10-Q 1 r1qtr2006kci10q.htm KCI 1Q 2006 10Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


Form 10-Q



QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2006

 

 

 

Commission File Number: 001-09913





KINETIC CONCEPTS, INC.

(Exact name of registrant as specified in its charter)


                           Texas                           

 

                      74-1891727                       

(State of Incorporation)

 

(I.R.S. Employer Identification No.)

 

 

 

 

 

 

8023 Vantage Drive
                San Antonio, Texas               

 


                           78230                           

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (210) 524-9000



     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  ___

     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                               Non-accelerated filer                                   

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

     Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

Common Stock: 71,676,089 shares as of May 4, 2006



Table of Contents

 

TABLE OF CONTENTS


KINETIC CONCEPTS, INC.





Table of Contents

 

TRADEMARKS


     The following terms used in this report are our trademarks:  AirMaxxis®, AtmosAir®, BariAir®, BariatricSupportÔ, BariKare®, BariMaxx® II, BariMaxx®, DynaPulse®, FirstStep®, FirstStep® AdvantageÔ, FirstStep® Plus, FirstStep Select®, FirstStep Select® Heavy Duty, FluidAir Elite®, FluidAir® II, KCI®, GranuFoam® Silver, KinAir® III, KinAir® IV, KinAir MedSurg®, KCI Express® Kinetic Concepts®, Kinetic TherapyÔ, MaxxAir ETS®, Maxxis® 300, Maxxis® 400, PediDyne®, PlexiPulse®, PlexiPulse® AC, Pulse ICÔ, Pulse SCÔ, RIK®, RotoProne®, Roto Rest®, Roto Rest® Delta, T.R.A.C.®, The Clinical Advantage®, TheraKair®, TheraKair® VisioÔ, TheraPulse®, TheraPulse® II, TheraPulse® ATPÔTheraRest®, TriaDyne® II, TriaDyne Proventa®, TriCell®, V.A.C.®, V.A.C.® ATS® , V.A.C. ® Freedom®, V.A.C.® TherapyÔ, The V.A.C.® SystemÔ, Vacuum Assisted Closure® and V.A.C.® Instill®.  All other trademarks appearing in this report are the property of their holders.

 

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS


     This Quarterly Report on Form 10-Q contains forward‑looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are covered by the "safe harbor" created by those sections. The forward‑looking statements are based on our current expectations and projections about future events. Discussions containing forward‑looking statements may be found in "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Risk Factors," and elsewhere in this report. In some cases, you can identify forward‑looking statements by terminology such as "may," "will," "should," "could," "predicts," "projects," "potential," "continue," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," or the negative of these terms and other comparable terminology, including, but not limited to, statements regarding the following:


     -
      projections of revenues, expenditures, earnings, or other financial items;

     -
      future demand for V.A.C. systems or other products;

     -
      the expected timing and outcome of pending litigation;

     -
      expectations for third-party and governmental reimbursement;

     -
      the plans, strategies and objectives of management for future operations;

     -
      expectation of market size and market acceptance or penetration of the products and services we offer;

     -
      expectations for the outcomes of our clinical trials;

     -
      attracting and retaining customers;

     -
      competition in our markets;

     -
      productivity of our sales force;

     -
      future economic conditions or performance, including seasonality;

     -
      changes in patient demographics;

     -
      estimated charges for compensation or otherwise; and

     -
      any statements of assumptions underlying any of the foregoing.

     These forward‑looking statements are only predictions, not historical facts, and involve certain risks and uncertainties, as well as assumptions.  Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward‑looking statements.  The factors that could contribute to such differences include those discussed under the caption "Risk Factors."  These risks include the fluctuations in our operating results and the possible inability to meet our published financial guidance; growing competition that we face; our dependence on our intellectual property; adverse results from pending litigation; our dependence on new technology; the clinical efficacy of V.A.C. therapy relative to alternate devices or therapies and the results from related clinical trials; and third-party and governmental reimbursement policies and collections for our products and those of our competitors.  You should consider each of the risk factors and uncertainties under the caption "Risk Factors" among other things, in evaluating KCI's prospects and future financial performance.  The occurrence of the events described in the risk factors could harm the business, results of operations and financial condition of KCI.  These forward‑looking statements are made as of the date of this report.  KCI disclaims any obligation to update or alter these forward‑looking statements, whether as a result of new information, future events or otherwise.


Table of Contents

 

PART I - FINANCIAL INFORMATION

 

ITEM 1.     FINANCIAL STATEMENTS

 

KINETIC CONCEPTS, INC. AND SUBSIDIARIES

 

Condensed Consolidated Balance Sheets

 

(in thousands)

 

 

 

 

 

 

 

 

March 31,  

 

December 31,

 

 

       2006       

 

       2005       

 

 

(unaudited) 

 

 

 

Assets:

 

 

 

 

Current assets:

 

 

 

 

   Cash and cash equivalents

$   136,503   

 

  123,383    

 

   Accounts receivable, net

287,564   

 

281,890    

 

   Inventories, net

30,820   

 

28,429    

 

   Deferred income taxes

25,666   

 

26,447    

 

   Prepaid expenses and other current assets

21,702   

 

16,908    

 

 

_______   

 

_______    

 

          Total current assets

502,255   

 

477,057    

 

 

 

 

 

 

 

 

 

 

 

Net property, plant and equipment

191,830   

 

192,243    

 

Debt issuance costs, less accumulated amortization of

 

 

 

 

     $13,024 in 2006 and $12,709 in 2005

7,231   

 

7,545    

 

Deferred income taxes

7,250   

 

6,895    

 

Goodwill

49,369   

 

49,369    

 

Other non-current assets, less accumulated amortization

 

 

 

 

     of $9,413 in 2006 and $9,310 in 2005

29,305   

 

29,002    

 

 

_______   

 

_______    

 

 

$  787,240   

 

$  762,111    

 

 

_______   

 

_______    

 

Liabilities and Shareholders' Equity:

 

 

 

 

Current liabilities:

 

 

 

 

   Accounts payable

$     39,806   

 

$    43,853    

 

   Accrued expenses and other

131,973   

 

170,695    

 

   Current installments of long-term debt

2,308   

 

1,769    

 

   Income taxes payable

26,546   

 

18,619    

 

 

_______   

 

_______    

 

          Total current liabilities

200,633   

 

234,936    

 

 

 

 

 

 

Long-term debt, net of current installments

292,187   

 

292,726    

 

Deferred income taxes

27,356   

 

30,622    

 

Other non-current liabilities

11,414   

 

12,361    

 

 

_______   

 

_______    

 

 

531,590   

 

570,645    

 

Shareholders' equity:

 

 

 

 

   Common stock; authorized 225,000 at 2006 and

 

 

 

 

     2005; issued and outstanding 71,227 at 2006

 

 

 

 

     and 70,307 at 2005

71   

 

70    

 

   Preferred stock; authorized 50,000 at 2006 and 2005;

 

 

 

 

     issued and outstanding 0 at 2006 and 2005

-   

 

-   

 

   Additional paid-in capital

563,325   

 

557,468    

 

   Deferred compensation

-   

 

(6,880)   

 

   Retained deficit

(317,399)  

 

(365,916)   

 

   Accumulated other comprehensive income

9,653   

 

6,724    

 

 

_______   

 

_______    

 

          Shareholders' equity

255,650   

 

191,466    

 

 

_______   

 

_______    

 

 

$  787,240   

 

$  762,111    

 

 

_______   

 

_______    

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.


Table of Contents

 

 

KINETIC CONCEPTS, INC. AND SUBSIDIARIES

 

Condensed Consolidated Statements of Earnings

 

(in thousands, except per share data)

 

(unaudited)

 

 

 

      Three months ended   

 

 

               March 31,           

 

 

    2006    

 

    2005    

 

Revenue:

 

 

 

 

   Rental

$ 226,977 

 

$ 195,936 

 

   Sales

92,268 

 

84,036 

 

 

_______ 

 

_______ 

 

         Total revenue

319,245 

 

279,972 

 

 

 

 

 

 

Rental expenses

140,417 

 

127,111 

 

Cost of goods sold

21,735 

 

20,781 

 

 

_______ 

 

_______ 

 

         Gross profit

157,093 

 

132,080 

 

 

 

 

 

 

Selling, general and administrative expenses

74,737 

 

60,156 

 

Research and development expenses

7,411 

 

6,210 

 

 

_______ 

 

_______ 

 

         Operating earnings

74,945 

 

65,714 

 

 

 

 

 

 

Interest income

982 

 

520 

 

Interest expense

(4,741)

 

(7,460)

 

Foreign currency gain (loss)

267 

 

(2,018)

 

 

_______ 

 

_______ 

 

         Earnings before income taxes

71,453 

 

56,756 

 

 

 

 

 

 

Income taxes

22,936 

 

19,581 

 

 

_______ 

 

_______ 

 

         Net earnings

$   48,517 

 

$   37,175 

 

 

_______ 

 

_______ 

 

         Net earnings per share:

 

 

 

 

             Basic

$       0.69 

 

$       0.54 

 

 

_______ 

 

_______ 

 

             Diluted

$       0.66 

 

$       0.51 

 

 

_______ 

 

_______ 

 

         Weighted average shares outstanding:

 

 

 

 

             Basic

70,667 

 

68,822 

 

 

_______ 

 

_______ 

 

             Diluted

73,275 

 

72,875 

 

 

_______ 

 

_______ 

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.

 

 


Table of Contents

 

KINETIC CONCEPTS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

  Three months ended          

 

                March 31,                   

 

     2006      

 

     2005     

Cash flows from operating activities:

 

 

 

   Net earnings

$    48,517 

 

$    37,175 

   Adjustments to reconcile net earnings to net cash provided

 

 

 

      by operating activities:

 

 

 

           Depreciation and amortization

18,634 

 

16,911 

           Provision for uncollectible accounts receivable

2,841 

 

4,203 

           Amortization of deferred gain on sale of headquarters facility

(268)

 

(268)

           Write-off of deferred debt issuance costs

 

1,421 

           Share-based compensation expense

2,998 

 

74 

           Tax benefit related to exercise of stock options

 

8,825 

           Excess tax benefit from share-based payment arrangements

(14,417)

 

(8,825)

           Change in assets and liabilities:

 

 

 

                 Increase in accounts receivable, net

(7,621)

 

(4,640)

                 Decrease (increase) in inventories, net

(2,202)

 

2,001 

                 Decrease (increase) in current deferred income taxes

781 

 

(1,117)

                 Increase in prepaid expenses and other current assets

(5,284)

 

(3,483)

                 Decrease in accounts payable

(3,958)

 

(3,777)

                 Decrease in accrued expenses and other

(39,120)

 

(29,001)

                 Increase in income taxes payable

23,164 

 

19,275 

                 Increase (decrease) in non-current deferred income taxes, net

(3,450)

 

724 

 

_______ 

 

_______ 

                     Net cash provided by operating activities

20,615 

 

39,498 

 

_______ 

 

_______ 

Cash flows from investing activities:

 

 

 

   Additions to property, plant and equipment

(14,552)

 

(14,268)

   Increase in inventory to be converted into equipment

 

 

 

      for short-term rental

(2,500)

 

(1,200)

   Dispositions of property, plant and equipment

395 

 

465 

   Increase in other non-current assets

      (436)

 

      (264)

 

_______ 

 

_______ 

                     Net cash used by investing activities

(17,093)

 

(15,267)

 

_______ 

 

_______ 

Cash flows from financing activities:

 

 

 

   Proceeds from (repayments of) long-term debt, capital lease

 

 

 

      and other obligations

52 

 

(75,003)

   Excess tax benefits from share-based payment arrangements

14,417 

 

   Proceeds from exercise of stock options

5,728 

 

1,798 

   Purchase of immature shares for minimum tax withholdings

(11,192)

 

   Proceeds from purchase of stock in ESPP and other

19 

 

 

_______ 

 

_______ 

                     Net cash provided (used) by financing activities

9,024 

 

(73,205)

 

_______ 

 

_______ 

Effect of exchange rate changes on cash and cash equivalents

574 

 

         (1,168)

 

_______ 

 

_______ 

Net increase (decrease) in cash and cash equivalents

13,120 

 

(50,142)

 

 

 

 

Cash and cash equivalents, beginning of period

123,383 

 

124,366 

 

_______ 

 

_______ 

Cash and cash equivalents, end of period

$  136,503 

 

$    74,224 

 

_______ 

 

_______ 

Cash paid during the three months for:

 

 

 

   Interest, net of cash received from interest rate swap agreements

$      2,725 

 

$      3,807 

   Income taxes, net of refunds

$      2,168 

 

$      2,178 

 

See accompanying notes to condensed consolidated financial statements.



Table of Contents

 

KINETIC CONCEPTS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)

(1)     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES


(a)     Basis of Presentation

     The unaudited condensed consolidated financial statements presented herein include the accounts of Kinetic Concepts, Inc., together with its consolidated subsidiaries ("KCI" or the “Company”).  The unaudited condensed consolidated financial statements appearing in this quarterly report on Form 10-Q should be read in conjunction with the financial statements and notes thereto included in KCI's latest Annual Report on Form 10-K for the fiscal year ended December 31, 2005.  The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles.  Operating results from interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole.  The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation of our results for the interim periods presented.  Certain prior period amounts have been reclassified to conform to the current period presentation.


(b)     Share-Based Compensation


     In December 2004, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 123 Revised (“SFAS 123R”), “Share-Based Payment.”  SFAS 123R eliminated the alternative to account for share-based compensation using Accounting Principles Board Opinion No. 25 (“APB 25”), “Accounting for Stock Issued to Employees,” and required such transactions be recognized as compensation expense in the statement of earnings based on their fair values on the date of grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  The Company adopted SFAS 123R on January 1, 2006 using the modified prospective transition method.  As such, the compensation expense recognition provisions of SFAS 123R apply to new awards and to any awards modified, repurchased or cancelled after the adoption date.  Additionally, for any unvested awards outstanding at the adoption date, the Company will recognize compensation expense over the remaining vesting period.  Prior to the adoption of SFAS 123R, the Company presented all tax benefits of deductions resulting from the exercise of stock options as operating cash flows in the statement of cash flows as required under SFAS No. 95, “Statement of Cash Flows.”  In accordance with SFAS 123R, the Company has now presented the cash flows for tax benefits resulting from the exercise of share-based payment arrangements in excess of the tax benefits recorded on compensation cost recognized for those options (excess tax benefits) as financing cash flows.


     The Company has elected to use the Black-Scholes model to estimate the fair value of option grants under SFAS 123R.  The Company believes that the use of the Black-Scholes model meets the fair value measurement objective of SFAS 123R and reflects all substantive characteristics of the instruments being valued.  Estimates of fair value are not intended to predict actual future events or the value ultimately realized by employees who receive share-based compensation awards, and subsequent events will not affect the original estimates of fair value made by the Company under SFAS 123R.


     As a result of adopting SFAS 123R on January 1, 2006, the Company’s earnings before income taxes and net earnings for the three months ended March 31, 2006 were $2.3 million and $1.5 million, respectively, or $0.02 per basic and diluted share, lower than if it had continued to account for share-based compensation under APB 25.  Additionally, for the three months ended March 31, 2006, the Company recorded a $15.2 million actual tax benefit from share-based payment arrangements, of which $14.4 million is reflected as a financing cash inflow, representing the excess tax benefit from share-based payment arrangements, as required under SFAS 123R.  The $14.4 million excess tax benefit would have been classified as an operating cash inflow under the provisions of APB 25.



