10-Q 1 r3qtr2005kci10q.htm KCI 3Q 2005 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 September 30, 2005

 

 

 

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 an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
                                                                                                                                                                                  Yes ___   No     X_

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: 69,877,955 shares as of October 31, 2005



TABLE OF CONTENTS


KINETIC CONCEPTS, INC.


 

 

 

 

 



Table of Contents

 

TRADEMARKS

 

     The following terms used in this report are our trademarks:  AirMaxxisÔ, AtmosAir®, BariAir®, BariKare®, BariMaxx® II, BariMaxx®, DynaPulse®, FirstStep®, FirstStep® AdvantageÔ, FirstStep® Plus, FirstStep Select®, FirstStep Select® Heavy Duty, FluidAir Elite®, FluidAir® II, KCI®, KinAir® III, KinAir® IV, KinAir MedSurg®, 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®, TheraPulse®, TheraPulse® II, TheraRest®, 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;

-  changes in patient demographics; 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; intense and 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)

 

 

 

 

 

 

 

 

September 30,

 

December 31,

 

 

        2005        

 

       2004       

 

 

(unaudited) 

 

 

 

Assets:

 

 

 

 

Current assets:

 

 

 

 

   Cash and cash equivalents

$    79,491   

 

  124,366    

 

   Accounts receivable, net

269,313   

 

252,822    

 

   Inventories, net

32,881   

 

35,590    

 

   Deferred income taxes

23,568   

 

24,836    

 

   Prepaid expenses and other current assets

19,680   

 

13,296    

 

 

_______   

 

_______    

 

          Total current assets

424,933   

 

450,910    

 

 

 

 

 

 

 

 

 

 

 

Net property, plant and equipment

175,301   

 

183,075    

 

Loan issuance costs, less accumulated amortization of

 

 

 

 

     $11,744 in 2005 and $8,317 in 2004

8,510   

 

11,937    

 

Deferred income taxes

11,808   

 

7,913    

 

Goodwill

49,369   

 

49,369    

 

Other assets, less accumulated amortization of $9,089

 

 

 

 

     in 2005 and $8,748 in 2004

29,199   

 

29,261    

 

 

_______   

 

_______    

 

 

$  699,120   

 

$  732,465    

 

 

_______   

 

_______   

 

Liabilities and Shareholders' Equity:

 

 

 

 

Current liabilities:

 

 

 

 

   Accounts payable

$     42,776   

 

$    43,246    

 

   Accrued expenses and other

146,531   

 

150,317    

 

   Current installments of long-term debt

2,420   

 

2,803    

 

   Income taxes payable

26,456   

 

20,821    

 

 

_______   

 

_______    

 

          Total current liabilities

218,183   

 

217,187    

 

 

 

 

 

 

Long-term debt, net of current installments

317,483   

 

442,943    

 

Deferred income taxes

10,668   

 

13,170    

 

Other noncurrent liabilities

9,370   

 

8,364    

 

 

_______   

 

_______    

 

 

555,704   

 

681,664    

 

Shareholders' equity:

 

 

 

 

   Common stock; authorized 225,000 at September 30, 2005

 

 

 

 

     and December 31, 2004; issued and outstanding 69,784

 

 

 

 

     at September 30, 2005 and 68,694 at December 31, 2004

70   

 

69    

 

   Preferred stock; authorized 50,000 at September 30, 2005

 

 

 

 

     and December 31, 2004; issued and outstanding 0 at

 

 

 

 

     September 30, 2005 and December 31, 2004

-   

 

-    

 

   Additional paid-in capital

551,247   

 

517,354    

 

   Deferred compensation

(6,142)  

 

(1,906)   

 

   Retained deficit

(412,283)  

 

(488,071)   

 

   Accumulated other comprehensive income

10,524   

 

23,355    

 

 

_______   

 

_______    

 

          Shareholders' equity

143,416   

 

50,801    

 

 

_______   

 

_______    

 

 

$  699,120   

 

$  732,465    

 

 

_______   

 

_______   

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.


Table of Contents

KINETIC CONCEPTS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

 

 

 

 

 

 

 

 

 

Three months ended    

 

Nine months ended     

 

            September 30,        

 

             September 30,        

 

    2005    

 

    2004    

 

    2005     

 

    2004    

Revenue:

 

 

 

 

 

 

 

   Rental

$ 221,747 

 

$ 188,637 

 

$ 628,732 

 

$ 530,124 

   Sales

90,601 

 

68,525 

 

257,799 

 

188,857 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Total revenue

312,348 

 

257,162 

 

886,531 

 

 718,981 

 

 

 

 

 

 

 

 

Rental expenses

136,160 

 

112,422 

 

394,412 

 

323,392 

Cost of goods sold

22,564 

 

18,816 

 

64,682 

 

52,144 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Gross profit

153,624 

 

125,924 

 

427,437 

 

343,445 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

73,269 

 

61,728 

 

201,494 

 

167,176 

Research and development expenses

7,724 

 

7,544 

 

20,697 

 

21,851 

Litigation settlement expense

72,000 

 

 

72,000 

 

Initial public offering expenses

 

 

 

19,836 

Secondary offering expenses

 

 

 

2,219 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Operating earnings

631 

 

56,652 

 

133,246 

 

132,363 

 

 

 

 

 

 

 

 

Interest income and other

2,504 

 

214 

 

3,522 

 

743 

Interest expense

(5,989)

 

(7,566)

 

(18,898)

 

(37,460)

Foreign currency gain (loss)

218 

 

1,964 

 

(3,040)

 

1,701 

 

_______ 

 

_______

 

_______ 

 

_______ 

         Earnings (loss) before income taxes (benefit)

(2,636)

 

51,264 

 

114,830 

 

97,347 

 

 

 

 

 

 

 

 

Income taxes (benefit)

(1,484)

 

18,455 

 

39,042 

 

35,045 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Net earnings (loss)

$  (1,152)

 

$   32,809 

 

$   75,788 

 

$   62,302 

 

 

 

 

 

 

 

 

Series A convertible preferred stock dividends

 

 

 

(65,604)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Net earnings (loss) available to common shareholders

$  (1,152)

 

$   32,809 

 

$   75,788 

 

$   (3,302)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Net earnings (loss) per share available to

 

 

 

 

 

 

 

           common shareholders:

 

 

 

 

 

 

 

             Basic

$      (0.02)

 

$       0.49 

 

$       1.09 

 

$     (0.05)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

             Diluted

$      (0.02)

 

$       0.46 

 

$       1.04 

 

$     (0.05)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Weighted average shares outstanding:

 

 

 

 

 

 

 

             Basic

69,587 

 

66,767 

 

69,229 

 

60,751 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

             Diluted

69,587 

 

71,774 

 

73,019 

 

60,751 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

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)

 

  Nine months ended September 30,  

 

    2005   

 

    2004     

Cash flows from operating activities:

 

 

 

   Net earnings

$    75,788 

 

$    62,302 

   Adjustments to reconcile net earnings to net cash provided

 

 

 

      by operating activities:

 

 

 

           Depreciation and amortization

51,213 

 

43,114 

           Provision for uncollectible accounts receivable

12,979 

 

7,904 

           Amortization of deferred gain on sale of headquarters facility

(803)

 

(803)

           Write-off of deferred loan issuance costs

2,308 

 

5,127 

           Non-cash amortization of stock awards

1,196 

 

218 

           Tax benefit related to exercise of stock options

19,978 

 

42,402 

           Change in assets and liabilities:

 

 

 

                 Increase in accounts receivable, net

(27,920)

 

(46,476)

                 Decrease (increase) in inventories, net

3,066 

 

(1,059)

                 Decrease (increase) in current deferred income taxes, net

1,268 

 

(1,566)

                 Decrease (increase) in prepaid expenses and other current assets

(5,932)

 

527 

                 Decrease in accounts payable

(293)

 

(4,147)

                 Increase (decrease) in accrued expenses and other

(1,306)

 

20,657 

                 Increase (decrease) in income taxes payable

5,635 

 

(36,186)

                 Increase (decrease) in deferred income taxes, net

(6,556)

 

    2,058 

 

_______ 

 

_______ 

                     Net cash provided by operating activities

130,621 

 

94,072 

 

_______ 

 

_______ 

Cash flows from investing activities:

 

 

 

   Additions to property, plant and equipment

(54,716)

 

(63,849)

   Decrease (increase) in inventory to be converted into equipment

 

 

 

      for short-term rental

1,300 

 

(2,200)

   Dispositions of property, plant and equipment

803 

 

1,471 

   Increase in other assets

      (405)

 

      (642)

                     Net cash used by investing activities

(53,018)

 

(65,220)

 

_______ 

 

_______ 

Cash flows from financing activities:

 

 

 

   Repayment of notes payable, long-term debt, capital lease

 

 

 

      and other obligations

(125,710)

 

(217,289)

   Proceeds from exercise of stock options

6,264 

 

9,556 

   Proceeds from purchase of stock in ESPP

2,213 

 

   Initial public offering of common stock:

 

 

 

      Proceeds from issuance of common stock

 

105,000 

      Stock issuance costs

 

(10,604)

 

_______ 

 

_______ 

                     Net cash used by financing activities

(117,233)

 

(113,337)

 

_______ 

 

_______ 

Effect of exchange rate changes on cash and cash equivalents

(5,245)

 

         (43)

 

_______ 

 

_______ 

Net decrease in cash and cash equivalents

(44,875)

 

(84,528)

 

 

 

 

Cash and cash equivalents, beginning of period

124,366 

 

156,064 

 

_______ 

 

_______ 

Cash and cash equivalents, end of period

$  79,491 

 

$    71,536 

 

_______ 

 

_______ 

Cash paid during the nine months for:

 

 

 

   Interest (1)

$    13,548 

 

$    29,701 

   Income taxes

$    15,413 

 

$    30,724 

Non-cash activity:

 

 

 

   Non-cash consideration for exercise of stock options

$             7 

 

$      6,443 

 

 

 

 

(1)  The amount reflected for 2004 includes purchase premiums of $7.7 million related to the prepayments on our 7 3/8% Senior

      Subordinated Notes due 2013.

 

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"). 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, 2004 and our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2005 and June 30, 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 reclassifications of amounts related to the prior year have been made to conform with the 2005 presentation.


