ICU Medical Announces Third Quarter 2024 Results and Updates Its Fiscal Year 2024 Guidance

ICUI 11.12.2024

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SAN CLEMENTE, Calif.,Nov. 12, 2024(GLOBE NEWSWIRE) --ICU Medical, Inc.(Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced financial results for the quarterly period endedSeptember 30, 2024.

Third Quarter 2024 Results

Third quarter 2024 revenue was$589.1 million, as compared to$553.3 millionin the same period in the prior year. GAAP gross profit for the third quarter of 2024 was$204.9 million, as compared to$183.9 millionin the same period in the prior year. GAAP gross margin for the third quarter of 2024 was 34.8%, as compared to 33.2% in the same period in the prior year. GAAP net loss for the third quarter of 2024 was$(33.0) million, or$(1.35)per diluted share, as compared to GAAP net income of$7.2 million, or$0.30per diluted share, for the third quarter of 2023. Adjusted diluted earnings per share for the third quarter of 2024 was$1.59as compared to$1.57for the third quarter of 2023. Adjusted EBITDA was$94.8 millionfor the third quarter of 2024 as compared to$89.8 millionfor the third quarter of 2023.

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, “Third quarter results were generally in line with our expectations."

Revenues by product line for the three and nine months endedSeptember 30, 2024and 2023 were as follows (in millions):

Three months endedSeptember 30,Nine months endedSeptember 30,
Product Line20242023$ Change20242023$ Change
Consumables$264.9$242.0$22.9$770.7$715.1$55.6
Infusion Systems159.8149.010.8480.7463.916.8
Vital Care*164.5162.32.2500.8492.38.5
Total**$589.2$553.3$35.9$1,752.2$1,671.3$80.9

*Vital Care includes Pfizer contract manufacturing revenue of$9.1 millionand$38.6 millionfor the three and nine months endedSeptember 30, 2024, respectively, as compared to$6.7 millionand$33.6 millionfor the three and nine months endedSeptember 30, 2023.** Totals may differ from the income statement due to the rounding of product lines.

Fiscal Year 2024 Guidance

For Fiscal Year 2024 the Company updated its estimates of GAAP net loss from a range of$(118)to$(108)to a range of$(130)to$(122)and GAAP diluted loss per share from a range of$(4.78)to$(4.38)to a range of$(5.28)to$(4.98). The Company updated the estimated range of its full year 2024 guidance of adjusted EBITDA from a range of$345 millionto$365 millionto a range of$355 millionto$365 millionand updated the estimated range of diluted earnings per share from a range of$4.95to$5.35to a range of$5.40to$5.70.

Conference Call

The Company will host a conference call to discuss its third quarter 2024 financial results, today at4:30 p.m. ET(1:30 p.m. PT). The call can be accessed at (800) 343-5172, conference ID "ICUMED". The conference call will be simultaneously available by webcast, which can be accessed by going to the Company's website atwww.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.

AboutICU Medical

ICU Medical(Nasdaq: ICUI) is a global leader in infusion systems, infusion consumables and high-value critical care products used in hospital, alternate site and home care settings. Our team is focused on providing quality, innovation and value to our clinical customers worldwide.ICU Medicalis headquartered inSan Clemente, California. More information aboutICU Medicalcan be found atwww.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 and 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, 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, the impact from fluctuations in foreign currency exchange rates, the impact of inflation on raw materials, freight charges and labor, rising interest rates, and the Company's ability to meet expectations regarding the ongoing integration of theSmiths Medicalbusiness. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company's filings with theSecurities and Exchange Commission("SEC"), which include those in the Company's most recent Annual Report on Form 10-K for the fiscal year endedDecember 31, 2023, and our subsequent filings with theSEC. 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 unless required by law.

