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 June 30, 2005 |
| | |
Commission file number 001-09913 |
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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 the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.
Common Stock: 69,637,157 shares as of August 1, 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 expenditures, revenues, earnings, or other financial items;
- - future demand for V.A.C. systems or other products;
- - the expected timing and outcome of pending litigation;
- - 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;
- - our expectations for third-party reimbursement;
- - future economic conditions or performance;
- - expectations for clinical trials;
- - attracting and retaining customers;
- - competition in our market;
- - productivity of our sales force;
- - 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 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) | |
| | | | |
| | June 30, | | December 31, |
| | 2005 | | 2004 |
| | (unaudited) | | |
| Assets: | | | |
| Current assets: | | | |
| Cash and cash equivalents | $ 150,172 | | $ 124,366 |
| Accounts receivable, net | 256,641 | | 252,822 |
| Inventories, net | 34,281 | | 35,590 |
| Deferred income taxes | 25,153 | | 24,836 |
| Prepaid expenses and other current assets | 18,319 | | 13,296 |
| | _______ | | _______ |
| Total current assets | 484,566 | | 450,910 |
| | | | |
| | | | |
| Net property, plant and equipment | 171,359 | | 183,075 |
| Loan issuance costs, less accumulated amortization of | | | |
| $10,518 in 2005 and $8,317 in 2004 | 9,736 | | 11,937 |
| Deferred income taxes | 9,962 | | 7,913 |
| Goodwill | 49,369 | | 49,369 |
| Other assets, less accumulated amortization of $8,979 in 2005 | | | |
| and $8,748 in 2004 | 29,445 | | 29,261 |
| | _______ | | _______ |
| | $ 754,437 | | $ 732,465 |
| | _______ | | _______ |
| Liabilities and Shareholders' Equity: | | | |
| Current liabilities: | | | |
| Accounts payable | $ 39,128 | | $ 43,246 |
| Accrued expenses and other | 145,631 | | 150,317 |
| Current installments of long-term debt | 2,925 | | 2,803 |
| Income taxes payable | 41,255 | | 20,821 |
| | _______ | | _______ |
| Total current liabilities | 228,939 | | 217,187 |
| | | | |
| Long-term debt, net of current installments | 366,978 | | 442,943 |
| Deferred income taxes | 11,237 | | 13,170 |
| Other noncurrent liabilities | 7,939 | | 8,364 |
| | _______ | | _______ |
| | 615,093 | | 681,664 |
| Shareholders' equity: | | | |
| Common stock; authorized 225,000 at June 30, 2005 and | | | |
| December 31, 2004; issued and outstanding 69,633 at June 30, 2005 | | | |
| and 68,694 at December 31, 2004 | 70 | | 69 |
| Preferred stock; authorized 50,000 at June 30, 2005 and December 31, 2004; | | | |
| issued and outstanding 0 at June 30, 2005 and December 31, 2004 | - | | - |
| Additional paid-in capital | 546,903 | | 517,354 |
| Deferred compensation | (6,542) | | (1,906) |
| Retained deficit | (411,131) | | (488,071) |
| Accumulated other comprehensive income | 10,044 | | 23,355 |
| | _______ | | _______ |
| Shareholders' equity | 139,344 | | 50,801 |
| | _______ | | _______ |
| | $ 754,437 | | $ 732,465 |
| | _______ | | _______ |
| | | | |
| See accompanying notes to condensed consolidated financial statements. |
Table of Contents
KINETIC CONCEPTS, INC. AND SUBSIDIARIES |
Condensed Consolidated Statements of Earnings |
(in thousands, except per share data) |
(unaudited) |
| | | | | | | |
| Three months ended | | Six months ended |
| June 30, | | June 30, |
| 2005 | | 2004 | | 2005 | | 2004 |
Revenue: | | | | | | | |
Rental | $ 211,049 | | $ 175,579 | | $ 406,985 | | $ 341,487 |
Sales | 83,162 | | 61,406 | | 167,198 | | 120,332 |
| _______ | | _______ | | _______ | | _______ |
Total revenue | 294,211 | | 236,985 | | 574,183 | | 461,819 |
| _______ | | _______ | | _______ | | _______ |
| | | | | | | |
Rental expenses | 131,141 | | 107,231 | | 258,252 | | 210,970 |
Cost of goods sold | 21,337 | | 16,560 | | 42,118 | | 33,328 |
| _______ | | _______ | | _______ | | _______ |
Gross profit | 141,733 | | 113,194 | | 273,813 | | 217,521 |
| | | | | | | |
Selling, general and administrative expenses | 68,069 | | 55,239 | | 128,225 | | 105,448 |
Research and development expenses | 6,763 | | 7,188 | | 12,973 | | 14,307 |
Initial public offering expenses | - | | 302 | | - | | 19,836 |
Secondary offering expenses | - | | 2,219 | | - | | 2,219 |
| _______ | | _______ | | _______ | | _______ |
Operating earnings | 66,901 | | 48,246 | | 132,615 | | 75,711 |
| | | | | | | |
Interest income | 498 | | 158 | | 1,018 | | 529 |
Interest expense | (5,449) | | (11,050) | | (12,909) | | (29,894) |
Foreign currency gain (loss) | (1,240) | | 201 | | (3,258) | | (263) |
| _______ | | _______ | | _______ | | _______ |
Earnings before income taxes | 60,710 | | 37,555 | | 117,466 | | 46,083 |
| | | | | | | |
Income taxes | 20,945 | | 13,520 | | 40,526 | | 16,590 |
| _______ | | _______ | | _______ | | _______ |
Net earnings | $ 39,765 | | $ 24,035 | | $ 76,940 | | $ 29,493 |
| | | | | | | |
Series A convertible preferred stock dividends | - | | - | | - | | (65,604) |
| _______ | | _______ | | _______ | | _______ |
Net earnings (loss) available to common shareholders | $ 39,765 | | $ 24,035 | | $ 76,940 | | $ (36,111) |
| _______ | | _______ | | _______ | | _______ |
Net earnings (loss) per share available to common shareholders: | | | | | | | |
Basic | $ 0.57 | | $ 0.37 | | $ 1.11 | | $ (0.63) |
| _______ | | _______ | | _______ | | _______ |
Diluted | $ 0.54 | | $ 0.34 | | $ 1.05 | | $ (0.63) |
| _______ | | _______ | | _______ | | _______ |
Weighted average shares outstanding: | | �� | | | | | |
Basic | 69,271 | | 65,087 | | 69,048 | | 57,709 |
| _______ | | _______ | | _______ | | _______ |
Diluted | 73,026 | | 71,303 | | 72,958 | | 57,709 |
| _______ | | _______ | | _______ | | _______ |
| | | | | | | |
| | | | | | | |
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) |
| Six months ended June 30, |
| 2005 | | 2004 |
Cash flows from operating activities: | | | |
Net earnings | $ 76,940 | | $ 29,493 |
Adjustments to reconcile net earnings to net cash provided | | | |
by operating activities: | | | |
Depreciation and amortization | 33,782 | | 27,763 |
Provision for uncollectible accounts receivable | 8,537 | | 6,053 |
Amortization of deferred gain on sale of headquarters facility | (535) | | (535) |
Write-off of deferred loan issuance costs | 1,421 | | 4,534 |
Non-cash amortization of stock awards | 611 | | 114 |
Tax benefit related to exercise of stock options | 16,956 | | 30,177 |
Change in assets and liabilities: | | | |
Increase in accounts receivable, net | (11,949) | | (20,741) |
Decrease in inventories, net | 1,398 | | 1,406 |
Increase in current deferred income taxes, net | (317) | | (1,346) |
Increase in prepaid expenses and other current assets | (4,670) | | (4,765) |
Decrease in accounts payable | (4,081) | | (800) |
Increase (decrease) in accrued expenses and other | (4,401) | | 15,945 |
Increase (decrease) in income taxes payable | 20,434 | | (39,403) |
Increase (decrease) in deferred income taxes, net | (4,106) | | 1,580 |
| _______ | | _______ |
Net cash provided by operating activities | 130,020 | | 49,475 |
| _______ | | _______ |
Cash flows from investing activities: | | | |
Additions to property, plant and equipment | (29,961) | | (42,376) |
Increase in inventory to be converted into equipment | | | |
for short-term rental | (2,200) | | (4,800) |
Dispositions of property, plant and equipment | 759 | | 1,293 |
Increase in other assets | (447) | | (264) |
Net cash used by investing activities | (31,849) | | (46,147) |
| _______ | | _______ |
Cash flows from financing activities: | | | |
Repayment of notes payable, long-term debt, capital lease | | | |
and other obligations | (75,814) | | (186,177) |
Proceeds from exercise of stock options | 5,209 | | 8,214 |
Proceeds from purchase of stock in ESPP | 2,131 | | - |
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 | (68,474) | | (83,567) |
| _______ | | _______ |
Effect of exchange rate changes on cash and cash equivalents | (3,891) | | (332) |
| _______ | | _______ |
Net increase (decrease) in cash and cash equivalents | 25,806 | | (80,571) |
| | | |
Cash and cash equivalents, beginning of period | 124,366 | | 156,064 |
| _______ | | _______ |
Cash and cash equivalents, end of period | $ 150,172 | | $ 75,493 |
| _______ | | _______ |
Cash paid during the six months for: | | | |
Interest (1) | $ 10,580 | | $ 25,431 |
Income taxes | $ 4,910 | | $ 28,283 |
Non-cash activity: | | | |
Non-cash consideration for exercise of stock options | $ 7 | | $ 6,354 |
| | | |
(1) The amount reflected for 2004 includes purchase premiums of $7.7 million related to the prepayments of 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 Report on Form 10-Q for the fiscal quarter ended March 31, 2005. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information necessary for a fair presentation of results of operations, financial position and cash flows in conformity with U.S. generally accepted accounting principles. Operating results from interim periods are not necessarily indicative of results that may be expected for the fiscal year as a whole. The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring accruals, considered necessary for a fair presentation of our results for the 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 earnings (loss) per share information):
| Three months ended | | Six months ended |
| June 30, | | June 30, |
| 2005 | | 2004 | | 2005 | | 2004 |
| | | | | | | |
Net earnings (loss) available to common shareholders | | | | | | | |
as reported | $ 39,765 | | $ 24,035 | | $ 76,940 | | $ (36,111) |
| _____ | | _____ | | _____ | | _____ |
Pro forma net earnings (loss) available to common shareholders: | | | | | | | |
Net earnings (loss) available to common | | | | | | | |
shareholders as reported | $ 39,765 | | $ 24,035 | | $ 76,940 | | $ (36,111) |
Compensation expense under intrinsic method | 352 | | 46 | | 400 | | 73 |
Compensation expense under fair value method | (1,706) | | (887) | | (2,715) | | (1,310) |
| _____ | | _____ | | _____ | | _____ |
Pro forma net earnings (loss) available to common shareholders | $ 38,411 | | $ 23,194 | | $ 74,625 | | $ (37,348) |
| _____ | | _____ | | _____ | | _____ |
Net earnings (loss) per share available to common shareholders as reported: | | | | | | | |
Basic | $ 0.57 | | $ 0.37 | | $ 1.11 | | $ (0.63) |
Diluted | $ 0.54 | | $ 0.34 | | $ 1.05 | | $ (0.63) |
| | | | | | | |
Pro forma net earnings (loss) per share available to common shareholders: | | | | | | | |
Basic | $ 0.55 | | $ 0.36 | | $ 1.08 | | $ (0.65) |
Diluted | $ 0.53 | | $ 0.33 | | $ 1.02 | | $ (0.65) |
| | | | | | | |
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 APB 25 and requires that such transactions be recognized as compensation expense in the statement of earnings based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the stock 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.