(b)     Stock-Based Compensation


     We use the intrinsic value method to account for our stock compensation plans. If the compensation cost for our stock-based employee compensation plans had been determined based upon a fair value method consistent with Statement of Financial Accounting Standards No. 123 ("SFAS 123"), "Accounting for Stock-Based Compensation," our net earnings (loss) available to common shareholders and net earnings (loss) per share would have been adjusted to the pro forma amounts indicated below. For purposes of pro forma disclosures, the estimated fair value of the options is recognized as an expense over the options' respective vesting periods. Our pro forma calculations are as follows (dollars in thousands, except for net earnings (loss) per share information):

 

 

      Three months ended

 

       Nine months ended

 

        September 30,        

 

       September 30,       

 

    2005    

 

   2004    

 

    2005   

 

    2004    

 

 

 

 

 

 

 

 

Net earnings (loss) available to common shareholders, as reported

$   (1,152)

 

$  32,809 

 

$  75,788 

 

$   (3,302)

 

_____ 

 

_____ 

 

_____ 

 

_____ 

Pro forma net earnings (loss) available to common shareholders:

 

 

 

 

 

 

 

   Net earnings (loss) available to common shareholders as reported

$   (1,152)

 

$  32,809 

 

$  75,788 

 

$   (3,302)

   Compensation expense under intrinsic method

389 

 

67 

 

789 

 

140 

   Compensation expense under fair value method

(1,806)

 

(963)

 

(4,521)

 

(2,273)

 

_____ 

 

______ 

 

_____ 

 

______ 

Pro forma net earnings (loss) available to common shareholders

$   (2,569)

 

$  31,913 

 

$  72,056 

 

$   (5,435)

 

_____ 

 

_____ 

 

_____ 

 

_____ 

Net earnings (loss) per share available to common shareholders, as reported:

 

 

 

 

 

 

 

   Basic

$     (0.02)

 

$      0.49 

 

$      1.09 

 

$    (0.05)

   Diluted

$     (0.02)

 

$      0.46 

 

$      1.04 

 

$    (0.05)

 

 

 

 

 

 

 

 

Pro forma net earnings (loss) per share available to common shareholders:

 

 

 

 

 

 

 

   Basic

$     (0.04)

 

$      0.48 

 

$      1.04 

 

$    (0.09)

   Diluted

$     (0.04)

 

$      0.44 

 

$      0.99 

 

$    (0.09)

 

 

 

 

 

 

 

 


     In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS 123 Revised “Share-Based Payment” (“SFAS 123R”).  SFAS 123R eliminates the alternative to account for stock-based compensation using the intrinsic value method under APB 25 and requires that such transactions be recognized as compensation expense in the statement of operations based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the award.  KCI will adopt SFAS 123R on January 1, 2006 using a modified prospective application.  As such, the compensation expense recognition provisions will 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, KCI will recognize compensation expense over the remaining vesting period.


     KCI has begun, but has not yet completed, evaluating the impact of adopting SFAS 123R on its results of operations.  KCI currently determines the fair value of stock-based compensation using a Black-Scholes option-pricing model.  In connection with evaluating the impact of adopting SFAS 123R, KCI determined we will continue to use the Black-Scholes option-pricing model, as we do not believe that we have enough historical data to support an alternative model.  KCI believes the adoption of SFAS 123R will result in additional compensation expense of approximately $7
$9 million, after taxes, for 2006.


     SFAS 123R also requires that realized tax benefits in excess of tax benefits on recognized compensation costs be reported as financing cash flows, rather than as operating cash flows as required under current literature.  While we cannot estimate what those amounts will be in the future, the tax benefit amounts recognized as operating cash flows in the first nine months of 2005 and 2004 were $20.0 million and $42.4 million, respectively, the majority of which would have been required to be reported as financing cash flows under the new accounting pronouncement.


     During the nine-month period ended September 30, 2005, we issued approximately 980,000 shares of common stock under our stock-based compensation plans resulting primarily from option exercises.  In addition, during the nine-month period ended September 30, 2005, we granted options to purchase approximately 550,000 shares of common stock and issued approximately 94,000 shares of restricted stock under our stock-based compensation plans.


(c)     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, 2004.



(2)     SUPPLEMENTAL BALANCE SHEET DATA

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

 

 

September 30,

 

December 31,

 

       2005         

 

        2004       

Trade accounts receivable:

 

 

 

   Facilities/dealers

$ 168,909    

 

$ 155,467    

 

 

 

 

   Third-party payers:

 

 

 

      Medicare / Medicaid

57,267    

 

46,120    

      Managed care, insurance and other

100,468    

 

102,496    

 

_______    

 

_______    

 

326,644    

 

304,083    

 

 

 

 

Employee and other receivables

2,227    

 

1,735    

 

_______    

 

_______    

 

328,871    

 

305,818    

 

 

 

 

Less:  Allowance for doubtful accounts

(59,558)   

 

(52,996)   

 

_______    

 

_______    

 

$ 269,313    

 

$ 252,822    

 

_______   

 

_______   

 

 

 

 

 

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

 

 

September 30,

 

December 31,

 

       2005         

 

        2004       

 

 

 

 

Finished goods

$     7,535     

 

$     8,884     

Work in process

2,723     

 

2,057     

Raw materials, supplies and parts

36,114     

 

40,418     

 

______     

 

______     

 

46,372     

 

51,359     

 

 

 

 

Less: Amounts expected to be converted

 

 

 

            into equipment for short-term rental

(7,800)    

 

(9,100)    

         Reserve for excess and obsolete inventory

(5,691)    

 

(6,669)    

 

______     

 

______     

 

$   32,881     

 

$   35,590     

 

______    

 

______    


(3)     EARNINGS (LOSS) PER SHARE


     The following table sets forth the reconciliation from basic to diluted weighted average common shares outstanding and the calculations of net earnings (loss) per common share available to common shareholders.  Net earnings (loss) per share available to common shareholders were calculated using the weighted average number of common shares outstanding (dollars in thousands, except per share data).  (See Note 1 (b).)

 

 

         Three months ended

 

             Nine months ended

 

            September 30,    

 

                 September 30,     

 

   2005   

 

    2004   

 

   2005   

 

    2004   

Net earnings (loss)

$  (1,152)

 

$ 32,809 

 

$ 75,788 

 

$   62,302 

Series A convertible preferred stock dividends

 

 

 

(65,604)

 

______ 

 

______ 

 

______ 

 

______ 

Net earnings (loss) available to common shareholders

$  (1,152)

 

$ 32,809 

 

$ 75,788 

 

$   (3,302)

 

______ 

 

______ 

 

______ 

 

______ 

Weighted average shares outstanding:

 

 

 

 

 

 

 

   Basic

69,587 

 

66,767 

 

69,229 

 

60,751 

   Dilutive potential common shares from stock options (1)

 

5,007 

 

3,790 

 

   Dilutive potential common shares from preferred stock conversion (1)

 

 

 

 

______ 

 

______ 

 

______ 

 

______ 

   Diluted

69,587 

 

71,774 

 

73,019 

 

60,751 

 

______ 

 

______ 

 

______ 

 

______ 

Basic net earnings (loss) per common share available to

 

 

 

 

 

 

 

   common shareholders

$    (0.02)

 

$      0.49 

 

$     1.09 

 

$      (0.05)

 

______ 

 

______ 

 

______ 

 

______ 

Diluted net earnings (loss) per common share available to

 

 

 

 

 

 

 

   common shareholders

$    (0.02)

 

$      0.46 

 

$     1.04 

 

$      (0.05)

 

______ 

 

______ 

 

______ 

 

______ 

 

(1)  Due to their antidilutive effect, 3,545 dilutive potential common shares from stock options have been excluded from the diluted weighted average

       shares calculation for the three-month period ended September 30, 2005.  In addition, due to their antidilutive effect, 5,606 dilutive potential

       common shares from the stock options and 3,994 dilutive potential common shares from the preferred stock conversion have been excluded from

       the diluted weighted average shares calculation for the nine-month period ended September 30, 2004.


(4)     OTHER COMPREHENSIVE INCOME


     KCI follows Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive Income," in accounting for comprehensive income and its components. Comprehensive income for the nine months ended September 30, 2005 and 2004 was $63.0 million and $64.1 million, respectively.  For the three months ended September 30, 2005 and 2004, comprehensive income was a loss of $670,000 and income of $34.2 million, respectively. The most significant adjustment to net earnings to arrive at comprehensive income consisted of a foreign currency translation adjustment gain of $410,000 and a loss of $13.1 million for the three-month and nine-month periods ended September 30, 2005, respectively.  For the three-month and nine-month periods ended September 30, 2004, the foreign currency translation adjustment gain was $2.3 million and $1,900, respectively.


(5)     LITIGATION SETTLEMENT


     
On September 30, 2005, KCI reached an agreement to settle our litigation with Novamedix Limited, a subsidiary of Orthofix International NV.  Under the terms of the settlement, KCI paid Novamedix $75.0 million and agreed to assign or license certain KCI foot pump patent rights to Novamedix.  KCI will also retain rights under the patents.  The settlement resolves and settles all claims between the parties in the case.  The settlement payment resulted in a charge of $72.0 million, net of recorded reserves of $3.0 million, or $47.4 million and $0.65 per diluted share, net of taxes, during the third quarter of 2005.



(6)     2004 INITIAL PUBLIC STOCK OFFERING


     On February 27, 2004, we completed an initial public offering (“IPO”) of our common stock, through which we sold 3.5 million newly‑issued shares and the selling shareholders sold an aggregate of 17.2 million existing shares at a price of $30.00 per share.  Net proceeds from the IPO to KCI were $94.4 million. The net proceeds, along with cash on hand, were used to redeem $71.75 million principal amount of our 73/8% Senior Subordinated Notes due 2013, together with a bond call premium of $5.3 million in connection with the redemption, to prepay $50.0 million of debt under our senior credit facility, and to pay management bonuses, payroll taxes and other expenses related to the IPO of $19.8 million.  In March 2004, we wrote off $3.3 million in loan issuance costs associated with the retirement of our debt, which was included in interest expense.


     As part of the IPO, the holders of our then-outstanding Series A convertible preferred stock received cumulative preferred dividends paid-in-kind through December 31, 2005 of $65.6 million, and immediately thereafter, all of the then-outstanding shares of preferred stock were automatically converted into approximately 19.2 million shares of common stock.


(7)     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 and Patient Care Systems, Inc. in the United States District Court for the Western District of Texas, San Antonio Division.  We have alleged infringement of three V.A.C. patents, two of which are owned by Wake Forest, arising from the manufacturing and marketing of a pump and dressing kits by BlueSky.  We have also asserted causes of action for breach of contract, tortious interference, unfair competition and conspiracy.  We are seeking damages and injunctive relief in the case.  BlueSky and Medela have asserted counterclaims against us for declarations of non-infringement and patent invalidity and violations of federal anti-trust laws.  A trial date has been set for May 31, 2006.


     On June 28, 2005, the Court issued a ruling on a Markman hearing, construing certain terms of U.S. Patent No. 5,636,643 (the “643 patent”) and ruling that other terms were definite and did not require construction by the Court.  A Markman hearing on construction of claims in U.S. Patent number 5,645,081 (the “081” patent”) and additional claims in the 643 patent is scheduled for November 14, 2005.  On September 7, 2005, we entered into a settlement with Patient Care Systems (“PCS”), pursuant to which the Court has 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.  On November 2, 2005, the Court denied defendants’ motions for summary judgment to dismiss our claims of tortious interference, unfair competition and conspiracy, but dismissed our breach of contract claim against Medela.  Medela remains a defendant in the lawsuit for our claims of conspiracy, patent infringement and other claims.  Although it is not possible to reliably predict the outcome of this litigation, we believe our claims are meritorious.  However, we may be unable to obtain an injunction against BlueSky, and we may not prevail in this litigation.  If we do not obtain an injunction or otherwise prevail, our share of the advanced wound-care market could be significantly reduced due to increased competition, and pricing of V.A.C. systems could decline significantly, either of which would materially and adversely affect our operating results.


     In 1998, Mondomed N.V. and Paul Hartmann A.G. filed an opposition in the European Patent Office to a Wake Forest European V.A.C. patent licensed to KCI.  In 2004, the European Patent Office issued an interlocutory decision upholding the patent.  The decision corrected the patent to expand the range of pressures covered by the patent claims from 0.10 - 0.99 atmospheres to 0.01 - 0.99 atmospheres and modified the patent claims to provide that the "screen means" is open-cell polymer foam.  Wake Forest and Paul Hartmann A.G. have appealed the decision.  Mondomed N.V. has entered into a settlement with us and has withdrawn from the opposition.  We presently believe it will take two or more years to complete the appeal process.  During the pendency of an appeal, the original patents remain in place.  If Wake Forest is not successful in its appeal, the patent claims could be narrowed or the patent could be invalidated, either of which may have a material adverse effect on our business.  We do not believe that any decision in this case will affect U.S. patents.



