0000883984-21-000024.txt : 20210804 0000883984-21-000024.hdr.sgml : 20210804 20210804161317 ACCESSION NUMBER: 0000883984-21-000024 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20210804 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20210804 DATE AS OF CHANGE: 20210804 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: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34634 FILM NUMBER: 211144163 BUSINESS ADDRESS: STREET 1: 951 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92763-6212 BUSINESS PHONE: 949-366-2183 MAIL ADDRESS: STREET 1: 951 CALLE AMANECER CITY: SAN CLEMENTE STATE: CA ZIP: 92763-6212 8-K 1 icui-20210804.htm 8-K icui-20210804
falseICU MEDICAL INC/DE000088398400008839842021-08-042021-08-04

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) August 4, 2021

ICU MEDICAL, INC.

(Exact name of registrant as specified in its charter)
Delaware001-3463433-0022692
(State or other jurisdiction
of incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
951 Calle Amanecer,San Clemente,California92673
(Address of principal executive offices)(Zip Code)

(949) 366-2183
Registrant's telephone number, including area code

N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading SymbolName of each exchange on which registered
Common stock, par value $0.10 per shareICUIThe Nasdaq Stock Market LLC
(Global Select Market)
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.





Item 2.02. Results of Operations and Financial Condition

    On August 4, 2021, ICU Medical, Inc. issued a press release announcing its earnings financial results for the second quarter of 2021. A copy of this earnings press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated in Item 2.02 by reference.
     
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
Press release, dated August 4, 2021 announcing ICU Medical, Inc.'s second quarter 2021 earnings.
104
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).




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 hereunto duly authorized.
 
    ICU MEDICAL, INC.
Date: August 4, 2021  By: /s/ Brian M. Bonnell
   Brian M. Bonnell
   Chief Financial Officer and Treasurer


EX-99.1 2 exhibit991q22021er.htm EX-99.1 Document

Exhibit 99.1
ICU Medical, Inc. Announces Second Quarter 2021 Results

Company Updated FY 2021 Guidance

SAN CLEMENTE, Calif., August 4, 2021 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products used in infusion therapy and critical care applications, today announced financial results for the quarter ended June 30, 2021.

Second Quarter 2021 Results

Second quarter 2021 revenue was $321.7 million, compared to $303.4 million in the same period last year. GAAP gross profit for the second quarter of 2021 was $123.5 million, as compared to $106.3 million in the same period last year. GAAP gross margin for the second quarter of 2021 was 38%, as compared to 35% in the same period last year. GAAP net income for the second quarter of 2021 was $28.4 million, or $1.31 per diluted share, as compared to GAAP net income of $18.9 million, or $0.88 per diluted share, for the second quarter of 2020. Adjusted diluted earnings per share for the second quarter of 2021 were $1.88 as compared to $1.65 for the second quarter of 2020. Also, adjusted EBITDA was $66.9 million for the second quarter of 2021 as compared to $58.1 million for the second quarter of 2020.

Adjusted EBITDA and adjusted diluted earnings per share are measures calculated and presented on the basis of methodologies other than in accordance with GAAP. Please refer to the Use of Non-GAAP Financial Information following the financial statements herein for further discussion and reconciliations of these measures to GAAP measures.

Vivek Jain, ICU Medical’s Chief Executive Officer, said, “Second quarter results were generally in line with our expectations.”

Revenues by product line for the three and six months ended June 30, 2021 and 2020 were as follows (in millions):
Three months ended
June 30,
Six months ended
June 30,
Product Line20212020$ Change20212020$ Change
Infusion Consumables$136.2$111.0$25.2$262.6$234.5$28.1
Infusion Systems84.791.1(6.4)169.0179.5(10.5)
IV Solutions*88.489.2(0.8)182.6193.5(10.9)
Critical Care12.412.10.325.524.51.0
$321.7$303.4$18.3$639.7$632.0$7.7
*IV Solutions includes $10.4 million and $24.3 million of contract manufacturing to Pfizer for the three and six months ended June 30, 2021, respectively, as compared to $15.5 million and $ 29.0 million for the three and six months ended June 30, 2020, respectively.

Fiscal Year 2021 Guidance Update

The Company is updating its full year 2021 guidance of adjusted EBITDA from a range of $245 million to $265 million to a range of $250 million to $260 million and adjusted diluted earnings per share from a range of $6.50 to $7.20 to a range of $6.80 to $7.20.

Conference Call

The Company will host a conference call to discuss second quarter 2021 financial results on the Company, today at 4:30 p.m. EDT (1:30 p.m. PDT). The call can be accessed at (866) 248-8441 or international (408) 774-4587. The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website at icumed.com, clicking on the Investors tab, clicking on Event Calendar and clicking on the Webcast icon and following the prompts. The webcast will also be available by replay.

About ICU Medical, Inc.