KCIhas 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 is also evaluating the use of different valuation models to determine the fair value of stock-based compensation, although no model selection has been made to date. KCI believes the adoption of SFAS 123R will have a significant impact on future results of operations, regardless of the valuation technique used. If we were to continue to use a Black-Scholes option pricing model consistent with our current practice, the adoption of SFAS 123R on January 1, 2006 would result in additional compensation expense of approximately $6– $8 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 the Company cannot estimate what those amounts will be in the future (because they depend on, among other things, when employees exercise stock options) the amount of tax benefits recognized as operating cash flows in the first six-months of 2005 and 2004 was $17.0 million and $30.2 million, respectively, the majority of which would have been required to be reported as financing cash flows under the new accounting pronouncement.
During the six-month period ended June 30, 2005, we issued approximately 831,000 shares of common stock under our stock-based compensation plans resulting primarily from option exercises. During the six-month period ended June 30, 2005, we granted options to purchase approximately 521,000 shares of common stock and issued approximately 91,000 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):
| June 30, | | December 31, |
| 2005 | | 2004 |
Trade accounts receivable: | | | |
Facilities/dealers | $ 160,300 | | $ 155,467 |
| | | |
Third-party payers: | | | |
Medicare / Medicaid | 58,224 | | 46,120 |
Managed care, insurance and other | 100,922 | | 102,496 |
| _______ | | _______ |
| 319,446 | | 304,083 |
| | | |
Employee and other receivables | 1,593 | | 1,735 |
| _______ | | _______ |
| 321,039 | | 305,818 |
| | | |
Less: Allowance for doubtful accounts | (64,398) | | (52,996) |
| _______ | | _______ |
| $ 256,641 | | $ 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):
| June 30, | | December 31, |
| 2005 | | 2004 |
| | | |
Finished goods | $ 6,518 | | $ 8,884 |
Work in process | 2,636 | | 2,057 |
Raw materials, supplies and parts | 44,407 | | 40,418 |
| ______ | | ______ |
| 53,561 | | 51,359 |
| | | |
Less: Amounts expected to be converted | | | |
into equipment for short-term rental | (11,300) | | (9,100) |
Reserve for excess and obsolete | | | |
inventory | (7,980) | | (6,669) |
| ______ | | ______ |
| $ 34,281 | | $ 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 | | Six months ended |
| June 30, | | June 30, |
| 2005 | | 2004 | | 2005 | | 2004 |
Net earnings | $ 39,765 | | $ 24,035 | | $ 76,940 | | $ 29,493 |
Series A convertible preferred stock dividends | - | | - | | - | | (65,604) |
| ______ | | ______ | | ______ | | ______ |
Net earnings (loss) available to common shareholders | $ 39,765 | | $ 24,035 | | $ 76,940 | | $ (36,111) |
| ______ | | ______ | | ______ | | ______ |
Weighted average shares outstanding: | | | | | | | |
Basic | 69,271 | | 65,087 | | 69,048 | | 57,709 |
Dilutive potential common shares from stock options (1) | 3,755 | | 6,216 | | 3,910 | | - |
Dilutive potential common shares from preferred stock conversion (1) | - | | - | | - | | - |
| ______ | | ______ | | ______ | | ______ |
Diluted | 73,026 | | 71,303 | | 72,958 | | 57,709 |
| ______ | | ______ | | ______ | | ______ |
Basic net earnings (loss) per common share available to | | | | | | | |
common shareholders | $ 0.57 | | $ 0.37 | | $ 1.11 | | $ (0.63) |
| ______ | | ______ | | ______ | | ______ |
Diluted net earnings (loss) per common share available to | | | | | | | |
common shareholders | $ 0.54 | | $ 0.34 | | $ 1.05 | | $ (0.63) |
| ______ | | ______ | | ______ | | ______ |
|
(1) Due to their antidilutive effect, 6,128 dilutive potential common shares from stock options and 6,013 dilutive potential common shares from |
the preferred stock conversion have been excluded from the diluted weighted average shares calculation for the six-month period ended |
June 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 six months ended June 30, 2005 and 2004 was $63.6 million and $29.8 million, respectively, and for the three months ended June 30, 2005 and 2004 was $31.0 million and $26.4 million, respectively. The most significant adjustment to net earnings to arrive at comprehensive income consisted of a foreign currency translation adjustment totaling $13.5 million and $2.3 million for the first six months of 2005 and 2004, respectively, and $8.2 million and $1.5 million for the second quarter of 2005 and 2004, respectively.
(5) 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.
(6) COMMITMENTS AND CONTINGENCIES
On August 28, 2003, KCI, KCI Licensing Inc., KCI USA, Inc. and Wake Forest University Health Sciences filed a lawsuit against BlueSky Medical Corporation, Medela, Inc., Medela AG and Patient Care Systems, Inc. in the United States District Court for the Western District of Texas, San Antonio Division, alleging infringement of multiple claims under two V.A.C. patents, arising from the manufacturing and marketing of a medical device by BlueSky. In addition to patent infringement, we asserted causes of action for breach of contract, tortious interference and unfair competition. We are seeking damages and injunctive relief in the case. BlueSky and Medela filed answers to the complaint and asserted counterclaims against us for declarations of non-infringement, patent invalidity and violations of federal anti-trust laws. BlueSky also filed a counterclaim alleging that the marketing of the V.A.C. system violates federal anti-trust laws. In the future, BlueSky could assert additional claims or seek to redesign its products in a manner that does not infringe our patents. On June 28, 2005, the Court issued a ruling on the Markman hearing in the case, 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. The Court has separately granted leave for both sides to file amended pleadings in the case. KCI’s amended pleadings assert infringement of an additional patent, U.S. Patent number 5,645,081 (the “081 patent”). The 643 and 081 patents are both owned by Wake Forest University and licensed exclusively to KCI. The defendants’ amended pleadings include additional anti-trust allegations against KCI. As a result of the amended pleadings, it is possible that an additional Markman hearing could be held. A new trial date has not yet been set for the case. 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 are unable to do so, BlueSky and others may 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 significantly, either of which would materially and adversely affect our operating results.
On February 21, 1992, Novamedix Limited filed a lawsuit against us in the United States District Court for the Western District of Texas, San Antonio Division. Novamedix manufactures a product that directly competes with one of our vascular products, the PlexiPulse. The suit alleges that PlexiPulse infringes several patents held by Novamedix, that we breached a confidential relationship with Novamedix and a variety of ancillary claims. Novamedix seeks injunctive relief and monetary damages. On April 12, 2004, a federal Magistrate completed a review of our motion for summary judgment. In his Memorandum and Recommendation on the summary judgment motions in the case, the Magistrate recommended to the Federal District Court Judge that one of Novamedix's causes of action for false advertising be significantly limited and that one of Novamedix's patent infringement damage theories be denied for summary judgment purposes. The Magistrate recommended that the remainder of our motions for summary judgment be denied. On September 1, 2004, the Magistrate issued a Supplemental Memorandum and Recommendation, and on February 22, 2005, the Magistrate issued a Clarification Order that broadened the claim construction of the Novamedix patents contained in the Supplemental Memorandum. On June 15, 2005, the Supplemental Memorandum and Recommendation and the Clarification Order was confirmed by the Federal District Court Judge in the case. A trial date in the case has been set for January 2006. Although it is not possible to reliably predict the outcome of the litigation, we continue to believe our defenses to Novamedix's claims are meritorious. However, we may not prevail in this litigation, and if we are unable to do so, the damages that may be awarded to Novamedix could be significant.
On July 1, 1998, Mondomed N.V. filed an opposition in the European Patent Office to a Wake Forest European V.A.C. patent licensed to KCI. Mondomed was joined in the opposition by Paul Hartmann A.G. on December 16, 1998. The patent was upheld at a hearing before a European Patent Office Opposition Division Panel on December 9, 2003, pursuant to a written interlocutory decision issued May 19, 2004. 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 polymer foam. Under European patent law, the "screen means" would include equivalents to polymer foam. The screen means helps to remove fluid from within and around the wound, distributes negative pressure within the wound, enhances the growth of granulation tissue and prevents wound overgrowth. In our V.A.C. systems, the foam dressing placed in the wound serves as the screen means. We use two different types of polymer foams as the screen means in our V.A.C. systems. Wake Forest and Paul Hartmann A.G. have appealed to the European Patent Office Board of Appeals in Munich, Germany. Mondomed N.V. has entered into a settlement with us. We presently believe it will take two or more years to complete the appeal process. During the pendency of an appeal, the original patents would 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 $23.7 million, we have no material long-term capital commitments.
