-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D6hFTXh9avYAo1q8NDmNkJVzou8Fny0C6JJcRjThH8JF2xx9OgFAVoIbWGOtwWFC NXA7tnOvwx3ENig7S3gQxQ== 0001104659-08-029959.txt : 20080505 0001104659-08-029959.hdr.sgml : 20080505 20080505171328 ACCESSION NUMBER: 0001104659-08-029959 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20080331 FILED AS OF DATE: 20080505 DATE AS OF CHANGE: 20080505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ICU MEDICAL INC/DE CENTRAL INDEX KEY: 0000883984 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 330022692 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-19974 FILM NUMBER: 08803609 BUSINESS ADDRESS: STREET 1: 951 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92763 BUSINESS PHONE: 949-366-2183 MAIL ADDRESS: STREET 1: 951 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92763 10-Q 1 a08-12227_110q.htm 10-Q

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

x

 

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

 

 

 

For the quarterly period ended: March 31, 2008

 

 

 

Or

 

 

 

o

 

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

 

 

 

For the transition period from:              to              

 

Commission File No.:   0-19974

 

ICU MEDICAL, INC.

(Exact name of Registrant as provided in charter)

 

Delaware

 

33-0022692

(State or Other Jurisdiction of

 

(I.R.S. Employer

Incorporation or Organization)

 

Identification No.)

 

 

 

951 Calle Amanecer, San Clemente, California

 

92673

(Address of Principal Executive Offices)

 

(Zip Code)

 

(949) 366-2183

(Registrant’s Telephone No. Including Area Code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.                                         Yes x           No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or smaller reporting company. See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer o

Accelerated filer x

Non-accelerated filer o

Small reporting company o

 

Indicate by check mark whether or not the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):

Yes o  No x

 

Indicate the number of shares outstanding in each of the issuer’s classes of common stock, as of the latest practicable date:

 

Class

 

Outstanding at April 15, 2008

Common

 

13,856,278

 

 



 

ICU Medical, Inc.
 

Index

 

 

 

Page Number

Part I - Financial Information

 

 

 

 

 

Item 1. Financial Statements (Unaudited)

 

 

Condensed Consolidated Balance Sheets, March 31, 2008 and December 31, 2007

 

3

 

 

 

Condensed Consolidated Statements of Income for the three months ended March 31, 2008 and 2007

 

4

 

 

 

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2008 and 2007

 

5

 

 

 

Condensed Consolidated Statements of Comprehensive Income for the three months ended March 31, 2008 and 2007

 

6

 

 

 

Notes to Condensed Consolidated Financial Statements

 

7

 

 

 

Item 2.

 

 

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

 

9

 

 

 

Item 3.

 

 

Quantitative and Qualitative Disclosures About Market Risk

 

15

 

 

 

Item 4.

 

 

Controls and Procedures

 

16

 

 

 

Part II - Other Information

 

17

 

 

 

Signature

 

19

 

2



 

ICU Medical, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Amounts in thousands, except share and per share data)

 

 

 

3/31/08

 

12/31/07 (1)

 

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

37,595

 

$

7,873

 

Marketable securities

 

61,540

 

87,770

 

Cash, cash equivalents and marketable securities

 

99,135

 

95,643

 

Accounts receivable, net of allowance for doubtful accounts of $583 and $655 as of March 31, 2008 and December 31, 2007, respectively

 

26,354

 

26,115

 

Inventories

 

21,275

 

19,504

 

Prepaid income taxes

 

1,923

 

2,740

 

Prepaid expenses and other current assets

 

3,861

 

4,746

 

Deferred income taxes - current portion

 

4,181

 

4,509

 

Total current assets

 

156,729

 

153,257

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT, net

 

73,677

 

72,708

 

INTANGIBLE ASSETS, net

 

11,600

 

11,884

 

DEFERRED INCOME TAXES- non-current

 

2,689

 

2,432

 

INCOME TAXES RECEIVABLE- non-current

 

1,848

 

1,848

 

OTHER ASSETS

 

465

 

465

 

 

 

$

247,008

 

$

242,594

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

7,741

 

$

8,439

 

Accrued liabilities

 

12,515

 

13,036

 

Total current liabilities

 

20,256

 

21,475

 

 

 

 

 

 

 

DEFERRED INCOME TAXES - non-current portion

 

4,325

 

4,325

 

INCOME TAXES PAYABLE - non-current portion

 

2,890

 

2,890

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Convertible preferred stock, $1.00 par value- Authorized - 500,000 shares, issued and outstanding - none

 

 

 

Common stock, $0.10 par value- Authorized — 80,000,000 shares, issued
14,746,951 shares at March 31, 2008 and December 31, 2007

 

1,475

 

1,475

 

Additional paid-in capital

 

70,846

 

74,805

 

Treasury stock, at cost - 890,673 and 1,057,501 shares at March 31, 2008 and December 31, 2007, respectively

 

(34,183

)

(40,776

)

Unrealized holding loss

 

(635

)

 

Retained earnings

 

179,902

 

177,004

 

Accumulated other comprehensive income

 

2,132

 

1,396

 

Total stockholders’ equity

 

219,537

 

213,904

 

 

 

$

247,008

 

$

242,594

 

 


(1) December 31, 2007 balances were derived from audited consolidated financial statements.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3



 

ICU Medical, Inc. and Subsidiaries

Condensed Consolidated Statements of Income

(Amounts in thousands, except share and per share data)

(unaudited)

 

 

 

Quarter ended March 31,

 

 

 

2008

 

2007

 

 

 

 

 

 

 

REVENUES:

 

 

 

 

 

Net sales

 

$

43,671

 

$

47,663

 

Other

 

983

 

1,170

 

TOTAL REVENUE

 

44,654

 

48,833

 

 

 

 

 

 

 

COST OF GOODS SOLD

 

26,883

 

29,617

 

 

 

 

 

 

 

Gross profit

 

17,771

 

19,216

 

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

 

 

 

Selling, general and administrative

 

13,108

 

11,999

 

Research and development

 

2,019

 

1,851

 

Total operating expenses, net

 

15,127

 

13,850

 

 

 

 

 

 

 

Income from operations

 

2,644

 

5,366

 

 

 

 

 

 

 

OTHER INCOME

 

1,556

 

9,399

 

 

 

 

 

 

 

Income before income taxes and minority interest

 

4,200

 

