,293

 

 

 

 

 

 

 

 

 

 

 

Gross profit:

 

 

 

 

 

 

 

 

 

Domestic rehabilitation

 

39,897

 

38,915

 

112,346

 

102,967

 

Regeneration

 

17,705

 

14,428

 

51,675

 

44,213

 

International

 

16,681

 

14,522

 

50,007

 

35,152

 

Consolidated gross profit

 

74,283

 

67,865

 

214,028

 

182,332

 

 

 

 

 

 

 

 

 

 

 

Income from operations:

 

 

 

 

 

 

 

 

 

Domestic rehabilitation

 

12,155

 

11,033

 

24,821

 

30,310

 

Regeneration

 

6,111

 

3,139

 

16,538

 

10,560

 

International

 

6,261

 

4,530

 

18,396

 

8,851

 

Income from operations of reportable segments

 

24,527

 

18,702

 

59,755

 

49,721

 

Expenses not allocated to segments

 

(6,261

)

(4,400

)

(14,965

)

(12,869

)

Consolidated income from operations

 

$

18,266

 

$

14,302

 

$

44,790

 

$

36,852

 

 

 

 

 

 

 

 

 

 

 

Number of operating days

 

63

 

63

 

191

 

191

 

 

The accounting policies of the reportable segments are the same as the accounting policies of the Company. The Company allocates resources and evaluates the performance of segments based on income from operations and therefore has not disclosed certain other items, such as interest, depreciation and amortization by segment. The Company does not allocate assets to reportable segments because a significant portion of assets are shared by the segments.

 

13



 

For the three and nine months ended September 29, 2007 and September 30, 2006, the Company had no individual customer or distributor that accounted for 10% or more of total revenues.

 

Net revenues, attributed to the geographic location of the customer, were as follows (in thousands):

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 29,
2007

 

September 30,
2006

 

September 29,
2007

 

September 30,
2006

 

 

 

 

 

 

 

 

 

 

 

United States

 

$

94,040

 

$

90,407

 

$

275,720

 

$

244,459

 

Europe

 

19,713

 

17,732

 

61,641

 

45,784

 

Other countries

 

6,031

 

5,066

 

17,508

 

12,050

 

Total consolidated net revenues

 

$

119,784

 

$

113,205

 

$

354,869

 

$

302,293

 

 

Total assets by region were as follows (in thousands):

 

 

 

September 29,
2007

 

December 31,
2006

 

United States

 

$

594,119

 

$

619,599

 

International

 

55,638

 

48,735

 

Total consolidated assets

 

$

649,757

 

$

668,334

 

 

7. Stock-Based Compensation

 

The Company has three stock option plans which provide for the issuance of options to employees, officers, directors and consultants:  the 2001 Omnibus Plan, the 1999 Option Plan and the 2001 Non-Employee Director’s Stock Option Plan (Stock Option Plans). Eligible employees can also purchase shares of the Company’s common stock at 85% of its fair market value on either the first day or the last day, whichever reflects the lowest fair market price, of each six-month offering period under the Company’s Employee Stock Purchase Plan (ESPP). Stock options granted under the Stock Option Plans have terms of up to ten years from the date of grant, and generally vest over a four-year period. The expense recognized under SFAS No. 123(R) is recognized on a straight-line basis over the vesting period. As of September 29, 2007, approximately 4.6 million shares were available for grant under the Stock Option Plans and 1.4 million shares were available for issuance under the ESPP.

 

The Company’s worldwide effective tax rate increased in connection with its adoption of SFAS No. 123(R) as of January 1, 2006. The aggregate SFAS No. 123(R) compensation expense results in a reduced tax benefit rate due to the required tax accounting for the mix of the Company’s outstanding and unvested incentive stock options and non-qualified stock options.

 

The fair value of each equity award is estimated on the date of grant using the Black-Scholes valuation model for option pricing using the assumptions noted in the following table. Expected volatility rates are based on the historical volatility (using daily pricing) of the Company’s stock. In accordance with SFAS No. 123(R), the Company reduces the calculated Black-Scholes value by applying a forfeiture rate, based upon historical pre-vesting option cancellations. The expected term of options granted is estimated

 

14



 

based on a number of factors, including the vesting term of the award, historical employee exercise behavior for both options that have run their course and outstanding options, the expected volatility of the Company’s stock and an employee’s average length of service. The risk-free interest rate is determined based upon a constant U.S. Treasury security rate with a contractual life that approximates the expected term of the option award.

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 29,
2007

 

September 30,
2006

 

September 29,
2007

 

September 30,
2006

 

Stock Option Plans:

 

 

 

 

 

 

 

 

 

Expected volatility

 

43.2

%

49.5

%

45.4

%

49.5

%

Risk-free interest rate

 

4.1

%

4.7

%

4.7

%

4.7

%

Forfeitures

 

8.0

%

7.5

%

8.0

%

7.5

%

Dividend yield

 

 

 

 

 

Expected term (in years)

 

4.1

 

3.7

 

4.0

 

3.7

 

Employee Stock Purchase Plan:

 

 

 

 

 

 

 

 

 

Expected volatility

 

38.4

%

31.0

%

38.4

%

38.0

%

Risk-free interest rate

 

4.6

%

5.2

%

4.6

%

4.9

%

Dividend yield

 

 

 

 

 

Expected term (in years)

 

0.5

 

0.5

 

0.5

 

0.5

 

 

The following table summarizes option activity under all plans from December 31, 2006 through September 29, 2007:

 

 

 

Number of Shares

 

Price per Share

 

Weighted
Average
Exercise Price
per Share

 

Weighted
Average
Remaining Life
in Years

 

Outstanding at December 31, 2006

 

2,649,790

 

$ 3.52 - $44.09

 

 

$

25.99

 

6.9

 

Granted

 

59,300

 

41.72 - 41.99

 

 

41.94

 

N/A

 

Exercised

 

(195,308

)

3.96 - 26.65

 

 

15.39

 

N/A

 

Cancelled/Expired/Forfeited

 

(104,575

)

3.76 - 41.99

 

 

32.24

 

N/A

 

Outstanding at March 31, 2007

 

2,409,207

 

3.52 - 44.09

 

 

26.97

 

7.8

 

Granted

 

539,500

 

39.07 - 39.99

 

 

39.85

 

N/A

 

Exercised

 

(86,999

)

4.05 - 39.40

 

 

18.19

 

N/A

 

Cancelled/Expired/Forfeited

 

(23,800

)

3.52 - 39.40

 

 

32.63

 

N/A

 

Outstanding at June 30, 2007

 

2,837,908

 

3.52 - 44.09

 

 

29.64

 

8.0

 

Granted

 

 

   N/A

 

 

N/A

 

N/A

 

Exercised

 

(29,925

)

4.05 - 39.40

 

 

24.73

 

N/A

 

Cancelled/Expired/Forfeited

 

(1,500

)

  39.40

 

 

39.40

 

N/A

 

Outstanding at September 29, 2007

 

2,806,483

 

3.52 - 44.09

 

 

29.69

 

7.8

 

Exercisable at September 29, 2007

 

1,067,814

 

3.52 - 41.72

 

 

22.33

 

6.7

 

Remaining reserved for grant at September 29, 2007

 

4,646,162

 

 

 

 

 

 

 

 

 

The aggregate intrinsic value of options outstanding at September 29, 2007 was approximately $54.5 million and the aggregate intrinsic value of options exercisable at September 29, 2007 was approximately $28.6 million. The total intrinsic value of options exercised during the three and nine months ended September 29, 2007 was approximately $0.7 million and $7.3 million, respectively. The weighted-average fair value per share for options that were not vested at December 31, 2006, not vested at March 31, 2007, vested during the three months ended March 31, 2007 and cancelled/expired/forfeited during the three months ended March 31, 2007, were $30.33, $31.69, $14.79 and $32.24, respectively. The weighted-average fair value per share for options that were not vested at December 31, 2006, not vested at June 30, 2007, vested during the three months ended June 30, 2007 and cancelled/expired/forfeited during the three months ended June 30, 2007, were $30.33, $33.56, $36.37 and $32.63, respectively. The weighted-average fair value per share for options that were not vested at December 31, 2006, not vested at September 29, 2007, vested during the three months ended September 29, 2007 and cancelled/expired/forfeited during the three months ended September 29, 2007, were $30.33, $34.21, $20.62 and $39.40, respectively. At September 29, 2007, there was approximately $20.1 million of

 

15



 

compensation expense that had not yet been recognized related to non-vested stock-based awards. That expense is expected to be recognized over a weighted-average period of 1.4 years, subject to the impact of the merger agreement discussed below. During the three months ended September 29, 2007, cash received from options exercised was $0.7 million.

 

The merger agreement discussed in Note 1 above provides that, except as otherwise agreed in writing by the holder and Parent (as defined in Note 1), each outstanding option to purchase common stock under the Stock Option Plans, vested or unvested, will be cancelled and only entitle the holder to receive a cash payment equal to the excess, if any, of the per share merger consideration over the per share exercise price of the applicable stock option, multiplied by the number of shares subject to the stock option, less any applicable taxes required to be withheld. In accordance with the merger agreement, immediately prior to the merger closing date there will be an early termination of the offering period, under the ESPP, that began on July 1, 2007 and participants’ payroll deductions will be applied to purchase shares in accordance with the terms of the ESPP. These shares will be treated in the same manner as the Company’s other outstanding common stock in the merger. The ESPP will terminate immediately prior to the closing of the merger.

 

8.  Contingencies

 

From time to time, the Company is involved in legal and administrative disputes and proceedings arising in the ordinary course of business. With respect to these matters, management believes that it has adequate insurance coverage or has made adequate accruals for related costs, and it may also have effective legal defenses. The Company is not aware of any pending proceedings or lawsuits that could have a material adverse effect on its business, financial condition and results of operations. As part of its business as a government supplier, both for Medicare and Medicaid beneficiaries and under contracts with veterans and other military agencies, the Company is subject to periodic audits of its billing and pricing practices and of its general compliance to contract terms and regulatory requirements, and the Company is exposed to claims of recovery and related fines and penalties if these audits reveal noncompliance. One of the Company’s supply contracts with a government agency has expired, and the Company has requested the government to permit the products sold under the expired contract to be moved to a comparable contract held by Aircast and to be sold under that contract. The agency will review compliance by the Company of its pricing obligations during the past five-year term of the expiring contract. Although the Company believes that it has been in material compliance with those obligations, no assurance can be given that the agency will agree with the Company’s analysis or that it will not seek repayment based on pricing discrepancies.

 

Pending Stockholder Litigation

 

On August 31, 2007 and September 6, 2007, two purported shareholder class action lawsuits were filed in California Superior Court, in the County of San Diego, on behalf of the Company’s public stockholders, challenging the Company’s proposed merger with Parent. The court ordered the two lawsuits consolidated for all purposes on September 21, 2007. The court further ordered that plaintiffs shall file a consolidated amended complaint as soon as practicable, and that the defendants need not respond to either of the two original complaints.

 

The two original complaints named the Company, ReAble Therapeutics, Inc., an affiliate of Parent, and the current members of the Company’s board of directors as defendants. One of the original complaints also named Blackstone as a defendant. The two substantially similar original complaints alleged, among other things, that the individual defendants breached their fiduciary duties of care, good faith and loyalty by approving the proposed merger with an allegedly inadequate price, without adequately informing themselves of the Company’s highest transactional value, and without adequately marketing the company to other potential buyers. The original complaints also alleged that the individual defendants and the Company failed to make full and adequate disclosures in the preliminary proxy statement regarding the proposed merger. The original complaints pray for, among other things, class certification, declaratory relief, an injunction of the proposed merger or a rescission order, corrective disclosures to the proxy statement, damages, interest, attorneys’ fees, expert fees and other costs; and such other relief as the court may find just and proper.

 

Discovery is ongoing and the parties have stipulated to a November 2, 2007 hearing on plaintiffs’ preliminary injunction motion, and a related briefing schedule. The Company believes that the lawsuit is without merit and intends to vigorously oppose it.

 

9.  Subsequent Event

 

In October 2007, in anticipation of the repayment of all amounts outstanding under the Company’s credit agreement in connection with the completion of its pending merger with ReAble Therapeutics Finance LLC, the Company paid $2.1 million to terminate its interest rate swap agreement.

 

16



 

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

 

The following discussion should be read in conjunction with our historical consolidated financial statements and the related notes thereto and the other financial data included in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2006.

 

Forward-Looking Statements

 

This quarterly report on Form 10-Q contains, in addition to historical information, statements by us with respect to our expectations regarding financial results and other aspects of our business that involve risks and uncertainties and may constitute forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These statements reflect our current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including, the risks discussed under Item 1A “Risk Factors” in this Form 10-Q. If the expectations or assumptions underlying our forward-looking statements prove inaccurate or if risks or uncertainties arise, actual results could differ materially from those predicted in any forward-looking statement.

 

Overview

 

We are a global provider of solutions for musculoskeletal and vascular health, specializing in rehabilitation and regeneration products for the non-operative orthopedic, spine and vascular markets. Our broad range of over 750 rehabilitation products, including rigid knee braces, soft goods, and cold therapy products, are used in the prevention of injury, in the treatment of chronic conditions and for recovery after surgery or injury. Our regeneration products consist of bone growth stimulation devices that are used to treat nonunion fractures and as an adjunct therapy after spinal fusion surgery. Our vascular systems products help prevent deep vein thrombosis and pulmonary embolism that can occur after orthopedic and other surgeries. We sell our products in the United States and in more than 75 other countries through networks of agents, distributors and our direct sales force that market our products to orthopedic and spine surgeons, podiatrists, orthopedic and prosthetic centers, third-party distributors, hospitals, surgery centers, physical therapists, athletic trainers and other healthcare professionals. Our rigid knee braces, soft goods, cold therapy, regeneration and vascular systems products represented 21%, 51%, 8%, 16% and 4%, respectively, of our consolidated net revenues for the first nine months of 2007.

 

Segments

 

The following are our reportable segments.

 

                  Domestic Rehabilitation consists of the sale of our rehabilitation products (rigid knee braces, soft goods, cold therapy and vascular systems products) in the United States through three sales channels, DonJoy, ProCare/Aircast and OfficeCare.