(7) 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. No discrete financial information is available for our product lines other than revenue. 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 or 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 | | Six months ended |
| June 30, | | June 30, |
| 2005 | | 2004 | | 2005 | | 2004 |
Revenue: | | | | | | | |
USA | | | | | | | |
V.A.C. | $ 172,014 | | $ 136,049 | | $ 323,577 | | $ 257,638 |
Therapeutic surfaces/other | 44,566 | | 43,599 | | 90,528 | | 91,951 |
| _______ | | _______ | | _______ | | _______ |
Subtotal - USA | 216,580 | | 179,648 | | 414,105 | | 349,589 |
| | | | | | | |
International | | | | | | | |
V.A.C. | 48,896 | | 30,432 | | 94,835 | | 57,153 |
Therapeutic surfaces/other | 28,735 | | 26,905 | | 65,243 | | 55,077 |
| _______ | | _______ | | _______ | | _______ |
Subtotal - International | 77,631 | | 57,337 | | 160,078 | | 112,230 |
| _______ | | _______ | | _______ | | _______ |
| $ 294,211 | | $ 236,985 | | $ 574,183 | | $ 461,819 |
| _______ | | _______ | | _______ | | _______ |
| | | | | | | |
Operating earnings: | | | | | | | |
USA | $ 80,788 | | $ 67,017 | | $ 149,886 | | $ 127,180 |
International | 10,345 | | 6,913 | | 25,557 | | 13,652 |
Initial public offering expenses | - | | (302) | | - | | (19,836) |
Secondary offering expenses | - | | (2,219) | | - | | (2,219) |
| | | | | | | |
Other (1): | | | | | | | |
Executive | (5,095) | | (4,058) | | (6,204) | | (8,654) |
Finance | (9,097) | | (6,845) | | (17,418) | | (12,716) |
Manufacturing/Engineering | (1,110) | | (2,072) | | (1,895) | | (3,663) |
Administration | (8,930) | | (10,188) | | (17,311) | | (18,033) |
| _______ | | _______ | | _______ | | _______ |
Total other | (24,232) | | (23,163) | | (42,828) | | (43,066) |
| _______ | | _______ | | _______ | | _______ |
| $ 66,901 | | $ 48,246 | | $ 132,615 | | $ 75,711 |
| _______ | | _______ | | _______ | | _______ |
| | | | | | | |
(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 Earnings. |
(8) SUBSEQUENT EVENT
On July 22, 2005, we made an optional debt prepayment of $50.0 million on our senior credit facility and wrote off approximately $887,000 in capitalized loan issuance costs. As of that date, the remaining outstanding balances on our senior credit facility and our 7 3/8% Senior Subordinated Notes due 2013 were $221.9 million and $97.8 million, respectively.
(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 June 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 June 30, 2005 and December 31, 2004 and the related condensed consolidating statements of earnings for the three and six-month periods ended June 30, 2005 and 2004, and the condensed consolidating statements of cash flows for the six-month periods ended June 30, 2005 and 2004, respectively.
| Condensed Consolidating Parent Company, |
| Guarantor And Non-Guarantor Balance Sheet |
| June 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 | $ - | | $ 106,330 | | $ 43,842 | | $ - | | $ 150,172 |
| Accounts receivable, net | - | | 184,727 | | 74,452 | | (2,538) | | 256,641 |
| Inventories, net | - | | 21,161 | | 13,120 | | - | | 34,281 |
| Deferred income taxes | - | | 25,153 | | - | | - | | 25,153 |
| Prepaid expenses and other current assets | - | | 12,452 | | 7,815 | | (1,948) | | 18,319 |
| | _______ | | _______ | | _______ | | _______ | | _______ |
| Total current assets | - | | 349,823 | | 139,229 | | (4,486) | | 484,566 |
| | | | | | | | | | |
| Net property, plant and equipment | - | | 120,307 | | 61,146 | | (10,094) | | 171,359 |
| Loan issuance costs, net | - | | 9,736 | | - | | - | | 9,736 |
| Deferred income taxes | - | | 3,671 | | 6,291 | | - | | 9,962 |
| Goodwill | - | | 39,779 | | 9,590 | | - | | 49,369 |
| Other assets, net | - | | 29,035 | | 8,672 | | (8,262) | | 29,445 |
| Intercompany investments and advances | 139,359 | | 470,826 | | 47,839 | | (658,024) | | - |
| | _______ | | ________ | | _______ | | _______ | | _______ |
| | $ 139,359 | | $ 1,023,177 | | $ 272,767 | | $ (680,866) | | $ 754,437 |
| | _____ | | ______ | | _____ | | _____ | | _____ |
| Liabilities and Shareholders' Equity: | | | | | | | | | |
| Current liabilities: | | | | | | | | | |
| Accounts payable | $ - | | $ 31,773 | | $ 7,355 | | $ - | | $ 39,128 |
| Accrued expenses and other | 14 | | 104,098 | | 41,519 | | - | | 145,631 |
| Current installments of long-term debt | - | | 2,925 | | - | | - | | 2,925 |
| Intercompany payables | - | | - | | 23,386 | | (23,386) | | - |
| Income taxes payable | - | | 43,203 | | - | | (1,948) | | 41,255 |
| | _______ | | _______ | | _______ | | _______ | | _______ |
| Total current liabilities | 14 | | 181,999 | | 72,260 | | (25,334) | | 228,939 |
| | | | | | | | | | |
| Long-term debt, net of current installments | - | | 366,978 | | - | | - | | 366,978 |
| Intercompany payables, noncurrent | - | | (26,564) | | 26,564 | | - | | - |
| Deferred income taxes | - | | 11,237 | | - | | - | | 11,237 |
| Other noncurrent liabilities | - | | 15,852 | | 349 | | (8,262) | | 7,939 |
| | _______ | | _______ | | _______ | | _______ | | _______ |
| | 14 | | 549,502 | | 99,173 | | (33,596) | | 615,093 |
| Shareholders' equity | 139,345 | | 473,675 | | 173,594 | | (647,270) | | 139,344 |
| | _______ | | ________ | | _______ | | _______ | | _______ |
| | $ 139,359 | | $ 1,023,177 | | $ 272,767 | | $ (680,866) | | $ 754,437 |
| | _____ | | ______ | | _____ | | _____ | | _____ |
| |
| 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 Earnings |
For the three months ended June 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 | $ - | | $ 164,514 | | $ 46,535 | | $ - | | $ 211,049 |
Sales | - | | 53,672 | | 31,309 | | (1,819) | | 83,162 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Total revenue | - | | 218,186 | | 77,844 | | (1,819) | | 294,211 |
| | | | | | | | | |
Rental expenses | - | | 84,536 | | 46,605 | | - | | 131,141 |
Cost of goods sold | - | | 16,522 | | 6,193 | | (1,378) | | 21,337 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Gross profit | - | | 117,128 | | 25,046 | | (441) | | 141,733 |
| | | | | | | | | |
Selling, general and administrative | | | | | | | | | |
expenses | - | | 55,589 | | 13,219 | | (739) | | 68,069 |
Research and development expenses | - | | 5,603 | | 1,160 | | - | | 6,763 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Operating earnings | - | | 55,936 | | 10,667 | | 298 | | 66,901 |
| | | | | | | | | |
Interest income | - | | 420 | | (268) | | 346 | | 498 |
Interest expense | - | | (5,038) | | (65) | | (346) | | (5,449) |
Foreign currency loss | - | | - | | (1,240) | | - | | (1,240) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings before income | | | | | | | | | |
taxes and equity in | | | | | | | | | |
earnings of subsidiaries | - | | 51,318 | | 9,094 | | 298 | | 60,710 |
| | | | | | | | | |
Income taxes | - | | 19,538 | | 1,304 | | 103 | | 20,945 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings before equity | | | | | | | | | |
in earnings of subsidiaries | - | | 31,780 | | 7,790 | | 195 | | 39,765 |
Equity in earnings of subsidiaries | 39,765 | | 7,790 | | - | | (47,555) | | - |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net earnings | $ 39,765 | | $ 39,570 | | $ 7,790 | | $ (47,360) | | $ 39,765 |
| _____ | | ______ | | _____ | | _____ | | _____ |
Parent Company Statement of Earnings |
For the three months ended June 30, 2004 |
(dollars in thousands) |
(unaudited) |
| | | | | | | | | |
| Kinetic | | | | | | | | Historical |
| 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 | $ - | | $ 138,371 | | $ 37,208 | | $ - | | $ 175,579 |
Sales | - | | 48,172 | | 20,733 | | (7,499) | | 61,406 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Total revenue | - | | 186,543 | | 57,941 | | (7,499) | | 236,985 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Rental expenses | - | | 71,943 | | 35,288 | | - | | 107,231 |
Cost of goods sold | - | | 13,840 | | 5,389 | | (2,669) | | 16,560 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Gross profit | - | | 100,760 | | 17,264 | | (4,830) | | 113,194 |
| | | | | | | | | |
Selling, general and administrative | | | | | | | | | |
expenses | - | | 46,859 | | 11,322 | | (2,942) | | 55,239 |
Research and development expenses | - | | 6,285 | | 903 | | - | | 7,188 |
Initial public offering expenses | 154 | | 148 | | - | | - | | 302 |
Secondary offering expenses | 2,219 | | - | | - | | - | | 2,219 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Operating earnings (loss) | (2,373) | | 47,468 | | 5,039 | | (1,888) | | 48,246 |
| | | | | | | | | |
Interest income | - | | 120 | | 38 | | - | | 158 |
Interest expense | - | | (11,050) | | (664) | | 664 | | (11,050) |
Foreign currency gain (loss) | - | | 928 | | (727) | | - | | 201 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings (loss) before income | | | | | | | | | |
taxes (benefit) and equity in | | | | | | | | | |
earnings of subsidiaries | (2,373) | | 37,466 | | 3,686 | | (1,224) | | 37,555 |
| | | | | | | | | |
Income taxes (benefit) | (1,254) | | 14,433 | | 782 | | (441) | | 13,520 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings (loss) before equity | | | | | | | | | |
in earnings of subsidiaries | (1,119) | | 23,033 | | 2,904 | | (783) | | 24,035 |
Equity in earnings of subsidiaries | 25,154 | | 2,905 | | - | | (28,059) | | - |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net earnings | $ 24,035 | | $ 25,938 | | $ 2,904 | | $ (28,842) | | $ 24,035 |
| _____ | | ______ | | _____ | | _____ | | _____ |
| | | | |
Condensed Consolidated Parent Company, |
Guarantor And Non-Guarantor Statement of Earnings |
For the six months ended June 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 | $ - | | $ 315,154 | | $ 91,831 | | $ - | | $ 406,985 |
Sales | - | | 112,897 | | 68,822 | | (14,521) | | 167,198 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Total revenue | - | | 428,051 | | 160,653 | | (14,521) | | 574,183 |