ICU MEDICAL, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)(In thousands)
September 30,2024December 31,2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$312,512$254,222
Short-term investment securities—501
TOTAL CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENT SECURITIES312,512254,723
Accounts receivable, net of allowance for doubtful accounts173,983161,566
Inventories692,038709,360
Prepaid income taxes5,78721,983
Prepaid expenses and other current assets73,73573,640
TOTAL CURRENT ASSETS1,258,0551,221,272
PROPERTY, PLANT AND EQUIPMENT, net595,627612,909
OPERATING LEASE RIGHT-OF-USE ASSETS59,75769,909
GOODWILL1,478,2931,472,446
INTANGIBLE ASSETS, net785,823870,588
DEFERRED INCOME TAXES40,64637,295
OTHER ASSETS86,83794,020
TOTAL ASSETS$4,305,038$4,378,439
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable$168,562$150,030
Accrued liabilities325,728268,215
Current portion of long-term debt51,00051,000
Income tax payable2,7677,714
Contingent earn-out liability1,5004,879
TOTAL CURRENT LIABILITIES549,557481,838
CONTINGENT EARN-OUT LIABILITY—3,991
LONG-TERM DEBT1,543,3421,577,770
OTHER LONG-TERM LIABILITIES80,389100,497
DEFERRED INCOME TAXES48,53855,873
INCOME TAX LIABILITY34,62535,060
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY:
Convertible preferred stock,$1.00par value; Authorized — 500 shares; Issued and outstanding — none——
Common stock,$0.10par value; Authorized — 80,000 shares; Issued —24,461 and 24,144 shares atSeptember 30, 2024andDecember 31, 2023, respectively, and outstanding — 24,459 and 24,141 shares atSeptember 30, 2024andDecember 31, 2023, respectively2,4462,414
Additional paid-in capital1,394,7991,366,493
Treasurystock, at cost(208)(262)
Retained earnings713,986807,846
Accumulated other comprehensive loss(62,436)(53,081)
TOTAL STOCKHOLDERS' EQUITY2,048,5872,123,410
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY$4,305,038$4,378,439

ICU MEDICAL, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In thousands, except per share data)
Three months endedSeptember 30,Nine months endedSeptember 30,
2024202320242023
TOTAL REVENUES$589,131$553,311$1,752,241$1,671,270
COST OF GOODS SOLD384,279369,3911,154,7171,102,982
GROSS PROFIT204,852183,920597,524568,288
OPERATING EXPENSES:
Selling, general and administrative162,707148,609479,913452,076
Research and development21,02820,87066,26062,933
Restructuring, strategic transaction and integration16,8287,16050,06930,527
Change in fair value of contingent earn-out(3,947)(15,572)(3,991)(12,256)
TOTAL OPERATING EXPENSES196,616161,067592,251533,280
INCOME FROM OPERATIONS8,23622,8535,27335,008
INTEREST EXPENSE, net(24,683)(24,175)(72,296)(70,811)
OTHER EXPENSE, net(1,481)(4,044)(7,206)(5,815)
LOSS BEFORE INCOME TAXES(17,928)(5,366)(74,229)(41,618)
(PROVISION) BENEFIT FOR INCOME TAXES(15,055)12,604(19,631)29,110
NET (LOSS) INCOME$(32,983)$7,238$(93,860)$(12,508)
NET (LOSS) INCOME PER SHARE
Basic$(1.35)$0.30$(3.85)$(0.52)
Diluted$(1.35)$0.30$(3.85)$(0.52)
WEIGHTED AVERAGE NUMBER OF SHARES
Basic24,43824,13224,35324,075
Diluted24,43824,36824,35324,075

ICU MEDICAL, INC.AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)(In thousands)
Nine months endedSeptember 30,
20242023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss$(93,860)$(12,508)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization166,519171,615
Noncash lease expense16,00816,543
Provision for doubtful accounts1,381865
Provision for warranty, returns and field action1,8015,597
Stock compensation34,36629,878
Loss on disposal of property, plant and equipment and other assets1841,757
Debt issuance costs amortization5,1115,108
Change in fair value of contingent earn-out liability(3,991)(12,256)
Usage of spare parts13,96513,587
Other7,2564,407
Changes in operating assets and liabilities, net of amounts acquired:
Accounts receivable(11,517)43,086
Inventories9,416(66,662)
Prepaid expenses and other current assets(11,188)11,295
Other assets(17,540)(18,860)
Accounts payable21,086(65,049)
Accrued liabilities20,484(10,532)
Income taxes, including excess tax benefits and deferred income taxes4,360(42,939)
Net cash provided by operating activities163,84174,932
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant and equipment(55,292)(53,956)
Proceeds from sale of assets6951,481
Intangible asset additions(8,317)(7,742)
Proceeds from sale and maturities of investment securities5002,920
Net cash used in investing activities(62,414)(57,297)
CASH FLOWS FROM FINANCING ACTIVITIES:
Principal repayments of long-term debt(38,250)(22,250)
Proceeds from exercise of stock options5,8834,022
Payments on finance leases(775)(681)
Payments of contingent earn-out liability(2,600)—
Tax withholding payments related to net share settlement of equity awards(11,867)(9,221)
Net cash used in financing activities(47,609)(28,130)
Effect of exchange rate changes on cash4,472(1,097)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS58,290(11,592)
CASH AND CASH EQUIVALENTS, beginning of period254,222208,784
CASH AND CASH EQUIVALENTS, end of period$312,512$197,192

Use of Non-GAAP Financial Information

This press release contains financial measures that are not calculated in accordance withU.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 include adjusted EBITDA, adjusted revenue, adjusted gross profit, adjusted selling, general and administrative, adjusted research and development, adjusted restructuring, strategic transaction and integration, adjusted change in fair value of contingent earn-out, adjusted (loss) income from operations, adjusted other expense, net, adjusted (loss) income before income taxes, adjusted (provision) benefit for income taxes, adjusted net (loss) income and adjusted diluted (loss) earnings per share, all of which exclude special items because they are highly variable or unusual and impact year-over-year comparisons.