ICU Medical, Inc. (Nasdaq:ICUI) develops, manufactures and sells innovative medical products used in infusion therapy, and critical care applications. ICU Medical's product portfolio includes IV smart pumps, sets, connectors, closed system transfer devices for hazardous drugs, sterile IV solutions, cardiac monitoring systems, along with pain management and safety software



technology designed to help meet clinical, safety and workflow goals. ICU Medical is headquartered in San Clemente, California. More information about ICU Medical, Inc. can be found at www.icumed.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ''will,'' ''expect,'' ''believe,'' ''could,'' ''would,'' ''estimate,'' ''continue,'' ''build,'' ''expand'' or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company's expectations, goals or intentions regarding the future. These forward-looking statements are based on management's current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company's products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of growth or improving efficiencies, unexpected changes in the Company's arrangements with its largest customers and the impact of the ongoing COVID-19 pandemic on the Company and our financial results. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company's filings with the Securities and Exchange Commission, which include those in the Company's most recent Annual Report on Form 10-K and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.



ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
 June 30,
2021
December 31,
2020
 (Unaudited)(1)
ASSETS  
CURRENT ASSETS:  
Cash and cash equivalents$462,037$396,097
Short-term investment securities14,66114,687
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES476,698410,784
Accounts receivable, net of allowance for doubtful accounts 120,782124,093
Inventories299,610314,928
Prepaid income taxes38,28529,480
Prepaid expenses and other current assets37,97941,492
TOTAL CURRENT ASSETS973,354920,777
PROPERTY AND EQUIPMENT, net458,785466,628
OPERATING LEASE RIGHT-OF-USE ASSETS43,31546,571
LONG-TERM INVESTMENT SECURITIES15,67012,974
GOODWILL32,92733,001
INTANGIBLE ASSETS, net189,620197,231
DEFERRED INCOME TAXES31,12031,034
OTHER ASSETS58,05155,475
TOTAL ASSETS$1,802,842$1,763,691
LIABILITIES AND STOCKHOLDERS’ EQUITY  
CURRENT LIABILITIES:  
Accounts payable$69,782$71,864
Accrued liabilities85,28397,021
Income tax payable2,299303
Contingent earn-out liability26,30026,300
TOTAL CURRENT LIABILITIES183,664195,488
OTHER LONG-TERM LIABILITIES42,95147,835
DEFERRED INCOME TAXES1,6631,663
INCOME TAX PAYABLE17,29916,440
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY:  
Convertible preferred stock, $1.00 par value Authorized—500 shares; Issued and outstanding— none
Common stock, $0.10 par value — Authorized, 80,000 shares; Issued — 21,219 shares at June 30, 2021 and 21,058 at December 31, 2020 and outstanding 21,208 shares at June 30, 2021 and 21,058 shares at December 31, 20202,1222,106
Additional paid-in capital705,582693,068
Treasury stock, at cost(2,269)(39)
Retained earnings860,781808,652
Accumulated other comprehensive loss(8,951)(1,522)
TOTAL STOCKHOLDERS' EQUITY1,557,2651,502,265
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$1,802,842$1,763,691
______________________________________________________
(1) December 31, 2020 balances were derived from audited consolidated financial statements.



ICU MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
Three months ended
June 30,
Six months ended
June 30,
2021202020212020
TOTAL REVENUES$321,677$303,379$639,723$631,986
COST OF GOODS SOLD198,148197,095403,514404,287
GROSS PROFIT123,529106,284236,209227,699
OPERATING EXPENSES:  
Selling, general and administrative73,92167,242146,312139,547
Research and development11,38510,27922,09421,025
Restructuring, strategic transaction and integration3,7536,4826,63618,789
Change in fair value of contingent earn-out2,7002,700
Contract settlement2512725
TOTAL OPERATING EXPENSES89,05986,728175,169182,086
INCOME FROM OPERATIONS34,47019,55661,04045,613
INTEREST EXPENSE(163)(771)(324)(967)
OTHER INCOME (EXPENSE), net5252,0531,208(3,427)
INCOME BEFORE INCOME TAXES34,83220,83861,92441,219
PROVISION FOR INCOME TAXES(6,434)(1,930)(9,795)(5,477)
NET INCOME$28,398$18,908$52,129$35,742
NET INCOME PER SHARE  
Basic$1.34$0.91$2.46$1.72
Diluted $1.31$0.88$2.40$1.66
WEIGHTED AVERAGE NUMBER OF SHARES  
Basic21,20020,88021,17620,831
Diluted 21,70321,50621,71821,545













Use of Non-GAAP Financial Information

This press release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles ("GAAP"). The non-GAAP financial measures should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. There are material limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may not be comparable to similarly titled non-GAAP financial measures used by other companies, including peer companies. Our management believes that the non-GAAP data provides useful supplemental information to management and investors regarding our performance and facilitates a more meaningful comparison of results of operations between current and prior periods. We use non-GAAP financial measures in addition to and in conjunction with GAAP financial measures to analyze and assess the overall performance of our business, in making financial, operating and planning decisions, and in determining executive incentive compensation. The non-GAAP financial measures included in this press release are adjusted EBITDA and adjusted diluted earnings per share ("Adjusted Diluted EPS").