| | | | | | | | | |
Rental expenses | - | | 165,099 | | 93,153 | | - | | 258,252 |
Cost of goods sold | - | | 32,477 | | 14,017 | | (4,376) | | 42,118 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Gross profit | - | | 230,475 | | 53,483 | | (10,145) | | 273,813 |
| | | | | | | | | |
Selling, general and administrative | | | | | | | | | |
expenses | - | | 103,588 | | 27,650 | | (3,013) | | 128,225 |
Research and development expenses | - | | 10,833 | | 2,140 | | - | | 12,973 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Operating earnings | - | | 116,054 | | 23,693 | | (7,132) | | 132,615 |
| | | | | | | | | |
Interest income | - | | 875 | | 227 | | (84) | | 1,018 |
Interest expense | - | | (12,887) | | (106) | | 84 | | (12,909) |
Foreign currency loss | - | | - | | (3,258) | | - | | (3,258) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings before income | | | | | | | | | |
taxes and equity in | | | | | | | | | |
earnings of subsidiaries | - | | 104,042 | | 20,556 | | (7,132) | | 117,466 |
| | | | | | | | | |
Income taxes | - | | 39,952 | | 3,034 | | (2,460) | | 40,526 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings before equity | | | | | | | | | |
in earnings of subsidiaries | - | | 64,090 | | 17,522 | | (4,672) | | 76,940 |
| | | | | | | | | |
Equity in earnings of subsidiaries | 76,940 | | 17,522 | | - | | (94,462) | | - |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net earnings | $ 76,940 | | $ 81,612 | | $ 17,522 | | $ (99,134) | | $ 76,940 |
| _____ | | ______ | | _____ | | _____ | | _____ |
Parent Company Statement of Earnings |
For the six months ended June 30, 2004 |
(dollars 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 | $ - | | $ 267,644 | | $ 73,843 | | $ - | | $ 341,487 |
Sales | - | | 94,585 | | 39,643 | | (13,896) | | 120,332 |
| ______ | | _______ | | _______ | | _______ | | _______ |
Total revenue | - | | 362,229 | | 113,486 | | (13,896) | | 461,819 |
| | | | | | | | | |
Rental expenses | - | | 140,479 | | 70,491 | | - | | 210,970 |
Cost of goods sold | - | | 29,036 | | 10,158 | | (5,866) | | 33,328 |
| ______ | | _______ | | _______ | | _______ | | _______ |
Gross profit | - | | 192,714 | | 32,837 | | (8,030) | | 217,521 |
| | | | | | | | | |
Selling, general and administrative | | | | | | | | | |
expenses | - | | 90,181 | | 18,209 | | (2,942) | | 105,448 |
Research and development expenses | - | | 12,546 | | 1,761 | | - | | 14,307 |
Initial public offering expenses | 19,584 | | 252 | | - | | - | | 19,836 |
Secondary offering expenses | 2,219 | | - | | - | | - | | 2,219 |
| ______ | | _______ | | _______ | | _______ | | _______ |
Operating earnings (loss) | (21,803) | | 89,735 | | 12,867 | | (5,088) | | 75,711 |
| | | | | | | | | |
Interest income | - | | 444 | | 85 | | - | | 529 |
Interest expense | - | | (29,894) | | (708) | | 708 | | (29,894) |
Foreign currency loss | - | | - | | (263) | | - | | (263) |
| ______ | | _______ | | _______ | | _______ | | _______ |
Earnings (loss) before income | | | | | | | | | |
taxes (benefit) and equity in | | | | | | | | | |
earnings of subsidiaries | (21,803) | | 60,285 | | 11,981 | | (4,380) | | 46,083 |
| | | | | | | | | |
Income taxes (benefit) | (8,540) | | 23,792 | | 2,915 | | (1,577) | | 16,590 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Earnings (loss) before equity | | | | | | | | | |
in earnings of subsidiaries | (13,263) | | 36,493 | | 9,066 | | (2,803) | | 29,493 |
Equity in earnings of subsidiaries | 42,756 | | 9,066 | | - | | (51,822) | | - |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net earnings | $ 29,493 | | $ 45,559 | | $ 9,066 | | $ (54,625) | | $ 29,493 |
| | | | | | | | | |
Series A convertible preferred stock dividends | (65,604) | | - | | - | | - | | (65,604) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net earnings (loss) available to common | | | | | | | | | |
shareholders | $ (36,111) | | $ 45,559 | | $ 9,066 | | $ (54,625) | | $ (36,111) |
| _____ | | ______ | | _____ | | _____ | | _____ |
| | | | |
Condensed Consolidating Parent Company, |
Guarantor And Non-Guarantor Statement of Cash Flows |
For the six months ended June 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 | $ 76,940 | | $ 81,612 | | $ 17,522 | | $ (99,134) | | $ 76,940 |
Adjustments to reconcile net earnings to net | | | | | | | | | |
cash provided by operating activities | (59,373) | | 15,748 | | 5,645 | | 91,060 | | 53,080 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net cash provided by operating activities | 17,567 | | 97,360 | | 23,167 | | (8,074) | | 130,020 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Cash flows from investing activities: | | | | | | | | | |
Additions to property, plant and equipment | - | | (20,202) | | (9,759) | | - | | (29,961) |
Increase in inventory to be converted into | | | | | | | | | |
equipment for short-term rental | - | | (2,200) | | - | | - | | (2,200) |
Dispositions of property, plant and | | | | | | | | | |
Equipment | - | | 315 | | 444 | | - | | 759 |
Decrease (increase) in other assets | - | | (181) | | 2,784 | | (3,050) | | (447) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net cash used by investing activities | - | | (22,268) | | (6,531) | | (3,050) | | (31,849) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Cash flows from financing activities: | | | | | | | | | |
Proceeds (repayments) of notes payable, long- | | | | | | | | | |
term debt, capital lease and other obligations | - | | (75,844) | | 30 | | - | | (75,814) |
Proceeds from exercise of stock options | 5,209 | | - | | - | | - | | 5,209 |
Proceeds from purchase of stock in ESPP | 2,131 | | - | | - | | - | | 2,131 |
Proceeds (payments) on intercompany | | | | | | | | | |
investments and advances | (6,962) | | 18,503 | | (8,268) | | (3,273) | | - |
Other | (17,945) | | 3,676 | | (4,019) | | 18,288 | | - |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net cash used by financing activities | (17,567) | | (53,665) | | (12,257) | | 15,015 | | (68,474) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Effect of exchange rate changes on | | | | | | | | | |
Cash and cash equivalents | - | | - | | - | | (3,891) | | (3,891) |
| _______ | | _______ | | _______ | | _______ | | _______ |
Net increase in cash and | | | | | | | | | |
cash equivalents | - | | 21,427 | | 4,379 | | - | | 25,806 |
Cash and cash equivalents, | | | | | | | | | |
beginning of period | - | | 84,903 | | 39,463 | | - | | 124,366 |
| _______ | | _______ | | _______ | | _______ | | _______ |
Cash and cash equivalents, end | | | | | | | | | |
of period | $ - | | $ 106,330 | | $ 43,842 | | $ - | | $ 150,172 |
| _____ | | _____ | | _____ | | _____ | | _____ |
Condensed Consolidating Guarantor, Non-Guarantor And |
Parent Company Statement of Cash Flows |
For the six months ended June 30, 2004 |
(dollars 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 | $ 29,493 | | $ 45,559 | | $ 9,066 | | $ (54,625) | | $ 29,493 |
Adjustments to reconcile net earnings to net | | | | | | | | | |
cash provided by operating activities | (12,584) | | (19,090) | | 1,416 | | 50,240 | | 19,982 |
| _______ | | _______ | | ______ | | ______ | | _______ |
Net cash provided by operating activities | 16,909 | | 26,469 | | 10,482 | | (4,385) | | 49,475 |
| _______ | | _______ | | ______ | | ______ | | _______ |
Cash flows from investing activities: | | | | | | | | | |
Additions to property, plant and equipment | - | | (28,010) | | (10,382) | | (3,984) | | (42,376) |
Increase in inventory to be converted into | | | | | | | | | |
equipment for short-term rental | - | | (4,800) | | - | | - | | (4,800) |
Dispositions of property, plant and | | | | | | | | | |
equipment | - | | 976 | | 317 | | - | | 1,293 |
Decrease (increase) in other assets | - | | (2,912) | | 2,328 | | 320 | | (264) |
| _______ | | _______ | | ______ | | ______ | | _______ |
Net cash used by investing activities | - | | (34,746) | | (7,737) | | (3,664) | | (46,147) |
| _______ | | _______ | | ______ | | ______ | | _______ |
Cash flows from financing activities: | | | | | | | | | |
Repayments of notes payable, long-term debt, | | | | | | | | | |
capital lease and other obligations | - | | (186,124) | | (53) | | - | | (186,177) |
Initial public offering of common stock: | | | | | | | | | |
Proceeds from issuance of common stock | 105,000 | | - | | - | | - | | 105,000 |
Stock issuance costs | (10,604) | | - | | - | | - | | (10,604) |
Proceeds from exercise of stock options | 8,214 | | - | | - | | - | | 8,214 |
Proceeds (payments) on intercompany | | | | | | | | | |
investments and advances | (118,328) | | 104,938 | | 13,047 | | 343 | | - |
Other | (1,191) | | 2,653 | | (9,500) | | 8,038 | | - |
| _______ | | _______ | | ______ | | ______ | | _______ |
Net cash provided (used) by financing activities | (16,909) | | (78,533) | | 3,494 | | 8,381 | | (83,567) |
| _______ | | _______ | | ______ | | ______ | | _______ |
Effect of exchange rate changes on | | | | | | | | | |
cash and cash equivalents | - | | - | | - | | (332) | | (332) |
| _______ | | _______ | | ______ | | ______ | | _______ |
Net increase (decrease) in cash and | | | | | | | | | |
cash equivalents | - | | (86,810) | | 6,239 | | - | | (80,571) |
Cash and cash equivalents, | | | | | | | | | |
beginning of period | - | | 129,695 | | 26,369 | | - | | 156,064 |
| _______ | | _______ | | ______ | | ______ | | _______ |
Cash and cash equivalents, end | | | | | | | | | |
of period | $ - | | $ 42,885 | | $ 32,608 | | $ - | | $ 75,493 |
| _______ | | _______ | | ______ | | ______ | | _______ |
| | | | |
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 clinically demonstrated to help promote wound healing and 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 complications such as skin breakdown associated with immobility and obesity.