     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. While provisions have been made in our financial statements for estimated exposures related to these claims and other ordinary course lawsuits where management deemed necessary, these provisions may prove to be inadequate. We have not experienced any significant losses due to product liability claims in the past and we believe that our liability insurance coverage is adequate.


     Other than commitments for new product inventory, including disposable "for sale" products of $21.7 million, we have no material long-term capital commitments.


(8)     SUBSEQUENT EVENT


     
On October 26, 2005, KCI was notified by the Centers for Medicare and Medicaid Services (“CMS”) that a pump and dressings marketed by BlueSky Medical Group, Inc. have been assigned to the codes for negative pressure wound therapy, effective immediately, in connection with the 2006 Healthcare Common Procedure Coding System (“HCPCS”) decisions.  The negative pressure wound therapy codes are the same codes assigned to KCI’s V.A.C. system and disposables.  KCI was subsequently advised by CMS that sales by Bluesky may be reimbursed immediately under the codes.


      In connection with the HCPCS decisions, CMS published revised code descriptors for certain HCPCS codes.  The code descriptors for negative pressure wound therapy dressings have been changed in a way that may permit BlueSky dressings to be classified under those codes.  Also, the existing code for reimbursement of V.A.C. disposable canisters will be eliminated effective December 31, 2005 and KCI will be required to bill Medicare Part B for V.A.C. canisters under an alternate existing code at a lower reimbursement rate.


(9)     SEGMENT AND GEOGRAPHIC INFORMATION


     We are principally engaged in the rental and sale of V.A.C. systems and therapeutic surfaces throughout the United States and in 17 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 units. 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 earnings before interest income and other, 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      

 

       Nine months ended         

 

             September 30,             

 

             September 30,             

 

     2005    

 

    2004     

 

    2005     

 

    2004     

Revenue:

 

 

 

 

 

 

 

   USA

 

 

 

 

 

 

 

      V.A.C.

$ 188,043 

 

$ 148,759 

 

$ 511,620 

 

$ 406,397 

      Therapeutic surfaces/other

44,297 

 

44,286 

 

134,825 

 

136,237 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Subtotal - USA

232,340 

 

193,045 

 

646,445 

 

542,634 

 

 

 

 

 

 

 

 

   International

 

 

 

 

 

 

 

      V.A.C.

52,486 

 

36,762 

 

147,321 

 

93,915 

      Therapeutic surfaces/other

27,522 

 

27,355 

 

92,765 

 

82,432 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Subtotal - International

80,008 

 

64,117 

 

240,086 

 

176,347 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

$ 312,348 

 

$ 257,162 

 

$ 886,531 

 

$ 718,981 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

 

 

 

 

 

 

 

Operating earnings:

 

 

 

 

 

 

 

   USA

$  89,421 

 

$   75,473 

 

$ 239,307 

 

$ 202,653 

   International

11,000 

 

9,303 

 

36,557 

 

22,955 

   Litigation settlement expense

(72,000)

 

 

(72,000)

 

   Initial public offering expenses

 

 

 

(19,836)

   Secondary offering expenses

 

 

 

(2,219)

 

 

 

 

 

 

 

 

   Other (1):

 

 

 

 

 

 

 

      Executive

(6,939)

 

(7,860)

 

(13,143)

 

(16,514)

      Finance

(9,441)

 

(7,376)

 

(26,859)

 

(20,092)

      Manufacturing/Engineering

(1,356)

 

(2,323)

 

(3,251)

 

(5,987)

      Administration

(10,054)

 

(10,565)

 

(27,365)

 

(28,597)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

         Total other

(27,790)

 

(28,124)

 

(70,618)

 

(71,190)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

$       631 

 

$  56,652 

 

$ 133,246 

 

$ 132,363 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

 

 

 

 

 

 

 

(1)  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 Operations.



(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, $97.8 million of the notes remained outstanding as of September 30, 2005.  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 September 30, 2005 and December 31, 2004 and the related condensed consolidating statements of operations for the three and nine-month periods ended September 30, 2005 and 2004, and the condensed consolidating statements of cash flows for the nine-month periods ended September 30, 2005 and 2004, respectively.


 

 

Condensed Consolidating Parent Company,

 

Guarantor And Non-Guarantor Balance Sheet

 

September 30, 2005

 

(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

$             - 

 

$    19,182 

 

$  60,309 

 

$              - 

 

$ 79,491 

 

   Accounts receivable, net

 

196,697 

 

77,422 

 

(4,806)

 

269,313 

 

   Inventories, net

 

19,108 

 

13,773 

 

 

32,881 

 

   Deferred income taxes

 

23,568 

 

 

 

23,568 

 

   Prepaid expenses and other current assets

 

16,952 

 

5,837 

 

(3,109)

 

19,680 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          Total current assets

 

275,507 

 

157,341 

 

(7,915)

 

424,933 

 

 

 

 

 

 

 

 

 

 

 

 

Net property, plant and equipment

 

124,369 

 

61,026 

 

(10,094)

 

175,301 

 

Loan issuance costs, net

 

8,510 

 

 

 

8,510 

 

Deferred income taxes

 

5,062 

 

6,746 

 

 

11,808 

 

Goodwill

 

39,779 

 

9,590 

 

 

49,369 

 

Other assets, net

 

28,650 

 

6,123 

 

(5,574)

 

29,199 

 

Intercompany investments and advances

143,430 

 

479,663 

 

55,089 

 

(678,182)

 

 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

 

 

$ 143,430 

 

$ 961,540 

 

$ 295,915 

 

$ (701,765)

 

$ 699,120 

 

 

_____ 

 

______ 

 

_____ 

 

_____ 

 

_____ 

 

Liabilities and Shareholders' Equity:

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

   Accounts payable

$             - 

 

$      33,961 

 

$     8,815 

 

$              - 

 

$    42,776 

 

   Accrued expenses and other

14 

 

104,668 

 

41,849 

 

 

146,531 

 

   Current installments of long-term debt

 

2,420 

 

 

 

2,420 

 

   Intercompany payables

 

 

37,697 

 

(37,697)

 

 

   Income taxes payable

 

29,565 

 

 

(3,109)

 

26,456 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          Total current liabilities

14 

 

170,614 

 

88,361 

 

(40,806)

 

218,183 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current installments

 

317,483 

 

 

 

317,483 

 

Intercompany payables, noncurrent

 

(26,152)

 

26,152 

 

 

 

Deferred income taxes

 

10,668 

 

 

 

10,668 

 

Other noncurrent liabilities

 

14,475 

 

469 

 

(5,574)

 

9,370 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          

14 

 

487,088 

 

114,982 

 

(46,380)

 

555,704 

 

Shareholders' equity

143,416 

 

474,452 

 

180,933 

 

(655,385)

 

143,416 

 

 

_______ 

 

________ 

 

_______ 

 

_______ 

 

_______ 

 

          

$ 143,430 

 

$ 961,540 

 

$ 295,915 

 

$ (701,765)

 

$ 699,120 

 

 

_____ 

 

______ 

 

_____ 

 

_____ 

 

_____ 

 

 



 

 

Condensed Consolidating Parent Company,

 

Guarantor And Non-Guarantor Balance Sheet

 

December 31, 2004

 

(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

$          - 

 

$      84,903 

 

$   39,463 

 

$              - 

 

$ 124,366 

 

   Accounts receivable, net

 

189,013 

 

69,749 

 

(5,940)

 

252,822 

 

   Inventories, net

 

19,523 

 

16,067 

 

 

35,590 

 

   Deferred income taxes

 

24,836 

 

 

 

24,836 

 

   Prepaid expenses and other current assets

 

8,472 

 

4,924 

 

(100)

 

13,296 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          Total current assets

 

326,747 

 

130,203 

 

(6,040)

 

450,910 

 

 

 

 

 

 

 

 

 

 

 

 

Net property, plant and equipment

 

120,729 

 

72,440 

 

(10,094)

 

183,075 

 

Loan issuance costs, net

 

11,937 

 

 

 

11,937 

 

Deferred income taxes

 

2,402 

 

5,511 

 

 

7,913 

 

Goodwill

 

39,779 

 

9,590 

 

 

49,369 

 

Other assets, net

 

29,117 

 

11,456 

 

(11,312)

 

29,261 

 

Intercompany investments and advances

50,814 

 

480,786 

 

30,931 

 

(562,531)

 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

 

$ 50,814 

 

$ 1,011,497 

 

$ 260,131 

 

$ (589,977)

 

$ 732,465 

 

 

_____ 

 

______ 

 

_____ 

 

______ 

 

______ 

 

Liabilities and Shareholders' Equity:

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

   Accounts payable

$           - 

 

$      31,203 

 

$   12,043 

 

$              - 

 

$    43,246 

 

   Accrued expenses and other

14 

 

113,672 

 

36,631 

 

 

150,317 

 

   Current installments of long-term debt

 

2,803 

 

 

 

2,803 

 

   Intercompany payables

 

3,729 

 

12,305 

 

(16,034)

 

 

   Income taxes payable

 

20,921 

 

 

(100)

 

20,821 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          Total current liabilities

14 

 

172,328 

 

60,979 

 

(16,134)

 

217,187 

 

 

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current installments

 

442,943 

 

 

 

442,943 

 

Intercompany payables, noncurrent

 

(28,444)

 

28,444 

 

 

 

Deferred income taxes

 

13,170 

 

 

 

13,170 

 

Other noncurrent liabilities

 

19,437 

 

239 

 

(11,312)

 

8,364 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          

14 

 

619,434 

 

89,662 

 

(27,446)

 

681,664 

 

Shareholders' equity

50,800 

 

392,063 

 

170,469 

 

(562,531)

 

50,801 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

          

$ 50,814 

 

$ 1,011,497 

 

$ 260,131 

 

$ (589,977)

 

$ 732,465 

 

 

_____ 

 

______ 

 

_____ 

 

_____ 

 

_____ 

 



 

 

 

Condensed Consolidated Parent Company,

Guarantor And Non-Guarantor Statement of Operations

For the three months ended September 30, 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

$           - 

 

$ 174,370 

 

$ 47,377 

 

$            - 

 

$ 221,747 

   Sales

 

65,319 

 

32,809 

 

(7,527)

 

90,601 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Total revenue

 

239,689 

 

80,186 

 

(7,527)

 

312,348 

 

 

 

 

 

 

 

 

 

 

Rental expenses

 

88,032 

 

48,128 

 

 

136,160 

Cost of goods sold

 

18,620 

 

6,990 

 

(3,046)

 

22,564 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Gross profit

 

133,037 

 

25,068 

 

(4,481)

 

153,624 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

 

 

 

 

 

 

   expenses

 

60,846 

 

14,034 

 

(1,611)

 

73,269 

Research and development expenses

 

6,282 

 

1,442 

 

 

7,724 

Litigation settlement expense

 

72,000 

 

 

 

72,000 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Operating earnings (loss)

 

(6,091)

 

9,592 

 

(2,870)

 

631 

 

 

 

 

 