Adjusted EBITDA excludes the following items from net income:

Interest, net: We exclude interest in deriving adjusted EBITDA as interest can vary significantly among companies depending on a company's level of income generating instruments and/or level of debt.

Stock compensation expense: Stock-based compensation is generally fixed at the time the stock-based instrument is granted and amortized over a period of several years. The value of stock options is determined using a complex formula that incorporates factors, such as market volatility, that are beyond our control. The value of our restricted stock awards is determined using the grant date stock price, which may not be indicative of our operational performance over the expense period. Additionally, in order to establish the fair value of performance-based stock awards, which are currently an element of our ongoing stock-based compensation, we are required to apply judgment to estimate the probability of the extent to which performance objectives will be achieved. Based on the above factors, we believe it is useful to exclude stock-based compensation in order to better understand our operating performance.

Intangible asset amortization expense: We do not acquire businesses or capitalize certain patent costs on a predictable cycle. The amount of purchase price allocated to intangible assets and the term of amortization can vary significantly and are unique to each acquisition. Capitalized patent costs can vary significantly based on our current level of development activities. We believe that excluding amortization of intangible assets provides the users of our financial statements with a consistent basis for comparison across accounting periods.

Depreciation expense: We exclude depreciation expense in deriving adjusted EBITDA because companies utilize productive assets of different ages and the depreciable lives can vary significantly resulting in considerable variability in depreciation expense among companies.

Restructuring, strategic transaction and integration: We incur restructuring and strategic transaction charges that result from events, which arise from unforeseen circumstances and/or often occur outside of the ordinary course of our ongoing business. Although these events are reflected in our GAAP financial statements, these unique transactions may limit the comparability of our ongoing operations with prior and future periods.

Change in fair value of contingent earn-out: We exclude the impact of certain amounts recorded in connection with business combinations. We exclude items that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing.

Contract settlement: Occasionally, we are involved in contract renegotiations that may result in one-time settlements. We exclude these settlements as they have no direct correlation to the operation of our ongoing business.

Taxes: We exclude taxes in deriving adjusted EBITDA as taxes are deemed to be non-core to the business and may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

Adjusted Diluted EPS excludes from diluted EPS, net of tax, stock compensation expense, intangible asset amortization expense, restructuring, strategic transaction and integration and contract settlement. The tax effect on the above adjustments is calculated using the specific tax rate applied to each adjustment based on the nature of the item/or the tax jurisdiction in which the item has been recorded.




From time to time in the future, there may be other items that we may exclude if we believe that doing so is consistent with the goal of providing useful information to investors and management.

The following tables reconcile our GAAP and non-GAAP financial measures:






ICU MEDICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)
(In thousands)
 Adjusted EBITDA
Three months Ended
June 30,
20212020
GAAP net income$28,398$18,908
Non-GAAP adjustments:
Interest, net(545)(161)
Stock compensation expense6,6815,410
Depreciation and amortization expense22,16421,618
Restructuring, strategic transaction and integration3,7536,482
Change in fair value of contingent earn-out2,700
Contract settlement1,210
Provision for income taxes6,4341,930
Total non-GAAP adjustments38,48739,189
 Adjusted EBITDA $66,885$58,097
 Adjusted diluted earnings per share
Three months ended
June 30,
20212020
 GAAP diluted earnings per share$1.31$0.88
 Non-GAAP adjustments:
Stock compensation expense$0.31$0.25
Amortization expense$0.27$0.27
Restructuring, strategic transaction and integration$0.17$0.30
Change in fair value of contingent earn-out$$0.13
Contract settlement$$0.06
Estimated income tax impact from adjustments$(0.18)$(0.24)
 Adjusted diluted earnings per share$1.88$1.65





ICU Medical, Inc. and Subsidiaries
Reconciliation of GAAP to Non-GAAP Financial Measures - Fiscal Year 2021 Outlook (Unaudited)
(In millions, except per share data)

Low End of GuidanceHigh End of Guidance
GAAP net income$97$106
Non-GAAP adjustments:
Interest, net(2)(2)
Stock compensation expense2626
Depreciation and amortization expense9090
Restructuring, strategic transaction and integration1515
Change in fair value of contingent earn-out
Provision for income taxes2425
Total non-GAAP adjustments$153$154
Adjusted EBITDA$250$260
GAAP diluted earnings per share$4.48$4.88
Non-GAAP adjustments:
Stock compensation expense$1.17$1.17
Amortization expense$1.07$1.07
Restructuring, strategic transaction and integration$0.69$0.69
Change in fair value of contingent earn-out$0.01$0.01
Estimated income tax impact from adjustments$(0.62)$(0.62)
Adjusted diluted earnings per share$6.80$7.20


CONTACT:
ICU Medical, Inc.
Brian Bonnell, Chief Financial Officer
(949) 366-2183
ICR, Inc.
John Mills, Partner
(646) 277-1254

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