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 72% of our revenue for the six months ended June 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 six months ended June 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.
Since the fourth quarter of 2000, our growth has been driven primarily by increased revenue from V.A.C. system rentals and sales, which accounted for approximately 73% of total revenue for the six months ended June 30, 2005, up from 68% for the same period in 2004. Over the past several years, we have experienced a seasonal slowing of V.A.C. revenue growth beginning in December and lasting through January, which we believe was 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 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 72 employees in the first six 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 rollout of the V.A.C.ATS and the V.A.C. Freedom, which began in late 2002. 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 four new 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 accounted for approximately $155.8 million in revenue in the first six months of 2005, up from $147.0 million in the prior-year period.
Recent Developments
On July 22, 2005, we made an optional debt prepayment of $50.0 million on our senior credit facility and wrote off approximately $887,000 in capitalized loan issuance costs. As of that date, the remaining outstanding balances on our senior credit facility and our 7 3/8% Senior Subordinated Notes due 2013 were $221.9 million and $97.8 million, respectively.
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 second quarter of 2005 to the second quarter of 2004 and the first six months of 2005 to the first six months of 2004:
| | |
| Revenue Relationship |
| | |
| Three months ended June 30, | Six months ended June 30, |
| | | % | | | | % |
| 2005 | 2004 | Change | | 2005 | 2004 | Change |
Revenue: | | | | | | | |
Rental | 72 % | 74 % | 20.2 % | | 71 % | 74 % | 19.2 % |
Sales | 28 | 26 | 35.4 | | 29 | 26 | 38.9 |
| ___ | ___ | | | ___ | ___ | |
Total revenue | 100 % | 100 % | 24.1 % | | 100 % | 100 % | 24.3 % |
| | | | | | | |
Rental expenses | 45 | 45 | 22.3 | | 45 | 46 | 22.4 |
Cost of goods sold | 7 | 7 | 28.8 | | 7 | 7 | 26.4 |
| ___ | ___ | | | ___ | ___ | |
Gross profit | 48 | 48 | 25.2 | | 48 | 47 | 25.9 |
| | | | | | | |
Selling, general and administrative expenses | 23 | 23 | 23.2 | | 23 | 23 | 21.6 |
Research and development expenses | 2 | 3 | (5.9) | | 2 | 3 | (9.3) |
Initial public offering expenses | - | - | - | | - | 4 | - |
Secondary offering expenses | - | 1 | - | | - | 1 | - |
| ___ | ___ | | | ___ | ___ | |
Operating earnings | 23 | 21 | 38.7 | | 23 | 16 | 75.2 |
| | | | | | | |
Interest income | - | - | 215.2 | | - | - | 92.4 |
Interest expense | (2) | (5) | (50.7) | | (2) | (6) | (56.8) |
Foreign currency gain (loss) | - | - | - | | (1) | - | - |
| ___ | ___ | | | ___ | ___ | |
Earnings before income taxes | 21 | 16 | 61.7 | | 20 | 10 | 154.9 |
| | | | | | | |
Income taxes | 7 | 6 | 54.9 | | 7 | 4 | 144.3 |
| ___ | ___ | | | ___ | ___ | |
Net earnings | 14 % | 10 % | 65.4 % | | 13 % | 6 % | 160.9 % |
| ___ | ___ | | | ___ | ___ | |
The following table sets forth, for the periods indicated, total revenue for advanced wound systems and therapeutic surfaces and the amount of revenue derived from each of our geographical segments: USA and International (dollars in thousands):
| Three months ended June 30, | Six months ended June 30, |
| | | % | | | | % |
| 2005 | 2004 | Change | | 2005 | 2004 | Change |
Total Revenue: | | | | | | | |
V.A.C. | | | | | | | |
Rental | $ 150,247 | $ 116,860 | 28.6 % | | $ 283,023 | $ 220,141 | 28.6 % |
Sales | 70,663 | 49,621 | 42.4 | | 135,389 | 94,650 | 43.0 |
| _______ | _______ | | | _______ | _______ | |
Total V.A.C. | 220,910 | 166,481 | 32.7 | | 418,412 | 314,791 | 32.9 |
| | | | | | | |
Therapeutic surfaces/other | | | | | | | |
Rental | 60,802 | 58,719 | 3.5 | | 123,962 | 121,346 | 2.2 |
Sales | 12,499 | 11,785 | 6.1 | | 31,809 | 25,682 | 23.9 |
| _______ | _______ | | | _______ | _______ | |
Total therapeutic surfaces/other | 73,301 | 70,504 | 4.0 | | 155,771 | 147,028 | 5.9 |
| | | | | | | |
Total rental revenue | 211,049 | 175,579 | 20.2 | | 406,985 | 341,487 | 19.2 |
Total sales revenue | 83,162 | 61,406 | 35.4 | | 167,198 | 120,332 | 38.9 |
| _______ | _______ | | | _______ | _______ | |
Total Revenue | $ 294,211 | $ 236,985 | 24.1% | | $ 574,183 | $ 461,819 | 24.3% |
| _______ | _______ | | | _______ | _______ | |
USA Revenue: | | | | | | | |
V.A.C. | | | | | | | |
Rental | $ 126,761 | $ 101,447 | 25.0% | | $ 238,910 | $ 191,354 | 24.9% |
Sales | 45,253 | 34,602 | 30.8 | | 84,667 | 66,284 | 27.7 |
| _______ | _______ | | | _______ | _______ | |
Total V.A.C. | 172,014 | 136,049 | 26.4 | | 323,577 | 257,638 | 25.6 |
| | | | | | | |
Therapeutic surfaces/other | | | | | | | |
Rental | 38,116 | 37,406 | 1.9 | | 77,073 | 77,207 | (0.2) |
Sales | 6,450 | 6,193 | 4.1 | | 13,455 | 14,744 | (8.7) |
| _______ | _______ | | | _______ | _______ | |
Total therapeutic surfaces/other | 44,566 | 43,599 | 2.2 | | 90,528 | 91,951 | (1.5) |
| | | | | | | |
Total USA rental | 164,877 | 138,853 | 18.7 | | 315,983 | 268,561 | 17.7 |
Total USA sales | 51,703 | 40,795 | 26.7 | | 98,122 | 81,028 | 21.1 |
| _______ | _______ | | | _______ | _______ | |
Total - USA Revenue | $ 216,580 | $ 179,648 | 20.6% | | $ 414,105 | $ 349,589 | 18.5% |
| _______ | _______ | | | _______ | _______ | |
International Revenue: | | | | | | | |
V.A.C. | | | | | | | |
Rental | $ 23,486 | $ 15,413 | 52.4% | | $ 44,113 | $ 28,787 | 53.2% |
Sales | 25,410 | 15,019 | 69.2 | | 50,722 | 28,366 | 78.8 |
| _______ | _______ | | | _______ | _______ | |
Total - V.A.C. | 48,896 | 30,432 | 60.7 | | 94,835 | 57,153 | 65.9 |
| | | | | | | |
Therapeutic surfaces/other | | | | | | | |
Rental | 22,686 | 21,313 | 6.4 | | 46,889 | 44,139 | 6.2 |
Sales | 6,049 | 5,592 | 8.2 | | 18,354 | 10,938 | 67.8 |
| _______ | _______ | | | _______ | _______ | |
Total therapeutic surfaces/other | 28,735 | 26,905 | 6.8 | | 65,243 | 55,077 | 18.5 |
| | | | | | | |
Total International rental | 46,172 | 36,726 | 25.7 | | 91,002 | 72,926 | 24.8 |
Total International sales | 31,459 | 20,611 | 52.6 | | 69,076 | 39,304 | 75.7 |
| _______ | _______ | | | _______ | _______ | |
Total - International Revenue | $ 77,631 | $ 57,337 | 35.4% | | $ 160,078 | $ 112,230 | 42.6% |
| _______ | _______ | | | _______ | _______ | |
Total Revenue. Total revenue for the second quarter of 2005 was $294.2 million, an increase of $57.2 million, or 24.1%, from the prior-year period. Total revenue for the first six months of 2005 was $574.2 million, an increase of $112.4 million, or 24.3%, 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. systems and related disposables. The growth in V.A.C. revenue was attributable to increased physician awareness of the benefits of V.A.C. therapy, increased product adoption across wound types, and the increased worldwide availability and acceptance of the V.A.C.ATS and V.A.C. Freedom. Foreign currency exchange movements accounted for 1.8% and 2.0% of the increase in total revenue in the second quarter and first six months of 2005, respectively, compared to the corresponding periods of the prior year.