     With the adoption of SFAS 123R, the Company estimates forfeitures when recognizing compensation cost.  The Company will adjust its estimate of forfeitures as actual forfeitures differ from its estimates, resulting in the recognition of compensation cost only for those awards that actually vest.  Prior to the adoption of SFAS 123R, the Company recorded forfeitures of stock-based compensation awards as they occurred.  As a result of this change, the Company recorded a cumulative effect of a change in accounting principle of approximately $114,000 as a reduction in share-based compensation expense in the Company's condensed consolidated statement of earnings for the three months ended March 31, 2006.


     The weighted-average estimated fair value of stock options granted during the three months ended March 31, 2006 was $18.30 per share using the Black-Scholes model with the following weighted average assumptions (annualized percentages):

 

 

   Three months ended   

 

       March 31, 2006       

Expected stock volatility

38.6%       

Expected dividend yield

-          

Risk-free interest rate

4.4%       

Expected life (years)

6.3          

 

     The expected stock volatility is based primarily on historical volatilities of similar entities.  The expected dividend yield is 0% as the Company has historically not paid cash dividends on its common stock.  The risk-free interest rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.  The Company has chosen to estimate expected life using the simplified method as defined in Staff Accounting Bulletin 107, rather than using its own historical expected life as there has not been sufficient history since the Company completed its initial public offering.


     Share-based compensation expense was recognized in the condensed consolidated statement of earnings for the three months ended March 31, 2006 as follows (dollars in thousands):

 

 

 

   Three months ended   

 

 

       March 31, 2006       

Rental expenses

 

$     807                

Cost of goods sold

 

         99                

Selling, general and administrative expenses

 

    2,092                

Pre-tax share-based compensation expense

 

    2,998                

Less:  Income tax benefits

 

     (962)               

 

 

_______               

Total share-based compensation

 

 

   expense, net of tax

 

$  2,036                

 

 

_______         


     Prior to 2006, as permitted by SFAS No. 123, “Accounting for Stock-Based Compensation,” the Company used the intrinsic value method prescribed under APB 25 to account for its stock compensation plans.  For the quarter ended March 31, 2005, the impact of adopting SFAS 123R approximates the SFAS 123 disclosure of pro-forma net earnings and net earnings per share as follows (amounts in thousands, except per share data):

 

 

   Three months ended   

 

       March 31, 2005       

 

 

Net earnings, as reported

$  37,175           

 

_______           

Pro forma net earnings:

 

   Net earnings, as reported

$  37,175           

   Compensation expense under intrinsic method

48           

   Compensation expense under fair value method

(1,009)          

 

_______           

Pro forma net earnings

$  36,214           

 

_______           

Net earnings per share, as reported:

 

   Basic

$      0.54           

   Diluted

$      0.51           

 

 

Pro forma net earnings per share:

 

   Basic

$      0.53           

   Diluted

$      0.50           

 

 

 

(c)     Additional New Accounting Pronouncements


     In November 2004, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 151 (“SFAS 151”), “Inventory Costs.”  This pronouncement amended the guidance in Accounting Research Bulletin No. 43, Chapter 4, “Inventory Pricing,” to clarify the accounting for abnormal amounts of idle facility expense, freight, handling costs, and wasted material (spoilage) and requires that allocation of fixed production overheads to the costs of conversion be based on the normal capacity of the production facilities.  The Company adopted SFAS 151 as of January 1, 2006 and the adoption of this statement did not have a material impact on its results of operations or its financial position.


     In May 2005, the FASB issued SFAS No. 154 (“SFAS 154”), “Accounting Changes and Error Corrections,” a replacement of APB Opinion No. 20 and FASB Statement No. 3.  SFAS 154 provides guidance on the accounting for and reporting of accounting changes and error corrections.  It establishes, unless impracticable, retrospective application as the required method for reporting a change in accounting principle.  SFAS 154 also provides guidance for determining whether retrospective application of a change in accounting principle is impracticable and for reporting a change when retrospective application is impracticable.  The reporting of a correction of an error by restating previously issued financial statements is also addressed by this Statement.  The Company adopted SFAS 154 as of January 1, 2006 and the adoption of this statement did not have a material impact on its results of operations or its financial position.


(d)     Other Significant Accounting Policies


     
For further information on our significant accounting policies, see Note 1 of the Notes to the Consolidated Financial Statements included in KCI's Annual Report on Form 10-K for the year ended December 31, 2005.



(2)     SUPPLEMENTAL BALANCE SHEET DATA

     Accounts receivable consist of the following (dollars in thousands):

 

 

March 31,     

 

December 31,

 

       2006          

 

        2005       

 

 

 

 

Trade accounts receivable:

 

 

 

    USA:

 

 

 

        Acute and extended care organizations

$ 91,007    

 

$ 94,438    

        Medicare / Medicaid

67,305    

 

64,223    

        Managed care, insurance and other

113,006    

 

108,066    

 

_______    

 

_______    

           USA - Trade accounts receivable

271,318    

 

266,727    

 

 

 

 

    International

81,182    

 

79,040    

 

_______    

 

_______    

        Trade accounts receivable

352,500    

 

345,767    

 

 

 

 

Employee and other receivables

2,798    

 

2,172    

 

_______    

 

_______    

        Gross accounts receivable

355,298    

 

347,939    

 

 

 

 

Less:  Allowance for doubtful accounts

(67,734)   

 

(66,049)   

 

_______    

 

_______    

 

$ 287,564    

 

$ 281,890    

 

_______    

 

_______    

 

 

 

 

 

 

    Inventories are stated at the lower of cost (first-in, first-out) or market (net realizable value).  Inventories consist of the following (dollars in thousands):

 

 

March 31,  

 

December 31,

 

      2006       

 

        2005       

 

 

 

 

Finished goods

$     7,103    

 

$     5,519    

Work in process

1,622    

 

2,705    

Raw materials, supplies and parts

36,544    

 

31,878    

 

______    

 

______    

 

45,269    

 

40,102    

 

 

 

 

Less: Amounts expected to be converted

 

 

 

            into equipment for short-term rental

(9,300)   

 

(6,800)   

         Reserve for excess and obsolete inventory

(5,149)   

 

(4,873)   

 

______    

 

______    

 

$   30,820    

 

$   28,429    

 

______   

 

______   

 



(3)     EARNINGS PER SHARE


     Net earnings per share were calculated using the weighted average number of shares outstanding.  The following table sets forth the reconciliation from basic to diluted weighted average shares outstanding and the calculations of net earnings per share (amounts in thousands, except per share data):

 

 

      Three months ended       

 

                March 31,               

 

      2006    

 

        2005    

 

 

 

 

Net earnings

$ 48,517 

 

$ 37,175 

 

______ 

 

______ 

Weighted average shares outstanding:

 

 

 

   Basic

70,667 

 

68,822 

   Dilutive potential common shares from

 

 

 

      stock options and restricted stock(1)

2,608 

 

4,053 

 

______ 

 

______ 

   Diluted

73,275 

 

72,875 

 

______ 

 

______ 

 

 

 

 

Basic net earnings per share

$     0.69 

 

$      0.54 

 

______ 

 

______ 

 

 

 

 

Diluted net earnings per share

$     0.66 

 

$      0.51 

 

______ 

 

______ 

 

 

 

 

(1)  Potentially dilutive stock options and restricted stock totaling 1,620 shares

       and 12 shares for the first quarter of 2006 and 2005, respectively, were

       excluded from the computation of diluted weighted average shares

       outstanding due to their antidilutive effect.

 

(4)     STOCK OPTION PLANS


     In December 1997, the Board of Directors approved the 1997 Management Equity Plan (the “Management Equity Plan”).  In January of 2004, the Board of Directors determined that no new equity grants would be made under the Management Equity Plan.  The maximum aggregate number of shares of common stock that could be issued in connection with grants under the Management Equity Plan, as amended, was approximately 13.9 million shares, subject to adjustment as provided for in the plan.  Outstanding grants under the Management Equity Plan are administered by the Compensation Committee of the Board of Directors.  The exercise price and term of options granted under the Management Equity Plan have been determined by the Compensation Committee or the entire Board of Directors.  However, in no event has the term of any option granted under the Management Equity Plan exceeded ten years.


     The 2003 Non-Employee Directors Stock Plan (the "Directors Stock Plan") became effective on May 28, 2003, and was amended and restated on November 9, 2004 and November 15, 2005.  Prior to January 1, 2005, the Directors Stock Plan provided for automatic grants to our non-employee directors of (a) options to purchase shares of common stock, (b) restricted stock that is subject to vesting requirements and (c) unrestricted stock that is not subject to vesting requirements.  As a result of amendments to the plan, grants of unrestricted stock awards have been eliminated.  The maximum aggregate number of shares of common stock that may be issued in connection with grants under the Directors Stock Plan is 400,000 shares, subject to adjustment as provided for in the plan.  The exercise price of options granted under this plan is determined as the fair market value of the shares of the Company's common stock on the date that such option is granted.  The options granted will vest and become exercisable incrementally over a period of three years.  The right to exercise an option terminates seven years after the grant date, unless sooner as provided for in the plan.  The Directors Stock Plan is administered by the Compensation Committee of the Board of Directors.  During the first quarter of 2006 and 2005, no grants were issued under this plan.


     On February 9, 2004, the Company's shareholders approved the 2004 Equity Plan and the 2004 Employee Stock Purchase Plan (the "2004 ESPP").  The 2004 Equity Plan was effective on February 27, 2004 and reserves for issuance a maximum of 7,000,000 shares of common stock to be awarded as stock options, stock appreciation rights, restricted stock and/or restricted stock units.  Of the 7,000,000 shares, 20% may be issued in the form of restricted stock, restricted stock units or a combination of the two.  The exercise price of options granted under this plan is determined as the fair market value of the shares of the Company’s common stock on the date that such option is granted.  The options granted will vest and become exercisable incrementally over a period of four years.  The right to exercise an option terminates ten years after the grant date, unless sooner as provided for in the plan.  Restricted stock and restricted stock units granted under these plans vest over a period of three to six years, although certain grants cliff-vest after six years, but contain provisions that allow for accelerated vesting over a shorter term if certain performance criteria are met.  The fair value of the restricted stock and restricted stock units is determined on the grant date based on the Company’s closing stock price.  The Company considers the likelihood of meeting the performance criteria when determining the vesting period on a periodic basis.  Restricted stock and restricted stock units granted are classified primarily as equity awards.


     During the first quarter of 2006 and 2005, we granted approximately 3,900 and 12,600 options, respectively, to purchase shares of common stock under the 2004 Equity Plan.  Additionally, during the first quarter of 2006, we issued approximately 1,400 shares of restricted stock and restricted stock units under this plan at a weighted average estimated fair value of $40.57.


     The 2004 ESPP became effective in the second quarter of 2004.  The maximum number of shares of common stock reserved for issuance under the 2004 ESPP is 2,500,000 shares.  Under the 2004 ESPP, each eligible employee is permitted to purchase shares of our common stock through regular payroll deductions in an amount between 1% and 10% of the employee's compensation for each payroll period, not to exceed $25,000 per year.  The 2004 ESPP provides for six‑month offering periods.  Each six‑month offering period will be composed of an identical six‑month purchase period.  Participating employees are able to purchase shares of common stock with payroll deductions at a purchase price equal to 85% of the fair market value of the common stock at either the beginning of each offering period or the end of each respective purchase period, whichever price is lower.  During the first quarter of 2006 and 2005, there were no purchases of common stock under the 2004 ESPP.


     The following table summarizes the number of common shares reserved for future issuance under our stock option plans as of March 31, 2006:

 

2003 Non-Employee Directors Stock Plan

244,378

2004 Equity Plan

5,306,365

2004 Employee Stock Purchase Plan

2,350,947

 

                

 

7,901,690

 

________

 

     A summary of our stock option activity, and related information, for the three months ended March 31, 2006 is set forth in the table below:

 

 

                                                  2006                                                      

 

 

 

Weighted   

 

 

 

 

Average   

 

 

 

Weighted   

Remaining 

Aggregate        

 

 

Average   

Contractual 

Intrinsic         

 

Options     

Exercise   

Term      

Value           

 

(in thousands)

     Price     

   (years)    

(in thousands)    

Options outstanding -

 

 

 

 

   beginning of year

6,862     

$  15.76     

 

 

Granted

4     

$  40.19     

 

 

Exercised

(1,222)    

$    4.91     

 

 

Forfeited/Expired

(26)    

$  49.23     

 

 

 

_____      

 

 

 

Options outstanding – March 31, 2006

5,618     

$  17.98     

3.83       

$ 144,634         

 

______   

 

 

 

Exercisable as of March 31, 2006

3,815     

$    7.29     

2.18       

$ 130,305         

 

______   

 

 

 

 

 

 

 

 

 


 

     The intrinsic value for stock options is defined as the difference between the current market value and the grant price.  During the first quarter of 2006, the total intrinsic value of stock options exercised was $40.4 million.  Cash received from stock options exercised during the quarter was $5.7 million and the actual tax benefit from share-based payment arrangements totaled $15.2 million.  The weighted-average estimated fair value of stock options granted during the quarter ended March 31, 2006 was $18.30.


     As of March 31, 2006, there was $20.5 million of total unrecognized compensation cost related to non-vested stock options granted under our various plans.  This unrecognized compensation cost is expected to be recognized over a weighted average period of 2.7 years.


     The following table summarizes restricted stock activity for the three months ended March 31, 2006:

 

 

 

 

 

 

 

 

 

 

 

Number of   

 

 

Weighted      

 

 

 

     Shares     

 

 

Average Grant  

 

 

 

(in thousands)

 

 

Date Fair Value 

Unvested Shares – January 1, 2006

 

 

193       

 

 

$   47.53       

Granted

 

 

1       

 

 

$   40.57       

Vested and Distributed

 

 

-       

 

 

$          -        

Forfeited

 

 

     (1)      

 

 

$   59.20       

 

 

 

___       

 

 

 

Unvested Shares – March 31, 2006

 

 

193       

 

 

$   47.41       

 

 

 

___       

 

 

 

 

     During the first quarter of 2006, the Company reclassified $6.9 million related to unvested restricted stock from deferred compensation to additional paid in capital as a result of the adoption of SFAS 123R.  As of March 31, 2006, there was $6.2 million of total unrecognized compensation cost related to non-vested restricted stock granted under our plans.  This unrecognized compensation cost is expected to be recognized over a weighted-average period of 2.5 years.  There was no vesting of restricted stock during the three months ended March 31, 2006.


     The Company has a policy of issuing new shares to satisfy stock option exercises and restricted stock award issuances.


(5)     OTHER COMPREHENSIVE INCOME


     KCI follows SFAS No. 130, "Reporting Comprehensive Income," in accounting for comprehensive income and its components.  For the three months ended March 31, 2006 and 2005, comprehensive income was $51.4 million and $32.6 million, respectively.  The most significant adjustment to net earnings to arrive at comprehensive income consisted of a foreign currency translation gain of $3.2 million and a loss of $5.3 million for the three-month periods ended March 31, 2006 and 2005, respectively.


(6)     COMMITMENTS AND CONTINGENCIES


     On August 28, 2003, KCI and its affiliates, together with Wake Forest University Health Sciences, filed a patent infringement lawsuit against BlueSky Medical Group, Inc., Medela, Inc., Medela AG (collectively, "Medela") and Patient Care Systems, Inc. (“PCS”) in the United States District Court for the Western District of Texas, San Antonio Division alleging infringement of three V.A.C. patents and related claims arising from the manufacturing and marketing of a pump and dressing kits by BlueSky.  We subsequently entered into a settlement with one of the defendants, PCS, pursuant to which the Court entered a final judgment and permanent injunction prohibiting PCS from further acts of infringement, unfair competition or false advertising through the sale or marketing of BlueSky products.  We are seeking damages and injunctive relief in the case against the remaining defendants.  A trial date has been set for May 30, 2006.