 

Through the DonJoy sales channel, we sell our rehabilitation products utilizing a few of our direct sales representatives and a network of approximately 392 independent commissioned sales representatives who are employed by approximately 44 independent sales agents. These sales representatives are primarily dedicated to the sale of our products to orthopedic surgeons, podiatrists, orthopedic and prosthetic centers, hospitals, surgery centers, physical therapists, athletic trainers and other healthcare professionals. Because certain of the DonJoy product lines require customer education on the application and use of the product, these sales representatives are technical specialists who receive extensive training both from us and the agent and use their expertise to help fit the patient with the product and assist the orthopedic professional in choosing the appropriate product to meet the patient’s needs. After a product order is received by a sales representative, we generally ship the product directly to the orthopedic professional and pay a sales commission to the agent. These commissions are reflected in sales and marketing expense in our consolidated financial statements. For certain custom rigid braces and other products, we sell directly to the patient and bill a third-party payor, if applicable, on behalf of the patient. We refer to this portion of our DonJoy channel as our Insurance channel.

 

Through the ProCare/Aircast sales channel, which is comprised of approximately 100 direct and independent representatives that manage over 380 dealers focused on primary and acute facilities, we sell our rehabilitation products to national third-party distributors, other regional medical supply dealers and medical product buying groups, generally at a discount from list prices. The majority of these products are soft goods which require little or no patient education.

 

17



 

The distributors and dealers generally resell these products to large hospital chains, hospital buying groups, primary care networks and orthopedic physicians for use by the patients.

 

Through the OfficeCare sales channel, we maintain an inventory of rehabilitation products (mostly soft goods) on hand at orthopedic practices for immediate distribution to the patient. For these products, we arrange billing to the patient or third-party payor after the product is provided to the patient. As of September 29, 2007, the OfficeCare program was located at over 1,200 physician offices throughout the United States. We have contracts with over 750 third-party payors.

 

                  Regeneration consists of the sale of our bone growth stimulation products in the United States. Our OL1000 product is sold through a combination of the DonJoy channel direct sales representatives and approximately 155 additional sales representatives dedicated to selling the OL1000 product, of which approximately 67 are employed by us. The SpinaLogic product is also included in this segment and is sold through a combination of several independent companies focused on selling spine products, including DePuy Spine and International Rehabilitative Science’s Inc. (does business as RS Medical), and certain of our direct sales representatives. These products are sold either directly to the patient or to independent distributors. We arrange billing to the third-party payors or patients, for products sold directly to the patient.

 

                  International consists of the sale of our products in foreign countries through wholly owned subsidiaries or independent distributors. We sell our products in over 75 foreign countries, primarily in Europe, Canada, Japan and Australia.

 

Our Strategy

 

Our strategy is to increase revenues and profitability and enhance cash flow by strengthening our market leadership position. Our key initiatives to implement this strategy include:

 

                  Increase our Lead in the Domestic Rehabilitation Market Segment. We believe we are the market leader in the Domestic Rehabilitation markets in which we compete. We believe we will be able to continue to grow our Domestic Rehabilitation business segment and increase our market share further by focusing on maintaining a continuous flow of new product introductions and continuing to enhance the productivity of our sales force and optimize our distribution strategy. Our key Domestic Rehabilitation growth strategies include the following:

 

Introduce New Products and Product Enhancements. We have a history of developing and introducing innovative products into the marketplace, and are committed to continuing that tradition by introducing new products across our product platform. In the twelve months ended September 29, 2007, we launched 15 new products. We believe that product innovation through effective and focused research and development will provide a sustainable competitive advantage. We believe we are currently a technology leader in several product categories and we intend to continue to develop next generation technologies.

 

Increase Sales Force Productivity. We have integrated the Aircast sales force into our existing sales organization and focused its various elements on specific targeted customers. Our sales representatives generally have a targeted customer base and a broad product offering for those customers. For example, the DonJoy sales force focuses on orthopedic and podiatry offices, orthotists, and athletic trainers, while the Aircast and ProCare sales force concentrates primarily on hospitals and third party distributors. With our focused sales organization and a sales compensation plan in place to incentivize all the sales representatives to sell the full range of products we offer, we believe that we can encourage cross-selling and increase the productivity of the entire sales force.

 

Expand Our OfficeCare and Insurance Channels. Through OfficeCare, we maintain an inventory of product (mostly soft goods) on hand at orthopedic practices for immediate distribution to the patient. For these products, we bill the patient or third-party payor after the product is provided to the patient. Through our Insurance channel, we also provide our custom knee braces and certain other products directly to patients and bill the patient or the patient’s third-party payor. Our OfficeCare and Insurance channels currently cover over 1,200 physician offices encompassing over 4,800 physicians. We believe that our OfficeCare and Insurance channels serve a growing need among orthopedic practices to improve inventory management and patient

 

18



 

service. Expanding our OfficeCare and Insurance channels also permits us to increase our weighted-average selling prices, as the units sold through these channels are billed to insurance companies and other third-party payors at higher prices than units sold through most of our other sales channels. Accordingly, our OfficeCare and Insurance initiatives represent opportunities for sales growth based on increases in both unit volume and average selling prices. We intend to expand our OfficeCare and Insurance channels into more large orthopedic offices, thereby increasing the number of potential customers to whom we sell our products. In the three months ended September 29, 2007, we added approximately 33 new offices to our OfficeCare and Insurance channels, net of account terminations.

 

Maximize Existing and Secure Additional National Accounts. We plan to capitalize on the growing practice in healthcare in which hospitals and other large healthcare providers seek to consolidate their purchasing activities to national buying groups. Contracts with these national accounts represent a significant opportunity for sales growth. We believe that our broad range of products is well suited to the goals of these buying groups and intend to aggressively pursue these contracts. In the twelve months ended September 29, 2007, we signed or renewed five significant national contracts; including a new three-year sole source contract with Consorta, Inc. for all of our bracing and soft goods products, a new private label contract with Amerinet, Inc. for our pain management and cold therapy products, a renewal of our sole source contract with Broadlane, Inc. for all of our soft goods, bracing and cold therapy products, a renewal of our multi-source agreement with Premier Purchasing Partners, L.P. for all of our bracing, soft goods, cold therapy and BGS products, and a renewal of our sole source bracing agreement with Healthtrust Purchasing Group, L.P. In addition, we successfully added Aircast products to each of these national contracts.

 

                  Grow Our Regeneration Business. We have increased the number of regeneration sales specialists dedicated to selling our OL1000 BGS product, and we have aligned these specialists with our DonJoy sales force. We believe these specialists will be able to use the established relationships of our DonJoy sales representatives to enhance sales of the OL1000 product. Our distribution arrangement with DePuy Spine became non-exclusive beginning in March 2006, permitting us to sell our SpinaLogic BGS product through our own sales representatives or other independent sales representatives in all territories where we choose to do so. We have added additional selling resources in those geographical parts of the country where sales were not meeting our expectations. We believe our patented Combined Magnetic field technology has features that make our BGS products significantly easier for patients to use than our competitors’ products. We believe that our new selling strategies for our Regeneration segment and our technology advantages will permit us to maintain or improve our growth in this business.

 

                  Expand International Sales . Since 2002, we have successfully established direct distribution capabilities in several major international markets. We believe that sales to foreign markets continue to represent a significant growth opportunity, and we intend to continue to develop direct distribution capabilities in selected additional foreign markets. We also believe we can increase our international revenues by expanding the number of our products we sell in international markets. Historically, we sold only a limited range of our products in our international markets. Beginning in 2005, we began to focus on selling an expanded range of soft goods, our cold therapy products and our BGS products in our International segment. In 2006, we completed the Axmed acquisition, which increased our international revenues in France. The Aircast acquisition, in April 2006, also substantially increased our international revenues, especially in Germany, France, the United Kingdom and Canada. Effective in April 2007, we began to directly distribute our products in two new markets, Italy and the Benelux countries. For the nine months ended September 29, 2007, international sales increased to 22.3% of our revenues.

 

                  Pursue Selective Acquisitions . We believe that acquisitions represent an attractive and efficient means to broaden our product lines, expand our geographic reach and increase our revenues and profitability. We intend to pursue acquisition opportunities that enhance sales growth, are accretive to earnings, increase customer penetration and/or provide geographic diversity. Since the beginning of 2005, we have completed four acquisitions, all of which we believe met these criteria: our acquisition of substantially all of the assets of Superior Medical Equipment, LLC (SME acquisition) and our acquisition of substantially all of the assets of the orthopedics soft goods business of Encore Medical, L.P. (OSG acquisition), both of which were completed in 2005, as well as the Axmed acquisition in January 2006 and the Aircast acquisition in April 2006.

 

19



 

Recent Developments

 

On July 15, 2007, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with ReAble Therapeutics Finance LLC, a Delaware limited liability company (“Parent”), and Reaction Acquisition Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Parent (“Merger Sub”). Parent is controlled by affiliates of The Blackstone Group (“Blackstone”). The Merger Agreement and the transactions contemplated thereby were unanimously approved by our board of directors and a transaction committee of the board of directors comprised entirely of independent directors. Under the terms of the Merger Agreement, Merger Sub will be merged with and into us (the “Merger”), and we will continue as the surviving corporation and a wholly-owned subsidiary of Parent. As of the effective time of the Merger, each issued and outstanding share of our common stock will generally be cancelled and converted into the right to receive $50.25 in cash, without interest. In addition, as of the effective date of the Merger, each outstanding vested and unvested stock option will be cancelled and the holder will receive a cash payment equal to the excess of the per share merger consideration over the per share exercise price multiplied by the number of shares subject to the option, less applicable withholding taxes.

 

Critical Accounting Policies and Estimates

 

Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates including those related to contractual allowances, doubtful accounts, inventories, rebates, product returns, warranty obligations, income taxes, intangible assets and stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our consolidated financial statements and this discussion and analysis of our financial condition and results of operations:

 

Provision for Contractual Allowances and Doubtful Accounts. We maintain provisions for estimated contractual allowances for reimbursement amounts from our third-party payor customers based on negotiated contracts and historical experience for non-contracted payors. We also maintain provisions for doubtful accounts for estimated losses resulting from the failure of our customers to make required payments. We have contracts with certain third-party payors for our third-party reimbursement billings, which call for specified reductions in reimbursement of billed amounts based upon contractual reimbursement rates. For both 2006 and the first nine months of 2007, we reserved for and reduced gross revenues from third-party payors, excluding those related to our Regeneration business, by approximately 36%, for estimated aggregate allowances related to these contractual arrangements with these payors. For our Regeneration business, we record revenues net of actual contractual allowances and discounts from our gross prices, which are determined on a specific identification basis and amount to approximately 42% of our gross prices for bone growth stimulation products.

 

Our reserve for doubtful accounts is based upon estimated losses from customers who are billed directly and the portion of third-party reimbursement billings that ultimately become the financial responsibility of the end user patients. Direct-billed customers represent approximately 75% of our net revenues for the three months ended September 29, 2007 and approximately 61% of our net accounts receivable at September 29, 2007. Since the beginning of 2006, we have experienced write-offs of less than 1% of related net revenues. Our third-party reimbursement customers, including insurance companies, managed care companies, certain governmental payors, such as Medicare, and patients for certain co-pay amounts, include all of our OfficeCare customers and certain other customers of our Domestic Rehabilitation business segment and the majority of our Regeneration customers. Our third-party payor customers represented approximately 25% of our net revenues for the three months ended September 29, 2007 and 39% of our net accounts receivable at September 29, 2007. For 2006 and the first nine months of 2007, we estimated bad debt expense to be approximately 10% and 17%, respectively, of gross revenues from third-party reimbursement customers, excluding those related to our Regeneration business, and 7% and 9%, respectively, of gross revenues from third-party reimbursement customers of our Regeneration business. This estimated bad debt expense for 2007 includes $4.6 million recorded in the second quarter of 2007 related to additional provisions for certain aged accounts receivable. We have experienced rapid growth in revenues from our third-party reimbursement customers. Together with our third-party billing and collections service provider, we also made changes to improve the cost-effectiveness of our billing and collections process in early 2006.  The rapid growth of these businesses, combined with the

 

20



 

transitional impact of the changes in our process, placed a strain on the effectiveness of our billing and collections process in 2006.  We recognized this strain and placed additional resources in this area beginning in late 2006.  We have seen improving trends in cash collections on current accounts receivable from third-party reimbursement customers.  However, in spite of the additional resources allocated, collections of certain aged receivables had not progressed as well as expected through June 2007. Accordingly, we increased our estimates of related bad debt expense for these aged accounts receivable. If the financial condition of our customers were to deteriorate resulting in an impairment of their ability to make payments or if third-party payors were to deny claims for late filings, incomplete information or other reasons, additional provisions may be required.

 

We rely heavily on a third-party billing service provider to bill and collect from certain of our third-party reimbursement customers and to provide information about the accounts receivable of these customers, including the data utilized to determine reserves for contractual allowances and doubtful accounts. Based on information currently available to us, we believe we have provided adequate reserves for our third-party payor accounts receivable. If claims are denied, or amounts are otherwise not paid, in excess of our estimates, the recoverability of our net accounts receivable could be reduced by a material amount. In addition, if our third-party insurance billing service provider does not perform to our expectations we may be required to increase our reserve estimates.

 

Reserve for Excess and Obsolete Inventories . We provide reserves for estimated excess or obsolete inventories equal to the difference between the cost of inventories on hand plus future purchase commitments and the estimated market value based upon assumptions about future demand. If future demand is less favorable than currently projected by management, additional inventory write-downs may be required. In addition, reserves for inventories on hand in our OfficeCare locations are provided based on historical shrinkage rates of approximately 16%. If actual shrinkage rates differ from our estimated shrinkage rates, revisions to the reserve may be required. We also provide reserves for newer product inventories, as appropriate, based on any minimum purchase commitments and our level of sales of the new products.

 

Rebates. We offer certain of our distributors rebates based on sales volume, sales growth and to reimburse the distributor for certain discounts. We record estimated reductions to revenues for customer rebate programs based upon historical experience and estimated revenue levels.

 

Returns and Warranties. We provide for the estimated cost of returns and product warranties at the time revenue is recognized based on historical trends. While we engage in extensive product quality programs and processes, including actively monitoring and evaluating the quality of our suppliers, our actual returns and warranty costs could differ from our estimates. If actual product returns, failure rates, material usage or service costs differ from our estimates, revisions to the estimated return and/or warranty liabilities may be required.

 

Valuation Allowance for Deferred Tax Asset. As of September 29, 2007, we had approximately $21.1 million of net deferred tax assets on our balance sheet related primarily to tax deductible goodwill arising at the date of our reorganization in 2001 and not recognized for book purposes, goodwill acquired in connection with our Regeneration acquisition and net tax loss carryforwards. Realization of our net deferred tax assets is dependent on our ability to generate future taxable income prior to the expiration of our net operating loss carryforwards. Our management believes that it is more likely than not that the deferred tax assets will be realized based on forecasted future taxable income. However, there can be no assurance that we will meet our expectations of future taxable income. Management will evaluate the realizability of the deferred tax assets on a quarterly basis to assess any need for valuation allowances.