Domestic Revenue. Total domestic revenue was $216.6 million for the second quarter of 2005 and $414.1 million for the first six months of 2005, representing increases of 20.6% and 18.5%, respectively, as compared to the prior-year periods. Total domestic V.A.C. revenue was $172.0 million for the second quarter of 2005 and $323.6 million for the first six months of 2005, representing increases of 26.4% and 25.6%, respectively, as compared to the prior-year periods. Domestic V.A.C. rental revenue of $126.8 million for the second quarter of 2005 increased $25.3 million, or 25.0%, due to a 26.6% increase in average units on rent compared to the prior-year period. For the first six months of 2005, domestic V.A.C. rental revenue of $238.9 million increased $47.6 million, or 24.9%, due to a 27.3% increase in average units on rent as compared to the prior-year period. The unit increases were partially offset by a 1.3% and 1.4% decline in the average V.A.C. rental pricing during the second quarter and first six months of 2005, respectively, primarily 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 collections and payment cycles of such payers. Domestic V.A.C. sales revenue of $45.3 million in the second quarter of 2005 and $84.7 million in the first six months of 2005 increased 30.8% and 27.7%, 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 a shift in pricing methodology for managed care organizations away from all-inclusive pricing.
Historically, we have experienced a seasonal slowing of V.A.C. revenue growth beginning in December and lasting through January, which we believe was 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.
Domestic therapeutic surfaces/other revenue was $44.6 million for the second quarter of 2005, an increase of 2.2% compared to the prior-year period. For the first six months of 2005, domestic therapeutic surfaces/other revenue was $90.5 million, a decrease of 1.5% compared to the prior-year period due primarily to lower sales. For the second quarter of 2005, domestic therapeutic surfaces rental revenue of $38.1 million increased 2.0%, as compared to the prior-year period, primarily due to a 1.5% increase in average units on rent as compared to the prior-year quarter. The average daily rental price was stable compared to the prior-year quarter. For the first six months of 2005, domestic therapeutic surfaces rental revenue of $77.0 million was comparable to the prior-year period. The average number of units on rent was essentially flat compared to the prior-year period.
International Revenue. Total international revenue was $77.6 million for the second quarter of 2005 and $160.1 million for the first six months of 2005, representing increases of 35.4% and 42.6%, 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 7.3% to the variance in the second quarter of 2005 and 8.2% to the variance in the first six months of 2005.
Total international V.A.C. revenue was $48.9 million in the second quarter of 2005 and $94.8 million in the first six months of 2005, representing increases of 60.7% and 65.9%, respectively, from the prior-year periods. Foreign currency exchange movements favorably impacted international V.A.C. revenue and accounted for 8.6% and 9.8% of the increase from the second quarter and first six months of the prior year, respectively. International V.A.C. rental revenue of $23.5 million for the second quarter of 2005 increased $8.1 million, or 52.4%, due to a 47.2% increase in average units on rent per month partially offset by a 1.4% decrease in average rental price driven by product mix changes. For the first six months of 2005, international V.A.C. rental revenue of $44.1 million increased $15.3 million, or 53.2%, due to a 46.9% increase in average units on rent per month. The average rental price for the first six months of 2005 was essentially flat as compared to the prior-year period. International V.A.C. sales revenue of $25.4 million in the second quarter of 2005 and $50.7 million in the first six months of 2005 increased 69.2% and 78.8%, respectively, from the prior-year periods due primarily to overall increased sales of V.A.C. disposables and increased price realization from the sale of higher therapy disposables.
International therapeutic surfaces/other revenue was $28.7 million for the second quarter of 2005 and $65.2 million for the first six months of 2005, representing increases of 6.8% and 18.5%, 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 second quarter and first six months of 2005, representing 5.8% and 6.6%, respectively, of the increases from the prior-year periods. The remaining increase was primarily due to an 8.3% and 6.8% increase in the average number of therapeutic surface rental units on rent for the second quarter and first six months of 2005, respectively, compared to the prior-year periods. This increase was partially offset by 6.9% and 5.8% declines in average rental pricing during the second quarter and first six months of 2005, respectively. The decline in average rental price resulted primarily from competitive pressures 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 62.1% in the second quarter of 2005 as compared to 61.1% in the prior-year quarter and 63.5% in the first six months of 2005 as compared to 61.8% in the prior-year period. This increase was due primarily to an increase in our sales force headcount from approximately 1,270 at June 30, 2004 to 1,515 at June 30, 2005. Additionally, we increased our investment in product marketing which was partially offset by efficiencies recognized in our service model.
Cost of Goods Sold. Cost of goods sold were $21.3 million in the second quarter of 2005 and $42.1 million in the first six months of 2005, representing increases of 28.8% and 26.4% respectively, over the prior-year periods. Sales margins in the second quarter of 2005 increased to 74.3% compared to 73.0% in the prior-year quarter. In the first six months of 2005, sales margins increased to 74.8% compared to 72.3% 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 $141.7 million in the second quarter of 2005 and $273.8 million in the first six months of 2005, representing increases of 25.2% and 25.9%, respectively, over the prior-year periods. Gross profit margin in the second quarter of 2005 was 48.2%, up from 47.8% in the prior-year quarter. For the first six months of 2005, gross profit margin was 47.7%, up from 47.1% in the prior-year period. Purchase discounts under an agreement with a primary supplier, strong margins on our Canadian sale in the first quarter of 2005 and efficiency improvements in our service model all contributed to the margin expansion.
Selling, General and Administrative Expenses. Selling, general and administrative expenses represented 23.1% of total revenue in the second quarter of 2005 compared to 23.3% in the prior-year period. In the first six months of 2005, these expenses represented 22.3% of total revenue compared to 22.8% in the prior-year period. Selling, general and administrative expenses include administrative labor and incentive 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 second quarter of 2005 were $6.8 million and represented 2.3% of total revenue as compared to 3.0% in the prior-year quarter. In the first six months of 2005, these expenses were $13.0 million and represented 2.3% of total revenue as compared to 3.1% in the prior-year period. Clinical spending was consistent as a percentage of revenue as compared to the prior-year periods. 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 and new applications of V.A.C. technology. We anticipate our rate of spending on research and development will increase in future periods.
Public Equity Offering Expenses. In the first six 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 second quarter of 2005 increased $18.7 million, or 38.7%. Operating margins increased to 22.7% from 20.4% in the prior-year period. For the first six months of 2005, operating earnings increased $56.9 million, or 75.2%, and operating margins increased to 23.1% from 16.4% in the prior-year period. Prior year operating margins were unfavorably impacted by the expenses incurred in connection with our 2004 stock offerings.
Interest Expense. Interest expense in the second quarter of 2005 was $5.4 million compared to $11.1 million in the prior-year period. Interest expense for the second quarter of 2004 included the payment of bond purchase premiums of $2.4 million and the write-off of $1.2 million of loan issuance costs on debt retired. The remaining variance of approximately $2.1 million in interest expense resulted from a decrease in our average outstanding debt balance from the prior-year period. In the first six months of 2005, interest expense was $12.9 million compared to $29.9 million in the prior-year period. Interest expense for the first six months of 2004 included the 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 $4.5 million of loan issuance costs on debt retired during the period. The remaining variance of approximately $4.8 million in interest expense resulted from a decrease in our average outstanding debt balance from the prior-year period, partially offset by the write-off of loan issuance costs of $1.4 million associated with the $75.0 million debt prepayment on our senior credit facility in the first six months of 2005.
Net Earnings. Net earnings for the second quarter of 2005 were $39.8 million, an increase of $15.7 million, or 65.4%, from the prior-year quarter. Net earnings for the first six months of 2005 were $76.9 million, an increase of $47.4 million, or 160.9%, from the prior-year period. Net earnings in 2004 were unfavorably impacted by the expenses incurred in connection with our stock offerings and debt prepayments. The effective income tax rate for the second quarter and first six months of 2005 was 34.5% compared to 36.0% for the prior-year periods. The income tax rate reduction was primarily attributable to a higher proportion of taxable income being generated in lower tax jurisdictions.
Net Earnings (Loss) per Share Available to Common Shareholders. Diluted net earnings per share available to common shareholders was $0.54 in the second quarter of 2005 compared to $0.34 in the prior-year quarter.For the first six months of 2005, diluted net earnings per share available to common shareholders was $1.05 compared to a net loss per diluted share of $0.63 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 six 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 six months ended June 30, 2005 and 2004 (dollars in thousands):
| Six months ended June 30, |
| 2005 | | | 2004 | |
| | | | | |
Net cash provided by operating activities | $ 130,020 | | | $ 49,475 | (1) |
Net cash used by investing activities | (31,849) | | | (46,147) | |
Net cash used by financing activities | (68,474) | (2) | | (83,567) | (3) |
Effect of exchange rates changes on cash | | | | | |
and cash equivalents | (3,891) | | | (332) | |
| ______ | | | ______ | |
Net increase (decrease) in cash and | | | | | |
cash equivalents | $ 25,806 | | | $ (80,571) | |
| ______ | | | ______ | |
| | | | | |
(1) Cash flow from operations 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. |
(2) This amount includes debt prepayments totaling $75.0 million on our senior credit facility. |
(3) This amount includes receipt of $94.4 million in proceeds from the IPO, net of expenses of $10.6 million, |
prepayment of $80.0 million on our senior credit facility and purchase of $106.1 million of our 73/8% Senior |
Subordinated Notes due 2013. |
At June 30, 2005, cash and cash equivalents of $150.2 million were available for general corporate purposes. On July 22, 2005, we used $50 million of these funds to prepay debt under our senior credit facility. At June 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 June 30, 2005, we had current assets of $484.6 million, including $34.3 million in inventory, and current liabilities of $228.9 million resulting in a working capital surplus of approximately $255.7 million compared to a surplus of $233.7 million at December 31, 2004. The increase in our working capital balance of approximately $22.0 million was related primarily to increased cash from operations during the first six months of 2005 decreased by the prepayment of $75.0 million in long-term debt during the first quarter.