     On June 28, 2005 the Court construed certain terms of U.S. Patent No. 5,636,643 (the “643 patent”) and ruled that other terms were sufficiently definite without further construction.  On January 26, 2006, the Court also ruled on construction of claims in U.S. Patent number 5,645,081 (the “081 patent”) and additional claims in the 643 patent.  The ruling, among other things, further defined components of certain claims related to our V.A.C. dressing.  In addition, on March 1, 2006, the Court denied BlueSky’s motions for summary judgment to dismiss our claims of patent infringement and granted our motion to exclude BlueSky’s damages claims against us.  The Court also dismissed all of BlueSky’s counterclaims against KCI and Wake Forest with prejudice.  The Court’s ruling did not affect Medela’s defenses and counterclaims.  The Court may reconsider any of its rulings at any time before trial.  In April 2006, the parties negotiated the simplification of the case by removing some of KCI’s lesser claims in exchange for the elimination of all of the Defendants’ remaining counterclaims.  The defenses of invalidity and non-infringement have not been affected by the recent simplification of the case.  While it is difficult to predict what effect recent Court rulings and pre-trial simplification of the case may have on the outcome of the central claims of infringement and invalidity, we presently do not believe that they have fundamentally impacted the nature of the litigation or our probability of success at trial.


     Although it is not possible to reliably predict the outcome of the BlueSky litigation, we believe our claims are meritorious.  However, the jury may not decide the case in our favor and we may be unable to obtain an injunction against BlueSky or otherwise prevail in this litigation.  If we do not obtain an injunction or otherwise prevail, our share of the wound-care market for our V.A.C. systems could be significantly reduced due to increased competition, and reimbursement of V.A.C. systems could decline significantly, either of which would materially and adversely affect our operating results.  We derived $186.1 million and $706.0 million in revenue, or approximately 58% of total revenue, for the three months ended March 31, 2006 and the year ended December 31, 2005, respectively, from our domestic V.A.C. products relating to the patents at issue.


     In 1998, Mondomed N.V. and Paul Hartmann AG filed an opposition in the European Patent Office (“EPO”) to a Wake Forest European V.A.C. patent licensed to KCI.  Mondomed entered into a settlement with us and withdrew from the opposition in 2004.  Effective April 3, 2006, the Company finalized an agreement with Hartmann for the withdrawal of the patent appeal pending before the EPO Board of Appeals.  As a result of the withdrawals, the patent opposition proceedings have been terminated and the EPO’s 2004 decision upholding and construing the patent will remain in place.  The EPO’s 2004 decision established a range of pressures covered by the patent claims from 7.6 – 752 millimeters of mercury (“mmHg”) of negative pressure and provided that the "screen means" term describing the dressing is an open-cell polymer foam.  Our V.A.C. systems typically operate between 50 and 200 mmHg of negative pressure, with a default setting of 125 mmHg.


     In connection with the withdrawal of the appeal, KCI and Hartmann also signed a letter of intent pursuant to which they plan to enter into a strategic cooperation for the distribution and rental of our V.A.C. line of products in Eastern Europe and for the co-promotion of V.A.C. products in the Swiss and German homecare markets.  Under the terms of the letter of intent, the parties have agreed to enter into various agreements embodying the cooperation.  In the event that the parties cannot reach one or more definitive agreements on the strategic relationships, KCI has agreed to pay Hartmann specified sums of up to $2.25 million.


     We are party to several additional lawsuits arising in the ordinary course of our business.  Additionally, the manufacturing and marketing of medical products necessarily entails an inherent risk of product liability claims.


     As of March 31, 2006, our commitments for the purchase of new product inventory, including approximately $20.0 million of disposable products from Avail Medical Products, Inc., were $32.4 million.  Other than commitments for new product inventory, we have no material long-term purchase commitments.


(
7)     SUBSEQUENT EVENT


     Effective April 3, 2006, the Company finalized an agreement with Paul Hartmann AG for the withdrawal of the patent appeal pending before the EPO Board of Appeals (See Note 6).


     On April 4, 2006, we reduced our senior credit facility by $25.0 million and wrote off approximately $370,000 of capitalized debt issuance costs.   As of that date, the remaining outstanding balance on our senior credit facility was $184.9 million and total debt outstanding was $269.5 million.


(8)     SEGMENT AND GEOGRAPHIC INFORMATION


     We are principally engaged in the rental and sale of advanced wound care systems and therapeutic systems and surfaces throughout the United States and in 18 primary countries internationally.  Revenues are attributed to individual countries based on the location of the customer.


     We define our business segments based on geographic management responsibility.  We have two reportable segments: USA, which includes operations in the United States, and International, which includes operations for all international countries. We have two primary product lines: V.A.C. and Therapeutic Surfaces/Other.  Revenues for each of our product lines are disclosed for our operating segments.  Other than revenue, no discrete financial information is available for our product lines.  Our product lines are marketed and serviced by the same infrastructure and, as such, we do not manage our business by product line, but rather by geographical segments.  We measure segment profit as operating earnings, which is defined as income before interest income, interest expense, foreign currency gains and losses, and income taxes.  All intercompany transactions are eliminated in computing revenue and operating earnings.


     Information on segments and a reconciliation of consolidated totals are as follows (dollars in thousands):

 

 

Three months ended       

 

             March 31,               

 

     2006   

 

    2005     

Revenue:

 

 

 

   USA:

 

 

 

      V.A.C.

$ 186,087 

 

$ 151,563 

      Therapeutic surfaces/other

46,563 

 

45,962 

 

_______ 

 

_______ 

         Subtotal - USA

232,650 

 

197,525 

 

 

 

 

   International:

 

 

 

      V.A.C.

56,867 

 

45,939 

      Therapeutic surfaces/other

29,728 

 

36,508 

 

_______ 

 

_______ 

         Subtotal - International

86,595 

 

82,447 

 

_______ 

 

_______ 

Total revenue

$ 319,245 

 

$ 279,972 

 

_______ 

 

_______ 

 

 

 

 

Operating earnings:

 

 

 

   USA

$  91,803 

 

$   69,098 

   International

12,490 

 

15,212 

 

 

 

 

   Other (1):

 

 

 

      Executive

(5,914)

 

(1,109)

      Finance

(9,878)

 

(8,321)

      Manufacturing/Engineering

(2,354)

 

(785)

      Administration

(11,202)

 

(8,381)

 

_______ 

 

_______ 

         Total other

(29,348)

 

(18,596)

 

_______ 

 

_______ 

Total operating earnings

$  74,945 

 

$  65,714 

 

_______ 

 

_______ 

 

 

 

 

(1)  Other includes general headquarter expenses which are not allocated to the

       individual segments and are included in selling, general and administrative

       expenses within our condensed consolidated statements of earnings.

 

 

(9)     GUARANTOR CONDENSED CONSOLIDATING FINANCIAL STATEMENTS


     On August 11, 2003, we issued and sold an aggregate of $205.0 million principal amount of 73/8% Senior Subordinated Notes due 2013.  Of this amount, $84.4 million of the notes remained outstanding as of March 31, 2006.


     The notes are fully and unconditionally guaranteed, jointly and severally, by each of KCI's direct and indirect 100% owned subsidiaries, other than any entity that is a controlled foreign corporation within the definition of Section 957 of the Internal Revenue Code or a holding company whose only assets are investments in a controlled foreign corporation.  Each of these subsidiaries is a restricted subsidiary, as defined in the indenture governing the notes.


     The following tables present the condensed consolidating balance sheets of KCI as a parent company, our guarantor subsidiaries and our non-guarantor subsidiaries as of March 31, 2006 and December 31, 2005 and the related condensed consolidating statements of earnings for the three months ended March 31, 2006 and 2005, and the condensed consolidating statements of cash flows for the three months ended March 31, 2006 and 2005.


Table of Contents


Condensed Consolidating Parent Company,

Guarantor and Non-Guarantor Balance Sheet

March 31, 2006

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Kinetic 

 

 

 

 

 

 

 

 

 

Concepts,

 

 

 

 

 

Reclassi- 

 

Kinetic 

 

Inc.   

 

 

 

Non-   

 

fications 

 

Concepts,

 

Parent  

 

Guarantor

 

Guarantor

 

and     

 

Inc.   

 

Company

 

Sub-   

 

Sub-   

 

elimi-   

 

and Sub-

Assets:

Borrower

 

  sidiaries  

 

  sidiaries  

 

  nations   

 

  sidiaries  

Current assets:

 

 

 

 

 

 

 

 

 

   Cash and cash equivalents

$            - 

 

$    85,568 

 

$  50,935 

 

$              - 

 

$ 136,503 

   Accounts receivable, net

 

209,136 

 

81,739 

 

(3,311)

 

287,564 

   Inventories, net

 

16,060 

 

14,760 

 

 

30,820 

   Deferred income taxes

 

25,666 

 

 

 

25,666 

   Prepaid expenses and other current assets

 

12,976 

 

8,726 

 

 

21,702 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

          Total current assets

 

349,406 

 

156,160 

 

(3,311)

 

502,255 

 

 

 

 

 

 

 

 

 

 

Net property, plant and equipment

 

135,056 

 

66,867 

 

(10,093)

 

191,830 

Debt issuance costs, net

 

7,231 

 

 

 

7,231 

Deferred income taxes

 

 

7,250 

 

 

7,250 

Goodwill

 

39,779 

 

9,590 

 

 

49,369 

Other non-current assets, net

 

28,712 

 

8,527 

 

(7,934)

 

29,305 

Intercompany investments and advances

255,665 

 

473,235 

 

62,071 

 

(790,971)

 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

 

$ 255,665 

 

$1,033,419 

 

$ 310,465 

 

$ (812,309)

 

$ 787,240 

 

______ 

 

_______ 

 

______ 

 

______ 

 

______ 

Liabilities and Shareholders' Equity:

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

   Accounts payable

$             - 

 

$     27,448 

 

$   12,358 

 

$              - 

 

$    39,806 

   Accrued expenses and other

14 

 

95,455 

 

36,504 

 

 

131,973 

   Current installments of long-term debt

 

2,308 

 

 

 

2,308 

   Intercompany payables

 

 

46,738 

 

(46,738)

 

   Income taxes payable

 

26,198 

 

348 

 

 

26,546 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

          Total current liabilities

14 

 

151,409 

 

95,948 

 

(46,738)

 

200,633 

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current installments

 

292,187 

 

 

 

292,187 

Intercompany payables, non-current

 

(26,114)

 

26,114 

 

 

Deferred income taxes

 

27,356 

 

 

 

27,356 

Other non-current liabilities

 

18,292 

 

1,053 

 

(7,931)

 

11,414 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

          

14 

 

463,130 

 

123,115 

 

(54,669)

 

531,590 

Shareholders' equity

255,651 

 

570,289 

 

187,350 

 

(757,640)

 

255,650 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

          

$ 255,665 

 

$1,033,419 

 

$ 310,465 

 

$ (812,309)

 

$ 787,240 

 

______ 

 

_______ 

 

______ 

 

______ 

 

______ 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.



 

 

Condensed Consolidating Parent Company,

 

 

Guarantor and Non-Guarantor Balance Sheet

 

 

December 31, 2005

 

 

(in thousands)

 

 

 

 

 

 

Kinetic 

 

 

 

 

 

 

 

 

 

 

 

Concepts,

 

 

 

 

 

Reclassi- 

 

Kinetic 

 

 

 

Inc.   

 

 

 

Non-   

 

fications 

 

Concepts,

 

 

 

Parent  

 

Guarantor

 

Guarantor

 

and     

 

Inc.   

 

 

 

Company

 

Sub-   

 

Sub-   

 

elimi-   

 

and Sub-

 

 

 

Borrower

 

  sidiaries  

 

  sidiaries  

 

  nations   

 

  sidiaries  

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

   Cash and cash equivalents

$            -   

 

$     72,475 

 

$   50,908  

 

$              - 

 

$ 123,383 

 

 

   Accounts receivable, net

-   

 

205,089 

 

77,822  

 

(1,021)

 

281,890 

 

 

   Inventories, net

-   

 

15,336 

 

13,093  

 

 

28,429 

 

 

   Deferred income taxes

-   

 

26,447 

 

-  

 

 

26,447 

 

 

   Prepaid expenses and other current assets

-   

 

10,895 

 

8,393  

 

(2,380)

 

16,908 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

          Total current assets

-   

 

330,242 

 

150,216  

 

(3,401)

 

477,057 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net property, plant and equipment

-   

 

138,272 

 

64,065  

 

(10,094)

 

192,243 

 

 

Debt issuance costs, net

-   

 

7,545 

 

-  

 

 

7,545 

 

 

Deferred income taxes

-   

 

 

6,895  

 

 

6,895 

 

 

Goodwill

-   

 

39,779 

 

9,590  

 

 

49,369 

 

 

Other non-current assets, net

-   

 

28,471 

 

5,606  

 

(5,075)

 

29,002 

 

 

Intercompany investments and advances

191,480   

 

470,604 

 

47,883  

 

(709,967)

 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

 

$ 191,480   

 

$ 1,014,913 

 

$ 284,255  

 

$ (728,537)

 

$ 762,111 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

Liabilities and Shareholders' Equity:

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

   Accounts payable

$            -   

 

$      29,960 

 

$   13,893  

 

$              - 

 

$    43,853 

 

 

   Accrued expenses and other

14   

 

126,672 

 

44,009  

 

 

170,695 

 

 

   Current installments of long-term debt

-   

 

1,769 

 

-  

 

 

1,769 

 

 

   Intercompany payables

-   

 

 

29,268 

 

(29,268)

 

 

 

   Income taxes payable

-   

 

20,999 

 

-  

 

(2,380)

 

18,619 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

          Total current liabilities

14   

 

179,400 

 

87,170  

 

(31,648)

 

234,936 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current installments

-   

 

292,726 

 

-  

 

 

292,726 

 

 

Intercompany payables, non-current

-   

 

(25,509)

 

25,509  

 

 

 

 

Deferred income taxes

-   

 

30,622 

 

-  

 

 

30,622 

 

 

Other non-current liabilities

-   

 

16,438 

 

998  

 

(5,075)

 

12,361 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

          

14   

 

493,677 

 

113,677  

 

(36,723)

 

570,645 

 

 

Shareholders' equity

191,466   

 

521,236 

 

170,578  

 

(691,814)

 

191,466 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

          

$ 191,480   

 

$ 1,014,913 

 

$ 284,255  

 

$ (728,537)

 

$ 762,111 

 

 

 

_______   

 

________ 

 

_______  

 

_______ 

 

_______ 

 

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.

 



 

Condensed Consolidating Parent Company,

Guarantor and Non-Guarantor Statement of Earnings

For the three months ended March 31, 2006

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Kinetic 

 

 

 

 

 

 

 

 

 

Concepts,

 

 

 

 

 

Reclassi- 

 

Kinetic 

 

Inc.   

 

 

 

Non-   

 

fications 

 

Concepts,

 

Parent  

 

Guarantor

 

Guarantor

 

and     

 

Inc.   