 

Income Taxes. In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes – an interpretation of SFAS No. 109, Accounting for Income Taxes , (FIN 48). FIN 48 prescribes a comprehensive model for how companies should recognize, measure, present, and disclose in their financial statements uncertain tax positions taken or expected to be taken on a tax return. Under FIN 48, tax positions shall initially be recognized in the financial statements when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and all relevant facts. FIN 48 also revises disclosure requirements to include an annual tabular rollforward of unrecognized tax benefits. The provisions of this interpretation were required to be adopted for fiscal periods beginning after December 15, 2006. We adopted FIN 48 on January 1, 2007. As a result of the implementation of FIN 48, we recognized $1.4 million in additional unrecognized tax benefits. A portion of the transition adjustment related to our historical exposures and was recorded as permitted by FIN 48 as a reduction of retained earnings in the amount of approximately $0.8 million. A portion of the transition adjustment related to Aircast exposures created prior to our acquisition of Aircast and was therefore recorded

 

21



 

as an increase of approximately $0.6 million in goodwill related to the Aircast acquisition. The offset of the transition adjustment was recorded as a reduction to deferred tax assets and additional taxes payable.

 

The transition adjustment included approximately $0.2 million of interest and approximately $0.1 million of penalties related to the unrecognized tax benefits. Interest costs and penalties related to income taxes are classified as a part of income tax provision in our financial statements.

 

Of the transition adjustment, a portion related to estimated possible transfer pricing exposures. Such estimates will be evaluated each quarter based on changes to transfer pricing and changes in foreign exchange rates. An estimate of the range of reasonably possible future changes cannot be made. United States federal and most state tax returns for all years after 2002 are subject to future examination by tax authorities. Open tax years for foreign jurisdictions vary.

 

Our balance of unrecognized tax benefits as of September 29, 2007 remained unchanged at $1.4 million. There were no changes required to be made to the balance as there were no new tax positions taken by us during the current period, no settlements with taxing authorities and no lapses of applicable statutes of limitations. Included in the balance of unrecognized tax benefits is $0.8 million of tax benefits that, if recognized, would affect the effective tax rate.  Also included in the balance of unrecognized tax benefits is $0.6 million of tax benefits that, if recognized, would result in adjustments to other tax accounts, primarily deferred taxes and goodwill.

 

Goodwill and Other Intangibles. In accordance with Statement of Financial Accounting Standards No. 142, or SFAS No. 142, Goodwill and Other Intangible Assets , we do not amortize goodwill. In lieu of amortization, we are required to perform an annual review for impairment. Goodwill is considered to be impaired if we determine that the carrying value of the segment or reporting unit exceeds its fair value. At October 1, 2006, our goodwill acquired through December 31, 2005 was evaluated for impairment and we determined that no impairment existed at that date. With the exception of goodwill related to our Regeneration acquisition of $39 million, we believe that the goodwill acquired through December 31, 2005 benefits the entire enterprise and since our reporting units share the majority of our assets, we compared the total carrying value of our consolidated net assets (including goodwill) to our fair value. With respect to goodwill related to our Regeneration acquisition, we compared the carrying value of the goodwill related to the Regeneration segment to the fair value of the Regeneration segment. We acquired additional goodwill in 2006 in connection with our Axmed and Aircast acquisitions. These additional goodwill amounts will be evaluated for impairment beginning in 2007.

 

At December 31, 2006, other intangibles were evaluated for impairment as required by SFAS No. 144, Accounting for Impairment or Disposal of Long-Lived Assets . The determination of the fair value of certain acquired assets and liabilities is subjective in nature and often involves the use of significant estimates and assumptions. Determining the fair values and useful lives of intangible assets requires the exercise of judgment. While there are a number of different generally accepted valuation methods to estimate the value of intangible assets acquired, we primarily used the undiscounted cash flows expected to result from the use of the assets. This method requires significant management judgment to forecast the future operating results used in the analysis. In addition, other significant estimates are required such as residual growth rates and discount factors. The estimates we have used are consistent with the plans and estimates that we use to manage our business and are based on available historical information and industry averages.

 

Stock-Based Compensation. As of January 1, 2006, we began recording compensation expense associated with stock options and other equity-based compensation in accordance with SFAS No. 123 (revised 2004), Share-Based Payment (SFAS No. 123(R)), using the modified prospective transition method. Under the modified prospective transition method, stock-based compensation expense for 2006 includes: 1) compensation expense for all stock-based awards granted on or after January 1, 2006 as determined based on the grant date fair value estimated in accordance with the provisions of SFAS No. 123(R) and 2) stock-based compensation awards granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair value estimated in accordance with the original provisions of SFAS No. 123. We recognize these compensation costs on a straight-line basis over the requisite service period of the award, which is generally four years. As a result of the adoption of SFAS No. 123(R), our net income for the three months ended September 29, 2007 and September 30, 2006, both have been reduced by stock-based compensation expense, net of taxes, of approximately $2.3 million, respectively, and our net income for the nine months ended September 29, 2007 and September 30, 2006, has been reduced by stock-based compensation expense, net of taxes, of approximately $5.5 million and $5.3 million, respectively.

 

The fair value of each equity award is estimated on the date of grant using the Black-Scholes valuation model for option pricing using management’s assumptions. Expected volatility rates are based on the historical volatility (using daily pricing) of our stock. In accordance with SFAS No. 123(R), we reduce the calculated Black-Scholes value by applying a forfeiture rate, based upon

 

22



 

historical pre-vesting option cancellations. The expected term of options granted is estimated based on a number of factors, including the vesting term of the award, historical employee exercise behavior for both options that have run their course and outstanding options, the expected volatility of our stock and an employee’s average length of service. The risk-free interest rate is determined based upon a constant U.S. Treasury security rate with a contractual life that approximates the expected term of the option award.

 

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 one five-week and two four-week periods. Our first and fourth quarters may have more or less operating days from year to year based on the days of the week on which holidays and December 31 fall. The quarters ended September 29, 2007 and September 30, 2006 each included 63 days. The nine months ended September 29, 2007 and September 30, 2006 each included 191 days.

 

Three Months Ended September 29, 2007 Compared To Three Months Ended September 30, 2006

 

Net Revenues. Set forth below are net revenues for our reporting segments (in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase

 

% Increase

 

Domestic Rehabilitation

 

$

74,935

 

62.6

 

$

74,640

 

65.9

 

$

295

 

0.4

 

Regeneration

 

19,105

 

15.9

 

15,767

 

13.9

 

3,338

 

21.2

 

International

 

25,744

 

21.5

 

22,798

 

20.2

 

2,946

 

12.9

 

Consolidated net revenues

 

$

119,784

 

100.0

 

$

113,205

 

100.0

 

$

6,579

 

5.8

 

 

Net revenues of our Domestic Rehabilitation segment stayed relatively consistent for the third quarter of 2007 compared to the third quarter of 2006 due primarily to the Domestic Rehabilitation net revenues for the third quarter of 2006 including the benefit of approximately $1.6 million related to a change in shipping terms for certain Aircast products from FOB destination to FOB shipping point and the shipment of certain products that were on backorder at the end of the second quarter of 2006 due to issues related to the integration of Aircast (our International segment included approximately $0.3 million in the third quarter of 2006 related to clearing these backorders). We had normal market growth in existing product lines and sales of new products in our Domestic Rehabilitation segment. We also increased the number of units billed to third-party payors, which are sold at higher average selling prices than units sold through our other channels. A substantial portion of the increased units billed to third-party payors resulted from the addition of approximately 220 net new OfficeCare locations since October 1, 2006. Net OfficeCare revenues for the third quarter of 2007 were $0.6 million higher than net OfficeCare revenues for the third quarter of 2006. Net revenues in our Regeneration segment increased due to market growth and our expanding distribution strategy in the United States that includes both direct and independent representatives. International net revenues increased in the third quarter of 2007 compared to the third quarter of 2006 due to increased sales volume from market growth, an expanding range of products sold internationally and the benefit of $1.2 million related to favorable changes in foreign exchange rates. Excluding the impact of changes in exchange rates, local currency international revenues increased 7.9% in the third quarter of 2007 compared to the third quarter of 2006. Net revenues in our Domestic Rehabilitation segment decreased as a percentage of total net revenues due to proportionately higher growth rates in our Regeneration and International segment revenues.

 

Gross Profit. Set forth below is gross profit information for our reporting segments (in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase

 

% Increase

 

Domestic Rehabilitation

 

$

39,897

 

53.2

 

$

38,915

 

52.1

 

$

982

 

2.5

 

Regeneration

 

17,705

 

92.7

 

14,428

 

91.5

 

3,277

 

22.7

 

International

 

16,681

 

64.8

 

14,522

 

63.7

 

2,159

 

14.9

 

Consolidated gross profit

 

$

74,283

 

62.0

 

$

67,865

 

59.9

 

$

6,418

 

9.5

 

 

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The increase in gross profit for the third quarter of 2007 compared to the third quarter of 2006 in total and as a percentage of net revenues is due to incremental gross profit from an increase in revenues and the absence in the third quarter of 2007 of $1.7 million of certain charges and expenses related to the Aircast and Axmed acquisitions and $0.8 million of expenses related to our headquarters move which were included in the third quarter of 2006. The increase in the International segment gross profit as a percentage of net revenues is related to favorable changes in product mix and foreign currency exchange rates.

 

Operating Expenses. Set forth below is operating expense information (in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase
(Decrease)

 

% Increase
(Decrease)

 

Sales and marketing

 

$

35,621

 

29.7

 

$

33,398

 

29.5

 

$

2,223

 

6.7

 

General and administrative

 

11,336

 

9.5

 

13,075

 

11.5

 

(1,739

)

(13.3

)

Research and development

 

2,018

 

1.7

 

2,580

 

2.3

 

(562

)

(21.8

)

Amortization of acquired intangibles

 

4,503

 

3.8

 

4,510

 

4.0

 

(7

)

(0.2

)

Merger costs

 

2,539

 

2.1

 

 

0.0

 

2,539

 

100.0

 

Consolidated operating expenses

 

$

56,017

 

46.8

 

$

53,563

 

47.3

 

$

2,454

 

4.6

 

 

Sales and Marketing Expenses. Sales and marketing expenses for the third quarter of 2007 increased compared to the third quarter of 2006 due to volume related increases in commissions, sales incentive bonuses and delivery charges due to the increase in revenues. These increases in selling and marketing expenses were partially offset by the absence in the third quarter of 2007 of integration costs of $0.4 million associated with the Aircast and Axmed acquisitions, and headquarter move costs of approximately $0.3 million, which were included in the third quarter of 2006.

 

General and Administrative Expenses. The decrease in general and administrative expenses for the third quarter of 2007 compared to the third quarter of 2006 is primarily due to the elimination of certain duplicate general and administrative expenses in connection with the integration of the acquired Aircast business and the absence in the third quarter of 2007 of integration costs of $0.3 million associated with the Aircast and Axmed acquisitions, and headquarter move costs of approximately $0.2 million, which were included in the third quarter of 2006.

 

Research and Development Expenses. The decrease in research and development expenses for the third quarter of 2007 compared to the third quarter of 2006 is primarily due to the absence in the third quarter of 2007 of headquarter move costs of approximately $0.2 million which were included in the third quarter of 2006.

 

Amortization of Acquired Intangibles. Amortization of acquired intangibles includes amortization expense related to intangible assets acquired in connection with the Regeneration acquisition, which are being amortized over lives ranging from four months to ten years, intangible assets acquired in connection with the Axmed acquisition, which are being amortized over lives ranging from one to nine years, and intangible assets acquired in connection with the Aircast acquisition which are being amortized over lives ranging from seven to 20 years.

 

Merger Costs. Merger costs of $2.5 million incurred in the third quarter of 2007 consist of certain costs related to the proposed merger with ReAble Therapeutics Finance LLC.

 

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Income from Operations. Set forth below is income from operations information for our reporting segments (in thousands):

 

 

 

Three Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase
(Decrease)

 

% Increase
(Decrease)

 

Domestic Rehabilitation

 

$

12,155

 

16.2

 

$

11,033

 

14.8

 

$

1,122

 

10.2

 

Regeneration

 

6,111

 

32.0

 

3,139

 

19.9

 

2,972

 

94.7

 

International

 

6,261

 

24.3

 

4,530

 

19.9

 

1,731

 

38.2

 

Income from operations of reportable segments

 

24,527

 

20.5

 

18,702

 

16.5

 

5,825

 

31.1

 

Expenses not allocated to segments

 

(6,261

)

(5.3

)

(4,400

)

(3.9

)

(1,861

)

(42.3

)

Consolidated income from operations

 

$

18,266

 

15.2

 

$

14,302

 

12.6

 

$

3,964

 

27.7

 

 

The increase in income from operations for our Domestic Rehabilitation segment is due to increased net revenues and gross profit and the absence in 2007 of certain integration costs and costs associated with our headquarters move, which we incurred in 2006 as discussed above. The increase in income from operations for our Regeneration and International segments is due primarily to increased net revenues and gross profit and reduced spending in general and administrative and research and development as discussed above.

 

Interest Expense, Net of Interest Income. Interest expense, net of interest income, was $5.3 million in the third quarter of 2007 compared to $6.3 million in the third quarter of 2006. Interest expense, net of interest income decreased in the third quarter of 2007 compared to the third quarter of 2006 due to the fact that we have reduced our debt balance by $48.8 million since October 1, 2006.

 

Other Income, Net. Other income for the third quarter of 2007 increased compared to the third quarter of 2006 primarily due to higher net foreign exchange transaction gains.

 

Provision for Income Taxes. Our estimated worldwide effective tax rate was 49.4% for the third quarter of 2007 compared to 48.5% for the third quarter of 2006. Our worldwide effective tax rate increased in connection with our adoption of SFAS No. 123(R) as of January 1, 2006. The stock-based compensation expense recorded in accordance with SFAS No. 123(R) results in a related tax benefit rate of only 23.2% and 13.4% for the third quarters of 2007 and 2006, respectively, due to the mix of our outstanding and unvested incentive stock options and non-qualified stock options.

 

Net Income . Net income was $6.7 million for the third quarter of 2007 compared to net income of $4.4 million for the third quarter of 2006 as a result of the changes discussed above.