14,765

 

 

 

 

 

 

 

PROVISION FOR INCOME TAXES

 

(1,302

)

(5,020

)

MINORITY INTEREST

 

 

70

 

 

 

 

 

 

 

NET INCOME

 

$

2,898

 

$

9,815

 

 

 

 

 

 

 

NET INCOME PER SHARE

 

 

 

 

 

Basic

 

$

0.21

 

$

0.67

 

Diluted

 

$

0.20

 

$

0.63

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF SHARES

 

 

 

 

 

Basic

 

13,751,622

 

14,581,699

 

Diluted

 

14,375,751

 

15,614,711

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4



 

ICU Medical, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Amounts in thousands)

(unaudited)

 

 

 

Quarter ended March 31,

 

 

 

2008

 

2007

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

Net income

 

$

2,898

 

$

9,815

 

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

 

 

 

 

 

Depreciation and amortization

 

3,410

 

2,566

 

Provision for doubtful accounts

 

(38

)

57

 

Minority interest

 

 

(70

)

Stock compensation

 

416

 

181

 

Cash provided (used) by changes in operating assets and liabilities

 

 

 

 

 

Accounts receivable

 

172

 

(306

)

Inventories

 

(1,646

)

151

 

Prepaid expenses and other assets

 

566

 

(560

)

Accounts payable

 

(699

)

(550

)

Accrued liabilities

 

(568

)

327

 

Prepaid and deferred income taxes

 

152

 

4,769

 

Net cash provided by operating activities

 

4,663

 

16,380

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property and equipment

 

(3,592

)

(7,064

)

Proceeds from finance loan repayments

 

24

 

23

 

Purchases of marketable securities

 

(9,027

)

(17,790

)

Proceeds from sale of marketable securities

 

34,622

 

11,729

 

Net cash provided (used) by investing activities

 

22,027

 

(13,102

)

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

Proceeds from exercise of stock options

 

1,071

 

602

 

Proceeds from employee stock purchase plan

 

744

 

742

 

Tax benefits from exercise of stock options

 

954

 

140

 

Purchase of treasury stock

 

 

(8,613

)

Net cash provided (used) by financing activities

 

2,769

 

(7,129

)

 

 

 

 

 

 

Effect of exchange rate changes on cash

 

263

 

4

 

 

 

 

 

 

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

29,722

 

(3,847

)

 

 

 

 

 

 

CASH AND CASH EQUIVALENTS, beginning of period

 

7,873

 

13,153

 

CASH AND CASH EQUIVALENTS, end of period

 

$

37,595

 

$

9,306

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5



 

ICU Medical, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Income

(Amounts in thousands)

(unaudited)

 

 

 

Quarter ended March 31,

 

 

 

2008

 

2007

 

 

 

 

 

 

 

Net income

 

$

2,898

 

$

9,815

 

 

 

 

 

 

 

Other comprehensive income, net of tax:

 

 

 

 

 

Foreign currency translation adjustment

 

736

 

50

 

 

 

 

 

 

 

Comprehensive income

 

$

3,634

 

$

9,865

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

6



 

ICU Medical, Inc.

Notes to Condensed Consolidated Financial Statements

March 31, 2008

(Amounts in tables in thousands except share and per share data)

(unaudited)

 

Note 1:   Basis of Presentation:  The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America and pursuant to the rules and regulations of the Securities and Exchange Commission and reflect all adjustments, which consist of only normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the consolidated results for the interim periods presented. Results for the interim period are not necessarily indicative of results for the full year. Certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s 2007 Annual Report to Stockholders.

 

ICU Medical, Inc. (the “Company”), a Delaware corporation, operates principally in one business segment engaged in the development, manufacturing and marketing of disposable medical devices. The Company’s devices are sold principally to distributors and medical product manufacturers throughout the United States and internationally. All subsidiaries are wholly or majority owned and included in the consolidated financial statements. All intercompany balances and transactions have been eliminated.

 

Note 2:   New Accounting Pronouncements:  In December 2007 the FASB issued Statement of Financial Accounting Standards (“SFAS”) 141R, “Business Combinations”. SFAS 141R amends the requirements for accounting for business combinations. SFAS 141R is effective for financial statements issued for fiscal years beginning after December 15, 2008. Accordingly, any business combinations the Company engages in will be recorded and disclosed following existing accounting principles until December 31, 2008.

 

Note 3:   Fair Value Measurement:  The Company adopted SFAS No. 157, “Fair Value Measurements,” (“SFAS 157”) as of January 1, 2008. This statement defines fair value, establishes a framework for measuring fair value and expands the related disclosure requirements. This statement applies under other accounting pronouncements that require or permit fair value measurements. The statement indicates, among other things, that a fair value measurement assumes that the transaction to sell an asset or transfer a liability occurs in the principal market for the asset or liability or, in the absence of a principal market, the most advantageous market for the asset or liability. SFAS 157 defines fair value based upon an exit price model.

 

SFAS 157 establishes a valuation hierarchy for disclosure of the inputs to valuation used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on our own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement.

 

The following table provides the assets and liabilities carried at fair value measured on a recurring basis as of March 31, 2008:

 

 

 

Fair value measurements at March 31, 2008
using

 

 

 

Total
carrying
value at
March 31,
2008

 

Quoted
prices in
active
markets for
identical
assets (level
1)

 

Significant
other
observable
inputs (level 2)

 

Significant
unobservable
inputs (level
3)

 

Available for sale securities

 

$

61,540

 

$

 

$

 

$

61,540

 

 

7



 

The Company’s marketable securities, all of which are considered “available for sale,” consist principally of corporate preferred stocks and federal-tax-exempt state and municipal government debt securities that reset dividend or interest rates at auction, principally from between seven and forty-nine day intervals.  The Company has included all of its marketable securities or $61.5 million as Level 3 assets due to the unobservable inputs caused by the lack of liquidity in the recent auctions. The valuation of these securities was based on recommended fair values provided by our broker combined with internal analysis of interest rate spreads and credit quality. They are carried at fair value that resulted in a temporary impairment of $0.6 million as of March 31, 2008 which is reflected in Unrealized Holding Loss in the Stockholders’ Equity section of the Condensed Consolidated Balance Sheet.