 

 

 

 

 

Interest income and other

 

2,382 

 

38 

 

84 

 

2,504 

Interest expense

 

(5,616)

 

(289)

 

(84)

 

(5,989)

Foreign currency gain

 

 

218 

 

 

218 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings (loss) before income taxes

 

 

 

 

 

 

 

 

 

         (benefit) and equity (deficit) in

 

 

 

 

 

 

 

 

 

         earnings of subsidiaries

 

(9,325)

 

9,559 

 

(2,870)

 

(2,636)

 

 

 

 

 

 

 

 

 

 

Income taxes (benefit)

 

(3,089)

 

2,546 

 

(941)

 

(1,484)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings (loss) before equity (deficit)

 

 

 

 

 

 

 

 

 

         in earnings of subsidiaries

 

(6,236)

 

7,013 

 

(1,929)

 

(1,152)

      Equity (deficit) in earnings of subsidiaries

(1,152)

 

7,013 

 

 

(5,861)

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net earnings (loss)

$ (1,152)

 

$      777 

 

$   7,013 

 

$ (7,790)

 

$  (1,152)

 

_____ 

 

______ 

 

_____ 

 

_____ 

 

_____ 



 

Condensed Consolidated Parent Company,

Guarantor And Non-Guarantor Statement of Earnings

For the three months ended September 30, 2004

(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

$          - 

 

$ 148,062 

 

$  40,575 

 

$            - 

 

$ 188,637 

   Sales

 

51,429 

 

24,143 

 

(7,047)

 

68,525 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Total revenue

 

199,491 

 

64,718 

 

(7,047)

 

257,162 

 

 

 

 

 

 

 

 

 

 

Rental expenses

 

74,041 

 

38,381 

 

 

112,422 

Cost of goods sold

 

15,759 

 

5,948 

 

(2,891)

 

18,816 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Gross profit

 

109,691 

 

20,389 

 

(4,156)

 

125,924 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

 

52,555 

 

11,108 

 

(1,935)

 

61,728 

Research and development expenses

 

6,506 

 

1,038 

 

 

7,544 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Operating earnings

 

50,630 

 

8,243 

 

(2,221)

 

56,652 

 

 

 

 

 

 

 

 

 

 

Interest income

 

165 

 

49 

 

 

214 

Interest expense

 

(7,566)

 

(339)

 

339 

 

(7,566)

Foreign currency gain

 

 

1,964 

 

 

1,964 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings before income

 

 

 

 

 

 

 

 

 

         taxes and equity in

 

 

 

 

 

 

 

 

 

         earnings of subsidiaries

 

43,229 

 

9,917 

 

(1,882)

 

51,264 

 

 

 

 

 

 

 

 

 

 

Income taxes

 

16,770 

 

2,362 

 

(677)

 

18,455 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings before equity

 

 

 

 

 

 

 

 

 

         in earnings of subsidiaries

 

26,459 

 

7,555 

 

(1,205)

 

32,809 

Equity in earnings of subsidiaries

32,809 

 

7,555 

 

 

(40,364)

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net earnings

$ 32,809 

 

$   34,014 

 

$    7,555 

 

$ (41,569)

 

$   32,809 

 

_____ 

 

______ 

 

_____ 

 

_____ 

 

_____ 

 



 


Condensed Consolidated Parent Company,

Guarantor And Non-Guarantor Statement of Earnings

For the nine months ended September 30, 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

$           - 

 

$ 489,524 

 

$ 139,208 

 

$            - 

 

$  628,732 

   Sales

 

178,216 

 

101,631 

 

(22,048)

 

257,799 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Total revenue

 

667,740 

 

240,839 

 

(22,048)

 

886,531 

 

 

 

 

 

 

 

 

 

 

Rental expenses

 

253,131 

 

141,281 

 

 

394,412 

Cost of goods sold

 

51,097 

 

21,007 

 

(7,422)

 

64,682 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Gross profit

 

363,512 

 

78,551 

 

(14,626)

 

427,437 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

 

164,434 

 

41,684 

 

(4,624)

 

201,494 

Research and development expenses

 

17,115 

 

3,582 

 

 

20,697 

Litigation settlement expense

 

72,000 

 

 

 

72,000 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Operating earnings

 

109,963 

 

33,285 

 

(10,002)

 

133,246 

 

 

 

 

 

 

 

 

 

 

Interest income and other

 

3,257 

 

265 

 

 

3,522 

Interest expense

 

(18,503)

 

(395)

 

 

(18,898)

Foreign currency loss

 

 

(3,040)

 

 

(3,040)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings before income

 

 

 

 

 

 

 

 

 

         taxes and equity in

 

 

 

 

 

 

 

 

 

         earnings of subsidiaries

 

94,717 

 

30,115 

 

(10,002)

 

114,830 

 

 

 

 

 

 

 

 

 

 

Income taxes

 

36,863 

 

5,580 

 

(3,401)

 

39,042 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Earnings before equity

 

 

 

 

 

 

 

 

 

         in earnings of subsidiaries

 

57,854 

 

24,535 

 

(6,601)

 

75,788 

 

 

 

 

 

 

 

 

 

 

      Equity in earnings of subsidiaries

75,788 

 

24,535 

 

 

(100,323)

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

      Net earnings

$ 75,788 

 

$   82,389 

 

$  24,535 

 

$ (106,924)

 

$    75,788 

 

_____ 

 

______ 

 

_____ 

 

_____ 

 

_____ 


 

 

Condensed Consolidated Parent Company,

Guarantor And Non-Guarantor Statement of Earnings

For the nine months ended September 30, 2004

(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

$            -  

 

$ 415,706 

 

$  114,418 

 

$             - 

 

$ 530,124 

   Sales

 

146,014 

 

63,786 

 

(20,943)

 

188,857 

 

______ 

 

_______ 

 

______ 

 

_______ 

 

_______ 

      Total revenue

 

561,720 

 

178,204 

 

(20,943)

 

 718,981 

 

 

 

 

 

 

 

 

 

 

Rental expenses

 

214,520 

 

108,872 

 

 

323,392 

Cost of goods sold

 

44,795 

 

16,106 

 

(8,757)

 

52,144 

 

______ 

 

_______

 

______ 

 

_______ 

 

_______ 

      Gross profit

 

302,405 

 

53,226 

 

(12,186)

 

343,445 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

 

 

 

 

 

 

 

   expenses

 

142,736 

 

29,317 

 

(4,877)

 

167,176 

Research and development expenses

 

19,052 

 

2,799 

 

 

21,851 

Initial public offering expenses

19,584 

 

252 

 

 

 

19,836 

Secondary offering expenses

2,219 

 

 

 

 

2,219 

 

______ 

 

_______ 

 

______ 

 

_______ 

 

_______ 

      Operating earnings (loss)

(21,803)

 

140,365 

 

21,110 

 

(7,309)

 

132,363 

 

 

 

 

 

 

 

 

 

 

Interest income

 

609 

 

134 

 

 

743 

Interest expense

 

(37,460)

 

(1,047)

 

1,047 

 

(37,460)

Foreign currency gain

 

 

1,701 

 

 

1,701 

 

______ 

 

_______ 

 

______ 

 

_______ 

 

_______ 

      Earnings (loss) before income

 

 

 

 

 

 

 

 

 

         taxes (benefit) and equity in

 

 

 

 

 

 

 

 

 

         earnings of subsidiaries

(21,803)

 

103,514 

 

21,898 

 

(6,262)

 

97,347 

 

 

 

 

 

 

 

 

 

 

Income taxes (benefit)

(8,540)

 

40,562 

 

5,277 

 

(2,254)

 

35,045 

 

______ 

 

_______ 

 

______ 

 

_______ 

 

_______ 

      Earnings (loss) before equity

 

 

 

 

 

 

 

 

 

         in earnings of subsidiaries

(13,263)

 

62,952 

 

16,621 

 

(4,008)

 

   62,302 

Equity in earnings of subsidiaries

75,565 

 

16,621 

 

 

(92,186)

 

 

______ 

 

_______ 

 

______ 

 

_______ 

 

_______ 

      Net earnings

$   62,302 

 

$    79,573 

 

$   16,621 

 

$  (96,194)

 

$    62,302 

 

 

 

 

 

 

 

 

 

 

Series A convertible preferred stock dividends

(65,604)

 

 

 

 

(65,604)

 

______ 

 

_______ 

 

______ 

 

_______ 

 

_______ 

      Net earnings (loss) available to common

 

 

 

 

 

 

 

 

 

         shareholders

$   (3,302)

 

$    79,573 

 

$   16,621 

 

$  (96,194)

 

$    (3,302)

 

______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

 

 

 

 

 

 



 

 

Condensed Consolidating Parent Company,

Guarantor And Non-Guarantor Statement of Cash Flows

For the nine months ended September 30, 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

$  75,788 

 

$   82,389 

 

$ 24,535 

 

$ (106,924)

 

$   75,788 

   Adjustments to reconcile net earnings to net

 

 

 

 

 

 

 

 

 

      cash provided by operating activities

(54,615)

 

(509)

 

10,769 

 

99,188 

 

54,833 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Net cash provided by operating activities

21,173 

 

81,880 

 

35,304 

 

(7,736)

 

130,621 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

   Additions to property, plant and equipment

 

(39,103)

 

(15,613)

 

 

(54,716)

   Decrease in inventory to be converted into

 

 

 

 

 

 

 

 

 

      equipment for short-term rental

 

1,300 

 

 

 

1,300 

   Dispositions of property, plant and

 

 

 

 

 

 

 

 

 

      equipment

 

406 

 

397 

 

 

803 

   Decrease (increase) in other assets

 

 

5,333 

 

(5,738)

 

(405)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Net cash used by investing activities

 

(37,397)

 

(9,883)

 

(5,738)

 

(53,018)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

   Proceeds (repayments) of notes payable, long-

 

 

 

 

 

 

 

 

 

      term debt, capital lease and other obligations

 

(125,843)

 

133 

 

 

(125,710)

   Proceeds from exercise of stock options

6,264 

 

 

 

 

6,264 

   Proceeds from purchase of stock in ESPP

2,213 

 

 

 

 

2,213 

   Proceeds (payments) on intercompany

 

 

 

 

 

 

 

 

 

      investments and advances

(12,584)

 

14,577 

 

(1,396)

 

(597)

 

   Other

(17,066)

 

1,062 

 

(3,312)

 

19,316 

 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Net cash used by financing activities

(21,173)

 

(110,204)

 

(4,575)

 

18,719 

 

(117,233)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Effect of exchange rate changes on

 

 

 

 

 

 

 

 

 

   cash and cash equivalents

 

 

 

(5,245)

 

(5,245)

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Net increase (decrease) in cash and

 

 

 

 

 

 

 

 

 

   cash equivalents

 

(65,721)

 

20,846 

 

 

(44,875)

Cash and cash equivalents,

 

 

 

 

 

 

 

 

 

   beginning of period

 

84,903 

 

39,463 

 

 

124,366 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

 

_______ 

Cash and cash equivalents, end

 

 

 

 

 

 

 

 

 

   of period

$            - 

 

$  19,182 

 

$ 60,309 

 

$            - 

 

$   79,491 

 

_____ 

 

_____ 

 

_____ 

 

_____ 

 

_____ 


 

Condensed Consolidating Parent Company,

Guarantor And Non-Guarantor Statement of Cash Flows

For the nine months ended September 30, 2004

(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

$    62,302 

 