 

Nine Months Ended September 29, 2007 Compared To Nine Months Ended September 30, 2006

 

Net Revenues. Set forth below are net revenues for our reporting segments (in thousands):

 

Net revenues:

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase

 

%
Increase

 

Domestic Rehabilitation

 

$

219,842

 

62.0

 

$

196,506

 

65.0

 

$

23,336

 

11.9

 

Regeneration

 

55,878

 

15.7

 

47,953

 

15.9

 

7,925

 

16.5

 

International

 

79,149

 

22.3

 

57,834

 

19.1

 

21,315

 

36.9

 

Consolidated net revenues

 

$

354,869

 

100.0

 

$

302,293

 

100.0

 

$

52,576

 

17.4

 

 

Net revenue increases of approximately $15.3 million and $9.6 million related to our Domestic Rehabilitation and International segments, respectively, are due to the fact that our acquisition of Aircast closed April 7, 2006. Accordingly, our revenue results for the nine months ended September 30, 2006 did not include a full nine months of Aircast revenue. The additional increase in net revenues of our Domestic Rehabilitation segment is partly due to normal market growth in existing product lines and sales of new products. We also increased the number of units billed to third-party payors, which are sold at higher average selling prices than units sold through our other channels. A substantial portion of the increased units billed to third-party payors resulted from the addition of approximately 220 net new OfficeCare locations since October 1, 2006. Net OfficeCare revenues for the first nine months

 

25



 

of 2007 were $4.5 million higher than net OfficeCare revenues for the first nine months of 2006. Net revenues in our Regeneration segment increased due to market growth and our expanding distribution strategy in the United States that includes both direct and independent representatives. International net revenues increased in the first nine months of 2007 compared to the first nine months of 2006, due to our acquisition of Aircast, increased sales volume due to market growth, an expanding range of products sold internationally and the benefit of $2.8 million related to favorable changes in foreign exchange rates. Excluding the impact of changes in exchange rates, local currency international revenues increased 32.1% in the first nine months of 2007 compared to the first nine months of 2006. Net revenues in our Domestic Rehabilitation and Regeneration segments decreased as a percentage of total net revenues due to a proportionately higher increase in our International segment revenues related to the acquisition of Aircast in April 2006.

 

Gross Profit. Set forth below is gross profit information for our reporting segments (in thousands):

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase

 

%
Increase

 

Domestic Rehabilitation

 

$

112,346

 

51.1

 

$

102,967

 

52.4

 

$

9,379

 

9.1

 

Regeneration

 

51,675

 

92.5

 

44,213

 

92.2

 

7,462

 

16.9

 

International

 

50,007

 

63.2

 

35,152

 

60.8

 

14,855

 

42.3

 

Consolidated gross profit

 

$

214,028

 

60.3

 

$

182,332

 

60.3

 

$

31,696

 

17.4

 

 

Consolidated gross profit increased for first nine months of 2007 compared to the first nine months of 2006 due to incremental gross profit from an increase in revenues, including the contribution from our Aircast acquisition, and the absence in the first nine months of 2007 of costs related to a write-up of acquired Axmed and Aircast inventories to fair value of $1.5 million, other integration costs of $3.3 million associated with the Aircast and Axmed acquisitions and $0.8 million of headquarter move costs which were included in the first nine months of 2006, offset by a $0.8 million charge to write-down raw material inventories in the first nine months of 2007 based on the results of a physical count of such inventories. Gross profit decreased as a percentage of net revenues in the Domestic Rehabilitation segment due to the impact of the raw material adjustment noted above, of which $0.6 million related to the Domestic Rehabilitation segment, a change in product mix to include more lower gross profit soft goods due to our recent acquisitions and increased costs of freight and distribution, manufacturing overhead and certain material costs. The increase in the International segment gross profit as a percentage of net revenues is primarily related to favorable changes in product mix and foreign currency exchange rates and the absence in the first nine months of 2007 of costs related to the write-up of acquired Axmed and Aircast inventories to fair value, which were included in the first nine months of 2006.

 

Operating Expenses. Set forth below is operating expense information (in thousands):

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase

 

%
Increase

 

Sales and marketing

 

$

111,795

 

31.5

 

$

92,375

 

30.6

 

$

19,420

 

21.0

 

General and administrative

 

35,229

 

9.9

 

35,709

 

11.8

 

(480

)

(1.3

)

Research and development

 

6,185

 

1.8

 

6,745

 

2.2

 

(560

)

(8.3

)

Amortization of acquired intangibles

 

13,490

 

3.8

 

10,651

 

3.5

 

2,839

 

26.7

 

Merger costs

 

2,539

 

0.7

 

 

0.0

 

2,539

 

100.0

 

Consolidated operating expenses

 

$

169,238

 

47.7

 

$

145,480

 

48.1

 

$

23,758

 

16.3

 

 

Sales and Marketing Expenses. Sales and marketing expenses for the first nine months of 2007 include $4.6 million related to an increase in estimates of bad debt provisions required for certain aged accounts receivable recorded in the second quarter of 2007. Sales and marketing expenses for the first nine months of 2007 also included volume related increases in commissions, sales incentive bonuses and delivery charges due to the increase in revenues, including the contribution from our Aircast acquisition. These increases were partially offset by the absence in the first nine months of 2007 of integration costs of $0.9 million associated to the Aircast and Axmed acquisitions and $0.3 million of headquarter move costs which were included in the first nine months of 2006.

 

General and Administrative Expenses. The decrease in general and administrative expenses in the first nine months of 2007 is primarily due to the absence in the first nine months of 2007 of integration costs of $0.7 million associated to the Aircast and Axmed acquisitions and $0.2 million of headquarter move costs which were included in the first nine months of 2006.

 

26



 

Research and Development Expenses. The decrease in research and development expenses for the first nine months of 2007 compared to the first nine months of 2006 is primarily due to the absence in first nine months of 2007 of headquarter move costs of approximately $0.2 million which were included in the first nine months of 2006.

 

Amortization of Acquired Intangibles. Amortization of acquired intangibles includes amortization expense related to intangible assets acquired in connection with the Regeneration acquisition, which are being amortized over lives ranging from four months to ten years, intangible assets acquired in connection with the Axmed acquisition, which are being amortized over lives ranging from one to nine years, and intangible assets acquired in connection with the Aircast acquisition which are being amortized over lives ranging from seven to 20 years. The increase in amortization of acquired intangibles is due to amortization expense related to the April 2006 acquisition of Aircast.

 

Merger Costs. Merger costs of $2.5 million incurred in the third quarter of 2007 consist of certain costs related to the proposed merger with ReAble Therapeutics Finance LLC.

 

Income from Operations. Set forth below is income from operations information for our reporting segments (in thousands):

 

 

 

Nine Months Ended

 

 

 

 

 

 

 

September 29,
2007

 

% of Net
Revenues

 

September 30,
2006

 

% of Net
Revenues

 

Increase
(Decrease)

 

% Increase
(Decrease)

 

Domestic Rehabilitation

 

$

24,821

 

11.3

 

$

30,310

 

15.4

 

$

(5,489

)

(18.1

)

Regeneration

 

16,538

 

29.6

 

10,560

 

22.0

 

5,978

 

56.6

 

International

 

18,396

 

23.2

 

8,851

 

15.3

 

9,545

 

107.8

 

Income from operations of reportable segments

 

59,755

 

16.8

 

49,721

 

16.5

 

10,034

 

20.2

 

Expenses not allocated to segments

 

(14,965

)

(4.2

)

(12,869

)

(4.3

)

(2,096

)

16.3

 

Consolidated income from operations

 

$

44,790

 

12.6

 

$

36,852

 

12.2

 

$

7,938

 

21.5

 

 

The decrease in income from operations for our Domestic Rehabilitation segment is due to increased net revenues and gross profit being more than offset by increased sales and marketing expenses as discussed above. The increase in income from operations for our Regeneration and International segments is due primarily to increased net revenues and gross profit.

 

Interest Expense, Net of Interest Income. Interest expense, net of interest income, was $16.9 million in the first nine months of 2007 compared to $15.7 million in the fist nine months of 2006. Interest expense, net of interest income, increased in the first nine months of 2007 compared to the first nine months of 2006 primarily due to an increase in our outstanding long-term debt balances in April 2006 to finance the Aircast acquisition.

 

Other Income, Net. Other income for the first nine months of 2007 primarily reflects net foreign exchange transaction gains. Other income for the first nine months of 2006 reflects net foreign exchange transaction gains, offset by a write-off of costs related to potential acquisition that was abandoned in the first quarter of 2006.

 

Provision for Income Taxes. Our estimated worldwide effective tax rate was 44.6% for the first nine months of 2007 compared to 45.7% for the first nine months of 2006. Our worldwide effective tax rate increased in connection with our adoption of SFAS No. 123(R) as of January 1, 2006. The stock-based compensation expense recorded in accordance with SFAS No. 123(R) results in a related tax benefit rate of only 31.4% and 22.0% for the first nine months of 2007 and 2006, respectively, due to the mix of our outstanding and unvested incentive stock options and non-qualified stock options.

 

Net Income . Net income was $16.1 million for the first nine months of 2007 compared to net income of $11.6 million for the first nine months of 2006 as a result of the changes discussed above.

 

Liquidity and Capital Resources

 

Our principal liquidity requirements are to service our debt and meet our working capital and capital expenditure needs. Total indebtedness at September 29, 2007 was $285.5 million. Total cash and cash equivalents were $11.9 million at September 29, 2007.

 

27



 

Net cash provided by operating activities was $47.5 million and $37.0 million for the nine months ended September 29, 2007 and September 30, 2006, respectively. The net cash provided by operations in the first nine months of 2007 primarily reflected positive operating results offset by an increase in net accounts receivable of $6.1 million and $2.5 million of merger costs consisting of transaction costs to close the proposed merger with ReAble Therapeutics Finance LLC. As required by SFAS No. 123(R), our cash flow provided by operating activities for the nine months ended September 29, 2007 is shown net of $1.8 million of excess tax benefits from stock options exercised, the amount deemed to be realized for tax purposes. These excess tax benefits are included in cash flows provided by financing activities for the nine months ended September 29, 2007. The net cash provided by operations in the first nine months of 2006 primarily reflected positive operating results offset by an increase in net accounts receivable and net inventories and payments made in connection with the integration of our recently acquired businesses.

 

Cash flows used in investing activities were $9.6 million and $327.1 million for the nine months ended September 29, 2007 and September 30, 2006, respectively. Cash used in investing activities for the first nine months of 2007 included $1.2 million used for a final payment related to our January 2006 acquisition of Axmed, $4.8 million used for additional costs related to the acquisition of Aircast, $1.5 million used for the Full90 convertible note investment discussed in Note 3 to the unaudited condensed consolidated financial statements included in Part I, Item 1, $5.5 million used for capital expenditures offset by $3.4 million in proceeds from the disposal of  the Aircast manufacturing facility which we vacated in connection with the integration of the Aircast business. Cash used in investing activities for the first nine months of 2006 included $16.3 million used for the acquisition of Axmed, $297.3 million used for the acquisition of Aircast, and $12.5 million used for capital expenditures. Capital expenditures for the nine months ended September 30, 2006 included $7.7 million related to tenant improvements and equipment for our corporate headquarters and the expansion of our Indianapolis distribution center.

 

Cash flows (used in) provided by financing activities were ($33.6) million and $292.4 million for the nine months ended  September 29, 2007 and September 30, 2006, respectively. In the first nine months of 2007, the cash used in financing activities included $41.8 million used to pay down long-term debt, offset by $5.3 million of net proceeds received from the exercise of stock options, $1.0 million received from the issuance of stock under our Employee Stock Purchase Plan and $1.8 million of excess tax benefits from stock options exercised. In the first nine months of 2006, the cash provided by financing activities included $286.8 million of net proceeds from long-term debt, $11.1 million of net proceeds received from the exercise of stock options and $0.9 million from the issuance of stock under our Employee Stock Purchase Plan.

 

Contractual Obligations and Commercial Commitments

 

In April 2006, we entered into a credit agreement with a syndicate of lenders and with Wachovia Bank, National Association, as administrative agent, to finance the Aircast acquisition and repay amounts outstanding under our previous credit agreement. The credit agreement provided for total borrowings of $400 million, consisting of a term loan of $350 million, which was fully drawn at closing and up to $50 million available under a revolving credit facility. As of September 29, 2007, the balance outstanding under the term loan was $285.5 million and $49.2 million was available under the revolving credit facility, net of $0.8 million of outstanding letters of credit. Under the credit agreement, up to $25 million of outstanding borrowings may be denominated in British Pounds or Euros.

 

Borrowings under the term loan and on the revolving credit facility bear interest at variable rates (either a LIBOR rate or the lenders’ base rate, as elected by us) plus a margin. The interest rate for the term loan is LIBOR plus a margin of 1.50%, or the lenders’ base rate plus a margin of 0.50%. The applicable margin on the revolving credit facility varies based on our leverage ratio. The interest rate for the revolving credit facility is LIBOR plus an applicable margin of 1.25% to 2.00%, or the lenders’ base rate plus an applicable margin of 0.25% to 1.00%. At our current leverage ratio, the applicable interest rate on the revolving credit facility is either LIBOR plus 1.5% or the lender’s base rate plus 0.5%.

 

Interest Rate Swap Agreement. In connection with our credit agreement, in April 2006 we entered into an interest rate swap agreement with Wachovia Bank for a notional amount of $250 million of the term loan. The interest rate swap agreement converts the variable LIBOR rate to a fixed LIBOR rate of 5.29% for a term of five years. Accordingly, with respect to a beginning notional amount of $250 million of the term loan, our interest rate is fixed at 6.79% (5.29% plus applicable margin of 1.50%) for the term of the swap. The notional amount of $250 million is scheduled to amortize to zero over the term of the swap in proportion to expected future cash flows. As of September 29, 2007, the outstanding notional amount of the interest rate swap was $250 million. Effective July 11, 2007, the notional amount of the swap was reduced to $187.5 million. Our interest rate swap qualifies as a cash flow hedge under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities . In accordance with SFAS No. 133, the fair market value of the swap at September 29, 2007 was recorded as a long-term liability, with the change in such fair value accounted for

 

28



 

in accumulated other comprehensive income (loss) included in the stockholders’ equity in the accompanying consolidated balance sheet. The weighted average interest rate applicable to our total borrowings as of September 29, 2007 was 6.87%. In October 2007, in anticipation of the repayment of all amounts outstanding under our credit agreement in connection with the completion of our pending merger with ReAble Therapeutics Finance LLC, we paid $2.1 million to terminate our interest rate swap agreement.