 

The following tables summarizes the change in the fair values for Level 3 items for the quarter ended March 31, 2008:

 

 

 

Level 3

 

Changes in fair value during the period ended March 31, 2008:

 

 

 

 

 

 

 

Beginning balance

 

$

 

Transfer into Level 3

 

62,175

 

Unrealized holding loss, included in stockholders’ equity

 

(635

)

Ending balance

 

$

61,540

 

 

In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities” (“SFAS 159”). SFAS 159 provides companies with an option to report selected financial assets and financial liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings at each subsequent reporting date. SFAS 159 was effective for the Company on January 1, 2008. The Company’s management did not elect to begin reporting any financial assets or liabilities at fair value upon adoption of SFAS 159. In addition, the Company’s management did not elect to report at fair value any new financial assets or liabilities entered into for the quarter ended March 31, 2008.

 

Note 4:   Inventories consisted of the following:

 

 

 

3/31/08

 

12/31/07

 

Raw material

 

$

15,653

 

$

15,622

 

Work in process

 

2,393

 

1,712

 

Finished goods

 

3,229

 

2,170

 

Total

 

$

21,275

 

$

19,504

 

 

Note 5:   Property and equipment consisted of the following:

 

 

 

3/31/08

 

12/31/07

 

Machinery and equipment

 

$

47,450

 

$

45,503

 

Land, building and building improvements

 

49,755

 

48,546

 

Molds

 

14,943

 

14,029

 

Computer equipment and software

 

9,301

 

8,927

 

Furniture and fixtures

 

1,999

 

1,982

 

Construction in progress

 

4,017

 

4,900

 

 

 

 

 

 

 

Total property and equipment, cost

 

127,465

 

123,887

 

Accumulated depreciation

 

(53,788

)

(51,179

)

 

 

 

 

 

 

Net property and equipment

 

$

73,677

 

$

72,708

 

 

Note 6:   Net income per share is computed by dividing net income by the weighted average number of common shares outstanding. Diluted net income per share is computed by dividing net income by the weighted average number of common shares outstanding plus dilutive securities. Dilutive securities are outstanding common stock options (excluding stock options with an exercise price in excess of the average market value for the period), less the number of shares that could have been purchased with the proceeds from the exercise of the options, using the treasury stock method, and were 624,129 and 1,033,012 for the quarters ended March 31, 2008 and 2007, respectively. Options that are antidilutive because their exercise price exceeded the average market price of its common stock for the period approximated 1,397,000 and 40,000 for the quarters ended March 31, 2008 and 2007, respectively.

 

Note 7:   Income Taxes:  Income taxes were accrued at an effective tax rate of 31.0% in the first quarter of 2008 compared to 34.0% in the first quarter of 2007. The effective tax rate differs from that computed at the federal statutory rate of 35% principally because of the effect of state income taxes, state tax credits, tax exempt incomes and deductions for Domestic Production Activities.

 

Note 8:   Major Customers and Geographic Information:  The Company had revenues equal to ten percent or more of total revenues from one customer, Hospira, Inc. Such revenues were 66% and 74% of total revenue for the quarters ended March 31, 2008 and 2007, respectively.

 

Note 9:   Legal Settlement:  In January 2007, the Company received $8.0 million in settlement of litigation against a law firm that formerly represented the Company in patent litigation matters. This is included in Other Income in the Condensed Consolidated Statements of Income for the quarter ended March 31, 2007.

 

Note 10: Commitments and Contingencies:  The Company is from time to time involved in various legal proceedings, either as a defendant or plaintiff, most of which are routine litigation in the normal course of business. The Company believes that the resolution of the legal proceedings in which it is currently involved will not have a material adverse effect on its financial position or results of operations.

 

In the normal course of business, the Company has agreed to indemnify officers and directors of the Company, to the maximum extent permitted under Delaware law and to indemnify customers as to certain intellectual property matters related to sales of the Company’s products. There is no maximum limit on the indemnification that may be required under these agreements. The Company has never incurred, nor does it expect to incur, any liability for indemnification. Except for indemnification agreements, the Company does not have any “off balance sheet arrangements”.

 

8



 

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

 

We are a leader in the development, manufacture and sale of proprietary, disposable medical connection systems for use in vascular therapy applications. Our devices are designed to protect patients from catheter related bloodstream infections and healthcare workers from exposure to infectious diseases through accidental needlesticks. We are also a leader in the production of custom I.V. systems and we incorporate our proprietary products into many of those custom I.V. systems. We are also a significant manufacturer of critical care medical devices, including catheters, angiography kits and cardiac monitoring systems.

 

Critical Accounting Policies

 

Our significant accounting policies are summarized in Note 1 to the Consolidated Financial Statements included in our 2007 Annual Report to Shareholders. In preparing our financial statements, we make estimates and assumptions that affect the expected amounts of assets and liabilities and disclosure of contingent assets and liabilities. We apply our accounting policies on a consistent basis. As circumstances change, they are considered in our estimates and judgments, and future changes in circumstances could result in changes in amounts at which assets and liabilities are recorded.

 

New Accounting Pronouncements

 

In December 2007, the FASB issued Statement of Financial Accounting Standards (“SFAS”) 141R, “Business Combinations” (SFAS 141R). SFAS 141R amends the requirements for accounting for business combinations. SFAS 141R will be effective for financial statements issued for fiscal years beginning after December 15, 2008. Accordingly, any business combinations we engage in will be recorded and disclosed following existing accounting principles until December 31, 2008.

 

We have implemented all new accounting pronouncements that are in effect and that may impact our consolidated financial statements and do not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on our consolidated financial statements.

 

Business Overview

 

Until the late 1990s, our primary emphasis in product development, sales and marketing was disposable medical connectors for use in I.V. therapy, and our principal product was the CLAVE. In the late 1990s, we commenced a transition from a product-centered company to an innovative, fast, efficient, low-cost manufacturer of custom I.V. systems, using processes that we believe can be readily applied to a variety of disposable medical devices. This strategy has enabled us to capture revenue on the entire I.V. delivery system, and not just a component of the system.

 

Our largest customer is Hospira. Our relationship with Hospira has been and will continue to be of singular importance to our growth. In the first quarter of 2008 and years ended 2007, 2006 and 2005, our revenues from worldwide sales to Hospira were 66%, 73%, 77% and 74%, respectively, of total revenues. We expect this percentage of revenue range will be maintained in the future as a result of sales of CLAVE products, custom products, new products and critical care products to Hospira. Hospira has a significant share of the I.V. set market in the U.S., and provides us access to that market. We expect that Hospira will be important to our growth for CLAVE, custom products, and our other products worldwide.