$   79,573 

 

$  16,621 

 

$ (96,194)

 

$  62,302 

   Adjustments to reconcile net earnings to net

 

 

 

 

 

 

 

 

 

      cash provided by operating activities

(33,065)

 

(27,840)

 

(2,261)

 

94,936 

 

31,770 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Net cash provided by operating activities

29,237 

 

51,733 

 

14,360 

 

(1,258)

 

94,072 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

   Additions to property, plant and equipment

 

(38,127)

 

(21,849)

 

(3,873)

 

(63,849)

   Increase in inventory to be converted into

 

 

 

 

 

 

 

 

 

      equipment for short-term rental

 

(2,200)

 

 

 

(2,200)

   Dispositions of property, plant and

 

 

 

 

 

 

 

 

 

      equipment

 

1,092 

 

379 

 

 

1,471 

   Decrease (increase) in other assets

 

(880)

 

6,748 

 

(6,510)

 

(642)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Net cash used by investing activities

 

(40,115)

 

(14,722)

 

(10,383)

 

(65,220)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

   Repayments of notes payable, long-term debt,

 

 

 

 

 

 

 

 

 

      capital lease and other obligations

 

(217,229)

 

(60)

 

 

(217,289)

   Proceeds from exercise of stock options

9,556 

 

 

 

 

9,556 

   Initial public offering of common stock:

 

 

 

 

 

 

 

 

 

      Proceeds from issuance of common stock

105,000 

 

 

 

 

105,000 

      Stock issuance costs

(10,604)

 

 

 

 

(10,604)

   Proceeds (payments) on intercompany

 

 

 

 

 

 

 

 

 

      investments and advances

(133,416)

 

101,050 

 

26,070 

 

6,296 

 

   Other

227 

 

(84)

 

(5,531)

 

5,388 

 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Net cash provided (used) by financing activities

(29,237)

 

(116,263)

 

20,479 

 

11,684 

 

(113,337)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Effect of exchange rate changes on

 

 

 

 

 

 

 

 

 

   cash and cash equivalents

 

 

 

(43)

 

(43)

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Net increase (decrease) in cash and

 

 

 

 

 

 

 

 

 

   cash equivalents

 

(104,645)

 

20,117 

 

 

(84,528)

Cash and cash equivalents,

 

 

 

 

 

 

 

 

 

   beginning of period

 

129,695 

 

26,369 

 

 

156,064 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

Cash and cash equivalents, end

 

 

 

 

 

 

 

 

 

   of period

$             - 

 

$   25,050 

 

$   46,486 

 

$            - 

 

$  71,536 

 

_______ 

 

_______ 

 

______ 

 

______ 

 

_______ 

 


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 “Risk Factors” below.


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 while helping to 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 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 revenue for the nine months ended September 30, 2005.


     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 nine months ended September 30, 2005, we directly bill our customers, such as hospitals and extended care facilities. In the U.S. home care 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 from the acute care setting.


     For the last several years, our growth has been driven primarily by increased revenue from V.A.C. system rentals and sales, which accounted for approximately 74% of total revenue for the nine months ended September 30, 2005, up from 70% for the same period in 2004.  Historically, we have experienced a seasonal slowing of V.A.C. revenue growth beginning in December and lasting through January, 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.


     We believe that the historical growth in our V.A.C. revenue has been due in part to the reimbursement code assigned to our V.A.C. systems and disposables by the
Centers for Medicare and Medicaid Services (“CMS”).  While in the past V.A.C. has been the only device assigned to the codes for negative pressure wound therapy, CMS recently advised us that a pump and dressing kits marketed by BlueSky Medical Group, Inc. have been assigned to the same negative pressure wound therapy codes under the Healthcare Common Procedure Coding System.  Also, the existing code for reimbursement of V.A.C. disposable canisters will be eliminated effective December 31, 2005, which will require us to bill Medicare Part B for V.A.C. canisters under an alternate existing code at a lower reimbursement rate.  As a result of these recent CMS decisions, we may experience increased competition from BlueSky products in future periods and the pricing we receive from other third-party payers may be negatively impacted, either of which could materially and adversely affect our business and operating results.



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


             -  Improving V.A.C. acceptance 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.  Recent advances
                include the use of V.A.C. in open abdominal wounds, dehisced sternal wounds and infected wounds,
                and for the instillation of wound treatment fluids.


             -  Strengthening our contractual relationships with third-party payers.


     We continue to focus our marketing and selling efforts on increasing physician awareness 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 goal of increasing physician awareness, we increased our total sales force by approximately 290 employees in the fiscal year of 2004 and 115 employees in the first nine months of 2005.


     Continuous enhancements in product portfolio and positioning are also important to our continued growth and market penetration. We continue to benefit from the V.A.C.ATS and the V.A.C. Freedom.  We believe these advanced systems have increased customer acceptance and the perceived value of V.A.C. therapy. We have also benefited from the introduction of dressing systems designed to improve ease-of-use and effectiveness in treating pressure ulcers and serious abdominal wounds.  At the same time, 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.


     Our other major product line, therapeutic surfaces, has continued to grow modestly internationally, while remaining stable in the U.S.   Therapeutic surfaces revenue was approximately $227.6 million in the first nine months of 2005, up from $218.7 million in the prior-year period.


Recent Developments


     
On October 26, 2005, KCI was notified by CMS that a pump and dressings marketed by BlueSky Medical Group Inc. have been assigned to the codes for negative pressure wound therapy, effective immediately, in connection with the 2006 Healthcare Common Procedure Coding System (“HCPCS”) decisions.  The negative pressure wound therapy codes are the same codes assigned to KCI’s V.A.C. system and disposables.  KCI was subsequently advised by CMS that sales by Bluesky may be reimbursed immediately under the codes.


      In connection with the HCPCS decisions, CMS published revised code descriptors for certain HCPCS codes.  The code descriptors for negative pressure wound therapy dressings have been changed in a way that may permit BlueSky dressings to be classified under those codes.  Also, the existing code for reimbursement of V.A.C. disposable canisters will be eliminated effective Decmeber 31, 2005 and KCI will be required to bill Medicare Part B for V.A.C. canisters under an alternate existing code at a lower reimbursement rate.



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 third quarter of 2005 to the third quarter of 2004 and the first nine months of 2005 to the first nine months of 2004:

 

 

 

 

                                                 Revenue Relationship                                                  

 

 

 

 

   Three months ended September 30,

        Nine months ended September 30,

 

 

 

% (1)     

 

 

 

% (1)     

 

    2005  

    2004  

 Change 

 

    2005  

    2004  

 Change 

Revenue:

 

 

 

 

 

 

 

   Rental

71 % 

73 % 

17.6 % 

 

71 % 

74 % 

18.6 % 

   Sales

29     

27     

32.2     

 

29     

26     

36.5     

 

___     

___     

 

 

___     

___     

 

      Total revenue

100 %

100 %

21.5 %

 

100 %

100 %

23.3 %

 

 

 

 

 

 

 

 

Rental expenses

44     

44     

21.1     

 

45     

45     

22.0     

Cost of goods sold

7     

7     

19.9     

 

7     

7     

24.0     

 

___     

___     

 

 

___     

___     

 

      Gross profit

49     

49     

22.0     

 

48     

48     

24.5     

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

24     

24     

18.7     

 

23     

23     

20.5     

Research and development expenses

2     

3     

2.4     

 

2     

3     

(5.3)    

Litigation settlement expense

23     

-     

-     

 

8     

-     

-     

Initial public offering expenses

-     

-     

-     

 

-     

3     

-     

Secondary offering expenses

-     

-     

-     

 

-     

-     

-     

 

___     

___     

 

 

___     

___     

 

      Operating earnings

-     

22     

(98.9)    

 

15     

19     

0.7     

 

 

 

 

 

 

 

 

Interest income and other

1      

-     

-     

 

-     

-     

374.0     

Interest expense

(2)    

(3)    

(20.8)    

 

(2)    

(5)    

(49.6)    

Foreign currency gain (loss)

-     

1     

(88.9)    

 

-     

-     

-     

 

___     

___     

 

 

___     

___     

 

      Earnings (loss) before income taxes (benefit)

(1)    

20     

(105.1)    

 

13     

14     

18.0     

 

 

 

 

 

 

 

 

Income taxes (benefit)

(1)    

7     

(108.0)    

 

4     

5     

11.4     

 

___     

___     

 

 

___     

___     

 

      Net earnings (loss)

- %

13 %

(103.5)%

 

9 %

9 %

21.6 %

 

___     

___     

 

 

___     

___     

 

 

 

 

 

 

 

 

 

(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 September 30,

           Nine months ended September 30,

 

 

 

%     

 

 

 

%     

 

     2005     

   2004     

Change 

 

    2005     

    2004     

Change 

Total Revenue:

 

 

 

 

 

 

 

  V.A.C.

 

 

 

 

 

 

 

     Rental

$ 162,814 

$ 129,885 

25.4 % 

 

$ 445,837 

$ 350,026 

27.4 % 

     Sales

77,715 

55,636 

39.7     

 

213,104 

150,286 

41.8     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

         Total V.A.C.

240,529 

185,521 

29.7     

 

658,941 

500,312 

31.7     

 

 

 

 

 

 

 

 

  Therapeutic surfaces/other

 

 

 

 

 

 

 

     Rental

58,933 

58,752 

0.3     

 

182,895 

180,098 

1.6     

     Sales

12,886 

12,889 

-     

 

44,695 

38,571 

15.9     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

         Total therapeutic surfaces/other

71,819 

71,641 

0.2     

 

227,590 

218,669 

4.1     

 

 

 

 

 

 

 

 

  Total rental revenue

221,747 

188,637 

17.6     

 

628,732 

530,124 

18.6     

  Total sales revenue

90,601 

68,525 

32.2     

 

257,799 

188,857 

36.5     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

       Total Revenue

$ 312,348 

$ 257,162 

21.5%  

 

$ 886,531 

$ 718,981 

23.3%  

 

_______ 

_______ 

 

 

_______ 

_______ 

 

USA Revenue:

 

 

 

 

 

 

 

  V.A.C.

 

 

 

 

 

 

 

     Rental

$ 137,252 

$ 111,328 

23.3%  

 

$ 376,162 

$ 302,682 

24.3%  

     Sales

50,791 

37,431 

35.7     

 

135,458 

103,715 

30.6     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

         Total V.A.C.

188,043 

148,759 

26.4     

 

511,620 

406,397 

25.9     

 

 

 

 

 

 

 

 

  Therapeutic surfaces/other

 

 

 

 

 

 

 

     Rental

37,438 

37,230 

0.6     

 

114,511 

114,437 

0.1     

     Sales

6,859 

7,056 

(2.8)    

 

20,314 

21,800 

(6.8)    

 

_______ 

_______ 

 

 

_______ 

_______ 

 

         Total therapeutic surfaces/other

44,297 

44,286 

-     

 

134,825 

136,237 

(1.0)    

 

 

 

 

 

 

 

 

  Total USA rental

174,690 

148,558 

17.6     

 

490,673 

417,119 

17.6     

  Total USA sales

57,650 

44,487 

29.6     

 

155,772 

125,515 

24.1     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

       Total - USA Revenue

$ 232,340 

$ 193,045 

20.4%  

 

$ 646,445 

$ 542,634 

19.1%  

 

_______ 

_______ 

 

 

_______ 

_______ 

 

International Revenue:

 

 

 

 

 

 

 

  V.A.C.