 

Repayment. We were initially required to make quarterly principal payments of $0.9 million on the term loan, beginning in June 2006. The balance of the term loan, if any, is due in full on April 7, 2013. In the nine months ended September 29, 2007 we made $41.8 million of prepayments on the term loan. Under the credit agreement, prepayments are applied to reduce outstanding principal balance in direct order of maturity to payments scheduled over the twelve months following the prepayment and thereafter to remaining scheduled principal payments on a prorated basis. Accordingly, no principal payments will be required until September 2009 and such payments have been reduced to $0.7 million per quarter. Any borrowings under the revolving credit facility are due in full on April 7, 2012. We are also required to make annual mandatory prepayments on the term loan in an amount equal to 50% of our excess cash flow if our ratio of total debt to consolidated EBITDA exceeds 2.50 to 1.00. Excess cash flow represents our net income adjusted for extraordinary gains or losses, depreciation, amortization and other non-cash charges, changes in working capital, changes in deferred revenues, payments for capital expenditures and permitted acquisitions and repayment of certain indebtedness. In addition, the term loan is subject to mandatory prepayments in an amount equal to (a) 100% of the net cash proceeds of certain debt issuances by us; (b) 50% of the net cash proceeds of certain equity issuances by us if our ratio of total debt to consolidated EBITDA exceeds 2.50 to 1.00; (c) 100% of the net cash proceeds of certain insurance, condemnation awards or other compensation in respect to any casualty event; and (d) 100% of the net cash proceeds of certain asset sales or other dispositions of property by us, in each case subject to certain exceptions. We were not required to make any mandatory prepayments for 2006 or the first nine months of 2007.

 

Security; Guarantees . Our obligations under our credit agreement are irrevocably guaranteed, jointly and severally, by us, and all of our current and future U.S. subsidiaries. In addition, the credit agreement and the guarantees thereunder are secured by substantially all of our U.S. assets, including real and personal property, inventory, accounts receivable, intellectual property and other intangibles.

 

Covenants. Our credit agreement imposes certain restrictions on us, including restrictions on the ability to incur indebtedness, incur or guarantee obligations, prepay other indebtedness or amend other debt instruments, pay dividends or make other distributions (except for certain tax distributions), redeem or repurchase equity, make investments, loans or advances, make acquisitions, engage in mergers or consolidations, change the business conducted by us and our subsidiaries, make capital expenditures, grant liens, sell assets and engage in certain other activities. Our credit agreement requires us to maintain: a ratio of total debt to consolidated EBITDA of no more than 3.50 to 1.00 and gradually decreasing to 2.50 to 1.00 for the first quarter of 2010 and thereafter; and a ratio of consolidated EBITDA to fixed charges of at least 1.50 to 1.00. Material violations of these covenants and restrictions, or the payment terms described above, can result in an event of default and acceleration of the entire indebtedness. We were in compliance with all covenants as of September 29, 2007.

 

Debt issuance costs. In 2006, we capitalized debt issuance costs of approximately $6.4 million in association with our credit agreement, which will be amortized over the term of the agreement. Remaining debt issuance costs of $4.9 million, net of accumulated amortization, were included in the accompanying balance sheet at September 29, 2007.

 

As part of our strategy, we may pursue additional acquisitions, investments and strategic alliances. We may require new sources of financing to consummate any such transactions, including additional debt or equity financing. We cannot assure you that such additional sources of financing will be available on acceptable terms, if at all. In addition, we may not be able to consummate any such transactions due to the operating and financial restrictions and covenants in our credit agreement.

 

Our ability to pay principal and interest on our indebtedness, fund working capital requirements and make anticipated capital expenditures will depend on our future performance, which is subject to general economic, financial and other factors, some of which are beyond our control. We believe that based on current levels of operations and anticipated growth, cash flow from operations, together with other available sources of funds including the availability of borrowings under our revolving credit facility, will be adequate for at least the next twelve months to make required payments of principal and interest on our indebtedness, to fund anticipated capital expenditures and for working capital requirements. There can be no assurance, however, that our business will generate sufficient cash flow from operations or that future borrowings will be available under the revolving credit facility in an amount sufficient to enable us to service our indebtedness or to fund our other liquidity needs. In such event, we may need to raise additional funds through public or private equity or debt financings. We cannot assure you that any such funds will be available to us on favorable terms or at all.

 

29



 

We do not currently have and have never had any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.

 

As of September 29, 2007, we had available liquidity of approximately $11.9 million in cash and cash equivalents and $49.2 million available under our revolving credit facility, net of $0.8 million of outstanding letters of credit. For the remainder of 2007, we have or expect to spend total cash of approximately $13.0 million for the following requirements:

 

                  up to approximately $4.9 million for estimated interest payments on our credit facility;

 

                  approximately $2.1 million to terminate our interest rate swap agreement;

 

                  approximately $2.0 million scheduled payments for noncancellable operating leases; and

 

                  up to approximately $4.0 million for capital expenditures.

 

In addition, we expect to make other general corporate payments in 2007.

 

Seasonality

 

We generally record our highest net revenues per day in the fourth quarter due to a greater number of orthopedic surgeries and injuries resulting from increased sports activity, particularly football and skiing. In addition, during the fourth quarter, a patient has a greater likelihood of having satisfied his or her annual insurance deductible than in the first three quarters of the year, and thus there is an increase in the number of elective orthopedic surgeries. We follow a manufacturing calendar that has a varied number of operating days in each quarter. Although on a per day basis revenues may be higher in a certain quarter, total net revenues may be higher or lower based upon the number of operating days in such quarter. Conversely, we generally have lower net revenues per day during our second quarter as a result of decreased sports activity, with the end of both football and skiing seasons. For 2007 and 2006, our number of operating days per quarter is as follows:

 

 

 

2007

 

2006

 

First quarter

 

64

 

64

 

Second quarter

 

64

 

64

 

Third quarter

 

63

 

63

 

Fourth quarter

 

62

 

61

 

Total operating days

 

253

 

252

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are exposed to certain market risks as part of our ongoing business operations. Our primary exposures include changes in interest rates and foreign exchange rates.

 

We are exposed to interest rate risk in connection with the term loan and borrowings under our revolving credit facility, which bear interest at floating rates based on the London Inter-Bank Offered Rate (LIBOR) or the prime rate plus an applicable borrowing margin. For variable rate debt, interest rate changes generally do not affect the fair market value of the underlying debt, but do impact future earnings and cash flows, assuming other factors are held constant.

 

Following a scheduled reduction in the notional amount of our interest rate swap agreement in October 2007, we have $98.0 million of variable rate debt represented by borrowings under our credit facility which are not covered by the interest rate swap agreement. Based on the balance of the variable rate debt outstanding under the credit facility as of September 29, 2007, an immediate change of one percentage point in the applicable interest rate would have caused an increase or decrease in interest expense of approximately $1.0 million on an annual basis. At September 29, 2007, up to $49.2 million of variable rate borrowings were available under our $50.0 million revolving credit facility. We may use derivative financial instruments, where appropriate, to manage our

 

30



 

interest rate risks. However, as a matter of policy, we do not enter into derivative or other financial investments for trading or speculative purposes. In April 2006, in connection with our credit agreement, we entered into an interest rate swap agreement for a notional amount of $250 million of the term loan. The interest rate swap agreement converts the variable LIBOR rate to a fixed LIBOR rate of 5.29% for a term of five years. Accordingly, with respect to a beginning notional amount of $250 million, our interest rate is fixed at 6.79% (5.29% plus applicable margin of 1.50%) for the term of the swap. The notional amount of $250 million is scheduled to amortize to zero over the term of the swap in proportion to expected cash flows. As of September 29, 2007, the outstanding notional amount of the interest rate swap was $187.5 million. Effective July 11, 2007, the notional amount of the swap was reduced to $187.5 million. For the quarter and nine months ended September 29, 2007, the change in fair value of the swap was accounted for as an increase in accumulated other comprehensive income (loss) included in stockholders’ equity in the accompanying consolidated balance sheet. In October 2007, in anticipation of the repayment of all amounts outstanding under our credit agreement in connection with the completion of our pending merger with ReAble Therapeutics Finance LLC, we paid $2.1 million to terminate our interest rate swap agreement.

 

Through our wholly owned international subsidiaries, we sell products in several foreign currencies, primarily Euros, Pounds Sterling and Canadian Dollars. The U.S. dollar equivalent of our international sales denominated in foreign currencies in the first quarters of 2007 and 2006 were favorably impacted by foreign currency exchange rate fluctuations with the weakening of the U.S. dollar against the foreign currencies of our subsidiaries. The U.S. dollar equivalent of the related costs denominated in these foreign currencies was unfavorably impacted during the same period. In addition, the costs associated with our Mexico-based manufacturing operations are incurred in Mexican pesos. As we continue to distribute and manufacture our products in selected foreign countries, we expect that future sales and costs associated with our activities in these markets will continue to be denominated in the applicable foreign currencies, which could cause currency fluctuations to materially impact our operating results. Occasionally we seek to reduce the potential impact of currency fluctuations on our net income through hedging transactions. As of September 29, 2007, we had outstanding hedges in the form of forward contracts to purchase Mexican pesos aggregating a U.S. dollar equivalent of $15.8 million. As of September 29, 2007, we had an unrealized foreign currency gain of $0.2 million related to these contracts.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures 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 Securities and Exchange 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. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in SEC Rules 13a – 15(e) and 15d – 15(e)) as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There has been no change to our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

From time to time, we are involved in legal and administrative disputes and proceedings arising in the ordinary course of business, most of which are not material to the conduct of our business. With respect to these ordinary course matters, management believes that it has adequate insurance coverage or has made adequate accruals for related costs, and it may also have effective legal defenses.

 

Pending Stockholder Litigation

 

On August 31, 2007 and September 6, 2007, two purported shareholder class action lawsuits were filed in California Superior Court, in the County of San Diego, on behalf of our public stockholders, challenging our proposed merger with Parent. The court ordered the two lawsuits consolidated for all purposes on September 21, 2007. The court further ordered that plaintiffs file a consolidated amended complaint as soon as practicable, and that the defendants need not respond to either of the two original complaints.

 

The two original complaints named us, ReAble Therapeutics, Inc., an affiliate of Parent, and the current members of our board of directors as defendants. One of the original complaints also named Blackstone as a defendant. The two substantially similar original complaints alleged, among other things, that the individual defendants breached their fiduciary duties of care, good faith and loyalty by approving the proposed merger with an allegedly inadequate price, without adequately informing themselves of the Company’s highest transactional value, and without adequately marketing the company to other potential buyers. The original complaints also alleged that the individual defendants and the Company failed to make full and adequate disclosures in the preliminary proxy statement regarding the proposed merger. The original complaints pray for, among other things, class certification, declaratory relief, an injunction of the proposed merger or a rescission order, corrective disclosures to the proxy statement, damages, interest, attorneys’ fees, expert fees and other costs; and such other relief as the court may find just and proper.

 

Discovery is ongoing and the parties have stipulated to a November 2, 2007 hearing on plaintiffs’ preliminary injunction motion, and a related briefing schedule. We believe that the lawsuit is without merit and intend to vigorously oppose it.

 

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ITEM 1A. RISK FACTORS
 

Our ability to achieve our operating and financial goals is subject to a number of risks, including risks relating to our business operations, our debt level and government regulations. If any of the following risks actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. The risk factors described below reflect any material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2006. The risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business operations.

 

Risks Related to the Proposed Merger

 

Failure to complete the proposed merger could negatively affect the Company.

 

On July 15, 2007, we entered into the Merger Agreement with Parent and Merger Sub. There is no assurance that the Merger Agreement and the proposed merger will be approved by our stockholders, and there is no assurance that the other conditions to the completion of the proposed merger will be satisfied. In connection with the proposed merger, we will be subject to several risks, including the following:

 

                  the occurrence of any effect, event, development or change that could give rise to the termination of the Merger Agreement;

 

                  the outcome of the legal proceedings instituted against us following announcement of entering into the Merger Agreement;

 

                  the inability to complete the merger due to the failure to obtain stockholder approval or the failure to satisfy other conditions to completion of the merger;

 

                  the failure of Parent or Merger Sub to obtain the necessary financing arrangements set forth in commitment letters received in connection with the proposed merger;

 

                  the payment of a significant break-up fee or expense reimbursement if the merger is not completed under certain circumstances;

 

                  risks that the proposed transaction disrupts current plans and operations and the potential difficulties in employee retention;

 

                  risks that the proposed transaction causes our distribution network, customers or vendors to terminate or reduce their relationship with us;

 

                  the amount of the costs, fees, expenses and charges related to the merger and the actual terms of certain financings that will need to be obtained for the merger; and

 

                  the impact of the substantial indebtedness that will need to be incurred to finance the consummation of the merger.

 

Any of these events could have a material negative impact on our results of operations and financial condition and could adversely affect the price of our common stock.

 

Risks Related to Our Business

 

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

 

Our growth strategy will continue to include the pursuit of acquisitions, both domestically and, in particular, internationally. We may not be able to identify acceptable opportunities or complete acquisitions of targets identified in a timely manner or on acceptable terms. Acquisitions involve a number of risks, including the following:

 

                                          our management’s attention will be diverted from our existing business while evaluating acquisitions and thereafter while integrating the operations and personnel of the new business into our business;

 

              we may experience adverse short-term effects on our operating results;

 

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                                          we may be unable to successfully and rapidly integrate the new businesses, personnel and products with our                existing business, including financial reporting, management and information technology systems;

 

                                          we may experience higher than anticipated costs of integration and unforeseen operating difficulties and expenditures;

 

                                          an acquisition may be in a market or geographical area in which we have little experience;

 

                                          we may have difficulty in retaining key employees, including employees who may have been instrumental to the success or growth of the acquired business; and

 

              we may use a substantial amount of our cash and other financial resources to consummate an acquisition.

 

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

 

Weaknesses in our internal control over financial reporting could result in material misstatements in our financial statements.

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal controls are processes designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. generally accepted accounting principles. A material weakness is a control deficiency, or combination of control deficiencies, that results in a more than remote likelihood that a material misstatement of annual or interim financial statements will not be prevented or detected.

 

Management determined that a material weakness in our internal control over financial reporting existed as of December 31, 2006 with regard to inventory that was in transit from the Aircast facilities in New Jersey to our facilities in Indianapolis and Tijuana, Mexico as a part of the integration of the Aircast business into our business operations. We did not perform adequate detailed procedures with respect to such inventory and failed to adequately reconcile the related intercompany transactions. See “Item 9A – Controls and Procedures” in our Annual Report on Form 10-K for the year ended December 31, 2006 for a more complete description of this material weakness.