 

Company

 

Sub-   

 

Sub-   

 

elimi-   

 

and Sub-

 

Borrower

 

  sidiaries  

 

  sidiaries  

 

  nations   

 

  sidiaries  

Revenue:

 

 

 

 

 

 

 

 

 

   Rental

$           - 

 

$ 177,674 

 

$ 49,303 

 

$            - 

 

$ 226,977 

   Sales and other

 

59,310 

 

41,022 

 

(8,064)

 

92,268 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Total revenue

 

236,984 

 

90,325 

 

(8,064)

 

319,245 

 

 

 

 

 

 

 

 

 

 

Rental expenses

 

89,701 

 

50,716 

 

 

140,417 

Cost of goods sold

 

18,140 

 

7,647 

 

(4,052)

 

21,735 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Gross profit

 

129,143 

 

31,962 

 

(4,012)

 

157,093 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

 

 

 

 

 

 

   expenses

 

63,417 

 

14,542 

 

(3,222)

 

74,737 

Research and development expenses

 

6,128 

 

1,283 

 

 

7,411 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Operating earnings

 

59,598 

 

16,137 

 

(790)

 

74,945 

 

 

 

 

 

 

 

 

 

 

Interest income

 

806 

 

176 

 

 

982 

Interest expense

 

(4,618)

 

(123)

 

 

(4,741)

Foreign currency gain

 

148 

 

119 

 

 

267 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings before income taxes and

 

 

 

 

 

 

 

 

 

         equity in earnings of subsidiaries

 

55,934 

 

16,309 

 

(790)

 

71,453 

 

 

 

 

 

 

 

 

 

 

Income taxes

 

21,112 

 

2,078 

 

(254)

 

22,936 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings before equity in

 

 

 

 

 

 

 

 

 

         earnings of subsidiaries

 

34,822 

 

14,231 

 

(536)

 

48,517 

Equity in earnings of subsidiaries

48,517 

 

14,231 

 

 

(62,748)

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net earnings

$   48,517 

 

$   49,053 

 

$  14,231 

 

$ (63,284)

 

$  48,517 

 

______ 

 

______ 

 

______ 

 

______ 

 

______ 

 

See accompanying notes to condensed consolidated financial statements.



 

Condensed Consolidating Parent Company,

Guarantor and Non-Guarantor Statement of Earnings

For the three months ended March 31, 2005

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Kinetic 

 

 

 

 

 

 

 

 

 

Concepts,

 

 

 

 

 

Reclassi- 

 

Kinetic 

 

Inc.   

 

 

 

Non-   

 

fications 

 

Concepts,

 

Parent  

 

Guarantor

 

Guarantor

 

and     

 

Inc.   

 

Company

 

Sub-   

 

Sub-   

 

elimi-   

 

and Sub-

 

Borrower

 

  sidiaries  

 

  sidiaries  

 

  nations   

 

  sidiaries  

Revenue:

 

 

 

 

 

 

 

 

 

   Rental

$            - 

 

$ 150,640 

 

$  45,296 

 

$            - 

 

$ 195,936 

   Sales and other

 

59,225 

 

37,513 

 

(12,702)

 

84,036 

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Total revenue

 

209,865 

 

82,809 

 

(12,702)

 

279,972 

 

 

 

 

 

 

 

 

 

 

Rental expenses

 

80,563 

 

46,548 

 

 

127,111 

Cost of goods sold

 

15,955 

 

7,824 

 

(2,998)

 

20,781 

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Gross profit

 

113,347 

 

28,437 

 

(9,704)

 

132,080 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

 

 

 

 

 

 

   expenses

 

47,999 

 

14,431 

 

(2,274) 

 

60,156 

Research and development expenses

 

5,230 

 

980 

 

 

6,210 

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Operating earnings

 

60,118 

 

13,026 

 

(7,430)

 

65,714 

 

 

 

 

 

 

 

 

 

 

Interest income

 

455 

 

495 

 

(430)

 

520 

Interest expense

 

(7,849)

 

(41)

 

430 

 

(7,460)

Foreign currency loss

 

 

(2,018)

 

 

(2,018)

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Earnings before income taxes and

 

 

 

 

 

 

 

 

 

         equity in earnings of subsidiaries

 

52,724 

 

11,462 

 

(7,430)

 

56,756 

 

 

 

 

 

 

 

 

 

 

Income taxes

 

20,414 

 

1,730 

 

(2,563)

 

19,581 

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Earnings before equity in

 

 

 

 

 

 

 

 

 

         earnings of subsidiaries

 

32,310 

 

9,732 

 

(4,867)

 

37,175 

Equity in earnings of subsidiaries

37,175 

 

9,732 

 

 

(46,907)

 

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Net earnings

$   37,175 

 

$   42,042 

 

$    9,732 

 

$ (51,774)

 

$    37,175 

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

 

See accompanying notes to condensed consolidated financial statements.

 


 

Condensed Consolidating Parent Company,

Guarantor and Non-Guarantor Statement of Cash Flows

For the three months ended March 31, 2006

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Kinetic 

 

 

 

 

 

 

 

 

 

Concepts,

 

 

 

 

 

Reclassi- 

 

Kinetic 

 

Inc.   

 

 

 

Non-   

 

fications 

 

Concepts,

 

Parent  

 

Guarantor

 

Guarantor

 

and     

 

Inc.   

 

Company

 

Sub-   

 

Sub-   

 

elimi-   

 

and Sub-

 

Borrower

 

  sidiaries  

 

  sidiaries  

 

  nations   

 

  sidiaries  

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

   Net earnings

$  48,517 

 

$  49,053 

 

$ 14,231 

 

$ (63,284)

 

$   48,517 

   Adjustments to reconcile net earnings to net

 

 

 

 

 

 

 

 

 

      cash provided (used) by operating activities

(59,936)

 

(23,536)

 

(9,469)

 

65,039 

 

(27,902)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net cash provided (used) by

 

 

 

 

 

 

 

 

 

         operating activities

(11,419)

 

25,517 

 

4,762 

 

1,755 

 

20,615 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

   Additions to property, plant and equipment

 

(7,512)

 

(7,040)

 

 

(14,552)

   Increase in inventory to be converted into

 

 

 

 

 

 

 

 

 

      equipment for short-term rental

 

(2,500)

 

 

 

(2,500)

   Dispositions of property, plant and

 

 

 

 

 

 

 

 

 

      equipment

 

289 

 

106 

 

 

395 

   Increase in other non-current assets

 

(366)

 

(2,929)

 

2,859 

 

(436)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net cash used by investing activities

 

(10,089)

 

(9,863)

 

2,859 

 

(17,093)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

   Proceeds from long-term debt, capital lease

 

 

 

 

 

 

 

 

 

      and other obligations

 

 

52 

 

 

52 

   Excess tax benefit from share-based

 

 

 

 

 

 

 

 

 

      payment arrangements

14,417 

 

 

 

 

14,417 

   Proceeds from exercise of stock options

5,728 

 

 

 

 

5,728 

   Purchase of immature shares for minimum

 

 

 

 

 

 

 

 

 

      tax withholdings

(11,192)

 

 

 

 

(11,192)

   Proceeds from purchase of stock in ESPP

 

 

 

 

 

 

      and other

19 

 

 

 

 

19 

   Proceeds (payments) on intercompany

 

 

 

 

 

 

 

 

 

      investments and advances

(7,363)

 

5,755 

 

3,680 

 

(2,072)

 

   Other

9,810 

 

(8,090)

 

822 

 

(2,542)

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net cash provided (used)

 

 

 

 

 

 

 

 

 

         by financing activities

11,419 

 

(2,335)

 

4,554 

 

(4,614)

 

9,024 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Effect of exchange rate changes on

 

 

 

 

 

 

 

 

 

   cash and cash equivalents

 

 

574 

 

 

574 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Net increase in cash and cash equivalents

 

13,093 

 

27 

 

 

13,120 

Cash and cash equivalents,

 

 

 

 

 

 

 

 

 

   beginning of period

 

72,475 

 

50,908 

 

 

123,383 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Cash and cash equivalents, end of period

$            - 

 

$  85,568 

 

$ 50,935 

 

$            - 

 

$  136,503 

 

______ 

 

______ 

 

______ 

 

______ 

 

______ 

 

See accompanying notes to condensed consolidated financial statements.


 

Condensed Consolidating Parent Company,

Guarantor and Non-Guarantor Statement of Cash Flows

For the three months ended March 31, 2005

(in thousands)

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

Kinetic 

 

 

 

 

 

 

 

 

 

Concepts,

 

 

 

 

 

Reclassi- 

 

Kinetic 

 

Inc.   

 

 

 

Non-   

 

fications 

 

Concepts,

 

Parent  

 

Guarantor

 

Guarantor

 

and     

 

Inc.   

 

Company

 

Sub-   

 

Sub-   

 

elimi-   

 

and Sub-

 

Borrower

 

  sidiaries  

 

  sidiaries  

 

  nations   

 

  sidiaries  

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

   Net earnings

$   37,175 

 

$   42,042 

 

$   9,732 

 

$ (51,774)

 

$   37,175 

   Adjustments to reconcile net earnings to net

      

 

      

 

      

 

      

 

      

      cash provided (used) by operating activities

(28,276)

 

(14,604)

 

(11,421)

 

56,624 

 

2,323 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Net cash provided (used) by

 

 

 

 

 

 

 

 

 

         operating activities

8,899 

 

27,438 

 

(1,689)

 

4,850 

 

39,498  

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

   Additions to property, plant and equipment

 

(8,861)

 

(5,407)

 

 

(14,268)

   Increase in inventory to be converted into

 

 

 

 

 

 

 

 

 

      equipment for short-term rental

 

(1,200)

 

 

 

(1,200)

   Dispositions of property, plant and

 

 

 

 

 

 

 

 

 

      equipment

 

120 

 

345 

 

 

465 

   Decrease (increase) in other non-current assets

 

(816)

 

2,863 

 

(2,311)

 

(264)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Net cash used by investing activities

 

(10,757)

 

(2,199)

 

(2,311)

 

(15,267)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

   Repayments of long-term debt, capital lease

 

 

 

 

 

 

 

 

 

      and other obligations

 

(75,000)

 

(3)

 

 

(75,003)

   Proceeds from exercise of stock options

1,798 

 

 

 

 

1,798 

   Proceeds (payments) on intercompany

 

 

 

 

 

 

 

 

 

      investments and advances

(6,386)

 

6,150 

 

6,426 

 

(6,190)

 

   Other

(4,311)

 

(810)

 

1,470 

 

3,651 

 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

      Net cash provided (used)

 

 

 

 

 

 

 

 

 

         by financing activities

(8,899)

 

(69,660)

 

7,893 

 

(2,539)

 

(73,205)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Effect of exchange rate changes on

 

 

 

 

 

 

 

 

 

   cash and cash equivalents

 

 

(1,168)

 

 

(1,168)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Net increase (decrease) in cash and

 

 

 

 

 

 

 

 

 

   cash equivalents

 

(52,979)

 

2,837 

 

 

(50,142)

Cash and cash equivalents,

 

 

 

 

 

 

 

 

 

   beginning of period

 

84,903 

 

39,463 

 

 

124,366 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Cash and cash equivalents, end of period

$            - 

 

$   31,924 

 

$  42,300 

 

$            - 

 

$  74,224 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

 

See accompanying notes to condensed consolidated financial statements.


Table of Contents


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


     The following discussion should be read in conjunction with the condensed consolidated financial statements and accompanying notes included in this report.  The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs.  Our actual results could differ materially from those discussed in the forward-looking statements.  Factors that could cause or contribute to these differences include, but are not limited to, those discussed under Part II, Item 1A. “Risk Factors.”


General


    
 Kinetic Concepts, Inc. is a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces.  We design, manufacture, market and service a wide range of proprietary products that can improve clinical outcomes and can help reduce the overall cost of patient care.  Our advanced wound care systems incorporate our proprietary V.A.C. technology, which has been demonstrated clinically to help promote wound healing and can help reduce the cost of treating patients with serious wounds.  Our therapeutic surfaces, including specialty hospital beds, mattress replacement systems and overlays, are designed to address pulmonary complications associated with immobility, to prevent skin breakdown and assist caregivers in the safe and dignified handling of obese patients.  We have an infrastructure designed to meet the specific needs of medical professionals and patients across all health care settings, including acute care hospitals, extended care facilities and patients’ homes both in the United States and abroad.


     We have direct operations in the United States, Canada, Western Europe, Australia, Singapore, Japan and South Africa, and we conduct additional business through distributors in Latin America, the Middle East, Eastern Europe and Asia.  We manage our business in two geographical segments: USA and International.  Operations in the United States accounted for approximately 73% of our total revenue for the three months ended March 31, 2006.


     We derive our revenue from both the rental and sale of our products.  In the U.S. acute care and extended care settings, which accounted for more than half of our U.S. revenue for the three months ended March 31, 2006, we directly bill our customers, such as hospitals and extended care facilities.  In the U.S. homecare setting, where our revenue comes predominantly from V.A.C. systems, we provide products and services directly to patients and we directly bill third‑party payers, such as Medicare and private insurance.  Internationally, most of our revenue is generated in the acute care setting.


     For the last several years, our growth has been driven primarily by increased revenue from V.A.C. systems, which accounted for approximately 76% of total revenue for the three months ended March 31, 2006, up from 71% for the same period in 2005.  Historically, we have experienced a seasonal slowing of domestic V.A.C. unit growth beginning in the fourth quarter and continuing into the first quarter, which we believe has been caused by year-end clinical treatment patterns, such as the postponement of elective surgeries and increased discharges of individuals from the acute care setting around the holidays.
  Although we do not know if our historical experience will prove to be indicative of future periods, a similar slow-down may recur in subsequent periods.


     We believe that the historical growth in our domestic V.A.C. revenue has been due in part to the availability of homecare reimbursement for our V.A.C. systems and disposables under the Medicare program, as administered by the Centers for Medicare and Medicaid Services (“CMS”).  Recently, a competitor’s product received similar homecare reimbursement under the Negative Pressure Wound Therapy (“NPWT”) codes.  We expect that other competitors’ products may be assigned to the same codes upon obtaining necessary approvals.  Also, effective January 1, 2006, CMS effectively reduced the reimbursement for V.A.C. disposable canisters through coding decisions.  More recently, on April 24, 2006, CMS posted proposed rules for the competitive bidding of Durable Medical Equipment in the homecare setting.  Although CMS has not yet decided on specific product categories that will be covered in 2007 competitive bidding, the category for NPWT is among those being considered for 2007 or in future rounds of the competitive bidding process.  As a result of CMS coding decisions and policies over time, we may experience increased competition from similarly-coded products in future periods and the market and reimbursement we receive from third-party payers may be negatively impacted.



     We believe that the key factors underlying V.A.C. growth over the past year have been:


     -  Improving V.A.C. adoption among customers and physicians, both in terms of the number of users and the
        extent of use by each customer or physician.


     -  Market expansion by adding new wound type indications for V.A.C. use and increasing the percentage of wounds
        that are considered good candidates for V.A.C. therapy.


     -  Strengthening our contractual relationships with third‑party payers.


     We continue to focus our marketing and selling efforts on increasing physician awareness and adoption of the benefits of V.A.C. therapy.  These efforts are targeted at physician specialties that provide care to the majority of patients with wounds in our target categories.  Within these specialties, we focus on those clinicians who serve the largest number of wound care patients.  In order to meet our goals of increasing physician awareness, we increased our total sales force by approximately 190 employees in 2005 and 62 employees in the first quarter of 2006.