 

 

 

 

 

 

 

     Rental

$   25,562 

$   18,557 

37.7%  

 

$  69,675 

$   47,344 

47.2%  

     Sales

26,924 

18,205 

47.9     

 

77,646 

46,571 

66.7     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

         Total V.A.C.

52,486 

36,762 

42.8     

 

147,321 

93,915 

56.9     

 

 

 

 

 

 

 

 

  Therapeutic surfaces/other

 

 

 

 

 

 

 

     Rental

21,495 

21,522 

(0.1)    

 

68,384 

65,661 

4.1     

     Sales

6,027 

5,833 

3.3     

 

24,381 

16,771 

45.4     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

         Total therapeutic surfaces/other

27,522 

27,355 

0.6     

 

92,765 

82,432 

12.5     

 

 

 

 

 

 

 

 

  Total International rental

47,057 

40,079 

17.4     

 

138,059 

113,005 

22.2     

  Total International sales

32,951 

24,038 

37.1     

 

102,027 

63,342 

61.1     

 

_______ 

_______ 

 

 

_______ 

_______ 

 

       Total - International Revenue

$   80,008 

$   64,117 

24.8%  

 

$ 240,086 

$ 176,347 

36.1%  

 

_______ 

_______ 

 

 

_______ 

_______ 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

      Total Revenue.  Total revenue for the third quarter of 2005 was $312.3 million, an increase of $55.2 million, or 21.5%, from the prior-year period.  Total revenue for the first nine months of 2005 was $886.5 million, an increase of $167.6 million, or 23.3%, from the prior-year period.  The growth in total revenue over the prior period was due primarily to increased rental and sales volumes for V.A.C. wound healing devices and related disposables.  The growth in V.A.C. revenue was attributable to increased physician awareness of the benefits of V.A.C. therapy and increased product adoption across wound types.  Foreign currency exchange movements accounted for 0.6% and 1.5% of the increase in total revenue in the third quarter and first nine months of 2005, respectively, compared to the corresponding periods of the prior year.


     Domestic Revenue. 
Total domestic revenue was $232.3 million for the third quarter of 2005 and $646.4 million for the first nine months of 2005, representing increases of 20.4% and 19.1%, respectively, as compared to the prior-year periods.  Total domestic V.A.C. revenue was $188.0 million for the third quarter of 2005 and $511.6 million for the first nine months of 2005, representing increases of 26.4% and 25.9%, respectively, as compared to the prior-year periods.  Domestic V.A.C. rental revenue of $137.3 million for the third quarter of 2005 increased $25.9 million, or 23.3%, due to a 28.3% increase in average units on rent compared to the prior-year period.  For the first nine months of 2005, domestic V.A.C. rental revenue of $376.2 million increased $73.5 million, or 24.3%, due to a 28.5% increase in average units on rent as compared to the prior-year period. The unit increases were partially offset by a 3.8% and 2.9% decline in the average V.A.C. rental pricing during the third quarter and first nine months of 2005, respectively, partially attributable to moving non-contracted payers in the home care market to contracted pricing.  Entering into payer agreements with non-contracted payers has the effect of decreasing the price paid by such payers while improving the protocols and payment cycles of such payers.  Domestic V.A.C. sales revenue of $50.8 million in the third quarter of 2005 and $135.5 million in the first nine months of 2005 increased 35.7% and 30.6%, respectively, from the prior-year periods. This was due to higher sales volumes for V.A.C. disposables associated with V.A.C. system rentals and the shift away from all-inclusive pricing arrangements with managed care organizations.


      Historically, we have experienced a seasonal slowing of V.A.C. unit growth beginning in December and lasting through January, 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. We experienced a similar seasonal slowing of our growth of V.A.C. revenue beginning in December 2004 and lasting through January 2005.  Although we do not know if our historical experience will prove to be indicative of future periods, a similar slow-down is expected during the fourth quarter of 2005.


      Domestic therapeutic surfaces/other revenue of $44.3 million for the third quarter of 2005 was essentially flat compared to the prior-year period.  For the first nine months of 2005, domestic therapeutic surfaces/other revenue was $134.8 million, a decrease of 1.0% compared to the prior-year period.  For the third quarter of 2005, domestic therapeutic surfaces rental revenue of $37.3 million increased 0.6%, as compared to the prior-year period.  For the first nine months of 2005, domestic therapeutic surfaces rental revenue of $114.3 million was comparable to the prior-year period.  The average units on rent and the average daily rental price were stable to the comparable periods in the prior year.


     International Revenue.  Total international revenue was $80.0 million for the third quarter of 2005 and $240.1 million for the first nine months of 2005, representing increases of 24.8% and 36.1%, respectively, from the prior-year periods as a result of increased V.A.C. demand, a $7.7 million government-funded sale of V.A.C. and surface products in Canada during the first quarter of 2005 and favorable foreign currency exchange movements.  Favorable foreign currency exchange movements contributed 2.5% to the variance in the third quarter of 2005 and 6.1% to the variance in the first nine months of 2005.


      Total international V.A.C. revenue was $52.5 million in the third quarter of 2005 and $147.3 million in the first nine months of 2005, representing increases of 42.8% and 56.9%, respectively, from the prior-year periods.  Foreign currency exchange movements favorably impacted international V.A.C. revenue and accounted for 2.9% and 7.1% of the increase from the third quarter and first nine months of the prior year, respectively.  International V.A.C. rental revenue of $25.6 million for the third quarter of 2005 increased $7.0 million, or 37.7%, due to a 37.2% increase in average units on rent per month.  For the first nine months of 2005, international V.A.C. rental revenue of $69.7 million increased $22.3 million, or 47.2%, due to a 43.1% increase in average units on rent per month.  The average rental price for the third quarter and first nine months of 2005 was essentially flat as compared to the prior-year periods.  International V.A.C. sales revenue of $26.9 million in the third quarter of 2005 and $77.6 million in the first nine months of 2005 increased 47.9% and 66.7%, respectively, from the prior-year periods due primarily to overall increased sales of V.A.C. disposables associated with the increase in rental units.


      International therapeutic surfaces/other revenue was $27.5 million for the third quarter of 2005 and $92.8 million for the first nine months of 2005, representing increases of 0.6% and 12.5%, respectively, from the prior-year periods. During the first quarter of 2005, we completed a $5.1 million sale of therapeutic surfaces in Canada.   Foreign currency exchange movements favorably impacted international therapeutic surfaces/other revenue for the third quarter and first nine months of 2005, representing 1.9% and 5.0%, respectively, of the increases from the prior-year periods.  For the third quarter of 2005, the remaining variance from the prior year quarter was primarily due to a 5.6% decrease in the average rental price, partially offset by a 3.9% increase in the average number of therapeutic surface rental units on rent.  For the first nine months of 2005, the remaining increase was due to a 6.3% increase in the average number of units on rent, which was offset by a 5.7% decline in the average rental pricing.  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 rental revenue, were 61.4% in
the third quarter of 2005 as compared to 59.6% in the prior-year quarter and 62.7% in the first nine months of 2005 as compared to 61.0% in the prior-year period.  This increase was due primarily to an increase in our sales force headcount from approximately 1,350 at September 30, 2004 to 1,558 at September 30, 2005.  Additionally, we increased our investment in product marketing, which was partially offset by efficiencies recognized in our service model including lower costs per work order.


     Cost of Goods Sold.  Cost of goods sold were $22.6 million in
the third quarter of 2005 and $64.7 million in the first nine months of 2005, representing increases of 19.9% and 24.0% respectively, over the prior-year periods.  Sales margins in the third quarter of 2005 increased to 75.1% compared to 72.5% in the prior-year quarter.  In the first nine months of 2005, sales margins increased to 74.9% compared to 72.4% in the prior-year period.  The increased margins were due to favorable changes in our product mix, continued cost reductions resulting from our global supply contract for V.A.C. disposables, the shift away from all-inclusive pricing arrangements with managed care organizations and favorable profit margins on the Canadian sale in the first quarter of 2005.


     Gross Profit
.  Gross profit was $153.6 million in the third quarter of 2005 and $427.4 million in the first nine months of 2005, representing increases of 22.0% and 24.5%, respectively, over the prior-year periods.  Gross profit margin in the third quarter of 2005 was 49.2%, up from 49.0% in the prior-year quarter.  For the first nine months of 2005, gross profit margin was 48.2%, up from 47.8% in the prior-year period. Purchase discounts under an agreement with a primary supplier, efficiency improvements in our service model that included lower costs per work order, favorable changes in our product mix and strong margins on our Canadian sale in the first quarter of 2005 contributed to the margin expansion.


     Selling, General and Administrative Expenses.  Selling, general and administrative expenses represented 23.5% of total revenue in the third quarter of 2005 compared to 24.0% in the prior-year period.  In the first nine months of 2005, these expenses represented 22.7% of total revenue compared to 23.3% 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 finance and information systems costs.


     Research and Development Expenses.  Research and development expenses in
the third quarter of 2005 were $7.7 million and represented 2.5% of total revenue as compared to 2.9% in the prior-year quarter.  In the first nine months of 2005, these expenses were $20.7 million and represented 2.3% of total revenue as compared to 3.0% in the prior-year period.  Clinical spending was consistent as a percentage of revenue as compared to the prior-year periods.  For the nine months ended 2005, the decline in research and development spending was due primarily to the termination of one research and development project and the timing of spending on other ongoing research and development projects.  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.  We anticipate our rate of spending on research and development as a percent of revenue may increase in future periods.


     Litigation Settlement Expense.  On September 30, 2005, we reached an agreement to settle our litigation with Novamedix Limited, a subsidiary of Orthofix International NV.  Under the terms of the settlement, we paid Novamedix $75.0 million.  The settlement payment resulted in a charge of $72.0 million, net of recorded reserves of $3.0 million, in the third quarter of 2005.


     Public Equity Offering Expenses.  In
the first nine months of 2004, we paid bonuses of $19.3 million, including related payroll taxes, and incurred approximately $562,000 of professional fees and other miscellaneous expenses in connection with our IPO.  In addition, we incurred $2.2 million in professional fees and other miscellaneous expenses in connection with our secondary offering, which was completed in June 2004.


     Operating Earnings.
  Operating earnings for the third quarter of 2005 were approximately $630,000 as compared to $56.7 million in the prior-year period due to the Novamedix litigation settlement recorded in the third quarter of 2005. For the first nine months of 2005, operating earnings were $133.2 million compared to $132.4 million, and operating margins were 15.0% compared to 18.4% in the prior-year period.  Current year operating margins were unfavorably impacted by the litigation settlement of $72.0 million recorded in the third quarter of 2005.  Prior-year operating margins were unfavorably impacted by the expenses incurred in connection with our 2004 stock offerings of $22.1 million.


      Interest Expense.  Interest expense in the third quarter of 2005 was $6.0 million compared to $7.6 million in the prior-year period.  Interest expense in the third quarter of 2005 and 2004 includes write-offs of approximately $890,000 and $590,000, respectively, on debt retired.  The remaining variance of approximately $2.0 million in interest expense resulted from a decrease in our average outstanding debt balance from the prior-year period.  In the first nine months of 2005, interest expense was $18.9 million compared to $37.5 million in the prior-year period.  Interest expense in the first nine months of 2005 includes write-offs of $2.3 million of loan issuance costs associated with the $125.0 million debt prepayment on our senior credit facility in the first nine months of 2005.  Interest expense for the first nine months of 2004 included payment of bond call and purchase premiums of $7.7 million associated with the redemption of a portion of our outstanding 7 3/8% Senior Subordinated Notes due 2013 and the write-off of $5.1 million of loan issuance costs on debt retired during the period.  The remaining variance of approximately $8.1 million in interest expense resulted from a decrease in our average outstanding debt balance from the prior-year period.