 

We have remediated this material weakness with a detailed analysis and reconciliation of the in-transit inventory and related intercompany accounts. We cannot assure you that additional control deficiencies or material weaknesses will not be identified by our management or independent registered public accounting firm in the future, including in connection with the integration of our Aircast acquisition, Axmed acquisition or other acquisitions we may consummate in the future. In addition, even after having taken these remediation steps, our internal controls may not prevent all potential errors or fraud. Any control system, no matter how well designed and implemented, can only provide reasonable and not absolute assurance that the objectives of the control system will be achieved. Failure to achieve adequate internal control over financial reporting could adversely affect our business operations and financial position.

 

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

 

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

 

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We have outsourced certain administrative functions relating to our OfficeCare and Insurance channels to a third-party contractor and this arrangement may not prove successful.

 

Our OfficeCare sales channel maintains an inventory of products (mostly soft goods) on hand at orthopedic practices for immediate distribution to patients. In our Insurance channel, we provide products, principally custom-made rigid knee braces, directly to patients. In both situations, we bill patients or their third-party payors after the product is provided to the patient. We outsource the revenue cycle of these channels, from billing to collections, to an independent third-party contractor. Our outsource contractor has undergone significant changes in their business operations in the last two years, including locating some administrative functions overseas, in order to improve performance from order entry to collections. We are also working closely with them to upgrade the software system used in these revenue cycle processes. The inability of this provider to upgrade its processes and demonstrate improved billing and collection results could have an adverse effect on our operations and financial results in the OfficeCare and Insurance channels.

 

We rely on intellectual property to develop and manufacture our products and our business could be adversely affected if and when we lose our intellectual property rights.

 

We hold or license U.S. and foreign patents relating to a number of our components and products and have patent applications pending with respect to other components and products. We also expect to apply for additional patents as we deem appropriate. We believe that many of our patents are, and will continue to be, extremely important to our success.

 

However, we cannot assure you that:

 

                  our existing or future patents, if any, will afford us adequate protection;

 

                  our patent applications will result in issued patents; or

 

                  our patents will not be circumvented or invalidated.

 

Our success also depends on non-patented proprietary know-how, trade secrets, processes and other proprietary information. We employ various methods to protect our proprietary information, including confidentiality agreements and proprietary information agreements with vendors, employees, consultants and others who have access to our proprietary information. However, these methods may not provide us with adequate protection. Our proprietary information may become known to, or be independently developed by, competitors, or our proprietary rights in intellectual property may be challenged, any of which could have an adverse effect on our business.

 

If we are not able to develop, license or acquire and market new products or product enhancements we may not remain competitive.

 

Our future success and the ability to grow our revenues and earnings require the continued development, licensing or acquisition of new products and the enhancement of our existing products. We may not be able to:

 

                  continue to develop or license successful new products and enhance existing products;

 

                  obtain required regulatory clearances and approvals for such products;

 

                  market such products in a commercially viable manner; or

 

                  gain market acceptance for such products.

 

We may be unable to remain competitive if we fail to develop, license or acquire and market new products and product enhancements. In addition, if any of our new or enhanced products contain undetected errors or design defects, especially when first introduced, our ability to market these products could be substantially delayed, resulting in lost revenues, potential damage to our reputation and/or delays in obtaining acceptance of the product by orthopedic and spine surgeons and other healthcare professionals.

 

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We rely heavily on our relationships with orthopedic professionals who prescribe and dispense our products and our failure to maintain these relationships could adversely affect our business.

 

The sales of our products depend significantly on the prescription or recommendation of such products by orthopedic and spine surgeons and other healthcare professionals. We have developed and maintain close relationships with a number of widely recognized orthopedic surgeons and specialists who support and recommend our products. Failure of our products to retain the support of these surgeons and specialists, or the failure of our products to secure and retain similar support from leading surgeons and specialists, could have an adverse effect on our business.

 

The majority of our sales force consists of independent agents and distributors who maintain close relationships with our hospital and physician customers.

 

Our success also depends largely upon arrangements with independent agents and distributors and their relationships with our hospital and physician customers in the marketplace. These agents and distributors are not our employees, and our ability to influence their actions and performance is limited. Our inability to effectively manage these agents and distributors or our failure generally to maintain relationships with these independent agents and distributors could have an adverse effect on our business.

 

We operate in a very competitive business environment.

 

The non-operative orthopedic and spine markets are highly competitive and fragmented. Our competitors include several large, diversified general orthopedic products companies and numerous smaller niche companies. Some of our competitors are part of corporate groups that have significantly greater financial, marketing and other resources than we have. Accordingly, we may be at a competitive disadvantage with respect to these competitors.

 

In the rehabilitation market, our primary competitors in the rigid knee bracing product line include Orthofix International, N.V., Bledsoe Brace Systems, Ossur hf. and Townsend Industries Inc. Our competitors in the soft goods products market include Biomet, Inc., DeRoyal Industries, Ossur hf. and Zimmer Holdings, Inc. Our primary competitors in the pain management products market include I-Flow Corp., Orthofix and Stryker Corporation.

 

In the regeneration market, our primary competitors selling bone growth stimulation products approved by the FDA for the treatment of nonunion fractures are Orthofix, Biomet, Inc. and Smith & Nephew. Biomet and Orthofix also sell bone growth stimulation products for use by spinal fusion patients. We estimate that Biomet has dominant shares of the U.S. markets for bone growth stimulation products used both to treat nonunion fractures and as adjunct therapy after spinal fusion surgery.

 

Our quarterly operating results are subject to substantial fluctuations and you should not rely on them as an indication of our future results.

 

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

 

                  the number of business days in each quarter;

 

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

 

                  our ability to meet the demand for our products;

 

                  the direct distribution of our products in foreign countries, which have more seasonality than the U.S.;

 

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

 

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

 

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                  the impact of any acquisitions that occur in a quarter;

 

                  fluctuations in gross profit due to changes in product mix;

 

                  the impact of any changes in generally accepted accounting principles;

 

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

 

                  the loss of any of our distributors;

 

                  changes in the treatment practices of orthopedic and spine surgeons and their allied healthcare professionals; and

 

                  the timing of significant orders and shipments.

 

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

 

Our business plan relies on certain assumptions for the market for our products, which, if incorrect, may adversely affect our profitability.

 

We believe that various demographics and industry specific trends will help drive growth in the rehabilitation and regeneration markets, including:

 

                  a growing elderly population with broad medical coverage, increased disposable income and longer life expectancy;

 

                  a growing emphasis on physical fitness, leisure sports and conditioning, which has led to increased injuries, especially among women; and

 

                  the increasing awareness and use of non-invasive devices for prevention, treatment and rehabilitation purposes.

 

These demographics and trends are beyond our control. The projected demand for our products could materially differ from actual demand if our assumptions regarding these factors prove to be incorrect or do not materialize or if alternative treatments to those offered by our products gain widespread acceptance.

 

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

 

The orthopedic products industry has experienced extensive litigation regarding patents and other intellectual property rights. We or our products may become subject to patent infringement claims or litigation or interference proceedings declared by the U.S. Patent and Trademark Office, or USPTO, or the foreign equivalents thereto to determine the priority of inventions. The defense and prosecution of intellectual property suits, USPTO interference proceedings or the foreign equivalents thereto and related legal and administrative proceedings are both costly and time consuming. An adverse determination in litigation or interference proceedings to which we may become a party could:

 

                  subject us to significant liabilities to third-parties;

 

                  require disputed rights to be licensed from a third-party for royalties that may be substantial; or

 

                  require us to cease using such technology.

 

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Any one of these outcomes could have an adverse effect on us. Furthermore, we may not be able to obtain necessary licenses on satisfactory terms, if at all. Accordingly, adverse determinations in a judicial or administrative proceeding or our failure to obtain necessary licenses could prevent us from manufacturing and selling our products, which would have a material adverse effect on our business, operating results and financial condition. Moreover, even if we are successful in such litigation, the expense of defending such claims could be material.

 

In addition, we have from time to time needed to, and may in the future need to, litigate to enforce our patents, to protect our trade secrets or know-how or to determine the enforceability, scope and validity of the proprietary rights of others. Such enforcement of our intellectual property rights could involve counterclaims against us. Any future litigation or interference proceedings will result in substantial expense to us and significant diversion of effort by our technical and management personnel.

 

We have limited suppliers for some of our components and products which makes us susceptible to supply shortages and could disrupt our operations.

 

Some of our important suppliers are in China and other parts of Asia and provide us predominately finished soft goods products. In fiscal year 2006, we obtained approximately 15% of our total purchased materials from suppliers in China and other parts of Asia. Political and economic instability and changes in government regulations in these areas could affect our ability to continue to receive materials from our suppliers there. The loss of our suppliers in China and other parts of Asia, any other interruption or delay in the supply of our required materials or our inability to obtain these materials at acceptable prices and within a reasonable amount of time could impair our ability to meet scheduled product deliveries to our customers and could hurt our reputation and cause customers to cancel orders.

 

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

 

Our international sales and profitability may be adversely affected by foreign currency exchange fluctuations and other risks.

 

We sell products in foreign currency through our foreign subsidiaries. The U.S. dollar equivalent of international sales denominated in foreign currencies in fiscal years 2006, 2005 and 2004 were favorably impacted by foreign currency exchange rate fluctuations with the weakening of the U.S. dollar against the foreign currencies of our subsidiaries. The U.S. dollar equivalent of the related costs denominated in these foreign currencies was unfavorably impacted during the same periods. In addition, the costs associated with our Mexico-based manufacturing operations are incurred in Mexican pesos. As we continue to distribute and manufacture our products in selected foreign countries, we expect that future sales and costs associated with our activities in these markets will continue to be denominated in the applicable foreign currencies, which could cause currency fluctuations to materially impact our operating results.

 

We are also subject to other risks inherent in international operations such as political and economic conditions, foreign regulatory requirements, exposure to different legal requirements and standards, exposure to different approaches to treating injuries, potential difficulties in protecting intellectual property, import and export restrictions, increased costs of transportation or shipping, currency fluctuations, difficulties in staffing and managing international operations, labor disputes, difficulties in collecting accounts receivable and longer collection periods and potentially adverse tax consequences. For example, in Germany, our largest foreign market, orthopedic professionals began re-using our bracing devices on multiple patients during 2004, which has adversely impacted our sales of these devices in this market since 2004. As we continue to expand our international business, our success will be dependent, in part, on our ability to anticipate and effectively manage these and other risks. If we are unable to do so, these and other factors may have an adverse effect on our international operations.

 

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The direct distribution of our products in selected foreign countries involves financial and operational risks.

 

Since 2002, we have been implementing a strategy to selectively replace our third-party international distributors with wholly owned distributorships, and in 2006 we increased the portion of our revenues derived from international customers to over 20% as a result of the Axmed and Aircast acquisitions and growth generally in international markets. We have subsidiaries in several foreign countries and plan to continue to expand our international business. Our foreign activities require experienced management in each subsidiary who are familiar with the market dynamics in the particular country and overall operational, financial, administrative and sales management to oversee the international business. We added significant capability in this regard during 2006, but are still in the process of adding certain of the management resources we need. We also are in the process of identifying and securing additional financial and operational controls for the international business. We cannot assure you that we will be able to successfully complete our international management team on a timely basis or secure and maintain adequate organizational controls in our foreign operations or that our international strategy will result in increased revenues or profitability.

 

Our concentration of manufacturing operations in Mexico increases our business and competitive risks.

 

Other than a relatively small manufacturing operation in Tunisia acquired in the recent Axmed acquisition and other than the manufacturing of our BGS products, our custom rigid knee braces and certain of our vascular products that is conducted in Vista, California, all of our manufacturing activities are carried out in our facility in Tijuana, Mexico. These operations are subject to risks of political and economic instability inherent in activities conducted in foreign countries. In addition, as a result of this concentration of manufacturing activities, our sales in foreign markets may be at a competitive disadvantage to products manufactured locally due to freight costs, custom and import duties and favorable tax rates for local businesses. In order to reduce the risk involved in the concentration of most of our manufacturing activities in one foreign jurisdiction and to compete successfully with foreign manufacturers, we may be required to open or expand manufacturing operations abroad, which would be costly to implement and may not effectively reduce the risk of doing business in foreign countries. We may not be able to successfully operate additional offshore manufacturing operations.

 

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

 

We face an inherent business risk of exposure to product liability claims in the event that the use of our technology or products is alleged to have resulted in adverse effects. We have, from time to time, been subject to product liability claims. In addition, we have operated a Knee Guarantee program since 2001 in relation to our Defiance knee brace. The Knee Guarantee program will, in specified instances, cover a patient’s insurance deductible up to $1,000, or give uninsured patients $1,000, towards surgery should an ACL re-injury occur while wearing the brace. In 2003, the Technology You Can Trust program was introduced in connection with our BGS products. If a patient has a nonunion fracture that fails to heal while using a BGS product, the Technology You Can Trust program will, if the patient meets the specified requirements of the program, refund the costs for treatment using the BGS product. Claims under the Technology You Can Trust program were not material and the program was terminated.

 

We maintain product liability insurance with coverage of an annual aggregate maximum of $20 million. The policy is provided on a claims made basis and is subject to annual renewal. There can be no assurance that liability claims will not exceed the coverage limit of such policy or that such insurance will continue to be available on commercially reasonable terms or at all. If we do not or cannot maintain sufficient liability insurance, our ability to market our products may be significantly impaired.

 

We may be adversely affected if we lose the services of any member of our senior management team.

 

We are dependent on the continued services of our senior management team, who have made significant contributions to our growth and success. Leslie H. Cross, our President and Chief Executive Officer, for example, has worked for us for nearly 17 years and helped lead our 1999 recapitalization and transition from ownership by Smith & Nephew to a stand-alone company. The loss of any one or more members of our senior management team could have a material adverse effect on us.

 

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Any claims relating to our improper handling, storage or disposal of wastes could be time consuming and costly.