     Our intellectual property is very important to maintaining our competitive position.  With respect to our V.A.C. business, we rely on our rights under the Wake Forest patents licensed to us and a number of KCI patents in the U.S. and internationally.  Continuous enhancements in product portfolio and positioning are also important to our continued growth and market penetration.  We believe our advanced V.A.C. systems have increased customer acceptance and the perceived value of V.A.C. therapy.  We have benefited from the introduction of specialized dressing systems designed to improve ease-of-use and effectiveness in treating pressure ulcers and serious abdominal wounds.  Our ongoing clinical experience and studies have increased the market acceptance of V.A.C. and expanded the range of wounds considered to be good candidates for V.A.C. therapy.  We believe this growing base of data and clinical experience has driven the trend toward use of the V.A.C. on a routine basis for appropriate wounds.


     In addition to our intellectual property estate, we believe that we have competitive strengths in areas such as superior clinical efficacy, which is supported by an extensive collection of published clinical studies, broad reach and customer relationships, our extensive service center network and our expertise in homecare reimbursement.


 

Recent Developments


     Effective April 3, 2006, the Company finalized an agreement with Paul Hartmann AG for the withdrawal of the patent appeal pending before the European Patent Office (“EPO”) Board of Appeals involving a Wake Forest patent licensed to KCI.  The proceedings were effectively terminated on April 3, 2006.  In connection with the withdrawal of the appeal, KCI and Hartmann also signed a letter of intent pursuant to which they plan to enter into a strategic cooperation for the distribution and rental of our V.A.C. line of products in Eastern Europe and for the co-promotion of V.A.C. products in the Swiss and German homecare markets.  Under the terms of the letter of intent, the parties have agreed to enter into various agreements embodying the cooperation.  In the event that the parties cannot reach one or more definitive agreements on the strategic relationships, KCI has agreed to pay Hartmann specified sums of up to $2.25 million.


     On April 4, 2006, we reduced our senior credit facility by $25.0 million and wrote off approximately $370,000 of capitalized debt issuance costs.  As of that date, the remaining outstanding balance on our senior credit facility was $184.9 million and total debt outstanding was $269.5 million.


Results of Operations


     The following table sets forth, for the periods indicated, the percentage relationship of each item to total revenue in the period, as well as the percentage change in each line item, comparing the first quarter of 2006 to the first quarter of 2005:

 

 

         Three months ended March 31,       

 

 

 

%        

 

    2006  

    2005  

 Change (1)  

Revenue:

 

 

 

   Rental

71 % 

70 % 

15.8 %   

   Sales

29     

30     

9.8       

 

___     

___     

 

      Total revenue

100 %

100 %

14.0 %  

 

 

 

 

Rental expenses

44     

46     

10.5       

Cost of goods sold

7     

7     

4.6       

 

___     

___     

 

      Gross profit

49     

47     

18.9       

 

 

 

 

Selling, general and administrative expenses

24     

21     

24.2       

Research and development expenses

2     

2     

19.3       

 

___     

___     

 

      Operating earnings

23     

24     

14.0       

 

 

 

 

Interest income

-      

-     

88.8       

Interest expense

(1)    

(3)    

36.4       

Foreign currency gain (loss)

-     

(1)    

-       

 

___     

___     

 

      Earnings before income taxes

22     

20     

25.9       

 

 

 

 

Income taxes

7     

7     

17.1       

 

___     

___     

 

      Net earnings

15 %

13 %

30.5 %  

 

___   

___   

 

 

 

 

 

(1) Percentage change represents the change in dollars between periods.


      The following table sets forth, for the periods indicated, total revenue for V.A.C. systems and therapeutic surfaces/other and the amount of revenue derived from each of our geographical segments: USA and International (dollars in thousands):

 

 

        Three months ended March 31,        

 

 

 

%

 

     2006     

   2005     

Change (1) 

Total Revenue:

 

 

 

  V.A.C.

 

 

 

     Rental

$ 165,432 

$ 132,776 

24.6 % 

     Sales

77,522 

64,726 

19.8     

 

_______ 

_______ 

 

         Total V.A.C.

242,954 

197,502 

23.0     

 

 

 

 

  Therapeutic surfaces/other

 

 

 

     Rental

61,545 

63,160 

(2.6)    

     Sales

14,746 

19,310 

(23.6)    

 

_______ 

_______ 

 

         Total therapeutic surfaces/other

76,291 

82,470 

(7.5)    

 

 

 

 

  Total rental revenue

226,977 

195,936 

15.8     

  Total sales revenue

92,268 

84,036 

9.8     

 

_______ 

_______ 

 

       Total Revenue

$ 319,245 

$ 279,972 

14.0%  

 

_______ 

_______ 

 

USA Revenue:

 

 

 

  V.A.C.

 

 

 

     Rental

$ 138,742 

$ 112,149 

23.7%  

     Sales

47,345 

39,414 

20.1     

 

_______ 

_______ 

 

         Total V.A.C.

186,087 

151,563 

22.8     

 

 

 

 

  Therapeutic surfaces/other

 

 

 

     Rental

39,593 

38,957 

1.6     

     Sales

6,970 

7,005 

(0.5)    

 

_______ 

_______ 

 

         Total therapeutic surfaces/other

46,563 

45,962 

1.3     

 

 

 

 

  Total USA rental

178,335 

151,106 

18.0     

  Total USA sales

54,315 

46,419 

17.0     

 

_______ 

_______ 

 

       Total - USA Revenue

$ 232,650 

$ 197,525 

17.8%  

 

_______ 

_______ 

 

International Revenue:

 

 

 

  V.A.C.

 

 

 

     Rental

$   26,690 

$   20,627 

29.4%  

     Sales

30,177 

25,312 

19.2     

 

_______ 

_______ 

 

         Total V.A.C.

56,867 

45,939 

23.8     

 

 

 

 

  Therapeutic surfaces/other

 

 

 

     Rental

21,952 

24,203 

(9.3)    

     Sales

7,776 

12,305 

(36.8)    

 

_______ 

_______ 

 

         Total therapeutic surfaces/other

29,728 

36,508 

(18.6)    

 

 

 

 

  Total International rental

48,642 

44,830 

8.5     

  Total International sales

37,953 

37,617 

0.9     

 

_______ 

_______ 

 

       Total - International Revenue

$   86,595 

$   82,447 

5.0%  

 

_______ 

_______ 

 

 

 

 

 

(1)  Percentage change represents the change in dollars between periods.


 

     For additional discussion on segment and geographical information, see Note 8 to our condensed consolidated financial statements.


     
Total Revenue.  Total revenue for the first quarter of 2006 was $319.2 million, an increase of $39.3 million, or 14.0%, from the prior-year period.  The growth in total revenue over the prior-year period was due primarily to increased rental and sales volumes for V.A.C. wound healing devices and related disposables, partially offset by lower surfaces sales.  The growth in V.A.C. revenue was attributable to volume increases driven by our continued focus on marketing and selling efforts, partially offset by lower homecare pricing.  Foreign currency exchange movements negatively impacted total revenue by 1.3% in the first quarter of 2006, compared to the prior-year period.


     Domestic Revenue. 
Total domestic revenue was $232.7 million for the first quarter of 2006, representing an increase of 17.8% as compared to the prior-year period.  Total domestic V.A.C. revenue was $186.1 million for the first quarter of 2006, representing an increase of 22.8% compared to the prior-year period.  For the first quarter of 2006, domestic V.A.C. rental revenue of $138.7 million increased $26.6 million, or 23.7%, due to a 23.7% increase in average units on rent compared to the prior-year period.  Domestic V.A.C. sales revenue of approximately $47.3 million in the first quarter of 2006 increased 20.1% from the prior-year period.  This was due primarily to higher sales volumes for V.A.C. disposables associated with the 23.7% increase in V.A.C. system unit rentals, partially offset by lower homecare pricing.


      Domestic therapeutic surfaces/other revenue was approximately $46.6 million for the first quarter of 2006, an increase of 1.3% as compared to the prior-year period.  For the first quarter of 2006, domestic therapeutic surfaces rental revenue of $39.6 million increased approximately $640,000, or 1.6%, due to a 1.3% increase in average units on rent, compared to the prior-year period.  The average daily rental price was stable compared to the prior-year period.


     International Revenue.  Total international revenue of $86.6 million increased 5.0% compared to the prior-year period due to a $10.9 million, or 23.8%, increase in V.A.C. revenue, partially offset by an unfavorable foreign currency exchange rate variance and a $6.8 million decline in surfaces revenue.  The decline in international surfaces revenue resulted from a large sale in the prior-year period to the Canadian Government of $5.1 million, adversely impacting international revenue growth by 7.0%.  Foreign currency exchange movements negatively impacted international revenue by 4.3%, compared to the first quarter of 2005.


      Total international V.A.C. revenue was $56.9 million in the first quarter of 2006 representing an increase of 23.8% from the prior-year period.  Foreign currency exchange rate movements resulted in a 3.9% decrease in international V.A.C. revenue from the prior-year period.  International V.A.C. rental revenue of $26.7 million for the first quarter of 2006 increased $6.1 million, or 29.4%, due to a 39.6% increase in average units on rent.  The average rental price for the first quarter of 2006 decreased 1.6% as compared to the prior-year period due to increased average units on rent in countries with lower reimbursement levels.  International V.A.C. sales revenue of $30.2 million in the first quarter of 2006 increased 19.2% from the prior-year period due primarily to overall increased sales of V.A.C. disposables associated with the increase in rental units.  The $2.6 million V.A.C. sale to the Canadian Government in the first quarter of 2005 negatively impacted international V.A.C. sales revenue growth by 13.7% for the first quarter of 2006, compared to the prior-year period.


      International therapeutic surfaces/other revenue was $29.7 million for the first quarter of 2006, representing a decrease of 18.6% from the prior-year period.  During the first quarter of 2005, we completed a $5.1 million sale of therapeutic surfaces to the Canadian Government.  Additionally, foreign currency exchange rate movements unfavorably impacted international therapeutic surfaces/other revenue by 4.9% for the first quarter of 2006, compared to the prior-year period.  The remaining variance from the prior-year period was primarily due to a 10.0% decrease in the average rental price, partially offset by a 5.6% increase in the average number of therapeutic surface rental units on rent.  The decline in average rental price resulted primarily from pricing pressure due to increased competition on our lower therapy products and changes in product mix.



     Rental Expenses.  Rental, or “field,” expenses are comprised of both fixed and variable costs.  Field expenses, as a percentage of total revenue, were lower in the first quarter of 2006 at 44.0% as compared to 45.4% in the prior-year period.  This decrease was due primarily to productivity improvements in our selling and service operations and lower marketing spending as a percentage of revenue.  Our sales and service headcount increased from approximately 3,100 at December 31, 2005 to approximately 3,200 at March 31, 2006.


     Cost of Goods Sold.  Cost of goods sold was $21.7 million in
the first quarter of 2006, representing an increase of 4.6% over the prior-year period.  Sales margins in the first quarter of 2006 increased to 76.4% compared to 75.3% in the prior-year period.  The increased margins were due to continued cost reductions resulting from our global supply contract for V.A.C. disposables.


     Gross Profit
.  Gross profit was $157.1 million in the first quarter of 2006, representing an increase of 18.9% over the prior-year period.  Gross profit margin in the first quarter of 2006 was 49.2%, up from 47.2% in the prior-year period.  Increased revenues, productivity improvements in our selling and service operations and continued cost reductions from our global supply contract for V.A.C. disposables contributed to the margin expansion.


     Selling, General and Administrative Expenses.  Selling, general and administrative expenses represented 23.4% of total revenue in the first quarter of 2006 compared to 21.5% in the prior-year period.  Selling, general and administrative expenses include administrative labor, incentive and sales commission compensation costs, product licensing expense, insurance costs, professional fees, depreciation, bad debt expense and information systems costs.  In the first quarter of 2006, we recorded expenses of approximately $2.1 million, before income taxes, related to share-based compensation resulting from the January 1, 2006 adoption of Statement of Financial Accounting Standards No. 123 Revised, “Share-Based Payment,” compared to approximately $74,000 in share-based compensation expense recorded in the first quarter of 2005.


     Research and Development Expenses.  Research and development expenses in
the first quarter of 2006 were $7.4 million and represented 2.3% of total revenue as compared to 2.2% in the prior-year period.  Research and development expenses relate to our investments in new advanced wound healing systems and dressings, new technologies in wound healing and tissue repair, new applications of V.A.C. technology and upgrading and expanding our surface technology.


          Operating Earnings.  Operating earnings for
the first quarter of 2006 were $74.9 million compared to $65.7 million in the prior-year period due primarily to increased revenue.  Operating margins for each of the three-month periods ended March 31, 2006 and 2005 were 23.5%.  The adoption of SFAS 123R negatively impacted our operating margin by 0.7% in the first quarter of 2006, compared to the prior-year period.


     Interest Expense.  Interest expense in the first quarter of 2006 was $4.7 million compared to $7.5 million in the prior-year period.  The decrease in interest expense was due to lower outstanding debt compared to the prior-year period and write-offs of debt issuance costs totaling $1.4 million in the first quarter of 2005, associated with optional debt payments on our senior credit facility totaling $75.0 million.  We plan to continue reducing leverage while maintaining a strong liquidity position.


     Net Earnings.
  Net earnings for the first quarter of 2006 were $48.5 million, compared to $37.2 million in the prior-year period.  The effective income tax rate for the first quarter of 2006 was 32.1% compared to 34.5% for the prior-year period.  The income tax rate reduction was partially attributable to a higher portion of taxable income being generated in lower tax jurisdictions.  The favorable resolution of a tax contingency resulted in an additional decrease in the effective income tax rate of 1.5%, which is applicable to only the first quarter of 2006.


     Net Earnings per Share.   Net earnings per diluted share was $0.66 in
the first quarter of 2006 compared to net earnings per diluted share of $0.51 in the prior-year period.


 

Liquidity and Capital Resources


General


     We require capital principally for capital expenditures, systems infrastructure, debt service, interest payments and working capital.  Our capital expenditures consist primarily of manufactured rental assets, computer hardware and software and expenditures related to the need for additional office space for our expanding workforce.  Working capital is required principally to finance accounts receivable and inventory.  Our working capital requirements vary from period-to-period depending on manufacturing volumes, the timing of shipments and the payment cycles of our customers and payers.


Sources of Capital


     Based upon the current level of operations, we believe our existing cash resources, as well as cash flows from operating activities and availability under our revolving credit facility, will be adequate to meet our anticipated cash requirements for at least the next twelve months.  During the first three months of 2006 and 2005, our primary source of capital was cash from operations.  The following table summarizes the net cash provided and used by operating activities, investing activities and financing activities for the three months ended March 31, 2006 and 2005 (dollars in thousands):

 

 

            Three months ended March 31,           

 

            2006       

 

       2005               

 

 

 

 

 

 

Net cash provided by operating activities

$     20,615 

 

 

$  39,498 

 

Net cash used by investing activities

(17,093)

 

 

(15,267)

 

Net cash provided (used) by financing activities

9,024 

 

 

(73,205)

(1)

Effect of exchange rates changes on cash and cash equivalents

574 

 

 

(1,168)

 

 

______ 

 

 

______ 

 

Net increase (decrease) in cash and cash equivalents

$     13,120 

 

 

$  (50,142)

 

 

______ 

 

 

______ 

 

 

 

 

 

 

 

(1)  This amount for 2005 includes debt prepayments totaling $75.0 million on our senior credit facility.

 

     At March 31, 2006, cash and cash equivalents of $136.5 million were available for general corporate purposes.  At March 31, 2006, availability under the revolving portion of our senior credit facility was $88.1 million, net of $11.9 million in letters of credit.