     Net Earnings (Loss).  Net loss for the third quarter of 2005 was $1.2 million, compared to net earnings of $32.8 million in the prior-year quarter.  Net earnings for the first nine months of 2005 were $75.8 million, an increase of $13.5 million, or 21.6%, from the prior-year period.  Net earnings in 2005 were unfavorably impacted by the Novamedix litigation settlement of $47.4 million, net of taxes, recorded in the third quarter of 2005.  Net earnings in 2004 were unfavorably impacted by the expenses incurred in connection with our stock offerings and debt prepayments of $21.6 million, net of taxes.  The effective income tax rate for the first nine months of 2005 was 34.0% compared to 36.0% for the prior-year comparable periods. The income tax rate reduction was primarily attributable to a higher portion of taxable income being generated in lower tax jurisdictions, as well as favorable resolution of certain foreign tax audits.


     Net Earnings (Loss) per Share Available to Common Shareholders.   Diluted net loss per share available to common shareholders was $0.02 in
the third quarter of 2005, which was unfavorably impacted by the litigation settlement charge of $47.4 million or $0.65 per share, net of taxes, compared to the net earnings per share available to common shareholders of $0.46 in the prior-year quarter.For the first nine months of 2005, diluted net earnings per share available to common shareholders was $1.04, which was unfavorably impacted by the litigation settlement charge of $0.65 per share, compared to a net loss per diluted share of $0.05 in the prior-year period, which was unfavorably impacted by expenses and preferred stock dividends associated with our stock offerings and debt prepayments.


 

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 cash on hand, as well as anticipated 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 nine months of 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 nine months ended September 30, 2005 and 2004 (dollars in thousands):

 

 

       Nine months ended September 30,       

 

           2005           

 

           2004           

 

 

 

 

 

 

Net cash provided by operating activities

$  130,621 

(1)

 

$  94,072 

(2)

Net cash used by investing activities

(53,018)

 

 

(65,220)

 

Net cash used by financing activities

(117,233)

(3)

 

(113,337)

(4)

Effect of exchange rates changes on cash

 

 

 

 

 

   and cash equivalents

(5,245)

 

 

(43)

 

 

______ 

 

 

______ 

 

Net decrease in cash and cash equivalents

$   (44,875)

 

 

$  (84,528)

 

 

______ 

 

 

______ 

 

 

 

 

 

 

 

(1)  This amount for 2005 is reduced by the Novamedix litigation settlement charge of $72.0 million, which

       includes the impact on the net loss of $47.4 million and the related tax benefit of $24.6 million.

(2)  Net cash from operations for 2004 includes $21.6 million of after-tax expenses associated with our stock

       offerings and debt prepayments.  Working capital changes include a tax payment of $26.3 million primarily

       related to an anti-trust litigation settlement we reached in 2002.  In addition, the current income tax payable

       reflects tax benefits of $7.2 million associated with our stock offerings and debt prepayments, which we

       realized in the first six months of 2004.

(3)  This amount for 2005 includes debt prepayments totaling $125.0 million on our senior credit facility.

(4)  This amount for 2004 includes receipt of $94.4 million in proceeds from the IPO, net of expenses of $10.6

       million, prepayment of $110.0 million on our senior credit facility and purchase of $107.2 million of our 73/8%

       Senior Subordinated Notes due 2013.

 

     At September 30, 2005, cash and cash equivalents of $79.5 million were available for general corporate purposes.  At September 30, 2005, 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 September 30, 2005, we had current assets of $424.9 million, including $32.9 million in inventory, and current liabilities of $218.2 million resulting in a working capital surplus of approximately $206.7 million compared to a surplus of $233.7 million at December 31, 2004. The decrease in our working capital balance of $27.0 million was related primarily to the prepayment of $125.0 million in long-term debt and the $75.0 million Novamedix litigation settlement paid during 2005, partially offset by increased cash from operations during the first nine months of 2005.



     As of September 30, 2005, we had $269.3 million of receivables outstanding, net of reserves of $59.6 million for doubtful accounts.  Our receivables were outstanding for an average of 79 days at September 30, 2005, which was an improvement from 85 days at September 30, 2004 and December 31, 2004.  This is due primarily to strong cash collections in the first nine months of 2005.  If rental and sales volumes for V.A.C. systems and related disposables continue to increase, and a significant portion of such an increase is generated in the home care market, we could experience increasing accounts receivable due to the extended payment cycles associated with most third‑party payers. We have adopted a number of policies and procedures designed to reduce these extended payment cycles.


Capital Expenditures


     During the first nine months of 2005 and 2004, we made capital expenditures of $54.7 million and $63.8 million, respectively, primarily on expanding the rental fleet and information technology purchases.  As of September 30, 2005, we had commitments to purchase new product inventory of $21.7 million over the next twelve months.  Other than commitments for new product inventory, we had no material long-term purchase commitments as of the end of the period.


Debt Service


     As of September 30, 2005, scheduled principal payments under our senior credit facility for the years 2005, 2006 and 2007 were $568,000, $2.3 million and $2.3 million, respectively. To the extent that we have excess cash, we may use it to reduce our outstanding debt.  On July 22, 2005, we made an optional debt prepayment of $50.0 million on our senior credit facility and wrote off approximately $890,000 in capitalized loan issuance costs.


Senior Credit Facility. 
 Our senior credit facility consists of a term loan facility and a revolving credit facility.  The following table sets forth the amounts outstanding under the term loan and the revolving credit facility, maturity dates, the effective interest rates on such outstanding amounts, and amounts available for additional borrowing thereunder, as of September 30, 2005 (in thousands):

 

 

 

 

 

Amount Available

 

 

Effective    

Amounts   

 For Additional

 Senior Credit Facility  

  Maturity  

Interest Rate 

Outstanding

      Borrowing       

 

 

 

 

 

Revolving credit facility

August 2009

-            

$             -   

$ 88,065 (1)      

Term loan facility

August 2010

4.94%  (2)  

221,907   

-            

 

 

 

_______   

______            

   Total

 

 

$ 221,907   

$ 88,065            

 

 

 

_______  

_______           

 

 

 

 

 

(1)  At September 30, 2005, 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 September 30, 2005 was 5.78%.


73/8% Senior Subordinated Notes due 2013.   On August 11, 2003, we issued an aggregate of $205.0 million principal amount of our 73/8% Senior Subordinated Notes due 2013.  As of September 30, 2005, $97.8 million principal amount of the notes remained outstanding.  We may purchase additional amounts of the 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 September 30, 2005, the fair values of our swap agreements were positive in the aggregate and were recorded as an asset of $2.1 million.  As a result of interest rate protection agreements, we recorded a reduction in interest expense of approximately $850,000 in the first nine months of 2005 and recorded interest expense of approximately $3.2 million in the first nine months of 2004.



Long-Term Commitments


     During the first nine months of 2005, we paid down $125.0 million in long-term debt obligations under our senior credit facility.  The following table summarizes our long-term debt obligations as of September 30, 2005, for each of the periods indicated (dollars in thousands):

 

       Year     

Long-Term  

    Payment  

Debt        

        Due      

  Obligations  

  2005

$       568      

  2006

2,420      

  2007

2,270      

  2008

2,270      

  2009

2,270      

  Thereafter

310,105      


Critical Accounting Estimates


     For a description of our critical accounting estimates, please see our Annual Report on Form 10-K for the year ended December 31, 2004 under the heading "Part II. Item 7.  Management's Discussion and Analysis of Financial Condition and Results of Operations‑Critical Accounting Estimates."


New Accounting Pronouncement


     In December 2004, the Financial Accounting Standards Board (“FASB”) issued SFAS 123 Revised “Share-Based Payment” (“SFAS 123R”).  SFAS 123R eliminates the alternative to account for stock-based compensation using the intrinsic value method under APB 25 and requires that such transactions be recognized as compensation expense in the statement of operations based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the award.  KCI will adopt SFAS 123R on January 1, 2006 using a modified prospective application.  As such, the compensation expense recognition provisions will 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, KCI will recognize compensation expense over the remaining vesting period.


     KCI has begun, but has not yet completed, evaluating the impact of adopting SFAS 123R on its results of operations.  KCI currently determines the fair value of stock-based compensation using a Black-Scholes option-pricing model.  In connection with evaluating the impact of adopting SFAS 123R, KCI determined we will continue to use the Black-Scholes option-pricing model, as we do not believe that we have enough historical data to support an alternative model.  KCI believes the adoption of SFAS 123R will result in additional compensation expense of approximately $7
$9 million, after taxes, for 2006.


     SFAS 123R also requires that realized tax benefits in excess of tax benefits on recognized compensation costs be reported as financing cash flows, rather than as operating cash flows as required under current literature.  While we cannot estimate what those amounts will be in the future, the tax benefit amounts recognized as operating cash flows in the first nine months of 2005 and 2004 were $20.0 million and $42.4 million, respectively, the majority of which would have been required to be reported as financing cash flows under the new accounting pronouncement.


 

Table of Contents

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.  BlueSky has received U.S. Food and Drug Administration (“FDA”) clearance of its pump and one of its dressings, which have recently been 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.   Also, BlueSky had previously announced that a large midwest managed care organization has implemented a coverage policy for its product.  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 these competitors or others are able to legally develop and market their products or obtain Medicare coverage or other third party reimbursement for competing products, our position in the wound care market could substantially erode or our pricing of V.A.C. systems could decline significantly, either of which could materially and adversely affect our operating results.


     In the U.S., our therapeutic surfaces business primarily competes with the Hill Rom Company and in Europe with Huntleigh Healthcare and Pegasus Limited. We also face the risk that innovation by our competitors in our markets may render our products less desirable or obsolete or that our competitors may effectively limit our market access through sole source contracts with GPOs, large health care providers or third-party payers, 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 place considerable importance on obtaining and maintaining patent protection for our products, particularly, our license rights under the Wake Forest patents that we rely on 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.  We may be unable to obtain an injunction against BlueSky, and we may not prevail in this litigation. If we are unable to do so, BlueSky and others may, among other things, gain access to our V.A.C. markets, which could erode our market position or cause the pricing of V.A.C. systems to decline, either of which would materially and adversely affect our operating results.



     In 1998, Mondomed N.V. and Paul Hartmann A.G. filed an opposition in the European Patent Office to a Wake Forest European V.A.C. patent licensed to KCI.  In 2004, the European Patent Office issued an interlocutory decision upholding the patent.  The decision corrected the patent to expand the range of pressures covered by the patent claims from 0.10 - 0.99 atmospheres to 0.01 - 0.99 atmospheres and modified the patent claims to provide that the "screen means" is open-cell polymer foam.  Wake Forest and Paul Hartmann A.G. have appealed the decision.  Mondomed N.V. has entered into a settlement with us and has withdrawn from the opposition.  We presently believe it will take two or more years to complete the appeal process.  During the pendency of an appeal, the original patents remain in place.  If Wake Forest is not successful in its appeal, the patent claims could be narrowed or the patent could be invalidated, either of which may have a material adverse effect on our business.  We do not believe that any decision in this case will affect U.S. patents.