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 to reduce these extended payment cycles. As of June 30, 2005, we had $256.6 million of receivables outstanding, net of reserves of $64.4 million for doubtful accounts. Our receivables were outstanding for an average of 79 days at June 30, 2005, which was an improvement from 82 days at June 30, 2004 and 85 days at December 31, 2004. This is due primarily to strong cash collections in the first six months of 2005.
Capital Expenditures
During the first six months of 2005 and 2004, we made capital expenditures of $30.0 million and $42.4 million, respectively, primarily on expanding the rental fleet and information technology purchases. As of June 30, 2005, we had commitments to purchase new product inventory of $23.7 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 June 30, 2005, scheduled principal payments under our senior credit facility for the years 2005, 2006 and 2007 were $1.4 million, $2.8 million and $2.8 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 $887,000 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 June 30, 2005 (in thousands):
| | | | Amount Available |
| | Effective | Amounts | For Additional |
Senior Credit Facility | Maturity | Interest Rate | Outstanding | Borrowing |
| | | | |
Revolving credit facility | August 2009 | - | $ - | $ 88,051 (1) |
Term loan facility | August 2010 | 4.57% (2) | 271,907 | - |
| | | _______ | ______ |
Total | | | $ 271,907 | $ 88,051 |
| | | _______ | _____ |
| | | | |
(1) At June 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 June 30, 2005 was 5.24%. |
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 June 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 June 30, 2005, the fair values of our swap agreements were positive in the aggregate and were recorded as an asset of $2.0 million. As a result of interest rate protection agreements, we recorded a reduction in interest expense of approximately $389,000 in the first six months of 2005 and recorded interest expense of approximately $2.4 million in the first six months of 2004.
Long-Term Commitments
During the first six months of 2005, we paid down $75.0 million in long-term debt obligations under our senior credit facility. The following table summarizes our long-term debt obligations as of June 30, 2005, for each of the periods indicated (dollars in thousands):
Year | Long-Term |
Payment | Debt |
Due | Obligations |
2005 | $ 1,388 |
2006 | 2,925 |
2007 | 2,775 |
2008 | 2,775 |
2009 | 2,775 |
Thereafter | 357,265 |
On July 22, 2005, we made an optional debt prepayment of $50.0 million on our senior credit facility which will reduce the annual payments required under the agreement.
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, FASB issued SFAS 123 Revised “Share-Based Payment” (“SFAS 123R”). SFAS 123R eliminates the alternative to account for stock-based compensation using APB 25 and requires that such transactions be recognized as compensation expense in the statement of earnings based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the stock 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.
KCIhas 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 is also evaluating the use of different valuation models to determine the fair value of stock-based compensation, although no model selection has been made to date. KCI believes the adoption of SFAS 123R will have a significant impact on future results of operations, regardless of the valuation technique used. If we were to continue to use a Black-Scholes option pricing model consistent with our current practice, the adoption of SFAS 123R on January 1, 2006 would result in additional compensation expense of approximately $6– $8 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 the Company cannot estimate what those amounts will be in the future (because they depend on, among other things, when employees exercise stock options) the amount of tax benefits recognized as operating cash flows in the first six-months of 2005 and 2004 was $17.0 million and $30.2 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 Corporation has introduced a medical device that is being marketed to directly compete with V.A.C. systems. BlueSky has received FDA clearance of its pump and one of its dressings. BlueSky has 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 a functionally or clinically equivalent competing product, our position in the wound care market could substantially erode or our pricing of V.A.C. systems may decline significantly, either of which would 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.
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
- 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. 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. We believe that the seasonal slowdown in the first quarter of 2005 was further impacted by the increase in our sales force during the fourth quarter of 2004, which had a negative impact on productivity during the fourth quarter of 2004 and the first quarter of 2005. We do not know if our beliefs will prove accurate or if this historical experience will prove to be indicative of future periods. 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. In any event, if we are unable to realize continued growth rates consistent with our expectations or those of the analysts covering us, as a result of the foregoing or other factors, we would expect to realize an immediate and substantial decline in the trading price of our stock. We would expect a similar or more significant decline in the trading price of our stock if we are unable to meet our published revenue and earnings guidance or the projections of the equity research analysts covering KCI.
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.
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 would incur substantial costs and diversion of management resources if we have to assert or defend our patent rights against others. 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 Corporation, Medela, Inc., Medela AG, and Patient Care Systems, Inc. alleging infringement of multiple claims under two 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. BlueSky and Medela filed answers to the complaint and asserted counterclaims against us for declarations of non-infringement, patent invalidity and violations of federal anti-trust laws. 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 begin marketing functionally or clinically equivalent competing products, which could erode our market position or cause the pricing of V.A.C. systems to decline significantly, either of which would materially and adversely affect our operating results.
Similarly, the primary European V.A.C. patent, which we rely upon for patent protection in Europe, was subject to an opposition proceeding before the Opposition Division of the European Patent Office. The patent was upheld at a hearing before a European Patent Office Opposition Division Panel on December 9, 2003, pursuant to a written interlocutory decision issued May 19, 2004. 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 polymer foam. Under European patent law, the "screen means" would include equivalents to polymer foam. The screen means helps to remove fluid from within and around the wound, distributes negative pressure within the wound, enhances the growth of granulation tissue and prevents wound overgrowth. In our V.A.C. systems, the foam dressing placed in the wound serves as the screen means. We use two different types of polymer foams as the screen means in our V.A.C. systems. Wake Forest and Paul Hartmann A.G. have appealed to the European Patent Office Board of Appeals in Munich, Germany. Mondomed N.V. has entered into a settlement with us. We presently believe it will take two or more years to complete the appeal process. During the pendency of an appeal, the original patents would 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 this decision will affect U.S. patents. The restriction on the type of screen means covered by the patent may lead competitors to believe that they can enter the market with products using screen means other than polymer foam. Although we do not believe that competitors seeking to "design around" our patents with products using another type of screen means would be as effective as the V.A.C., such products, if successfully marketed, could erode our market position or cause the pricing of V.A.C. systems to decline significantly, either of which would materially and adversely affect our operating results.
We also have agreements with third parties, including our exclusive license of the V.A.C. patents from Wake Forest, that provide for licensing of their patented or proprietary technologies. These agreements include royalty-bearing licenses. If we were to lose the rights to license these technologies, or our costs to license these technologies were to materially increase, our business would suffer.
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.
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 suffer.
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 as a result, deter the adoption of V.A.C. in those wound types or others. Moreover, 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.
In recent months, we have discontinued three clinical trials relating to V.A.C. In a sternal wound study, we terminated the trial because physicians refused on ethical grounds to allow their patients to be assigned to the control group. In an open fracture trial, patient enrollment was unacceptably low because standard surgical practice moved to closing compound fractures wounds rather than leaving them open through completion of the healing process, which was the primary endpoint of the trial. We also terminated an open abdominal wound study because the trial produced data for a range of wound types that was too broad to have meaningful statistically significant results. We have recently completed two trials which are in the process of being submitted for publication, but no assurance can be given that these studies will ultimately be published in major journals or otherwise widely disseminated to physicians who prescribe our products. If we are unable to complete or publish successful clinical trial results, our business and operating results could be negatively impacted.
In December 2004, the Agency for Healthcare Research and Quality (AHRQ) released a technology assessment on negative pressure therapy for wound healing. The report indicated that the body of evidence it reviewed was insufficient to support conclusions about the efficacy of V.A.C. therapy. While commenting favorably on our then-ongoing clinical trials, the assessment only reviewed six randomized controlled clinical trials on the V.A.C. and did not address the substantial body of other clinical evidence. However, this report’s conclusions are generally consistent with technology assessment reports that have been released by others regarding V.A.C. therapy. We believe that clinicians and payers evaluate a broader range of clinical evidence than was considered in the report. Although the technology assessment does not have any legal or binding effect, any technology assessment which is negative, including the above-mentioned report, could impede further adoption of the V.A.C. or cause usage of our V.A.C. systems to decline, which would materially and adversely affect our business and operating results.
Changes to third-party reimbursement policies could reduce the reimbursement we receive for our products.
Our products are rented and sold to hospitals and skilled nursing facilities that receive reimbursement for the products and services they provide from various public and private third-party payers, including Medicare, Medicaid and private insurance programs. We also act as a durable medical equipment, or DME, supplier and, as such, we furnish our products directly to customers and subsequently bill third-party payers such as Medicare, Medicaid and private insurance and managed care organizations. As a result, the demand for our products in any specific care setting is dependent, in part, on the reimbursement policies (including coverage and payment policies) of the various payers in that setting. Some state and private payers make adjustments to their reimbursement policies to reflect federal changes as well as to make their own changes. If coverage and payment policies for our products are revised or otherwise withdrawn under existing Medicare or Medicaid policies, demand for our products would decrease. In addition, in the event any public or private third-party payers challenge our billing, documentation or other practices as inconsistent with their reimbursement policies, we could experience significant delays, reductions or denials in obtaining reimbursement. In light of increased controls on health care spending, especially on Medicare and Medicaid spending, the outcome of future coverage or payment decisions for any of our products by governmental or private payers remains uncertain.
In 2003, the Centers for Medicare and Medicaid Services, or CMS, issued new regulations on inherent reasonableness of such charges. While these regulations do not have an impact on us currently, future coverage or payment decisions could impact our V.A.C. systems or any of our other products. If providers, suppliers and other users of our products and services are unable to obtain sufficient reimbursement for the provision of our products, demand for our products will decrease. In addition, under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, or MMA, a number of changes were made to the Medicare payment methodology for items of DME, including certain payment freezes, a competitive bidding program and clinical and quality standards. We have recently been informed 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 competitive bidding. CMS is currently conducting a pilot technology assessment on negative pressure wound therapy as part of the strategic evaluation of the regulatory requirements for competitive bidding. The assessment will be based on clinical benefits, functional design and cost of the intervention. Because this is a pilot assessment with no specific targeted use, neither the outcome nor the impact of the assessment can be predicted at this time. However, even an assessment that is merely perceived to be negative could aversely affect the reimbursement of the V.A.C.