 

We believe the success of the CLAVE has motivated, and will continue to motivate others to develop one-piece, swabbable, needleless connectors that may incorporate many of the same functional and physical characteristics as the CLAVE. We are aware of a number of such products. We have patents covering the technology embodied in the CLAVE and intend to enforce those patents as appropriate. If we are not successful in enforcing our patents, competition from such products could adversely affect our market share and prices for our CLAVE products. Although overall pricing has been stable recently, the average price of our CLAVE products may decline in the future. There is no assurance that our current or future products will be able to successfully compete with products developed by others.

 

We are reducing our dependence on our current proprietary products by introducing new products and systems and acquiring product lines. Under one of our Hospira Agreements, we manufacture custom I.V. systems for sale by Hospira and jointly promote the products. In 2004, we made our initial investment in a company developing a new medical device. Sales depend on the success of efforts to develop and market the device, and there can be no certainty that those efforts will succeed. In 2005, we acquired Hospira’s Salt Lake City manufacturing facility and entered into the Manufacturing Commercialization and Development Agreement contract (“MCDA”) to produce their invasive monitoring, angiography products and certain other products they had manufactured at that facility. We also contract with group purchasing organizations and

 

9



 

independent dealer networks for inclusion of our CLAVE and custom products in the product offerings of those entities. We are expanding our custom products business through increased sales to medical product manufacturers and independent distributors. Custom products, which include custom I.V., custom oncology and custom critical care products, accounted for approximately $14.9 million or 33% of total revenue in the first quarter of 2008. We expect continued increases in sales of custom products. We have recently introduced a number of new products:  the TEGO for use in dialyses, the Orbit 90 diabetes set, and a line of oncology products including the SPIROS male luer connector device, the Genie vial access device and custom I.V sets and ancillary products specifically designed for oncology therapy. There is no assurance that we will be successful in finding acquisition opportunities, or in acquiring companies or products or that we will successfully integrate them into our existing business.

 

Custom products and new products will be of increasing importance to us in future years. We expect continued growth in our CLAVE products in the U.S., but at a modest growth rate. We also potentially face substantial increases in competition in our CLAVE business. Growth for all of our products outside the U.S. could be substantial, although to date it has been relatively modest. Therefore, we are directing increasing product development, acquisition, sales and marketing efforts to custom products and other products that lend themselves to customization and new products in the U.S. and international markets.

 

We believe that achievement of our growth objectives worldwide will require increased efforts by us in sales and marketing and product development in these markets.

 

There is no assurance that we will be successful in implementing our growth strategy. The custom products market is small, and we could encounter customer resistance to custom products. Further, we could encounter increased competition as other companies see opportunity. Product development or acquisition efforts may not succeed, and even if we do develop or acquire products, there is no assurance that we will achieve profitable sales of such products. An adverse change in our relationship with Hospira, or a deterioration of Hospira’s position in the market, could have an adverse effect on us. Increased expenditures for sales and marketing and product acquisition and development may not yield desired results when expected, or at all. While we have taken steps to control those risks, there are certain of those risks which may be outside of our control, and there is no assurance that steps we have taken will succeed.

 

The following table sets forth, for the periods indicated, total revenues by product as a percentage of total revenues:

 

 

 

Quarter ended
March 31,

 

Fiscal Year Ended

 

Product Line

 

2008

 

2007

 

2007

 

2006

 

2005

 

CLAVE

 

41

%

35

%

38

%

34

%

40

%

Custom products

 

33

%

31

%

31

%

28

%

27

%

Critical care

 

17

%

25

%

23

%

25

%

20

%

Other products

 

7

%

7

%

7

%

12

%

11

%

License, royalty and revenue share

 

2

%

2

%

1

%

1

%

2

%

Total

 

100

%

100

%

100

%

100

%

100

%

 

We sell our I.V. administration products to independent distributors and through agreements with Hospira and certain other medical product manufacturers. Most independent distributors handle the full line of our I.V. administration products. We sell our invasive monitoring, angiography and I.V. administration products through three agreements with Hospira (the “Hospira Agreements”). Under a 1995 agreement, Hospira purchases CLAVE products, principally bulk, non-sterile connectors and the CLC2000. Under a 2001 agreement, we sell custom I.V. systems to Hospira. Our 1995 and 2001 agreements with Hospira provide Hospira with conditional exclusive and nonexclusive rights to distribute all existing ICU Medical products worldwide with terms that extend to 2014. Under the 2005 MCDA, we sell Hospira invasive monitoring, angiography and other products which they formerly manufactured at the Salt Lake City facility. The terms of the MCDA extend to 2025. We also sell certain other products to a number of other medical product manufacturers.

 

We believe that as healthcare providers continue to either consolidate or join major buying organizations, the success of our products will depend, in part, on our ability, either independently or through strategic relationships such as our Hospira relationship, to secure long-term contracts with large healthcare providers and major buying organizations. As a result of this marketing and distribution strategy we derive most of our revenues from a relatively small number of distributors and manufacturers. The loss of a strategic relationship with a customer or a decline in demand for a manufacturing customer’s products could have a material adverse effect on our operating results.

 

10



 

We have an ongoing program to increase systems capabilities, improve manufacturing efficiency, reduce labor costs, reduce time needed to produce an order, and minimize investment in inventory. These include the use of automated assembly equipment for new and existing products and use of larger molds and molding machines. In 2006, we centralized our proprietary molding in Salt Lake City and expanded our production facility in Mexico which took over the majority of our manual assembly previously done in Salt Lake City. In 2007, we began a significant initiative to improve production processes, called the “ICU Production System” or “IPS”, which we believe will enable us to further improve our manufacturing efficiency. We started IPS in our Mexico facility in 2007 and started it in our Salt Lake City facility in 2008. We plan to begin building a manufacturing facility in China in 2008 to manufacture components for products that will be sold in domestic and international markets. We expect this facility will be operational in early 2009. We may establish additional production facilities outside the U.S. There is no assurance as to the benefits of IPS or our success in establishing manufacturing facilities in China and elsewhere outside the U.S.