 

Our facilities and operations are subject to federal, state and local environmental and occupational health and safety requirements of the United States and foreign countries, including those relating to discharges of substances to the air, water, and land, the handling, storage and disposal of wastes and the cleanup of properties affected by pollutants. In the future, federal, state, local or foreign governments could enact new or more stringent laws or issue new or more stringent regulations concerning environmental and worker health and safety matters that could affect our operations. We became the owner of a New Jersey factory as a result of the Aircast acquisition and that factory is the site of an environmental clean-up project that is currently being performed by a prior owner. We sold that factory in August 2007. Also, contamination may be found to exist at our other current, former or future facilities, including the facility in Tempe, Arizona that we occupied following the Regeneration acquisition, or off-site locations where we have sent wastes. We could be held liable for such contamination, which could have a material adverse effect on our business or financial condition. In addition, changes in environmental and worker health and safety requirements or liabilities from newly discovered contamination could have a material effect on our business or financial condition.

 

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

 

Nearly all of our rehabilitation products are manufactured in our new facility in Tijuana, Mexico, with a number of products for the European market manufactured in our recently-acquired Tunisian facility. The products that are still manufactured in Vista, California consist of our custom rigid bracing products, which remain in the U.S. to facilitate quick turn-around on custom orders and the Regeneration product line. These facilities and the manufacturing equipment we use to produce our products would be difficult to repair or replace. Our facilities may be affected by natural or man-made disasters. If one of our facilities were affected by a disaster, we would be forced to rely on third-party manufacturers or shift production to another manufacturing facility. In such an event, we would face significant delays in manufacturing which would prevent us from being able to sell our products. In addition, our insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.

 

Because we have various mechanisms in place to discourage takeover attempts, a change in control of our company that a stockholder may consider favorable could be prevented.

 

Provisions of our certificate of incorporation and bylaws may discourage, delay or prevent a change in control of our company that a stockholder may consider favorable. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors and take other corporate actions. These provisions include:

 

                  authorizing the issuance of “blank check” preferred stock by our board of directors to increase the number of outstanding shares and thwart a takeover attempt;

 

                  a classified board of directors with staggered, three-year terms, which may lengthen the time required to gain control of the board of directors;

 

                  prohibiting cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates;

 

                  requiring supermajority voting to effect particular amendments to our certificate of incorporation and bylaws;

 

                  limitations on who may call special meetings of stockholders;

 

                  prohibiting stockholder action by written consent, thereby requiring all actions to be taken at a meeting of the stockholders; and

 

                  establishing advance notice requirements for the nomination of candidates for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings.

 

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In addition, Section 203 of the Delaware General Corporation Law prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally defined as a person that together with its affiliates owns or within the last three years has owned 15% of the corporation’s voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. Accordingly, Section 203 may discourage, delay or prevent a change in control of our company.

 

As a result, these provisions could limit the price that investors are willing to pay in the future for shares of our common stock.

 

Risks Related to Government Regulation

 

Our failure to comply with regulatory requirements or receive regulatory clearance or approval for our products or operations in the United States or abroad would adversely affect our revenues and potential for future growth.

 

Our products are medical devices that are subject to extensive regulation in the United States by the Food and Drug Administration, or FDA, and by respective authorities in foreign countries where we do business. The FDA regulates virtually all aspects of a medical device’s design and testing, manufacture, safety, labeling, storage, recordkeeping, reporting, clearance and approval, promotion and distribution. The FDA also regulates the export of medical devices to foreign countries. Failure to comply with the regulatory requirements of the FDA and other applicable U.S. regulatory requirements may subject a company to administrative or judicially imposed sanctions ranging from warning letters to criminal penalties or product withdrawal. Unless an exemption applies, a medical device must receive either clearance or premarket approval from the FDA before it can be marketed in the United States. The FDA’s 510(k) clearance process for Class II devices usually takes from three to twelve months, but may take significantly longer. The premarket approval process for Class III devices generally takes from one to three years from the time the application is filed with the FDA, but also can be significantly longer. Premarket approval typically requires extensive clinical data and can be significantly longer, more expensive and more uncertain than the 510(k) clearance process. Despite the time, effort and expense expended, there can be no assurance that a particular device will be approved or cleared by the FDA through either the 510(k) clearance process or the premarket approval process.

 

Medical devices may only be marketed for the indications for which they are approved or cleared. We may be required to obtain additional new premarket approvals, premarket approval supplements or 510(k) clearances to market additional products or for new indications for or modifications to our existing products. We cannot be certain that we would obtain additional premarket approvals or 510(k) clearances in a timely manner or at all. We have modified various aspects of our devices in the past and we determined that new approvals, supplements or clearances were not required. The FDA may not agree with our decisions not to seek approvals, supplements or clearances for particular device modifications. If the FDA requires us to obtain premarket approvals, supplement approvals or 510(k) clearances for any modification to a previously cleared or approved device, we may be required to cease manufacturing and marketing the modified device or to recall such modified device until we obtain FDA clearance or approval and we may be subject to significant regulatory fines or penalties. In addition, there can be no assurance that the FDA will clear or approve such submissions in a timely manner, if at all.

 

Our failure to obtain FDA clearance or approvals of new products, new indications or product modifications that we develop in the future, any limitations imposed by the FDA on such products’ development or use, or the costs of obtaining FDA clearance or approvals could have a material adverse effect on our business.

 

In many of the foreign countries in which we market our products, we are subject to extensive regulations essentially the same as those of the FDA, including those in Germany, our largest foreign market. The regulation of our products in Europe falls primarily within the European Economic Area, which consists of the twenty-seven member states of the European Union, as well as Iceland, Liechtenstein and Norway. The Council of the European Union (formerly the Council of the European Communities) and the Council of the European Parliament have adopted three directives in order to harmonize national provisions regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices to ensure that medical devices marketed are safe and effective for their intended uses. The member states of the European Economic Area have implemented the directives into their respective national law. Medical devices that comply with the conformity requirements of the national provisions and the directives will be entitled to bear a CE marking. Unless an exemption applies, only medical devices which bear a CE marking may be marketed within the European Economic Area. Switzerland also allows the marketing of medical devices that bear a CE marking. Due to the movement towards harmonization of standards in the European Union and the expansion of the European Union, we expect a changing regulatory environment in Europe characterized by a shift from a country-by-country regulatory system to a European Union-wide single regulatory system. Failure to receive, or delays in the receipt of, relevant foreign qualifications, such as the CE marking, could have a material adverse effect on our international operations.

 

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Legislative or regulatory initiatives and reforms could adversely impact our business.

 

In both the United States and certain international markets, there have been a number of legislative and regulatory initiatives and changes, such as the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Food and Drug Administration Amendments Act of 2007, which could and have altered the healthcare system in ways that could impact our ability to sell our medical devices profitably. Recent, widely-publicized events concerning the safety certain drug, food and medical device products have raised concerns among members of Congress, medical professionals, and the public regarding the FDA’s handling of these events and its perceived lack of oversight over regulated products. The increased attention to safety and oversight issues could result in, among other things, new and more burdensome legal and regulatory requirements or a more cautious approach by the FDA to device clearances and approvals and post-market compliance, which could prevent, delay clearance or approval of our new products or product modifications, or require us to expend additional resources on post-market studies and controls.

 

In addition, changes in the regulatory status of our medical devices could adversely affect our operations and financial results. The FDA has the authority to reclassify devices, either on its on initiative or in response to a petition filed by a third party. For instance, a third party filed a petition with the FDA in February 2005 seeking to reclassify non-invasive BGS devices from Class III to Class II, but withdrew the petition after the FDA proposed to deny it. We cannot be sure that changes in the classification of our devices or other regulatory changes will not be proposed or implemented that adversely impact our business.

 

Our products are subject to recalls even after receiving FDA clearance or approval, or after receiving CE-markings, which would harm our reputation and business.

 

We are subject to medical device reporting, or MDR, regulations that require us to report to the FDA or governmental authorities in other countries if our products cause or contribute to a death or serious injury or malfunction in a way that would be reasonably likely to contribute to death or serious injury if the malfunction were to recur. The FDA and similar governmental authorities in other countries have the authority to require the recall of our products in the event of material deficiencies or defects in design or manufacturing, and we have been subject to product recalls in the past. A government mandated, or voluntary, recall by us could occur as a result of component failures, manufacturing errors or design defects, including defects in labeling. Any recall would divert managerial and financial resources and could harm our reputation with customers. There can be no assurance that there will not be product recalls in the future or that such recalls would not have a material adverse effect on our business.

 

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

 

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

 

If 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 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 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 FDA or another regulatory agency determines that our promotional materials or training constitutes promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory enforcement actions, including the issuance of a warning letter, injunction, seizure, civil fine and criminal penalties.

 

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Although our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.  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.

 

Audits or denials of our claims by government agencies as well as failure to comply with governmental purchasing programs’ pricing practices and/or contract requirements could reduce our revenues or profits.

 

As part of our business structure, we submit claims directly to and receive payments directly from the Medicare and Medicaid programs, as well as other governmental payors, such as military and veterans’ healthcare programs. Therefore, we are subject to extensive government regulation, including requirements for maintaining certain documentation to support our claims. Medicare contractors, Medicaid agencies and government contracting agencies periodically conduct pre- and post-payment review and other audits of claims, and are under increasing pressure to scrutinize more closely healthcare claims and supporting documentation generally. We periodically receive requests for documentation during governmental audits of individual claims either on a pre-payment or post-payment basis. As a result of such audits, we may be subject to requests for refunds. We cannot assure you that such reviews and/or other audits of our claims will not result in material delays in payment, material recoupments or denials and fines or penalties, any of which could reduce our revenues or profits.

 

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

 

Changes in United States coverage and reimbursement policies for our products by third-party payors or reductions in reimbursement rates for our products could adversely affect our business and results of operations.

 

Our products are sold to healthcare providers and physicians who may receive reimbursement for the cost of our products from private third-party payors and, to a lesser extent, from Medicare, Medicaid and other governmental programs. In certain circumstances, such as for our Regeneration products and the products sold through our OfficeCare program, we submit claims to third-party payors for reimbursement. Our ability to sell our products successfully will depend in part on the purchasing and practice patterns of healthcare providers and physicians, who are influenced by cost containment measures taken by third-party payors. Limitations or reductions in third-party coverage and reimbursement of our products can have a material adverse effect on our sales and profitability.

 

The United States Congress and state legislatures from time-to-time consider reforms in the healthcare industry that may modify reimbursement methodologies and practices, including controls on spending by the Medicare and Medicaid programs. It is not clear at this time what proposals, if any, will be adopted or, if adopted, what effect these proposals would have on our business. Many private health insurance plans model their coverage and reimbursement policies after Medicare policies. Therefore, congressional or regulatory measures that reduce Medicare reimbursement rates could cause private health insurance plans to reduce their reimbursement rates for our products, which could have an adverse effect on our ability to sell our products or cause our orthopedic professional customers to prescribe less expensive products introduced by us and our competitors.

 

With the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or Modernization Act, a number of changes have been mandated that affect Medicare payment methodology and conditions for coverage for our orthotic devices and durable medical equipment, including our bone growth stimulators. These changes include a freeze in reimbursement levels for certain medical devices from 2004 through 2008, competitive bidding requirements, new clinical conditions for payment and quality standards. The changes affect our products generally, although specific products may be affected by some but not all of the Modernization Act’s provisions. CMS has proposed, for instance, that our Class III bone growth stimulator devices be subject to the freeze in reimbursement levels for 2007 and 2008. If finalized, Class III devices such as our bone growth stimulator product would not receive an increase in reimbursement levels under Medicare. Class III bone growth stimulator devices, however, are not subject to competitive bidding. The Modernization Act, however, does subject off-the-shelf orthotic devices to competitive bidding. The Modernization Act requires competitive bidding to be implemented in phases, with the initial phase now scheduled to begin on July 1, 2008. The bidding process for this initial phase of competitive bidding closed on September 25, 2007. Under competitive bidding, Medicare will change its approach to reimbursing certain items and services of durable medical equipment, orthotics, prosthetics and supplies covered by Medicare from the current fee schedule amount to an amount established through a bidding process between the government and suppliers. Competitive bidding may reduce the number of suppliers providing certain items and

 

43



 

services to Medicare beneficiaries and the amounts paid for such items and services. Also, Medicare payments in regions not subject to competitive bidding may be reduced using payment information from regions subject to competitive bidding. Any payment reductions or the inclusion of certain of our orthotic devices in competitive bidding, in addition to the other changes to Medicare reimbursement and standards contained in the Modernization Act, could have a material adverse effect on our results of operations.

 

The Centers for Medicare and Medicaid Services, or CMS, released its final regulations regarding the implementation of competitive bidding on April 2, 2007. The final regulations indicate, among other things, how CMS will determine which products and which metropolitan statistical areas of the United States will be subject to competitive bidding. The final regulations also describe how CMS plans to award contracts and how it will evaluate bids and set payment rates. In conjunction with issuing its final regulations, CMS announced the ten areas of the United States in which the initial phase of competitive bidding will be implemented, as well as the product categories subject to the initial phase. CMS did not select off-the-shelf orthotics as a product category for the initial phase, although these products could be made subject to competitive bidding during future rounds of the program. The regulation also includes a new definition of “off-the-shelf orthotics,” so that the category will include only orthotics that “require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit the individual.”  CMS further defines “minimal self-adjustment” to mean “adjustments that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform without the assistance of a certified orthotist, or an individual who has specialized training.”  CMS also deferred for future rulemaking any policy on applying the competitive bidding payment rate to areas not selected for competitive bidding. Despite the issuance of final regulations on competitive bidding, significant uncertainty remains as to how the competitive bidding program will be implemented and whether any of our products will be made subject to competitive bidding during future rounds of the program. At this time, therefore, we do not have sufficient details to assess the impact that competitive bidding would have on our business.

 

In addition, CMS finalized its interim final regulation implementing “inherent reasonableness” authority. The final regulation went into effect on February 13, 2006 and essentially kept in place policies first announced in 2002 in the earlier interim final regulation. The regulation allows the agency and its contractors to make adjustments to payment amounts for certain items and services covered by Medicare when the existing payment amount is determined to be grossly excessive or grossly deficient. The regulation lists factors that may be used to determine whether an existing reimbursement rate is grossly excessive or grossly deficient and to determine what is a realistic and equitable payment amount. Also, under the regulation, a payment amount will not be considered grossly excessive or grossly deficient if an overall payment adjustment of less than fifteen percent would be necessary to produce a realistic and equitable payment amount. The Modernization Act clarified that the use of inherent reasonableness authority is precluded for devices provided under competitive bidding. When using the inherent reasonableness authority, CMS may reduce reimbursement levels for certain items and services, which could have a material adverse effect on our results of operations.