Also, in December 2002, we submitted a written request to the medical directors of the four Durable Medical Equipment Regional Carriers, or DMERCs, seeking clarification of a number of issues with respect to the DMERCs' "Negative Pressure Wound Therapy Policy." That policy establishes Medicare Part B home care reimbursement criteria for our V.A.C. products. In June 2003, we received a response from the medical directors and, in some instances, their interpretation of the policy differed from our interpretation. Later, each of the medical directors issued interpretations within their regions which were more restrictive than the original policy. Since that time, we have had a variety of interactions with the DMERC medical directors. Most recently, the medical directors have indicated that they will not promulgate a comprehensive redraft of the original policy and that policy interpretation will be handled separately by each of the four regional DMERCs. We have been informed that two of the four DMERC medical directors will reinstate the original policy. We will continue our dialogue with the two other DMERC medical directors on these issues. At this point in time, we cannot predict the outcome of these discussions. A more restrictive interpretation of the policy may restrict the usage of V.A.C. in their regions.
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 Corporation, Medela, Inc., Medela AG, and Patient Care Systems, Inc. alleging infringement of multiple claims under two 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.
Similarly, in 1992, Novamedix Limited filed a lawsuit against us alleging, among other things, that the PlexiPulse product manufactured by us infringes several patents held by Novamedix. Novamedix seeks injunctive relief and significant monetary damages. Since that time, a federal Magistrate has made a number of rulings relating to the interpretation of the patents inconsistent with our position, which have been affirmed by the trial court. A trial date in the case has been set. We may not prevail in this litigation, and if we are unable to do so, we expect that the damages that may be awarded to Novamedix would be significant.
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 would 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, we may incur significant product development costs and experience material delivery delays if we lose any significant supplier.
We obtain some of our finished products and components included in our products from a limited group of suppliers, and, in one case, a sole-source supplier. We have entered into a sole-source agreement with Avail Medical Products, Inc., or Avail, for V.A.C. disposables. This supply agreement was recently extended through October 2007, with automatic extensions for additional twelve-month periods if neither party gives notice of termination. V.A.C. disposables represented approximately 22% of our revenue for the six months ended June 30, 2005. V.A.C. therapy cannot be administered without the appropriate use of our V.A.C. rental unit in conjunction with the related V.A.C. disposables. We maintain an inventory of disposables sufficient to support our business for approximately six weeks in the United States and eight weeks in Europe. Additionally, we have ensured that Avail has duplicate manufacturing facilities, tooling, and raw material resources for the production of our disposables. Any shortage of V.A.C. disposables could lead to lost revenue from decreased V.A.C. rentals. If we lose any supplier or if a sole-source supplier experiences any manufacturing problems, we could be required to qualify one or more replacement suppliers and may be required to conduct a significant level of process and component validation to incorporate new suppliers of components included in our products. The need to change suppliers to provide us with components might cause material delays in delivery, which could negatively impact revenue, or might otherwise cause significantly increased costs.
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 recent 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 U.S. Food and Drug Administration, or 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 June 30, 2005, we have six interest rate swap agreements pursuant to which we have fixed the rates on $250.0 million, or 91.9%, of our variable rate debt as follows:
- 2.150% per annum on $60.0 million of our variable rate debt through August 22, 2005;
- 2.130% per annum on $20.0 million of our variable rate debt through August 22, 2005;
- 2.135% per annum on $20.0 million of our variable rate debt through August 21, 2005;
- 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 June 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 June 30, 2005 | | |
| 2005 | 2006 | 2007 | 2008 | 2009 | Thereafter | Total | Fair Value |
Long‑term debt | | | | | | | | |
Fixed rate | $ - | $ 150 | $ - | $ - | $ - | $ 97,846 | $ 97,996 | $ 102,888 |
Average interest rate | - | 7.000 % | - | - | - | 7.375 % | 7.374 % | |
Variable rate | $ 1,388 | $ 2,775 | $ 2,775 | $ 2,775 | $ 2,775 | $ 259,419 | $ 271,907 | $ 271,907 |
Average interest rate | 5.240 % | 5.240 % | 5.240 % | 5.240 % | 5.240 % | 5.240 % | 5.240 % | |
Interest rate swaps (1) | | | | | | | | |
Variable to fixed | $ 100,000 | $ 150,000 | $ - | $ - | $ - | $ - | $ 250,000 | $ (2,007) |
Average pay rate | 2.143 % | 2.774 % | - | - | - | - | 2.521 % | |
Average receive rate | 3.458 % | 3.490 % | - | - | - | - | 3.477 % | |
| | | | | | | | |
(1) Interest rate swaps are included in the variable rate debt under long-term debt. As of June 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, 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 $25.6 million for the six months ended June 30, 2005. We estimate that a 10% fluctuation in the value of the dollar relative to these foreign currencies at June 30, 2005 would change our net income for the six months ended June 30, 2005 by approximately $1.7 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, KCI Licensing Inc., KCI USA, Inc. and Wake Forest University Health Sciences filed a lawsuit against BlueSky Medical Corporation, Medela, Inc., Medela AG and Patient Care Systems, Inc. in the United States District Court for the Western District of Texas, San Antonio Division, alleging infringement of multiple claims under two V.A.C. patents, arising from the manufacturing and marketing of a medical device by BlueSky. In addition to patent infringement, we asserted causes of action for breach of contract, tortious interference and unfair competition. We are seeking damages and injunctive relief in the case. BlueSky and Medela filed answers to the complaint and asserted counterclaims against us for declarations of non-infringement, patent invalidity and violations of federal anti-trust laws. BlueSky also filed a counterclaim alleging that the marketing of the V.A.C. system violates federal anti-trust laws. In the future, BlueSky could assert additional claims or seek to redesign its products in a manner that does not infringe our patents. On June 28, 2005, the Court issued a ruling on the Markman hearing in the case, 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. The Court has separately granted leave for both sides to file amended pleadings in the case. KCI’s amended pleadings assert infringement of an additional patent, U.S. Patent number 5,645,081 (the “081 patent”). The 643 and 081 patents are both owned by Wake Forest University and licensed exclusively to KCI. The defendants’ amended pleadings include additional anti-trust allegations against KCI. As a result of the amended pleadings, it is possible that an additional Markman hearing could be held. A new trial date has not yet been set for the case. 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 are unable to do so, BlueSky and others may 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 significantly, either of which would materially and adversely affect our operating results.
On February 21, 1992, Novamedix Limited filed a lawsuit against us in the United States District Court for the Western District of Texas, San Antonio Division. Novamedix manufactures a product that directly competes with one of our vascular products, the PlexiPulse. The suit alleges that PlexiPulse infringes several patents held by Novamedix, that we breached a confidential relationship with Novamedix and a variety of ancillary claims. Novamedix seeks injunctive relief and monetary damages. On April 12, 2004, a federal Magistrate completed a review of our motion for summary judgment. In his Memorandum and Recommendation on the summary judgment motions in the case, the Magistrate recommended to the Federal District Court Judge that one of Novamedix's causes of action for false advertising be significantly limited and that one of Novamedix's patent infringement damage theories be denied for summary judgment purposes. The Magistrate recommended that the remainder of our motions for summary judgment be denied. On September 1, 2004, the Magistrate issued a Supplemental Memorandum and Recommendation, and on February 22, 2005, the Magistrate issued a Clarification Order that broadened the claim construction of the Novamedix patents contained in the Supplemental Memorandum. On June 15, 2005, the Supplemental Memorandum and Recommendation and the Clarification Order was confirmed by the Federal District Court Judge in the case. A trial date in the case has been set for January 2006. Although it is not possible to reliably predict the outcome of the litigation, we continue to believe our defenses to Novamedix's claims are meritorious. However, we may not prevail in this litigation, and if we are unable to do so, the damages that may be awarded to Novamedix could be significant.
On July 1, 1998, Mondomed N.V. filed an opposition in the European Patent Office to a Wake Forest European V.A.C. patent licensed to KCI. Mondomed was joined in the opposition by Paul Hartmann A.G. on December 16, 1998. The patent was upheld at a hearing before a European Patent Office Opposition Division Panel on December 9, 2003, pursuant to a written interlocutory decision issued May 19, 2004. 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 polymer foam. Under European patent law, the "screen means" would include equivalents to polymer foam. The screen means in the patent, among other things, helps to remove fluid from within and around the wound, distributes negative pressure within the wound, enhances the growth of granulation tissue and prevents wound overgrowth. In our V.A.C. systems, the foam dressing placed in the wound serves as the screen means. We use two different types of polymer foams as the screen means in our V.A.C. systems. Wake Forest and Paul Hartmann A.G. have appealed to the European Patent Office Board of Appeals in Munich, Germany. Mondomed N.V. has entered into a settlement with us. We presently believe it will take two or more years to complete the appeal process. During the pendency of an appeal, the original patents would 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 and we believe that our liability insurance coverage is adequate.
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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On May 24, 2005, we held our Annual Meeting of Shareholders. At the meeting, our shareholders elected the following individuals to serve as our directors:
Class A Directors: | | For | | Withheld |
| | | | |
James R. Leininger, M.D. | | 45,120,634 | | 1,457,017 |
Dennert O. Ware | | 45,120,568 | | 1,457,083 |
| | | | |
Our shareholders further approved and authorized the ratification of the appointment of Ernst & Young LLP as our independent accountants for the fiscal year ended December 31, 2005. With respect to this matter, 44,917,641 shares were voted in favor of ratification, 1,657,030 shares were voted against, and 2,980 shares abstained.
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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 | Amended and Restated Articles of Incorporation of KCI(1) |
3.3 | Third Amended and Restated By-laws of KCI(2) |
31.1 | Certificate of the Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 |
| dated August 4, 2005. |
31.2 | Certificate of the Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 |
| dated August 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 August 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: August 4, 2005 By: /s/ DENNERT O. WARE Dennert O. Ware
President and Chief Executive Officer
(Duly Authorized Officer)
Date: August 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 | Amended and Restated Articles of Incorporation of KCI(1) |
3.3 | Third Amended and Restated By-laws of KCI(2) |
31.1 | Certificate of the Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 |
| dated August 4, 2005. |
31.2 | Certificate of the Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 |
| dated August 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 August 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. |