 

We distribute products through three distribution channels. Product revenues for each distribution channel were as follows:

 

 

 

Quarter ended
March 31,

 

Fiscal Year Ended

 

Channel

 

2008

 

2007

 

2007

 

2006

 

2005

 

Medical product manufacturers

 

68

%

74

%

71

%

76

%

76

%

Independent domestic distributors

 

18

%

14

%

16

%

14

%

16

%

International customers

 

14

%

12

%

13

%

10

%

8

%

Total

 

100

%

100

%

100

%

100

%

100

%

 

Sales to international customers do not include bulk CLAVE products sold to Hospira in the U.S., but used in I.V. products manufactured by Hospira and exported. Those sales are included in sales to medical product manufacturers. Other sales to Hospira for destinations outside the U.S. are included in sales to international customers.

 

Quarter-to-quarter comparisons: We present summarized income statement data in Item 1. Financial Statements. The following table shows, for the year 2007 and the first quarters of 2008 and 2007, the percentages of each income statement caption in relation to total revenues.

 

 

 

Year

 

Quarter ended
March 31,

 

 

 

2007

 

2008

 

2007

 

Revenue

 

 

 

 

 

 

 

Net sales

 

99

%

98

%

98

%

Other

 

1

%

2

%

2

%

Total revenues

 

100

%

100

%

100

%

 

 

 

 

 

 

 

 

Gross profit

 

42

%

40

%

39

%

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

 

24

%

29

%

24

%

Research and development expenses

 

5

%

5

%

4

%

Total operating expenses

 

29

%

34

%

28

%

 

 

 

 

 

 

 

 

Income from operations

 

13

%

6

%

11

%

Other income

 

5

%

3

%

19

%

Income before income taxes and minority interest

 

18

%

9

%

30

%

Income taxes

 

6

%

3

%

10

%

Minority interest

 

0

%

0

%

0

%

Net income

 

12

%

6

%

20

%

 

Quarterly results:  The healthcare business in the United States is subject to seasonal fluctuations, and activity tends to diminish somewhat in the summer months of June, July and August, when illness is less frequent than in winter months and patients tend to postpone elective procedures. This may cause seasonal fluctuations in our business. In addition, we can experience fluctuations in net sales as a result of variations in the ordering patterns of our largest customers, which may be driven more by production scheduling and their inventory levels, and less by seasonality. Our expenses often

 

11



 

do not fluctuate in the same manner as net sales, which may cause fluctuations in operating income that are disproportionate to fluctuations in our revenue.

 

Quarter Ended March 31, 2008 Compared to the Quarter Ended March 31, 2007

 

Revenues were $44.7 million in the first quarter of 2008 compared to $48.8 million in the first quarter of 2007.

 

Distribution channels:  Net U.S. sales to Hospira in the first quarter of 2008 were $28.8 million, compared to net sales of $34.4 million in the first quarter of 2007. This $5.6 million decrease was primarily comprised of $4.9 million of decreases in critical care product due to lower prices charged under the MCDA and lower unit sales of certain critical care products. Custom product sales, which includes custom I.V. systems, custom critical care and custom oncology sales, to Hospira approximated $7.3 million in the first quarter of 2008 compared to $7.9 million in the first quarter of 2007. The decrease in custom sales was primarily from $0.8 million in lower custom critical care sales. We expect a decrease in our sales to Hospira in 2008 compared to 2007 because the decline in critical care and custom critical care products will be only partially offset by the growth in custom I.V. systems, CLAVE and new oncology products.

 

Net sales to independent domestic distributors (including Canada) in the first quarter of 2008 and 2007 were $7.7 and $6.9 million, respectively, an increase of $0.8 million or 12%. This increase was primarily from increased sales in CLAVE of $0.4 million and custom products of $0.6 million from increased unit volume. We expect that sales to domestic distributors will increase principally from growth in CLAVE and custom products, with modest sales growth in other products, including new products, although there is no assurance that these expectations will be realized.

 

Net sales to international customers (excluding Canada) were $6.2 million in the first quarter of 2008, compared to $5.7 million in the first quarter of 2007, an increase of $0.5 million. This increase resulted primarily from $0.7 million of increased CLAVE sales, from increased unit volume. We expect increases in sales in 2008 compared to 2007 to international customers across most areas and principal product lines, although there is no assurance that these expectations will be realized.

 

Product and other revenue:  Net sales of CLAVE products were $18.3 million in the first quarter of 2008 compared to $17.1 million in the first quarter of 2007, an increase of $1.2 million or seven percent. This increase was primarily due to a 27% or $0.7 million increase in international sales and a 28% increase or $0.4 million increase in domestic distributer sales.

 

Net sales of custom products, which includes custom I.V. systems, custom critical care and custom oncology sales, were $14.9 million in the first quarter of 2008 compared to $15.3 million in the first quarter of 2007. New sales of custom oncology products of $0.9 million were offset by decreased sales in custom I.V. systems of $0.5 million and custom critical care products of $0.8 million. The decrease in custom I.V. system revenue was primarily due to lower unit sales. The decrease in custom critical care products was primarily due to lower unit sales and lower prices under the MCDA.

 

Critical care product sales were $7.4 million in the first quarter of 2008 compared to $12.4 million in the first quarter of 2007. This decrease was due to lower unit volume and lower prices under the MCDA. We expect further price decreases in 2009.

 

Our new oncology product sales, including custom oncology, were $1.3 million in the first quarter of 2008.

 

Other revenue consists of license, royalty and revenue share income and was approximately $1.0 million in the first quarters of 2008 and $1.2 million in the first quarter of 2007. We may receive other license fees or royalties in the future for the use of our technology. There is no assurance as to amounts or timing of any future payments, or whether such payments will be received.

 

Gross margin for the first quarter of 2008 and 2007 was 40% and 39%, respectively. The margin improvement on a year-over-year basis is attributable to improved efficiencies and productivity gains in our Salt Lake City and Mexico manufacturing facilities. These productivity gains were offset primarily by reduced plant operations in the last 10 days of December 2007 and early January 2008 in order to perform planned preventative maintenance, and this affected our gross margins by three and a half percentage points. Excluding this preventative maintenance, we would have achieved gross margins of 43% compared to 39% for the comparable period last year.

 

We estimate our gross margin in 2008 will approximate 45%. However, there is no assurance these expectations will be realized.