For the three months endedSeptember 30, 2024and 2023, special items include the following:

Contract manufacturing: We manufacture certain products for Pfizer in accordance with a manufacturing services agreement. We do not include the contract revenue in our adjusted revenue as the commercial relationship under this agreement was originally negotiated contemporaneously with a business combination and is not indicative of a normal market transaction.

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.

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.

Quality system and product-related remediation:We exclude certain quality system and product-related remediation charges in determining our non-GAAP financial measures as they may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

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

Asset write-offs and similar charges: Occasionally, we may write-off certain assets or we may sell certain assets. We exclude the non-cash gain/loss on the write-off/sale of these assets in determining our non-GAAP financial measures as they may limit the comparability of our ongoing operations with prior and future periods and distort the evaluation of our normal operating performance.

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.

In addition to the above special items, Adjusted EBITDA additionally excludes the following items from net income:

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.

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.

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, the special items listed above. The tax effect on the special items 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. Additionally, adjusted diluted EPS may exclude the income tax impact of certain non-recurring discrete tax items that are not reflective of income tax expense/benefit incurred as a result of current period earnings/ loss, as well as the impact of certain deferred tax valuation allowances when assessed against non-GAAP profitability.

We also present Free cash flow as a non-GAAP financial measure as management believes that this is an important measure for use in evaluating overall company financial performance as it measures our ability to generate additional cash flow from business operations. Free cash flow should be considered in addition to, rather than as a substitute for, net income as a measure of our performance or net cash provided by operating activities as a measure of our liquidity. Additionally, our definition of free cash flow is limited and does not represent residual cash flows available for discretionary expenditures due to the fact that the measure does not deduct the payments required for debt service and other obligations or payments made for business acquisitions. Therefore, we believe it is important to view free cash flow as supplemental to our entire statement of cash flows.

The following tables reconcile our non-GAAP financial measures for the periods presented:

ICU MEDICAL, INC. AND SUBSIDIARIESReconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(In thousands, except per share data)
Adjusted EBITDA
Three months endedSeptember 30,
20242023
GAAP net (loss) income$(32,983)$7,238
Non-GAAP adjustments:
Interest, net24,68324,175
Stock compensation expense11,77010,947
Depreciation and amortization expense55,67558,371
Restructuring, strategic transaction and integration16,8287,160
Change in fair value of contingent earn-out(3,947)(15,572)
Quality system and product-related charges7,7374,016
Asset write-offs and similar charges—6,083
Legal settlement20—
Provision (Benefit) for income taxes15,055(12,604)
Total non-GAAP adjustments127,82182,576
Adjusted EBITDA$94,838$89,814

ICU MEDICAL, INC. AND SUBSIDIARIESReconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(In thousands, except percentages and per share)

The Company’sU.S.GAAP results for the three months endedSeptember 30, 2024included special items which impacted theU.S.GAAP measures as follows:

TotalrevenuesGrossprofitSelling,general andadministrativeResearchanddevelopmentRestructuring,strategictransactionandintegrationChange infair value ofcontingentearn-outIncome(loss) fromoperations(Loss)incomebeforeincometaxesProvisionfor incometaxesNet (loss)incomeDiluted(loss)earningsper share
Reported (GAAP)$589,131$204,852$162,707$21,028$16,828$(3,947)$8,236$(17,928)$(15,055)$(32,983)$(1.35)
Reported percent of total revenues (or percent of (loss) income before income taxes for benefit (provision) for income taxes)35%28%4%3%(1)%1%(3)%(84.0)%(6)%
Contract manufacturing(9,063)—————————
Stock compensation expense—1,816(9,287)(667)——11,77011,770(2,825)8,9450.36
Amortization expense—692(33,611)———34,30334,303(8,338)25,9651.06
Restructuring, strategic transaction and integration————(16,828)—16,82816,828(4,043)12,7850.52
Change in fair value of contingent earn-out—————3,947(3,947)(3,947)—(3,947)(0.16)
Quality system and product-related remediation—7,737————7,7377,737(1,839)5,8980.24
Legal settlement——(20)———2020—20—
Tax expense from valuation allowance*————————22,39422,3940.91
Earnings per share impact on net loss due to basic versus diluted weighted average shares——————————0.01
Adjusted (Non-GAAP)**$580,068$215,097$119,789$20,361$—$—$74,947$48,783$(9,706)$39,077$1.59
Adjusted percent of total revenues (or percent of (loss) income before income taxes for benefit (provision) for income taxes)37%21%4%—%—%13%8%19.9%7%

