ICU医疗 2025年季度报告

Forward-Looking Statements This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities LitigationReform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statementscontained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of1934, as amended (the “Exchange Act”). All statements, other than statements of present and historical fact, contained in this Quarterly Reporton Form 10-Q, including, without limitation, statements regarding: our future results of operations and financial position, business strategy andapproach; the anticipated benefits and costs associated with our purchase agreement with OPF (as defined below); expected capitalexpenditures; anticipated consumer demand; supply chain constraints; timing and resolution of the 2025 Warning Letter (as defined below); theexpected impact of macroeconomic developments, such as foreign exchange, inflation and interest rates, and new accounting and tax The forward looking statements in this Quarterly Report on Form 10-Q are only predictions and are based largely on our currentexpectations and projections about future events and financial trends that we believe may affect our business, financial condition and results ofoperations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of •our failure to compete successfully with our competitors and maintain market share; •significant decline in demand for our products; •our inability to fund substantial investment in product development and recover such investment through commercial product sales; •prolonged periods of inflation, rising interest rates and the impact of foreign currency exchange rates as a result of the current globalmacroeconomic and geopolitical conditions, for example, armed conflicts between Ukraine and Russia and in Israel; •significant changes in U.S. trade, tax or other policies that restrict imports or increase import tariffs for certain countries, particularlyMexico and Costa Rica, will escalate trade wars and will have a material adverse effect on our results of operations.•continuing pressures to reduce healthcare costs and inadequate coverage and reimbursement;•disruptions at the FDA, other government agencies or notified bodies caused by funding shortages, global health concerns, or turnoverof personnel;•failure to protect our information technology systems against security breaches, service interruptions, or misappropriation of data;•our exposure to risks related to foreign currency exchange rates;•damage to any of our manufacturing facilities or disruption to our supply chain network;•our dependence on single and limited source third-party suppliers, which subjects our business and results of operations to risks of •our ability to comply with applicable laws, rules and regulations, including, without limitation, matters raised in a warning letter issuedby the FDA in 2025, regarding modifications to our cleared MedFusion™ Model 4000 Syringe Infusion Pump and CADD™ Solis VIPAmbulatory Infusion Pump that could affect the safety or effectiveness of these devices and could impact our continued commercial For a more detailed discussion of these and other factors, see the information under the sections entitled “Summary Risk Factors,” PartI. Item 1A. “Risk Factors” and Part II. Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in ourAnnual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 Annual Report on Form 10-K”) filed with the Securitiesand Exchange Commission (the “SEC”), and the sections in this Quarterly Report on Form 10-Q entitled Part II. Item 1A “Risk Factors” andPart I. Item 2 “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in each case as updated by our Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantifiedand some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The eventsand circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially fromthose projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties mayemerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable ICU MEDICAL, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)(In thousands, except per share data) Table of Contents CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) NET LOSS Note 1:Basis of P