 

12



 

Selling, general and administrative expenses (“SG&A”) were $13.1 million, and were 29% of revenues in the first quarter of 2008, compared with $12.0 million and 25% in the first quarter of 2007. Increased compensation and benefit expenses of $0.8 million and moderate increases in sales and marketing promotional costs, travel and consulting costs of $0.7 million were offset by lower legal costs of $0.8 million. The higher compensation and benefits costs were primarily in incentive compensation and higher salary costs. The lower legal fees are primarily due to two legal actions being concluded in the first half of 2007. We expect SG&A in 2008 to approximate 26% of revenue. Increases in costs for sales personnel is expected to be more than offset by a significant decrease in expenses associated with patent and other litigation. There is no assurance that these expectations will be realized.

 

Research and development expenses (“R&D”) were $2.0 million or five percent of revenue in the first quarter of 2008 compared to $1.9 million or four percent of revenue in the first quarter of 2007. We expect R&D in 2008 to be four to five percent of revenue, although there is no assurance that these expectations will be realized.

 

Other income was $1.6 million of in the first quarter of 2008 and $9.4 million of income in the first quarter of 2007. Interest income was $1.1 million in the first quarters of 2008 and 2007, respectively. Other income in the first quarter of 2007 includes a $8.0 million payment to us for a settlement of litigation against a law firm that formerly represented us in patent litigation.

 

Income taxes were accrued at an effective tax rate of 31.0% in the first quarter of 2008 compared to 34% in the first quarter of 2007. The effective tax rate differs from that computed at the federal statutory rate of 35% principally because of, state income taxes, state credits, tax exempt incomes and deductions for Domestic Production Activities. We expect our effective rate to be approximately 31.0% in 2008.

 

Liquidity and Capital Resources

 

During the first quarter of 2008, our cash, cash equivalents and marketable securities increased by $3.5 million.

 

Operating Activities: Our cash provided by operating activities tends to increase over time because of our positive operating results. However, it is subject to fluctuations, principally from the impact of integrating new locations from acquisitions, changes in net income, accounts receivable, inventories, payment of trade and other liabilities and the timing of tax payments.

 

During the first quarter of 2008 cash provided by operations was $4.7 million. Cash flow from operations for the first quarter of 2008 was mainly comprised of $2.9 million of net income, depreciation and amortization of $3.4 million and net decreases in our operating assets and liabilities of $2.0 million.

 

Investing Activities:  During the first quarter of 2008, cash provided by investing activities was $22.0 million. This was principally comprised of $25.6 million in net investment proceeds, offset by purchases of property and equipment of $3.6 million which were primarily for equipment and mold additions.

 

We estimate that capital expenditures for all of 2008 will be approximately $20.0 million, which includes costs to build a manufacturing facility in China. Amounts of spending are estimates and actual spending may substantially differ from those amounts.

 

Financing Activities:   Cash provided by financing activities in the first quarter of 2008 was $2.8 million from the sale of 166,828 shares of our stock for stock options, including tax benefits, and the employee stock purchase plan.

 

We have a substantial cash and marketable security position generated from profitable operations and stock sales, principally from the exercise of employee stock options. We maintain this position to fund our growth, meet increasing working capital requirements, fund capital expenditures, and to take advantage of acquisition opportunities that may arise. Our primary investment goal is capital preservation, as further described in Item 3. Quantitative and Qualitative Disclosures about Market Risk.

 

Most of our marketable securities are invested in “auction rate securities.”  Our auction rate securities are tax exempt debt securities and corporate preferred securities. Auctions of these securities are conducted generally at seven to forty-nine day intervals, depending on the terms of the security, and the securities are bought or sold depending on the interest or dividend rates bid for the securities. Up until February 2008, the auction rate securities market was highly liquid. During the week of February 11, 2008, a substantial number of auctions “failed,” meaning that there was not enough demand to sell the

 

13



 

entire issue at auction; the immediate effect of a failed auction is that holders cannot sell the securities and the interest or dividend rate on the security generally resets to a “penalty” rate. If an auction fails, the ability of the holder of the security to liquidate the security would depend on the success of a subsequent auction, whether the issuer raises other financing to redeem the securities, or whether the holder is able to sell the securities to another party; there is no assurance that any of these events will occur. All of our securities are investment grade, and we do not expect any credit losses, but we may not be able to sell our securities to meet working capital needs. We have succeeded in selling some of these securities at par and are attempting to sell more at par, but there is no assurance as to when we will be able to sell additional securities and whether we will be able to sell them without incurring losses.

 

We are considering investment alternatives for the future. We intend to continue our objectives of avoiding credit and market risk, but there is no assurance that investment yield will be comparable, on an after-tax basis, to the yields on auction rate securities.

 

We believe that our existing cash, cash equivalents and marketable securities along with funds expected to be generated from future operations will provide us with sufficient funds to finance our current operations for the next twelve months.

 

Off Balance Sheet Arrangements

 

In the normal course of business, we have agreed to indemnify our officers and directors to the maximum extent permitted under Delaware law and to indemnify customers as to certain intellectual property matters related to sales of our products. There is no maximum limit on the indemnification that may be required under these agreements. We have never incurred, nor do we expect to incur, any liability for indemnification. Except for indemnification agreements, we do not have any “off balance sheet arrangements”.

 

Contractual Obligations

 

We have contractual obligations of approximately the amounts set forth in the table below. These amounts exclude purchase orders for goods and services for current delivery. The majority of our purchase orders are blanket purchase orders that represent an estimated forecast of goods and services. We do not have a commitment liability on the blanket purchase orders. Since we do not have the ability to separate out blanket purchase orders from non-blanket purchase orders for goods and services for current delivery, these amounts are excluded from the table below. The commitments under the MCDA are those to fund certain research and development to improve critical care products and develop new products for sale to Hopsira and to provide sales specialists focused on critical care. We believe that our existing cash and marketable securities along with funds expected to be generated from future operations will provide us with sufficient funds to meet commitments under all of our contractual obligations. There are no obligations past 2009. (In thousands)

 

 

 

2008

 

2009

 

MCDA

 

$

8,000

 

$

5,500

 

Property and equipment

 

2,934

 

 

Total

 

$

10,934

 

$

5,500

 

 

Forward Looking Statements

 

Various portions of this Report, including this Management’s Discussion and Analysis, describe trends in our business and finances that we perceive and state some of our expectations and beliefs about our future. These statements about the future are “forward looking statements,” and we identify them by using words such as “believe,” “expect,” “estimate,” “plan,” “will,” “continue,” “could,” “may,” and by similar expressions and statements about aims, goals and plans. The forward looking statements are based on the best information currently available to us and assumptions that we believe are reasonable, but we do not intend the statements to be representations as to future results. They include, among other things, statements about:

 

      future operating results and various elements of operating results, including future expenditures on sales and marketing and product development, future sales and unit volumes of products, future license, royalty and revenue share income, production costs, gross margins, litigation expense, SG&A, R&D expense, future costs of expanding our custom I.V. systems business, income, losses, cash flow, changes in working capital items such as receivables and inventory, selling prices, and income taxes;

 

14



 

      factors affecting operating results, such as shipments to specific customers, reduced dependence on current proprietary products, expansion in international markets, selling prices, future increases or decreases in sales of certain products and in certain markets and distribution channels, increases in systems capabilities, introduction and sales of new products, warranty claims, rebates, product returns, bad debt expense, inventory requirements, manufacturing efficiencies and cost savings, unit manufacturing costs;  establishment of production facilities outside the U.S., adequacy of production capacity, results of R&D, asset impairment losses, relocation of manufacturing facilities and personnel, effect of expansion of manufacturing facilities on production efficiencies and resolution of production inefficiencies, business seasonality and fluctuations in quarterly results, customer ordering patterns and the effects of new accounting pronouncements;

 

      new or extended contracts with manufacturers and buying organizations, dependence on a small number of customers, effect of the acquisition of Hospira’s Salt Lake City manufacturing facility and the manufacture of products for Hospira under the MCDA, cost savings and use of our systems and procedures under the MCDA, and the outcome of our strategic initiatives; regulatory approvals and compliance; outcome of litigation; competitive and market factors, including continuing development of competing products by other manufacturers, consolidation of the healthcare provider market and downward pressure on selling prices; future purchases of treasury stock; working capital requirements; liquidity and realizable value of our marketable securities, outcome of future auctions of auction rate securities, future investment alternatives, foreign currency denominated financial instruments; capital expenditures; acquisitions of other businesses or product lines; indemnification liabilities; contractual liabilities.

 

The kinds of statements described above and similar forward looking statements about our future performance are subject to a number of risks and uncertainties which one should consider in evaluating the statements. First, one should consider the factors and risks described in the statements themselves. Those factors are uncertain, and if one or more of them turn out differently than we currently expect, our operating results may differ materially from our current expectations.

 

Second, one should read the forward looking statements in conjunction with the Risk Factors in Item 1A of our 2007 Annual Report to the Securities and Exchange Commission (SEC). Also, our actual future operating results are subject to other important factors that we cannot predict or control, including among others the following:

 

      general economic and business conditions;

      the effect of price and safety considerations on the healthcare industry;

      competitive factors, such as product innovation, new technologies, marketing and distribution strength and price erosion;

      unanticipated market shifts and trends;

      the impact of legislation affecting government reimbursement of healthcare costs;

      changes by our major customers and independent distributors in their strategies that might affect their efforts to market our products;

      unanticipated production problems; and

      the availability of patent protection and the cost of enforcing and of defending patent claims.

 

We disclaim any obligation to update the statements or to announce publicly the result of any revision to any of the statements contained herein to reflect future events or developments.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

We have a portfolio of corporate preferred stocks and federal-tax-exempt state and municipal government debt securities of $61.5 million as of March 31, 2008. The securities are all “investment grade” and we believe that we have virtually no exposure to credit risk. Dividend and interest rates reset at auction for most of the securities at seven to forty-nine day intervals so we have very little market risk, that is, risk that the fair value of the security will change because of changes in market interest rates. As of March 31, 2008, we had declines o f $0.6 million in the market values of these securities.

 

Up until early February 2008, the market for our securities was highly liquid. Liquidity has been substantially impaired since then. See Part I, Item 1A. Risk Factors in our 2007 Annual Report to the SEC We could be adversely affected by turbulence in the credit markets and Part I, Item 7. Management Discussion and Analysis of Financial Condition and Results of Operations, Liquidity and Capital Resources, Financing Activities. We intend to continue our objectives of

 

15



 

avoiding credit and market risk in the future.

 

Our future earnings are subject to potential increase or decrease because of changes in short-term interest rates. Generally, each one-percentage point change in the discount rate will cause our overall yield to change by two-thirds to three-quarters of a percentage point, depending upon the relative mix of federal-tax-exempt securities and corporate preferred stocks in the portfolio and market conditions specific to the securities in which we invest.

 

Foreign currency exchange risk for financial instruments on our balance sheet, which consist of cash, accounts receivable and accounts payable, is not significant to our financial statements. Sales from the U.S. and Mexico to foreign distributors are all denominated in U.S. dollars. We have manufacturing, sales and distribution facilities in several countries and we conduct business transactions denominated in various foreign currencies, principally the Euro and Mexican Peso. Cash and receivables in those countries have been insignificant and are generally offset by accounts payable and accruals in the same foreign currency, except for Italy, where our net Euro asset position at March 31, 2008 was approximately €5.1 million. We expect that in the future, with the growth of our European distribution operation, that net Euro denominated instruments will continue to increase. We currently do not hedge our foreign currency exposures.

 

Our exposure to commodity price changes relates primarily to certain manufacturing operations that use resin, a petroleum-based raw material. We manage our exposure to changes in those prices through our procurement and supply chain management practices and the effect of price changes has not been material. We are not dependent upon any single source for any of our principal raw materials and all such materials and products are readily available.

 

Item 4.    Controls and Procedures

 

Disclosure Controls and Procedures

 

Our principal executive officer and principal financial officer have concluded, based on their evaluation of our disclosure controls and procedures (as defined in Regulations 13a-14(c) and 15a-14(c) under the Securities Exchange Act of 1934) as of the end of the period covered by this Report, that our disclosure controls and procedures are effective to ensure that the information we are required to disclose in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure and that such information is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities Exchange Commission. There were no significant changes in our internal controls or in other factors that could significantly affect our internal controls subsequent to the date of the principal executive officer’s and principal financial officer’s evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

16



 

PART II
OTHER INFORMATION

 

Item 1. Legal Proceedings

 

We have not been required to pay any penalty to the IRS for failing to make disclosures required with respect to certain transactions that have been identified by the IRS as abusive or that have a significant tax avoidance purpose.