     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 of 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 price we may charge or the demand for our products may decrease.


     
In this regard, CMS from time to time publishes reimbursement policies and rates that may favorably or unfavorably affect the reimbursement price and market for our products.  For example, in the past our V.A.C. therapy unit has been the only device assigned to the CMS reimbursement codes for negative pressure wound therapy.  However, CMS recently advised us that a pump and dressing kits marketed by BlueSky have been assigned to the same negative pressure wound therapy codes under the Healthcare Common Procedure Coding System.  Also,the existing code for reimbursement of V.A.C. disposable canisters will be eliminated effective December 31, 2005, which will require us to bill Medicare Part B for V.A.C. canisters under an alternate existing code at a lower reimbursement rate.  As a result of these recent CMS decisions, we may experience increased competition from BlueSky products in future periods and the pricing we receive from other third-party payers may be negatively impacted, either of which could materially and adversely affect our business and operating results.


     The reimbursement of our products is also subject to review by the medical directors of the four Durable Medical Equipment Regional Carriers, or DMERCs.  Recently, the medical directors indicated that policy interpretation will be handled separately by each of the four regional DMERCs.   As a result, our products in the past at times have not been and in the future may not be reimbursed uniformly by each of the four regional DMERCs, which could adversely affect our business and operations in a particular region or, in the event of an adverse determination by all of the DMERCs, in all regions.


     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.  If our V.A.C. system were subject to a competitive bidding process, the price at which we are reimbursed would likely decrease substantially, which would have a material adverse effect on our business and operating results.  In any event, a negative assessment with respect to the efficacy of the V.A.C., or one that is perceived to be negative, could aversely affect the reimbursement of or demand for the V.A.C.



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. 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 has been favorably affected by our historical rates of growth in revenue and earnings per share. We do not expect that these growth rates are sustainable.  If we are unable to realize continued growth rates consistent with our expectations or those of the analysts covering us, we would expect to realize an immediate and substantial decline in the trading price of our stock. Historically, V.A.C. revenue growth has been somewhat seasonal with a slowdown in V.A.C. rentals beginning in December and lasting through January, which we believe is caused by year-end clinical treatment patterns.  Although we do not know if our historical experience will prove to be indicative of future periods, a similar slow-down may begin during the fourth quarter of 2005.  In any event, 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, KCI has 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 maintaining and increasing 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 a clinical trial conducted by us or others fails to demonstrate statistically significant results supporting the efficacy of V.A.C. therapy, physicians may elect not to use V.A.C. therapy as a treatment for the type of wound in question, or generally.  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 are involved in a number of legal proceedings that are costly to defend and, if adversely determined, could materially and adversely affect our operating results.


     We presently are involved with a number of legal proceedings relating to our products and the intellectual property rights of ourselves and others.  For example, in 2003, we filed a lawsuit against BlueSky Medical Group, Inc. Medela, Inc., Medela AG, and Patient Care Systems, Inc. alleging 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.  We may be unable to obtain an injunction against BlueSky, and we may not prevail in this litigation.  If we are unable to do so, BlueSky and others may, among other things, gain access to our V.A.C. markets, which could erode our market position or cause the pricing of V.A.C. systems to decline, either of which would materially and adversely affect our operating results.


     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 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 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 recently conducted by Michigan Blue Cross.  We reviewed a preliminary report of their findings and filed a response in December 2004.  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, sole-source 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.  V.A.C. disposables represented approximately 22% of our total revenue for the nine months ended September 30, 2005, and V.A.C. rental and sales represented approximately 74% of our total revenue for the same period.  Accordingly, a material or continued shortage of V.A.C. disposables would inevitably cause our revenue to decline and may also reduce our market position.


     We have a long-term supply agreement with Avail through October 2007, with automatic extensions for additional twelve month periods.  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.



     We understand that Avail relies exclusively on Foamex International, Inc. ("Foamex") for the supply of foam used in the V.A.C. disposable dressings.  Foamex recently filed for Chapter 11 bankruptcy reorganization.  While in bankruptcy, Foamex could breach or terminate its contract 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 would jeopardize Avail’s supply of foam and hence our supply of 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 materially adverse effect on our entire V.A.C. business.


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 MMA eliminated annual payment increases on the V.A.C. system for the foreseeable future and initiated a competitive bidding program. At this time, we are unable to determine whether and to what extent these changes would be applied to our products and our business but this or similar legislative efforts in the future 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.


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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.


     Our senior credit facility requires that we fix the base-borrowing rate applicable to at least 50% of the outstanding amount of our term loan under our senior credit facility for a period of two years from the date of issuance. As of September 30, 2005, we have three interest rate swap agreements pursuant to which we have fixed the rates on $150.0 million, or 67.6%, 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 September 30, 2005.  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 September 30, 2005                 

 

 

 

     2005    

    2006   

    2007  

    2008  

    2009  

Thereafter

    Total    

Fair Value 

Long‑term debt

 

 

 

 

 

 

 

 

   Fixed rate

$             -

$        150

$           -

$           -

$           -

$   97,846

$   97,996

$ 101,421

   Average interest rate

-

7.000 %

-

-

-

7.375 %

7.374 %

 

   Variable rate

$        568

$     2,270

$   2,270

$   2,270

$   2,270

$ 212,259

$ 221,907

$ 221,907

   Average interest rate

5.780 %

5.780 %

5.780 %

5.780 %

5.780 %

5.780 %

5.780 %

 

Interest rate swaps (1)

 

 

 

 

 

 

 

 

   Variable to fixed

$             -

$ 150,000

$           -

$           -

$           -

$             -

$ 150,000

$   (2,108)

   Average pay rate

-

2.774 %

-

-

-

-

2.774 %

 

   Average receive rate

-

4.020 %

-

-

-

-

4.020 %

 

 

 

 

 

 

 

 

 

 

      (1)  Interest rate swaps are included in the variable rate debt under long-term debt. As of September 30, 2005, the fair value

             of our swap agreements were positive in the aggregate and recorded as an asset.


Foreign Currency and Market Risk


     We have direct foreign operations in Western Europe, Canada, Australia, Japan 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.


     We maintain no other derivative instruments to mitigate our exposure to currency translation and/or transaction risk. International operations reported operating profit of $36.6 million for the nine months ended September 30, 2005. We estimate that a 10% fluctuation in the value of the dollar relative to these foreign currencies at September 30, 2005 would change our net income for the nine months ended September 30, 2005 by approximately $2.4 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


Evaluation of Disclosure Controls and Procedures


     Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our 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, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of such period, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported on a timely basis, and 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 Control


     There have not been any changes in our 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 fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our 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 and Patient Care Systems, Inc. in the United States District Court for the Western District of Texas, San Antonio Division.  We have alleged infringement of three V.A.C. patents, two of which are owned by Wake Forest, arising from the manufacturing and marketing of a pump and dressing kits by BlueSky.  We have also asserted causes of action for breach of contract, tortious interference, unfair competition and conspiracy.  We are seeking damages and injunctive relief in the case.  BlueSky and Medela have asserted counterclaims against us for declarations of non-infringement and patent invalidity and violations of federal anti-trust laws.  A trial date has been set for May 31, 2006.


     On June 28, 2005, the Court issued a ruling on a Markman hearing, construing certain terms of U.S. Patent No. 5,636,643 (the “643 patent”) and ruling that other terms were definite and did not require construction by the Court.  A Markman hearing on construction of claims in U.S. Patent number 5,645,081 (the “081” patent”) and additional claims in the 643 patent is scheduled for November 14, 2005.  On September 7, 2005, we entered into a settlement with Patient Care Systems (“PCS”), pursuant to which the Court has 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.  On November 2, 2005, the Court denied defendants’ motions for summary judgment to dismiss our claims of tortious interference, unfair competition and conspiracy, but dismissed our breach of contract claim against Medela.  Medela remains a defendant in the lawsuit for our claims of conspiracy, patent infringement and other claims.  Although it is not possible to reliably predict the outcome of this litigation, we believe our claims are meritorious.  However, we may be unable to obtain an injunction against BlueSky, and we may not prevail in this litigation.  If we do not obtain an injunction or otherwise prevail, our share of the advanced wound-care market could be significantly reduced due to increased competition, and pricing of V.A.C. systems could decline significantly, either of which would materially and adversely affect our operating results.


     In 1998, Mondomed N.V. and Paul Hartmann A.G. filed an opposition in the European Patent Office to a Wake Forest European V.A.C. patent licensed to KCI.  In 2004, the European Patent Office issued an interlocutory decision upholding the patent.  The decision corrected the patent to expand the range of pressures covered by the patent claims from 0.10 - 0.99 atmospheres to 0.01 - 0.99 atmospheres and modified the patent claims to provide that the "screen means" is open-cell polymer foam.  Wake Forest and Paul Hartmann A.G. have appealed the decision.  Mondomed N.V. has entered into a settlement with us and has withdrawn from the opposition.  We presently believe it will take two or more years to complete the appeal process.  During the pendency of an appeal, the original patents remain in place.  If Wake Forest is not successful in its appeal, the patent claims could be narrowed or the patent could be invalidated, either of which may have a material adverse effect on our business.  We do not believe that any decision in this case will affect U.S. patents.


     On September 30, 2005, KCI and its affiliates reached an agreement to settle its litigation with Novamedix Limited, a subsidiary of Orthofix International NV.  The case was originally filed by Novamedix in 1992 and relates to KCI’s PlexiPulse line of foot pump products used for the prevention of deep-vein thrombosis.  Under the terms of the settlement, KCI paid Novamedix $75 million and agreed to assign or license certain KCI foot pump patent rights to Novamedix.  KCI will also retain rights under the patents.  The settlement resolves and settles all claims between the parties in the case.


     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. While provisions have been made in our financial statements for estimated exposures related to these claims and other ordinary course lawsuits where management deemed necessary, these provisions may prove to be inadequate. We have not experienced any significant losses due to product liability claims in the past and we believe that our liability insurance coverage is adequate.


 

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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    

Letter, dated September 14, 2005, from KCI to Mark B. Carbeau outlining the terms of his employment.

10.2    

Letter, dated September 19, 2005 from KCI to Christopher M. Cashman outlining the terms of his employment.

31.1    

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

 

   dated November 4, 2005.

31.2    

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

 

   dated November 4, 2005.

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 November 4, 2005.

 

                                   

 

 

 

(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.



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SIGNATURES

      

       Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 




                                                                                                KINETIC CONCEPTS, INC.
                                                                                                (REGISTRANT)

 

Date:      November 4, 2005                                                   By:      /s/  DENNERT O. WARE
                                                                                                Dennert O. Ware
                                                                                                President and Chief Executive Officer
                                                                                                (Duly Authorized Officer)

 

 

Date:      November 4, 2005                                                   By:      /s/  MARTIN J. LANDON
                                                                                                Martin J. Landon
                                                                                                Vice President and Chief Financial Officer
                                                                                                (Principal Financial and Accounting Officer)



 

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    

Letter, dated September 14, 2005, from KCI to Mark B. Carbeau outlining the terms of his employment.

10.2    

Letter, dated September 19, 2005 from KCI to Christopher M. Cashman outlining the terms of his employment.

31.1    

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

 

   dated November 4, 2005.

31.2    

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

 

   dated November 4, 2005.

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 November 4, 2005.

 

                                   

 

 

 

(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.