Working Capital


     At March 31, 2006, we had current assets of $502.3 million, including $30.8 million in inventory, and current liabilities of $200.6 million resulting in a working capital surplus of approximately $301.7 million compared to a surplus of $242.1 million at December 31, 2005.  The increase in our working capital surplus of $59.6 million was primarily due to a $13.1 million increase in cash and a $42.8 million reduction in total accounts payable and accrued expenses.


     If rental and sales volumes for V.A.C. systems and related disposables continue to increase, we believe that a significant portion of this increase could occur in the homecare market, which could have the effect of increasing accounts receivable due to the extended payment cycles we experience with most third‑party payers.  We have adopted a number of policies and procedures designed to reduce these extended payment cycles.  As of March 31, 2006, we had $287.6 million of receivables outstanding, net of reserves of $67.7 million for doubtful accounts.  Our net receivables were outstanding for an average of 81 days at March 31, 2006 as compared to 80 days at December 31, 2005.


 

Capital Expenditures


     During the first three months of 2006 and 2005, we made capital expenditures of $14.6 million and $14.3 million, respectively, due primarily to expanding the rental fleet and information technology purchases.


Debt Service


     As of March 31, 2006, we had approximately $209.9 million and $84.4 million in debt outstanding under our senior credit facility and our senior subordinated notes, respectively.  Scheduled principal payments under our senior credit facility for the years 2006, 2007 and 2008 are $1.6 million, $2.2 million and $2.2 million, respectively.  Our outstanding senior subordinated notes will mature in 2013 and have scheduled interest payments in May and November of each year.   To the extent that we have excess cash, we may use it to reduce our outstanding debt obligations.


     
On April 4, 2006, we reduced our senior credit facility by $25.0 million and wrote off approximately $370,000 of capitalized debt issuance costs.


Senior Credit Facility


     Our senior credit facility consists of a seven-year term loan facility and a $100 million six-year revolving credit facility.  The following table sets forth the amounts outstanding under the term loan and the revolving credit facility, the effective interest rates on such outstanding amounts and amounts available for additional borrowing thereunder, as of March 31, 2006 (dollars in thousands):

 

 

 

 

 

Amount Available

 

Maturity   

Effective    

Amounts   

 For Additional

 Senior Credit Facility  

       Date       

Interest Rate 

Outstanding

      Borrowing       

 

 

 

 

 

Revolving credit facility

August 2009 

-            

$             -   

$ 88,072 (1)        

Term loan facility

August 2010 

5.16%  (2)  

209,906   

-              

 

 

 

_______   

______              

   Total

 

 

$ 209,906   

$ 88,072              

 

 

 

_______   

_______         

 

 

 

 

 

(1)  At March 31, 2006, amounts available under the revolving portion of our credit facility reflected a

       reduction of $11.9 million for letters of credit issued on our behalf, none of which have been

       drawn upon by the beneficiaries thereunder.

(2)  The effective interest rate includes the effect of interest rate hedging arrangements.  Excluding the

       interest rate hedging arrangements, our nominal interest rate as of March 31, 2006 was 6.73%.

 

Senior Subordinated Notes


     On August 11, 2003, we issued an aggregate of $205.0 million principal amount of our senior subordinated notes. 
As of March 31, 2006, $84.4 million principal amount of the notes remained outstanding.  We may purchase additional amounts of our senior subordinated notes in the open market and/or in privately negotiated transactions from time to time, subject to limitations in our senior credit facility.


Interest Rate Protection


     As of March 31, 2006 and December 31, 2005, the fair values of our swap agreements were positive in the aggregate and were recorded as an asset of $1.3 million and $1.8 million, respectively.  If these interest rate protection agreements were not in place, interest expense would have been approximately $654,000 and $26,000 higher for the three months ended March 31, 2006 and 2005, respectively.


Long-Term Commitments


     The following table summarizes our long-term debt obligations as of March 31, 2006, for each of the periods indicated (dollars in thousands):

 

       Year     

Long-Term  

    Payment  

Debt        

        Due      

  Obligations  

      2006

$      1,769      

      2007

2,158      

      2008

2,158      

      2009

2,158      

      2010

201,813      

  Thereafter

84,439      

 

Critical Accounting Estimates


Revenue Recognition and Accounts Receivable Realization


     We recognize revenue in accordance with Staff Accounting Bulletin No. 104,“Revenue Recognition,” when each of the following four criteria are met:


     1)     A contract or sales arrangement exists.
     2)     Products have been shipped and title has transferred or services have been rendered.
     3)     The price of the products or services is fixed or determinable.
     4)     Collectibility is reasonably assured.


     We recognize rental revenue based on the number of days a product is used by the patient/facility and the contracted rental rate for contracted customers and generally, retail price for non-contracted customers.  Sales revenue is recognized when products are shipped and title has transferred. In addition, we establish reserves against revenue to provide for adjustments including capitation agreements, evaluation/free trial days, credit memos, volume discounts, pricing adjustments, utilization adjustments, product returns, cancellations, estimated uncollectible amounts and payer adjustments based on historical experience.


     Domestic trade accounts receivable consist of amounts due directly from acute and extended care organizations, third‑party payers (both governmental and non-governmental) and patient pay accounts.  Included within the domestic third-party payers accounts receivable balances are amounts that have been or will be billed to patients once the primary payer portion of the claim has been settled by the third‑party payer.  International trade accounts receivable consist of amounts due primarily from acute care organizations.


     The domestic third‑party payer reimbursement process requires extensive documentation, which has had the short-term effect of slowing both the billing and cash collection cycles relative to the rest of the business, and therefore, increasing total accounts receivable.  Because of the extensive documentation required and the requirement to settle a claim with the primary payer prior to billing the secondary and/or patient portion of the claim, the collection period for a claim in our homecare business may, in some cases, extend beyond one year prior to full settlement of the claim.


     We utilize a combination of factors in evaluating the collectibility of accounts receivable.  For unbilled receivables, we establish reserves against revenue to allow for denied or uncollectible items.  In addition, items that remain unbilled for more than a specified period of time, or beyond an established billing window, are reserved against revenue.  For billed receivables, we generally establish reserves against revenue and bad debt based on a combination of factors including historic adjustment rates for credit memos and cancelled transactions, the portion of revenue not expected to be collected and, based on historical experience, the length of time that the receivables are past due.  The reserve rates vary by payer group.  In addition, we have recorded specific reserves for bad debt when we become aware of a customer's inability or refusal to satisfy its debt obligations, such as in the event of a bankruptcy filing.  If circumstances change, such as higher than expected claims denials, payment defaults or an unexpected material adverse change in a major customer's or payer's ability to meet its obligations, our estimates of the realizability of amounts due from trade receivables could be reduced by a material amount.  If we were to experience a 1% change in the historical collection rate of our total trade accounts receivable, total revenue for the first quarter of 2006 would have been impacted by approximately $8.0 million.


     For a description of our other critical accounting estimates, please see our Annual Report on Form 10-K for the year ended December 31, 2005 under the heading Part II, Item 7. “Management's Discussion and Analysis of Financial Condition and Results of Operations
– Critical Accounting Estimates."


New Accounting Pronouncements


     In November 2004, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 151 (“SFAS 151”), “Inventory Costs.”  This pronouncement amended the guidance in Accounting Research Bulletin No. 43, Chapter 4, “Inventory Pricing,” to clarify the accounting for abnormal amounts of idle facility expense, freight, handling costs, and wasted material (spoilage) and requires that allocation of fixed production overheads to the costs of conversion be based on the normal capacity of the production facilities.  The Company adopted SFAS 151 as of January 1, 2006 and the adoption of this statement did not have a material impact on its results of operations or its financial position.


     In December 2004, the FASB issued SFAS No. 123 Revised (“SFAS 123R”),“Share-Based Payment.”  SFAS 123R eliminated the alternative to account for share-based compensation using Accounting Principles Board Opinion No. 25, (“APB 25”),“Accounting for Stock Issued to Employees,” and required such transactions be recognized as compensation expense in the statement of earnings based on their fair values on the date of the grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  The Company adopted SFAS 123R on January 1, 2006 using the modified prospective transition method.  As such, the compensation expense recognition provisions of SFAS 123R applies to new awards and to any awards modified, repurchased or cancelled after the adoption date.  Additionally, for any unvested awards outstanding at the adoption date, the Company will recognize compensation expense over the remaining vesting period.  Prior to the adoption of SFAS 123R, the Company presented all tax benefits of deductions resulting from the exercise of stock options as operating cash flows in the statement of cash flows as required under SFAS No. 95, “Statement of Cash Flows.”  In accordance with SFAS 123R, the Company has now presented the cash flows for tax benefits resulting from the exercise of share-based payment arrangements in excess of the tax benefits recorded on compensation cost recognized for those options (excess tax benefits) as financing activity cash flows.


     The Company has elected to use the Black-Scholes model to estimate the fair value of option grants under SFAS 123R.  The Company believes that the use of the Black-Scholes model meets the fair value measurement objective of SFAS 123R and reflects all substantive characteristics of the instruments being valued.  Estimates of fair value are not intended to predict actual future events or the value ultimately realized by employees who receive share-based compensation awards, and subsequent events will not affect the original estimates of fair value made by the Company under SFAS 123R.


     With the adoption of SFAS 123R, the Company estimates forfeitures when recognizing compensation costs.  The Company will adjust its estimate of forfeitures as actual forfeitures differ from its estimates, resulting in the recognition of compensation cost only for those awards that actually vest.  Prior to the adoption of SFAS 123R, the Company recorded forfeitures of stock-based compensation awards as they occurred.  As a result of this change, the Company recorded a cumulative effect of a change in accounting principle of approximately $114,000 as a reduction in share-based compensation expense in the Company's condensed consolidated statement of earnings for the three months ended March 31, 2006.


     As of March 31, 2006, there was $20.5 million of total unrecognized compensation cost related to non-vested stock options granted under our various plans.  This unrecognized compensation cost is expected to be recognized over a weighted-average period of 2.7 years.


     As of March 31, 2006, there was $6.2 million of total unrecognized compensation cost related to non-vested restricted stock granted under our various plans.  This unrecognized compensation cost is expected to be recognized over a weighted-average period of 2.5 years.


     In May 2005, the FASB issued SFAS No. 154 (“SFAS 154”), “Accounting Changes and Error Corrections,” a replacement of APB Opinion No. 20 and FASB Statement No. 3.  SFAS 154 provides guidance on the accounting for and reporting of accounting changes and error corrections.  It establishes, unless impracticable, retrospective application as the required method for reporting a change in accounting principle.  SFAS 154 also provides guidance for determining whether retrospective application of a change in accounting principle is impracticable and for reporting a change when retrospective application is impracticable.  The reporting of a correction of an error by restating previously issued financial statements is also addressed by this Statement.  The Company adopted SFAS 154 as of January 1, 2006 and the adoption of this statement did not have a material impact on its results of operations or its financial position.


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ITEM 3.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK


     We are exposed to various market risks, including fluctuations in interest rates and variability in currency exchange rates.  We have established policies, procedures and internal processes governing our management of market risk and the use of financial instruments to manage our exposure to such risk.


Interest Rate Risk


     We have variable interest rate debt and other financial instruments, which are subject to interest rate risk and could have a negative impact on our business if not managed properly.  We have a risk management policy, which is designed to reduce the potential negative earnings effect arising from the impact of fluctuating interest rates.  We manage our interest rate risk on our borrowings through interest rate swap agreements which effectively convert a portion of our variable-rate borrowings to a fixed rate basis through August 21, 2006, thus reducing the impact of changes in interest rates on future interest expenses. We do not use financial instruments for speculative or trading purposes.


     As of March 31, 2006, we have three interest rate swap agreements pursuant to which we have fixed the rates on $150.0 million, or 71.5%, of our variable rate debt as follows:


     -  2.755% per annum on $50.0 million of our variable rate debt through August 21, 2006;
     -  2.778% per annum on $50.0 million of our variable rate debt through August 21, 2006; and
     -  2.788% per annum on $50.0 million of our variable rate debt through August 21, 2006.


     The table below provides information about our long-term debt and interest rate swaps, both of which are sensitive to changes in interest rates, as of March 31, 2006.  For long-term debt, the table presents principal cash flows and related weighted average interest rates by expected maturity dates.  For interest rate swaps, the table presents notional amounts and weighted average interest rates by expected (contractual) maturity dates.  Notional amounts are used to calculate the contractual payments to be exchanged under the contract.  Weighted average variable rates are based on implied forward rates in the yield curve at the reporting date (dollars in thousands):

 

                                                                          Expected Maturity Date As of March 31, 2006                                                 

 

    2006   

    2007    

    2008    

    2009    

Thereafter

    Total    

Fair Value

Long-term debt 

 

 

 

 

 

 

 

   Fixed rate

$        150

$         —

$         —

$        —

$   84,439

$  84,589

$   86,700 

   Average interest rate

7.000%

7.375%

7.374%

 

   Variable rate

$     1,619

$    2,158

$    2,158

$   2,158

$ 201,813

$209,906

$ 209,906 

   Average interest rate (1)

6.730%

6.730%

6.730%

6.730%

6.730%

6.730%

 

 

 

 

 

 

 

 

 

Interest rate swaps (2)

 

 

 

 

 

 

 

   Variable to fixed-notional amount

$ 150,000

$        —

$        —

$        —

$          —

$150,000

$     1,343 

   Average pay rate

2.774%

2.774%

 

   Average receive rate

4.967%

4.967%

 


          (1)     The average interest rates for future periods are based on the current period nominal interest rates.
          (2)     Interest rate swaps are included in the variable rate debt under long-term debt.  The fair value of our interest rate swap
                    agreements were positive in the aggregate and were recorded as an asset at March 31, 2006.


Foreign Currency and Market Risk


     We have direct operations in Western Europe, Canada, Australia and South Africa and distributor relationships in many other parts of the world. Our foreign operations are measured in their applicable local currencies.  As a result, our financial results could be affected by factors such as changes in foreign currency exchange rates or weak economic conditions in the foreign markets in which we have operations.  Exposure to these fluctuations is managed primarily through the use of natural hedges, whereby funding obligations and assets are both managed in the applicable local currency.


     KCI faces transactional currency exposures when its foreign subsidiaries enter into transactions, generally on an intercompany basis, denominated in currencies other than their local currency.  These nonfunctional currency exposures relate primarily to intercompany receivables and payables arising from intercompany purchases of manufactured products.  KCI enters into forward currency exchange contracts to mitigate the impact of currency fluctuations on transactions denominated in nonfunctional currencies, thereby limiting risk that would otherwise result from changes in exchange rates.  The periods of the forward currency exchange contracts correspond to the periods of the exposed transactions.


     At March 31, 2006, we had outstanding forward currency exchange contracts to sell approximately $9.7 million of various currencies.  Based on our overall transactional currency rate exposure, movements in the currency rates will not materially affect our financial condition.  We are exposed to credit loss in the event of nonperformance by counterparties on their outstanding forward currency exchange contracts, but do not anticipate nonperformance by any of the counterparties.


     International operations reported operating profit of $12.5 million for the three months ended March 31, 2006.  We estimate that a 10% fluctuation in the value of the dollar relative to these foreign currencies at March 31, 2006 would change our net income for the three months ended March 31, 2006 by approximately $1.2 million.  Our analysis does not consider the implications that such fluctuations could have on the overall economic activity that could exist in such an environment in the U.S. or the foreign countries or on the results of operations of these foreign entities.

 

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ITEM 4.     CONTROLS AND PROCEDURES


     Disclosure Controls and Procedures.  The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report.  Based on such evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act and are effective in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including the Company’s Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.