_______________________

* The Company’s non-GAAP annual effective tax rate is calculated without the tax expense related to the valuation allowance against certainU.S.Federal and State deferred tax assets. The valuation allowance was recorded based on an assessment of available positive and negative evidence, including, predominantly, an estimate that we will be in a three-year cumulativeU.S.loss position on a GAAP basis as ofSeptember 30, 2024. However, based on the same assessment, including, predominantly, our being, and expectation of remaining for 2024, in a three-year cumulativeU.S.income position on a non-GAAP basis, which excludes the impact of our non-GAAP adjustments, we concluded that recording a valuation allowance would not have been appropriate for non-GAAP reporting. As a result, the tax expense for the valuation allowance was added back to our calculation of non-GAAP annual effective tax rate.** Amounts may not foot due to rounding.

ICU MEDICAL, INC. AND SUBSIDIARIESReconciliation of GAAP to Non-GAAP Financial Measures (Unaudited)(continued)(In thousands, except percentages and per share)

The Company’sU.S.GAAP results for the three months endedSeptember 30, 2023included special items which impacted theU.S.GAAP measures as follows:

TotalrevenuesGrossprofitSelling,general andadministrativeResearchanddevelopmentRestructuring,strategictransactionandintegrationChange infair value ofcontingentearn-outIncomefromoperationsOtherexpense,net(Loss)incomebeforeincometaxesBenefit(provision)for incometaxesNetincomeDilutedearningsper share
Reported (GAAP)$553,311$183,920$148,609$20,870$7,160$(15,572)$22,853$(28,219)$(5,366)$12,604$7,238$0.30
Reported percent of total revenues (or percent of (loss) income before income taxes for benefit (provision) for income taxes)33%27%4%1%(3)%4%(5)%(1)%234.9%1%
Contract manufacturing(6,696)——————————
Stock compensation expense—1,754(8,743)(450)——10,947—10,947(2,627)8,3200.34
Amortization expense——(33,411)———33,411—33,411(8,179)25,2321.04
Restructuring, strategic transaction and integration————(7,160)—7,160—7,160(1,722)5,4380.22
Change in fair value of contingent earn-out—————15,572(15,572)—(15,572)—(15,572)(0.64)
Quality system and product-related remediation—4,016————4,016—4,016(974)3,0420.12
Asset write-offs and similar charges—6,306————6,3062236,083(1,513)4,5700.19
Adjusted (Non-GAAP)*$546,615$195,996$106,455$20,420$—$—$69,121$(27,996)$40,679$(2,411)$38,268$1.57
Adjusted percent of total revenues (or percent of (loss) income before income taxes for benefit (provision) for income taxes)36%19%4%—%—%13%(5)%7%5.9%7%

_____________*Amounts may not foot due to rounding

ICU MEDICAL, INC. AND SUBSIDIARIESReconciliation of Net Cash Provided by Operating Activities to Free Cash Flow (Unaudited)(In thousands)
Three months endedSeptember 30,Nine months endedSeptember 30,
2024202320242023
Net cash provided by operating activities$36,09735,161$163,841$74,932
Purchase of property, plant and equipment(19,910)(21,467)(55,292)(53,956)
Proceeds from sale of assets3506951,481
Free cash flow$16,190$13,744$109,244$22,457

ICU MEDICAL, INC.AND SUBSIDIARIESFiscal Year 2024Outlook (Unaudited)(In millions, except per share data)
Low End of GuidanceHigh End of Guidance
GAAP net loss$(130)$(122)
Non-GAAP adjustments:
Interest, net9797
Stock compensation expense4646
Depreciation and amortization expense223223
Restructuring, strategic transaction and integration6565
Quality and regulatory initiatives and remediation3030
Change in fair value of contingent earn-out(4)(4)
Provision for income taxes2830
Total non-GAAP adjustments$485$487
Adjusted EBITDA$355$365
GAAP basic/diluted loss per share$(5.28)$(4.98)
Non-GAAP adjustments:
Stock compensation expense1.871.87
Amortization expense5.535.53
Restructuring, strategic transaction and integration2.642.64
Quality and regulatory initiatives and remediation1.221.22
Change in fair value of contingent earn-out(0.16)(0.16)
Tax expense from valuation allowance2.292.29
Estimated income tax impact from adjustments(2.71)(2.71)
Adjusted diluted earnings per share$5.40$5.70

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

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Source: ICU Medical, Inc.

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