 

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We cannot assure you that third-party coverage or reimbursement for our products will continue to be available or at what rate such products will be reimbursed. Failure by users of our products to obtain sufficient coverage and reimbursement from third-party payors for our products or adverse changes in governmental and private payors’ policies toward coverage and reimbursement for our products could have a material adverse effect on our results of operations.

 

Changes in international regulations regarding coverage and reimbursement for our products could adversely affect our business and results of operations.

 

Similar to our domestic business, our success in international markets also depends upon coverage and reimbursement of our products through government-sponsored healthcare payment systems and third-party payors, the portion of cost subject to reimbursement, and the cost allocation 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 that 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 standards. Any developments in our foreign markets that eliminate or reduce reimbursement rates for our products could have an adverse effect on our ability to sell our products or cause our orthopedic professional customers to use less expensive products in these markets.

 

Medicare laws mandating new supplier quality standards and conditions for coverage could adversely impact our business.

 

Medicare regulations require entities or individuals submitting claims and receiving payment to obtain a supplier number, which in turn is predicated on compliance with a number of supplier standards. Under the Modernization Act, any entity or individual that bills Medicare for durable medical equipment, such as bone growth stimulators and orthotics and that has a supplier number will also be subject to new quality standards as a condition of receiving payment from the Medicare program. On August 14, 2006, CMS finalized its supplier quality standards, and in November 2006, CMS published a list of recognized independent accreditation organizations that may accredit suppliers as meeting the quality standards. We were required to become accredited to continue to bill Medicare as a supplier. We have completed the process of becoming accredited.

 

The final quality standards include business-related standards, such as financial and human resources management standards, which are applicable to all durable medical equipment, orthotics and prosthetics suppliers. The final quality standards also contain certain product-specific standards, including several standards related to customized orthotics products, which focus on product specialization and service standards for such items. The Modernization Act also authorizes CMS to establish clinical conditions for payment for durable medical equipment, including establishing types or classes of covered items that require a prescription and a face-to-face examination of the individual by a physician or practitioner. CMS has proposed to expand the face-to-face visit requirement for clinical conditions of coverage to prosthetics, orthotics and supplies (POS), because the agency believes that items of POS require the same level of medical intervention and skill as durable medical equipment. These new supplier quality standards and proposed clinical conditions for payment could affect our ability to bill Medicare, could limit or reduce the number of individuals who can fit, sell or provide our products and could restrict coverage for our products.

 

Healthcare reform, managed care and buying groups have put downward pressure on the prices of our products.

 

The development of managed care programs in which the providers contract to provide comprehensive healthcare to a patient population at a fixed cost per person (referred to as capitation) has put pressure on, and is expected to continue to cause, healthcare providers to lower costs. One result has been, and is expected to continue to be, a shift toward lower-priced products, and any such shift in our product mix to lower margin, off-the-shelf products could have an adverse impact on our operating results. For example, in our rigid knee-bracing segment, we and many of our competitors are offering lower-priced, off-the-shelf products in response to managed care customers.

 

A further result of managed care and the related pressure on costs has been the advent of buying groups in the United States. Such buying groups enter into preferred supplier arrangements with one or more manufacturers of orthopedic or other medical products in return for price discounts. The extent to which such buying groups are able to obtain compliance by their members with such preferred supplier agreements varies considerably depending on the particular buying groups. In response to the organization of

 

45



 

new buying groups, we have entered into national contracts with selected groups and believe that the high levels of product sales to such groups and the opportunity for increased market share have the potential to offset the financial impact of discounting. We believe that our ability to maintain our existing arrangements will be important to our future success and the growth of our revenues. In addition, we may not be able to obtain new preferred supplier commitments for major buying groups, in which case we could lose significant potential sales, to the extent these groups are able to command a high level of compliance by their members. On the other hand, if we receive preferred supplier commitments from particular groups which do not deliver high levels of compliance, we may not be able to offset the negative impact of lower per unit prices or lower margins with any increases in unit sales or in market share.

 

In international markets, we have experienced downward pressure on product pricing and other effects of healthcare reform similar to that which we have experienced in the United States. We expect healthcare reform and managed care to continue to develop in our primary international markets, which we expect will result in further downward pressure in product pricing. The timing and effects on us of healthcare reform and the development of managed care in international markets cannot currently be predicted.

 

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 orthopedic practitioners), the United States Congress and state legislatures have periodically considered proposals that limit the types of orthopedic professionals who can fit or sell our orthotic device products or who can seek reimbursement for them. Several states have adopted legislation which imposes certification or licensing requirements on the measuring, fitting and adjusting of certain orthotic devices. Although some of these state laws exempt manufacturers’ representatives, other states’ laws subject the activities of such representatives to certification or licensing requirements. Additional states may be considering similar legislation. Such laws could limit our potential customers in those jurisdictions in which such legislation or regulations are enacted. 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, we cannot predict the effect of implementation of BIPA or implementation of other such laws will have on our business.

 

We could be subject to governmental investigations under various healthcare “fraud and abuse” laws with respect to our business arrangements with prescribing physicians and other health care professionals.

 

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

 

                  the federal Anti-Kickback Statute, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual, or furnishing or arranging for 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;

 

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

 

                  the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits executing a scheme to defraud any healthcare benefit program;

 

                  the federal False Statements Statute, which prohibits 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;

 

46



 

                  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 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 Law and the Stark Law, 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 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. Recently, the United States Attorney’s Office has entered into Deferred Prosecution Agreements (DPA) with four of five large companies in the orthopedics industry providing for settlement of alleged criminal violations of Federal Anti-Kickback Statute. The DPAs require significant remediation and cooperation with federal authorities and continued compliance with the relevant federal statutes, including, the appointment of an independent monitor selected by the government to evaluate and monitor each company’s compliance with the DPA, the strengthening of the internal corporate compliance function, specific limitations on and approval procedures for all consulting agreements with healthcare professionals and the entry into five year Corporate Integrity Agreements.

 

We have numerous business arrangements with physicians and other potential referral sources, including but not limited to arrangements whereby physicians serve as consultants to DJO or serve as speakers for training, educational and marketing programs provided by DJO. Many of these arrangements involve payment for services or coverage of, or reimbursement for, common business expenses (such as meals, travel and accommodations) associated with the arrangement. Governmental authorities could attempt to take the position that one or more of these arrangements, or the payments or other remuneration provided thereunder, violates the Anti-Kickback Statute, the Stark Law or similar state laws. In addition, if any of our past or present arrangements were found to violate such laws, federal authorities or whistleblowers could take the position that our submission of claims for payment to a federal health care program for items or services realized as a result of such violations also violate the federal False Claims Act.

 

If our past or present operations are found to be in violation of any of the laws described above or the other similar governmental regulations to which we or our customers are subject, we may be subject to the applicable penalty associated with the violation, including civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our operations. Similarly, if the physicians or other providers or entities with whom we do business are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on us. Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of interpretations, and additional legal or regulatory change. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation.

 

47



 

Risks Related to our Debt

 

We substantially increased our indebtedness in connection with the Aircast acquisition.

 

In order to finance the purchase price of the Aircast acquisition and to cover related acquisition costs as well as repay our existing bank debt, we entered into a new credit facility on April 7, 2006, consisting of a term loan of $350 million which was fully drawn at closing and up to $50 million available under a revolving credit facility. Following the transaction, we are a much more highly leveraged company, and our flexibility in conducting business operations and continuing to invest in growth opportunities could be reduced as a result of this increased indebtedness. Our increased indebtedness could limit our ability to obtain future additional financing we may need to fund future working capital, capital expenditures, product development or acquisitions. As of September 29, 2007, the balance outstanding under the term loan was $285.5 million and $49.2 million was available under the revolving credit facility, net of outstanding letters of credit.

 

Our debt agreements contain operating and financial restrictions, which restrict our business and financing activities.

 

The operating and financial restrictions and covenants in our credit agreement and any future financing agreements may adversely affect our ability to finance future operations, meet our capital needs or engage in our business activities. Currently, our existing credit agreement restricts our ability to:

 

                  incur additional indebtedness;

 

                  issue redeemable equity interests and preferred equity interests;

 

                  pay dividends or make distributions, repurchase equity interests or make other restricted payments;

 

                  redeem subordinated indebtedness;

 

                  create liens;

 

                  enter into certain transactions with affiliates;

 

                  make investments;

 

                  sell assets; or

 

                  enter into mergers or consolidations.

 

With respect to mergers or acquisitions, our credit agreement limits our ability to finance acquisitions through additional borrowings. In addition, our credit agreement prohibits us from acquiring assets or the equity of another company unless:

 

                  we are not in default under the credit agreement;

 

                  after giving pro forma effect to the transaction, we remain in compliance with the financial covenants contained in the credit agreement;

 

                  if the acquisition price is greater than $15 million, the company we are acquiring has positive EBITDA;

 

                  the acquisition price is less than $75 million individually and less than $200 million in the aggregate with all other permitted acquisitions consummated during the term of the credit agreement; and

 

                  if the acquisition involves assets outside the United States, the acquisition price is less than $40 million in the aggregate with all other permitted acquisitions consummated outside the United States during the term of the agreement.

 

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Restrictions contained in our credit agreement could:

 

                  limit our ability to plan for or react to market conditions or meet capital needs or otherwise restrict our activities or business plans; and

 

                  adversely affect our ability to finance our operations, acquisitions, investments or strategic alliances or other capital needs or to engage in other business activities that would be in our interest.

 

A breach of any of these covenants, ratios, tests or other restrictions could result in an event of default under the credit agreement. Upon the occurrence of an event of default under the credit agreement, the lenders could elect to declare all amounts outstanding under the credit agreement, together with accrued interest, to be immediately due and payable. If we were unable to repay those amounts, the lenders could proceed against the collateral granted to them to secure such indebtedness. If the lenders under the credit agreement accelerate the payment of the indebtedness, there can be no assurance that our assets would be sufficient to repay in full such indebtedness and our other indebtedness.

 

We may not be able to generate sufficient cash to service our indebtedness, which could require us to reduce our expenditures, sell assets, restructure our indebtedness or seek additional equity capital.

 

We may not have sufficient cash to service our indebtedness. Our ability to satisfy our obligations will depend upon, among other things:

 

                  our future financial and operating performance, which will be affected by prevailing economic conditions and financial, business, regulatory and other factors, many of which are beyond our control; and

 

                  the future availability of borrowings under our revolving credit facility or any successor facility, the availability of which depends or may depend on, among other things, our complying with covenants in the credit agreement.

 

If we cannot service our indebtedness, we will be forced to take actions such as reducing or delaying acquisitions, investments, strategic alliances and/or capital expenditures, selling assets, restructuring or refinancing our indebtedness, or seeking additional equity capital or bankruptcy protection. We cannot assure you that any of these remedies can be effected on satisfactory terms, if at all. In addition, the terms of existing or future debt agreements may restrict us from adopting any of these alternatives.

 

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ITEM 2.           UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3.           DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4.           SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

None.

 

ITEM 5.           OTHER INFORMATION

 

None.

 

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ITEM 6.           EXHIBITS

 

(a)  Exhibits

 

2.1

 

Agreement and Plan of Merger among ReAble Therapeutics Finance LLC, Reaction Acquisition Merger Sub, Inc. and DJO Incorporated, dated July 15, 2007 (Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 16, 2007)

 

 

 

3.1

 

Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 4.1 to the Registration Statement of the Registrant on Form S-8 (Reg. No. 333-73966))

 

 

 

3.2

 

Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to the Registration Statement of the Registrant on Form S-3 (Reg. No. 333-111465))

 

 

 

3.3

 

Amended and Restated By-laws of the Registrant (Incorporated by reference to Exhibit 4.2 to the Registration Statement of the Registrant on Form S-8 (Reg. No. 333-73966))

 

 

 

3.4

 

Certificate of Ownership and Merger of DJO Merger Sub, Inc. with and into dj Orthopedics, Inc. dated May 26, 2006 (Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 1, 2006)

 

 

 

10.1

 

Form of Change in Control Severance Agreement entered into with Chief Executive Officer (Incorporated by reference to the Registrant’s Report on Form 8-K filed on September 25, 2007)

 

 

 

10.2

 

Form of Change in Control Severance Agreement entered into with other Named Executive Officers (Incorporated by reference to the Registrant’s Report on Form 8-K filed on September 25, 2007)

 

 

 

31.1+

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended

 

 

 

31.2+

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended

 

 

 

32.0+*

 

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 


+

 

Filed herewith

 

 

 

*

 

This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of DJO Incorporated, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

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SIGNATURES

 

Pursuant to the requirements 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 INCORPORATED

 

 

(Registrant)

 

 

 

Date: October 29, 2007

 

BY:

/s/ Leslie H. Cross

 

 

 

Leslie H. Cross

 

 

President and Chief Executive Officer

 

 

(Principal Executive Officer)

 

 

 

Date: October 29, 2007

 

BY:

/s/ Vickie L. Capps

 

 

 

Vickie L. Capps

 

 

Executive Vice President, Chief

 

 

Financial Officer and Treasurer

 

 

(Principal Financial and Accounting Officer)

 

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INDEX TO EXHIBITS

 

2.1

 

Agreement and Plan of Merger among ReAble Therapeutics Finance LLC, Reaction Acquisition Merger Sub, Inc. and DJO Incorporated, dated July 15, 2007 (Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 16, 2007)

 

 

 

3.1

 

Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 4.1 to the Registration Statement of the Registrant on Form S-8 (Reg. No. 333-73966))

 

 

 

3.2

 

Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to the Registration Statement of the Registrant on Form S-3 (Reg. No. 333-111465))

 

 

 

3.3

 

Amended and Restated By-laws of the Registrant (Incorporated by reference to Exhibit 4.2 to the Registration Statement of the Registrant on Form S-8 (Reg. No. 333-73966))

 

 

 

3.4

 

Certificate of Ownership and Merger of DJO Merger Sub, Inc. with and into dj Orthopedics, Inc. dated May 26, 2006 (Incorporated by reference to the Registrant’s Report on Form 8-K filed on July 1, 2006)

 

 

 

10.1

 

Form of Change in Control Severance Agreement entered into with Chief Executive Officer (Incorporated by reference to the Registrant’s Report on Form 8-K filed on September 25, 2007)

 

 

 

10.2

 

Form of Change in Control Severance Agreement entered into with other Named Executive Officers (Incorporated by reference to the Registrant’s Report on Form 8-K filed on September 25, 2007)

 

 

 

31.1+

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended

 

 

 

31.2+

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended

 

 

 

32.0+*

 

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 


+

 

Filed herewith

 

 

 

*

 

This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of DJO Incorporated, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 


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