     Changes in Internal Controls.  There have not been any changes in the Company’s internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the quarter ended March 31, 2006 that have materially affected, or are reasonably likely to materially effect, the Company’s internal control over financial reporting.


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PART II - OTHER INFORMATION


ITEM 1.
     LEGAL PROCEEDINGS


     On August 28, 2003, KCI and its affiliates, together with Wake Forest University Health Sciences, filed a patent infringement lawsuit against BlueSky Medical Group, Inc., Medela, Inc., Medela AG (collectively, "Medela") and Patient Care Systems, Inc. (“PCS”) in the United States District Court for the Western District of Texas, San Antonio Division alleging infringement of three V.A.C. patents and related claims arising from the manufacturing and marketing of a pump and dressing kits by BlueSky.  We subsequently entered into a settlement with one of the defendants, PCS, pursuant to which the Court entered a final judgment and permanent injunction prohibiting PCS from further acts of infringement, unfair competition or false advertising through the sale or marketing of BlueSky products.  We are seeking damages and injunctive relief in the case against the remaining defendants.  A trial date has been set for May 30, 2006.


     On June 28, 2005 the Court construed certain terms of U.S. Patent No. 5,636,643 (the “643 patent”) and ruled that other terms were sufficiently definite without further construction.  On January 26, 2006, the Court also ruled on construction of claims in U.S. Patent number 5,645,081 (the “081 patent”) and additional claims in the 643 patent.  The ruling, among other things, further defined components of certain claims related to our V.A.C. dressing.  In addition, on March 1, 2006, the Court denied BlueSky’s motions for summary judgment to dismiss our claims of patent infringement and granted our motion to exclude BlueSky’s damages claims against us.  The Court also dismissed all of BlueSky’s counterclaims against KCI and Wake Forest with prejudice.  The Court’s ruling did not affect Medela’s defenses and counterclaims.  The Court may reconsider any of its rulings at any time before trial.  In April 2006, the parties negotiated the simplification of the case by removing some of KCI’s lesser claims in exchange for the elimination of all of the Defendants’ remaining counterclaims.  The defenses of invalidity and non-infringement have not been affected by the recent simplification of the case.  While it is difficult to predict what effect recent Court rulings and pre-trial simplification of the case may have on the outcome of the central claims of infringement and invalidity, we presently do not believe that they have fundamentally impacted the nature of the litigation or our probability of success at trial.


     Although it is not possible to reliably predict the outcome of the BlueSky litigation, we believe our claims are meritorious.  However, the jury may not decide the case in our favor and we may be unable to obtain an injunction against BlueSky or otherwise prevail in this litigation.  If we do not obtain an injunction or otherwise prevail, our share of the advanced wound-care market for our V.A.C. system could be significantly reduced due to increased competition, and reimbursement of V.A.C. systems could decline significantly, either of which would materially and adversely affect our operating results.  We derived $186.1 million and $706.0 million in revenue, or approximately 58% of total revenue, for the three months ended March 31, 2006 and the year ended December 31, 2005, respectively, from our domestic V.A.C. products relating to the patents at issue.


     In 1998, Mondomed N.V. and Paul Hartmann AG filed an opposition in the European Patent Office (“EPO”) to a Wake Forest European V.A.C. patent licensed to KCI.  Mondomed entered into a settlement with us and withdrew from the opposition in 2004.  Effective April 3, 2006, the Company finalized an agreement with Hartmann for the withdrawal of the patent appeal pending before the EPO Board of Appeals.  As a result of the withdrawals, the patent opposition proceedings have been terminated and the EPO’s 2004 decision upholding and construing the patent will remain in place.  The EPO’s 2004 decision established a range of pressures covered by the patent claims from 7.6 – 752 millimeters of mercury (“mmHg”) of negative pressure and provided that the "screen means" term describing the dressing is an open-cell polymer foam.  Our V.A.C. systems typically operate between 50 and 200 mmHg of negative pressure, with a default setting of 125 mmHg.


     In connection with the withdrawal of the appeal, KCI and Hartmann also signed a letter of intent pursuant to which they plan to enter into a strategic cooperation for the distribution and rental of our V.A.C. line of products in Eastern Europe and for the co-promotion of V.A.C. products in the Swiss and German homecare markets.  Under the terms of the letter of intent, the parties have agreed to enter into various agreements embodying the cooperation.  In the event that the parties cannot reach one or more definitive agreements on the strategic relationships, KCI has agreed to pay Hartmann specified sums of up to $2.25 million.


     We are a party to several additional lawsuits arising in the ordinary course of our business.  Additionally, the manufacturing and marketing of medical products necessarily entails an inherent risk of product liability claims.


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ITEM 1A.     RISK FACTORS


Risks Related to Our Business


We face significant and increasing competition, which could adversely affect our operating results.


     Historically, our V.A.C. systems have competed primarily with traditional wound care dressings, other advanced wound care dressings, skin substitutes, products containing growth factors and other medical devices used for wound care.  As a result of the success of our V.A.C. systems, competitors have announced or introduced products similar to or designed to mimic our V.A.C. systems.  In this regard, BlueSky Medical Group, Inc. is marketing a pump and dressing kits to compete directly with V.A.C. systems.  In 2004, BlueSky received U.S. Food and Drug Administration (“FDA”) clearance of its pump and one of its dressings, which in 2005 were also assigned by the Centers for Medicare and Medicaid Services (“CMS”) to the reimbursement codes for Negative Pressure Wound Therapy, the same codes assigned to our V.A.C. systems and disposables.  In the future, it is possible that manufacturers or dealers of other V.A.C.-like products will obtain similar FDA approvals and CMS coding, which would increase the number of competitors in advanced wound care.


     We believe the BlueSky device violates our intellectual property rights and have taken legal action against BlueSky, its supplier and several of its distributors to protect our rights.  While we have successfully challenged the marketing of imitative V.A.C. systems by several European companies, we may not be successful in our challenge of BlueSky and may not prevail in the pending litigation.  If competitors are able to legally develop and market products similar to the V.A.C., our share of the wound care market could substantially erode and our reimbursement for V.A.C. systems could decline significantly, either of which would materially and adversely affect our operating results.  We derived $186.1 million and $706.0 million in revenue, or approximately 58% of total revenue, for the three months ended March 31, 2006 and the year ended December 31, 2005, respectively, from our domestic V.A.C. products relating to the patents at issue.


     In the U.S., our therapeutic surfaces business primarily competes with the Hill-Rom Company and Sizewise Rentals and in Europe with Huntleigh Healthcare and Pegasus Limited. We face the risk that innovation by our competitors in our markets may render our products less desirable or obsolete.  Additionally, our competitors may effectively limit our market access through the execution of sole-source contracts with group purchasing organizations, large health care providers or third-party payers or may gain access to our current sole-source contracts with these group purchasing organizations through dual or multi-competitive arrangements, which also would adversely affect our operating results.


Our intellectual property is very important to our competitive position, especially for our V.A.C. products. If we are unsuccessful in protecting and maintaining our intellectual property, particularly our rights under the Wake Forest patents, our competitive position would be harmed.


     We invest substantial resources and place considerable importance on obtaining and maintaining patent protection for our products, particularly, our license rights under the Wake Forest patents on which we rely in our V.A.C. business. We have numerous patents on our existing products and processes, and we file applications as appropriate for patents covering new technologies as they are developed. However, the patents we own, or in which we have rights, may not be sufficiently broad to protect our technology position against competitors. Issued patents owned by us, or licensed to us, may be challenged, invalidated or circumvented, or the rights granted under issued patents may not provide us with competitive advantages. We incur substantial costs and diversion of management resources when we have to assert or defend our patent rights against others.  Moreover, third parties may claim that we are infringing their intellectual property rights, and we may be found to infringe those intellectual property rights. Any unfavorable outcome in intellectual property disputes or litigation could cause us to lose our intellectual property rights in technology that is material to our business. In addition, we may not be able to detect infringement by third parties, and could lose our competitive position if we fail to do so.


     In 2003, we filed a lawsuit against BlueSky Medical Group, Inc., Medela, Inc., Medela AG and Patient Care Systems, Inc.  In the case, we allege infringement of multiple claims under three V.A.C. patents arising from the manufacturing and marketing of a medical device by BlueSky.  We are seeking damages and injunctive relief in the case.  Although it is not possible to reliably predict the outcome of the BlueSky litigation, we believe our claims are meritorious.  However, the jury may not decide the case in our favor and we may be unable to obtain an injunction against BlueSky or otherwise prevail in this litigation.  If we do not obtain an injunction or otherwise prevail, our share of the advanced wound-care market for our V.A.C. system could be significantly reduced due to increased competition, and reimbursement for V.A.C. systems could decline significantly, either of which would materially and adversely affect our operating results.  We derived $186.1 million and $706.0 million in revenue, or approximately 58% of our total revenue, for the three months ended March 31, 2006 and the year ended December 31, 2005, respectively, from our domestic V.A.C. products relating to the patents at issue.


     We expect similar litigation may arise in the future.  We also are subject to product liability litigation and risk arising from the manufacture and marketing of our medical products.  The costs of pursuing or defending this litigation and other litigation that may arise may be substantial.  Any adverse determination also could materially and adversely affect our operating results.


     We also have agreements with third parties, including our exclusive license of the V.A.C. patents from Wake Forest, that provide for licensing of their patented or proprietary technologies. These agreements include royalty-bearing licenses. If we were to lose the rights to license these technologies, or our costs to license these technologies were to materially increase, our business would suffer.


Changes to third-party reimbursement policies could reduce the reimbursement we receive for and adversely affect the demand for our products.


     The demand for our products is highly dependent on the policies of third-party payers such as Medicare, Medicaid, private insurance and managed care organizations that reimburse us for the sale and rental of our products.  If coverage or payment policies of these third-party payers are revised in light of increased controls on health care spending or otherwise, the amount we may be reimbursed or the demand for our products may decrease.


     From time to time, the Centers for Medicare and Medicaid Services (“CMS”) publishes reimbursement policies and rates that may favorably or unfavorably affect the reimbursement and market for our products.  In the past, our V.A.C. systems and disposables were the only devices assigned to the CMS reimbursement codes for Negative Pressure Wound Therapy (“NPWT”).  In 2005, CMS assigned a pump and dressing kits marketed by BlueSky to the same NPWT codes under the Healthcare Common Procedure Coding System.  In the future, we expect that manufacturers or dealers of products designed to mimic the V.A.C. may obtain NPWT coding upon obtaining necessary approvals, which would increase competition.  Also, the unique existing code for reimbursement of V.A.C. disposable canisters was eliminated effective December 31, 2005, and consequently, we are required to bill Medicare Part B for V.A.C. canisters under a more generic existing code at a lower reimbursement rate beginning January 1, 2006.  As a result of this reduced reimbursement for V.A.C. canisters, we experienced a reduction in revenue of approximately $2.9 million during the first quarter of 2006.  As a result of these recent CMS decisions we are experiencing increased competition from BlueSky products and inquiries from other third-party payers regarding reimbursement levels.  Either increased competition or reduced reimbursement could materially and adversely affect our business and operating results.


     The assignment of CMS reimbursement codes to competing products increases the likelihood of our V.A.C. products being subjected to the Medicare competitive bidding process in 2007, which could negatively impact KCI’s revenue from products that are reimbursed by Medicare in the homecare setting.  Any declines in Medicare reimbursement could materially and adversely affect our business.  In addition, it is possible that KCI would not be contracted as a supplier of NPWT under a Medicare competitive acquisition program.  On April 24, 2006, CMS posted proposed rules on competitive bidding of Durable Medical Equipment in the homecare setting.  Although CMS has not yet decided on specific product categories that will be covered in 2007 competitive bidding, the category for NPWT is among those being considered under the proposed rule and may be included in the final rules, which should be adopted later this year, or in future rounds of the competitive bidding process.  In addition, the proposed rules would require suppliers to meet certain new quality standards to participate in the competitive acquisition program and to continue to provide Medicare-covered Durable Medical Equipment going forward.  Although KCI has met certain accreditation standards, including accreditation from the Joint Commission on Accreditation of Healthcare Organizations (“JCAHO”), there can be no assurance that KCI will meet the new quality standards, when finalized.


     The reimbursement of our products is also subject to review by government contractors that administer payments under federal health care programs, including Medicare Durable Medical Equipment Regional Carriers (“DMERCs”).  These contractors are delegated certain authority to make local or regional determinations and policies for coverage and payment of durable medical equipment in the home.  Adverse determinations and changes in policies can lead to denials of our charges for our products and/or requests to recoup alleged overpayments made to us for our products.  Such adverse determinations and changes can often be challenged only through an administrative appeals process.  In this regard, we currently have approximately $13.1 million in outstanding receivables from CMS, including both unbilled items and claims where coverage or payment was initially denied, which relate to Medicare V.A.C. placements that have extended beyond four months in the home.  We are in the process of submitting all unbilled claims for payment and appealing the remaining claims through the appropriate administrative processes necessary to obtain payment.  We may not be successful in collecting these amounts.  Further changes in policy or adverse determinations, including any that may arise due to the forthcoming changes in Medicare contractors where the current DMERCs are being replaced by new Medicare Administrative Contractors later this year, may result in increases in denied claims and outstanding receivables.  In addition, if our appeals are unsuccessful and/or there are further policy changes, we may be unable to continue to provide the same types of services that are represented by these disputed types of claims in the future.


     On April 12, 2006, the CMS issued a notice of proposed rulemaking, which includes the first significant changes to the Inpatient Prospective Payment System (“IPPS”) since its implementation in 1983. The IPPS is the Medicare payment system for inpatient hospital services. Under this proposal, CMS would assign payment values for most inpatient hospital services in a manner that is based on weighted averages of national hospital costs for providing the services, rather than the current method, which is based on a weighted average of hospital charges for such services. The resulting changes, if enacted, could place further downward pressure on pricing for the products that we provide to acute care hospitals for inpatient services.


     Due to the increased scrutiny and publicity of increasing health care costs, we may be subject to future assessments or studies by CMS, the FDA, or other agencies, which could lead to other changes in their reimbursement policies that adversely affect our business.   In this regard, we were informed in November 2004 that CMS intends to evaluate the clinical efficacy, functionality and relative cost of the V.A.C. system and a variety of other medical devices to determine whether they should be included in a competitive bidding process.  A negative assessment with respect to the efficacy of the V.A.C., or one that is perceived to be negative, could adversely affect the reimbursement of, or demand for, the V.A.C.


     The Office of the Inspector General (“OIG”) has initiated a study on NPWT for 2006.  The OIG Office of Evaluations and Inspections evaluates effectiveness and efficiency of a wide range of programs of the Department of Health and Human Services.  We have participated in similar studies in the past on other product lines.  As part of the current study, the OIG has requested copies of our billing records for Medicare V.A.C. placements.  KCI submitted all copies as requested and plans to cooperate fully with any and all future requests associated with these evaluations.  In the event we are unable to satisfy the OIG in connection with this study, our prior billings could be subject to claims audits, which could result in demands by third-party payers for refunds or recoupments of amounts previously paid to us.  The results of this study could also factor into determinations of the inherent reasonableness of our V.A.C. pricing, to what extent our V.A.C. therapy will be subject to the competitive bidding process and to other Medicare and third-party payer determinations on coverage or reimbursement.


If we are unable to develop new generations of V.A.C. and therapeutic surface products and enhancements to existing products, we may lose market share as our existing patent rights begin to expire over time.