 

In an action filed June 16, 2004 entitled ICU Medical, Inc. v. Alaris Medical Systems, Inc. in the United States District Court for the Central District of California, we alleged that Alaris infringes ICU’s patent through the manufacture and sale of the SmartSite and SmartSite Plus Needle-Free Valves and Systems.  On August 2, 2004 the Court denied our request for a preliminary injunction.  On December 27, 2004, we amended our complaint to allege that Alaris infringes three additional patents.  On July 17, 2006, the Court issued an order interpreting certain claims in the asserted patents in a manner that, if upheld, could significantly impair our ability to enforce those patents against Alaris and potentially others.  The Court also issued partial summary judgment in favor of Alaris based on one of those interpretations.  On January 22, 2007, the Court granted Alaris’ summary judgment motion of invalidity as to the remaining claims asserted against Alaris and on February 22, 2007, the Court entered judgment dismissing those remaining claims.  The Court’s order affected only the asserted claims of the patents in suit, not other claims in the patents. Following entry of the judgment dismissing our case, the Court heard Alaris’ motion to recover its fees, costs and expenses, and on April 16, 2007, the Court granted in part Alaris’ motion.  On June 28, 2007, the Court awarded Alaris $4.8 million in fees and costs, which were later increased to $5.0 million, plus post judgment interest.  We have appealed the Court’s decisions. Because the award of fees and costs is a judgment against us and the outcome of the appeal is uncertain, we recorded a charge of $4.8 million in our financial statements for the quarter ended June 30, 2007.   We have not paid the judgment, pending outcome of the appeal.

 

In an action filed July 6, 2006 entitled Medegen MMS, Inc. v. ICU Medical, Inc. filed in the United States District Court for the Central District of California, Medegen alleged that ICU Medical infringed one of its patents by offering for sale and selling the CLC2000 and TEGO. Medegen sought monetary damages and injunctive relief.  In March 2007, Medegen withdrew its action as to the TEGO.  On June 21, 2007, the Court issued an order interpreting certain terms and phrases of Medegen’s patent in a manner that we believe supported our position.  On September 14, 2007, the Court issued an order granting our summary judgment motion of non-infringement and entered judgment of non-infringement, dismissing Medegen’s case with prejudice, on October 19, 2007. On October 19, 2007, the Court also dismissed, without prejudice, our counterclaims that the asserted patent is invalid and unenforceable due to inequitable conduct by Medegen before the United States Patent and Trademark Office. Medegen has appealed the Court’s claim construction and summary judgment orders. We intend to defend ourselves in the appeal and to vigorously pursue our claims against Medegen.

 

In an action filed July 27, 2007 entitled ICU Medical, Inc. v. RyMed Technologies, Inc. (“RyMed”), in the United States District Court for the District of Delaware, we alleged that RyMed infringes certain of ICU’s patents through the manufacture and sale of certain products, including its InVision-Plus valves.  We seek monetary damages and injunctive relief and intend to vigorously pursue this matter.  RyMed has denied our allegations and sued us in the United States District Court for the Central District of California seeking a declaratory judgment of non-infringement and invalidity of our patents and alleging that we have infringed RyMed’s trademark and engaged in unfair competition and other improper conduct. RyMed seeks monetary damages and injunctive relief. ICU has moved to dismiss RyMed’s California case and will continue to defend ourselves vigorously in this action.

 

We are from time to time involved in various other legal proceedings, either as a defendant or plaintiff, most of which are routine litigation in the normal course of business. We believe that the resolution of the legal proceedings in which we are involved will not have a material adverse effect on our financial position or results of operations.

 

Item 1A. Risk Factors.

 

In evaluating an investment in our common stock, investors should consider carefully, among other things, the risk factors previously disclosed in Part II, Item 1A of our Annual Report to the Securities and Exchange Commission for the year ended December 31, 2007, as well as the information contained in this Quarterly Report and our other reports and registration statements filed with the Securities and Exchange Commission. There have been no material changes in the risk factors as previously disclosed under “Risk Factors” in Part II, Item 1A of our Annual Report to the Securities and Exchange Commission for the year ended December 31, 2007.

 

17



 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

Inapplicable

 

Item 3. Default Upon Senior Securities

 

Inapplicable

 

Item 4. Submission of Matters to a Vote of Security Holders

 

Inapplicable

 

Item 5. Other Information

 

None

 

Item 6. Exhibits

 

Exhibit 31.1

 

Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

Exhibit 31.2:

 

Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

Exhibit 32:

 

Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

Exhibit 100.INS

 

XBRL Instance Document

 

 

 

Exhibit 100.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

Exhibit 100.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

Exhibit 100.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

Exhibit 100.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

18



 

Signature

 

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.

 

 

ICU Medical, Inc.

(Registrant)

 

 

/s/ Scott E. Lamb

 

Date: May 1, 2008

Scott E. Lamb

 

 

Chief Financial Officer

 

 

(Principal Financial Officer)

 

 

 

19


EX-31.1 2 a08-12227_1ex31d1.htm EX-31.1

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002

 

I, George A. Lopez, certify that:

 

1.                                       I have reviewed this quarterly report on Form 10-Q of ICU Medical, Inc.:

 

2.                                       Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.                                       Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.                                       The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:

 

a)                                      designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)                                     designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)                                      evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)                                     disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                                       The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

a)              all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)             any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 1, 2008

 

/s/ George A. Lopez, M.D.

 

 

     Chief Executive Officer

 


EX-31.2 3 a08-12227_1ex31d2.htm EX-31.2

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002

 

I, Scott E. Lamb, certify that:

 

1.               I have reviewed this quarterly report on Form 10-Q of ICU Medical, Inc.:

 

2.               Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.               Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.               The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:

 

a)              designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b)             designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c)              evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d)             disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.               The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

 

a)              all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b)             any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 1, 2008

 

/s/ Scott E. Lamb

 

 

     Chief Financial Officer

 


EX-32 4 a08-12227_1ex32.htm EX-32

Exhibit 32

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of ICU Medical, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2008 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, George A. Lopez, Chief Executive Officer, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

May 1, 2008

 

/s/ George A. Lopez, M.D.

 

 

     George A. Lopez, M.D.

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of ICU Medical, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2008 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Scott E. Lamb, Chief Financial Officer, certify pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

 

May 1, 2008

 

/s/ Scott E. Lamb

 

 

     Scott E. Lamb

 

 


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