     Our success is dependent upon the successful development, introduction and commercialization of new generations of products and enhancements to existing products. Innovation in developing new product lines and in developing enhancements to our existing V.A.C. and therapeutic surfaces products is required for us to grow and compete effectively.  Our new and enhanced products may extend the uses and benefits for which our current products are intended or approved.  Over time, our existing foreign and domestic patent protection in both the V.A.C. and therapeutic surfaces businesses will begin to expire, which could allow competitors to adopt our older unprotected technology into competing product lines. If we are unable to continue developing proprietary product enhancements to V.A.C. systems and therapeutic surfaces products that effectively make older products obsolete, we may lose market share in our existing lines of business. In addition, if we fail to develop new lines of products, we will not be able to penetrate new markets. Innovation in enhancements and new products requires significant capital commitments and investments on our part, which we may be unable to recover.


If our future operating results do not meet our expectations or those of the equity research analysts covering us, the trading price of our common stock could fall dramatically.


     We have experienced and expect to continue to experience fluctuations in revenue and earnings for a number of reasons, including:


     -  the level of acceptance of our V.A.C. systems by customers and physicians;
     -  the type of indications that are appropriate for V.A.C. use and the percentages of wounds that are good
        candidates for V.A.C. Therapy;
     -  clinical studies that may be published regarding the efficacy of V.A.C. Therapy, including studies published
        by our competitors in an effort to challenge the efficacy of the V.A.C.;
     -  developments or any adverse determination in our pending litigation;
     -  third-party government or private reimbursement policies with respect to V.A.C. treatment and competing
        products; and
     -  new or enhanced competition in our primary markets.


     We believe that the trading price of our common stock is based, among other factors, on our expected rates of growth in revenue and earnings per share. If we are unable to realize growth rates consistent with our expectations or those of the analysts covering us, we would expect to realize a decline in the trading price of our stock. Historically, domestic V.A.C. unit growth has been somewhat seasonal with a slowdown in V.A.C. rentals beginning in the fourth quarter and continuing into the first quarter, which we believe is caused by year-end clinical treatment patterns. The adverse effects in our business arising from seasonality may become more pronounced in future periods as the market for the V.A.C. systems matures and V.A.C. growth rates decrease.


     Because our staffing and operating expenses are based on anticipated revenue levels, and because a high percentage of our costs are fixed, even small decreases in revenue or delays in the recognition of revenue could cause significant variations in our operating results from quarter to quarter. In the short term, we do not have the ability to adjust spending in a time-effective manner to compensate for any unexpected revenue shortfall, which also could cause a significant decline in the trading price of our stock.


Failure of any of our randomized and controlled studies or a third-party study or assessment to demonstrate V.A.C. therapy's clinical efficacy may reduce physician usage of V.A.C. and cause our V.A.C. revenue to decline.


     For the past several years, we have been conducting a number of clinical studies designed to test the efficacy of V.A.C. across targeted wound types.  A successful clinical trial program is necessary to maintain and increase sales of V.A.C. products, in addition to supporting and maintaining third-party reimbursement of the product in the United States and abroad, particularly in Europe, Canada and Japan.  If, as a result of poor design, implementation or otherwise, a clinical trial conducted by us or others fails to demonstrate statistically significant results supporting the efficacy or cost effectiveness of V.A.C. therapy, physicians may elect not to use V.A.C. therapy as a treatment in general, or for the type of wound in question.  Furthermore, in the event of an adverse clinical trial, V.A.C. therapy may not achieve “standard-of-care” designations for the wound types in question, which could deter the adoption of V.A.C. in those wound types or others.  If we are unable to develop a body of statistically significant evidence from our clinical trial program, whether due to adverse results or the inability to complete properly designed studies, domestic and international public and private payers could refuse to cover V.A.C. therapy, limit the manner in which they cover V.A.C. therapy, or reduce the price they are willing to pay or reimburse for V.A.C. therapy.


We may be subject to claims audits that could harm our business and financial results.


     As a health care supplier, we are subject to extensive government regulation, including laws regulating reimbursement under various government programs.  The billing, documentation and other practices of health care suppliers are subject to scrutiny, including claims audits.  To ensure compliance with Medicare regulations, contractors, such as the DMERCs, which serve as the government's agents for the processing of claims for products sold for home use, periodically conduct audits and request medical records and other documents to support claims submitted by us for payment of services rendered to our customers.  Because we are a Durable Medical Equipment (“DME”) supplier, those audits involving home use include review of patient claims records.  Such audits can result in delays in obtaining reimbursement and denials of claims for payment submitted by us.  In addition, the government could demand significant refunds or recoupments of amounts paid by the government for claims which are determined by the government to be inadequately supported by the required documentation.


     In addition, private payers may also conduct audits, such as one conducted by Michigan Blue Cross.  We reviewed a preliminary report of their findings and filed a response in December 2004 and are currently negotiating on specific claims.  Although no abusive or fraudulent practices were identified by the payer, it is unclear what refunds or recoupments will be expected based on claims reviews. KCI will have appeal rights with regard to any such determinations.


Because we depend upon a limited group of suppliers and, in some cases, exclusive suppliers for products essential to our business, we may incur significant product development costs and experience material delivery delays if we lose any significant supplier, which could materially impact our rental and sales of V.A.C. systems and disposables.


     We obtain some of our finished products and components from a limited group of suppliers.  In particular, we rely exclusively on Avail Medical Products, Inc. for the manufacture and packaging of our V.A.C. disposables.  V.A.C. therapy cannot be administered without the appropriate use of our V.A.C. units in conjunction with the related V.A.C. disposables.  Total V.A.C. rental and sales revenue represented approximately 76% of our total revenue for the first quarter of 2006, of which sales of V.A.C. disposables represented approximately 22%.  Accordingly, a shortage of V.A.C. disposables would inevitably cause our revenue to decline and, if material or continued, a shortage may also reduce our market position.


     We have a long-term evergreen supply agreement with Avail through October 2008, which automatically extends for additional twelve-month periods in October of each year, unless either party gives notice to the contrary. We require Avail to maintain duplicate manufacturing facilities, tooling and raw material resources for the production of our disposables in different locations to decrease the risk of supply interruptions from any single Avail manufacturing facility.  However, should Avail or Avail’s suppliers fail to perform in accordance with their agreement and our expectations, our supply of V.A.C. disposables could be jeopardized, which could negatively impact our V.A.C. revenue. The terms of the supply agreement provide that key indicators be provided to us that would alert us to Avail's inability to perform under the agreement. We maintain an inventory of disposables sufficient to support our business for approximately six weeks in the United States and eight weeks in Europe. However, in the event that we are unable to replace a shortfall in supply, our revenue could be negatively impacted in the short term.


     Avail relies exclusively on Foamex International, Inc. for the supply of foam used in the V.A.C. disposable dressings.  In 2005, Foamex filed for Chapter 11 bankruptcy reorganization.  While in bankruptcy, Foamex could breach or terminate its purchase orders with Avail, reject, delay or refuse to fulfill Avail orders, cease production of the foam necessary for our V.A.C. products, or sell production to a third-party.  Any of these outcomes could jeopardize Avail’s supply of foam and hence our supply of V.A.C. disposables.  Similarly, we contract exclusively with Noble Fiber Technologies, LLC. for the supply of specialized silver-coated foam for use in our line of silver dressings.  In the event that Noble experiences manufacturing interruptions, our supply of silver V.A.C. dressings could be jeopardized.  We are in the process of identifying other suppliers that could provide inventory to meet our needs in the event that Avail, Foamex or Noble are unable to fulfill our requirements for V.A.C. disposables.  If we are required but unable to timely procure an alternate source for this foam at an appropriate cost, our ability to obtain the raw material resources required for our V.A.C. disposables could be compromised, which would have a material adverse effect on our entire V.A.C. business.


We could be subject to governmental investigations under the federal False Claims Act, the Anti-Kickback Statute or the Stark Law.


     There are numerous rules and requirements governing the submission of claims for payment to federal health care programs. If we fail to adhere to these requirements in any material respects, the government could allege that claims we have submitted for payment violate the federal False Claims Act (“FCA”), which generally prohibits the making of false statements to the government to receive payment. Violation of the criminal FCA can result in imprisonment of five years and a fine of up to $250,000 for an individual or $500,000 for an organization and up to three times the amount of the improper payment. Imposition of such penalties or exclusions would result in a significant loss of reimbursement and may have a material adverse effect on our financial condition.


     In the past year, the federal government has significantly increased investigations of medical device manufacturers with regard to alleged kickbacks to physicians who use and prescribe their products. The federal Anti-Kickback Statute is a criminal statute that prohibits the offering, payment, solicitation or receipt of remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, for (1) the referral of patients or arranging for the referral of patients to receive services for which payment may be made in whole or in part under a federal or state health care program; or (2) the purchase, lease, order, or arranging for the purchase, lease or order of any good, facility, service or item for which payment may be made under a federal or state health care program. Generally, courts have taken a broad interpretation of the scope of the Anti-Kickback Statute. The criminal sanctions for a conviction under the Anti-Kickback Law are imprisonment for not more than five years, a fine of not more than $25,000 or both, for each incident or offense, although under 18 U.S.C.  Section 3521, this fine may be increased to $250,000 for individuals and $500,000 for organizations. If a party is convicted of a criminal offense related to participation in the Medicare program or any state health care program, or is convicted of a felony relating to health care fraud, the secretary of the United States Department of Health and Human Services is required to bar the party from participation in federal health care programs and to notify the appropriate state agencies to bar the individual from participation in state health care programs. Imposition of such penalties or exclusions would result in a significant loss of reimbursement and may have a material adverse effect on our financial condition and results of operations.


     Federal authorities have also increased enforcement with regard to the federal physician self-referral and payment prohibitions (commonly referred to as the "Stark Law").  The Stark Law generally forbids, absent qualifying for one of the exceptions, a physician from making referrals for the furnishing of any "designated health services," for which payment may be made under the Medicare or Medicaid programs, to any “entity” with which the physician (or an immediate family member) has a "financial relationship."  DME items are designated health services.  Our arrangements with physicians who prescribe our products, including arrangements whereby physicians serve as speakers and consultants for KCI, could implicate the Stark Law. In the case of a prohibited financial relationship between a physician and KCI, the physician may not order Medicare or Medicaid covered DME from us, and we may not present a claim for Medicare or Medicaid payment for such items. Penalties for Stark Law violations include denial of payments for items provided pursuant to a prohibited order, civil monetary penalties of up to $15,000 for each illegal referral and up to $100,000 for any scheme designed to circumvent the Stark Law requirements. Prosecution under the Stark Law could have a material adverse impact on our financial condition and results of operations.


     In some cases, Anti-Kickback Statute or Stark Law violations may also be prosecuted under the FCA, which increases potential liability.  Even the assertion of a violation under any of these provisions could have a material adverse effect on our financial condition and results of operations.


We are subject to numerous laws and regulations governing the health care industry, and non-compliance with such laws, as well as changes in such laws or future interpretations of such laws, could reduce demand for and limit our ability to distribute our products and could cause us to incur significant compliance costs.


     There are widespread legislative efforts to control health care costs in the United States and abroad, which we expect will continue in the future. Recent publicity has highlighted the need to control health care spending at the federal (Medicare) and state (Medicaid) levels. We believe this pressure will intensify over time. For example, the enactment of the Medicare Modernization Act eliminated annual payment increases on the V.A.C. system for the foreseeable future and initiated a competitive bidding program. These legislative efforts could negatively impact demand for our products.


     Substantially all of our products are subject to regulation by the FDA and its foreign counterparts. Complying with FDA requirements and other applicable regulations imposes significant costs and expenses on our operations. If we fail to comply with applicable regulations, we could be subject to enforcement sanctions, our promotional practices may be restricted, and our marketed products could be subject to recall or otherwise impacted. In addition, new FDA guidance and new and amended regulations that regulate the way we do business may occasionally result in increased compliance costs. Recently, the FDA published notice of its intent to implement new dimensional requirements for hospital bed side rails that may require us to change the size of openings in new side rails for some of our surface products. Over time, related market demands might also require us to retrofit products in our existing rental fleet, and more extensive product modifications might be required if FDA decides to eliminate certain exemptions in their proposed guidelines. Regulatory authorities in Europe and Canada have also recently adopted the revised standard, IEC 60601, requiring labeling and electro-magnetic compatibility modifications to several product lines in order for them to remain state-of-the-art. Listing bodies in the U.S. are expected to adopt similar revised standards in 2010. Each of these revised standards will entail increased costs relating to compliance with the new mandatory requirements.



     We are also subject to various federal and state laws pertaining to health care fraud and abuse, including prohibitions on the submission of false claims and the payment or acceptance of kickbacks or other remuneration in return for the purchase or lease of our products. The United States Department of Justice and the Office of the Inspector General of the United States Department of Health and Human Services have launched an enforcement initiative, which specifically targets the long-term care, home health and DME industries. Sanctions for violating these laws include criminal penalties and civil sanctions, including fines and penalties, and possible exclusion from the Medicare, Medicaid and other federal health care programs.


     In addition, we are subject to various environmental laws and regulations both within and outside the United States affecting the use of substances in our manufacturing and sterilization processes.  Compliance with such laws can entail substantial cost and any failure to comply could result in substantial fines, penalties and delays in marketing the affected products.


 

Table of Contents


ITEM 6.     EXHIBITS


      A list of all exhibits filed or included as part of this quarterly report on form 10-Q is as follows:

 

Exhibits

                 Description

 

 

3.1    

Restated Articles of Incorporation (with Amendments) of KCI(1).

3.2    

Third Amended and Restated By-laws of KCI(2).

10.1    

Executive Deferred Compensation Plan.

31.1    

Certificate of the Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002

 

   dated May 9, 2006.

31.2    

Certificate of the Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002

 

   dated May 9, 2006.

32.1    

Certificate of the Chief Executive Officer and Chief Financial Officer pursuant to section 18 U.S.C. section

 

   1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 dated May 9, 2006.

 

 

 

                                   

 

 

 

(1) Filed as an exhibit to the Registration Statement on Form S-1 filed on February 2, 2004.

 

(2) Filed as an exhibit to the Registration Statement on Form S-1 filed on May 28, 2004.



Table of Contents

 

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.

 




                                                                                                KINETIC CONCEPTS, INC.
                                                                                                (REGISTRANT)

 

Date:      May 9, 2006                                                         By:      /s/  DENNERT O. WARE
                                                                                                Dennert O. Ware
                                                                                                President and Chief Executive Officer
                                                                                                (Duly Authorized Officer)

 

 

Date:      May 9, 2006                                                         By:      /s/  MARTIN J. LANDON
                                                                                                Martin J. Landon
                                                                                                Vice President and Chief Financial Officer
                                                                                                (Principal Financial and Accounting Officer)



Table of Contents

 

INDEX OF EXHIBITS

 

Exhibits

                 Description

 

 

3.1    

Restated Articles of Incorporation (with Amendments) of KCI(1).

3.2    

Third Amended and Restated By-laws of KCI(2).

10.1    

Executive Deferred Compensation Plan.

31.1    

Certificate of the Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002

 

   dated May 9, 2006.

31.2    

Certificate of the Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002

 

   dated May 9, 2006.

32.1    

Certificate of the Chief Executive Officer and Chief Financial Officer pursuant to section 18 U.S.C. section

 

   1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 dated May 9, 2006.

 

 

 

                                   

 

 

 

(1) Filed as an exhibit to the Registration Statement on Form S-1 filed on February 2, 2004.

 

(2) Filed as an exhibit to the Registration Statement on Form S-1 filed on May 28, 2004.